{"id":"nsw:sl-2024-0373","name":"Assisted Reproductive Technology Regulation 2024","slug":"assisted-reproductive-technology-regulation-2024","collection":"regulation","jurisdiction":"nsw","status":"in_force","isInForce":true,"actNumber":"373 of 2024","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":174233,"registerId":"nsw-sl-2024-0373-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"# Part 1 Preliminary\n\nPart 1 Preliminary","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name of regulation","content":"#### 1 Name of regulation\n\n1 Name of regulation\n\n> This regulation is the [Assisted Reproductive Technology Regulation 2024](/view/html/inforce/current/sl-2024-0373).","sortOrder":1},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 Commencement\n\n2 Commencement\n\n> This regulation commences on 1 September 2024.\n> \n> Note—\n> \n> This regulation replaces the [Assisted Reproductive Technology Regulation 2014](/view/html/repealed/current/sl-2014-0555), which is repealed on 1 September 2024 by the [Subordinate Legislation Act 1989](/view/html/inforce/current/act-1989-146), section 10(2).","sortOrder":2},{"sectionNumber":"3","sectionType":"section","heading":"Definitions","content":"#### 3 Definitions\n\n3 Definitions\n\n> In this regulation—\n> \n> ART legislation means—\n> \n> > (a) the Act and this regulation, and\n> \n> > (b) the following Acts, and regulations made under those Acts—\n> > \n> > > (i) the [Human Cloning for Reproduction and Other Prohibited Practices Act 2003](/view/html/inforce/current/act-2003-020),\n> > \n> > > (ii) the [Prohibition of Human Cloning for Reproduction Act 2002](http://www.legislation.gov.au/) of the Commonwealth,\n> > \n> > > (iii) the [Research Involving Human Embryos Act 2002](http://www.legislation.gov.au/) of the Commonwealth,\n> > \n> > > (iv) the [Research Involving Human Embryos (New South Wales) Act 2003](/view/html/inforce/current/act-2003-021).\n> \n> federal accreditation means accreditation by—\n> \n> > (a) the Reproductive Technology Accreditation Committee of the Fertility Society of Australia and New Zealand, or\n> \n> > (b) a body prescribed under the [Research Involving Human Embryos Act 2002](http://www.legislation.gov.au/) of the Commonwealth, section 8, definition of accredited ART centre, paragraph (b).\n> \n> relevant person, for Part 3—see section 11.\n> \n> the Act means the [Assisted Reproductive Technology Act 2007](/view/html/inforce/current/act-2007-069).\n> \n> Note—\n> \n> The Act and the [Interpretation Act 1987](/view/html/inforce/current/act-1987-015) contain definitions and other provisions that affect the interpretation and application of this regulation.","sortOrder":3},{"sectionNumber":"Part 2","sectionType":"part","heading":"Registration as ART provider and provision of ART services","content":"# Part 2 Registration as ART provider and provision of ART services\n\nPart 2 Registration as ART provider and provision of ART services","sortOrder":4},{"sectionNumber":"4","sectionType":"section","heading":"Registration application fee—the Act, s 7(2)","content":"#### 4 Registration application fee—the Act, s 7(2)\n\n4 Registration application fee—the Act, s 7(2)\n\n> An application for registration must be accompanied by a fee of $3,418.\n> \n> **s 4:** Am 2025 (452), Sch 1\\[1\\].","sortOrder":5},{"sectionNumber":"5","sectionType":"section","heading":"Matters to be included in registration application—the Act, s 7(3)(e)","content":"#### 5 Matters to be included in registration application—the Act, s 7(3)(e)\n\n5 Matters to be included in registration application—the Act, s 7(3)(e)\n\n> An application for registration must state—\n> \n> > (a) whether or not the applicant has been convicted of contravening any ART legislation, and\n> \n> > (b) whether or not the applicant has ever been refused federal accreditation, and\n> \n> > (c) if the applicant has, or has ever had, federal accreditation—whether or not the applicant has had federal accreditation cancelled, revoked or suspended, and\n> \n> > (d) if the applicant is a corporation—\n> > \n> > > (i) the corporation’s Australian Company Number, and\n> > \n> > > (ii) the address of the corporation’s registered office, and\n> > \n> > > (iii) the address of the corporation’s principal place of business.","sortOrder":6},{"sectionNumber":"6","sectionType":"section","heading":"Annual registration fee—the Act, s 7(8)","content":"#### 6 Annual registration fee—the Act, s 7(8)\n\n6 Annual registration fee—the Act, s 7(8)\n\n> > (1) The annual registration fee is $2,420.\n> \n> > (2) A registered ART provider must pay the annual registration fee before the anniversary of the registered ART provider’s registration each year.