EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER SUBSECTION 85B(1)
NO. PB 5 OF 2007
Purpose and operation
- 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. Subsection 85B(1) of the Act enables the Minister to determine those pharmaceutical benefits for which there exists a price difference between what the Government is prepared to subsidise and that required by the manufacturer, and to determine in respect of each of those benefits the price to pharmacist which is to be used as a basis for reimbursement and the price to pharmacist sought by the manufacturer. Section 85B is used for special patient contribution items, for the therapeutic group premium policy and for the brand premium policy.
5. The determination sets out the conditions under which subsection 85B(1) applies. The Schedule to the determination lists those pharmaceutical benefits to which subsection 85B(1) applies, the form (strength, type, size etc.), the brand, the pack size, the price to pharmacist that the Government is prepared to pay and the price to pharmacist that the manufacturer requires.
6. This determination amends the Schedule to the Principal Determination made on
7 November 2006 with effect from 1 December 2006 (No. PB 48 of 2006), in order to change the drug and form description for Bleomycin Sulfate, due to the relisting of Sodium Chloride injection 10 mL as an approved solvent for supply when the injectable forms are prescribed with a solvent, with effect from 1 January 2007.
Consultations
7. 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.
8. 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.
9. Details of the determination are set out in the Attachment.
10. This determination is a legislative instrument for the purposes of the
Legislative Instruments Act 2003.
11. This determination was made on 1 December 2006 and commenced on 1 January 2007.
ATTACHMENT
Paragraph 1 provides that this determination commences on 1 January 2007.
Paragraph 2 provides that the determination No. PB 48 of 2006 under subsection 85B(1) of the National Health Act 1953 made on 7 November 2006 with effect from 1 December 2006 is, in this Determination, referred to as the Principal Determination.
Paragraph 3 provides for an amendment to the Schedule, in order to change the name of the pharmaceutical benefit Bleomycin Sulfate to “Bleomycin Sulfate with any determined brand of Sodium Chloride Injection” and the form (strength, type, size, etc.) from “Powder for injection 15,000 I.U.” to “Powder for injection 15,000 I.U. (with required solvent)”.
The Schedule to the determination lists those pharmaceutical benefits to which subsection 85B(1) applies, the form (strength, type, size etc.), the brand, the pack size, the price to pharmacist that the Government is prepared to pay and the price to pharmacist that the manufacturer requires.