EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER SUBSECTION 85B(1)
NO. PB 5 OF 2005
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.
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.
“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.
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.
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.
The determination made under section 85B(1) of the Act on 17 November 2004 with effect from 1 December 2004 is repealed and substituted with this determination.
This determination is remade to give effect, as from 1 April 2005, to changes to the list of drugs and medicinal preparations available as pharmaceutical benefits, as recommended by the Pharmaceutical Benefits Committee. Changes to the Schedule to this determination are detailed in the attached summary of changes
Consultations
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.
The determination gives effect to recommendations made by the PBAC. Prior to the making of this determination significant consultations have been undertaken by the PBAC by means of its consideration of submissions made by applicants for drugs to be listed on the PBS. 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.
Details of the determination are set out in the Attachment.
This determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The determination was made on 22 March 2005 and commenced on 1 April 2005.
SUMMARY OF CHANGES
LIST OF MANUFACTURERS
Additions
GC GlaxoSmithKline Consumer Healthcare
Brands where a therapeutic group premium has changed to a brand premium
Nizatidine Capsule 150 mg (AS)
Capsule 300 mg (AS)
Brands to which a brand premium now applies
Hypromellose with Ocular lubricating gel 3 mg-2 mg per g, 10 g (NV)
Carbomer 980
Paracetamol Tablet 665 mg (modified release) (GC)
Sertraline Hydrochloride Tablet equivalent to 50 mg sertraline (PF)
Tablet equivalent to 100 mg sertraline (PF)
Terbinafine Hydrochloride Tablet equivalent to 250 mg terbinafine (NV)
Brand to which a brand premium will no longer apply (brand deleted from the PBS)
Sulindac Tablet 200 mg (FR)
Brands with an increased brand premium
Atenolol Tablet 50 mg (AP)
Brimonidine Tartrate Eye drops 2 mg per mL, 5 mL (AG)
Carbamazapine Tablet 100 mg (NV)
Tablet 200 mg (NV)
Carbomer 980 Ocular lubricating gel 2 mg per g, 10 g (NV)
Codeine Phosphate with Tablet 30 mg-500 mg (SW)
Paracetamol
Diclofenac Sodium Tablet 25 mg (enteric coated) (NV)
Tablet 50 mg (enteric coated) (NV)
Felodipine Tablet 2.5 mg (extended release) (AP)
Tablet 5 mg (extended release) (AP)
Tablet 10 mg (extended release) (AP)
Isosorbide Mononitrate Tablet 60 mg (sustained release) (AP)
Tablet 120 mg (sustained release) (AP)
Lisinopril Tablet 5 mg (AP)
Tablet 10 mg (AP)
Tablet 20 mg (AP)
Metoprolol Tartrate Tablet 50 mg (AP)
Tablet 50 mg (NV)
Tablet 100 mg (AP)
Tablet 100 mg (NV)
Paraffin – Soft White with Pack containing 2 tubes eye ointment, compound, 3.5 g (AG)
Paraffin – Liquid
Pilocarpine Hydrochloride Eye drops 5 mg per mL, 15 mL (AG)
Eye drops 10 mg per mL, 15 mL (AG)
Eye drops 20 mg per mL, 15 mL (AG)
Eye drops 30 mg per mL, 15 mL (AG)
Eye drops 40 mg per mL, 15 mL (AG)
Pindolol Tablet 5 mg (NV)
Tablet 15 mg (NV)
Polyvinyl Alcohol Eye drops 30 mg per mL, 15 mL (AG)
Potassium Chloride Tablet 600 mg (sustained release) (NV)
Propranolol Hydrochloride Tablet 10 mg (AP)
Tablet 40 mg (AP)
Brands with an decreased brand premium
Diphenoxylate Tablet 2.5 mg-25 micrograms (PH)
Hydrochloride with
Atropine Sulfate
Loperamide Hydrochloride Capsule 2 mg (JC)
Omeprazole Magnesium Tablet equivalent to 20 mg omeprazole
Pilocarpine Hydrochloride Eye drops 60 mg per mL, 15 mL (AG)
Sulfasalazine Tablet 500 mg (enteric coated) (PH)
Thyroxine Sodium Tablet equivalent to 50 micrograms anydrous thyroxine
sodium (SI)
Brands with price changes but no change in brand premium
Aspirin Tablet 100 mg (MX)
Cyproterone Acetate Tablet 50 mg (SC)
Tablet 100 mg (SC)
Leflunomide Tablet 10 mg (AV)
Tablet 20 mg (AV)
Thyroxine Sodium Tablet equivalent to 100 micrograms anydrous thyroxine
sodium (SI)
Tablet equivalent to 200 micrograms anydrous thyroxine
sodium (SI)
Triamcinolone Acetonide Ear ointment 1 mg-2.5 mg (neomycin)-250 micrograms-
with Neomycin Sulfate, 100,000 units per g, 5 g (BQ)
Gramicidin and Nystatin
ATTACHMENT
Paragraph 1 provides that this determination commences on 1 April 2005.
Paragraph 2 provides that the determination under subsection 85B(1) of the National Health Act 1953 made on 17 November 2004 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 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.