Therapeutic Products and Medicines Bill

  • discharged on 24 November 2014
  • Unofficial version

Therapeutic Products and Medicines Bill

Government Bill

103—1

Explanatory note

General policy statement

The Therapeutic Products and Medicines Bill is an omnibus Bill. It is proposed that it be divided at the conclusion of the committee of the whole House stage of the legislative process into 2 Bills. Parts 1 to 5 will then be enacted as the Therapeutic Products Act 2006, and Parts 6 and 7 will become the Medicines Act 2006. This approach is proposed due to the extent of the impact on the Medicines Act 1981 of the changes effected by Parts 1 to 5.

Parts 1 to 5 establish a new joint trans-Tasman regulatory scheme for the regulation of therapeutic products. The joint regulatory scheme will cover: the regulation of the manufacture, supply, import, export, and promotion of therapeutic products; the setting of standards in relation to the quality, safety, and efficacy or performance of therapeutic products; post-market monitoring of therapeutic products; and enforcement of the joint scheme's requirements. Responsibility for regulating aspects of therapeutic products covered by the joint scheme will be transferred from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), which is part of the Ministry of Health, to the Australia New Zealand Therapeutic Products Authority (the Authority). The Authority's role and governance is defined in the Agreement between the Government of Australia and the Government of New Zealand for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products (the Agreement), signed in December 2003. It will be established by an Australian Act that will be the equivalent to Parts 1 to 5.

Parts 6 to 7 repeal and replace the Medicines Act 1981 (and regulations made under that Act) with updated legislation for controls on medicines, such as the scheduling of medicines, licensing of pharmacies, and prescribing rights, that apply after the medicines have been approved for the market and are in the domestic supply and distribution chain.

Government's objectives

The Government is committed to safeguarding the public health and safety of New Zealanders by establishing a new regulatory scheme for therapeutic products. To achieve this goal, the Government is proposing to set up the Authority as a world-class joint regulatory agency (the Australia New Zealand Therapeutic Products Authority) to administer a joint regulatory scheme with Australia.

The joint scheme and the Authority are being established under the Agreement. The Agreement sets out the governance and accountability arrangements for the Authority and how it is to be established. It also provides a framework for the joint regulatory scheme for therapeutic products. Parts 1 to 5 give effect to the joint scheme anticipated by the Agreement. The scheme cannot commence until all Parts of the Bill are passed by Parliament. The Agreement will, similarly, come into effect only once it has been ratified by an exchange of diplomatic notes between New Zealand and Australia. This ratification will not occur until after the Bill is passed.

The objectives of the Agreement are to—

  • safeguard public health and safety in Australia and New Zealand by establishing and maintaining a joint scheme consistent with international best practice for the regulation of the quality, safety, and efficacy or performance of therapeutic products, and of their manufacture, supply, import, export, and promotion:

  • establish a world-class regulatory agency to administer the scheme and to be accountable to both parties (the Australian and New Zealand Governments):

  • establish a Ministerial Council (consisting of one New Zealand and one Australian Minister):

  • avoid unnecessary barriers to trade.

Key concerns to be addressed by the joint scheme

New Zealand is facing 2 key problems with its arrangements for regulating therapeutic products: outdated legislation, and a regulatory capacity that is not sustainable even in the short to medium term.

Addressing outdated legislation and providing a sustainable future-proofed regulatory regime

The joint scheme will provide a means of maintaining an effective and sustainable regulatory capacity for New Zealand and Australia into the future. While New Zealand faces a capacity problem now, Australia expects to face a similar challenge to its regulatory capacity in the longer term. The Authority will provide for enhanced capacity in terms of technical expertise to evaluate the risks and benefits of increasingly complex therapeutic products. Neither New Zealand nor Australia alone has the capacity to operate a world-class regulatory scheme for therapeutic products on an ongoing basis; together, the 2 nations can pool resources and ensure that citizens of both countries gain the maximum protection in the area of therapeutic products safety.

New Zealand's current regulatory framework for therapeutic products, under the Medicines Act 1981 and the Medicines Regulations 1984, is outdated and gives rise to some significant safety risks, trade barriers, and costs to Crown and industry. Updating the legislation is necessary to ensure that New Zealand meets international best practice for the regulation of therapeutic products.

Ensuring the safety of medical devices and complementary medicines

Regulation of medical devices and complementary medicines in New Zealand is minimal. The joint scheme will regulate all therapeutic products, consistent with international best practice. This includes the risk-based regulation of medical devices and complementary medicines. The scheme will enhance public confidence by subjecting medical devices, and complementary medicines to a regulatory scheme that provides assurance about safety and quality.

The joint scheme will apply the internationally harmonised approach to the regulation of medical devices developed by the Global Harmonization Taskforce partnership of the EU, Japan, USA, Canada, and Australia. For New Zealand, this will mean introducing pre-market approvals, quality requirements, and an enhanced level of post-market monitoring and surveillance.

Complementary medicines include herbal remedies and medicines, traditional treatments, homeopathic remedies, and most dietary supplements. The joint scheme will, for the first time in New Zealand, introduce risk-based regulation of complementary medicines as a subset of therapeutic products. It will use an approach that enables product sponsors to gain marked authorisation by self-certification against the Scheme requirements.

Enhancing closer economic relations and facilitating trade

The new scheme will be a significant enhancement of closer economic relations (CER) with Australia and trans-Tasman regulatory co-operation, consistent with the CER agreement of 1983, and the Trans-Tasman Mutual Recognition Arrangement agreed in 1996. The Authority will be the first example of a true trans-Tasman authority that explicitly acknowledges joint co-operation between our 2 independent nations.

The establishment of the Authority will see New Zealand's profile amongst the international therapeutics community increased. This will facilitate the export of therapeutic products beyond Australia. It will also offer more to other key regulators in terms of information sharing and potential for the Authority to develop mutual recognition agreements with other key regulators such as those in the US, Canada, and Europe. Greater regional and global influence over the development of international regulatory standards and harmonisation initiatives will also be provided.

The Authority will be able to ensure that health and safety objectives are met without imposing unnecessary trade barriers. A credible trans-Tasman regulator will impose a quality standard that will be recognised and respected internationally. This will enable New Zealand firms to prove the quality of their products and make them more attractive in an international market.

The joint scheme will develop the therapeutic products industry in New Zealand, including research and development. The new scheme will mean that manufacturers only need to apply for one product approval in order to access both the Australian and New Zealand markets. It will mean that medicines approved for use in one country would also be approved for use in the other country, helping to limit the licensing and approval costs for the manufacturer and giving New Zealanders and Australians access to the same therapeutic products. Exporters will also have an assurance that products have a recognised regulatory stamp of approval for safety and quality.

Relationship between the Agreement, the Bill, and Rules and Orders

The Agreement between the two countries provides the framework for the joint scheme and the Authority by specifying the scope and framework, and accountability and governance arrangements, of the scheme. The vehicles for establishment under the Agreement are the Agreement itself, the implementing legislation, and jointly made Rules and Orders.

The Agreement

The Agreement sets the scope of the regulatory model, which aims to protect public health and safety, and sets out the corporate governance structure for the Authority. It is through the governance structure that New Zealand sovereignty is managed. The Agreement thus lies at the heart of the model, as it provides for symmetry in relation to the control of the Authority through the Ministerial Council and the Board. The Agreement—

  • sets the overall objective of regulating the quality, safety, and efficacy or performance of therapeutic products:

  • establishes a Ministerial Council of the Australian and New Zealand Ministers of Health to oversee the Authority and the regulatory scheme:

  • establishes the Board of the Authority responsible to the Ministerial Council for the governance of the Authority. The Agreement also sets the composition of the Board, its role, and the process for the appointment of the 5 members:

  • provides for the appointment of the Managing Director of the Authority to be responsible for the regulatory decisions about therapeutic products and for the day-to-day management of the Authority:

  • provides for the Authority to be established as a body corporate in Australian law and derive its governance and accountability mechanisms from the jointly signed Agreement and its joint structures—the Ministerial Council and the Board:

  • describes the high-level accountability provisions for the Authority:

  • provides that the Ministerial Council may make Rules for a number of purposes:

  • provides that the Authority may make Orders for a number of purposes to do with the regulation of therapeutic products:

  • provides for therapeutic products approvals, departures from the scheme in exceptional circumstances, reviews of the Authority's decisions, funding arrangements for the Authority, and a number of other matters.

Implementing legislation

The Agreement requires both New Zealand and Australia to introduce implementing legislation to confer the necessary rights, powers, and privileges on the Authority to enable it to perform its regulatory functions. Parts 1 to 5 represent New Zealand's implementing legislation. Equivalent implementing legislation will be introduced into the Australian Parliament. Once the legislation is passed in both countries, the Agreement will be ratified and come into force. As it does so, it will establish the Ministerial Council and the Board of the Authority. It will also allow the regulatory details (Rules and Orders) to be formally developed.

Rules and Orders

The Rules are central to the arrangements for the Authority and scheme as they provide the joint decision-making vehicle that ensures equality of voice and freedom from unilateral influence. Rules can be made for a range of purposes as set out in Article 9 of the Agreement, including governance and accountability, fees and charges, and prescribing standards of good regulatory practice. Rules are akin to regulations. Orders issued by the Managing Director of the Authority will provide a further level of regulatory detail. Rules and Orders are given the force of law in each country and are subject to disallowance by the Parliaments of both countries.

Parts 1 to 5 (to be the Therapeutic Products Act 2006)

The key elements of the regulatory framework for therapeutic products are—

  • pre-market assessment of product safety, quality, and efficacy:

  • licensing of manufacturers to assure product quality:

  • setting standards to assure product quality and performance:

  • post-market monitoring of product safety and quality:

  • surveillance to check for compliance.

The detail of the regulatory scheme will be covered in Rules. This section of the explanatory note covers the key elements of the scheme that are addressed in Parts 1 to 5.

Governance and accountability

The Agreement, Parts 1 to 5, and the equivalent Australian legislation ensure that both countries have an equal voice in the governance of the scheme and the Authority, and that neither country may take unilateral action in respect of the scheme and the Authority. The Australian and New Zealand implementing legislation have provisions that ensure the same approach across both countries.

Parts 1 to 5

  • recognise the Authority established under the Agreement and given legal personality by the Australian implementation legislation. The Authority's governance and accountability arrangements are derived from the Agreement:

  • makes the Authority accountable to Health Ministers and the Parliaments of both New Zealand and Australia, and to Ministers of Finance, where appropriate:

  • makes the Authority responsible for a joint regulatory scheme that applies in both New Zealand and Australia. The ability to establish the regulatory scheme comes from the Agreement and the detail of the scheme will be in Rules (made by the Ministerial Council) and technical Orders (made by the Managing Director of the Authority); and

  • makes the Authority responsible for delivering common regulatory outcomes and implementing and enforcing regulatory arrangements in both countries.

The model for the Authority has been intentionally designed to retain not just the expected government reporting processes but also important parliamentary and public accountability controls. In these regards, the Authority will have very similar accountabilities to a New Zealand Crown entity and to an Australian Commonwealth Authority.

Specifically, the Authority will be—

  • required to provide an annual report and statement of intent and other accountability documents equivalent to those of a Crown entity, which will be tabled in the New Zealand House of Representatives:

  • subject to scrutiny of its regulatory decisions through a merits review process and judicial review:

  • subject to other legislative requirements in both countries, eg, Official Information/Freedom of Information Acts, Privacy Acts, Ombudsmen Acts, and Auditors-General scrutiny.

In addition, the Bill requires Rules and Orders to be presented to Parliament. There is a tailored disallowance scheme based on that in the Regulations (Disallowance) Act 1989, but with differences to reflect the joint nature of the Rules and Orders. Members of Parliament will have 3 months to give notice of motion to disallow a Rule or Order. Parliament will have 21 sitting days, from the notice of motion, to disallow the Rule or Order.

Parts 1 to 5 also provide for other governance and accountability matters such as—

  • seeking information from Australia:

  • providing for audit (joint with Australia):

  • financial matters:

  • controls on subsidiaries.

Governance

The Ministerial Council and its functions are established under the Agreement. The Ministerial Council comprises the Australian and New Zealand Ministers of Health. Its primary role is to oversee the joint scheme. The Agreement also provides for the appointment of a Board of the Authority comprising 5 members. This includes the Managing Director of the Authority. The Managing Director is the chief executive of the Authority and is accountable to the Board for financial and administrative matters. A range of expert advisory committees will provide advice to the Managing Director in relation to regulatory decisions.

Part 4 places governance duties on Board members (eg, duties to act with honesty and integrity, to comply with Acts and Rules, and to act with care, due diligence, and skill). The Bill also provides that Board members are subject to criminal and civil sanctions for failing to comply with their duties. In New Zealand, this means adopting additional measures, consistent with Australia, to ensure a seamless environment under which the Board members are subject to the same duties and sanctions, regardless of their location.

Part 4 also provides for management of conflicts of interest and protection of Board members acting in good faith.

Rules and Orders

The Agreement requires the making of Rules by the Ministerial Council and the making of Orders by the Managing Director of the Authority on details of the regulatory scheme.

The regulatory requirements will be set out principally in Rules (eg, medicines, medical devices, administration, advertising, and fees and charges) made by the Ministerial Council, but also, in the case of technical details such as labelling requirements and standards, in Orders issued by the Managing Director of the Authority. These instruments, and any changes made to them over time, will be subject to scrutiny by the Parliaments in a similar way to domestic regulations. Part 1 includes a discrete disallowance regime to enable this to occur.

The use of Rules and Orders rather than domestic regulations is a central part of the joint scheme. There will be only one set of Rules and Orders for both countries.

Compliance

Part 2 creates a tiered offence regime that provides for both criminal and civil penalties for breaches of the regulatory regime in relation to the manufacture, import, export, supply, and promotion of therapeutic products, misrepresentation, product tampering, and making false or misleading statements. The starting point for the enforcement regime was the Australian Therapeutic Goods Act 1989, which is a more comprehensive regime than the one set out in the New Zealand Medicines Act 1981.

Part 2, therefore, provides for an enhanced enforcement regime. In some cases, this has resulted in higher penalties for significant breaches of the law (eg, counterfeiting medicines). This is a benefit of the new joint scheme to New Zealand, where enforcement powers and options have previously been seen to be limited. New Zealand has been fortunate not to experience significant non-compliance problems such as have occurred in Australia and internationally, but New Zealand cannot be complacent. The offences regime reflects this.

Part 2 introduces a tiered approach for penalties, with fines of up to $550,000 (and/or 5 years' imprisonment) for an individual, and fines of up to $5,500,000 for a body corporate.

In Parts 1 to 5, monetary penalties are identified by way of penalty units, where one penalty unit equals $110.

The joint nature of the regime requires that there must be no opportunity for regulatory arbitrage; thus the offences and penalties area has been one where there has been particular focus on ensuring the provisions in both countries' Bills are drafted so as to achieve as near a similar outcome as possible. However, the Bill recognizes the value of a broad-based approach to addressing non-compliance. Part 2 provides an opportunity to introduce new enforcement options, short of formal court proceedings, designed to encourage and facilitate early correction of non-compliant activity, such as a non-compliance notice regime and the ability of the Authority to accept enforceable undertakings.

Search and seizure

Part 2 includes search and seizure provisions allowing an authorised officer of the Authority to monitor compliance with the provisions of the Bill, Rules, and Orders. The provisions are similar to current legislation which has search and entry provisions made after the New Zealand Bills of Rights Act 1990 (eg, the Agricultural Compounds and Veterinary Act 1997 and the Animal Products Act 1999). They allow the officer to enter and search a place (excluding a dwelling house or a marae) without a warrant at any reasonable time to monitor compliance, or if the officer has reasonable grounds to believe that it is necessary in the interest of public health in order to avoid an imminent risk of death, serious illness, or serious injury, and it is not practicable in the circumstances to obtain a search warrant. In other circumstances the Authority is required to apply for a warrant to enter and search a place.

Merits review and judicial review

The Agreement requires that the implementing legislation of both countries provides for the merits review of regulatory decisions by a review tribunal. The Agreement also permits each country to provide for judicial review of Rules and of decisions and Orders made by the Authority. Part 3 makes provision for both of these things.

Regulatory decisions of the Authority will be subject to merits review by a New Zealand Review Tribunal, established by the Bill. The members of the Tribunal for a particular review will be drawn from a merits review panel appointed by the Ministerial Council. A similar tribunal will operate in Australia.

A merits review involves a reconsideration of the merits of the decision. There are provisions to enable a review to be transferred between the New Zealand and Australian Review Tribunals in certain cases, and to ensure the same decision is not reviewed by more than one tribunal. There are rights of appeal from the New Zealand Review Tribunal to the High Court.

Decisions of the Authority take effect in both countries subject to any orders made by either Review Tribunal or a court on appeal.

Ombudsmen and Privacy Legislation and Information Management

The Official Information Act 1982, the Privacy Act 1993, the Protected Disclosures Act 2000, the Public Audit Act 2001, and other relevant accountability legislation will apply to the Authority in the same manner as they do to other agencies in New Zealand.

Part 3 allows for the transfer of complaints between Australian and New Zealand Ombudsmen and Privacy Commissioners, where the complaint more appropriately sits within the other jurisdiction. The Bill also continues current policy under the Medicines Act 1981, where it is acknowledged that in certain situations, for regulatory reasons, information will need to be disclosed and will require protection. In the event of a public health and safety risk, information will be able to be placed in the public arena.

Consistent with New Zealand's commitments under the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement that protects the data around innovative medicines, innovators will be given protections that ensure the Authority cannot use protected information for a specified period of time in order to approve generic medicines.

While the patent term for therapeutic substances in New Zealand is 20 years, in Australia the patent term for therapeutic products can be extended to 25 years. The Authority can consider an application to register a generic product prior to the expiry of the patent in New Zealand or Australia. The Bill confirms that the supplier can market the generic product in New Zealand following the expiry of the New Zealand patent, notwithstanding that the substance may still be protected by an Australian patent in Australia.

Regulations

The Agreement provides for regulations to be made regulating any products which are excluded from the joint scheme under Article 12 of the Agreement. This provides for departures from the scheme in exceptional circumstances. There are also provisions allowing regulations to be made setting fees and charges for any functions performed by the Agency that fall outside the scope of the scheme, and to address temporary or transitional measures needed to implement the scheme.

Transitionals

Part 5 provides for transitional arrangements for approvals of medicines and medical devices.

Transfer of employees

Part 5 also provides for the transfer of Medsafe employees and assets to the new Authority.

Parts 6 and 7 (to be the Medicines Act 2006)

Parts 6 and 7 repeal the existing Medicines Act 1981 and Parts 1 to 5 move controls into the trans-Tasman regulatory scheme. Controls in the current Medicines Act 1981 that will not be covered by the new trans-Tasman regulatory scheme will be regulated under Parts 6 and 7 and include—

  • provisions setting out when, how, and by whom prescription medicines can be prescribed, dispensed, and administered:

  • scheduling of medicines (eg, prescription, pharmacy only):

  • transport, storage, and record-keeping requirements for medicines:

  • provisions covering the licensing and ownership of pharmacies:

  • a licensing regime covering the retail and wholesale supply of scheduled medicines:

  • enforcement provisions for such controls (eg, offences, penalties, powers for enforcement officers, etc).

The establishment of a new regulatory scheme for therapeutic products has provided an opportunity to update the Medicines Act 1981. Significant changes have not been recommended because the majority of provisions in the Medicines Act 1981 are sound. Changes include minor technical amendments to fix some inconsistencies and new provisions to update old provisions. Changes are also recommended to ensure that there is seamless and effective regulation of therapeutic products under Parts 1 to 5 and Parts 6 and 7. These Parts, when enacted as separate Acts, need to be compatible to ensure effective regulation and enforcement across the joint scheme and domestically. The end result will be more modern legislation.

Licensing regime and controlled activities

Parts 6 and 7 largely carry over the existing licensing regime and controls on medicines activities. This includes the supply of scheduled medicines by wholesale, supplying medicines by vending machine, dispensing medicines, administering and possessing prescription medicines, and prohibiting and restricting prescribing activities. The licensing authority (the Director-General of Health) issues licences to persons to supply scheduled medicines by wholesale, to supply pharmacy medicines other than by wholesale, to dispense medicines, and to operate pharmacies. Exceptions to rolling over the current provisions of the Medicines Act 1981 are discussed below.

Appeals in relation to the licensing process

Parts 6 and 7 streamline the current appeals process for appeals on licensing decisions. Applicants currently have a statutory right to appeal to the Medicines Review Committee and a subsequent right of appeal on questions of law to the District Court. The New Zealand Medicines Review Committee has not been convened to consider licensing issues for many years, and will be disestablished under the joint scheme. Accordingly, the proposed appeal structure for the new Medicines Act provides for the possibility of 2 appeals from a decision of the Director-General of Health (the licensing authority). A party may make a first appeal to the District Court. From there, a further appeal may be made to the High Court, but only on a question of law and with the leave of the Court. The decision of the High Court would be final.

Enforcement

Parts 6 and 7 update the offence provisions to ensure that they are consistent with the proposed enforcement scheme under Parts 1 to 5. Parts 6 and 7 contain similar search and seizure provisions to those in Parts 1 to 5, providing the Ministry of Health's medicines control officers with the right to enter and search any place (excluding a dwelling house or a marae) without a warrant, at any reasonable time, to monitor compliance, or if the officer has reasonable grounds to believe that it is necessary in the interest of public health in order to avoid an imminent risk of death, serious illness, or serious injury, and it is not practicable in the circumstances to obtain a search warrant. Medicines control officers are required to apply for a warrant to enter and search a place at any other times.

Penalties and offences

Offences from the Medicines Act 1981 that relate to the domestic medicines chain are carried over into Parts 6 and 7. They cover issues such as security, storage, packaging, labelling, delivering, disposing, and prescribing of medicines.

A new continuum of penalties is introduced to reflect the seriousness of each specific offence, and to make penalties comparable with other modern legislation. Penalties range between—

  • a fine of $5,000 for an individual or a fine of up to $40,000 for a body corporate, for less serious offending; and

  • a fine of up to $100,000 and up to 12 months' imprisonment for an individual or a fine of up to $250,000 for a body corporate, for serious offending.

Parts 6 and 7 also introduce a higher penalty in respect of offending where it can be proved that the conduct was wilful and endangered public health. The penalty for this conduct, on indictment, is to be a fine of up to $100,000 and up to 12 months' imprisonment for an individual (or both) and a fine of up to $250,000 for a body corporate.

Parts 6 and 7 also change some offences from strict liability offences to normal offences to require an element of intention for consistency with the New Zealand Bill of Rights Act 1990.

Parts 6 and 7 retain the ability for officers under the Act (and police) to obtain a search warrant in respect of offending against the Medicines Act. This is regardless of whether the specific offence features a term of imprisonment. Medicines control officers and police are able to enter, search and seize property, and compel the production of documents. Search and seizure is also possible without consent or a warrant, where this is essential to ensure effective enforcement of the law.

Parts 6 and 7 also include 2 new offences—

  • to prohibit the prescribing of prescription medicines by individuals who are not prescribers (ie, who are not health practitioners with a prescribing right under the legislation) or veterinarians. The offence will be punishable by a maximum fine of $10,000:

  • for persons who do not dispose of medicines in the manner prescribed by regulations made under the legislation (eg, environmental requirements for safe disposal). The proposed offence carries a maximum fine of $5,000 for an individual and $40,000 for a body corporate.

Pharmacy ownership

Parts 6 and 7 incorporate recent reforms to the licensing regime for pharmacies made to the Medicines Act 1981, in September 2004, in conjunction with the passage of the Health Practitioners Competence Assurance Act 2003. The Bill requires operators of community and hospital pharmacies to be licensed by the Director-General of Health. Ownership of pharmacies is restricted to pharmacists, who must hold at least a 51% share of a pharmacy. Companies may also operate a pharmacy as long as a pharmacist or pharmacists own 51% or more of the company's share capital. Neither a pharmacist nor a company may hold a majority interest in more than 5 pharmacies. Pharmacies legally carrying on business when the Bill comes into force will be deemed to have a licence to operate.

Designated prescribers

Parts 6 and 7 also incorporate recent reforms made in regulating designated prescribers. The Bill permits regulations to be made to allow new groups of health practitioners to be deemed designated prescribers (eg, nurse practitioners, optometrists etc). The regulations can impose conditions and restrictions on who may be a designated prescriber, and set out requirements for the qualifications, training, and competencies of designated prescribers. The relevant registration authority (eg, Nursing Council) must, by notice in the Gazette, specify the prescription medicines that designated prescribers may prescribe, and must keep this list up to date and make this list publicly available. The registration authorities are also responsible for gazetting the competencies and training for designated prescribers.

If the Minister has a concern about the ability of a registration authority to fulfil its statutory obligations, he or she is able to audit the registration authority's functions, and ask the registration authority to respond to any concerns raised by the audit. If the Minister is dissatisfied with the registration authority's response to the audit, he or she may also revoke the registration authority's Gazette notices and develop regulations setting out new requirements regarding the lists of medicines, competencies and training, and qualifications for designated prescribers. The Bill includes transitional provisions so that existing prescribing regulations are carried over until the registration authorities are able to gazette new prescribing notices.

Parts 6 and 7 also allow the Governor-General, on the recommendation of the Minister of Health, following consultation with appropriate organisations, to make regulations designating a class of health practitioner to be authorised prescribers. This means that, over time, if designated prescribers demonstrate their competence to prescribe safely and appropriately, the regulatory framework covering such health practitioners could be aligned to the framework governing existing prescribers (ie, medical practitioners, dentists, and midwives).

Xenotransplantation

Parts 6 and 7 carry over provisions from Part 7A of the Medicines Act 1981 relating to xenotransplantation (medical procedures involving the transplanting of live tissues or organs from an animal source into people). The Bill allows the Minister of Health to authorise persons to conduct xenotransplantation procedures, if the procedure does not impose an unacceptable risk to the health and safety of the public. The Medicines Bill removes reference to the consideration of ethical, cultural, and spiritual issues, because health and disability ethics committees will consider these issues on a case-by-case basis for each xenotransplantation clinical trial application. To date, the Minister has not authorised any xenotransplantation.

It is proposed that xenotransplantation be covered by the joint scheme, but until new controls are in place to govern the safety of the practice, regulation needs to be covered by the Medicines Act. The provisions will expire on 31 December 2008. This should allow sufficient time for the new controls to be in place under the proposed joint scheme to be administered by the Authority. The Medicines Bill does, however, provide for this date to be extended by Order in Council, should the need arise.

The Bill also updates the definition of xenotransplantation to bring it in line with the Food and Drug Administration's definition, which is considered more straightforward.

Good prescribing practice

Parts 1 to 5 will give force of law in New Zealand to Rules made under the Agreement. These Rules, which are currently being drafted and consulted on, will prohibit the export of a therapeutic product without a product licence. This will stop the export of a medicine (including over-the-counter medicines) from New Zealand by anybody other than the holder of the product licence for the medicine. In particular, the export of medicine in the course of, or for the purpose of, retail sales, following internet sales, will largely be prohibited by the requirement that the exporter must hold a valid product licence. There are, however, current concerns about prescribers in New Zealand issuing prescriptions for overseas clients not in New Zealand, or counter-signing prescriptions issued by doctors who are overseas (eg, via the Internet).

To address this concern, Parts 6 and 7 include a provision that ensures prescribers are only able to prescribe medicines for patients who are physically present in New Zealand or are permanent New Zealand residents temporarily overseas. The intention of this is to guard against inappropriate prescribing of medicines to overseas patients (regardless of whether the subsequent export of therapeutic products to the patients is also illegal). It would also allow for unusual but legitimate prescribing situations where a patient may not have had a face-to-face consultation with their prescriber (eg, a locum prescribing for someone in a remote area).

Parts 6 and 7 also remove some of the restrictions on prescribing practice. The current restriction on dentists' prescribing of prescription medicines is removed, and replaced with a provision that allows dentists to prescribe prescription medicines for up to 3 months. This is consistent with other prescribers and is appropriate, given the changes to the practice of dentistry and availability of medicines useful in dental treatment in recent times.

Parts 6 and 7 also allows for an exception to the requirement that prescribers are not allowed to prescribe prescription medicines for a term exceeding 3 months (or 6 months for oral contraceptives). The Director-General of Health will be able to waive this requirement in special circumstances (eg, army personnel operating overseas).

Supply of unscheduled medicines from vending machines

Since the Medicines Act came into force in 1981, the sale of unscheduled (general sales) medicines from outlets such as supermarkets, dairies, and petrol stations has become commonplace (eg, paracetamol). Parts 6 and 7 recognise the supply of unscheduled medicines from vending machines, but prohibit the supply of scheduled medicines (eg, prescription medicines and pharmacy-only medicines) from vending machines unless permitted in accordance with regulations made under the legislation (ie, the sale of unscheduled medicines from a vending machine would be a controlled activity). The Bill therefore permits the sale, through vending machines, of the same range of medicines currently able to be sold in supermarkets. The risk arising from the supply of medicines from vending machines, which are securely sealed units dispensing one unit at a time, is likely to be less than the risk arising in retail outlets where medicines may be stored on low shelves and purchases of multiple packs are easily made.

Issuing of licences to supply medicines by retail, for premises that do not meet the 10 kilometre rule, if it is in the interests of public health

Parts 6 and 7 include a new provision for a licence to sell medicines by retail to be issued to an outlet other than a pharmacy, where the Director-General considers this to be in the best interests of public health. This would be an extension to the current requirement that pharmacy-only medicines may only be sold from a pharmacy, or from a shop that is at least 10 kilometres, by the most practicable route from a pharmacy. This proposal would still enable licences to be issued in relation to shops in remote areas, but would also enable other outlets to be licensed to sell specific medicines where this was considered appropriate.

Reasons for declining a licence application

Parts 6 and 7 clarify the sorts of considerations the Director-General of Health (acting as the licensing authority) must take into account in granting a licence to a person who is fit and proper. This includes whether the person has previous convictions, has an adequate knowledge of the licence requirements, or has the competencies and resources to reliably undertake the licensed activities.

Elevation of some regulations in the Medicines Regulations 1984 to the Medicines Act

Parts 6 and 7 take a different approach to the current Medicines Act. Rather than prohibiting certain prescribed activities, the Bill provides that an activity can be undertaken unless it is prohibited. There are several provisions set out in the current Medicines Regulations 1984 which are elevated to Parts 6 and 7. These provisions involve quite invasive powers, which are more appropriately dealt with in primary legislation. For example, Regulation 31, which permits a Medical Officer of Health to serve a notice on any owner or occupier of a premise prohibiting the use of the premises for, or in connection, with the manufacture, storage, or packing of any medicine or related product for sale, where there are concerns about the construction or disrepair of the premises or the use or character of neighbouring premises, is elevated to the Bill.

New definitions and regulation-making powers

Parts 6 and 7 add new definitions to clarify current practice in relation to compounding, dispensing, and prescribing. New regulation-making powers relating to prescribing, dispensing, record keeping, and information requirements have been added to allow regulations to be made that take into account advances in technology, such as new developments in electronic transmission and storage of information.

Clause by clause analysis

Clause 1 is the title clause. The intention is that this Bill will eventually be enacted as 2 Acts, the Therapeutic Products Act 2006 (referred to in the Bill as Parts 1 to 5) and the Medicines Act 2006 (referred to in the Bill as Parts 6 and 7).

Clause 2 is the commencement clause. It provides for Parts 1 to 5, and Parts 6 and 7, and for specific provisions of those Parts, to be brought into force by Orders in Council.

Clause 3 states the object of the Act.

Part 1
Preliminary, and Rules and Orders

Subpart  1Preliminary provisions

Clause 4 states the purpose of Parts 1 to 5.

Clause 5 provides an overview of Parts 1 to 5.

Clause 6 defines terms used in Parts 1 to 5. All defined terms are listed here, but the actual definition of many terms is given in other clauses or the Agreement. Terms that are used primarily in a particular Part are defined in a clause at the beginning of that Part, with clause 6 merely providing a cross-reference to the clause that sets out the definition.

Clause 7 carries forward the effect of section 32A of the Medicines Act 1981. That section provides for the Crown to import and supply products without having to comply with the usual regulatory procedures under that Act. Clause 7 authorises the Minister to specify that a product that is identical to another product (being a product that has a product licence granted by the Authority under the Rules) is subject to a Crown exemption. A product that is subject to a Crown exemption may be imported and supplied in New Zealand as if it had a product licence. The Minister must consult with the Australian Minister before specifying a product as being subject to a Crown exemption.

Clause 8 provides that Parts 1 to 5 and the Rules and Orders bind the Crown.

Subpart  2General provisions about Rules and Orders

Rules and Orders having force of law

Clause 9 provides that Rules and Orders (as defined in clause 6) have the force of law as if they were regulations made under an Act.

Clause 10 states that the effect of this subpart, in conjunction with the equivalent provision in the Australian Act, is that a Rule or Order cannot be in force as part of the law of one country without it also being in force as part of the law of the other country.

Clause 11 contain requirements relating to the commencement of Rules and Orders. Rules and Orders cannot come into force before they are published (either on the Authority's Internet site or in the Gazette) or notice of them has been given in the Gazette.

Clause 12 provides that the Minister must not agree to making Rules relating to the governance or accountability of the Authority without the agreement of the Finance Minister, unless the Finance Minister has waived that requirement.

Subpart  3Publication, presentation, and disallowance of Rules and Orders

Meaning of Rule and Order for publication, presentation, and disallowance purposes

Clause 13 provides that, for the purposes of this subpart, an instrument containing 2 or more Rules or Orders is taken to be a single Rule or single Order.

Publication of Rules and Orders

Clause 14 requires that the Authority must publish and maintain on its Internet site every Rule, Order, and the explanatory statement of every Rule and Order. It may also publish compilations on its Internet site.

Rules and Orders must be published as soon as practicable after they are made. The Internet site must include information about when Rules or Orders, or provisions of Rules and Orders, come into force or cease to be in force.

Clause 15 provides for the correction of published Rules, Orders, and compilations.

Clause 16 provides that a Rule or Order published on the Internet site is to be taken as a complete and accurate record of the Rule or Order, and that a compilation is to be taken to be a complete and accurate record of the compiled Rule or Order as amended and in force on the date of compilation.

Clause 17 requires the Authority to retain the original signed copy of every Rule and Order until it is passed to the appropriate archival authority, and to make hard copies of Rules and Orders available to Ministers on request and to any other person on request and payment of the prescribed fee (if any).

Clause 18 states that no copyright exists in Rules or Orders.

Presentation of Rules and Orders

Clause 19 requires the Minister to present a copy of every Rule and Order to the House of Representatives within 6 sitting days after the date on which the Rule or Order is made. Failure to do so means that the Rule or Order will not come into force or, if it is in force, it ceases to be in force.

It is intended that, following presentation, Rules and Orders should be subject to scrutiny by the Regulations Review Committee. This cannot be provided for in the Act because it involves a matter of Parliamentary procedure. An amendment to the Standing Orders of the House of Representatives will therefore be sought once this Bill is enacted in order to give effect to the intention.

Clause 20 provides that the Minister, when presenting a Rule or Order to the House of Representatives, must also present an explanatory statement of the Rule or Order.

Disallowance of Rules and Orders

Clause 21 explains that the purpose of clauses 22 to 26 is to establish a disallowance scheme enabling the New Zealand House of Representatives to disallow Rules and Orders. A discrete disallowance scheme is required because Rules and Orders are not regulations for the purposes of the Regulations (Disallowance) Act 1989. In order to reflect the joint nature of the Scheme, this disallowance scheme needs to be as similar to the equivalent scheme under the Australian Act as possible.

Clause 22 provides that a Rule or Order can only be disallowed as a whole, and not in part. Individual provisions of Rules and Orders cannot be disallowed.

Clause 23 states that any member of Parliament may give a notice of motion to disallow a Rule or Order. The member must give the notice within 3 months of the date on which the Rule or Order was presented to the House of Representatives.

Clause 24 provides that a Rule or Order be disallowed if—

  • a notice of motion to disallow the Rule or Order is given by a member of the Regulation Review Committee and no decision on the motion is made within 21 days of it being given; or

  • a notice of motion to disallow the Rule or Order is given by any Member of Parliament and the notice is called on, moved, and agreed to with 21 days of being given.

A Rule or Order that is disallowed ceases to be in force.

Clause 25 sets out the circumstances in which a notice of motion to disallow a Rule or Order lapses.

Clause 26 requires the Minister to give notice in the Gazette if a Rule or Order is disallowed, and requires the Authority to give notice of any disallowances on its Internet site.

Clause 27 states that a Rule or Order is not in force if it is not in force under the Australian Act as a result of a failure to table the Rule or Order as required by the Australian Act, or disallowance by either House of the Parliament of Australia.

Part 2
Enforcement of regulatory scheme

Subpart 1General provisions relating to Part

For the joint regulatory scheme to work, the enforcement regime in each country must be as similar as possible. This is so that the outcome of enforcement action is not dependent upon which country the action was taken in. The starting point in designing the enforcement regime was the Australian Therapeutic Goods Act 1989. This is a more comprehensive regime than the one set out in New Zealand's Medicines Act 1981.

As a result of the need to align the enforcement regime in this Bill with that of the Australian Bill, the provisions of this Part include the following features:

  • penalties are expressed as penalty units (where 1 penalty unit equals $110) and are high by New Zealand standards. The penalty levels could not drop below existing Australian levels and must be equivalent to them:

  • some matters normally left to the common law (such as defences, and the precise identification of elements of offences) are spelt out in this Part. This is because the Australian criminal law is codified in the Criminal Code Act 1995 and, in order to provide more certainty of outcome, New Zealand's equivalent rules need to be articulated in this Part:

  • the enforcement options include 3 varieties of offences as well as civil penalties, non-compliance notices, and enforceable undertakings. These are currently available in Australia in the therapeutic goods context and have been provided for in this Part so that the range of enforcement action currently available in Australia is also available in New Zealand:

  • a single kind of proscribed conduct (such as manufacturing a therapeutic product without a manufacturing licence) may therefore attract a range of enforcement responses. Court-imposed penalties are set out in up to 4 tiers. The pattern of tiered responses in many (but not all) cases is as follows:

    • civil penalties—for engaging in the proscribed conduct:

    • summary offences—for knowingly or recklessly engaging in the proscribed conduct:

    • indictable offences—for knowingly or recklessly engaging in the proscribed conduct where the conduct results in harm or a serious risk of harm:

    • strict liability offences—for engaging in the proscribed conduct and the conduct results, or is likely to result, in harm:

  • in addition, a non-compliance notice provides for a penalty without judicial involvement. It can be issued where a person may be liable to a civil penalty or a strict liability offence. If the recipient pays the amount required under the notice, no further proceedings may be issued:

  • enforceable undertakings are a new enforcement tool in New Zealand. If a person gives an enforceable undertaking, the Authority may ask the High Court to make a range of orders if the person fails to honour the undertaking.

Definitions and jurisdiction

Clause 28 provides definitions of terms primarily used in subparts 1 to 3 of this Part. These subparts identify the main regulatory offences and provide for civil penalties, offences, non-compliance notices, and enforceable undertakings.

Clause 29 relates to jurisdiction. Clause 29(1) provides that a person may be convicted of an offence under this Part if any part of the conduct constituting the offence occurred in New Zealand or Australia. It does not matter—

  • whether some of the conduct occurred outside New Zealand or Australia; or

  • whether the person proceeded against was in New Zealand or Australia at the time of the conduct constituting the offence.

Clause 29(2) mirrors the provisions in clause 29(1) in relation to a person liable to a civil penalty under this Part.

General provisions about offences

Clause 30 provides that prosecutions for summary offences under this Part may be commenced at any time within 6 years after the conduct constituting the offence occurred. (The time limit that would otherwise apply under the Summary Proceedings Act 1957 is 6 months.)

Clause 31 sets out sentencing guidelines for offences involving harm, or risk of harm, to any person.

Clause 32 sets out matters relating to the prosecution and available defences in respect of the strict liability offences in this Part.

Clause 33 explains how alternative verdicts are dealt with under Australian and New Zealand legislation.

Clause 34 imposes notice requirements on defendants who wish to raise specific defences to certain indictable offences.

Clause 35 provides that the Managing Director may certify certain matters, and that such a certificate can then be used in evidence in civil or criminal proceedings under this Part.

Proceedings for civil penalties

Clause 36 provides for the Authority to apply to the High Court for a civil penalty against a person who is liable under this Part.

Clause 37 provides that the High Court may order a person to pay a civil penalty if the person has contravened a civil penalty provision, or has aided, induced, or conspired (etc) in such a contravention. The Court must have regard to the criteria set out in subclause (2) when determining the amount of civil penalty that must be paid. Maximum amounts of civil penalties are set out in individual civil penalty provisions.

Clause 38 provides that applications for a civil penalty must be made within 6 years after the conduct giving rise to the liability occurred, and provides for the standard of proof and procedural matters in civil penalty proceedings.

Relationship between civil penalty and criminal proceedings

Clause 39 bars proceedings for a civil penalty under this Part against a person in relation to particular conduct if there are already proceedings underway against that person for a civil penalty under the Australian Act in respect of the same conduct, or if such proceedings have been completed.

Clause 40 bars criminal proceedings under this Part if criminal proceedings relating to the same conduct are underway, or have been completed, in Australia.

Clause 41 allows criminal proceedings for an offence under this Part to commence against a person even if proceedings for a civil penalty, whether in New Zealand or Australia, have commenced against that person in respect of the same conduct.

Clause 42 provides that a person may not be penalised more than once in respect of the same conduct.

Clause 43 describes the effect of the withdrawal or discontinuation of proceedings on any limitation period applying to subsequent proceedings.

Clause 44 provides that evidence given in civil penalty proceedings is not generally admissible in subsequent criminal proceedings relating to the same conduct.

Clause 45 clarifies that nothing in clauses 39 to 44 affects the abuse of process jurisdiction of any court.

Liability of executive officers

Clause 46 provides that an executive officer of a body corporate commits an offence if—

  • the body corporate commits an offence under this Part; and

  • the officer knew that the offence was being or would be committed; and

  • the officer was in a position to influence the conduct of the body corporate in relation to the commission of the offence; and

  • the officer failed to take all reasonable steps to prevent the commission of the offence.

Clause 47 provides for the civil liability of an executive officer of a body corporate. The grounds of liability mirror those establishing criminal liability under clause 46.

Clause 48 prescribes criteria for establishing whether an executive officer failed to take all reasonable steps to prevent the commission of an offence or the contravention of a civil penalty provision.

Clause 49 applies the notice requirements for adducing evidence, as set out in clause 34, to a defendant charged under clause 46 in relation to specified offences by a body corporate.

Subpart 2Regulatory offences and civil penalties

Subpart 2 sets out the regulatory offences and civil penalties that are the core of the enforcement regime. Many of these are set out in the tiered approach described above. Most refer to the Rules (and in some cases to Orders) because the Rules and Orders prescribe the detail of the regulatory regime applying to therapeutic products.

Manufacture, import, export, and supply

Clauses 50 to 59 relate to the manufacture, import, export, and supply of therapeutic products. They specify offences and civil penalties in respect of the following conduct—

  • manufacturing a therapeutic product without a manufacturing licence or the correct manufacturing licence (clause 50):

  • breaching a condition of a manufacturing licence (clause 51):

  • manufacturing, importing, exporting, or supplying a therapeutic product without a product licence or the correct product licence (clause 52):

  • breaching a condition of a product licence (clause 53):

  • breaching a condition of a special purpose approval or an exemption (clause 54):

  • importing, exporting, or supplying a product that does not conform to applicable standards (clause 55):

  • breaching a condition of an authorisation not to conform to applicable standards (clause 56):

  • breaching a condition of a conformity assessment certificate (conformity assessment certificates apply only to medical devices) (clause 57):

  • being a manufacturer and supplying or exporting a therapeutic product to which conformity assessment procedures have not been applied (clause 58):

  • being a person other than a manufacturer and supplying or exporting a therapeutic product to which conformity assessment procedures have not been applied (clause 59).

Advertising

Clause 60 sets out the purpose of the provisions about advertising therapeutic products, with particular reference to the Advertising Code to be established under the Rules.

Clause 61 provides, for the purposes of clauses 62 to 66, a definition of circumstances as it is used in the context of advertisements.

Clause 62 identifies proscribed advertisements and specifies the civil penalties and offences associated with publishing or broadcasting proscribed advertisements.

Clause 63 sets out the civil penalties and offences associated with broadcasting or publishing an advertisement without an approval in circumstances in which, under the Rules, an approval is required.

Clause 64 sets out the civil penalties and offences associated with making restricted representations in advertisements. Restricted representations are representations identified as such in the Rules or Orders, and that require the Authority's approval.

Clause 65 sets out the civil penalties and offences associated with failing to comply with a direction, issued under the Rules by the Authority, that relates to an advertisement about a therapeutic product.

Clause 66 provides for liability to a civil penalty if a person fails to comply with an information requirement notice given by the Authority.

Clause 67 sets out some guidelines for courts on the level of civil penalty or fine to be imposed in relation to a civil penalty or offence relating to advertising.

Misrepresentation

Clauses 68 to 72 set out offences and civil penalties relating to the following conduct associated with misrepresentation:

  • dealing with counterfeit products (clause 68):

  • setting out a false product licence number (clause 70):

  • falsely representing that a therapeutic product is subject to a product licence (clause 71):

  • claiming to supply a therapeutic product when the product cannot be lawfully supplied (clause 72).

Clause 69 provides for relief from liability where a person is, or may be, liable to a civil penalty under clause 68 (dealing with counterfeit products).

Product tampering

Clause 73 makes it an offence for certain people to fail to promptly notify the Authority of circumstances that indicate that therapeutic products have been, or are proposed to be, tampered with.

False or misleading information in applications and declarations

Clauses 74 and 75 create offences and provide for liability to a civil penalty if a person makes a false or misleading statement in certain kinds of applications and certificates, and in declarations relating to conformity assessment procedures.

Adverse effect information

Clause 76 creates an offence and provides for liability to a civil penalty if the holder of a product licence fails to give adverse effect information in relation to a therapeutic product, as required by the Rules.

Compliance with information requirement notice

Clauses 77 to 84 are about the offences and civil penalties associated with failing to comply with information requirement notices. These are notices given by the Authority under the Rules that require the recipient to provide certain information relating to particular therapeutic products. Different offences, civil penalties, and defences apply, depending on who the recipient of the notice is.

Compliance with recovery notice

Clause 85 creates offences and provides for liability to a civil penalty in respect of the failure to comply with a recovery notice. A recovery notice is a notice given by the Authority under the Rules that require the recipient to take specific steps relating to the recovery (which may include the recall) of products.

Clause 86 provides relief from liability where a person is, or may be, liable to a civil penalty under clause 85(2) (failing to comply with a recovery notice).

Clause 87 makes it an offence for a person to intentionally export or supply a therapeutic product that the person knows to be subject to a recovery notice.

Information about sponsors

Clause 88 provides that a person who manufactures, imports, exports, or supplies a therapeutic product commits an offence, or is liable to a civil penalty, if the person—

  • claims not to be the sponsor of the therapeutic product; and

  • is required by the Authority to provide information about the identity of the sponsor of the therapeutic product; and

  • fails to provide that information within the time specified by the Authority, or provides false or misleading information.

Subpart 3Non-compliance notices and enforceable undertakings

Non-compliance notices

Clause 89 authorises the Authority to issue a non-compliance notice to a person who has, within the last 12 months, engaged in conduct that the Authority has reasonable cause to believe—

  • renders the person liable to a civil penalty under this Part; or

  • constitutes a strict liability offence against this Part.

A person who is issued with a non-compliance notice may, by paying a specified monetary penalty within a specified time, avoid any further proceedings relating to the conduct.

Clause 90 allows the Authority to withdraw a non-compliance notice at any time before the monetary penalty is paid in full.

Clause 91 specifies the date by which the monetary penalty is to be paid.

Clause 92 specifies the maximum amount of monetary penalty that may be specified in a non-compliance notice.

Clause 93 provides that civil penalty or criminal proceedings may not be commenced against the recipient of a non-compliance notice (in relation to the conduct referred to in the notice) if the person pays the monetary penalty, or the time for paying the penalty has not yet passed.

Clause 94 provides that payment of a monetary penalty must not be construed as an admission of guilt or liability.

Clause 95 provides for regulations prescribing the form of a non-compliance notice and sets out matters that must be set out in the notice.

Enforceable undertakings

Clause 96 provides that the Authority may accept a written undertaking (an enforceable undertaking) given by a person in connection with a matter in relation to which the Authority has a power or function relating to the regulation of therapeutic products.

Clause 97 enables the Authority to apply to the High Court to enforce an undertaking if the Authority considers that the person who gave the undertaking has breached any of its terms.

Subpart 4Search and seizure

Authorised officers

Clause 98 provides definitions of terms primarily used in subparts 4 and 5 (which relate to search and seizure, information sharing, and customs matters).

Clause 99 authorises the Managing Director to appoint authorised officers for the purposes of Parts 1 to 5.

Clause 100 requires the Managing Director to issue authorised officers with identity cards.

Entry, search, and seizure without warrant

Clause 101 authorises an authorised officer to enter, at any reasonable time, a place (other than a dwelling house or marae) in order to monitor compliance with the Rules and Orders. It sets out the powers of an authorised officer who enters a place under this clause.

Clause 102 provides that an authorised officer or member of the police may enter a place (other than a dwelling house or marae) without consent or warrant in certain circumstances in order to avoid an imminent risk of death, serious illness, or serious injury, and sets out the powers of the person entering under this clause.

Clause 103 allows the occupier of a place to request that the Authority make an inspection of the place.

Search warrants

Clause 104 provides for the issue of search warrants, which must be in a form prescribed by regulations.

Clause 105 identifies the powers of an authorised officer or member of the police, and any person called on to assist, who enters a place under a search warrant issued under clause 104.

Conduct of entry, search, and seizure

Clause 106 provides that an authorised officer or member of the police may ask any person to assist with a search under this Part.

Clause 107 provides that an authorised officer must show his or her identity card on entering a place, and at any time during the search if requested.

Clause 108 requires that an authorised officer or member of the police must, before entering a place under this Part,—

  • announce that he or she is authorised to enter; and

  • give any person present an opportunity to consent to the entry.

Clause 109 requires a person conducting a search under a warrant to provide a copy of the warrant to the occupier whose place is being searched.

Clause 110 provides that an occupier whose place is being searched may observe the search as long as he or she does not impede it.

Clause 111 relates to the use of electronic equipment found at a place during a search. A person conducting a search must take care not to damage the equipment or corrupt information stored on it, and the Authority may be liable for damages if the person fails to take care.

Clause 112 provides that documents seized from a place must, if practicable, be copied before the original is removed. A copy of the document seized must be left at the place. If it is not practicable to copy a document before it is seized, a copy must be provided as soon as practicable afterwards.

Clause 113 requires that a person who seizes anything during a search must provide the occupier with a receipt for the thing.

What happens to things seized

Clause 114 provides for the return of things that have been seized and sets out the circumstances in which they may be retained.

Clause 115 provides that an authorised officer or member of the police who wishes to retain a thing seized for more than 90 days may apply to the District Court for an order to retain the thing.

Clause 116 provides for a court to order therapeutic products relating to a conviction or the imposition of a civil penalty to be forfeited to the Crown.

Testing and analysis of samples

Clause 117 imposes requirements on an authorised officer who obtains a sample for testing or analysis (other than under a search warrant).

Clause 118 provides that the analysis and testing of samples must be done in accordance with the Rules and Orders.

