EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
ARRANGEMENTS UNDER SECTION 100
HIGHLY SPECIALISED DRUGS PROGRAM
NO. PB 47 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 Highly Specialised Drugs Program is a set of Arrangements made under subparagraph 100(1)(b)(i) of the Act for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who are receiving treatment with highly specialised drugs at private hospitals as non-admitted patients, day admitted patients or patients on discharge.
9. The Arrangements under subparagraph 100(1)(b)(i) of the Act made on 12 March 2007 with effect from
1 April 2007 (No. PB 25 of 2007), as amended on 30 March 2007 with effect from 1 May 2007 (No. PB 36 of 2007), are amended by these Arrangements.
10. These Arrangements give effect, as from 1 July 2007, to changes to Schedule 1 in order to alter the circumstances for the supply of the highly specialised drugs Lanreotide Acetate and Octreotide Acetate.
11. These Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.
12. Details of the Arrangements are set out in the Attachment.
13. The Arrangements were made on 7 June 2007 and commenced on 1 July 2007.
Consultations
14. 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.
15. 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.
16. The Commonwealth/State Highly Specialised Drugs Working Party (HSDWP) is a non-statutory body established by the Australian Health Ministers Advisory Council (AHMAC). The HSDWP makes recommendations to the PBAC on the suitability of certain drugs for listing under the Highly Specialised Drugs Program. The HSDWP considers the funding and administrative aspects of supply through the hospital system, and a recommendation for listing must be supported by a majority of Working Party members. The HSDWP consists of representatives from State and Territory Health Departments and the Australian Private Hospitals Association, and is chaired by a representative of the Commonwealth Department of Health and Ageing.
ATTACHMENT
Paragraph 1 provides that these Arrangements commence on 1 July 2007.
Paragraph 2 provides that the Arrangements under subparagraph 100(1)(b)(i) of the National Health Act 1953 made on 12 March 2007, with effect from 1 April 2007 (No. PB 25 of 2007), as amended on 30 March 2007 with effect from 1 May 2007 (No. PB 36 of 2007), are, in these Arrangements, referred to as the Principal Arrangements.
Paragraph 3 (a) provides for the alteration of circumstances for the highly specialised drug Lanreotide Acetate specified in Schedule 1 to the Principal Arrangements.
Paragraph 3 (b) provides for the alteration of circumstances for the highly specialised drug Octreotide Acetate specified in Schedule 1 to the Principal Arrangements.
The Schedules
Schedule 1 to the Arrangements lists those drugs and medicinal preparations that are highly specialised drugs when prescribed by a medical practitioner for the circumstances specified.
Schedule 2 to the Arrangements lists the forms (strength, type, size etc), the manner of administration and the brands of those drugs and medicinal preparations that are highly specialised drugs when prescribed by a medical practitioner for the circumstances specified in Schedule 1.
Schedule 3 to the Arrangements lists those highly specialised drugs the complete pack of which shall be supplied regardless of any lesser quantity ordered in the prescription.
Schedule 4 to the Arrangements lists those highly specialised drugs to which paragraph 19A of these Arrangements applies, the form (strength, type, size etc.), the brand, the pack size, the price to pharmacist that the Government is prepared to pay (Commonwealth price) and the price to pharmacist that the manufacturer requires.