EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 44 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 June 2009, was made on 1 May 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 June 2009.
Paragraph 2: provides that Schedule 1 amends PB 121 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Addition of Brands
Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
(Omegapharm Irinotecan)
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
(Omegapharm Irinotecan)
Alteration of Brands
Vinorelbine Solution for I.V. infusion 10 mg (as tartrate) in 1 mL
From:
Vinorelbine 10 Link
To:
Vinorelbine Link
Solution for I.V. infusion 50 mg (as tartrate) in 5 mL
From:
Vinorelbine 50 Link
To:
Vinorelbine Link
Overview
The National Health Act 1953, enacted by the Australian Parliament, serves to provide timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community through the Australian Pharmaceutical Benefits Scheme (PBS). This Act, particularly under Part VII, regulates the supply of listed drugs and medicinal preparations as pharmaceutical benefits. A key feature of the Act is subsection 100(1), which empowers the Minister to make special arrangements for ensuring an adequate supply of special pharmaceutical products to individuals in isolated areas or those receiving medical treatment where the PBS cannot efficiently or effectively supply the required pharmaceuticals or where the benefits are inadequate for the treatment. The Chemotherapy Pharmaceuticals Access Program is one such arrangement, aimed at providing chemotherapy pharmaceuticals at public hospitals to non-admitted, day admitted, and discharged patients. These arrangements, subject to amendment by legislative instruments, are designed to address gaps in the efficient and effective supply of essential pharmaceutical products to those in need, particularly in clinical settings.
This legislative instrument, F2009L01715, amends the previously established Chemotherapy Pharmaceuticals Access Program arrangements under subsection 100(b)(i) of the National Health Act 1953. The amendments, effective from 1 June 2009, were made in response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body, provides recommendations to the Minister on the availability of drugs and medicinal preparations as pharmaceutical benefits, taking into account their clinical effectiveness, safety, and cost-effectiveness. These legislative changes facilitate the implementation of public hospital pharmaceutical reforms, which offer subsidised access to cancer chemotherapy drugs listed on the PBS for day admitted and non-admitted public hospital patients. Participating states in these reforms include Victoria, Western Australia, Queensland, and the Northern Territory.
Scope and Application
The National Health Act 1953, as amended by the instrument F2009L01715, applies to the provision of chemotherapy pharmaceuticals under the Chemotherapy Pharmaceuticals Access Program, which is designed to ensure that Australians in need of chemotherapy treatment have access to necessary pharmaceutical benefits, particularly those who are living in isolated areas or are receiving medical treatment where the standard provisions of the Pharmaceutical Benefits Scheme (PBS) are inadequate. The Act applies to individuals who fall under these specific circumstances and the entities responsible for administering the PBS, including public hospitals and participating state governments. The legislative instrument extends the provisions of the Act to cover the supply of certain chemotherapy drugs to non-admitted and day admitted patients within public hospitals, facilitating a more efficient and accessible distribution of pharmaceutical benefits. The geographic reach of this Act is national, with the implementation of the Chemotherapy Pharmaceuticals Access Program being coordinated through agreements between the Australian Government and participating states. The Act does not specify exclusions or exemptions but operates under the general framework provided by the National Health Act 1953, which includes the potential for the Minister to vary or revoke special arrangements as needed.
Key Provisions
The National Health Act 1953, through its Part VII, governs the Australian Pharmaceutical Benefits Scheme (PBS) and the supply of listed drugs and medicinal preparations as pharmaceutical benefits (subsection 85(1)). This legislative framework is designed to ensure that the Australian community has timely, reliable, and affordable access to necessary and cost-effective medicines. The PBS operates under the broad regulatory oversight provided by the Act, with specific provisions such as subsection 100(1) allowing the Minister to make special arrangements for supplying certain pharmaceutical products to individuals living in isolated areas or receiving medical treatment where standard PBS provisions are inadequate or inefficient (subsection 100(1)). These special arrangements are subject to alteration or revocation by the Minister (subsection 100(2)), and they take precedence over the general provisions of Part VII (subsection 100(3)).
Under the Act, the Minister's power to make special arrangements is intended to ensure that essential medications are accessible to all Australians, regardless of geographical or medical treatment constraints. This is particularly relevant under the Chemotherapy Pharmaceuticals Access Program, which aims to provide chemotherapy drugs to non-admitted patients, day admitted patients, and patients on discharge from public hospitals. These special arrangements, which are subject to the Act's provisions, are meant to bridge gaps in standard pharmaceutical benefit provision. The arrangements are also subject to the declaration under subsection 85(2), which outlines the drugs and medicinal preparations covered by the PBS and any restrictions on their prescribing.
The obligations imposed by the Act on the parties involved are primarily centred around the effective and efficient supply of pharmaceutical benefits, particularly for those in isolated areas or under special medical treatment circumstances. The Act mandates that the Minister, in consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), ensures that special arrangements are in place and functioning effectively. The PBAC, established under section 100A, plays a crucial role in advising the Minister on which drugs and medicinal preparations should be available as pharmaceutical benefits. This includes considerations of the medical conditions for which the medicines have been approved, their clinical effectiveness, safety, and cost-effectiveness compared to other treatments.
In terms of penalties and consequences for non-compliance, the Act does not explicitly detail the penalties for breaches of the provisions related to special arrangements under subsection 100(1). However, general provisions under the National Health Act 1953 may apply, which could include civil or criminal penalties depending on the nature and severity of the breach. For instance, breaches of health-related legislation can lead to fines, imprisonment, or both, depending on the specific provisions and the jurisdiction in which the breach occurs. The precise penalties would be determined by the courts in the context of the particular case, taking into account the seriousness of the breach and any mitigating or aggravating factors.