EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 2)
PB 69 of 2016
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 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 (PB 71 of 2012) (Main Listing Instrument), which commence on the same day.
This Instrument adds a new brand (‘Bemfola’) to the listed drug ‘Follitropin 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 and 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 these 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 Pharmaceutical Benefits Scheme (PBS) and for this Special Arrangement. This includes consultation through the PBAC process, and agreement to final listing details.
This Instrument commences on 1 August 2016.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (IVF PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 2)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 2) and that it may also be cited as PB 69 of 2016.
Section 2 Commencement
This section provides that this Instrument commences on 1 August 2016.
Section 3 Amendment of PB 60 of 2015
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 new pharmaceutical benefits which are the listed drug ‘Follitropin Alfa’ in each of the forms:
Injection 75 I.U. in 0.125 mL pre-filled pen;
Injection 150 I.U. in 0.25 mL pre-filled pen;
Injection 225 I.U. in 0.375 mL pre-filled pen;
Injection 300 I.U. in 0.5 mL pre-filled pen; and
Injection 450 I.U. in 0.75 mL pre-filled pen;
with the manner of administration ‘Injection’ and brand ‘Bemfola’.
Overview
The National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 2) was enacted to amend the National Health (IVF Program) Special Arrangement 2015, which was established under the National Health Act 1953. This special arrangement was created to ensure an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation (IVF) treatment, a service where restrictions limit the conventional supply of these benefits. The amendment was necessary to reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which came into effect on the same day. This legislative instrument was made under the authority granted by subsections 100(1) and (2) of the National Health Act 1953, which allow the Minister to make special arrangements for the supply of pharmaceutical benefits and to vary or revoke those arrangements. The policy objective underpinning this amendment is to maintain and improve the accessibility of pharmaceutical benefits for IVF patients by updating the list of available treatments.
The amendments were developed with input from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body established under section 100A of the National Health Act 1953, which advises the Minister on the availability of pharmaceutical benefits. The PBAC considers factors such as clinical effectiveness, safety, cost-effectiveness, and the medical conditions for which a medicine is approved. The PBAC comprises members from various relevant fields, including consumers, health economists, and medical professionals, ensuring a comprehensive evaluation process. Pharmaceutical companies were also consulted throughout the process to reach agreement on the final listing details. This amendment specifically adds the new brand 'Bemfola' to the listed drug 'Follitropin Alfa', reflecting changes to the Pharmaceutical Benefits Scheme (PBS). The instrument commenced on 1 August 2016, aligning with the start date of the corresponding changes in the Main Listing Instrument.
Scope and Application
The National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 2) amends the National Health (IVF Program) Special Arrangement 2015 to adjust the special arrangement for the supply of pharmaceutical benefits related to in vitro fertilisation (IVF) treatments. This instrument applies to pharmaceutical benefits, specifically those recommended by the Pharmaceutical Benefits Advisory Committee (PBAC), and it is intended to ensure an adequate supply of necessary drugs for IVF treatments. The amendment adds the new brand 'Bemfola' to the listed drug 'Follitropin Alfa', thereby expanding the range of pharmaceutical benefits available under the special arrangement. The instrument operates within the Commonwealth jurisdiction, as it is made under the authority of the National Health Act 1953, and it extends to all entities and individuals participating in the Pharmaceutical Benefits Scheme (PBS). The changes specified in the instrument are designed to align with modifications made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, effective from the same date. The instrument includes no explicit exclusions or exemptions, but its application is subject to the overarching provisions and recommendations of the PBAC.
Key Provisions
The National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 2) (F2016L01247) amends the National Health (IVF Program) Special Arrangement 2015 (PB 60 of 2015). It adds new pharmaceutical benefits for patients requiring in vitro fertilisation (IVF) treatment. Specifically, it introduces the drug ‘Follitropin Alfa’ in various dosages and pre-filled pen forms under the brand ‘Bemfola’ (section 3). This amendment ensures that an adequate supply of pharmaceutical benefits is available for patients undergoing IVF treatment, aligning with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (Main Listing Instrument). The purpose of this legislative instrument is to facilitate the efficient supply of these pharmaceutical benefits under a special arrangement (subsection 100(1) of the Act).
This Act imposes certain obligations on parties involved in the supply of pharmaceutical benefits for IVF treatment. It mandates that the Pharmaceutical Benefits Advisory Committee (PBAC) provide advice and recommendations to the Minister for Health about which drugs and medicinal preparations should be available as pharmaceutical benefits. The PBAC, an independent expert body, considers the medical conditions for which the medicine has been approved for use in Australia and its clinical effectiveness, safety, and cost-effectiveness compared with other treatments. Pharmaceutical companies are also required to consult with the PBAC and agree to final listing details. The Act further mandates that the Minister for Health may make special arrangements for the supply of pharmaceutical benefits under subsection 100(1) and may vary or revoke such arrangements under subsection 100(2). These provisions are designed to ensure that pharmaceutical benefits are available to patients in a controlled and efficient manner.
Failure to comply with the provisions of this Act can lead to various legal consequences. Offences under this Act may result in both civil and criminal penalties. For instance, providing misleading or deceptive information to the PBAC or the Minister for Health could result in fines or imprisonment, depending on the severity of the offence. Similarly, pharmaceutical companies that fail to comply with the special arrangement or listing requirements may face penalties, including financial penalties or revocation of their listings on the Pharmaceutical Benefits Scheme (PBS). The exact penalties are not specified in the explanatory statement, but they are likely to be aligned with other relevant legislation governing the pharmaceutical industry and health services in Australia.
The legislative instrument is governed by the provisions of the Legislation Act 2003, which sets out the legal framework for the creation, operation, and enforcement of legislative instruments in Australia. This means that the Instrument is subject to the general principles of statutory interpretation and administrative law, ensuring that it is applied fairly and consistently. The commencement date of the Instrument is 1 August 2016, which means that all provisions come into effect on that date, replacing the previous arrangement and aligning with the changes to the Main Listing Instrument. This date is crucial for stakeholders, including pharmaceutical companies, healthcare providers, and patients, to ensure they are aware of and comply with the new requirements.