EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DECLARATION UNDER SUBSECTION 85(2AA)
NO. PB 15 OF 2005
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 2005. 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 2005 and came into operation with effect from 1 August 2005.
ATTACHMENT
Paragraph 1 provides that this declaration commences on 1 August 2005.
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, establishes the framework for the Australian Pharmaceutical Benefits Scheme (PBS), with the overarching objective of ensuring that Australians have timely, reliable, and affordable access to necessary and cost-effective medicines. The Act is instrumental in regulating the supply of listed drugs and medicinal preparations as pharmaceutical benefits. One of its critical components is the ability of the Minister for Health to declare drugs and medicinal preparations to which Part VII of the Act applies or to cease their application, subject to the advice of the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body established under the Act, advises the Minister on which drugs and medicinal preparations should be included in the PBS, considering factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness. This legislative instrument, effective from 1 August 2005, provides a formal mechanism for updating the list of pharmaceutical benefits in line with PBAC recommendations.
Scope and Application
The Australian Pharmaceutical Benefits Scheme (PBS) is governed by Part VII of the National Health Act 1953, which aims to ensure timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community. The Act applies to drugs and medicinal preparations that are declared by the Minister as pharmaceutical benefits, and the Pharmaceutical Benefits Advisory Committee (PBAC) advises on which drugs should be included in the PBS. This advice is mandatory before the Minister can declare a drug to be a pharmaceutical benefit. The declaration under subsection 85(2AA) of the Act specifies the drugs that cease to be pharmaceutical benefits, effective from 1 August 2005, following the PBAC’s recommendation. The PBAC, an independent body comprising experts from various relevant fields, ensures that decisions are based on clinical effectiveness, safety, and cost-effectiveness. This legislative instrument, effective from 1 August 2005, reflects the PBAC's advice and the Minister's subsequent declaration.
Key Provisions
The National Health Act 1953 (the Act) establishes the Australian Pharmaceutical Benefits Scheme (PBS) to ensure Australians have access to necessary, cost-effective medicines (subsection 84(1)). Part VII of the Act applies to drugs and medicinal preparations that are considered pharmaceutical benefits (subsection 85(2)). The Minister for Health and Ageing has the authority to declare which drugs and medicinal preparations are included in or excluded from the PBS (subsections 85(2) and 85(2AA)). This includes the power to cease listing a drug or medicinal preparation as a pharmaceutical benefit (subsection 85(2AA)). To make such a declaration, the Minister must first obtain written advice from the Pharmaceutical Benefits Advisory Committee (PBAC) (subsection 85(2AB)). The advice must then be presented to both Houses of Parliament along with the declaration (subsection 85(2AC)). The declaration, which came into effect on 1 August 2005, specifies the drugs and preparations that are no longer considered pharmaceutical benefits.
The Act imposes specific obligations on the Minister and the PBAC. The Minister must seek advice from the PBAC before making any declaration under subsection 85(2AA) (subsection 85(2AB)). The PBAC, an independent expert body, advises the Minister on which drugs and medicinal preparations should be included in the PBS (subsection 101(4)). The PBAC’s recommendations must consider the medical conditions for which the medicine is approved, its clinical effectiveness, safety, and cost-effectiveness compared to other treatments. Additionally, the Minister must lay the PBAC's advice before each House of Parliament when making a declaration (subsection 85(2AC)).
Failure to comply with the provisions of the Act may result in legal consequences. The Act does not specify particular offences, penalties, or consequences for non-compliance in this context. However, any actions taken under the authority of the Act must adhere to the outlined procedures, including the requirement to consult with the PBAC and present its advice to Parliament. Non-compliance with these obligations could potentially lead to judicial review or other legal remedies. For example, if the Minister fails to obtain the PBAC's advice before making a declaration, the declaration may be subject to challenge in court on the grounds that the statutory process was not followed. Similarly, if the PBAC’s advice is not laid before Parliament as required, the declaration may be deemed invalid.