Assisted Reproductive Technology Regulation 2026

1Short title

This regulation may be cited as the Assisted Reproductive Technology Regulation 2026.

2Commencement

This regulation commences on 1 March 2026.

3Definitions

In this regulation—

audit has the meaning given by the accreditation standard.

audit report, for an audit, means the written report about the audit prepared by the certifying body that conducted the audit.

certifying body has the meaning given by the accreditation standard.

Reproductive Technology Accreditation Committee means the Reproductive Technology Accreditation Committee of The Fertility Society of Australia and New Zealand ACN 006 214 115.

4Informing a person about basic matters or extended matters—Act, s 14

(1)For section 14(2) of the Act, definition basic matters, paragraph (c), the following matters are prescribed—

(a)the risks, benefits and limitations, of which the ART provider is aware or ought reasonably to be aware, in relation to—

(i)obtaining a gamete from the person for an ART procedure; or

(ii)undergoing an ART procedure, having regard to the person’s circumstances;

(b)the cost of an ART service to be provided to the person;

(c)the options available to the person for storing or otherwise dealing with gametes obtained from the person, or embryos created from the gametes, that are not used by the person for an ART procedure.

(2)For section 14(2) of the Act, definition extended matters, paragraph (g), the following matters are prescribed—

(a)for a person providing their gametes as donated gametes—the risks, benefits and limitations, of which the ART provider is aware or ought reasonably to be aware, in relation to obtaining the gametes from the person for an ART procedure;

(b)for a person undergoing an ART procedure, or an intended parent if a surrogate undergoes an ART procedure, that uses a donated gamete or donated embryo—

(i)the risks, benefits and limitations, of which the ART provider is aware or ought reasonably to be aware, in relation to undergoing the procedure, having regard to the person’s circumstances; and

(ii)the matters mentioned in subsection (1)(b) and (c); and

(iii)the relevant medical history of the donor of a donated gamete to be used in the procedure, whether or not the donated gamete was used to create an embryo to be used in the procedure; and

(iv)the date the donated gamete, or a gamete used to create the donated embryo, was obtained from the gamete provider; and

(v)the maximum period, consented to by the gamete provider, during which the donated gamete or donated embryo may be used in an ART procedure.

Note—

See section 27 of the Act in relation to the maximum period for the gamete provider’s consent.

5Matters about which counselling must be provided—Act, s 15

(1)For section 15(5) of the Act, each of the following matters is a matter about which counselling under section 15(1) of the Act is to be provided—

(a)the social and psychological implications of donating a gamete or embryo for use in an ART procedure;

(b)the effect of consent mentioned in section 18 of the Act for the use of a donated gamete or donated embryo in an ART procedure;

(c)the timing for modifying or withdrawing consent under section 20 of the Act and the effect of the modification or withdrawal on the use of a donated gamete or donated embryo in an ART procedure;

(d)the ways in which an approval of the chief executive given under section 39B of the Act may affect the effect of consent mentioned in paragraph (b);

(e)the collection of information by an ART provider under part 2, division 6 of the Act;

(f)the disclosure of information by an ART provider or the chief executive under part 2, division 7 of the Act;

(g)the inclusion of information in the donor conception information register under part 3, division 3 of the Act;

(h)the disclosure of information in the donor conception information register under part 3, division 4 of the Act.

(2)For section 15(5) of the Act, each of the following matters is a matter about which counselling under section 15(2) of the Act is to be provided—

(a)the social and psychological implications of a decision to use a donated gamete or donated embryo in an ART procedure for each of the following persons—

(i)the person proposing to undergo the procedure, if the person is an intended parent;

(ii)a spouse of the person, other than a spouse from whom the person is separated and is living separately and apart;

(b)the possible effects of a decision to use a donated gamete or donated embryo in an ART procedure for a donor-conceived person born as a result of the procedure;

(c)the cultural, philosophical, religious or other beliefs of the person provided with counselling that may influence a decision of the person about storing or otherwise dealing with gametes or embryos that are not used by the person for an ART procedure;

Example—

a belief of the person that an embryo not used by the person for an ART procedure should not be disposed of

(d)the matters mentioned in subsection (1)(b) to (d);

(e)the collection of information, by an ART provider under section 35(2)(b) of the Act, about a child born as a result of an ART procedure;

(f)the disclosure of information, by an ART provider or the chief executive under part 2, division 7 of the Act, about a donor-conceived person;

(g)the inclusion of information about a donor-conceived person in the donor conception information register under part 3, division 3 of the Act;

(h)the disclosure of information about a donor-conceived person in the donor conception information register under part 3, division 4 of the Act.

6Matter to be included in consent of gamete provider—Act, s 18

For section 18(2)(c) of the Act, an acknowledgement that the gamete provider has been informed by the ART provider to whom the donated gametes or donated embryos are provided, about how and when the gamete provider’s consent may be modified or withdrawn under section 20 of the Act is prescribed.

