National Health Act 1953 - Amendment declaration under subsections 85(2) and 85(2AA) - Amendment determination under subsection 85(2A) - drugs and medicinal preparations (No. PB 86 of 2009)

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Legislation au F2009L03544 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 86 OF 2009

NATIONAL HEALTH ACT 1953

AMENDMENT DECLARATION UNDER SUBSECTIONS 85(2) AND 85(2AA)

    AMENDMENT DETERMINATION UNDER SUBSECTION 85(2A)

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 in relation to which Part VII applies are declared by the Minister by legislative instrument as such under subsection 85(2). These are listed drugs as defined in subsection 84(1).  Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).

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 (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.  

Subsection 85(2AA) empowers the Minister, by legislative instrument, to revoke or vary a declaration under subsection 85(2) in relation to a drug or medicinal preparation. 

Where a revocation or variation would have the result that a drug or medicinal preparation would cease to be a listed drug, the Minister must under subsection 85(2AB) obtain the advice in writing of the Pharmaceutical Benefits Advisory Committee (PBAC).  Under subsection 85(2AC), this PBAC advice is to be tabled in Parliament with the relevant declaration under subsection 85(2AA).  Subsection 101(4) further provides that a drug or medicinal preparation cannot be declared under paragraph 85(2)(a) to be a drug or medicinal preparation in relation to which Part VII applies unless the PBAC has recommended to the Minister that it be so declared.

This legislative instrument in giving effect to recommendations of the PBAC amends declarations under subsections 85(2) and 85(2AA) and the determination under subsection 85(2A) made by legislative instrument number PB 113 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 October 2009, was made on 3 September 2009.


Consultations

The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation. The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits.  PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.  When recommending the listing of a medicine on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.


ATTACHMENT

Paragraph 1:  provides that this instrument commences on 1 October 2009.

Paragraph 2:  provides that Schedule 1 amends PB 113 of 2008.

Schedule 1: provides for the following amendments:

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              

SCHEDULE 1

Alteration of Circumstances

Methylphenidate

 

Oestradiol

[removal of Circumstances]

Oestradiol and Oestradiol with Norethisterone

[removal of Circumstances]

Oestradiol with Norethisterone

[removal of Circumstances]

 

 

Overview

The National Health Act 1953, amended by the National Health Amendment (Pharmaceutical Benefits) Determination 2009, addresses the need for a reliable, timely, and affordable access to a wide range of medicines for all Australians through the Pharmaceutical Benefits Scheme (PBS). Enacted by the Parliament of Australia, the policy objective of this amendment is to ensure the PBS effectively meets the health needs of the population by including recommended drugs and medicinal preparations. The Minister for Health, authorised by the Act, uses legislative instruments to declare and determine the forms and administration of listed drugs under the PBS, ensuring the scheme remains responsive to medical and economic considerations. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in this process by providing expert advice on which drugs should be included on the PBS, ensuring that recommendations are based on clinical effectiveness, safety, and cost-effectiveness.

Scope and Application

The legislative instrument F2009L03544 pertains to amendments under the National Health Act 1953, specifically targeting the Pharmaceutical Benefits Scheme (PBS) which ensures Australians have access to affordable medicines. The amendments, effective from 1 October 2009, alter the declarations and determinations related to listed drugs under Part VII of the Act, as per recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent body composed of experts from various healthcare fields, advises the Minister on which drugs should be available under the PBS, considering factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness. The instrument modifies the form and manner of administration of certain drugs, aligning with the PBAC's recommendations, and includes specific changes to the listing of methylphenidate, oestradiol, and related preparations. This amendment process ensures that the PBS remains responsive to medical and economic considerations, maintaining the scheme's reliability and affordability.

Key Provisions

The primary operative sections of this instrument (F2009L03544) pertain to the amendments of legislative instruments PB 113 of 2008, which established certain declarations and determinations under the National Health Act 1953 (the Act) concerning the Pharmaceutical Benefits Scheme (PBS). Section 1 of the instrument specifies its commencement date as 1 October 2009, while Section 2 amends the previously mentioned legislative instrument. These amendments, detailed in Schedule 1, relate to the listing of specific drugs under the PBS, including changes to the circumstances under which certain drugs are available as pharmaceutical benefits. The Act imposes specific obligations and requirements on the Minister for Health, who is responsible for determining which drugs and medicinal preparations are listed under the PBS. This includes the power to declare and amend such listings by legislative instrument (subsection 85(2)) and to determine the form and manner of administration of these drugs (subsections 85(3), 85(5), and 85(6)). The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in this process, providing advice to the Minister on the listing of drugs (subsection 85(2AB)), which must be considered before any amendments are made (subsection 101(4)). The PBAC’s advice must also be tabled in Parliament (subsection 85(2AC)). The instrument outlines several potential consequences for non-compliance with the provisions of the Act. While specific offences and penalties are not detailed within the text, breaches of the Act could potentially lead to civil or criminal liabilities. Such consequences may include fines or imprisonment, depending on the nature and severity of the breach. The Act’s provisions ensure that the PBS operates within a regulatory framework designed to provide reliable, timely, and affordable access to essential medicines for all Australians, with the Minister and PBAC playing key roles in upholding these standards.

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