EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER PARAGRAPH 98C(1)(b)
No. PB 40 OF 2007
Purpose and operation
1. The purpose of the Australian Pharmaceutical Benefits Scheme (PBS) is to provide timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.
2. The PBS is regulated by Part VII of the National Health Act 1953 (the Act), which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits.
3. “Pharmaceutical benefit” is defined under subsection 84(1) of the Act as a drug or medicinal preparation in relation to which, by virtue of section 85 of the Act, Part VII of the Act applies.
4. Paragraph 98C(1)(b) of the Act provides that the Minister may, from time to time, determine the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
5. The determination under paragraph 98C(1)(b) of the Act sets out the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
6. The determination, made under paragraph 98C(1)(b) of the Act on 30 March 2007 with effect from 1 May 2007 (No. PB 34 of 2007), is amended by this determination.
7. This determination gives effect, as from 1 June 2007, to the deletion of the pharmaceutical benefit Cholestyramine from Schedule 4.
Consultations
8. The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits. Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared. When recommending a medicine be listed 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.
9. The determination gives effect to recommendations made by the PBAC. PBAC members are selected 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.
10. Details of the determination are set out in the Attachment.
11. This determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
12. The determination was made on 26 April 2007 and commenced on 1 June 2007.
ATTACHMENT
Paragraph 1 provides that this determination commences on 1 June 2007.
Paragraph 2 provides that the Determination (No. PB 34 of 2007) under subsection 98C(1)(b) of the National Health Act 1953 made on 30 March 2007 with effect from 1 May 2007 is, in this Determination, referred to as the Principal Determination.
Paragraph 3 provides for the deletion of the pharmaceutical benefit Cholestyramine from Schedule 4 to the Principal Determination.
The Schedules
Schedule 1 to the determination lists those pharmaceutical benefits that involve the admixture of ready-prepared ingredients.
Schedule 2 to the determination lists those drugs that are to be used in the preparation of extemporaneously-prepared pharmaceutical benefits and that are unstable or packed sterile and unused quantities of which are unsuitable for future use.
Schedule 3 to the determination lists those pharmaceutical benefits that are classified as dangerous drugs for the purpose of payment of a dangerous drug fee.
Schedule 4 to the determination lists those pharmaceutical benefits the complete pack of which shall be supplied regardless of any lesser quantity ordered in the prescription.