7Consent for each cycle of ART procedure—Act, s 19

For section 19(2) of the Act, a separate consent of a person who undergoes an ART procedure involving different cycles is required for each cycle.

8Inquiries about whether gamete provider still alive—Act, s 26

(1)For section 26(5)(b) of the Act, the following inquiries are prescribed—

(a)attempting to contact the gamete provider using any contact information the ART provider has for the gamete provider;

(b)if there is a connection with another State—inquiring whether the death of the gamete provider has been registered under a law of the other State that provides for the registration of deaths;

(c)if a gamete or embryo to be used in an ART procedure was supplied from an ART provider in a place outside Australia (an overseas ART provider)—

(i)asking the overseas ART provider whether the gamete provider is still alive; and

(ii)if the overseas ART provider tells the ART provider that the gamete provider has died, asking the overseas ART provider for the date of the death.

(2)For subsection (1)(b), there is a connection with another State if—

(a)the residential address of the gamete provider most recently recorded by the ART provider is an address in another State; or

(b)a gamete or embryo to be used in an ART procedure was supplied from an ART provider in another State.

9Requirements for independent review body—Act, s 31

For section 31(2)(b) of the Act, the following requirements are prescribed—

(a)the body must be—

(i)established by a licensed ART provider; or

(ii)established by another person and engaged by a licensed ART provider;

(b)each person who constitutes the body must be independent of the person from whom a gamete is retrieved and the person’s spouse;

Examples of persons who are not independent of the person or the person’s spouse—

•a family member of the person or the person’s spouse

•a fertility specialist or legal representative engaged by the person or the person’s spouse

•a counsellor who provides or has provided counselling services to the person or the person’s spouse

(c)the body must include 1 or more persons with the following experience—

(i)5 or more years experience in medical ethics;

(ii)5 or more years experience in mental health;

(iii)5 or more years experience in law;

(iv)5 or more years experience in child protection or child welfare.

10Disclosure of health information to particular persons—Act, s 38

(1)For section 38(2)(f) of the Act, the following persons are prescribed—

(a)a person, other than a donor-conceived person, of whom the donor mentioned in section 38(2) of the Act is a biological parent;

(b)a parent of, or other person with parental responsibility for, a person mentioned in paragraph (a);

(c)a parent of, or other person with parental responsibility for, a person who is a descendant mentioned in section 38(2)(b) of the Act.

(2)For section 38(3)(f) of the Act, the following persons are prescribed—

(a)a person, other than a donor-conceived person, of whom the donor mentioned in section 38(3)(a) of the Act is a biological parent;

(b)a parent of, or other person with parental responsibility for, a person mentioned in paragraph (a);

(c)a descendant of the donor-conceived person mentioned in section 38(3) of the Act;

(d)a parent of, or other person with parental responsibility for, a descendant mentioned in paragraph (c).

11Relevant information to be included in register—Act, s 44

For section 44(2)(n) of the Act, the following information is prescribed—

(a)information stating whether a donated gamete obtained from the donor was a human sperm or human egg;

(b)if it is known that the donor has died—

(i)information stating the donor has died; and

(ii)the date of death of the donor, if known; and

(iii)the cause of death of the donor, if known.

12Evidence of death of party to private donor conception procedure—Act, s 47

(1)For section 47(4) of the Act, a certificate issued under a relevant law that evidences the registration of the death of a party to the procedure is authorised.

(2)In this section—

relevant law means—

(a)if the party’s death is registered under the Births, Deaths and Marriages Registration Act 2023—that Act; or

(b)if the party’s death is registered under a law of another State that provides for the registration of deaths—that law; or

(c)if the party’s death is registered under a law of any place outside Australia—the law of the place.

13Accreditation standard—Act, s 56A

For section 56A(1)(b) of the Act, the document called ‘Code of practice for assisted reproductive technology units’, developed by the Reproductive Technology Accreditation Committee and published by The Fertility Society of Australia and New Zealand ACN 006 214 115 is approved.

Note—

The document is available on the website of The Fertility Society of Australia and New Zealand.

14Documents to be included in application for licence—Act, s 57

For section 57(2)(b)(v) of the Act, the following documents are prescribed—

(a)a copy of the audit report for the most recent audit of the ART services provided by the applicant that has been conducted;

(b)a declaration, in the approved form, that the applicant is solvent and able to pay the costs associated with operating and maintaining record-keeping systems and systems for storing human biological products as stated in the approved form.

15Application fee for licence—Act, s 57

For section 57(2)(c) of the Act, the following fees are prescribed—

(a)for an application for a licence—3,324 fee units;

(b)for an application for a further licence under section 57(4) of the Act—

(i)for a term of 1 year—995.5 fee units; or

(ii)for a term of 3 years—2,991 fee units.

