EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 114 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 December 2009, was made on 13 November 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 December 2009.
Paragraph 2: provides that Schedule 1 amends PB 55 of 2009.
Schedule 1: provides for the following amendments:
SCHEDULE 2
Addition of Brands
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in |
| I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Irinotecan Alphapharm) |
SCHEDULE 4
Price Decrease
The following chemotherapy pharmaceuticals reflect a price decrease in Column 5 — Approved price and Column 6 — Price claimed by manufacturer.
Folinic Acid | Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL |
Ondansetron | I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL |
| I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL |