Clause 8 describes the products that the regulatory scheme would cover. It states that therapeutic products are divided into 4 types (medicines, medical devices, APIs, and NHPs) and provides examples of each type of product. Clause 8(3)(b) includes diagnostic software as an example of a medical device.

Point-of-care testing is medical laboratory testing that is performed in a range of settings. Examples include urine pregnancy test kits, finger stick blood glucose meters, and rapid antigen tests for COVID-19. We understand that some point-of-care testing devices contain software that is separate from the device. We recommend amending the reference to “diagnostic software” in clause 8(3)(b) to apply to cellphone-based diagnostic software.

Clause 9 provides that therapeutic products, excluding APIs, would be regulated by market authorisations. Clause 9(2) states that, generally, a medicine, medical device, or NHP cannot be imported, supplied, or exported unless it has a market authorisation. Clause 67(2) specifies the exemptions to this. They apply if a licence, permit, or provision of subpart 3 of Part 3 allows the person to do so or if the product is a low concentration NHP.

We recommend inserting clause 9(5A) to reflect that some activities involving unauthorised products would be allowed under the legislation. Our proposed amendment provides examples of when unauthorised products could be imported, supplied, or used.

Under clause 9(3)(c), to obtain a market authorisation for an NHP, an applicant would need to satisfy the Regulator about its safety and quality. We have recommended above an amendment to clause 3(c) to include the substantiation of health benefit claims for NHPs as a purpose of the bill. We recommend a similar amendment to clause 9(3)(c) to require an applicant to satisfy the Regulator that the proposed claims about the health benefits of an NHP are substantiated.

Clause 16 provides that a therapeutic product would be any product that was intended for use in, on, or in relation to humans for a therapeutic purpose (these purposes are listed in clause 15). Clause 16 also enables regulations to be made to include and exclude products from the regime.

We were advised that, if the bill is enacted, regulations would be made to clarify that a food regulated under the Food Act would not be a therapeutic product. This would allow flexibility because some products regulated under that Act may need to be regulated as NHPs or medicines in the future.

Many submitters requested that the bill provide more clarity, particularly when distinguishing between foods and products that are regulated under the legislation. We agree that certainty is important to enable effective policy and regulatory decisions where multiple regimes interact, as with food and NHPs. On balance, we think certainty rather than flexibility is needed for clause 16. We therefore recommend inserting clause 16(2A), which would exclude products for which there is a standard (within the meaning of section 4(1) of the Food Standards Australia New Zealand Act 1991). However, regulations could be made under clause 16(1) to include a product by declaring that it was a therapeutic product.

Clause 25 relates to medical devices that are personalised for particular patients. They are divided into three groups depending on the degree of personalisation and how they are produced: adaptable devices, patient-matched devices, or custom-made devices.

Clause 25 also defines a “device production system”. It is a system (consisting of hardware, software, and the raw materials used in producing devices) intended to be used in health care settings to produce a patient-matched device at the point of care.

Several submitters considered that the definitions in clause 25 were too narrow and did not necessarily reflect current thinking regarding clinical and technical considerations. They suggested that the definition should be moved to secondary legislation to enable more flexibility and to align with appropriate competent authorities and globally recognised standards.

We recognise that primary legislation must be clear to ensure that secondary legislation is appropriately empowered. However, this must be balanced against the need to maintain flexibility by having the ability to amend the definitions. We agree that the bill should be amended to enable more flexible definitions of the terms to be set in secondary legislation. Therefore, we recommend including a rule-making power in clause 25 to allow for the Regulator to:

• specify subcategories of each type of personalised device in rules

• declare specific products to be in one of the categories in clause 25(1)(a) to (c)

• declare that specific products are not personalised medical devices or device production systems.

Clause 26 defines “software as a medical device” (SaMD). It is software that meets the definition of a therapeutic product without any associated hardware (other than an unrelated device that is needed solely to present a user interface). An example of SaMD is computer-aided detection (CAD) software that performs image processing to help detect breast cancer.

