EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 132 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 55 of 2009 which came into effect on 1 July 2009. 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 February 2010, was made on 22 December 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 February 2010.
Paragraph 2: provides that Schedule 1 amends PB 55 of 2009.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Brands Added
Gemcitabine | Powder for I.V. infusion 200 mg (as hydrochloride) (Gemcitabine Ebewe) Powder for I.V. infusion 1 g (as hydrochloride) (Gemcitabine Ebewe) |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL (Irinotecan Ebewe) I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Irinotecan Ebewe) I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL (Irinotecan Ebewe) I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL (Irinotecan Ebewe) |
Brand Deleted
Mitozantrone | Injection 10 mg (as hydrochloride) in 5 mL (Mitozantrone Ebewe) |
Overview
The National Health Act 1953 was enacted to establish and regulate the Australian Pharmaceutical Benefits Scheme (PBS) aimed at ensuring affordable and timely access to necessary and cost-effective medicines for the Australian community. The Act, overseen by the Commonwealth, operates under the principle of providing pharmaceutical benefits as stipulated in Part VII. The Act allows the Minister to make special arrangements for supplying certain pharmaceutical products to individuals in isolated areas or those receiving medical treatment where the standard PBS provisions are inadequate, as outlined in subsection 100(1). This mechanism ensures that individuals in specific circumstances can access necessary medications efficiently. The Chemotherapy Pharmaceuticals Access Program, established under these provisions, facilitates the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted, day admitted, and discharged patients, addressing the need for accessible and efficient chemotherapy treatment.
This legislative instrument, effective from 1 February 2010, amends the previous arrangements made under subparagraph 100(b)(i) of the Act to enhance the Chemotherapy Pharmaceuticals Access Program. The amendments, recommended by the Pharmaceutical Benefits Advisory Committee, were made to align with the evolving needs of patients requiring chemotherapy treatments. The instrument ensures that the PBS continues to meet the medical needs of Australians by updating the list of available chemotherapy pharmaceuticals, thereby improving access and treatment options for those in need.
Scope and Application
The National Health Act 1953, as amended, regulates the Australian Pharmaceutical Benefits Scheme (PBS), ensuring timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community. The Act applies to all persons and entities within the Commonwealth of Australia, providing for the supply of listed drugs and medicinal preparations as pharmaceutical benefits. Under the Act, the Minister can make special arrangements for providing an adequate supply of special pharmaceutical products to persons living in isolated areas or receiving medical treatment where pharmaceutical benefits cannot be conveniently or efficiently supplied or are inadequate. This includes the Chemotherapy Pharmaceuticals Access Program, which facilitates the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients, and patients on discharge. The arrangements can be varied or revoked by the Minister, and the Act's provisions apply subject to any special arrangements made. The Chemotherapy Pharmaceuticals Access Program is an example of such special arrangements, and these arrangements are detailed in subordinate instruments that may include additions and deletions of specific drugs and brands as recommended by the Pharmaceutical Benefits Advisory Committee.
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) allows the Minister to make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons living in isolated areas or who are receiving medical treatment where pharmaceutical benefits cannot be conveniently or efficiently supplied under Part VII of the Act or are inadequate for that medical treatment (subsection 100(1)(a) and (b)). Subsection 100(2) permits the Minister to vary or revoke a special arrangement made under subsection 100(1). These provisions ensure that essential chemotherapy pharmaceuticals can be supplied under specific conditions not covered by the general provisions of the Pharmaceutical Benefits Scheme (PBS).
The Act imposes specific obligations and requirements on the entities involved in the supply of chemotherapy pharmaceuticals under these special arrangements. The Minister is responsible for ensuring that adequate supplies of specified chemotherapy drugs are available to those in need, particularly in isolated areas or where standard PBS provisions are insufficient. This includes making necessary arrangements, as well as varying or revoking those arrangements if required. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role by recommending which drugs should be included in the PBS and the special arrangements. Hospitals and healthcare providers must adhere to the guidelines and requirements set forth by these arrangements to ensure the appropriate and timely supply of these essential medications.
There are no specific offences, penalties, or civil/criminal consequences detailed for breaches of the special arrangements within the text. However, non-compliance with the provisions of the National Health Act 1953 could potentially lead to legal consequences under other relevant sections of the Act or other applicable legislation. The Act generally focuses on ensuring the availability and efficient supply of necessary pharmaceutical benefits, with the primary emphasis on safeguarding public health rather than penalising non-compliance directly within these special arrangements.