EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 127 OF 2009
NATIONAL HEALTH ACT 1953
AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBSECTION 100(1)
SPECIAL AUTHORITY PROGRAM (TRASTUZUMAB)
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 Special Authority Program (Trastuzumab) 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 require treatment with trastuzumab.
This legislative instrument amends the Arrangements made under subparagraph 100(b)(i) (PB 56 of 2009) which came into effect on 1 July 2009. The amendments are set out in the items of Schedule 1 to the instrument.
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 January 2010, was made on
11 December 2009.
Consultations
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.
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.
ATTACHMENT
Paragraph 1 provides that this instrument commences on 1 January 2010.
Paragraph 2 provides that Schedule 1 amends PB 56 of 2009.
Schedule 1 provides for the following amendments:
Item 1 amends paragraph 20 to refer to the Highly Specialised Drugs Program Arrangements for Public Hospitals 2010 (PB 125 of 2009) (the 2010 HSD arrangements), commencing 1 January 2010, rather than the Highly Specialised Drugs Program Arrangements for Public Hospitals 2009 (PB 61 of 2009) which were revoked by the 2010 HSD arrangements. The effect is to clarify that for the purposes of paragraph 19, the dispensed price is to be ascertained in accordance with paragraphs 33 to 35 of the arrangements made under subparagraph 100(1)(b)(i) of the Act for highly specialised drugs and set out in No. PB 125 of 2009 as if those arrangements applied to trastuzumab.
Item 2 omits paragraph 22(c), in relation to the online incentive fee for public hospital authorities. This paragraph has been removed because the online incentive payment is in fact payable under administrative, rather than legislative, arrangements in accordance with the Fourth Community Pharmacy Agreement (the Agreement). Accordingly, reference to the fee in the Arrangements is unnecessary. The omission of this paragraph does not affect any person’s entitlement to receive the fee under the Agreement.