Some submitters suggested that the bill should distinguish between software as a medical device and software in a medical device (SiMD). They noted that several other jurisdictions recognise this distinction. SiMD does not treat, prevent, or alleviate medical conditions, injuries, and diseases; nor does it sustain life, or investigate physiological processes. Instead, it facilitates communications between a patient and doctor. SiMD also poses no more risk of harm to patients that any other applications that are used to facilitate remote interactions.

We understand that secondary legislation will be developed to specify detailed regulations and rules for SaMD if the bill is enacted. They would be based on international best practice for regulating the different phases of software development. However, we recommend several amendments to the bill to clarify what is not intended to be captured under these provisions. We recommend amending clause 26(4) to make it clear that SiMD is not intended to be captured in this clause. We also recommend amending clause 26(5) to include a rule-making power to enable the Regulator to determine criteria and thresholds for when a therapeutic product would be regulated as SaMD.

Under clause 29, a therapeutic product is an NHP if it consists only of 1 or more of the NHP ingredients listed in clause 30 and permitted additives or formulation aids. Clause 30 defines “NHP ingredient”, “recognised NHP ingredient”, and “additive or formulation aid”.

Clause 30(1)(b) specifies that an NHP ingredient is a substance or mixture of substances that:

• is obtained by expression, extraction, distillation, purification, or a traditional preparation of anything referred to in paragraph (a) (clause 30(1)(b)(ii))²

• is not subject to any other process involving chemical transformation other than hydrolysis or electrolysis (clause 30(1)(b)(ii)).

Some submitters expressed concern that this clause would not allow for emerging manufacturing innovations. We agree that the bill should be amended to enable rules to be made to allow for permitted forms of chemical transformations other than hydrolysis or electrolysis. We recommend amending clause 30(1)(b)(ii) accordingly.

Clause 32 provides that a medicine, medical device, or an API would be a biologic if it contained:

• human or non-human cells (including blood, tissues, and whole organs) and subcellular components of them (clause 32(2)(a))

• micro-organisms (including bacteria, viruses, and mycoplasma) and components of them (clause 32(2)(b))

• material that is derived from anything referred to in paragraph (a) or (b) (whether modified, engineered or otherwise) (clause 32(2)(c))

• anything that is synthesised or manufactured for the purpose of having the same effect as anything referred to in paragraph (a) or (b) (clause 32(2)(d)).

We consider that the Regulator should be able to make determinations in situations where it is unclear whether a product is a biologic. We recommend inserting clause 32(2B), which would enable the Regulator to set rules to do so.

Clause 37 defines compounding a medicine as producing a quantity of it ready for supply to a specific patient in response to a specific request for that supply. Clause 37(3) provides that a medicine would require compounding if it did not have a market authorisation and needed to be compounded by a pharmacist for each patient. Clause 76 sets out the circumstances in which a pharmacist would be allowed to compound medicines.

We understand that compounding is an important and routine activity in the healthcare system. It is used when a patient needs a medication that is not commercially available or when they have unique medical needs. Examples of needs include allergies or difficulty swallowing medication in its standard form.

Several submitters believed this clause was too restrictive because it did not allow for situations where medicines may need to be compounded in advance of a prescription request. They noted that the ability to compound in advance is useful for preparing ward stock in hospitals, paediatric formulations, and items with high turnover. One submitter suggested that, for items where there is a known constant demand, a pharmacy should be allowed to compound ahead of receiving an individual request. It considered that this would prevent delay in patient treatment.

We acknowledge that it is important to enable some degree of compounding to continue under the new legislation. However, we believe it is equally important to create a structure that prevents manufacturers and pharmacists from undermining the overall integrity of the legislation by providing large quantities of compounded medicines. We consider that this objective could be achieved by specifying rules under clause 72 (Person in supply chain must comply with rules) about when, how, and who could compound.

We recommend amending clause 76 to allow anticipatory compounding and compounding of standard solutions to occur in certain situations. They would be before receiving a request for supply for a specific patient in anticipation of a request, or in circumstances permitted via rules.

Clause 38 defines dispensing a medicine as bringing it to a state ready for immediate supply to a specific patient.

