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melbournefertility.com.au

Clause 2 of 5Victoria

Who regulates fertility treatment in Victoria

Since 1 January 2025, the regulator for assisted reproductive treatment in Victoria has been the Secretary of the Department of Health. Inside the department, the Health Regulator, a branch responsible for most of the department’s regulatory functions, counts assisted reproductive treatment among the areas it regulates.

General information, not legal advice. The Department of Health’s page on assisted reproductive treatment regulation is the official place to check the current arrangements.

The regulator

The Secretary and what the role covers

In the Act, “Secretary” means the Department Head of the Department of Health, in the sense the Public Administration Act 2004 gives that term. The department’s page lists the regulator’s functions under the Act; two of them are below, and the department’s page has the full list:

  • running the registration system under the Act
  • monitoring and enforcing compliance with the Act and the Regulations.

The department says ART providers in Victoria need to be registered by the Secretary and to hold current RTAC accreditation. The register of registered ART providers must be published on the department’s website (s 81(3)).

Registration comes with conditions. The department says every registration carries the general conditions the Regulations prescribe, plus any specific conditions imposed under section 75A, and that under those conditions registered providers must tell the Secretary about adverse events within specified timeframes. An application for registration must include the name of the provider’s designated officer (r 24).

Health Regulator

The Health Regulator

The Minister for Health announced the Health Regulator in December 2023, as a new branch of the department. The department calls it its main regulatory oversight branch, there to make sure people and organisations comply with health laws so that Victorians are protected from serious harm. Its own page describes three kinds of work:

  • granting permissions and licences
  • checking that the law is complied with, and enforcing it
  • work on regulatory reform and policy.

New compliance and enforcement powers for the Health Regulator came into force on 1 March 2025.

Former regulator

VARTA, the former regulator

Before 1 January 2025, these functions belonged to the Victorian Assisted Reproductive Treatment Authority, known as VARTA. The Health Legislation Amendment (Regulatory Reform) Act 2024 received Royal Assent on 29 October 2024, and the department says it moved VARTA’s functions to the Secretary and to a new Donor Conception Registrar, employed within the department, from 1 January 2025. The Act now records that the Authority was abolished, and its members went out of office, on the day Part 2 of the 2024 Act came into operation (ss 150 and 151).

The department’s guide to the reforms says that, because regulating treatment and overseeing the donor conception registers now sit in different areas of the department, the Regulations’ references to VARTA were replaced with the Secretary or the Donor Conception Registrar, whichever fits. The registers have their own pages: the department’s donor conception register services.

Donor material

Moving donor eggs, sperm or embryos

The department says that, before moving donor material into or out of Victoria, a person must make a certification about certain matters. It says this replaced VARTA’s pre-approval process from 1 January 2025, so there is no longer a wait for the regulator’s approval before the material moves, and that the person certifying must keep records about what they certified.

Offences

The department says that moving donor material without making a certification, and otherwise complying with the Act, is an offence, and so is making a false or misleading certification.

It also says that bringing donor gametes, or an embryo produced from them, into Victoria from a prohibited location is an offence under section 37E of the Act. On 24 December 2024, it says, the Secretary declared Ukraine a prohibited location from 1 January 2025. It adds that a person may apply, on a Schedule 9 form, for an exemption from section 37E to bring such gametes or embryos in from Ukraine.

Dates

How the arrangements got here, and what is still to come

  1. April 2018

    A review of Victoria’s regulatory framework for assisted reproductive treatment began. That year the Minister for Health also asked the Health Complaints Commissioner to inquire into the practices of providers in Victoria.

  2. 13 December 2019

    The Assisted Reproductive Treatment Regulations 2019 came into operation.

  3. December 2023

    The Health Regulator was announced.

  4. 29 October 2024

    The 2024 Regulatory Reform Act received Royal Assent.

  5. 1 January 2025

    The Secretary became the regulator, and VARTA’s functions moved to the Secretary and the Donor Conception Registrar.

  6. 1 March 2025

    The Health Regulator’s new compliance and enforcement powers came into force.

  7. 2 June 2026

    Parliament received the Health Legislation Amendment (Regulatory Reform) Bill 2026.

  8. 4 August 2026

    The 2026 Act was assented to. Its Part 1 and Part 3 came into operation the next day; its other provisions start on days to be proclaimed.

  9. 30 September 2026

    Section 9 of the 2026 Act came into operation, as the ART Act’s endnotes record. It sets 1 July 2028 as the date from which section 75D, the offence of contravening a condition of registration, applies.

  10. By 2 June 2027

    Any of those other provisions not yet started, except section 5, comes into operation on this day.

  11. By 1 January 2029

    Section 5, the duty for registered providers to comply with an approved accreditation scheme, comes into operation on this day if it has not started before.

So the 2026 Act is partly in force: section 9 has started, and the rest of its Part 2 starts on proclaimed days, by 2 June 2027 at the latest, or for section 5 by 1 January 2029. As its provisions start, it lets the Secretary approve an accreditation scheme for registered providers (new s 72A) and requires providers to comply with it unless they have a reasonable excuse (new s 73). It repeals the Act’s definition of RTAC accreditation, and it lets the Secretary grant and refuse registration and issue certificates of registration. Registration then lasts 3 years unless the Secretary sets a longer or shorter period, and a person refused registration or renewal may ask VCAT to review the decision. As those provisions start, it will also give the Secretary further inspection powers.

Behind it sits a national decision. The department reports that Health Ministers agreed the Australian Commission on Safety and Quality in Health Care should provide accreditation for assisted reproductive treatment services, supported by updated national standards. It says it will develop general conditions to work alongside those proposed national arrangements. Until the 2026 Act’s accreditation provisions start, section 74(4) still ties registration to RTAC accreditation.