EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 28 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 March 2008, was made on 1 February 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 March 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 [addition of powder for I.V. infusion 100 mg (as disodium heptahydrate)]
SCHEDULE 2
Item Addition
Pemetrexed Powder for I.V. infusion 100mg (as disodium heptahydrate)
Brand Addition
Oxaliplatin Powder for I.V. infusion 50 mg (Oxaliplan 50)
Oxaliplatin Powder for I.V. infusion 100 mg (Oxaliplan 100)
Overview
The National Health Act 1953, amended in 2008, addresses the need for a reliable and affordable access to necessary and cost-effective medicines for Australians. This legislation, enacted by the Parliament of Australia, outlines the Australian Pharmaceutical Benefits Scheme (PBS) under Part VII of the Act, which ensures the supply of listed drugs and medicinal preparations. The Act allows the Minister to make special arrangements for the supply of pharmaceutical benefits, particularly for those living in isolated areas or receiving medical treatment where conventional PBS provisions are inadequate. This includes the Chemotherapy Pharmaceuticals Access Program, which ensures public hospitals can provide chemotherapy pharmaceuticals to non-admitted and day admitted patients, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee. The amendments introduced by the instrument aim to expand the availability of certain chemotherapy drugs, ensuring better access and continuity of care for patients requiring these treatments.
Scope and Application
The National Health Act 1953 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. The Act applies to the supply of listed drugs and medicinal preparations as pharmaceutical benefits, and under subsection 100(1), the Minister is empowered to make special arrangements for providing an adequate supply of special pharmaceutical products to 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 of the Act or are inadequate for that medical treatment. The Chemotherapy Pharmaceuticals Access Program, which is a legislative instrument, is a set of arrangements made under subparagraph 100(b)(i) of the Act for the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients, and patients on discharge. The geographic and jurisdictional reach of the Act is national, as it applies throughout Australia, and is implemented through agreements between the Australian Government and participating states. The Act does not specify any exclusions, exemptions, or thresholds, and its application may be extended or restricted through subordinate instruments. The amendments to the Chemotherapy Pharmaceuticals Access Program, set out in the legislative instrument, involve the addition of new chemotherapy drugs and brands to the program, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee.
Key Provisions
The main operative sections of the National Health Act 1953 Amendment Special Arrangements under Subsection 100(1) Chemotherapy Pharmaceuticals Access Program (F2008L00286) pertain to the provisions for the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients, and patients on discharge. The Act, under section 100(1), allows the Minister to make special arrangements for providing adequate supplies of special pharmaceutical products to individuals living in isolated areas or those receiving medical treatment under circumstances where pharmaceutical benefits cannot be conveniently or efficiently supplied in accordance with Part VII of the Act or are inadequate for the treatment. The Act also provides for the variation or revocation of these special arrangements under section 100(2) and confirms that Part VII of the Act applies subject to any special arrangements made under section 100(1). The declaration under subsection 85(2) of the Act lists the drugs and medicinal preparations applicable under these arrangements, with specific restrictions if any, for prescribing these pharmaceuticals as benefits.
The obligations imposed on the parties or entities governed by this Act include ensuring that the Chemotherapy Pharmaceuticals Access Program is implemented in accordance with the legislative instrument. This involves the Australian Government, participating states, and public hospitals working together to provide timely, reliable, and affordable access to necessary and cost-effective chemotherapy pharmaceuticals. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body, plays a crucial role in making recommendations to the Minister about which drugs should be available as pharmaceutical benefits. The PBAC considers the medical conditions for which the medicine has been approved, its clinical effectiveness, safety, and cost-effectiveness compared to other treatments. The Australian Government and participating states must enter into agreements through the Australian Health Care Agreements to implement the pharmaceutical reforms, which include the Chemotherapy Pharmaceutical Access Program.
The Act also outlines the consequences for non-compliance with its provisions. Offences and penalties under this Act may include civil or criminal penalties for those who breach the special arrangements for providing pharmaceutical benefits. The maximum penalties for such breaches are not explicitly stated in the document, but they may include fines and imprisonment, depending on the severity of the breach and the specific provisions of the Act. Additionally, failure to comply with the recommendations of the PBAC or the terms of the agreements between the Australian Government and participating states could result in legal action or other enforcement measures.