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.
Overview
The National Health Act 1953 was enacted to provide the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), ensuring all Australians have reliable, timely, and affordable access to a wide range of medicines. The Act empowers the Minister to make special arrangements for the supply of special pharmaceutical products under subsection 100(1) where standard PBS provisions are inadequate, such as in isolated areas or for specific medical treatments. This legislative instrument, Special Authority Program (Imatinib) No. PB 85 of 2007, repeals special arrangements for the supply of the drug imatinib, effective from 1 November 2007. Imatinib, previously supplied under special arrangements for the treatment of gastrointestinal tumours and chronic myeloid leukaemia, will now be supplied as a pharmaceutical benefit under Part VII of the Act. The repeal follows the decision of the Pharmaceutical Benefits Advisory Committee and consultations with relevant stakeholders, including the Restrictions Working Group and the Highly Specialised Drugs Working Group.
Scope and Application
The National Health Act 1953, specifically Part VII, governs the Pharmaceutical Benefits Scheme (PBS) through which the Commonwealth ensures Australians have reliable, timely, and affordable access to a wide range of medicines. Under subsection 85(1) of the Act, the Commonwealth provides pharmaceutical benefits in accordance with Part VII for drugs and medicinal preparations declared by the Minister through legislative instruments, subject to certain determinations. However, under subsection 100(1), the Minister has the authority to make special arrangements for the supply of certain special pharmaceutical products, particularly for individuals in isolated areas or receiving medical treatment where conventional pharmaceutical benefits are inadequate. Subsection 100(2) further empowers the Minister to vary or revoke these special arrangements. The instrument F2007L03949 repeals the special arrangements for the supply of imatinib, effective from 1 November 2007, transitioning it from a special authority program drug to a standard listed drug under subsection 85(1). This change was made following consultations with relevant working groups and the drug's sponsor, reflecting a shift in the supply mechanism for imatinib as part of the PBS.
Key Provisions
The National Health Act 1953 (the Act) is foundational in providing reliable, timely, and affordable access to a range of medicines for Australians, primarily through the Pharmaceutical Benefits Scheme (PBS). Under section 85(1) of the Act, the Commonwealth provides these benefits, which include a list of drugs and medicinal preparations declared by the Minister (subsection 85(2)). These drugs and preparations constitute pharmaceutical benefits under Part VII of the Act and are subject to determinations regarding their form, manner of administration, and brand.
Subsection 100(1) of the Act allows the Minister to make special arrangements for the supply of special pharmaceutical products, such as imatinib, when regular PBS provisions are inadequate or inconvenient. This is particularly relevant for individuals in isolated areas or undergoing medical treatments where standard pharmaceutical benefits are not sufficient. These special pharmaceutical products can be drugs or medicinal preparations declared under section 100AA or subsection 85(1). Importantly, subsection 100(2) empowers the Minister to vary or revoke these special arrangements as necessary.
The main operative sections of the Special Arrangements Repeal for the Special Authority Program (Imatinib) involve the repeal of the special arrangements for imatinib, which was previously supplied under the Special Authority Program. Effective from 1 November 2007, the instrument repeals Instrument PB 55 of 2007, which was made on 2 October 2007. The decision to transfer imatinib to the PBS list followed consultations with various working groups and the drug sponsor, ensuring a considered approach to this change.
The obligations imposed by this legislative instrument primarily concern the Minister's authority to make and adjust special arrangements for pharmaceutical products. The Minister must ensure that any special arrangements comply with the provisions of subsection 100(1) and (2), particularly in the context of imatinib's transition from the Special Authority Program to the PBS. This involves careful monitoring and potentially revising these arrangements to meet the needs of patients who require imatinib for the treatment of gastrointestinal tumours and chronic myeloid leukaemia.
Breaches of the obligations or non-compliance with the special arrangements could lead to civil or criminal consequences, depending on the severity of the breach. However, the specific offences, penalties, or consequences are not detailed within the instrument itself. Typically, penalties for non-compliance with health-related legislation can range from fines to more severe criminal charges, depending on the nature and impact of the breach.