Assisted Reproductive Technology in Australia: The legal landscape

There is no national legislation regulating Assisted Reproductive Technology (ART) in Australia, with the responsibility falling to the individual States and Territories.

The following is an overview of current ART specific state and territory legislation; however it should be noted that ART is also impacted by provisions in various other pieces of legislation such as human tissue¹ and research² legislation.

Issues arising out of the lack of uniformity⁴ include potential impacts on children of the lack of an Australian national donor register, unregulated donation in some jurisdictions and variation in the rights of children to seek genetic and medical information. Shortages of egg and sperm donation and an over reliance on imported gametes also potentially result in increased risk in the absence of a uniform national quality standard.

Inconsistencies between provisions in applicable legislation have required parties to seek Court determination on issues such as retrieval of gametes from deceased or unresponsive persons⁵, as well as ‘jurisdiction shopping’ by taking gametes interstate to a less regulated jurisdiction⁶.

RTAC Accreditation

Throughout Australia ART clinics require accreditation by the Reproductive Technology Accreditation Committee (RTAC) in order to operate, and they are expected to comply with the largely self-regulated framework of:

• The Ethical Guidelines on the Use of Reproductive Technology in Clinical Practice and Research, published by the National Health and Medical Research Council (NHRMC)
• The Code of Practice for Assisted Reproductive Technology Units by RTAC.

RTAC is a professional group of the Fertility Society of Australia and New Zealand (FSANZ), and accordingly not a strictly independent body given that it is funded by the industry it seeks to regulate. It also has limited powers, which are essentially either to certify or not to certify, and whilst it receives reports from providers of adverse events it does not make this information publicly available. There have been calls⁷ for establishment of an independently funded body with graduated regulatory powers and a formal complaints process.

What does this mean for providers?

ART providers operating across multiple jurisdictions currently face increased compliance costs due to the unnecessarily complex regulatory and legal environment and the need to comply with different requirements in different locations. At times uncertainty regarding their legal obligations requires providers to seek legal advice, or a court’s determination, to ensure that proposed actions are lawful.

Increased calls for uniformity, via harmonised state and territory legislation, suggest that changes are ahead, with opportunity for input from the industry and interest groups likely to feature. Most recently, following a meeting of Australian Health Ministers on Friday 13 June, a 3 month ‘rapid review’ of the sector by state health officials has been proposed, including assessing the benefits of a national approach⁸.

¹ E.g. Human Tissue Act 1983 (NSW).
² E.g. Research Involving Human Embryos Act 2002 (Cth).
³ At the time of writing only the first stage of the Queensland legislation has come into effect.
⁴ Including as outlined in the FSANZ Findings, Recommendations and Framework for an Australian 10 Year Fertility Roadmap Report November 2024. Retrieved here.
⁵ Such as in Hosseini v Genea Ltd [2021] NSWSC 1568.
⁶ As intended in Griffin v Attorney General NSW [2025] NSWSC 433, 6 May 2025.
⁷ For example, the FSANZ November 2024 report, above.
⁸ As reported by ABC News in ‘National review launched into IVF accreditation following second Monash embryo mix-up’, 13 June 2025. Retrieved here.