Assisted Reproductive Treatment Act 2008

• Women and couples seeking ART treatment in Victoria, including those using donor gametes or embryos.
• Donors of gametes and embryos, who must meet consent, counselling, and health screening requirements.
• ART providers (clinics and practitioners), who must be registered, comply with treatment standards, and maintain detailed records.
• Surrogacy participants: women wishing to carry a child for another person and intended parents must in most cases obtain Patient Review Panel approval (section 39).
• Donor-conceived persons, who have rights of access to information about their genetic origins under Part 6.
• The Assisted Reproductive Treatment Authority (VARTA), which registers providers, maintains the Central Register, and enforces compliance.
• The Patient Review Panel, which considers applications for approvals that require independent review.
• The Secretary of the Department, who has enforcement powers including issuing prohibition notices (section 116A) and information production notices (section 116J).

Registered ART providers must:

• Ensure that treatment proceeds only with the required consents in place under section 10 and 11. For a donor treatment procedure, both the patient and their partner (if any) must consent (section 10(1)(a)).
• Arrange or verify counselling before treatment, and inform patients about counselling requirements for donors (section 13, section 18).
• Comply with the 10-family rule for donations (section 29).
• Not carry out a prohibited procedure (sections 26-30), including cloning, sex selection for non-medical purposes, or destructive embryo research.
• Comply with storage limits: gametes and embryos can only be stored for the statutory periods unless the Patient Review Panel approves an extension (sections 31, 31A, 32, 33, 33A).
• Keep records of consent, withdrawal, and related documents and transfer them when required (sections 22-23).

Donors must:

• Give informed consent, undergo required counselling, and comply with information requirements (sections 17-19).

Surrogacy participants (section 39): Most surrogacy arrangements require Patient Review Panel approval before the procedure is carried out.

Persons holding information about donor procedures must supply information to the Donor Conception Registrar when required (section 56B) and comply with information and document production notices from the Secretary (section 116J).

VARTA registers ART providers, maintains the Central Register, receives and investigates complaints, and publishes guidance. It may revoke or suspend registrations and refer matters to the Secretary for enforcement action.

The Patient Review Panel may approve:

• Storage periods for gametes or embryos beyond the statutory defaults (sections 31A, 33A).
• Surrogacy arrangements under section 39, weighing the medical, psychological, and social circumstances of the parties.

The Secretary (since the 2024 amendments) may:

• Give a prohibition notice to a regulated person prohibiting conduct that contravenes the Act (section 116A). The notice does not affect criminal proceedings.
• Accept enforceable undertakings from regulated persons (section 116C) and enforce them in the Magistrates' Court (section 116H).
• Give information or document production notices requiring a person to produce specified information or documents (section 116J).

The Donor Conception Registrar (sections 56-63N) processes applications from donor-conceived persons, donors, and their relatives for identifying information. The Registrar may access historical records held by the Public Record Office (section 56A). Contact preferences (section 63I) give donors and donor-conceived persons a mechanism to specify how they wish to be approached if contact is sought.

The most serious offences carry penalties of 480 penalty units or 4 years imprisonment or both. These apply to the core prohibited procedures (section 26: procedures using gametes from children; related serious prohibitions). Related serious offences carry 240 penalty units or 2 years imprisonment or both (sections 27, 28, 30 for cloning, non-medical sex selection, and destructive embryo research).

60 penalty units (natural persons) or 300 penalty units (bodies corporate) apply to contravening an information or document production notice (section 116K).

120 penalty units (natural persons) or 600 penalty units (bodies corporate) apply to contravening a prohibition notice (section 116B).

50 penalty units apply to a range of lesser offences including knowingly contacting a donor-conceived person in breach of their contact preference (section 63O), and disclosing confidential Central Register information (sections 66A, 66B).

Infringement notices may be used for prescribed offences.

Consent and counselling. Before an ART provider carries out a treatment procedure, the required consents must be in place in the prescribed form (sections 10-11). Consent may be withdrawn at any time before the procedure commences (section 20). Consent is automatically taken to be withdrawn on separation for certain procedures (section 20A, inserted in 2010). Records must be maintained and transferred to the new provider if the patient changes clinics (sections 22-23).

Storage. Gametes may be stored for the statutory period (section 31). If a longer period is sought, an application must be made to the Patient Review Panel (section 31A). The responsible person (the ART provider holding the gametes) must remove gametes from storage within the time period fixed by the Panel or the Act (section 31B). Similar rules apply to embryos (sections 32-34A).

Surrogacy. A surrogacy arrangement that involves a woman who will not be the genetic parent of the child requires Patient Review Panel approval in the circumstances described in section 39. The Panel assesses the application against criteria prescribed in Part 4.

