EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 12 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 92 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 January 2008, was made on 14 December 2007.
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 January 2008.
Paragraph 2: provides that Schedule 1 amends PB 92 of 2007.
Schedule 1: provides for the following amendments:
SUMMARY OF CHANGES
SCHEDULE 2
Addition
Overview
The National Health Act 1953, enacted by the Parliament of Australia, establishes the legislative framework for the Pharmaceutical Benefits Scheme (PBS). The primary objective of the Act is to ensure that all Australians have reliable, timely, and affordable access to a broad range of medicines. Section 100(1) of the Act allows the Minister for Health to make special arrangements for ensuring an adequate supply of special pharmaceutical products to individuals in isolated areas or receiving medical treatment where the PBS cannot provide convenient or efficient pharmaceutical benefits, or where the benefits are inadequate for their treatment. The Highly Specialised Drugs Program, an amendment made under subsection 100(1), aims to provide adequate supplies of highly specialised drugs to patients receiving treatment at private hospitals, addressing a gap in the standard PBS provisions for such patients. This legislative instrument, effective from 1 January 2008, was designed to enhance access to necessary medications for patients in unique medical situations, aligning with the overarching policy objective of the National Health Act to improve health outcomes through accessible pharmaceutical benefits.
Scope and Application
The National Health Act 1953, as amended by the instrument F2007L04909, pertains to the Pharmaceutical Benefits Scheme (PBS) and the special arrangements for highly specialised drugs. The Act applies to the provision of pharmaceutical benefits to all Australians, overseen by the Commonwealth. Under the Act, the Minister for Health and Ageing has the authority to make special arrangements for ensuring that an adequate supply of special pharmaceutical products is available to persons in isolated areas or receiving medical treatment where conventional PBS provisions are inadequate. The Highly Specialised Drugs Program, a subset of these special arrangements, focuses on ensuring the availability of these drugs to patients in private hospitals, whether they are non-admitted, day admitted, or on discharge. The Act’s scope includes drugs and medicinal preparations declared by the Minister, with specific arrangements for highly specialised drugs listed in Schedule 6 of the declaration. The amendments made by the instrument, effective from 1 January 2008, update the existing arrangements to include Efavirenz Tablet 200 mg. These special arrangements are subject to the oversight of the Pharmaceutical Benefits Advisory Committee (PBAC) and the Commonwealth/State Highly Specialised Drugs Working Party (HSDWP), which recommend suitable drugs for inclusion in the PBS and the Highly Specialised Drugs Program respectively.
Key Provisions
The main operative sections of this legislation are subsections 100(1) and 100(2) of the National Health Act 1953 (the Act), which allow the Minister to make special arrangements for the supply of highly specialised drugs to certain individuals (subsection 100(1)) and to vary or revoke such arrangements (subsection 100(2)). These arrangements ensure that an adequate supply of special pharmaceutical products is available to those in isolated areas or receiving medical treatment where conventional pharmaceutical benefits are inadequate (subsection 100(1)(a) and (b)). The Highly Specialised Drugs Program is an example of such special arrangements, specifically designed to provide access to highly specialised drugs for non-admitted, day admitted, or discharged patients in private hospitals (Schedule 6).
The Act imposes several obligations on the parties involved. Firstly, the Minister must ensure that the special arrangements are made in accordance with the provisions of the Act. This involves consulting with relevant expert bodies such as the Pharmaceutical Benefits Advisory Committee (PBAC) and the Commonwealth/State Highly Specialised Drugs Working Party (HSDWP). The PBAC must recommend drugs for inclusion on the Pharmaceutical Benefits Scheme (PBS), considering factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness (subsection 101(4)). The HSDWP advises the PBAC on the suitability of drugs for the Highly Specialised Drugs Program, considering funding and administrative aspects (Schedule 2). Furthermore, the Minister must ensure that the amendments to the Highly Specialised Drugs Program, as outlined in Schedule 1, are implemented effectively and in line with the objectives of the Act.
Any breaches of the provisions of the Act can lead to both civil and criminal consequences. For instance, if a person or entity fails to comply with the special arrangements made under subsection 100(1), they may face penalties as stipulated in the relevant sections of the Act. While the specific penalties are not detailed in the explanatory statement, they could include fines or other sanctions as prescribed by law. Additionally, failure to adhere to the recommendations of the PBAC or HSDWP could result in the Minister taking action to rectify non-compliance, potentially leading to further legal or administrative repercussions. The Act ensures that the availability of highly specialised drugs is managed efficiently and effectively to meet the needs of those who require them, while also holding parties accountable for any breaches.