EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DECLARATION UNDER SUBSECTION 85(2AA)
NO. PB 1 OF 2005
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.
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.
“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.
Subsection 85(2) of the Act empowers the Minister to declare the drugs and medicinal preparations to which Part VII of the Act applies.
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.
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.
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.
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 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
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.
The declaration gives effect to recommendations made by the PBAC. Prior to the making of this declaration significant consultations have been undertaken by the PBAC by means of its consideration of submissions made by applicants for drugs to be listed on the PBS. 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.
Details of the declaration are set out in the Attachment.
This declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The declaration was made on 22 March 2005 and came into operation with effect from 1 April 2005.
ATTACHMENT
Paragraph 1 provides that this declaration commences on 1 April 2005.
Paragraph 2 lists the drugs and medicinal preparations which are no longer pharmaceutical benefits.
Overview
The National Health Act 1953 was enacted to establish and regulate the Australian Pharmaceutical Benefits Scheme (PBS), aiming to ensure timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community. The Act is overseen by the Australian Parliament and its primary objective is to manage the supply of listed drugs and medicinal preparations as pharmaceutical benefits. To address the need for expert guidance in determining which drugs should be included in the PBS, the Act established the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body tasked with making recommendations to the Minister for Health and Ageing. The explanatory statement for the declaration under subsection 85(2AA) of the Act outlines the process by which certain drugs and medicinal preparations may cease to be pharmaceutical benefits, following advice from the PBAC. This legislative instrument, effective from 1 April 2005, reflects the PBAC’s recommendations and facilitates the necessary adjustments to the PBS list, ensuring that the scheme remains effective and relevant.
Scope and Application
The National Health Act 1953, specifically through the declaration under subsection 85(2AA), governs the Australian Pharmaceutical Benefits Scheme (PBS) which aims to ensure that the Australian community has timely, reliable, and affordable access to necessary and cost-effective medicines. This Act applies to the Minister for Health and Ageing, who has the authority to declare which drugs and medicinal preparations qualify as pharmaceutical benefits under Part VII of the Act. The Minister must obtain the written advice of the Pharmaceutical Benefits Advisory Committee (PBAC) before making such a declaration, and this advice must be presented to both Houses of Parliament. The declaration, effective from 1 April 2005, specifies certain drugs and medicinal preparations that are to be removed from the list of pharmaceutical benefits. The PBAC, an independent expert body established under section 100A of the Act, provides recommendations to the Minister on which drugs should be available as pharmaceutical benefits, considering factors such as clinical effectiveness, safety, and cost-effectiveness. The declaration under subsection 85(2AA) applies nationally and is a legislative instrument under the Legislative Instruments Act 2003.
Key Provisions
The main operative sections of the National Health Act 1953, as referenced in the Explanatory Statement, pertain to the Australian Pharmaceutical Benefits Scheme (PBS) and its administration under Part VII. Specifically, subsection 85(2) (referenced in the text) allows the Minister to declare drugs and medicinal preparations that are eligible for inclusion as pharmaceutical benefits. Conversely, subsection 85(2AA) provides the Minister with the authority to declare that certain drugs or classes of drugs will no longer be considered pharmaceutical benefits. This means that the Minister can remove drugs from the list of those covered by the PBS. Before making such a declaration, the Minister must obtain written advice from the Pharmaceutical Benefits Advisory Committee (PBAC) under subsection 85(2AB). The PBAC’s advice, as required by subsection 85(2AC), must then be presented to both Houses of Parliament.
The obligations and requirements imposed by the Act on the parties it governs include the necessity for the Minister to consult with the PBAC before making any declaration that affects the status of drugs as pharmaceutical benefits. This requirement is explicitly stated in subsection 85(2AB) and involves obtaining written advice from the PBAC. The PBAC, established under section 100A, must consider various factors such as the medical conditions for which the medicine is approved, its clinical effectiveness, safety, and cost-effectiveness compared to alternative treatments. Additionally, the PBAC is composed of members from diverse backgrounds, including consumers, health economists, pharmacists, general practitioners, and specialists, ensuring a broad perspective in their recommendations.
The consequences for non-compliance with the provisions of the National Health Act 1953, as detailed in the Explanatory Statement, are primarily civil and administrative in nature. However, the specific offences, penalties, or consequences for breaches of the Act are not explicitly outlined in the provided text. In general, failure to follow the procedural requirements, such as not consulting with the PBAC before making a declaration, could lead to administrative penalties or legal challenges regarding the validity of the Minister’s actions. Additionally, if a drug is incorrectly removed from the PBS without proper consultation and advice, it could potentially lead to legal disputes and the need for corrective actions to restore the drug’s status. The maximum penalties for such breaches are not detailed in the text but would typically be determined by the specific administrative or judicial processes involved.