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.
Overview
The National Health (IVF/GIFT Program) Special Arrangement Amendment Instrument 2012 was enacted to amend the National Health (IVF/GIFT Program) Special Arrangement 2011, addressing the need for an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation or gamete intra-fallopian transfer treatment. This instrument was created under the authority of the Minister for Health, pursuant to subsections 100(1) and 100(2) of the National Health Act 1953, aiming to ensure that the special arrangement relating to IVF and GIFT treatments allows for the most efficient and convenient supply of pharmaceutical benefits. The changes implemented by this legislative instrument reflect amendments made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010, which were based on recommendations from the Pharmaceutical Benefits Advisory Committee. This committee, established under section 100A of the Act, advises the Minister on which drugs should be available as pharmaceutical benefits, considering factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness. The instrument commenced on 1 March 2012, and it is compatible with the human rights and freedoms recognised in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Scope and Application
The National Health (IVF/GIFT Program) Special Arrangement Amendment Instrument 2012 amends the National Health (IVF/GIFT Program) Special Arrangement 2011, which is designed to ensure an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation or gamete intra-fallopian transfer treatment. The amendment applies to the Commonwealth of Australia under the National Health Act 1953, specifically Part VII, and is intended to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010. This legislative instrument allows the addition of a pharmaceutical benefit, specifically the 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'. The purpose of this amendment is to provide patients with the choice of access to Choriogonadotropin Alfa in the form of a pre-filled pen or a pre-filled syringe, ensuring more convenient or efficient supply of the pharmaceutical benefit. The amendment takes into account recommendations from the Pharmaceutical Benefits Advisory Committee, which advises the Minister for Health on which drugs and medicinal preparations should be available as pharmaceutical benefits. This legislative instrument is compatible with the human rights and freedoms recognised in the international instruments listed in the Human Rights (Parliamentary Scrutiny) Act 2011 and commences on 1 March 2012.
Key Provisions
The National Health (IVF/GIFT Program) Special Arrangement Amendment Instrument 2012 amends the existing special arrangement under the National Health Act 1953 to improve access to pharmaceutical benefits for patients requiring in vitro fertilisation (IVF) or gamete intra-fallopian transfer (GIFT) treatment. The main operative sections of this instrument (sections 3 and 4) make amendments to the Special Arrangement to allow the addition of a new pharmaceutical benefit, specifically the 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 amendment aims to provide patients with the choice of accessing Choriogonadotropin Alfa either in a pre-filled pen or a pre-filled syringe, thereby enhancing convenience and potentially improving treatment outcomes.
The Act imposes certain obligations and requirements on the parties involved. Firstly, the Minister for Health is responsible for making special arrangements to ensure an adequate supply of pharmaceutical benefits for patients in isolated areas or those receiving treatment for which generally available benefits are inadequate. The Minister also has the authority to vary or revoke these special arrangements. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role by providing expert advice and recommendations on which drugs should be included as pharmaceutical benefits. The PBAC's recommendations must consider the medical conditions for which the medicine has been approved, its clinical effectiveness, safety, and cost-effectiveness compared to other treatments. Additionally, the PBAC is required to take into account various stakeholder interests, including those of consumers, health economists, practising pharmacists, general practitioners, clinical pharmacologists, and specialists.
Under this instrument, breaches of the requirements or obligations set out in the Act may lead to specific offences and penalties. However, the explanatory statement does not explicitly detail the maximum penalties for such breaches. Generally, the Act allows for civil and criminal consequences for non-compliance, including fines and potential imprisonment, depending on the severity of the breach. It is essential for parties governed by this Act to adhere to the outlined obligations and requirements to avoid any adverse legal repercussions. Compliance with the Act and its special arrangements ensures that patients receive the necessary pharmaceutical benefits for their treatment, ultimately contributing to better health outcomes.