We note that pharmacists perform a number of clinical checks before they dispense medication to patients. They include ensuring that patients receive the correct medication at the correct dose, checking for possible medicine interactions, and liaising with prescribers about dose and medication changes. We recommend amending clause 38 by specifying examples of the steps that might be involved in dispensing.

Clause 60 lists the matters that the Regulator would need to consider when determining whether a person (person A) was a fit and proper person for the purposes of a particular provision of the legislation. Clause 60(2) provides that references to person A in clause 60(1)(a) to (g) include a reference to each person who is or has been their senior manager. It also includes a person of whom person A is or has been a senior manager.

We understand that current and former senior managers are included in the evaluation because they may significantly affect the management and operations of a company. This would include being involved in decisions about manufacturing, distributing, and promoting therapeutic products. Excluding current and former senior managers from the evaluation could therefore create a gap in the Regulator’s ability to ensure product safety. Further, the Regulator needs to have regard to matters relating to current and former senior managers. However, the Regulator would not be bound to determine that their conduct disqualified a company from being deemed a fit and proper person.

To reduce the risk of clause 60(2) becoming unworkable, we consider that this provision should be limited to a period of 7 years before the date of the application. We recommend amending this clause accordingly.

Clause 61 defines the terms “health benefit claim” and “permitted health benefit claim”. Clause 192 provides that the sponsor of an NHP would only be allowed to make permitted health benefit claims about the NHP. A claim about an NHP is a health benefit claim if it states or implies that the product is beneficial for a therapeutic purpose. For an NHP with a market authorisation, a permitted health benefit claim means a standard health benefit claim for the NHP identified in the market authorisation. It also means a custom health benefit claim set out in the market authorisation. A permitted health benefit claim for an NHP that does not have a market authorisation means a standard health benefit claim for the NHP.

Under clause 61(4), a health benefit claim about an NHP may be substantiated by scientific evidence, evidence of traditional use, or both. We consider that claims about NHPs should not be permitted if there is no scientific evidence or evidence of traditional use. We therefore recommend amending this clause by replacing “may” with “must”.

Clause 61(5) states that information about the traditional use of a product or ingredient that is in a pharmacopeia listed in the regulations is prima facie (on the face of it) evidence of that use. We understand that the pharmacopeia would be developed in regulations that would be consulted on.

Some submitters requested that all evidence from recognised pharmacopeia be accepted. We note, however, that this could be problematic if a recognised pharmacopeia contained statements that recent evidence disputed and the pharmacopeia had not been updated. Accordingly, we recommend amending clause 61(5) to specify that information about the traditional use of a product or ingredient that is in a pharmacopeia listed in the regulations would be sufficient evidence. However, this would not apply if there was recent traditional evidence to the contrary for the particular traditional ingredient or product.

Clause 62 provides for the rules setting out the health benefit claims that could be made about NHPs. We understand that the details for a business to substantiate health benefit claims itself using scientific evidence would also be set in rules. We recommend amending clause 62 to enable businesses to substantiate a relationship between an NHP or NHP ingredient against a pre-approved list of health benefits and qualifiers that are set out in rules. Rules would also set out any requirements for self-substantiation.

A range of provisions in the bill would enable a health practitioner or veterinarian to undertake certain controlled activities with a medicine or medical device that did not have an NZ authorisation. Satisfying the special case requirement in clause 65 would be one of the conditions for doing so.

Clause 65(2) sets out when the special case requirement would be met. The health practitioner or veterinarian would need to be satisfied that there was no available medicine with an NZ authorisation that was suitable to meet the clinical needs of the patient. They would also need to be satisfied that it was appropriate to carry on the activity with the medicine or device that did not have an NZ authorisation.

Clause 65(3) states that, for the purposes of subsection (2)(b), the health practitioner or veterinarian must have regard to any criteria or requirements in the regulations. The Regulations Review Committee noted that the phrases “have regard to” and “requirements” are contradictory. It pointed out that a “requirement” is something that a person must do. However, the clause would only require the health practitioner to “have regard to it”, which does not have an element of compulsion. The committee recommended that we clarify whether the intent of clause 65(3) is for health practitioners and veterinarians to “have regard to criteria” or “meet requirements” in the regulations. It also recommended that we amend the bill to more clearly reflect the intent.

