National Health Act 1953 - Amendment declaration under subsections 85(2) and 85(2AA) - drugs and medicinal preparations (No. PB 61 of 2007)

Administered by Department of Health, Disability and Ageing

Legislation au F2007L02626 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 61 OF 2007

NATIONAL HEALTH ACT 1953

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

 

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 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 subsection 85(2) made by legislative instrument number PB 48 of 2007 which came into effect on 1 August 2007.  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 September 2007, was made on 14 August 2007.

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 September 2007.

Paragraph 2:  provides that Schedule 1 amends PB 48 of 2007.

Schedule 1: provides for the following amendments:

 

SCHEDULE 1

 

Item Added

Cetuximab

 

Item Deleted

 “Phenex-1”

 

 

 

Overview

The National Health Act 1953, amended by instrument number PB 61 of 2007, addresses the need for the Commonwealth to provide reliable, timely, and affordable access to a wide range of medicines for all Australians through the Pharmaceutical Benefits Scheme (PBS). This instrument amends the declarations under subsection 85(2) of the Act to reflect recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body, makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits, taking into account factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness. The amendments to the PBS list, as set out in the Schedule, come into effect on 1 September 2007, and the PBAC's advice is tabled in Parliament as required under subsection 85(2AC). This legislative instrument ensures the PBS remains current and effective in meeting the health needs of Australians.

Scope and Application

The National Health Act 1953 Amendment Declaration under subsections 85(2) and 85(2AA) pertains to the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have reliable, timely, and affordable access to a broad range of medicines. This instrument, effective from 1 September 2007, amends the declarations made under subsection 85(2) by legislative instrument number PB 48 of 2007, which came into effect on 1 August 2007. The Minister for Health is empowered to declare which drugs and medicinal preparations are covered by Part VII of the Act through legislative instruments, with certain exclusions or variations requiring the advice of the Pharmaceutical Benefits Advisory Committee (PBAC) and subsequent tabling in Parliament. The PBAC, an independent expert body, comprises members from various health-related fields and consumer interests, ensuring recommendations for PBS listings are based on clinical effectiveness, safety, and cost-effectiveness. This amendment, detailed in Schedule 1 of the instrument, adds Cetuximab to the list of covered drugs while removing "Phenex-1".

Key Provisions

The key operative sections of this legislation are found in subsections 85(2) and 85(2AA) of the National Health Act 1953. Subsection 85(2) allows the Minister to declare by legislative instrument which drugs and medicinal preparations will be subject to Part VII of the Act, thereby making them eligible for inclusion in the Pharmaceutical Benefits Scheme (PBS). Subsection 85(2AA) provides the Minister with the authority to revoke or vary these declarations through another legislative instrument. The operation of these sections is such that the Minister can add or remove drugs from the list of those covered by the PBS, thereby controlling which medications are provided with Commonwealth-subsidised access. The obligations imposed on the parties by this Act include ensuring that the Pharmaceutical Benefits Advisory Committee (PBAC) provides written advice when a drug or medicinal preparation is proposed for revocation or variation, as required by subsection 85(2AB). The Minister must then table this advice in Parliament as stipulated in subsection 85(2AC). Furthermore, under subsection 101(4), no drug or medicinal preparation can be declared under paragraph 85(2)(a) unless the PBAC has recommended it to the Minister. This ensures a structured and evidence-based approach to the inclusion or exclusion of drugs from the PBS. In terms of offences, penalties, or consequences for breach, the Act does not explicitly outline specific criminal or civil penalties for non-compliance with its provisions. However, the procedural obligations, such as the requirement for PBAC advice and its tabling in Parliament, are critical. Failure to adhere to these obligations could potentially lead to legal scrutiny or challenges regarding the validity of the Minister's actions. Additionally, any substantive errors or omissions in the legislative instruments could be subject to judicial review, leading to potential revocation or amendment of the instruments in question.

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