EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
ARRANGEMENTS UNDER SECTION 100
CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM
NO. PB 4 OF 2007
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.
2. 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.
3. “Pharmaceutical benefit” is defined under subsection 84(1) of the Act as a drug or medicinal preparation in relation to which, by virtue of section 85 of the Act, Part VII of the Act applies.
4. 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.
5. Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
6. Subsection 100(3) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).
7. 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.
8. 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.
9. These Arrangements amend Schedule 2 to the Principal Arrangements made on
7 November 2006 with effect from 1 December 2006 (No. PB 52 of 2006), in order to list MX brands of Oxaliplatin powder for I.V. infusion 50 mg and powder for I.V. infusion 100 mg with effect from 1 January 2007.
10. These Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.
11. Details of the Arrangements are set out in the Attachment.
12. These Arrangements were made on 1 December 2006 and commenced on 1 January 2007.
Consultations
13. The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits. Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared. When recommending a medicine be listed 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.
14. PBAC members are selected 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.
15. 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 these Arrangements commence on 1 January 2007.
Paragraph 2 provides that the Arrangements (No. PB 52 of 2006) under subparagraph 100(1)(b)(i) of the National Health Act 1953 made on 7 November 2006 with effect from 1 December 2006 are, in these Arrangements, referred to as the Principal Arrangements.
Paragraph 3 provides for the addition of MX brands of Oxaliplatin powder for I.V. infusion 50 mg and powder for I.V. infusion 100 mg to Schedule 2 to the Principal Arrangements. Schedule 2 to the Principal Arrangements lists the forms (strength, type, size etc), the manner of administration, the maximum quantity, maximum number of repeats and the brands of those drugs and medicinal preparations that are declared under subparagraph 100(1)(b)(i) of the Act to be chemotherapy pharmaceuticals.