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.