We understand that clause 65 is intended to work with professional standards set under the Health Practitioners Competence Assurance Act and secondary legislation. This would provide criteria and other requirements that a practitioner would need to consider. The requirements are intended to help mitigate some of the risks associated with importing and using unauthorised products.

We acknowledge that the use of the term “requirements” may appear inconsistent with the phrase “have regard to”. However, we received advice that specific requirements could be needed that would apply in the context of clause 65. Possible examples include requiring a prescription for an unauthorised product to be filled by an individual with expertise in sourcing medicines from overseas. In this situation, the term “criteria” would be unlikely to capture the need for a health practitioner to undertake certain procedural steps when carrying on an activity involving an unauthorised medicine. As procedural requirements are not usually discretionary or subjective, compliance with these requirements should be mandatory.

To address the Regulations Review Committee’s concerns, we recommend amending the bill to specify that criteria should be applied as part of exercising clinical judgment. Accordingly, we recommend amending clause 65(3) to establish:

• criteria that a health practitioner must have regard to in reaching a professional judgement that it is appropriate to carry on the activity with the medicine or device that does not have an NZ authorisation

• procedural requirements that a health practitioner must comply with when carrying on an activity with an unauthorised medicine or device that is permitted because the special case requirement has been satisfied.

We also recommend amending clause 65(2)(a) to provide that the criteria should include the extent to which an available medicine or medical device is affordable to the patient or their whānau. We discuss the rationale for this recommendation later, in connection with clause 105 (Patient or carer importing medicine for personal use).

Clause 66 defines what it means to work in a business or undertaking or for a person. Clause 66(1)(e) states that it means to carry out work in any capacity in the business or undertaking or for the person, including work as an outworker (including a homeworker).

We recommend amending this clause to specify that “homeworker” has the meaning provided in section 5 of the Employment Relations Act 2000.

Clause 72 would require a person in the supply chain to comply with any requirements in the rules about any of the matters listed in the clause. Clause 88 would allow a health practitioner to import a medicine or medical device that did not have an NZ authorisation in certain situations. We recommend amending clause 72(1) to enable rules to be made to set product quality assurance requirements for importing products that do not have standard or provisional authorisation.

Clause 88 would enable a health practitioner to import a medicine or medical device that did not have an NZ authorisation for any indication under certain conditions. They would need to import it for the purpose of supplying it to a patient to whom they are allowed to supply it. The product could not be a medicine that required compounding.

For consistency with the provisions in clause 84,³ we propose two amendments to clause 88. We recommend amending clause 88 to require the health practitioner to satisfy the special case requirements in clause 65. We also recommend amending clause 88 to enable health practitioners to import a medicine or medical device for a patient of, and at the request of, another health practitioner who is allowed to supply the medicine or device to the patient.

Clause 92 would allow a person who worked for a health practitioner to supply by non-wholesale supply a pharmacy medicine with an NZ authorisation. They could only do so if:

• section 83 allowed the health practitioner to supply it⁴

• it was supplied for an authorised indication

• the worker supplied it to a patient of the health practitioner, and under the general supervision of the health practitioner.

We understand that the term “general supervision” is intended to allow for remote working arrangements—that is, the health practitioner would not need to be physically present when the staff engaged in the relevant activity. They would, however, otherwise need to be monitoring the activity. We recommend inserting clause 92(5), which would make it clear that “general supervision” could include remote monitoring.

Although the bill relates to therapeutic products for humans, many of these products can also be used for treating animals, particularly dogs, cats, and other small animals. Clauses 93 to 101 would allow veterinarians and their staff (clause 101) to use human therapeutic products if they chose to.

Clauses 93 to 101 refer to the patient of a veterinarian. Clauses 94, 96, and 97 also refer to the patient of the veterinarian being in New Zealand or ordinarily being resident in New Zealand. We consider that the bill as introduced could imply that veterinarians’ patients could include humans. We recommend inserting in clause 14 a definition of a patient in relation to a veterinarian. Our proposed definition would specify that the patient of a veterinarian is an animal under the care of that veterinarian.

