EXPLANATORY STATEMENT
Issued by the Minister for Health and Ageing
NATIONAL HEALTH ACT 1953
AMENDMENT TO ARRANGEMENTS MADE UNDER SUBPARAGRAPH 100(1)(b)(i) – IVF/GIFT PROGRAM
INSTRUMENT NUMBER PB 78 of 2010
Authority for the Arrangements
This legislative instrument is made pursuant to subsection 100(2) of the National Health Act 1953 (“the Act”) and varies the legislative instrument titled Arrangements made under subparagraph 100(1)(b)(i) – IVF/GIFT Program (as amended) (“PB 26 of 2007”).
Part VII of the Act is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits. Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) are declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs.
Subsection 100(1) of the Act empowers the Minister, in some circumstances, to make special arrangements for the supply of special pharmaceutical products as an alternative to the supply of pharmaceutical benefits under Part VII. The Minister can make special arrangements under subsection 100(1) to ensure that an adequate supply of special pharmaceutical products will be available to persons who are:
living in isolated areas (paragraph 100(1)(a)); or
receiving medical treatment in such circumstances that pharmaceutical benefits cannot be conveniently or efficiently supplied in accordance with Part VII (subparagraph 100(1)(b)(i); or
inadequate for that medical treatment (subparagraph 100(1)(b)(ii).
PB 26 of 2007 is made under subparagraph 100(1)(b)(i) of the Act and provides for the supply of certain special pharmaceutical products to be made available to persons who are receiving medical treatment in such circumstances that pharmaceutical benefits cannot be conveniently or efficiently supplied in accordance with Part VII of the Act.
A special pharmaceutical product is defined under subsection 100AA(1) as a drug or medicinal preparation:
that has been declared to be a drug or medicinal preparation under subsection 100AA(2); or
that is composed of one or more drugs or medicinal preparations declared as such under subsection 100AA(2) and one or more additives declared declared as such subsection 100AA(2); or
that has been declared under subsection 85(2) as a drug or medicinal preparation to which Part VII applies.
The drugs that are the subject of PB 26 of 2007 are special pharmaceutical products by virtue of having been declared under subsection 85(2) to be drugs or medicinal preparations to which Part VII applies. These drugs are listed in the Schedule to PB 26 of 2007.
Subsection 100(3) provides that Part VII has effect subject to a special arrangement under subsection 100(1). This means that a special arrangement made under subsection 100(1) can modify the operation of Part VII in relation to the relevant special pharmaceutical products which are the subject of the arrangement.
Subsection 100(2) empowers the Minister to vary or revoke a special arrangement made under subsection 100(1).
Purpose of the Arrangements
PB 26 of 2007 provides for special arrangements for the IVF/GIFT Program. These special arrangements relate specifically to the supply of special pharmaceutical products required by patients who are receiving in vitro fertilisation or gamete intra-fallopian transfer treatment. Patients who are eligible to be provided with special pharmaceutical products under PB 26 of 2007 will be provided with the relevant special pharmaceutical products free of charge.
The purpose of these special arrangements is to ensure that an adequate supply of the special pharmaceutical products listed in the Schedule to PB 26 of 2007 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 drugs cannot conveniently or efficiently be supplied as pharmaceutical benefits under Part VII.
Special circumstances
In Australia, patients undergoing in vitro fertilisation or gamete intra-fallopian transfer treatment must be admitted as in-patients at IVF/GIFT clinics accredited as Assisted Reproductive Technology centres.
In accordance with PB 26 of 2007 (as amended by this instrument), the special pharmaceutical products used in vitro fertilisation or gamete intra-fallopian transfer treatment are supplied to an accredited IVF/GIFT clinic on the basis of evidence of treatment provided to in-patients for in vitro fertilisation or gamete intra-fallopian transfer treatment. Such treatment is evidenced by one of the four item numbers of the Health Insurance (General Medical Services Table) Regulations 2009 (“GMST”) that correspond to the procedures known as in vitro fertilisation or gamete intra-fallopian transfer treatment.
Reimbursement for supply of the special pharmaceutical products listed in the Schedule to PB 26 of 2007 is only available to an accredited IVF/GIFT clinic under these Arrangements on the basis of payment of a Medicare benefit for one of the four item numbers of the GMST.
The Arrangements do not extend to the supply of the special pharmaceutical products for in vitro fertilisation or gamete intra-fallopian transfer treatment in conjunction with surrogacy arrangements.
Variation
This legislative instrument varies PB 26 of 2007 as follows:
to allow patients receiving treatment as described in items 13201 and 13202 of the GMST to be provided with the special pharmaceutical products listed in Part 1 of the Schedule to PB 26 of 2007 free of charge;
to allow patients receiving treatment as described in item 13201 of the GMST to be provided with the special pharmaceutical products listed in Part 2 of the Schedule to PB 26 of 2007 free of charge;
to allow the addition of the drug Ganirelix to Part 1 of the Schedule.
This legislative instrument commences on 1 August 2010.
Consultations
PB 26 of 2007 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 and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits or as special pharmaceutical products. 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.
The Publishing Industry Liaison and Listing Section of the Pharmaceutical Evaluation Branch provided advice that the above variations would be required to reflect the discontinuation of items by the manufacturer.
ATTACHMENT
SPECIAL ARRANGEMENTS (VARIATION) MADE UNDER
SUBSECTION 100(2)
1. Commencement
Clause 1 provides that these Special Arrangements (Variation) commence on
1 August 2010.
2. Variation of PB 26 of 2007
Clause 2 provides that Schedule 1 to this instrument varies PB 26 of 2007.
Schedule 1:
Schedule 1 sets out the variations to the Arrangements made under s100(1)(b)(i) of the National Health Act (IVF/GIFT Program) in the instrument known as PB 26 of 2007.
Item [1]:
Item [1] removes the reference to item 13200 or 13203 of the Health Insurance (General Medical Services Table) Regulations 2009 in subparagraph 3(a), and inserts in its place item 13200, 13201, 13202 and 13203 of the Health Insurance (General Medical Services Table) Regulations 2009.
Item [2]:
Item [2] removes the reference to item 13200 of the Health Insurance (General Medical Services Table) Regulations 2009 in subparagraph 3(b), and inserts in its place item 13200 or 13201 of the Health Insurance (General Medical Services Table) Regulations 2009.
Item [3]:
Item [3] removes all references to item 13200 or 13203, as the case requires, of the Health Insurance (General Medical Services Table) Regulations 2009 in paragraph 4 of the Arrangements, and inserts in its place item 13200, 13201, 13202 or 13203, as the case requires, of the Health Insurance (General Medical Services Table) Regulations 2009.
Item [4]:
Item [4] removes all references to item 13200 or 13203 in these circumstances, in paragraph 5 of the Arrangements, and inserts in its place item 13200, 13201, 13202 or 13203 in these circumstances.
Item [5]:
Item [5] inserts into the Schedule the drug Ganirelix: Injection 250 micrograms (as acetate) in 0.5 mL pre-filled syringe.