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 50 of 2008)

Administered by Department of Health, Disability and Ageing

Legislation au F2008L01382 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 50 OF 2008

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 88 of 2007 which came into effect on 1 December 2007.  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 2008, was made on 1 May 2008.

 


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 2008.

Paragraph 2:  provides that Schedule 1 amends PB 88 of 2007.

Schedule 1: provides for the following amendments:

 

 

SCHEDULE 1

Addition of Listed Drugs

Duloxetine

Pramipexole

 

Alteration of Circumstances

Flucloxacillin [deletion of powder for oral suspension 125 mg (as magnesium) per 5 mL, 100 mL]

Glucose Indicator—Blood [addition of electrode strips, 100 (FreeStyle Lite)]

Tacrolimus [additional availability for the treatment of patients with lung transplants]

 

SCHEDULE 2

Alteration of Circumstances

Flucloxacillin [deletion of powder for oral suspension 125 mg (as magnesium) per 5 mL, 100 mL]

 

 

Overview

The National Health Act 1953, as amended by legislative instrument F2008L01382, aims to facilitate the efficient and effective administration of the Pharmaceutical Benefits Scheme (PBS). Enacted by the Australian Parliament, the Act seeks to ensure that all Australians have reliable, timely, and affordable access to a broad range of medicines. The legislative instrument amends previous declarations and determinations made under the Act, implementing the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body established under section 100A of the Act, advises the Minister on which drugs and medicinal preparations should be available as pharmaceutical benefits. This amendment process underscores the policy objective of maintaining the PBS as a balanced and sustainable system, ensuring that the medicines listed are both clinically effective and cost-effective, while also considering the medical conditions they treat and their safety profile.

Scope and Application

The National Health Act 1953, through its Part VII, provides the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have reliable, timely, and affordable access to a broad range of medicines. The Act applies to all Australians and is administered at the Commonwealth level, impacting the healthcare sector and the pharmaceutical industry directly. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body, plays a pivotal role in advising the Minister on which drugs and medicinal preparations should be included in the PBS. The Act enables the Minister to declare by legislative instrument drugs and medicinal preparations that fall under the PBS, as well as to determine their forms and administration methods. The PBAC's recommendations are crucial, as a drug or medicinal preparation cannot be declared unless the PBAC has advised the Minister to do so. This legislative instrument, which amends previous declarations and determinations, came into effect on 1 June 2008, following recommendations from the PBAC. The amendments include the addition of new drugs like Duloxetine and Pramipexole to the PBS, as well as changes to the availability and forms of existing drugs such as Flucloxacillin and Tacrolimus.

Key Provisions

The main operative sections of this instrument are found in subsections 85(2), 85(2AA), and 85(2A) of the National Health Act 1953. These sections pertain to the declaration and determination of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS). Specifically, subsection 85(2) allows the Minister to declare by legislative instrument drugs and medicinal preparations to which Part VII applies, thereby making them listed drugs. Subsection 85(2AA) empowers the Minister to revoke or vary such declarations through legislative instruments. Subsection 85(2A) enables the Minister to determine the form, manner of administration, and brand of listed drugs, governing what constitutes a pharmaceutical benefit under Part VII. These provisions impose several obligations on the Minister and related entities. The Minister must ensure that the PBS provides reliable, timely, and affordable access to a wide range of medicines for Australians, as required by Part VII. In making declarations and determinations under subsections 85(2) and 85(2A), the Minister must follow the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) as mandated by subsection 101(4). The PBAC, an independent expert body, advises on which drugs and medicinal preparations should be available as pharmaceutical benefits, considering factors such as clinical effectiveness, safety, and cost-effectiveness. The Minister must also obtain the written advice of the PBAC before revoking or varying a declaration that would result in a drug or medicinal preparation ceasing to be a listed drug, as stipulated in subsection 85(2AB), and table this advice in Parliament as per subsection 85(2AC). The legislation includes provisions for offences and penalties for breaches, though the specific penalties are not detailed in the explanatory statement. Generally, breaches of provisions under the National Health Act 1953 can lead to civil or criminal penalties, depending on the nature and severity of the breach. For instance, individuals or entities found to be in violation of the Act's requirements may face fines, imprisonment, or both. The exact penalties would depend on the specific section breached and the circumstances of the offence, with maximum penalties often specified within the relevant sections of the Act itself.

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