Access to donor information. An adult donor-conceived person may apply to the Donor Conception Registrar for identifying information about the donor (section 56). The Registrar processes the application, provides explanatory material, and may access Public Record Office records for pre-1988 procedures (sections 56A, 56B). Contact preferences must be respected and an undertaking to comply must be given before identifying information is disclosed (section 63O).

Enforcement. The Secretary issues a prohibition notice or information production notice giving the regulated person at least 10 business days to comply (section 116J(2)(d)). Enforceable undertakings are accepted in writing and may be enforced by the Magistrates' Court (section 116H). Criminal proceedings are stayed while an enforceable undertaking is in force (section 116F) but may recommence if the undertaking is withdrawn (section 116G).

• Sex Discrimination Act 1984 (Cth), s 22: The Federal Court in EHT18 v Melbourne IVF [2018] FCA 1421 held that section 10(1)(a) of this Act, to the extent it required a married but separated woman to obtain her estranged husband's consent, was inconsistent with and inoperative by force of section 109 of the Constitution. This constitutional interaction directly affects who may access treatment.
• Status of Children Act 1974 (Vic): Closely related legislation that deals with the parentage of children born through donor treatment (paragraph 15 of EHT18). Provisions introduced by this Act into the Status of Children Act establish parentage rules for same-sex couples and donor-conceived children.
• Charter of Human Rights and Responsibilities Act 2006 (Vic): Section 32 of the Charter requires compatible interpretation of statutory provisions. The court in EHT18 considered whether the Charter could be used to read down section 10(1)(a) (paragraphs 37-53), ultimately resolving the matter on s 109 grounds instead.
• Infertility Treatment Act 1995 (Vic): Replaced by this Act. Transitional provisions preserve prior licences and registrations.
• Research Involving Human Embryos Act 2002 (Cth): Governs embryo research at the Commonwealth level and interacts with Victorian prohibitions.

Section 10(1)(a) and separated spouses. Following EHT18 v Melbourne IVF [2018] FCA 1421, section 10(1)(a) does not require a woman who is separated but not yet divorced to obtain her estranged husband's consent. The section is inoperative to that extent by operation of s 109 of the Constitution. Providers and advisers must be aware that the statutory text does not reflect the current operational position for separated married women.

10-family rule. Section 29 prohibits using donated gametes to create more than 10 families. This limit counts all uses of a donor's gametes, including prior uses at different clinics. Providers must check the donor registry before proceeding. Breach is a criminal offence.

Consent withdrawal and separation. Section 20A deems consent to a treatment procedure to be withdrawn on separation in specified circumstances. An ART provider who proceeds after separation without checking consent status risks committing an offence.

Pre-1988 procedures. Persons born through donor treatment procedures carried out before 1988 may have reduced information available (section 56A). Clinics that existed before 1988 should be aware that historical records held at the Public Record Office may be accessed by the Donor Conception Registrar.

Enforceable undertakings block criminal proceedings. While an enforceable undertaking is in force, criminal proceedings cannot be commenced for the conduct covered by the undertaking (section 116F). If a regulated person accepts an undertaking and then complies, criminal proceedings cannot be commenced at all (section 116E). Regulators considering prosecution should make the decision before accepting an undertaking.

Example 1: IVF with donor sperm. A single woman seeks IVF at a registered ART provider using donor sperm. As she has no "partner" within the meaning of section 3, she does not need a partner's consent. The provider checks the donor is eligible and that using the donor's gametes will not create more than 10 families (section 29). Required counselling is arranged. The woman consents in the prescribed form and treatment proceeds.

Example 2: Surrogacy arrangement. Two intended parents want to commission a surrogacy arrangement. Because the surrogate will carry a child who is not her genetic child, section 39 requires the parties to apply to the Patient Review Panel for approval. The Panel considers the medical, psychological, and social circumstances of all parties. Without Panel approval, the ART provider cannot legally carry out the procedure.

Example 3: Donor-conceived adult seeking origin information. A 25-year-old person discovers they were born through IVF using donor sperm. They apply to the Donor Conception Registrar under section 56 for identifying information about the donor. The Registrar may provide the information subject to section 63O: if the donor has lodged a contact preference, the applicant must give an undertaking to comply with that preference before receiving identifying information.

Example 4: Prohibition notice. VARTA determines that a registered ART provider has carried out a procedure in breach of section 10 by proceeding without the required consent. The Secretary may give the provider a prohibition notice under section 116A requiring it to stop that practice, in addition to or instead of commencing a criminal prosecution. If the provider contravenes the notice, the penalty is up to 120 penalty units for individuals or 600 units for bodies corporate.