EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DECLARATION UNDER SUBSECTION 85(2AA)
NO. PB 3 OF 2007
Purpose and operation
- 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 January 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 1 December 2006 and came into operation with effect from 1 January 2007.
ATTACHMENT
Paragraph 1 provides that this declaration commences on 1 January 2007.
Paragraph 2 lists the drugs and medicinal preparations which are no longer pharmaceutical benefits.
Overview
The National Health Act 1953 was enacted to provide a framework for the regulation of health services and public health in Australia. One of the key components of this Act is the Australian Pharmaceutical Benefits Scheme (PBS), which aims to ensure affordable access to necessary and cost-effective medicines for the Australian community. The PBS is regulated under Part VII of the Act, which applies to the supply of listed drugs and medicinal preparations as pharmaceutical benefits. The Act empowers the Minister to declare which drugs and medicinal preparations are included as pharmaceutical benefits and also allows for the removal of such drugs and preparations from the list, subject to the advice of the Pharmaceutical Benefits Advisory Committee (PBAC). This process ensures that the PBS remains effective and responsive to the community's health needs by regularly reviewing and updating the list of approved pharmaceutical benefits.
Scope and Application
The Australian Pharmaceutical Benefits Scheme (PBS), as regulated by Part VII of the National Health Act 1953, is designed to ensure that Australians have timely, reliable, and affordable access to necessary and cost-effective medicines. This Act applies to drugs and medicinal preparations that have been listed as pharmaceutical benefits, and it empowers the Minister for Health to declare which drugs and medicinal preparations are included or excluded from this list. Specifically, the Act allows the Minister to declare, through a written instrument, that certain drugs or classes of drugs will cease to be pharmaceutical benefits under Part VII of the Act, effective from a specified date. Before making such a declaration, the Minister is required to seek and consider the advice of the Pharmaceutical Benefits Advisory Committee (PBAC), which must then be laid before Parliament. The PBAC, an independent expert body established by the Act, provides recommendations to the Minister regarding which drugs should be available as pharmaceutical benefits, taking into account factors such as clinical effectiveness, safety, and cost-effectiveness. This declaration, made on 1 December 2006 and effective from 1 January 2007, specifies the drugs and medicinal preparations that have been removed from the list of pharmaceutical benefits, in line with the PBAC's advice.
Key Provisions
The primary sections relevant to this legislation are subsections 85(2), 85(2AA), and 85(2AB) of the National Health Act 1953. Subsection 85(2) allows the Minister to declare which drugs and medicinal preparations are covered by Part VII of the Act, which pertains to pharmaceutical benefits. Conversely, subsection 85(2AA) empowers the Minister to declare that certain drugs or classes of drugs and medicinal preparations shall cease to be pharmaceutical benefits. Before making such a declaration, subsection 85(2AB) requires the Minister to obtain written advice from the Pharmaceutical Benefits Advisory Committee (PBAC), and this advice must be laid before each House of Parliament alongside the declaration.
The Act imposes specific obligations on the Minister and the PBAC. The Minister must consult with the PBAC before making any declaration under subsection 85(2AA). The PBAC must provide its advice in writing, and this advice must be considered by the Minister. Once the Minister decides to proceed with the declaration, the PBAC’s advice must be laid before each House of Parliament. Additionally, the PBAC’s role is to make recommendations to the Minister based on clinical effectiveness, safety, and cost-effectiveness of the drugs and medicinal preparations.
Failure to comply with the requirements of the Act can lead to significant consequences. While the explanatory statement does not explicitly detail offences or penalties, the legislative framework suggests that any failure to adhere to the prescribed process for declaring pharmaceutical benefits could be subject to legal scrutiny. Typically, breaches of legislative instruments can result in civil or criminal penalties, although the specifics, such as maximum penalties, are not detailed in the provided explanatory statement. It is likely, however, that non-compliance could lead to legal actions or administrative sanctions as outlined in the broader legislative context.