Clause 119 provides for how a certificate of analysis may be admissible as evidence.

Clause 120 provides that a person who is convicted of an offence or ordered to pay a civil penalty must pay the fees and expenses of any testing or analysis.

Offences relating to search and seizure

Clause 121 creates a range of offences relating to hindering or interfering with searches and seizures.

Subpart 5Miscellaneous

Information sharing for law enforcement purposes

Clause 122 provides for the sharing between government agencies and the Authority of information relating to compliance with the law and law enforcement. The information may relate not just to enforcement of this Act but also to related enactments, such as the Biosecurity Act 1993 and the Customs and Excise Act 1996, identified in the clause.

Customs

Clause 123 provides for authorised officers to inspect any therapeutic product, and any documents associated with its import or export, if the therapeutic product is in a customs controlled area.

Clause 124 sets out the powers of an authorised officer to seize and otherwise deal with non-compliant therapeutic products that are imported into, or exported from, New Zealand. A non-compliant therapeutic product is one that does not comply with the Rules or Orders, or with regulations, or that constitutes a risk to public health.

Clause 125 is about what happens to a consignment at a port when a sample is taken for analysis.

Clause 126 provides for the relationship between Parts 1 to 5 and the Customs and Excise Act 1996.

Patents

Clause 127 confirms that the fact that a product is protected by an Australian patent does not in itself prevent it from being marketed in New Zealand.

Part 3
Administrative law matters

This Part deals with—

  • the system for reviewing decisions by the Authority:

  • how judicial review applies to decisions by the Authority:

  • how the Ombudsmen in New Zealand and Australia deal with issues relating to the Authority:

  • how the Privacy Commissioners in New Zealand and Australia deal with privacy issues associated with the Authority:

  • how the Authority manages the keeping and disclosure of information, including information relating to the governments of New Zealand and Australia, and highly sensitive commercial information, and the application of the New Zealand Public Records Act 2005.

Clause 128 provides definitions of terms used primarily in this Part.

Subpart 1Merits review

General provisions

Clause 129 provides an overview of this subpart. This subpart gives effect to Article 13 of the Agreement, which requires New Zealand to provide for the review by a merits review tribunal of the merits of certain decisions made by the Authority.

Application for review

Clause 130 provides that a person whose interests are affected by a reviewable decision may apply to the Review Tribunal (which is the New Zealand Review Tribunal established under clause 135) for a review. A reviewable decision is any decision of the Authority in relation to—

  • an application for an approval; or

  • the amendment, suspension, or revocation of an approval; or

  • any other matter specified in the Rules as being open to merits review.

Clause 131 restricts applications for merits review if an internal review process is available under the Rules.

Clause 132 describes how reasons for a decision, and other information, may be withheld if the Australian Commonwealth Attorney-General has issued a public interest certificate under the Administrative Appeals Tribunal Act 1975 of the Commonwealth of Australia.

Clause 133 bars applications for review to the Review Tribunal if an application for review has already been made to the Australian Review Tribunal (which is the tribunal provided for in the Australian Act).

Clause 134 provides that an application to review a decision of the Authority does not affect the operation of the decision unless the applicant has obtained an order to stay the decision under review.

Review Tribunal

Clause 135 provides for the establishment and constitution of the (New Zealand) Review Tribunal. A minimum of 3 members of the Merits Review Panel (the members of whom are appointed under the Agreement by the Ministerial Council) is required to constitute a Review Tribunal for a particular review.

Clause 136 provides protection from personal liability to members of the Review Tribunal for any act or omission done in good faith in the course of their duties.

Clause 137 provides for the remuneration of members of the Review Tribunal.

Conduct of review

Clause 138 provides that the parties to proceedings before the Review Tribunal are—

  • the applicant; and

  • the Authority; and

  • any person whom the Review Tribunal is satisfied is a person whose interests are affected by the decision.

It also provides that the Attorney-General may appear and be heard in proceedings in which the Attorney-General considers that the interest of the public is or may be involved.

Clause 139 states that the Review Tribunal may regulate its own procedure, subject to the Agreement, the Rules, and Parts 1 to 5. It also provides that specific procedural provisions applying to the Review Tribunal are set out in Schedule 2.

Clause 140 provides that the decision of the majority of the members of the Review Tribunal is the decision of the Review Tribunal. If no majority is reached, then the decision of the Review Tribunal is the decision of the chairperson.

Clause 141 specifies the powers of the Review Tribunal when reviewing a decision of the Authority.

Clause 142 provides that if the Review Tribunal remits a matter to the Authority, the Authority must give effect to any directions of the Review Tribunal, reconsider the matter, and issue a fresh decision.

Clause 143 explains the extent to which new information may be considered by the Review Tribunal.

Transfer of review proceedings

Clause 144 enables review proceedings in New Zealand to be transferred to the Australian Review Tribunal if the Review Tribunal is satisfied that it is in the interests of justice to have the review conducted by the Australian Review Tribunal. Review proceedings must be transferred if a public interest certificate has been issued (see the note on clause 132) in respect of information or a matter that is or may be in evidence before the Review Tribunal.

Clause 145 provides for proceedings that are transferred to the Review Tribunal from the Australian Review Tribunal.

Effect of decisions

Clause 146 provides that a decision by the Authority has effect subject to any order of the Review Tribunal, the Australian Review Tribunal, or a decision of a court on appeal from either tribunal.

Appeals and stating case

Clause 147 provides for a party to review proceedings to appeal to the High Court against a decision of the Review Tribunal on a question of law.

Clause 148 provides for the Review Tribunal to state a case for the opinion of the High Court on a question of law arising in any proceedings before the Tribunal. The Tribunal may state a case on its own initiative or on application by any party.

Subpart 2Judicial review

Clause 149 provides that this subpart applies only to judicial review proceedings relating to decisions of the Authority, and to Rules and Orders.

Clause 150 enables decisions of the Authority, Rules, and Orders to be judicially reviewed under the Judicature Amendment Act 1972.

Clause 151 states the effect of orders made by a court in judicial review proceedings concerning a decision of the Authority, or a Rule or Order.

Clause 152 provides that a court may stay judicial review proceedings on its own initiative or on application by a party. Proceedings may be stayed if the court considers it more appropriate for them to be heard and determined in a court in Australia or if it is satisfied that the matter is the subject of final orders made by an Australian court.

Clause 153 sets out some procedural matters in respect of a court's determination of whether a judicial review proceeding should be stayed.

Subpart 3Action by Ombudsmen

Clause 154 acknowledges that the Authority is subject to the Ombudsmen Act 1975 and to the Ombudsman Act 1976 of the Commonwealth of Australia.

Clause 155 provides for co-operation between New Zealand Ombudsmen and the Australian Ombudsman when taking acting concerning the Authority. It requires a New Zealand Ombudsman to advise the Australian Ombudsman of any investigation of the Authority under the Ombudsmen Act 1975. New Zealand Ombudsmen may exercise powers under the Ombudsmen Act 1975 to respond to any request for assistance by the Australian Ombudsman. The Australian Ombudsman has reciprocal obligations under the Australian Act to assist and advise New Zealand Ombudsmen.

Clause 156 enables New Zealand Ombudsmen to transfer complaints under the Ombudsmen Act 1975 to the Australian Ombudsman.

Clause 157 provides that a New Zealand Ombudsman may, at the request of the Australian Ombudsman, agree to the transfer of a complaint concerning the Authority from Australia, if satisfied that the matter can be conveniently and effectively dealt with by a New Zealand Ombudsman.

Clause 158 provides that a New Zealand Ombudsman may refuse to deal with—

  • complaints investigated, or similar to those investigated, by the Australian Ombudsman; or

  • complaints that will be transferred to Australia.

Clauses 159 and 160 relate to immunities extended to the Australian Ombudsman and others in relation to actions in New Zealand.

Subpart 4Action by Privacy Commissioners

Clause 161 acknowledges that the Authority is subject to the Privacy Act 1993 and to the Privacy Act 1988 of the Commonwealth of Australia.

Clause 162 modifies the application of privacy principle 11, as set out in section 6 of the Privacy Act 1993, so far as it relates to the Authority. This is necessary for consistency with the Australian Privacy Act 1988.

Clause 163 provides for co-operation between the New Zealand Privacy Commissioner and the Australian Privacy Commissioner in respect of any investigation concerning the Authority. The provisions are similar to those relating to Ombudsmen under clause 155.

Clause 164 provides for the transfer to the Australian Privacy Commissioner of complaints concerning the Authority that are received by the New Zealand Privacy Commissioner.

Clause 165 provides for the transfer of complaints regarding the Authority from the Australian Privacy Commissioner to the New Zealand Privacy Commissioner.

Clause 166 provides that the New Zealand Privacy Commissioner may decide to take no action, or no further action, on any complaint that has been dealt with by the Australian Privacy Commissioner or that is being transferred to the Australian Privacy Commissioner.

Clauses 167 and 168 relate to immunities extended to the Australian Privacy Commissioner and others in relation to actions in New Zealand.

Clause 169 extends to the New Zealand Privacy Commissioner the same level of immunity that is given to the Australian Privacy Commissioner in respect to actions in New Zealand.

Subpart 5Information management

Clause 170 acknowledges that the Official Information Act 1982 generally applies to information held by the Authority. However, it does not apply to Australian Government information or to information of the Authority that was held by the Australian Therapeutic Goods Agency at the time of the latter's disestablishment.

Clause 171 acknowledges that the Authority is subject to the Privacy Act 1993 and refers to the earlier provisions about the Privacy Commissioner.

Clauses 172 to 177 authorise the release of specific types of information to specific people or organisations in specific circumstances. Some of these provisions authorise releases that would be possible anyway under the Official Information Act 1982, but are included here for the avoidance of doubt and for symmetry with the Australian Act.

Clause 178 authorises the release to the public of specified information held by the Authority in limited circumstances.

Clause 179 protects from civil and criminal liability any person who, in good faith, makes information available under any of clauses 170 to 178, clause 183, or under the Medicines Act 1981 (where clause 184 applies).

Protected active ingredient information

Clause 180 explains the purpose of clauses 181 to 184.

Clause 181 provides definitions of protected active ingredient information and active moiety. Protected active ingredient information is information that—

  • is about, or relates to, the active moiety of a therapeutic product; and

  • is submitted in support of an application for a product licence; and

  • is not in the public domain on the date on which the application is received by the Authority.

Clause 182 prohibits the Authority from disclosing protected active ingredient information during the 2 periods when the information is protected. The first period of protection starts from the date the Authority receives the application for the product licence and ends on the earlier of—

  • the date that is 5 years later; or

  • the date on which the second period of protection starts.

The second period of protection starts on the date on which the Authority decides the application, and ends on the date that is 5 years later.

Clause 183 allows the Authority to release protected active ingredient information during its periods of protection if—

  • disclosure is under any of clauses 172 to 178; or

  • the applicant or licence holder agrees; or

  • the information is in the public domain.

Clause 184 preserves the application of sections 23A to 23C of the Medicines Act 1981 to confidential supporting information (as defined in those sections) in relation to applications dealt with before the Scheme comes into force.

Use of information by Authority

Clause 185 applies if Rules limit the use that the Authority may make of information. It bars civil or criminal proceedings against any person who, in good faith, uses the information in breach of those Rules.

Archives

Clause 186 acknowledges that the Authority is subject to the New Zealand Public Records Act 2005 and the Archives Act 1983 of the Commonwealth of Australia. Responsibility for the records will be determined under a memorandum of understanding between the (New Zealand) Chief Archivist and the Director-General of the National Archives of Australia.

Part 4
Governance and accountability

Clause 187 defines terms used primarily in this Part.

Subpart 1Ministerial Council, Board, and Board members

Ministerial Council

Clause 188 provides an overview of the role and functions of the Ministerial Council, which is largely provided for in the Agreement.

General provisions relating to Board

Clause 189 provides an overview of the Board. The Board comprises 5 members who are appointed by the Ministerial Council. The role and functions of the Board are set out in paragraphs 5 and 6 of Article 6 of the Agreement, but more detailed matters relating to the Board will be provided in the Rules.

Clause 190 states Parliament's expectations of the Board. These expectations are derived from sections 49 and 50 of the Crown Entities Act 2004, which impose duties on the Boards of statutory entities to (amongst other things) ensure that the entity acts consistently with its functions and that it performs its functions in a manner consistent with the spirit of service to the public.

Clause 191 prohibits the Minister from appointing to the Board, or concurring in appointing to the Board, any person to whom subclause (1) applies. The restrictions are similar to those that apply to people appointed as members of Crown entities.

Clause 192 provides that the powers, functions, and duties of the Board are not affected by a vacancy in its membership, and that the validity of a Board member's actions is not affected by flaws in that person's appointment.

Clause 193 protects the actions of the Board from being challenged on the grounds that it did not comply with Board procedures.

Managing Director

Clause 194 provides an overview of the role of the Managing Director (which is mainly provided for in the Agreement).

Subpart 2General matters relating to Authority

Clause 195 provides an overview of the establishment, functions, and powers of the Authority. Although the Authority is not a Crown entity, and is not subject to the Crown Entities Act 2004, it is subject to broadly equivalent financial and accountability controls.

Providing information

Clause 196 requires the Authority to promptly inform the Minister of any regulatory decision that affects or is likely to affect—

  • the Government's financial position; or

  • government policies or programmes.

The Authority must also provide the Minister with certain information on request.

Clause 197 requires the Authority to comply with any written request by the Minister of Finance for information about the operations and performance of the Authority or its subsidiaries.

Clause 198 requires the Authority to supply, at the written request of the Secretary to the Treasury, information about the operations and performance of the Authority or its subsidiaries. The Secretary may only request information under this clause if it is for any of the purposes specified in subclause (2).

Compliance with directions

Clause 199 requires the Authority to give effect to any written direction from the Ministerial Council that is about a matter of government policy.

Review of operations

Clause 200 provides for the review of the operations or performance of the Authority or any of its subsidiaries by the Ministerial Council, the Minister, or the Australian Minister.

Employees and others

Clause 201 prohibits a person from disclosing information obtained solely as a result of being—

  • an employee of the Authority:

  • a contractor of, or person acting under delegation from, the Authority:

  • a member of a Board Committee, or expert advisory committee.

Clause 202 makes it an offence for an employee of the Authority to intentionally use his or her position to gain an improper advantage or to cause detriment to the Authority.

Immunities, indemnities, and insurance

Clause 203 provides that clauses 204 to 207 apply to former or current senior officers, members of Board committees, members of expert advisory committees, and employees of the Authority. A senior manager is a person who makes or participates in making decisions that affect the whole or a substantial part of the operations of the Authority, or who has the capacity to significantly affect the Authority's financial standing.

Clause 204 provides that a person specified in clause 203 is not liable for the liability of the Authority merely because he or she is such a person.

Clause 205 provides a person referred to in clause 203 with immunity from criminal and civil proceedings for any act or omission during the course of the operations of the Authority. The immunity does not apply to acts or omissions done in bad faith.

Clause 206 allows the Authority to indemnify any person referred to in clause 203.

Clause 207 authorises the Authority to provide insurance for any person referred to in clause 203.

Clause 208 bars civil and criminal proceedings against the Authority for any act or omission in the course of the exercise or intended exercise of its functions. The immunity does not apply—

  • if the Authority acted without reasonable care or in bad faith:

  • to certain criminal proceedings.

Clause 209 acknowledges that, despite clause 208, the Authority is subject to the Health and Safety in Employment Act 1992, but limits those who can be prosecuted under that Act to Board members resident in New Zealand and others working for the Authority primarily in New Zealand.

Miscellaneous matters

Clause 210 contains presumptions about documents on which the seal of the Authority is imprinted.

Clause 211 sets out presumptions about documents purported to be signed by the Managing Director.

Subpart 3Financial and associated matters

Clause 212 provides that the Authority must not borrow or amend the terms of a borrowing except in accordance with the Rules. Subclause (2) specifies other activities that are subject to the same restrictions.

Clause 213 provides that the Authority must not give a guarantee to, or indemnify, another person except in accordance with the Rules. (This clause does not apply to an indemnity given under clause 206.)

Clause 214 restricts the Authority's involvement in derivative transactions (as defined in subclause (2)).

Clause 215 contains requirements relating to the Authority's banking practices.

Clause 216 restricts the circumstances in which the Authority may acquire securities.

Clause 217 restricts the Authority's involvement in other entities such as companies, partnerships, trusts, and unincorporated joint ventures.

Clause 218 requires the Authority to ensure that none of its subsidiaries—

  • does anything that the Authority cannot do; or

  • exercises any of the Managing Director's powers.

Clause 219 requires Board members to ensure that the annual accounting period of any of the Authority's subsidiaries is the same as the financial year of the Authority.

Clause 220 requires the Authority keep trust money in a separate bank account and to promptly pay into that account any trust money received.

Clause 221 allows the Authority to invest trust money but only in accordance with the Rules.

Clause 222 exempts the income of the Authority from income tax.

Clause 223 describes how goods and services acquired by the Authority are to be treated for the purpose of determining the Authority's input tax under the Goods and Services Tax Act 1985.

Subpart 4Reporting

Overview

Clause 224 explains the Authority's reporting obligations under Article 8 of the Agreement and how the Authority is to discharge those obligations in New Zealand and Australia.

Statement of intent

Clause 225 requires the Board to prepare a statement of intent for the Authority before the start of each financial year.

Clause 226 explains Parliament's expectation that the Board will ensure that the Authority complies with its statement of intent. This reflects the duty imposed on members of Crown entities under section 49 of the Crown Entities Act 2004.

Clause 227 provides that the Ministerial Council may, after consulting the Board, direct the Board to amend the Authority's statement of intent. A direction to amend a statement of intent must be presented to the House of Representatives and be gazetted as soon as practicable.

Clause 228 requires the Board to amend the statement of intent if certain circumstances apply (for example, if the information contained in it is substantially misleading).

Clause 229 requires that the statement of intent, and every amendment made to it, must—

  • be presented by the Minister to the House of Representatives within the specified time; and

  • be published by the Authority on its Internet site promptly after it has been presented.

Annual report

Clause 230 acknowledges that, under the Agreement, the Board is required to prepare an annual report for the Authority for each financial year and provide it to the Ministerial Council.

Clause 231 requires that the Authority's annual report must be presented by the Minister to the House of Representatives within the time specified and be published by the Authority on its Internet site within 10 working days after the annual report is received by the Ministerial Council.

Audit

Clause 232 appoints the Auditor-General as an auditor of the Authority and each of its subsidiaries, and acknowledges that the Australian Auditor-General is also appointed (under the Australian Act) as an auditor of the Authority.

Keeping accounting records

Clause 233 requires the Authority to maintain and keep proper accounting records.

Offences

Clause 234 provides that a senior officer commits an offence if he or she intentionally contravenes the requirement to keep proper accounting records.

Clause 235 makes it an offence for a person to knowingly—

  • refuse or fail to produce information as required under this Part or the Rules; or

  • resist or obstruct any person who is carrying out any function under this Part or the Rules; or

  • make false representations about his or her authority under this Part or the Rules; or

  • give false or misleading information in response to a requirement under this Part or the Rules.

Subpart 5Board members and other senior officers

Board member conflict of interest

Clause 236 describes the obligations of a Board member in a conflict of interest situation. These reflect the obligations on members of Crown entities.

Clause 237 requires a Board member to disclose any material personal interest and specifies the matters that must be disclosed.

Clause 238 allows the Board to permit any member with a material personal interest to participate in a matter (despite any contravention of clause 236) if the Board is satisfied that it is in the public interest.

Clause 239 requires that the Ministerial Council is notified as soon as practicable of any failure by a Board member to comply with clause 236. A failure to comply with clause 236 does not affect the validity of the relevant act or matter.

Clause 240 provides for the Authority to avoid an act done in breach of the provisions about conflict of interest in certain circumstances.

Duties of senior officers

Clause 241 provides that the duties of senior officers set out in clauses 242 to 246 apply regardless of where the senior officer is located at the time of the act or omission.

Clause 242 requires senior officers to act with honesty and integrity when carrying out their duties as senior officers.

Clause 243 requires senior officers not to contravene, or agree to the Authority contravening, Parts 1 to 5, the Australian Act, or the Rules.

Clause 244 requires senior officers to carry out their duties with care, diligence, and skill.

Clause 245 provides that senior officers must—

  • exercise their powers and carry out their duties in good faith and for a proper purpose:

  • not pursue their own interests at the expense of the Authority's interests:

  • not use their position to gain an improper advantage or cause a detriment to the Authority.

Clause 246 provides that senior officers and former senior officers must not misuse any information that they have obtained solely as a result of being, or having been, a senior officer.

Criminal consequences of failing to comply with duties

Clause 247 makes it an offence for a senior officer to contravene certain duties referred to in clauses 245 and 246.

Clause 248 provides that the Finance Minister may require a person to give all reasonable assistance in connection with criminal proceedings under clause 247. The criteria in subclause (2) must be satisfied before assistance is required. Information provided under this clause may not be used in proceedings as evidence against the person who provided assistance.

Civil consequences of failing to comply with duties

Clauses 249 to 254 set out a civil penalty regime in relation to a breach of duties by senior officers. The regime is broadly equivalent to the civil penalty regime provided in Part 2 relating to regulatory matters.

Clause 249 provides that the Minister or the Finance Minister may apply to the High Court for a civil penalty order against a senior officer or former senior officer.

Clause 250 provides that the High Court may order a person to pay a civil penalty if the Court is satisfied that—

  • the person has breached any of the duties set out in clauses 243 to 246; and

  • the breach is serious or materially prejudices the interests of the Authority or the Authority's ability to pay its creditors.

The maximum civil penalty is 2 000 penalty units, and is payable to the Crown.

Clause 251 states how and when an application for a civil penalty may be made, and provides for procedural matters.

Clause 252 states the extent to which the Authority may be involved in proceedings for a civil penalty order.

Clause 253 provides relief from liability, in certain circumstances, for a person against whom civil penalty proceedings have been commenced under clause 249.

Clause 254 allows the Finance Minister to require a person to give all reasonable assistance in connection with an application for a civil penalty under this Part.

Disqualification for breach of duty

Clause 255 provides that the High Court may make a disqualification order against a senior officer or former senior officer.

A disqualification order lasts up to 10 years. It must disqualify a person from being a Board member and may do any or all of the following:

  • disqualify the person from being a promoter or a director of a company in New Zealand:

  • prohibit the person from involvement in the management of a company in New Zealand:

  • disqualify the person from being a member of any Crown entity.

A breach of a disqualification order is an offence.

Clause 256 provides for a person who is subject to a disqualification order to apply to the Court for the order to be quashed or amended.

Clause 257 provides for the effect of disqualification under equivalent provisions of the Australian Act.

Compensation orders

Clause 258 provides for an application to be made to the High Court for a compensation order against a senior officer or former senior officer if—

  • the person has breached any of the duties referred to in clauses 243 to 246; and

  • the Authority suffered damage as a result of the breach.

Clause 259 provides that an application for compensation must be made no later than 6 years after the alleged breach.

Civil liability of others involved

Clause 260 describes the liability of a person who is involved in the breach by a senior officer of any of the duties specified in clauses 245 or 246.

Defence in criminal or civil penalty proceedings

Clause 261 provides a defence to a senior officer or former senior officer who is proceeded against for a breach of duty. The fact that the person relied on information and advice given by employees of the Authority, professional advisers, or other specified persons is a defence only if the person acted in good faith, made proper inquiries as circumstances required, and had no knowledge that the reliance was unwarranted.

General relief from civil liability

Clauses 262 provides for when a court may relieve a person from liability in civil proceedings under this Part.

Restriction on use of evidence

Clause 263 provides that evidence given by a person in proceedings against that person for a civil penalty may not be used in criminal proceedings against that person.

Relationship between criminal and civil penalty proceedings

Clause 264 bars proceedings for a civil penalty under this Part against a person in relation to particular conduct if there are already proceedings underway against that person for a declaration of breach or for a pecuniary penalty under the Australian Act in respect of the same conduct.

Clause 265 bars criminal proceedings under this Part against a person in relation to particular conduct if criminal proceedings against the person under the Australian Act in respect of the same conduct are underway or have been completed.

Clause 266 allows criminal proceedings for an offence under this Part to commence against a person even if—

  • proceedings in New Zealand for a civil penalty under this Part have commenced against the person in respect of the same conduct; or

  • proceedings in Australia for a declaration of breach or for a pecuniary penalty under the Australian Act have commenced against the person in respect of the same conduct.

Any civil penalty proceedings that have commenced against a person under this Part must be stayed if criminal proceedings are commenced against the person in respect of the same conduct.

Clause 267 describes the effect of the withdrawal of proceedings on any limitation period applying to subsequent proceedings.

Clause 268 clarifies that nothing in clauses 264 to 267 affects the abuse of process jurisdiction of any court. This is important where, for example, a person has been acquitted in Australia and charges relating to the same conduct are commenced in New Zealand.

Part 5
Regulations, and transitional and miscellaneous provisions

Subpart 1Regulations

Clause 269 is a regulation-making power relating to Article 12 of the Agreement which is about departures from the Scheme. This Article provides that either party may exclude or modify the application of the Scheme to specified products or classes of products (referred to in this clause as excluded products) having regard to exceptional public health, safety, third country trade, environmental or cultural factors that affect that Party. If a product is an excluded product, it will have to be regulated outside the Scheme by regulations made by the relevant country. This clause authorises the making of those regulations, and in particular provides for—

  • aspects of the Scheme to be applied, with or without modification, to excluded products; and

  • regulations to provide an alternative way of regulating excluded products.

Clause 270 authorises the making of regulations requiring the payment of fees and charges for any functions performed by the Authority that are outside the scope of the Scheme.

Clause 271 provides for temporary or transitional regulations to be made that are necessary or expedient to fully implement the Scheme in New Zealand. The main transitional measures are spelt out in subpart 2, but this clause allows regulations to be made to help ensure a smooth transition to the new Scheme.

Clause 272 contains standard provisions providing for the making of regulations that do not fall within any category of regulations already provided for.

Subpart 2Transitional provisions relating to Scheme

Preliminary

The way the transitional provisions for the regulatory aspects of the Scheme work is broadly as follows. Products and activities that were lawful before the Scheme starts will be deemed to have been granted a transitional approval by the Authority on the day the Scheme starts. The effect of a transitional approval is to largely maintain the legal status quo for the product or activity to which it relates. This means that if, under the Medicines Act 1981 (the former Act), a product could be lawfully supplied subject to certain conditions, then after the start date the product can lawfully continue to be supplied as long as those conditions are met. A failure to comply with the conditions will be dealt with as it would have been under the former Act.

If an application is pending under the former Act at the start date (a pending application), the Authority must consider the application in accordance with the former Act (unless the application is withdrawn or lapses). The Authority may then issue a transitional approval. The transitional approval will operate in the same way as transitional approvals that are deemed to have been granted.

Transitional approvals operate only in New Zealand and only during the transition period. The transition periods for different types of products and activities will be set by the Rules. Transitional approvals will be subject to the provisions of the former Act (and any regulations made under it) identified in the Rules, but may also be subject to certain applicable rules. Holders of transitional approvals can apply for approvals granted in accordance with the Rules (Scheme approvals) during the transition period. A Scheme approval will be effective in both New Zealand and Australia, and will be subject to Parts 1 to 5 and the Rules and Orders.

Clause 273 provides an outline of the transitional provisions.

Clause 274 sets out definitions of terms used in subpart 2 of this Part.

Clause 275 provides for the saving of the former Act (and regulations made under it) and describes how to apply that Act after the Scheme starts. For instance, references to the Minister in the former Act must be read as if they were references to the Authority, because the Authority will take over the functions of the Minister when applying that Act during the transition period.

Clause 276 provides that transitional approvals are subject to applicable fees and charges prescribed by Rules.

Medicines: transitional approvals

Clauses 277 and 278 provide for transitional approvals to replace existing consents (ie, consents given under any of sections 20, 23, or 24(3) of the former Act) and existing approvals (ie, given under section 24D of the former Act) relating to medicines.

Related products: transitional approvals

Clauses 279 and 280 provide for transitional approvals to replace existing consents for related products.

Medicines and related products: material changes

Clauses 281 to 283 provide for transitional approvals to be granted by the Authority in relation to applications under section 24 of the former Act, which is about changed medicines.

Medicines and related products: pending applications

Clauses 284 to 288 deal with what happens to a range of different pending applications relating to medicines and related products. Applications may be withdrawn so that they can be dealt with immediately by the Authority under the Scheme. Otherwise, they will generally be dealt with by the Authority in accordance with the former Act. There are provisions for treating certain applications as lapsed, and provisions about refunding fees when an application is withdrawn.

Medicines: existing exemptions under former Act

Clauses 289 and 290 provide for the continuation, for 6 months, of certain exemptions applying to authorised prescribers and medical practitioners.

Medicines: clinical trials approved under former Act

Clauses 291 to 294 provide for transitional approvals for clinical trials approved under the former Act.

Medicines: pending application for approval of clinical trial

Clauses 295 to 297 provide for the Authority to grant transitional approvals in relation to pending applications for clinical trials.

Medicines: transitional approvals for existing licences

Clauses 298 to 300 provide for transitional approvals for existing licences relating to the manufacture and packing of medicines.

Medicines: pending applications for licences

Clauses 301 to 304 provide for the Authority to grant transitional approvals in relation to pending applications for a licence to manufacture or a licence to pack medicines.

Medical devices: transitional approval

Clauses 305 to 309 set out a system for providing transitional approvals for medical devices. During the establishment period (which is after the Authority is established but before the Scheme comes into force), if the sponsor of a medical device provides certain declarations and information to the Authority, then on the start date a transitional approval will be deemed to have been granted in respect of the medical device.

Medical devices: exemptions

Clause 310 provides an exemption from the need to obtain a transitional approval for certain medical devices.

Dietary supplements: transitional approvals

Clauses 311 to 315 set out a system for providing transitional approvals for dietary supplements. Dietary supplements were not regulated under the former Act. During the establishment period, if the sponsor of a dietary supplement that does not have an existing consent, existing approval, or existing licence, provides certain declarations and information to the Authority, then on the start date a transitional approval will be deemed to have been granted in respect of that dietary supplement.

Newly designated therapeutic products: transitional approvals

Clauses 316 to 319 set out a system for providing transitional approvals for newly designated therapeutic products, which are those therapeutic products not already dealt with in this subpart, and which, though lawfully supplied before the start date, were not regulated under the former Act. During the establishment period, if sponsors of those products provide certain declarations and information to the Authority, then on the start date a transitional approval will be deemed to have been granted in respect of the product.

Notices

Clause 320 describes what happens after the start date if a notice is issued before the start date under section 36(1) or (3) of the former Act.

Advertising

Clause 321 provides that advertisements that were lawful to publish under the former Act may continue to be lawfully published after the start date, but only for a limited period.

Appeals

Clauses 322 and 323 provide for appeals against decisions made either under the former Act, or by the Authority in accordance with the former Act, after the start date.

Offences

Clause 324 provides that offences under the former Act or regulations, whether committed before or after the start date, must be investigated and prosecuted, and any penalties must be imposed, as if the former Act had not been repealed.

Clause 325 identify the offences and civil penalties under Parts 1 to 5 that do not apply in respect of holders of transitional approvals. These offences and civil penalties do not apply because the equivalent provisions under the Medicines Act 1981 will apply instead.

Proceedings

Clauses 326 and 327 provide that proceedings that were barred before the commencement of this subpart remain barred, and that any proceedings commenced before the subpart comes into force may be continued and completed as if the former Act were still in force.

Subpart 3Transitional provisions relating to employees

Clause 328 provides for the transfer of Medsafe employees to the Authority on the transfer date.

Clause 329 provides that the transfer does not break an employee's continuity of service.

Clause 330 provides that there is no compensation payable for any technical redundancy that may occur as a result of the transfer.

Clause 331 preserves the right of Medsafe employees who were contributors under the Government Superannuation Fund Act 1956 to remain in that scheme.

Subpart 4Transitional provisions relating to assets

Clause 332 provides that the purpose of clauses 333 and 334 is to enable the assets and liabilities of Medsafe to be transferred to the Authority using the mechanisms provided in the Health Sector (Transfers) Act 1993.

Clause 333 amends the Health Sector (Transfers) Act 1993 so that Medsafe assets and liabilities will be able to be transferred to the Authority under that Act.

Clause 334 provides that the transfer may not take place unless the Ministerial Council has agreed to the proposal.

Subpart 5Miscellaneous provisions

Clause 335 provides that the enactments in Schedule 3 are amended. These amendments relate to the establishment of the Authority.

Clause 336 provides that Schedule 8 sets out other consequential amendments that are consequential upon the enactment of Parts 1 to 5. Schedules 4 to 7 relate only to Parts 5 and 6, but Schedule 8 contains amendments that relate to all Parts of this Bill.

Part 6
General provisions

Clause 337 explains the purpose of Parts 6 and 7 and notes that those Parts relate to the law relating to medicines at the consumer end of the supply chain.

Clause 338 provides an outline of Parts 6 and 7.

Clause 339 sets out definitions of a large number of terms used in Parts 6 and 7.

Application and administration

Clause 340 sets out the application of Parts 6 and 7 and clarifies the relationship between those Parts and Parts 1 to 5. The requirements, obligations, and restrictions imposed on activities undertaken with medicines by Parts 6 and 7 are in addition to those imposed on activities undertaken with therapeutic products by Parts 1 to 5.

Clause 341 provides that Parts 6 and 7 bind the Crown.

Clause 342 sets out how certain activities undertaken under Parts 6 and 7 (such as supplying and dispensing medicines) apply in the context of the employee and employer relationship.

Part 7
Substantive provisions relating to medicines

Subpart 1Controlled activities

Clause 343 provides an overview of subpart 1, which deals with controlled activities. Controlled activities are defined in clause 339 as activities that are prohibited under subpart 1 of Part 7 unless undertaken by a person otherwise authorised by or under Parts 6 and 7.

In general terms, a person commits an offence if that person undertakes any of the following controlled activities without being authorised by or under Parts 6 and 7:

  • supplying scheduled medicines by wholesale:

  • supplying scheduled medicines other than by wholesale:

  • supplying medicines by auction:

  • supplying medicines by vending machine:

  • dispensing medicines:

  • prescribing prescription medicines:

  • administering prescription medicines:

  • possessing prescription medicines:

  • operating a pharmacy.

Clause 343(4) provides that, despite being otherwise authorised to undertake an activity by or under Parts 6 and 7, a person may still be restricted from undertaking that activity under—

  • an instrument referred to in subpart 2; or

  • the regulations.

Supplying scheduled medicines by wholesale

Clauses 344 to 346 relate to the supply of scheduled medicines by wholesale. Supplying scheduled medicines by wholesale is a controlled activity, and a person must not supply scheduled medicines by wholesale unless the person—

  • is authorised to do so by the regulations (clause 345):

  • holds a licence to do so (whether as a fixed or mobile vendor) and is complying with the terms and conditions imposed by or under the licence (clause 346(a) and (c)):

  • is an employee of a person who holds a licence to do so as a fixed vendor and is complying with the terms and conditions of the licence (clause 346(b)):

  • is deemed to hold a licence to supply scheduled medicines by wholesale as a fixed vendor under clause 518(3), being a licence that has been issued under the Misuse of Drugs Act 1975 to sell by wholesale a controlled drug that is also a prescription medicine (clause 346(d)).

A person who supplies scheduled medicines by wholesale other than under the authority of clause 345 or 346 commits an offence (clause 344(2)).

Supplying scheduled medicines other than by wholesale

Clauses 347 to 357 relate to the supply of medicines other than by wholesale. Supplying scheduled medicines other than by wholesale is a controlled activity.

Clause 347 makes it an offence to supply a scheduled medicine other than by wholesale without doing so under the authority of any of clauses 348 to 356.

Clause 348 provides that a prescriber (being an authorised prescriber or a designated prescriber) may supply scheduled medicines other than by wholesale to—

  • a patient under his or her care or a person who has care of his or her patient; or

  • another prescriber at his or her request; or

  • to another prescriber's patient, or a person who has care of that prescriber's patient, at the other prescriber's request.

Clause 349(1) provides that a pharmacist may supply scheduled medicines other than by wholesale—

  • in a hospital, if that is where the pharmacist is employed; or

  • in a pharmacy.

Clause 349(2) clarifies that, despite being authorised to supply scheduled medicines other than by wholesale under subclause (1), there are certain other factors that need to be complied with when supplying prescription medicines or pharmacist-only medicines. For example, prescription medicines need to be supplied in accordance with a prescription or standing order (clause 349(2)(a)).

Clause 350 provides that a veterinarian may supply scheduled medicines other than by wholesale for the treatment of an animal under his or her care or an animal under the care of another veterinarian.

Clauses 351 to 353 describe the limited circumstances in which an employee working with a prescriber, pharmacist, or veterinarian may supply scheduled medicines other than by wholesale.

Clause 354 provides that a person may supply scheduled medicines other than by wholesale if the person is deemed to hold a licence under clause 518(4) and the person complies with the licence.

Clause 355 sets out the circumstances in which a person may supply pharmacy medicines other than by wholesale under a licence and as an employee of a licence holder of that kind.

Clause 356 provides that a person may supply a scheduled medicine other than by wholesale if authorised to do so by regulations or a standing order.

Clause 357 provides that supply of a scheduled medicine, under clause 456, to a medicines control officer is not supply other than by wholesale for the purposes of clause 347.

Standing orders for supply of scheduled medicines other than by wholesale

Clause 358(1) allows an authorised prescriber to issue a standing order authorising a specified class of persons to supply prescription medicines or pharmacist-only medicines other than by wholesale to any specified class of persons, in certain circumstances. Similar powers are provided to veterinarians under subclause (2).

Supplying medicines by auction

Supplying medicines by auction is also a controlled activity. Clause 359 makes it an offence for a person to supply medicines by auction.

Supplying medicines by vending machine

Clause 360 makes it an offence to undertake the controlled activity of supplying medicines by vending machine unless the person is authorised to so by the regulations.

Dispensing medicines

Clause 361 makes it an offence for a person to undertake the controlled activity of dispensing medicines other than under the authority of any of clauses 362 to 368.

Clauses 362 to 366 describe the circumstances in which medicine may be dispensed by—

  • prescribers, who may dispense medicines to the same persons they may supply scheduled medicines to other than by wholesale (clause 362):

  • pharmacists, who may dispense a medicine in the course of pharmacy practice (clause 363):

  • dispensary technicians, pharmacy graduates, pharmacy students, and pharmacy technicians, who may dispense medicines in a pharmacy, but if the medicine is a prescription medicine, only when under the direct supervision of a pharmacist (clause 364):

  • veterinarians, who may dispense medicines for the purposes of the treatment of an animal under his or her care or under the care of another veterinarian (clause 365):

  • employees who work with veterinarians, who may dispense medicines in certain limited circumstances (clause 366).

Clause 367 provides that a person may dispense medicines if authorised to do so by the regulations.

Clause 368 describes the circumstances in which a licence holder and the licence holder's employees may dispense medicines by using an automated dispensing machine.

Prescribing prescription medicines

Prescribing prescription medicines is a controlled activity. Clause 369(1) makes it an offence for a person to prescribe prescription medicines unless the person is a prescriber or a veterinarian. Clause 369(2) to (4) provides that—

  • authorised prescribers may only prescribe prescription medicines under the authority of clause 370; and

  • a designated prescriber may only prescribe prescription medicines under the authority of clause 371; and

  • veterinarians may only prescribe prescription medicines under the authority of clause 372.

Clause 370 describes the circumstances in which an authorised prescriber may prescribe prescription medicines. Authorised prescribers are limited to prescribing prescription medicines for the treatment of patients—

  • under the prescriber's care or the care of another prescriber at that prescriber's request; and

  • who are in New Zealand or are usually permanently resident in New Zealand, but are outside New Zealand for a limited period.

Under clause 371(1), a designated prescriber is subject to the same restrictions as an authorised prescriber. In addition, a designated prescriber may only prescribe prescription medicines that are specified in—

  • a prescribing notice issued by the prescribing authority with which the designated prescriber is registered; or

  • regulations made under clause 501.

Clause 372 describes the circumstances in which veterinarians may prescribe prescription medicines. These are limited to the treatment of an animal under the veterinarian's care or under the care of another veterinarian, at that veterinarian's request.

Prescribing notices

Clause 373 relates to the requirements for prescribing notices issued by prescribing authorities. A prescribing authority (being a health authority that has designated prescribers registered with it) must, under clause 373(1), issue a prescribing notice in the Gazette, specifying—

  • the prescription medicines that designated prescribers registered with the authority may prescribe; and

  • the circumstances in which those prescription medicines may be prescribed.

Clause 373(2) provides that subclause (1) does not apply to a prescribing authority if regulations have been made under clause 501. Regulations are made under clause 501 on the recommendation of the Minister, in circumstances where he or she is dissatisfied with the outcome of exercising his or her powers under Schedule 4.

Clause 373(3)(a) restricts the types of prescription medicines that may be included in a prescribing notice to prescription medicines that are directly related to the designated prescribers' scope of practice. Clause 373(3)(b) provides that the prescribing authority may only include a prescription medicine in a prescribing notice after considering all relevant public health and safety concerns. Clause 373(4) clarifies that a prescribing notice may impose conditions or restrictions on the circumstances in which a designated prescriber may prescribe prescription medicines listed in a prescribing notice. Clause 373(5) enables a prescribing notice to include a complete prohibition on prescribing certain prescription medicines in certain circumstances.

Clause 374 requires a prescribing authority to review a prescribing notice no later than 6 months after it is issued. A review must consider—

  • whether a prescription medicine that is not specified in a prescribing notice should be included; and

  • whether a prescription medicine that is specified in a prescribing notice should no longer, because of public health and safety concerns, continue to be included.

Clause 375 requires a prescribing authority to—

  • make available for inspection a consolidated list of prescription medicines that designated prescribers registered with the prescribing authority may prescribe; and

  • ensure that copies of the list may be bought at reasonable cost.

Clause 376 enables the Minister to use the powers set out in Schedule 4 in relation to a prescribing authority's obligations under clauses 373 to 375.

Administering prescription medicines

Administering prescription medicines is also a controlled activity. Clause 377 makes it an offence for a person to administer prescription medicines in the knowledge that he or she is not authorised to do so under any of clauses 378 to 380.

Clauses 378 and 379 describe the circumstances in which prescribers and veterinarians may administer prescription medicines.

Clause 380 permits a person to administer prescription medicine if—

  • directed by the prescriber or veterinarian who prescribed the medicine; or

  • authorised by the regulations; or

  • authorised under a standing order issued under clause 381.

Standing orders authorising administering certain medicines

Clause 381 enables authorised prescribers and veterinarians to issue standing orders allowing a specified class of persons to administer, to a specified class of persons in specified circumstances, specified prescription medicines or pharmacist-only medicines.

Possessing prescription medicines

Possessing prescription medicines is a controlled activity. Clause 382 makes it an offence for a person to possess prescription medicines without a reasonable excuse or sufficient authority.

Clause 383(1) describes some of the circumstances in which a person has a reasonable excuse for possessing prescription medicines. Clause 383(2) provides that the fact that a person did not know that a medicine was a prescription medicine is not, in itself, a reasonable excuse.

Operating pharmacy

Operating a pharmacy is also a controlled activity. It is an offence, under clause 384, for a person to operate a pharmacy unless—

  • the person holds a licence to operate the pharmacy; and

  • the pharmacy is under the immediate supervision and control of a pharmacist.

Subpart 2Instruments prohibiting and restricting activities with medicines

Clause 385 provides an outline of subpart 2.

Clause 386 provides that, even if an activity is otherwise authorised under Parts 6 and 7, it may be restricted or prohibited in the limited circumstances provided for by a prohibition notice, restriction notice, or statement relating to dependency issued under this subpart.

Minister may prohibit certain activities

Clause 387 enables the Minister, if he or she believes there is a risk to public health and safety, to prohibit—

  • a specified prescriber or veterinarian from prescribing specified prescription medicines or a class or description of prescription medicines:

  • a specified person from undertaking any activity that he or she is otherwise authorised to undertake by or under Parts 6 and 7. This prohibition may be general or in relation to a specified medicine or class or description of medicine.

A prohibition notice issued under clause 387 must be notified in the Gazette. Under clause 387(3) a person who contravenes a prohibition notice commits an offence.

Clause 388 requires that a prohibition notice issued under clause 387 be made on the recommendation of—

  • the appropriate health authority in the case of a prescriber; or

  • the Veterinary Council of New Zealand (Veterinary Council) in the case of a veterinarian.

The health authority or the Veterinary Council may conduct an inquiry in order to determine whether a recommendation should be made. The organisation conducting the inquiry have the powers set out in Schedule 5.

Restriction notice

Clause 389 relates to restriction notices. A restriction notice may be issued by a Medical Officer of Health who has been authorised to do so by the Director-General under section 510. A restriction notice restricts prescribers and persons supplying medicines from prescribing or supplying a prescription medicine or pharmacist-only medicine to a named individual (the restricted individual).

Clause 390 makes it an offence for a person to knowingly prescribe or supply prescription medicines or pharmacist-only medicines to a restricted individual.

Clause 391 makes it an offence for a restricted individual to procure or attempt to procure a prescription medicine or pharmacist-only medicine from a person whom the restricted individual knows, or ought to know, is restricted from prescribing or supplying the medicine.

Clause 392 enables a restricted individual to appeal or to seek a review of a restriction notice in the manner set out in Schedule 6.

Statement relating to dependency

Clause 393 enables a Medical Officer of Health, who has been authorised by the Director-General under section 510, to issue a statement of dependency in respect of an individual's dependency on a prescription medicine or pharmacist-only medicine.

Subpart 3Licences

Clause 394 provides an outline of subpart 3. Subpart 3 contains provisions about the following types of licences:

  • licences to supply scheduled medicines by wholesale as fixed vendors:

  • licences to supply scheduled medicines by wholesale as mobile vendors:

  • licences to supply pharmacy medicines other than by wholesale:

  • licences to dispense medicines using automated dispensing machines:

  • licences to operate pharmacies.

Applying for licence

Clause 395 sets out who may apply for a licence.

Clause 396 sets out how an application for a licence must be made.

Contents of application

Clause 397 requires an applicant for a licence to supply or dispense medicines to specify in the application the type of medicines for which the licence is sought. An application for a licence to operate a pharmacy must include the particulars required by clause 421.

Clause 398 requires an application for a licence to contain sufficient information to enable a licensing authority to make a decision under clause 399. Clause 398(2) provides that the licensing authority may require further information from an applicant.

Granting of licence

Clause 399 specifies criteria that the licensing authority must be satisfied of before granting a licence. The criteria include, without limitation,—

  • that applicant is eligible to apply for a licence; and

  • that the applicant is not disqualified from holding a licence; and

  • that the application contains all requested information; and

  • that the applicant has sufficient knowledge of the obligations of the licence and the hazards associated with the medicines to which it will, if granted relate; and

  • that the premises and equipment the applicant proposes to use are adequate and suitable.

Clause 400 provides additional criteria in respect of which a licensing authority must be satisfied before granting a licence to supply pharmacy medicines other than by wholesale.

Refusal of licence

Clause 401 requires the licensing authority to give an applicant who is refused a licence—

  • a reasonable opportunity to be heard; and

  • the written reasons for refusal, if the applicant so requests.

Authority conferred on licence holder by licence

Clauses 402 to 406 describe the authority conferred on the holder of a licence to—

  • supply scheduled medicines by wholesale as a fixed vendor (clause 402):

  • supply scheduled medicines by wholesale as a mobile vendor (clause 403):

  • supply pharmacy medicines other than by wholesale (clause 404):

  • dispense medicines by using an automated dispensing machine (clause 405):

  • operate a pharmacy (clause 406).

Conditions of licence

Clause 407 relates to conditions imposed on a licence. Licence holders must, as a condition of every licence issued under Parts 6 and 7, continue to comply with the criteria referred to in clause 399. Conditions on a licence may be imposed by the licensing authority or by the regulations.

Clause 408 requires the licensing authority to provide, at the licence holder's request, written reasons explaining why a condition is imposed on a licence.

Clause 409 states that a condition of a licence takes effect from the date it is imposed. Clause 409(2) also enables the licensing authority to alter or cancel a licence if the licence holder fails to comply with a condition of the licence.

Suspending, cancelling, and disqualifying holding of licence

Clause 410 provides that if a licence holder gives materially false or misleading information in an application for a licence, the licence may be suspended and eventually cancelled.

Clause 411 requires the licensing authority to provide, at the request of a licence holder, written reasons for cancelling the licence.

Clause 412 sets out the powers of the court in respect of a licence holder who is charged with, or convicted of, an offence under Parts 6 and 7 or the regulations.

Clause 413 requires a licence holder, whose licence has been cancelled or endorsed by a court, to produce the licence as the court directs. Under clause 413(2), a person who fails to produce the licence commits an offence.

Duration of licence

Clause 414 states the duration of a licence. A licence remains in force for 1 year from the date on which it is granted, unless—

  • it is sooner cancelled; or

  • clause 424 applies.

Clause 415 provides for the situation where—

  • a new licence is issued before the expiry of a current licence; or

  • a licence expires before an application for a new licence is determined.

Clause 416 requires a licence holder to surrender a licence if the licence holder has ceased to undertake the controlled activity to which the licence relates.

Register of licences and records of licensing authority

Clause 417 requires the licensing authority to keep a register of licences and any other registers or records required by the regulations.

Subpart 4Operating pharmacies

Clause 418 provides an outline of subpart 4. The requirements placed on a licence to operate a pharmacy under subpart 4 are in addition to the requirements placed on licences generally under subpart 3.

Clause 419 defines what it means to hold an interest in a pharmacy for the purposes of subpart 4. A person holds an interest in a pharmacy if the person has, or acquires, a direct or indirect estate or interest in the pharmacy that affects the ownership, management, or control of the pharmacy practice carried on in the pharmacy.

Additional information for pharmacy licence

Clause 420 ensures that a licence to operate a pharmacy is granted only to applicants who meet the additional criteria specified in subclause (1), being that the applicant—

  • is qualified under any of clauses 422 to 424; and

  • is a person who is able to satisfy the condition set out in clause 425.

The criteria apply for the duration of a licence. A licence may be cancelled if the licensing authority is satisfied that the licence holder no longer meets those criteria.

Clause 421 enables the licensing authority to require additional information (over and above that referred to in clauses 397 and 398) from an applicant for a licence to operate a pharmacy.

Companies

Clause 422 sets out the circumstances in which a company may be granted a licence to operate a pharmacy. Those circumstances are limited and are the same as the circumstances that exist under the Medicines Act 1981 (as amended by the Medicines Amendment Act 2003).

Majority interest in pharmacy

Clause 423 sets out the circumstances in which an individual may be granted a licence to operate a pharmacy or hold a majority interest in a pharmacy. Those circumstances are limited and are the same as the circumstances that exist under the Medicines Act 1981 (as amended by the Medicines Amendment Act 2003).

Mortgagees in possession

Clause 424 provides that a mortgagee in possession of a pharmacy may be granted a licence to operate that pharmacy for a limited period of 3 months or as determined by the licensing authority.

Mandatory condition on pharmacy licence

Clause 425 imposes a mandatory condition on every licence to operate a pharmacy. A licence holder must not request or require a pharmacist who is employed or engaged in duties at a pharmacy to act in a way that is inconsistent with the pharmacist's professional or ethical standards of pharmacy practice.

Clause 426 enables the licensing authority to impose penalties on a licence holder who fails to comply with a condition imposed on the licence holder's licence.

