Medicines Amendment Bill

  • enacted

Commentary

Recommendation

The Health Committee has examined the Medicines Amendment Bill, and recommends that it be passed with the amendments shown.

Introduction

This bill seeks to amend the Medicines Act 1981 in order to modernise the definitions of medicine, medical device, and therapeutic purpose; to amend the medicine approval process to make it less prescriptive and to make some changes to the prescribing framework, and some minor or technical changes.

The bill is an interim measure intended to address some problematic provisions of the Medicines Act, in advance of a comprehensive overhaul of the medicines legislation. The comprehensive overhaul will be undertaken via the Therapeutic Products and Medicines Bill which is intended to be progressed in 2013 and is a key part of the legislative infrastructure required to establish the Australia New Zealand Therapeutic Products Authority (ANZTPA).

ANZTPA will replace Australia’s Therapeutic Goods Administration and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). It will create a single market for therapeutic products by administering a single regulatory scheme across both countries. It will regulate the full range of therapeutic products including prescription medicines, over-the-counter medicines, medical devices, and biological medicines.

This commentary covers the main amendments we recommend to the bill.

Commencement clause

We recommend that the default commencement date for the provisions in the bill that would come into force by Order in Council be amended. Any provision relating to the medicines approvals process that had not come into force earlier would come into force on 1 July 2017, and any other provision in the bill that had not come into force earlier would come into force on 1 July 2014.

The bill seeks to remove the provisions in the Act that deal with the process for medicines approvals and replace them with a regulation-making power. The new regulations would be expected to include a new approval process for medicines. Setting an earlier commencement date for these provisions would require the development of a New Zealand-only medicines approval process, concurrently with the development of a medicines approval process for the joint ANZTPA regulatory scheme. Any New Zealand-only scheme would be in force for a short time before being replaced by the ANZTPA regulatory scheme before 1 July 2017. The extended commencement date means that legislative change and prolonged consultation can be avoided.

Setting the commencement date at 1 July 2017 recognises that if negotiations on ANZTPA progress according to schedule, the medicines approvals provisions in the bill will be superseded. If negotiations are prolonged, however, the bill provides an alternative avenue for making the desired amendments to the medicines approvals process.

Definitions

There was general support for updating the definitions of medicine, medical device, and therapeutic purpose to align them with international norms. We do not consider full alignment with the regulatory definitions used in Australia appropriate. The definitions in the bill have been developed to reflect New Zealand’s current regulatory framework, and will be reviewed and updated by the Therapeutic Products and Medicines Bill, which is required to establish the Australia New Zealand Therapeutic Products Agency.

Delegated prescriber

The delegated prescriber category would enable a registered health professional to prescribe within limited parameters, under the sanction of an authorised prescriber. The intention of delegated prescribing is to give patients more convenient, efficient access to medicines by broadening the range of practitioners who may prescribe, while ensuring patients’ safety. A delegated prescribing order is the mechanism by which specific conditions and restrictions on prescribing would be imposed for an individual delegated prescriber. The limits on prescribing by delegated prescribers would reflect their required level of qualifications, training, and competency. Delegated prescribing would be monitored by the authorised prescriber who issued the order.

An application for delegated prescribing rights would require the support of the relevant responsible authority and the approval of the Minister of Health. We recommend that the implementation of delegated prescribing rights be via regulation. Requiring a regulatory mechanism enables scrutiny by the Regulation Review Committee and reflects the significant responsibilities that accompany any form of prescribing.

To ensure clarity about the controls on delegated prescribing, we recommend adding more detail to section 105D, which sets out the kinds of regulations that could be made relating to delegated prescribers. Regulations could then be made granting delegated prescribing rights, regulating how delegated prescribing orders are issued, setting out the supervisory responsibilities of authorised prescribers, and imposing other requirements on delegated prescribers.

We recommended inserting new section 105DA to ensure that the prescription medicines that may be prescribed under a delegated prescribing order be specified by the Director-General of Health by notice in the Gazette rather than specified in delegated prescriber regulations. Specifying the list via Gazette notice would enable the list to be updated more efficiently in response to changes in best practice and to changes in product funding within a therapeutic group. This would also require the Director-General of Health to consult with the relevant organisations or bodies that are considered representative of persons likely to be substantially affected before specifying the prescription medicines by notice in the Gazette.

Temporary prescribing

As introduced the bill contains provisions for temporary prescribing rights. However, it has since been determined that designated and delegated prescribing regulations can specify a time limit, as well as other conditions that would enable the authorisation of temporary prescribing rights. Accordingly a separate provision for temporary prescribing is superfluous. We therefore recommend the deletion of new section 47C.

Regulations relating to designated prescribing

Clause 34 makes changes to the regulation-making powers in section 105 of the Act. This section of the Act allows regulations to be made authorising designated prescribing and specifying the prescription medicines that can be prescribed. We recommend amending the bill to reinsert a deleted reference to description of medicines in section 105(1)(qa) to ensure flexibility in drawing up the list of medicines. We further recommend that the medicines that designated prescribers can prescribe be specified by the Director-General by notice in the Gazette. As noted previously, specifying the medicines via Gazette notice would enable the list to be updated more efficiently.

Functions, powers and procedures of the Medicines Review Committee

Clause 8 seeks to amend section 13, to give the Medicines Review Committee the power to investigate any objections to the Minister’s decisions on the distribution of medicines. We consider the wording of new section 13(1)(a) too narrow, and believe it should also allow appeals against the imposition of conditions on approvals. Accordingly we recommend amending section 13(1)(a) to ensure that the committee provides an avenue for appeal in this respect.

Applications for Minister’s consent

Sections 21 and 23 (inserted by clause 12) 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. We believe that the term applicant in section 21(1) and 23(1) needs to be defined more clearly, as the provision as introduced implies that an overseas manufacturer could submit an application, which is not the intention. Therefore, we recommend amending new sections 21(1) and 23(1) to include a requirement that the applicant for consent be a person or company in New Zealand. We recommend an equivalent amendment to new section 24(3) (inserted by clause 14), regarding consent for distribution of changed medicines.

Grant of licenses

We recommend amending clause 27 to allow the licensing authority to take determinations of professional conduct committees into account when assessing an applicant’s fitness to hold a license. We note that new section 51(1A) does not preclude other considerations than those specified being taken into account for this purpose.

Amendments to Misuse of Drugs Act 1975

We recommend the insertion of new clauses 38A to 38E and 39A which make consequential amendments to the Misuse of Drugs Act 1975.

These amendments would ensure nurse practitioners retain their current controlled drug prescribing rights once the Medicines Amendment Bill is enacted and nurse practitioners are named as authorised prescribers.

This section would also ensure that the current mechanism allowing prescribing authorisation via regulation is retained for optometrists once the Medicines Amendment Bill is enacted and optometrists are named as authorised prescribers.

We were concerned about the reference to midwives prescribing pethidine as it is no longer the preferred pain medication during childbirth. We recommend removing the reference to midwives prescribing pethidine. Midwives’ prescribing rights regarding controlled drugs would be set out in regulations.

Appendix

Committee process

The Medicines Amendment Bill was referred to the committee on 28 February 2012. The closing date for submissions was 13 April 2012. We received and considered 43 submissions from interested groups and individuals. We heard 19 submissions in Wellington.

We received advice from the Ministry of Health.

Committee membership

Dr Paul Hutchison (Chairperson)

Shane Ardern

Dr Jackie Blue

Dr Cam Calder

Kevin Hague

Iain Lees-Galloway

Andrew Little

Barbara Stewart

Hon Maryan Street

Dr Jian Yang