EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 42 OF 2009
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 119 of 2008 which came into effect on 1 December 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 June 2009, was made on 1 May 2009.
Consultations
The Department consulted with the Pharmaceutical Benefits Advisory Committee (PBAC) during the regular process of its meetings to consider applications in order to recommend to the Minister which medicines should be subsidised through the Pharmaceutical Benefits Scheme. The Committee is independent of Government and includes members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. The Committee has received submissions and representations from interested pharmaceutical companies and has recommended the changes to the Minister who has determined the changes to the conditions under paragraph 98C(1)(b) which appear in this Determination.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 June 2009.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 4
Listed Drugs Deleted
Metoprolol succinate
Oestrogens―Conjugated with Medroxyprogesterone
Overview
The National Health Act 1953, enacted by the Commonwealth Parliament, provides the legislative framework for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to a broad range of affordable and reliable medicines. The Act was amended in 2009 through the National Health Amendment Determination (No. 42) 2009 (F2009L01714), which modifies the conditions under which payments are made for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. This amendment was introduced to address the need for updating and refining the conditions governing payments under the PBS, ensuring the scheme remains effective and responsive to changes in the pharmaceutical landscape. The Minister for Health determined these changes following consultations with the Pharmaceutical Benefits Advisory Committee, an independent body comprising experts from various health-related fields, ensuring a balanced and comprehensive review of the PBS.
Scope and Application
The National Health Act 1953, as amended by the National Health Amendment Determination under Paragraph 98C(1)(b) (instrument number PB 42 of 2009), applies to the Pharmaceutical Benefits Scheme (PBS), which is the legislative basis for providing reliable, timely, and affordable access to a wide range of medicines for all Australians. This Act governs the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The Act applies to all persons and entities involved in the supply of pharmaceutical benefits, including pharmaceutical companies, healthcare providers, and patients. The geographic reach of the Act is national, as it is a Commonwealth Act, and it extends to all states and territories within Australia. The Act includes exclusions and thresholds, such as specific listed drugs that are not covered under the PBS, and it can be extended or restricted through subordinate instruments such as legislative instruments made by the Minister. The amendments made by this instrument are set out in the items of Schedule 1 to the instrument, which include the deletion of certain listed drugs from the PBS.
Key Provisions
The main sections of this legislative instrument, specifically the National Health Act 1953 Amendment Determination under paragraph 98C(1)(b), concern the conditions under which payments are made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. These conditions are detailed in the determination, which outlines how the Pharmaceutical Benefits Scheme (PBS) operates. Section 85(1) stipulates that benefits are provided by the Commonwealth in accordance with Part VII of the Act, while section 85(2) allows the Minister to declare drugs and medicinal preparations as listed drugs through legislative instruments. Subsections 85(3), 85(5), and 85(6) empower the Minister to determine the form, administration, and brand of pharmaceutical items, respectively, which in turn govern the pharmaceutical benefit under Part VII of the Act.
The obligations and requirements imposed by the Act on the parties governed by it include ensuring that pharmaceutical benefits are provided in accordance with the conditions set out in the determination. Approved pharmacists and approved medical practitioners must adhere to these conditions when supplying pharmaceutical benefits, ensuring that the benefits provided are in line with the PBS framework. Additionally, the Minister has the authority to determine a responsible person for a brand of a pharmaceutical item under section 84AF, which may involve specific obligations related to the management and supply of listed drugs.
Offences, penalties, or civil/criminal consequences for breaches of the Act are not explicitly detailed in this particular determination, but the Act as a whole includes provisions for penalties. Typically, non-compliance with the conditions set forth in the determination could lead to civil or criminal penalties, depending on the severity and nature of the breach. For instance, providing pharmaceutical benefits outside the specified conditions could result in fines or other sanctions as stipulated under the relevant sections of the Act. However, for specific penalties and enforcement details, one would need to refer to the broader legislative framework of the National Health Act 1953.