Registration as an ART provider. The Act requires providers to be registered. This regulation fixes the application fee at $3,418 (section 4) and the annual registration fee at $2,420 (section 6(1)). Annual fees are payable before the anniversary of registration each year (section 6(2)). The application must disclose any prior convictions under ART legislation, any refusal, cancellation, revocation or suspension of federal accreditation, and the corporation’s Australian Company Number, registered office, and principal place of business if the applicant is a corporation (section 5).

Federal accreditation. The regulation distinguishes between providers that hold federal accreditation (by the Reproductive Technology Accreditation Committee of the Fertility Society of Australia and New Zealand, or a body prescribed under the Commonwealth Research Involving Human Embryos Act 2002) and those that do not. Non‑accredited providers must meet the infection control standards set out in the Department’s “Infection Prevention and Control in Healthcare Settings” (15 September 2023) and paragraph 5.2.4 of the NHMRC’s ethical guidelines as in force from time to time (section 8). This creates a tiered regulatory burden: accredited providers are taken to satisfy infection control through their existing accreditation, whereas unaccredited providers must independently comply with the specified standards.

Central register for surrogacy information. Part 3 (sections 11-15) creates a new data‑collection and disclosure regime specific to surrogacy arrangements. A “relevant person” is an adult who was born as a result of a surrogacy arrangement and whose parentage has been transferred by a parentage order (section 11). The Secretary must enter into the central register the child’s full name, date and place of birth, and sex; the birth parent’s and each gamete provider’s full name, residential address, date and place of birth, ethnicity and physical characteristics, and medical history or genetic test results relevant to the future health of the child or descendants (section 12(1)). The Secretary must also enter the sex and year of birth of each biological sibling of the child (section 12(1)(c)). The regulation permits the relevant person to voluntarily provide additional information: residential address, medical history or genetic test results relevant to the health of the birth parent, gamete provider, or their descendants (section 12(2)). On application by a relevant person, the Secretary must disclose certain information about each birth parent or gamete provider: residential address, date and place of birth, ethnicity and physical characteristics, and relevant medical history or genetic test results (section 13). The Secretary must also disclose the sex and year of birth of biological siblings (section 14). Birth parents and gamete providers may apply to learn the sex and year of birth of the relevant person (section 15). The note to section 13 clarifies that the Act’s section 41F also requires the name of the birth parent or gamete provider to be given, and disclosure may be made only to an adult.

Maximum number of families per donor. Section 15A, inserted by 2025 (555), prescribes classes of women who are exempt from the general limit on the number of families that may receive treatment using a particular donor’s gametes (Act, section 27). The exemption applies to women who, before 1 October 2025, had an embryo of themselves or their spouse held in storage, reserved the use of a gamete held in storage, or reserved the use of a particular donor’s gamete held outside the State and commenced preliminary treatment with a registered ART provider no more than three months before that date. The exemption does not apply unless the provider informs the woman that offspring of the donor may have been born to more than five women, and gives that information before using the embryo or gamete. The exemption applies only to the specific embryos and gametes referred to in the paragraphs.

Relevant person. In Part 3 only, “relevant person” means an adult born through a surrogacy arrangement whose parentage has been transferred by a parentage order (section 11). This is a precise subset of donor‑conceived persons, not all donor‑conceived individuals.

ART legislation. The term is defined in section 3 to include the Act and this regulation, plus the Human Cloning for Reproduction and Other Prohibited Practices Act 2003 (NSW), the Commonwealth Prohibition of Human Cloning for Reproduction Act 2002, the Commonwealth Research Involving Human Embryos Act 2002, and the Research Involving Human Embryos (New South Wales) Act 2003, together with regulations under those Acts. This definition governs the scope of disclosures required in registration applications (section 5(a)) and notice obligations (section 7(a)).

Registered ART providers are the primary duty‑holders. They must pay application and annual fees, disclose their accreditation and conviction history, notify the Secretary of specified events or changes (convictions, accreditation status changes, corporate details), meet infection control standards if not federally accredited, employ or contract counsellors who meet prescribed qualifications, take reasonable steps to establish whether a gamete provider is alive when the last known address is interstate, keep records of compliance with the maximum‑families limit, and supply identifying information about women and offspring in response to written directions. Providers that handle donated gametes must also inform exempted women that offspring of the donor may have been born to more than five families.

