EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 75 OF 2009
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 the 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 113 of 2008 which came into effect on 1 December 2008. 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 September 2009, was made on 31 July 2009.
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 September 2009.
Paragraph 2: provides that Schedule 1 amends PB 113 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Addition of Listed Drugs
Poly-l-lactic acid |
Silver sulfadiazine |
Sodium bicarbonate |
Alteration of Circumstances
Cladribine | [addition of streamlined authority code 3180] |
Fotemustine | [addition of streamlined authority code 3181] |
Irinotecan | [addition of streamlined authority code 3184] |
Lansoprazole | [addition of the tablet 30 mg (orally disintegrating)] |
Raltitrexed | [addition of streamlined authority code 3185] |
Topotecan | [addition of streamlined authority code 3186] |
Overview
The National Health Act 1953, as amended by the legislative instrument F2009L03148, provides the legislative framework for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have reliable, timely, and affordable access to a wide range of medicines. Enacted by the Parliament of Australia, the purpose of this legislation is to establish the PBS, enabling the Commonwealth to provide benefits in accordance with Part VII, particularly through the listing of drugs and medicinal preparations. This legislative instrument, which came into effect on 1 September 2009, amends previous declarations and determinations to align with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body. The PBAC’s role is to recommend which drugs and medicinal preparations should be available under the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness. The amendments in this instrument, which reflect the PBAC’s advice, include the addition of new drugs such as Poly-l-lactic acid, Silver sulfadiazine, and Sodium bicarbonate to the PBS, as well as modifications to the circumstances under which certain drugs like Cladribine and Irinotecan are listed.
Scope and Application
The legislation F2009L03148, an amendment to the National Health Act 1953, specifically targets the Pharmaceutical Benefits Scheme (PBS) administered by the Commonwealth of Australia. This Act applies to all Australian citizens and residents who are eligible for the PBS, as well as to pharmaceutical entities involved in the manufacture, supply, and distribution of medicines listed on the PBS. The Act governs the criteria and process by which drugs and medicinal preparations are included or excluded from the PBS, with the ultimate authority for these decisions residing with the Minister for Health. The geographic scope of this legislation is national, as the PBS is a federal initiative designed to provide equitable access to essential medications across the entire country. The amendments set out in this legislation are made pursuant to the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises on the clinical and cost-effectiveness of medicines. The amendments involve the addition of specific drugs to the PBS list and adjustments to the circumstances under which certain drugs can be prescribed or supplied, reflecting changes in medical practice and new therapeutic options. The Act does not specify exclusions or thresholds but rather operates through the mechanisms of declarations and determinations made by the Minister, which can be further detailed in subordinate instruments.
Key Provisions
The National Health Act 1953, as amended by the instrument number PB 75 of 2009, establishes the Pharmaceutical Benefits Scheme (PBS) which ensures accessible and affordable medicines for Australians. Key sections of this legislation, particularly under Part VII, outline how the Commonwealth provides pharmaceutical benefits (section 85(1)). The Minister can declare drugs and medicinal preparations as listed drugs under subsection 85(2), which are then subject to the provisions of the PBS. This declaration process is crucial for determining which drugs are eligible for subsidy and inclusion on the PBS (subsection 84(1)). Additionally, the Minister can determine the specific forms of listed drugs, such as their strength, type, and size (subsection 85(3)), as well as the manner of administration (subsection 85(5)) and the brand of the pharmaceutical item (subsection 85(6)). These determinations are fundamental in defining what constitutes a pharmaceutical benefit under the Act.
The obligations imposed by this legislation on parties and entities are significant. The Minister, guided by the Pharmaceutical Benefits Advisory Committee (PBAC), must make informed decisions on which drugs to include in the PBS. The PBAC, an independent expert body, recommends drugs based on their medical efficacy, safety, and cost-effectiveness (subsection 101(4)). Furthermore, before revoking or varying a declaration regarding a listed drug, the Minister must obtain written advice from the PBAC, which must also be tabled in Parliament (subsections 85(2AB) and 85(2AC)). This ensures a thorough and transparent process for any changes to the PBS listings.
In terms of penalties and consequences, the Act does not explicitly detail specific offences or penalties for non-compliance within the instrument itself. However, general provisions under the National Health Act 1953 outline that breaches of the Act can lead to criminal and civil penalties, including fines and imprisonment, depending on the severity of the breach. The instrument focuses primarily on the administrative and procedural aspects of the PBS, leaving detailed penalties to be inferred from broader legal frameworks governing health legislation in Australia.