EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 62 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 August 2009, was made on 6 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 August 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
Arsenic |
Bimatoprost with timolol |
High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate |
Praziquantel |
Rivaroxaban |
Sitagliptin with metformin |
Soy lecithin |
Alteration of Circumstances
Chorionic Gonadotrophin | [deletion of injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL] |
Clopidogrel | [addition of streamlined authority code 3146 and corresponding circumstances] |
Glucose Indicator — Blood | [addition of electrode strips, 50 (MyGlucoHealth) and deletion of electrode strips, 100 (TrueSense)] |
Oxybutynin | [addition of transdermal patches 36 mg, 8] |
Quetiapine | [addition of streamlined authority code 3151 and corresponding circumstances] |
SCHEDULE 1A
Addition of Listed Drug
SCHEDULE 2A
Addition of Listed Drugs
Bimatoprost with timolol |
Soy lecithin |
SCHEDULE 3
Addition of Allowable Compounds
Bimatoprost with timolol |
Sitagliptin with metformin |
Voriconazole with Water — Purified BP |
Overview
The National Health Act 1953, amended by the instrument F2009L02705, serves to refine the legislative framework of the Pharmaceutical Benefits Scheme (PBS), which is the basis for ensuring Australians have timely and affordable access to a broad range of medicines. Enacted by the Parliament of Australia, this legislation aims to address the need for a dynamic and responsive system that can adapt to new medical advancements and shifting healthcare needs. The amendments made by the instrument focus on updating the list of approved drugs and medicinal preparations that qualify for PBS benefits, as well as adjusting the specific forms and circumstances under which these drugs can be administered. This ensures that the PBS remains effective in providing necessary pharmaceutical benefits while considering factors such as clinical effectiveness, safety, and cost-effectiveness. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on these matters, ensuring that the PBS continues to meet the evolving healthcare demands of the Australian population.
Scope and Application
The National Health Act 1953 Amendment Instrument, PB 62 of 2009, applies to the Pharmaceutical Benefits Scheme (PBS) administered by the Commonwealth of Australia under Part VII of the Act. It involves the regulation and listing of drugs and medicinal preparations, including extemporaneously-prepared ones, which are subject to the provisions of the Act. The instrument allows the Minister for Health to declare and determine forms, manners of administration, and brands of listed drugs through legislative instruments, subject to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent body comprising experts from various relevant fields, advises on the listing of medicines based on their medical conditions, clinical effectiveness, safety, and cost-effectiveness. The instrument's amendments, detailed in Schedules 1, 1A, 2A, and 3, involve adding new listed drugs and allowable compounds and altering circumstances for existing drugs. This legislative instrument, which commenced on 1 August 2009, extends the scope and application of the PBS by modifying previous declarations and determinations, ensuring the availability of essential medicines for Australians.
The instrument's jurisdiction is national, operating under the Commonwealth's legislative authority. It does not specify exclusions, exemptions, or thresholds but extends its application through subordinate instruments made by the Minister for Health. These instruments provide detailed regulations and updates to the PBS list, ensuring the scheme remains responsive to medical advancements and healthcare needs. The PBAC's role in providing advice and recommendations is integral to the instrument's operation, ensuring that decisions regarding the listing of drugs on the PBS are evidence-based and consider a wide range of health-related factors.
Key Provisions
The main operative sections of this legislative instrument (F2009L02705) primarily amend the Pharmaceutical Benefits Scheme (PBS) under Part VII of the National Health Act 1953. Specifically, it amends the declarations and determinations made by the Minister under subsections 85(2) and 85(2A) of the Act. These amendments, detailed in Schedule 1, involve adding new listed drugs to the PBS, altering the circumstances under which certain drugs can be administered, and adjusting the allowable compounds for specific drugs (subsections 85(2) and 85(3)). The instrument also includes provisions for the revocation or variation of existing declarations under subsection 85(2AA) and mandates the Minister to obtain advice from the Pharmaceutical Benefits Advisory Committee (PBAC) if such changes would result in a drug ceasing to be a listed drug (subsections 85(2AB) and 85(2AC)).
The Act imposes several obligations on the Minister. The Minister must consult with the PBAC before revoking or varying a declaration regarding a listed drug under subsection 85(2AA). If such a revocation or variation would result in the cessation of a drug being listed, the Minister is required to obtain written advice from the PBAC, which must then be tabled in Parliament (subsections 85(2AB) and 85(2AC)). The PBAC, an independent expert body, must recommend that a drug or medicinal preparation be declared as a listed drug under subsection 85(2) before the Minister can make such a declaration (subsection 101(4)). Additionally, the Minister must ensure that the amendments made by this instrument align with the PBAC’s recommendations.
Under the Act, breaches of the requirements set out in the legislation can result in significant civil or criminal penalties. For instance, if the Minister fails to consult with the PBAC or does not table the PBAC’s advice in Parliament as required, they may be subject to legal action. While the specific penalties are not detailed in the explanatory statement, generally, breaches of statutory obligations can lead to fines, imprisonment, or other legal consequences depending on the severity and nature of the breach. The Act ensures that the PBS operates within a well-defined regulatory framework to provide affordable and reliable access to medicines for all Australians.