EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 43 of 2009
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 120 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 June 2009, was made on 1 May 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 June 2009.
Paragraph 2: provides that Schedule 1 amends PB 120 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Form Added
Deferiprone
Alteration of Circumstances
Infliximab [for the treatment of severe chronic plaque psoriasis]
Overview
The National Health Act 1953, as amended by the instrument F2009L01716, provides a legislative framework for the Highly Specialised Drugs Program, which aims to ensure that individuals receiving treatment with highly specialised drugs at private hospitals as non-admitted, day admitted patients, or patients on discharge have access to an adequate supply of these drugs. This program falls under subsection 100(1) of the Act, allowing the Minister to make special arrangements to meet specific needs not adequately addressed by the Pharmaceutical Benefits Scheme (PBS). The instrument, which commenced on 1 June 2009, amends the arrangements made under subparagraph 100(b)(i) effective from 1 December 2008. The amendments outlined in Schedule 1 aim to enhance the availability and administration of highly specialised drugs, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and the Commonwealth/State Highly Specialised Drugs Working Party (HSDWP). The PBAC, an independent expert body, advises on which drugs should be available as pharmaceutical benefits, considering factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness. Meanwhile, the HSDWP focuses on the funding and administrative aspects of drug supply through the hospital system, ensuring recommendations are well-supported by a majority of its members.
Scope and Application
The Highly Specialised Drugs Program, governed by the National Health Act 1953, facilitates the provision of special pharmaceutical products to Australians residing in isolated areas or undergoing medical treatments where conventional pharmaceutical benefits under Part VII of the Act are inadequate or impractical to supply. The Minister for Health and Ageing can establish these special arrangements under subsection 100(1) of the Act, with the flexibility to vary or revoke them as stipulated in subsection 100(2). The legislative instrument, PB 43 of 2009, amends the existing arrangements made under subparagraph 100(b)(i) (PB 120 of 2008) which took effect on 1 December 2008. These amendments, effective from 1 June 2009, focus on ensuring an adequate supply of highly specialised drugs for patients in private hospitals, including non-admitted, day admitted patients, and those on discharge. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending drugs for inclusion in the PBS, considering factors such as medical condition approval, clinical effectiveness, safety, and cost-effectiveness. The Commonwealth/State Highly Specialised Drugs Working Party (HSDWP) further advises the PBAC on the suitability of drugs for the Highly Specialised Drugs Program, taking into account funding and administrative aspects of hospital supply.
Key Provisions
The National Health Act 1953, as amended by the instrument F2009L01716, provides the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have reliable access to a broad range of medications (subsection 85(1)). Under subsection 85(2), the Minister declares which drugs and medicinal preparations are subject to the PBS. Section 100(1) allows the Minister to make special arrangements to ensure an adequate supply of certain pharmaceutical products, especially for those in isolated areas or receiving medical treatments where the standard PBS provisions are inadequate (subsection 100(1)(a) and (b)). These special arrangements can be varied or revoked by the Minister (subsection 100(2)) and take precedence over the standard provisions of the Act (subsection 100(3)). Schedule 6 of the declaration lists drugs eligible for these special arrangements.
The Act imposes several obligations on the parties involved. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent body established under section 100A, recommends which drugs should be included in the PBS. A drug cannot be declared under section 85(2) unless recommended by the PBAC (subsection 101(4)). The PBAC's recommendations consider the medical conditions for which the drug is approved, its clinical effectiveness, safety, and cost-effectiveness compared to other treatments. The Commonwealth/State Highly Specialised Drugs Working Party (HSDWP) further recommends drugs for inclusion in the Highly Specialised Drugs Program, considering funding and administrative aspects. Their recommendations must be supported by a majority of the Working Party members.
The Act also outlines penalties and consequences for non-compliance. While specific penalties are not detailed in the explanatory statement, breaches of the provisions governing the PBS and special arrangements can potentially result in both civil and criminal penalties, depending on the nature and severity of the breach. The consequences could include fines, imprisonment, or other legal actions as prescribed by relevant laws. The Act's provisions ensure that the PBS operates effectively and that Australians have access to necessary medications, especially those requiring special arrangements.