EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (IVF/GIFT Program) Special Arrangement Amendment Instrument 2012 (No.2)
PB 78 of 2012
Authority
Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits. 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) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).
Purpose
The purpose of this legislative instrument, made under subsections 100(1) and (2) of the Act, is to amend the National Health (IVF/GIFT Program) Special Arrangement 2011 (PB 93 of 2011) (the Special Arrangement) to make changes to the special arrangement relating to the IVF/GIFT Program.
The purpose of the Special Arrangement is to ensure that an adequate supply of the pharmaceutical benefits 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 pharmaceutical benefits can more conveniently or efficiently be supplied under a special arrangement.
The changes made by this instrument reflect changes made by the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (main listing instrument), which commences on the same day. This instrument amends Schedule 1 of the Special Arrangement to add two pharmaceutical benefits with the listed drug ‘Human Menopausal Gonadotrophin’ and brands ‘Menopur 600’ and ‘Menopur 1200’. The forms for the pharmaceutical benefits being added are ‘Powder for injection 600IU with solvent’ and ‘Powder for injection 1200IU with solvent’.
This instrument also amends section 7 of the Special Arrangement and replaces Schedule 1 of the Special Arrangement to reflect that the main listing instrument will use the code ‘D(100)’ instead of the letter ‘D’ for listed drugs that are only available under section 100 special arrangements and the code ‘PB(100)’ instead of the letters ‘PB’ for pharmaceutical benefits that are only available under section 100 special arrangements.
This instrument also amends Schedule 2 of the Special Arrangement to add the Responsible Person Ferring Pharmaceutical Pty Ltd to the Special Arrangement.
Consultation
The Special Arrangement 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 about which drugs and medicinal preparations should be available as pharmaceutical benefits. 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.
Pharmaceutical companies were consulted throughout the process for additions and changes to listings on the PBS and for this Special Arrangement. This includes consultation through the PBAC process, and agreement to final listing details.
This Instrument commences on 1 October 2012.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.