EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 50 OF 2010
NATIONAL HEALTH ACT 1953
AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBSECTION 100(1)
CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM
Summary
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 amendment provides for a deletion of a form of a chemotherapy pharmaceutical available at public hospitals to non-admitted patients, day-admitted patients or patients on discharge. The amendment is set out in the items of Schedule 1 to the instrument.
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.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 June 2010, was made on 15 May 2010.
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 June 2010.
Paragraph 2: provides that Schedule 1 amends PB 55 of 2009.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Deletion of Form
Cetuximab | Solution for I.V. infusion 100 mg in 50 mL |
SCHEDULE 3
Deletion of Form
Cetuximab | Solution for I.V. infusion 100 mg in 50 mL |
Overview
The National Health Act 1953, enacted by the Australian Parliament, governs the Australian Pharmaceutical Benefits Scheme (PBS), which aims to ensure timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community. This Act, under Part VII, allows for the supply of listed drugs and medicinal preparations as pharmaceutical benefits. One of its provisions, subsection 100(1), enables the Minister to make special arrangements for providing an adequate supply of special pharmaceutical products to people living in isolated areas or receiving medical treatment where pharmaceutical benefits are either inadequate or cannot be conveniently or efficiently supplied in accordance with the Act. In May 2010, an amendment to the Chemotherapy Pharmaceuticals Access Program Arrangements was enacted to give effect to the recommendations of the Pharmaceutical Benefits Advisory Committee. This amendment, which came into effect on 1 June 2010, involved the deletion of a form of a chemotherapy pharmaceutical available at public hospitals to non-admitted patients, day-admitted patients, or patients on discharge. This legislative change was aimed at ensuring the program operates efficiently and effectively, maintaining the balance between access to necessary treatments and cost-effectiveness within the PBS framework.
Scope and Application
The National Health Act 1953, as amended by the legislative instrument F2010L01489, applies to the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day-admitted patients and patients on discharge. This Act operates within the Commonwealth jurisdiction and is regulated by Part VII, which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits. The Act enables the Minister to make special arrangements under subsection 100(1) to ensure an adequate supply of special pharmaceutical products for persons living in isolated areas or receiving medical treatment in circumstances where pharmaceutical benefits cannot be conveniently or efficiently supplied in accordance with Part VII, or are inadequate for that medical treatment. This legislative instrument specifically amends the Chemotherapy Pharmaceuticals Access Program Arrangements made under subparagraph 100(b)(i) by deleting a form of a chemotherapy pharmaceutical available at public hospitals to non-admitted patients, day-admitted patients or patients on discharge. This amendment is effective from 1 June 2010 and constitutes a legislative instrument under the Legislative Instruments Act 2003. The changes were made based on recommendations from the Pharmaceutical Benefits Advisory Committee, which considers the medical conditions, clinical effectiveness, safety, and cost-effectiveness of the pharmaceutical products.
Key Provisions
The key operative sections of this legislative instrument are sections 100(1), (2) and (3) of the National Health Act 1953. Section 100(1) provides that the Minister may make special arrangements for providing an adequate supply of special pharmaceutical products to certain persons, including those receiving medical treatment in circumstances where pharmaceutical benefits cannot be conveniently or efficiently supplied under Part VII of the Act, or where pharmaceutical benefits are inadequate for that treatment. Section 100(2) allows the Minister to vary or revoke any special arrangements made under section 100(1). Section 100(3) provides that Part VII of the Act applies subject to any special arrangements made under section 100(1). The amendments made by this instrument are set out in the Schedules.
The obligations and requirements imposed by this Act on the parties it governs include that the Minister must make special arrangements for providing an adequate supply of special pharmaceutical products to certain persons under section 100(1). The Minister must also ensure that any special arrangements made under section 100(1) are varied or revoked if necessary under section 100(2). The Act also requires the Minister to ensure that Part VII of the Act applies subject to any special arrangements made under section 100(1) under section 100(3).
Any breach of the Act or any special arrangements made under section 100(1) may result in civil or criminal consequences. The maximum penalty for a contravention of the Act is imprisonment for two years or a fine of up to $22,000, or both, under section 124(1) of the Act. The maximum penalty for an offence under a special arrangement made under section 100(1) is a fine of up to $11,000 under section 124(2) of the Act. The Act also provides for other civil and criminal consequences for breach, such as the cancellation or suspension of a pharmaceutical benefit under section 126 of the Act.