EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 19 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 93 of 2007 which came into effect on 1 December 2007. 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 February 2008, was made on 2 January 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 February 2008.
Paragraph 2: provides that Schedule 1 amends PB 93 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Alteration of Circumstances
Pemetrexed [for the treatment of patients with mesothelioma]
SCHEDULE 2
Alteration of Maximum Quantity
Cetuximab Solution for I.V. infusion 100 mg in 50 mL From: 6 To: 1
SCHEDULE 3
Alteration of Maximum Quantity
Cetuximab Solution for I.V. infusion 100 mg in 50 mL From: 4 To: 1
Alteration of Purposes
Pemetrexed Powder for I.V. infusion 500 mg (as disodium heptahydrate) [for the treatment of patients with mesothelioma]
Overview
The National Health Act 1953 was enacted to regulate the supply of listed drugs and medicinal preparations as pharmaceutical benefits, with the overarching goal of providing timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community. Under the Act, the Australian Government, through the Minister for Health, has the authority to make special arrangements for the supply of special pharmaceutical products to people living in isolated areas or receiving medical treatment where the Pharmaceutical Benefits Scheme (PBS) cannot efficiently supply the required medication or the benefits are inadequate for their treatment. This legislative instrument amends the Chemotherapy Pharmaceuticals Access Program Arrangements under the Act to 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. The amendments are based on recommendations from the Pharmaceutical Benefits Advisory Committee and are implemented through an agreement between the Australian Government and participating states.
This legislative instrument, which came into effect on 1 February 2008, was made by the Minister for Health under the authority of the National Health Act 1953. The policy objective of the amendments is to improve access to chemotherapy pharmaceuticals for patients in clinical settings within public hospitals, thereby ensuring that they receive necessary and cost-effective treatments as recommended by the Pharmaceutical Benefits Advisory Committee.
Scope and Application
The National Health Act 1953, as amended, provides the legislative framework for the Australian Pharmaceutical Benefits Scheme (PBS), which aims to ensure that necessary and cost-effective medicines are accessible, reliable, and affordable for the Australian community. Under the Act, the Minister is empowered to make special arrangements for the supply of pharmaceutical benefits, particularly for individuals residing in isolated areas or undergoing medical treatments where the standard provisions of the Act are not efficiently applicable. This is achieved through specific legislative instruments, such as the Chemotherapy Pharmaceuticals Access Program, which facilitates the supply of chemotherapy pharmaceuticals in public hospitals to non-admitted patients, day admitted patients, and patients on discharge. The Act applies nationally, and its provisions are implemented through agreements between the Australian Government and participating States, currently including Victoria, Western Australia, Queensland, and the Northern Territory. The Act does not specify explicit exclusions but allows the Minister to vary or revoke any special arrangements made under it. These special arrangements are further detailed and amended through subordinate instruments such as legislative instruments, ensuring that the Chemotherapy Pharmaceuticals Access Program remains aligned with the recommendations of the Pharmaceutical Benefits Advisory Committee.
Key Provisions
The main operative sections of the legislation pertain to the amendments made to the Chemotherapy Pharmaceuticals Access Program under subsection 100(1) of the National Health Act 1953 (the Act) (100(1)). Specifically, this legislative instrument amends the Chemotherapy Pharmaceuticals Access Program Arrangements made by legislative instrument number PB 93 of 2007, which came into effect on 1 December 2007. The amendments are detailed in the items of Schedule 1 to this instrument, and the instrument itself is set to commence on 1 February 2008 (paragraph 1). These amendments include alterations to the circumstances under which certain chemotherapy pharmaceuticals are provided, as well as adjustments to the maximum quantities of these pharmaceuticals that can be supplied (Schedule 1, Schedule 2, and Schedule 3).
The Act imposes obligations on the Minister for Health to ensure that special arrangements are made to provide adequate supplies of special pharmaceutical products to persons living in isolated areas or receiving medical treatment under circumstances where standard pharmaceutical benefits are inadequate or cannot be conveniently supplied. Under subsection 100(1) of the Act, the Minister is authorised to make these special arrangements and may vary or revoke them as necessary (100(2)). The Chemotherapy Pharmaceuticals Access Program is an example of such special arrangements, specifically designed to supply chemotherapy pharmaceuticals to non-admitted patients, day admitted patients, and patients on discharge in public hospitals.
Breach of the provisions set out in this legislative instrument could lead to civil or criminal penalties, depending on the nature and severity of the contravention. The Act does not specify maximum penalties for breaches of these arrangements, but general provisions of the National Health Act 1953 and other relevant legislation may apply. For instance, significant non-compliance with provisions related to the supply of pharmaceuticals could result in fines or other legal consequences as determined by the courts. It is essential for all parties involved to adhere to these arrangements to ensure the timely and appropriate supply of necessary chemotherapy pharmaceuticals to patients in need.