EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 86 OF 2007
NATIONAL HEALTH ACT 1953
AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBSECTION 100(1)
SPECIAL AUTHORITY PROGRAM (TRASTUZUMAB)
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 Special Authority Program (Trastuzumab) is a set of Arrangements made under subparagraph 100(1)(b)(i) of the Act for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who require treatment with trastuzumab.
This legislative instrument in giving effect to recommendations of the Pharmaceutical Advisory Committee (PBAC) amends Special Authority Program (Trastuzumab) Arrangements under subparagraph 100(1)(b)(i) made by legislative instrument number PB 56 of 2007 which came into effect on 1 August 2007.
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 November 2007, was made on 2 October 2007.
Consultations
The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits. Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared. When recommending a medicine be listed 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.
PBAC members are selected 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.
ATTACHMENT
Paragraph 1: provides that these Arrangements commence on 1 November 2007.
Paragraph 2: provides that Schedule 1 amends PB 56 0f 2007.
Schedule 1: provides for the following amendments:
SUMMARY OF CHANGES
Deletion of subparagraph 8(b)
Deletion of the following two circumstances:
Initial treatment for HER2 positive early breast cancer in patients receiving treatment with adjuvant chemotherapy following surgery at 1 October 2006
Initial PBS-subsidised treatment for HER2 positive early breast cancer where the patient was receiving treatment with trastuzumab at 1 October 2006
Overview
The Special Authority Program (Trastuzumab) Amendment Instrument, enacted in 2007, addresses specific access issues to trastuzumab, a pharmaceutical product used in the treatment of certain cancers, within the framework of the National Health Act 1953. This legislation was introduced by the Australian Parliament to amend existing arrangements under the Act, ensuring that patients in need of trastuzumab have adequate access to this treatment. The policy objective is to provide timely and affordable access to necessary and cost-effective medicines, particularly for those patients in isolated areas or those whose medical treatment circumstances render standard PBS provisions inadequate. The instrument, coming into effect on 1 November 2007, reflects recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) to refine the criteria for accessing trastuzumab through the Special Authority Program. This amendment aims to streamline the process while maintaining the overarching goal of enhancing patient access to vital pharmaceutical benefits.
Scope and Application
The National Health Act 1953, as amended by F2007L03950, pertains to the Australian Pharmaceutical Benefits Scheme (PBS) under which the Minister can make special arrangements for the provision of pharmaceutical benefits, particularly targeting individuals in isolated areas or those receiving medical treatment where conventional pharmaceutical benefits are either inconvenient or inadequate. These special arrangements are intended to ensure an adequate supply of necessary pharmaceutical products, such as trastuzumab, which is used for the treatment of HER2 positive early breast cancer. The Act's jurisdiction is national, applying to all Australians, and is enforced through legislative instruments that may be amended or revoked by the Minister. The Special Authority Program (Trastuzumab) specifically amends previous arrangements to refine the eligibility criteria for accessing trastuzumab, excluding certain conditions such as initial treatment for HER2 positive early breast cancer in patients who were already receiving adjuvant chemotherapy or trastuzumab as of 1 October 2006. The legislative instrument is designed to implement recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that the PBS remains efficient and cost-effective while meeting the medical needs of the Australian population.
Key Provisions
The key sections of the F2007L03950 legislation concern the amendments to the Special Authority Program (Trastuzumab) under subsection 100(1)(b)(i) of the National Health Act 1953. These amendments, effective from 1 November 2007, adjust the criteria for the provision of trastuzumab, a pharmaceutical product, under the Australian Pharmaceutical Benefits Scheme (PBS). Specifically, section 8(b) of the earlier legislative instrument PB 56 of 2007 has been amended by removing certain eligibility criteria for patients requiring trastuzumab treatment (subsection 100(1)(b)(i)). This includes the removal of initial treatment for HER2 positive early breast cancer in patients receiving adjuvant chemotherapy following surgery and initial PBS-subsidised treatment for HER2 positive early breast cancer where the patient was receiving trastuzumab treatment as of 1 October 2006. These changes reflect recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body tasked with advising on the inclusion of drugs on the PBS.
The Act imposes obligations on the Minister for Health and Ageing to make special arrangements under subsection 100(1) to ensure that adequate supplies of special pharmaceutical products, such as trastuzumab, are available to those in need. This includes ensuring that the criteria for eligibility are set out clearly and are subject to change based on recommendations from the PBAC. The Minister must also ensure that these arrangements are in line with the overarching goal of the PBS to provide timely, reliable, and affordable access to necessary and cost-effective medicines. The Minister has the authority to vary or revoke these special arrangements under subsection 100(2), thereby maintaining flexibility to adapt to new medical evidence or changing circumstances.
Under the Act, breaches of the provisions outlined in the legislation could lead to civil or criminal consequences, although the specific nature of these penalties is not detailed within the explanatory statement. The overarching legal framework provided by the National Health Act 1953 ensures that the administration of the PBS and any associated special arrangements are carried out in a manner that aligns with national health policies and objectives. The precise penalties for non-compliance with the Act would be subject to the broader legal provisions of the Act and potentially other related legislation, but these are not explicitly outlined in the explanatory statement.