2026 reforms
National reforms
- In June 2025, Health Ministers commissioned a Rapid Review of Assisted Reproductive Technology and In Vitro Fertilisation Regulation and Accreditation in Australia (Rapid Review). This followed two high-profile mistaken embryo transfers and broader public concern about safety and quality in the sector.
- The Rapid Review was led by a Victorian team on behalf of all jurisdictions, with the final report provided to Health Ministers for consideration at their meeting in September 2025.
- A copy of the Rapid Review report is available on the Commonwealth Department of Health, Disability and Ageing website.
- A key finding of the Rapid Review was that the current industry-led accreditation scheme is not adequate and lacks the transparency and rigour that governments and the community expect.
- In response, Health Ministers agreed that the Australian Commission on Safety and Quality in Health Care (Commission) should provide independent accreditation for assisted reproductive treatment (ART) services, supported by updated national standards developed by the Commission.
- More information on the new accreditation scheme, national standards and implementation timeframes is available on the Commission's website.
Victorian reforms
- Legislative changes are required to support implementation of the new national accreditation scheme in Victoria.
- On 2 June 2026, the Health Legislation Amendment (Regulatory Reform) Bill 2026 was introduced to Parliament.
- The Bill proposes changes to the Assisted Reproductive Treatment Act 2008 (ART Act) to remove references to the current accreditation arrangements and instead require registered ART providers to comply with an approved accreditation scheme. This will align Victorian requirements with the new national accreditation scheme and ART standards developed by the Commission.
- The Bill also proposes changes to the registration framework for Victorian ART providers and expands the inspection powers of the Secretary of the Department of Health in their role as regulator.
- The Bill and further details of the proposed changes can be accessed on the Victorian legislation website.
2024 reforms summary
- On 29 October 2024, the Health Legislation Amendment (Regulatory Reform) Bill 2024 received Royal Assent and became an Act of the Parliament of Victoria.
- The Health Legislation Amendment (Regulatory Reform) Act 2024 (the Act) made reforms to health regulation in Victoria to better protect Victorians and provide greater consistency to regulation across the health system.
- This included reforms to the regulation of ART under the ART Act.
- In summary, the reforms included transferring responsibility for ART regulation from the Victorian Assisted Reproductive Treatment Authority (VARTA) to the Department of Health (the department), changes to the functions currently undertaken by VARTA, and improvements to the compliance and enforcement tools available to regulate ART.
- Amendments to the Assisted Reproductive Treatment Regulations 2019 (ART Regulations) were also necessary to ensure that the amended legislation operates as intended.
- These reforms came into effect on 1 January 2025.
Establishment of the Health Regulator
In December 2023, the Minister for Health announced the establishment of the Health Regulator – a new branch of the department responsible for most of the department's regulatory functions. The Minister also announced that proposed reforms to ART regulation in Victoria were being developed, including transferring responsibility for the regulation of registered ART providers from VARTA to the Health Regulator.
Consultation and feedback
In May 2024, the department consulted with stakeholders by publishing a consultation paper. Feedback on the consultation paper informed the design of the proposed reforms and continues to inform planning and implementation. A consultation summary is available, see Reforms to health regulation in Victoria.
Legislative changes
On 13 August 2024, the Victorian Government introduced the Health Legislation Amendment (Regulatory Reform) Bill 2024 (the Bill) into the Parliament of Victoria. On 29 October 2024, the Bill received Royal Assent and became an Act of the Parliament of Victoria.
The Health Legislation Amendment (Regulatory Reform) Act 2024 (the Act) made reforms to health regulation in Victoria to:
- Improve compliance and enforcement powers across the health system.
- Change how ART is regulated in Victoria and the functions currently delivered by VARTA.
Updates to ART regulations
Amendments were made to the ART Regulations, as required to give effect to the changes made to the ART Act. For example, the updated ART Regulations set out details of:
- Matters that must be certified when donor gametes, or embryos formed from them, are moved into or out of Victoria.
- Information to be provided to individuals engaging with the Donor Conception Registers, to assist them in navigating issues that might arise.
Details of the updates to the ART Act and ART Regulations are in the Assisted reproductive treatment reform guide.
More information
For more detailed information on the regulation of ART and ART providers following these changes, see Assisted reproductive treatment regulation.
Information on the Donor Conception Registers following these changes will be available soon.
For more information about the reforms, email the department's Legislative and Regulatory Reform Team at legandregreform@health.vic.gov.au.
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