EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 102 OF 2009
NATIONAL HEALTH ACT 1953
AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBSECTION 100(1)
CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM
Purpose and operation
The purpose of the Australian Pharmaceutical Benefits Scheme (PBS) is to provide timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.
The PBS is regulated by Part VII of the National Health Act 1953 (the Act), which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits.
Subsection 85(1) of the Act provides that benefits shall be provided by the Commonwealth in accordance with Part VII of the Act in respect of pharmaceutical benefits.
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 Chemotherapy Pharmaceuticals Access Program is a set of Arrangements made under subparagraph 100(b)(i) of the Act for the purpose of the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients and patients on discharge.
These Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends Chemotherapy Pharmaceuticals Access Program Arrangements under subparagraph 100(b)(i) made by legislative instrument number PB 55 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 November 2009, was made on 8 October 2009.
Consultations
The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations 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. When recommending the listing of a medicine 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.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 November 2009.
Paragraph 2: provides that Schedule 1 amends PB 55 of 2009.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Addition of Brands
Gemcitabine | Powder for I.V. infusion 200 mg (as hydrochloride) (Gemcitabine Actavis) |
| Powder for I.V. infusion 1 g (as hydrochloride) (Gemcitabine Actavis) |
Overview
The National Health Act 1953, as amended by the legislative instrument F2009L03892, was enacted to address the need for timely, reliable and affordable access to necessary and cost-effective medicines for Australians, particularly for those in isolated areas or undergoing specific medical treatments. This legislation provides the regulatory framework for the Australian Pharmaceutical Benefits Scheme (PBS), which aims to supply listed drugs and medicinal preparations as pharmaceutical benefits. The Act, overseen by the Australian Parliament, empowers the Minister to make special arrangements under subsection 100(1) to ensure an adequate supply of special pharmaceutical products to those in need. This includes chemotherapy pharmaceuticals, which are critical for the treatment of cancer patients, and the Chemotherapy Pharmaceuticals Access Program is a prime example of such special arrangements, ensuring that non-admitted patients, day admitted patients, and patients on discharge at public hospitals have access to necessary chemotherapy drugs.
The explanatory statement for the legislative instrument F2009L03892 indicates that this amendment was introduced to refine the existing Chemotherapy Pharmaceuticals Access Program, in response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body established under the Act, advises the Minister on the availability of drugs and medicinal preparations as pharmaceutical benefits, considering factors such as clinical effectiveness, safety, and cost-effectiveness. The amendments, effective from 1 November 2009, include the addition of specific brands of Gemcitabine, a chemotherapy drug, to the list of pharmaceuticals available under the Program, thereby enhancing access and treatment options for patients requiring these medications.
Scope and Application
The National Health Act 1953, specifically through its Amendment Special Arrangements under Subsection 100(1), pertains to the Chemotherapy Pharmaceuticals Access Program which is designed to facilitate the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients, and patients on discharge. The Act applies to any individual or entity involved in the supply of these pharmaceuticals in the specified circumstances, ensuring that they are provided efficiently and effectively where conventional arrangements under the Pharmaceutical Benefits Scheme (PBS) are inadequate or inconvenient. The jurisdictional reach of this Act is national, as it is governed under the Commonwealth of Australia, but it affects the delivery of pharmaceutical benefits across the entire country. While the Act aims to extend access to necessary chemotherapy drugs, it does not explicitly exclude any particular groups or medications from its purview, except as delineated in the Schedule 6 of the declaration under subsection 85(2) of the Act, which lists the drugs and medicinal preparations available under special arrangements. The application and interpretation of the Act may be further defined through subordinate instruments, which allow for variations or revocations of special arrangements as needed.
Key Provisions
The main operative sections of this legislation, the National Health Act 1953 Amendment Special Arrangements under Subsection 100(1) Chemotherapy Pharmaceuticals Access Program, include sections 100(1), 100(2), and 100(3). Section 100(1) allows the Minister to make special arrangements to ensure an adequate supply of special pharmaceutical products is available to people in isolated areas or 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) allows the Minister to vary or revoke a special arrangement made under section 100(1). Section 100(3) states that Part VII of the Act has effect subject to any special arrangement made under section 100(1). The Chemotherapy Pharmaceuticals Access Program, established under these provisions, is designed to ensure the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients, and patients on discharge.
The obligations and requirements imposed by this Act on the parties or entities it governs include ensuring the timely, reliable, and affordable access to necessary and cost-effective medicines, particularly for those in isolated areas or receiving medical treatment where conventional pharmaceutical benefits are inadequate. The Minister, under section 100(1), is required to make special arrangements to facilitate the supply of such medicines. Furthermore, the Pharmaceutical Benefits Advisory Committee (PBAC) is mandated to make recommendations to the Minister regarding which drugs and medicinal preparations should be available as pharmaceutical benefits, taking into account clinical effectiveness, safety, and cost-effectiveness.
The Act imposes several potential consequences for breaches or non-compliance. While specific offences and penalties are not detailed in the explanatory statement, breaches of the provisions under the National Health Act 1953 could result in legal action, including civil or criminal penalties. These may include fines or imprisonment, depending on the severity and nature of the breach. The maximum penalties would be in line with those prescribed under the general provisions of the National Health Act 1953 and related legislation, but the exact penalties would depend on the specific nature of the offence. The Act also allows for the variation or revocation of special arrangements made under section 100(1) if deemed necessary by the Minister.