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 106 of 2009)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L04287 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 106 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 declare 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.

A provision-by-provision description of the instrument is contained in the Attachment.

This instrument, expressed to commence on 1 December 2009, was made on
12 November 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 December 2009.

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

Schedule 1: provides for the following amendments:

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              

SCHEDULE 1

 

Addition of Listed Drugs

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid

Artemether with lumefantrine

Calcipotriol with betamethasone

Clopidogrel with aspirin

Hydroxyethyl starch 130/0.4

Polyethylene glycol 400

Prasugrel

 

Alteration of Circumstances

Calcipotriol

[deletion of the ointment 50 micrograms per g, 30 g]

Glucose Indicator—Blood

[addition of reagent strips, 50 (Lifeline Attest)]

Montelukast

[addition of circumstances in respect of the tablet, chewable, 5 mg (as sodium)]

Olanzapine

[addition of the powder for injection 210 mg (as pamoate monohydrate) with diluent and the powder for injection 300 mg (as pamoate monohydrate) with diluent]

Pramipexole

[in respect of the treatment of Parkinson disease]

Sunitinib

[addition of circumstances]

 

Deletion of Listed Drug

Tamarindus indica seed polysaccharide

 

SCHEDULE 2A

Addition of Listed Drug

Polyethylene glycol 400

 

 

Deletion of Listed Drug

Tamarindus indica seed polysaccharide

 

SCHEDULE 3

Addition of Allowable Compounds

Artemether with Lumefantrine

Calcipotriol with Betamethasone

Clopidogrel with Aspirin

 

SCHEDULE 6

Addition of Listed Drug

Ambrisentan

 

Overview

The National Health Act 1953, amended by the legislative instrument F2009L04287, addresses the need to regulate and ensure the availability of pharmaceutical benefits in Australia. Enacted by the Australian Parliament, this Act provides the legal framework for the Pharmaceutical Benefits Scheme (PBS), ensuring that Australians have access to a broad range of affordable and reliable medications. The policy objective of the Act is to make essential medicines accessible to the public while managing costs through a structured benefits schedule. This legislative instrument, effective from 1 December 2009, implements recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), thereby updating the list of listed drugs and the circumstances under which these benefits can be prescribed. These amendments ensure that the PBS remains responsive to new medical advancements and public health needs, balancing cost-effectiveness and clinical efficacy.

Scope and Application

The National Health Act 1953 Amendment Instrument pertains to the Pharmaceutical Benefits Scheme (PBS), which is administered by the Commonwealth to ensure reliable, timely, and affordable access to a wide range of medicines for all Australians. The Act applies to the Minister for Health who declares drugs and medicinal preparations as listed drugs under subsection 85(2), and these are then subject to the provisions of Part VII of the Act. This includes certain extemporaneously-prepared medicinal preparations declared under paragraph 85(2)(b). The instrument empowers the Minister to determine the form and manner of administration of listed drugs and the brands of pharmaceutical items that constitute the pharmaceutical benefit, except for certain extemporaneously-prepared pharmaceutical benefits. The Pharmaceutical Benefits Advisory Committee (PBAC) provides written advice to the Minister, which must be tabled in Parliament when a drug or medicinal preparation is proposed to be removed from the list of PBS-listed drugs. The amendments listed in Schedules 1 to 6 of this instrument, which commenced on 1 December 2009, implement PBAC recommendations concerning changes to the list of available pharmaceutical benefits and the circumstances under which they may be prescribed. The Act applies nationally, with the Minister’s decisions and recommendations by the PBAC impacting all Australians who rely on the PBS for access to medicines.

Key Provisions

The main operative sections of the National Health Act 1953 Amendment Instrument (F2009L04287) pertain to amendments of the Pharmaceutical Benefits Scheme (PBS) (sections 85(2), 85(2AA), and 85(2A)). These sections allow the Minister for Health to declare which drugs and medicinal preparations are covered by the PBS and to determine the specific forms and administration of these listed drugs. The instrument, which commenced on 1 December 2009, amends earlier legislative instruments from 2008, updating the list of drugs available under the PBS and the circumstances in which they may be prescribed. The Act imposes obligations on the Minister for Health to consult with the Pharmaceutical Benefits Advisory Committee (PBAC) before making certain amendments. Specifically, if a drug or medicinal preparation is to be revoked or varied to cease being a listed drug, the Minister must obtain written advice from the PBAC, and this advice must be tabled in Parliament (subsections 85(2AA) and 85(2AB)). Additionally, a drug or medicinal preparation cannot be declared under section 85(2)(a) unless the PBAC has recommended it (subsection 101(4)). The PBAC, an independent expert body, evaluates the clinical effectiveness, safety, and cost-effectiveness of drugs before making its recommendations. Failure to comply with the requirements of the Act may lead to civil or criminal penalties, although specific penalties are not detailed in the explanatory statement. The amendments introduced by this instrument are intended to ensure that the PBS remains up-to-date with the latest medical recommendations and that Australians have access to effective and affordable medications. The instrument itself does not explicitly detail penalties for non-compliance but implies that adherence to the outlined procedures is necessary to maintain the integrity of the PBS.

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