EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 15 OF 2012
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.
Changes to PB 119 of 2008 made by this instrument
This instrument amends Schedule 4 of PB 119 of 2008 by deleting the pharmaceutical item oestradiol in the form transdermal patches 8 mg, 8.
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.
General
The instrument commences on 1 April 2012.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The National Health Act 1953, enacted by the Australian Parliament, provides the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have reliable, timely, and affordable access to a range of medicines. The Act authorises the Minister for Health to determine, among other things, the conditions under 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 introduced by the National Health Amendment (No. 1) Instrument 2012 (PB 15 of 2012) provide for changes to these conditions, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). This instrument, which came into effect on 1 April 2012, modifies the previous legislative instrument PB 119 of 2008, by altering the conditions for payments in respect of certain pharmaceutical benefits. The PBAC, which comprises members from various sectors including consumers, health economists, and medical specialists, plays a pivotal role in advising the Minister on which medicines should be subsidised under the PBS.
Scope and Application
The National Health Act 1953, through its Amendment Determination under paragraph 98C(1)(b), governs the conditions for payments made by the Commonwealth concerning the supply of pharmaceutical benefits. These payments are facilitated by approved pharmacists and approved medical practitioners as per the Pharmaceutical Benefits Scheme (PBS). The Act applies to the Minister for Health who, by legislative instrument, declares drugs and medicinal preparations to be subject to the provisions of Part VII, which governs the PBS. This includes determining the form, manner of administration, and brand of pharmaceutical items. The Minister may also determine the conditions under which payments will be made for the supply of these pharmaceutical benefits, as per the determinations set out in Schedule 1 of the instrument. The changes introduced by this instrument, which amend the earlier legislative instrument PB 119 of 2008, specifically pertain to the deletion of the pharmaceutical item oestradiol in the form of transdermal patches 8 mg, 8. The instrument, which takes effect from 1 April 2012, is subject to consultation with the Pharmaceutical Benefits Advisory Committee and operates within the national jurisdiction of Australia.
Key Provisions
The main operative sections of this legislative instrument amend the determination under paragraph 98C(1)(b) of the National Health Act 1953, which sets out the conditions for payments made by the Commonwealth regarding the supply of pharmaceutical benefits. This change is specified in Schedule 1, which deletes the pharmaceutical item oestradiol in the form of transdermal patches 8 mg, 8. The Pharmaceutical Benefits Scheme (PBS) under Part VII of the Act is governed by these determinations, which detail the conditions for Commonwealth payments for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners.
The Act imposes several obligations and requirements on parties involved in the PBS. Firstly, the Minister is responsible for determining the conditions under which payments will be made for pharmaceutical benefits. This includes determining the forms of listed drugs, their manner of administration, and the brands of pharmaceutical items. The Minister must consult with the Pharmaceutical Benefits Advisory Committee (PBAC), which provides recommendations based on submissions from various stakeholders including consumers, health economists, and medical professionals. The Act also mandates that the Minister declare by legislative instrument which drugs and medicinal preparations are covered under the PBS, with the exception of some medicinal preparations with additives.
In terms of civil and criminal consequences for breach, the Act does not explicitly state penalties for non-compliance with the provisions of the PBS. However, breaches of the Act or its regulations could potentially lead to civil penalties, such as fines, or criminal charges if the breach is deemed to be of a serious nature. The specific penalties would depend on the nature and severity of the breach, as well as any applicable regulations or subsidiary legislation. The determinations made under the Act are subject to review and amendment, as evidenced by the changes to PB 119 of 2008 made by this instrument, reflecting ongoing adjustments to the scheme based on recommendations from the PBAC and other consultations.