EXPLANATORY STATEMENT
Issued by the Minister for Health and Ageing
NATIONAL HEALTH ACT 1953
AMENDMENT TO ARRANGEMENTS MADE UNDER SUBPARAGRAPH 100(1)(b)(i) – IVF/GIFT PROGRAM
INSTRUMENT NUMBER PB 12 of 2011
Authority for the Arrangements
This legislative instrument is made pursuant to subsection 100(2) of the National Health Act 1953 (“the Act”) and varies the legislative instrument titled Arrangements made under subparagraph 100(1)(b)(i) – IVF/GIFT Program (as amended) (“PB 26 of 2007”).
Part VII of 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.
The drugs that are the subject of PB 26 of 2007 have been declared under subsection 85(2) to be drugs or medicinal preparations to which Part VII applies. These drugs are listed in the Schedule to PB 26 of 2007.
PB 26 of 2007 is made under subparagraph 100(1)(b)(i) of the Act and provides for the supply of certain medicines to be made available to persons who are receiving medical treatment in circumstances where pharmaceutical benefits cannot be conveniently or efficiently supplied in accordance with Part VII of the Act.
Subsection 100(3) provides that Part VII has effect subject to a special arrangement under subsection 100(1). This means that a special arrangement made under subsection 100(1) can modify the operation of Part VII in relation to the relevant medicines which are the subject of the arrangement.
Subsection 100(2) empowers the Minister to vary or revoke a special arrangement made under subsection 100(1).
Purpose of the Arrangements
PB 26 of 2007 provides for special arrangements for the IVF/GIFT Program. These special arrangements relate specifically to the supply of certain medicines required by patients who are receiving in vitro fertilisation or gamete intra-fallopian transfer treatment.
The purpose of these special arrangements is to ensure that an adequate supply of the special pharmaceutical products listed in the Schedule to PB 26 of 2007 is available for patients who require in vitro fertilisation or gamete intra-fallopian transfer treatment. Restrictions on the provision of these treatments mean that these drugs cannot conveniently or efficiently be supplied as pharmaceutical benefits under Part VII.
Variation
This legislative instrument varies PB 26 of 2007 to allow the addition of the drug Cetrorelix to Part 1 of the Schedule.
This legislative instrument commences on 1 February 2011.
Consultations
PB 26 of 2007 was made having regard to advice provided by the Pharmaceutical Benefits Advisory Committee (PBAC), an 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 or as special pharmaceutical products. Part VII of the Act only applies to drugs or medicinal preparations recommended by the PBAC. When making recommendations, 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.
Overview
The National Health Act 1953, amended by the instrument F2011L00171, addresses the specific needs of patients undergoing in vitro fertilisation (IVF) and gamete intra-fallopian transfer (GIFT) treatments by ensuring the availability of essential pharmaceutical products not conveniently supplied under the Pharmaceutical Benefits Scheme (PBS). The instrument, enacted by the Minister for Health and Ageing, aims to modify the existing special arrangements made under subparagraph 100(1)(b)(i) of the Act, specifically to include the drug Cetrorelix in the IVF/GIFT Program. The policy objective behind this amendment is to facilitate timely and efficient access to necessary medications for patients undergoing these specialised fertility treatments, thereby enhancing treatment outcomes and patient care. The decision to include Cetrorelix was informed by recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that the drug meets criteria of clinical effectiveness, safety, and cost-effectiveness.
Scope and Application
The National Health Act 1953, as amended by the legislative instrument PB 12 of 2011, pertains specifically to the supply of certain medicines required for patients undergoing in vitro fertilisation (IVF) or gamete intra-fallopian transfer (GIFT) treatment. This legislation provides special arrangements for the IVF/GIFT Program, ensuring an adequate supply of specified pharmaceutical products for patients who need these treatments. These arrangements are made under subparagraph 100(1)(b)(i) of the Act, and they modify the operation of Part VII of the Act, which is the legislative basis for the Pharmaceutical Benefits Scheme (PBS). The Act applies to persons receiving medical treatment under these specific conditions and to the drugs listed in the Schedule to PB 26 of 2007. The geographic reach of this Act is national, applying across Australia, and it extends to all persons requiring IVF or GIFT treatments. The amendments to PB 26 of 2007, through PB 12 of 2011, include the addition of the drug Cetrorelix to the list of special pharmaceutical products available under the IVF/GIFT Program, effective from 1 February 2011. The Act does not specify any exclusions or thresholds for eligibility but operates under the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), which advises the Minister on the clinical effectiveness, safety, and cost-effectiveness of the drugs to be included.
Key Provisions
The main provisions of the instrument concern the amendment of the legislative instrument titled "Arrangements made under subparagraph 100(1)(b)(i) – IVF/GIFT Program" (PB 26 of 2007) under the National Health Act 1953 (the Act). The amendment, represented by PB 12 of 2011, introduces the drug Cetrorelix to the list of special pharmaceutical products available under the IVF/GIFT Program (section 100(2)). These special arrangements are made to ensure that patients who require in vitro fertilisation or gamete intra-fallopian transfer treatment have access to necessary medications that cannot be conveniently or efficiently supplied under the Pharmaceutical Benefits Scheme (Part VII of the Act) due to restrictions on the provision of these treatments (section 100(1)(b)(i)).
The Act imposes obligations on parties to ensure the availability of these special pharmaceutical products for eligible patients. These obligations include the procurement and supply of specified drugs, adherence to the conditions set out in the amended legislative instrument, and compliance with any further instructions or guidelines issued by the Minister for Health and Ageing. Pharmaceutical entities, healthcare providers, and patients must work together to ensure that the medications listed in the Schedule are appropriately supplied to those in need.
Breaching the obligations set out in the Act may result in civil or criminal penalties. While the specific penalties are not detailed in the explanatory statement, it is known that violations of the National Health Act 1953 can lead to fines, imprisonment, or both, depending on the nature and severity of the breach. The maximum penalties can vary significantly, reflecting the seriousness of non-compliance with health regulations designed to protect public health and safety. It is crucial for all parties involved to understand and adhere to the requirements to avoid potential legal repercussions.