National Health Act 1953 - Arrangements made under subparagraph 100(1)(b)(i) - IVF/GIFT Program (No. PB 41 of 2007)

Administered by Department of Health, Disability and Ageing

Legislation au F2007L01249 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

ARRANGEMENTS UNDER SECTION 100

IVF/GIFT PROGRAM

No. PB 41 of 2007

 

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 2006 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 2006.

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 12 March 2007 with effect from 1 April 2007 (No. PB 26 of 2007), are amended by these arrangements.                                  

15.           These Arrangements give effect, as from 1 June 2007, to the addition of Progesterone pessary 100 mg (Orion Laboratories Pty Ltd) and pessary 200 mg (Orion Laboratories Pty Ltd) to Part 2 of the Schedule.

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.

20. These Arrangements were made on 26 April 2007 and commenced on 1 June 2007.

 

 

ATTACHMENT

Paragraph 1 provides that these Arrangements commence on 1 June 2007.

Paragraph 2 provides that the Arrangements made on 12 March 2007 with effect from 1 April 2007 (No. PB 26 of 2007) are, in these Arrangements, referred to as the Principal Arrangements.

Paragraph 3 provides for the amendment of Part 2 of The Schedule to the Principal Arrangements.

 

The Schedule to the Principal 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 2006;

(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 2006, where the luteal phase is defined as the time span from embryo transfer until implantation confirmed by positive beta human chorionic gonadotrophin measurement.

Overview

The National Health Act 1953, enacted by the Australian Parliament, serves as the legislative foundation for the regulation and administration of health services and pharmaceutical benefits in Australia. This Act was introduced to address the need for a structured and efficient system to provide healthcare and pharmaceuticals to the Australian population. One of the key provisions of this Act is the establishment of the Pharmaceutical Benefits Scheme (PBS), which ensures affordable and timely access to necessary medications. The Act empowers the Minister to declare drugs and medicinal preparations as pharmaceutical benefits, with special arrangements available under section 100 for specific circumstances such as isolated areas or inadequate treatment options. The explanatory statement for the IVF/GIFT Program Arrangements, issued under section 100 of the Act, highlights the special requirements for patients undergoing in vitro fertilisation or gamete intra-fallopian transfer treatments, ensuring these patients have access to necessary pharmaceutical products that might not be conveniently supplied under the general provisions of the PBS. These arrangements, which were updated on 26 April 2007 and took effect from 1 June 2007, reflect the policy objective of addressing specific medical needs through targeted pharmaceutical supply mechanisms.

Scope and Application

The IVF/GIFT Program Arrangements under Section 100 of the National Health Act 1953 are specifically designed to ensure an adequate supply of special pharmaceutical products for patients undergoing in vitro fertilisation (IVF) or gamete intra-fallopian transfer (GIFT) treatment. These arrangements apply to patients who are receiving such treatments at clinics accredited as Assisted Reproductive Technology (ART) centres, where the special pharmaceutical products are supplied based on evidence of treatment provided to in-patients. The arrangements, effective from 1 June 2007, facilitate reimbursement for these products to ART centres on the basis of payment of a Medicare benefit for certain item numbers corresponding to IVF or GIFT procedures. This legislation extends to the inclusion of Progesterone pessary 100 mg and 200 mg (Orion Laboratories Pty Ltd) for luteal phase support in patients undergoing IVF treatment, as specified in Part 2 of the Schedule. The arrangements are subject to the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), which advises on the availability of drugs and medicinal preparations as pharmaceutical benefits, considering factors such as clinical effectiveness, safety, and cost-effectiveness. These arrangements do not extend to cover pharmaceutical products used in conjunction with surrogacy arrangements.

Key Provisions

The primary sections of the legislation under consideration are subsections 100(1) and 100(2) of the National Health Act 1953. Subsection 100(1) allows the Minister to establish special arrangements for the supply of pharmaceutical products to people in isolated areas or those receiving medical treatment where conventional pharmaceutical benefits are inadequate or cannot be efficiently provided under Part VII of the Act (section 84). Subsection 100(2) further provides the Minister with the authority to modify or revoke any such special arrangements (subsection 100(2)). These provisions are crucial for ensuring that special pharmaceutical products are made available under specific circumstances where the standard provisions of the Act do not suffice. The Act imposes several obligations and requirements on the parties involved. Firstly, the Minister is responsible for making the special arrangements under subsection 100(1), ensuring that these arrangements are in line with the legislative intent to provide adequate pharmaceutical products under specified circumstances. These special arrangements must be made with due regard to the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body established under section 100A of the Act. The PBAC plays a critical role in advising the Minister on which drugs and medicinal preparations should be included as pharmaceutical benefits, taking into account factors such as clinical effectiveness, safety, and cost-effectiveness. Additionally, reimbursement for the supply of special pharmaceutical products is contingent upon the provision of treatment to in-patients for in vitro fertilisation or gamete intra-fallopian transfer treatment, as evidenced by specific item numbers from the Health Insurance (General Medical Services Table) Regulations 2006. The legislation also delineates the potential consequences for non-compliance with the special arrangements. While the Act does not explicitly state the penalties for breach, it is understood that any deviation from the prescribed arrangements could result in the ineligibility for reimbursement of pharmaceutical benefits under Medicare. This effectively places a substantial burden on the entities involved, as failure to comply with the stipulated conditions could lead to financial penalties and legal repercussions. The absence of explicit penalties in the text might imply reliance on broader administrative and legal frameworks to address breaches, ensuring that the integrity of the special arrangements and the availability of necessary pharmaceutical products are upheld. In conclusion, the special arrangements for the IVF/GIFT Program under the National Health Act 1953 are designed to ensure that patients receiving in vitro fertilisation or gamete intra-fallopian transfer treatment have access to necessary pharmaceutical products when standard provisions are insufficient. The Minister's role in establishing and managing these arrangements, alongside the advisory function of the PBAC, underscores the importance of tailored provisions to meet specific medical needs. Compliance with these arrangements is critical, as non-compliance could result in the denial of reimbursement and other potential legal consequences.

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