EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DECLARATION UNDER SUBSECTION 85(2AA)
NO. PB 30 OF 2006
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 August 2006. 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 26 July 2006 and came into operation with effect from
1 August 2006.
ATTACHMENT
Paragraph 1 provides that this declaration commences on 1 August 2006.
Paragraph 2 lists the drugs and medicinal preparations which are no longer pharmaceutical benefits.
Overview
The Australian Pharmaceutical Benefits Scheme (PBS) is established under Part VII of the National Health Act 1953, which aims to provide affordable access to necessary and cost-effective medicines for the Australian community. The Act empowers the Minister to declare drugs and medicinal preparations as pharmaceutical benefits, and subsequently, under subsection 85(2AA), to remove them from the PBS list. This legislative instrument, F2006L02514, outlines the declaration made by the Minister on 26 July 2006, effective from 1 August 2006, to remove certain drugs and medicinal preparations from the PBS list. This declaration was made in accordance with the advice from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established to recommend drugs for inclusion on the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness. The PBAC's advice was obtained as required by the Act and laid before each House of the Parliament prior to the declaration.
Scope and Application
The Australian Pharmaceutical Benefits Scheme (PBS) under Part VII of the National Health Act 1953 aims to ensure timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community. This legislative instrument pertains to the declaration by the Minister for Health and Ageing, under subsection 85(2AA) of the Act, of specific drugs and medicinal preparations that are to cease being pharmaceutical benefits from a designated date, in this instance, 1 August 2006. The declaration is effective throughout Australia, given the Act's national jurisdiction. It applies to the entities and individuals involved in the supply and prescription of these pharmaceuticals, impacting the pharmaceutical industry and relevant healthcare providers. The process requires the Pharmaceutical Benefits Advisory Committee (PBAC) to provide written advice to the Minister before such a declaration can be made, and this advice must be presented to Parliament. This legislative instrument includes the details of the specific drugs removed from the PBS list and is subject to the oversight and processes stipulated by the Legislative Instruments Act 2003.
Key Provisions
The Australian Pharmaceutical Benefits Scheme (PBS) aims to ensure Australians have access to necessary, cost-effective medicines (subsection 85(2)). This objective is achieved through the operation of Part VII of the National Health Act 1953, which specifies the supply of listed drugs and medicinal preparations as pharmaceutical benefits (subsection 84(1)). The Minister has the authority to declare drugs and preparations that qualify as pharmaceutical benefits (subsection 85(2)) and can also revoke this status (subsection 85(2AA)). However, any declaration to remove a drug or medicinal preparation from the PBS list must be preceded by written advice from the Pharmaceutical Benefits Advisory Committee (PBAC) (subsection 85(2AB)), and this advice must be tabled in Parliament along with the Minister’s declaration (subsection 85(2AC)).
The obligations under the Act primarily rest on the Minister for Health and Ageing, who must consult with the PBAC before making any declaration under subsection 85(2AA) (subsection 85(2AB)). The PBAC, composed of experts from various fields such as consumers, health economists, pharmacists, general practitioners, and clinical specialists, provides recommendations based on the clinical effectiveness, safety, and cost-effectiveness of the drugs in question (subsection 101(4)). The Minister must adhere to these recommendations when deciding whether to declare a drug as a pharmaceutical benefit. Furthermore, the PBAC’s advice must be made public and laid before each House of the Parliament as part of the legislative process (subsection 85(2AC)).
Failure to comply with the legislative requirements can result in significant consequences. If the Minister does not follow the PBAC’s advice before making a declaration, this could be seen as an administrative error or a breach of the statutory process, potentially leading to judicial review. The Act does not explicitly state maximum penalties for such breaches, but non-compliance with legislative procedures can attract penalties under the relevant administrative law provisions. Additionally, any misrepresentation or failure to disclose relevant information by the PBAC could also lead to civil or criminal penalties, depending on the severity and intent of the breach.