EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 8 of 2010
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. 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 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 54 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 March 2010, was made on 5 February 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 March 2010.
Paragraph 2: provides that Schedule 1 amends PB 54 of 2009.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Alteration of Circumstances
Infliximab | [addition of the drug ustekinumab to the list of interchangeable biological agents for the treatment of severe chronic plaque
psoriasis and amendment of definition of Biological Treatment Cycle] |
SCHEDULE 2
Deletion of Form
Epoetin Beta | Injection 1,000 units in 0.3 mL pre-filled syringe |
Alteration of Brand
Thalidomide | Capsule 50 mg From: Thalidomide Pharmion To: Thalomid |
Overview
The National Health Act 1953, amended by the instrument F2010L00475, seeks to address the problem of ensuring that Australians, particularly those in remote or requiring specific medical treatments, have adequate access to necessary pharmaceutical products. This Act, enacted by the Parliament of Australia, establishes the Pharmaceutical Benefits Scheme (PBS) to provide reliable, timely, and affordable access to a range of medicines. The legislation allows for special arrangements under subsection 100(1) to ensure that particular groups, such as those in isolated areas or receiving specific treatments, have access to necessary pharmaceutical benefits. The amendments under this instrument, effective from 1 March 2010, specifically target the Highly Specialised Drugs Program, refining the criteria for special arrangements to better meet the needs of non-admitted patients, day admitted patients, and those on discharge who require highly specialised drugs. The policy objective is to ensure that Australians in need of specialised treatments have access to the necessary pharmaceutical products, thereby improving health outcomes and ensuring equitable access across the nation.
Scope and Application
The National Health Act 1953, as amended by the legislative instrument F2010L00475, specifically pertains to the Highly Specialised Drugs Program under section 100 of the Act. This program aims to ensure the availability of highly specialised pharmaceutical products to individuals receiving treatment in private hospitals as non-admitted, day admitted, or discharge patients, where standard pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS) are either inadequate or inefficiently supplied. The Act applies to drugs and medicinal preparations declared by the Minister under subsection 85(2), with the Highly Specialised Drugs Program focusing on those drugs listed in Schedule 6 of the Act. The geographic reach of the Act is national, as it operates across all states and territories within Australia. The Act does not specify exclusions or exemptions, but the arrangements can be varied or revoked by the Minister under subsection 100(2). The legislative instrument also extends the application of the Act through subordinate instruments, such as amendments to existing arrangements, as seen in the alterations to the drug listing and brand specifications in Schedule 1 and Schedule 2 of the instrument. This amendment, which came into effect on 1 March 2010, was made following recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and the Commonwealth/State Highly Specialised Drugs Working Party (HSDWP), ensuring that the program aligns with clinical effectiveness, safety, and cost-effectiveness standards.
Key Provisions
The main operative sections of this legislation are primarily concerned with the amendment of the Highly Specialised Drugs Program under the National Health Act 1953 (the Act). Section 100(1) of the Act allows the Minister to make special arrangements for the provision of special pharmaceutical products to certain groups, including those in isolated areas or receiving medical treatment under specific circumstances. The current legislative instrument amends the arrangements made under paragraph 100(b)(i) (PB 54 of 2009), which came into effect on 1 July 2009. These amendments, detailed in Schedule 1, include the addition of the drug ustekinumab to the list of interchangeable biological agents for the treatment of severe chronic plaque psoriasis and the amendment of the definition of a Biological Treatment Cycle. Additionally, there are alterations to the brand names of certain drugs, such as the change from Thalidomide Pharmion to Thalomid for thalidomide.
The Act imposes several obligations and requirements on the parties involved. Firstly, the Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in recommending which drugs and medicinal preparations should be available as pharmaceutical benefits under 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 takes 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. Furthermore, 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, considering the funding and administrative aspects of supply through the hospital system.
The legislation also outlines potential consequences for breaches. While the explanatory statement does not explicitly mention offences, penalties, or civil/criminal consequences for breaches, it is clear that the provisions under the Act are designed to ensure that the Highly Specialised Drugs Program operates effectively and that patients receive the necessary medications in a timely and efficient manner. Any failure to comply with the requirements set out in the Act or the amendments made by this legislative instrument could potentially lead to legal consequences, though the specific penalties are not detailed in the explanatory statement. The overarching intent is to ensure the adequacy and efficiency of the pharmaceutical benefits provided under the Act.