EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 1 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT DECLARATION UNDER SUBSECTIONS 85(2) AND 85(2AA)
AMENDMENT DETERMINATION UNDER SUBSECTION 85(2A)
Purpose and Operation
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations in relation to which Part VII applies are declared by the Minister by legislative instrument as such under subsection 85(2). These are listed drugs as defined in subsection 84(1). Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).
The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)). These determinations govern (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.
Subsection 85(2AA) empowers the Minister, by legislative instrument, to revoke or vary a declaration under subsection 85(2) in relation to a drug or medicinal preparation.
Where a revocation or variation would have the result that a drug or medicinal preparation would cease to be a listed drug, the Minister must under subsection 85(2AB) obtain the advice in writing of the Pharmaceutical Benefits Advisory Committee (PBAC). Under subsection 85(2AC), this PBAC advice is to be tabled in Parliament with the relevant declaration under subsection 85(2AA). Subsection 101(4) further provides that a drug or medicinal preparation cannot be declared under paragraph 85(2)(a) to be a drug or medicinal preparation in relation to which Part VII applies unless the PBAC has recommended to the Minister that it be so declared.
This legislative instrument in giving effect to recommendations of the PBAC amends declarations under subsection 85(2) and determinations under subsection 85(2A) made by legislative instrument number PB 88 of 2007 which came into effect on 1 December 2007. The amendments are set out in the items of Schedule 1 to the instrument.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 January 2008, was made on 19 November 2007.
Consultations
The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation.The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations 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. When recommending the listing of a medicine 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.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 January 2008.
Paragraph 2: provides that Schedule 1 amends PB 88 of 2007.
Schedule 1: provides for the following amendments:
SUMMARY OF CHANGES
SCHEDULE 1
Addition of Item
Varenicline
Alteration of Circumstances
Pemetrexed
Overview
The National Health Act 1953, enacted by the Australian Parliament, is the legislative foundation of the Pharmaceutical Benefits Scheme (PBS), which ensures that Australians have reliable, timely, and affordable access to a broad range of medicines. The Act was introduced to address the gap in providing a structured and regulated system for the availability of pharmaceutical products. The Act allows the Minister for Health to declare by legislative instrument the drugs and medicinal preparations subject to the PBS under subsection 85(2), with the advice and recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body, evaluates the medical conditions for which medicines are approved, their clinical effectiveness, safety, and cost-effectiveness compared to other treatments. This legislative instrument amends previous declarations and determinations made in 2007, incorporating recommendations from the PBAC and reflecting changes such as the addition of Varenicline and alterations in the circumstances for Pemetrexed, with the aim of maintaining and improving the efficacy and accessibility of pharmaceutical benefits under the PBS.
Scope and Application
The National Health Act 1953, as amended by the legislative instrument F2007L04463, applies to all individuals and entities that are eligible for the Pharmaceutical Benefits Scheme (PBS). This scheme is a Commonwealth initiative designed to provide Australians with reliable, timely, and affordable access to a wide range of medicines. The Act specifically governs the declaration and determination of listed drugs under Part VII, which includes the listing of drugs and medicinal preparations, their forms, and methods of administration. The Minister has the authority to make these declarations and determinations, subject to the advice of the Pharmaceutical Benefits Advisory Committee (PBAC). The instrument in question amends previous declarations and determinations, as set out in Schedule 1, which came into effect on 1 January 2008, and is based on the PBAC's recommendations. The geographic scope of this legislation is national, applying across all states and territories within Australia. The PBAC, an independent expert body, ensures that any recommendations for changes to the PBS are thoroughly considered, taking into account factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness.
Key Provisions
The National Health Act 1953 Amendment Instrument (F2007L04463) amends existing legislative instruments under sections 85(2) and 85(2AA) of the National Health Act 1953 (the Act). Specifically, it updates the list of drugs and medicinal preparations that qualify for benefits under the Pharmaceutical Benefits Scheme (PBS) as declared by the Minister (subsection 85(2)). For instance, this instrument adds Varenicline to the list of listed drugs and modifies the circumstances under which Pemetrexed is eligible for PBS benefits (Schedule 1). The Minister, guided by recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), can also determine the specific form and manner of administration of these drugs, as well as which brand qualifies for PBS coverage (subsections 85(3), 85(5), and 85(6)). Moreover, this instrument empowers the Minister to revoke or vary existing declarations regarding a drug's eligibility for PBS benefits, subject to obtaining written advice from the PBAC, which must be tabled in Parliament (subsections 85(2AA), 85(2AB), and 85(2AC)).
The Act imposes several obligations on the Minister and the PBAC. The Minister must ensure that the PBS provides reliable, timely, and affordable access to a wide range of medicines for Australians by making appropriate declarations and determinations under the Act. This includes obtaining the PBAC's written advice before revoking or varying any drug declaration that would result in the drug ceasing to be a listed drug (subsection 85(2AB)). The PBAC, in turn, must recommend to the Minister which drugs and medicinal preparations should be available as pharmaceutical benefits, considering factors such as medical conditions for which the medicine has been approved, its clinical effectiveness, safety, and cost-effectiveness (subsection 101(4)). Furthermore, a drug or medicinal preparation cannot be declared under the Act unless the PBAC has recommended it (subsection 85(2)(a)).
There are no specific offences, penalties, or civil/criminal consequences outlined for breaches of the amended provisions within this instrument. However, non-compliance with the Act's requirements could potentially lead to legal challenges or administrative actions, depending on the context and the specific provisions involved. The Act's overarching aim is to ensure the efficient and effective administration of the PBS, which in turn supports the health and well-being of Australians by making essential medicines accessible and affordable.