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 59 of 2008)

Administered by Department of Health, Disability and Ageing

Legislation au F2008L02048 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 59 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 July 2008, was made on 3 June 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 July 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

Cinacalcet

Cystine with carbohydrate

Memantine

Tyrosine with carbohydrate

 

Alteration of Circumstances

Adalimumab [for the treatment of severe active psoriatic arthritis]

Calcipotriol [addition of scalp solution 50 micrograms (as monohydrate) per mL, 30 mL]

Donepezil

Etanercept [for the treatment of severe active psoriatic arthritis]

Galantamine

Gefitinib

Oestradiol and Oestradiol with Norethisterone [composition of the oestradiol (only) patches]

Rivastigmine

Sevelamer

Terbinafine [addition of cream containing terbinafine hydrochloride 10 mg per g, 15 g]

 

SCHEDULE 6

Addition of Listed Drugs

Natalizumab

Raltegravir

 

Overview

The National Health Act 1953 was amended in 2008 to provide for the inclusion of certain drugs and medicinal preparations on the Pharmaceutical Benefits Scheme (PBS) by legislative instrument. This amendment was made to ensure that Australians have reliable, timely, and affordable access to a wide range of medicines. The enacting body was the Australian Parliament, with the policy objective being to expand the scope of pharmaceutical benefits available under the PBS. This legislative instrument, which came into effect on 1 July 2008, was made to implement the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body, advises the Minister on which drugs and medicinal preparations should be available as pharmaceutical benefits, taking into account factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness.

Scope and Application

The National Health Act 1953 Amendment Instrument pertains to the Pharmaceutical Benefits Scheme (PBS), which is governed by Part VII of the Act, providing Australians with access to affordable and timely medicines. This instrument specifically amends the declarations under subsections 85(2) and 85(2AA), and the determination under subsection 85(2A), initially set out in legislative instrument number PB 88 of 2007. The amendments, which came into effect on 1 July 2008, involve the addition of new listed drugs and changes to the circumstances under which certain drugs are listed. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body, plays a crucial role in advising the Minister on which drugs and preparations should be available as pharmaceutical benefits, ensuring recommendations consider medical conditions, clinical effectiveness, safety, and cost-effectiveness. This legislative instrument ensures the PBS remains responsive to evolving healthcare needs by incorporating the PBAC's recommendations into the Act.

Key Provisions

The National Health Act 1953, as amended, governs the Pharmaceutical Benefits Scheme (PBS) which provides Australians with access to affordable medicines. Section 85(1) outlines that the Commonwealth offers benefits under this scheme. Drugs and medicinal preparations eligible for these benefits are declared by the Minister through legislative instruments under subsection 85(2). These are referred to as listed drugs, defined in subsection 84(1). Certain extemporaneously-prepared medicinal preparations also qualify for benefits under paragraph 85(2)(b). The Minister has the authority to specify the form, administration, and brand of a listed drug through determinations under subsections 85(3), 85(5), and 85(6), respectively. Subsection 85(2AA) allows the Minister to revoke or modify these declarations by legislative instrument. However, if such a revocation or variation would result in a drug or medicinal preparation ceasing to be listed, the Minister must seek advice from the Pharmaceutical Benefits Advisory Committee (PBAC) under subsection 85(2AB), which must be tabled in Parliament as per subsection 85(2AC). The entities and parties governed by the Act, including the Minister and the PBAC, have specific obligations under the legislation. The Minister must ensure that the declarations and determinations regarding listed drugs are made in accordance with the provisions of the Act. This includes consulting with the PBAC before making any amendments that could result in a drug or medicinal preparation being delisted. The PBAC, on the other hand, has the responsibility of providing expert recommendations to the Minister on which drugs and medicinal preparations should be included in the PBS. When making these recommendations, the PBAC considers the medical conditions for which the medicine has been approved, its clinical effectiveness, safety, and cost-effectiveness compared to other treatments. Failure to comply with the obligations and provisions of the Act may result in legal consequences. While the specific penalties for breaches are not detailed in the Act, breaches of legislative instruments generally can lead to civil and criminal penalties. Civil penalties may include fines, while criminal penalties could involve imprisonment, depending on the severity of the breach and the specific provisions of the Act or subordinate legislation. The exact penalties would be determined by the courts when adjudicating on cases of non-compliance.

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