16Conditions of licence—Act, s 59

For section 59(1) of the Act, the following conditions are prescribed—

(a)the licensed provider’s licence number must be stated on the licensed provider’s website;

(b)the licensed provider must give the chief executive a copy of the audit report for each audit of the ART services provided by the licensed provider as soon as practicable after receiving the audit report for the audit.

17Chief executive to be notified of certain events—Act, s 61

For section 61(1) of the Act, table, item 9—

(a)an event stated in column 1 of the following table is prescribed; and

(b)the time stated in column 2 opposite the event is specified for the event.

Column 1	Column 2
Event	Time within which notice to be given
1  The licensed provider does something for which the consent of a person is required under part 2, division 3 of the Act without the prior written consent of the person	7 days
2  The licensed provider does something for which the consent of a person is required under part 2, division 3 of the Act in a way that is inconsistent with the prior written consent of the person	7 days
3  The licensed provider reasonably believes practices at a laboratory owned or operated by the provider— (a)  are inconsistent with acceptable industry standards for providing ART services; or (b)  have resulted in, or could result in, physical or psychological harm to a person provided with ART services or a person born as a result of an ART procedure	7 days
4  The licensed provider’s business operations have been disrupted, for example, by a natural disaster, a fault with equipment or an attack on, or failure of, electronic information systems, to the extent that—    (a)  ART services can not be provided; or (b)  patient care is compromised or is likely to be compromised; or (c)  the disruption has resulted in, or the licensed provider reasonably believes the disruption could result in, physical or psychological harm to a person provided with ART services or a person born as a result of an ART procedure	7 days
5  If the licensed provider is a corporation— (a)  a licence or other authorisation to provide ART services, however called, held by an associated entity of the corporation under a law of another State is cancelled or suspended under that law; or (b)  an associated entity of the corporation is prohibited from providing some or all ART services, however called, in another State under a law of that State	7 days
6  If the licensed provider is a corporation— (a)  any assets or liabilities of the licensed provider are merged with assets or liabilities of another corporation; or (b)  another change in relation to assets or liabilities of the licensed provider occurs, if the change affects, or is likely to affect, the ownership, governance or operations of the licensed provider; or (c)  another change in relation to the operations of the licensed provider occurs, if the change materially affects, or will materially affect, the provision of ART services by the licensed provider	21 days
7  If the licensed provider is a corporation that is a subsidiary of another corporation (the parent entity)— (a)  any assets or liabilities of the parent entity are merged with assets or liabilities of another corporation; or (b)  another change in relation to assets or liabilities of the parent entity occurs, if the change affects, or is likely to affect, the ownership, governance or operations of the parent entity or the licensed provider; or (c)  another change in relation to the operations of the parent entity occurs, if the change materially affects, or will materially affect, the provision of ART services by the licensed provider	21 days

18Circumstances for cancelling or suspending licence—Act, s 64

(1)For section 64(2)(c) of the Act, the following circumstances are prescribed—

(a)a licence or other authorisation to provide ART services, however called, held by the person under a law of another State is cancelled or suspended under that law;

(b)the person is prohibited from providing some or all ART services, however called, in another State under a law of that State;

(c)the person is or has been under voluntary administration under the Corporations Act;

(d)the person is or has been an insolvent under administration;

(e)any of the personnel, within the meaning of the accreditation standard, who are engaged in the provision of ART services by the person cease to perform their role and, within 30 days, replacement personnel have not been appointed to perform the role.

(2)For subsection (1)(a) to (d), if the person is a corporation, the reference to the person in each paragraph includes a reference to an associated entity of the corporation.

19Information for public register of licensed providers—Act, s 65

For section 65(2)(f) of the Act, the following information is prescribed—

(a)if a licensed provider’s licence is or has been subject to a specific condition under section 59(2) of the Act—

(i)the specific condition; and

(ii)the date the specific condition was imposed on the licence; and

(iii)if the specific condition has been removed, the date of the removal;

(b)if a prohibition notice is or has been issued to a licensed provider under section 63 of the Act—

(i)the particulars of the matters stated in the prohibition notice; and

(ii)the date the prohibition notice took effect; and

(iii)if the prohibition notice has been revoked, the date of the revocation;

(c)if a licensed provider’s licence is or has been suspended under section 64 of the Act—

(i)the reason for the suspension; and

(ii)the date the suspension took effect; and

(iii)if the suspension has been lifted, the date it was lifted.

20Matter court must take into account when considering compensation—Act, s 115

For section 115(5) of the Act, whether the exercise, or purported exercise, of a power by or for an inspector was lawful is a matter the court must take into account.

21Prescribed accreditation—Act, sch 1

For schedule 1 of the Act, definition prescribed accreditation, the Reproductive Technology Accreditation Committee is prescribed.