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 31 of 2009)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L01248 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 31 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 May 2009, was made on 2 April 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 May 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

Lanthanum

Paclitaxel, nanoparticle albumin-bound

Sunitinib

Teriparatide

 

Alteration of Circumstances

Hydromorphone [addition of the tablet (modified release) containing hydromorphone hydrochloride 8 mg, tablet (modified release) containing hydromorphone hydrochloride 16 mg, tablet (modified release) containing hydromorphone hydrochloride 32 mg and tablet (modified release) containing hydromorphone hydrochloride 64 mg]

Sevelamer

 

Deletion of Listed Drug

Zonisamide

 

SCHEDULE 2

Alteration of Circumstances

Hydromorphone [addition of the tablet (modified release) containing hydromorphone hydrochloride 8 mg, tablet (modified release) containing hydromorphone hydrochloride 16 mg, tablet (modified release) containing hydromorphone hydrochloride 32 mg and tablet (modified release) containing hydromorphone hydrochloride 64 mg]

 

Overview

The National Health Act 1953, enacted by the Australian Parliament, serves as the legislative basis for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have reliable, timely, and affordable access to a range of medicines. This Act addresses the gap in the availability of medications by outlining the process through which pharmaceutical benefits are provided and regulated. The 2009 amendment to this Act, made under subsections 85(2) and 85(2AA), aims to refine the criteria for listing drugs and medicinal preparations that qualify for PBS coverage. This amendment follows recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body that advises the Minister on which drugs should be available as pharmaceutical benefits. The policy objective is to enhance the efficacy and cost-effectiveness of the PBS, ensuring that only those drugs that meet specific clinical and economic criteria are included.

Scope and Application

The National Health Act 1953, as amended, applies to the provision of pharmaceutical benefits through the Pharmaceutical Benefits Scheme (PBS), which is designed to ensure that all Australians have reliable, timely, and affordable access to a wide range of medicines. The Act is applicable to drugs and medicinal preparations that are declared by the Minister to be listed drugs under subsection 85(2), and these declarations are made by legislative instrument. The geographic reach of the Act is national, as it is a Commonwealth Act. The Act also applies to certain extemporaneously-prepared medicinal preparations, which are subject to declarations under paragraph 85(2)(b). The Minister has the authority to determine the form, manner of administration, and brands of listed drugs, which are governed by legislative instruments under subsections 85(3), 85(5), and 85(6) respectively. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in advising the Minister on which drugs and preparations should be included in the PBS, and its recommendations are mandatory for the Minister under subsection 101(4). The Act extends its application through subordinate instruments, such as legislative instruments made under subsections 85(2), 85(2AA), and 85(2A). The instrument in question, PB 31 of 2009, commenced on 1 May 2009 and amends earlier declarations and determinations to reflect the PBAC's recommendations.

Key Provisions

The primary operative sections of the National Health Act 1953 Amendment Declaration under Subsections 85(2) and 85(2AA) and Amendment Determination under Subsection 85(2A) (F2009L01248) focus on the Pharmaceutical Benefits Scheme (PBS). The Act, specifically Part VII, mandates the Commonwealth to provide reliable, timely, and affordable access to a wide range of medicines for all Australians (subsection 85(1)). Subsection 85(2) allows the Minister to declare drugs and medicinal preparations by legislative instrument, which are listed drugs as defined in subsection 84(1). The Minister can also determine the form or manner of administration of these listed drugs through subsections 85(3), 85(5), and 85(6). Additionally, subsection 85(2AA) empowers the Minister to revoke or vary a declaration by legislative instrument, provided the Pharmaceutical Benefits Advisory Committee (PBAC) advises in writing if the revocation or variation would result in the drug or preparation ceasing to be a listed drug. The Act imposes several obligations and requirements on the parties and entities it governs. The Minister must seek advice from the PBAC before revoking or varying a declaration that would result in the cessation of a drug or medicinal preparation from being a listed drug (subsection 85(2AB)). The PBAC's advice must be tabled in Parliament along with the relevant declaration (subsection 85(2AC)). Furthermore, a drug or medicinal preparation cannot be declared under paragraph 85(2)(a) unless the PBAC recommends it (subsection 101(4)). The PBAC, an independent expert body established by section 100A, recommends drugs and medicinal preparations for inclusion in the PBS based on clinical effectiveness, safety, and cost-effectiveness. There are no specific offences, penalties, or civil/criminal consequences outlined in the text for breach of the provisions in this Act. However, the integrity of the PBS and the advice provided by the PBAC are crucial, as any failure to adhere to the recommended procedures could undermine the scheme's effectiveness and the trust placed in the PBAC's recommendations. Ensuring compliance with these provisions is essential to maintain the PBS's reliability and affordability for Australians.

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