Clause 105 would enable an individual (person A) to import a medicine if they complied with the personal use import conditions. This could include a medicine that did not have an NZ authorisation. The conditions are that person A would need to have acquired the medicine lawfully and the medicine would need to be intended for them or for a specific person or animal for whom they were a carer. Person A could not be acting in the course of a business or undertaking when importing the medicine. They would also need to comply with the luggage conditions or delivery conditions.

Under the luggage conditions in clause 105(5), person A would need to bring the medicine into New Zealand with them in their personal luggage. If person A was not the patient, the patient would need to be travelling with them. The amount of medicine imported at any one time could not exceed the amount prescribed, if prescribed by a recognised prescriber or an overseas health professional or veterinarian. Otherwise, the amount could not exceed 3 months’ standard supply.

Clause 105(6) specifies the conditions for delivery (by post or courier) that would need to be met:

• The medicine could not be a prescription medicine.

• The amount of medicine imported by person A at any one time could not exceed 3 months’ standard supply.

• The amount of medicine imported for the patient (regardless of who imported it or how it was imported) could not exceed 15 months’ standard supply in any 12-month period.

A number of submitters expressed concern that clause 105 would prevent patients from buying prescription medicines online from an overseas website and having them delivered. They considered that having to bring the medicine into the country in their own luggage would be to too expensive or impractical for many patients. Some submitters were particularly concerned that they would no longer be able to import generic cancer medications, which are cheaper overseas. At present, this is allowed under section 29 of the Medicines Act. They suggested that clause 105(6) be amended to allow non-subsidised prescription medicines to be imported for personal use.⁵

We were advised that clause 105(6) was developed in response to increasing concerns about the importation of prescription medicines obtained from overseas sources, such as online sellers. Some of the prescription medicines entering the country as personal imports have not been prescribed or may be of poor quality, adulterated, or counterfeit. The bill seeks to balance personal freedoms against the need to protect consumers from unknowingly purchasing unsafe or ineffective products.

Further, allowing personal importation of prescription medicines by delivery could reduce the incentive for product manufacturers to apply for an NZ authorisation for their product. This could reduce the range of safe and effective prescription medicines available from New Zealand suppliers in the longer term.

We acknowledge the concerns of submitters and the requests for patients to continue to have access to affordable lifesaving or life-prolonging medicines. We agree that prescription medicines should be allowed to be imported by delivery under certain conditions. We consider that any amendments should support the policy objectives of addressing the safety risks from counterfeit and contaminated products. This could be achieved by requiring the patient to maintain a close connection with their New Zealand-based health practitioner.

We believe any amendments should also encourage a sustainable and regular pathway to bring new medicines to New Zealand. This could be achieved by maintaining the supply limits for personal importation. Maintaining the restrictions on advertising unauthorised products would also reduce the risk that manufacturers would market their product directly to patients rather than seeking an NZ authorisation.

We recommend amending clause 105 to remove the prohibition on importing prescription medicines as part of the delivery conditions. Instead, we recommend introducing two additional requirements. If it is a prescription medicine, the medicine would need to be prescribed by a New Zealand health practitioner prescriber for that medicine. This would need to be consistent with clause 65 (Special case requirement). The person importing the medicine would also need to import it with the intention of it being used by the patient in New Zealand (clause 105(4)(ba)).

We recommend inserting a rule-making power in clause 105 to enable the inclusion of safeguards. They would reduce the risk of medicines being purchased from an overseas distributor that the Regulator knew or suspected was supplying counterfeit or contaminated products.

As previously noted, clause 65 sets out the special case requirement. When deciding whether it is appropriate to carry on an activity with a medicine without an NZ authorisation, the health practitioner or veterinarian must have regard to any criteria or requirements in the regulations. As noted earlier, we are proposing an amendment that the criteria should include the extent which an available medicine or medical device is affordable to the patient or their whānau.

