EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 85 of 2009
NATIONAL HEALTH ACT 1953
AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBSECTION 100(1)
HIGHLY SPECIALISED DRUGS PROGRAM FOR PUBLIC HOSPITALS
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(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 public 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 61 of 2009) which came into effect on 1 July 2009. 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 September 2009, was made on 21 August 2009.
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 September 2009.
Paragraph 2: provides that Schedule 1 amends PB 61 of 2009.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Alteration of Circumstances
Overview
The National Health Act 1953, amended by the legislative instrument F2009L03333, addresses the need for an adequate supply of highly specialised drugs for public hospital patients who are receiving treatment as non-admitted, day admitted, or discharge patients. This legislative instrument, introduced by the Parliament of Australia, aims to facilitate the provision of these special pharmaceutical products under the Highly Specialised Drugs Program for Public Hospitals. The amendments, effective from 1 September 2009, adjust the special arrangements previously made under the Act to better meet the needs of these patients. The changes are guided by recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and the Commonwealth/State Highly Specialised Drugs Working Party (HSDWP), ensuring that the drugs listed are both clinically effective and cost-effective.
Scope and Application
The National Health Act 1953, as amended by the instrument F2009L03333, applies to the provision of pharmaceutical benefits through the Pharmaceutical Benefits Scheme (PBS) which ensures Australians have access to a wide range of affordable medicines. The Act applies to drugs and medicinal preparations declared by the Minister to be part of the PBS, with the exception of some medicinal preparations with additives. The Highly Specialised Drugs Program for Public Hospitals, under subsection 100(1) of the Act, makes special arrangements to provide an adequate supply of special pharmaceutical products to persons receiving treatment in isolated areas or under circumstances where the PBS is inadequate. This program is specifically tailored for non-admitted patients, day admitted patients, and patients on discharge in public hospitals who require highly specialised drugs. The arrangements are subject to modification or revocation by the Minister and are effective as per the legislative instrument. The instrument also references the Pharmaceutical Benefits Advisory Committee (PBAC) and the Commonwealth/State Highly Specialised Drugs Working Party (HSDWP), both of which play crucial roles in recommending and considering the suitability of drugs for inclusion in the PBS.
Key Provisions
The main operative sections of the legislative instrument are sections 100(1) and 100(2) of the National Health Act 1953, which provide the Minister with the authority to make special arrangements for the provision of special pharmaceutical products to individuals in isolated areas or those receiving medical treatment where the Pharmaceutical Benefits Scheme (PBS) does not adequately meet their needs. Specifically, section 100(1) allows for special arrangements to be made under two circumstances: (a) individuals living in isolated areas; and (b) those receiving medical treatment where pharmaceutical benefits cannot be conveniently or efficiently supplied under Part VII of the Act or are inadequate for that treatment. Section 100(2) grants the Minister the power to vary or revoke any special arrangements made under section 100(1). The instrument amends the Highly Specialised Drugs Program for Public Hospitals, which was established under section 100(b)(i) to provide an adequate supply of special pharmaceutical products to patients receiving highly specialised drug treatments at public hospitals.
The Act imposes several obligations and requirements on the parties it governs. Firstly, the Minister for Health and Ageing is responsible for making special arrangements for the provision of special pharmaceutical products under section 100(1). These arrangements must be made in accordance with the criteria set out in the Act and must ensure that an adequate supply of the necessary drugs is available. Secondly, the Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending which drugs and medicinal preparations should be available as pharmaceutical benefits. Under subsection 101(4) of the Act, a drug or medicinal preparation cannot 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. The PBAC's recommendations take into account various factors, including 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. Thirdly, the Commonwealth/State Highly Specialised Drugs Working Party (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 Act also imposes specific offences, penalties, or civil/criminal consequences for breach. While the explanatory statement does not detail specific penalties, breaches of the Act or the regulations made under it can generally lead to civil or criminal penalties. For civil penalties, the Act provides for fines and enforcement actions. For criminal penalties, the severity of the offence determines the potential penalties, which can include substantial fines and, in some cases, imprisonment. The specific penalties applicable to a breach would depend on the nature and circumstances of the offence, as well as any relevant guidelines or precedents established by courts.