EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DECLARATION UNDER SUBSECTION 85(2AA)
NO. PB 13 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 April 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 24 March 2006 and came into operation with effect from 1 April 2006.
ATTACHMENT
Paragraph 1 provides that this declaration commences on 1 April 2006.
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 an accessible and affordable pharmaceutical benefits system. Central to this objective is the Australian Pharmaceutical Benefits Scheme (PBS), which aims to ensure timely and cost-effective access to necessary medicines for the Australian community. The Act, through Part VII, governs the supply of listed drugs and medicinal preparations, defining "pharmaceutical benefit" as a drug or preparation covered under section 85. The Minister is empowered to declare which drugs and preparations are included in the scheme, with the Pharmaceutical Benefits Advisory Committee (PBAC) providing essential advice on such declarations. This framework ensures that decisions about which medicines are subsidised are informed by expert analysis of their medical efficacy, safety, and cost-effectiveness.
Scope and Application
The Australian Pharmaceutical Benefits Scheme (PBS), regulated 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 defines a "pharmaceutical benefit" as a drug or medicinal preparation to which Part VII applies. The Minister has the authority to declare which drugs and medicinal preparations are eligible for inclusion or exclusion from this list, with the Pharmaceutical Benefits Advisory Committee (PBAC) providing essential advice on these matters. The declaration in question specifies the removal of certain drugs and preparations from the PBS list, effective from 1 April 2006, based on the PBAC's recommendations. These recommendations consider the clinical effectiveness, safety, and cost-effectiveness of the drugs compared to alternative treatments. The PBAC, an independent body comprising experts from various health-related fields, advises the Minister on which drugs should be included in the PBS, ensuring a balanced and informed decision-making process. This legislative instrument, coming into effect on 1 April 2006, was declared on 24 March 2006 and is subject to the provisions of the Legislative Instruments Act 2003.
Key Provisions
The key operative sections of this legislation concern the Pharmaceutical Benefits Scheme (PBS) as regulated by Part VII of the National Health Act 1953. Subsection 85(2AA) of the Act allows the Minister to declare, through a written instrument, that a specific drug or medicinal preparation, or a class of such items, shall no longer be considered a pharmaceutical benefit under Part VII of the Act. This is effective as from the date specified in the declaration. For example, the drugs and preparations listed in the declaration cease to be pharmaceutical benefits from 1 April 2006. The declaration also includes the reasons for this decision based on the advice from the Pharmaceutical Benefits Advisory Committee (PBAC), as mandated by subsection 85(2AB). This advice must be obtained in writing and provided to the Minister before any such declaration is made, and it must be laid before each House of the Parliament as stipulated in subsection 85(2AC).
The Act imposes specific obligations and requirements on the parties involved. The Minister must consult with the PBAC before making any declaration under subsection 85(2AA). This ensures that the decision to remove a drug or medicinal preparation from the list of pharmaceutical benefits is informed by expert advice. The PBAC, which is composed of experts from various relevant fields, evaluates the medical conditions for which a medicine is approved, its clinical effectiveness, safety, and cost-effectiveness compared to other treatments. The PBAC's recommendation is crucial as a drug or medicinal preparation cannot be declared a pharmaceutical benefit unless the PBAC has recommended it, as per subsection 101(4) of the Act. This consultation process is integral to ensuring that the decisions align with public health needs and economic considerations.
There are specific consequences for breaches of the Act's provisions. While the explanatory statement does not detail specific offences, penalties, or civil/criminal consequences, it is understood that any actions taken under the authority of the Act must comply with the legislative requirements. Failure to adhere to the procedural mandates, such as not obtaining the requisite advice from the PBAC before making a declaration, could potentially lead to legal challenges or administrative actions. However, the exact nature of these consequences is not explicitly outlined in the provided text. The overarching aim of the Act is to ensure that the PBS operates efficiently and effectively, providing affordable access to necessary and cost-effective medicines, while also maintaining the integrity and reliability of the pharmaceutical benefits system.