NSW legislation limits the number of families that can be created with donated embryos or gametes (i.e., ova and sperm) using assisted reproductive technology (ART). Under the Assisted Reproductive Technology Act 2007 (ART Act), an ART provider must not provide ART treatment using a donated gamete if it is likely to result in offspring being born to more than five women. This is an important protective provision that seeks to limit the number of biological siblings a donor-conceived person has, to reduce the risk of consanguinity.
NSW Health has recently become aware that an ART provider in NSW has been incorrectly interpreting this limit as only applying within NSW, rather than a limit that applied worldwide. As a result, some women were informed by the ART provider that their treatment would be temporarily paused.
The NSW Government recognises the significant emotional, physical and financial impacts a decision to pause ART treatment can have on those women and families, through no fault of their own.
In response, the NSW Government has created an exemption to enable any affected women and families to continue their ART treatment.
The NSW Government has created an exemption by making amendments to the Assisted Reproductive Regulation 2024 (Regulation). The amended Regulation, which commenced on 17 October 2025, has created a class of women who are exempt from the application of section 27 of the ART Act.
This amendment will enable women and families who are directly affected by an ART provider's incorrect interpretation of the 'five women limit' to continue their treatment.
The exemption applies to women who, before 1 October 2025, either:
The exemption applies in relation to both:
The exemption does not apply to women and families seeking treatment in the future using gametes or embryos not currently in storage or reserved for use by particular women. The usual five women limit in the ART Act will apply to all future treatment.
Women (or their spouse) who have already had a child using donated gametes, or using an embryo created from a donated gamete, can continue with any current or future treatment to extend their family using that donor's gametes. The limit in the ART Act does not apply to women in these circumstances.
To ensure affected women can continue their treatment, the NSW Government will not take regulatory action against an ART provider for a breach of section 27 of the ART Act where they provide ART treatment to women falling within one of the exempted classes between 1 October 2025 and the commencement of the amended Regulation.
Section 27 will not prevent an ART provider from providing ART treatment using a donated gamete to a woman falling within one of the exempted classes, even if offspring of the donor have been born to more than five women.
However, before providing treatment, the ART provider must inform the woman undergoing treatment that offspring of the donor may have been born to more than five women.
Section 27 of the ART Act continues to apply to ART providers providing treatment to any woman who does not meet the exemption criteria outlined above.
ART providers in NSW must not provide treatment to a woman if the treatment is likely to result in offspring of the donor being born to more than five women whether in NSW or elsewhere, including overseas.
The five women limit includes any woman who has conceived using the donor’s gametes, whether through ART treatment or other means, as well as the donor’s current partner and any former partners. The limit may be less than five women if a lesser limit is specified by the donor.
This limit has not changed in scope or quantity since the ART Act commenced in 2010.
NSW Health reminds all ART providers that the NSW Government takes breaches of the ART Act very seriously. The maximum penalty for a breach of section 27 of the ART Act is 800 penalty units in the case of a corporation, and 400 penalty units in any other case (currently $88,000 and $44,000 respectively, per breach).