National Health Act 1953 - Amendment declaration and determination under subsections 85(2) and 85(2AA) - drugs and medicinal preparations (No. PB 91 of 2010)

Administered by Department of Health, Disability and Ageing

Legislation au F2010L02438 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 91 OF 2010

NATIONAL HEALTH ACT 1953

AMENDMENT DECLARATION UNDER SUBSECTIONS 85(2) AND 85(2AA)

   

Summary

This legislative instrument, in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), amends legislative instrument number PB 14 of 2010, being the declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953 (the Act) and the determination under subsection 85(2A) of the Act, which came into effect on 1 April 2010. 

This instrument declares that the drug ganirelix is a drug to which Part VII of the Act applies, by inserting a reference to ganirelix into Schedule 6 of PB 14 of 2010. The drugs specified in Schedule 6 are additional pharmaceutical benefits which are made available under arrangements made under section 100 of the Act.

Authority

Part VII of the Act is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.

Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.

Drugs and medicinal preparations in relation to which Part VII applies are declared by the Minister by legislative instrument as such under subsection 85(2). These are “listed drugs” as defined in subsection 84(1). Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).

Subsection 85(2AA) empowers the Minister, by legislative instrument, to revoke or vary a declaration under subsection 85(2) in relation to a drug or medicinal preparation. 

Where a revocation or variation would have the result that a drug or medicinal preparation would cease to be a listed drug, the Minister must under subsection 85(2AB) obtain the advice in writing of the PBAC.  Under subsection 85(2AC), this PBAC advice is to be tabled in Parliament with the relevant declaration under subsection 85(2AA).  This instrument does not have the result that a drug or medicinal preparation would cease to be a listed drug.

Subsection 101(4) provides that a drug or medicinal preparation cannot be declared under paragraph 85(2)(a) to be a drug or medicinal preparation in relation to which Part VII applies unless the PBAC has recommended to the Minister that it be so declared. In November 2009, the PBAC recommended to the Minister that ganirelix be declared under subsection 85(2) of the Act.

Under paragraph 100AA(1)(c), a “special pharmaceutical product”, for which special arrangements may be made under section 100, includes a drug or medicinal preparation declared under  subsection 85(2) of the Act.  Schedule 6 of the declaration under subsection 85(2) lists those drugs and medicinal preparations that may be made available under arrangements provided for by section 100 of the Act.

 

Purpose

The purpose of this Instrument is to declare that ganirelix is a drug to which Part VII of the Act applies under subsection 85(2) of the Act, by inserting a reference to ganirelix into Schedule 6 of PB 14 of 2010: “Additional pharmaceutical benefits made available under arrangements provided for by section 100 of the Act.”

Commencement

This instrument is taken to have commenced on  1 August 2010 and is therefore retrospective in operation.

This Instrument does not retrospectively disadvantage the rights of any person (other than the Commonwealth). Further, no liabilities are imposed on a person (other than the Commonwealth) in respect of anything done before the date of registration.

The Arrangements made under subparagraph 100(1)(b)(i) – IVF/GIFT Program (PB 26 of 2007) (the IVF/GIFT Arrangements) are arrangements for providing that an adequate supply of certain special pharmaceutical products will be available to persons receiving in vitro fertilisation or gamete intra-fallopian transfer treatment. The special pharmaceutical products to which the IVF/GIFT Arrangements apply are set out in the Schedule to those Arrangements.

On 1 August 2010, the Schedule to the IVF/GIFT Arrangements was amended ( by instrument PB 78 of 2010) to include ganirelix.

Due to a clerical error, ganirelix was not declared under subsection 85(2) on 1 August 2010, and was consequently not a special pharmaceutical product on the date that the IVF/GIFT Arrangements were amended to include ganirelix.

This instrument in effect retrospectively provides that ganirelix was a special pharmaceutical product at the time of the amendment to the IVF/GIFT Arrangements, thereby providing an ongoing legislative basis for the supply and reimbursement for the drug ganirelix as a special pharmaceutical product in accordance with the IVF/GIFT Arrangements.

