EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 112 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 December 2009, was made on 12 November 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 December 2009.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 4
Addition of Listed Drugs
Calcipotriol with betamethasone |
Polyethylene glycol 400 |
Deletion of Form
Calcipotriol Ointment 50 micrograms per g, 30 g
Overview
The National Health Act 1953 Amendment Determination under paragraph 98C(1)(b), instrument number PB 112 of 2009, addresses the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This amendment, enacted by the Australian Parliament, seeks to refine and update the existing framework of the Pharmaceutical Benefits Scheme (PBS) to ensure it continues to provide reliable, timely, and affordable access to a wide range of medicines for all Australians. The policy objective is to align the conditions of payments with the current requirements of the PBS, ensuring that the scheme operates efficiently and effectively. The determination, which amends the previous legislative instrument made in 2008, includes specific changes such as the addition of listed drugs like Calcipotriol with betamethasone and Polyethylene glycol 400, and the deletion of certain forms of listed drugs, reflecting the outcomes of consultations with the Pharmaceutical Benefits Advisory Committee and other stakeholders.
Scope and Application
The National Health Act 1953, through its Amendment Determination under paragraph 98C(1)(b), governs the conditions under which payments for pharmaceutical benefits will be made by the Commonwealth to approved pharmacists and approved medical practitioners. This legislation applies to all entities and individuals involved in the supply of pharmaceutical benefits as part of the Pharmaceutical Benefits Scheme (PBS). The PBS ensures Australians have access to a wide range of affordable medicines. The Act's jurisdiction extends nationally, covering all states and territories within Australia. The Minister has the authority to determine the specific conditions, forms, and brands of drugs that qualify for benefits, which are listed by legislative instruments. Notably, the Act includes exclusions such as certain medicinal preparations with additives. This Amendment Determination modifies the conditions of payments effective from 1 December 2009, adjusting the terms set forth in the previous legislative instrument, PB 119 of 2008. The changes, outlined in Schedule 1, include the addition of new listed drugs such as Calcipotriol with betamethasone and Polyethylene glycol 400, while also removing certain forms of Calcipotriol Ointment.
Key Provisions
The main operative sections of this legislation pertain to the amendments made to the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. Specifically, section 85(1) outlines the provision of benefits by the Commonwealth, while section 85(2) details the declaration of listed drugs by the Minister. Additionally, section 85(3) allows the Minister to determine the form of a listed drug, section 85(5) addresses the manner of administration, and section 85(6) specifies the brand of the pharmaceutical item. The amendments made by this legislative instrument (F2009L04263) concern the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as provided under section 98C(1)(b).
The obligations imposed by the Act on the parties it governs include the requirement for the Minister to determine the form, manner of administration, and brand of pharmaceutical items listed under the PBS. Furthermore, the Minister must ensure that payments are made in accordance with the conditions specified in the amended determination. Approved pharmacists and approved medical practitioners must comply with these conditions to receive payments for the supply of pharmaceutical benefits.
The Act imposes penalties and consequences for breaches of its provisions. Under section 98C(1)(b), the Minister has the authority to determine the conditions for payments, and failure to adhere to these conditions can result in civil or criminal consequences. The maximum penalties for breaches are not explicitly stated in the provided text but would typically be outlined in the relevant sections of the Act or in associated regulations. Compliance with the Act is crucial for all parties involved to avoid potential legal ramifications.