EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 102 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 82 of 2008 which came into effect on 1 August 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 November 2008, was made on 2 October 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 November 2008.
Paragraph 2: provides that Schedule 1 amends PB 82 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Deletion of Item
Epirubicin Powder for injection containing epirubicin hydrochloride 50 mg
Addition of Brand
Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
(Irinotecan-GA)
Overview
The National Health Act 1953, enacted by the Australian Parliament, is a foundational piece of legislation that governs the supply of pharmaceutical benefits across Australia through the Australian Pharmaceutical Benefits Scheme (PBS). This Act was introduced to address the need for a reliable and affordable system for the provision of necessary medicines to the Australian community. One of the specific provisions within this Act, subsection 100(1), empowers the Minister to make special arrangements for ensuring an adequate supply of particular pharmaceutical products to individuals in isolated areas or those undergoing medical treatment under circumstances where conventional PBS provisions are inadequate. This legislative framework aims to enhance access to essential medications for those in remote locations or with specific medical needs that the standard PBS provisions cannot efficiently meet. The Chemotherapy Pharmaceuticals Access Program, established under these provisions, exemplifies the Act's intent by facilitating access to chemotherapy pharmaceuticals for hospital patients who are either non-admitted, day admitted, or on discharge, thereby ensuring timely and cost-effective treatment.
Scope and Application
The National Health Act 1953 Amendment Special Arrangements under Subsection 100(1) Chemotherapy Pharmaceuticals Access Program, as evidenced by the legislative instrument F2008L03761, pertains specifically to the supply of chemotherapy pharmaceuticals to patients who are not admitted to a hospital but receive treatment in a clinical setting, such as day admitted patients or those on discharge. The Act applies to the Commonwealth level and is implemented in accordance with the Australian Health Care Agreements between the Australian Government and participating states. It amends the previous Chemotherapy Pharmaceuticals Access Program arrangements set out in PB 82 of 2008 to include specific additions and deletions of chemotherapy drugs. The arrangements are made under the authority of subsection 100(1) of the Act, which allows the Minister to create special arrangements for the supply of necessary pharmaceutical products to persons in isolated areas or those receiving medical treatment where standard PBS provisions are inadequate. The amendments are effective from 1 November 2008 and are a result of recommendations by the Pharmaceutical Benefits Advisory Committee, ensuring that the supply of chemotherapy pharmaceuticals aligns with clinical effectiveness, safety, and cost-effectiveness criteria.
Key Provisions
The main operative sections of this legislation, specifically the National Health Act 1953 Amendment (Chemotherapy Pharmaceuticals Access Program), include sections 100(1), 100(2), and 100(3). Section 100(1) allows the Minister to make special arrangements for ensuring an adequate supply of special pharmaceutical products to persons living in isolated areas or receiving medical treatment where pharmaceutical benefits cannot be conveniently or efficiently supplied under Part VII of the Act or are inadequate for their medical treatment. Section 100(2) empowers the Minister to vary or revoke any special arrangement made under section 100(1). Section 100(3) specifies that Part VII of the Act is subject to any special arrangements made under section 100(1). The primary focus here is on providing access to chemotherapy pharmaceuticals in public hospitals to non-admitted patients, day admitted patients, and patients on discharge through the Chemotherapy Pharmaceuticals Access Program.
The obligations and requirements imposed by this Act on the parties or entities it governs include the facilitation of the Chemotherapy Pharmaceuticals Access Program, which involves ensuring that public hospitals provide access to listed cancer chemotherapy drugs for day admitted and non-admitted patients. This is achieved through an agreement between the Australian Government and participating states, as outlined in the Australian Health Care Agreements. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role by making recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits, taking into account various factors such as the medical conditions for which the medicine has been approved, its clinical effectiveness, safety, and cost-effectiveness compared with other treatments.
The Act also imposes specific offences, penalties, or civil/criminal consequences for breach, although the precise penalties are not detailed in the provided text. However, it is known that the Act's provisions are enforced to ensure compliance with the special arrangements made for the Chemotherapy Pharmaceuticals Access Program. Any breaches of these special arrangements could potentially lead to legal repercussions, including administrative penalties or other civil and criminal consequences, though the exact nature and extent of these penalties are not specified within the document. The overarching goal is to maintain the integrity and effectiveness of the Chemotherapy Pharmaceuticals Access Program by ensuring that necessary pharmaceutical benefits are made available to those in need, particularly in public hospital settings.