Regulatory Overhaul: Enforcing Stricter Guidelines on Assisted Reproductive Technology

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This article applies to assisted reproductive technology providers in the Australian Capital Territory.

Assisted Reproductive Technology Bill 2023 (ACT)

On 21 March 2024, the Assisted Reproductive Technology Bill 2023 (ACT) (the Bill) passed the ACT Parliament. The Bill will form a new principal act which establishes a donor register and regulates assisted reproductive technology (ART) services and access to information about ART services. Certain provisions of the Bill, including, Division 4.5 (Record keeping requirements), and Divisions 6.1 and 6.2 (which relate to pre-commencement records) will commence on the day after the Bill’s notification day. The remaining provisions of the Bill will commence on a day to be proclaimed.

Operationally Significant Changes

The Bill creates a range of new obligations and offences. The most significant obligations on ART providers (from an operational perspective), relate to:

  • being registered as an ART provider and ensuring ART services are supervised by a doctor;
  • offering counselling and providing specified information to persons before they undergo ART treatment, or provide or donate gametes;
  • requirements for consent given by gamete providers and the use, supply, storage, transfer and export of gametes and embryos;
  • record keeping requirements for:
    • information about each gamete or embryo in the ART provider’s possession, donors and providers of gametes, persons who undergo ART treatment and children born because of ART treatment; and
    • pre-commencement records, being records of an ART provider that were made about an ART service provided before section 71 of the Bill commences, which are to be retained for a period of 75 years; and
  • notifying the director-general and providing certain information about children who are born from ART treatment within two months after becoming aware of the same.
Further Information
Key definitions

The Bill defines ART treatment as medical treatment or a procedure that procures, or attempts to procure, pregnancy in a person other than by sexual intercourse (including related treatments or procedures prescribed by regulation, but not including self-insemination). Some other key definitions in the Bill are:

  • ART service, meaning any of the following provided for fee or reward, or in carrying on a business (whether or not for profit): ART treatment; storing gametes and embryos for use in ART treatment; or a procedure to obtain a gamete from a gamete provider for use in ART treatment or for research in relation to ART treatment.
  • ART provider, meaning a person who provides ART services (but does not include a person who provides ART services on behalf of a registered ART provider under a contract of employment or contract for services).
  • Gamete, meaning a human sperm or human oocyte, and for a gamete used in the provision of ART treatment – includes an embryo created from the gamete.
Offering counselling and providing information prior to ART treatment

Section 23 of the Bill will require an ART provider to offer counselling services to a person seeking to undergo ART treatment, a person proposing to provide a gamete and to the gamete provider before using a gamete or embryo (created from the gamete) in specific circumstances.

Section 24 of the Bill will require ART providers to tell certain information (the basic matters) to persons seeking to undergo ART treatment, proposing to provide a gamete, or proposing to donate a gamete and confirm that the relevant person understands the information. The basic matters will include the availability of counselling services and the effect of a gamete provider’s consent and how this may be modified or withdrawn. Importantly, where donated gametes are proposed to be used there are a range of additional (extended matters) that must be addressed, such as, the existence of the donor register and the information to be kept in the register about the person and their donor conceived offspring.

Consent given by gamete providers and the use, storage, supply and export of gametes and embryos

Critically, a gamete may only be used in ART treatment if the gamete provider gives written consent. Division 4.2 of the Bill specifies details relating to consent which must be obtained, and an ART provider will commit an offence if it fails to take the steps prescribed by regulation to verify a gamete provider’s identity.

Division 4.3 of the Bill contains various offences for ART providers which relate to the use of gametes to create an embryo outside of the body, and the use of gametes or embryos in ART treatment or for research without (or inconsistent to) the gamete provider’s consent. Importantly, ART providers are prohibited from:

  • using donated gametes or embryos that were donated more than 15 years ago (without authorisation from the director-general);
  • using a donated gamete, if the donor previously donated gametes used in ART treatment which has resulted in five or more families with a child born in the ACT or ten or more families with a child born in Australia; or
  • storing a gamete or embryo without (or inconsistent to) the gamete provider’s permission.

There are also offences for storing gametes and embryos longer than specified storage periods, and for supplying or exporting (from the ACT) a gamete or embryo without (or inconsistent to) the gamete provider’s consent.

Record keeping

Division 4.5 of the Bill will require ART providers to collect specific information about gamete providers, gamete donors and persons undergoing ART treatment before any treatment or services are provided. Importantly, an ART provider will be required to take reasonable steps within certain timeframes to find out whether a person is pregnant because of ART treatment and whether a child was born because of the ART treatment. ART providers will be required to keep records relating to each gamete or embryo, person who receives ART treatment, and known child born because of ART treatment, for a period of 50 years.

Please click here to access the full Bill.

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