EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 89 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER PARAGRAPH 98C(1)(b)
Purpose and operation
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).
The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)). These determinations govern what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act. Under section 84AF, the Minister may determine a responsible person for a brand of a pharmaceutical item.
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.
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.
This legislative instrument amends the determination under section 98C(1)(b) made by legislative instrument number PB 79 of 2008 which came into effect on 1 August 2008. The amendments are set out in the items of Schedule 1 to the instrument.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 September 2008, was made on 1 August 2008.
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.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 September 2008.
Paragraph 2: provides that Schedule 1 amends PB 79 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Addition of Listed Drug
Clarithromycin Powder for oral liquid 250 mg per 5 mL, 50 mL
with Water –
Purified BP
Deletion of Listed Drug
Dipivefrine Eye drops containing dipivefrine hydrochloride 1 mg per mL, 10 mL
SCHEDULE 4
Addition of Listed Drug
Clarithromycin Powder for oral liquid 250 mg per 5 mL, 50 mL
Overview
The National Health Act 1953 was enacted to provide a legislative foundation for the Pharmaceutical Benefits Scheme (PBS), ensuring that all Australians have reliable, timely, and affordable access to a wide range of medicines. This Act empowers the Minister for Health to declare drugs and medicinal preparations as pharmaceutical benefits and to determine their forms, manner of administration, and brands. The purpose of the amendment determination under paragraph 98C(1)(b) is to set out the conditions under which payments for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners will be made by the Commonwealth. This legislative instrument, numbered PB 89 of 2008, amends the previous determination made in PB 79 of 2008, effective from 1 August 2008, to commence on 1 September 2008. The amendments include the addition of Clarithromycin Powder for oral liquid 250 mg per 5 mL, 50 mL with Water – Purified BP to the list of drugs under Schedule 1 and Schedule 4, and the deletion of Dipivefrine Eye drops containing dipivefrine hydrochloride 1 mg per mL, 10 mL. The Pharmaceutical Benefits Advisory Committee, established under section 100A of the Act, provides expert recommendations to the Minister, ensuring that only clinically effective, safe, and cost-effective medicines are included in the PBS.
Scope and Application
The National Health Act 1953, as amended, establishes the Pharmaceutical Benefits Scheme (PBS) under which the Commonwealth provides accessible, timely, and affordable access to a wide range of medicines for all Australians. The Act applies to pharmaceutical benefits provided by the Commonwealth, which includes listed drugs declared by the Minister to be part of the PBS. These drugs are listed under subsection 85(2) and their forms and manners of administration are determined by legislative instruments. The Act also applies to approved pharmacists and medical practitioners who supply these pharmaceutical benefits, with payments to them governed by conditions set out in determinations made under section 98C(1)(b). The geographic scope of the Act is national, extending across all states and territories of Australia. There are no stated exclusions within the Act itself; however, recommendations from the Pharmaceutical Benefits Advisory Committee are necessary for a drug to be declared under the Act. Subordinate instruments can further extend or restrict the application of the Act by detailing specific drugs and their forms, administration methods, and the conditions for payments to suppliers. The amendments to the determination under section 98C(1)(b), effective from 1 September 2008, adjust the list of drugs available under the PBS, adding Clarithromycin Powder for oral liquid and removing Dipivefrine Eye drops.
Key Provisions
The main operative sections of the instrument involve the amendment of the determination under paragraph 98C(1)(b) of the National Health Act 1953, which governs the conditions under which payments will be made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This is set out in Schedule 1, which amends the previous determination (PB 79 of 2008) by adding Clarithromycin Powder for oral liquid 250 mg per 5 mL, 50 mL with Water – Purified BP to the list of listed drugs, and by removing Dipivefrine Eye drops containing dipivefrine hydrochloride 1 mg per mL, 10 mL from the list (sections 1 and 2 of Schedule 1). This legislative instrument commences on 1 September 2008.
The obligations imposed by this Act on the parties it governs include compliance with the newly amended conditions for the supply of pharmaceutical benefits. Approved pharmacists and approved medical practitioners must adhere to the updated list of listed drugs, ensuring that they supply only those drugs that have been officially declared under the Act. This includes the addition of Clarithromycin Powder for oral liquid 250 mg per 5 mL, 50 mL with Water – Purified BP and the removal of Dipivefrine Eye drops containing dipivefrine hydrochloride 1 mg per mL, 10 mL from the list of listed drugs (subsection 85(2)).
Failure to comply with the provisions of this Act may result in various consequences, although the specific offences, penalties, or consequences are not detailed in the Explanatory Statement. Generally, under the National Health Act 1953, breaches of the provisions concerning the supply of pharmaceutical benefits could lead to civil or criminal penalties, depending on the nature and severity of the breach. Civil penalties could include fines, while criminal penalties might involve imprisonment, reflecting the importance of adhering to the regulations to ensure reliable, timely, and affordable access to medicines for all Australians. The maximum penalties would be in accordance with the broader provisions of the National Health Act 1953 and any other relevant legislation.