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’.