EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 93 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.
As of 1 September 2009, some of the chemotherapy pharmaceuticals that are available for supply under the Program will no longer require an authority from the Medicare Australia CEO. Medical practitioners who prescribe these drugs to their patients (and approved hospital authorities acting on their behalf) will only need to record a four digit code on the patient’s medication chart to indicate that these drugs have been prescribed in accordance with the circumstances set out in this legislative instrument.
This legislative instrument amends Chemotherapy Pharmaceuticals Access Program Arrangements under subparagraph 100(b)(i) made by legislative instrument number PB 55 of 2009 to give effect to the new streamlined authority requirements for some chemotherapy pharmaceuticals. In addition, this instrument gives effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). 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 October 2009, was made on 10 September 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.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 October 2009.
Paragraph 2: provides that Schedule 1 amends PB 55 of 2009.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Addition of Brands
Oxaliplatin | Powder for I.V. infusion 50 mg (Oxaliplatin Alphapharm) |
| Powder for I.V. infusion 100 mg (Oxaliplatin Alphapharm) |
Overview
The National Health Act 1953, as amended by the legislative instrument PB 93 of 2009, addresses the issue of providing timely, reliable, and affordable access to necessary and cost-effective medicines in Australia. This Act, enacted by the Australian Parliament, facilitates the Australian Pharmaceutical Benefits Scheme (PBS) which is designed to supply listed drugs and medicinal preparations as pharmaceutical benefits. To further the PBS's goal, the Act allows for special arrangements to be made for the supply of specific pharmaceutical products, such as chemotherapy drugs, under certain circumstances. This legislative instrument streamlines the authority requirements for some chemotherapy pharmaceuticals by removing the need for an authority from the Medicare Australia CEO for certain drugs, thus simplifying the prescription process for medical practitioners and hospital authorities.
The Chemotherapy Pharmaceuticals Access Program, implemented under the authority of the Act, ensures that chemotherapy pharmaceuticals are made available to non-admitted patients, day admitted patients, and patients on discharge at public hospitals. The changes introduced by PB 93 of 2009 align with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and reflect the objective of enhancing the efficiency and accessibility of essential medical treatments, particularly in the context of chemotherapy pharmaceuticals. These amendments streamline the administrative process by requiring only a four-digit code on the patient's medication chart to indicate that the drugs have been prescribed under the circumstances specified in this legislative instrument.
Scope and Application
The National Health Act 1953, as amended, provides a framework for the supply of pharmaceutical benefits in Australia, primarily through the Australian Pharmaceutical Benefits Scheme (PBS). This legislation applies to the Commonwealth, aiming to ensure that necessary and cost-effective medicines are accessible to the Australian community. Under Part VII of the Act, the Minister has the authority to make special arrangements to ensure an adequate supply of special pharmaceutical products, such as chemotherapy drugs, to individuals living in isolated areas or receiving medical treatment where standard PBS provisions may be inadequate or inefficient. This is particularly relevant for patients requiring chemotherapy who are not admitted to hospitals, day admitted patients, and those on discharge. The Chemotherapy Pharmaceuticals Access Program, established under subsection 100(b)(i) of the Act, streamlines the process for supplying these medications, allowing for simplified authority requirements for certain chemotherapy drugs as of 1 September 2009. These arrangements are further guided by recommendations from the Pharmaceutical Benefits Advisory Committee, an independent body that assesses the clinical effectiveness, safety, and cost-effectiveness of medicines for inclusion in the PBS.
Key Provisions
The main operative sections of this legislation (F2009L03546) pertain to the amendments of the Chemotherapy Pharmaceuticals Access Program under the National Health Act 1953. These amendments, effective from 1 October 2009, modify the authority requirements for the supply of certain chemotherapy pharmaceuticals at public hospitals. Specifically, under these new arrangements, certain chemotherapy pharmaceuticals no longer require an authority from the Medicare Australia CEO (section 100(1)). Instead, medical practitioners who prescribe these drugs to their patients need only record a four-digit code on the patient’s medication chart (section 100(b)(i)). This streamlined process aims to facilitate the timely and efficient supply of necessary pharmaceutical benefits, particularly for patients receiving chemotherapy treatments in non-admitted, day-admitted, or discharge scenarios.
The obligations imposed by this Act on the parties involved, particularly medical practitioners and hospital authorities, are primarily administrative. They must ensure that the four-digit code is accurately recorded on the patient’s medication chart to signify that the drugs have been prescribed under the specified circumstances outlined in the legislation. This recording is crucial as it signifies compliance with the streamlined authority requirements. Furthermore, the Pharmaceutical Benefits Advisory Committee (PBAC) plays a significant role in advising the Minister on which drugs should be available under the Chemotherapy Pharmaceuticals Access Program. The PBAC’s recommendations, based on clinical effectiveness, safety, and cost-effectiveness, are instrumental in shaping the amendments to the Program.
There are no explicit offences, penalties, or civil/criminal consequences detailed in this legislation for breaches of the streamlined authority requirements. However, non-compliance with the recording of the four-digit code on the patient’s medication chart could potentially lead to administrative penalties or other repercussions under broader health regulations. The primary focus of the legislation is to ensure that the streamlined process is followed to facilitate the efficient supply of necessary chemotherapy pharmaceuticals, thereby ensuring patients receive timely and appropriate medical treatment.