EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 65 OF 2007
NATIONAL HEALTH ACT 1953
AMENDMENT 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 54 of 2007 which came into effect on 1 August 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 September 2007, was made on 14 August 2007.
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 Australian and Queensland are participating in the reforms.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 September 2007.
Paragraph 2: provides that Schedule 1 amends PB 54 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Item Added
Cetuximab
SCHEDULE 2
Item Added
Cetuximab Solution for I.V. infusion 100 mg in 50 mL
Brands Added
Ondansetron I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL (Onsetron)
I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL (Onsetron)
SCHEDULE 3
Item Added
Cetuximab Solution for I.V. infusion 100 mg in 50 mL
Overview
The National Health Act 1953 was enacted to establish a framework for the provision of health services in Australia, with a particular focus on the Pharmaceutical Benefits Scheme (PBS). The Act was introduced to address the need for a national system that ensures access to necessary and cost-effective medicines for all Australians. The PBS, governed by Part VII of the Act, provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits. To further enhance the availability and accessibility of essential medicines, particularly in unique circumstances, the Act allows the Minister to make special arrangements under subsection 100(1) to ensure an adequate supply of pharmaceutical products for people living in isolated areas or receiving medical treatment where standard PBS provisions are inadequate. The Chemotherapy Pharmaceuticals Access Program is an example of such special arrangements, enabling the supply of chemotherapy pharmaceuticals to non-admitted patients, day admitted patients, and patients on discharge at public hospitals, as recommended by the Pharmaceutical Benefits Advisory Committee. This legislative instrument, made under the authority of the National Health Act 1953, aims to improve access to necessary chemotherapy treatments and is implemented through agreements between the Australian Government and participating States.
Scope and Application
The National Health Act 1953, as amended by F2007L02635, governs the provision of pharmaceutical benefits through the Australian Pharmaceutical Benefits Scheme (PBS). The Act applies to all persons and entities within Australia, ensuring they have access to necessary and cost-effective medicines. The Chemotherapy Pharmaceuticals Access Program, introduced under subsection 100(1) of the Act, specifically provides special arrangements for the supply of chemotherapy pharmaceuticals to individuals in isolated areas or those receiving medical treatment where standard PBS provisions are inadequate. The Act extends its reach nationally, with states participating in the program through agreements under the Australian Health Care Agreements. The amendments under this instrument, effective from 1 September 2007, include the addition of Cetuximab and Ondansetron to the PBS, facilitating access to these cancer treatment drugs for eligible patients in public hospitals. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending which drugs should be included in the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness.
Key Provisions
The main sections of the legislative instrument, PB 65 of 2007, amend the arrangements under subsection 100(1) of the National Health Act 1953 to enhance access to chemotherapy pharmaceuticals through the Chemotherapy Pharmaceuticals Access Program. Specifically, this instrument introduces amendments that were recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) and are intended to improve the availability of certain chemotherapy drugs for patients receiving treatment in public hospitals (sections 2 and 3). The amendments include adding Cetuximab and specific formulations of Ondansetron to the list of drugs available under the Program (Schedules 1 and 2). These changes ensure that more patients can access necessary cancer treatment medications within a clinical setting, thereby improving patient care and outcomes.
The obligations and requirements imposed by this Act on the relevant parties are primarily focused on ensuring the timely and efficient supply of listed chemotherapy drugs to eligible patients. The Act mandates the Minister to make special arrangements for the supply of pharmaceutical benefits to persons who cannot access these benefits conveniently or efficiently under the standard provisions of Part VII of the Act (subsection 100(1)). The amendments made by PB 65 of 2007 require that the Chemotherapy Pharmaceuticals Access Program be updated to include the newly listed drugs, thereby expanding the range of available treatments. The Act also allows the Minister to vary or revoke these special arrangements if necessary (subsection 100(2)). Furthermore, it ensures that Part VII of the Act is subject to these special arrangements, thus maintaining a balance between standard provisions and special needs (subsection 100(3)).
Any breach of the provisions under the National Health Act 1953, including those amended by PB 65 of 2007, can result in significant civil or criminal consequences. The Act provides for a range of penalties for non-compliance, including fines and imprisonment. For example, under section 121, a person who contravenes a provision of the Act can be fined up to $22,200 for an individual or $111,000 for a body corporate. These penalties reflect the importance of adhering to the legislative requirements designed to ensure the availability and accessibility of essential pharmaceutical benefits. Additionally, any failure to comply with the provisions of the Act may also result in the revocation of the special arrangements, thereby affecting the supply of necessary medications to eligible patients.