Regulation

Registration of fertility treatment providers in Victoria

Clinics providing assisted reproductive treatment (ART) in Victoria are required to be registered with VARTA and must hold accreditation from the Reproductive Technology Accreditation Committee (RTAC) of the Fertility Society of Australia. In addition to complying with requirements of the Assisted Reproductive Treatments Act 2008 (ART Act), ART providers must adhere to relevant legislation and industry guidelines.

Postponement of scheduled RTAC audits in 2020 in response to the COVID-19 situation

In response to COVID-19, RTAC announced on 27 March 2020 that it will suspend the 2020 audit program. All licences will be extended for a period up to 12 months. Audits are expected to recommence in January 2021 pending the advice of medical authorities, however, may resume earlier if the COVID-19 crisis resolves more quickly than predicted.

FSA COVID-19 Interim Policy regarding postponement of scheduled RTAC audits

Conditions of registration

The ART Act provides that a person who holds RTAC accreditation may apply to VARTA for registration as an ART provider in Victoria. VARTA is authorised to impose conditions on the registration of an ART provider if it is considered necessary in the public interest.

As a matter of practice, VARTA imposes conditions of registration on all ART providers to protect the health and welfare of all those undergoing assisted reproductive treatment and promote compliance with the ART Act. These conditions are reviewed annually and are updated as appropriate.

General conditions

VARTA monitors the activities of ART providers, tracks developments in the sector, and analyses incidents which indicate the desirability of improvements in ART provider processes. The general conditions imposed on all ART providers in Victoria include requirements that providers:

•   have appropriate governance, processes and systems in place to ensure compliance with applicable laws, and RTAC accreditation

•   provide specified information and attestations to VARTA to assist in industry monitoring

•   notify VARTA of any incidents which occur.

Registered ART providers are required to provide information to VARTA on a regular basis to ensure the requirements of the conditions are being met. The general conditions of registration can be accessed here.

Adverse incident reporting

Under the Conditions of Registration, an ART provide must give the Authority written notice of:

• any actual or potential contravention of the Act or Regulations;
• any actual or potential breach of its conditions for registration or conditions attached to any approval granted by the Authority;
• any incident that is reported to RTAC as part of accreditation requirements; and
• any contravention of the guiding principles of the Act in carrying out activities regulated by the Act, including any incident which is or is likely to be harmful to the health or wellbeing of patients, donors, gametes or embryos –  by the ART provider or by a doctor carrying out treatment procedures on its behalf.

VARTA’s Guidance Note on adverse incident reporting is intended to help registered ART providers comply with Condition 2.6 of the Conditions for Registration (regarding the notification of incidents to VARTA) by providing additional information about the types of incidents that should be reported. The Guidance Note is available here.

Specific conditions

In addition to general conditions, VARTA may impose specific conditions on the registration of some registered ART providers if this is deemed necessary to minimise specific risks, improve systems for legislative compliance and/or prioritise patient welfare. Specific conditions may be imposed in response to the occurrence of specific incidents, a risk assessment of current practices or new initiatives, or developments in the sector which make adjustments necessary in the public interest.

Suspension of registration

VARTA may suspend the registration of an ART provider, either in whole or in part, if it reasonably believes that the ART provider has contravened a condition of registration, or it is otherwise satisfied that there are reasonable grounds for suspension, it may suspend the provider’s registration.

The list of current ART providers registered with VARTA is available here.

Class imports and exports

Overseas class import and export

The ART Act states that donor sperm, donor eggs or embryos produced using donor sperm and/or eggs (embryos) must not be taken into or out of Victoria without the written approval of VARTA. This means that ART providers in Victoria that wish to move donor sperm or eggs into or out of Victoria on behalf of a class of intended recipients must apply to VARTA for approval under section 36 of the ART Act.

The process for seeking approval for a class application to import donor sperm or eggs on behalf of intended recipients in Victoria involves a two-step process.

1. An ART provider must first seek in-principle approval for a proposed arrangement with an overseas provider.
2. Once the arrangement is approved, the ART provider needs to submit an application each time they wish to import donor sperm or eggs on behalf of a class of applicants under the approved arrangement.

Information relating to the application process is set out in the Guideline for class applications to import donor gametes from an overseas sperm or egg bank for ART providers which has been developed by VARTA.

Guide to class import arrangements

Interstate class import and export

Victorian ART providers seeking approval from VARTA to import or export donor sperm or eggs interstate, including requests to import and export between its interstate counterpart ART provider under section 36(2) of the ART Act, must complete an ART provider interstate class application to import or export donated gametes.

All completed forms should be forwarded to regulation@varta.org.au.

Interstate class import and export application form

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