On 22 May 2024, the Honourable Minster for Health, Mental Health and Ambulance Services introduced the Assisted Reproductive Technology Bill 2024 (the Bill).

The Bill is the first dedicated legislative instrument for the regulation of Assisted Reproductive Technology (ART) services in Queensland, and follows in the footsteps of reforms in other jurisdictions including New South Wales, Victoria and South Australia.

The Bill proposes, amongst other items:

• Authority to provide ART services and licensing requirements;
• Establishment of the Donor Conception Information Register;
• Processes for retrieval of gametes from deceased or unresponsive persons;
• Family size limits;
• Sex selection; and
• Annotation of Birth Certificates for Donor Conception.

Background

ART services in Queensland are currently regulated through licensing/accreditation requirements through the Fertility Society of Australia and New Zealand, the Reproductive Technology Accreditation Committee, and the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (Ethical Guidelines), published by the National Health and Medical Research Committee.

The Bill provides for end to end regulation of the provision of ART services in Queensland, as well as the maintenance of service standards, with regulatory enforcement powers.

Authority to provide ART services and licensing requirements

The Bill proposes three functions:

1. regulation on who can provide ART services;
2. a requirement for licencing; and
3. enforcement powers to maintain the standard of ART services.

The Bill seeks to mandate that a person must not provide an ART service unless the person is a licensed ART provider. An ART provider is a person who provides an ART service. The definition of 'ART service' is broad and includes any of the following where provided for fee or reward or in carrying on a business (whether or not for profit):

1. an ART procedure;
2. the storage of gametes and embryos for use in an ART procedure; or
3. obtaining a gamete from a gamete provider for use in an ART procedure.

An 'ART procedure' means:

1. any medical treatment or other procedure that procures, or attempts to procure, pregnancy in a person other than by sexual intercourse; or
2. a related treatment or other procedure prescribed by regulation.

Examples include artificial insemination, in-vitro fertilisation and gamete intrafallopian transfer.

The Bill proposes mandatory licensing ART providers, i.e., those persons who provide an ART service. A person may apply for a licence if the person has RTAC accreditation, is not completely prohibited from providing ART services by a prohibition notice issued by the chief executive, and the person satisfies any other requirements prescribed by regulation. Licences would be subject to conditions prescribed by regulation, as well as any other specific conditions imposed by the chief executive.

The chief executive would be required to refuse to grant a licence if the chief executive is satisfied that the licence should not be granted because there were contraventions of the conditions of any previous licence held by the applicant, contraventions of the Act or any related ART legislation, the risk to the health, safety or welfare of persons provided with ART services by the applicant or of persons born as a result of the provision of ART services, or any other relevant matter.

ART providers would be required to notify the chief executive within seven days of 'serious adverse events'. The definition of serious adverse event will be prescribed by regulation or by conditions of the provider's licence. ART providers would be required to notify the chief executive of changes to RTAC accreditation (including ceasing to hold such accreditation) within 14 days, and changes of medical and other key personnel within the ART provider with 21 days.

The chief executive would be able to issue an improvement notice to a licensed provider to rectify particular matters to prevent or minimise a risk to health, safety or welfare of persons to whom ART services are provided or of persons born as a result of the provision of ART services. The chief executive would also be able to issue prohibition notices if they reasonably believe that the person should be prohibited from providing ART services or stated ART services because of certain contraventions. Prohibition notices could be issued to any persons, including licensed providers.

Establishment of donor conception information register

The Bill proposes to establish a comprehensive donor conception information registry. The register would include:

1. information sets required to be given to the registrar by ART providers within three months of becoming aware of the birth of a donor-conceived child;
2. certain historical information that relates to the birth of a donor-conceived person prior to the commencement of the legislation, which must be given within six months after commencement or longer period as permitted by the registrar; and
3. information voluntarily provided by parties to private donor conception procedures.

The donor registry guarantees that individuals conceived via donors are afforded access to their genetic heritage. Donor-conceived persons aged 16 years or older can apply for information held on the register.

It is proposed that the register will hold three main categories of information including:

• donor's information: full name and contact information, date and place of birth, ethnicity and physical characteristics, relevant medical history, donor profile information, the place where the donor's gamete was originally obtained;
• full name and date of birth of the person who gave birth to the donor-conceived person as a result of the procedure and the full name and date of birth of any spouse of that person at the time of the procedure;
• donor-conceived persons information: full name, the date and place of birth and sex of the donor-conceived person born as a result of the procedure;
• the number of any donor-conceived siblings of the donor-conceived person, if that information has been recorded and kept; and
• if the procedure was carried out by an ART provider, the name of the provider and the place where the procedure was carried out.

