EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 96 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 October 2008, was made on 1 September 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 October 2008.
Paragraph 2: provides that Schedule 1 amends PB 82 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Addition of Brand
Cisplatin I.V. injection 100 mg in 100 mL (Pfizer Australia Pty Ltd)
Overview
The National Health Act 1953, enacted by the Parliament of Australia, serves to establish the Australian Pharmaceutical Benefits Scheme (PBS), aimed at ensuring timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community. This Act, particularly Part VII, regulates the supply of listed drugs and medicinal preparations as pharmaceutical benefits. The Chemotherapy Pharmaceuticals Access Program, introduced under subsection 100(1) of the Act, addresses the gap in providing adequate pharmaceutical benefits to patients who are either in isolated areas or undergoing medical treatment where conventional PBS supply is not feasible or adequate. The program was designed to meet these specific needs through special arrangements, ensuring that non-admitted patients, day admitted patients, and patients on discharge at public hospitals receive necessary chemotherapy pharmaceuticals.
The amendments to the Chemotherapy Pharmaceuticals Access Program, as specified in the legislative instrument number PB 96 of 2008, were made in response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established under the Act. The PBAC advises the Minister on which drugs and medicinal preparations should be available as pharmaceutical benefits, taking into account their clinical effectiveness, safety, and cost-effectiveness. The legislative instrument, effective from 1 October 2008, updates the Chemotherapy Pharmaceuticals Access Program by incorporating new arrangements, including the addition of specific chemotherapy drugs such as Brand Cisplatin, to enhance access and treatment options for patients under public hospital care.
Scope and Application
The National Health Act 1953, as amended by the Chemotherapy Pharmaceuticals Access Program Arrangement, applies to individuals who are receiving medical treatment under circumstances where pharmaceutical benefits cannot be conveniently or efficiently supplied in accordance with Part VII of the Act, or where such benefits are inadequate for their medical treatment. This Act operates on a national level, with the special arrangements being applicable across Australia, including in the states of Victoria, Western Australia, Queensland, and the Northern Territory, which have agreed to participate in the reforms. The arrangements are made under subsection 100(1) of the Act, allowing the Minister to establish special provisions for the supply of necessary pharmaceutical products to eligible persons, including those living in isolated areas. The Chemotherapy Pharmaceuticals Access Program specifically targets the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients, and patients on discharge. The Act does not specify exclusions or thresholds within the explanatory statement, but it does mention that the Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role in recommending which drugs and medicinal preparations should be available as pharmaceutical benefits. This legislative instrument is subject to potential variation or revocation by the Minister, as outlined in subsection 100(2) of the Act.
Key Provisions
The main operative sections of the Australian Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953 (the Act) are sections 85 and 100. Section 85(1) mandates the Commonwealth to provide benefits in accordance with Part VII of the Act, which governs the supply of listed drugs and medicinal preparations as pharmaceutical benefits (subsection 85(1)). Section 100(1) empowers the Minister to make special arrangements for the supply of special pharmaceutical products to individuals in isolated areas or receiving medical treatment where pharmaceutical benefits cannot be conveniently or efficiently supplied under Part VII or are inadequate for the treatment (subsection 100(1)). The Chemotherapy Pharmaceuticals Access Program, detailed under subparagraph 100(b)(i), facilitates the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients, and patients on discharge.
The Act imposes several obligations on the parties involved. Firstly, the Minister is tasked with ensuring that special arrangements are made to provide an adequate supply of special pharmaceutical products to eligible individuals (subsection 100(1)). Additionally, the Pharmaceutical Benefits Advisory Committee (PBAC), as established under section 100A, must recommend which drugs and medicinal preparations should be available as pharmaceutical benefits. The PBAC comprises experts from various fields, including consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and specialists. When recommending the listing of a medicine on the PBS, the PBAC considers the medicine's medical conditions, clinical effectiveness, safety, and cost-effectiveness compared to other treatments.
The Act also outlines offences and penalties for breaches. Although the Explanatory Statement does not specify detailed penalties, general provisions under the National Health Act 1953 may include fines or imprisonment for violations related to the provision or administration of pharmaceutical benefits. The specific penalties would depend on the nature and severity of the breach, as well as any additional legislative provisions or regulations that apply.
The Chemotherapy Pharmaceuticals Access Program, as amended by this legislative instrument, ensures that public hospitals can provide Australian Government-subsidised access to a range of cancer chemotherapy drugs listed on the PBS. This is achieved through agreements between the Australian Government and participating states, with Victoria, Western Australia, Queensland, and the Northern Territory currently participating in the reforms. The amendments include the addition of specific chemotherapy drugs, such as BrandCisplatin I.V. injection 100 mg in 100 mL (Pfizer Australia Pty Ltd), to the list of pharmaceuticals available under the program, facilitating better access to necessary treatments for patients.