Clause 116 provides for emergency situations. It would enable the chief executive of the Ministry to make an emergency arrangements notice allowing a person or class of persons to do something that would otherwise contravene a provision of subpart 1 or 2. Those subparts relate to market authorisation requirements and controlled activities and supply chain activities.

Clause 116(7) would require the chief executive, before making an emergency arrangements notice, to consult the Regulator and comply with any requirements in the regulations about making the notice.

The Regulations Review Committee noted that it is unusual that there is no ministerial involvement in the use of these emergency powers. It pointed out that secondary legislation used to respond to emergencies often does not have the same level of safeguards as other legislation. This is because of the need to respond to emergency situations quickly. The committee considered that a high level of accountability is therefore important for making secondary legislation, which ministerial involvement can help with.

The Regulations Review Committee recommended that we:

• consider whether the power to make emergency arrangements notices under clause 116 should be subject to some sort of ministerial involvement

• recommend that the bill be amended so that either the Minister makes the emergency arrangements notices, or the chief executive is required to consult the Minister before making a notice under clause 116.

We consider that the chief executive should be required to consult the Minister before making a notice. We recommend amending clause 116(7) accordingly.

Clause 124 sets out the criteria for issuing a market authorisation for an NHP. They include criteria relating to the NHP ingredients, the safety and quality of the NHP, standard and custom health benefit claims, and applicable product and export standards.

Clause 124(1)(c) states that an NHP meets the criteria for a market authorisation if the Regulator is satisfied on reasonable grounds that the NHP will meet the product standards that apply to it. We note that many NHPs may not have relevant product standards. Therefore, we recommend amending clause 124(1)(c) to refer to any product standards that might apply to an NHP.

We also recommend a change to clause 124(1)(d) to provide consistency with the new clause 62(2A). That is, if the sponsor proposes to make any health benefit claim of the kind referred to in section 62(2A), the NHP would meet the criteria in the rules for that claim).

Under clause 129, if a major change occurred to a therapeutic product with a market authorisation, the changed product would be different from the original one. The original product’s market authorisation would not cover the changed product and a separate market authorisation would need to be obtained.

Clause 129(1)(a) specifies that a major change means a change to the product itself or to any matter or information relating to the product that may have a significant impact on:

• the safety, quality, or efficacy of a medicine

• the safety, quality or performance of a medical device

• the quality or safety of an NHP.

We consider that the threshold of “may have a significant impact” is too low. Accordingly, we recommend amending clause 129(1)(a) by replacing “may” with “is likely to”.

Clause 149 specifies the periods when protected active ingredient information could not normally be disclosed or used.

We received advice that clause 149, as introduced, could create a risk of New Zealand not upholding its international obligations. This situation could arise if the Regulator did not determine an application for a market authorisation within 5 years. We recommend amending clause 149(3) to specify that an innovative medicines application that was not resolved within 5 years would be deemed to have been refused by the Regulator. A resolution would include the issuing of a provisional authorisation.

Clauses 177 and 178 provide that a licence or permit could not be transferred except in the limited circumstances set out in clause 178. That clause relates to the death, bankruptcy, or insolvency of a licence or permit holder. In all three situations, the licence or permit would automatically transfer to somebody else. Respectively, they are the executor or administrator of the estate; the Official Assignee; or the liquidator, administrator, receiver, statutory manager, or similar office holder.

Clause 178(4) states that a person to whom a licence or permit is transferred by this section must notify the Regulator of the event that triggered the transfer within 5 working days after the event occurs.

We sought advice on why the licence would be transferred rather than cancelled in these circumstances. The licence being transferable appeared to be inconsistent with the fact that people need to meet strict criteria to obtain a licence or permit.

We were advised that, in general, transfers are prohibited because it is appropriate for the Regulator to consider whether a person seeking to take over the licence or permit meets the criteria in Part 5 of the bill. However, the events listed in clause 178 (death, bankruptcy, and insolvency) can happen suddenly and without notice to third parties. If a licence or permit is automatically terminated, there is a risk that individuals and parties in the supply chain could be contravening the law.

