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 96 of 2009)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L03829 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 96 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 November 2009, was made on 2 October 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 November 2009.

Paragraph 2:  provides that Schedule 1 amends PB 113 of 2008.

Schedule 1: provides for the following amendments:

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              

SCHEDULE 1

 

Alteration of Circumstances

Bortezomib

Ciprofloxacin

[addition of circumstances in respect of the ear drops 3 mg (as hydrochloride) per mL, 5 mL]

Ezetimibe with Simvastatin

[addition of the tablet 10 mg-10 mg and the tablet 10 mg-20 mg]

Lansoprazole

[deletion of the capsule 30 mg and the sachet containing granules for oral suspension, 30 mg per sachet]

Terbutaline

[deletion of the nebuliser solution containing terbutaline sulfate 5 mg in
2 mL single dose units, 30]

Thyrotropin Alfa

[addition of streamlined authority code 3193]

Tobramycin

[addition of the injection 500 mg (as sulfate) in 5 mL (without preservative)]

 

SCHEDULE 6

Addition of Listed Drug

Lenalidomide

 

Overview

The National Health Act 1953, amended by the National Health Amendment Instrument 2009 (No. 1) (F2009L03829), addresses the need for reliable, timely, and affordable access to a broad range of medicines for Australians through the Pharmaceutical Benefits Scheme (PBS). This legislative instrument was introduced to give effect to the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises the Minister on which drugs and medicinal preparations should be included in the PBS. The amendments are designed to ensure the PBS remains responsive to the medical needs of Australians, taking into account clinical effectiveness, safety, and cost-effectiveness of the listed drugs. The instrument, which commenced on 1 November 2009, amends earlier legislative instruments to reflect the PBAC's recommendations, ensuring the PBS continues to provide necessary pharmaceutical benefits in alignment with contemporary medical standards and economic considerations.

Scope and Application

The National Health Act 1953, as amended by the legislative instrument numbered PB 96 of 2009, pertains to the Pharmaceutical Benefits Scheme (PBS) administered by the Commonwealth to ensure Australians have reliable, timely, and affordable access to a range of medicines. This Act applies to drugs and medicinal preparations that are declared by the Minister as pharmaceutical benefits under subsection 85(2). These listed drugs are subject to various determinations regarding their form, administration, and brand, which are managed through legislative instruments. The Act extends to any drugs or medicinal preparations that are extemporaneously prepared, subject to specific declarations. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending the listing of medicines on the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness. The amendments effected by PB 96 of 2009, which came into force on 1 November 2009, adjust the declarations and determinations made by PB 113 of 2008, reflecting the PBAC’s advice and introducing new listings or removing existing ones based on their recommendations. This legislative instrument ensures the PBS remains responsive to medical needs and economic considerations.

Key Provisions

The key operative sections of this legislation (F2009L03829) amend the National Health Act 1953 to adjust the list of pharmaceutical benefits available under the Pharmaceutical Benefits Scheme (PBS). Specifically, section 85(2) and section 85(2AA) allow the Minister to declare by legislative instrument which drugs and medicinal preparations are covered under the PBS. This instrument amends previous declarations made in 2008, adjusting the list of covered drugs and their specific forms and strengths. The amendments also include the addition of new drugs like Lenalidomide and changes to existing listings such as Bortezomib, Ciprofloxacin, Ezetimibe with Simvastatin, Lansoprazole, Terbutaline, Thyrotropin Alfa, and Tobramycin. The Act imposes several obligations on the parties it governs. Firstly, the Minister is required to consult with the Pharmaceutical Benefits Advisory Committee (PBAC) before revoking or varying a declaration concerning a drug or medicinal preparation, as stipulated in section 85(2AB). Additionally, the PBAC's advice must be tabled in Parliament, as per section 85(2AC). The PBAC itself must recommend whether a drug should be listed on the PBS based on criteria such as medical conditions, clinical effectiveness, safety, and cost-effectiveness. This recommendation process ensures that the decisions are informed by expert medical advice. The legislation outlines specific consequences for breaches of the Act. While the explanatory statement does not detail penalties or specific offences, the overarching Act under which these amendments operate includes provisions for enforcement. Violations of the National Health Act 1953 could potentially lead to civil or criminal penalties, though the exact nature of these penalties would depend on the specific breach and other relevant laws. The Act's provisions are designed to ensure compliance with the declared pharmaceutical benefits and maintain the integrity of the PBS. In summary, this legislative instrument amends the list of pharmaceutical benefits under the PBS by adding new drugs and modifying existing listings. The process involves consultation with the PBAC and ensures that expert advice informs the decision-making process. The amendments are intended to enhance the availability of certain medications to Australians while maintaining the scheme's integrity and effectiveness.

Legal classification tags

Area of Law
Health Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Licensing & Registration
Reporting & Disclosure Obligations

Interactions

Authorises

All Versions

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.