EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DECLARATION UNDER SUBSECTION 85(2AA)
No. PB 22 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. Subsection 85(2) of the Act empowers the Minister to declare the drugs and medicinal preparations to which Part VII of the Act applies.
5. Subsection 85(2AA) of the Act allows the Minister to declare, by instrument in writing, that a drug or medicinal preparation, or class of drugs and medicinal preparations, shall cease to be a drug or medicinal preparation, or a class of drugs or medicinal preparations, to which Part VII of the Act applies.
6. Subsection 85(2AB) of the Act provides that before making a declaration under subsection 85(2AA), the Minister shall obtain the advice in writing of the Pharmaceutical Benefits Advisory Committee (PBAC) in relation to the proposed declaration.
7. Subsection 85(2AC) of the Act provides that an advice under subsection 85(2AB) from the PBAC shall be laid before each House of the Parliament with the declaration under subsection 85(2AA) to which it relates.
8. The declaration specifies the names of drugs and medicinal preparations that the delegate of the Minister has declared no longer to be pharmaceutical benefits under Part VII of the Act as from 1 April 2007. The advice from the PBAC agrees to the deletion from the list of pharmaceutical benefits of the drugs named by the delegate in the declaration and the reasons for the agreement.
Consultations
9. The 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.
10. The declaration 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.
11. Details of the declaration are set out in the Attachment.
12. This declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
13. The declaration was made on 12 March 2007 and came into operation with effect from 1 April 2007.
ATTACHMENT
Paragraph 1 provides that this declaration commences on 1 April 2007.
Paragraph 2 lists the drugs and medicinal preparations which are no longer pharmaceutical benefits.
Overview
The National Health Act 1953, enacted by the Australian Parliament, primarily governs the provision of health services and the regulation of pharmaceuticals within the country. This Act establishes the Australian Pharmaceutical Benefits Scheme (PBS), which aims to ensure that Australians have timely, reliable, and affordable access to necessary and cost-effective medications. The legislation was introduced to address the need for a structured system to manage the availability and cost of essential drugs and medicinal preparations. The Act empowers the Minister to declare which drugs and preparations are covered under the PBS, with certain provisions requiring consultation with the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, composed of experts from various relevant fields, advises the Minister on the suitability of drugs for inclusion in the PBS based on clinical effectiveness, safety, and cost-effectiveness. This legislative instrument, which specifies the cessation of certain drugs and preparations as pharmaceutical benefits, reflects the PBAC’s recommendations and is subject to parliamentary oversight.
Scope and Application
The National Health Act 1953 governs the Australian Pharmaceutical Benefits Scheme (PBS), which aims to ensure that the Australian community has timely, reliable, and affordable access to necessary and cost-effective medicines. Under Part VII of the Act, the Minister for Health and Ageing is empowered to declare which drugs and medicinal preparations qualify as pharmaceutical benefits, with the process involving advice from the Pharmaceutical Benefits Advisory Committee (PBAC). This legislation applies to all entities involved in the supply of drugs and medicinal preparations in Australia, encompassing both public and private sectors. The geographic reach of this Act is national, extending throughout the Commonwealth of Australia. The Act does not specify exclusions, but the PBAC's recommendations, which must be obtained before a drug can be declared as a pharmaceutical benefit, may inherently exclude certain medications. The Act may also be extended or restricted through subordinate instruments, although the specific details of such instruments are not outlined in the explanatory statement.
Key Provisions
The key provisions of the legislation revolve around the Australian Pharmaceutical Benefits Scheme (PBS) and its regulation under the National Health Act 1953. The Act, specifically Part VII, governs the supply of drugs and medicinal preparations as pharmaceutical benefits. According to subsection 85(2) of the Act, the Minister is empowered to declare which drugs and medicinal preparations are covered under the PBS. Furthermore, subsection 85(2AA) allows the Minister to declare, by written instrument, that certain drugs or classes of drugs and medicinal preparations will no longer be considered pharmaceutical benefits under Part VII of the Act. This means that from a certain date, these drugs will no longer be listed on the PBS, thereby affecting their availability and funding for patients.
Under the Act, the Minister is required to obtain written advice from the Pharmaceutical Benefits Advisory Committee (PBAC) before making any declaration under subsection 85(2AA). This advice must be provided in accordance with subsection 85(2AB) and subsequently laid before each House of the Parliament, as stipulated in subsection 85(2AC). The PBAC is an independent expert body established by section 100A of the Act, tasked with recommending which drugs and medicinal preparations should be available as pharmaceutical benefits. This recommendation process takes into account factors such as the medical conditions for which the medicine is approved, its clinical effectiveness, safety, and cost-effectiveness.
Failure to comply with the Act's requirements may result in various consequences. For instance, under subsection 101(4) of the Act, a drug or medicinal preparation cannot be declared as a pharmaceutical benefit unless the PBAC has recommended it. Additionally, the Act outlines potential penalties for breaches, although specific details on penalties are not provided in the explanatory statement. The consequences for non-compliance may include legal action, fines, or other civil and criminal penalties, though the maximum penalties are not specified in this particular document.