EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 92 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 74 of 2008 which came into effect on 1 August 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 October 2008, was made on 1 September 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 October 2008.
Paragraph 2: provides that Schedule 1 amends PB 74 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Alteration of Circumstances
Amoxycillin [deletion of tablet, chewable, 250 mg (as trihydrate)]
Rosiglitazone
Overview
The National Health Act 1953, as amended by the instrument F2008L03433, addresses the need for reliable, timely, and affordable access to a wide range of medicines for all Australians through the Pharmaceutical Benefits Scheme (PBS). Enacted by the Parliament of Australia, the Act provides the legislative basis for the PBS, which ensures that drugs and medicinal preparations are declared as listed drugs by the Minister, facilitating their inclusion on the PBS. The amendments introduced by this instrument serve to update the list of medicines covered under the PBS in line with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that the PBS remains responsive to the latest medical evidence and economic considerations. This approach helps maintain the balance between providing necessary treatments and controlling healthcare costs.
Scope and Application
The National Health Act 1953 Amendment Declaration under Subsections 85(2) and 85(2AA), and Amendment Determination under Subsection 85(2A) pertains to the Pharmaceutical Benefits Scheme (PBS) managed by the Commonwealth to ensure Australians have reliable, timely, and affordable access to a wide range of medicines. The Act applies to drugs and medicinal preparations that are declared by the Minister as listed drugs under subsection 85(2), as well as certain extemporaneously-prepared medicinal preparations. The Minister has the authority to determine the form, administration, and brand of these listed drugs by legislative instrument, which governs what constitutes a pharmaceutical benefit under Part VII of the Act. This legislative instrument, effective from 1 October 2008, amends previous declarations and determinations made under PB 74 of 2008, specifically addressing the listing and form of certain drugs such as Amoxycillin and Rosiglitazone. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending drugs for listing on the PBS, and their advice is mandatory for certain declarations, ensuring a balanced consideration of medical effectiveness, safety, and cost-effectiveness.
Key Provisions
The National Health Act 1953, particularly Part VII, is the foundational legislation for the Pharmaceutical Benefits Scheme (PBS), which ensures all Australians have access to affordable and reliable medications. Subsection 85(1) mandates that the Commonwealth provides these pharmaceutical benefits in accordance with Part VII. The Minister declares drugs and medicinal preparations that fall under Part VII by legislative instrument, as stated in subsection 85(2). These listed drugs are defined in subsection 84(1) and also include certain extemporaneously-prepared medicinal preparations under paragraph 85(2)(b). Furthermore, the Minister can determine the form and manner of administration of a listed drug, as well as specific brands, by legislative instrument under subsections 85(3), 85(5), and 85(6), respectively. Subsection 85(2AA) allows the Minister to revoke or vary these declarations by legislative instrument, but if this would result in a drug ceasing to be a listed drug, the Minister must obtain written advice from the Pharmaceutical Benefits Advisory Committee (PBAC) under subsection 85(2AB). This advice must then be tabled in Parliament as per subsection 85(2AC). A drug or medicinal preparation can only be declared under subsection 85(2)(a) if the PBAC has recommended it, as per subsection 101(4).
The obligations imposed by the Act require the Minister to ensure that the PBS operates smoothly and effectively. The Minister must consult with the PBAC, an independent body established by section 100A, which comprises experts from various fields relevant to pharmaceuticals. The PBAC's role is to recommend which drugs and medicinal preparations should be listed on the PBS based on factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness. The Minister's decisions on declarations and determinations must align with these recommendations. Additionally, the Minister must obtain and table PBAC advice when revoking or varying declarations that would result in a drug no longer being listed.
Failure to comply with the requirements of the Act can lead to significant consequences. While the explanatory statement does not specify particular offences or penalties, breaches of legislative instruments can generally result in civil or criminal penalties, depending on the nature and severity of the breach. For instance, non-compliance with PBS regulations might lead to fines or other enforcement actions. The Pharmaceutical Benefits Advisory Committee's recommendations are integral to the PBS's operation, and any failure to follow their advice when required could result in invalid declarations or determinations, leading to potential legal or administrative repercussions.