Women receiving ART treatment using donated gametes are affected by the maximum‑families rules. The regulation exempts certain women who had embryos or gametes in storage or reserved before 1 October 2025, but only if the provider gives the required information beforehand. Women who do not fall within the prescribed classes will be subject to the Act’s limit on the number of families per donor.

Gamete donors are indirectly affected. The central register captures identifying information about each gamete provider under a surrogacy arrangement (section 12(1)(b)), and that information may be disclosed to the relevant person (section 13). Donors of gametes used in non‑surrogacy ART are not within Part 3, but the Secretary can require providers to give identifying information about women who used a donor’s gametes and any offspring (section 19). The maximum‑families limit directly constrains how many families can use a single donor’s gametes, reducing the donor’s potential genetic reach.

Birth parents under surrogacy arrangements are also subject to information collection. Their residential address, ethnicity, medical history, and family medical history are entered in the central register and may be disclosed to the relevant person. They may apply for disclosure of the sex and year of birth of the relevant person (section 15).

Relevant persons (adults born through surrogacy with a parentage order) are the intended beneficiaries of the disclosure regime. They can apply to receive detailed identifying and medical information about birth parents and gamete providers, as well as the sex and year of birth of biological siblings. They may also voluntarily contribute their own medical history to the register (section 12(2)).

The Secretary of NSW Health is responsible for maintaining the central register, entering information, processing applications for disclosure, issuing written directions for information, and considering psychological reports before approving contact between applicants and the person whose information is sought. The Secretary must also be notified of events or changes under section 7.

Counsellors are affected by the qualification requirements in section 9. Only psychologists, health practitioners with recognised psychiatry or general practice qualifications (who are not providing the ART services to which the counselling relates), or persons eligible for membership of the Australian Association of Social Workers are qualified to provide counselling services under the Act. This excludes practitioners without those specific credentials.

The broader community is affected through the registry’s privacy implications. The central register collects sensitive personal and medical information, including about family members of birth parents and gamete providers (section 12(1)(b)(vi)(C) and (D)). That information is disclosable to relevant persons, raising trade‑offs between reproductive transparency and privacy rights of third parties.

Duties of ART providers. The regulation imposes several specific duties. Under section 5, an applicant for registration must state whether it has been convicted of contravening any ART legislation, whether it has ever been refused federal accreditation, and whether accreditation has been cancelled, revoked or suspended; if the applicant is a corporation, it must provide its Australian Company Number, registered office address, and principal place of business. Section 7 requires a registered provider to give notice to the Secretary if it is convicted under any ART legislation, is refused federal accreditation, or has accreditation cancelled, revoked or suspended; if the provider is a corporation, it must notify changes to the same corporate details listed in section 5. Section 8 obliges providers without federal accreditation to meet the two infection control documents. Section 9 limits counselling to qualified persons, so providers must ensure their counsellors are psychologists, qualified health practitioners not providing the treatment, or social workers eligible for AASW membership. Section 10 requires a provider to take reasonable steps to establish whether a gamete provider is alive when the last known address is interstate by obtaining a death certificate from the interstate registering authority. Under section 15B, providers must keep records of all steps taken to ensure compliance with the maximum‑families limit in section 27(1) of the Act for each woman who was given ART treatment using a donated gamete. Section 18 requires providers to give the Secretary, when reporting a donor under section 41U of the Act, identifying information about each woman who has undergone treatment using that donor’s gamete and each offspring born. Section 19 empowers the Secretary to direct a person (including a provider) to give information about women and offspring.

Duties of the Secretary. The Secretary must enter in the central register the surrogacy information listed in section 12(1) (child’s details, birth parent and gamete provider details, sibling details). The Secretary must, on application by a relevant person, disclose the information in sections 13 and 14 (address, DOB, POB, ethnicity, medical history, sibling sex and year of birth). The Secretary must, on application by a birth parent or gamete provider, disclose the relevant person’s sex and year of birth (section 15). The Secretary must take into account a psychological report obtained at the applicant’s cost when forming an opinion under section 40A(3) of the Act about whether contact between the applicant and the person whose information is sought is justified (section 16). The Secretary must give notice to an applicant within 28 days (section 17).