The Bill would enable donor-conceived persons to access both identifying and non-identifying information about their donor from the register without needing donor consent (although contact information about the donor would only be available with the consent of the donor). It would also allow donor-conceived individuals and their parents to request non-identifying information about related persons, such as donor-conceived siblings. Donors would be able to obtain non-identifying information about donor-conceived offspring, and identifying or contact information about any such offspring with their consent. Parents or another person with parental responsibility for a donor-conceived person under 16 years can access non-identifying information about the donor, or identifying information and contact information about the donor only with the donor's consent. Other specific access arrangements to the register are set out in the Bill.

Finally, the Bill proposes a consent-based system for sharing personal identifying information.

Prior to 2004 and the adoption of the Ethical Guidelines, donors could donate anonymously on the understanding that their contact details would not be provided to donor-conceived persons. The Explanatory Notes to the Bill acknowledge this, but states:

The operation of these clauses will alter the nature of an agreement that a donor may have entered into with an ART provider or other person at the time of donating a gamete prior to commencement of the Bill (and particularly prior to commencement of the NHMRC Guidelines in 2004) that the donor’s identity would not be disclosed to a person born as a result of the donor conception ART procedure. Under the Bill, the information must be provided to the Register and will be disclosed to a donor-conceived person if they apply for it.

Although historical donors may have been assured anonymity at the time they donated, these individuals made the decision to donate as competent adults, in full knowledge that the donation of their gametes may result in the conception and birth of a child. By comparison, donor-conceived people had no choice in the method of their conception and subsequently should not be denied the ability to have access to information about their genetic origins due to the timing and circumstances of their birth. In addition, submissions provided to the LAS Committee as part of its Inquiry outlined that ongoing donor anonymity is an increasingly redundant concept due to advances in at-home DNA testing kits and the use of social media, which are assisting donor-conceived people to identify the donor outside of regulated frameworks.

It is proposed that the implementation of the Bill will be complemented by a public awareness campaign about changes to the law, and the development of resources for donors to understand the impact this may have on their circumstances.

Retrieval and use of gametes from deceased or unresponsive persons

Posthumous retrieval of gametes from people who are deceased in Queensland is permitted under the Transplantation and Anatomy Act 1979 (Qld). There is currently no regulatory regime applying to the use of that material in Queensland.

The Bill proposes a Division dealing specifically with the retrieval and use of gametes from deceased or unresponsive persons. A person is defined as 'unresponsive' if:

1. the person's respiration or circulation of blood is being maintained in a hospital by artificial means; and
2. a medical practitioner has certified in writing that they are of the opinion that the person would die if the artificial means of respiration or circulation was withdrawn.

Posthumous retrieval is only permitted if the person had given consent to the retrieval of their gametes for use in an ART procedure for their spouse, or the person has not expressly objected to the posthumous use of their gametes for such a purpose and is likely to have supported the posthumous use for that purposes.

Requests for retrieval could only be made by the deceased or unresponsive person's surviving spouse or, in exceptional cases, another family member on the spouse's behalf.

An ART provider could only use a gamete retrieved from a deceased or unresponsive person under the Bill if its use had been authorised by an independent review body.

Family limits

The Bill proposes a cap on the number of Australian families that can be formed using gametes or embryos from a single donor, setting the maximum at 10. ART providers must not use a donated gamete or donated embryo in an ART procedure if it would result in more than 10 donor-related Australian families, and the provider knew it would have that result. The due diligence required of an ART provider would include:

1. searching the provider's records;
2. making reasonable enquiries of the donor; and
3. if the provider has reason to believe that another ART provider in Australia has obtained a gamete or an embryo from the donor, requesting information from that other provider.

ART providers may face a penalty of a fine of up to 400 penalty units or a two-year prison sentence.

Importantly, the Bill has defined Donor-related Australian families as families that include:

1. a person born as a result of an ART procedure carried out in Australia using a gamete obtained from the same donor or using an embryo created from a gamete obtained from the same donor; and
2. the family of the donor if the donor has a child who was born in Australia but was not donor-conceived.

Sex selection

The previous (and current position) of the Ethical Guidelines provide that sex selection may be used to reduce the risk of transmission of a genetic condition, disease or abnormality that would severely limit the quality of life of the person who would be born.

The Bill proposes to prohibit sex selection by an ART provider, with a maximum fine of 240 penalty units or two years imprisonment. There would be an exception where it is necessary for a child to be of a particular sex so as to reduce the risk of the transmission of a genetic abnormality or genetic disease to the child.

Addendum to birth certificates

The Bill proposes an amendment to the Births, Deaths and Marriages Act 2023 (Qld) requiring the registrar, upon application from a donor-conceived person who is at least 16 years of age, to attach an addendum to a birth certificate stating that further information is available in a register kept by the registrar. This is to ensure individuals can discover their donor status independently, even if their parents choose not to disclose this information. Ultimately, obtaining further information from the registrar will be at the individual's discretion.