EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER PARAGRAPH 98C(1)(b)
No. PB 40 OF 2007
Purpose and operation
1. 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. 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.
5. 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.
6. The determination, made under paragraph 98C(1)(b) of the Act on 30 March 2007 with effect from 1 May 2007 (No. PB 34 of 2007), is amended by this determination.
7. This determination gives effect, as from 1 June 2007, to the deletion of the pharmaceutical benefit Cholestyramine from Schedule 4.
Consultations
8. 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.
9. 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.
10. Details of the determination are set out in the Attachment.
11. This determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
12. The determination was made on 26 April 2007 and commenced on 1 June 2007.
ATTACHMENT
Paragraph 1 provides that this determination commences on 1 June 2007.
Paragraph 2 provides that the Determination (No. PB 34 of 2007) under subsection 98C(1)(b) of the National Health Act 1953 made on 30 March 2007 with effect from 1 May 2007 is, in this Determination, referred to as the Principal Determination.
Paragraph 3 provides for the deletion of the pharmaceutical benefit Cholestyramine from Schedule 4 to the Principal Determination.
The Schedules
Schedule 1 to the determination lists those pharmaceutical benefits that involve the admixture of ready-prepared ingredients.
Schedule 2 to the determination lists those drugs that are to be used in the preparation of extemporaneously-prepared pharmaceutical benefits and that are unstable or packed sterile and unused quantities of which are unsuitable for future use.
Schedule 3 to the determination lists those pharmaceutical benefits that are classified as dangerous drugs for the purpose of payment of a dangerous drug fee.
Schedule 4 to the determination lists those pharmaceutical benefits the complete pack of which shall be supplied regardless of any lesser quantity ordered in the prescription.
Overview
The National Health Act 1953, enacted by the Parliament of Australia, governs the provision of pharmaceutical benefits through the Australian Pharmaceutical Benefits Scheme (PBS). The primary purpose of the Act is to ensure timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community. Part VII of the Act regulates the supply of listed drugs and medicinal preparations as pharmaceutical benefits, with the Minister authorised under section 98C(1)(b) to determine the conditions for Commonwealth payments for these benefits. The determination process involves recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body that assesses the clinical effectiveness, safety, and cost-effectiveness of medicines. This legislative framework aims to balance accessibility to essential medications with fiscal responsibility, ensuring that the PBS remains sustainable while meeting the health needs of the population.
Scope and Application
The National Health Act 1953, as amended by the determination under paragraph 98C(1)(b) No. PB 40 of 2007, applies to the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This legislation is instrumental in regulating the Australian Pharmaceutical Benefits Scheme (PBS), which aims to ensure that Australians have access to necessary and cost-effective medicines. The Act applies nationally, covering all states and territories across Australia. It sets the conditions for payments made by the Commonwealth for the supply of these benefits. Notably, this determination deletes Cholestyramine from Schedule 4, effective from 1 June 2007. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a pivotal role in this process, making recommendations to the Minister for Health and Ageing, which are then implemented through legislative instruments under the Act. The Act's scope is further extended through subordinate instruments, ensuring comprehensive regulation of the PBS.
Key Provisions
The Australian Pharmaceutical Benefits Scheme (PBS) under Part VII of the National Health Act 1953 aims to ensure affordable access to necessary and cost-effective medicines for Australians. This scheme is regulated by the Act, which outlines the conditions for the supply of listed drugs and medicinal preparations as pharmaceutical benefits (section 84(1)). The Minister, under paragraph 98C(1)(b), determines the conditions for Commonwealth payments for the supply of these benefits by approved pharmacists and medical practitioners (section 98C(1)(b)). The determination under consideration amends a previous determination (No. PB 34 of 2007), effective from 1 June 2007, by removing Cholestyramine from Schedule 4, which lists benefits supplied in complete packs regardless of prescription quantities (Attachment, paragraph 3).
The determination is made in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body established by the Act (section 100A). The PBAC advises the Minister on which drugs and preparations should be available under the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness (subsection 101(4)). The PBAC comprises experts from various fields, including consumers, health economists, and medical professionals, ensuring a comprehensive review of each recommendation (section 100A).
Under this determination, various obligations are imposed on approved pharmacists and medical practitioners. These professionals must comply with the conditions set out in the determination when supplying pharmaceutical benefits. This includes adhering to the updated Schedule 4, which no longer lists Cholestyramine as a drug that must be supplied in complete packs. The determination also outlines the requirements for admixture of ingredients, use of unstable or sterile drugs, and the classification of dangerous drugs for fee purposes (Schedules 1 to 4).
The Act imposes several consequences for non-compliance with the provisions outlined in the determination. While specific offences and penalties are not detailed in the text, breaches of the National Health Act 1953 could result in civil or criminal penalties, depending on the nature and severity of the breach. The maximum penalties for breaches of the Act can vary, but they may include fines and imprisonment. Approved pharmacists and medical practitioners are expected to familiarise themselves with the requirements to avoid potential legal repercussions.