EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 130 OF 2008
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 121 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 January 2009, was made on 3 December 2008.
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.
The public hospital pharmaceutical reforms provide Australian Government subsidised access to a range of cancer chemotherapy drugs, listed on the PBS, for day admitted and non-admitted public hospital patients within a clinical setting under the Chemotherapy Pharmaceutical Access Program. The pharmaceutical reforms are implemented by means of an agreement between the Australian Government and participating States through the Australian Health Care Agreements. To date, Victoria, Western Australia, Queensland and the Northern Territory are participating in the reforms.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 January 2009.
Paragraph 2: provides that Schedule 1 amends PB 121 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Addition of Brands
Carboplatin Solution for I.V. injection 450 mg in 45 mL (Baxter Carboplatin)
Paclitaxel Solution concentrate for I.V. infusion 30 mg in 5 mL (Baxter Paclitaxel)
Solution concentrate for I.V. infusion 100 mg in 16.7 mL (Baxter Paclitaxel)
Solution concentrate for I.V. infusion 300 mg in 50 mL (Baxter Paclitaxel)
Overview
The National Health Act 1953, enacted by the Commonwealth Parliament, was amended through the legislative instrument F2008L04643 to address the need for providing timely, reliable, and affordable access to necessary and cost-effective medicines for Australians. The specific problem or gap it was introduced to address is the need for special arrangements for the supply of pharmaceutical products, particularly chemotherapy pharmaceuticals, to patients in isolated areas or those receiving medical treatment where the Pharmaceutical Benefits Scheme (PBS) does not adequately meet their needs. This amendment allows the Minister to make special arrangements under subsection 100(1) to ensure an adequate supply of these essential pharmaceuticals.
The Chemotherapy Pharmaceuticals Access Program, amended under this instrument, provides arrangements for the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients, and patients on discharge, thereby ensuring these patients have access to necessary medications within a clinical setting. These amendments, which came into effect on 1 January 2009, are made in response to the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and are implemented through agreements between the Australian Government and participating states.
Scope and Application
The National Health Act 1953 applies to the supply of pharmaceutical benefits, regulated by the Australian Pharmaceutical Benefits Scheme (PBS), which aims to provide affordable access to necessary and cost-effective medicines for the Australian community. Under subsection 100(1) of the Act, the Minister is empowered to make special arrangements for the supply of pharmaceutical products, particularly for individuals in isolated areas or receiving medical treatment where conventional PBS provisions are inadequate. This legislative framework includes the ability to amend or revoke these special arrangements as needed, ensuring flexibility in meeting the health needs of specific populations. The Chemotherapy Pharmaceuticals Access Program, established under these provisions, facilitates the supply of chemotherapy pharmaceuticals to non-admitted patients, day admitted patients, and discharged patients at public hospitals, aligning with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). This program operates across multiple states through agreements under the Australian Health Care Agreements, currently involving Victoria, Western Australia, Queensland, and the Northern Territory. The legislative instrument amending these arrangements, effective from 1 January 2009, incorporates additions such as specific brands of Carboplatin and Paclitaxel to the list of available pharmaceuticals.
Key Provisions
The main operative sections of the National Health Act 1953 Amendment Special Arrangements Under Subsection 100(1) Chemotherapy Pharmaceuticals Access Program (F2008L04643) are sections 100(1), 100(2), and 100(3). Section 100(1) allows the Minister to make special arrangements for providing an adequate supply of special pharmaceutical products to persons 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 the treatment. Section 100(2) empowers the Minister to vary or revoke these special arrangements. Section 100(3) clarifies that Part VII of the Act operates subject to any special arrangements made under section 100(1).
The obligations and requirements imposed by the Act on the parties and entities it governs include ensuring that special arrangements made under section 100(1) are adhered to, particularly in relation to the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients, and patients on discharge. These obligations extend to the Pharmaceutical Benefits Advisory Committee (PBAC), which must recommend which drugs and medicinal preparations should be available as pharmaceutical benefits based on criteria such as medical conditions, clinical effectiveness, safety, and cost-effectiveness. Participating states must also implement these reforms through agreements under the Australian Health Care Agreements.
The Act provides for various offences, penalties, and consequences for breaches, although specific maximum penalties are not detailed in the explanatory statement. Breaches of the special arrangements or failure to comply with the obligations set forth in the Act may result in civil or criminal consequences. These could include fines, revocation of the special arrangement, or other administrative actions deemed necessary to enforce compliance with the Act’s provisions. The Act also implies that non-compliance with the recommended listing of medicines on the PBS by the PBAC could lead to potential legal or administrative repercussions, although these are not explicitly detailed in the explanatory statement.