EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 13 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 March 2009, was made on 30 January 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 March 2009.
Paragraph 2: provides that Schedule 1 amends PB 121 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Addition of Brands
Vinorelbine Solution for I.V. infusion 10 mg (as tartrate) in 1 mL (Vinorelbine 10 Link)
Solution for I.V. infusion 50 mg (as tartrate) in 5 mL (Vinorelbine 50 Link)
Deletion of Brand
Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
(Irinotecan-GA)
Overview
The National Health Act 1953 was enacted to provide for the supply of listed drugs and medicinal preparations as pharmaceutical benefits, ensuring timely, reliable, and affordable access for the Australian community to necessary and cost-effective medicines. The Act, administered by the Australian Parliament, was introduced to address the need for a structured framework to regulate the supply of pharmaceuticals within the Australian Pharmaceutical Benefits Scheme (PBS). One significant gap addressed by the Act was the need for special arrangements to ensure that patients in isolated areas or those receiving medical treatment under specific circumstances have access to necessary pharmaceutical products. The policy objective of the Act is to make essential medicines available and affordable to the public, overseen by the Minister for Health, who has the authority to make special arrangements under subsection 100(1) of the Act to ensure an adequate supply of special pharmaceutical products.
The Chemotherapy Pharmaceuticals Access Program, established under the Act, represents a legislative instrument designed to provide access to chemotherapy pharmaceuticals at public hospitals for non-admitted patients, day admitted patients, and patients on discharge. This program was developed in response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and aims to ensure that patients receive timely and appropriate pharmaceutical benefits, particularly in clinical settings where standard PBS provisions may not be adequately met. The amendments to the program, as outlined in the legislative instrument PB 13 of 2009, were introduced to refine the access to certain chemotherapy drugs, including the addition and deletion of specific brands to improve the effectiveness and cost-efficiency of the pharmaceutical benefits provided.
Scope and Application
The National Health Act 1953 (the Act) applies to the provision of pharmaceutical benefits, which are regulated under Part VII of the Act. Special arrangements under subsection 100(1) of the Act are made to ensure an adequate supply of special pharmaceutical products, including chemotherapy drugs, for certain groups of people. These special arrangements apply to individuals living in isolated areas and those receiving medical treatment where pharmaceutical benefits cannot be efficiently supplied or are inadequate under the regular provisions of Part VII. The Chemotherapy Pharmaceuticals Access Program is one such arrangement, specifically facilitating the supply of chemotherapy drugs to non-admitted patients, day admitted patients, and patients on discharge at public hospitals. The Act's jurisdiction extends to the Commonwealth level, with its provisions applicable nationally. The Act may be extended or restricted through subordinate instruments, such as the amendments outlined in this legislative instrument. This instrument, effective from 1 March 2009, amends previous arrangements (PB 121 of 2008) to update the list of eligible chemotherapy drugs under the program.
Key Provisions
The main operative sections of the National Health Act 1953 Amendment Special Arrangements under Subsection 100(1) Chemotherapy Pharmaceuticals Access Program are subsections 100(1) and 100(2). Subsection 100(1) (1) allows the Minister to make special arrangements for providing an adequate supply of special pharmaceutical products to certain individuals, including those living in isolated areas or receiving medical treatment where pharmaceutical benefits cannot be conveniently or efficiently supplied under the regular provisions of the Act or are inadequate for their treatment. Subsection 100(2) (2) gives the Minister the authority to vary or revoke these special arrangements as necessary. The Act ensures that the special arrangements are subject to Part VII of the Act (subsection 100(3)).
The obligations and requirements imposed by this legislation on the parties or entities it governs include ensuring that the special arrangements are made in accordance with the provisions of the Act and that they provide an adequate supply of necessary pharmaceutical products to the targeted individuals. The Minister must ensure that the special arrangements are implemented effectively and that they meet the needs of those who require them. Furthermore, the Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending which drugs and medicinal preparations should be available as pharmaceutical benefits, taking into account factors such as 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.
Any breaches of this legislation may result in civil or criminal consequences. While specific penalties are not outlined in the explanatory statement, breaches of the National Health Act 1953 may generally result in fines or imprisonment, depending on the nature and severity of the breach. The maximum penalties for breaches of the Act can vary, but they may include fines of up to $22,000 for individuals and $110,000 for corporations, as well as imprisonment for up to five years. It is essential for parties and entities governed by this legislation to comply with its provisions to avoid potential penalties and ensure the continued availability of necessary pharmaceutical products to those in need.