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 47 of 2009)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L02287 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 47 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 July 2009, was made on 4 June 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 July 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

Arginine with carbohydrate

Atovaquone with proguanil

Bevacizumab

Mupirocin

 

Alteration of Circumstances

Amino acid formula with vitamins and minerals without lysine and low in tryptophan [addition of the sachets containing oral powder 20 g, 30 (GA gel)]

Cephazolin [additional availability for the treatment of cellulitis]

Imatinib [for the continuing treatment of acute lymphoblastic leukaemia]

Latanoprost with Timolol

Modafinil

Oestradiol and Oestradiol with Norethisterone [deletion of the pack containing 12 tablets oestradiol 2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg]

Oestradiol with Norethisterone [deletion of the tablets containing 1 mg oestradiol (as hemihydrate) with 500 micrograms norethisterone acetate, 28 and the tablets containing 2 mg oestradiol (as hemihydrate) with 1 mg norethisterone acetate, 28]

Ondansetron [additional availability of the syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL for the management of nausea and vomiting associated with cytotoxic chemotherapy]

Risedronic Acid [addition of the tablet containing risedronate sodium 150 mg]

Travoprost with Timolol

 

Deletion of Listed Drug

Anecortave

SCHEDULE 2A

 

Addition of Listed Drug

Framycetin

 

Alteration of Circumstances

Latanoprost with Timolol

Travoprost with Timolol

 

 

 

 

SCHEDULE 3

 

Addition of Allowable Compound

Atovaquone with Proguanil

 

SCHEDULE 6

 

Addition of Listed Drug

Etravirine

 

Overview

The National Health Act 1953, amended by the instrument F2009L02287, is designed to regulate the Pharmaceutical Benefits Scheme (PBS) and ensure that Australians have reliable, timely, and affordable access to a range of medications. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on which drugs should be included in the PBS, taking into account factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness. The instrument updates the legislative declarations and determinations concerning listed drugs, allowable compounds, and the circumstances under which certain medications can be administered, reflecting the PBAC's recommendations. These amendments aim to enhance the availability and administration of specific medications on the PBS, thereby improving patient access to necessary treatments. Enacted by the Commonwealth Parliament, the policy objective is to ensure the PBS remains a sustainable and effective mechanism for providing essential medicines to the Australian population.

Scope and Application

The Pharmaceutical Benefits Scheme (PBS), established under Part VII of the National Health Act 1953, provides Australians with access to a wide range of medicines. The scheme is administered by the Commonwealth, with drugs and medicinal preparations declared as listed drugs by the Minister through legislative instruments, as per subsection 85(2). This Act applies to the entities and individuals involved in the provision and administration of these pharmaceutical benefits, including drug manufacturers, healthcare providers, and patients. The geographic reach of the Act is national, as it is a Commonwealth law. The Act does not specify exclusions or thresholds; however, the Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in recommending which drugs should be listed on the PBS. The Minister may revoke or vary these declarations based on PBAC advice, as per subsections 85(2AA) and 85(2AB). This legislative instrument, effective from 1 July 2009, amends previous declarations and determinations to reflect the PBAC's recommendations, ensuring the PBS remains aligned with medical needs and cost-effectiveness.

Key Provisions

The National Health Act 1953 (the Act) governs the Pharmaceutical Benefits Scheme (PBS) through Part VII, which ensures Australians have access to affordable medicines (subsection 85(1)). The Minister, by legislative instrument, declares drugs and medicinal preparations covered by the PBS (subsection 85(2)). These are referred to as listed drugs as defined in subsection 84(1). Additionally, certain extemporaneously-prepared medicinal preparations can be included under paragraph 85(2)(b). The Minister can also determine the form or manner of administration of a listed drug (subsections 85(3) and 85(5)) and identify specific brands (subsection 85(6)). These declarations and determinations are fundamental to defining what constitutes a pharmaceutical benefit under Part VII of the Act. The Act imposes several obligations on the Minister and the Pharmaceutical Benefits Advisory Committee (PBAC). The Minister must consult with the PBAC before revoking or varying a declaration under subsection 85(2) (subsection 85(2AB)). This advice must be obtained in writing and tabled in Parliament along with the relevant declaration (subsection 85(2AC)). Furthermore, a drug or medicinal preparation cannot be declared as a listed drug unless the PBAC has recommended it to the Minister (subsection 101(4)). The PBAC, comprising experts from various fields, evaluates the clinical effectiveness, safety, and cost-effectiveness of medicines to make recommendations. Failure to comply with the requirements of the Act can result in various consequences. While the Act does not explicitly outline specific offences or penalties, breaches of the obligations imposed by the Act could potentially lead to legal actions, including civil penalties or enforcement actions by the Commonwealth. The precise penalties for non-compliance are not detailed in the Act itself but may be subject to other relevant laws and regulations. The legislative instrument, which came into effect on 1 July 2009, amends previous declarations and determinations made under the Act. The amendments include the addition of new listed drugs such as Arginine with carbohydrate, Atovaquone with proguanil, and Bevacizumab, as well as alterations to the circumstances under which certain drugs are available, such as the addition of sachets containing oral powder 20 g, 30 (GA gel) for Amino acid formula with vitamins and minerals without lysine and low in tryptophan. Other changes involve the deletion of specific formulations, such as the pack containing 12 tablets oestradiol 2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg for Oestradiol and Oestradiol with Norethisterone. These amendments ensure that the PBS remains up-to-date with the latest medical recommendations and needs.

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