EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DECLARATION UNDER SUBSECTION 85(2AA)
NO. PB 29 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 December 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 23 November 2005 and came into operation with effect from 1 December 2005.
ATTACHMENT
Paragraph 1 provides that this declaration commences on 1 December 2005.
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, provides the legislative framework for the Australian Pharmaceutical Benefits Scheme (PBS). The primary purpose of the PBS, as outlined in the Act, is to ensure timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community. The Act's Part VII regulates the supply of listed drugs and medicinal preparations as pharmaceutical benefits. A significant component of this regulation is the role of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established under section 100A of the Act, which advises the Minister on which drugs and preparations should be available as pharmaceutical benefits. The Minister's power to declare drugs and preparations as pharmaceutical benefits is subject to the PBAC's recommendation, with considerations including clinical effectiveness, safety, and cost-effectiveness. This legislative instrument, F2005L03722, was introduced to address the need for updating the list of pharmaceutical benefits by removing certain drugs and preparations from the PBS, in line with PBAC advice.
Scope and Application
The Australian Pharmaceutical Benefits Scheme (PBS) is governed under Part VII of the National Health Act 1953, which pertains to the supply of listed drugs and medicinal preparations as pharmaceutical benefits. The Act enables the Minister for Health to declare which drugs and medicinal preparations are covered by the PBS. However, it also allows the Minister, upon advice from the Pharmaceutical Benefits Advisory Committee (PBAC), to cease the coverage of certain drugs and preparations by issuing a written declaration. This process involves the PBAC recommending the removal of specific drugs or classes of drugs from the PBS list, which the Minister then formalises through a legislative instrument. The declaration specifies the names of the drugs and preparations that will no longer be considered pharmaceutical benefits under the Act, effective from the specified date. This mechanism ensures that the PBS remains aligned with contemporary medical needs, cost-effectiveness, and clinical efficacy, reflecting ongoing expert advice and parliamentary oversight.
Key Provisions
The main operative sections of the declaration under subsection 85(2AA) of the National Health Act 1953 pertain to the removal of certain drugs and medicinal preparations from the list of pharmaceutical benefits under Part VII of the Act. Specifically, subsection 85(2AA) allows the Minister to declare, in writing, that certain drugs or classes of drugs will no longer be considered pharmaceutical benefits. The declaration in question specifies the drugs and preparations that will cease to be pharmaceutical benefits from 1 December 2005. The declaration follows advice from the Pharmaceutical Benefits Advisory Committee (PBAC), as mandated by subsection 85(2AB), which must be obtained before any such declaration is made. This advice is then tabled before each House of Parliament as per subsection 85(2AC).
The obligations imposed by this Act on the relevant parties are primarily centered around the role of the Minister and the PBAC. The Minister must consult with the PBAC before making any declaration under subsection 85(2AA). The PBAC, which includes experts from various health-related fields, must provide written advice to the Minister. This advice must be considered before any declaration is made, and the advice itself must be laid before Parliament. The PBAC’s role is to ensure that the recommendations for pharmaceutical benefits are based on sound clinical, economic, and safety considerations. Their advice is a critical step in the process, ensuring that the Minister’s decision is informed by expert opinion.
In terms of offences, penalties, or consequences for breach, the Act does not explicitly detail specific penalties for non-compliance with the declaration. However, the legislative framework surrounding the National Health Act 1953 implies that any failure to adhere to the declared provisions could potentially result in legal consequences. For example, if a pharmaceutical benefit is unlawfully continued to be provided after the declaration, this could be considered a breach of the Act, potentially leading to civil or criminal penalties. The exact penalties would depend on the specific circumstances and any additional legislation that may apply. Given that the Act aims to regulate the availability and accessibility of medicines in Australia, non-compliance could also result in broader regulatory actions by health authorities.