Regulation
From 1 January 2025, the Secretary for the Department of Health is the regulator for Assisted Reproductive Treatment (ART) in Victoria.
The legislation that regulates ART in Victoria includes:
The functions of the regulator under the Act are:
- to administer the registration system under the Act
- to regulate the bringing into or taking out of Victoria of donor gametes or embryos produced from donor gametes
- to grant exemptions in relation to donor gametes or embryos produced from donor gametes being brought into and out of Victoria
- to monitor and enforce compliance with the Act and the Regulations
- to monitor programs and activities carried out under the Act and the Regulations.
In performing these functions, the regulator adheres to the guiding principles of the Assisted Reproductive Treatment Act 2008 and ensures that:
- the welfare and interests of persons born or to be born as a result of treatment procedures are paramount
- treatment procedures do not exploit, in trade or otherwise, the reproductive capabilities of individuals or children born as a result of treatment procedures
- children born as the result of the use of donated gametes have a right to information about their donors
- the health and wellbeing of persons undergoing treatment procedures is protected at all times and
- persons seeking to undergo treatment procedures are not discriminated against on the basis of their sexual orientation, marital or relationship status, gender identity, sex characteristics, race or religion.
Registered Assisted Reproductive Treatment Clinics
Clinics providing assisted reproductive treatment in Victoria are required to be registered by the Secretary of the Department of Health and must hold current accreditation from the Reproductive Technology Accreditation Committee (RTAC) of the Fertility Society of Australia and New Zealand.
The Secretary may impose specific conditions on the registration of an ART clinic and has the power to suspend either in whole, or in part a clinic's registration.
Guidelines to support an application for registration are under development. To apply for registration, contact the Health Regulator at artregulation@health.vic.gov.au
Movement of donor material (eggs, sperm or embryos)
A person must make a certification in relation to certain matters, before moving donor material in or out of Victoria. Moving donor material without having made a certification and otherwise complying with the Act is an offence.
Import
From 1 January 2025, before a person (either an individual or a registered ART clinic) brings donated gametes and/or embryos produced from donated gametes (donor material) into Victoria, they must provide a certification in the required form to the Secretary, setting out that specified certification criteria have been met. It is an offence to move donated material without making the certification and otherwise complying with the Act and Regulations.
Some of the matters that must be certified are set out in section 36 of the amended Act, and some are detailed in the amended Regulations.
Information about the matters to be certified is included in the Assisted reproductive treatment reform guide.
Note on existing VARTA approvals
Before the amendments to the Act it was necessary to obtain approval from the Victorian Assisted Reproductive Treatment Authority (VARTA) before moving donor material into or out of Victoria. This certification process replaces that pre-approval process. From 1 January certification is necessary before moving donor material into or out of Victoria, even if VARTA has previously approved the movement of the donor material.
The import certification form and associated guidelines about the certification criteria are under development. To make a certification to bring donor material into Victoria, contact the Health Regulator at artregulation@health.vic.gov.au.
Export
From 1 January 2025, before a person (either an individual or a registered ART clinic) takes donated gametes and/or embryos produced from donated gametes (donor material) from Victoria, they must provide a certification in the required form to the Secretary, setting out that specified certification criteria have been met. It is an offence to move donated material without making the certification and otherwise complying with the Act and Regulations.
The export certification form and associated guidelines about the certification criteria are under development. To make a certification to take donor material from Victoria, email artregulation@health.vic.gov.au.
Incident reporting
Registered ART clinics are required to adhere to any conditions of registration.
Where a condition requires notification of incidents, the ART clinic must provide the Secretary with written notice of the incident in the prescribed timeframe using the ‘Clinic ’.
For questions relating to conditions of registration or access to the clinic portal, email artregulation@health.vic.gov.au
Reviewed 19 December 2024