National Health Act 1953 - Amendment special arrangements under subsection 100(1) - Highly Specialised Drugs Program (No. PB 51 of 2010)

Administered by Department of Health, Disability and Ageing

Legislation au F2010L01429 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

AMENDMENT SPECIAL ARRANGEMENTS – HIGHLY SPECIALISED DRUGS PROGRAM FOR PUBLIC HOSPITALS 

INSTRUMENT NUMBER PB 51 of 2010

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 to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).

Subsection 100(1) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to  persons:                

(a) who are living in isolated areas; or

(b) who are receiving medical treatment in such circumstances that pharmaceutical      benefits: 

(i) cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or

(ii) are inadequate for that medical treatment.

Subsection 100(2) of the Act provides that the Minister may vary or revoke a special         arrangement made under subsection 100(1).

Subsection 100(3) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).

The declaration made under subsection 85(2) of the Act sets out the drugs and medicinal preparations to which Part VII of the Act applies.  Under subsection 100AA(1)(c) a special pharmaceutical product, for which special arrangements may be made under section 100,  includes a drug or medicinal preparation declared under subsection 85(2) of the Act.      Schedule 6 of the declaration under subsection 85(2) lists those drugs and medicinal      preparations that may be made available under arrangements provided for by section 100 of the Act.

 

The Highly Specialised Drugs Program for public hospitals is a set of Arrangements made under subparagraph 100(1) of the Act for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who are receiving treatment with highly specialised drugs at public hospitals as non-admitted patients, day admitted patients or patients on discharge.

 

This legislative instrument amends the Arrangements made under subparagraph 100(1)

(PB 125 of 2009) which came into effect on 1 January 2010.  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 2010, was made on 19 May 2010.

Consultations

The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits.  Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared.  When recommending a medicine be listed 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.

PBAC members are selected 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.

The Commonwealth/State Highly Specialised Drugs Working Party (HSDWP) is a non-statutory body established by the Australian Health Ministers Advisory Council (AHMAC).  The HSDWP makes recommendations to the PBAC on the suitability of certain drugs for listing under the Highly Specialised Drugs Program.  The HSDWP considers the funding and administrative aspects of supply through the hospital system, and a recommendation for listing must be supported by a majority of Working Party members.  The HSDWP consists of representatives from State and Territory Health Departments and the Australian Private Hospitals Association, and is chaired by a representative of the Commonwealth Department of Health and Ageing.

 


ATTACHMENT

Paragraph 1:  provides that this instrument commences on 1 June 2010.

Paragraph 2:  provides that Schedule 1 amends PB 125 of 2009.

Schedule 1: provides for the following amendments: 

 

SCHEDULE 2

Addition of Forms

Darunavir

Tablet 150 mg (as ethanolate)

Everolimus

Tablet 1 mg

 

Overview

The National Health Act 1953, as amended by the instrument F2010L01429, aims to address the gap in providing reliable, timely, and affordable access to highly specialised drugs for patients receiving treatment in public hospitals. This legislative instrument, introduced by the Parliament of Australia, was enacted to facilitate the Highly Specialised Drugs Program for public hospitals. The policy objective is to ensure that patients in need of highly specialised drugs, who may not be adequately served under the standard Pharmaceutical Benefits Scheme (PBS), receive these critical treatments. The instrument amends the existing arrangements to update the list of drugs covered by the program and to ensure that public hospitals have an adequate supply of these necessary medications. This amendment aims to support the effective and efficient treatment of patients with complex medical needs within the public hospital system.

Scope and Application

This legislative instrument amends the Highly Specialised Drugs Program for public hospitals, which is established under section 100 of the National Health Act 1953. The Act applies to the provision of pharmaceutical benefits for Australians, with the Commonwealth ensuring reliable, timely, and affordable access to a wide range of medicines. Specifically, the Act allows the Minister to make special arrangements for providing an adequate supply of special pharmaceutical products to persons receiving medical treatment in certain circumstances. The Highly Specialised Drugs Program is one such arrangement, designed to ensure that patients in public hospitals who require highly specialised drugs have access to them. The amended arrangements, effective from 1 June 2010, include the addition of certain drugs to the list of those available under the Program. The Act applies nationally, and the special arrangements are subject to the recommendations of the Pharmaceutical Benefits Advisory Committee and the Commonwealth/State Highly Specialised Drugs Working Party, who consider the clinical, funding, and administrative aspects of drug provision.

Key Provisions

The key operative sections of this legislation, particularly sections 100(1) and 100(3) of the National Health Act 1953, establish the framework for the Highly Specialised Drugs Program for public hospitals. Section 100(1) allows the Minister to make special arrangements to ensure the availability of pharmaceutical products for individuals in isolated areas or receiving medical treatment where standard pharmaceutical benefits are inadequate. Section 100(3) ensures that Part VII of the Act operates in accordance with any special arrangements made under section 100(1). The amendments to the program, detailed in Schedule 1, introduce new drugs to be covered under these special arrangements, thereby expanding the scope of available treatments for public hospital patients. The Act imposes several obligations on the parties involved. The Minister for Health and Ageing is tasked with making the necessary special arrangements under section 100(1) to provide access to highly specialised drugs for eligible patients. The Pharmaceutical Benefits Advisory Committee (PBAC), as outlined in section 100A, must recommend which drugs and medicinal preparations should be available as pharmaceutical benefits. Additionally, the Commonwealth/State Highly Specialised Drugs Working Party (HSDWP) plays a role in assessing the suitability of certain drugs for the program and making recommendations to the PBAC. These bodies must adhere to the criteria set forth in the Act for declaring drugs as pharmaceutical benefits, considering factors such as clinical effectiveness, safety, and cost-effectiveness. Breaching the provisions of the National Health Act 1953 can result in civil or criminal consequences. While the Act itself does not specify penalties for non-compliance, general provisions in Australian law may apply. For instance, failure to comply with ministerial declarations or regulatory requirements can result in fines or other penalties under relevant legislation. Additionally, any misuse of funds or improper administration of the Highly Specialised Drugs Program could lead to investigations and legal action under the Commonwealth's public sector laws, potentially resulting in substantial fines and imprisonment for individuals found guilty of misconduct.

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Health Law
Pharmaceutical Law
Instrument
Regulation
Concepts
Commencement Provisions
Licensing & Registration
Reporting & Disclosure Obligations
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Pharmaceutical Benefits Scheme
Special Arrangements

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