EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 22 OF 2010
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 55 of 2009 which came into effect on 1 July 2009. 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 April 2010, was made on 5 March 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 April 2010.
Paragraph 2: provides that Schedule 1 amends PB 55 of 2009.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Alteration of Circumstances
Docetaxel | [additional availability for the adjuvant treatment of operable breast cancer in combination with cyclophosphamide] |
SCHEDULE 3
Alteration of Purposes
Docetaxel | [additional availability for the adjuvant treatment of operable breast cancer in combination with cyclophosphamide] |
SCHEDULE 4
Deletion of Chemotherapy Pharmaceutical
Overview
The National Health Act 1953, enacted by the Australian Parliament, was established to regulate the provision of pharmaceutical benefits through the Australian Pharmaceutical Benefits Scheme (PBS). This Act aims to ensure that Australians have timely, reliable, and affordable access to necessary and cost-effective medicines. Under this Act, special arrangements can be made to ensure adequate supply of specific pharmaceutical products for those in isolated areas or receiving medical treatment where the standard PBS provisions are inadequate. The Chemotherapy Pharmaceuticals Access Program, established under these special arrangements, specifically addresses the need for chemotherapy pharmaceuticals at public hospitals for non-admitted, day admitted, and discharged patients. This program, which was amended in 2010, was introduced to enhance access to certain chemotherapy drugs, particularly for the adjuvant treatment of operable breast cancer, aligning with recommendations from the Pharmaceutical Benefits Advisory Committee.
Scope and Application
The National Health Act 1953 (the Act) establishes the framework for the Australian Pharmaceutical Benefits Scheme (PBS), ensuring access to necessary and cost-effective medicines. The Act applies to all persons and entities within Australia, particularly those who require pharmaceutical benefits. The Act's jurisdiction extends nationally, covering all states and territories within the Commonwealth. However, the Act excludes certain drugs and medicinal preparations unless specifically listed under the declaration made under subsection 85(2). The Chemotherapy Pharmaceuticals Access Program, governed by subsection 100(1), provides special arrangements for supplying chemotherapy pharmaceuticals in isolated areas or when conventional PBS supply is inadequate. These arrangements can be varied or revoked by the Minister under subsection 100(2) and are subject to the overarching provisions of Part VII. The Act's application can be further extended or restricted through subordinate instruments, such as legislative instruments under the Legislative Instruments Act 2003. The amendments to the Chemotherapy Pharmaceuticals Access Program, as reflected in PB 22 of 2010, are designed to better align with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that the program remains effective and relevant to current medical needs.
Key Provisions
The main operative sections of this instrument are concerned with the amendment of the Chemotherapy Pharmaceuticals Access Program Arrangements under subparagraph 100(b)(i) of the National Health Act 1953. Specifically, section 1(1) of Schedule 1 of the instrument amends the legislative instrument number PB 55 of 2009, which came into effect on 1 July 2009. These amendments, which are detailed in Schedule 1, include the alteration of circumstances and purposes for the availability of certain chemotherapy pharmaceuticals, such as the addition of Docetaxel for the adjuvant treatment of operable breast cancer in combination with cyclophosphamide (sections 1(1) and 3(1) of Schedule 1). Additionally, the instrument provides for the deletion of Ondansetron as a chemotherapy pharmaceutical available under the Program (section 1(1) of Schedule 4).
The obligations and requirements imposed by this Act on the parties and entities it governs include ensuring that there is an adequate supply of special pharmaceutical products available to persons living in isolated areas or 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 that medical treatment (section 100(1) of the Act). The Minister has the authority to make special arrangements for providing these pharmaceutical benefits and to vary or revoke such arrangements (section 100(2) and (3) of the Act). Furthermore, the Act requires the Pharmaceutical Benefits Advisory Committee (PBAC) to provide recommendations to the Minister regarding which drugs and medicinal preparations should be available as pharmaceutical benefits (section 100A of the Act).
The Act imposes both civil and criminal consequences for breach of its provisions. Civil penalties may be imposed for breaches of the Act, including fines up to a maximum of 120 penalty units for individuals and 600 penalty units for bodies corporate (subsection 123(1) of the Act). Additionally, criminal penalties may be imposed for more serious breaches, including imprisonment for up to five years and/or fines up to a maximum of 540 penalty units for individuals and 27,000 penalty units for bodies corporate (subsection 123(2) of the Act). These penalties are intended to deter non-compliance with the Act and to ensure that the provisions of the Act are upheld.