EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 8 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 February 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 February 2011.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 4
Deletion of Form
Hydrocortisone | Eye ointment containing hydrocortisone acetate 5 mg per g, 5 g |
Overview
The National Health Act 1953 was enacted to provide for national health security and to facilitate cooperation between the Commonwealth and the states in the provision of health services. This Act was introduced to address the need for a structured approach to managing health services and ensuring equitable access to health benefits across Australia. The Pharmaceutical Benefits Scheme (PBS), a key component of the Act, aims to provide reliable, timely, and affordable access to a wide range of medicines for all Australians. The Act empowers the Minister to determine the conditions under which payments are made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The 2011 amendments to the Act, made through legislative instrument number PB 8 of 2011, were introduced in response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). These amendments modify the conditions for payments concerning the supply of pharmaceutical benefits, ensuring that the scheme remains responsive to the evolving needs of the Australian population. The policy objective of these amendments is to maintain the integrity and effectiveness of the PBS in providing affordable and accessible medication to Australians.
Scope and Application
The National Health Act 1953 Amendment Determination under paragraph 98C(1)(b) amends the conditions governing payments made by the Commonwealth for the supply of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS). This legislation applies to approved pharmacists and approved medical practitioners who supply listed drugs declared by the Minister. The amendments, which came into effect on 1 February 2011, are based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body comprising members from various healthcare interests and professions. The Act provides a national framework for the PBS, ensuring reliable, timely, and affordable access to medicines for Australians. The Minister determines the form and manner of administration of listed drugs and the responsible persons for pharmaceutical brands, which are all subject to the conditions set out in the Act. These conditions, now amended, specify the circumstances under which payments will be made to approved pharmacists and approved medical practitioners for the supply of pharmaceutical benefits. The amendments are detailed in Schedule 1 of the instrument, which includes changes such as the deletion of certain forms of hydrocortisone eye ointment from the PBS.
Key Provisions
The main operative sections of this legislative instrument (F2011L00164) amend the conditions under which payments will be made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. Specifically, the amendments pertain to the forms of certain pharmaceutical items that are eligible for these payments (paragraph 98C(1)(b) of the National Health Act 1953). These amendments are detailed in Schedule 1 of the instrument, which specifies the changes to the existing determinations set out in PB 119 of 2008. The instrument is designed to reflect recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) and it came into effect on 1 February 2011.
The Act imposes several obligations and requirements on the parties involved. Firstly, the Minister must ensure that payments for pharmaceutical benefits are made according to the conditions specified in the amended determinations. Approved pharmacists and approved medical practitioners must adhere to these conditions when supplying pharmaceutical benefits to ensure they are eligible for Commonwealth payments. The Minister also has the responsibility to determine the conditions for such payments, and these determinations must be consistent with the overall objectives of the Pharmaceutical Benefits Scheme (PBS), which aims to provide reliable, timely, and affordable access to medicines for all Australians.
Failure to comply with the conditions set out in the amended determinations can lead to various consequences. While the specific offences, penalties, or consequences for breach are not detailed in the legislative instrument, the National Health Act 1953 and other related legislation likely provide for administrative, civil, or criminal penalties for non-compliance. For instance, the Act may specify penalties for fraudulent claims or misrepresentation, which could include fines or other sanctions. Approved pharmacists and approved medical practitioners who do not comply with the conditions may also face the risk of their payments being disallowed or recouped by the Commonwealth.
Additionally, the Pharmaceutical Benefits Scheme operates under a framework of regulations and guidelines that are designed to ensure the integrity and effectiveness of the scheme. Breaches of these conditions could also result in administrative actions, such as audits or investigations, to ensure compliance and protect the interests of the Commonwealth and the public. The consequences for non-compliance can thus range from financial penalties to more severe sanctions, depending on the nature and extent of the breach.