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 23 of 2008)

Administered by Department of Health, Disability and Ageing

Legislation au F2008L00281 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 23 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 March 2008, was made on 1 February 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 March 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

Isoleucine with carbohydrate

Valine with carbohydrate

 

Alteration of Circumstances

Adalimumab [for the initial treatment of adult patients with severe active psoriatic arthritis and for the treatment of adult patients with severe active rheumatoid arthritis]

Amino acid formula with vitamins and minerals without methionine [addition of oral liquid 130 mL, 30 (HCU Cooler)]

Amino acids – synthetic, formula

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids

Anakinra [for the treatment of adult patients with severe active rheumatoid arthritis]

Bupropion

Etanercept [for the initial treatment of adult patients with severe active psoriatic arthritis and for the treatment of adult patients with severe active rheumatoid arthritis]

Imiquimod

Ipratropium [deletion of nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) per mL, 20 mL]

Oxybutynin

Pemetrexed [addition of powder for I.V. infusion 100 mg (as disodium heptahydrate)]

Protein hydrolysate formula with medium chain triglycerides

Ranibizumab

Sevelamer

 

SCHEDULE 6

Addition of Listed Drug

Abatacept

Ibandronic acid

 

 

Overview

The National Health Act 1953 was enacted to provide the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), ensuring Australians have reliable, timely, and affordable access to a wide range of medicines. This Act is administered by the Commonwealth and serves to list drugs and medicinal preparations that qualify for PBS benefits, which are declared by the Minister through legislative instruments. The 2008 amendments to the Act, specifically the legislative instrument F2008L00281, were made to update the list of drugs and medicinal preparations available under the PBS, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). These amendments, effective from 1 March 2008, include the addition of new drugs and modifications to existing listings, aiming to enhance the availability of effective and cost-efficient pharmaceutical options to the public. The PBAC, an independent expert body, plays a crucial role in advising the Minister on the suitability of drugs for inclusion on the PBS, thereby directly contributing to the policy objective of the Act to improve public health outcomes through accessible pharmaceutical care.

Scope and Application

The National Health Act 1953, as amended by the legislative instrument F2008L00281, pertains specifically to the Pharmaceutical Benefits Scheme (PBS) administered by the Commonwealth of Australia. This Act ensures that Australians have access to a broad range of affordable and reliable medicines. It applies to the Minister for Health, who, under subsection 85(2), declares drugs and medicinal preparations as listed drugs to be covered under the PBS. These listed drugs are defined in subsection 84(1) and include both listed and certain extemporaneously-prepared drugs. The geographic scope of the Act is national, as it pertains to the Commonwealth of Australia. The Act allows for the form, manner of administration, and brand of listed drugs to be determined by the Minister through legislative instruments. Additionally, the Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role by providing advice to the Minister on which drugs should be included in the PBS, and this advice must be tabled in Parliament when a drug is to be added or removed from the PBS list. This legislative instrument, effective from 1 March 2008, amends previous declarations to include new drugs such as Isoleucine with carbohydrate and Valine with carbohydrate, while also altering the circumstances for the administration of existing drugs like Adalimumab and Etanercept.

Key Provisions

The National Health Act 1953, as amended, establishes the Pharmaceutical Benefits Scheme (PBS) through which the Commonwealth ensures that Australians have reliable, timely, and affordable access to a wide range of medicines (subsection 85(1)). This Act is primarily concerned with the listing and administration of pharmaceutical benefits, which are drugs and medicinal preparations declared by the Minister under subsection 85(2). These drugs are referred to as listed drugs and are defined in subsection 84(1). Certain extemporaneously-prepared medicinal preparations are also included under the scheme as a result of declarations under paragraph 85(2)(b). The Act imposes specific obligations on the Minister, who is responsible for determining the form or forms of a listed drug by legislative instrument (subsection 85(3)), the manner of administration of the form of the listed drug (subsection 85(5)), and the brand of the pharmaceutical item (subsection 85(6)). These determinations, except for certain extemporaneously-prepared pharmaceutical benefits, govern what constitutes the pharmaceutical benefit under Part VII of the Act (subsection 84(1)). Subsection 85(2AA) further empowers the Minister to revoke or vary a declaration under subsection 85(2) regarding a drug or medicinal preparation, but where such a revocation or variation would result in a drug or medicinal preparation ceasing to be a listed drug, the Minister must obtain written advice from the Pharmaceutical Benefits Advisory Committee (PBAC) (subsection 85(2AB)). This advice must be tabled in Parliament along with the relevant declaration (subsection 85(2AC)). Additionally, subsection 101(4) stipulates that a drug or medicinal preparation cannot be declared under paragraph 85(2)(a) unless the PBAC has recommended it to the Minister. Failure to comply with the provisions of the National Health Act 1953 could result in various civil and criminal consequences. While the Act does not explicitly state penalties for non-compliance, breaches of legislative instruments and regulations under the Act could lead to enforcement actions by relevant authorities, potentially resulting in fines or other legal repercussions. The precise penalties would depend on the nature and severity of the breach, as well as the specific provisions of any related regulations or subsidiary legislation. Overall, the Act aims to regulate the pharmaceutical benefits available to Australians through the PBS, ensuring that the medications listed are safe, effective, and cost-efficient. By mandating consultation with the PBAC and providing for the listing and administration of pharmaceutical benefits, the Act seeks to maintain a reliable and accessible healthcare system for all Australians.

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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.