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 34 of 2010)

Administered by Department of Health, Disability and Ageing

Legislation au F2010L00919 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 34 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 an addition 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, expressed to commence on 1 May 2010, was made on 1 April 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 May 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

Lacosamide

 

Alteration of Circumstances

Amino acid formula with vitamins and minerals without lysine and low in tryptophan

[alteration of the description of the oral powder 400 g]

Amino acid formula with vitamins and minerals without methionine

[alteration of the description of the oral powder 400 g]

Carmellose with glycerin

[addition of the eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, single dose units 0.4 mL, 30]

Levodopa with Carbidopa and Entacapone

[amendment of “Parkinson’s disease” to “Parkinson disease” and consequent change to the streamlined authority codes]

 

SCHEDULE 2A

Alteration of Circumstances

Carmellose with glycerin

[addition of the eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, single dose units 0.4 mL, 30]

 

Overview

The National Health Act 1953, amended by legislative instrument F2010L00919, aims to refine and update the Pharmaceutical Benefits Scheme (PBS). Enacted by the Parliament of Australia, the Act provides a legislative foundation for the PBS, ensuring Australians have access to affordable and reliable medicines. The amendments introduced by this instrument follow recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and aim to address gaps in the availability of certain drugs and modifications to the circumstances under which specific medications can be prescribed. The policy objective is to maintain the integrity and efficacy of the PBS by incorporating expert advice and ensuring the scheme remains responsive to healthcare needs.

Scope and Application

The legislative instrument F2010L00919 amends the National Health Act 1953, specifically affecting the Pharmaceutical Benefits Scheme (PBS) managed under the Act. This Act applies to the Commonwealth and provides a framework for the provision of pharmaceutical benefits to Australians. The amendments declared by this instrument primarily concern the list of drugs and medicinal preparations available as pharmaceutical benefits and the conditions under which these benefits may be prescribed. These changes are made in response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an expert body tasked with advising on the inclusion of medicines on the PBS. The amendments are detailed in the items of Schedule 1 and include the addition of certain drugs, such as Lacosamide, and modifications to the circumstances under which other drugs and medicinal preparations can be prescribed. The Minister's authority to declare and determine the forms, administration, and brands of pharmaceutical items under the Act is exercised through these legislative instruments, which govern what constitutes a pharmaceutical benefit under Part VII of the Act. The instrument, which commenced on 1 May 2010, ensures that the PBS remains responsive to clinical and economic considerations by incorporating expert advice from the PBAC.

Key Provisions

The main operative sections of the legislation (National Health Act 1953, as amended) concern the declaration of drugs and medicinal preparations available as pharmaceutical benefits and the circumstances under which these benefits may be prescribed. Specifically, subsection 85(2) allows the Minister to declare drugs and certain extemporaneously-prepared medicinal preparations as listed drugs through legislative instruments. Subsection 85(2AA) provides the Minister with the authority to revoke or vary these declarations, but requires the Minister to obtain written advice from the Pharmaceutical Benefits Advisory Committee (PBAC) before doing so if the result would be the cessation of a drug or preparation as a listed drug. Additionally, subsection 85(2A) enables the Minister to determine the form and manner of administration of these listed drugs. The Act imposes several obligations on the parties it governs. Firstly, the Minister is required to make declarations under subsection 85(2) regarding the drugs and medicinal preparations that are available as pharmaceutical benefits. This declaration process must be done through a legislative instrument. Secondly, when revoking or varying a declaration under subsection 85(2AA), the Minister must obtain advice from the PBAC and table this advice in Parliament as per subsection 85(2AB) and subsection 85(2AC). Finally, the Minister must ensure that any declaration of a drug or medicinal preparation under paragraph 85(2)(a) is preceded by a PBAC recommendation, as per subsection 101(4). The legislation also outlines penalties and consequences for non-compliance. While the specific penalties are not detailed in the text provided, the Act generally allows for both civil and criminal penalties for breaches of its provisions. These could include fines or imprisonment, depending on the nature and severity of the breach. The precise penalties would be determined according to other sections of the Act or related legislation, not specified in the provided excerpt. The overarching purpose of these penalties is to enforce compliance with the Act's requirements and to ensure the proper administration of the Pharmaceutical Benefits Scheme.

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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.