EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 118 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 declare changes to the list of drugs and medicinal preparations available as pharmaceutical benefits and the circumstances in which the pharmaceutical benefits may be prescribed. 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 2010, was made on
4 December 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 January 2010.
Paragraph 2: provides that Schedule 1 amends PB 113 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Alteration of Circumstances
Adalimumab | [amendment of circumstances for the initial treatment of adult patients with severe active rheumatoid arthritis] |
Anakinra | [amendment of circumstances for the initial treatment of adult patients with severe active rheumatoid arthritis] |
Etanercept | [amendment of circumstances: (a) for the initial treatment of adult patients with severe active rheumatoid arthritis, and (b) for the initial treatment of patients 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis] |
Glucose Indicator—Blood | [alteration of the ‘electrode strips, 50 (Accu-Chek Performa)’ to ‘test strips, 100 (Accu-Chek Performa)’ and the alteration in each instance of the description ‘electrode strips’ or ‘reagent strips’ to ‘test strips’] |
SCHEDULE 3
Addition of Allowable Compound
Tenofovir with Emtricitabine and Efavirenz |
SCHEDULE 6
Addition of Listed Drug
Tenofovir with emtricitabine and efavirenz |
Overview
The National Health Act 1953 Amendment Declaration under Subsections 85(2) and 85(2AA) Amendment Determination under Subsection 85(2A) (F2009L04558) was enacted in 2009 to address the need for updated declarations and determinations concerning the Pharmaceutical Benefits Scheme (PBS). The PBS, established under the National Health Act 1953, ensures Australians have reliable, timely, and affordable access to a wide range of medicines. This legislation was enacted by the Parliament of Australia and aims to provide the necessary flexibility to the Minister of Health to amend the list of drugs and the conditions under which they can be prescribed, in alignment with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC).
The amendments outlined in this legislative instrument were made to incorporate the recommendations of the PBAC regarding changes to the list of drugs and the circumstances under which pharmaceutical benefits may be prescribed. This includes altering the circumstances for specific drugs and adding new allowable compounds and listed drugs, as detailed in Schedules 1, 3, and 6 of the instrument. The instrument, which commenced on 1 January 2010, also includes provisions for the revocation or variation of previous declarations and determinations, ensuring the PBS remains current and responsive to the needs of the Australian population.
Scope and Application
The National Health Act 1953, as amended by this legislative instrument, applies to the provision of pharmaceutical benefits in Australia through the Pharmaceutical Benefits Scheme (PBS). The Act governs the listing of drugs and medicinal preparations that are available as pharmaceutical benefits, as well as the circumstances under which these benefits may be prescribed. This legislative instrument, which comes into effect on 1 January 2010, amends previous declarations and determinations to update the list of drugs and medicinal preparations eligible for pharmaceutical benefits and to alter the circumstances in which these benefits can be prescribed. The amendments are applicable nationally, affecting all entities and individuals involved in the provision and administration of pharmaceutical benefits in Australia. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body, plays a crucial role in recommending which drugs and medicinal preparations should be available as pharmaceutical benefits, ensuring that the amendments reflect clinical effectiveness, safety, and cost-effectiveness. The PBAC's advice is mandatory for the Minister to consider before making declarations or determinations under the Act.
The amendments specified in this instrument are set out in the Schedule and include changes to the listing of drugs for specific medical conditions, such as rheumatoid arthritis, and the addition of new pharmaceutical preparations like Tenofovir with Emtricitabine and Efavirenz. These changes are designed to improve access to essential medicines and ensure that the PBS remains responsive to medical needs and advancements. Any revocations or variations of existing declarations must be accompanied by written advice from the PBAC and tabled in Parliament, as mandated by the Act. This legislative instrument ensures the ongoing relevance and efficacy of the PBS in providing reliable, timely, and affordable access to medicines for all Australians.
Key Provisions
The main operative sections of this legislative instrument, expressed to commence on 1 January 2010, involve amendments to the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. These amendments are primarily detailed in Schedule 1 and relate to changes in the list of drugs and medicinal preparations available as pharmaceutical benefits and the circumstances in which these benefits may be prescribed. For example, the alterations to the circumstances for the initial treatment of adult patients with severe active rheumatoid arthritis for drugs such as Adalimumab, Anakinra, and Etanercept are outlined in Schedule 1 (subsections 85(2) and 85(2AA)). Additionally, there are changes to the form of the pharmaceutical benefit, such as the alteration from 'electrode strips' to 'test strips' for Glucose Indicator—Blood (subsection 85(3)). The instrument also includes additions to the list of allowable compounds and listed drugs, such as Tenofovir with Emtricitabine and Efavirenz, as detailed in Schedule 3 and Schedule 6, respectively.
The Act imposes several obligations on the parties and entities it governs. Firstly, the Minister is required to declare drugs and medicinal preparations under subsection 85(2), with any changes to these declarations to be made by legislative instrument (subsection 85(2AA)). Furthermore, the Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in this process by providing written advice to the Minister, which must be tabled in Parliament if a revocation or variation would result in a drug ceasing to be a listed drug (subsections 85(2AB) and 85(2AC)). The PBAC is an independent expert body established by section 100A, and its recommendations are based on the clinical effectiveness, safety, and cost-effectiveness of the drugs and medicinal preparations.
Failure to comply with the provisions of the Act may result in various consequences. While the explanatory statement does not specify any particular offences, penalties, or maximum penalties, breaches of the Act or the regulations made under it could potentially lead to civil or criminal consequences, depending on the nature and severity of the breach. For example, unauthorised changes to the list of drugs or medicinal preparations without following the required legislative process could be subject to legal action, including fines or other penalties as prescribed by the relevant legislation.
Overall, the legislative instrument aims to update the list of pharmaceutical benefits available under the PBS, ensuring that Australians have access to necessary and affordable medications. The involvement of the PBAC in the process ensures that recommendations are evidence-based and take into account various factors, such as clinical effectiveness, safety, and cost-effectiveness.