We believe it is unlikely that a receiver, executor, or administrator would be aware of a licence or permit immediately after the event occurred. We therefore consider that requiring the transferee to notify the Regulator within 5 working days is an insufficient notice period. We recommend amending the notice period in clause 178(4) to 10 working days. Under our proposed amendment, this would commence from the earliest of:

• the transferee becoming aware that the licence or permit existed, or the date a reasonably prudent and responsible person should have become aware

• the continuation of any activity authorised under the licence or permit.

Clause 181 would prohibit a licensee, permit holder, or their senior manager from attempting to induce a health practitioner or veterinarian to act unprofessionally.

Subpart 3 of Part 8 lists the strict liability offences in the bill and splits them into three levels, with varying penalties.⁶ Clause 264 provides that contravening clause 181 is a strict liability offence with a level 1 penalty. A person who commits an offence under level 1 is liable to a fine of up to $100,000 (for an individual) or up to $500,000 otherwise.

We note that clause 181 has an intention element, and is therefore not a strict liability offence. We therefore recommend inserting as clause 248A the offence of inducing a health practitioner or veterinarian to act unprofessionally. We also recommend amending clause 264 by removing the reference to clause 181 as a strict liability offence.

Clause 184 would prohibit a licensee, or a senior manager, from engaging in adverse conduct in relation to a responsible person for a retaliatory reason. This provision is similar to the protections provided to a person who makes a disclosure under the Protected Disclosures (Protection of Whistleblowers) Act 2022.

We consider that a person who makes a good faith disclosure to the Regulator under clause 183 (Responsible person must report non-compliance) should be immune from civil proceedings. Examples would include breaches of trade secrets, employment contracts, or confidentiality agreements. We recommend inserting this immunity as clause 183(3A).

Clause 187 would prohibit a person from tampering with a therapeutic product, threatening to do so, or claiming to have done so. Under clause 187(3)(a), tampering with a therapeutic product means interfering with the product itself, its manufacturing process, its performance, its identification or labelling, its package, or its product or consumer information.

We note that, in the course of undertaking a supply chain activity with a therapeutic product, a person could do something of the kind referred to in clause 187(3)(a). However, this would be a normal part of carrying on that activity. We recommend amending clause 187(4), which would make it clear that a person would not be tampering in these situations.

Clause 189 would require a sponsor or a person in the supply chain to notify the Regulator of suspected tampering. We recommend inserting clause 189(3), which would provide immunity from civil proceedings to a person who made a good faith disclosure to the Regulator under clause 189. This would replicate our proposed amendment to clause 184.

Clause 193 provides definitions of the terms “advertisement”, “communication”, and “distribute”. An advertisement for a therapeutic product means a communication made for the purpose of promoting the product. A communication means a communication made in any way whatsoever. To distribute includes to make available to, or otherwise bring to the notice of, the public or a section of the public. The clause also sets out the activities that would not be considered advertisements.

Clause 194 would prohibit a person from advertising a therapeutic product unless it had the appropriate market authorisation and complied with the advertising and distribution requirements.

A number of submitters raised concerns about these provisions. The submitters considered that the definitions were too broad and confusing and they were unsure how they would be applied. They were concerned that the definition could extend to a range of communications. They might include patient appeals for fundraising, advocacy activities, satire, research, news reporting, protest and industrial action, and public discussion.

We were advised that clauses 193 and 194 are intended to prevent the promotion of therapeutic products in New Zealand that do not have an NZ authorisation. They are not intended to capture occasions when therapeutic products are mentioned but are not promoted.

We think amendments to the bill are needed to indicate the types of communications that are not intended to be captured. We recommend amending clause 194 to specify that a communication that was exempted under the regulations could be a communication that involved unauthorised therapeutic products.

“Astroturfing” means disguising a professionally orchestrated public relations or marketing campaign by presenting it as having arisen from unsolicited public comments or grass-roots support. To mitigate the risk of astroturfing, we recommend amending the bill to enable regulations to be made under clauses 193(3)(f) or 194(g). The regulations we envisage would require a person to disclose any funding or in-kind support received from the sponsor, manufacturer, or supplier of the therapeutic product that was being communicated or advertised.

