EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER SUBSECTION 85B(1)
NO. PB 33 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The determination made under section 85B(1) of the Act on 26 July 2005 with effect from 1 August 2005 is repealed and substituted with this determination.
This determination is remade to give effect, as from 1 December 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. 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 23 November 2005 and commenced on 1 December 2005.
SUMMARY OF CHANGES
LIST OF MANUFACTURERS
Additions
HX Hexal Australia Pty Ltd
MQ Merck Pharmaceuticals
PC Pfizer Consumer Healthcare Pty Ltd
VT Valeant Pharmaceuticals Australasia Pty Ltd
Deletions
AW Arrow Pharmaceuticals Limited
EX Essex Laboratories
WR Warner Lambert Consumer Healthcare Pty Ltd
ZH Shinnick Pharmaceuticals Pty Limited
Brands to which a brand premium now applies
Alendronate Sodium Tablet equivalent to 70 mg alendronic acid (MK)
Cyclosporin Capsule 25 mg (HX)
Capsule 50 mg (HX)
Capsule 100 mg (HX)
Metformin Hydrochloride Tablet 1 g (AL)
Methylphenidate Tablet 10 mg (NV)
Hydrochloride
Pravastatin Sodium Tablet 10 mg (BQ)
Tablet 20 mg (BQ)
Tablet 40 mg (BQ)
Tablet 80 mg (BQ)
Brand to which a brand premium will no longer apply (brand deleted from the PBS)
Famotidine Tablet 20 mg (AD)
Tablet 40 mg (AD)
Flutamide Tablet 250 mg (EX)
Levonorgestrel with Pack containing 6 tablets 50 micrograms-30 micrograms,
Ethinyloestradiol 5 tablets 75 micrograms-40 micrograms and 10 tablets
125 micrograms-30 micrograms (SC)
Brands with an increased brand premium
Brinzolamide Eye drops 10 mg per mL, 5 mL (AQ)
Colchicine Tablet 500 micrograms (AS)
Cyclosporin Capsule 25 mg (NV)
Capsule 50 mg (NV)
Capsule 100 mg (NV)
Erythromycin Capsule 250 mg (containing enteric coated pellets) (MX)
Meloxicam Tablet 7.5 mg (BY)
Tablet 15 mg (BY)
Metoprolol Tartrate Tablet 50 mg (NV)
Tablet 100 mg (NV)
Omeprazole Magnesium Tablet equivalent to 20 mg omeprazole (AP)
Potassium Chloride Tablet 600 mg (sustained release) (NV)
Prednisolone Sodium Oral solution equivalent to 5 mg prednisolone per mL, 30mL
Phosphate (AS)
Brands with price changes but no change in brand premium
Clarithromycin Tablet 250 mg (AB)
Erythromycin Ethyl Tablet equivalent to 400 mg erythromycin (AB)
Succinate
Erythromycin Ethyl Powder for oral liquid equivalent to 200 mg erythromycin
Succinate with Water – per 5 mL, 100 mL (AB)
Purified BP Powder for oral liquid equivalent to 400 mg erythromycin
per 5 mL, 100 mL (AB)
Leflunomide Tablet 10 mg (AV)
Tablet 20 mg (AV)
Metformin Hydrochloride Tablet 500 mg (AL)
Tablet 500 mg (MQ)
Tablet 850 mg (AL)
Tablet 850 mg (MQ)
Paracetamol Tablet 665 mg (modified release) (GC)
Quinine Sulfate Tablet 300 mg (AS)
Roxithromycin Tablet 150 mg (AV)
Tablet 300 mg (AV)
Terbinafine Hydrochloride Tablet equivalent to 250 mg terbinafine (NV)
Tramadol Hydrochloride Capsule 50 mg (CS)
Alteration of Manufacturer’s Code
From To
Aluminium Hydroxide – Tablet 200 mg-200 mg WR PC
Dried with Magnesium Oral suspension 200 mg-200 mg WR PC
Hydroxide per 5 mL, 500 mL
Bleomycin Sulfate Powder for injection 15,000 I.U. ZH SI
Metformin Hydrochloride Tablet 500 mg AW MQ
Tablet 850 mg AW MQ
Metoclopramide Tablet 10 mg ID VT
Hydrochloride
Nitrazepam Tablet 5 mg ID VT
ATTACHMENT
Paragraph 1 provides that this determination commences on 1 December 2005.
Paragraph 2 provides that the determination under subsection 85B(1) of the National Health Act 1953 made on 26 July 2005 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 August 2005 and the pharmaceutical benefit is supplied before 1 March 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.