Rights of relevant persons. A relevant person has the right to apply for disclosure of the information listed in section 13 (address, DOB, POB, ethnicity, medical history of birth parents and gamete providers, and family medical history) and the sex and year of birth of biological siblings (section 14). They may also voluntarily provide their own residential address and medical history for inclusion in the register (section 12(2)). The note to section 13 confirms that the Act requires the name of the birth parent or gamete provider to be given, so a relevant person effectively has a statutory right to know the identity of the adults involved in their conception.

Rights of birth parents and gamete providers. They may apply to the Secretary for disclosure of the sex and year of birth of the relevant person (section 15). They do not receive identifying information about the relevant person.

Rights of women using donated gametes. The exemption in section 15A gives certain women who had embryos or gametes stored or reserved before 1 October 2025 a right to receive ART treatment using those gametes or embryos beyond the general limit of five families. However, the provider must first inform the woman of the possible existence of more than five families of offspring. The exemption is restricted to the specific embryos and gametes identified in the paragraphs.

Qualification rights for counsellors. Psychologists, health practitioners with recognised psychiatry or general practice qualifications who are not treating the patient, and persons eligible for AASW membership have a right to provide counselling services under the Act. Others are excluded.

The regulation itself does not create offences or set penalties. Penalties are provided in the Assisted Reproductive Technology Act 2007. However, the regulation imposes duties that, if breached, may lead to enforcement action under the Act. For example, a registration application that does not comply with section 5 may be rejected, and a provider that fails to comply with notice obligations under section 7 may face consequences under the Act’s provisions on registration conditions. The Act penalises unregistered provision of ART services and failure to comply with certain requirements. While the source does not list specific penalty amounts, practitioners should be aware that the Act carries maximum penalties for non‑compliance, and the regulation’s duties are legally binding. The regulation also indirectly enforces standards through the registration framework: a provider that loses federal accreditation or is convicted under ART legislation must notify the Secretary, potentially triggering review of registration. The Secretary’s power under section 19 to require information includes identifying information, and failure to comply with a written direction may be an offence under the Act. The psychological report requirement (section 16) imposes a cost barrier on applicants seeking contact; while not a penalty, it filters applications. The savings provision (section 20) ensures continuity, meaning non‑compliance that started under the 2014 regulation continues to be relevant. There is no provision in the regulation for civil penalties, infringement notices, or enforceable undertakings; enforcement is likely through the Act’s general scheme, which includes criminal offences and court orders. The regulation’s practical enforcement relies on the Secretary’s oversight and the threat of refusal or cancellation of registration. For providers, the greatest risk is reputational and regulatory: failure to comply with infection control standards, counsellor qualifications, or record‑keeping requirements could result in loss of registration or accreditation, effectively shutting down the business. The four‑yearly amendment cycle (the 2024 regulation replaces the 2014 regulation) suggests periodic review, but immediate enforcement mechanisms are left to the Act. The note in section 2 of the regulation reminds readers that the 2014 regulation is repealed under the Subordinate Legislation Act 1989, section 10(2), signalling that compliance with the old regulation is no longer sufficient.

