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.
Overview
The National Health (IVF/GIFT Program) Special Arrangement Amendment Instrument 2012 (No.2) was enacted to amend the National Health (IVF/GIFT Program) Special Arrangement 2011, introduced under the National Health Act 1953. The primary purpose of this legislation is to ensure an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation or gamete intra-fallopian transfer treatment, thereby facilitating the efficient provision of these treatments. This Act was created under the authority of the Minister for Health, who has the power to make special arrangements for the supply of pharmaceutical benefits, as stipulated in subsections 100(1) and (2) of the National Health Act 1953. The policy objective is to maintain and enhance the availability of essential medications, such as Human Menopausal Gonadotrophin, under the Pharmaceutical Benefits Scheme (PBS) to support these specialised treatments. The amendment reflects updates made in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and involves the addition of specific pharmaceutical benefits and a responsible person to the Special Arrangement.
Scope and Application
The National Health (IVF/GIFT Program) Special Arrangement Amendment Instrument 2012 (No. 2) amends the National Health (IVF/GIFT Program) Special Arrangement 2011 to incorporate changes in the listing of pharmaceutical benefits for in vitro fertilisation and gamete intra-fallopian transfer treatments. This amendment is designed to ensure an adequate supply of these pharmaceutical benefits for patients needing these treatments, which are restricted in their provision and thus more efficiently supplied under a special arrangement. The instrument applies to the pharmaceutical benefits listed in Schedule 1, specifically the addition of Human Menopausal Gonadotrophin brands Menopur 600 and Menopur 1200, and the modification of codes for listed drugs and benefits available under section 100 special arrangements. Additionally, it updates Schedule 2 to include the Responsible Person Ferring Pharmaceutical Pty Ltd within the Special Arrangement. The amendment is made in accordance with advice from the Pharmaceutical Benefits Advisory Committee, an independent body that recommends drugs and medicinal preparations for inclusion as pharmaceutical benefits, considering factors such as clinical effectiveness and cost-effectiveness. The changes reflect updates in the main listing instrument, effective from 1 October 2012.
Key Provisions
The key provisions of the National Health (IVF/GIFT Program) Special Arrangement Amendment Instrument 2012 (No.2) focus on making changes to the special arrangement for the IVF/GIFT Program, specifically concerning the supply of pharmaceutical benefits. Section 3 of the instrument amends Schedule 1 of the Special Arrangement to add two new pharmaceutical benefits: 'Human Menopausal Gonadotrophin' under the brands 'Menopur 600' and 'Menopur 1200'. The forms for these benefits include 'Powder for injection 600IU with solvent' and 'Powder for injection 1200IU with solvent'. This amendment ensures that patients requiring in vitro fertilisation or gamete intra-fallopian transfer treatment have access to these necessary pharmaceutical benefits. Section 7 of the Special Arrangement is also amended to reflect changes in the coding system, replacing the letter 'D' with the code 'D(100)' for listed drugs available only under section 100 special arrangements, and the letters 'PB' with the code 'PB(100)' for pharmaceutical benefits available only under section 100 special arrangements.
The obligations and requirements imposed by this Act on the parties involved are primarily centred around ensuring the availability and correct coding of pharmaceutical benefits for IVF/GIFT treatments. The Special Arrangement, as amended, mandates that the specified drugs and their forms be included in the supply of benefits for eligible patients. Additionally, the Act requires that the Responsible Person, in this case, Ferring Pharmaceutical Pty Ltd, be added to the Special Arrangement, ensuring that the company is officially recognised as a supplier of these benefits. This amendment ensures that the pharmaceutical benefits are supplied under the correct regulatory framework, facilitating efficient and convenient access for patients.
Any breach of the provisions in this Act could result in civil or criminal consequences. While the explanatory statement does not explicitly detail the penalties for non-compliance, breaches of similar legislative instruments under the National Health Act 1953 could potentially lead to fines, imprisonment, or both. The exact penalties would be determined based on the specific nature and severity of the breach, as well as relevant case law and statutory provisions. It is important for all parties to adhere to the requirements to avoid any potential legal ramifications.