EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 26 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 April 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 April 2011.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 4
Addition of Listed Drug
Adapalene with benzoyl peroxide |
Overview
The National Health Act 1953, enacted by the Parliament of Australia, serves as the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures reliable, timely, and affordable access to a wide range of medicines for Australians. Under this Act, the Minister has the authority to determine conditions for payments related to the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This legislative instrument, PB 26 of 2011, amends the previous determination under section 98C(1)(b) of the Act, specifically updating the conditions for payments in respect of the supply of pharmaceutical benefits. These amendments are made in response to recommendations from the Pharmaceutical Benefits Advisory Committee and are designed to align with the policy objective of providing appropriate and efficient access to medications under the PBS. The changes, which include the addition of Adapalene with benzoyl peroxide to the listed drugs, aim to enhance the effectiveness of the Scheme by ensuring that the supply of pharmaceutical benefits meets the evolving healthcare needs of the Australian population.
Scope and Application
The National Health Act 1953, as amended by the legislative instrument PB 26 of 2011, governs the Pharmaceutical Benefits Scheme (PBS) under which the Commonwealth provides subsidised access to a wide range of medicines. This Act applies to all approved pharmacists and approved medical practitioners who supply pharmaceutical benefits, and the amendments outlined in PB 26 pertain specifically to the conditions governing Commonwealth payments for these benefits. The Act's jurisdictional reach is national, as it applies across all states and territories in Australia. The amendments, effective from 1 April 2011, concern the conditions under which payments will be made for the supply of pharmaceutical benefits, as determined by the Minister under paragraph 98C(1)(b) of the Act. These amendments are made in response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which includes representatives from various sectors such as consumers, health economists, and medical professionals. The legislative instrument includes specific changes, such as the addition of Adapalene with benzoyl peroxide as a listed drug, which is detailed in Schedule 1 of the instrument.
Key Provisions
The main sections of this legislation amend the National Health Act 1953, specifically the conditions under which payments are made for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners (paragraph 98C(1)(b)). These amendments are detailed in Schedule 1, which came into effect on 1 April 2011 (paragraph 1). The amendments were made following recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and include changes to the conditions of supply for certain pharmaceutical items, such as the addition of Adapalene with benzoyl peroxide as a listed drug (Schedule 4). This amendment allows for the Commonwealth to provide payments for the supply of this specific drug under the Pharmaceutical Benefits Scheme (PBS).
The Act imposes certain obligations on parties involved in the PBS. Approved pharmacists and approved medical practitioners must adhere to the conditions outlined in the determination under paragraph 98C(1)(b) when supplying pharmaceutical benefits. These conditions include criteria such as the form and manner of administration of the drugs, which are determined by the Minister (subsection 85(3), 85(5)). The Minister can also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF). Furthermore, the Minister must consult with the PBAC, which comprises experts from various relevant fields, before making these determinations.
Failure to comply with the conditions set out in the determination can result in significant consequences. While specific offences and penalties are not detailed in the provided text, it is common under Australian legislation for breaches of conditions in such schemes to be subject to both civil and criminal penalties. Typically, civil penalties might include fines, while criminal penalties could involve imprisonment, depending on the severity and intent of the breach. The exact penalties would be determined by the relevant courts and authorities enforcing the provisions of the National Health Act 1953. The Act, by its nature, aims to ensure that the PBS remains effective and accessible, thereby maintaining the health and well-being of the Australian population.