EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DECLARATION UNDER SUBSECTION 85(2AA)
No. PB 44 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 July 2007. The advice from the PBAC agrees to the deletion from the list of pharmaceutical benefits of the drugs and medicinal preparations named by the delegate in the declaration and outlines 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 7 June 2007 and came into operation with effect from 1 July 2007.
ATTACHMENT
Paragraph 1 provides that this declaration commences on 1 July 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, establishes the legislative framework for the Australian Pharmaceutical Benefits Scheme (PBS). This Act aims to ensure that Australians have timely, reliable, and affordable access to necessary and cost-effective medicines. Part VII of the Act governs the PBS, detailing the supply of listed drugs and medicinal preparations as pharmaceutical benefits. To maintain the integrity and relevance of the PBS, the Act allows the Minister to declare which drugs and medicinal preparations are included as pharmaceutical benefits. In accordance with the Act, the Minister must obtain the written advice of the Pharmaceutical Benefits Advisory Committee (PBAC) before making such declarations, ensuring that recommendations are based on clinical effectiveness, safety, and cost-effectiveness. This legislative instrument, F2007L01699, specifies drugs and medicinal preparations that ceased to be pharmaceutical benefits from 1 July 2007, following PBAC recommendations.
Scope and Application
The Australian Pharmaceutical Benefits Scheme (PBS), governed by 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. The Act applies to drugs and medicinal preparations that are classified as pharmaceutical benefits, as determined by the Minister for Health and Ageing under subsection 85(2) of the Act, with the requirement of obtaining written advice from the Pharmaceutical Benefits Advisory Committee (PBAC) before any declaration is made. This legislative framework extends its reach across Australia, impacting various stakeholders including consumers, healthcare providers, and pharmaceutical entities. Notably, the Act does not specify exclusions or exemptions beyond the criteria set for pharmaceutical benefits, and its application can be extended or restricted through subordinate instruments issued by the Minister, subject to the advice of the PBAC. The declaration under subsection 85(2AA) specifies particular drugs and medicinal preparations that will cease to be pharmaceutical benefits from 1 July 2007, following the PBAC's recommendation and subsequent parliamentary review.
Key Provisions
The Australian Pharmaceutical Benefits Scheme (PBS) is governed by Part VII of the National Health Act 1953, which ensures that Australians have access to necessary and cost-effective medicines. The Minister has the authority under section 85(2) to declare which drugs and medicinal preparations are eligible for PBS coverage, while section 85(2AA) empowers the Minister to declare that certain drugs or classes of drugs will no longer be covered under the scheme. Before making such a declaration, the Minister must obtain written advice from the Pharmaceutical Benefits Advisory Committee (PBAC) under section 85(2AB), which is then tabled in Parliament in accordance with section 85(2AC).
The obligations imposed by the Act on the relevant parties include the requirement for the Minister to consult with the PBAC before making a declaration that removes a drug or class of drugs from the PBS list, as outlined in section 85(2AB). The PBAC, established under section 100A of the Act, is tasked with providing expert advice and recommendations to the Minister on the inclusion or exclusion of drugs from the PBS. The PBAC’s recommendations must be considered by the Minister when deciding whether to remove a drug from the PBS list, as stipulated in section 101(4). Additionally, the declaration made by the Minister under section 85(2AA) must specify the names of the drugs and the effective date of the removal from the PBS list, as illustrated in the attachment to the Explanatory Statement.
Failure to comply with the provisions of the Act can result in legal consequences. While the Explanatory Statement does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches of the Act’s provisions, it is understood that any failure to adhere to the legislative requirements may lead to legal action. The penalties for non-compliance could potentially include fines or other sanctions as prescribed by relevant Australian legislation. It is crucial for parties involved in the administration of the PBS to ensure strict adherence to the Act’s requirements to avoid any legal repercussions.