The regulation expressly defines “ART legislation” to include four other Acts and their regulations: the Human Cloning for Reproduction and Other Prohibited Practices Act 2003 (NSW), the Commonwealth Prohibition of Human Cloning for Reproduction Act 2002, the Commonwealth Research Involving Human Embryos Act 2002, and the Research Involving Human Embryos (New South Wales) Act 2003. This means that a conviction under any of those laws triggers the disclosure obligations in sections 5(a) and 7(a) of this regulation. The regulation also references the Commonwealth Act’s definition of “accredited ART centre” for the purpose of “federal accreditation” (section 3). Providers who hold federal accreditation under that Commonwealth scheme are exempt from the infection control standards in section 8. The regulation incorporates the NHMRC’s Ethical guidelines on the use of assisted reproductive technology in clinical practice and research, as in force from time to time, specifically paragraph 5.2.4 (section 8(b)). This means the regulation dynamically refers to an external code that can change without amendment of the regulation. Similarly, the Department’s Infection Prevention and Control in Healthcare Settings (15 September 2023) is incorporated by reference (section 8(a)). The regulation interacts with interstate death registration laws: section 10 allows a provider to rely on a certificate from the registering authority of another State or Territory under that jurisdiction’s corresponding registration law. The Act itself remains the primary source of duties and penalties; this regulation fills in details such as fees, timeframes, and data fields. The regulation is subordinate to the Act, so any inconsistency must be resolved in favour of the Act. The research and human cloning Acts are referenced to ensure consistency across the regulatory landscape for ART and embryo research. The regulation does not purport to override privacy laws such as the Privacy and Personal Information Protection Act 1998 (NSW), but the central register provisions create specific statutory authorisations for collection and disclosure of personal information, which may override otherwise applicable privacy principles. Practitioners should also consider the Health Records and Information Privacy Act 2002 (NSW) regarding the medical history and genetic test results collected under sections 12 and 13. The regulation’s disclosure regime for surrogacy information exists alongside the Act’s general donor information provisions; the regulation clarifies the detail for surrogacy‑specific data. The maximum‑families exemption in section 15A interacts with the Act’s section 27, which sets the general limit; the regulation carves out exceptions for pre‑existing arrangements. Finally, the savings provision (section 20) ensures that acts done under the 2014 regulation continue to have effect, smoothing the transition but also meaning that obligations that arose before 1 September 2024 may still be relevant for compliance and disclosure.

The regulation was made on an unspecified date and commenced on 1 September 2024. It replaced the Assisted Reproductive Technology Regulation 2014, which was repealed on the same day by operation of the Subordinate Legislation Act 1989, section 10(2). The regulation has been amended twice as reflected in the source text. Amendment 2025 (452) (Sch 1[1] and [2]) adjusted the fees: the registration application fee was set at $3,418 (section 4) and the annual registration fee at $2,420 (section 6). It is not clear from the source what the previous fees were, but the amendment indicates fee revision. Amendment 2025 (555) (Sch 1) inserted two new provisions: section 15A (prescribed classes of women exempt from the maximum number of families) and section 15B (record‑keeping for donated gamete treatment). Section 15A also introduced a defined term “relevant date” meaning 1 October 2025. These amendments were added after the initial commencement, meaning the regulation as originally gazetted did not contain those provisions. The amendment history shows that the regulation is a living instrument responsive to policy changes regarding donor limits. The inclusion of a prospective date (1 October 2025) for the exemption cut‑off indicates that the regulation anticipates transitional arrangements for women who had embryos or gametes stored before that date. No other amendments are noted. The lack of amendment history for Part 3 suggests the surrogacy register provisions were part of the original instrument. The savings provision (section 20) ensures continuity but does not itself amend the regulation. Practitioners should monitor future amendments, particularly regarding fee amounts (which may be indexed) and the maximum‑families rules (which may be further refined). The regulation does not include a sunset clause in the text provided, but the Subordinate Legislation Act 1989 generally provides for automatic repeal after a period unless re‑made.

The source text does not reference any litigation or court decisions. The regulation is a subordinate instrument providing administrative detail; it is unlikely to be the direct subject of litigation. However, disputes may arise under the Act regarding, for example, the Secretary’s refusal to disclose information under the central register provisions, or the application of the maximum‑families exemptions. No cases are cited in the regulation itself. The regulation’s reliance on the NHMRC guidelines and the Department’s infection control document could give rise to interpretive challenges if those external documents are amended or if a provider challenges the application of a particular standard. Ethical guidelines that are “in force from time to time” (section 8) may raise issues of delegated law‑making and procedural fairness if changes are made without notice. The psychological report requirement (section 16) could be challenged on the basis that the applicant bears the cost, potentially creating a barrier to access to information. The definition of “relevant person” in section 11 limits the disclosure rights to adults who have obtained a parentage order; a person born through surrogacy who has not obtained such an order may test the limits of this definition. The regulation’s provisions on identifying information about women and offspring (sections 18 and 19) could be subject to privacy challenges, particularly if the Secretary’s direction is overly broad. At the time of writing, no litigation history is provided in the source, and the regulation has been in force for less than two years. The amendment inserting section 15A took effect only in 2025, so litigation may yet emerge around the cut‑off date of 1 October 2025 and the scope of the exemption. Practitioners should stay alert to future cases interpreting the Act and this regulation.

