EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 4 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER PARAGRAPH 98C(1)(b)
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 to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).
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 what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act. Under section 84AF, the Minister may determine a responsible person for a brand of a pharmaceutical item.
Paragraph 98C(1)(b) of the Act provides that the Minister may, from time to time, determine the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
The determination under paragraph 98C(1)(b) of the Act sets out the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
This legislative instrument amends the determination under section 98C(1)(b) made by legislative instrument number PB 52 of 2007 which came into effect on 1 August 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 January 2007, was made on 19 November 2007.
Consultations
The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits. Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared. When recommending a medicine be listed 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 2008.
Paragraph 2: provides that Schedule 1 amends PB 52 of 2007.
Schedule 1: provides for the amendment of SCHEDULE 4 [addition of Varenicline, Box containing 11 tablets 0.5 mg (as tartrate) and 14 tablets 1 mg (as tartrate) in the first pack and 28 tablets 1 mg (as tartrate) in the second pack]
Overview
The National Health Act 1953, enacted by the Commonwealth Parliament, serves as the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which aims to ensure that Australians have dependable, timely, and cost-effective access to a broad spectrum of medicines. Under this Act, the Commonwealth is mandated to provide benefits in accordance with Part VII, with drugs and medicinal preparations being declared by the Minister through legislative instruments. The 2008 amendment to the Act, specifically the determination under paragraph 98C(1)(b), refines the conditions governing payments made for the supply of pharmaceutical benefits by approved pharmacists and medical practitioners. This amendment, effective from 1 January 2008, was made to incorporate the addition of Varenicline, a medication used for smoking cessation, into the PBS, thereby extending the range of treatments available under the scheme. The policy objective of these amendments is to enhance the availability of essential medications to the public, ensuring they receive effective treatment in a cost-efficient manner.
Scope and Application
The F2007L04466 National Health Act 1953 Amendment Determination, issued under paragraph 98C(1)(b) of the National Health Act 1953, governs the conditions under which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The Act applies to the Minister for Health and Ageing, who has the authority to determine these conditions, and it impacts pharmaceutical benefits provided through the Pharmaceutical Benefits Scheme (PBS), which ensures reliable, timely, and affordable access to a wide range of medicines for all Australians. The Act operates on a national level, affecting entities involved in the supply of pharmaceutical benefits, including pharmaceutical companies, pharmacists, and medical practitioners. The determination includes amendments to the conditions set forth in the original determination made by legislative instrument number PB 52 of 2007, which became effective on 1 August 2007. The amendments, detailed in Schedule 1, include the addition of Varenicline in specific dosages to the list of drugs covered by the PBS. The instrument itself is effective from 1 January 2008 and is subject to changes and updates through subordinate instruments.
Key Provisions
The primary sections of this legislation, specifically sections 84, 85, 84AF, and 98C(1)(b), outline the framework for the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. Section 85(1) mandates that the Commonwealth provide benefits in accordance with Part VII of the Act, which concerns pharmaceutical benefits. This includes the declaration of drugs and medicinal preparations that are subject to the PBS (section 85(2)). The Minister, through legislative instruments, can also determine the form or manner of administration of these drugs, as well as specific brands (sections 85(3), 85(5), and 85(6)). Furthermore, section 84AF allows the Minister to designate a responsible person for a brand of a pharmaceutical item. Lastly, section 98C(1)(b) empowers the Minister to establish the conditions under which payments for pharmaceutical benefits are made by approved pharmacists and medical practitioners.
The obligations imposed by this legislation are primarily on the Minister for Health and Ageing, who is responsible for declaring drugs and medicinal preparations for inclusion in the PBS and determining the specific forms, administration methods, and brands eligible for benefits. The Pharmaceutical Benefits Advisory Committee (PBAC), established under section 100A of the Act, plays a crucial role by recommending which drugs should be included in the PBS based on clinical effectiveness, safety, and cost-effectiveness. Moreover, any drug or medicinal preparation cannot be declared under Part VII unless recommended by the PBAC (subsection 101(4)).
Failure to comply with the provisions of this legislation can lead to civil or criminal consequences, although specific penalties are not detailed within the explanatory statement. Typically, breaches of the National Health Act 1953, such as unauthorized supply of pharmaceutical benefits or non-compliance with declared conditions, can result in substantial fines or imprisonment. The exact penalties would depend on the nature and severity of the breach, as outlined in other sections of the Act. The amendments introduced by this legislative instrument aim to refine the conditions for payments concerning the supply of pharmaceutical benefits, ensuring that the PBS remains effective and accessible for all Australians.