EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 18 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 February 2008, was made on 2 January 2008.
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 February 2008.
Paragraph 2: provides that Schedule 1 amends PB 52 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 4
Listed Drug and Form Alteration
From:
Metoprolol Pack containing 15 tablets metoprolol succinate 23.75 mg (controlled release), 15 tablets metoprolol succinate 47.5 mg (controlled release) and 15 tablets metoprolol succinate 95 mg (controlled release)
To:
Metoprolol Pack containing 15 tablets 23.75 mg (controlled release), 15 tablets 47.5 mg
succinate (controlled release) and 15 tablets 95 mg (controlled release)
Overview
The National Health Act 1953, enacted by the Parliament of Australia, forms the legislative basis for the Pharmaceutical Benefits Scheme (PBS), which ensures all Australians have reliable, timely, and affordable access to a wide range of medicines. This Act was introduced to address the need for a structured and equitable system for distributing pharmaceutical benefits. Under the authority provided by the Act, the Minister for Health and Ageing determines the conditions for Commonwealth payments related to the supply of pharmaceutical benefits by approved pharmacists and medical practitioners. The 2008 amendment to this Act, specifically the Amendment Determination under paragraph 98C(1)(b), refines the conditions for such payments, ensuring the PBS remains effective and responsive to the evolving healthcare needs of the population. This legislative instrument, which came into effect on 1 February 2008, reflects ongoing policy objectives to maintain the integrity and efficiency of the PBS.
Scope and Application
The National Health Act 1953, as amended by the F2008L00039 instrument, applies to all persons and entities involved in the supply of pharmaceutical benefits, including approved pharmacists and medical practitioners, and governs the conditions under which these benefits are provided. The Act's jurisdiction extends across the Commonwealth of Australia, ensuring that all Australians have access to affordable and reliable medications. The Pharmaceutical Benefits Scheme (PBS) is managed by the Commonwealth, and the Minister for Health and Ageing is responsible for determining the drugs and forms that qualify for benefits. The Pharmaceutical Benefits Advisory Committee (PBAC) provides recommendations on which drugs should be included in the PBS, taking into account factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness. The instrument specifies that the amendments to the determination under section 98C(1)(b) of the Act will take effect from 1 February 2008, modifying the conditions for payments concerning the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners as outlined in Schedule 1 of the instrument.
Key Provisions
The primary operative sections of this legislation (sections 84, 85, 84AF, and 98C) establish the framework for the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. Section 85(1) specifies that the Commonwealth provides pharmaceutical benefits as outlined in Part VII, while section 85(2) allows the Minister to declare drugs and medicinal preparations as part of the PBS. Section 85(3) and 85(5) further detail the form and administration of these drugs, and section 85(6) allows for the identification of specific pharmaceutical brands. Section 84AF provides authority for the Minister to designate a responsible person for pharmaceutical brands. The most relevant section, 98C(1)(b), empowers the Minister to determine the conditions under which payments will be made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
The Act imposes several obligations and requirements on the parties involved. Firstly, the Pharmaceutical Benefits Advisory Committee (PBAC) must recommend the inclusion of a drug or medicinal preparation in the PBS before the Minister can declare it under section 85(2). This recommendation process, detailed in section 100A and subsection 101(4), ensures that only medicines meeting certain criteria for medical use, clinical effectiveness, safety, and cost-effectiveness are considered. Additionally, approved pharmacists and approved medical practitioners must adhere to the conditions set out by the Minister under section 98C(1)(b) to be eligible for payments for supplying pharmaceutical benefits. These conditions are detailed in the Schedule 1 amendments made by this instrument.
There are no specific offences, penalties, or civil/criminal consequences outlined in the explanatory statement for breaches of the conditions set by the Minister under section 98C(1)(b). However, failure to comply with the recommendations of the PBAC or the conditions specified by the Minister could result in non-compliance with the Act, potentially leading to legal repercussions. The legislation ensures that the PBS operates efficiently and effectively, providing Australians with access to necessary and affordable medicines, while also maintaining strict oversight and control over the types of drugs available under the scheme.