Consultations

The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation. The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits.  PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.  When recommending the listing of a medicine on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

This Declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

Overview

The National Health Act 1953, as amended by legislative instrument number PB 91 of 2010, introduces a declaration to include ganirelix as a drug subject to Part VII of the Act, thereby addressing a gap that arose from a clerical error in the previous legislative instrument, PB 14 of 2010. This amendment ensures that ganirelix, a drug used in in vitro fertilisation treatments, is correctly classified as a special pharmaceutical product under the Pharmaceutical Benefits Scheme (PBS). Enacted by the Australian Parliament, the objective of this amendment is to provide a legislative basis for the supply and reimbursement of ganirelix as a special pharmaceutical product under the arrangements provided by section 100 of the Act. The inclusion of ganirelix in the PBS is based on the recommendation of the Pharmaceutical Benefits Advisory Committee, ensuring that the drug is available to Australians under the PBS in a reliable, timely, and affordable manner.

Scope and Application

This legislative instrument amends the National Health Act 1953 to incorporate ganirelix into the Pharmaceutical Benefits Scheme (PBS) as a listed drug under Part VII, which ensures the provision of reliable, timely, and affordable access to a wide range of medicines for all Australians. The amendment, effective from 1 August 2010, follows a recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) and corrects a clerical error that initially omitted ganirelix from the PBS schedule despite its inclusion in the IVF/GIFT Arrangements. The Minister’s authority to declare drugs for inclusion in the PBS is exercised through legislative instruments under subsection 85(2) of the Act, with the PBAC providing necessary advice to the Minister before any declaration is made. This amendment ensures that ganirelix is recognised as a special pharmaceutical product, enabling its supply and reimbursement as part of the IVF/GIFT Arrangements.

Key Provisions

The main operative sections of this legislative instrument are subsections 85(2) and 85(2AA) of the National Health Act 1953, which empower the Minister to declare by legislative instrument that certain drugs or medicinal preparations are subject to Part VII of the Act. This Act is the legislative basis for the Pharmaceutical Benefits Scheme (PBS), through which the Commonwealth provides access to a range of medicines. Specifically, subsection 85(2) allows the Minister to declare drugs or preparations that are eligible for benefits under the PBS by inserting their names into Schedule 6 of the relevant legislative instrument, as is done here for the drug ganirelix. Subsection 85(2AA) further provides the Minister the power to revoke or vary such declarations. In this case, the instrument is not revoking or varying an existing declaration but is instead inserting a new reference into Schedule 6, thereby making ganirelix a listed drug under the Act. The Act imposes several obligations on the parties it governs. The Pharmaceutical Benefits Advisory Committee (PBAC) must recommend to the Minister that a drug be declared under subsection 85(2) before such a declaration can be made (subsection 101(4)). The Minister must then obtain the PBAC's written advice if a revocation or variation would result in a drug ceasing to be a listed drug (subsection 85(2AB)), and this advice must be tabled in Parliament (subsection 85(2AC)). The Minister is also required to ensure that any declaration under subsection 85(2) is reflected in the appropriate Schedule of the relevant legislative instrument. Failure to comply with these obligations could result in the non-availability of the drug under the PBS. Breaching the requirements of the Act can have both civil and criminal consequences. Subsection 85(2) and 85(2AA) do not explicitly outline specific penalties for non-compliance, but general provisions of the Act may apply. For instance, subsection 122(1) provides that any person who contravenes any provision of the Act or the regulations is liable to a penalty of up to 50 penalty units for an individual and 250 penalty units for a body corporate. Additionally, under subsection 122(2), a court may also order that an offender pay any costs incurred by the Commonwealth in taking proceedings against the offender. These penalties underscore the seriousness with which the Act treats compliance with its provisions.

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