EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (IVF Program) Special Arrangement Amendment Instrument 2015 (No. 1)
PB 86 of 2015
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 Program) Special Arrangement 2015 (PB 60 of 2015) (the Special Arrangement) to make changes to the special arrangement relating to the IVF 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 treatment. Restrictions on the provision of this treatment mean that these pharmaceutical benefits can more conveniently or efficiently be supplied under a special arrangement.
This Instrument reflects changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (main listing instrument), which also commences on the same day.
This Instrument adds two new pharmaceutical benefits ‘Follitropin Alfa with Lutropin Alfa’ and ‘Lutropin Alfa’.
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 September 2015.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (IVF PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2015 (No. 1)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (IVF Program) Special Arrangement Amendment Instrument 2015 (No. 1) and that it may also be cited as PB 86 of 2015.
Section 2 Commencement
This section provides that this Instrument commences on 1 September 2015.
Section 3 Amendments to PB 60 of 20115
This section provides that Schedule 1 amends the National Health (IVF Program) Special Arrangement 2015 (PB 60 of 2015) (the Special Arrangement).
Schedule 1
Item 1 amends Schedule 1 of the Special Arrangement by adding the pharmaceutical benefit for ‘Follitropin Alfa with Lutropin Alfa ’ in the form ‘Powder for injection 150 I.U. and 75 I.U. with solvent’ with the manner of administration ‘Injection’ and brand ‘Pergoveris’.
Item 2 amends Schedule 1 of the Special Arrangement by adding the pharmaceutical benefit for ‘Lutropin Alfa’ in the form ‘Powder for injection 75 I.U. with solvent’ with the manner of administration ‘Injection’ and brand ‘Luveris’.
Overview
The National Health (IVF Program) Special Arrangement Amendment Instrument 2015 (No. 1) was enacted to address the need for a special arrangement to ensure an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation treatment. The instrument amends the National Health (IVF Program) Special Arrangement 2015, incorporating changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This was done under the authority provided by subsection 100(1) of the National Health Act 1953, which allows the Minister to make special arrangements for the supply of pharmaceutical benefits. The policy objective behind this legislative instrument is to ensure that patients needing IVF treatment have access to the necessary pharmaceutical benefits, with the amendments reflecting the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). This PBAC, established under section 100A of the Act, advises the Minister on which drugs and medicinal preparations should be available as pharmaceutical benefits, taking into account various factors including clinical effectiveness, safety, and cost-effectiveness.
Scope and Application
The National Health (IVF Program) Special Arrangement Amendment Instrument 2015 (No. 1) amends the National Health (IVF Program) Special Arrangement 2015 to enhance the supply of pharmaceutical benefits for patients requiring in vitro fertilisation treatment. This legislative instrument applies to the supply of specific pharmaceutical benefits under the National Health Act 1953, particularly those related to IVF treatments. It extends to the Commonwealth level, governing the national framework for the supply of pharmaceutical benefits and ensuring that these are made available through special arrangements that accommodate restrictions on the provision of this treatment. The Instrument specifically adds two new pharmaceutical benefits, 'Follitropin Alfa with Lutropin Alfa' and 'Lutropin Alfa', to the IVF Program, reflecting changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments were made following recommendations from the Pharmaceutical Benefits Advisory Committee, which consulted extensively with pharmaceutical companies and other stakeholders to ensure the recommendations were based on clinical effectiveness, safety, and cost-effectiveness. The Instrument commenced on 1 September 2015 and is subject to the provisions of the Legislative Instruments Act 2003.
Key Provisions
The main operative sections of the National Health (IVF Program) Special Arrangement Amendment Instrument 2015 (No. 1) (PB 86 of 2015) concern the addition of two new pharmaceutical benefits related to in vitro fertilisation (IVF) treatment. Section 3 of the Instrument amends the National Health (IVF Program) Special Arrangement 2015 (PB 60 of 2015) to include 'Follitropin Alfa with Lutropin Alfa' in the form 'Powder for injection 150 I.U. and 75 I.U. with solvent' and 'Lutropin Alfa' in the form 'Powder for injection 75 I.U. with solvent', both administered by injection. These additions are made to ensure an adequate supply of pharmaceutical benefits for patients requiring IVF treatment. The Instrument reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (main listing instrument), which also commenced on 1 September 2015.
The obligations and requirements imposed by this Act on the parties or entities it governs include ensuring that the pharmaceutical benefits specified are available and supplied in a manner that meets the needs of patients undergoing IVF treatment. This involves the pharmaceutical companies providing the necessary drugs and ensuring they are listed and available under the special arrangement. The Minister for Health, guided by recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), oversees the implementation and compliance with these arrangements. The PBAC, an independent expert body, advises the Minister on which drugs should be available as pharmaceutical benefits, taking into account medical conditions, clinical effectiveness, safety, and cost-effectiveness. Pharmaceutical companies must consult with the PBAC and agree to final listing details to ensure that the pharmaceutical benefits are appropriately included and supplied.
The Instrument outlines specific consequences for breaches of its provisions. While the Act itself does not explicitly state the penalties for non-compliance, the general legislative framework under which this Instrument operates implies that failure to comply with the special arrangement could lead to various civil or criminal consequences. These might include fines, corrective actions, or even revocation of the special arrangement if the Minister deems it necessary. However, the exact penalties would depend on the specific nature and severity of the breach, as well as any additional regulations or guidelines that may apply.
In summary, the National Health (IVF Program) Special Arrangement Amendment Instrument 2015 (No. 1) introduces new pharmaceutical benefits for IVF treatment, mandates their inclusion under a special arrangement, and requires compliance by pharmaceutical companies and oversight by the Minister for Health. While specific penalties for non-compliance are not detailed in the Instrument, breaches could lead to significant consequences under the broader legislative framework.