EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 25 OF 2009
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 121 of 2008 which came into effect on 1 December 2008. 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 2009, was made on 3 March 2009.
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 April 2009.
Paragraph 2: provides that Schedule 1 amends PB 121 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Addition of Forms
Gemcitabine Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL
(Gemcitabine Ebewe)
Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL
(Gemcitabine Ebewe)
Overview
The National Health Act 1953, enacted by the Australian Parliament, aims to provide Australians with timely, reliable, and affordable access to necessary and cost-effective medicines through the Australian Pharmaceutical Benefits Scheme (PBS). Under Part VII of the Act, the Commonwealth supplies pharmaceutical benefits, with provisions for special arrangements to ensure adequate supply to those in isolated areas or receiving treatment where standard PBS provisions are inadequate. One such special arrangement is the Chemotherapy Pharmaceuticals Access Program, which provides access to chemotherapy drugs for non-admitted and day-admitted patients, and those on discharge. This program was introduced to address the specific needs of patients receiving chemotherapy outside of standard admitted patient settings.
The Chemotherapy Pharmaceuticals Access Program is governed by the special arrangements under subsection 100(1) of the National Health Act 1953, allowing the Minister to ensure an adequate supply of chemotherapy drugs where standard PBS provisions are not feasible or sufficient. This program is implemented through legislative instruments, such as the one referenced as PB 25 of 2009, which amends previous arrangements to include additional chemotherapy drugs. The program is part of broader public hospital pharmaceutical reforms, agreed upon between the Australian Government and participating states, to provide subsidised access to cancer chemotherapy drugs listed on the PBS within a clinical setting. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role in recommending drugs for inclusion in the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness.
Scope and Application
The National Health Act 1953, through its Part VII, regulates the Australian Pharmaceutical Benefits Scheme (PBS), which ensures that the Australian community has timely, reliable, and affordable access to necessary and cost-effective medicines. Under subsection 100(1) of the Act, the Minister is empowered to make special arrangements for ensuring an adequate supply of certain pharmaceutical products to individuals living in isolated areas or receiving medical treatment under circumstances where the standard PBS provisions are inadequate or impractical. Specifically, the Chemotherapy Pharmaceuticals Access Program is a special arrangement made under this provision, targeting the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients, and patients on discharge. These special arrangements are applicable nationally, subject to agreements between the Australian Government and participating states, with Victoria, Western Australia, Queensland, and the Northern Territory currently participating in the reforms. The Act's provisions apply to all persons and entities involved in the supply of listed drugs and medicinal preparations as pharmaceutical benefits, with specific amendments and additions to the program detailed in Schedule 1 of the legislative instrument.
Key Provisions
The main operative sections of this legislation are sections 100(1), 100(2), and 100(3) of the National Health Act 1953, which provide for special arrangements for the supply of pharmaceutical benefits, particularly chemotherapy drugs, to individuals who are either living in isolated areas or receiving medical treatment in circumstances where standard pharmaceutical benefits under Part VII are inadequate (100(1)). These arrangements can be varied or revoked by the Minister (100(2)), and they operate subject to the provisions of Part VII (100(3)). The Chemotherapy Pharmaceuticals Access Program is established under these provisions to ensure that chemotherapy drugs are available to non-admitted patients, day admitted patients, and patients on discharge in public hospitals.
The Act imposes obligations on the Minister to ensure that special arrangements are made for the supply of necessary chemotherapy pharmaceuticals, particularly in cases where standard provisions under the Act are not feasible or adequate. This involves the Minister working with the Pharmaceutical Benefits Advisory Committee (PBAC) to recommend and implement the necessary changes to the PBS list and associated access programs. The Act also requires that any special arrangements made must be in accordance with the Act, ensuring that they are legally compliant and serve the intended purpose of improving access to necessary medications.
In terms of offences, penalties, or consequences for breach, the Act does not explicitly detail specific penalties for non-compliance with the Chemotherapy Pharmaceuticals Access Program. However, breaches of any legislative instrument made under the National Health Act 1953 could potentially lead to civil or criminal consequences depending on the severity and intent of the breach. For instance, if an entity fails to comply with the special arrangements for the supply of chemotherapy drugs, this could result in legal action against the entity, potentially leading to fines or other penalties as determined by a court. Additionally, such breaches could impact the health and well-being of patients, leading to significant reputational and operational consequences for the involved parties.