EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 52 OF 2011
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER PARAGRAPH 98C(1)(b)
Summary
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) 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 provide for changes to 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 amendments are set out in the items of Schedule 1 to the instrument.
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.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument constitutes a legislative instrument for the purposes of the Legislative Instruments Act 2003.
This instrument commences on 1 August 2011.
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 August 2011.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 3
Addition of Forms
Fentanyl | Lozenges 200 micrograms (as citrate), 30 Lozenges 400 micrograms (as citrate), 30 Lozenges 600 micrograms (as citrate), 30 Lozenges 800 micrograms (as citrate), 30 Lozenges 1200 micrograms (as citrate), 30 Lozenges 1600 micrograms (as citrate), 30 Transdermal patch 2.55 mg Transdermal patch 5.10 mg Transdermal patch 7.65 mg Transdermal patch 10.20 mg |
Overview
The National Health Act 1953, enacted by the Australian Parliament, establishes the legislative framework for the Pharmaceutical Benefits Scheme (PBS), ensuring Australians have access to affordable and timely medicines. This Act allows the Commonwealth to provide benefits in respect of pharmaceutical benefits through approved pharmacists and medical practitioners. The Pharmaceutical Benefits Advisory Committee (PBAC) advises the Minister on which medicines should be subsidised, and based on these recommendations, the Minister may determine the conditions under which payments will be made. The instrument F2011L01544, which came into effect on 1 August 2011, amends a previous determination under section 98C(1)(b) to update the conditions for payments in respect of the supply of pharmaceutical benefits. These amendments follow the PBAC's recommendations and are intended to refine the criteria and administration of the PBS, ensuring it continues to meet the health needs of Australians effectively.
Scope and Application
The National Health Act 1953 governs the Pharmaceutical Benefits Scheme (PBS), under which the Commonwealth provides access to a range of medicines for all Australians. Under the Act, the Minister declares drugs and medicinal preparations to be listed drugs through legislative instruments, and these instruments also determine the form and manner of administration of these drugs, as well as the brands associated with them. The Act applies to these declared pharmaceutical items and the persons and entities involved in their supply, including approved pharmacists and approved medical practitioners. The legislation applies nationally, as it is a Commonwealth Act. This particular legislative instrument amends the conditions under which payments are made by the Commonwealth for the supply of pharmaceutical benefits, following recommendations from the Pharmaceutical Benefits Advisory Committee. The instrument specifies the forms and brands of particular drugs that are subject to these amended conditions. This instrument constitutes a legislative instrument under the Legislative Instruments Act 2003 and commenced on 1 August 2011. The Minister made this determination after consulting with the Pharmaceutical Benefits Advisory Committee, which includes representatives from various health-related interests and professions.
Key Provisions
The primary operative sections of this legislative instrument (F2011L01544) pertain to the amendments made to the determination under paragraph 98C(1)(b) of the National Health Act 1953, which governs the conditions for Commonwealth payments regarding the supply of pharmaceutical benefits by approved pharmacists and medical practitioners. These amendments, effective from 1 August 2011, are detailed in Schedule 1 to the instrument and are based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). Specifically, they introduce changes to the conditions under which the Commonwealth will make payments for the supply of pharmaceutical benefits by approved pharmacists and medical practitioners.
The amendments imposed by this Act require that approved pharmacists and medical practitioners adhere to the newly set conditions for the supply of pharmaceutical benefits. This includes compliance with the new forms of pharmaceutical items, such as the various dosages of Fentanyl lozenges and transdermal patches, which are now listed under the Act. The Act also mandates that the Minister's determinations regarding the form, administration, and brand of pharmaceutical items must be followed meticulously. These conditions are crucial in ensuring that the Pharmaceutical Benefits Scheme (PBS) remains effective in providing reliable, timely, and affordable access to medicines for all Australians.
The instrument imposes several obligations on the parties it governs. Approved pharmacists and medical practitioners must ensure that the pharmaceutical benefits they supply comply with the new conditions outlined in the Act. This includes adherence to the specific forms and dosages of listed drugs, such as the various Fentanyl lozenges and transdermal patches. Furthermore, they must ensure that their supply practices align with the Minister's determinations regarding the form, administration, and brand of pharmaceutical items. Failure to comply with these obligations could result in the Commonwealth not making payments for the supplied pharmaceutical benefits.
In terms of consequences for breach, the Act does not explicitly detail specific offences, penalties, or consequences for non-compliance within the provided text. However, it is reasonable to infer that non-compliance with the conditions set forth in the Act could lead to the Commonwealth withholding payments for supplied pharmaceutical benefits. Given that the Act is part of the legislative framework supporting the PBS, any significant non-compliance could potentially undermine the effectiveness of the scheme, leading to broader implications for public health and access to essential medications. The precise legal ramifications would need to be interpreted in the context of the broader legislative framework and any relevant case law.