EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 70 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 August 2009, was made on 10 July 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 August 2009.
Paragraph 2: provides that Schedule 1 amends PB 55 of 2009.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Addition of Listed Drug
SCHEDULE 2
Addition of Listed Drug
Addition of Form
Gemcitabine | Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL |
Addition of Brands
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL (Paclitaxel Actavis) |
| Solution concentrate for I.V. infusion 100 mg in 16.7 mL (Paclitaxel Actavis) |
| Solution concentrate for I.V. infusion 150 mg in 25 mL (Paclitaxel Actavis) |
| Solution concentrate for I.V. infusion 300 mg in 50 mL (Paclitaxel Actavis) |
SCHEDULE 4
Price Decrease
All drugs listed in Schedule 4 reflect a price decrease in Column 5 — Approved price and Column 6 — Price claimed by manufacturer. |
Overview
The National Health Act 1953, enacted by the Australian Parliament, was introduced to provide a structured framework for the regulation of health services and pharmaceuticals within Australia. One of the significant gaps it aimed to address was ensuring equitable and efficient access to necessary and cost-effective medicines for all Australians, particularly those in isolated areas or undergoing specific medical treatments where conventional supply mechanisms under the Pharmaceutical Benefits Scheme (PBS) might be inadequate. Under the Act, the Minister for Health is empowered to make special arrangements to ensure an adequate supply of specific pharmaceutical products to those in need, as detailed in subsection 100(1). This provision was designed to respond to the unique needs of certain patient groups, thereby enhancing the overall efficacy of the PBS. The Chemotherapy Pharmaceuticals Access Program, operating under these special arrangements, was established to ensure that chemotherapy pharmaceuticals are made available to non-admitted patients, day admitted patients, and those on discharge from public hospitals, reflecting the policy objective of making essential medical treatments accessible and affordable.
Scope and Application
The Chemotherapy Pharmaceuticals Access Program Amendment (No. 2) Instrument 2009 amends the arrangements under the National Health Act 1953 for providing special access to chemotherapy pharmaceuticals, particularly for non-admitted patients, day admitted patients, and patients on discharge at public hospitals. This instrument applies to the Minister of Health, who is responsible for making special arrangements for the supply of these pharmaceuticals under subsection 100(1) of the Act, and extends to the entities and individuals who benefit from these arrangements, including patients who cannot conveniently or efficiently receive pharmaceutical benefits under the standard provisions of the Act. The amendments reflect recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and primarily involve the addition of new chemotherapy drugs, such as Arsenic and Gemcitabine, along with specific brand formulations of Paclitaxel, to the list of pharmaceuticals covered under the special arrangements. The changes also include adjustments to the approved prices of listed drugs, ensuring that they are reflective of current market conditions and manufacturer claims. This legislative instrument has a national reach, operating within the framework established by the National Health Act 1953, which is a Commonwealth Act. The amendments introduced by this instrument are effective from 1 August 2009 and are intended to enhance the availability and affordability of essential chemotherapy drugs for patients in need, particularly in scenarios where standard PBS provisions may be inadequate.
Key Provisions
The main operative sections of this legislative instrument (F2009L02871) include subsections 85(1) and 100(1) of the National Health Act 1953, which establish the framework for the Australian Pharmaceutical Benefits Scheme (PBS) and allow the Minister to make special arrangements for the supply of special pharmaceutical products. Section 100(1) allows the Minister to create arrangements for ensuring an adequate supply of special pharmaceutical products to persons living in isolated areas or receiving medical treatment under specific circumstances where the standard provisions of Part VII of the Act are inadequate or inefficient. Section 100(2) and 100(3) permit the Minister to vary or revoke these special arrangements, with Part VII of the Act being subject to any such arrangements. The Chemotherapy Pharmaceuticals Access Program, established under this authority, is designed to supply chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients, and patients on discharge.
The Act imposes several obligations on the parties and entities it governs. The Minister is required to consult with the Pharmaceutical Benefits Advisory Committee (PBAC) when making special arrangements for pharmaceutical benefits, ensuring that recommendations are considered based on clinical effectiveness, safety, and cost-effectiveness. The PBAC, an independent expert body, is responsible for making recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. The PBAC must take into account various factors, including the medical conditions for which a medicine has been approved for use in Australia, its clinical effectiveness, safety, and cost-effectiveness compared with other treatments.
The Act also includes provisions for offences, penalties, and civil or criminal consequences for breaches. While specific maximum penalties are not detailed in the provided text, breaches of the Act can lead to significant legal consequences. Non-compliance with the requirements set out in the Act, such as failing to adhere to the special arrangements for pharmaceutical benefits, could result in penalties. These may include fines, imprisonment, or other sanctions as prescribed by law. The exact penalties would depend on the nature and severity of the breach, as well as any additional provisions outlined in other parts of the National Health Act 1953 or related legislation.