National Health Act 1953 - Amendment special arrangements under subparagraph 100(1)(b)(i) - IVF/GIFT Program (No. PB 76 of 2007)

Administered by Department of Health, Disability and Ageing

Legislation au F2007L03773 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBPARAGRAPH 100(1)(b)(i)

IVF/GIFT PROGRAM

No. PB 76 of 2007

 

Authority for the Arrangements

Part VII of the National Health Act 1953 (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) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs. 

The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)).  These determinations govern (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.

Subsection 100(1) of the Act empowers the Minister to make special arrangements for the supply of special pharmaceutical products as an alternative to the supply of pharmaceutical benefits under Part VII.  This can be done for providing that an adequate supply of special pharmaceutical products will be available to persons who are living in isolated areas; or who are receiving medical treatment in such circumstances that pharmaceutical benefits cannot be conveniently or efficiently supplied in accordance with Part VII, or are inadequate for that medical treatment. A special pharmaceutical product under subsection 100AA(1) is a drug or medicinal preparation declared under subsection 100AA(1), or one composed of one or more of these and a declared additive; or a drug or medicinal preparation which has been declared under subsection 85(2) as a drug or medicinal preparation to which Part VII applies.

Subsection 100(3) provides that Part VII has effect subject to a special arrangement under section 100. This means, for example, that it does not matter if a special arrangement for the supply of a drug declared under subsection 85(2) is inconsistent with determinations relating to the supply of the drug as a pharmaceutical benefit under Part VII.  The drugs which are the subject of these special arrangements are declared under subsection 85(2).

Subsection 100(2) empowers the Minister to vary or revoke a special arrangement made under subsection 100(1).

Purpose of the Arrangements

The amended 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.

The purpose of the Arrangements is to ensure that an adequate supply of the special pharmaceutical products listed in the Schedule to the Arrangements is available for patients who require in vitro fertilisation or gamete intra-fallopian transfer treatment.  Restrictions on the provision of these treatments means 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 clinics accredited as Assisted Reproductive Technology (ART) centres.

In accordance with the 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.

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.                                       

This legislative instrument amends the Arrangements for the IVF/GIFT Program which were made on 12 March 2007 with effect from 1 April 2007 (No. PB 26 of 2007).  The effect of the amendments is to reflect a name change for the manufacturer of 3 of the drugs supplied under the Arrangements. 

A provision-by-provision description of the instrument is contained in the Attachment.

This instrument, expressed to commence on 1 October 2007, was made on 14 September 2007.                                

Consultations

The Arrangements were 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.

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.

 

 

ATTACHMENT

Paragraph 1:  provides that this instrument commences on 1 October 2007.

Paragraph 2:  provides that Schedule 1 amends PB 26 of 2007.

Schedule 1: sets out the amendments to the Schedule to the Arrangements. 

 

SUMMARY OF CHANGES

 

The manufacturer for the various forms of the drugs Choriogonadotropin Alfa, Follitropin Alfa and Progesterone is changed from Serono Australia Pty Ltd (SG) to Merck Serono Australia Pty Ltd (SG).

 

Overview

The National Health Act 1953, enacted by the Parliament of Australia, establishes the Pharmaceutical Benefits Scheme (PBS) to ensure Australians have access to reliable, timely, and affordable medicines. This Act empowers the Minister for Health to make special arrangements for the supply of pharmaceutical products that cannot conveniently or efficiently be supplied under the PBS, such as those needed for in vitro fertilisation (IVF) and gamete intra-fallopian transfer (GIFT) treatments. These special arrangements were introduced to address the problem of ensuring an adequate supply of necessary pharmaceutical products for patients undergoing IVF/GIFT treatments, who must be admitted as in-patients at accredited Assisted Reproductive Technology (ART) centres. The policy objective is to facilitate the availability of these special pharmaceutical products by providing reimbursement to ART centres based on evidence of treatment and payment of a Medicare benefit for the procedures. The explanatory statement details amendments made to reflect changes in the manufacturer's name for certain drugs used in IVF/GIFT treatments, ensuring continued supply and compliance with the special arrangements.

Scope and Application

The National Health Act 1953 Amendment Special Arrangements under subparagraph 100(1)(b)(i) IVF/GIFT Program No. PB 76 of 2007 pertains specifically to the provision of special pharmaceutical products for patients undergoing in vitro fertilisation (IVF) or gamete intra-fallopian transfer (GIFT) treatment. This legislative instrument is grounded in Part VII of the National Health Act 1953, which governs the Pharmaceutical Benefits Scheme (PBS). The Act ensures that patients who require IVF or GIFT treatment have access to necessary medications, which cannot conveniently or efficiently be supplied under the general PBS framework. The amendments to the Arrangements were made to reflect a name change for the manufacturer of certain drugs involved in the treatment, ensuring that the supply chain remains uninterrupted. These arrangements apply to accredited ART centres that provide evidence of treatment to in-patients for IVF or GIFT procedures. The special pharmaceutical products are supplied based on the payment of a Medicare benefit corresponding to the relevant item numbers for IVF or GIFT procedures under the Health Insurance (General Medical Services Table) Regulations 2006. Notably, the Arrangements do not extend to treatments involving surrogacy arrangements. The amendments made by this legislative instrument, which commenced on 1 October 2007, reflect a name change for the manufacturer of three drugs used in IVF/GIFT treatments, updating the Schedule to the Arrangements accordingly.

Key Provisions

The primary operative sections of the F2007L03773 legislative instrument involve amendments to the National Health Act 1953, specifically concerning the IVF/GIFT Program. Section 100(1) of the Act allows the Minister to make special arrangements for the supply of special pharmaceutical products, which are drugs or medicinal preparations used in in vitro fertilisation (IVF) or gamete intra-fallopian transfer (GIFT) treatments. These special arrangements are made to ensure an adequate supply of the necessary pharmaceutical products for patients undergoing these treatments (subsection 100(1)(b)(i)). The supply of these products is governed by specific conditions, including that they can only be supplied to accredited ART centres, and reimbursement is contingent on the payment of a Medicare benefit for the relevant treatment item number (subsection 100(1)(c)). The Act imposes several obligations on the parties involved in the IVF/GIFT Program. Firstly, the Minister must ensure that the special pharmaceutical products are available and supplied to accredited ART centres in accordance with the arrangements. ART centres must provide evidence of treatment provided to in-patients for IVF or GIFT treatments and must only claim reimbursement for the supply of these products if they have received payment of a Medicare benefit for the relevant treatment item number. Additionally, the Act mandates that the Pharmaceutical Benefits Advisory Committee (PBAC) be consulted, and its recommendations considered, when making decisions about the pharmaceutical benefits to be provided under the Act. The PBAC’s role is to ensure that the medicines recommended are clinically effective, safe, and cost-effective. There are potential civil and criminal consequences for breaches of the Act. Although the specific penalties are not detailed in the explanatory statement, breaches of the National Health Act 1953 can generally result in substantial fines and, in serious cases, imprisonment. For example, individuals or entities that fail to comply with the special arrangements for the supply of pharmaceutical products, or that submit fraudulent claims for Medicare benefits, may face criminal charges. Civil penalties can also be imposed for breaches of the Act, including fines and orders for restitution. The maximum penalties would depend on the nature and severity of the breach, and would be determined by the courts in accordance with the provisions of the Act and any other relevant legislation.

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