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 87 of 2010)

Administered by Department of Health, Disability and Ageing

Legislation au F2010L02529 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 87 OF 2010

NATIONAL HEALTH ACT 1953

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

    AMENDMENT DETERMINATION UNDER SUBSECTION 85(2A)

Summary

This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends declarations under subsections 85(2) and 85(2AA) and the determination under subsection 85(2A) made by legislative instrument number PB 14 of 2010 which came into effect on 1 April 2010.  The amendments declare additions and changes to the list of drugs and medicinal preparations available as pharmaceutical benefits and the circumstances in which the pharmaceutical benefits may be prescribed.  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 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 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.

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, expressed to commence on 1 October 2010, was made on 17 September 2010.

 

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 2010.

Paragraph 2:  provides that Schedule 1 amends PB 14 of 2010.

Schedule 1: provides for the following amendments:

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              

 

SCHEDULE 1

Addition of Listed Drug

Eletriptan

 

Alteration of Circumstances

Exenatide

Pioglitazone

Rosiglitazone

Rosiglitazone with metformin

Sitagliptin

Sitagliptin with metformin

Vildagliptin

[Availability of all PBS-subsidised drugs of the dipeptidyl peptidase 4 inhibitor (gliptin), thiazolidinedione (glitazone) and glucagon-like peptide-1 classes amended to allow patients with type 2 diabetes to switch between them without having to demonstrate a loss of diabetic control prior to switching]

 

 

Overview

The National Health Act 1953 was enacted to establish the legislative basis for the Pharmaceutical Benefits Scheme (PBS), ensuring Australians have reliable, timely, and affordable access to a broad range of medicines. The Act was introduced to address the gap in providing equitable access to essential medications across the nation. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body, plays a crucial role in advising the Minister on which drugs and medicinal preparations should be available as pharmaceutical benefits under the Act. The PBAC considers various factors, including clinical effectiveness, safety, and cost-effectiveness, when making recommendations. The 2010 amendments to the Act, implemented through legislative instruments, aim to update the list of drugs and medicinal preparations available under the PBS, as well as the circumstances under which these benefits can be prescribed, in line with PBAC recommendations. These amendments ensure the PBS remains responsive to evolving medical needs and evidence-based practices.

Scope and Application

The National Health Act 1953 (the Act) forms the legislative foundation for the Pharmaceutical Benefits Scheme (PBS) through which the Commonwealth ensures Australians have reliable, timely, and affordable access to a broad spectrum of medicines. The Act applies to pharmaceutical benefits provided by the Commonwealth, with drugs and medicinal preparations that qualify for these benefits declared by the Minister through legislative instruments under subsection 85(2). These declarations list drugs that are subject to the provisions of Part VII of the Act, including certain extemporaneously-prepared medicinal preparations as specified under paragraph 85(2)(b). The Minister can also determine the forms, administration methods, and brands of pharmaceutical items under subsections 85(3), 85(5), and 85(6), respectively, thereby governing what constitutes a pharmaceutical benefit under Part VII. The Act's jurisdiction extends nationally, covering all entities and individuals involved in the provision and prescription of pharmaceutical benefits. However, the Pharmaceutical Benefits Advisory Committee (PBAC) must provide written advice to the Minister before any drug or medicinal preparation can be declared or revoked under subsection 85(2AA), with this advice tabled in Parliament as per subsection 85(2AC). This legislative instrument, which amends previous declarations made by PB 14 of 2010, came into effect on 1 October 2010, and includes changes to the list of drugs available under the PBS as well as alterations to the circumstances under which certain drugs may be prescribed.

Key Provisions

The main operative sections of this legislation are subsections 85(2), 85(2AA), and 85(2A) of the National Health Act 1953. These sections allow the Minister to declare and determine which drugs and medicinal preparations are eligible for pharmaceutical benefits and the conditions under which they can be prescribed (subsection 85(2)), as well as to revoke or vary these declarations (subsection 85(2AA)). Subsection 85(2A) enables the Minister to determine the form and manner of administration of listed drugs, and to designate specific brands that qualify as pharmaceutical benefits. The amendments outlined in Schedule 1 to this instrument further specify which drugs are added to or altered in the list of pharmaceutical benefits, and the circumstances under which they can be prescribed. The obligations imposed on the parties governed by this Act primarily concern the Minister's responsibility to consult with the Pharmaceutical Benefits Advisory Committee (PBAC) when considering the addition, alteration, or revocation of a drug or medicinal preparation on the list of pharmaceutical benefits (subsection 85(2AB)). The Minister must obtain written advice from the PBAC before making such changes and must table this advice in Parliament (subsection 85(2AC)). Additionally, the PBAC's recommendations must be considered before a drug or medicinal preparation can be declared under subsection 85(2)(a) (subsection 101(4)). Failure to comply with the requirements of this Act may result in civil or criminal consequences. While specific penalties are not detailed in the Act, breaches of legislative instruments generally may attract penalties such as fines or imprisonment, depending on the severity of the breach. The exact penalties would be determined by the relevant courts when adjudicating on cases of non-compliance.

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