Several provisions in the regulation contain traps for the unwary. The registration application must state whether the applicant has been convicted of contravening any ART legislation (section 5(a) - note the wide definition includes four other Acts). A failure to disclose a prior conviction could lead to refusal or later cancellation, even if the conviction was minor or unrelated to fertility practice. The notice obligation under section 7 applies not only to the provider’s own convictions but also to any refusal, cancellation, revocation or suspension of federal accreditation. A temporary suspension triggers reporting without delay. The infection control standards in section 8 apply only to providers without federal accreditation, but the standards incorporate documents that may be amended without notice. Providers must track changes to the NHMRC ethical guidelines paragraph 5.2.4 and the Department’s infection control document. The counsellor qualification requirements (section 9) exclude many experienced counsellors who are not psychologists, not health practitioners with recognised psychiatry or general practice qualifications, and not eligible for AASW membership. This may restrict an ART provider’s ability to use counsellors who are, for example, registered with the Psychotherapy and Counselling Federation of Australia but who lack AASW eligibility. The reasonable steps to establish if a gamete provider is alive (section 10) apply only when the last known address is interstate. If the address is in NSW or unknown, the regulations do not specify what steps are required, leaving providers to rely on the Act’s more general provisions. The central register for surrogacy information (Part 3) applies only to surrogacy arrangements that result in the birth of a child. If a surrogacy arrangement does not result in a live birth, no information is entered. The definition of “relevant person” in section 11 is narrow: only adults born through surrogacy and whose parentage has been transferred by a parentage order can apply for disclosure. This excludes, for instance, a child or adolescent, and may exclude a person whose parentage was transferred by other means (though parentage orders are the standard legal mechanism in NSW). The disclosure provisions under sections 13, 14, and 15 apply to “each birth parent” and “a gamete provider”. The regulation does not define “birth parent” but the Act likely does; providers must ensure they correctly identify all relevant parties. Section 15A exemptions for the maximum number of families come with strings attached. The provider must inform the woman before using the embryo or gamete that offspring of the donor may have been born to more than five women. If the provider fails to give this information, the exemption does not apply even if the woman qualifies. The exemption applies only to embryos and gametes specifically identified in the three subparagraphs; a woman cannot rely on general storage. The “relevant date” of 1 October 2025 is a hard cut‑off; any embryo or gamete not stored or reserved before that date does not qualify. Section 15B imposes a record‑keeping duty “for each woman who was given ART treatment using a donated gamete.” This means providers must document compliance steps for all women, not only those seeking exemption. The psychological report under section 16 must be obtained at the applicant’s own cost and must accompany the application. If the report is not provided, the Secretary may not be satisfied, and the application may stall. The 28‑day period for notice under section 17 runs from the date of application; a provider or applicant who expects a quicker response may need to manage expectations. Section 18 requires providers to give identifying information about each woman who has undergone treatment using the donor’s gamete and each offspring born. This is a broad disclosure obligation that may conflict with privacy expectations of former patients, but is mandatory. Section 19 empowers the Secretary to require information about a “specified donor”, without limitation on past or future patients. The savings provision (section 20) means that any notice, direction, or authorisation given under the 2014 regulation continues in force. Providers should check whether they are relying on pre‑existing approvals that may not align with the new regulation’s detail. Finally, the fees in sections 4 and 6 have been amended by 2025 (452); providers should ensure they pay the current amounts and not the original fees.

To comply with the Assisted Reproductive Technology Regulation 2024, an ART provider should take the following practical steps.

Registration and fees. When applying for initial registration, include the $3,418 application fee (section 4) and answer the questions in section 5 truthfully: disclose any convictions under ART legislation, any refusal, cancellation, revocation or suspension of federal accreditation, and if a corporation, the Australian Company Number, registered office, and principal place of business. After registration, pay the annual fee of $2,420 before each anniversary of the date of registration (section 6). Set up a calendar reminder well in advance to avoid late payment, which could risk cancellation.

