Medicines Amendment Bill

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Explanatory note

General policy statement

In New Zealand, medicines and medical devices are regulated by the Medicines Act 1981 and its associated regulations. The Medicines Amendment Bill will address some problematic provisions of the Medicines Act 1981 to—

  • modernise the definitions of medicine, medical device, and therapeutic purpose to align the boundary between medicines and medical devices with international norms:

  • amend the approval process for new medicines:

  • align the prescribing framework for nurse practitioners and optometrists with medical practitioners, dentists, and midwives:

  • establish a new category of delegated prescriber, whose members will be allowed to prescribe under an authorisation (a delegated prescribing order) issued by an authorised prescriber:

  • establish a mechanism to allow time-limited demonstration sites of extended prescribing rights to new groups of health practitioners:

  • make minor and technical amendments to update and clarify the provisions for granting licences to manufacture, pack, and sell medicines and to operate a pharmacy:

  • expand the regulation-making powers in the Act to provide for new standards and innovative practice, such as electronic prescribing.

Regulatory impact statement

The Ministry of Health produced a regulatory impact statement on 2 December 2010 to help inform the main policy decisions taken by the Government relating to the contents of this Bill.

A copy of this regulatory impact statement can be found at—

Clause by clause analysis

Clause 1 is the Title clause.

Clause 2 provides for the commencement of the Act.

Clause 3 provides that the Bill amends the Medicines Act 1981.

Part 1
Amendments to principal Act

Clause 4 amends section 2 by inserting a new definition of authorised prescriber, which includes nurse practitioners and optometrists. Nurse practitioners and optometrists currently have prescribing rights conferred on them by regulations rather than the Act. Clause 4 also inserts definitions relating to delegated prescribers, definitions of nurse practitioner and optometrist, and a definition of responsible authority.

Clause 5 amends the definitions of medicine and prescription medicine in section 3.

Clause 6 inserts new section 3A, which contains a new definition of medical device.

Clause 7 substitutes new section 4 with an amended definition of therapeutic purpose.

Clause 8 amends section 13, which describes the functions, powers, and procedures of the Medicines Review Committee. The amendments ensure that the committee has the power to investigate objections to decisions of the Minister to refuse to give consent, or provisional consent, to the distribution of a medicine.

Clause 9 makes amendments to section 18 to replace references to individual categories of authorised prescriber with a general reference to authorised prescribers and also to insert a reference to delegated prescribers.

Clause 10 amends section 19 so that a prescription medicine may be administered in accordance with the directions of a delegated prescriber as well as an authorised prescriber.

Clause 11 makes amendments to section 20 that are consequential on the substitution of new sections 20A to 23AAB.

Clause 12 repeals sections 21 to 23 and substitutes new provisions. Those provisions set out the criteria to be applied when the Minister determines whether to give consent, or provisional consent, to the distribution of a new medicine. They also make provision about applications for the Minister's consent, and the procedure to be followed when those applications are determined. The details of that procedure will be set out in regulations. New sections 22A and 23AAB contain a process for objecting to a decision of the Minister. New section 23 sets out the process for applying for provisional consent to the distribution of a medicine. New section 23AAB deals with the duration and effect of provisional consents.

Clause 13 makes consequential amendments to section 23A.

Clause 14 repeals section 24, which makes provision for applications to distribute changed medicines, and inserts new sections 23D to 24AA. The changes broadly mirror those made in relation to the process for applying for the Minister's consent under section 20.

Clause 15 makes an amendment to section 26 that is consequential on the replacement of section 24.

Clause 16 amends section 27 to reflect the change to the definition of therapeutic purpose.

Clauses 17 to 20 make amendments that are consequential on the changes made by clause 14.

Clause 21 amends section 42C. This section restricts authorised prescribers from holding an interest in pharmacies. The amendments extend that restriction to delegated prescribers.

Clause 22 amends section 43. That section contains restrictions on the possession of prescription medicines. Clause 22 updates the section to refer to delegated prescribers and delegated prescribing orders. The definition of authorised prescriber in section 43(6) is repealed because the expression is already defined in section 2(1).

Clause 23 inserts new sections 47A to 47C. New sections 47A and 47B enable the Minister to approve a class of registered health professionals to have delegated prescribing rights. Applications for delegated prescribing rights will be made by the authority with responsibility for the registration and oversight of that class of health professionals under the Health Practitioners Competence Assurance Act 2003. An authorised prescriber (other than a designated precriber) may then issue a delegated prescribing order to a member of such a class of registered health professionals, and that person will then be authorised to prescribe prescription medicines in accordance with the delegated prescribing order. New section 47C makes provision for temporary prescribing rights. These will be authorised by the Minister in favour of a class of registered health professionals and will be limited to a specified place and for a limited period of up to 1 year.

Clause 24 amends section 48 to replace references to individual categories of authorised prescriber with a general reference to authorised prescribers, to insert references to delegated prescribers, and to update the list of authorities in section 48(2).

Clause 25 makes an amendment to section 49 to replace references to individual categories of authorised prescriber with a general reference to authorised prescribers and to insert a reference to delegated prescribers.

Clause 26 amends section 49A to replace references to individual categories of authorised prescriber with a general reference to authorised prescribers and to insert a reference to delegated prescribers.

Clause 27 makes changes to section 51, which makes provision for the grant of licences. A new subsection (1A) enables a licensing authority to take into account previous convictions when considering the applicant's fitness to hold a licence. New subsection (4) provides that licence conditions may be imposed by the licensing authority as well as by regulations made under the Act. New subsections (6) to (6AAB) set out the process for dealing with a licence holder who has failed or is failing to comply with licence conditions.

Clause 28 makes consequential amendments to section 52.

Clause 29 amends section 76A to insert a reference to delegated prescribers.

Clause 30 substitutes new section 87, which includes a reference to delegated prescribers.

Clauses 31 and 32 make further amendments that are consequential on the changes made by clause 14.

Clause 33 updates section 96, which applies certain provisions of the Act to related products in the same way as they apply to medicines.

Clause 34 makes changes to the regulation-making powers in section 105 to enable regulations to be made declaring substances or articles to be medicines and medical devices, and to broaden the existing power to make regulations about the issue of prescriptions so that regulations about the storage and transmission of prescriptions (including electronic prescriptions) may be made. The changes also update references to authorised prescribers and allow regulations to be made about delegated prescribing orders.

Clause 35 replaces references in section 105A to individual categories of authorised prescriber with a general reference to authorised prescribers.

Clause 36 inserts new section 105D, which contains a new power to make regulations about qualifications for delegated prescribers, and new section 105E, which makes provision for material to be incorporated by reference into regulations made under section 105.

Clause 37 adds new Schedule 3, which contains further provision for incorporation by reference.

Part 2
Consequential amendments to other enactments, transitional provisions, and related matters

Clauses 38 to 44 amend the Misuse of Drugs Act 1975, amend and revoke certain regulations, and make a transitional provision.