EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 111 OF 2010
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 December 2010.
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 December 2010.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 4
Addition of Item
Degarelix | Powder for injection 120 mg (as acetate) with solvent, syringe and needles, 2 |
Deletion of Form
Macrogol 3350 | Sachets containing powder for oral solution 6.563 g with electrolytes, 30 |
Overview
The National Health Act 1953, as amended by the legislative instrument numbered PB 111 of 2010, addresses the need for updating the conditions under which payments are made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This legislative instrument, which came into effect on 1 December 2010, is an amendment to an earlier legislative instrument (PB 119 of 2008) and aims to implement the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent committee comprising experts from various healthcare sectors, provides advice to the Minister on which medicines should be subsidised under the Pharmaceutical Benefits Scheme (PBS). The policy objective of this amendment is to ensure that the PBS remains responsive to the evolving healthcare needs of Australians by updating the conditions for pharmaceutical benefit payments, thereby maintaining the scheme's reliability, timeliness, and affordability.
Scope and Application
The National Health Act 1953, as amended by the legislative instrument F2010L03128, governs the provision of pharmaceutical benefits in Australia through the Pharmaceutical Benefits Scheme (PBS). This Act applies to approved pharmacists and approved medical practitioners who supply pharmaceutical benefits. The amended determination under paragraph 98C(1)(b) sets out the conditions for Commonwealth payments regarding these supplies. The legislation encompasses the geographic jurisdiction of the Commonwealth, extending its reach to all states and territories in Australia. The determination does not specify any exclusions or exemptions, but it does outline specific thresholds and conditions that must be met for payments to be made. The Minister retains the authority to extend or restrict the application of these provisions through subordinate instruments, ensuring that the PBS remains responsive to changing healthcare needs and recommendations from the Pharmaceutical Benefits Advisory Committee. The instrument takes effect from 1 December 2010, implementing the changes recommended by the PBAC to ensure that the scheme remains effective and accessible for all Australians.
Key Provisions
The main operative sections of this legislative instrument, under the National Health Act 1953, involve amendments to the conditions under which payments will be made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners (paragraph 98C(1)(b)). Specifically, Schedule 1 of the instrument introduces changes to the listed drugs and their forms, as well as the conditions for payments related to these drugs. These amendments are a response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and are aimed at updating the Pharmaceutical Benefits Scheme (PBS) to reflect the latest clinical and cost-effectiveness data.
The obligations and requirements imposed by this Act on the parties it governs include ensuring that any pharmaceutical benefits supplied meet the conditions set out in the amended determination. This involves approved pharmacists and approved medical practitioners adhering to the specific forms and brands of pharmaceutical items that are now eligible for Commonwealth payments. The Minister's determinations under sections 85 and 84AF of the Act play a crucial role in defining which drugs and forms are covered, and under what conditions payments will be made. These obligations necessitate that practitioners stay informed about the changes and ensure their practices comply with the updated conditions.
Offences and penalties for breach of this Act are not explicitly detailed in the legislative instrument but can be inferred from the broader legislative framework of the National Health Act 1953. Generally, failure to comply with the conditions set forth in the PBS can result in civil or criminal consequences, including fines and potential exclusion from the scheme. The penalties for non-compliance can vary based on the severity and intent of the breach, but specific maximum penalties would be detailed in the overarching Act rather than this particular instrument.
In summary, this legislative instrument amends the conditions for Commonwealth payments for pharmaceutical benefits under the PBS. It imposes specific obligations on approved pharmacists and approved medical practitioners to adhere to the new conditions regarding drug forms and brands. Breaches of these conditions can lead to significant civil or criminal penalties, underscoring the importance of compliance with the updated provisions.