EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
SPECIAL ARRANGEMENTS REPEAL UNDER SUBSECTION 100(1)
SPECIAL AUTHORITY PROGRAM (IMATINIB)
No. PB 85 of 2007
Legislation and authority
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits. Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument under subsection 85(2). These are listed drugs which subject to usual determinations under section 85 relating to form, manner of administration, and brand of pharmaceutical item constitute pharmaceutical benefits under Part VII.
Subsection 100(1) of the Act empowers the Minister to make special arrangements for the supply of special pharmaceutical products as an alternative to the supply of pharmaceutical benefits under Part VII. This can be done for providing that an adequate supply of special pharmaceutical products will be available to persons who are living in isolated areas; or who are receiving medical treatment in such circumstances that pharmaceutical benefits cannot be conveniently or efficiently supplied in accordance with Part VII, or are inadequate for that medical treatment. Special pharmaceutical products in accordance with section 100AA are drugs or medicinal preparations declared under that section, or which have been declared under subsection 85(1).
Subsection 100(2) empowers the Minister to vary or revoke a special arrangement made under subsection 100(1).
Purpose
This legislative instrument repeals special arrangements made under subsection 100(1) for the purposes of the Special Authority Program for the supply of the drug imatinib in the treatment of gastrointestinal tumour and chronic myeloid leukaemia. Imatinib is presently a listed drug under subsection 85(1), and it is intended that from 1 November 2007 it be supplied as a pharmaceutical benefit under Part VII in accordance with determinations made under section 85.
Operation
The instrument repeals Instrument PB 55 of 2007 relating to the special arrangements for the supply of imatinib.
This instrument, expressed to commence on 1 November 2007, was made on 2 October 2007.
A provision-by-provision description of the instrument is contained in the Attachment.
Consultations
The decision by the Pharmaceutical Benefits Advisory Committee to transfer imatinib (Glivec®) from the Section 100 Special Authority Program Drugs to Section 85 was taken following consultation with the Restrictions Working Group (which includes representatives from Medicare Australia) and the Highly Specialised Drugs Working Group (which includes representatives from State health departments) and also with the sponsor of the drug.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 November 2007.
Paragraph 2: provides that PB 55 of 2007 is repealed by this instrument.