EXPLANATORY STATEMENT
Issued by Authority of the Minister for Health
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (IVF/GIFT PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012
PB 9 of 2012
Authority
Subsection 100(1) enables the Minister to make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available to persons:
(a) who are living in isolated areas: or
(b) who are receiving treatment in circumstances in which generally available pharmaceutical benefits are inadequate for that treatment; or
(c) if the pharmaceutical benefits covered by the arrangements can be more conveniently or efficiently supplied under the arrangements.
Subsection 100(2) provides that the Minister may vary or revoke a special arrangement made under subsection (1).
Subsection 100(3) provides that Part VII of the Act, and regulations and other legislative 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 100(2) of the National Health Act 1953 (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.
Amendments
This instrument makes changes to the pharmaceutical benefits available under the Special Arrangement. The changes made by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (the main listing instrument) made under sections 84AF, 85, 85A and 101 of the Act, which commences on the same day.
This legislative instrument amends the Special Arrangement to allow the addition of a pharmaceutical benefit, which is the listed drug ‘Choriogonadotrophin Alfa’ in the form ’Solution for injection 250 micrograms in 0.5ml pre-filled pen’ with manner of administration ‘Injection’ and brand ‘Ovidrel’. This will allow patients the choice of access to Choriogonadotropin Alfa in the form of a pre-filled pen or a pre-filled syringe.
Consultations
The amendment in this Instrument 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.
Statement of Compatibility
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
This legislative instrument commences on 1 March 2012.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.