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 124 of 2008)

Administered by Department of Health, Disability and Ageing

Legislation au F2008L04633 Not in force Legislative Instrument

Legislation content

 

EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 124 OF 2008

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 January 2009, was made on 3 December 2008.

 


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 January 2009.

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

Schedule 1: provides for the following amendments:

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        

SCHEDULE 1

Addition of Listed Drug

Ibandronic acid

Posaconazole

 

Deletion of Listed Drugs

Aminoglutethimide

Piperazine Oestrone

 

Alteration of Circumstances

Glucose Indicator—Blood [addition of electrode strips, 50 (FreeStyle)]

Temozolomide [addition of the capsule 140 mg]

Zoledronic acid

 

SCHEDULE 6

Deletion of Listed Drug

Ibandronic acid

 

Overview

The National Health Act 1953 was enacted to establish the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to affordable and reliable medications. The 2008 amendment, introduced by legislative instrument F2008L04633, addressed the need to update the list of drugs and medicinal preparations available under the PBS. This amendment was made in accordance with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established to advise the Minister on the availability of pharmaceutical benefits. The PBAC's recommendations take into account factors such as the clinical effectiveness, safety, and cost-effectiveness of medicines. The amendment, which commenced on 1 January 2009, involved the addition, deletion, and alteration of certain drugs and medicinal preparations on the PBS list, reflecting the PBAC's advice and ensuring the scheme remains responsive to healthcare needs.

Scope and Application

The National Health Act 1953, as amended by the legislative instrument PB 124 of 2008, governs the Pharmaceutical Benefits Scheme (PBS) under which the Commonwealth provides access to a range of medicines for all Australians. The Act applies to the Minister for Health, who, by legislative instrument, declares drugs and medicinal preparations that are subject to the Act. The Act applies nationally, covering all drugs and medicinal preparations listed under the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent body composed of experts in various health-related fields, advises the Minister on which drugs and medicinal preparations should be available under the PBS, taking into account factors such as clinical effectiveness and cost-effectiveness. This legislative instrument, which came into effect on 1 January 2009, amends previous declarations and determinations made under the Act, specifically altering the list of drugs subject to the PBS by adding and removing certain drugs and modifying the circumstances under which others are listed. These changes are implemented through Schedule 1 of the instrument, reflecting the PBAC's recommendations.

Key Provisions

The National Health Act 1953 (the Act) provides the legislative basis for the Pharmaceutical Benefits Scheme (PBS) through Part VII, which aims to ensure reliable, timely, and affordable access to a wide range of medicines for all Australians (subsection 85(1)). The Minister declares drugs and medicinal preparations under subsection 85(2) that are subject to Part VII of the Act. These declarations are made by legislative instrument and list specific drugs, as defined in subsection 84(1), which are included as listed drugs. The Minister can also determine the form or administration of these listed drugs, as well as specific brands, through determinations under subsections 85(3), 85(5), and 85(6). If a revocation or variation of a declaration would result in a drug or medicinal preparation ceasing to be listed, the Minister must obtain written advice from the Pharmaceutical Benefits Advisory Committee (PBAC) under subsection 85(2AB), which must then be tabled in Parliament (subsection 85(2AC)). The entities governed by the Act, primarily the Minister and the PBAC, have specific obligations. The Minister is responsible for declaring and determining drugs and their forms under subsections 85(2) and 85(3), and must seek PBAC advice before revoking or varying certain declarations (subsection 85(2AB)). The PBAC, an independent expert body, recommends which drugs and medicinal preparations should be available as pharmaceutical benefits, considering factors such as clinical effectiveness, safety, and cost-effectiveness (section 100A). The PBAC must recommend the listing of a medicine before it can be declared by the Minister under subsection 101(4). Failure to comply with the requirements of the Act may result in civil or criminal consequences. For example, if a drug is supplied without the appropriate declaration or determination in place, it may be considered an offence under the Act, leading to potential penalties. However, the specific offences, penalties, or consequences are not detailed in the provided text. It is important to note that the precise penalties for breaches of the Act may vary and should be referred to in the full text of the legislation or relevant legal commentaries.

Legal classification tags

Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Reporting & Disclosure Obligations
Licensing & Registration
Compliance Obligations

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.