EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (IVF/GIFT Program) Special Arrangement Amendment Instrument 2013 (No.1)
PB 44 of 2013
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.
This Instrument inserts a new Schedule 3 into the Special Arrangement with additional treatment conditions, if any; patients are required to satisfy to be able to be supplied a pharmaceutical benefit under the Special Arrangement. Additional treatment conditions associated with eligibility for supply of brands of Corifollitropin Alfa have been included in new Schedule 3.
This Instrument also makes changes to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (main listing instrument), which commence on the same day. This instrument amends Schedule 1 of the Special Arrangement to change the brand name for two listed brands of Progesterone from Orion Laboratories Pty Ltd to Oripro.
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 August 2013.
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/GIFT PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2013 (No. 1)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (IVF/GIFT Program) Special Arrangement Amendment Instrument 2013 (No. 1) and that it may also be cited as PB 44 of 2013.
Section 2 Commencement
This section provides that this Instrument commences on 1 August 2013.
Section 3 Amendments to PB 93 of 2011
This section provides that Schedule 1 amends the National Health (IVF/GIFT Program) Special Arrangement 2011 (PB 93 of 2011) (the Special Arrangement).
Schedule 1
Item 1 amends the definition of ‘eligible patient’ in section 4 of the Special Arrangement to provide that to be an eligible patient a person has to satisfy the treatment conditions, if any, for the pharmaceutical benefit as specified in new Schedule 3 to the Special Arrangement. This is in addition to having to be an eligible person under the Health Insurance Act 1973 and be receiving treatment under Medicare items 13200, 13201, 13202 or 13203.
Item 2 amends the entry for Progesterone in the form Pessary 100 mg in the Special Arrangement to change the name of the listed brand with that form from Orion Laboratories Pty Ltd to Oripro.
Item 3 amends the entry for Progesterone in the form Pessary 200 mg in the Special Arrangement to change the name of the listed brand with that form from Orion Laboratories Pty Ltd to Oripro.
Item 4 inserts Schedule 3 which sets out treatment conditions.