EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DECLARATION UNDER SUBSECTION 85(2AA)
No. PB 19 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 March 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 14 February 2007 and came into operation with effect from 1 March 2007.
ATTACHMENT
Paragraph 1 provides that this declaration commences on 1 March 2007.
Paragraph 2 lists the drugs and medicinal preparations which are no longer pharmaceutical benefits.
Overview
The National Health Act 1953, enacted by the Parliament of Australia, addresses the need for a structured and regulated system to ensure that Australians have access to necessary and cost-effective medicines. This Act, particularly through Part VII, governs the Australian Pharmaceutical Benefits Scheme (PBS), which aims to provide affordable and reliable access to essential medicines. The Act empowers the Minister to declare which drugs and medicinal preparations are covered under the PBS, ensuring that the scheme remains responsive to medical, economic, and clinical needs. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister, ensuring recommendations are based on clinical effectiveness, safety, and cost-effectiveness. This legislative framework is designed to balance the availability of necessary treatments with fiscal responsibility and public health objectives.
Scope and Application
The National Health Act 1953, as amended, regulates the Australian Pharmaceutical Benefits Scheme (PBS) through Part VII, ensuring that Australians have timely, reliable, and affordable access to necessary and cost-effective medicines. The Act applies to drugs and medicinal preparations that are designated as pharmaceutical benefits, and the Minister for Health and Ageing is authorised to declare which drugs and medicinal preparations fall under this category, subject to the recommendation of the Pharmaceutical Benefits Advisory Committee (PBAC). The Minister can also declare that certain drugs or classes of drugs will no longer be considered pharmaceutical benefits, a process that requires the prior written advice of the PBAC and subsequent presentation of this advice to Parliament. The Act extends across the Commonwealth of Australia, affecting all persons and entities involved in the supply and prescription of these medications, as well as the pharmaceutical industry and the broader healthcare sector. This legislative instrument, effective from 1 March 2007, specifies particular drugs and medicinal preparations that are removed from the list of pharmaceutical benefits, following the PBAC's recommendations.
Key Provisions
The Australian Pharmaceutical Benefits Scheme (PBS), which is established under Part VII of the National Health Act 1953 (the Act), aims to ensure that Australians have timely, reliable and affordable access to necessary and cost-effective medicines (subsection 84(1)). The Act defines a "pharmaceutical benefit" as a drug or medicinal preparation in relation to which Part VII of the Act applies (subsection 85(2)). This means that the Minister has the authority to declare which drugs and medicinal preparations are eligible for the PBS (subsection 85(2)). However, the Act also allows the Minister to remove certain drugs and medicinal preparations from the PBS (subsection 85(2AA)). Any such decision must be preceded by written advice from the Pharmaceutical Benefits Advisory Committee (PBAC) (subsection 85(2AB)). The PBAC is an independent expert body that provides recommendations to the Minister regarding which drugs and medicinal preparations should be included on the PBS (subsection 101(4)).
The Act imposes specific obligations on the Minister and the PBAC in relation to the PBS. The Minister must consult with the PBAC before making any declaration regarding the inclusion or exclusion of drugs and medicinal preparations from the PBS (subsection 85(2AB)). The PBAC, in turn, must provide written advice to the Minister before any such declaration is made (subsection 101(4)). The PBAC's advice must be laid before each House of the Parliament along with the Minister's declaration (subsection 85(2AC)). Additionally, the PBAC must consider several factors when making recommendations to the Minister, including the medical conditions for which a medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments (subsection 101(4)).
Failure to comply with the requirements of the Act may result in civil or criminal consequences. While the Act does not explicitly outline the penalties for non-compliance, it is important to note that the Minister's decisions regarding the PBS are subject to judicial review. If a court finds that the Minister has acted beyond their powers or in a manner that is unreasonable, they may quash the Minister's decision and order the Minister to take appropriate action. In addition, the Minister may be liable for damages if their decision causes loss or damage to an individual or entity. Furthermore, any individual or entity that deliberately or recklessly breaches the provisions of the Act may be subject to fines and/or imprisonment. The maximum penalties for such offences are set out in the Crimes Act 1914.