Regulation

Legislation and guidelines

Victorian fertility legislation

Provision of assisted reproductive treatment legislation

The primary legislation that regulates the provision of assisted reproductive treatment (ART) in Victoria is the Assisted Reproductive Treatment Act 2008 (Vic) (ART Act). This Act has a number of purposes, including to:

  • regulate the use of ART and artificial insemination (other than self-insemination)
  • regulate access to information about the treatment procedures carried out under the ART Act
  • promote research into the incidence, causes and prevention of infertility
  • make provision with respect to surrogacy arrangements
  • establish VARTA
  • provide for the keeping of the Central and Voluntary Registers by VARTA.

The Assisted Reproductive Treatment Regulations 2019 (Vic) (Regulations) outline requirements for a range of matters which relate to the provision of ART, including details around counselling and consent requirements, expenses that may be reimbursed to a surrogate, and information that must be recorded by ART providers and with donor registers.

Visit www.legislation.vic.gov.au to access the most up-to-date versions of the ART Act and Regulations.

The Secretary to the Department of Health and Human Services (DHHS) has issued Guidelines under section 100A(1) of the ART Act in relation to the performance of functions and the exercise of powers by VARTA in managing the donor conception registers and providing donor linking services.

DHHS Guidelines

Right to Know obligations

The Assisted Reproductive Treatment Amendment Act 2016 amended the Assisted Reproductive Treatment Act 2008 to give all donor-conceived people, no matter when they were born, the right to know their genetic heritage.

These amendments allow all donor-conceived persons to access identifying information about their donor regardless of the year they were born. The amendments also allow the lodging of contact preferences by all parties involved and enforce their compliance. Contact preferences permit the parties to decide on the terms of contact and whether they want contact at all. Contact, if chosen, may afford donor-conceived people the opportunity to learn more about their identity, background and medical history.

As part of these reforms, the management of the Central and Voluntary Registers were moved from the Registry of Births, Deaths and Marriages to VARTA to allow for a ‘one door in’ provision of support and information to donors, donor-conceived people, and their families. The new laws came into effect on 1 March 2017. Further information on donor linking services is available here.

Donor treatment procedures and legal parentage legislation

The Status of Children Act 1974 (Vic) outlines presumptions of parentage in relation to assisted reproductive treatment procedures including donor treatment procedures, same sex relationships, single women, and posthumous use of gametes. The Births, Deaths and Marriages Registration Act 1996 (Vic) establishes the requirements for birth registration of a child conceived as the result of a donor treatment procedure.

Visit www.legislation.vic.gov.au to access the most up-to-date versions of these Acts.

Surrogacy legislation

Part 4 of the Assisted Reproductive Treatment Act 2008 makes provisions in relation to surrogacy arrangements in Victoria. The Status of Children Act 1974 (Vic) outlines presumption of parentage in relation to children born as a result of a surrogacy arrangement. This Act also outlines the requirements for making a substitute parentage order by the parents of a child born from a surrogacy arrangement. The Births, Deaths and Marriages Registration Act 1996 (Vic) outlines the requirements for birth registration of a child conceived via a surrogacy arrangement.

Visit www.legislation.vic.gov.au to access the most up-to-date versions of these Acts.

Further information about entering into a surrogacy arrangement in Victoria can be found here.

The Assisted Reproductive Treatment Regulations 2019 commenced on 13 December 2019 and replaced the earlier Regulations. The new Regulations expand the costs that can be reimbursed to a surrogate and include:

  • Reasonable medical expenses that are not recoverable under Medicare, health insurance or another scheme, including costs incurred prior to conception, costs associated with the pregnancy and birth and costs in relation to the child born.
  • Reasonable legal, counselling, and out of pocket expenses incurred by the surrogate. Out of pocket expenses include, but are not limited to, travel, accommodation and childcare costs.
  • Actual lost earnings incurred by the surrogate if she takes unpaid leave for up to two months at the time of the birth, and for any other period that the surrogate is unable to work on medical grounds as a result of the surrogacy arrangement.
  • Premiums, or increases to premiums for health, life or disability insurances obtained in relation to the surrogacy, that are not recoverable under insurance or another scheme.