Clause 208 would enable an inspector, for regulatory purposes, to enter a place where a supply chain activity was being carried on. They could also enter a place where an activity was being undertaken to which a licence or permit related. Clause 210 sets out what the inspector could do having entered the place.

Clause 210(5) states that this section does not permit the inspector to access or require anyone to give them (or anyone else) access to any computer system or data storage device that is not part of a therapeutic product. We consider that this clause, as introduced, would prevent inspectors from being able to collect digitally stored records and information relating to a therapeutic product. Therefore, we recommend deleting it.

Clause 226 would empower the Regulator in relation to oversupplied persons. An individual would be deemed an oversupplied person if they were addicted or habituated to a prescription or pharmacist medicine. They would also be considered an oversupplied person if they had obtained more of those medicines than was reasonably necessary for their own therapeutic purposes.

We recommend inserting clause 345A, which would clarify the relationship between the Privacy Act and certain provisions in the bill. Our proposed new clause would specify that the Regulator would need to be satisfied that disclosing personal information was reasonably necessary for the purpose of the legislation.

Clause 347 would enable the Regulator to establish 1 or more advisory committees to advise the Regulator in performing their functions and exercising their powers.

We believe that public confidence in the future regime would be enhanced by requiring the Regulator to publish certain information on its website. We recommend amending clause 347 to require publication of the name of any advisory committee established under this provision, the committee’s terms of reference, and its membership. If the Regulator was satisfied that publishing any of the names could affect the safe or effective operation of the committee, they could publish a statement to this effect.

Clause 363 would require the Regulator to maintain a register of all therapeutic products, licences, and permits. The register would need to be publicly available.

Clause 363(2)(a) specifies that the register would need to include all therapeutic products for which an application for a market authorisation had been made but not yet determined. It would also need to include therapeutic products for which a market authorisation had been refused. Several submitters expressed concern that a requirement to publish when a market authorisation had been applied for but not yet determined could have implications for commercial confidentiality. They also noted that the requirement to include products for which a market authorisation had been refused could also have implications for potential sponsors. Consequently, sponsors could choose not to proceed with an application or to delay submission, limiting the choice of or timely access to medical devices for New Zealanders. We acknowledge these concerns and recommend amending clause 363(2)(a)(ii) so that it would only apply to unauthorised products that the applicant was supplying under another provision in the bill.

Clause 380 would require the Regulator to consult affected people before regulations, rules, a Regulator’s notice, or an exemption were made. It provides that the Regulator would need to consult the people who they thought:

• were likely to be substantially affected by the instrument (clause 380(3)(a)(i)); or

• have knowledge, skills, and experience of any mātauranga Māori that is relevant to the instrument (clause 380(3)(a)(ii)).

We note that the use of “or” rather than “and” is unusual. It appears to give the Regulator the choice of consulting either people who were likely to be substantially affected or people who have relevant knowledge, skills, and experience of any mātauranga Māori. We recommend amending this clause to make it clear that the Regulator would need to consult both of the groups listed in subparagraph (i) and (ii).

Clause 391 would insert new sections 14A and 14B into the Health Practitioners Competence Assurance Act. Proposed new section 14A relates to amending a scope of practice that includes prescribing of medicinal products.

New section 14A(3) would enable the Minister to direct the responsible authority to amend the scope of practice to revoke or amend the prescribing provisions. We recommend amending section 14A(3) to specify that the directions could only be to the scope of practice to the extent that it related to prescribing therapeutic products.

Clause 398 would amend section 1 of the Medicines Act by renaming it the Pharmacy Ownership Act 1981.

Clause 402 would repeal Part 1 of the Act. Part 1 includes section 6, which states that the Act binds the Crown. We note that the effect of the repeal would be that the Medicines Act would not bind the Crown. This is inconsistent with the bill, which would bind the Crown (under clause 6).

We sought advice on why section 6 of the Medicines Act should be repealed even though that Act would continue to operate if the bill came into force, albeit in a reduced form. We were advised that the proposed repeal of section 6 is no longer appropriate given that the pharmacy ownership provisions of the Act would be retained. Therefore, we recommend amending clause 402 to retain section 6 of the Medicines Act.