EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 37 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 April 2008, was made on 3 March 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 April 2008.
Paragraph 2: provides that Schedule 1 amends PB 93 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Alteration of Circumstances
Docetaxel
Pemetrexed
SCHEDULE 2
Item Addition
Cetuximab Solution for I.V. infusion 100 mg in 20 mL
Solution for I.V. infusion 500 mg in 100 mL
Brand Addition
Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL (Irinotecan Sandoz)
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Irinotecan Sandoz)
Alteration of Maximum Quantity | From | To |
Pemetrexed Powder for I.V. infusion 500 mg (as disodium heptahydrate) | 2 | 1 |
| | |
Alteration of Maximum Number of Repeats | From | To |
Pemetrexed Powder for I.V. infusion 500 mg (as disodium heptahydrate) | 2 | 3 |
SCHEDULE 3
Item Addition
Cetuximab Solution for I.V. infusion 100 mg in 20 mL
Solution for I.V. infusion 500 mg in 100 mL
Item Deletion
Pemetrexed
SCHEDULE 4
Item Deletion
Pemetrexed
Overview
The National Health Act 1953, enacted by the Australian Parliament, was established to provide the framework for the Australian Pharmaceutical Benefits Scheme (PBS), ensuring timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community. The Act, particularly through Part VII, facilitates the supply of listed drugs and medicinal preparations as pharmaceutical benefits. The Chemotherapy Pharmaceuticals Access Program, an arrangement under subsection 100(1) of the Act, was introduced to address the need for accessible and efficient supply of special pharmaceutical products, such as chemotherapy drugs, to patients in isolated areas or those receiving medical treatment where the standard provisions of the PBS are inadequate. This initiative, governed by the Minister’s authority to make special arrangements, was designed to enhance the accessibility and efficiency of pharmaceutical benefits for specified patient groups, reflecting the policy objective of improving health outcomes through equitable access to essential medications.
The 2008 legislative instrument, F2008L00702, amending the Chemotherapy Pharmaceuticals Access Program Arrangements, reflects recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The amendments, effective from 1 April 2008, were aimed at updating the list of chemotherapy pharmaceuticals available under the Program, ensuring that the supply of these critical medications meets the evolving needs of patients in clinical settings. This legislative change was part of broader public hospital pharmaceutical reforms, which were implemented through agreements between the Australian Government and participating states, enhancing the reach and effectiveness of the PBS in providing subsidised access to cancer chemotherapy drugs for non-admitted and day admitted patients in public hospitals.
Scope and Application
The National Health Act 1953, through its Part VII, regulates the Australian Pharmaceutical Benefits Scheme (PBS) to ensure timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community. Specifically, the Act allows the Minister to make special arrangements under subsection 100(1) for providing an adequate supply of special pharmaceutical products, including chemotherapy pharmaceuticals, to individuals in isolated areas or receiving medical treatment where the standard PBS supply is inadequate or inefficient. This is particularly pertinent for non-admitted and day admitted patients in public hospitals, as well as patients on discharge, under the Chemotherapy Pharmaceuticals Access Program. The Act's jurisdiction is national, with the special arrangements implemented through agreements between the Australian Government and participating states, currently including Victoria, Western Australia, Queensland, and the Northern Territory. The Chemotherapy Pharmaceuticals Access Program, governed by this Act, involves amendments to the PBS listings and quantities of specific drugs to meet the therapeutic needs of patients under the program. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending the inclusion of drugs on the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness. This legislative instrument, which came into effect on 1 April 2008, amends the arrangements made under subsection 100(b)(i) of the Act, incorporating changes to the listed drugs and their quantities, as recommended by the PBAC.
Key Provisions
The National Health Act 1953, specifically under section 100(1), allows the Minister to make special arrangements for the supply of pharmaceutical benefits that cannot be efficiently provided under the standard provisions of the Act. This is particularly pertinent for people living in isolated areas or those undergoing medical treatments where the standard provisions are inadequate. These special arrangements are detailed in subsection 100(1) and can be varied or revoked under subsection 100(2). Subsection 100(3) ensures that these special arrangements apply subject to the overarching provisions of Part VII of the Act.
The obligations imposed by this legislation on the parties involved are primarily administrative and compliance-focused. The Minister, through the Australian Pharmaceutical Benefits Advisory Committee (PBAC), must ensure that the special arrangements meet the needs of the specified groups, such as those living in isolated areas or receiving complex medical treatments. The committee must consider factors like clinical effectiveness, safety, and cost-effectiveness when making recommendations for pharmaceutical inclusions. Additionally, participating states must implement the reforms as per the agreements under the Australian Health Care Agreements, ensuring that the necessary infrastructure and protocols are in place to deliver these pharmaceutical benefits effectively.
Violating the provisions of the National Health Act 1953 can lead to both civil and criminal consequences. While specific penalties are not detailed in the explanatory statement, breaches of health-related legislation in Australia can typically result in fines, imprisonment, or both, depending on the severity of the breach. For instance, supplying pharmaceuticals in a manner contrary to the Act could result in significant penalties, reflecting the seriousness of ensuring the safe and effective distribution of medications under the PBS. The exact penalties would be determined by the courts based on the specific circumstances of the offence.