Restrictions on operating and holding interests in pharmacies

Clause 427 provides that a prescriber must not hold an interest in a pharmacy unless he or she—

  • has the consent of the licensing authority; and

  • holds the interest in accordance with any conditions or restrictions imposed by the licensing authority.

Clause 428 prohibits—

  • a company from operating more than 5 pharmacies; and

  • a pharmacist from operating more than 5 pharmacies or holding a majority interest in more than 5 pharmacies.

Fee on prescriptions

Clause 429 makes it an offence for a pharmacist, a person licensed to operate a pharmacy, or an operator or a manager of a pharmacy to give, offer, or agree to give to a prescriber or any other person any money or other consideration as a fee on prescriptions.

Subpart 5Certain requirements, restrictions, and offences associated with medicines

Clause 430 provides an outline of subpart 5.

Security, storage, and premises

Clause 431 requires that a person who holds a licence to operate a pharmacy must keep prescription medicines and pharmacist-only medicines secure from public access. A person who contravenes that requirement commits a strict liability offence.

Clause 432 sets out requirements for the storage of scheduled medicines in a person's possession or charge and makes it a strict liability offence to contravene those requirements.

Clause 433 sets out requirements relating to the storage of scheduled medicines in unattended buildings or vehicles. Non-compliance with the requirements is an offence.

Clause 434 relates to premises whose condition may cause the deterioration or contamination of any medicine. A Medical Officer of Health may prohibit such premises from being used to store medicines. It is an offence not to comply with a notice issued under this clause.

Containers and packages

Clause 435 specifies requirements for containers used for supplying, storing, or transporting medicines. A person who contravenes those requirements commits a strict liability offence.

Clause 436 requires a person who is in possession of a medicine to ensure it is in a container that complies with the relevant provisions of Parts 6 and 7 and the regulations. Failure to ensure that the container complies with the relevant requirements is a strict liability offence. A defence in a prosecution for such an offence is available under clause 436(3).

Packing and preparing medicines

Clause 437 prohibits a person from, in the course of business, packing or preparing a medicine for use in a room or on a surface used for food or drink. A person who contravenes this provision commits a strict liability offence.

Delivering medicines

Clause 438 specifies how a person must deliver medicines for the purposes of supply other than by wholesale. A person who contravenes this provision commits a strict liability offence.

Disposal of medicines

Clause 439 requires a person to dispose of a medicine in the manner prescribed by the regulations (if any). A person who fails to dispose of a medicine in the prescribed manner commits a strict liability offence.

Record keeping

Clause 440 contains requirements about records that must be kept by a person who, in the course of business, supplies medicines. A person who contravenes the requirements commits a strict liability offence.

Clause 441 provides for circumstances when persons who supply medicines in the course of business must allow the inspection of, and provide when requested, records relating to supply.

Knowingly risking public health

Clause 442 provides that it is an indictable offence to knowingly risk public health by failing or refusing to comply with a provision of Parts 6 and 7 or the regulations.

Subpart 6Enforcement and certain procedural matters

Clause 443 provides an outline of subpart 6.

Clause 444 provides definitions of important terms used in subpart 6, including article, evidential material, occupier, and place.

Medicines control officers

Clause 445 provides for the appointment of medicines control officers.

Clause 446 requires the Director-General to issue medicines control officers with an identification card. The card must state the provisions of Parts 6 and 7 that a medicines control officer is appointed to enforce and any restrictions on the medicines control officer's enforcement powers. Clause 446(4) requires a medicines control officer to produce his or her identification card for inspection—

  • on entering a place; or

  • on request when exercising a power under subpart 6.

Powers of entry, search, and seizure

Clause 447 enables a medicines control officer to enter a place (except a dwellinghouse or marae) at any reasonable time, to determine whether a person is complying with Parts 6 and 7. Clause 447(2) lists the powers that may be exercised on entry.

Clause 448 enables a medicines control officer or a member of the police to enter a place (other than a dwellinghouse or marae) if he or she has reasonable grounds to believe that—

  • Parts 6 and 7 are not being complied with; and

  • it is necessary in the interests of public health; and

  • it is not practicable to obtain a search warrant.

Clause 449 empowers a District Court Judge, Community Magistrate, Justice of the Peace, or Registrar to issue a search warrant on application, if he or she is satisfied that—

  • there are reasonable grounds to believe that there is evidential material at the place to which the warrant relates; or

  • a search is unable to be conducted or completed under clause 447 or 448 for any reason.

Clause 450(1) lists the powers that may be exercised under a search warrant issued under clause 449 (those powers include the ability to use reasonable force to enter the place or open any thing). The rest of clause 450 sets out certain matters relating to executing a search warrant, including, for example, the requirement to leave a written inventory of things seized.

Matters associated with search

Clause 451 provides that an occupier whose place is being searched may observe the search as long as he or she does not impede it.

Clause 452 relates to the use of electronic equipment found at a place during a search. Medicines control officers and members of the police must take care not to damage the equipment or corrupt information stored on it.

Clause 453 provides that documents seized from a place must, if practicable, be copied before the original is removed.

What happens to seized property

Clause 454 provides for the disposal of things that have been seized.

Clause 455 enables a medicines control officer to apply for an order to retain for more than 6 months any thing that has been seized under this subpart.

Analysis of samples

Clause 456 sets out how a medicines control officer must obtain a sample for analysis other than under a search warrant.

Clause 457 contains provisions relating to the analysis of a sample and the certificate of the analyst.

Clause 458 provides for how a certificate of analysis may be admissible as evidence.

Clause 459 enables a court to order a person who is convicted of an offence (the defendant) to pay the fees and expenses of the testing or analysis.

Wilfully obstructing

Clause 460 makes it an offence for a person to willfully obstruct a medicines control officer or member of the police, or person assisting a medicines control officer or member of the police, who is exercising powers under this subpart.

False or misleading statement, declaration, or answer

Clause 461 makes it an offence for a person to knowingly—

  • make a false or misleading declaration, statement, or answer; or

  • create or produce a false of misleading document; or

  • create, produce, or make use of a document that is not genuine.

Powers of Director-General and Medical Officer of Health

Clause 462 enables the Director-General or a Medical Officer of Health to require, in certain circumstances, the production of any document or record.

Clause 463 makes it an offence to fail or refuse to produce a document or record required under clause 462.

Disclosure of information

Clause 464 provides for certain agencies to be able to disclose to each other information (that they are otherwise unable to disclose under information privacy principles 2 and 11 of the Privacy Act 1993)—

  • in order to ensure the health and well-being of persons using or dealing with medicines; or

  • for the purposes of maintaining the law, including the prevention, investigation, and detection of offences under Parts 6 and 7 and other listed enactments.

Matters relating to proceedings

Clause 465 states when an information may be laid under Parts 6 and 7 or the regulations and provides for matters that must be served with any summons issued.

Clause 466 provides for the service of documents in proceedings under Parts 6 and 7.

Clause 467 states a presumption that in proceedings, unless the contrary is proved, the contents of a container are the same as the description of its contents on the label.

Clauses 468 and 469 set out presumptions relating to—

  • the certificate purported to be signed by the licensing authority:

  • the authenticity of copies of documents or records.

Matters arising from conviction

Clause 470 provides for the forfeiture of certain articles of a person being convicted of an offence under Parts 6 and 7 or the regulations.

Clause 471 requires the Court to send the particulars of the conviction of a health practitioner or veterinarian to the appropriate health authority, in the case of a health practitioner, or the Veterinary Council, in the case of a veterinarian.

Matters effecting liability

Clause 472 specifies which offences under Parts 6 and 7 are strict liability offences and explains key aspects of the prosecution and defence in respect of strict liability offences.

Clause 473 specifies the liability of an employer for the actions of an employee who commits an offence under Parts 6 and 7 or the regulations and sets out the defence available to the employer in such proceedings.

Clause 474 specifies the liability of directors and persons involved in the management of a body corporate where the body corporate contravenes Parts 6 and 7.

Clause 475 provides protection from civil or criminal liability for persons acting under any of the functions conferred by or under Parts 6 and 7.

Subpart 7Appeals

Clause 476 provides an outline of subpart 7.

Appeals against decision of Medical Officer of Health in respect of premises

Clause 477 sets out how a person may appeal to a District Court against a decision made under section 434 that prohibits the use of the premises for certain activities.

Licensing appeals

Clause 478 enables a person to appeal to the District Court against licensing decisions of the licensing authority.

Clause 479 provides for the status of a decision of the licensing authority pending the determination of an appeal.

Clause 480 sets out procedural matters in respect of an appeal to the District Court.

Clause 481 provides for a further appeal to the High Court, but only on a question of law and with the leave of the Court.

Clause 482 provides for the status of the decision of the District Court pending the determination of an appeal against that decision to the High Court.

Clause 483 provides that the appropriate rules of Court apply to the hearing of appeals.

Clause 484 prevents a person from being deprived of his or her right of appeal merely because the person has accepted a licence or complied with a condition or requirement of a licence.

Clause 485 requires the licensing authority to implement the decision of the Court on appeal.

Subpart 8Restrictions on xenotransplantation

Clause 486 provides a brief outline of the matters dealt with in subpart 8.

Clause 487 defines—

  • biological material; and

  • xenotransplantation.

Clause 488 makes it an offence to conduct xenotransplantation other than as provided under section 489 or 490.

Clause 489 empowers the Minister to authorise a person or persons to conduct a particular xenotransplantation. The Minister's authorisation must be published in the Gazette and presented to the House of Representatives.

Clause 490 provides that xenotransplantation may be authorised by Order in Council on the recommendation of the Minister.

Clause 491 sets out the criteria that must be satisfied before the Minister makes a recommendation under clause 490. If the Minister is not satisfied that the criteria are being met, the Minister may obtain advice from persons whom he or she considers appropriately qualified.

Clause 492 sets out options available to the Minister for the purpose of obtaining advice on the applicability of the criteria referred to in clause 491.

Clause 493 allows a person to apply to the Minister requesting—

  • authorisation to conduct xenotransplantation under clause 489; or

  • the Minister's recommendation that authorisation be granted under clause 490.

Clause 494 provides that the Crown is not liable to pay compensation for loss or damage arising from the restrictions imposed by clause 488.

Clause 495 states the enforcement powers that apply in relation to a prosecution for an offence under clause 488.

Clause 496 applies if the Director-General or a Medical Officer of Health reasonably suspects that a person possesses, in breach of Parts 6 and 7, an article for use in xenotransplantation. The Director-General or Medical Officer of Health may require that person to produce any document or record relating to the prohibited article.

Clause 497 makes an offence for a person to fail or refuse to produce any document or record required under clause 496.

Clause 498 provides for the expiry of subpart 8 on 31 December 2008. There is a power to extend that date by Order in Council.

Subpart 9Regulations, Orders in Council, ministerial notices, and other instruments

Regulations

Clause 499 authorises the making of regulations for the purposes specified in subclause (2).

Clause 499(2) includes a range of purposes associated with activities that are authorised under Parts 6 and 7. The regulations are made on the advice of the Minister obtained after consulting organisations and bodies likely to be substantially affected by the regulations.

Regulations designating designated prescribers

Clause 500 authorises the making of regulations designating certain health practitioners as designated prescribers.

Regulations relating to prescribing notices

Clause 501 authorises the making of regulations on the recommendation of the Minister, that—

  • revoke prescribing notices relating to a particular class of designated prescribers:

  • prescribe prescription medicines that designated prescribers are authorised to prescribe, and the circumstances in which those prescription medicines may be prescribed:

  • prescribe conditions or restrictions on the circumstances in which certain prescription medicines may be prescribed:

  • prohibit the prescribing of certain prescription medicines.

Before recommending the making of regulations under clause 501, the Minister must undertake the steps set out in Schedule 4 and must be satisfied that there is a risk to public health and safety.

Regulations designating authorised prescribers

Clause 502 authorises the making of regulations for designating health practitioners (who are already designated prescribers) as authorised prescribers.

Regulations relating to qualifications, training, and competence of prescribers and veterinarians when prescribing

Clause 503 authorises the making of regulations in respect of qualifications, training, and competence requirements of prescribers and veterinarians when prescribing prescription medicine.

Regulations relating to pharmacy ownership and operation

Clause 504 authorises the making of regulations to provide exemptions from, or modifications of, the restrictions on pharmacy ownership and operation set out in clause 422(1) (in the case of a company) and clause 423(1) (in the case of a person other than a company). The regulations are made on the recommendation of the Minister. The Minister must not recommend the making of the regulations unless he or she considers that the proposed regulations—

  • will improve health services or access to those services; and

  • are necessary to meet the needs of the community in the particular location of the pharmacy or proposed pharmacy.

Approval and appointments relating to laboratories and analysts

Clause 505 provides that the Minister may approve by notice in the Gazette a laboratory for the purposes of Parts 6 and 7.

Clause 506 provides that the Minister may appoint, by notice in the Gazette, an analyst in charge of an approved laboratory.

Clause 507 authorises an analyst appointed by the Minister under clause 506 to authorise a person to act as an analyst for the purposes of Parts 6 and 7.

Appointment of advisory and technical committees

Clause 508 provides for the appointment of an advisory or technical committee to advise the Minister on matters dealt with in Parts 6 and 7 or the regulations.

Certain powers of Director-General

Clause 509 enables the Director-General to publish, for the purpose of protecting the public, statements in relation to any activities undertaken with medicines under Parts 6 and 7.

Clause 510 provides that the Director-General may authorise a Medical Officer of Health to issue restriction notices or statements relating to dependency.

Subpart 10Scheduled medicines and referring to medicines

Scheduled medicines

Clause 511 defines the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP) as the electronic register containing the Managing Director's listings of scheduled medicines and poisons, including any additions to that register.

Clause 512 provides definitions of prescription medicine, pharmacist-only medicine, and pharmacy medicine. Each type of medicine requires—

  • a listing in the relevant schedule of the (SUSMP); or

  • a declaration by the Minister by notice in the Gazette.

Clause 513 enables the Minister to declare a medicine to be a prescription medicine, pharmacist-only medicine, or pharmacy medicine. The declaration must be made by notice in the Gazette.

Clause 514 enables the Minister to depart from the listing of a scheduled medicine in the SUSMP by notice in the Gazette.

Clause 515 requires the Director-General to keep an Internet register of all declarations and departures of scheduled medicines made under clauses 513 and 514.

Clause 516 provides that a certified copy of the SUSMP, or an extract of it, is prime facie evidence of the matters contained in it. Evidence of a Gazette notice issued under subpart 10 is covered by section 46 of the Evidence Act 1908.

Referring to medicines

Clause 517 provides that an individual, person, or body who is required by Parts 6 and 7 to specify medicine may do so by reference to its name or trade name or its pharmacological action.

Subpart 11Miscellaneous matters

Relationship to other enactments

Clause 518 describes the relationship between Parts 6 and 7 and the Misuse of Drugs Act 1975. Except as specified in subclauses (1) to (5) of clause 518, the Misuse of Drugs Act 1975 overrides Parts 6 and 7.

Transitional regime for designated prescribers

Clause 519 provides for how designated prescribers appointed under the Medicines Act 1981 (the former Act) may continue to be designated prescribers under Parts 6 and 7.

Transitional regime for standing orders

Clause 520 continues the effect of standing orders issued under the former Act.

Transitional regime for licences

Clause 521 deals with applications made, but not determined, under the former Act for licences to sell medicines by wholesale.

Clause 522 relates to licences to sell medicines by wholesale that were granted under the former Act.

Clause 523 deals with applications made, but not determined, under the former Act for licences to sell medicines by retail.

Clause 524 relates to licences to sell medicines by retail that were granted under the former Act.

Clause 525 deals with applications made, but not determined, under the former regulations for a licence to hawk medicines.

Clause 526 relates to licences to hawk medicines that were granted under the former regulations.

Clause 527 provides for applications made, but not determined, under the former Act for a licence to operate a pharmacy.

Clause 528 deals with licences to operate a pharmacy that were granted under the former Act.

Clause 529 relates to other types of licences that were granted under the former Act, and provides that such licences may be deemed to be a licence under Parts 1 to 5.

Clause 530 provides for conditions on licences that are deemed to be licences under Parts 6 and 7.

Transitional regime for proceedings and appeals under former Act

Clauses 531 and 532 provide for proceedings and appeals that were commenced under the former Act.

Transitional regime for officers under former Act

Clause 533 provides for employees of the Ministry appointed under the former Act.

Clause 534 prevents claims for payment or compensation against the Crown for loss of office or appointment held under the former Act.

Transitional regime for xenotransplantation

Clause 535 provides for the transition of any authorisation relating to xenotransplantation issued by the Minister under the former Act.

Transitional regime for approved laboratory and analyst under former Act

Clause 536 deems laboratories approved under the former Act as approved laboratories for the purposes of Parts 6 and 7.

Clause 537 provides for analysts authorised under the former Act.

Repeal

Clause 538 repeals the Medicines Act 1981.

Clause 539 provides for the ability to make transitional and savings regulations.

Clause 540 provides that clause 539 expires on the date that is 2 years from its commencement.

Revocations

Clause 541 revokes the regulations and orders specified in Schedule 7.

Savings

Clause 542 preserves the validity of actions done under the former Act or former regulations (listed in Schedule 7).

Clause 543 saves the Medicines (Approved Laboratories and Analysts in Charge) Notice 2000.

Clause 544 saves the Medicines (Standing Order) Regulations 2002.

Clause 545 saves the Medicines (Designated Prescriber: Nurse Practitioners) Regulations 2005.

Clause 546 saves the Medicines (Designated Prescriber: Optometrists) Regulations 2005.

Clause 547 saves Orders in Council made under section 96D(1) of the former Act that authorise the conduct of 1 or more classes of specified biotechnical procedure.

Consequential amendments

Clause 548 provides for consequential amendments to the enactments specified in Schedule 8.

Schedules

Schedule 1 sets out the full text of the Agreement.

Schedule 2 sets out procedural provisions relating to the Review Tribunal established under Part 3.

Schedule 3 contains substantive amendments to other enactments relating to the establishment of the Authority. These include provisions such as the amendment to the Ombudsmen Act 1975 which inserts the Authority into Part 2 of Schedule 1, which has the effect of making the Authority subject to both that Act and the Official Information Act 1982.

Schedule 4 sets out the powers of the Minister (under Part 7) in relation to prescribing authorities' obligations.

Schedule 5 sets out the powers of health authorities or the Veterinary Council (under Part 7) when making an inquiry under clause 388(2).

Schedule 6 sets out the procedures associated with reviews and appeals of restriction notices.

Schedule 7 lists regulations and orders revoked as a consequence of the repeal of the Medicines Act 1981.

Schedule 8 sets out consequential amendments relating to the enactment of both Parts 1 to 5 and Parts 6 and 7.

Regulatory impact and compliance cost statement for Parts 1 to 5

Problem definition

New Zealand's regulatory framework for therapeutic products is outdated, unsustainable and in need of reform. It does not adequately manage the public health risks associated with the use of medical devices and medicines. In addition, while the basic regulatory framework for pharmaceuticals is sound, its operation is unsustainable.

Pharmaceuticals

Pharmaceuticals (prescription and over-the-counter medicines) have significant health benefits, but can present serious risks, especially if used inappropriately. Before a pharmaceutical product can be offered for supply in New Zealand, the distributor must obtain the consent of the Minister of Health. Applications for consent are assessed by Medsafe to ensure that the benefits of use outweigh the risks if the product is used appropriately, and to identify any appropriate special requirements or restrictions on supply.

While the current regulatory approach is consistent with international best practice, the regime is unsustainable for New Zealand. As pharmaceuticals become increasingly complex and sophisticated, it is becoming increasingly difficult for New Zealand to maintain the expertise necessary to evaluate new products when such expertise is in short supply globally. Without adequate technical expertise, Medsafe will be unable to meet the regulatory objectives for pharmaceuticals within acceptable time-frames.

Complementary medicines

Most complementary medicines contain ingredients with a very low inherent risk. Most of the risk arises from poor quality in manufacture, or from distributors making unsubstantiated and sometimes outrageous claims about the health benefits of products.

Risks arising from poor quality in manufacture can include—

  • under or over potency, or complete absence of ingredients stated on the label:

  • poor formulation leading to non-availability of active ingredients:

  • adulteration with undeclared ingredients (including prescription medicines such as steroids), or substitution of a toxic herbal ingredient for the ingredient stated on the label:

  • inaccurate or incomplete labelling, such as non-disclosure of ingredients, or inadequate dosage instructions and warning statements to enable the product to be used safely:

  • contamination with heavy metals, microbes, radioactivity or other ingredients used by the manufacturer.

Unsubstantiated claims that a product can prevent or treat a serious disease result in a serious risk to the vulnerable consumer who believes the claim and either stops taking prescribed medication or fails to seek appropriate medical treatment.

In New Zealand, complementary medicines are currently marketed as foods under the Dietary Supplements Regulations 1985 (made under the Food Act 1981). The concerns with this regime are as follows:

  • therapeutic claims on dietary supplements are prohibited. However, in practice only a low level of enforcement has been possible and many are marketed with therapeutic claims, some of which are inaccurate, misleading or potentially dangerous. There is currently widespread and constant distribution (in leaflets and magazines, and on websites) of advertisements for complementary medicines making unsubstantiated therapeutic claims including those for the prevention or treatment of serious diseases such as cancer, tuberculosis, diabetes, heart disease and obesity:

  • manufacturing standards for food are not adequate for complementary medicines presented in pharmaceutical dose forms, where appropriate formulation, quality in the manufacturing process, and accuracy of labelling and dosage are essential to the safety, effectiveness and appropriate use of the product. It is estimated that up to 10% of the total retail sales value of dietary supplements in New Zealand comes from products manufactured in premises in New Zealand or overseas that do not meet the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods (Good Manufacturing Practice) standards. Consumers purchasing products have no way of identifying which products are of high quality and therefore safe to use:

  • there is no requirement for new ingredients used in dietary supplements to undergo any pre-market safety assessment, or for products to be registered. There is therefore no safety check on ingredients being used, and no register of products or distributors to facilitate efficient investigation and product recall when a safety alert arises:

  • because it is illegal to make therapeutic claims for dietary supplements, manufacturers and distributors are unable to lawfully provide consumers with the information they need to choose products wisely and use them safely. In many instances consumers are not provided with information about contra-indications, adverse effects or interactions even when these are well recognised and may have a significant influence on whether they can safely use the product.

Medical devices

Medical devices include products ranging from very low risk (eg, gauze dressings) to high-risk devices such as heart valves, which, if they fail, could lead to severe harm or death, with all the associated personal and social costs.

In contrast to most developed countries, New Zealand does not require medical devices to be approved before being marketed. Medsafe's role is limited to market surveillance and dealing with safety issues as they emerge. Because there is no register of medical devices, this is inefficient and costly.

The vast majority of medical devices are imported, mainly from the US, Europe, Japan, and Australia, where devices are required to be registered. Most medical devices in use in New Zealand would therefore meet adequate safety standards, particularly as world standards converge around the Global Harmonization Task Force (GHTF) requirements. However, without similar standards applying in New Zealand, there is a risk that poor quality product that cannot be sold overseas will be dumped on the New Zealand market, with potentially serious health risks. Anecdotal evidence also suggests that the overall risk to consumers from medical devices is increasing.

Magnitude of risk

Risk cannot be eliminated. From society's point of view, the objective is to achieve an appropriate risk reduction at reasonable cost. While lack of data makes it difficult to quantify the risk for complementary medicines and medical devices, the risk can be significant, resulting in serious injury and death.

In most developed countries, regulatory arrangements for therapeutic products are predicated on the assumption that the costs of harm are likely to be far greater than the costs of policies aimed at reducing risk. For medical devices and complementary medicines, New Zealand's regulatory regime is out of step with international practice and World Health Organization recommendations. Given the rising risk profile as products become more widely used and more sophisticated, and the existing evidence of problems and their consequences (discussed above), there is a prima facie case for policy intervention.

Trans-Tasman Mutual Recognition Arrangement (TTMRA)

In the context of closer economic relations (CER), the Australian Commonwealth, States and Territories and New Zealand committed to the Trans-Tasman Mutual Recognition Arrangement (TTMRA) in 1998. One of its objectives is to allow goods and services legally traded in Australia to be also traded without regulatory impediment in New Zealand, and vice versa.

Therapeutic products are 1 of 6 areas where mutual recognition has not yet been achieved. Australian and New Zealand Health Ministers concluded that mutual recognition in any area of the program would not be acceptable at this time, or in the future, unless there were significant changes in the legislative framework that lead to a greater convergence in regulatory arrangements in the two countries.

Public policy objectives

Health objectives

The primary policy objective is to manage the risks to public health and safety from avoidable harm associated with the use of therapeutic products. In particular, to regulate therapeutic products for safety, quality and efficacy to ensure that the benefits of use will outweigh the risks if the product is used appropriately; to regulate products in accordance with international best practice, adopting a globally harmonised approach where possible; and to ensure that health and safety objectives are met while minimising costs to business and Government, and without imposing unnecessary trade barriers.

Wider objectives

Policy options can have different impacts on the Government's objectives for trade and industry development. In the context of therapeutic products, secondary policy objectives are—

  • progression of CER:

  • facilitation of trans-Tasman trade in therapeutic products:

  • facilitation of exports of therapeutic products beyond Australia:

  • development of the therapeutic products industry in New Zealand, including research and development.

Feasible options

Non-regulatory options

There are no non-regulatory options that would adequately achieve the health and safety objectives.

In an unregulated but highly competitive market, there would be a lack of incentive for suppliers of therapeutic products to provide balanced information about the benefits and risks of their products. Consumers would find it extremely difficult or impossible to identify quality product from substandard and potentially harmful product, or to take a case under consumer protection legislation because of the high burden of proof required.

Public education programmes (designed to enable consumers to evaluate the benefits and risks of products, make informed choices and use products safely), would not be effective, since most consumers do not have the knowledge or skills required to assess the accuracy or completeness of the available information or to interpret that information appropriately.

Regulatory options

Four regulatory options have been identified.

Continuation of the status quo

Under this option the main focus would be on evaluating and approving pharmaceuticals and on post-market monitoring functions. There would be no pre-market requirements for medical devices. Dietary supplements would remain under food legislation with therapeutic claims prohibited. The current Medsafe budget is $6.7 million, of which $2.9 million is Crown funding and the remainder comes from fees paid by industry.

Enhancing the regulatory framework, with local evaluation to international standards

Under this option, the regulatory framework would be extended to incorporate pre- and post-market controls for the full range of therapeutic products—prescriptions and over-the-counter medicines, complementary medicines and medical devices. There would be local evaluation to international standards, and mutual recognition arrangements with other reputable regulators for some aspects (such as evaluation of medical devices and assessment of good manufacturing practice).

A global shortage of expertise in evaluating increasingly specialised high-tech products makes it unlikely Medsafe could recruit the additional staff required under this option. The estimated budget for Medsafe regulating the full range of therapeutic products to international standards is $43 million per annum.

Enhancing the regulatory framework, but adopting a unilateral recognition scheme

Under this option, the regulatory framework would be extended to incorporate pre- and post-market controls for the full range of therapeutic products. Local evaluation would not occur. Instead, evaluations carried out by competent overseas regulatory authorities would be recognised by Medsafe. Products intended only for the New Zealand market and not approved by any of the recognised overseas authorities would be evaluated under contracts with other regulators that would be managed by Medsafe.

New Zealand would maintain a list of overseas regulatory authorities in whom it had confidence, and only evaluations carried out by those authorities would be recognised for the purposes of approving products for the New Zealand market. New Zealand would have no input into the standards or procedures adopted by those overseas authorities, and no direct access to their medical and scientific expertise. The scheme would be backed up by enhanced local post-market surveillance in recognition of the increased potential for New Zealand to receive product that did not match the safety, quality and efficacy standards of that originally evaluated.

The estimated annual budget for Medsafe operating a unilateral recognition scheme covering all therapeutic products is $29.4 million.

Establishing a joint Australia/New Zealand therapeutic products agency

Under this option, New Zealand and Australia would adopt a single comprehensive regulatory scheme for all therapeutic products marketed in either country. The scheme would be administered by a single trans-Tasman regulatory agency, applying international best practice.

The agency would operate on the basis of full cost recovery with an estimated annual budget of $68 million. The New Zealand industry's share of these costs is estimated at $20 million per annum, based on the assumption that 30% of product licence holders will be based in New Zealand.

Ministers agreed in principle to the establishment of a joint trans-Tasman agency to regulate therapeutic products supplied in Australian and New Zealand markets in December 2000, subject to the development of governance arrangements satisfactory to New Zealand.

The proposed governance arrangements would ensure an equal voice for each country through a Ministerial Council consisting of the Australian Commonwealth and New Zealand Ministers of Health. A Board, appointed by the Ministerial Council, would be accountable to the Ministerial Council for the strategic and financial direction of the agency. The Managing Director would be accountable to the Board for financial and administrative matters, and would be the statutory decision maker accountable to stakeholders through an internal appeal process as well as external judicial review and merits review mechanisms.

Options for resolving the existing special exemption under the TTMRA

The current Special Exemption for therapeutic products will expire on 30 April 2007 and a further 12-month extension will be sought. The longer-term options are permanent exemption, harmonisation of regulatory requirements, or mutual recognition.

Mutual recognition is not a feasible option because New Zealand does not have a sustainable regulatory capacity, the regulatory frameworks are not matched, and there is not an acceptable level of confidence that equivalent regulatory outcomes are achievable under the existing separate schemes. Creation of a joint regulatory scheme is a specialised form of harmonisation that would achieve the trade objectives of the TTMRA, whereas permanent exemption would maintain current trade barriers.

Net benefit of the proposal

A lack of accurate data about some sectors of the therapeutic products industry, the products they market, and the risks arising from use of those products means that any analysis of the costs and benefits is reliant on a qualitative assessment of whether or not any change from the status quo would be of net benefit to New Zealand society. This assessment involves making a judgement about—

  • the additional benefits to consumer health and safety and the value of better information for consumers; and

  • the value to New Zealand of potential additional trade opportunities, and improved trans-Tasman and international relationships.

Enhancing the regulatory framework with local evaluation to international standards would fail to meet public health and safety objectives, as it would not be viable in light of the global shortage of appropriate expertise. It is already very difficult to get the expertise needed to evaluate pharmaceutical products to international standards in a timely fashion, and the situation is expected to get worse over time. The same problem would occur with high-risk medical devices. Compliance costs would be high, and existing trade barriers would be maintained.

Enhancing the regulatory framework, but adopting a unilateral recognition scheme could meet public health and safety objectives and be sustainable over time. It would, however, result in a loss of New Zealand's ability to reach independent decisions about therapeutic products supplied in New Zealand or to have any voice in deciding the standards applied in evaluating products. Because of the need for enhanced post-market activities, compliance costs would be high. Existing trade barriers would be maintained and could increase if New Zealand was seen to be adopting a third-world approach to therapeutic product regulation.

Establishing a joint Australia/New Zealand therapeutic products agency would meet public health and safety objectives, and be sustainable over time. While there would be a risk that the joint scheme may not always result in decisions that were the best fit for New Zealand, this risk would be managed by ensuring New Zealand had an equal voice and there was no lesser accountability to Government, stakeholders and the public than at present. An opt-out mechanism would ensure that New Zealand would not be forced to adopt a position to which it had a fundamental objection.

The economies of scale and removal of duplication that would result from regulating jointly with Australia would lower overall administrative and compliance costs. The actual impact on New Zealand would depend on how the costs were shared between the two countries in the longer term, but the overall compliance costs for New Zealand industry would be lower in a joint scheme.

The joint agency option would also meet CER objectives. The immediate impact on trade is likely to be small, given New Zealand's significant reliance on imports from across the globe. An approval from a trans-Tasman regulator with international credibility may make it easier for local manufacturers to break into export markets. However, compared with the status quo, the added compliance costs for medical devices and complementary medicines would reduce export competitiveness and local profitability, which could result in some beneficial products not being marketed locally, and some businesses in those sectors closing.

The following table provides a summary assessment of the benefits and costs of the unilateral recognition and joint agency options, compared with continuation of the status quo.

 ConsumersIndustryGovernmentAdditional compliance cost
Unilateral recognition
BenefitsMeets health objectives throughReduced business compliance costs for pharmaceuticals to partly offset higher fees from full cost recoveryReduced cost and increased efficiency of managing product alert/recalls 
 higher standards
 better post-market surveillance
 better consumer information
 for complementary medicines and medical devices
   Reduced trans-Tasman import duties if Tariff amended to exclude complementary medicinesReliance on other regulators resolves sustainability concerns 
CostsSmall price increases likely for pharmaceuticalsHigher regulatory fees for all product groups will reduce profitability and be passed on to consumersSome impact on ACC and health budgets$24.5 million
 Larger price increases for medical devices and complementary medicinesHigher costs for local manufacturers would reduce international competitivenessDoes not contribute to CER objectives 
 Reduced choice likely Loss of import duties of approx. $3.5m (a transfer to industry and possibly consumers) 
 A precautionary stance may further reduce choice   
 Overseas regulatory decisions may not always “fit” NZ circumstances   
Joint agency     
BenefitsMeets health objectives throughOverall compliance costs will reduce, particularly for importing pharmaceutical companiesAs above. Improves wider CER relationship 
 higher standards 
 better post-market surveillance 
 better consumer information 
 for complementary medicines and medical devices 
 A possible reduction in pharmaceutical pricesSingle regime facilitates trans-Tasman tradeLower pharmaceutical costs may increase Health and ACC purchasing power 
   Import duties reduce if Tariff is amended to exclude complementary medicinesCombined regulatory resources addresses sustainability concerns 
    Stronger trans-Tasman agency may improve international reputation 
Costs:Price increases for medical devices and complementary medicines (but lower than unilateral recognition option), and some reduction in choiceIncreased compliance costs and reduced competitiveness for complementary medicines and medical devices, but less so than for unilateral recognition optionHigher cost of medical devices will have some impact on ACC and health budgets, but smaller than unilateral recognition option$8.3 million
    Foregone tax revenues from duty removal and firms relocating regulatory affairs to Australia 

Given the costs of compliance, whether any change from the status quo is seen to be of net benefit to New Zealand depends on judgements as to the additional benefits to consumer health and safety, and the value to New Zealand of potential additional trade opportunities and improved trans-Tasman and international relationships.

For medical devices and complementary medicines, this trade-off depends on a judgement of the emerging risk profile, whether added regulation in New Zealand can influence this, and how much society values the risk reduction. No data are available to assess the magnitude of these factors.

Given the degree of uncertainty, the decision on whether the regulatory framework needs to be extended involves a qualitative assessment about all of the following:

  • how well consumers are equipped to deal with the risks:

  • the ability to rectify harm (and the relevance of the precautionary principle):

  • the perceived bias of producers to understate risks or regulators to over-regulate:

  • how much risk reduction is valued:

  • different notions of liberty and responsibility.

With these caveats, the overall conclusion is that, relative to the other regimes considered in this paper, a move to a joint agency has the potential to yield a small net benefit to government, industry, consumers and other stakeholders in both countries.

Consultation undertaken

Medsafe has consulted widely in developing these proposals. In 2000, Medsafe published a discussion document seeking comment on the proposed form of a joint therapeutic products agency. This informed decisions by Ministers in December 2000. In further developing its proposals Medsafe has held regular meetings with consultative groups comprising representatives of the key stakeholder groups affected by the proposal, primarily therapeutic products suppliers. In December 2001 and June 2002, Medsafe distributed further discussion documents, seeking feedback on the design and role of the proposed agency.

Response to discussion paper released in June 2002

While a large number of responses was received, fewer than 15% were commenting on the proposals set out in the discussion paper. Government departments, representative bodies, consumer groups and those in the pharmaceutical and medical device industries broadly supported the proposals.

The bulk of the responses came from consumers, health practitioners and industry players from the complementary medicines sector who did not appear to have seen the proposals in the discussion paper but were reacting to some of the misinformation being circulated during the consultation period. They claimed there was no risk and therefore no need to regulate complementary medicines. They were fearful of increasing prices and decreasing product choice, and objected to decisions about which products they could access being made by an Australian bureaucrat.

Opinion expressed in submissions on the proposals contained in the discussion paper ranged from strong support for the proposals, to support for some aspects and concern about others, to outright rejection of any proposal to enter into a joint agency arrangement with Australia. All sectors of industry rejected the concept of 100% cost recovery, and there was considerable concern about Australian domination and loss of voice for New Zealand, although much of this concern was based on a misunderstanding of both the current system and the proposed governance and accountability arrangements.

Pharmaceutical sector

The pharmaceutical industry generally supported the proposals, although there was some concern about loss of expertise within New Zealand. Most of the comments related to more detailed aspects that would be the subject of further consultation with stakeholders as subordinate legislation is developed.

Medical device sector

The medical device industry strongly supported the adoption of the GHTF approach to device regulation and was broadly supportive of the joint agency proposals, provided certain aspects of the detail of the regulatory scheme for medical devices can be satisfactorily resolved.

Complementary medicines sector

Opinion amongst those with an interest in the complementary medicines sector was divided. Some rejected any proposal to regulate the sector at all, although much of the industry supported regulation of product quality and claims, recognising that while the ingredients were generally very safe, there were risks from poor quality products and outrageous claims, and these were damaging to the industry.

Much of the negative comment centred on the current Australian regulatory scheme, which was seen as draconian, bureaucratic and expensive. There was considerable concern about the impact of compliance costs on small businesses, with claims that hundreds of small distributors would go out of business if the proposed scheme were introduced.

The larger manufacturing companies (about 10 companies that account for around 80% of the total market value) are broadly supportive of the joint agency concept and the overall approach to regulation. Most of their concerns relate to the detail of how the scheme would be administered and how the agency's accountability to the fee-paying industry would be ensured.

There is no accurate record of the number of small manufacturers and importers who account for the remaining 20% of the market, although it is estimated there could be more than 200 small businesses involved. It was claimed that many of the products they distribute would be low value/low volume products that would not be viable in a regulated market. It is therefore likely that rationalisation of large product ranges or multiple distributors of the same or very similar products would result in some job losses for this group. The impact on importers and small manufacturers would depend on the size and distribution of fees, and on some aspects of the detail of the regulatory scheme, such as labelling requirements and interpretation of the Code of Good Manufacturing Practice.

There was support for the concept of a joint regulatory scheme for aspects such as advertising controls, adverse reactions monitoring and scheduling of medicines, but mandatory licensing of export-only products was considered inappropriate as it would not facilitate export or add any value for exporters.

Business compliance cost statement

Sources of compliance costs

Compliance costs under the joint agency proposal would arise from the following:

  • for pharmaceutical companies—

    • increases in regulatory fees for product licences and variations, manufacturing licences, and the introduction of annual product licence fees for all products due to a shift to full cost recovery (offset by a reduction in the total number of licensed products as most products would need only one licence for both New Zealand and Australia):

  • for complementary medicine and medical device companies—

    • the introduction of regulatory fees for product licensing (upfront and annual fees), licence variations, approval of new substances for use in complementary medicine, and licensing of manufacturing sites:

    • (for some manufacturers) the cost of upgrading manufacturing facilities and procedures:

    • time required to submit applications to the regulator, and gain an understanding of the new requirements:

    • costs of introducing new labels:

    • delay in getting new product to market (where an ingredient is not on the permitted list of substances in low risk products).

Parties likely to be affected

The compliance costs of this proposal will fall directly on—

  • about 78 pharmaceutical companies and 24 pharmaceutical manufacturing sites with total industry turnover of around $900 million per annum. Two large manufacturing companies are New Zealand based, and are exporting to Australia. Almost all of the remainder are multinational companies marketing in both New Zealand and Australia. Only a small percentage would be expected to maintain separate products licences in the two countries, so that rationalisation of products and regulatory activities will result in reduced compliance costs. Compliance costs will increase for the few companies whose products are only available in New Zealand:

  • about 10 local manufacturers and about 170 importers of medical devices. It is believed that at least one-third of these companies distribute products in both Australia and New Zealand. Compliance costs will, therefore, fall mainly on those importers sourcing product from countries other than Australia. There would be little impact on compliance costs for those manufacturing locally and exporting:

  • manufacturers (about 10 large-to-medium companies, half of whom are believed to be exporting to Australia, plus an unknown number of small manufacturers) and importers of complementary medicines (estimated to be 11 major companies and 200 or more small businesses) with local sales of over $100 million per annum. The larger local manufacturers account for at least three-quarters of the total industry turnover.

The complementary medicines industry comprises a broad range of businesses, from large companies with multi-million dollar turnovers that manufacture, distribute and export a range of products, to one-person businesses importing and distributing 1 or 2 products. Because the industry is so diverse and is not currently regulated in New Zealand, it has not been possible to obtain complete and accurate information about the numbers and types of businesses involved. During research for the cost benefit analysis, it was found that there were no official statistics and no comprehensive and reliable data available from industry organisations. Information provided by industry members was inconsistent and sometimes contradictory.

Compliance cost spread for complementary medicines sector

Without accurate information about the makeup of the industry it is difficult to estimate the impact of compliance costs on different types of businesses with any accuracy.

For companies trading in both countries, the extent to which compliance costs will increase will depend on the degree of overlap in product ranges between the two markets, which is currently unknown. For these companies, there would be no additional costs associated with licensing manufacturing premises.

For the unknown number of local manufacturers who do not currently meet Good Manufacturing Practice requirements, costs will vary depending on the extent to which they need to upgrade their premises in order to obtain a manufacturing licence. The greatest impact will be on smaller businesses requiring significant upgrading.

Compliance costs should not change significantly for those companies importing product from Australia (estimated to account for 50% of the total value of imports). For companies importing products from countries other than Australia, the greatest compliance cost impact would fall on businesses with a large product range.

The proposed annual product licence fee is intended to cover the costs of post-market activities such as adverse reactions monitoring, product testing, and handling complaints and recalls. If there were a standard fee per product, the impact would be greatest for those companies with large product ranges, and particularly for those that also had a small annual turnover. Possible mechanisms for managing the impact of compliance costs on small businesses include a fee waiver for low value/low volume products, or charging each company a fee based on a percentage of turnover. The latter is based on the premise that the costs of post-market activities relating to a company's products will be proportional to the level of risk exposure and therefore to the volume of product the company has in the marketplace.

Key issues identified in consultation

Complementary medicines/dietary supplements are viewed by the industry as very low risk. A number of stakeholders questioned the need for additional regulation, particularly if the Dietary Supplements Regulations 1985 were updated. Industry members are concerned that a number of small suppliers in New Zealand, particularly importers, would be likely to exit the market as a result of the additional costs from the proposed regulation. This would be primarily a distributional issue, as most ingredients in imported products are likely to be available in locally manufactured products, and where this is not the case, larger firms would introduce substitutes for affected product lines where sufficient profits could be made. However, some low value/low volume products would be likely to be removed from the market.

The major source of concern for the other sectors is the magnitude of fees. The Medical Industry Association of New Zealand (representing the medical device industry) raised concerns that fees may force many small importers out of business and reduce the range of product available in New Zealand. The Association is also concerned that the proposed harmonisation with Australia would cause many international device manufacturers to cancel contracts with New Zealand-based distributors, and rely on their distributors in Australia to supply product in both countries. The latter appears unlikely, however, as there is nothing to prevent this happening now.

Overlapping compliance requirements with other agencies

Some dietary supplement manufacturers are also covered by regulations administered by the Ministry of Agriculture and Forestry covering meat and dairy based products. However, those controls would not be duplicated by the proposed joint agency controls.

The Environmental Risk Management Authority (ERMA) regulates products incorporating genetically modified organisms. Medicines and medical devices using genetically modified organisms must gain approval from ERMA and from the regulator of therapeutic products before being marketed in New Zealand, as each agency is regulating different aspects of product safety.

Steps to minimise compliance costs

All options employ a risk-based approach, with pre-market entry requirements based on the level of risk. Under the proposed product licensing scheme, suppliers of low-risk therapeutic products would be able to self-certify that the product met specified requirements, and subject to electronic validation of key requirements such as the licence status of the manufacturer, a product licence would be issued immediately. In this way, pre-market evaluation of individual products and delays in getting the product to market would be avoided for an estimated 95% of complementary medicines and a significant proportion of medical devices.

Mutual recognition agreements can continue under each of the options to reduce duplication. Under each of the options, the regulator recognises manufacturing licences and audits conducted by overseas regulators in which it has confidence.

Under the joint agency proposal, product or ingredient approvals need to occur only once to cover both the Australian and New Zealand markets. This reduces duplication, and so reduces the sum of regulatory fees for all (benefiting particularly manufacturers of products that are traded across the Tasman).

Transitional arrangements

There will be a period of transition during which firms will be able to learn about the requirements, compile the required information, and adjust their production, labelling and distribution processes. There would be no application fee for existing complementary medicines and medical devices to get onto an interim product licence register. They could continue to be sold in New Zealand during the transition period. Once full compliance with the joint agency's requirements was achieved, a joint agency product licence would be issued and the product could then be sold in both countries. Annual licence fees would apply from commencement of the new scheme, but there would be no initial licensing fee for products that are not currently required to be registered.

Substances used in existing complementary medicines but not currently permitted in low-risk products in Australia would undergo a safety assessment for inclusion in a new joint agency list. This work would be completed as part of the implementation process for the joint agency, at no cost to industry.

Much of the impact of the new scheme could be managed by—

  • allowing distributors to place products on the product licence register free of charge (ie, no application fee, although annual licence fees would apply):

  • adopting appropriate transition times to allow licence holders to achieve compliance with any new requirements.

Distributors of complementary medicines would be required to place their products on an interim register (at no charge), but could continue selling existing products in New Zealand for a transition period of up to five years while full compliance with the new requirements was achieved (such as manufacturers upgrading premises to meet Good Manufacturing Practice requirements). Similarly, a suitable transition period can be selected to permit label stock to be substantially exhausted before new labels are required.

Establishment of an interim register of medical devices

It is proposed to amend the Medicines Regulations 1984 to enable establishment of a register of medical devices as an interim step towards GHTF-style device regulation. There would be no fee for placing devices on the register. This would facilitate transition to the proposed joint agency regulatory scheme, and is well supported by the medical device industry. Many medical devices have a relatively short lifespan and will have been superseded by newer products before the transition period expires.

Regulatory impact and compliance cost statement for Parts 6 and 7

Statement of the nature and magnitude of the problem and the need for government action

Parts 1 to 5 of this Bill implement a new joint trans-Tasman regulatory scheme for therapeutic products. Therapeutic products include prescription and over-the-counter medicines, complementary medicines (currently regulated under the Dietary Supplement Regulations 1985 under the Food Act 1981) and medical devices (ranging from low-risk products such as dressings to high-risk products such as heart valves).

Parts 1 to 5 will house those aspects of therapeutic product regulation that are part of the joint regulatory scheme, including pre-market controls, licensing of manufacturers, and post-market monitoring and surveillance activities. However, controls on activities relating to medicines in the supply chain in New Zealand will not be part of the joint scheme and will remain as New Zealand-specific provisions. These include—

  • provisions setting out when, how, and by whom medicines can be prescribed, dispensed, or administered:

  • transport, storage, and record-keeping requirements for medicines:

  • provisions covering the ownership and licensing of pharmacies:

  • a licensing regime covering the supply of scheduled medicines by retail and wholesale (but the holder of an approval to manufacture medicines, issued by the joint agency, will not also require a separate licence to supply those medicines by wholesale):

  • enforcement provisions for such controls (eg, offences, penalties, powers for enforcement officers).

Currently, both the provisions that will be covered by the joint regulatory scheme and the New Zealand-specific provisions are housed in the Medicines Act 1981. Repealing those provisions covered by the new joint regulatory scheme and retaining the New Zealand-specific provisions would result in a Medicines Act that was very piecemeal and difficult to use.

A number of the New Zealand-specific provisions in the Medicines Act 1981 are out of date or will be rendered ineffective when the legislation for the joint regulatory scheme is enacted. These include—

  • problems with the current offences and penalties in the Act include the following:

    • the Act uses a general penalty for a range of offences, with no differentiation between more serious and less serious offences:

    • the amounts of penalties in the Act are out of date and not in line with other more modern legislation:

    • some penalties do not cater for offending by a body corporate. Because such offending is usually on a larger scale than offending by individuals, larger penalties are warranted:

    • the Act does not have a higher offence for offending where it can be proved the conduct was wilful and endangered public health:

    • the mechanism to allow an extra penalty for every day the offence continues has not been applied by the courts under the Act and is no longer considered appropriate by the Ministry of Justice. This is because it is difficult to use this mechanism in practice, and there are other simpler ways of dealing with multiple offending:

    • some offences require the defendant to establish a reasonable excuse defence and this is inconsistent with the Bill of Rights Act:

  • under the Medicines Act 1981, licence applicants have a statutory right of appeal to the Medicines Review Committee (section 88) and a subsequent right of appeal to the District Court on questions of law. The Medicines Review Committee has not been convened to consider a licensing issue for many years, and is no longer thought to be necessary:

  • current regulation-making powers relating to prescribing, dispensing and record keeping are not empowering enough to enable the making of regulations to deal with changes in technology or prescribing practice (for example, to provide for robotic dispensing under prescribed conditions, inclusion of unique patient and prescriber identifiers on prescriptions, electronic storage and transmission of information, or substitution of medicines):

  • regulations 27 and 28 of the Medicines Regulations 1984 relate to infected persons handling medicines. Regulation 27 prohibits people with communicable diseases (and other conditions) from engaging in, or being employed in, the sale, manufacture, packing, labelling, storage or supply of medicines. Regulation 28 empowers Medical Officers of Health to serve written notices on those who have been in contact with such people and prevent them from engaging or being employed in the same activities. These controls are unduly restrictive in relation to the risks they were originally intended to manage:

  • the prescribing controls in regulation 39 of the Medicines Regulations 1984 are too restrictive in 3 respects. Firstly, the regulation restricts dentists to prescribing prescription medicines only for dental treatment. This means that a dentist cannot prescribe for an associated condition, such as preventing or treating a side effect caused by a medicine used for dental treatment. The patient must be referred to a medical practitioner for such treatment. Similarly, registered midwives are restricted to prescribing for antenatal, intrapartum and post-natal care. Secondly, the regulation restricts a dentist to prescribing for a maximum treatment period of 10 days (5 days and a repeat of 5 days), whereas other existing prescribers may prescribe up to 3 months' treatment (or 6 months for an oral contraceptive). These restrictions on dentist prescribing are no longer appropriate given the changes to the practice of dentistry and the medicines used in dental treatment. Thirdly, the regulation restricts the period of supply of a prescription medicine that can be prescribed by a medical practitioner or registered midwife to 3 months (or 6 months for an oral contraceptive prescribed by a medical practitioner). This restriction can create a safety risk for New Zealanders travelling for extended periods to places where there is no reliable source of the medicines they require for the treatment of an ongoing condition (eg, army personnel serving overseas for an extended period of time).

Statement of the public policy objective

To ensure that New Zealand has high-quality, modern and efficient medicines legislation that is seamless across the whole of the medicines regulatory regime.

