EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
ARRANGEMENTS UNDER SECTION 100
IVF/GIFT PROGRAM
NO. PB 22 OF 2006
Authority for the Arrangements
1. The Pharmaceutical Benefits Scheme (PBS) provides timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.
2. The PBS is regulated by Part VII of the National Health Act 1953 (the Act) which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits.
3. Subsection 84(1) of the Act defines ‘pharmaceutical benefit’ as a drug or medicinal preparation in relation to which, by virtue of section 85 of the Act, Part VII of the Act applies.
4. Subsection 85(2) of the Act empowers the Minister to declare those drugs and medicinal preparations to which Part VII of the Act applies and the restrictions, if any, that apply to the prescribing of such drugs and medicinal preparations as pharmaceutical benefits. Schedule 6 of the declaration under subsection 85(2) of the Act lists those drugs and medicinal preparations that may be made available under arrangements provided for by section 100 of the Act.
5. Subsection 100(1) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons:
(a) who are living in isolated areas; or
(b) who are receiving medical treatment in such circumstances that pharmaceutical benefits:
(i) cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or
(ii) are inadequate for that medical treatment.
6. Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
7. Subsection 100(3) of the Act provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).
Purpose of the Arrangements
8. These Arrangements for the IVF/GIFT Program relate specifically to the supply of special pharmaceutical products required by patients who are receiving in vitro fertilisation or gamete intra-fallopian transfer treatment.
9. The purpose of the Arrangements is to ensure that an adequate supply of the special pharmaceutical products listed in the Schedule of these Arrangements are available for patients who require in vitro fertilisation or gamete intra‑fallopian transfer treatment, in circumstances where the special pharmaceutical products cannot otherwise be conveniently or efficiently supplied in accordance with Part VII of the Act.
Special circumstances
10. The restrictions on the provision of in vitro fertilisation or gamete intra-fallopian transfer treatment means that an adequate supply of the special pharmaceutical products listed in the Schedule of these Arrangements cannot be conveniently or efficiently supplied otherwise in accordance with Part VII of the Act.
11. In Australia, patients undergoing in vitro fertilisation or gamete intra‑fallopian transfer treatment must be admitted as in-patients at clinics accredited as Assisted Reproductive Technology (ART) centres.
12. In accordance with these Arrangements, the special pharmaceutical products used in in vitro fertilisation or gamete intra‑fallopian transfer treatment are supplied to an ART centre 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 two item numbers from the Health Insurance (General Medical Services) Table Regulations 2005 that correspond to the procedures known as in vitro fertilisation or gamete intra-fallopian transfer treatment. Reimbursement for supply of the special pharmaceutical products in the Schedule is only available to ART centres under these Arrangements on the basis of payment of a medicare benefit for one of the two item numbers from the Health Insurance (General Medical Services) Table Regulations 2005.
13. These Arrangements do not extend to permit the supply of the special pharmacy products in the Schedule to these Arrangements for in vitro fertilisation or gamete intra‑fallopian transfer treatment in conjunction with surrogacy arrangements.
14. The arrangements for the IVF/GIFT Program made on 23 November 2005, with effect from 1 December 2005 are repealed and replaced with these Arrangements.
15. These Arrangements were re-made on 24 March 2006, with effect from 1 April 2006, to delete the following forms and strengths from the list of special pharmaceutical products available for IVF and GIFT procedures:
- Follitropin Beta solution for injection 100 I.U. in 0.5 mL single use vial;
- Follitropin Beta solution for injection 150 I.U. in 0.5 mL single use vial; and
- Follitropin Beta solution for injection 200 I.U. in 0.5 mL single use vial.
These forms and strengths have been discontinued by the manufacturer.
Consultations
16. These arrangements have been 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. 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.
17. 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 functons of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.
18. These Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.
19. Details of these Arrangements are set out in the Attachment.
ATTACHMENT
Paragraph 1(a) provides that these Arrangements commence on 1 April 2006.
Paragraph 1(b) provides that the Arrangements made on 23 November 2005 with effect from 1 December 2005 are repealed on commencement of these Arrangements.
Paragraph 2 provides that the special pharmaceutical products listed in the Schedule to these Arrangements will be provided free of charge to eligible persons under the Health Insurance Act 1973.
Paragraph 3 describes the only two treatments (that is, in vitro fertilisation or gamete intra-fallopian transfer treatment) for which supply of the special pharmaceutical products listed in the Schedule to these Arrangements will be allowed under these Arrangements.
Paragraph 4 sets out the evidence required to determine eligibility for supply of the special pharmaceutical products under these Arrangements, that is, payment of a edicare benefit for one of the item numbers from the Health Insurance (General Medical Services) Table Regulations 2005 for in vitro fertilisation or gamete intra-fallopian transfer treatment (either item 13200 or item 13203).
Paragraph 5 provides that the supply of the special pharmaceutical products in the Schedule is prohibited under these Arrangements for in vitro fertilisation or gamete intra-fallopian transfer treatment in conjunction with surrogacy arrangements.
Paragraph 6 provides that under these Arrangements a medical provider must supply the patient’s medicare number to Medicare Australia, as a condition of supply of the special pharmaceutical products in the Schedule.
The Schedule to these Arrangements has two parts:
(i) Part 1 – special pharmaceutical products for patients receiving treatment as described in item 13200 or 13203 of the Health Insurance (General Medical Services Table) Regulations 2005;
(ii) Part 2 - special pharmaceutical products for luteal phase support in certain patients receiving treatment as described in item 13200 of the Health Insurance (General Medical Services) Table Regulations, where the luteal phase is defined as the time span from embryo transfer until implantation confirmed by positive beta human chorionic gonadotrophin measurement.