National Health Act 1953 - Amendment Special Arrangements under subsection 100(1) - Highly Specialised Drugs Program (No. PB 95 of 2008)

Administered by Department of Health, Disability and Ageing

Legislation au F2008L03436 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 95 of 2008

NATIONAL HEALTH ACT 1953

AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBSECTION 100(1)

HIGHLY SPECIALISED DRUGS PROGRAM

 

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 and the restrictions, if any, that apply to the prescribing of such drugs and medicinal preparations as pharmaceutical benefits. 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 is a set of Arrangements made under subparagraph 100(b)(i) 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 private hospitals as non-admitted patients, day admitted patients or patients on discharge.

This legislative instrument amends the Arrangements made under subparagraph 100(b)(i) (PB 80 of 2008) which came into effect on 1 August 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 October 2008, was made on 1 September 2008.

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 October 2008.

Paragraph 2:  provides that Schedule 1 amends PB 80 of 2008.

Schedule 1: provides for the following amendments: 

 

 

SCHEDULE 2

Addition of form

Clozapine  Oral liquid 50 mg per mL, 100 mL

 

 

Overview

The National Health Act 1953, enacted by the Parliament of Australia, establishes the legislative framework for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to reliable, timely, and affordable medicines. One of the Act's provisions, specifically subsection 100(1), allows the Minister for Health to make special arrangements to ensure an adequate supply of specialised pharmaceutical products for individuals in isolated areas or those undergoing medical treatments where the PBS does not provide sufficient or efficient pharmaceutical benefits. The Highly Specialised Drugs Program is an example of such an arrangement, aimed at ensuring that individuals receiving highly specialised drugs at private hospitals have adequate access. This legislative instrument, introduced on 1 September 2008 and commencing on 1 October 2008, amends the existing Highly Specialised Drugs Program to update its arrangements, ensuring continued and improved access to necessary treatments. The policy objective is to support efficient and effective medical treatment through the provision of specialised pharmaceutical products where the standard PBS provisions may be inadequate.

Scope and Application

The National Health Act 1953, as amended by the instrument F2008L03436, applies to the Pharmaceutical Benefits Scheme (PBS) under which the Commonwealth provides access to a wide range of medicines for Australians. This Act applies to both individuals and entities involved in the provision and supply of pharmaceutical benefits, particularly focusing on the declaration of drugs and medicinal preparations that are subject to the scheme. The Act extends its reach nationally, ensuring consistent access to these benefits across the Commonwealth. The Highly Specialised Drugs Program, an amendment under the Act, specifically targets individuals receiving treatment with highly specialised drugs at private hospitals, ensuring an adequate supply of these medications is available under certain conditions. This program is designed for non-admitted patients, day admitted patients, and those on discharge, thereby extending the application of the Act to these particular medical circumstances. The amendments made by this instrument, effective from 1 October 2008, include the addition of Clozapine oral liquid 50 mg per mL, 100 mL to the Highly Specialised Drugs Program.

Key Provisions

The key provisions of the legislation amend the Highly Specialised Drugs Program under the National Health Act 1953 (the Act). Section 100(1) allows the Minister to make special arrangements for providing an adequate supply of special pharmaceutical products to certain individuals, including those in isolated areas or receiving medical treatment where pharmaceutical benefits cannot be conveniently or efficiently supplied under the Act. The amendments, which came into effect on 1 October 2008, modify the existing arrangements (PB 80 of 2008) and are detailed in Schedule 1 of the instrument. These amendments specifically add a new form of Clozapine, Oral liquid 50 mg per mL, 100 mL, to the list of drugs available under the Highly Specialised Drugs Program. The Act imposes certain obligations on the parties involved. The Minister for Health and Ageing is responsible for making special arrangements under section 100(1) of the Act to ensure an adequate supply of highly specialised drugs for eligible patients. The Pharmaceutical Benefits Advisory Committee (PBAC) must recommend which drugs and medicinal preparations should be available as pharmaceutical benefits under section 100A. The PBAC considers clinical effectiveness, safety, and cost-effectiveness. The Commonwealth/State Highly Specialised Drugs Working Party (HSDWP) advises the PBAC on the suitability of drugs for listing under the Highly Specialised Drugs Program. The HSDWP's recommendations must be supported by a majority of its members and consider funding and administrative aspects. The Act also outlines consequences for non-compliance. Breaches of the provisions could result in civil or criminal penalties, depending on the nature and severity of the breach. For instance, unauthorised supply of pharmaceutical benefits could lead to fines or imprisonment. Specific maximum penalties are not detailed in the Act but would typically be outlined in related legislation or regulations. Non-compliance with the Act could also result in the revocation of special arrangements made under section 100(1).

Legal classification tags

Area of Law
Pharmaceutical Law
Instrument
Legislative Instrument
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.