EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 14 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 subsections 85(2) and 85(2AA) and the determination 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 February 2008, was made on 2 January 2008.
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 February 2008.
Paragraph 2: provides that Schedule 1 amends PB 88 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Addition of Listed Drug
Metoprolol succinate
Alteration of Circumstances
Influenza Vaccine
Metoprolol
Pemetrexed
Pioglitazone
SCHEDULE 2A
Addition of Listed Drug
Tamarindus indica seed polysaccharide
Overview
The National Health Act 1953, as amended by legislative instrument F2008L00033, aims to regulate the Pharmaceutical Benefits Scheme (PBS) to ensure reliable, timely, and affordable access to medicines for all Australians. This amendment, enacted by the Australian Parliament, addresses the need to update the list of listed drugs and medicinal preparations covered under the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a pivotal role in recommending which drugs should be included on the PBS, taking into account factors such as clinical effectiveness, safety, and cost-effectiveness. This legislative instrument amends previous declarations and determinations to reflect the PBAC's recommendations, ensuring that the PBS remains responsive to evolving medical needs and advancements in pharmaceutical treatments.
Scope and Application
The National Health Act 1953, as amended by the legislative instrument F2008L00033, pertains to the Pharmaceutical Benefits Scheme (PBS) under which the Commonwealth provides access to a range of medicines for all Australians. This Act applies to drugs and medicinal preparations, including those that are listed, as defined in subsection 84(1), and certain extemporaneously-prepared medicinal preparations. The Minister can declare these items through legislative instruments, and can also determine the forms, administration, and brands of these pharmaceutical items under subsections 85(3), 85(5), and 85(6) respectively. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in advising on the listing of medicines, with its recommendations being necessary for any declaration under subsection 85(2)(a). The PBAC, consisting of members from various health-related fields, provides a formal process for consultation on these matters. This legislative instrument amends previous declarations and determinations, as set out in Schedule 1, and introduces new listings and changes to existing ones, as detailed in Schedule 2A.
Key Provisions
The National Health Act 1953, as amended by legislative instrument F2008L00033, outlines the framework for the Pharmaceutical Benefits Scheme (PBS) which ensures Australians have access to affordable and reliable medicines. The key operative sections (subsections 85(1), 85(2), 85(2AA), 85(2A), 85(3), 85(5), and 85(6)) provide that the Commonwealth will supply pharmaceutical benefits for declared drugs and medicinal preparations, and that the Minister for Health can declare and determine the specifics of these benefits through legislative instruments. These declarations and determinations include the form, manner of administration, and brand of the pharmaceutical items, thereby defining what constitutes a pharmaceutical benefit under the Act.
The Act imposes several obligations on the parties it governs. The Minister for Health must consult with the Pharmaceutical Benefits Advisory Committee (PBAC) when making declarations or determinations that could result in a drug or medicinal preparation ceasing to be a listed drug (subsection 85(2AB)). The PBAC, an independent expert body established by section 100A, recommends drugs and preparations that should be available under the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness. Additionally, the Minister must obtain written advice from the PBAC and table it in Parliament when making any revocations or variations to declarations (subsection 85(2AC)). This legislative instrument, effective from 1 February 2008, amends previous declarations and determinations made in PB 88 of 2007 to incorporate the PBAC's recommendations.
Failure to comply with the provisions of the Act can result in various civil and criminal consequences. Although the Act does not explicitly state penalties for non-compliance, breaches of the legislative requirements could potentially lead to legal actions. For instance, if the Minister fails to consult with the PBAC or does not table the required advice in Parliament, this could be considered an administrative error with possible repercussions under the relevant administrative law. Additionally, any misrepresentation or fraudulent activity in the declaration or determination process might attract penalties under other related legislation, such as the Crimes Act 1914.
The legislative instrument amends previous declarations and determinations, adding new listed drugs such as Metoprolol succinate and Tamarindus indica seed polysaccharide, and altering the circumstances for existing drugs like Influenza Vaccine, Metoprolol, Pemetrexed, and Pioglitazone. These amendments reflect the PBAC's recommendations and are aimed at ensuring that the PBS remains effective and responsive to the healthcare needs of Australians.