Ongoing notification. Appoint a compliance officer to monitor events that trigger notification under section 7: any conviction under ART legislation, any change in federal accreditation status (refusal, cancellation, revocation or suspension), and corporate detail changes. Notify the Secretary immediately upon any such event. Maintain a log of notifications with copies of correspondence.

Infection control. If the provider does not hold federal accreditation, obtain and implement the infection control standards in the Department’s “Infection Prevention and Control in Healthcare Settings” (15 September 2023) and paragraph 5.2.4 of the NHMRC ethical guidelines (as amended from time to time). Create a policy document cross‑referencing these standards, and conduct staff training. Keep records of audits and corrective actions. If the provider later obtains federal accreditation, the infection control obligation ceases.

Counselling. Ensure that any counsellor providing services under the Act is a psychologist, or a health practitioner with recognised psychiatry or general practice qualifications who does not also provide the ART services to the same patient, or a person eligible for membership of the Australian Association of Social Workers (section 9). Obtain and keep copies of counsellors’ qualifications and registration evidence. Do not use counsellors who are, for example, life coaches or counsellors registered only with non‑statutory bodies.

Gamete provider alive checks. When a gamete provider’s last known address is in another State or Territory, take reasonable steps as defined in section 10 by requesting a death certificate from the relevant interstate registering authority. Document the request and response. If the address is within NSW or unknown, consider what other steps the Act might require - the regulation does not prescribe them, but a provider should still document diligent efforts.

Central register for surrogacy information. For every surrogacy arrangement that results in the birth of a child, the provider must ensure the Secretary receives the information listed in section 12(1) to be entered in the central register. This includes the child’s full name, date and place of birth, sex; the birth parent’s and each gamete provider’s full name, residential address, date and place of birth, ethnicity and physical characteristics, medical history or genetic test results relevant to future health (including family members). The provider should collect this information at the outset of the surrogacy arrangement, with appropriate consents, and transmit it promptly to the Secretary. Also collect the sex and year of birth of each biological sibling. If a relevant person (adult born through surrogacy with a parentage order) voluntarily offers their address or medical history, pass that to the Secretary for entry under section 12(2).

Disclosure applications. When a relevant person applies for information under sections 13 or 14, the Secretary must disclose. The provider should cooperate with the Secretary by providing any requested data. For birth parent or gamete provider applications under section 15, similarly cooperate. Ensure the applicant understands the cost and process for the psychological report under section 16 if they seek contact. The report must be obtained at the applicant’s own cost and accompany the application. The Secretary will consider it before forming an opinion on contact.

Maximum families and record‑keeping. If the provider uses donated gametes, track the number of families that have received treatment using each donor. The Act’s general limit is five families, but section 15A exempts certain women who had embryos or gametes stored or reserved before 1 October 2025, provided the provider informs the woman before treatment that offspring of the donor may have been born to more than five families. Create a system to flag these exemptions. Maintain detailed records under section 15B of all steps taken to ensure compliance with the limit for each woman given ART treatment using a donated gamete. Keep copies of the disclosure statements given to women.

Information requests. Under sections 18 and 19, the provider must respond to written directions from the Secretary by providing identifying information about women who have undergone treatment using a specified donor’s gametes and about any offspring born. Designate a senior staff member to manage these requests, and maintain a secure database to retrieve the information quickly. Comply within any timeframes specified by the Secretary.

Timeframes. Note the 28‑day period for the Secretary to give notice to an applicant under section 17. Providers should not assume shorter processing times.

Transition. Review any existing arrangements under the now‑repealed 2014 regulation. The savings provision (section 20) preserves their effect, but ensure they align with the new regulation’s requirements. Update all policies, consent forms, and data collection templates to reflect the central register provisions and the maximum‑families exemption details.

Staff training. Train all clinical and administrative staff on these obligations, especially the notification triggers, counselling qualification restrictions, and the requirement to inform exempted women about the possibility of more than five families. Document training sessions.

Privacy and consent. Given the sensitive personal information collected, ensure compliance with relevant NSW privacy legislation. Collect express consents from birth parents, gamete providers, and siblings for the collection and disclosure of their information, referencing the statutory authorisation in the regulation.