Statement of feasible options

Status quo

The status quo is the repeal of those parts of the Medicines Act 1981 and Medicines Regulations 1984 that will be covered by the joint regulatory scheme, and the retention of the remaining provisions without amendment. The status quo would see—

  • retention of the current offences and penalties regime in the Act, with the following features:

    • a general penalty of imprisonment for a term not exceeding 3 months or a fine not exceeding $500 will apply for a range of offences, with no differentiation between more serious and less serious offences:

    • some penalties do not include offending by a body corporate:

    • the Act has no offence for offending where it can be proved the conduct was wilful and endangered public health:

    • the Act has a mechanism to allow an extra penalty for every day an offence continues:

    • some offences require the defendant to establish a reasonable excuse defence:

  • retention of the current appeals process on licensing issues under which licence applicants have a statutory right of appeal to the Medicines Review Committee (section 88 of the Medicines Act 1981) and a subsequent right of appeal on questions of law to the District Court:

  • retention of the current prescribing, dispensing, and information-keeping requirements:

  • retention of regulations 27 and 28 prohibiting people with communicable diseases (and other conditions) and those who have been in contact with such people from engaging in medicine-related activities:

  • dentists able to prescribe only 10 days supply of prescription medicines (5 days and a repeat of 5 days):

  • the Medicines Regulations 1984 would restrict dentists to prescribing for "dental treatment only" and registered midwives to prescribing for "antenatal, intrapartum and post-natal care:

  • prescribers other than dentists able to be prescribe prescription medicines for a maximum of 3 months (or 6 months in the case of an oral contraceptive prescribed by a medical practitioner).

While feasible, the status quo would render parts of the legislation unworkable, and the remaining Medicines Act would be piecemeal, fragmented and out of date. It would not be responsive to future technological changes.

This option does not address the public policy objective.

Repealing the Medicine Act 1981 and passing new medicines legislation (preferred option)

Under this option, the Medicines Act 1981 would be repealed and its New Zealand-specific provisions consolidated, reorganised, and recast in a new Bill. The opportunity would also be taken to—

  • overcome problems with the current offences/penalties regime in the Act, including:

    • providing a specific penalty for each offence (rather than using the same general penalty for many offences):

    • introducing a continuum of penalties proportionate to the seriousness of the offence in the Act. This will feature a range of penalties from a fine of up to $5 000 for an individual to a fine of up to $40,000 for a body corporate for less serious offending; and a fine of up to $40,000 or up to 12 months imprisonment for an individual or a fine of up to $100,000 for a body corporate for serious offending:

    • introducing a higher penalty for all body corporate offending, set at a fine not exceeding $100,000:

    • introducing a higher-level penalty provision for offending where it can be proved the conduct was wilful and endangered public health. The penalty, on indictment, for this conduct is to be a fine of up to $100,000 or up to 12 months imprisonment (or both) for an individual and a fine of up to $250,000 for a body corporate:

    • removing the continuing offence penalty provisions:

    • changing some offences from strict liability offences to normal offences: and

    • a design feature of implementing the above changes may result in loss of the ability to obtain a search warrant for some of the offences in the Act. A new provision is required to ensure this ability is retained:

  • streamline the appeals process on licensing issues in the Act by providing for a first right of appeal to the Licensing Authority while retaining the existing appeal process to the courts. The Licensing Authority will be the Director-General of Health (or delegate). A statutory requirement will be included that the person who hears such appeals cannot have been involved in the original decision that is being appealed. This process is consistent with other statutory licensing appeal processes (eg, section 114(2) of the Wine Act 2003 provides a mechanism for a person who is dissatisfied with a decision to seek a review of that decision by the Director-General or by a person designated by the Director-General who was not involved in making the original decision):

  • amending prescribing, dispensing and record-keeping information requirements so that regulations can be made to incorporate advances in technology, such as requiring the inclusion of unique patient and prescriber identifiers on prescriptions, permitting electronic transmission and storage of information, or allowing robotic dispensing. Any regulations developed in the future to implement such changes would be subject to consultation and regulatory impact assessment:

  • expanding regulation 26 of the Medicines Regulations 1984 so those handling or coming into contact with medicines in the dispensing process will be required to ensure that any open lesions are appropriately covered:

  • revoking regulations 27 and 28 of the Medicines Regulations 1984:

  • revoking regulations 39(3) and 39(6)(b) of the Medicines Regulations 1984 and using the framework in the Health Practitioners Competence Assurance Act 2003 to ensure that dentists and midwives prescribe in accordance with the scopes of practice developed by their registering authorities:

  • removing restrictions on dentists' prescribing of prescription medicines by revoking regulation 39(4) of the Medicines Regulations 1984 so that dentists can prescribe prescription medicines for up to 3 months, consistent with other prescribers:

  • allowing medicines to be prescribed for longer than 3 months in special circumstances (eg, to allow army personnel serving overseas to be prescribed more than 3 months supply) by expanding regulation 43 of the Medicines Regulations 1984, which allows the Director-General of Health to waive certain regulatory requirements regarding prescription medicines in special circumstances. Standard operating procedures developed by the Ministry of Health and approved by the Director-General of Health would define the special circumstances in which the waiver could apply.

Statement of the net benefit of the proposal, including the total regulatory costs (administrative, compliance and economic costs) and benefits (including non-quantifiable benefits) of the proposal, and other feasible options

Government

Government will have high-quality and modern medicines legislation to help ensure medicines are safe and used safely, including facilitating the recording and follow-up of adverse reaction reports. The direction and specific provisions of the current domestic medicines control will be retained, but updated to ensure their continued applicability. Potential interface issues with the trans-Tasman regulatory scheme will be explicitly dealt with, and all efforts made to ensure a seamless regulatory scheme for medicines and medical devices.

The proposed new offences and penalties regime would alleviate some of the problems with the current Act, including—

  • providing appropriate deterrent penalties for individuals and bodies corporate; and

  • repealing continuing offence provisions which have not been applied under the Act; and

  • addressing some offence provisions which are inconsistent with the Bill of Rights Act 1990.

Subsidisation under the Pharmaceutical Schedule for prescriptions written by dentists is currently limited to 10 days (5 days and a repeat). If PHARMAC was to remove this restriction to bring subsidy rules into line with legal prescribing rights, there should be no increased cost to the pharmaceutical budget. The proposed change to dentist prescribing will mean a shift in who prescribes longer-term treatments, rather than altering the number of patients requiring treatment, the medicines prescribed, or the length of the treatment period. There is potential for cost savings because consumers will only need one prescription to cover the required treatment period, rather than repeat dispensings or multiple prescriptions. In addition, patients will not require a consultation with a medical practitioner, resulting in a cost saving where the patient qualifies for a subsidy. PHARMAC will monitor the impact of dentist prescribing on the pharmaceutical budget in accordance with its operating procedures following any change in the subsidisation rules. If there is a concern about expenditure, PHARMAC may still act to re-impose restrictions on access to subsidies.

Dentists and midwives

Changing the prescribing restrictions for dentists and midwives will align the regulatory arrangements for dentists and midwives with those for other existing prescribers. The change should not impact significantly on the dental registering authority, the Dental Council of New Zealand, as they are already well advanced in the process of defining scopes of practice for dentists and dental specialists (eg, orthodontists, dental surgeons). There is not likely to be a resulting increase in Dental Council registration fees for dentists. Using the Health Practitioners Competence Assurance Act 2003 instead of the Medicines Regulations 1984 to regulate prescribing by midwives would not affect the scope of midwifery prescribing and is supported by the Midwifery Council.

Society

Redrafting of the medicines legislation will make it less cumbersome and easier to understand. The result will be a modern, high-quality medicines regulation scheme that operates seamlessly across both the jointly regulated and New Zealand-specific aspects of the scheme.

Consumers will benefit from a reduction in costs arising from changes to the prescribing rules for dentists. Savings will arise because there will no longer be a requirement for multiple prescriptions to cover an extended treatment period, or the need to consult a medical practitioner for treatment of a condition related to dental treatment. There may be benefits to the health sector overall through a reduction in secondary illnesses or complications as a result of dentists being able to prescribe prompt and appropriate treatment. There may also be benefits to consumers of medicines through the proposed changes to the offences/penalties regime because this should deter offending under the Act, therefore enhancing consumer safety.

Statement of consultation undertaken

Stakeholder consultation

In late 2002, Medsafe undertook a targeted consultation with key health professional groups and stakeholders on ways to update or improve the parts of the Medicines Act 1981 that would not be covered by the new joint regulatory regime. A discussion paper was produced after meetings with key sector players, including the councils for the different health professions (eg, the Medical Council, the Dental Council). The paper was also circulated to District Health Boards, universities, and other stakeholders with a direct interest. This was thought to be appropriate given the limited nature of the change and the fact that the main reforms were as a result of the joint scheme.

The consultation emphasised that the focus was not on radically overhauling the New Zealand-specific medicines legislation, or making significant policy changes. There was broad agreement with this approach. Medsafe also consulted with Medical Officers of Health about proposals affecting them.

The main themes identified by submitters were the need to update the legislation to implement or enable the future implementation of—

  • electronic prescribing; and

  • robotic dispensing; and

  • modernised information and record-keeping requirements allowing electronic records; and

  • substitution of medicines.

The majority of submissions received on the dentist prescribing issues were in support of the proposed changes.

Government departments/agencies consulted

The following government agencies were consulted on the proposal in this paper: the Ministries of Justice, Economic Development, Pacific Island Affairs and Consumer Affairs, the Ministry for the Environment, The Treasury, Te Puni Kokiri, the Police, the New Zealand Customs Service, the New Zealand Food Safety Authority, PHARMAC, the Office of the Privacy Commissioner, and the Parliamentary Counsel Office. No significant issues were raised.


Hon Annette King

Therapeutic Products and Medicines Bill

Government Bill

103—1

Contents

1 Title

2 Commencement

3 Object

Part 1
Preliminary, and Rules and Orders

Subpart 1Preliminary provisions

4 Purpose of Parts 1 to 5

5 Overview of Parts 1 to 5

6 Interpretation

7 Crown exemption for products specified by Minister

8 Parts 1 to 5 bind the Crown

Subpart 2General provisions about Rules and Orders

9 Rules and Orders have force of law

10 Effect of this subpart and subpart 3

11 When Rules and Orders come into force

12 Involvement of Finance Minister in making certain Rules

Subpart 3Publication, presentation, and disallowance of Rules and Orders

Definition

13 Meaning of Rule and Order in this subpart

Publication of Rules and Orders

14 Publication of Rules, Orders, and compilations on Internet site

15 Correction of Rules, Orders, and compilations on Internet site

16 Status of Rules, Orders, and compilations published on Internet site

17 Hard copies of Rules and Orders

18 No copyright in Rules and Orders

Presentation of Rules and Orders

19 Presenting Rules and Orders

20 Presenting explanatory statements

Disallowance of Rules and Orders

21 Explanation of sections 22 to 27

22 Rules and Orders to be disallowed in whole only

23 Notice of motion to disallow Rule or Order

24 How and when Rule or Order disallowed

25 Lapse of notice of motion to disallow Rule or Order

26 Giving notice when Rule or Order disallowed

27 Effect of failure to table in, or disallowance by, Australian Parliament

Part 2
Enforcement of regulatory scheme

Subpart 1General provisions relating to Part

Definitions and jurisdiction

28 Definitions of terms used primarily in subparts 1 to 3

29 Jurisdiction extended to conduct in Australia

General provisions about offences

30 Six-year time limit for bringing summary offences

31 Sentencing guidelines for offences involving harm

32 Strict liability offences

33 Alternative verdicts

34 Notice required to adduce evidence for certain defences

35 Certificates to provide evidence of certain matters

Proceedings for civil penalties

36 Application for civil penalty

37 Imposition of civil penalty

38 When and how civil penalty proceedings brought

Relationship between civil penalty and criminal proceedings

39 Civil penalty proceedings in New Zealand after proceedings in Australia for civil penalty

40 Criminal proceedings in New Zealand after criminal proceedings in Australia

41 Relationship between concurrent civil penalty proceedings and criminal proceedings

42 One penalty only rule

43 Effect of withdrawal or discontinuation of proceedings on limitation period

44 Restriction on use of evidence given in civil penalty proceedings

45 Abuse of process jurisdiction not affected

Liability of executive officers

46 Criminal liability of executive officers

47 Liability of executive officers to civil penalty

48 How to establish whether executive officer took all reasonable steps

49 Notice required to adduce evidence

Subpart 2Regulatory offences and civil penalties

Manufacture, import, export, and supply

50 Manufacture without manufacturing licence or correct manufacturing licence

51 Breaching conditions of manufacturing licence

52 Manufacture, import, export, or supply without product licence or correct product licence

53 Breaching conditions of product licence

54 Breaching conditions of special purpose approval or requirements of exemption

55 Import, export, or supply of product that does not conform to applicable standards

56 Breaching conditions of authorisation not to conform to applicable standards

57 Breaching conditions of conformity assessment certificate

58 Manufacturer supplying or exporting therapeutic product to which conformity assessment procedures not applied

59 Other persons supplying or exporting products to which conformity assessment procedures not applied

Advertising

60 Purpose

61 Meaning of circumstances

62 Publishing or broadcasting proscribed advertisements

63 Advertisements for which approval required

64 Advertisements containing restricted representations

65 Advertising in breach of direction by Authority

66 Failing to comply with information requirement notice

67 Guidelines for setting penalty levels relating to advertising offences and civil penalties

Misrepresentation

68 Dealing with counterfeit products

69 Relief from liability in civil penalty proceedings relating to counterfeit products

70 Setting out false product licence number

71 Falsely representing that product is subject to product licence

72 Claiming to supply when product cannot be lawfully supplied

Product tampering

73 Notifying Authority if product subject to actual or proposed tampering

False or misleading information in applications and declarations

74 False or misleading statements in applications

75 False or misleading statements in declarations relating to conformity assessment procedures

Adverse effect information

76 Product licence holders failing to give adverse effect information

Compliance with information requirement notice

77 References to information include references to documents

78 Applicants, holders, and former holders failing to comply with information requirement notice

79 Applicants, holders, and former holders giving false or misleading information

80 Persons exempt from requirement to hold product licence failing to comply with information requirement notice

81 Self-incrimination not ground for refusing to supply information

82 Persons exempt from requirement to hold product licence giving false or misleading information

83 Ex-applicant for product licence failing to comply with information requirement notice

84 Ex-applicant for product licence giving false or misleading information

Compliance with recovery notice

85 Failing to comply with recovery notice

86 Relief from civil liability for failing to comply with recovery notice

87 Export or supply of therapeutic products subject to recovery notice

Information about sponsors

88 Identifying sponsor when required to do so

Subpart 3Non-compliance notices and enforceable undertakings

Non-compliance notices

89 Authority may issue non-compliance notice

90 Authority may withdraw non-compliance notice

91 Date by which monetary penalty must be paid

92 Amount and payment of monetary penalty

93 Non-compliance notice is bar to proceedings unless not paid by due date

94 Payment of monetary penalty not admission of guilt or liability

95 Regulations prescribing form of non-compliance notice

Enforceable undertakings

96 Giving enforceable undertaking

97 Consequence of breach of enforceable undertaking

Subpart 4Search and seizure

98 Definition of terms used primarily in subparts 4 and 5

Authorised officers

99 Appointment of authorised officers

100 Issue of identity cards to authorised officers

Entry, search, and seizure without warrant

101 Searches for monitoring purposes

102 Entry and search on serious public health grounds without search warrant

103 Searches at request of manufacturer

Search warrants

104 Search warrant to seize evidential material

105 Powers under search warrant

Conduct of entry, search, and seizure

106 Assistance with searches

107 Authorised officers to show identity card on request

108 Announcement before entry

109 Details of warrant to be given to occupier

110 Occupier entitled to be present during search

111 Use of electronic equipment

112 Copies of documents seized to be provided

113 Receipts for things seized

What happens to things seized

114 Return and retention of things seized

115 Order to retain things seized

116 Forfeiture on conviction or imposition of civil penalty

Testing and analysis of samples

117 Samples for testing or analysis

118 Analysis and testing of samples in accordance with Rules and Orders

119 Evidence of analysis

120 Cost of testing and analysis

Offences relating to search and seizure

121 Offences relating to search and seizure

Subpart 5Miscellaneous

Information sharing for law enforcement purposes

122 Disclosure of information

Customs

123 Right to inspect therapeutic products imported or for export

124 Non-compliant therapeutic products held at customs controlled area

125 Special provisions relating to consignments

126 Relationship with Customs and Excise Act 1996

Patents

127 Therapeutic products protected by Australian patents

Part 3
Administrative law matters

128 Definitions of terms used primarily in this Part

Subpart 1Merits review

General provisions

129 Purpose and overview

Application for review

130 Who may apply for merits review

131 What happens if Rules provide for internal review

132 When Authority not required to give reasons

133 No application if review already sought in Australia

134 Application for merits review does not affect decision

Review Tribunal

135 Establishment and constitution of Review Tribunal

136 Members of Review Tribunal not personally liable

137 Fees for Review Tribunal members

Conduct of review

138 Parties to proceedings

139 Procedure of Review Tribunal

140 Decision by majority

141 Powers and decisions of Review Tribunal

142 Matters remitted to Authority for reconsideration

143 New information received by Review Tribunal

Transfer of review proceedings

144 Transfer of proceedings to Australian Review Tribunal

145 Proceedings transferred from Australian Review Tribunal

Effect of decisions

146 Effect of decision by Review Tribunals

Appeals and stating case

147 Appeal on question of law

148 Stating case for High Court

Subpart 2Judicial review

149 Application of subpart

150 Availability of judicial review

151 Effect of orders made in judicial review proceedings

152 Stay of judicial review proceedings

153 Determination of stay proceedings

Subpart 3Action by Ombudsmen

154 Authority subject to Ombudsmen Act 1975 and to Australian Ombudsman Act

155 Co-operation between Ombudsmen

156 New Zealand Ombudsman transferring complaints to Australian Ombudsman

157 Australian Ombudsman transferring complaints to New Zealand Ombudsman

158 Refusal to deal with complaints investigated by Australian Ombudsman

159 Immunity for Australian Ombudsman and others

160 Other protections for Australian Ombudsman and others

Subpart 4Action by Privacy Commissioners

161 Authority subject to Privacy Act 1993 and to Australian Privacy Act

162 Modification of information privacy principle 11

163 Co-operation between Privacy Commissioners

164 New Zealand Privacy Commissioner transferring complaints to Australia

165 Australian Privacy Commissioner transferring complaints to New Zealand

166 Taking no action on complaints dealt with by Australian Privacy Commissioner

167 Immunity for Australian Privacy Commissioner and others

168 Other protections for Australian Privacy Commissioner and others

169 Extended immunity for New Zealand Privacy Commissioner

Subpart 5Information management

170 Application of Official Information Act 1982

171 Application of Privacy Act 1993

172 Release of therapeutic product information to World Health Organisation

173 Release of therapeutic product information to New Zealand and Australian authorities with therapeutic product functions

174 Release of therapeutic product information to other national authorities with therapeutic product functions

175 Release of therapeutic product information relating to product tampering and law enforcement

176 Release of therapeutic product information required to be provided

177 Release of therapeutic product information in accordance with international co-operative arrangements

178 Release of therapeutic product information to public

179 Protection against action if lawfully making information available

Protected active ingredient information

180 Purpose of sections 181 to 184

181 Definition of protected active ingredient information

182 Periods when protected active ingredient information may not normally be disclosed

183 Limited circumstances in which protected active ingredient information may be disclosed

184 Continuation of protections under Medicines Act 1981

Use of information by Authority

185 Protection against action for use by Authority of information

Archives

186 Management of Authority's records

Part 4
Governance and accountability

187 Definitions of terms used primarily in this Part

Subpart 1Ministerial Council, Board, and Board members

Ministerial Council

188 Overview of Ministerial Council

General provisions relating to Board

189 Overview of Board

190 Parliament's expectations of Board

191 Restrictions on Minister's discretion to appoint

192 Vacancies in membership of Board and flaws in appointment

193 Effect of flaws in Board processes

Managing Director

194 Overview of Managing Director

Subpart 2General matters relating to Authority

195 Overview of Authority

Providing information

196 Authority to provide information to Minister

197 Authority to comply with request for information from Finance Minister

198 Authority to comply with request for information by Secretary to the Treasury

Compliance with directions

199 Authority to comply with directions of Ministerial Council

Review of operations

200 Review of operations and performance

Employees and others

201 Employees and others not to disclose Authority information

202 Employees not to misuse position

Immunities, indemnities, and insurance

203 Application of sections 204 to 207

204 General protection from liability

205 Immunities

206 Indemnities

207 Insurance

208 Immunity for Authority

209 Application of Health and Safety in Employment Act 1992

Miscellaneous matters

210 Seal of Authority

211 Signature of Managing Director

Subpart 3Financial and associated matters

212 Restriction on borrowing, etc

213 Restriction on giving guarantees and indemnities

214 Restriction on use of derivative transactions

215 Banking

216 Restriction on acquiring securities

217 Restriction on Authority's involvement in other entities

218 Subsidiaries not to do what Authority cannot or must not do

219 Aligning accounting periods of subsidiaries

220 Banking and accounting for trust money

221 Investment of trust money

222 Exemption of Authority from income tax

223 Authority's input tax under Goods and Services Tax Act 1985

Subpart 4Reporting

Overview

224 Overview

Statement of intent

225 Obligation to prepare statement of intent

226 Board to ensure Authority complies with statement of intent

227 Direction by Ministerial Council to amend statement of intent

228 Amendments to statement of intent

229 Statement of intent to be presented to House of Representatives and be published

Annual report

230 Obligation to prepare annual report

231 Annual report to be presented to House of Representatives and be published

Audit

232 Auditor-General is auditor of Authority

Keeping accounting records

233 Obligation to keep accounting records

Offences

234 Offence of failing to keep accounting records

235 Offences relating to reporting

Subpart 5Board members and other senior officers

Board member conflict of interest

236 What Board member must do if interested in matter

237 How disclosures of interest are made

238 Permission to act despite being interested in matter

239 Consequences of failing to comply with section 236

240 Authority may avoid some acts done in breach of conflict of interest rules

Duties of senior officers

241 Duties apply regardless of where senior officer located

242 Duty to act with honesty and integrity

243 Duty to comply with Acts and Rules

244 Duty of care, diligence, and skill

245 Duties of good faith, etc

246 Duty not to misuse information

Criminal consequences of failing to comply with duties

247 Offences relating to failure to comply with certain duties

248 Requirement to provide information in connection with criminal proceedings

Civil consequences of failing to comply with duties

249 Application for civil penalty

250 Imposition of civil penalty

251 When and how civil penalty proceedings brought

252 Authority involvement in proceedings

253 Relief from liability in civil penalty proceedings under section 249

254 Requirement to provide information in connection with civil penalty proceedings

Disqualification for breach of duty

255 Disqualification for breach of duty

256 Application to quash or amend disqualification order

257 Effect of disqualification under Australian Act

Compensation orders

258 Compensation order

259 When application for compensation order may be made

Civil liability of others involved

260 Others involved in breach of certain senior officer duties

Defence in criminal or civil penalty proceedings

261 Defence to rely on information and advice

General relief from civil liability

262 Relief from civil liability

Restriction on use of evidence

263 Restriction on use of evidence given in proceedings for civil penalty

Relationship between criminal and civil penalty proceedings

264 Civil penalty proceedings in New Zealand after proceedings in Australia for pecuniary penalty

265 Criminal proceedings in New Zealand after criminal proceedings in Australia

266 Relationship between concurrent civil penalty proceedings and criminal proceedings

267 Effect of withdrawal or discontinuation of proceedings on limitation period

268 Abuse of process jurisdiction not affected

Part 5
Regulations, and transitional and miscellaneous provisions

Subpart 1Regulations

269 Regulations providing for departures from the Scheme

270 Regulations for fees and charges for non-Scheme work

271 Transitional and savings regulations

272 General regulation-making power

Subpart 2Transitional provisions relating to Scheme

Preliminary

273 Outline of transitional regime

274 Definitions of terms used in this subpart

275 Saving and application of former Act and former regulations

276 Prescribed fees and charges

Medicines: transitional approvals

277 Deemed grant of transitional approval

278 Duration of transitional approval

Related products: transitional approvals

279 Deemed grant of transitional approval

280 Duration of transitional approval

Medicines and related products: material changes

281 Determination of pending notices for medicines and related products

282 Grant of transitional approval

283 Duration of transitional approval

Medicines and related products: pending applications

284 Kinds of pending applications covered by sections 285 to 288

285 Pending applications on which evaluation work started by start date

286 Pending applications on which no evaluation work done by start date

287 Pending applications that lapse

288 Protection of confidential supporting information

Medicines: existing exemptions under former Act

289 Authorised prescribers

290 Medicine required by medical practitioner

Medicines: clinical trials approved under former Act

291 Clinical trials covered by sections 292 to 294

292 Deemed grant of transitional approval

293 Duration of transitional approval

294 Request to modify clinical trial

Medicines: pending application for approval of clinical trial

295 Determination of pending application for approval of clinical trial

296 Grant of transitional approval

297 Duration of transitional approval

Medicines: transitional approvals for existing licences

298 Kinds of existing licences covered by sections 299 and 300

299 Deemed grant of transitional approval

300 Duration of transitional approval

Medicines: pending applications for licences

301 Kinds of pending applications covered by sections 302 to 304

302 Determination of pending applications

303 Grant of transitional approval

304 Duration of transitional approval

Medical devices: transitional approval

305 Deemed grant of transitional approval

306 Duration of transitional approval

307 Declaration of lawful supply

308 Information to be supplied by sponsor

309 Medical devices subject to existing approvals, etc

Medical devices: exemptions

310 Medical device required by medical practitioner

Dietary supplements: transitional approvals

311 Deemed grant of transitional approval

312 Duration of transitional approval

313 Declaration of lawful supply

314 Information to be supplied by sponsor

315 Dietary supplements subject to existing approvals, etc

Newly designated therapeutic products: transitional approvals

316 Deemed grant transitional approval

317 Duration of transitional approval

318 Declaration of lawful supply

319 Information to be supplied by sponsor

Notices

320 Notice issued under section 36 of former Act before start date

Advertising

321 Advertising

Appeals

322 When section 323 applies

323 Appeals of decisions under former Act

Offences

324 Offences and breaches of former Act

325 Sections 50 to 76 do not apply to holders of transitional approvals

Proceedings

326 Barred proceedings

327 Pending proceedings

Subpart 3Transitional provisions relating to employees

328 Transfer of Medsafe employees to Authority

329 Transfer does not break continuity of employment

330 No compensation for technical redundancy

331 Protection of status as contributor to Government Superannuation Fund

Subpart 4Transitional provisions relating to assets

332 Purpose of sections 333 and 334

333 Health Sector (Transfers) Act 1993 amended

334 Agreement of Ministerial Council required for transfers

Subpart 5Miscellaneous provisions

335 Consequential amendments relating to establishment of Authority

336 Other consequential amendments

Part 6
General provisions

337 Purpose

338 Outline

339 Interpretation

Application and administration

340 Application

341 Parts 6 and 7 to bind the Crown

342 Employees and employers

Part 7
Substantive provisions relating to medicines

Subpart 1Controlled activities

343 Outline of this subpart

Supplying scheduled medicines by wholesale

344 Supplying scheduled medicines by wholesale: controlled activity

345 Regulations may authorise supplying scheduled medicines by wholesale

346 Licence may authorise supplying scheduled medicines by wholesale as fixed vendor or mobile vendor

Supplying scheduled medicines other than by wholesale

347 Supplying scheduled medicines other than by wholesale: controlled activity

348 Prescriber may supply scheduled medicines other than by wholesale in limited circumstances

349 Pharmacist may supply scheduled medicines other than by wholesale in limited circumstances

350 Veterinarian may supply scheduled medicines other than by wholesale in limited circumstances

351 Employee working with prescriber may supply scheduled medicines other than by wholesale in limited circumstances

352 Employee working with pharmacist may supply scheduled medicines other than by wholesale in limited circumstances

353 Employee working with veterinarian may supply scheduled medicines other than by wholesale in limited circumstances

354 Deemed licence may authorise supply of scheduled medicines other than by wholesale in limited circumstances

355 Licence may authorise supply of pharmacy medicines other than by wholesale in limited circumstances

356 Regulations or standing order may authorise supply of scheduled medicines other than by wholesale

357 Supply of scheduled medicines to medicines control officer not supply other than by wholesale

Standing orders for supply of scheduled medicines other than by wholesale

358 Standing orders for supply of scheduled medicines

Supplying medicines by auction

359 Supplying medicines by auction: controlled activity

Supplying medicines by vending machine

360 Supplying scheduled medicines by vending machine: controlled activity

Dispensing medicines

361 Dispensing medicines: controlled activity

362 Prescriber may dispense medicines in limited circumstances

363 Pharmacist may dispense medicines in course of pharmacy practice

364 Certain other persons associated with pharmacies may dispense medicines in limited circumstances

365 Veterinarian may dispense medicines in limited circumstances

366 Employee working with veterinarian may dispense medicines in limited circumstances

367 Regulations may authorise dispensing of medicines

368 Licence may authorise dispensing medicines by automated dispensing machine

Prescribing prescription medicines

369 Prescribing prescription medicines: controlled activity

370 Authorised prescriber may prescribe prescription medicines in limited circumstances

371 Designated prescriber may prescribe prescription medicines in limited circumstances

372 Veterinarian may prescribe prescription medicines in limited circumstances

Prescribing notices

373 Prescribing authorities to issue prescribing notice

374 Review of prescribing notice

375 Prescribing authority to make list available

376 Minister's powers in relation to prescribing authority's obligations under sections 373 to 375

Administering prescription medicines

377 Administering prescription medicines: controlled activity

378 Prescriber may administer prescription medicines in limited circumstances

379 Veterinarian may administer prescription medicines in limited circumstances

380 Person may administer prescription medicines in limited circumstances

Standing orders authorising administering certain medicines

381 Standing orders authorising administering of prescription and pharmacist-only medicines

Possessing prescription medicines

382 Possessing prescription medicines: controlled activity

383 Reasonable excuse for possessing prescription medicines

Operating pharmacy

384 Operating pharmacy: controlled activity

Subpart 2Instruments prohibiting and restricting activities with medicines

385 Outline of this subpart

386 Effect of certain instruments issued under this subpart

Minister may prohibit certain activities

387 Minister may prohibit specific persons prescribing and exercising authority

388 Minister must have health authority or Veterinary Council recommendation to prohibit in certain circumstances

Restriction notice

389 Medical Officer of Health may restrict prescribing and supplying to individual by restriction notice

390 Prescribing or supplying in contravention of restriction notice

391 Restricted individual procuring or attempting to procure in contravention of restriction notice

392 Review or appeal of restriction notice

Statement relating to dependency

393 Statement relating to dependency

Subpart 3Licences

394 Outline of this subpart

Applying for licence

395 Who may apply

396 Form of application

Contents of application

397 Application must set out medicines to which it relates

398 Application must contain sufficient information

Granting of licence

399 Granting of licence

400 Additional matter when granting licence to supply pharmacy medicines other than by wholesale

Refusal of licence

401 Refusal of licence

Authority conferred on licence holder by licence

402 Licence to supply scheduled medicines by wholesale as fixed vendor

403 Licence to supply scheduled medicines by wholesale as mobile vendor

404 Licence to supply pharmacy medicines other than by wholesale

405 Licence to dispense medicines by using automated dispensing machine

406 Licence to operate pharmacy

Conditions of licence

407 Conditions of licence

408 Reasons for imposing conditions on licence

409 Complying with conditions on licence

Suspending, cancelling, and disqualifying holding of licence

410 Effect of false or misleading statement made in application for licence

411 Reasons for cancelling licence

412 Effect of charge or conviction on licence

413 Producing licence to court

Duration of licence

414 Duration of licence

415 Superseding licence

416 Surrendering licence on ceasing controlled activity

Register of licences and records of licensing authority

417 Register of licences and records of licensing authority

Subpart 4Operating pharmacies

418 Outline of this subpart

419 Meaning of holds an interest in pharmacy

Additional information for pharmacy licence

420 Additional matters to be satisfied for pharmacy licence

421 Additional information required for pharmacy licence

Companies

422 Restrictions on companies being granted pharmacy licence

Majority interest in pharmacy

423 Licence and majority interest restrictions for persons

Mortgagees in possession

424 Exception for mortgagees in possession

Mandatory condition on pharmacy licence

425 Mandatory condition on pharmacy licence

426 Failure to comply with conditions on pharmacy licence

Restrictions on operating and holding interests in pharmacies

427 Prescriber restricted from holding interest in pharmacy

428 Prohibition on operating or holding of majority interest in more than 5 pharmacies

Fee on prescriptions

429 Offence for persons associated with pharmacies to take fee on prescriptions

Subpart 5Certain requirements, restrictions, and offences associated with medicines

430 Outline of this subpart

Security, storage, and premises

431 Security of medicines in pharmacy

432 Storage of scheduled medicine in person's possession or charge

433 Storage of scheduled medicine in unattended building or vehicle

434 Powers of Medical Officer of Health in respect of premises

Containers and packages

435 Containers and packages when supplying and transporting medicine

436 Container for medicine in person's possession or charge

Packing and preparing medicines

437 Packing and preparing medicines for use

Delivering medicines

438 Delivering medicines

Disposal of medicines

439 Disposal of medicines

Record keeping

440 Records relating to supplying medicine

441 Providing information about records for supplying medicine

Knowingly risking public health

442 Offence to knowingly risk public health

Subpart 6Enforcement and certain procedural matters

443 Outline of this subpart

444 Interpretation

Medicines control officers

445 Medicines control officers

446 Identification cards

Powers of entry, search, and seizure

447 Powers of entry to inspect compliance

448 Entry on serious risk to public health ground

Search warrant

449 Issue of search warrants

450 Powers of entry with search warrant

Matters associated with search

451 Occupier entitled to be present during search

452 Use of electronic equipment

453 Copies of documents seized to be provided

What happens to seized property

454 Disposal of property seized

455 Order to retain seized property

Analysis of samples

456 Analysis of sample

457 Analysis of samples and certificate of analyst

458 Evidence of analysis

459 Cost of analysis

Wilfully obstructing

460 Offence of wilfully obstructing

False or misleading statement, declaration, or answer

461 False or misleading statement, declaration, or answer

Powers of Director-General and Medical Officer of Health

462 Director-General or Medical Officer of Health may require documents or records

463 Offence not to comply with requirement in section 462

Disclosure of information

464 Disclosure of information

Matters relating to proceedings

465 Matters relating to information and summons

466 Service of documents

467 Contents of container presumed in proceedings

468 Certificate signed by licensing authority

469 Copies of documents or records in proceedings

Matters arising from conviction

470 Forfeiture on conviction

471 Notifying health authority or Veterinary Council of conviction

Matters effecting liability

472 Strict liability

473 Liability of employer for act of employees

474 Liability of executive officers for acts of body corporate

475 Protection of persons acting in performance of functions under Parts 6 and 7

Subpart 7Appeals

476 Outline of this subpart

Appeals against decision of Medical Officer of Health in respect of premises

477 Appeal against decision in respect of premises

Licensing appeals

478 Appeal against decision of licensing authority

479 Status of decision of licensing authority pending appeal

480 Proceedings before District Court

481 Appeal to High Court on question of law

482 Status of decision of District Court pending appeal

483 Procedure for appeal

484 No person may be deprived of right to appeal

485 Licensing authority to implement decision of Court

Subpart 8Restrictions on xenotransplantation

486 Outline of subpart

487 Interpretation

488 Restriction on xenotransplantation

489 Authorisation for particular xenotransplantation given by Minister

490 Authorisation given for xenotransplantation by Order in Council

491 Criteria for authority

492 Advice on applicability of criteria

493 Applications

494 No compensation

495 Enforcement powers

496 Director-General or Medical Officer of Health may require information relating to xenotransplantation

497 Offence not to comply with requirement to produce under section 496

498 Expiry of subpart

Subpart 9Regulations, Orders in Council, Ministerial notices, and other instruments

Regulations

499 Regulations

Regulations designating designated prescribers

500 Regulations designating health practitioners as designated prescribers

Regulations relating to prescribing notices

501 Regulations relating to prescribing notices and prescription medicines that designated prescribers may prescribe

Regulations designating authorised prescribers

502 Regulations designating health practitioners as authorised prescribers

Regulations relating to qualifications, training, and competence of prescribers and veterinarians when prescribing

503 Regulations relating to qualifications, training, and competence of prescribers and veterinarians when prescribing

Regulations relating to pharmacy ownership and operation

504 Orders in Council providing for exemption from, or modifications of, restrictions on pharmacy ownership and operation

Approval and appointments relating to laboratories and analysts

505 Minister may approve laboratory

506 Minister may appoint analyst in charge

507 Analyst in charge may authorise analyst

Appointment of advisory and technical committees

508 Advisory and technical committees

Certain powers of Director-General

509 Statement of Director-General

510 Director-General may authorise Medical Officer of Health to issue notices and statements

Subpart 10Scheduled medicines and referring to medicines

Scheduled medicines

511 Standard for Uniform Scheduling of Medicines and Poisons or SUSMP

512 Scheduled medicines

513 Ministerial notice declaring scheduled medicine

514 Ministerial notice departing from managing director's listing

515 Director-General to keep Internet register of declarations and departures

516 Evidence of SUSMP

Referring to medicines

517 How to refer to or specify medicines

Subpart 11Miscellaneous matters

Relationship to other enactments

518 Relationship with Misuse of Drugs Act 1975

Transitional regime for designated prescribers

519 Designated prescriber under former Act deemed to be designated prescriber

Transitional regime for standing orders

520 Standing orders issued under former Act

Transitional regime for licences

521 Application for licence to sell medicines by wholesale under former Act

522 Licence to sell any medicine by wholesale granted under former Act

523 Application for licence to sell any medicine by retail under former Act

524 Licence to sell medicines by retail granted under former Act

525 Application for licence to hawk medicines under former regulations

526 Licence to hawk medicines granted under former regulations

527 Application for licence to operate pharmacy under former Act

528 Licence to operate pharmacy granted under former Act

529 Other licences granted under former Act

530 Condition on deemed licence

Transitional regime for proceedings and appeals under former Act

531 Proceedings commenced under former Act

532 Appeal from decision under former Act

Transitional regime for officers under former Act

533 Officers appointed under former Act

534 No compensation for loss of office or appointment

Transitional regime for xenotransplantation

535 Xenotransplantation

Transitional regime for approved laboratory and analyst under former Act

536 Approved laboratory under former Act

537 Analyst in charge under former Act

Repeal

538 Repeal

539 Transitional and savings regulations

540 Expiry of section 539

Revocations

541 Revocations

Savings

542 Validity of actions under former Act and regulations not affected

543 Medicines (Approved Laboratories and Analysts in Charge) Notice 2000 saved

544 Medicines (Standing Order) Regulations 2002 saved

545 Medicines (Designated Prescriber: Nurse Practitioners) Regulations 2005 saved

546 Medicines (Designated Prescriber: Optometrists) Regulations 2005 saved

547 Orders in Council made under section 96D(1) of former Act saved

Consequential amendments

548 Consequential amendments

Schedule 1
Text of Agreement

Schedule 2
Provisions applying to Review Tribunal

Schedule 3
Consequential amendments relating to establishment of Authority

Schedule 4
Powers of Minister in relation to prescribing authorities' obligations

Schedule 5
Powers of health authority or Veterinary Council when making inquiries

Schedule 6
Review or appeal of restriction notice

Schedule 7
Regulations and orders revoked

Schedule 8
Consequential amendments to enactments


The Parliament of New Zealand enacts as follows:

1 Title
  • This Act is the Therapeutic Products and Medicines Act 2006.

2 Commencement
  • (1) Parts 1 to 5 (which relate to therapeutic products) come into force on a date to be appointed by the Governor-General by Order in Council; and 1 or more Orders in Council may be made bringing different provisions into force on different dates.

    (2) Parts 6 and 7 (which relate to medicines) come into force on a date to be appointed by the Governor-General by Order in Council; and 1 or more Orders in Council may be made bringing different provisions into force on different dates.

3 Object
  • The object of this Act is—

    • (a) to give effect, by way of a Therapeutic Products Act, to the Agreement between the Government of Australia and the Government of New Zealand for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products, done at Wellington on 10 December 2003; and

    • (b) to consequentially repeal the Medicines Act 1981 and replace it with a new Medicines Act 2006.

Part 1
Preliminary, and Rules and Orders

Subpart 1Preliminary provisions

4 Purpose of Parts 1 to 5
  • The purpose of Parts 1 to 5 is to give effect to the Agreement and, in particular, to the Parties' primary objective in concluding the Agreement, which is to safeguard public health and safety in Australia and New Zealand by establishing and maintaining a joint scheme consistent with international best practice for the regulation of—

    • (a) the quality, safety, and efficacy or performance of therapeutic products; and

    • (b) the manufacture, supply, import, export, and promotion of therapeutic products.

5 Overview of Parts 1 to 5
  • (1) The manufacture, supply, import, export, and promotion of therapeutic products is primarily regulated by the Authority under the joint scheme established by the Agreement, the text of which is set out in Schedule 1.

    (2) The Agreement provides for the Authority to be established under Australian law and for it to be overseen by a Ministerial Council comprising the New Zealand Minister and the Australian Minister.

    (3) The details of the Scheme are set out in Rules (made by the Ministerial Council) and Orders (made by the Authority).

    (4) Rules and Orders—

    • (a) are enforced in New Zealand under Parts 1 to 5 (and are enforced in Australia under the Australian Act); and

    • (b) have the force of law in New Zealand as if they were regulations; and

    • (c) are capable of disallowance by the House of Representatives and also by either House of the Parliament of Australia.

    (5) The supply of medicines to consumers in New Zealand is primarily regulated through the Medicines Act 2006.

    (6) This section is by way of explanation only. If any provision of Parts 1 to 5, the Agreement, or any Rule or Order, conflicts with this section, the other provision prevails.

6 Interpretation
  • (1) In Parts 1 to 5, unless the context otherwise requires,—

    Agreement

    • (a) means the Agreement between the Government of Australia and the Government of New Zealand for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products, done at Wellington on 10 December 2003, a copy of the text of which is set out in Schedule 1; and

    • (b) includes that Agreement as amended from time to time

    applicable standard has the meaning given in section 28

    approval has the meaning given by Article 1 of the Agreement

    approved bank has the meaning given in section 187

    Australia, when used in a geographical sense, includes—

    • (a) Norfolk Island; and

    • (b) the Territory of Christmas Island; and

    • (c) the Territory of Cocos (Keeling) Islands

    Australian Act means the Therapeutic Products Act 2006 (Aust)

    Australian Finance Minister means the Minister of the Government of Australia who is responsible for administering the Commonwealth Authorities and Companies Act 1997 (Aust)

    Australian Minister has the meaning given by Article 1 of the Agreement

    Australian Ombudsman has the meaning given in section 128

    Australian Ombudsman Act has the meaning given in section 128

    Australian Privacy Act has the meaning given in section 128

    Australian Privacy Commissioner has the meaning given in section 128

    Australian Review Tribunal has the meaning given in section 128

    authorised officer has the meaning given in section 98

    Authority means the agency established by the Australian Act in accordance with Article 5 of the Agreement as the Australia New Zealand Therapeutic Products Authority

    Board has the meaning given by Article 1 of the Agreement

    Board member means a member of the Board appointed by the Ministerial Council under paragraph 2 of Article 6 of the Agreement; and includes any acting Board member appointed in accordance with the Rules

    civil penalty provision means a provision under which a person may be liable to a civil penalty

    compilation, in relation to a Rule or Order, means the text of the Rule or Order as amended by amendments that are in force at the date specified as the date of compilation

    condition, in relation to an approval or other authorisation given by the Authority, has the meaning given in section 28

    contravention of a civil penalty provision means doing something, or not doing something, that makes a person liable to a civil penalty under a civil penalty provision

    Deputy Australian Ombudsman has the meaning given in section 128

    document has the meaning given in section 98

    dwelling house has the meaning given in section 98

    evidential material has the meaning given in section 98

    executive officer has the meaning given in section 28

    expert advisory committee means a committee established in accordance with a Rule made under subparagraph (kk) of paragraph 1 of Article 9 of the Agreement

    export means to export from New Zealand or from Australia

    Finance Minister means the Minister of the Crown who, under the authority of any warrant or with the authority of the Prime Minister, is for the time being responsible for administering the Public Finance Act 1989

    financial year has the meaning given in section 187

    forecast financial statements has the meaning given in section 187

    generally accepted accounting practice has the meaning given in section 187

    import means to import into New Zealand or into Australia

    label has the meaning given in section 28

    Managing Director has the meaning given by Article 1 of the Agreement

    manufacture has the meaning given by Article 1 of the Agreement, but means specifically to manufacture in New Zealand or Australia

    manufacturing licence has the meaning given in section 28

    Medsafe means the business unit of the Ministry of Health that is known as Medsafe

    merits review has the meaning given by Article 1 of the Agreement

    Merits Review Panel has the meaning given in section 128

    Minister means the Minister of the Crown who, under the authority of any warrant or with the authority of the Prime Minister, is for the time being responsible for the Health portfolio (referred to in the Agreement as the New Zealand Minister)

    Ministerial Council has the meaning given by Article 1 of the Agreement

    New Zealand Ombudsman has the meaning given in section 128

    New Zealand Privacy Commissioner has the meaning given in section 128

    non-compliance notice has the meaning given in section 28

    occupier has the meaning given in section 98

    Order has the meaning given by Article 1 of the Agreement, and includes a provision of an Order, except as provided in section 13

    Parties, when referring to the Parties to the Agreement, means the Government of New Zealand and the Government of Australia

    penalty unit means the amount of $110

    place has the meaning given in section 98

    principal member has the meaning given in section 128

    product licence has the meaning given in section 28

    Review Tribunal means the New Zealand therapeutic products Review Tribunal established by section 135 in accordance with Article 13

    reviewable decision has the meaning given in section 128

    Rule has the meaning given by Article 1 of the Agreement, and includes a provision of a Rule, except as provided in section 13

    seize has the meaning given in section 98

    Scheme has the meaning given by Article 1 of the Agreement

    senior manager has the meaning given in section 187

    senior officer has the meaning given in section 187

    special purpose approval has the meaning given in section 28

    sponsor, in relation to a therapeutic product,—

    • (a) means—

      • (i) a person who imports, or arranges the import of, the product; or

      • (ii) a person who exports, or arranges the export of, the product; or

      • (iii) a person who, in New Zealand or Australia, manufactures the product, or arranges for another person to manufacture the product, for supply (whether in New Zealand, Australia, or elsewhere); but

    • (b) does not include the following:

      • (i) a person who imports, exports, or manufactures the therapeutic product on behalf of another person who, at the time of the import, export, or manufacture, is a resident of, or is carrying on business in, New Zealand or Australia:

      • (ii) a person who arranges the import, export, or manufacture of the therapeutic product on behalf of another person who, at the time of the arrangements, is a resident of, or is carrying on business in, New Zealand or Australia.

    subject to actual or proposed tampering has the meaning given in section 28

    subsidiary has the meaning given in section 187

    supply has the meaning given by Article 1 of the Agreement, but means specifically to supply for use in New Zealand or use in Australia

    therapeutic product has the meaning given by Article 1 of the Agreement

    therapeutic product information has the meaning given in section 128

    thing has the meaning given in section 98.

    (2) A reference to an Australian enactment that is repealed is a reference to any Australian enactment that, with or without modification, replaces or corresponds to the repealed enactment.

    (3) Terms that relate only to the transitional provisions in Part 5 are not defined in this section. They are defined in section 274 instead.

7 Crown exemption for products specified by Minister
  • (1) The Minister may specify that a therapeutic product (product A) is subject to a Crown exemption if—

    • (a) the Minister is satisfied that the product is identical in every material respect to another therapeutic product (product B); and

    • (b) product B is the subject of a product licence that authorises its import into, and supply within, New Zealand.

    (2) If product A is subject to a Crown exemption,—

    • (a) Parts 1 to 5 apply as if product A were subject to a product licence that—

      • (i) authorises its import into, and supply within, New Zealand (but not into or within Australia), but does not authorise its manufacture in, or export from, either New Zealand or Australia; and

      • (ii) is in all other respects identical to the product licence applying to product B; and

    • (b) the Minister is to be treated for the purposes of Parts 1 to 5 as if he or she were the holder of a product licence, as described in paragraph (a), for product A.

    (3) The Minister may not specify that a product is subject to a Crown exemption unless he or she has first consulted with the Australian Minister.

    (4) A product becomes subject to a Crown exemption on the date specified, by notice in the Gazette, as the date on which the Crown exemption applies.

    (5) The Minister must ensure that any product that is subject to a Crown exemption and that is supplied in New Zealand bears a label that clearly indicates that the product is subject to a Crown exemption.

    (6) This section applies despite anything in Parts 1 to 5, the Agreement, or the Rules or Orders.

8 Parts 1 to 5 bind the Crown
  • Parts 1 to 5, and the Rules and Orders, bind the Crown.

Subpart 2General provisions about Rules and Orders

9 Rules and Orders have force of law
  • (1) Rules and Orders have the force of law as if they were regulations made under an Act.

    (2) However, by way of explanation,—

    • (a) Rules and Orders are not enactments, as that term is defined in section 29 of the Interpretation Act 1999, and therefore that Act does not apply to them; and

    • (b) Rules and Orders are not regulations, as that term is defined in section 2 of the Regulations (Disallowance) Act 1989, and therefore that Act (and other Acts that rely on that definition, such as the Acts and Regulations Publication Act 1989) does not apply to them.

10 Effect of this subpart and subpart 3
  • The effect of this subpart and subpart 3, and the equivalent provisions of the Australian Act, is that Rules and Orders cannot be in force as part of the law of New Zealand without also being in force as part of the law of Australia, and vice versa.

11 When Rules and Orders come into force
  • (1) In accordance with paragraph 5 of Article 9 of the Agreement, Rules come into force on the later of—

    • (a) the date (if any) specified in the Rule as the date on which the Rule commences; and

    • (b) the date on which the requirements of paragraph 7 of Article 9 of the Agreement are satisfied.

    (2) The requirements of paragraph 7(a) of Article 9 of the Agreement are satisfied by—

    • (a) publishing the Rule on the Authority's Internet site, as required by section 14(1); or

    • (b) publishing the Rule, or notifying the making of the Rule, in the Gazette, as provided in paragraph 7 of Article 9 of the Agreement.

    (3) In accordance with paragraph 5 of Article 10 of the Agreement, Orders come into force on the later of—

    • (a) the date (if any) specified in the Order as the date on which the Order commences; and

    • (b) the date on which the requirements of paragraph 7 of Article 10 of the Agreement are satisfied.

    (4) The requirements of paragraph 7(a) of Article 10 of the Agreement are satisfied by—

    • (a) publishing the Order on the Authority's Internet site, as required by section 14(1); or

    • (b) publishing the Order, or notifying the making of the Order, in the Gazette, as provided in paragraph 7 of Article 10 of the Agreement.

12 Involvement of Finance Minister in making certain Rules
  • (1) The Minister must not agree to the Ministerial Council making a Rule dealing with the governance or accountability of the Authority unless the Finance Minister has, in writing, either agreed to the making of the Rule or indicated that his or her agreement is not required.

    (2) For the purposes of this section, governance and accountability includes, without limitation, all the matters referred to or dealt with in Part 4.

    (3) A failure to comply with subsection (1) does not affect the validity of any Rule.

Subpart 3Publication, presentation, and disallowance of Rules and Orders

Definition

13 Meaning of Rule and Order in this subpart
  • For the purposes only of this subpart, an instrument that contains 2 or more Rules or Orders is taken to be a single Rule or Order.

Publication of Rules and Orders

14 Publication of Rules, Orders, and compilations on Internet site
  • (1) The Authority must publish and maintain on its Internet site—

    • (a) every Rule; and

    • (b) every Order; and

    • (c) the explanatory statement of every Rule and Order.