Removal of requirement for police and child protection order checks

The Assisted Reproductive Treatment Amendment Act 2020 received Royal Assent on 10 June 2020 and commenced on 8 July 2020. The effect of the amendments is to remove the requirement that a woman and her partner (if any), and parties to a surrogacy arrangement, must undergo a criminal records and child protection order check prior to accessing fertility treatment under the ART Act. In practice, this means that ART providers are no longer required to ask a woman seeking treatment and her partner, if any, or parties to a surrogacy arrangement to:

  • undergo a criminal records check
  • arrange for a child protection order check to be undertaken by the Department of Health and Human Services
  • assess the checks to determine whether any offences or orders detailed in the checks give rise to a presumption against treatment.

While the checks are no longer required, a number of safeguards remain in place. In particular, ART providers continue to have a statutory obligation to have regard to the guiding principles set out in section 5 of the ART Act when making a decision about whether to treat a person. These principles include that the welfare and interests of the child to be born are paramount. ART providers will continue to be able to refuse treatment if they reasonably believe that a child to be born from treatment may be at risk of abuse or neglect. The Patient Review Panel has an ongoing role in reviewing any decision by an ART provider on this basis.

ART Amendment Act 2020

Guidance Note for ART providers on legislative changes June 2020

Removal of requirement for married women to seek consent of spouse for treatment if separated

The Assisted Reproductive Treatment Amendment (Consent) Act 2019 amended the Assisted Reproductive Treatment Act 2008 to ensure that a married woman is not required to obtain the consent of her spouse to undergo a treatment procedure using donor sperm in circumstances where the woman is separated from her spouse. Further, it amended the Status of Children Act 1974 so that presumptions as to parentage of children operate consistently with the amendments made to the Assisted Reproductive Treatment Act 2008, and to clarify requirements for counsellors for the purposes of surrogacy arrangements commissioned without the assistance of a registered assisted reproductive treatment.

Artificial insemination legislation

Under the Assisted Reproductive Treatment Regulations 2019, there is a new requirement for registered assisted reproductive treatment (ART) providers and doctors carrying out artificial insemination outside a registered clinic setting to provide VARTA with the email address of the donor, the woman, and her partner if any, in relation to donor treatment procedures, and artificial insemination using donor sperm.

The new Regulations include minor amendments to the prescribed consent forms to enhance monitoring of the restriction on treatment procedures that may result in more than ten women having children who are genetic siblings, and to include a definition of ‘partner’ in the consent to treatment form. They also require information to be kept and provided to VARTA about whether a donor intends to donate gametes or embryos to any other registered ART provider or to a doctor carrying out artificial insemination outside a registered clinic, and if so, details of that provider or doctor.

Legislation relating to use and research involving human embryos and gametes

The Human Tissue Act 1982 (Vic) prohibits the unauthorised buying or selling of human tissue, including eggs, sperm and embryos. Research involving human embryos and gametes is regulated by the Research Involving Human Embryos Act 2008 (Vic) and the Prohibition of Human Cloning for Reproduction Act 2008 (Vic). These Acts mirror the Research Involving Human Embryos Act 2002 (Cth) and Prohibition of Human Cloning for Reproduction Act 2002 (Cth).

Visit www.legislation.vic.gov.au (Vic) and www.legislation.gov.au (Cth) to access the most up-to-date versions of these Acts.

National fertility guidelines

NHMRC Ethical guidelines on the provision of assisted reproductive technology in clinical practice and research

The Ethical guidelines on the use of assisted reproductive technology in clinical practice and research underpin the regulation of assisted reproductive treatment (ART) practice across Australia. The guidelines were developed by the National Health and Medical Research Council (NHMRC) and provide an overarching framework for the conduct of ART in both clinical practice and research. They are intended to be read in conjunction with relevant federal and state legislation and are designed for use by ART clinicians, clinic nurses, embryologists, counsellors and administrators and researchers. The guidelines were most recently revised in 2017.

