EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 30 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 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 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 April 2008, was made on 3 March 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 April 2008.
Paragraph 2: provides that Schedule 1 amends PB 88 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Addition of Listed Drugs
Benzathine benzylpenicillin
Paliperidone
Alteration of Circumstances
Docetaxel
Famciclovir [tablet 250 mg]
Methylphenidate [addition of capsule containing methylphenidate hydrochloride 20 mg (modified release), capsule containing methylphenidate hydrochloride 30 mg (modified release) and capsule containing methylphenidate hydrochloride 40 mg (modified release)]
Oestradiol [deletion of nasal spray containing oestradiol hemihydrate 150 micrograms per actuation,
60 actuations, 4.2 mL]
Pemetrexed
Tacrolimus
Terbinafine
SCHEDULE 1A
Addition of Listed Drug
Fentanyl
SCHEDULE 2
Addition of Listed Drug
Benzathine benzylpenicillin
SCHEDULE 6
Addition of Listed Drug
Sitaxentan
Overview
The National Health Act 1953, as amended by the instrument F2008L00691, addresses the need for a reliable, timely, and affordable access to a wide range of medicines for all Australians through the Pharmaceutical Benefits Scheme (PBS). The Act provides the legislative basis for the PBS, which is overseen by the Commonwealth and implemented through the Minister for Health, who declares and determines the form, administration, and brand of listed drugs. The instrument, made under the authority of subsections 85(2), 85(2AA), and 85(2A) of the Act, updates the list of drugs and medicinal preparations available under the PBS based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). This committee, an independent expert body, evaluates the medical conditions for which medicines have been approved, their clinical effectiveness, safety, and cost-effectiveness. The amendments made by this instrument, effective from 1 April 2008, include the addition of new drugs such as Benzathine benzylpenicillin, Paliperidone, and Fentanyl, as well as modifications to the circumstances under which certain drugs are listed, reflecting the ongoing need to balance access to necessary medications with fiscal responsibility and efficacy.
Scope and Application
The National Health Act 1953 Amendment Declaration under Subsections 85(2) and 85(2AA) Amendment Determination under Subsection 85(2A) applies to the Pharmaceutical Benefits Scheme (PBS), which ensures reliable, timely, and affordable access to a wide range of medicines for Australians. The Act applies to pharmaceutical benefits provided by the Commonwealth and is administered by the Minister, who can declare drugs and medicinal preparations as listed drugs through legislative instruments. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in this process, making recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits, based on their medical conditions, clinical effectiveness, safety, and cost-effectiveness. The amendment determination under this Act specifies which drugs and medicinal preparations are included in the PBS and governs what constitutes the pharmaceutical benefit under Part VII of the Act. This instrument, which came into effect on 1 April 2008, amends previous declarations and determinations by adding and altering listed drugs, ensuring the PBS remains up to date with the latest medical advancements.
Key Provisions
The main operative sections of this legislation, as outlined in the explanatory statement, are subsections 85(2), 85(2AA), and 85(2A) of the National Health Act 1953. Subsection 85(1) mandates that the Commonwealth provides benefits in accordance with Part VII, which governs the Pharmaceutical Benefits Scheme (PBS). Subsection 85(2) allows the Minister to declare by legislative instrument which drugs and medicinal preparations are subject to the PBS. Subsection 85(2AA) empowers the Minister to revoke or vary such declarations, while subsection 85(2A) allows the Minister to determine the form, administration, and brand of a listed drug. These provisions are essential for maintaining the integrity of the PBS by ensuring that only specified drugs and preparations are covered and that the details of their administration and form are clearly defined.
The obligations imposed by this Act on the parties and entities it governs are primarily administrative and procedural. The Minister, in consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), must ensure that only recommended drugs and medicinal preparations are included in the PBS list. The PBAC, an independent expert body, must provide recommendations to the Minister based on factors such as the medical conditions for which the medicine is approved, its clinical effectiveness, safety, and cost-effectiveness. The Minister must obtain PBAC advice in writing before revoking or varying any declarations, and this advice must be tabled in Parliament. The Act also requires the Minister to ensure that the PBS remains accessible and affordable, maintaining the balance between cost and quality of healthcare for Australians.
Breaches of this legislation can lead to civil or criminal consequences. While the explanatory statement does not specify maximum penalties, penalties for non-compliance with health and safety regulations can vary. Typically, civil penalties can include fines that are substantial enough to deter non-compliance, while criminal penalties can include imprisonment, depending on the severity and intent behind the breach. The precise penalties would be determined by the specific regulations and statutes under which the breach is prosecuted. Additionally, failure to follow the recommended procedures for listing or delisting drugs can result in legal challenges and reputational damage for both the Minister and the PBAC.
Overall, this legislation is designed to ensure that the PBS operates efficiently and effectively, providing reliable access to necessary medications. The involvement of the PBAC in the decision-making process ensures that the recommendations are based on expert medical and economic advice, which is crucial for the sustainability and efficacy of the PBS. The procedural requirements for the Minister and the PBAC are designed to maintain transparency and accountability in the administration of the PBS.