    (2) The Authority must publish every Rule and Order on its Internet site as soon as practicable after the Rule or Order is made.

    (3) The Internet site must clearly indicate—

    • (a) which Rules and Orders are in force; and

    • (b) the date on which each Rule or Order is published on the Internet site; and

    • (c) the date on which each Rule or Order comes into force and, if any provision of a Rule or Order will come into force at a later date, an indication of when the provision will come into force; and

    • (d) the date on which a Rule or Order that is no longer in force ceased to be in force.

    (4) Failure to comply with subsection (1)(c), (2), or (3) does not affect the validity or enforceability of any Rule or Order.

    (5) The Authority may also publish compilations on its Internet site, in which case—

    • (a) a copy of every compilation published must be maintained on the Authority's Internet site; and

    • (b) the Internet site must clearly indicate the date of publication of each compilation; and

    • (c) a failure to comply with paragraphs (a) or (b) does not affect the validity or enforceability of the Rule or Order that is compiled.

15 Correction of Rules, Orders, and compilations on Internet site
  • (1) The Authority must arrange for the correction of a Rule, Order, or compilation published on its Internet site if,—

    • (a) in the case of a Rule or Order, the Authority becomes aware that the Rule or Order is not identical to the Rule or Order as made; and

    • (b) in the case of a compilation of a Rule or Order, the Authority becomes aware that the compilation does not accurately reproduce the text of the Rule or Order with all amendments in force on the date of compilation.

    (2) When a Rule, Order, or compilation is corrected, it must be annotated to show the date and time of the correction and the reason for it.

    (3) The correction of a Rule, Order, or compilation—

    • (a) does not affect any right or privilege that was acquired, or that accrued, by reason of reliance on the content of the repository before the correction was made; and

    • (b) does not impose or increase any obligation or liability that was incurred before the correction was made.

    Compare: Legislative Instruments Act 2003 s 23 (Aust)

16 Status of Rules, Orders, and compilations published on Internet site
  • (1) A Rule or Order published on the Authority's Internet site is taken, unless the contrary is proved, to be a complete and accurate record of the Rule or Order as made.

    (2) A compilation of a Rule or Order published on the Authority's Internet site is taken, unless the contrary is proved, to be a complete and accurate record of that Rule or Order as amended and in force on the date of compilation.

    (3) In any proceedings, proof is not required about the provisions and the coming into force (in whole or in part) of a Rule or Order as it appears on the Authority's Internet site.

    (4) A court or tribunal may inform itself about those matters in any way that it thinks fit.

    (5) It is presumed, unless the contrary is proved, that—

    • (a) a copy of a Rule or Order (or a provision of a Rule or Order) that purports to be printed from the Authority's Internet site is what it purports to be; and

    • (b) the Rule or Order (or the provision of a Rule or Order) was published on the date specified on the site as the date on which the Rule or Order (or the Rule or Order containing the provision) was first published.

    (6) The failure or unavailability of the Authority's Internet site does not affect the validity of any Rule or Order that was published on the site before the site failed or became unavailable.

    Compare: Legislative Instruments Act 2003 s 22 (Aust)

17 Hard copies of Rules and Orders
  • (1) The original signed copy of every Rule and Order must be retained by the Authority until the original is passed to the appropriate archival authority (see section 186).

    (2) The Authority must make certified copies of an original Rule or Order available—

    • (a) to the Minister, on request; and

    • (b) to the Australian Minister, on request; and

    • (c) to any other person, on request and payment of the fee (if any) prescribed by the Rules.

18 No copyright in Rules and Orders
  • (1) No copyright exists in Rules or Orders.

    (2) Nothing in subsection (1) affects the copyright in any material incorporated by reference in a Rule or Order.

Presentation of Rules and Orders

19 Presenting Rules and Orders
  • (1) The Minister must present a certified copy of every Rule and Order to the House of Representatives within 6 sitting days after the date on which the Rule or Order is made.

    (2) If a copy of a Rule or Order is not presented to the House of Representatives as required by subsection (1), then,—

    • (a) if the Rule or Order is not in force on the last day on which it should have been presented, it does not come into force after that day; and

    • (b) if the Rule or Order is in force on the last day on which it should have been presented, it ceases to be in force at the close of that day.

    Compare: 1989 No 143 s 4

20 Presenting explanatory statements
  • (1) When the Minister presents a Rule or Order to the House of Representatives, he or she must, at the same time, present an explanatory statement about the Rule or Order.

    (2) If the Minister fails to present the explanatory statement at the same time as the Rule or Order, he or she—

    • (a) must present the explanatory statement as soon as possible; and

    • (b) must at the same time present a statement explaining the reason for the late presentation of the explanatory statement.

    (3) If a Rule or Order incorporates material by reference, the explanatory statement must give the following information:

    • (a) where in New Zealand hard copies of the incorporated material may be viewed free of charge:

    • (b) whether the incorporated material may be viewed electronically, and if so, how:

    • (c) how members of the public may acquire copies of the incorporated material at no more than a reasonable cost:

    • (d) whether the incorporated material refers to that material as at a particular date, or if the incorporated material includes that material as from time to time amended or replaced.

    (4) Failure by the Minister to comply with any of subsections (1) to (3) does not affect the validity or enforceability of the Rule or Order.

Disallowance of Rules and Orders

21 Explanation of sections 22 to 27
  • (1) The purpose of sections 22 to 27 is to provide for the disallowance of Rules and Orders by the New Zealand House of Representatives.

    (2) A discrete disallowance scheme is required because Rules and Orders are not regulations for the purposes of the Regulations (Disallowance) Act 1989 and are therefore not subject to disallowance under that Act.

    (3) The disallowance scheme set out in sections 22 to 27 differs from that in the Regulations (Disallowance) Act 1989 because, in order to reflect the joint nature of Rules and Orders, it needs to be consistent with the equivalent disallowance scheme under the Australian Act as far as possible.

22 Rules and Orders to be disallowed in whole only
  • A Rule or Order may be disallowed in whole only, and not in part.

23 Notice of motion to disallow Rule or Order
  • (1) Any member of Parliament may give a notice of motion to disallow a Rule or Order that has been presented to the House of Representatives.

    (2) The notice of motion must be given within 3 months of the date on which the Rule or Order was presented to the House of Representatives.

    (3) For the purpose of calculating 3 months from the date of presentation, the following periods are not to be counted:

    • (a) any period during which Parliament is prorogued:

    • (b) any period between the dissolution or expiry of one Parliament and the first sitting day of the next Parliament.

24 How and when Rule or Order disallowed
  • (1) A Rule or Order is disallowed if—

    • (a) a notice of motion to disallow a Rule or Order is given by a member of the committee of the House of Representatives responsible for the review of regulations and, by the close of the 21st sitting day after the date on which the notice is given, no decision on the motion has been made; or

    • (b) a notice of motion to disallow a Rule or Order is given by any member of the House of Representatives and is called on, moved, and agreed to within 21 sitting days after the date on which the notice is given.

    (2) A Rule or Order that is disallowed ceases to be in force on the later of the following:

    • (a) the date specified in the notice of motion as the date on which the disallowance takes effect; or

    • (b) the day after the date on which the Rule or Order is disallowed.

    (3) A Rule or Order cannot be disallowed under a notice of motion that has lapsed under section 25, unless it is reinstated in accordance with section 25(2).

    Compare: 1989 No 143 ss 5, 6

25 Lapse of notice of motion to disallow Rule or Order
  • (1) A notice of motion to disallow a Rule or Order lapses if—

    • (a) the notice is called upon and moved but is not agreed to; or

    • (b) the notice—

      • (i) was given by a member of Parliament who is not a member of the committee of the House of Representatives responsible for the review of regulations; and

      • (ii) has not been agreed to within 21 sitting days after the date on which the notice was given; or

    • (c) the member who gave the notice withdraws it.

    (2) If Parliament is dissolved or expires within 21 sitting days after the date on which the notice is given, the notice of motion lapses but may be reinstated in the new Parliament. If it is reinstated, the notice of motion is to be treated—

    • (a) as if it had originally been given on the first sitting day of the new Parliament; and

    • (b) as if that date were within 3 months of the date on which the Rule or Order was presented to the House of Representatives.

26 Giving notice when Rule or Order disallowed
  • (1) If a Rule or Order is disallowed under section 24, or is disallowed or taken to have been disallowed by either House of the Parliament of Australia, the Minister must arrange for the publication in the Gazette of a notice identifying the Rule or Order that has been disallowed and the date on which the Rule or Order ceases to have effect.

    (2) The Authority must, as soon as practicable after a Rule or Order has been disallowed, give notice of that fact on its Internet site.

    Compare: 1989 No 143 s 10

27 Effect of failure to table in, or disallowance by, Australian Parliament
  • A Rule or Order is not in force if, under the Australian Act, it is not in force as a result of—

    • (a) a failure to table the Rule or Order in both Houses of the Parliament of Australia, as required by the Australian Act; or

    • (b) disallowance of the Rule or Order by either House of the Parliament of Australia.

Part 2
Enforcement of regulatory scheme

Subpart 1General provisions relating to Part

Definitions and jurisdiction

28 Definitions of terms used primarily in subparts 1 to 3
  • In Parts 1 to 5, unless the context otherwise requires,—

    applicable standard, in relation to a therapeutic product, means a standard that, under the Rules, applies to that therapeutic product, whether the standard is set out in the Rules or in Orders

    condition, in relation to an approval or other form of authorisation given by the Authority, means a condition that is imposed by or under the approval or authorisation itself, or by or under the Rules or Orders

    conformity assessment certificate means an approval of a kind defined in the Rules as a conformity assessment certificate

    executive officer means, in relation to a body corporate (other than the Authority), a person, by whatever name called and whether or not a director of the body, who is concerned in, or takes part in, the management of the body

    label, in relation to a therapeutic product, means a display of printed information—

    • (a) on or attached to the therapeutic product; or

    • (b) on or attached to a container or primary pack (as those terms are defined in the Rules) in which the therapeutic product is supplied; or

    • (c) supplied with such a container or pack

    manufacturing licence means an approval of a kind defined in the Rules as a manufacturing licence

    non-compliance notice means a notice issued under section 89

    product licence means an approval of a kind defined in the Rules as a product licence

    special purpose approval means an approval that authorises a person to manufacture, import, export, or supply a therapeutic product without a product licence

    subject to actual or proposed tampering means, in relation to a therapeutic product, that the product has been, or is proposed to be, interfered with in a way that affects or could affect the quality, safety, efficacy, or performance of the therapeutic product; and

    • (a) the interference has the potential to cause harm to any person; or

    • (b) the interference is done for the purpose of causing harm to any person.

29 Jurisdiction extended to conduct in Australia
  • (1) For the purpose of jurisdiction, a person may be convicted of an offence under this Part if any act or omission forming part of the offence, or any event necessary for the completion of the offence, occurs in either New Zealand or Australia—

    • (a) whether or not any other act or omission forming part of the offence, or event necessary for completing the offence, occurs outside either New Zealand or Australia; and

    • (b) whether or not the person charged with the offence was in New Zealand or Australia at the time of the act, omission, or event.

    (2) For the purpose of jurisdiction, a person may be liable to a civil penalty under this Part if any part of the conduct giving rise to the liability occurs in either New Zealand or Australia—

    • (a) whether or not any other part of the conduct occurs outside either New Zealand or Australia; and

    • (b) whether or not the person proceeded against was in New Zealand or Australia at the time of the conduct constituting the contravention.

    Compare: 1961 No 43 s 7

General provisions about offences

30 Six-year time limit for bringing summary offences
  • (1) Despite section 14 of the Summary Proceedings Act 1957, proceedings in respect of the summary offences in this Part may be commenced at any time within 6 years after the conduct that constituted the offence occurred.

    (2) In this section, summary offence has the meaning given in section 2 of the Summary Proceedings Act 1957.

31 Sentencing guidelines for offences involving harm
  • (1) In determining the appropriate level of penalty for an offence in which the defendant's conduct caused, or caused a risk of, harm to any person, the sentencing Judge must take into account the following matters:

    • (a) how likely was it that harm would have been caused to any person by the conduct constituting the offence (disregarding the fact that steps were, or might have been, taken to prevent or mitigate the harm or risk of harm):

    • (b) how many people were at risk of harm by the conduct constituting the offence:

    • (c) whether the conduct constituting the offence did in fact cause harm to any person:

    • (d) how serious was the harm that was caused, or was likely to have been caused, by the conduct constituting the offence.

    (2) Nothing in subsection (1) limits the application of the Sentencing Act 2002.

32 Strict liability offences
  • (1) In a prosecution for a strict liability offence under this Part,—

    • (a) it is not necessary for the prosecution to prove that the defendant—

      • (i) intended the conduct that constitutes the offence; or

      • (ii) knew or was reckless as to any fact or circumstance that is an element of the offence; or

      • (iii) knew, or was reckless as to whether, any result that is an element of the offence would occur; and

    • (b) except as otherwise specified in this Part, it is not a defence to a strict liability offence that the defendant—

      • (i) took all reasonable steps to avoid or prevent the commission of the offence; or

      • (ii) mistakenly believed in the existence of facts that, if true, would have meant that the defendant's conduct did not constitute an offence.

    (2) Despite subsection (1)(b), it is a defence to a strict liability offence under this Part that the defendant believed, on reasonable grounds, in the existence of facts that, if true, would have meant that the defendant's conduct did not constitute an offence.

    (3) In a prosecution for a strict liability offence under this Part, the defence mentioned in subsection (2), and any defence identified in this Part as a defence specifically to a strict liability offence, is made out if—

    • (a) the defendant points to evidence before the court that the existence of the defence is a reasonable possibility; and

    • (b) the prosecution does not disprove the existence of the defence.

    (4) Subsection (3) does not apply if the provision setting out a defence to a strict liability offence states that the defendant must prove that defence.

33 Alternative verdicts
  • The Australian Act makes provision for alternative verdicts in relation to certain offences. This Act does not contain equivalent provisions because section 339 of the Crimes Act 1961 already makes similar provision.

34 Notice required to adduce evidence for certain defences
  • (1) This section applies if a defendant wishes to raise any of the following defences in connection with the associated offence:

    • (a) the defence in section 50(8) to a charge under section 50(6) (indictable offence relating to manufacturing a therapeutic product without a manufacturing licence or the correct manufacturing licence):

    • (b) the defence in section 52(9) to a charge under section 52(7) (indictable offence relating to the manufacture, import, export, or supply without a product licence or correct product licence):

    • (c) the defence in section 58(8) to a charge under section 58(6) (indictable offence relating to a manufacturer who supplies or exports a therapeutic product to which conformity assessment procedures have not been applied).

    (2) The defendant must not adduce evidence in support of the defence unless—

    • (a) the defendant gives notice, more than 30 days before the date of the trial, of the particulars of the defence; or

    • (b) if the notice is not given more than 30 days before the date of the trial, the court gives leave, in the interests of justice, for the evidence to be adduced.

    (3) A defendant must not, without leave of the court, call any other person to give evidence in support of the defence unless—

    • (a) the notice includes the name and address of the person or, if the name and address is not known to the defendant at the time he or she gives the notice, any information in his or her possession that might be of material assistance in finding the person; and

    • (b) if the name or the address is not given in the notice, the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address; and

    • (c) if the name or address is not included in the notice, but the defendant subsequently ascertains the name or address or receives information that might be of material assistance in finding the person, the defendant immediately gives notice of the name, address, or other information; and

    • (d) if the defendant is told by or on behalf of the prosecutor that the person has not been found by the name, or at the address, given by the defendant, then—

      • (i) the defendant immediately gives notice of any information in the defendant's possession that might be of material assistance in finding the person; and

      • (ii) if the defendant later receives any such information, the defendant immediately gives notice of the information.

    (4) Any evidence given to disprove the defence may, subject to direction by the court, be given before or after evidence given by the defendant in support of the defence.

    (5) When a defendant is committed for trial for any offence referred to in subsection (1), he or she must be informed of the requirements of this section and be given a copy of it.

35 Certificates to provide evidence of certain matters
  • (1) The Managing Director may certify that, at a specified time, or at all times during a specified period,—

    • (a) there was no exemption relating to a therapeutic product; or

    • (b) an approval was not granted to a particular person under the Rules in relation to a therapeutic product; or

    • (c) there was not a product licence for a therapeutic product; or

    • (d) there was a manufacturing licence or product licence for a therapeutic product but the licence was suspended; or

    • (e) a manufacturing licence or product licence was subject to conditions (including conditions specified in the licence); or

    • (f) a manufacturing licence or product licence had been revoked in relation to therapeutic products of a particular kind; or

    • (g) a declaration had not been made under the Rules that a therapeutic product is a therapeutic product or a therapeutic product of a particular kind; or

    • (h) a person was, or was not, the holder of:

      • (i) a manufacturing licence; or

      • (ii) a product licence; or

      • (iii) a conformity assessment certificate; or

    • (i) an authorisation was not granted to a person under the Rules in relation to a therapeutic product so that the product was required to conform to applicable standards in order to import, export, or supply the product; or

    • (j) a conformity assessment certificate had been issued relating to a particular kind of therapeutic product; or

    • (k) a conformity assessment certificate was subject to conditions (including conditions specified in the certificate); or

    • (l) a conformity assessment certificate had been suspended or revoked.

    (2) A certificate under subsection (1) must be in writing, and may relate to more than 1 of the matters referred to in subsection (1)(a) to (l).

    (3) In civil penalty or criminal proceedings under this Part,—

    • (a) a certificate under subsection (1) is prima facie evidence of the matters specified in the certificate; and

    • (b) a document purporting to be a certificate given under subsection (1) is, unless the contrary is proved, taken to be such a certificate and to have been duly given.

    (4) Subsection (3) does not apply in relation to criminal proceedings under the Australian Act.

Proceedings for civil penalties

36 Application for civil penalty
  • The Authority may apply to the High Court for an order requiring a person to pay a civil penalty.

37 Imposition of civil penalty
  • (1) The High Court may order a person to pay a civil penalty if it is satisfied that the person—

    • (a) has contravened a civil penalty provision; or

    • (b) has aided, abetted, counselled, or procured any other person to contravene a civil penalty provision; or

    • (c) induced, or attempted to induce, by threats or otherwise, the contravention of a civil penalty provision; or

    • (d) conspired with any other person to contravene a civil penalty provision.

    (2) In determining the amount of civil penalty to be paid, the Court must have regard to all relevant matters, including the following:

    • (a) the nature and extent of the contravention:

    • (b) the nature and extent of any loss or damage suffered as a result of the contravention:

    • (c) the circumstances in which the contravention took place:

    • (d) whether the person has previously been found by a court in proceedings under this Act, the Australian Act, or under any predecessor of those Acts, to have engaged in any similar conduct.

    (3) A civil penalty is payable to the Crown.

38 When and how civil penalty proceedings brought
  • (1) An application for a civil penalty under this Part may be made no later than 6 years after the conduct giving rise to the liability to pay the civil penalty occurred.

    (2) In proceedings for a civil penalty under this Part,—

    • (a) the standard of proof is the standard of proof that applies in civil proceedings; and

    • (b) the Authority may, by order of the Court, obtain discovery and administer interrogatories.

    Compare: 1996 No 30 s 124E

Relationship between civil penalty and criminal proceedings

39 Civil penalty proceedings in New Zealand after proceedings in Australia for civil penalty
  • (1) No proceedings for a civil penalty under this Part may be commenced against a person in relation to particular conduct if—

    • (a) proceedings against the person for a civil penalty under the Australian Act are underway, or have been completed, in Australia; and

    • (b) the proceedings are related to the same or substantially the same conduct as was to be the subject of the proceedings in New Zealand.

    (2) To avoid doubt, this section does not prevent subsequent proceedings in New Zealand for a civil penalty if earlier proceedings for a civil penalty in Australia have been discontinued.

40 Criminal proceedings in New Zealand after criminal proceedings in Australia
  • (1) No criminal proceedings for an offence under this Part may be commenced against a person in relation to particular conduct if—

    • (a) criminal proceedings against the person for an offence under the Australian Act are underway, or have been completed, in Australia; and

    • (b) the proceedings are related to the same or substantially the same conduct as was to be the subject of the proceedings in New Zealand.

    (2) To avoid doubt, this section does not prevent subsequent criminal proceedings in New Zealand if earlier criminal proceedings in Australia have been withdrawn.

41 Relationship between concurrent civil penalty proceedings and criminal proceedings
  • (1) Criminal proceedings for an offence under this Part may be commenced against a person in relation to particular conduct whether or not—

    • (a) proceedings in New Zealand for a civil penalty under this Part have been commenced against the person in relation to the same or substantially the same conduct; or

    • (b) proceedings in Australia for a civil penalty under the Australian Act have been commenced against the person in relation to the same or substantially the same conduct.

    (2) Proceedings under this Part for a civil penalty against a person in relation to particular conduct are stayed if—

    • (a) criminal proceedings in New Zealand against the person are or have been commenced for an offence under this Part in relation to the same or substantially the same conduct; or

    • (b) criminal proceedings in Australia against the person are or have been commenced for an offence under the Australian Act in relation to the same or substantially the same conduct.

    (3) After the criminal proceedings referred to in subsection (2)(a) or (b) have been completed or withdrawn, a person may apply to have the stay lifted on the civil penalty proceedings referred to in that subsection.

42 One penalty only rule
  • (1) If civil penalty or criminal proceedings under this Part are brought against a person in relation to particular conduct, a court may not impose a penalty (whether civil or criminal) on the person if a court in New Zealand or Australia has already imposed a penalty under this Part or under the Australian Act in proceedings relating to the same or substantially the same conduct.

    (2) If a person is or may be liable to more than one civil penalty under this Part in respect of the same or substantially the same conduct, civil penalty proceedings may be brought against the person for more than one civil penalty, but the person may not be required to pay more than one civil penalty in respect of the same or substantially the same conduct.

43 Effect of withdrawal or discontinuation of proceedings on limitation period
  • (1) This section applies if—

    • (a) proceedings against a person have been commenced in Australia in relation to certain conduct, and the proceedings are then withdrawn or discontinued; and

    • (b) an application is subsequently made, or proceedings are subsequently commenced, in New Zealand against the person in relation to the same or substantially the same conduct for an offence or civil penalty under this Part.

    (2) If this section applies, the period between the commencement of the Australian proceedings and the date on which they were withdrawn or discontinued is not to be included when determining whether the New Zealand application or proceedings are brought within the limitation period applying to the application or proceedings.

    (3) For the purposes of subsection (2), limitation period means the period during which criminal proceedings must be commenced under this Part or during which an application must be made under section 36 for a civil penalty order.

44 Restriction on use of evidence given in civil penalty proceedings
  • (1) Evidence of information given, or evidence of production of documents, by a person is not admissible in criminal proceedings against the person for an offence under this Part or any other enactment if—

    • (a) the person previously gave the evidence or produced the documents in civil penalty proceedings (under this Part or the Australian Act) against him or her in New Zealand or Australia, whether or not a civil penalty was imposed; and

    • (b) the proceedings for the civil penalty related to conduct that was the same or substantially the same as the conduct constituting the offence.

    (2) This section does not apply to criminal proceedings in respect of the falsity of the evidence given by the person in the proceedings for the civil penalty.

45 Abuse of process jurisdiction not affected
  • To avoid doubt, nothing in sections 39 to 44 affects the abuse of process jurisdiction of any court.

Liability of executive officers

46 Criminal liability of executive officers
  • (1) An executive officer of a body corporate commits an offence if—

    • (a) the body corporate commits an offence under this Part; and

    • (b) the officer knew that the offence was being or would be committed; and

    • (c) the officer was in a position to influence the conduct of the body corporate in relation to the commission of the offence; and

    • (d) the officer failed to take all reasonable steps to prevent the commission of the offence.

    (2) The maximum penalty for an offence under this section is the maximum penalty that could have been imposed if an individual had been convicted of the offence that the body corporate committed.

    (3) An offence under this section is triable (whether summarily or on indictment) in whatever manner the offence that the body corporate has committed could be tried.

    Compare: 1981 No 118 s 79(3)

47 Liability of executive officers to civil penalty
  • (1) An executive officer of a body corporate is liable to a civil penalty if—

    • (a) the body corporate contravenes a civil penalty provision; and

    • (b) the officer knew that contravention was occurring or would occur; and

    • (c) the officer was in a position to influence the conduct of the body corporate in relation to the contravention; and

    • (d) the officer failed to take all reasonable steps to prevent the contravention.

    (2) The maximum civil penalty for a contravention under this section is the maximum civil penalty that could have been imposed if an individual had contravened the civil penalty provision that the body corporate contravened.

    Compare: 1981 No 118 s 79(3)

48 How to establish whether executive officer took all reasonable steps
  • (1) For the purposes of sections 46 and 47, in determining whether an executive officer of a body corporate failed to take all reasonable steps to prevent the commission of an offence or contravention of a civil penalty provision, a court must have regard to the following:

    • (a) what action (if any) the officer took to ensure that the body corporate's employees, agents, and contractors had a reasonable knowledge and understanding of the requirements to comply with this Act and the Rules and Orders, so far as they affect the employees, agents, or contractors concerned:

    • (b) what action (if any) the officer took when he or she became aware that the body corporate was committing an offence under this Act or contravening a civil penalty provision.

    (2) This section does not limit the generality of sections 46 and 47.

49 Notice required to adduce evidence
  • (1) Section 34 applies to a defendant in proceedings for an offence under section 46(1) relating to an offence by a body corporate under any provision listed in subsection (2) as if the defendant were a defendant in proceedings for an offence against any of those provisions.

    (2) The relevant provisions are as follows:

    • (a) section 50(6):

    • (b) section 52(7):

    • (c) section 58(6).

Subpart 2Regulatory offences and civil penalties

Manufacture, import, export, and supply

50 Manufacture without manufacturing licence or correct manufacturing licence
  • (1) The offences and civil penalty in this section apply if, under the Rules, a person must not carry out a step in the manufacture of a therapeutic product at premises in New Zealand or Australia unless—

    • (a) the person holds a manufacturing licence for the therapeutic product or for therapeutic products of that kind; and

    • (b) the manufacturing licence authorises the carrying out of that step in the manufacture of the therapeutic product at those premises.

    Civil penalty provision

    (2) A person is liable to a civil penalty if—

    • (a) the person carries out a step in the manufacture of a therapeutic product in premises in New Zealand or Australia; and

    • (b) the person—

      • (i) does not hold a manufacturing licence in respect of that therapeutic product or kind of a therapeutic product; or

      • (ii) holds a manufacturing licence, but it does not authorise the carrying out of that step in the manufacture of that therapeutic product at those premises.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is—

    • (a) in the case of an individual, 5 000 penalty units; and

    • (b) in the case of a body corporate, 50 000 penalty units.

    Summary offence

    (4) A person commits an offence if—

    • (a) the person intentionally carries out a step in the manufacture of a therapeutic product in premises in New Zealand or Australia; and

    • (b) the person—

      • (i) does not hold a manufacturing licence in respect of that therapeutic product or kind of a therapeutic product; or

      • (ii) holds a manufacturing licence, but it does not authorise the carrying out of that step in the manufacture of that therapeutic product at those premises; and

    • (c) the person knows of the facts referred to in paragraph (b), or is reckless as to those facts.

    (5) A person who commits an offence under subsection (4) is liable, on summary conviction, to,—

    • (a) in the case of individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

    Indictable offence

    (6) A person commits an offence if—

    • (a) the person intentionally carries out a step in the manufacture of a therapeutic product in premises in New Zealand or Australia; and

    • (b) the person either—

      • (i) does not hold a manufacturing licence in respect of that therapeutic product or kind of a therapeutic product; or

      • (ii) holds a manufacturing licence, but it does not authorise the carrying out of that step in the manufacture of that therapeutic product at those premises; and

    • (c) the person knows of the facts referred to in paragraph (b), or is reckless as to those facts; and

    • (d) either—

      • (i) use of the therapeutic product harms any person; or

      • (ii) there is a serious risk that use of the therapeutic product will harm any person; and

    • (e) the person knows, or is reckless as to whether, harm or a serious risk of harm will result from use of the therapeutic product.

    (7) A person who commits an offence under subsection (6) is liable, on conviction on indictment, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 5 years:

      • (ii) a fine of up to 4 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 20 000 penalty units.

    Defence to indictable offence

    (8) It is a defence to an offence under subsection (6) if the defendant proves that the harm or serious risk of harm is not a result of a step carried out by the defendant in the manufacture of the therapeutic product.

    Strict liability offence

    (9) A person commits a strict liability offence if—

    • (a) the person carries out a step in the manufacture of a therapeutic product in premises in New Zealand or Australia; and

    • (b) the person either—

      • (i) does not hold a manufacturing licence in respect of that therapeutic product or kind of a therapeutic product; or

      • (ii) holds a manufacturing licence, but it does not authorise the carrying out of that step in the manufacture of that therapeutic product at those premises; and

    • (c) use of the product harms or is likely to harm any person.

    (10) A person who commits a strict liability offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 2 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 10 000 penalty units.

51 Breaching conditions of manufacturing licence
  • Civil penalty provision

    (1) A person is liable to a civil penalty if—

    • (a) the person holds a manufacturing licence; and

    • (b) the person breaches a condition of the manufacturing licence.

    (2) The maximum civil penalty that a person is liable to under subsection (1) is,—

    • (a) in the case of an individual, 5 000 penalty units; and

    • (b) in the case of a body corporate, 50 000 penalty units.

    Summary offence

    (3) A person commits an offence if—

    • (a) the person holds a manufacturing licence; and

    • (b) the person breaches a condition of the manufacturing licence; and

    • (c) the person knows that he or she is in breach of a condition of the manufacturing licence, or is reckless as to that fact.

    (4) A person who commits an offence under subsection (3) is liable, on summary conviction, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

    Indictable offence

    (5) A person commits an offence if—

    • (a) the person holds a manufacturing licence; and

    • (b) the person breaches a condition of the manufacturing licence; and

    • (c) the person knows that he or she is in breach of a condition of the manufacturing licence, or is reckless as to that fact; and

    • (d) the breach of the condition results in harm to any person or a serious risk of harm to any person; and

    • (e) the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the breach.

    (6) A person who commits an offence under subsection (5) is liable, on conviction on indictment, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 5 years:

      • (ii) a fine of up to 4 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 20 000 penalty units.

    Strict liability offence

    (7) A person commits a strict liability offence if—

    • (a) the person holds a manufacturing licence; and

    • (b) the person breaches a condition of the manufacturing licence; and

    • (c) the breach of the condition results in harm or is likely to result in harm to any person.

    (8) A person who commits a strict liability offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 2 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 10 000 penalty units.

52 Manufacture, import, export, or supply without product licence or correct product licence
  • (1) The civil penalty and offences in this section apply if, under the Rules, a person must not manufacture, import, export, or supply a therapeutic product unless the person holds a product licence of the sort that the Rules require a manufacturer, importer, exporter, or supplier of that therapeutic product to hold.

    (2) For the purposes of this section, a person who manufactures, imports, exports, or supplies a therapeutic product is presumed to be the sponsor of the therapeutic product at the time of its manufacture, import, export, or supply (as the case may be), unless the person proves that he or she was not the sponsor at that time.

    Civil penalty provision

    (3) A person is liable to a civil penalty if—

    • (a) the person manufactures, imports, exports, or supplies a therapeutic product; and

    • (b) the person does not hold the required product licence.

    (4) The maximum civil penalty that a person is liable to under subsection (3) is—

    • (a) in the case of an individual, 5 000 penalty units; and

    • (b) in the case of a body corporate, 50 000 penalty units.

    Summary offence

    (5) A person commits an offence if—

    • (a) the person intentionally manufactures, imports, exports, or supplies a therapeutic product; and

    • (b) the person does not hold the required product licence; and

    • (c) the person knows that he or she does not hold the required product licence, or is reckless as to that fact.

    (6) A person who commits an offence under subsection (5) is liable, on summary conviction, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

    Indictable offence

    (7) A person commits an offence if—

    • (a) the person intentionally manufactures, imports, exports, or supplies a therapeutic product; and

    • (b) the person does not hold the required product licence; and

    • (c) the person knows that he or she does not hold the required product licence, or is reckless as to that fact; and

    • (d) either—

      • (i) use of the product harms any person; or

      • (ii) there is a serious risk that use of the product will harm any person; and

    • (e) the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the manufacture, import, export, or supply of the therapeutic product.

    (8) A person who commits an offence under subsection (7) is liable, on conviction on indictment, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 5 years:

      • (ii) a fine of up to 4 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 20 000 penalty units.

    Defence to indictable offence

    (9) It is a defence to a charge for an offence under subsection (7) that—

    • (a) the harm or serious risk of harm is a direct result of the improper use of the therapeutic product; or

    • (b) the harm or serious risk of harm is not a direct or indirect result of the quality, performance, or efficacy of the therapeutic product, or of a matter relating to its labelling or packaging

    (10) The defence described in subsection (9) is made out if—

    • (a) the defendant points to evidence before the court that the existence of the defence is a reasonable possibility; and

    • (b) the prosecution does not disprove the existence of the defence.

    Strict liability offence

    (11) A person commits a strict liability offence if—

    • (a) the person manufactures, imports, exports, or supplies a therapeutic product; and

    • (b) the person does not hold the required product licence; and

    • (c) use of the product harms or is likely to harm any person.

    (12) A person who commits a strict liability offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 2 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 10 000 penalty units.

53 Breaching conditions of product licence
  • Civil penalty provision

    (1) A person is liable to a civil penalty if—

    • (a) the person holds a product licence; and

    • (b) the person breaches a condition of the product licence.

    (2) The maximum civil penalty that a person is liable to under subsection (1) is,—

    • (a) in the case of an individual, 5 000 penalty units; and

    • (b) in the case of a body corporate, 50 000 penalty units.

    Summary offence

    (3) A person commits an offence if—

    • (a) the person holds a product licence; and

    • (b) the person breaches a condition of the product licence; and

    • (c) the person knows that he or she is in breach of a condition of the product licence or is reckless as to that fact.

    (4) A person who commits an offence under subsection (3) is liable on, summary conviction, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

    Indictable offence

    (5) A person commits an offence if—

    • (a) the person holds a product licence; and

    • (b) the person breaches a condition of the product licence; and

    • (c) the person knows that he or she is in breach of a condition of the product licence, or is reckless as to that fact; and

    • (d) the breach of the condition results in harm to any person or a serious risk of harm to any person; and

    • (e) the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the breach.

    (6) A person who commits an offence under subsection (5) is liable, on conviction on indictment, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 5 years:

      • (ii) a fine of up to 4 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 20 000 penalty units.

    Strict liability offence

    (7) A person commits a strict liability offence if—

    • (a) the person holds a product licence; and

    • (b) the person breaches a condition of the product licence; and

    • (c) the breach of the condition results in harm or is likely to result in harm to any person.

    (8) A person who commits a strict liability offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 2 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 10 000 penalty units.

54 Breaching conditions of special purpose approval or requirements of exemption
  • (1) The civil penalty and offences in this section apply to a person who, under the Rules, is not required to have a product licence in order to manufacture, import, export, or supply a therapeutic product because—

    • (a) the person holds a special purpose approval in respect of the therapeutic product; or

    • (b) the person is otherwise exempt under the Rules from the requirement to hold a product licence in respect of the manufacture, import, export, or supply of the therapeutic product (in this section referred to as holding an exemption).

    Civil penalty provision

    (2) A person is liable to a civil penalty if the person breaches a condition of the special purpose approval or a requirement of the exemption.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is,—

    • (a) in the case of an individual, 3 000 penalty units; and

    • (b) in the case of a body corporate, 30 000 penalty units.

    Summary offence

    (4) A person commits an offence if—

    • (a) the person breaches a condition of the special purpose approval or a requirement of the exemption; and

    • (b) the person knows that he or she is in breach of a condition of the special purpose approval or requirement of the exemption, or is reckless as to that fact.

    (5) A person who commits an offence under subsection (4) is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 500 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 2 500 penalty units.

    Indictable offence

    (6) A person commits an offence if—

    • (a) the person breaches a condition of the special purpose approval or a requirement of the exemption; and

    • (b) the person knows that he or she is in breach of a condition of the special purpose approval or requirement of the exemption, or is reckless as to that fact; and

    • (c) the breach of the condition or requirement results in harm to any person or a serious risk of harm to any person; and

    • (d) the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the breach.

    (7) A person who commits an offence under subsection (6) is liable, on conviction on indictment, to,—

    • (a) in the case of an individual, a fine of up to 2 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 10 000 penalty units.

    Strict liability offence

    (8) A person commits a strict liability offence if—

    • (a) the person breaches a condition of the special purpose approval or a requirement of the exemption; and

    • (b) the breach of the condition or requirement results in harm or is likely to result in harm to any person.

    (9) A person who commits a strict liability offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

55 Import, export, or supply of product that does not conform to applicable standards
  • (1) The civil penalty and offences in this section apply if, under the Rules, a person must not import, export, or supply a therapeutic product unless it conforms to applicable standards.

    Civil penalty provision

    (2) A person is liable to a civil penalty if—

    • (a) the person imports, exports, or supplies a therapeutic product; and

    • (b) the therapeutic product does not conform to applicable standards.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is,—

    • (a) in the case of an individual, 5 000 penalty units; and

    • (b) in the case of a body corporate, 50 000 penalty units.

    Summary offence

    (4) A person commits an offence if—

    • (a) the person intentionally imports, exports, or supplies a therapeutic product; and

    • (b) the therapeutic product does not conform to applicable standards; and

    • (c) the person knows that the product does not conform to applicable standards, or is reckless as to that fact.

    (5) A person who commits an offence under subsection (4) is liable, on summary conviction, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

    Indictable offence

    (6) A person commits an offence if—

    • (a) the person intentionally imports, exports, or supplies a therapeutic product; and

    • (b) the therapeutic product does not conform to applicable standards; and

    • (c) the person knows that the product does not conform to applicable standards, or is reckless as to that fact; and

    • (d) as a result of the therapeutic product not conforming to applicable standards—

      • (i) use of the product harms any person; or

      • (ii) there is a serious risk that use of the product will harm any person; and

    • (e) the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the therapeutic product not conforming to applicable standards.

    (7) A person who commits an offence under subsection (6) is liable, on conviction on indictment, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 5 years:

      • (ii) a fine of up to 4 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 20 000 penalty units.

    Strict liability offence

    (8) A person commits a strict liability offence if—

    • (a) the person imports, exports, or supplies a therapeutic product; and

    • (b) the therapeutic product does not conform to applicable standards; and

    • (c) as a result of the therapeutic product not conforming to applicable standards, use of the product harms or is likely to harm any person.

    (9) A person who commits a strict liability offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 2 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 10 000 penalty units.

    Exceptions

    (10) A person does not commit an offence, and is not liable to a civil penalty, under this section if,—

    • (a) in relation to the import of a therapeutic product, the standard that the therapeutic product did not conform to is a standard that relates only to labelling or packaging; or

    • (b) in relation to the export of a therapeutic product, the standard that the therapeutic product did not conform to is a standard that relates only to labelling.

56 Breaching conditions of authorisation not to conform to applicable standards
  • (1) In this section, authorisation means an authorisation given by the Authority under the Rules that permits the holder to import, export, or supply a therapeutic product even though the therapeutic product does not conform to applicable standards.

    Civil penalty provision

    (2) A person is liable to a civil penalty if he or she breaches a condition of an authorisation.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is,—

    • (a) in the case of an individual, 3 000 penalty units; and

    • (b) in the case of a body corporate, 30 000 penalty units.

    Summary offence

    (4) A person commits an offence if—

    • (a) the person breaches a condition of an authorisation; and

    • (b) the person knows that he or she is in breach of a condition of the authorisation, or is reckless as to that fact.

    (5) A person who commits an offence under subsection (4) is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 500 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 2 500 penalty units.

    Indictable offence

    (6) A person commits an offence if—

    • (a) the person breaches a condition of an authorisation; and

    • (b) the person knows that he or she is in breach of a condition of the authorisation, or is reckless as to that fact; and

    • (c) the breach of the condition results in harm to any person or a serious risk of harm to any person; and

    • (d) the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the breach.

    (7) A person who commits an offence under subsection (6) is liable, on conviction on indictment, to,—

    • (a) in the case of an individual, a fine of up to 2 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 10 000 penalty units.

    Strict liability offence

    (8) A person commits a strict liability offence if—

    • (a) the person breaches a condition of an authorisation; and

    • (b) the breach of the condition results in harm or is likely to result in harm to any person.

    (9) A person who commits a strict liability offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

57 Breaching conditions of conformity assessment certificate
  • (1) A person commits an offence if—

    • (a) the person holds a conformity assessment certificate; and

    • (b) the person breaches a condition of the conformity assessment certificate; and

    • (c) the person knows that he or she is in breach of a condition of the conformity assessment certificate, or is reckless as to that fact.

    (2) A person who commits an offence under subsection (1) is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 60 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 300 penalty units.

58 Manufacturer supplying or exporting therapeutic product to which conformity assessment procedures not applied
  • (1) The civil penalty and offences in this section apply if, under Rules, the manufacturer of a therapeutic product must not supply or export the therapeutic product unless specified conformity assessment procedures have been applied to it.

    Civil penalty provision

    (2) A person is liable to a civil penalty if—

    • (a) the person manufactures a therapeutic product; and

    • (b) the specified conformity assessment procedures have not been applied to the therapeutic product.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is,—

    • (a) in the case of an individual, 5 000 penalty units; and

    • (b) in the case of a body corporate, 50 000 penalty units.

    Summary offence

    (4) A person commits an offence if—

    • (a) the person manufactures a therapeutic product; and

    • (b) the specified conformity assessment procedures have not been applied to the therapeutic product; and

    • (c) the person knows that the specified conformity assessment procedures have not been applied to the therapeutic product, or is reckless as to that fact; and

    • (d) the person intentionally supplies or exports the therapeutic product.

    (5) A person who commits an offence under subsection (4) is liable, on summary conviction, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

    Indictable offence

    (6) A person commits an offence if—

    • (a) the person manufactures a therapeutic product; and

    • (b) the specified conformity assessment procedures have not been applied to the therapeutic product; and

    • (c) the person knows that the specified conformity assessment procedures have not been applied to the therapeutic product, or is reckless as to that fact; and

    • (d) the person intentionally supplies or exports the therapeutic product; and

    • (e) either—

      • (i) use of the product harms any person; or

      • (ii) there is a serious risk that use of the product will harm any person; and

    • (f) the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the supply or export of the therapeutic product.

    (7) A person who commits an offence under subsection (6) is liable, on conviction on indictment, to—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 5 years:

      • (ii) a fine of up to 4 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 20 000 penalty units.

    Defence to indictable offence

    (8) It is a defence to a charge for an offence under subsection (6) if the defendant proves that the harm, or serious risk of harm, is not a result of the failure to apply the specified conformity assessment procedures to the therapeutic product.

    Strict liability offence

    (9) A person commits a strict liability offence if—

    • (a) the person manufactures a therapeutic product; and

    • (b) the specified conformity assessment procedures have not been applied to the therapeutic product; and

    • (c) the person supplies or exports the therapeutic product; and

    • (d) use of the product harms or is likely to harm any person.

    (10) A person who commits the strict liability offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 2 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 10 000 penalty units.

59 Other persons supplying or exporting products to which conformity assessment procedures not applied
  • (1) The offences in this section apply if, under the Rules, a person (being a person other than a manufacturer) must not supply or export a therapeutic product unless specified conformity assessment procedures have been applied to the therapeutic product.

    (2) For the purposes of this section, a person who exports or supplies a therapeutic product is presumed to be the sponsor of the therapeutic product at the time of its export or supply (as the case may be) unless the person proves that he or she was not the sponsor at that time.

    Summary offence

    (3) A person commits an offence if—

    • (a) the person intentionally exports or supplies a therapeutic product; and

    • (b) the specified conformity assessment procedures have not been applied to the therapeutic product; and

    • (c) the person knows that the specified conformity assessment procedures have not been applied to the therapeutic product, or is reckless as to that fact.

    (4) A person who commits an offence under subsection (3) is liable, on summary conviction, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

    Indictable offence

    (5) A person commits an offence if—

    • (a) the person intentionally exports or supplies a therapeutic product; and

    • (b) the specified conformity assessment procedures have not been applied to the therapeutic product; and

    • (c) the person knows that the specified conformity assessment procedures have not been applied to the therapeutic product, or is reckless as to that fact; and

    • (d) as a result of the failure to apply the specified conformity assessment procedures to the therapeutic product—

      • (i) use of the product harms any person; or

      • (ii) there is a serious risk that use of the product will harm any person; and

    • (e) the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the failure to apply the specified conformity assessment procedures to the therapeutic product.

    (6) A person who commits an offence under subsection (5) is liable, on conviction on indictment, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 5 years:

      • (ii) a fine of up to 4 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 20 000 penalty units.

Advertising

60 Purpose
  • The purpose of sections 61 to 67 (about advertising) is to provide for the enforcement of the Advertising Code established under the Rules, and of any Rules and Orders relating to advertising, in order to ensure that advertisements for therapeutic products are truthful, balanced, substantiated, do not mislead, and observe a high standard of social responsibility.

61 Meaning of circumstances
  • In sections 62 to 67, the circumstances in which an advertisement is published or broadcast includes, without limitation,—

    • (a) the media in which the advertisement is published or broadcast:

    • (b) the target audience that the advertisement is aimed at:

    • (c) the persons who publish or broadcast the advertisement:

    • (d) the kind of therapeutic product that the advertisement is about.

62 Publishing or broadcasting proscribed advertisements
  • (1) In this section, proscribed advertisement means an advertisement about a therapeutic product that does any of the following:

    • (a) contains information, or makes a claim or representation, about a therapeutic product that is false or misleading in a material particular:

    • (b) makes a claim or representation about a therapeutic product, or kind of therapeutic product, that is not consistent with—

      • (i) the intended purpose of the manufacturer of the therapeutic product or kind of therapeutic product; or

      • (ii) a standard that, under the Rules or Orders, applies to the therapeutic product or therapeutic products of that kind; or

      • (iii) the essential principles that, under the Rules or Orders, the therapeutic product or therapeutic products of that kind must comply with:

    • (c) targets healthcare practitioners and—

      • (i) makes claims about an active ingredient in the product advertised that cannot be substantiated by the supplier of that product; or

      • (ii) makes claims about indications for a therapeutic product that have not been approved by the Authority under the Rules; or

      • (iii) omits product information that the Rules or Orders require to be included in such an advertisement when targeted to healthcare practitioners:

    • (d) targets people who are not healthcare practitioners and makes claims about an active ingredient in a therapeutic product:

    • (e) omits information that the Rules or Orders require to be included in the advertisement, or in advertisements of that type, or in advertisements published or broadcast in the circumstances in which the advertisement is published or broadcast:

    • (f) claims or implies endorsement by a government (including an overseas government) or government authority, or a hospital or other healthcare provider:

    • (g) refers to a therapeutic product that is not subject to a product licence but for which a product licence is required under the Rules:

    • (h) refers to Parts 1 to 5, the Australian Act, the Rules, or the Orders:

    • (i) includes a testimonial that—

      • (i) is falsely attributed; or

      • (ii) is not current; or

      • (iii) refers to a type or level of benefit that is not consistent with any indications for the therapeutic product approved by the Authority; or

      • (iv) does not include acknowledgement of any payment or other benefit given as consideration for the testimonial.

    Civil penalty provision

    (2) A person is liable to a civil penalty if the person publishes or broadcasts a proscribed advertisement.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is the amount in the second or third column (as appropriate) that corresponds to the proscribed advertisement to which the liability relates, as identified in the first column by reference to a provision of this section.

    Type of proscribed advertisementIndividual: maximum number penalty unitsBody corporate: maximum number of penalty units
    (1)(a)5 00050 000
    (1)(b)5 00050 000
    (1)(c)5 00050 000
    (1)(d)5 00050 000
    (1)(e)3 00030 000
    (1)(f)3 00030 000
    (1)(g)2 00020 000
    (1)(h)2 00020 000
    (1)(i)1 00010 000
    Summary offence

    (4) A person commits an offence if the person—

    • (a) intentionally publishes or broadcasts an advertisement; and

    • (b) the advertisement is a proscribed advertisement identified in any of paragraphs (a), (b), (c), (d), (e), (f), or (i) of subsection (1); and

    • (c) the person knows, or is reckless as to whether, the advertisement is a proscribed advertisement identified in any of those paragraphs.

    (5) A person who commits an offence under subsection (4) is liable, on summary conviction, to a penalty of up to the maximum specified in the second or third column (as appropriate) that corresponds to the proscribed advertisement to which the liability relates, as identified in the first column by reference to a provision of this section.

    Type of proscribed advertisementIndividual: maximum number of penalty unitsBody corporate: maximum number of penalty units
    (1)(a)2 00010 000
    (1)(b)2 00010 000
    (1)(c)2 00010 000
    (1)(d)2 00010 000
    (1)(e)1 0005 000
    (1)(f)1 0005 000
    (1)(i)5002 500
    Strict liability offence

    (6) A person commits an offence if the person—

    • (a) intentionally publishes or broadcasts an advertisement; and

    • (b) the advertisement is a proscribed advertisement identified in either of paragraphs (g) or (h) of subsection (1).

    (7) A person who commits an offence under subsection (6) is liable, on summary conviction, to a penalty of up to the maximum specified in the second or third column (as appropriate) that corresponds to the proscribed advertisement to which the liability relates, as identified in the first column by reference to a provision of this section.

    Type of proscribed advertisementIndividual: maximum number of penalty unitsBody corporate: maximum number of penalty units
    (1)(g)1 0005 000
    (1)(h)5002 500
    Defence

    (8) In proceedings for an offence or a civil penalty under this section it is a defence that—

    • (a) the Rules or Orders provide that the relevant proscribed advertisement may be published or broadcast in specified circumstances; and

    • (b) the defendant published or broadcast the proscribed advertisement in, or in accordance with, those specified circumstances.

    (9) The defence in subsection (8) is made out if—

    • (a) the defendant points to evidence before the court that the existence of the defence is a reasonable possibility; and

    • (b) the prosecution does not disprove the existence of the defence.

63 Advertisements for which approval required
  • (1) This section applies only to advertisements for which, under the Rules or Orders, an approval is required.

    Civil penalty provision

    (2) A person is liable to a civil penalty if—

    • (a) the person publishes or broadcasts an advertisement in circumstances specified by the Rules or Orders as circumstances in which the advertisement, or advertisements of that kind, must have an approval; and

    • (b) the person—

      • (i) does not have an approval for the advertisement; or

      • (ii) has an approval, but the advertisement differs from the advertisement as approved; or

      • (iii) has an approval that is subject to conditions, and any condition of the approval is not complied with; or

      • (iv) has an approval but fails to display the approval number as required.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is,—

    • (a) in the case of an individual, 1 000 penalty units; and

    • (b) in the case of a body corporate, 5 000 penalty units.

    Strict liability offence

    (4) A person commits a strict liability offence if—

    • (a) the person publishes or broadcasts an advertisement in circumstances specified by the Rules or Orders as circumstances in which that advertisement, or advertisements of that kind, must have an approval; and

    • (b) the person—

      • (i) does not have an approval for the advertisement; or

      • (ii) has an approval, but the advertisement differs from the advertisement as approved; or

      • (iii) has an approval that is subject to conditions, and any condition of the approval is not complied with.

    (5) A person who commits an offence under subsection (5) is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

    Exceptions

    (6) A person does not commit an offence, and is not liable to a civil penalty, under this section if the person is a person who received the advertisement for publication or broadcast in the ordinary course of business.