NHMRC Ethical guidelines 2017

Accreditation of ART providers by the Reproductive Technology Accreditation Committee (RTAC) is required for ART clinical practice nationally. Accreditation from RTAC requires ART providers to comply with ART laws and relevant guidelines. RTAC was established by the Fertility Society of Australia (FSA). The RTAC Code of Practice (revised in October 2017) has been developed to:

  • promote continuous improvement in the quality of care offered to people accessing fertility treatment
  • provide a framework and set criteria for the auditing process that leads to accreditation of organisations that deliver fertility services
  • ensure the auditing process is carried out in an independent, non-adversarial and constructive manner.

RTAC is currently undertaking a review of the Code of Practice. Further information on this work is available here.

RTAC Code of Practice – October 2017 

2019 review of ART in Victoria

In 2018-19, Michael Gorton AM led an Independent Review of Assisted Reproductive Treatment in Victoria. The Review was informed by extensive consultations with many stakeholders involved in or impacted by assisted reproductive treatment. The Victorian Government has released the interim and final reports of the Review and is in the process of considering the Review’s key findings and wide-ranging recommendations.

Gorton Review - Interim and Final Reports

Legislation around Australia

Legislation and regulation of fertility treatment and donor conception varies across Australian states and territories. Health Law Central provides an overview of ART and donor conception regulation around Australia.

History of Victorian legislation

Infertility (Medical Procedures) Act 1984

Following the first IVF birth in Australia, the Victorian Government established a review of IVF research and practice which led to the proclamation of the Infertility (Medical Procedures) Act 1984, enacted in 1988. The accompanying Infertility (Medical Procedures) Regulations 1988 set out requirements in relation to counselling, the Central Register, artificial insemination and donor expenses. This was the first legislation worldwide to regulate IVF and associated human embryo research.

Infertility Treatment Act 1995

As a result of the Infertility Treatment Act 1995, the Infertility Treatment Authority (now the Victorian Assisted Reproductive Treatment Authority or VARTA) was established. The 1995 Act was more comprehensive than its predecessor and sought to bring the law up-to-date with developments in science and technology, such as the use of preimplantation genetic diagnosis. This Act was supported by the Infertility Treatment Regulations 1997 which outlined requirements in relation to counselling, information and the donor registers.

In 2004, the Victorian Government asked the Victorian Law Reform Commission to review aspects of the Infertility Treatment Act 1995 and provide recommendations for changes. The commission presented 130 recommendations to the Victorian Government in June 2007 relating to eligibility for assisted reproductive treatment, self-insemination, donation of gametes, posthumous use of gametes and embryos, legal parentage, access to information regarding donor conception, birth registration and surrogacy.

Assisted reproductive technology & adoption: Final report

Assisted Reproductive Treatment Act 2008

The Victorian Law Reform Commission’s recommendations on reform of the Infertility Treatment Act 1995 led to the development of the Assisted Reproductive Treatment Act 2008. The Act altered eligibility for ART and the types of services that could be provided by clinics. It also removed the research provisions from the Infertility Treatment Act 1995 and the Research Involving Human Embryos Act 2008 and the Prohibition of Human Cloning for Reproduction Act 2008 were enacted to cover research. The research Acts mirror Commonwealth legislation of the same name. All Victorian Acts can be found at legislation.vic.gov.au.

Assisted Reproductive Treatment Amendment Act 2016

The Assisted Reproductive Treatment Amendment Act 2016 (Vic) amended the ART Act to give all donor-conceived people, no matter when they were born, the right to know their genetic heritage. As a result, donors no longer have the ability to veto the release of their identifying information to their donor offspring but will be able to determine how - or if - they have contact with an applicant. The amendments also provided for the management of the Central Register and Voluntary Register to be moved from the Registry of Births, Deaths and Marriages to VARTA. This transition has enabled VARTA's Donor Registers Service to be a ‘one door in’ provider of support and information to donors, donor-conceived people, and their families. The new laws came into effect on 1 March 2017.

Other legislative changes

Find out more about other legislative changes here.

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