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 39 of 2009)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L01713 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 39 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 June 2009, was made on 1 May 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 June 2009.

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

Schedule 1: provides for the following amendments:

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              

SCHEDULE 1

Alteration of Circumstances

Adalimumab [in respect of the injection 40 mg in 0.8 mL pre-filled syringe and injection 40 mg in
0.8 mL pre-filled pen – additional availability for the treatment of chronic plaque psoriasis]

Etanercept [for the treatment of chronic plaque psoriasis]

Glucose Indicator—Blood [deletion of electrode strips, 50 (GlucoCare Super Sensor)]

Pantoprazole [addition of the sachet containing granules 40 mg (as sodium sequihydrate)]

 

Deletion of Listed Drug

Efalizumab

Oestrogens— Conjugated

Oestrogens—Conjugated with Medroxyprogesterone

 

SCHEDULE 3

Deletion of Listed Drug

Medroxyprogesterone

Oestrogens—Conjugated

Overview

The National Health Act 1953 was enacted by the Parliament of Australia to establish the legislative framework for the Pharmaceutical Benefits Scheme (PBS), which aims to ensure that all Australians have reliable, timely, and affordable access to a wide range of medicines. This Act provides the basis for the Commonwealth to provide pharmaceutical benefits by listing specific drugs and medicinal preparations that are eligible for subsidy. The Act was amended by the instrument F2009L01713, which came into effect on 1 June 2009, to reflect the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). This amendment involved altering the circumstances for certain drugs and deleting others from the list of pharmaceutical benefits under the PBS. The PBAC, an independent expert body, plays a crucial role in advising the Minister on which drugs should be listed, considering factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness. The objective of these amendments is to ensure the PBS remains responsive to the evolving healthcare needs of Australians.

Scope and Application

The National Health Act 1953, as amended by the legislative instrument PB 39 of 2009, pertains to the Pharmaceutical Benefits Scheme (PBS) administered by the Commonwealth to ensure affordable access to medicines for Australians. This Act applies to pharmaceutical benefits provided under Part VII, which encompasses listed drugs and certain extemporaneously-prepared medicinal preparations. The Minister for Health has the authority to declare and determine these listed drugs and their respective forms, manners of administration, and brands through legislative instruments. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on drug listings, with recommendations required for any drug to be declared as a listed drug. The amendments effective from 1 June 2009 include additions and deletions to the list of drugs eligible for PBS benefits, reflecting PBAC recommendations and adjustments in therapeutic needs. This legislative instrument ensures the PBS remains responsive to evolving healthcare requirements and maintains its objective of providing reliable, timely, and affordable access to necessary medications.

Key Provisions

The primary operative sections of this legislative instrument (sections 85(2), 85(2AA), and 85(2A)) empower the Minister to declare and determine the form, administration, and brand of listed drugs under the Pharmaceutical Benefits Scheme (PBS). Section 85(2) allows the Minister to declare by legislative instrument which drugs and medicinal preparations are subject to the PBS. This declaration lists specific drugs (subsection 85(2)(a)) and includes certain extemporaneously-prepared medicinal preparations (subsection 85(2)(b)). Section 85(2AA) grants the Minister the authority to revoke or vary these declarations. Importantly, any revocation or variation that would result in a drug no longer being listed must be accompanied by written advice from the Pharmaceutical Benefits Advisory Committee (PBAC), which is then tabled in Parliament (subsection 85(2AB) and 85(2AC)). The obligations imposed by this Act on the Minister and the PBAC are significant. The Minister must ensure that all declarations and determinations regarding listed drugs are made in accordance with the recommendations of the PBAC, which must consider clinical effectiveness, safety, cost-effectiveness, and the medical conditions for which the medicine is approved. The PBAC, composed of experts from various fields including health economists, pharmacists, and medical specialists, must provide written advice on any proposed revocations or variations of drug listings. This advice must be tabled in Parliament, ensuring transparency and accountability in the decision-making process. Failure to comply with the requirements of the Act can result in serious consequences. While specific offences and penalties are not detailed in the explanatory statement, non-compliance with the recommendations of the PBAC or failure to table the PBAC advice in Parliament could lead to legal challenges or administrative penalties. The Act itself does not specify maximum penalties, but breaches of similar legislative requirements in other contexts can result in substantial fines and other sanctions under Australian law. The integrity of the PBS and the availability of affordable medicines for Australians depend on strict adherence to these obligations and processes.

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