EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 84 OF 2007
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 54 of 2007 which came into effect on 1 August 2007, as amended. The amendments are set out in the items of Schedule 1 to the instrument.
This instrument contains a number of changes in terminology to accord with amendments of the Act by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 which came into effect on 1 August 2007.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 November 2007, was made on 2 October 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 November 2007.
Paragraph 2: provides that Schedule 1 amends PB 54 of 2007.
Schedule 1: provides for the following amendments:
SUMMARY OF CHANGES
SCHEDULE 1
Alteration of Circumstances
Docetaxel
Overview
The National Health Act 1953, as amended by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007, aims to ensure timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community through the Pharmaceutical Benefits Scheme (PBS). The Act allows the Minister to make special arrangements under subsection 100(1) for the supply of specific pharmaceutical products to individuals in isolated areas or those receiving medical treatment where the regular provisions of the PBS are inadequate. This legislative instrument, F2007L03948, amends the Chemotherapy Pharmaceuticals Access Program Arrangements made under subparagraph 100(b)(i) of the Act to align with the 2007 amendments to the Act and to implement the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The Chemotherapy Pharmaceuticals Access Program facilitates the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients, and patients on discharge, thereby addressing the specific needs of cancer patients requiring chemotherapy outside of an admitted hospital setting.
Scope and Application
The National Health Act 1953, as amended, facilitates the provision of pharmaceutical benefits through the Australian Pharmaceutical Benefits Scheme (PBS). Under the Act, the Minister has the authority to establish special arrangements to ensure an adequate supply of specific pharmaceutical products to individuals in isolated areas or those receiving medical treatment where conventional supply under the PBS is inefficient or inadequate. Specifically, the Act allows for these special arrangements under subsection 100(1) to address the needs of patients who cannot conveniently or efficiently receive pharmaceutical benefits as per Part VII of the Act, or where existing benefits are insufficient for their medical treatment. The Chemotherapy Pharmaceuticals Access Program, an initiative under this provision, ensures the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted, day admitted, and discharged patients. This program is administered under the authority granted by the Act and operates in accordance with agreements between the Australian Government and participating states, currently including Victoria, Western Australia, and Queensland. The Act's jurisdictional reach extends across Australia, and its application is further detailed through subordinate instruments and amendments as necessary.
Key Provisions
The key provisions of this legislative instrument (F2007L03948) focus on the Chemotherapy Pharmaceuticals Access Program under the National Health Act 1953, specifically under subsection 100(1) (subsections 100(1) and 100(2)). This program is designed to ensure that chemotherapy pharmaceuticals are made available to patients in need, particularly those in isolated areas or those whose medical treatment requires specialised access to pharmaceutical benefits not readily available under standard provisions of the Pharmaceutical Benefits Scheme (PBS). This program facilitates the supply of these pharmaceuticals at public hospitals to non-admitted patients, day admitted patients, and patients on discharge.
Under this legislation, the Minister is empowered to make special arrangements to ensure that adequate supplies of these pharmaceuticals are available to those who need them. The special arrangements outlined in this instrument are tailored to address specific gaps in the supply chain, particularly for chemotherapy drugs that are listed on the PBS but require special access protocols due to the nature of the patients’ medical conditions or the settings in which they receive treatment. This ensures that these patients receive the necessary medications in a timely and efficient manner, thereby improving their access to essential treatments.
The obligations imposed by this Act on the parties involved include ensuring that the special arrangements are adhered to strictly, particularly in terms of the supply, storage, and administration of chemotherapy pharmaceuticals. The Act also mandates that any amendments or revocations to these special arrangements are communicated effectively to all relevant stakeholders, including healthcare providers and patients. This ensures that there is a clear understanding of the changes and their implications for the delivery of healthcare services.
Breaches of the provisions set out in this Act can result in both civil and criminal consequences. The maximum penalties for contravening the Act depend on the severity of the breach. For instance, the Act provides for fines and imprisonment for serious breaches that impact patient safety or the integrity of the pharmaceutical supply chain. Additionally, there may be administrative penalties for non-compliance with the specific requirements outlined in the Chemotherapy Pharmaceuticals Access Program, such as failure to report discrepancies in the supply or administration of chemotherapy drugs. The penalties are designed to enforce compliance and maintain the high standards required for the safe and effective delivery of healthcare services.