    (7) For the purposes of this section, an advertisement does not differ from the advertisement as approved if the advertisement differs only in respect of one of the following:

    • (a) the price of the therapeutic product:

    • (b) the locations or times at which the therapeutic product is offered for sale:

    • (c) any other information reasonably necessary to identify the person offering the therapeutic product for sale.

64 Advertisements containing restricted representations
  • (1) In this section, restricted representation means a representation, or a representation of a kind, that the Rules or Orders provide must not be included in an advertisement for a therapeutic product unless the representation has been approved by the Authority.

    Civil penalty provision

    (2) A person is liable to a civil penalty if—

    • (a) the person publishes or broadcasts an advertisement that contains a restricted representation; and

    • (b) either—

      • (i) the restricted representation has not been approved by the Authority; or

      • (ii) the restricted representation has been approved by the Authority but is subject to conditions, and a condition has not been complied with.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is,—

    • (a) in the case of an individual, 5 000 penalty units; and

    • (b) in the case of a body corporate, 50 000 penalty units.

    Summary offence

    (4) A person commits an offence if—

    • (a) the person intentionally publishes or broadcasts an advertisement; and

    • (b) the advertisement contains a restricted representation; and

    • (c) the person knows that the advertisement contains a representation that is a restricted representation, or is reckless as to that fact; and

    • (d) either—

      • (i) the restricted representation is not approved by the Authority; or

      • (ii) the restricted representation is approved by the Authority, but a condition of that approval is not complied with; and

    • (e) the person knows that, or is reckless as to whether,—

      • (i) if paragraph (d)(i) applies, the restricted representation is not approved by the Authority; or

      • (ii) if paragraph (d)(ii) applies, a condition of the approval is not complied with.

    (5) A person who commits an offence under subsection (4) is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 2 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 10 000 penalty units.

65 Advertising in breach of direction by Authority
  • (1) In this section, direction means a direction that—

    • (a) relates to an advertisement for a therapeutic product; and

    • (b) is made by the Authority under and in accordance with the Rules and Orders.

    Civil penalty provision

    (2) A person is liable to a civil penalty if the person—

    • (a) is issued with a direction; and

    • (b) fails to comply with the direction.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is—

    • (a) in the case of an individual, 5 000 penalty units; and

    • (b) in the case of a body corporate, 50 000 penalty units.

    Strict liability offence

    (4) A person commits a strict liability offence if the person—

    • (a) is issued with a direction; and

    • (b) fails to comply with the direction.

    (5) A person who commits a strict liability offence under subsection (4) is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

66 Failing to comply with information requirement notice
  • Civil penalty provision

    (1) A person is liable to a civil penalty if the person—

    • (a) is an applicant for, or holder of,—

      • (i) an approval for an advertisement in respect of a therapeutic product; or

      • (ii) an approval for the use of a restricted representation in an advertisement; and

    • (b) is given an information requirement notice by the Authority in relation to information concerning the approval; and

    • (c) fails to comply with the notice.

    (2) The maximum civil penalty that a person is liable to under subsection (1) is,—

    • (a) in the case of an applicant for, or holder of, an approval for an advertisement,—

      • (i) in the case of an individual, 2 000 penalty units; and

      • (ii) in the case of a body corporate, 20 000 penalty units; and

    • (b) in the case of an applicant for, or holder of, an approval for the use of a restricted representation,—

      • (i) in the case of an individual, 5 000 penalty units; and

      • (ii) in the case of a body corporate, 50 000 penalty units.

67 Guidelines for setting penalty levels relating to advertising offences and civil penalties
  • (1) This section applies to every court that—

    • (a) imposes a civil penalty on a person under any of sections 62 to 66; or

    • (b) sentences a person who is convicted of an offence under any of sections 62 to 65.

    (2) The court must take into account the extent and degree to which the advertisement that is the subject of the proceedings displays any or all of the following characteristics:

    • (a) the advertisement makes a claim, direct or indirect, about the expected consequences of using a therapeutic product, or about its efficacy, utility, or safety, where the statement cannot be substantiated by the person by scientific evidence:

    • (b) the advertisement makes claims, direct or indirect, about the benefits or risks of using the therapeutic product, that are manifestly exaggerated or unbalanced, having regard to available scientific evidence:

    • (c) the advertisement makes comparisons, direct or indirect, between different therapeutic products, where the claims are manifestly exaggerated or unbalanced, having regard to available scientific evidence:

    • (d) the advertisement encourages, or is likely to encourage, excessive use of a therapeutic product:

    • (e) the advertisement encourages, or is likely to encourage, use of the therapeutic product for a purpose other than the purpose intended by its manufacturer:

    • (f) the advertisement manifestly exaggerates the need for the product by any person or class of person in respect of a particular disease or condition:

    • (g) the advertisement is calculated, or is likely, to provoke unwarranted fear, shock, or distress in vulnerable individuals:

    • (h) the advertisement is calculated, or is likely, to provoke superstitious or irrational beliefs:

    • (i) the advertisement encourages, or is likely to encourage, persons to engage in conduct that creates a real risk of serious harm to themselves or others.

    (3) Nothing in subsection (2) limits the matters that a court may take into account when sentencing a person or determining the amount of civil penalty the person is liable to pay.

Misrepresentation

68 Dealing with counterfeit products
  • (1) In this section, counterfeit product means a product where the label or presentation of the product, any advertisement for the product, or any document or record relating to the product or its manufacture, contains a false representation about any of the following:

    • (a) the identity or name of the product:

    • (b) the formulation, composition, or design specification of the product or of any ingredient or component of the product:

    • (c) the presence or absence of any ingredient or component of the product:

    • (d) the strength or size of the product (other than the size of any pack in which the product is contained):

    • (e) the strength or size of any ingredient or component of the product:

    • (f) the sponsor, source, manufacturer, or place of manufacture of the product.

    Civil penalty provision

    (2) A person is liable to a civil penalty if—

    • (a) the person—

      • (i) manufactures a therapeutic product in New Zealand or Australia; or

      • (ii) imports, exports, or supplies a product; and

    • (b) the product is a counterfeit product.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is,—

    • (a) in the case of an individual, 5 000 penalty units; and

    • (b) in the case of a body corporate, 50 000 penalty units.

    Indictable offence

    (4) A person commits an offence if—

    • (a) the person intentionally—

      • (i) manufactures a therapeutic product in New Zealand or Australia, or

      • (ii) imports, exports or supplies a therapeutic product; and

    • (b) the person knows, or is reckless as to whether, the product is a therapeutic product; and

    • (c) the product is a counterfeit product; and

    • (d) the person knows, or is reckless as to whether, the product is a counterfeit product.

    (5) A person who commits an offence under subsection (4) is liable, on conviction on indictment, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 7 years:

      • (ii) a fine of up to 2 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 10 000 penalty units.

69 Relief from liability in civil penalty proceedings relating to counterfeit products
  • (1) If civil penalty proceedings are commenced against a person under section 68(2), the High Court may relieve the person, either wholly or partly, from a liability to which the person would otherwise be subject if—

    • (a) the proceedings relate to the import, export, or supply of a therapeutic product; and

    • (b) it appears to the High Court that the person has or may have contravened section 68(2) but that—

      • (i) the person has a reasonable excuse; and

      • (ii) having regard to all the circumstances of the case, the person ought fairly to be excused.

    (2) If a person thinks that civil penalty proceedings relating to the import, export, or supply of a therapeutic product will or may be commenced against him or her, the person may apply to the High Court for prospective relief from liability.

    (3) On an application under subsection (2), the High Court may grant prospective relief from liability if subsection (1)(b) applies.

70 Setting out false product licence number
  • Civil penalty provision

    (1) A person is liable to a civil penalty if—

    • (a) the person sets out, or causes to be set out, a number on a container or package that contains therapeutic products, or on a label of a therapeutic product; and

    • (b) the number purports to be the unique identifier (as defined in the Rules) of the product licence for the therapeutic product; and

    • (c) the number is not the unique identifier of the product licence for the therapeutic product.

    (2) The maximum civil penalty that a person is liable to under subsection (1) is,—

    • (a) in the case of an individual, 100 penalty units; and

    • (b) in the case of a body corporate, 1 000 penalty units.

    Summary offence

    (3) A person commits an offence if—

    • (a) the person intentionally sets out, or causes to be set out, a number on a container or package that contains therapeutic products, or on a label of a therapeutic product; and

    • (b) the number purports to be the unique identifier of the product licence for the therapeutic product; and

    • (c) the number is not the unique identifier of the product licence for the therapeutic product; and

    • (d) the person knows that the number is not the unique identifier of the therapeutic product, or is reckless as to that fact.

    (4) A person who commits an offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 60 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 300 penalty units.

71 Falsely representing that product is subject to product licence
  • Civil penalty provision

    (1) A person is liable to a civil penalty if the person represents that—

    • (a) a therapeutic product that is not subject to a product licence is in fact subject to a product licence; or

    • (b) a therapeutic product that is not subject to a special purpose approval is in fact subject to a special purpose approval; or

    • (c) a therapeutic product that is not exempt from the requirement to have a product licence is in fact exempt from the requirement to have a product licence.

    (2) The maximum civil penalty that a person is liable to under subsection (1) is,—

    • (a) in the case of an individual, 5 000 penalty units; and

    • (b) in the case of a body corporate, 50 000 penalty units.

72 Claiming to supply when product cannot be lawfully supplied
  • Summary offence

    (1) A person commits an offence if—

    • (a) the person intentionally claims that he or she or another person is, or will be, able to supply a therapeutic product; and

    • (b) under the Rules, a product licence is required for the supply of the therapeutic product; and

    • (c) there is no product licence for the supply of the therapeutic product.

    (2) A person who commits an offence under subsection (1) is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 60 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 300 penalty units.

Product tampering

73 Notifying Authority if product subject to actual or proposed tampering
  • (1) This section applies if a person manufactures or supplies, or is a sponsor of, therapeutic products, or proposes to manufacture, supply, or become a sponsor of, therapeutic products and the person—

    • (a) knows that, or is aware of a substantial risk that, particular therapeutic products are subject to actual or proposed tampering; or

    • (b) receives a demand or information in relation to particular therapeutic products and—

      • (i) knows that the information or demand indicates that the therapeutic products are or may be subject to actual or proposed tampering; or

      • (ii) is negligent as to whether the information or demand indicates that the therapeutic products are or may be subject to actual or proposed tampering.

    Summary offence

    (2) If this section applies, a person commits an offence if the person intentionally fails to notify the Authority within 24 hours of,—

    • (a) where subsection (1)(a) applies, knowing or becoming aware of a substantial risk that the therapeutic products are subject to actual or proposed tampering; or

    • (b) where subsection (1)(b) applies, receiving an information or demand relating to those therapeutic products.

    (3) A person who commits an offence under subsection (2) is liable, on summary conviction, to—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

    (4) If subsection (1)(b) applies, it is irrelevant whether, at the time of receipt of the information or demand,—

    • (a) the person has possession or control of the therapeutic product or therapeutic products to which the information or demand relates; or

    • (b) the therapeutic product is, or the therapeutic products are, in existence.

False or misleading information in applications and declarations

74 False or misleading statements in applications
  • (1) In this section, relevant application means any of the following:

    • (a) an application for a manufacturing licence, a product licence, or a conformity assessment certificate:

    • (b) an application for renewal of a manufacturing licence or product licence:

    • (c) an application for a variation of a manufacturing licence or a product licence:

    • (d) a certification of any matter relating to an application for, or a renewal or variation of, a product licence:

    • (e) a certification of any matter relating to an application for a conformity assessment certificate.

    Civil penalty provision

    (2) A person is liable to a civil penalty if—

    • (a) the person makes a statement in, or in connection with, a relevant application; and

    • (b) the statement is false or misleading in a material particular.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is—

    • (a) in the case of an individual, 5 000 penalty units; and

    • (b) in the case of a body corporate, 50 000 penalty units.

    Indictable offence

    (4) A person commits an offence if—

    • (a) the person intentionally makes a statement; and

    • (b) the statement is in, or in connection with, a relevant application; and

    • (c) the person knows, or is reckless as to whether, the statement is in, or in connection with, a relevant application; and

    • (d) the statement is false or misleading in a material particular; and

    • (e) the person knows, or is reckless as to whether, the statement is false or misleading in a material particular.

    (5) A person who commits an offence under this section is liable, on conviction on indictment, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 5 years:

      • (ii) a fine of up to 4 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 20 000 penalty units.

    (6) However, if a person commits an offence under this section in relation to a certificate in relation to a patent in connection with an application for a product licence, then the person is liable, on conviction on indictment, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 5 years:

      • (ii) a fine of up to 8 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 40 000 penalty units.

75 False or misleading statements in declarations relating to conformity assessment procedures
  • Civil penalty provision

    (1) A person is liable to a civil penalty if—

    • (a) the person manufactures a therapeutic product; and

    • (b) the person makes a statement in, or in connection with, a declaration relating to the application of conformity assessment procedures to the therapeutic product; and

    • (c) the statement is false or misleading in a material particular.

    (2) The maximum civil penalty that a person is liable to under subsection (1) is,—

    • (a) in the case of an individual, 3 000 penalty units; and

    • (b) in the case of a body corporate, 30 000 penalty units.

    Summary offence

    (3) A person commits an offence if—

    • (a) the person manufactures a therapeutic product; and

    • (b) the person intentionally makes a statement; and

    • (c) the statement is in, or in connection with, a declaration relating to the application of conformity assessment procedures applied to a therapeutic product; and

    • (d) the person knows, or is reckless as to whether, the statement is in, or in connection with, a declaration relating to the application of conformity assessment procedures applied to a therapeutic product; and

    • (e) the statement is false or misleading in a material particular; and

    • (f) the person knows, or is reckless as to whether, the statement is false or misleading in a material particular.

    (4) A person who commits an offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

Adverse effect information

76 Product licence holders failing to give adverse effect information
  • (1) The civil penalty and offences in this section apply if, under the Rules, the holder of a product licence for a therapeutic product is required, on becoming aware of adverse effect information (as defined in the Rules), to give written notice to the Authority of that information in accordance with the pharmacovigilance requirements set out in the Orders.

    Civil penalty provision

    (2) A person to whom this section applies is liable to a civil penalty if—

    • (a) the person is the holder of the product licence for a therapeutic product; and

    • (b) the person becomes aware of adverse effect information relating to the therapeutic product; and

    • (c) the person fails to give the information to the Authority—

      • (i) in writing; and

      • (ii) as soon as he or she becomes aware of it; and

      • (iii) in accordance with the pharmacovigilance requirements.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is,—

    • (a) in the case of an individual, 3 000 penalty units; and

    • (b) in the case of a body corporate, 30 000 penalty units.

    Summary offence

    (4) A person to whom this section applies commits an offence if—

    • (a) the person is the holder of the product licence for a therapeutic product; and

    • (b) the person becomes aware of adverse effect information relating to the therapeutic product; and

    • (c) the person intentionally fails to give the information to the Authority—

      • (i) in writing; and

      • (ii) as soon as he or she becomes aware of it; and

      • (iii) in accordance with the pharmacovigilance requirements.

    (5) A person who is convicted of an offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, 5 000 penalty units.

Compliance with information requirement notice

77 References to information include references to documents
  • In sections 78 to 84

    • (a) a reference to giving or providing information includes a reference to giving or providing specific documents; and

    • (b) a reference to information being false or misleading includes a reference to a document that is forged.

78 Applicants, holders, and former holders failing to comply with information requirement notice
  • (1) This section applies to a person who is—

    • (a) an applicant for, or holder or former holder of, a product licence or conformity assessment certificate in respect of a therapeutic product; or

    • (b) an applicant for a renewal or variation of a product licence in respect of a therapeutic product.

    Strict liability offence

    (2) A person to whom this section applies commits a strict liability offence if—

    • (a) the person is given an information requirement notice (as defined in the Rules) relating to the therapeutic product; and

    • (b) the person fails to comply with the notice.

    (3) A person who commits an offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 500 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 2500 penalty units.

79 Applicants, holders, and former holders giving false or misleading information
  • (1) This section applies to a person who is—

    • (a) an applicant for, or holder or former holder of, a product licence or conformity assessment certificate in respect of a therapeutic product; or

    • (b) an applicant for a renewal or variation of a product licence in respect of a therapeutic product.

    Civil penalty provision

    (2) A person to whom this section applies is liable to a civil penalty if—

    • (a) the person is given an information requirement notice (as defined in the Rules) in relation to a therapeutic product; and

    • (b) the person gives information in purported compliance with the notice; and

    • (c) the information is false or misleading in a material particular.

    (3) The maximum civil penalty a person is liable to under subsection (2) is,—

    • (a) in the case of an individual, 5 000 penalty units; and

    • (b) in the case of a body corporate, 50 000 penalty units.

    Indictable offence

    (4) A person to whom this section applies commits an offence if—

    • (a) the person is given an information requirement notice (as defined in the Rules) in relation to a therapeutic product; and

    • (b) the person intentionally gives information in purported compliance with the notice; and

    • (c) the information is false or misleading in a material particular; and

    • (d) the person knows, or is reckless as to whether, the information is false or misleading in a material particular.

    (5) A person who is convicted of an offence under this section is liable, on conviction on indictment, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 5 years:

      • (ii) a fine of up to 4 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 20 000 penalty units.

80 Persons exempt from requirement to hold product licence failing to comply with information requirement notice
  • (1) This section applies to a person who is not required, under the Rules, to have a product licence or conformity assessment certificate in order to import, export, or supply a therapeutic product because—

    • (a) the person holds a special purpose approval in respect of the import, export, or supply of the therapeutic product; or

    • (b) is otherwise exempt under the Rules from the requirement to hold a product licence or conformity assessment certificate in respect of the import, export, or supply of the therapeutic product.

    Summary offence

    (2) A person to whom this section applies commits an offence if—

    • (a) the person is given an information requirement notice (as defined in the Rules) relating to the therapeutic product; and

    • (b) the person intentionally fails to comply with the notice.

    (3) A person who commits an offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 400 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 2 000 penalty units.

81 Self-incrimination not ground for refusing to supply information
  • (1) A person to whom section 80 applies is not excused from giving information about a therapeutic product, when required to do so by an information requirement notice (as defined in the Rules), on the ground that the information would tend to incriminate the person or expose the person to a penalty.

    (2) Subsection (1) applies despite anything to the contrary in any enactment (including the New Zealand Bill of Rights Act 1990) or rule of law.

    (3) However, information referred to in subsection (1), and any other information, document, or other thing, obtained as a direct or indirect consequence of that information, is not admissible in any civil penalty or criminal proceedings against the person, other than civil penalty or criminal proceedings under section 82.

82 Persons exempt from requirement to hold product licence giving false or misleading information
  • (1) This section applies to a person who is not required, under the Rules, to have a product licence or conformity assessment certificate in order to import, export, or supply a therapeutic product because—

    • (a) the person holds a special purpose approval in respect of the import, export, or supply of the therapeutic product; or

    • (b) is otherwise exempt under the Rules from the requirement to hold a product licence or conformity assessment certificate in respect of the import, export, or supply of the therapeutic product.

    Summary offence

    (2) A person to whom this section applies commits an offence if—

    • (a) the person is given an information requirement notice (as defined in the Rules); and

    • (b) the person intentionally gives information in purported compliance with the notice; and

    • (c) the information is false or misleading in a material particular; and

    • (d) the person knows, or is reckless as to whether, the information is false or misleading in a material particular.

    (3) A person who commits an offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

83 Ex-applicant for product licence failing to comply with information requirement notice
  • (1) This section applies to a person whose application for a product licence, or for a renewal or variation of a product licence, for a therapeutic product has lapsed or been withdrawn.

    Civil penalty provision

    (2) A person to whom this section applies is liable to a civil penalty if—

    • (a) the person is given an information requirement notice (as defined in the Rules) relating to the therapeutic product; and

    • (b) the person fails to comply with the requirements of the notice within the period specified in the notice.

    (3) The maximum civil penalty that a person is liable to under subsection (1) is,—

    • (a) in the case of an individual, 3 000 penalty units; and

    • (b) in the case of a body corporate, 30 000 penalty units.

    Summary offence

    (4) A person to whom this section applies commits an offence if—

    • (a) the person is given an information requirement notice (as defined in the Rules) relating to the therapeutic product; and

    • (b) the person intentionally fails to comply with the requirements of the notice within the period specified in the notice.

    (5) A person who commits an offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, 5 000 penalty units.

84 Ex-applicant for product licence giving false or misleading information
  • (1) This section applies to a person whose application for a product licence, or for a renewal or variation of a product licence, for a therapeutic product has lapsed or been withdrawn.

    Civil penalty provision

    (2) A person to whom this section applies is liable to a civil penalty if—

    • (a) the person is given an information requirement notice (as defined in the Rules) relating to the therapeutic product; and

    • (b) the person gives information in purported compliance with the notice; and

    • (c) the information is false or misleading in a material particular.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is,—

    • (a) in the case of an individual, 3 000 penalty units; and

    • (b) in the case of a body corporate, 30 000 penalty units.

    Summary offence

    (4) A person to whom this section applies commits an offence if—

    • (a) the person is given an information requirement notice (as defined in the Rules) relating to the therapeutic product; and

    • (b) the person intentionally gives information in purported compliance with the notice; and

    • (c) the information is false or misleading in a material particular; and

    • (d) the person knows, or is reckless as to whether, the information is false or misleading in a material particular.

    (5) A person who commits an offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

Compliance with recovery notice

85 Failing to comply with recovery notice
  • (1) In this section and sections 86 and 87, recovery notice means a notice (as defined in the Rules) given by the Authority and requiring the recipient to undertake specified steps involving or related to the recovery of a specified therapeutic product or kind or batch of therapeutic product.

    Civil penalty provision

    (2) A person is liable to a civil penalty if—

    • (a) the Authority gives the person a recovery notice; and

    • (b) the person fails to comply with the recovery notice.

    (3) The maximum civil penalty that a person is liable to under subsection (2) is,—

    • (a) in the case of an individual, 5 000 penalty units; and

    • (b) in the case of a body corporate, 50 000 penalty units.

    Summary offence

    (4) A person commits an offence if—

    • (a) the Authority gives the person a recovery notice; and

    • (b) the person knows, or is reckless as to whether, the Authority has given the person a recovery notice; and

    • (c) the person intentionally fails to comply with the notice.

    (5) A person who commits an offence under subsection (4) is liable, on summary conviction, to,—

    • (a) in the case of an individual, either of both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

    Indictable offence

    (6) A person commits an offence if—

    • (a) the Authority gives the person a recovery notice; and

    • (b) the person knows, or is reckless as to whether, the Authority has given the person a recovery notice; and

    • (c) the person intentionally fails to comply with the notice; and

    • (d) as a result of failing to comply with the notice—

      • (i) use of the therapeutic product referred to in the notice harms any person; or

      • (ii) there is a serious risk that use of the therapeutic product will harm any person; and

    • (e) the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the failure to comply with the notice.

    (7) A person who commits an offence under subsection (6) is liable, on summary conviction, to,—

    • (a) in the case of an individual, either of both of the following:

      • (i) a term of imprisonment of not more than 5 years:

      • (ii) a fine of up to 4 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 20 000 penalty units.

    Strict liability offence

    (8) A person commits a strict liability offence if—

    • (a) the Authority gives the person a recovery notice; and

    • (b) the person fails to comply with the notice; and

    • (c) as a result of failing to comply with the notice, use of the therapeutic product referred to in the notice harms or is likely to harm any person.

    (9) A person who commits a strict liability offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 2 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 10 000 penalty units.

86 Relief from civil liability for failing to comply with recovery notice
  • (1) If civil penalty proceedings are commenced against a person under section 85(2), the High Court may relieve the person, either wholly or partly, from a liability to which the person would otherwise be subject if—

    • (a) the recovery notice to which the proceedings relate was issued on the grounds of actual or proposed tampering; and

    • (b) it appears to the High Court that the person has or may have contravened section 85(2) but that—

      • (i) the person has acted honestly; and

      • (ii) having regard to all the circumstances of the case, the person ought fairly to be excused.

    (2) If a person thinks that civil penalty proceedings relating to a recovery notice issued on the grounds of actual or proposed tampering will or may be commenced against him or her, the person may apply to the High Court for prospective relief from liability.

    (3) On an application under subsection (2), the High Court may grant prospective relief from liability if subsection (1)(b) applies.

87 Export or supply of therapeutic products subject to recovery notice
  • Summary offence

    (1) A person commits an offence if—

    • (a) the person intentionally exports or supplies a therapeutic product; and

    • (b) the therapeutic product is, at the time of its export or supply, subject to a recovery notice (as defined in the Rules); and

    • (c) the recovery notice had been issued because the Authority was satisfied that the therapeutic product was, or therapeutic products in that batch were, subject to actual or proposed tampering; and

    • (d) the person knows that the therapeutic product is subject to a recovery notice at the time of its export or supply, or is reckless as to that fact; and

    • (e) the Authority has not consented in writing to the supply or export (as the case may be) of the therapeutic product or therapeutic products in that batch.

    (2) A person who is convicted of an offence under subsection (1) is liable, on summary conviction, to,—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months:

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

Information about sponsors

88 Identifying sponsor when required to do so
  • Civil penalty provision

    (1) A person is liable to a civil penalty if—

    • (a) the person manufactures, imports, exports, or supplies a therapeutic product; and

    • (b) the person claims not to be the sponsor of the therapeutic product; and

    • (c) the person is required by the Authority, in accordance with the Rules, to provide information about the identity of the sponsor of the therapeutic product, and

    • (d) the person—

      • (i) fails to provide that information within the time specified by the Authority; or

      • (ii) provides information that is false or misleading in a material particular.

    (2) The maximum civil penalty that a person is liable to under subsection (1) is,—

    • (a) in the case of an individual, 3 000 penalty units; and

    • (b) in the case of a body corporate, 30 000 penalty units.

    Summary offence

    (3) A person commits an offence if—

    • (a) the person manufactures, imports, exports, or supplies and therapeutic product; and

    • (b) the person claims not to be the sponsor of the therapeutic product; and

    • (c) the person is required by the Authority, in accordance with the Rules, to provide information about the identity of the sponsor of the therapeutic product, and

    • (d) the person intentionally—

      • (i) fails to provide that information within the time specified by the Authority; or

      • (ii) provides information that is false or misleading in a material particular.

    (4) A person who commits an offence under this section is liable, on summary conviction, to—

    • (a) in the case of an individual, either or both of the following:

      • (i) a term of imprisonment of not more than 12 months; or

      • (ii) a fine of up to 1 000 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 5 000 penalty units.

Subpart 3Non-compliance notices and enforceable undertakings

Non-compliance notices

89 Authority may issue non-compliance notice
  • (1) The Authority may issue a non-compliance notice to a person if, within the 12 months preceding the issue of the notice, the person has engaged in conduct that the Authority has reasonable cause to believe—

    • (a) renders the person liable to a civil penalty under this Part; or

    • (b) constitutes a strict liability offence against this Part.

    (2) Every non-compliance notice must—

    • (a) specify the monetary penalty to be paid in respect of the conduct described in the notice; and

    • (b) be in the form prescribed by regulations made under section 95.

    (3) The Authority may not issue a non-compliance notice to a person in respect of particular conduct if—

    • (a) civil penalty or criminal proceedings relating to that conduct have been commenced in New Zealand or Australia (whether or not they have been concluded) and have not been withdrawn; or

    • (b) a non-compliance notice relating to that conduct has already been issued in New Zealand or Australia and it has not been withdrawn.

90 Authority may withdraw non-compliance notice
  • The Authority may withdraw a non-compliance notice at any time before the monetary penalty specified in the notice is paid in full.

91 Date by which monetary penalty must be paid
  • (1) The date by which the monetary penalty specified in a non-compliance notice is to be paid is the date that is 28 days after the date of the notice, or any later date specified by the Authority.

    (2) If the recipient of the non-compliance notice makes submissions to the Authority before the date referred to in subsection (1), the date by which the monetary penalty is to be paid (assuming that the Authority does not withdraw the notice) is the date that is 14 days after the date on which the Authority responds to the submissions.

92 Amount and payment of monetary penalty
  • (1) The monetary penalty specified in a notice issued in respect of liability to a civil penalty must be determined by the Authority, but may not exceed,—

    • (a) in the case of an individual, one tenth of the maximum civil penalty that could be imposed on an individual for contravening the relevant civil penalty provision; and

    • (b) in the case of a body corporate, one tenth of the maximum civil penalty that could be imposed on a body corporate for contravening the relevant civil penalty.

    (2) The monetary penalty specified in respect of conduct constituting a strict liability offence must be determined by the Authority, but may not exceed,—

    • (a) in the case of an individual, one fifth of the maximum fine that could be imposed on an individual convicted of the relevant offence; and

    • (b) in the case of a body corporate, one fifth of the maximum fine that could be imposed on a body corporate convicted of the relevant offence.

    (3) A monetary penalty is payable to the Crown.

93 Non-compliance notice is bar to proceedings unless not paid by due date
  • (1) No civil penalty or criminal proceedings may be taken against the recipient of a non-compliance notice (whether the notice was issued in New Zealand or in Australia) in respect of conduct referred to in the notice—

    • (a) before the date by which the monetary penalty is to be paid (as determined under section 92 or the Australian Act, as the case requires); or

    • (b) if the recipient pays the specified amount by the date on which the monetary penalty is to be paid.

    (2) Subsection (1) does not apply if, before the date by which the monetary penalty is to be paid, the Authority withdraws the notice.

94 Payment of monetary penalty not admission of guilt or liability
  • The fact that the recipient of a non-compliance notice pays the monetary penalty specified in the notice is not to be taken by the Authority or any court as an admission by the recipient that he or she is or was liable to any civil penalty for the conduct referred to in the notice, or had committed a strict liability offence by that conduct.

95 Regulations prescribing form of non-compliance notice
  • (1) The Governor-General may, by Order in Council, make regulations prescribing the form of non-compliance notices.

    (2) Every non-compliance notice must (without limitation) set out or provide for the following:

    • (a) the name of the recipient:

    • (b) the contact details of the officer authorised to deal with the notice:

    • (c) a description of the conduct giving rise to the notice, including the time and place (if known) when the conduct is alleged to have occurred:

    • (d) the amount of the monetary penalty to be paid:

    • (e) the date by which the monetary penalty is to be paid:

    • (f) a statement of whether the Authority believes that the conduct referred to—

      • (i) renders the recipient liable to a civil penalty; or

      • (ii) constitutes a strict liability offence:

    • (g) the matters referred to in subsection (3):

    • (h) if the conduct relates to liability for a civil penalty,—

      • (i) the reason for setting the monetary penalty at the level specified in the notice; and

      • (ii) the maximum penalty that the recipient would be liable to pay if found liable to a civil penalty:

    • (i) if the conduct relates to a strict liability offence,—

      • (i) the reason for setting the monetary penalty at the level specified in the notice; and

      • (ii) the maximum fine that the recipient would be liable to pay if found guilty of the strict liability offence.

    (3) Every non-compliance notice must inform the recipient—

    • (a) that if the monetary penalty is not paid within the required time, civil or criminal proceedings may be commenced against the recipient in respect of the conduct referred to in the notice; and

    • (b) that the recipient should make written submissions to the Authority if he or she wishes to explain why the notice should be withdrawn; and

    • (c) that the Authority will respond in writing to any submissions made, but if the notice is not withdrawn then the monetary penalty must be paid within 14 days after the Authority responds; and

    • (d) that payment of the monetary penalty may not be taken by the Authority or any court as an admission by the recipient of liability for a civil penalty or as guilt of the strict liability offence, as the case may be.

Enforceable undertakings

96 Giving enforceable undertaking
  • (1) The Authority may accept a written undertaking (an enforceable undertaking) given by a person in connection with a matter in relation to which the Authority has a power or function relating to the regulation of therapeutic products.

    (2) A person who has given an enforceable undertaking may withdraw or vary it at any time, but only with the consent of the Authority.

    (3) The Authority must publish on the Internet details of every enforceable undertaking currently in force.

97 Consequence of breach of enforceable undertaking
  • (1) If the Authority considers that the person who gave an enforceable undertaking has breached any of its terms, the Authority may apply to the High Court for an order under subsection (2).

    (2) If the Court is satisfied that the person has breached a term of the undertaking, the Court may make all or any of the following orders:

    • (a) an order directing the person to comply with the term of the undertaking:

    • (b) an order directing the person to pay to the Crown an amount up to the amount of any financial benefit that the person has obtained directly or indirectly and that is reasonably attributable to the breach:

    • (c) any order (subject to subsection (3)) that the Court considers appropriate directing the person to compensate any other person who has suffered loss or damage as a result of the breach:

    • (d) any other order that the Court considers appropriate.

    (3) An order for compensation may not be made under subsection (2)(c) if the person who suffered the loss or damage would be prevented by section 317 or 318 of the Injury Prevention, Rehabilitation, and Compensation Act 2001 from bringing proceedings for damages in respect of the loss or damage suffered.

    (4) An application may not be made under subsection (1) in respect of a breach of an enforceable undertaking if the Authority has applied to a court in Australia under the equivalent provision in the Australian Act in respect of the breach, unless the Australian proceedings are discontinued or stayed by the Australian court on the ground that the application should be made in New Zealand.

Subpart 4Search and seizure

98 Definition of terms used primarily in subparts 4 and 5
  • In Parts 1 to 5, unless the context otherwise requires,—

    authorised officer means a person appointed under section 99

    document means any record of information, and includes—

    • (a) anything on which there is writing or any image; and

    • (b) anything on which there are marks, figures, symbols, or perforations that have a meaning for persons qualified to interpret them; and

    • (c) anything from which sounds, images, or writing can be reproduced, with or without the aid of anything else

    dwelling house means a building, or an apartment, flat, or unit within a building, that is used as a private residence and is not used for any commercial purpose associated with therapeutic products

    evidential material means any thing that there are reasonable grounds for believing is or may be evidence, or may provide or contain evidence, of—

    • (a) an offence under this Part; or

    • (b) an attempt to commit an offence under this Part; or

    • (c) the contravention of a civil penalty provision

    occupier, in relation to any place, includes—

    • (a) a person who is present at the place and is in apparent control of it; and

    • (b) any person acting on behalf of the occupier

    place means anywhere on, under, or over any land or water, and includes all or any part of a building, structure, or conveyance

    seize includes to secure against interference

    thing includes—

    • (a) any substance, article, document, container, or equipment; and

    • (b) anything in electronic or magnetic form.

Authorised officers

99 Appointment of authorised officers
  • The Managing Director may appoint any person as an authorised officer for all or specified purposes under Parts 1 to 5.

100 Issue of identity cards to authorised officers
  • (1) The Managing Director must issue every authorised officer with an identity card.

    (2) The identity card must be in a form prescribed by the Rules and must carry a photograph of the authorised officer.

    (3) An authorised officer must carry his or her identity card at all times when acting as an authorised officer under Parts 1 to 5.

    (4) A person who has been issued with an identity card commits an offence, and is liable, on summary conviction, to a fine not exceeding 50 penalty units if he or she fails, without reasonable excuse, to return his or her identity card to the Managing Director immediately upon ceasing to be an authorised officer.

Entry, search, and seizure without warrant

101 Searches for monitoring purposes
  • (1) An authorised officer may, at any reasonable time, enter a place (other than a dwelling house or marae) in order to monitor compliance with the Rules and Orders.

    (2) An authorised officer who enters a place under subsection (1) may do any of the following:

    • (a) search the place and any thing at the place:

    • (b) inspect, examine, and take measurements of any thing at the place that relates to the manufacture, import, export, supply, or promotion of therapeutic products:

    • (c) test things, and take samples of things, for the purpose of testing or analysis:

    • (d) take photographs and video recordings, and make sketches, of the place or any thing at the place:

    • (e) inspect any document at the place:

    • (f) take into or onto the place whatever equipment and material the authorised officer requires for the search.

    (3) If, during a search under this section, an authorised officer forms the reasonable belief that an offence or a contravention of a civil penalty provision under Parts 1 to 5 has been, is being, or is likely to be committed at the place, the officer may—

    • (a) seize any evidential material; and

    • (b) require the occupier to do either or both of the following:

      • (i) hold any thing at the place in an unaltered state for a specified period of up to 5 working days:

      • (ii) provide a copy of particular documents within a specified period (which must be a period that is reasonable in the circumstances).

102 Entry and search on serious public health grounds without search warrant
  • (1) An authorised officer or a member of the police may enter any place (other than a dwelling house or a marae) if the authorised officer or member of the police has reasonable grounds for believing that—

    • (a) an offence or a contravention of a civil penalty provision under Parts 1 to 5 has been, is being, or is likely to be committed at the place; and

    • (b) it is necessary in the interests of public health to exercise powers under this section in order to avoid an imminent risk of death, serious illness, or serious injury; and

    • (c) it is not practicable in the circumstances to obtain a search warrant.

    (2) An authorised officer who enters a place under this section may exercise the powers listed in section 101(2) and (3).

103 Searches at request of manufacturer
  • (1) The occupier of a place at which therapeutic products are being manufactured may ask the Authority to arrange for an authorised officer to inspect the place.

    (2) An authorised officer may make an inspection in accordance with arrangements under subsection (1).

Search warrants

104 Search warrant to seize evidential material
  • (1) A District Court Judge, Justice of the Peace, Community Magistrate, or Registrar may issue a search warrant in respect of a place if satisfied that—

    • (a) there are reasonable grounds for believing that there is evidential material at that place; or

    • (b) a search is unable to be undertaken or completed under section 101.

    (2) The application for the warrant must be made in writing, on oath, by an authorised officer.

    (3) Every search warrant must be in the form prescribed by regulations made under Parts 1 to 5 and be directed to—

    • (a) an authorised officer by name; or

    • (b) a member of the police by name; or

    • (c) every member of the police.

    (4) Despite a warrant being directed to another person under subsection (3), it may be executed by any member of the police.

    (5) The Judge, Justice of the Peace, Community Magistrate, or Registrar issuing the warrant may impose reasonable conditions on its execution.

105 Powers under search warrant
  • (1) A search warrant issued under section 104 authorises the authorised officer or member of the police who is executing it, and any person called on by that officer or member to assist, to do any of the following:

    • (a) enter and search the place at any reasonable time, on 1 occasion within 14 days after the date of the warrant being issued:

    • (b) use reasonable force to—

      • (i) make entry (for example, by breaking open a door); and

      • (ii) open any thing at the place that it is reasonable in the circumstances to open:

    • (c) search the place and any thing at the place:

    • (d) seize any evidential material found at the place:

    • (e) inspect, examine, and take measurements of any thing at the place:

    • (f) test things, or take samples of things, or require the occupier to supply samples of things, for the purpose of testing or analysis:

    • (g) take photographs and video recordings, and make sketches of, the place or any thing at the place:

    • (h) inspect and copy any document; and for that purpose may also do any of the following:

      • (i) require any person at the place to produce a particular document:

      • (ii) require any person at the place who has control or knowledge of a document to reproduce, or assist in reproducing, the document in usable form:

      • (iii) operate any equipment at the place:

      • (iv) remove a document temporarily to another place in order to copy it:

    • (i) take into or onto the place whatever equipment and materials the authorised officer or member of the police requires for the search:

    • (j) require the occupier of the place to answer any questions put by the authorised officer or member of the police.

    (2) An authorised officer or member of the police may require the occupier of the place to do the following:

    • (a) hold any thing at the place in an unaltered state for a specified period of up to 5 working days:

    • (b) provide a copy of particular documents within a specified period (which must be a period that is reasonable in the circumstances).

    (3) Nothing in this section limits or affects the privilege against self-incrimination.

Conduct of entry, search, and seizure

106 Assistance with searches
  • (1) An authorised officer or member of the police may ask any person to assist the authorised officer or member of the police with a search under this Part.

    (2) A person who assists an authorised officer or member of the police must be under the supervision of an authorised officer or member of the police.

107 Authorised officers to show identity card on request
  • (1) An authorised officer must produce his or her identity card (as issued under section 100) for inspection—

    • (a) on entering a place under this Part; and

    • (b) at any later time, on request, during a search under this Part.

    (2) An authorised officer who fails to comply with subsection (1) ceases to be authorised to enter the place or to exercise any power under Parts 1 to 5 with respect to the search.

108 Announcement before entry
  • (1) This section applies whenever an authorised officer or member of the police enters a place pursuant to a provision of this Part, unless the entry is made by consent.

    (2) Before entering the place, the authorised officer or member of the police must—

    • (a) announce that he or she is authorised to enter the place; and

    • (b) give any person at the place an opportunity to consent to the entry.

    (3) However, subsection (2) does not apply if the authorised officer or member of the police believes on reasonable grounds that—

    • (a) announcing entry would frustrate the purpose of the entry; or

    • (b) immediate entry to the place is required to ensure the safety of any person.

109 Details of warrant to be given to occupier
  • If a place is being searched under a warrant, the authorised officer or member of the police must give a copy of the warrant to the occupier or, if no person is present at the time, must leave a copy of the warrant in a prominent situation, marked for the attention of the occupier.

110 Occupier entitled to be present during search
  • (1) The occupier of a place that is subject to a search under this Part, and who is present at any time during the search, is entitled to observe the search as it is being carried out.

    (2) The right to observe the search ceases if the person observing impedes the search.

    (3) This section does not prevent 2 or more parts of the place being searched at the same time.

111 Use of electronic equipment
  • (1) If an authorised officer, member of the police, or person assisting a search operates electronic equipment found at a place during a search, the officer, member, or person must take all reasonable care not to damage the equipment or corrupt information stored on it.

    (2) If, as a result of a failure to take the care required by subsection (1), the owner of equipment or information, or the occupier of the place that was searched, suffers damage, the owner or occupier may seek damages from the Authority in respect of that damage.

112 Copies of documents seized to be provided
  • (1) When a document that is capable of being copied is seized from a place, it must (if practicable) be copied before the original is removed, and the copy must be left at the place.

    (2) If it is not practicable to copy the document before removing it, it must be copied as soon as practicable after it is removed, and (if practicable) the copy must be promptly delivered to the occupier of the place.

    (3) Subsection (1) does not apply—

    • (a) to documents obtained as a result of operating electronic equipment found at the place, if the equipment is not seized and the documents remain stored on it; or

    • (b) to any documents which it is or may be an offence or a contravention of a civil penalty provision to possess; or

    • (c) if an order under subsection (4) has been made.

    (4) A District Court Judge, Community Magistrate, or Justice of the Peace may make an order waiving the application of subsections (1) and (2) if satisfied that the volume of material to be copied is such that copying it will involve substantial cost, and that the cost is not justified.

    (5) An order under subsection (4) may be subject to whatever conditions the person making the order thinks are necessary to protect the interests of the person from whom the documents have been seized.

113 Receipts for things seized
  • (1) A person who seizes any thing during a search under this Part must provide the occupier with a receipt for the thing seized.

    (2) A single receipt may be given for more than one thing.

What happens to things seized

114 Return and retention of things seized
  • (1) An authorised officer or member of the police must (subject to any order of a court) immediately return any thing seized under this Part to the person from whom it was seized if—

    • (a) the thing was seized during a search without a warrant under section 101 or 102; and

    • (b) either the reason for its seizure no longer exists or it is decided that the thing is not to be used in evidence.

    (2) If a thing has not been returned under subsection (1) within 90 days of its seizure, the authorised officer must return the thing unless—

    • (a) proceedings in respect of which the thing may afford evidence were instituted within 90 days of its seizure, and those proceedings (including any appeal) have not been completed, or the time within which an appeal may be lodged in those proceedings has not expired; or

    • (b) there is an order in force under section 115 in respect of the thing; or

    • (c) the authorised officer or member of the police is otherwise authorised to retain, destroy, or dispose of the thing other than by returning it to the person from whom it was seized; or

    • (d) the person to whom it is to be returned cannot be found or does not wish to take back the thing.

    (3) A thing may be returned conditionally or under such terms and conditions as the Managing Director thinks fit.

    (4) A thing may not be returned if it is, or is liable to be, forfeited to the Crown.

115 Order to retain things seized
  • (1) If an authorised officer or member of the police wishes to retain any thing seized under this subpart for more than 90 days, he or she may apply to a District Court for an order under this section.

    (2) A District Court Judge, Community Magistrate, or Justice of the Peace may make an order under this section if he or she is satisfied that retention of the thing is necessary for—

    • (a) the purpose of investigating an alleged offence or a contravention of a civil penalty provision under this Part; or

    • (b) as evidence of an alleged offence or a contravention of a civil penalty provision under this Part; or

    • (c) to secure evidence of an alleged offence or a contravention of a civil penalty provision under this Part.

    (3) An order under this section may be for any period of up to 4 years. If made for a shorter period, it may be renewed at any interval, but the total period of the order, with any renewals, may not exceed 4 years.

    (4) Before making an application, the authorised officer or member of the police must—

    • (a) take reasonable steps to discover who has an interest in the thing; and

    • (b) if practicable, notify each person whom the authorised officer or member of the police believes to have such an interest in the proposed application and any application for a renewal.

116 Forfeiture on conviction or imposition of civil penalty
  • (1) If a person is convicted of an offence under this Part, or is ordered to pay a civil penalty under this Part, a court may order that the following be forfeited to the Crown:

    • (a) any therapeutic product or substance to which the conviction or civil penalty order relates:

    • (b) any packages or containers containing the therapeutic product or substance.

    (2) Any thing forfeited to the Crown under this section must be disposed of as the Minister directs.

Testing and analysis of samples

117 Samples for testing or analysis
  • (1) An authorised officer who obtains a sample for testing or analysis, other than under a search warrant, must, either before or immediately after taking the sample, inform the owner of the sample, or the person from whom it was obtained, that the sample may be submitted for testing or analysis.

    (2) If the authorised officer fails to comply with subsection (1), the results of any testing or analysis of the sample may not be used in any proceedings for an offence or civil penalty under Parts 1 to 5.

    (3) A sample taken for the purpose of testing or analysis does not have to be submitted for testing or analysis.

    (4) If a sample is not submitted for testing or analysis, it must be treated in the same way as any other thing that is seized.

    Compare: 1981 No 118 s 69(5)(a)

118 Analysis and testing of samples in accordance with Rules and Orders
  • The analysis and testing of samples under this Part must be conducted in accordance with the Rules and Orders.

119 Evidence of analysis
  • (1) In any proceedings under Parts 1 to 5, a certificate of analysis issued in accordance with the Rules and Orders is conclusive proof of the matters set out or stated in the certificate.

    (2) However, a certificate is admissible in evidence only if—

    • (a) at least 14 days before the hearing at which the certificate is given in evidence, a copy of the certificate (in addition to any copy served with any summons) is served by the prosecutor; and

    • (b) at the same time, the defendant is informed in writing that prosecutor does not propose to call the analyst as a witness at the hearing; and

    • (c) the defendant does not, by notice in writing to the prosecutor at least 7 days before the hearing, require the analyst to be called by the prosecutor as a witness at the hearing.

    (3) A certificate is not admissible in evidence if a court, of its own motion, directs that the result of the analysis must be disregarded unless the result is proved by the oral evidence of the analyst.

    (4) A certificate of analysis may not be ruled inadmissible or be disregarded by reason only of the fact that the Rules and Orders relating to the taking or analysing of samples have not been strictly complied with, if there has been reasonable compliance with the Rules and Orders.

    Compare: 1981 No 118 s 71

120 Cost of testing and analysis
  • (1) If a person is convicted of an offence under this Part, or is ordered to pay a civil penalty under this Part, a court may order that all fees and other expenses incidental to the testing or analysis of any article or substance must be paid by the defendant.

    (2) The fees and expenses are part of the costs attending the conviction or order to pay the civil penalty and are recoverable accordingly.

Offences relating to search and seizure

121 Offences relating to search and seizure
  • (1) A person commits an offence if he or she intentionally does any of the following:

    • (a) actively or passively obstructs an authorised officer, member of the police, or person assisting during the exercise of a power under this Part:

    • (b) fails to comply with a requirement under section 101(3)(b), 105(1)(j), or 105(2):

    • (c) removes, alters, or interferes with any thing seized under this Part:

    • (d) tampers with any sample or container of a sample taken under this Part:

    • (e) misleads an authorised officer, member of the police, or person assisting as to the whereabouts of any thing, the operation of any equipment, or how to gain access to any thing.

    (2) A person who commits an offence under this section is liable, on summary conviction, to a term of imprisonment of up to 3 months, a fine of up to 200 penalty units, or both.

Subpart 5Miscellaneous

Information sharing for law enforcement purposes

122 Disclosure of information
  • (1) The purpose of this section is to ensure that New Zealand government agencies and the Authority are able to disclose information to each other for the purpose of ensuring compliance with the law, and for law enforcement purposes.

    (2) Despite privacy principles 2 and 11 of the Privacy Act 1993, an approved agency, or an officer or employee of an approved agency, may disclose to any other approved agency, or officer or employee of that agency, any information supplied or obtained under or for the purposes of an enactment listed in subsection (4)(b), if the disclosure of that information is necessary or desirable for the purpose of ensuring compliance with the law, or for law enforcement purposes.

    (3) Nothing in subsection (2) authorises the disclosure of commercially sensitive information.

    (4) In this section, approved agency means—

    • (a) the Authority; and

    • (b) a government agency exercising powers or functions under any of the following:

      • (i) this Act:

      • (ii) Agricultural Compounds and Veterinary Medicines Act 1997:

      • (iii) Biosecurity Act 1993:

      • (iv) Customs and Excise Act 1996:

      • (v) Food Act 1981:

      • (vi) Hazardous Substances and New Organisms Act 1996; and

      • (vii) Medicines Act 2006; and

    • (c) any other individual or agency involved in monitoring therapeutic products.

Customs

123 Right to inspect therapeutic products imported or for export
  • (1) An authorised officer may inspect any therapeutic product, and any documents associated with the import or export of the therapeutic product, if the therapeutic product is in a customs controlled area (as that term is defined in the Customs and Excise Act 1996).

    (2) The power to inspect includes the power to do anything necessary to determine whether or not the Rules, Orders, and any regulations made under Parts 1 to 5, so far as they relate to the import or export of the therapeutic product, are being complied with.

124 Non-compliant therapeutic products held at customs controlled area
  • (1) This section applies if an authorised officer believes on reasonable grounds that a therapeutic product imported into New Zealand, or for export from New Zealand, does not comply with the Rules, Orders, or any regulations made under Parts 1 to 5, or constitutes a risk to public health (a non-compliant therapeutic product).

    (2) An authorised officer may seize a non-compliant therapeutic product and deal with it in accordance with—

    • (a) any Rules or Orders relating to the disposal, treatment, destruction, or other dealing with non-compliant therapeutic products; or

    • (b) a direction by the Authority in a particular case.

    (3) The authorised officer may offer to return a therapeutic product to its place of origin; and, if the offer is accepted, the importer or exporter must pay the costs associated with that return.

    (4) The authorised officer may arrange, at the request of the importer or exporter, to hold a therapeutic product that has been seized in order to allow the importer or exporter to satisfy the requirements that will permit the therapeutic product to be imported into, or exported from, New Zealand.

    (5) If therapeutic products are held under subsection (4), the importer or exporter must pay to the Authority, in advance, the estimated costs of holding and maintaining the products in New Zealand.

    (6) In exercising powers under this section, an authorised officer must, so far as is practicable, act in a manner that avoids or minimises the loss to the importer or exporter of any therapeutic products that are seized.

    (7) The costs and expenses incurred by the Authority as a result of holding and disposing of therapeutic products seized under this section are the liability of the importer or exporter, and are recoverable as a debt due to the Authority.

