EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 40 OF 2010
NATIONAL HEALTH ACT 1953
AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBSECTION 100(1)
CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM
Summary
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 provide for additional brands of chemotherapy pharmaceuticals available at public hospitals to non-admitted patients, day-admitted patients or patients on discharge. The amendments are set out in the items of Schedule 1 to the instrument.
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.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 May 2010, was made on 11 April 2010.
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 May 2010.
Paragraph 2: provides that Schedule 1 amends PB 55 of 2009.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Addition of Brands
Fludarabine | Powder for I.V. injection containing fludarabine phosphate 50 mg (Farine) |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg
in 2 mL (Tecan) I.V. injection containing irinotecan hydrochloride trihydrate 100 mg
in 5 mL (Tecan) |
Overview
The National Health Act 1953 was enacted to provide for the supply of listed drugs and medicinal preparations as pharmaceutical benefits under the Australian Pharmaceutical Benefits Scheme (PBS). This scheme aims to ensure timely, reliable, and affordable access to necessary and cost-effective medicines for the Australian community. The Act was amended in 2010 to include special arrangements for the provision of certain pharmaceutical products to address specific needs, such as for people living in isolated areas or those receiving medical treatment under circumstances where standard PBS provisions are inadequate. The amendments in question, introduced as PB 40 of 2010, pertain to the Chemotherapy Pharmaceuticals Access Program, which was established to ensure adequate supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day-admitted patients, and patients on discharge. These amendments were made in response to recommendations from the Pharmaceutical Benefits Advisory Committee, reflecting a policy objective to enhance access to necessary pharmaceutical treatments under the PBS.
Scope and Application
The National Health Act 1953, as amended by the legislative instrument F2010L00943, pertains specifically to the Chemotherapy Pharmaceuticals Access Program, which is designed to ensure that an adequate supply of special pharmaceutical products, particularly chemotherapy drugs, is available to certain patients in public hospitals. This Act applies to persons receiving medical treatment in circumstances where the supply of pharmaceutical benefits under the general provisions of the Act is not convenient or efficient, such as non-admitted patients, day-admitted patients, or those on discharge. The geographic reach of this Act is national, governed by the Commonwealth. The Act allows the Minister to make special arrangements to address these specific circumstances under subsection 100(1) and can vary or revoke such arrangements as necessary under subsection 100(2). This legislative instrument, which commenced on 1 May 2010, amends the previous arrangements made under PB 55 of 2009, effective from 1 July 2009, by adding specific brands of chemotherapy pharmaceuticals to those available under the program. The changes outlined in Schedule 1 of the instrument include the addition of brands such as Fludarabine and Irinotecan, ensuring an expanded range of chemotherapy drugs are accessible to patients in need.
Key Provisions
The main operative sections of this legislative instrument concern the amendments to the Chemotherapy Pharmaceuticals Access Program Arrangements under subparagraph 100(b)(i) of the National Health Act 1953. Specifically, section 1 of the instrument states that it commences on 1 May 2010, and section 2 amends PB 55 of 2009. Schedule 1 of the instrument, which details the amendments, includes the addition of specific brands of chemotherapy pharmaceuticals that are now available at public hospitals to non-admitted patients, day-admitted patients, or patients on discharge. The brands listed in Schedule 2 are Fludarabine Powder for I.V. injection containing fludarabine phosphate 50 mg (Farine) and Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL (Tecan) and 100 mg in 5 mL (Tecan).
The obligations and requirements imposed by this Act on the parties or entities it governs include ensuring that the amended Chemotherapy Pharmaceuticals Access Program Arrangements are implemented effectively. This involves making the newly listed chemotherapy pharmaceuticals available to the specified patient groups at public hospitals, as outlined in Schedule 1. These arrangements are intended to ensure that patients who are not admitted to hospital, those admitted for the day, and those being discharged have access to necessary chemotherapy drugs, thereby facilitating their continued treatment outside of a traditional hospital admission setting.
In terms of offences, penalties, or consequences for breach, the Act itself does not explicitly detail penalties for non-compliance with the amended arrangements. However, general provisions of the National Health Act 1953 may apply, and breaches of the Act could result in civil or criminal penalties. These could include fines or other sanctions imposed by the relevant authorities, depending on the severity and nature of the breach. It is important for entities governed by this Act to ensure compliance to avoid any potential legal repercussions.