EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (IVF Program) Special Arrangement Amendment Instrument 2016
(No. 5)
PB 115 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 subsection 100(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 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), which commence on the same day.
This Instrument removes a form of the listed drug ‘Choriogonadotropin Alfa’, as requested by the supplier.
A provision by provision description of this instrument is contained in the Attachment.
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 are consulted throughout the process for additions and changes to listings on the Pharmaceutical Benefits Scheme (PBS), including consultation through the PBAC process and agreement to final listing details.
This Instrument commences on 1 January 2017.
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. 5)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 5), and that it may also be cited as PB 115 of 2016.
Section 2 Commencement
This section provides that this Instrument commences on 1 January 2017.
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 Amendments
Item 1 amends Schedule 1 of the Special Arrangement by removing a form of the listed drug ‘Choriogonadotropin Alfa’, being the form ‘Solution for injection 250 micrograms in 0.5 mL pre-filled syringe’, with the manner of administration of ‘Injection’, brand of ‘Ovidrel’ and Section 100 only code of ‘D(100)’.
Overview
The National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 5) was enacted to make amendments to the National Health (IVF Program) Special Arrangement 2015, under the authority granted by the National Health Act 1953. This legislative instrument was introduced to address the need for adjustments in the supply of pharmaceutical benefits for patients undergoing in vitro fertilisation (IVF) treatment, ensuring that these benefits are supplied in a manner that is both convenient and efficient. The Australian Parliament authorised the Minister for Health to implement these special arrangements, with a clear policy objective to maintain an adequate supply of necessary pharmaceutical benefits for IVF patients. This legislative instrument reflects changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and removes a specific form of the drug 'Choriogonadotropin Alfa' from the IVF Program, as requested by the drug supplier. The changes were made after consultation with the Pharmaceutical Benefits Advisory Committee, an expert body that provides recommendations to the Minister regarding which drugs should be available as pharmaceutical benefits, taking into account their clinical effectiveness, safety, and cost-effectiveness.
Scope and Application
The National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 5) amends the National Health (IVF Program) Special Arrangement 2015 to ensure an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation treatment. The Act applies to drugs and medicinal preparations recommended by the Pharmaceutical Benefits Advisory Committee, which advises the Minister for Health on which drugs should be available as pharmaceutical benefits, taking into account their clinical effectiveness, safety, cost-effectiveness, and the medical conditions for which they are approved. The special arrangement is intended to facilitate the more convenient or efficient supply of these pharmaceutical benefits under specific conditions. The changes made by this legislative instrument, which commenced on 1 January 2017, remove a particular form of the drug 'Choriogonadotropin Alfa' from the IVF Program, as requested by the supplier. This amendment reflects changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and is subject to the provisions of Part VII of the National Health Act 1953, which governs the supply of pharmaceutical benefits.
Key Provisions
The primary operative sections of the National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 5) (referred to as the Instrument) are detailed in Sections 1 and 3. Section 1 states that this Instrument is the National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 5), and it may also be cited as PB 115 of 2016. Section 3 details the amendments to the National Health (IVF Program) Special Arrangement 2015 (PB 60 of 2015), the Special Arrangement, by removing a specific form of the listed drug 'Choriogonadotropin Alfa'. This form is described as 'Solution for injection 250 micrograms in 0.5 mL pre-filled syringe', administered by injection, branded as 'Ovidrel', and coded under Section 100 as 'D(100)'. This change is detailed in Schedule 1 of the Instrument.
The Act imposes several obligations and requirements on the parties and entities it governs. Under Section 100 of the National Health Act 1953, the Minister has the authority to make special arrangements for the supply of pharmaceutical benefits. This authority includes the ability to vary or revoke these special arrangements as necessary. The Instrument amends the Special Arrangement to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). The Pharmaceutical Benefits Advisory Committee (PBAC) provides advice to the Minister, ensuring that recommendations for pharmaceutical benefits consider clinical effectiveness, safety, and cost-effectiveness. Pharmaceutical companies are also consulted throughout the process to ensure alignment with final listing details on the Pharmaceutical Benefits Scheme (PBS).
In terms of offences, penalties, or consequences for breach, the Instrument itself does not specify particular sanctions for non-compliance with its provisions. However, under the National Health Act 1953, breaches of the Act's provisions can lead to civil or criminal penalties, depending on the nature and severity of the breach. The Act allows for the imposition of fines and, in more serious cases, imprisonment. The specific penalties are determined by the courts based on the relevant provisions of the Act and the circumstances of the offence. The National Health Act 1953 provides the framework within which these penalties are applied, and the Instrument operates under this legislative umbrella.