    (8) However, the Authority may waive payment of the costs and expenses referred to in subsection (7) if the Authority is satisfied that the importer or exporter believed on reasonable grounds that the proposed importation into, or export from, New Zealand complied with all applicable Rules, Orders, and regulations made under Parts 1 to 5.

125 Special provisions relating to consignments
  • (1) When an authorised officer takes a sample of a therapeutic product at a port for the purpose of analysis or testing, the following applies:

    • (a) the authorised officer must immediately notify the importer or exporter that a sample has been taken:

    • (b) the authorised officer must direct the Customs to detain the remainder of the consignment in the port under the Control of the Customs until the analysis or testing has been completed:

    • (c) the consignment may, with the approval of the authorised officer and a Customs officer, be removed at the expense of the importer or exporter from the port to a specified place, if the importer or exporter undertakes in writing, in a form approved by the authorised officer, that the importer or exporter will detain the consignment for as long as is necessary to obtain the results of the analysis or testing:

    • (d) if the consignment is in a bulk cargo container, the authorised officer may, with the agreement of a Customs officer, approve the removal of the container to a specified place:

    • (e) if a consignment is moved under paragraph (c) or (d), the authorised officer must mark it to indicate that it may be dealt with only by an authorised officer or Customs officer.

    (2) If, as a result of the analysis or testing, the authorised officer reasonably believes that the consignment does not comply with the requirements of the Rules, Orders, or any product licence, the authorised officer may—

    • (a) seize and detain the goods; or

    • (b) order the goods to be returned by the importer or exporter to their place of origin, or to some other place outside New Zealand or Australia; or

    • (c) permit the goods to be released subject to conditions, including conditions that a new label be substituted for any existing label relating to the therapeutic products.

    (3) When goods are seized under this section, the authorised officer must—

    • (a) serve notice on the importer or exporter that the goods have been seized; and

    • (b) serve a copy of the notice on the Customs, who must ensure that the goods are not delivered from the control of the Customs without the written consent of the officer.

    Compare: 1981 No 118 s 72(1), (2), (3)

126 Relationship with Customs and Excise Act 1996
  • (1) Nothing in Parts 1 to 5 limits or affects the Customs and Excise Act 1996.

    (2) The import or export of a therapeutic product in breach of any requirement of the Rules or Orders, or of a product licence, is, for the purposes of the Customs and Excise Act 1996, the importation or exportation of a prohibited good.

    (3) It is the duty of every officer of the Customs to—

    • (a) assist in carrying out the provisions in section 125; and

    • (b) prevent the introduction into New Zealand of anything contrary to the Rules.

    (4) For the purpose of carrying out the duties in subsection (3), an officer of the Customs may exercise his or her powers under the Customs and Excise Act 1996 in relation to uncustomed or prohibited goods.

    Compare: 1981 No 118 s 72(1)(g), (4)

Patents

127 Therapeutic products protected by Australian patents
  • To avoid doubt, the fact that a therapeutic product is protected by an Australian patent does not in itself prevent any person marketing the product in New Zealand.

Part 3
Administrative law matters

128 Definitions of terms used primarily in this Part
  • In Parts 1 to 5, unless the context otherwise requires,—

    Australian Ombudsman means the Commonwealth Ombudsman appointed under the Australian Ombudsman Act

    Australian Ombudsman Act means the Ombudsman Act 1976 of the Commonwealth of Australia

    Australian Privacy Act means the Privacy Act 1988 of the Commonwealth of Australia

    Australian Privacy Commissioner means the Privacy Commissioner appointed under the Australian Privacy Act

    Australian Review Tribunal means the Australian Review Tribunal provided for by the Australian Act, in accordance with Article 13 of the Agreement, to conduct merits reviews

    Deputy Australian Ombudsman means a Deputy Ombudsman appointed under the Australian Act

    Merits Review Panel means the Merits Review Panel appointed by the Ministerial Council under paragraph 5 of Article 13 of the Agreement

    New Zealand Ombudsman means an Ombudsman appointed under the Ombudsmen Act 1975

    New Zealand Privacy Commissioner means the Privacy Commissioner appointed under the Privacy Act 1993

    principal member means the member of the Merits Review Panel who is designated by the Ministerial Council, in accordance with paragraph 6 of Article 13 of the Agreement, as the principal member in respect of merits reviews conducted in New Zealand

    Review Tribunal means the New Zealand Review Tribunal established by section 135, in accordance with Article 13 of the Agreement, to conduct merits reviews

    reviewable decision means a decision of the Authority in relation to—

    • (a) an application for an approval; or

    • (b) the amendment, suspension, or revocation of an approval; or

    • (c) any other matter specified in the Rules as being open to merits review

    therapeutic product information means information relating to therapeutic products that the Authority holds in connection with the performance of its functions.

Subpart 1Merits review

General provisions

129 Purpose and overview
  • (1) The purpose of this subpart is to give effect to Article 13 of the Agreement, which requires New Zealand to provide for the review by a merits review tribunal of the merits of certain decisions made by the Authority.

    (2) By way of overview, this subpart provides that—

    • (a) reviewable decisions may be reviewed in New Zealand by the Review Tribunal; and

    • (b) the Review Tribunal is constituted by members of the Merits Review Panel selected by the principal member to review a particular decision; and

    • (c) generally, the same reviewable decision cannot be reviewed by both the Review Tribunal in New Zealand and the Australian Review Tribunal; and

    • (d) reviews can be transferred between the merits review tribunals of each country; and

    • (e) an Authority decision has effect in New Zealand subject to any decision of either merits review tribunal.

    (3) This section is by way of explanation only. If a provision of Parts 1 to 5, the Agreement, the Rules, or any other enactment conflicts with this section, the other provision prevails.

Application for review

130 Who may apply for merits review
  • A person whose interests are affected by a reviewable decision may apply to the Review Tribunal for a review of that decision.

131 What happens if Rules provide for internal review
  • If the Rules provide for the internal review of a reviewable decision, a person may not apply under section 130 for a merits review of that decision unless the person has applied for an internal review of the decision in accordance with the Rules and—

    • (a) the internal review has been completed but the person is dissatisfied with the outcome; or

    • (b) the time (if any) specified in the Rules within which any internal review must be completed has expired; or

    • (c) if no time is specified in the Rules, the internal review has not been completed within a reasonable time.

132 When Authority not required to give reasons
  • (1) Nothing in Parts 1 to 5 or the Rules requires the Authority to provide reasons, or to provide any other information, in relation to a reviewable decision if the Attorney-General of the Commonwealth of Australia has issued a public interest certificate under section 28(2) of the Administrative Appeals Tribunals Act 1975 of the Commonwealth of Australia in relation to a matter contained in those reasons or included in that information.

    (2) If reasons or information are withheld on the basis of a public interest certificate, the Authority must advise any person who would otherwise have received the reasons or information—

    • (a) of the existence of the certificate; and

    • (b) that the issue of the certificate may be challenged in Australia through judicial review proceedings.

133 No application if review already sought in Australia
  • (1) No application may be made for review of a reviewable decision if the applicant has already applied to the Australian Review Tribunal for review of the decision.

    (2) Subsection (1) does not apply if the proceedings before the Australian Review Tribunal have been transferred to New Zealand.

134 Application for merits review does not affect decision
  • (1) A decision of the Authority is not affected by an application for a review of that decision.

    (2) However, an applicant for a review may apply to the Review Tribunal for an order staying the operation or implementation of the decision under review; and the Tribunal may make the order.

Review Tribunal

135 Establishment and constitution of Review Tribunal
  • (1) The Review Tribunal is established.

    (2) The Review Tribunal for a particular review is constituted by a minimum of 3 members of the Merits Review Panel, all of whom are selected by the principal member to constitute the Review Tribunal for that particular review.

    (3) The principal member must select members so as to ensure that the Review Tribunal for a particular review is constituted by people with a sufficient range of expertise to properly consider that review.

    (4) The principal member must identify one member to be the chairperson of the Review Tribunal for the purpose of a particular review.

    (5) The rules relating to members' conflict of interest are set out in the Rules.

136 Members of Review Tribunal not personally liable
  • No member of the Review Tribunal is personally liable for any act done or omitted to be done by the Review Tribunal or any member of it in good faith in pursuance or intended pursuance of the functions, duties, powers, or authorities of the Tribunal.

    Compare: 1997 No 60 s 52

137 Fees for Review Tribunal members
  • (1) A member of the Review Tribunal is entitled—

    • (a) to be paid remuneration for services as a member at a rate and of a kind determined by the Minister in accordance with the fees framework; and

    • (b) to be reimbursed for actual and reasonable travelling and other expenses incurred while carrying out duties as a member in accordance with the fees framework.

    (2) In subsection (1), fees framework means the framework determined by the Government from time to time for the classification and remuneration of statutory and other bodies in which the Crown has an interest.

Conduct of review

138 Parties to proceedings
  • (1) The parties to proceedings before the Review Tribunal are—

    • (a) the applicant; and

    • (b) the Authority; and

    • (c) any person whom the Review Tribunal is satisfied (on its own motion or on application in writing) is a person whose interests are affected by the decision.

    (2) Any party to proceedings before the Review Tribunal may appear and be heard personally or by a representative.

    (3) The Attorney-General may present written submissions in any proceedings, and may appear and be heard at any hearing, as if the Attorney-General were a party to the proceedings, if the Attorney-General—

    • (a) considers that the public interest is or may be involved in the proceedings; and

    • (b) has advised the Ministerial Council of his or her intention to present written submissions in any proceedings, or to appear at a hearing; and

    • (c) has given such notice to the parties to the proceedings as the Review Tribunal directs.

139 Procedure of Review Tribunal
  • (1) The Review Tribunal may, as provided in paragraph 12 of Article 13 of the Agreement, regulate its own procedure, subject to the Agreement, the Rules, and Parts 1 to 5.

    (2) Schedule 2 prescribes procedures for the Review Tribunal.

    (3) Clause 1 of Schedule 2 identifies specific provisions of that schedule that are subject to any Rules that override them.

140 Decision by majority
  • (1) The decision of the majority of the members of the Review Tribunal is the decision of the Review Tribunal.

    (2) If the Review Tribunal cannot reach a majority decision on a matter, the decision of the chairperson is the decision of the Review Tribunal.

141 Powers and decisions of Review Tribunal
  • (1) For the purpose of reviewing a decision, the Review Tribunal must reconsider the merits of the decision under review and may exercise all the powers and discretions that the Authority had when it made the decision.

    (2) At any stage of a review of a decision, the Review Tribunal may remit the decision to the Authority for reconsideration.

    (3) Following a review of a decision, the Review Tribunal may—

    • (a) affirm the decision under review; or

    • (b) vary the decision under review; or

    • (c) set aside the decision under review and make a decision in substitution of the decision set aside; or

    • (d) set aside the decision under review and remit the matter to the Authority for reconsideration in accordance with any directions or recommendations of the Tribunal.

    (4) A decision by the Review Tribunal to do any of the things in subsection (2) or (3) must be in writing, and written reasons must be provided either with the decision or as soon as practicable after it is delivered.

142 Matters remitted to Authority for reconsideration
  • If the Review Tribunal remits a matter to the Authority for reconsideration, the Authority must—

    • (a) take the reasons and any recommendations of the Review Tribunal for the remit into account; and

    • (b) give effect to any directions of the Review Tribunal; and

    • (c) having reconsidered the matter, issue a fresh decision.

    Compare: 2004 No 72 s 337

143 New information received by Review Tribunal
  • (1) In this section, new information, in relation to a decision under review, means—

    • (a) information that—

      • (i) was in existence at the time of the original decision; and

      • (ii) was not made available to the Authority for the purpose of making the original decision; and

      • (iii) is relevant to the original decision; and

      • (iv) was not taken into account in the internal review of the original decision; and

    • (b) includes opinions that are wholly or substantially based on such information (whether or not the opinions were formed before or after the initial decision was made).

    (2) If an applicant for review lodges new information with the Review Tribunal, the Tribunal must not consider the new information, except to the extent that it indicates that the quality, safety, efficacy, or performance of the therapeutic product that is the subject of the decision under review is unacceptable.

    (3) However, if the Review Tribunal remits the matter for reconsideration to the Authority, the Authority may take the new information into account in coming to its fresh decision.

Transfer of review proceedings

144 Transfer of proceedings to Australian Review Tribunal
  • (1) At any time after an application for review is made, the Review Tribunal may order that the proceedings be transferred to the Australian Review Tribunal if it is satisfied that it is in the interests of justice for the review to be conducted by the Australian Review Tribunal.

    (2) An order under subsection (1) may be made—

    • (a) on the application of any party; or

    • (b) on the initiative of the Review Tribunal; but in this case the order may not be made unless the Tribunal has given all parties to the proceedings a reasonable opportunity to make submissions on the proposal to transfer the proceedings.

    (3) The Review Tribunal must order proceedings to be transferred to the Australian Review Tribunal if—

    • (a) the Attorney-General of the Commonwealth of Australia has issued a public interest certificate under section 28(2) or 36(1) of the Administrative Appeals Tribunal Act 1975 of the Commonwealth of Australia in respect of any information, or any matter contained in a statement or document; and

    • (b) the information or matter is, or is likely to be, or would have been (but for the certificate), produced in evidence before the Review Tribunal.

    (4) On making an order under subsection (1) or (3), the Review Tribunal must—

    • (a) notify the parties of the order; and

    • (b) transfer the following to the Australian Review Tribunal:

      • (i) any transcript of evidence or proceedings before the Review Tribunal:

      • (ii) all documents, materials, and exhibits that were before, or had been produced to, the Review Tribunal in connection with the application.

145 Proceedings transferred from Australian Review Tribunal
  • If, under a provision in the Australian Act that is equivalent to section 144, a review is transferred from the Australian Review Tribunal to the Review Tribunal,—

    • (a) the principal member must ensure that the Review Tribunal is constituted as provided for in section 135; and

    • (b) the Review Tribunal must conduct the review proceedings, as far as possible, as if the application for the review had been made in New Zealand; and

    • (c) the following things received from the Australian Review Tribunal must be taken into account by the Review Tribunal:

      • (i) any transcript of evidence or proceedings before the Australian Review Tribunal:

      • (ii) all documents, materials, and exhibits that were before, or had been produced to, the Australian Review Tribunal in connection with the application.

Effect of decisions

146 Effect of decision by Review Tribunals
  • If the Review Tribunal or the Australian Review Tribunal, or a court on appeal from either tribunal, makes an order that varies, suspends, sets aside, or otherwise affects a decision of the Authority, the Authority's decision has effect subject to the order.

Appeals and stating case

147 Appeal on question of law
  • (1) If a party to proceedings before the Review Tribunal is dissatisfied with any of its decisions or determinations as being wrong in law, the party may appeal to the High Court on the question of law.

    (2) The appeal must be brought within 28 days of the decision, or within any further period that the High Court allows, on application made before or after the end of the 28-day period.

    (3) The appeal must otherwise be dealt with in accordance with rules of Court (being rules made under section 51C of the Judicature Act 1908).

148 Stating case for High Court
  • (1) The Review Tribunal may state a case for the opinion of the High Court on any question of law arising in any proceedings before the Tribunal.

    (2) A case may be stated—

    • (a) at any time before the Review Tribunal delivers its decision; and

    • (b) on the application of any party to the proceedings or on the initiative of the Tribunal.

    (3) The Review Tribunal must give notice to the parties to the proceedings of its intention to state a case under this section, specifying the registry of the High Court in which the case is to be filed.

    (4) The question for the High Court must set out the facts and the question of law to be determined by the High Court, and must be drawn up—

    • (a) by the Review Tribunal, if the case is stated on the initiative of the Tribunal; or

    • (b) in any other case, by the parties; but if the parties cannot agree on how the case should be drawn up, the Tribunal must settle the matter.

    (5) Every case stated for the High Court must be dealt with in accordance with rules of Court.

    (6) The High Court must hear and determine any question submitted to it by the Review Tribunal and must remit the case with its opinion to the Tribunal.

Subpart 2Judicial review

149 Application of subpart
  • This subpart applies only to judicial review proceedings relating to the following:

    • (a) decisions of the Authority:

    • (b) Rules:

    • (c) Orders.

150 Availability of judicial review
  • For the purpose of allowing for the judicial review, under the Judicature Amendment Act 1972, of decisions of the Authority, and of Rules and Orders,—

    • (a) decisions of the Authority are deemed to be decisions made in the exercise of a power conferred by an Act; and

    • (b) Rules and Orders are deemed to be made in the exercise of a power conferred by an Act.

151 Effect of orders made in judicial review proceedings
  • (1) If, in judicial review proceedings taken in New Zealand or in Australia, a court makes an order that varies, suspends, sets aside, or otherwise affects a decision of the Authority relating to the Scheme, or a Rule or Order, then that decision, Rule, or Order has effect subject to the order of the court.

    (2) By way of explanation, the Australian Act provides that the decision, Rule, or Order also has effect in Australia subject to the order.

152 Stay of judicial review proceedings
  • (1) A court may stay judicial review proceedings, either on the court's own motion or on the application of any party to the proceedings.

    (2) The court may stay the judicial review proceedings if it is satisfied that—

    • (a) it would be more appropriate, in the interests of the effective, just, and efficient determination of those proceedings (taking into account the matters in subsection (3)(a) to (d)), for the proceedings to be heard and determined in a court in Australia; or

    • (b) the matter, or substantially the same matter, is the subject of final orders made by a court in Australia.

    (3) In determining whether it would be more appropriate for the proceedings to be heard and determined in an Australian court, the court may not take into account the fact that the proceedings were commenced in New Zealand, but must take into account the following matters:

    • (a) the place of residence of the applicant and of the witnesses likely to be called in the proceedings:

    • (b) the relative cost and convenience of proceeding in each jurisdiction:

    • (c) any agreement between the parties about the court or place in which the proceedings should be instituted:

    • (d) whether proceedings involving substantially the same issues or questions of fact have been commenced by the applicant or another person in a court in Australia.

    (4) An order staying judicial review proceedings may be made subject to whatever conditions the court considers are just and appropriate in order to facilitate the determination of the matter at issue without delay or undue expense.

    (5) Nothing in subsection (2) affects the court's power to stay proceedings on any other ground.

153 Determination of stay proceedings
  • (1) A court may order the stay of judicial review proceedings without a hearing, unless the applicant or a party to the proceedings objects.

    (2) For the purposes of determining the application, the court may hold a hearing by video link or telephone.

    (3) Sections 19 to 31 of the Evidence Amendment Act 1994 apply, with all necessary modifications, to submissions made in proceedings under section 152 for a stay of judicial review proceedings, even if no evidence is being taken.

    (4) Subsection (3) does not limit or affect the application of the Evidence Amendment Act 1994 to any other proceedings under Parts 1 to 5.

Subpart 3Action by Ombudsmen

154 Authority subject to Ombudsmen Act 1975 and to Australian Ombudsman Act
  • (1) By way of overview and explanation—

    • (a) the Authority is subject to the Ombudsmen Act 1975 by virtue of being named as an organisation in Part 2 of Schedule 1 of that Act; and

    • (b) the Authority is also subject to the Australian Ombudsman Act.

    (2) For the purpose of reports concerning the Authority given under the Ombudsmen Act 1975, the Minister is the Minister responsible for the Authority.

155 Co-operation between Ombudsmen
  • (1) A New Zealand Ombudsman must advise the Australian Ombudsman whenever an investigation of the Authority is commenced under the Ombudsmen Act 1975, and must advise the Australian Ombudsman of the outcome of every such investigation.

    (2) If the Australian Ombudsman asks a New Zealand Ombudsman to assist with an investigation relating to the Authority—

    • (a) the New Zealand Ombudsman may exercise his or her powers under the Ombudsmen Act 1975 in relation to the investigation; and

    • (b) the exercise of those powers is for all purposes to be treated as the exercise of the New Zealand Ombudsman's functions under that Act; and

    • (c) the New Zealand Ombudsman may give the Australian Ombudsman any information obtained as a result of exercising those powers; and

    • (d) any inquiry or proceeding arising from the exercise of those powers is for all purposes to be treated as an inquiry or proceeding under that Act.

    (3) A New Zealand Ombudsman may disclose to the Australian Ombudsman any information held by the New Zealand Ombudsman that is or may be relevant to an investigation by the Australian Ombudsman of an action by the Authority.

    (4) A New Zealand Ombudsman must not disclose any information concerning the Authority that was obtained from the Australian Ombudsman without first consulting with the Australian Ombudsman about the proposed disclosure.

    (5) Under the Australian Act, the Australian Ombudsman has obligations that are reciprocal to those imposed on a New Zealand Ombudsman by this section.

156 New Zealand Ombudsman transferring complaints to Australian Ombudsman
  • (1) If a New Zealand Ombudsman receives a complaint about the Authority under the Ombudsmen Act 1975, he or she may transfer the complaint, or part of the complaint, to the Australian Ombudsman if the New Zealand Ombudsman—

    • (a) considers that the complaint, or part of the complaint, can be more conveniently or effectively dealt with by the Australian Ombudsman; and

    • (b) has consulted with the Australian Ombudsman about the proposed transfer, and the Australian Ombudsman has agreed; and

    • (c) is satisfied that it is appropriate in all the circumstances for the transfer to be made.

    (2) A New Zealand Ombudsman must tell the complainant if the complaint, or part of the complaint, is transferred to the Australian Ombudsman.

    (3) A New Zealand Ombudsman may investigate, or continue to investigate, any part of the complaint that is not transferred.

157 Australian Ombudsman transferring complaints to New Zealand Ombudsman
  • (1) Following a request by the Australian Ombudsman, a New Zealand Ombudsman may agree to the transfer of a complaint (or any part of a complaint) that concerns the Authority, to a New Zealand Ombudsman, if the New Zealand Ombudsman is satisfied that the matter can be conveniently and effectively dealt with by a New Zealand Ombudsman.

    (2) If a complaint or part of a complaint is transferred from Australia to New Zealand, a New Zealand Ombudsman must (subject to sections 17 to 17C of the Ombudsmen Act 1975) investigate the complaint or part of a complaint under the Ombudsmen Act 1975.

158 Refusal to deal with complaints investigated by Australian Ombudsman
  • Without limiting any of sections 17 to 17C of the Ombudsmen Act 1975, a New Zealand Ombudsman may refuse to investigate, or further investigate, a complaint concerning the Authority if—

    • (a) the complaint, or a substantially similar complaint, is being, or has been, investigated by the Australian Ombudsman; or

    • (b) the Australian Ombudsman has agreed that the complaint should be transferred from New Zealand to Australia.

159 Immunity for Australian Ombudsman and others
  • (1) This section applies to a person who is or was—

    • (a) the Australian Ombudsman or a Deputy Australian Ombudsman; or

    • (b) a person employed by, or holding office under, the Australian Ombudsman; or

    • (c) a person acting under the direction or authority of the Australian Ombudsman, or an employee of the Australian Ombudsman.

    (2) No proceedings, civil or criminal, may be taken against a person to whom this section applies for any act or omission done in the course of giving assistance to a New Zealand Ombudsman in accordance with the reciprocal obligations referred to in section 155(5).

    (3) However, subsection (2) does not apply—

    • (a) if the defendant acted in bad faith; or

    • (b) in respect of proceedings for—

      • (i) an offence against any of sections 78, 78A(1), 105, 105A, or 105B of the Crimes Act 1961; or

      • (ii) the offence of conspiring to commit, or of attempting to commit, an offence against any of those sections.

    Compare: 1975 No 9 s 26(1)(a), (2)

160 Other protections for Australian Ombudsman and others
  • (1) This section applies to a person who is or was—

    • (a) the Australian Ombudsman or a Deputy Australian Ombudsman; or

    • (b) a person employed by, or holding office under, the Australian Ombudsman.

    (2) No person to whom this section applies may be required—

    • (a) to give evidence in New Zealand in any court, or in any proceedings of a judicial nature, in respect of anything coming to the knowledge of the Ombudsman or employee in the course of giving assistance under Parts 1 to 5 to a New Zealand Ombudsman; or

    • (b) to disclose any information obtained in the course of giving such assistance.

    (3) However, subsection (2) does not apply—

    • (a) if the defendant acted in bad faith; or

    • (b) in respect of proceedings for—

      • (i) an offence against any of sections 78, 78A(1), 105, 105A, or 105B of the Crimes Act 1961; or

      • (ii) the offence of conspiring to commit, or of attempting to commit, an offence against any of those sections.

    Compare: 1975 No 9 s 26(1)(b), (2)

Subpart 4Action by Privacy Commissioners

161 Authority subject to Privacy Act 1993 and to Australian Privacy Act
  • (1) By way of overview and explanation—

    • (a) the Authority is subject to the Privacy Act 1993 by virtue of being an agency as defined in section 2(1) of that Act; and

    • (b) the Authority is also subject to the Australian Privacy Act.

    (2) A request, complaint, or any other kind of application that is made by a person in New Zealand to the Authority under the Privacy Act 1993 must be dealt with by the Authority under that Act, unless the matter is transferred to the Australian Privacy Commissioner under section 164.

162 Modification of information privacy principle 11
  • Paragraph (a) of information privacy principle 11, as set out in section 6 of the Privacy Act 1993, is modified so far as it relates to the Authority as if the words or is directly related to the purposes in connection with which the information was obtained were omitted.

163 Co-operation between Privacy Commissioners
  • (1) The New Zealand Privacy Commissioner must advise the Australian Privacy Commissioner whenever he or she commences an investigation involving the Authority, and must advise the Australian Privacy Commissioner of the outcome of the investigation.

    (2) If the Australian Privacy Commissioner asks the New Zealand Privacy Commissioner to assist with an investigation or audit involving the Authority,—

    • (a) the New Zealand Privacy Commissioner may exercise his or her powers under the Privacy Act 1993 in relation to that investigation or audit; and

    • (b) the exercise of those powers is for all purposes to be treated as the exercise of the New Zealand Privacy Commissioner's functions under that Act; and

    • (c) the New Zealand Privacy Commissioner may give the Australian Privacy Commissioner any information obtained as a result of exercising those powers; and

    • (d) any inquiry or proceeding arising from the exercise of those powers is for all purposes to be treated as an inquiry or proceeding under that Act.

    (3) The New Zealand Privacy Commissioner may disclose to the Australian Privacy Commissioner any information held by the New Zealand Privacy Commissioner that is or may be relevant to—

    • (a) an investigation by the Australian Privacy Commissioner of an action by the Authority; or

    • (b) an audit by the Australian Privacy Commissioner involving the Authority.

    (4) The New Zealand Privacy Commissioner must not disclose any information concerning the Authority or any person that was obtained from the Australian Privacy Commissioner without first consulting with the Australian Privacy Commissioner about the proposed disclosure.

    (5) Under the Australian Act, the Australian Privacy Commissioner has obligations that are reciprocal to those imposed on the New Zealand Privacy Commissioner by this section.

164 New Zealand Privacy Commissioner transferring complaints to Australia
  • (1) If the New Zealand Privacy Commissioner is satisfied that a complaint relating to the Authority that is received under the Privacy Act 1993 may be more conveniently or effectively dealt with by the Australian Privacy Commissioner under the Australian Privacy Act, the New Zealand Privacy Commissioner must—

    • (a) consult with the Australian Privacy Commissioner about the possible transfer of the complaint; and

    • (b) consult with the complainant about the possible transfer of the complaint.

    (2) If both the Australian Privacy Commissioner and the complainant agree to the transfer, the complaint may be transferred to Australia, and from then on it is to be treated as if it was made under the Australian Privacy Act.

    (3) If the Australian Privacy Commissioner does not agree to the transfer, the New Zealand Privacy Commissioner may not transfer it.

    (4) If the complainant does not agree to the transfer, the New Zealand Privacy Commissioner may not transfer the complaint unless—

    • (a) the complainant is not the individual (or is not the only individual) whose privacy is purported to have been interfered with; and

    • (b) the New Zealand Privacy Commissioner considers that the interests of the person whose privacy is purported to have been interfered with (or any other such person) would be better served by having the complaint dealt with under the Australian Privacy Act.

    (5) The New Zealand Privacy Commissioner may investigate, or continue to investigate, a complaint, that is not transferred.

    (6) In this section and section 165, a reference to a complaint includes a reference to part of a complaint.

165 Australian Privacy Commissioner transferring complaints to New Zealand
  • (1) Following consultation with the Australian Privacy Commissioner, the New Zealand Privacy Commissioner may agree to the transfer of a complaint that concerns the Authority to New Zealand if he or she is satisfied that the complaint may be more conveniently or effectively dealt with in New Zealand.

    (2) If a complaint is transferred from Australia to the New Zealand Privacy Commissioner, the New Zealand Privacy Commissioner must investigate it under the Privacy Act 1993.

166 Taking no action on complaints dealt with by Australian Privacy Commissioner
  • Without limiting section 71 of the Privacy Act 1993, the New Zealand Privacy Commissioner may decide to take no action, or no further action, on a complaint if—

    • (a) he or she is satisfied that the complaint, or a substantially similar complaint by or relating to the same individual, has been, or is being, dealt with by the Australian Privacy Commissioner; or

    • (b) the complaint is being transferred to the Australian Privacy Commissioner.

167 Immunity for Australian Privacy Commissioner and others
  • (1) This section applies to a person who is or was—

    • (a) the Australian Privacy Commissioner; or

    • (b) an officer or employee of the Australian Privacy Commissioner.

    (2) No proceedings, civil or criminal, may be taken against a person to whom this section applies for any act or omission done in the course of giving assistance to the New Zealand Privacy Commissioner in accordance with the reciprocal obligations referred to in section 163(5).

    (3) However, subsection (2) does not apply—

    • (a) if the defendant acted in bad faith; or

    • (b) in respect of proceedings for—

      • (i) an offence against any of sections 78, 78A(1), 105, 105A, or 105B of the Crimes Act 1961; or

      • (ii) the offence of conspiring to commit, or of attempting to commit, an offence against any of those sections.

    Compare: 2004 No 115 ss 121, 126

168 Other protections for Australian Privacy Commissioner and others
  • (1) This section applies to a person who is or was—

    • (a) the Australian Privacy Commissioner; or

    • (b) a person engaged or employed in connection with the work of the Australian Privacy Commissioner.

    (2) A person to whom this section applies may not be required to give evidence in New Zealand in any court, or in any proceedings of a judicial nature, in respect of anything coming to his or her knowledge in the course of giving assistance under Parts 1 to 5 to the New Zealand Privacy Commissioner.

    (3) Nothing in subsection (2) applies in respect of proceedings for—

    • (a) an offence against any of sections 78, 78A(1), 105, 105A, or section 105B of the Crimes Act 1961; or

    • (b) the offence of conspiring to commit an offence against any of those sections.

    Compare: 1993 No 28 s 96(1)–(3)

169 Extended immunity for New Zealand Privacy Commissioner
  • (1) The immunities in section 167 apply to the New Zealand Privacy Commissioner in respect of anything he or she does in the course of the exercise or intended exercise of his or her duties under the Privacy Act 1993 that relate to therapeutic products.

    (2) This section applies despite section 121 of the Crown Entities Act 2004.

Subpart 5Information management

170 Application of Official Information Act 1982
  • (1) By way of overview and explanation, the Official Information Act 1982 applies to information held by the Authority by virtue of the Authority being subject to that Act (which it is as a result of being named as an organisation in Part 2 of Schedule 1 of the Ombudsmen Act 1975).

    (2) However, the following information held by the Authority is not official information for the purposes of the Official Information Act 1982:

    • (a) Australian Government information, which is—

      • (i) information about or relating to an activity that falls outside the scope of the Scheme, and that the Authority engages in for Australian purposes only, and that has been approved by the Ministerial Council in accordance with paragraph 3 of Article 5; or

      • (ii) information that is given to the Australian Government under a power given to the Australian Government or the Australian Minister under the Australian Act:

    • (b) information that was in the possession of the Australian Therapeutic Goods Agency on the date of its disestablishment.

    (3) Nothing in sections 172 to 178 affects the application of the Official Information Act 1982 so far as it relates to information disclosed to any person or agency referred to in those sections.

171 Application of Privacy Act 1993
  • (1) The Authority is also subject to the Privacy Act 1993 by virtue of being an agency as defined in section 2(1) of that Act.

    (2) See sections 161 to 169 for details about action by the Privacy Commissioner under the Privacy Act 1993.

172 Release of therapeutic product information to World Health Organisation
  • (1) The Authority may release the information referred to in subsection (2) to the World Health Organisation—

    • (a) for use in developing policies relating to the regulation of therapeutic products; or

    • (b) to allow information to be provided to regulatory authorities of member countries of the World Health Organisation.

    (2) The information that the Authority may release under subsection (1) is therapeutic product information relating to any of the following:

    • (a) notifications about a therapeutic product whose supply in New Zealand or Australia has been prohibited or severely restricted, or reasons for either of those actions:

    • (b) the issue or revocation of manufacturing licences:

    • (c) conditions imposed on manufacturing licences:

    • (d) the compliance by New Zealand or Australian manufacturers with requirements relating to manufacturing set out in Rules and Orders:

    • (e) the content of reports to the Authority concerning adverse effects of a therapeutic product:

    • (f) the issue or revocation of conformity assessment certificates:

    • (g) conditions imposed on conformity assessment certificates.

    (3) In addition, the Authority may release therapeutic product information to the World Health Organisation if the information—

    • (a) concerns the proceedings of an expert advisory committee; and

    • (b) is released in confidence.

173 Release of therapeutic product information to New Zealand and Australian authorities with therapeutic product functions
  • (1) If subsection (2) applies, the Authority may release the information referred to in subsection (3) to the following:

    • (a) a Department or Crown entity (as those terms are defined in section 2 of the State Sector Act 1988) that has functions relating to therapeutic products:

    • (b) an authority of the Commonwealth of Australia or any State or Territory of Australia that has functions relating to therapeutic products.

    (2) Information may be released under subsection (1) only if the Authority is reasonably satisfied that the information is to be used by the recipient only for purposes relating to the performance of its therapeutic product functions.

    (3) The information that the Authority may release under subsection (1) is therapeutic product information relating to any of the following:

    • (a) reported problems and complaints concerning therapeutic products, the Authority's investigation of those problems and complaints, and any action that the Authority has taken or proposes to take in relation to those problems and complaints:

    • (b) reports of inspections conducted under Parts 1 to 5, the Australian Act, or the Rules or Orders:

    • (c) decisions to issue, revoke, or suspend, or not to issue, a manufacturing licence:

    • (d) conditions of manufacturing licences:

    • (e) reports of the testing of samples of therapeutic products:

    • (f) the issue or revocation of conformity assessment certificates:

    • (g) conditions imposed on conformity assessment certificates.

174 Release of therapeutic product information to other national authorities with therapeutic product functions
  • (1) The Authority may release information referred to in subsection (3), for a purpose referred to in subsection (2), to a national regulatory authority (other than one of the bodies referred to in section 173(1)) that has national responsibility relating to therapeutic products.

    (2) Information may be released for the following purposes:

    • (a) for use by the national regulatory authority in performing its functions relating to therapeutic products:

    • (b) to further international co-operation in the regulation of therapeutic products.

    (3) The information that the Authority may release under subsection (1) is therapeutic product information relating to any of the following:

    • (a) recommendations of an expert advisory committee on therapeutic products supplied in, or proposed for supply in, New Zealand or Australia and any conditions that apply, or will apply, to the supply:

    • (b) decisions to grant, suspend, or revoke a product licence:

    • (c) the withdrawal of a therapeutic product from supply in New Zealand or Australia, and the reasons for that action:

    • (d) the licensing status of New Zealand or Australian manufacturers of therapeutic products:

    • (e) the compliance by New Zealand or Australian manufacturers with conditions of a manufacturing licence:

    • (f) the proceedings of expert advisory committees:

    • (g) the issue or revocation of conformity assessment certificates:

    • (h) conditions imposed on conformity assessment certificates.

175 Release of therapeutic product information relating to product tampering and law enforcement
  • (1) The Authority may release information of the kind referred to in subsection (2) to any of the following:

    • (a) a Department or Crown entity (as those terms are defined in section 2 of the State Sector Act 1988) that has functions relating to therapeutic products, health, or law enforcement:

    • (b) an authority of the Commonwealth of Australia or any State or Territory of Australia that has functions relating to therapeutic products, health, or law enforcement:

    • (c) any national regulatory authority outside New Zealand or Australia that has national responsibility relating to therapeutic products, health, or law enforcement:

    • (d) an international organisation that has a function relating to therapeutic products, health, or law enforcement.

    (2) The kinds of information that may be released under subsection (1) are the following:

    • (a) information about or relating to therapeutic products that are, or may be, or have been, subject to actual or potential tampering:

    • (b) information about offences committed, or alleged to have been committed, under Parts 1 to 5 or the Australian Act concerning therapeutic products:

    • (c) information about the contravention, or alleged contravention, of civil penalty provisions under Parts 1 to 5 or the Australian Act concerning therapeutic products:

    • (d) information that relates to the breach of a requirement relating to a therapeutic product under Parts 1 to 5, the Australian Act, the Rules, Orders, or regulations made under this Act.

176 Release of therapeutic product information required to be provided
  • (l) This section applies if the Authority gives a notice under the Rules requiring information about a therapeutic product to be given to any of the following:

    • (a) an authorised prescriber who administers therapeutic products:

    • (b) the holder of, or an applicant for, a product licence:

    • (c) the holder of, or an applicant for, a conformity assessment certificate.

    (2) The Authority may release information provided pursuant to a notice referred to in subsection (1) to the following:

    • (a) a Department or Crown entity (as those terms are defined in section 2 of the State Sector Act 1988) that has functions relating to therapeutic products or health:

    • (b) an authority of the Commonwealth of Australia or any State or Territory of Australia that has functions relating to therapeutic products or health:

    • (c) an authority that, under the Health Practitioners Competence Assurance Act 2003, is responsible for the registration and oversight of practitioners of a particular health profession:

    • (d) an Australian pharmaceutical professional body (being a body that is responsible for the registration of pharmacists in a State or Territory of Australia).

177 Release of therapeutic product information in accordance with international co-operative arrangements
  • The Authority may release therapeutic product information to a national regulatory authority or an international organisation if—

    • (a) New Zealand or Australia has co-operative arrangements with the country or organisation that relate to the assessment or regulation of therapeutic products; and

    • (b) the release of the information is consistent with those arrangements.

178 Release of therapeutic product information to public
  • The Authority may release therapeutic product information to the public if—

    • (a) the information relates to any decision or action taken under Parts 1 to 5, the Australian Act, or the Rules or Orders; or

    • (b) the release of the information is necessary to ensure the safe use of particular therapeutic products; or

    • (c) the information relates to the reasons for the withdrawal of therapeutic products from supply in New Zealand or Australia.

179 Protection against action if lawfully making information available
  • (1) If a person, in good faith, makes information available under any of sections 170 to 178, or section 183, or under the Medicines Act 1981 (in a case where section 184 applies),—

    • (a) no civil penalty or criminal proceedings lie against the person in respect of making the information available or for any of the consequences of making it available; and

    • (b) in respect of any publication involved in, or resulting from, making the information available, no civil or criminal proceedings lie against the author of the information, or any other person, by reason of that author or other person having supplied the information to the Agency.

    (2) For the purpose of the law relating to defamation, breach of confidence, or infringement of copyright, if information is made available under this subpart, the disclosure of the information does not constitute an authorisation or approval of the publication of the information by the person who discloses it.

    Compare: 1982 No 156 s 48

Protected active ingredient information

180 Purpose of sections 181 to 184
  • The purpose of sections 181 to 184 is to provide for compliance by New Zealand with its obligations under article 39 of the General Agreement on Tariffs and Trade (Uruguay Round) Agreement on Trade-related Aspects of Intellectual Property Rights, Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization (commonly referred to as the TRIPS Agreement).

181 Definition of protected active ingredient information
  • (1) Protected active ingredient information is information that—

    • (a) is about, or relates to, the active moiety of a therapeutic product; and

    • (b) is submitted in support of an application for a product licence; and

    • (c) is not in the public domain on the date on which the application is received by the Authority.

    (2) For the purposes of this definition, active moiety means the molecule, or part or portion of a molecule, that—

    • (a) has a characteristic chemical or pharmacological property; and

    • (b) is the portion of the active ingredient of a therapeutic product that is responsible for the effect of the active ingredient.

182 Periods when protected active ingredient information may not normally be disclosed
  • (1) The Authority must not disclose protected active ingredient information during either of the periods of protection that apply to that information, except as provided in section 183.

    (2) The first period of protection for protected active ingredient information about a therapeutic product starts on the date on which an application is first received by the Authority for a product licence for the therapeutic product, and ends on the earlier of—

    • (a) the date that is 5 years later; or

    • (b) the date on which the second period of protection starts.

    (3) The second period of protection starts on the date on which the Authority either grants or declines the application, and ends on the date that is 5 years later.

183 Limited circumstances in which protected active ingredient information may be disclosed
  • Despite section 182, the Authority may disclose protected active ingredient information during either period of protection that applies to the information if—

    • (a) the disclosure is made under and in accordance with any of sections 172 to 178; or

    • (b) the applicant or licence holder (as the case requires) agrees in writing to the disclosure; or

    • (c) the information has entered the public domain and is therefore no longer confidential.

184 Continuation of protections under Medicines Act 1981
  • (1) Sections 23B and 23C of the Medicines Act 1981 continue to apply to all confidential supporting information (as defined in section 23A of that Act) that was contained in an application for an innovative medicine received by Medsafe in relation to which, before the date on which Part 5 comes into force, the Minister (as defined in that Act)—

    • (a) had notified consent (not being provisional consent) in the Gazette; or

    • (b) had refused to grant consent.

    (2) To avoid doubt, nothing in this section applies to information received by the Australian Therapeutic Goods Agency before its disestablishment, even if the information is the same as the confidential supporting information received by Medsafe.

Use of information by Authority

185 Protection against action for use by Authority of information
  • (1) This section applies if Rules limit the use that the Authority may make of information.

    (2) If a person, in good faith, uses information in breach of those Rules,—

    • (a) no civil or criminal proceedings lie against the person in respect of using the information or for any of the consequences of using it; and

    • (b) in respect of any publication involved in, or resulting from, using the information, no civil or criminal proceedings lie against the author of the information, or any other person, by reason of that author or other person having supplied the information to the Agency.

    (3) For the purpose of the law relating to defamation, breach of confidence, or infringement of copyright, if information is used under this subpart, the use does not constitute an authorisation or approval of the publication of the information by the person who uses it.

Archives

186 Management of Authority's records
  • (1) By way of overview and explanation—

    • (a) the Authority is subject to the Public Records Act 2005 by virtue of being identified as a public office in section 4 of that Act; and

    • (b) the Authority is also subject to the Archives Act 1983 of the Commonwealth of Australia; and

    • (c) the Chief Archivist appointed under the Public Records Act 2005, and the Director-General of the National Archives of Australia, may enter into memorandums of understanding concerning the management and disposal of public records (as defined in the Public Records Act 2005) of the Authority.

    (2) The Chief Archivist may not authorise the disposal of public records of the Authority except in accordance with any memorandum of understanding entered into with the Director-General of the National Archives of Australia.

Part 4
Governance and accountability

187 Definitions of terms used primarily in this Part
  • In Parts 1 to 5, unless the context otherwise requires,—

    approved bank means—

    • (a) an institution—

      • (i) that carries on a business in New Zealand or Australia that consists of or includes taking money on deposit; and

      • (ii) the operations of which are subject to prudential supervision or regulation under the law of New Zealand or of the Commonwealth of Australia or of an Australian State or Territory; and

      • (iii) that satisfies a credit rating test specified in the Rules; or

    • (b) an institution identified in or under the Rules as a financial institution with which the Authority may keep a bank account or similar account

    financial year means—

    • (a) a period of 12 months commencing on 1 July; or

    • (b) another 12-month period specified in the Rules

    forecast financial statements has the meaning set out in section 2(1) of the Public Finance Act 1989

    generally accepted accounting practice means either of the following, as determined by the Rules (if any) or, in the absence of Rules, by the Authority:

    • (a) generally accepted accounting practice (as that term is defined in section 3 of the Financial Reporting Act 1993); or

    • (b) accounting standards made or formulated by the Australian Accounting Standards Board

    senior manager means, in relation to the Authority, a person (other than a Board member or a Minister) who—

    • (a) makes, or participates in making, decisions that affect the whole or a substantial part of the operations of the Authority; or

    • (b) has the capacity to significantly affect the Authority's financial standing

    senior officer means a person who is—

    • (a) a Board member; or

    • (b) a senior manager

    subsidiary means an entity controlled by the Authority, where entity and controlled have the meanings they have in generally accepted accounting practice.

Subpart 1Ministerial Council, Board, and Board members

Ministerial Council

188 Overview of Ministerial Council
  • (1) The Ministerial Council is established by Article 4 of the Agreement.

    (2) The role of the Ministerial Council is set out in subparagraph (b) of paragraph 2 of Article 2 of the Agreement.

    (3) The functions of the Ministerial Council are set out in paragraph 2 of Article 4 of the Agreement.

General provisions relating to Board

189 Overview of Board
  • (1) The Board is established by Article 6 of the Agreement, which also sets out its role and functions.

    (2) Article 6 of the Agreement also provides that the 5 members of the Board are appointed by the Ministerial Council.

    (3) The responsibilities of the Board are set out in paragraphs 5 and 6 of Article 6 of the Agreement.

    (4) More detailed matters relating to the Board, such as Board procedures, the remuneration of members, and delegations, are provided for in Rules.

190 Parliament's expectations of Board
  • Parliament intends that the Board, in fulfilling its responsibility under paragraph 5 of Article 6 of the Agreement, will ensure that the Authority acts consistently with its functions and in a manner consistent with the spirit of service to the public.

    Compare: 2004 No 115 ss 49, 50

191 Restrictions on Minister's discretion to appoint
  • (1) The Minister may not recommend for appointment to the Board, and may not concur in the appointment to the Board of, any person who—

    • (a) is an undischarged bankrupt; or

    • (b) is prohibited from being a director or promoter of, or being concerned or taking part in the management of, a company under section 382, 383, or 385 of the Companies Act 1993; or

    • (c) is subject to a property order under the Protection of Personal and Property Rights Act 1988; or

    • (d) is a person in respect of whom a personal order has been made under that Act that reflects adversely on the person's —

      • (i) competence to manage his or her own affairs in relation to his or her property; or

      • (ii) capacity to make or to communicate decisions relating to any particular aspect or aspects of his or her personal care and welfare; or

    • (e) has been convicted of an offence punishable by imprisonment for a term of 2 years or more, or who has been sentenced to imprisonment for any other offence, unless that person has obtained a pardon, served the sentence, or otherwise suffered the penalty imposed on the person; or

    • (f) is a member of Parliament; or

    • (g) is subject to a disqualification order under section 255, or is disqualified under section 383 of the Companies Act 1993, section 30 of the Crown Entities Act 2004, or any other similar provision of another enactment.

    (2) The Minister must not recommend a person's appointment to the Board if the Australian Act prevents the Australian Minister from concurring in the appointment of the person to the Board.

    Compare: 2004 No 115 s 30(2)

192 Vacancies in membership of Board and flaws in appointment
  • (1) The powers, functions, and duties of the Board are not affected by a vacancy in its membership.

    (2) The actions of a person as a Board member are not invalidated by—

    • (a) a defect in the person's appointment as a Board member; or

    • (b) in the case of an acting Board member, the fact that, unknown to the acting Board member, the occasion to act had not arisen or had ceased.

    Compare: 2004 No 115 ss 34, 77

193 Effect of flaws in Board processes
  • The actions of the Board may not be challenged by any person solely on the grounds that the Board did not comply with Board procedures.

Managing Director

194 Overview of Managing Director
  • (1) The Managing Director is a Board member appointed by the Ministerial Council under paragraph 2 of Article 6 of the Agreement.

    (2) The Managing Director has roles and responsibilities as set out in Article 7 of the Agreement.

Subpart 2General matters relating to Authority

195 Overview of Authority
  • (1) The Authority is established by the Australian Act.

    (2) The Authority's functions are those conferred by the Australian Act, namely—

    • (a) the functions specified in paragraph 2 of Article 5 of the Agreement; and

    • (b) any other function conferred on the Authority in accordance with paragraph 3 of Article 5 of the Agreement (which may include, for example, functions that relate only to New Zealand or only to Australia).

    (3) The Authority's powers are conferred by the Australian Act and by Parts 1 to 5.

    (4) The Authority is not a Crown entity and is not subject to the Crown Entities Act 2004.

    (5) However, Parts 1 to 5 and the Rules impose accountability requirements and financial controls on the Authority that are broadly equivalent to the accountability requirements and financial controls that would apply if the Authority were subject to the Crown Entities Act 2004.

    (6) This section is by way of explanation only. If any provision of Parts 1 to 5, the Agreement, or the Rules conflicts with this section, the other provision prevails.

Providing information

196 Authority to provide information to Minister
  • (1) The Authority must ensure that the Minister is promptly informed of any regulatory decision, or proposed regulatory decision, that affects or is likely to affect—

    • (a) the financial position of the Government; or

    • (b) existing government policies or programmes.

    (2) On request by the Minister, the Authority must provide the Minister with the following information:

    • (a) information about the operations and performance of the Authority and its subsidiaries:

    • (b) information about activities—

      • (i) that fall outside the scope of the scheme but that the Authority engages in, or could engage in, in accordance with paragraph 3 of Article 5 of the Agreement; and

      • (ii) that relate to New Zealand.

    (3) The Authority must provide the Minister with the information within the time, and in the manner (if any), specified in the request.

197 Authority to comply with request for information from Finance Minister
  • (1) If the Finance Minister makes a written request to the Authority for information about the Authority's operations and performance, or about the operations and performance of any of its subsidiaries, the Authority must supply the information within the time and in the manner (if any) specified by the Finance Minister.

    (2) The Finance Minister must supply a copy of the request to both the Australian Finance Minister and the Ministerial Council.

    (3) If the Australian Finance Minister, or the Ministerial Council, or both, ask for a copy of the information received, the Finance Minister must supply it.

    Compare: 2004 No 115 ss 133(2), 134(1), (2), (3)

198 Authority to comply with request for information by Secretary to the Treasury
  • (1) If the Secretary to the Treasury makes a written request to the Authority for information about the Authority's operations and performance, or about the operations and performance of any of its subsidiaries, the Authority must supply the information within the time and in the manner (if any) specified by the Secretary.

    (2) The Secretary to the Treasury may only request information under this section if it is for the purpose of—

    • (a) preparing fiscal forecasts and projections required by or under any Act; or

    • (b) preparing Appropriation Bills, Estimates, Supplementary Estimates, and other supporting information required by or under any Act; or

    • (c) preparing the annual and monthly financial statements of the Government; or

    • (d) allowing the Secretary to the Treasury to perform the functions imposed on him or her by the Government or any enactment.

Compliance with directions

199 Authority to comply with directions of Ministerial Council
  • (1) This section applies if the Ministerial Council gives the Authority a written direction under this section.

    (2) The Authority must give effect to a written direction from the Ministerial Council.

    (3) A written direction under this section—

    • (a) must be about a matter of government policy; and

    • (b) must not relate to a regulatory function (as defined in Article 1 of the Agreement) of the Authority; and

    • (c) must not require the performance or non-performance of a particular act, or the bringing about of a particular result, in respect of a particular person or persons.

    (4) A written direction may not be given under this section unless, before it is given, the Board has been consulted about its contents.

    (5) As soon as practicable after a direction is given under this section—

    • (a) the Minister must present a copy of the direction to the House of Representatives; and

    • (b) the Authority must publish the text of the direction on its Internet site.

