EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 56 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 93 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 June 2008, was made on 1 May 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 June 2008.
Paragraph 2: provides that Schedule 1 amends PB 93 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Brand Deletion
Oxaliplatin Powder for I.V. infusion 50 mg (Oxaliplan 50)
Powder for I.V. infusion 100 mg (Oxaliplan 100)
Overview
The National Health Act 1953 was enacted to provide for the supply of listed drugs and medicinal preparations as pharmaceutical benefits, regulated by Part VII of the Act. This Act was introduced to address the need for timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community. The Parliament of Australia established this Act to ensure that the Commonwealth provides benefits in accordance with Part VII of the Act, including special arrangements under subsection 100(1) for ensuring an adequate supply of special pharmaceutical products to those living in isolated areas or receiving medical treatment where pharmaceutical benefits cannot be conveniently or efficiently supplied under Part VII. The policy objective is to provide subsidised access to cancer chemotherapy drugs for day admitted and non-admitted public hospital patients within a clinical setting through the Chemotherapy Pharmaceutical Access Program.
Scope and Application
The Chemotherapy Pharmaceuticals Access Program is an initiative under the National Health Act 1953, designed to ensure that patients receiving chemotherapy treatments have timely and reliable access to necessary pharmaceutical benefits. The Act applies to individuals residing in isolated areas or those receiving medical treatment in circumstances where conventional pharmaceutical benefits under Part VII of the Act are either inadequate or cannot be conveniently or efficiently supplied. The program specifically targets non-admitted patients, day admitted patients, and patients on discharge within public hospitals, ensuring they receive the required chemotherapy drugs as part of their treatment. The geographic reach of this Act is national, with implementation coordinated through agreements between the Australian Government and participating states such as Victoria, Western Australia, Queensland, and the Northern Territory. The Act allows the Minister to make special arrangements under subsection 100(1), which can be varied or revoked under subsection 100(2). The scope of the Act is further extended by subordinate instruments, particularly those listed in Schedule 6, which detail the drugs and medicinal preparations eligible for special arrangements.
Key Provisions
The main operative sections of this legislation, particularly those relevant to the Chemotherapy Pharmaceuticals Access Program, are sections 100(1) and 100(2) of the National Health Act 1953 (the Act). Section 100(1) empowers the Minister to make special arrangements for the provision of an adequate supply of special pharmaceutical products to persons living in isolated areas or those receiving medical treatment where pharmaceutical benefits cannot be conveniently or efficiently supplied in accordance with Part VII of the Act, or where such benefits are inadequate for that medical treatment. Section 100(2) allows the Minister to vary or revoke these special arrangements as deemed necessary. The Act further stipulates that Part VII of the Act operates subject to any special arrangement made under section 100(1).
The obligations imposed by the Act on the parties involved, particularly in the context of the Chemotherapy Pharmaceuticals Access Program, include the responsibility of the Minister to ensure that the special arrangements are made to provide adequate pharmaceutical supplies to eligible patients. Additionally, participating states and territories are required to implement these arrangements in accordance with the Australian Health Care Agreements. Hospitals participating in the program must ensure that they provide access to listed chemotherapy drugs under the program to eligible patients within a clinical setting. The Pharmaceutical Benefits Advisory Committee (PBAC) has the responsibility to recommend which drugs and medicinal preparations should be available as pharmaceutical benefits, taking into account factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness.
Breaches of the provisions outlined in the Act may lead to both civil and criminal consequences. Under section 102 of the Act, any person who contravenes a provision of the Act, or an order made under the Act, is liable to a penalty. The maximum penalty for such an offence is generally set out in the relevant provision of the Act. For instance, section 102(1) states that a person who contravenes a provision of the Act is liable to a penalty of up to 100 penalty units for a corporation. Civil penalties may also apply for breaches of the Act, which could result in compensation or other remedies being sought by affected parties. Additionally, in cases where the breach results in harm to patients, there may be further civil or criminal liability under other relevant legislation.