EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER SUBSECTION 85B(1)
NO. PB 27 OF 2006
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. The determination made under section 85B(1) of the Act on 24 March 2006 with effect from 1 April 2006 (No. PB 17 of 2006) is repealed and substituted with this determination.
7. This determination is remade to give effect, as from 1 July 2006, to changes in brand premiums, therapeutic group premiums and special patient contributions resulting from the new (reduced) wholesale markups under the Fourth Community Pharmacy Agreement. Clause 14.2 of the Agreement provides for a reduced wholesale markup of 7.5 per cent (equivalent to 7.0 per cent wholesale margin) on the ex-manufacturer’s price of pharmaceutical benefits medicines, and the introduction of a cap of $69.94 for medicines priced over $930.06 (ex-manufacturer).
8. The reduced wholesale markups have resulted in decreases in the prices which the Government is prepared to subsidise, together with decreases in the prices required by manufacturers. The effect of these price decreases care detailed in the attached summary of changes.
Consultations
9. The Fourth Community Pharmacy Agreement (“the Fourth Agreement”) between the Commonwealth and the Pharmacy Guild of Australia, was signed on 16 November 2005 and is due to expire on 30 June 2010. The Pharmacy Guild of Australia represents a majority of approved pharmacists in Australia.
10. 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.
11. 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.
12. Details of the determination are set out in the Attachment.
13. This determination is a legislative instrument for the purposes of the
Legislative Instruments Act 2003.
14. The determination was made on 15 June 2006 and commenced on 1 July 2006.
SUMMARY OF CHANGES
LIST OF MANUFACTURERS
Additions
DT DermaTech Laboratories Pty Ltd
Brands with a decreased special patient contribution
All special patient contribution brands
Brands with a decreased therapeutic group premium
All therapeutic group premium brands
Brands with a decreased brand premium
All brand premium brands except for the following:
(a) brands with no change in brand premium:
- Aluminium Hydroxide – Dried with Magnesium Hydroxide, tablet 200 mg-200 mg (PF)
- Clomiphene Citrate, tablet 50 mg (SG)
- Salbutamol Sulfate, pressurised inhalation equivalent to 100 micrograms salbutamol per dose, 200 doses (CFC-free formulation) (GK)
- Simvastatin, tablet 40 mg (FR)
(b) brands with an increased brand premium:
- Bromocriptine Mesylate, capsule equivalent to 10 mg bromocriptine (NV)
(c) brands to which a brand premium now applies:
- Hydrocortisone Acetate, cream 10 mg per g, 50 g (DT)
ATTACHMENT
Paragraph 1 provides that this determination commences on 1 July 2006.
Paragraph 2 provides that the determination under subsection 85B(1) of the National Health Act 1953 made on 24 March 2006 (No. PB 17 of 2006) is repealed.
Paragraph 3 defines the term “authority prescription”.
Paragraph 4 provides that the Schedule to the determination lists those brands of pharmaceutical benefits to which subsection 85B(1) apply.
Paragraph 5 provides that where a form and brand of pharmaceutical benefit is listed in Part A of the Schedule, Part B of the Schedule lists the quantity or number of units that is to be used for determining the manufacturer’s price for sales, and the price claimed by the manufacturer, for that form and brand.
Paragraph 6 provides that Part C of the Schedule lists the manufacturer’s price for sales for a particular form and brand that is listed in Part A of the Schedule.
Paragraph 7 provides that Part D of the Schedule lists the price claimed by the manufacturer for a particular form and brand that is listed in Part A of the Schedule.
Paragraph 8 lists those pharmaceutical benefits for which section 85B of the Act will not apply, if the prescription was written before 1 April 2006 and the pharmaceutical benefit is supplied before 1 October 2006.
Paragraph 9 lists the names of the manufacturers of those brands of pharmaceutical benefits, listed under “Brand” in Part A of the Schedule, to which this determination 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.