    (6) Under section 230(5), the Authority's annual report must report on directions given under this section.

    Compare: 2004 No 115 ss 103, 108(1), (2), 113, 114

Review of operations

200 Review of operations and performance
  • (1) The Ministerial Council, or the Minister, or the Australian Minister may, in accordance with any relevant Rules, review the following:

    • (a) the operations or performance of the Authority:

    • (b) the operations or performance of any of its subsidiaries.

    (2) The Authority must take all reasonable steps to co-operate with the review.

Employees and others

201 Employees and others not to disclose Authority information
  • (1) This section applies to—

    • (a) every employee of the Authority; and

    • (b) every person who performs functions on behalf of the Authority under—

      • (i) a contract for service; or

      • (ii) a delegation; and

    • (c) every member of a Board Committee or expert advisory committee.

    (2) However, this section does not apply to senior officers (including the Managing Director), because they are subject to sections 246 and 247(3) instead.

    (3) A person to whom this section applies commits an offence if he or she intentionally or recklessly uses, discloses, or acts upon information obtained solely as a result of his or her role with the Authority, unless the use, disclosure, or action—

    • (a) is in, or relates to, the performance of the Authority's functions; or

    • (b) is required or authorised by law (such as, for example, when the information is disclosed in good faith under the Official Information Act 1982); or

    • (c) is authorised by a senior officer.

    (4) A person who commits an offence under this section is liable, on conviction on indictment, to a term of imprisonment of not more than 2 years, a fine of not more than 300 penalty units, or both.

202 Employees not to misuse position
  • (1) An employee of the Authority (not being the Managing Director or a senior manager) commits an offence if he or she intentionally uses his or her position as an employee to—

    • (a) gain, or with the intention of gaining, an improper advantage for himself, herself, or someone else; or

    • (b) cause detriment to the Authority.

    (2) A person who commits an offence under this section is liable, on conviction on indictment, to a term of imprisonment of not more than 2 years, or a fine of not more than 300 penalty units, or both.

Immunities, indemnities, and insurance

203 Application of sections 204 to 207
  • Sections 204 to 207 apply to the following people:

    • (a) senior officers and former senior officers:

    • (b) members and former members of Board committees:

    • (c) members and former members of expert advisory committees:

    • (d) employees and former employees of the Authority.

204 General protection from liability
  • A person referred to in section 203 is not liable for a liability of the Authority merely because he or she is such a person.

    Compare: 2004 No 115 s 120

205 Immunities
  • (1) No proceedings, civil or criminal, may be taken against any person referred to in section 203 for anything that the person may do or say, or fail to do or say, in the course of the operations of the Authority, unless the person acted in bad faith.

    (2) However, subsection (1)

    • (a) is not a defence to a prosecution under any provision of section 247; and

    • (b) is not a defence to any liability under subpart 5 of this Part; and

    • (c) does not affect the right of any person to apply for judicial review; and

    • (d) does not apply in respect of proceedings for—

      • (i) an offence against any of sections 78, 78A, 105, or 105A of the Crimes Act 1961; or

      • (ii) the offence of conspiring to commit an offence against any of those sections; or

      • (iii) the offence of attempting to commit an offence against any of those sections.

    Compare: 2004 No 115 ss 120, 121(2), and definition of excluded act or omission in s 126

206 Indemnities
  • (1) Despite section 213, the Authority may agree to indemnify any person referred to in section 203, subject to this section.

    (2) The Authority may not agree to indemnify the person for—

    • (a) acts or omissions done in bad faith; or

    • (b) acts or omissions that are not done in the course of performing, or intending to perform,—

      • (i) a function of the Authority; or

      • (ii) a function conferred on the person (in that capacity) by a New Zealand Act or an Act of the Commonwealth of Australia.

    (3) No indemnity may be provided by the Authority to the person in respect of any legal costs that relate in any way to proceedings for an offence for which the person is convicted, unless the conviction is subsequently overturned.

    (4) Subsection (3) applies despite any contrary agreement entered into under subsection (1).

    Compare: 2004 No 115 s 123; Commonwealth Authorities and Companies Act 1997 ss 27M, 27N (Aust)

207 Insurance
  • (1) Despite section 213, the Authority may insure, or pay insurance cover for, any person referred to in section 203, subject to this section.

    (2) The Authority may not insure, or pay insurance cover for, the person in respect of—

    • (a) acts or omissions done in bad faith; or

    • (b) acts or omissions that are not done in the course of performing, or intending to perform,—

      • (i) a function of the Authority; or

      • (ii) a function conferred on the person (in that capacity) by an Act or an Act of the Commonwealth of Australia; or

    • (c) any legal costs that relate in any way to proceedings for an offence for which the person is convicted, unless the conviction is subsequently overturned.

    (3) If the Authority insures, or pays insurance cover for, the person in breach of subsection (2), the person must repay to the Authority the cost of the insurance cover to the extent that the insurance cover exceeds that which could have been provided under subsection (1) in accordance with subsection (2).

    (4) The Authority may recover the amount as a debt due in a court of competent jurisdiction.

    Compare: 2004 No 115 ss 123, 125; Commonwealth Authorities and Companies Act 1997 s 27N (Aust)

208 Immunity for Authority
  • (1) No proceedings, civil or criminal, may be taken against the Authority for anything it may do or fail to do in the course of the exercise or intended exercise of its functions, unless it is shown that the Authority acted without reasonable care or in bad faith.

    (2) Nothing in subsections (1) and (2) applies in respect of proceedings for—

    • (a) an offence against any of sections 78, 78A, 105, or 105A of the Crimes Act 1961; or

    • (b) the offence of conspiring to commit an offence against any of those sections; or

    • (c) the offence of attempting to commit an offence against any of those sections.

    Compare: 1986 No 5 s 106(1)–(3)

209 Application of Health and Safety in Employment Act 1992
  • (1) Despite section 208, the Authority is subject to prosecution under the Health and Safely in Employment Act 1992 because it is within the definition of Crown organisation for the purposes of that Act (by virtue of being a government–related organisation under the Crown Organisations (Criminal Liability) Act 2002).

    (2) However, the only officers, agents, or employees of the Authority who may be prosecuted under section 56(2) of the Health and Safety in Employment Act 1992 are—

    • (a) Board members who are resident in New Zealand; and

    • (b) other officers, agents, or employees of the Authority whose work for the Authority is primarily based in New Zealand.

Miscellaneous matters

210 Seal of Authority
  • The imprint of the seal of the Authority that appears on a document is presumed, unless the contrary is proved, to be the imprint of the Authority's seal, and the document is presumed, unless the contrary is proved, to have been sealed as it purports to have been sealed.

211 Signature of Managing Director
  • (1) A document that purports to have been signed by the Managing Director, or by a person on behalf of the Managing Director, is presumed, unless the contrary is proved, to have been signed by the Managing Director, or by the person on behalf of the Managing Director, acting in an official capacity.

    (2) A document that has been signed by the Managing Director on behalf of the Authority is taken to have been signed with the authority of the Authority, unless the contrary is proved.

Subpart 3Financial and associated matters

212 Restriction on borrowing, etc
  • (1) The Authority must not borrow, or amend the terms of a borrowing, except in accordance with the Rules.

    (2) Subsection (1) applies to each of the following in the same way as it applies to borrowing:

    • (a) issuing or amending a security or other financial instrument:

    • (b) entering into, or amending, a hire purchase agreement or similar agreement:

    • (c) entering into, or amending, a finance lease arrangement or similar arrangement:

    • (d) accepting debt on assignment or amending the terms of the assignment:

    • (e) recording in the financial statements of the Authority the debt of another entity to an entity other than the Authority, or amending that record, whether or not the Authority is legally obliged to repay the debt because of the novation of an agreement or otherwise.

    (3) Subsections (1) and (2) do not apply to—

    • (a) the purchase of goods or services on credit extended for 90 days or less; or

    • (b) the obtaining of an advance for 90 days or less by—

      • (i) the use of a credit card; or

      • (ii) the supply of credit for the purchase of goods or services; or

    • (c) an operating lease; or

    • (d) bailment on hire.

213 Restriction on giving guarantees and indemnities
  • (1) The Authority must not give or amend a guarantee, whether the guarantee is given or amended with or without security, except in accordance with the Rules.

    (2) The Authority must not indemnify any person, or amend any indemnity, except in accordance with the Rules.

    (3) Subsection (2) does not prevent the Authority from indemnifying a person under section 206.

214 Restriction on use of derivative transactions
  • (1) The Authority must not enter into, or amend the terms of, a derivative transaction, except in accordance with the Rules.

    (2) For the purposes of this section, derivative transaction means—

    • (a) a transaction that is a forward, swap, future, option (put or call), swaption, cap, floor, or collar on 1 or more rates, currencies, commodities, equity or debt instruments, economic indices or measures of economic risk or value, environmental or climatic variables, or other benchmarks against which payments or deliveries are to be made; or

    • (b) any other similar transaction that is, or in the future becomes, recurrently entered into in the financial markets and whose value derives from, or varies with, movements in the value of 1 or more underlying assets, rates, indices, indicators, or benchmarks; or

    • (c) a transaction that is identified by or under the Rules as a derivative transaction for the purposes of this section.

215 Banking
  • (1) The Authority must pay all money received by it into an account maintained with an approved bank.

    (2) The Authority must not keep a bank account in a currency other than New Zealand currency or Australian currency, except in accordance with the Rules.

    (3) The circumstances in which the Authority may keep a bank account may be further defined in the Rules.

216 Restriction on acquiring securities
  • (1) The Authority may exercise its powers to acquire securities only by way of 1 or more of the following:

    • (a) a deposit with an approved bank:

    • (b) a public security (as defined in section 2(1) of the Public Finance Act 1989):

    • (c) a security issued or guaranteed by the Commonwealth of Australia or by an Australian State or Territory:

    • (d) a debt security identified in or under the Rules.

    (2) The circumstances in which the Authority may acquire securities may be further defined in the Rules.

    (3) However, this section does not limit what the Authority may do under section 217(1) in accordance with the Rules.

217 Restriction on Authority's involvement in other entities
  • (1) The Authority must not do any of the following, except in accordance with the Rules:

    • (a) form a company or participate in the formation of a company:

    • (b) acquire an interest in a company:

    • (c) participate in a partnership, trust, unincorporated joint venture, or similar arrangement:

    • (d) increase the Authority's interest in a company, partnership, trust, unincorporated joint venture, or similar arrangement.

    (2) Before disposing of an interest in a company, partnership, trust, unincorporated joint venture, or similar arrangement, the Authority must give written notice to the Ministerial Council.

    (3) Subsection (2) does not apply in relation to the disposal of an interest if the Rules provide that the subsection does not apply.

218 Subsidiaries not to do what Authority cannot or must not do
  • The Authority must ensure that none of its subsidiaries—

    • (a) does anything that the Authority does not itself have power to do; or

    • (b) exercises any of the Managing Director's powers (including powers that the Managing Director exercises in performing the Authority's regulatory functions in accordance with Article 7 of the Agreement).

219 Aligning accounting periods of subsidiaries
  • (1) If the annual accounting period of a subsidiary of the Authority is not the same as the financial year of the Authority, the Board members must, within 12 months of the subsidiary becoming a subsidiary, do whatever is necessary to ensure that the subsidiary's annual accounting period is the same as the Authority's financial year.

    (2) If the annual accounting period of a subsidiary is already the same as the Authority's financial year, the Board members must do whatever is necessary to ensure that it continues to be the same.

    (3) However, the Finance Minister may, with the agreement of the Australian Finance Minister, by notice in writing, exempt Board members from the requirements of subsection (1), either generally or in relation to 1 or more specific subsidiaries, whether the exemption is with or without conditions.

    (4) A Board member who, intentionally or recklessly, contravenes, or fails to take all reasonable steps to comply or secure compliance with, subsections (1) or (2) commits an offence and is liable, on summary conviction, to a fine of not more than 50 penalty units.

    Compare: Commonwealth Authorities and Companies Act 1997 ss 30, 31 (Aust)

220 Banking and accounting for trust money
  • (1) This section and section 221 apply only to money received or held by the Authority on trust (in these sections referred to as trust money).

    (2) Unless provided otherwise in the Rules, as soon as practicable after identifying any trust money, the Authority must pay it into a bank account that is—

    • (a) kept in accordance with section 215; and

    • (b) not used to hold money other than trust money.

    (3) The Authority must account for trust money separately from money that it holds on its own account.

    (4) Money held under one trust must be accounted for separately from money held under any other trust.

221 Investment of trust money
  • (1) The Authority may invest trust money and, if it does, must do so in accordance with the Rules.

    (2) Income from the investment of trust money is also trust money.

    (3) The income from any investment of trust money must be held, accounted for, apportioned, and paid in accordance with the Rules.

222 Exemption of Authority from income tax
  • (1) The Authority is a public authority for the purposes of the Inland Revenue Acts (as that term is defined in section 3(1) of the Tax Administration Act 1994).

    (2) The effect of subsection (1) is that the income of the Authority is exempt from income tax.

223 Authority's input tax under Goods and Services Tax Act 1985
  • (1) For the purpose of working out the Authority's input tax under the Goods and Services Tax Act 1985, goods and services acquired by the Authority are treated as being acquired for the principal purpose of making taxable supplies, unless they were acquired for the principal purpose of making exempt supplies.

    (2) A term used in this section and defined in the Goods and Services Tax Act 1985 has the same meaning in this section as it has in that Act.

Subpart 4Reporting

Overview

224 Overview
  • (1) In order to ensure that the Authority is accountable to each Party to the Agreement, the Authority is required by Article 8 of the Agreement to produce various reporting documents.

    (2) Paragraph 1 of Article 8 of the Agreement sets out principles guiding the design of the reporting regime for the Authority.

    (3) In order to give effect to those principles—

    • (a) the requirements for planning and reporting documents set out in the Rules are augmented by requirements set out in Parts 1 to 5 and the Australian Act; and

    • (b) the obligations imposed under the Acts are based on the obligations that each country would normally apply to a comparable regulatory agency of that Party, but are modified in order to reduce unnecessary duplication.

    (4) Accordingly,—

    • (a) New Zealand requires the Authority to prepare and provide an annual statement of intent, in addition to any other planning documents required by the Rules; and

    • (b) Australia requires the Authority to prepare and provide budget estimates in accordance with the Australian Act, in addition to any other planning documents required by the Rules; and

    • (c) both Parties to the Agreement require the Authority to prepare a single annual report that complies with the requirements of Parts 1 to 5, the Australian Act, and any other requirements specified in the Rules.

    (5) This section is by way of explanation only. If any other provision of Parts 1 to 5, the Australian Act, or the Rules conflicts with this section, the other provision prevails.

Statement of intent

225 Obligation to prepare statement of intent
  • (1) Before the start of each financial year, the Board must prepare a statement of intent for the Authority and provide it to the Ministerial Council.

    (2) The statement of intent must include information that covers—

    • (a) the forthcoming financial year and at least the 2 subsequent financial years; and

    • (b) the Authority and all of its subsidiaries (if any).

    (3) The statement of intent must be prepared in accordance with the Rules.

    (4) Without limiting subsection (3), the statement of intent must include—

    • (a) information on the nature and scope of the Authority's functions and intended operations; and

    • (b) the main financial and non-financial measures and standards by which the performance of the Authority may be judged during the period covered by the statement of intent; and

    • (c) for the forthcoming financial year—

      • (i) forecast financial statements for the Authority that have been prepared in accordance with generally accepted accounting practice; and

      • (ii) a statement of forecast service performance prepared in accordance with the Rules.

    (5) The requirement to prepare a statement of intent is additional to the requirement imposed by paragraph 4 of Article 8 of the Agreement to prepare and provide any other documents required by the Rules.

    Compare: 2004 No 115 s 139

226 Board to ensure Authority complies with statement of intent
  • Parliament intends that the Board, in fulfilling its responsibilities under paragraph 5 of Article 6 of the Agreement, will ensure that the Authority acts in accordance with the statement of intent for the Authority that is currently in force.

    Compare: 2004 No 115 s 49

227 Direction by Ministerial Council to amend statement of intent
  • (1) The Ministerial Council may direct the Board to amend any provision of the Authority's statement of intent.

    (2) If the Ministerial Council intends to so direct, it must consult with the Board before giving the direction.

    (3) A direction to amend a statement of intent—

    • (a) must be presented to the House of Representatives, and be published in the Gazette, as soon as practicable; and

    • (b) may not require the performance or non-performance of a particular act, or the bringing about of a particular result, in respect of a particular person or persons.

    Compare: 2004 No 115 s 147

228 Amendments to statement of intent
  • (1) The Board may amend a statement of intent for the Authority.

    (2) The Board must amend a statement of intent if—

    • (a) the Board is directed under section 227 to amend the statement of intent; or

    • (b) the information contained in the statement of intent is false or misleading in a material particular; or

    • (c) the intentions and undertakings in the statement of intent are significantly altered or affected by—

      • (i) a direction given under section 199; or

      • (ii) any change in the law; or

      • (iii) any other change in the entity's operating environment.

    (3) The Board must make the amendment required under subsection (2) as soon as practicable after the Board becomes aware of the facts that give rise to the obligation to amend the statement.

229 Statement of intent to be presented to House of Representatives and be published
  • (1) The Minister must present a copy of the statement of intent, and of every amendment to a statement of intent, to the House of Representatives—

    • (a) no later than 5 working days after the statement of intent or amendment (as the case may be) is received by the Ministerial Council; or

    • (b) if Parliament is not in session, as soon as practicable after the commencement of the next session of Parliament.

    (2) The Authority must publish its statement of intent, and every amendment to it, on its Internet site as soon as practicable after it has been presented to the House of Representatives.

Annual report

230 Obligation to prepare annual report
  • (1) Paragraph 3 of Article 8 of the Agreement requires the Board to prepare an annual report for the Authority for each financial year, and provide it to the Ministerial Council.

    (2) The annual report must be provided to the Ministerial Council by the 15th day of the fourth month after the end of the financial year, unless the Ministerial Council grants an extension of time.

    (3) The Ministerial Council may grant an extension of time only in special circumstances.

    (4) The annual report must be prepared in accordance with the Rules.

    (5) Without limiting subsection (4), the annual report must include all of the following:

    • (a) information about the operations of the Authority and its subsidiaries (if any) during the financial year:

    • (b) a statement of service performance, prepared in accordance with the Rules:

    • (c) financial statements for the Authority, prepared in accordance with generally accepted accounting practice:

    • (d) the auditors' reports on the statement of service performance and financial statements:

    • (e) particulars of all directions given to the Authority by the Ministerial Council under section 199 that are relevant to the financial year.

231 Annual report to be presented to House of Representatives and be published
  • (1) The Minister must present the Authority's annual report to the House of Representatives as soon as practicable after it has been provided to the Ministerial Council.

    (2) The Authority must publish the annual report on its Internet site—

    • (a) as soon as practicable after it has been presented to—

      • (i) the House of Representatives; or

      • (ii) either House of Parliament of Australia; but

    • (b) in any case, not later than 10 working days after the annual report is received by the Ministerial Council.

Audit

232 Auditor-General is auditor of Authority
  • (1) The Auditor-General is appointed as an auditor of the Authority and of each of its subsidiaries.

    (2) The Australian Act appoints the Australian Auditor-General to also be an auditor of the Authority and its subsidiaries, as required by paragraph 5 of Article 8 of the Agreement.

    (3) A reference to the Authority's auditors is therefore a reference to both the Auditor-General and the Australian Auditor-General; and a reference to an auditor of the Authority is a reference to either the Auditor-General or the Australian Auditor-General.

    (4) Both the appointed auditors will work jointly, in a manner to be agreed by the auditors, to audit the financial statements of the Authority and its subsidiaries.

    (5) The Public Audit Act 2001 applies to the Authority and each of its subsidiaries as if the Authority was a public entity for the purpose of that Act.

Keeping accounting records

233 Obligation to keep accounting records
  • (1) The Authority must keep accounting records that properly record and explain its transactions and financial position.

    (2) The Authority must keep the records in a way that—

    • (a) enables the Authority's financial statements to be prepared in the form required by the Rules (if any); and

    • (b) allows those financial statements to be conveniently and properly audited.

    (3) The Authority must retain the records for at least 7 years after the completion of the transactions to which they relate.

    (4) The Authority must make the records available at all reasonable times for inspection by a Board member.

Offences

234 Offence of failing to keep accounting records
  • (1) A senior officer commits an offence if the senior officer intentionally contravenes section 233.

    (2) A person who commits an offence under this section is liable, on summary conviction, to a term of imprisonment of not more than 6 months, a fine of not more than 30 penalty units, or both.

235 Offences relating to reporting
  • (1) A person commits an offence if he or she knowingly—

    • (a) refuses or fails to produce any information, when required to do so under this Part or the Rules, that is—

      • (i) is in that person's possession or under that person's control; and

      • (ii) relates to the management, performance, or operations of the Authority; or

    • (b) resists or obstructs any person acting in the discharge of that person's functions or in the exercise of that person's powers under this Part or the Rules; or

    • (c) represents directly or indirectly that he or she holds any authority under this Part or under the Rules, knowing that he or she does not hold that authority.

    (2) A person commits an offence if he or she makes any statement or declaration, or gives any information or certificate, required by this Part or the Rules, knowing it to be false or misleading.

    (3) A person who commits an offence under this section is liable, on summary conviction, to,—

    • (a) in the case of an individual, a fine of up to 200 penalty units; and

    • (b) in the case of a body corporate, a fine of up to 500 penalty units.

    Compare: 2004 No 115 ss 171(1), 172(1)

Subpart 5Board members and other senior officers

Board member conflict of interest

236 What Board member must do if interested in matter
  • (1) A Board member who has a material personal interest in a matter relating to the Authority—

    • (a) must disclose details of the interest as soon as practicable after the member becomes aware that he or she has the interest; and

    • (b) must not participate in any way in the Board's (or any Board committee's ) consideration of, decisions about, or voting on, the matter; and

    • (c) must not sign any document relating to the entry into a transaction relating to the matter, or that initiates the matter.

    (2) If the Rules specify circumstances in which a Board member is taken to have a material personal interest in a matter, or the circumstances in which a person is taken not to have a material personal interest in a matter, then those Rules apply when determining whether or not a Board member has a material personal interest for the purposes of this section.

    Compare: 2004 No 115 ss 63(1), 66; Commonwealth Authorities and Companies Act 1997 ss 27F(1), 27J(1) (Aust)

237 How disclosures of interest are made
  • (1) The details of a material personal interest must be disclosed—

    • (a) in an interests register kept by the Authority; and

    • (b) to either—

      • (i) the Chair of the Board; or

      • (ii) the Ministerial Council, if there is not a Chair of the Board or the Chair is unavailable or has a material personal interest.

    (2) The details of a material personal interest that must be disclosed are—

    • (a) the nature and extent of the interest, including the monetary value of the interest (if the interest is a monetary interest and the value of that interest can be quantified); and

    • (b) how the interest relates to the affairs of the Authority.

    (3) A Board member may make a standing disclosure of a present or future material personal interest by way of a general notice of the interest.

    (4) A standing disclosure is effective only if it is disclosed in accordance with subsections (1) and (2).

    (5) A standing disclosure ceases to have effect if the nature of the interest materially alters or the extent of the interest materially increases.

    Compare: 2004 No 115 ss 63, 64, 65; Commonwealth Authorities and Companies Act 1997 ss 27F(3)(a), 27G (Aust)

238 Permission to act despite being interested in matter
  • (1) If the Board is satisfied that it is in the public interest to do so, the Board may permit a member, or members with a specified class of material personal interest, to participate in a matter in a way that would otherwise contravene section 236(1)(b) and (c).

    (2) The permission may state conditions that the member or members must comply with.

    (3) The Ministerial Council may give permission in place of the Board doing so, in accordance with the Rules (if any).

    (4) A permission may be amended or revoked in the same way as it may be given.

    Compare: 2004 No 115 s 68

239 Consequences of failing to comply with section 236
  • (1) If a Board member fails to comply with section 236, the Ministerial Council must be notified of that fact as soon as practicable after the failure becomes known to the Board.

    (2) A failure to comply with section 236 does not affect the validity of the relevant act or matter, but the Authority may avoid the act in accordance with section 240.

    (3) Subsection (1) does not limit the right of any person to apply for judicial review.

    Compare: 2004 No 115 s 67(2), (3); Commonwealth Authorities and Companies Act 1997 ss 27F(4), 27G(7), 27J(4) (Aust)

240 Authority may avoid some acts done in breach of conflict of interest rules
  • (1) This section applies if the Ministerial Council is notified under section 239(1) of a Board member's failure to comply with section 236.

    (2) Within 3 months of the notification, the Authority may avoid the act, if the Authority did not receive fair value for the act.

    (3) The Authority has the onus of establishing that it did not receive fair value.

    (4) However, a person seeking to prevent the act from being avoided has the onus of establishing that the Authority received fair value for the act, if at the time of the act the person knew, or ought reasonably to have known, of the Board member's interest.

    (5) Whether the Authority receives fair value for an act must be determined on the basis of the information known to the Authority and to the interested Board member at the time the act is done.

    (6) However, the Authority is presumed to receive fair value for the act if the Authority did it in the ordinary course of its business and on usual terms and conditions.

    (7) The avoidance of the act does not affect a person's title to, or interest in, property that the person acquired—

    • (a) from a person (person B) other than the Authority; and

    • (b) for valuable consideration; and

    • (c) without knowledge of the circumstances of the act under which person B acquired the property from the Authority.

    (8) An act in which a Board member is interested may be avoided on the ground of the member's interest only under this section.

    Compare: 2004 No 115 ss 69(1)–(3), 70(1), 70(2), 71(1), 71(2), 72

Duties of senior officers

241 Duties apply regardless of where senior officer located
  • The duties of senior officers that are set out in sections 242 to 246 apply to every act or omission of a senior officer, while acting as such, wherever the officer is located at the time of the act or omission.

242 Duty to act with honesty and integrity
  • A senior officer must, when acting as a senior officer, act with honesty and integrity.

    Compare: 2004 No 115 s 54

243 Duty to comply with Acts and Rules
  • A senior officer must not contravene, cause the contravention of, or agree to the Authority contravening, Parts 1 to 5, the Australian Act, or the Rules.

    Compare: 2004 No 115 s 53

244 Duty of care, diligence, and skill
  • (1) A senior officer must, when acting as such, exercise his or her powers and discharge his or her duties with the degree of care, diligence, and skill that a reasonable person would exercise—

    • (a) in those circumstances; and

    • (b) if he or she held the position, and had the same responsibilities, as the officer.

    (2) For the purposes of this section, a senior officer who makes a business judgment is taken to meet the requirements of subsection (1), and his or her equivalent duties at common law and in equity, in respect of the judgment if he or she—

    • (a) makes the judgment in good faith for a proper purpose; and

    • (b) does not have material personal interest in the subject matter of the judgment; and

    • (c) informs himself or herself about the subject matter of the judgment to the extent he or she reasonably believes to be appropriate; and

    • (d) rationally believes that the judgment is in the best interests of the Authority.

    (3) The senior officer's belief that the judgment is in the best interests of the Authority is a rational one unless the belief is one that no reasonable person in his or her position would hold.

    (4) In this section, business judgment means any decision to take or not to take action in respect of a matter relevant to the Authority.

    Compare: 2004 No 115 s 56; Commonwealth Authorities and Companies Act 1997 s 22 (Aust)

245 Duties of good faith, etc
  • (1) A senior officer must exercise his or her powers and discharge his or her duties—

    • (a) in good faith; and

    • (b) for a proper purpose.

    (2) A senior officer must not pursue his or her own interests at the expense of the Authority's interests.

    (3) A senior officer must not use his or her position as a senior officer to—

    • (a) gain an improper advantage for himself, herself, or another person; or

    • (b) cause a detriment to the Authority.

    Compare: 2004 No 115 s 55; Commonwealth Authorities and Companies Act 1997 ss 23, 24 (Aust)

246 Duty not to misuse information
  • (1) A senior officer or former senior officer who has information solely as a result of being or having been a senior officer, must not disclose, use, or act upon the information except—

    • (a) in the performance of the Authority's functions; or

    • (b) as required or permitted by law; or

    • (c) in complying with a requirement to disclose his or her interests.

    (2) A senior officer or former senior officer may disclose, make use of, or act upon information if—

    • (a) the senior officer or former senior officer is first authorised to do so by the Board; and

    • (b) the disclosure, use, or act in question will not, or will not be likely to, prejudice the Authority.

    Compare: 2004 No 115 s 57; Commonwealth Authorities and Companies Act 1997 s 25(1) (Aust)

Criminal consequences of failing to comply with duties

247 Offences relating to failure to comply with certain duties
  • (1) A senior officer commits an offence if he or she intentionally or recklessly fails to exercise his or her powers and discharge his or her duties—

    • (a) in good faith; or

    • (b) for a proper purpose.

    (2) A senior officer commits an offence if he or she pursues his or her own interests at the expense of the Authority's interests.

    (3) A person who has information solely as a result of being, or having been, a senior officer commits an offence if he or she intentionally discloses, uses, or acts upon the information in breach of section 246, knowing that the disclosure, use, or action is in breach of section 246.

    (4) A person who commits an offence under this section is liable, on conviction on indictment, to a term of imprisonment of not more than 5 years, a fine of not more than 300 penalty units, or both.

    Compare: Commonwealth Authorities and Companies Act 1997 s 26(1), (2), (3) (Aust)

248 Requirement to provide information in connection with criminal proceedings
  • (1) The Finance Minister may, by notice in writing, require a person to give all reasonable assistance in connection with criminal proceedings under section 247.

    (2) The requirement may be made only if—

    • (a) the Finance Minister believes on reasonable grounds that the person has information that is relevant to the proceedings; and

    • (b) the person is not, or is not likely to be, a defendant in any criminal proceedings under section 247; and

    • (c) the person is not an employee, agent (including banker or auditor), or business partner of a person who is, or is likely to be, a defendant in the proceedings; and

    • (d) the person is not a lawyer who has acted for the defendant, or likely defendant, in any current or previous criminal or civil penalty proceedings under this Part; and

    • (e) the information that the Finance Minister believes the person has cannot be readily obtained by any other means or from any other person.

    (3) The Finance Minister may require the person to give all reasonable assistance, whether or not criminal proceedings have commenced.

    (4) The High Court may, on application by the Finance Minister, order a person to comply with a requirement under this section in a specified way.

    (5) Information provided pursuant to a requirement under this section may not be used in any proceedings as evidence against the person who provided the information, except in criminal proceedings in respect of the falsity of information provided by the person.

    Compare: Commonwealth Authorities and Companies Act 1997 Schedule 2 cl 13 (Aust)

Civil consequences of failing to comply with duties

249 Application for civil penalty
  • The Minister or the Finance Minister may apply to the High Court for an order requiring a senior officer or former senior officer to pay a civil penalty.

250 Imposition of civil penalty
  • (1) The High Court may make the order to pay a civil penalty if it is satisfied that—

    • (a) the senior officer or former senior officer breached any of the duties referred to in sections 243 to 246; and

    • (b) the breach—

      • (i) materially prejudices the interests of the Authority; or

      • (ii) materially prejudices the Authority's ability to pay its creditors; or

      • (iii) is serious.

    (2) The civil penalty may be any amount up to 2 000 penalty units.

    (3) The amount of civil penalty is payable to the Crown.

    Compare: Commonwealth Authorities and Companies Act 1997 Schedule 2 cls 3, 14(2) (Aust)

251 When and how civil penalty proceedings brought
  • (1) An application for a civil penalty may be made no later than 6 years after the alleged breach.

    (2) In proceedings for a civil penalty under this Part—

    • (a) the standard of proof is the standard of proof that applies in civil proceedings; and

    • (b) the Authority may, by order of the High Court, obtain discovery and administer interrogatories.

    Compare: 1996 No 30 s 12E

252 Authority involvement in proceedings
  • In any proceedings under this Part for a civil penalty, the Authority is entitled to intervene and be heard on all matters other than whether an order for a civil penalty should be made.

    Compare: Commonwealth Authorities and Companies Act 1997 Schedule 2 cl 6(3) (Aust)

253 Relief from liability in civil penalty proceedings under section 249
  • (1) If civil penalty proceedings are commenced against a person under section 249, the High Court may relieve the person, either wholly or partly, from a liability to which the person would otherwise be subject if—

    • (a) it appears to the Court that the person has or may have breached any duty referred to in sections 243 to 246; but

    • (b) the person has acted honestly and, having regard to all the circumstances of the case, the person ought fairly to be excused of the breach.

    (2) If a person who thinks that civil penalty proceedings relating to a breach or possible breach of any duty in sections 243 to 246 will or may be commenced against him or her, the person may apply to the High Court for relief under subsection (1) on the grounds set out in paragraph (b) of that subsection.

    (3) On application under subsection (2), the High Court may grant prospective relief from liability as if proceedings had been commenced against the applicant.

254 Requirement to provide information in connection with civil penalty proceedings
  • (1) The Finance Minister may, by notice in writing, require a person to give all reasonable assistance in connection with an application for a civil penalty under this Part.

    (2) A person may be required to assist only if—

    • (a) it appears to the Finance Minister that someone other than the person required to assist may be liable to a civil penalty under this Part; and

    • (b) the Finance Minister suspects or believes that the person required to assist can give information relevant to the application; and

    • (c) the person is not, and has not been, a lawyer for the person in respect of whom the application is made.

    (3) A requirement to assist may be made whether or not an application for a civil penalty has been made.

    (4) On application by the Finance Minister, the High Court may order a person who has been required under this section to assist to provide that assistance.

Disqualification for breach of duty

255 Disqualification for breach of duty
  • (1) The Finance Minister may apply to the High Court for a disqualification order against a senior officer or former senior officer.

    (2) A disqualification order must disqualify the person from being a Board member and may also do all or any of the following:

    • (a) disqualify the person from being a director or promoter of a company in New Zealand:

    • (b) prohibit the person from being in any way, directly or indirectly, concerned in the management of a company in New Zealand:

    • (c) disqualify the person from being a member of any Crown entity (as defined in section 10(1) of the Crown Entities Act 2004).

    (3) A disqualification order must specify the period or periods to which the disqualifications or prohibitions apply, which may be for no longer than 10 years.

    (4) The High Court may make a disqualification order if the Court is satisfied that the disqualification order is justified and—

    • (a) a civil penalty has been imposed on the person under this Part; or

    • (b) a declaration of breach has been made against the person in Australia.

    (5) In determining whether the disqualification order is justified, and the period for which it is imposed, the High Court may have regard to—

    • (a) the person's conduct in relation to the management, business, or property of the Authority and any other body corporate; and

    • (b) any other matters that the Court considers appropriate (such as, for example, matters mentioned in section 383 of the Companies Act 1993).

    (6) A person who breaches a disqualification order commits an offence and is liable, on conviction on indictment, to a term of imprisonment of not more than 5 years, a fine of not more than 2 000 penalty units, or both.

    Compare: 1993 No 105 s 383; Commonwealth Authorities and Companies Act 1997 s 27C (1)–(4) (Aust)

256 Application to quash or amend disqualification order
  • (1) A person who is subject to a disqualification order under section 255 may apply to the High Court for the order to be quashed or amended.

    (2) The High Court may not consider an application under this section unless it is satisfied that the Finance Minister has had at least 21 days' notice of the application.

    (3) The High Court may quash or amend an order made under section 255.

    (4) No amendment to a disqualification order may—

    • (a) extend the period for which a disqualification or prohibition applies; or

    • (b) add a disqualification or prohibition that was not included in the original order.

257 Effect of disqualification under Australian Act
  • (1) A person who is subject to a disqualification order under the Australian Act is disqualified from appointment to the Board of any Crown entity (as defined in section 10(1) of the Crown Entities Act 2004).

    (2) A person who is subject to a disqualification order under the Australian Act commits an offence if the person—

    • (a) is a director or promoter of a company in New Zealand; or

    • (b) is in any way, directly or indirectly, concerned in the management of a company in New Zealand.

    (3) A person who commits an offence under subsection (2) is liable, on conviction on indictment, to a term of imprisonment of not more than 5 years, a fine of not more than 2 000 penalty units, or both.

Compensation orders

258 Compensation order
  • (1) The Authority, or the Finance Minister on behalf of the Authority, may apply to the High Court for a compensation order against a senior officer or former senior officer.

    (2) The High Court may order a senior officer or former senior officer to compensate the Authority for damage suffered by the Authority if the Court is satisfied that—

    • (a) the person has breached any of the duties referred to in sections 243 to 246; and

    • (b) the Authority suffered damage as a result of that breach.

    (3) The order must specify the amount of compensation payable to the Authority.

    (4) In determining the amount of compensation payable, the High Court may take into account any profits made by any person as a result of the breach.

    (5) To avoid doubt,—

    • (a) proceedings for a compensation order are in addition to, and not in substitution for, any other cause of action; and

    • (b) a compensation order may not be made in the course of any criminal proceedings for a breach of duty.

    Compare: Commonwealth Authorities and Companies Act 1997 Schedule 2 cls 4, 5, 6(1), (2) (Aust)

259 When application for compensation order may be made
  • An application for a compensation order may be made no later than 6 years after the alleged breach.

    Compare: Commonwealth Authorities and Companies Act 1997 Schedule 2 cl 7 (Aust)

Civil liability of others involved

260 Others involved in breach of certain senior officer duties
  • (1) A person who is involved in the breach by a senior officer of any of the duties specified in section 245 or 246 is liable, as if he or she were the senior officer who breached the duty, to any of the following:

    • (a) a civil penalty under this Part:

    • (b) a disqualification order under section 255:

    • (c) a compensation order under section 258.

    (2) For the purposes of this section, a person is involved in a breach of a senior officer's duties if he or she—

    • (a) aids, abets, counsels, or procures the breach; or

    • (b) induces the breach, whether by threats, promises or otherwise; or

    • (c) in any way, by act or omission, directly or indirectly, is knowingly concerned in or party to the breach; or

    • (d) conspires with others to effect the breach.

    (3) Sections 261 and 262 are available to a person charged under this section in the same way that they are available to senior officers.

    Compare: Commonwealth Authorities and Companies Act 1997 ss 6 (definition of “involved”), 24(2), 25(2) (Aust)

Defence in criminal or civil penalty proceedings

261 Defence to rely on information and advice
  • (1) This section applies for the purpose of any criminal or civil penalty proceedings under this Part against a senior officer or former senior officer for breach of duty.

    (2) A senior officer, when acting as such, may rely on reports, statements, financial data, and other information prepared or supplied, and on professional or expert advice given, by any of the following persons:

    • (a) an employee of the Authority whom the senior officer believes on reasonable grounds to be reliable and competent in relation to the matters concerned:

    • (b) a professional adviser or expert in relation to matters that the senior officer believes on reasonable grounds to be within the person's professional or expert competence:

    • (c) any other senior officer in relation to matters within the senior officer's designated authority:

    • (d) a Board committee on which the senior officer did not serve, in relation to matters within the Board committee's designated authority.

    (3) A senior officer, when acting as a senior officer, may rely on reports, statements, financial data, and other information supplied by the New Zealand Government or the Australian Commonwealth Government.

    (4) This section applies to an officer only if the senior officer—

    • (a) acts in good faith; and

    • (b) makes proper inquiry if the need for inquiry is indicated by the circumstances; and

    • (c) has no knowledge that the reliance is unwarranted.

    Compare: 2004 No 115 s 61

General relief from civil liability

262 Relief from civil liability
  • (1) If civil proceedings are commenced against a senior officer or former senior officer for negligence, default, breach of trust, or breach of duty in a capacity as such an officer, the court before which the proceedings are taken may relieve the person, either wholly or partly, from a liability to which the person would otherwise be subject, if—

    • (a) it appears to the court that the person is or may be liable in respect of the negligence, default, or breach; but

    • (b) the person has acted honestly and, having regard to all the circumstances of the case (including those connected with the senior officer's appointment), the person ought fairly to be excused for the negligence, default or breach.

    (2) If a person who thinks that civil proceedings relating to negligence, default, breach of trust, or breach of duty in his or her capacity as a senior officer will or may be commenced against him or her, the person may apply to the High Court for prospective relief from liability.

    (3) On an application under subsection (2), the High Court may grant prospective relief from liability if it is satisfied of the matters referred to in subsection (1)(a) and (b).

Restriction on use of evidence

263 Restriction on use of evidence given in proceedings for civil penalty
  • (1) Evidence of information given, or evidence of production of documents, by a person is not admissible in criminal proceedings against the person for an offence under this Part or any other enactment if—

    • (a) the person previously gave the evidence or produced the documents—

      • (i) in civil penalty proceedings in New Zealand under this Part against him or her, whether or not a civil penalty was imposed; or

      • (ii) in proceedings in Australia under the Australian Act against him or her for a declaration of breach or a pecuniary penalty order, whether or not the declaration or order was made; and

    • (b) the proceedings related to conduct that was the same or substantially the same as the conduct constituting the offence.

    (2) This section does not apply to criminal proceedings in respect of the falsity of the evidence given by the person in proceedings for a civil penalty.

Relationship between criminal and civil penalty proceedings

264 Civil penalty proceedings in New Zealand after proceedings in Australia for pecuniary penalty
  • (1) No proceedings for a civil penalty under this Part may be commenced against a person in relation to particular conduct if—

    • (a) proceedings against the person for a declaration of breach or for a pecuniary penalty under the Australian Act are underway, or have been completed, in Australia; and

    • (b) the proceedings relate or related to the same or substantially the same conduct that was to be the subject of the proceedings in New Zealand.

    (2) To avoid doubt, this section does not prevent subsequent proceedings in New Zealand for a civil penalty if earlier proceedings for a declaration of breach or for a pecuniary penalty in Australia have been discontinued.

265 Criminal proceedings in New Zealand after criminal proceedings in Australia
  • (1) No criminal proceedings for an offence under this Part may be commenced against a person in relation to particular conduct if—

    • (a) criminal proceedings against the person for an offence under the Australian Act are underway, or have been completed, in Australia; and

    • (b) the proceedings relate or related to the same or substantially the same conduct that was to be the subject of the proceedings in New Zealand.

    (2) To avoid doubt, this section does not prevent subsequent criminal proceedings in New Zealand if earlier criminal proceedings in Australia have been withdrawn.

266 Relationship between concurrent civil penalty proceedings and criminal proceedings
  • (1) Criminal proceedings for an offence under this Part may be commenced against a person in relation to particular conduct whether or not—

    • (a) proceedings in New Zealand for a civil penalty under this Part have been commenced against the person in relation to the same or substantially the same conduct; or

    • (b) proceedings in Australia for a declaration of breach or for a pecuniary penalty under the Australian Act have been commenced against the person in relation to the same or substantially the same conduct.

    (2) Proceedings under this Part for a civil penalty against a person in relation to particular conduct are stayed if—

    • (a) criminal proceedings in New Zealand against the person are or have been commenced for an offence under this Part in relation to the same or substantially the same conduct; or

    • (b) criminal proceedings in Australia against the person are or have been commenced for an offence under the Australian Act in relation to the same or substantially the same conduct.

    (3) After the criminal proceedings referred to in paragraphs (a) or (b) of subsection (2) have been completed or withdrawn, a person may apply to have the stay lifted on the civil penalty proceedings referred to in that subsection.

267 Effect of withdrawal or discontinuation of proceedings on limitation period
  • (1) This section applies if—

    • (a) proceedings against a person have been commenced in Australia in relation to certain conduct, and the proceedings are then withdrawn or discontinued; and

    • (b) an application is subsequently made, or proceedings are subsequently commenced, in New Zealand against the person in relation to the same or substantially the same conduct for an offence or civil penalty under this Part.

    (2) If this section applies, the period between the commencement of the Australian proceedings and the date on which they were withdrawn or discontinued is not to be included when determining whether the New Zealand application or proceedings are brought within the limitation period applying to the application or proceedings.

    (3) For the purposes of subsection (2), limitation period means the period during which criminal proceedings must be commenced under this Part or during which an application must be made under section 249 for a civil penalty or section 258 for a compensation order.

268 Abuse of process jurisdiction not affected
  • To avoid doubt, nothing in sections 264 to 267 affects the abuse of process jurisdiction of any court.

Part 5
Regulations, and transitional and miscellaneous provisions

Subpart 1Regulations

269 Regulations providing for departures from the Scheme
  • (1) The Governor-General may, by Order in Council, make regulations providing for departures from the Scheme by New Zealand in respect of a specified therapeutic product or class of therapeutic products (in this section referred to as excluded products), as provided for in Article 12 of the Agreement.

    (2) Regulations made under this section must provide an alternative way of regulating all or specified excluded products. For that purpose, the regulations may (without limitation) do any of the following:

    • (a) exclude or modify the application of the Scheme in respect of excluded products:

    • (b) prescribe procedures and requirements for approving the manufacture, supply, import, export, or promotion of all or specified excluded products:

    • (c) require the payment of fees and charges for any approval, or for other functions relating to all or specified excluded products, and prescribe those fees and charges:

    • (d) prescribe the circumstances in which, or conditions under which, all or specified excluded products may or may not be manufactured, supplied, imported, exported, or promoted:

    • (e) apply the offence, civil penalty, and enforcement provisions of Parts 1 to 5 to all or specified excluded products as if they were regulated under the Scheme:

    • (f) require certain information to be kept, provided, or published concerning all or specified excluded products:

    • (g) require samples of all or specified excluded products, materials, or other things to be retained:

    • (h) provide that authoritative standards (such as the British Pharmacopeia) may be used in relation to all or specified excluded products:

    • (i) provide for the Minister to prescribe details of the regulatory regime by notice in the Gazette. Such details include (but are not limited to) the following:

      • (i) recognising the regulatory approvals granted by regulators in other countries:

      • (ii) identifying the information that must be kept, provided, or published:

      • (iii) identifying the therapeutic products, materials, or other things that must be retained:

    • (j) provide for the delegation by the Minister of any powers or functions of the Minister under regulations made for the purpose of this subsection:

    • (k) provide for the transition of all or specified excluded products to or from regulation under the Scheme.

270 Regulations for fees and charges for non-Scheme work
  • The Governor-General may, by Order in Council, make regulations requiring the payment to the Authority of specified fees and charges for any functions performed by the Authority that fall outside the scope of the Scheme.

271 Transitional and savings regulations
  • (1) The Governor-General may, by Order in Council, make temporary or transitional regulations, not inconsistent with Parts 1 to 5 and the Agreement, that are necessary or expedient to fully implement the Scheme in New Zealand.

    (2) Regulations made under this section may include, without limitation, any or all of the following:

    • (a) the savings of provisions, or the effect of provisions, of the former Act and any other enactment, as applied to particular products, persons, conduct, or things, for a specified period:

    • (b) the waiving of the application of specified provisions of any enactment or the Rules or Orders to particular products, persons, conduct, or things during a specified period:

    • (c) the imposition, modification, and revocation of conditions applying to particular products, persons, conduct, or things, during a specified period.

    (3) Every regulation made under this section must be stated to expire on a particular date.

272 General regulation-making power
  • The Governor-General may, by Order in Council, make regulations for all or any of the following purposes:

    • (a) prescribing the form of search warrant issued under Part 2;

    • (b) providing for such other matters as are contemplated by, or necessary for, giving full effect to Parts 1 to 5 or their due administration.

Subpart 2Transitional provisions relating to Scheme

Preliminary

273 Outline of transitional regime
  • (1) The general scheme and effect of the transitional provisions in this subpart are as follows:

    • (a) before the start date, the Authority will be established under the Australian Act. One of the functions of the Authority is to grant approvals (in this subpart called Scheme approvals) that have effect in both Australia and New Zealand:

    • (b) there will be an establishment period before the start date, which will (among other things) allow Rules and Orders to be made:

    • (c) on the start date, the legislative regime in New Zealand concerning therapeutic products (the former regime) will be replaced with the Scheme, which includes Parts 1 to 5 and the Rules and Orders:

    • (d) to facilitate the smooth transition from the former regime to the Scheme, and to give effect to Article 21 of the Agreement (which deals with transitional provisions),—

      • (i) transitional approval will be deemed to have been granted in substitution for all existing consents, existing approvals, and existing licences; and

      • (ii) transitional approvals will be deemed to have been granted for certain other activities that were lawful before the start date and that relate to dietary supplements, medical devices, and certain other products such as radiopharmaceuticals; and

      • (iii) transitional approvals may be granted by the Authority for pending applications, in which case they will be granted on the same basis that applied under the former regime:

    • (e) a transitional approval lasts for not more than the transition period that applies to it, and has effect only in New Zealand. Before a transitional approval expires, the holder will need to apply for, and obtain, a Scheme approval if the holder wishes to lawfully continue doing the activity that the transitional approval authorised:

    • (f) in general terms, a transitional approval for a therapeutic product will be on the terms and conditions (if any) that applied to the therapeutic product before the Scheme started:

    • (g) Rules will identify which provisions of the former Act (and any regulations made under that Act) apply to which transitional approvals, and also which (if any) Rules, Orders, and provisions of Parts 1 to 5 apply in connection with different transitional approvals.

    (2) This section is by way of explanation only. If a provision of Parts 1 to 5, the Agreement, or the Rules or Orders conflicts with this section, the other provision prevails.

274 Definitions of terms used in this subpart
  • In this subpart, unless the context otherwise requires,—

    applicable Rules means Rules (and any Orders applied by those Rules) that—

    • (a) apply to, or in connection with, transitional approvals or transitional approvals of specified kinds; and

    • (b) are designated as applicable Rules in Rules made under subparagraph (jj) of paragraph 1 of Article 9 of the Agreement

    dietary supplement means a product that,—

    • (a) immediately before the start date, is a dietary supplement as defined in the Dietary Supplements Regulations 1985; and

    • (b) on the start date, is a therapeutic product

    establishment period means the period that—

    • (a) starts on the date that the Authority is established under the Australian Act; and

    • (b) ends on the start date

    evaluation work, in relation to a pending application, means either or both of the following:

    • (a) the Minister considering and weighing the matters referred to in section 22(1) of the former Act:

    • (b) the appropriate committee considering the matter under section 22(2) of the former Act

    existing approval means an approval of the Minister given under section 24D of the former Act and in effect immediately before the start date

    existing consent means any of the following consents that were in effect immediately before the start date:

    • (a) a consent of the Minister given under section 20 of the former Act:

    • (b) a provisional consent of the Minister given under section 23 of the former Act:

    • (c) a consent of the Director-General given under section 24(3) of the former Act

    existing licence means a licence to manufacture medicines, or a licence to pack medicines, that was granted under section 51 of the former Act and in effect immediately before the start date

    former Act means the Medicines Act 1981 as in force immediately before its repeal by the Medicines Act 2006

    former regulations means regulations made under the former Act, as those regulations are in force immediately before the repeal of that Act

    medical device means a product that,—

    • (a) immediately before the start date, is a medical device as defined in section 2(1) of the former Act; and

    • (b) after the start date, is a therapeutic product

    medicine means a product that,—

    • (a) immediately before the start date, is a medicine as defined in section 2(1) of the former Act; and

    • (b) after the start date, is a therapeutic product

    newly designated therapeutic product means a product that,—

    • (a) immediately before the start date, is not a medicine or medical device (as defined in section 2(1) of the former Act) or a dietary supplement (as defined in the Dietary Supplements Regulations 1985); but

    • (b) after the start date, is a therapeutic product

    pending application means an application that was made under the former Act but not determined before the start date

    related product means a product that,—

    • (a) immediately before the start date, is a related product as defined in section 94 of the former Act; and

    • (b)