\n> \n> **s 6:** Am 2025 (452), Sch 1\\[2\\].","sortOrder":7},{"sectionNumber":"7","sectionType":"section","heading":"Notice of events or changes—the Act, s 8(1)(e)","content":"#### 7 Notice of events or changes—the Act, s 8(1)(e)\n\n7 Notice of events or changes—the Act, s 8(1)(e)\n\n> A registered ART provider must give notice to the Secretary of the following events or changes—\n> \n> > (a) the ART provider is convicted of contravening any ART legislation,\n> \n> > (b) the ART provider is refused federal accreditation,\n> \n> > (c) the ART provider has its federal accreditation cancelled, revoked or suspended,\n> \n> > (d) if the ART provider is a corporation, changes to the following—\n> > \n> > > (i) the corporation’s Australian Company Number,\n> > \n> > > (ii) the address of the corporation’s registered office,\n> > \n> > > (iii) the address of the corporation’s principal place of business.","sortOrder":8},{"sectionNumber":"8","sectionType":"section","heading":"Infection control standards—the Act, s 10","content":"#### 8 Infection control standards—the Act, s 10\n\n8 Infection control standards—the Act, s 10\n\n> An ART provider that does not have federal accreditation must meet the infection control standards in—\n> \n> > (a) the document entitled Infection Prevention and Control in Healthcare Settings published by the Department on 15 September 2023, and\n> \n> > (b) paragraph 5.2.4 of the document entitled Ethical guidelines on the use of assisted reproductive technology in clinical practice and research published by the National Health and Medical Research Council, as in force from time to time.","sortOrder":9},{"sectionNumber":"9","sectionType":"section","heading":"Qualifications of counsellors—the Act, s 12(2C)","content":"#### 9 Qualifications of counsellors—the Act, s 12(2C)\n\n9 Qualifications of counsellors—the Act, s 12(2C)\n\n> A person is qualified to provide counselling services if the person is—\n> \n> > (a) a psychologist, or\n> \n> > (b) a health practitioner who—\n> > \n> > > (i) is not providing ART services to which the counselling relates, and\n> > \n> > > (ii) has qualifications in—\n> > > \n> > > > (A) psychiatry recognised by the Royal Australian and New Zealand College of Psychiatrists, or\n> > > \n> > > > (B) general practice recognised by the Royal Australian College of General Practitioners, or\n> \n> > (c) eligible for membership of the Australian Association of Social Workers.","sortOrder":10},{"sectionNumber":"10","sectionType":"section","heading":"Establishing whether gamete provider is alive—the Act, s 24(3)(b)","content":"#### 10 Establishing whether gamete provider is alive—the Act, s 24(3)(b)\n\n10 Establishing whether gamete provider is alive—the Act, s 24(3)(b)\n\n> > (1) An ART provider takes reasonable steps to establish whether a gamete provider is alive if—\n> > \n> > > (a) the last address of the gamete provider known by the ART provider is in another State or Territory, and\n> > \n> > > (b) the ART provider obtains a certificate from the registering authority of the other State or Territory as to whether the gamete provider’s death is recorded in the register kept under the corresponding registration law of the other State or Territory.\n> \n> > (2) In this section—\n> > \n> > corresponding registration law means a law of another State or Territory that provides for the registration of deaths.\n> > \n> > registering authority means an authority responsible under a corresponding registration law for the registration of deaths.","sortOrder":11},{"sectionNumber":"Part 3","sectionType":"part","heading":"Central register—surrogacy information","content":"# Part 3 Central register—surrogacy information\n\nPart 3 Central register—surrogacy information","sortOrder":12},{"sectionNumber":"11","sectionType":"section","heading":"Definition","content":"#### 11 Definition\n\n11 Definition\n\n> In this part—\n> \n> relevant person means an adult—\n> \n> > (a) who was born as a result of a surrogacy arrangement, and\n> \n> > (b) whose parentage has been transferred by a parentage order.","sortOrder":13},{"sectionNumber":"12","sectionType":"section","heading":"Information to be entered in central register—the Act, s 41B(1)","content":"#### 12 Information to be entered in central register—the Act, s 41B(1)\n\n12 Information to be entered in central register—the Act, s 41B(1)\n\n> > (1) For a surrogacy arrangement that results in the birth of a child, the Secretary must enter in the central register—\n> > \n> > > (a) the following information about the child—\n> > > \n> > > > (i) full name,\n> > > \n> > > > (ii) date of birth,\n> > > \n> > > > (iii) place of birth,\n> > > \n> > > > (iv) sex, and\n> > \n> > > (b) the following information about each birth parent or gamete provider under the surrogacy arrangement—\n> > > \n> > > > (i) full name,\n> > > \n> > > > (ii) residential address,\n> > > \n> > > > (iii) date of birth,\n> > > \n> > > > (iv) place of birth,\n> > > \n> > > > (v) ethnicity and physical characteristics,\n> > > \n> > > > (vi) medical history or genetic test results in relation to the following persons that are relevant to the future health of the child or the child’s descendants—\n> > > > \n> > > > > (A) the birth parent,\n> > > > \n> > > > > (B) the gamete provider,\n> > > > \n> > > > > (C) members of the birth parent’s family,\n> > > > \n> > > > > (D) members of the gamete provider’s family, and\n> > \n> > > (c) the sex and year of birth of each biological sibling of the child.\n> \n> > (2) If provided voluntarily by a relevant person, the Secretary must also enter the following information about the relevant person in the central register—\n> > \n> > > (a) residential address,\n> > \n> > > (b) medical history or genetic test results in relation to the person that are relevant to the future health of—\n> > > \n> > > > (i) the birth parent, or\n> > > \n> > > > (ii) the gamete provider, or\n> > > \n> > > > (iii) the birth parent’s descendants, or\n> > > \n> > > > (iv) the gamete provider’s descendants.","sortOrder":14},{"sectionNumber":"13","sectionType":"section","heading":"Disclosure about birth parents and gamete providers—the Act, s 41F(1) and (2)","content":"#### 13 Disclosure about birth parents and gamete providers—the Act, s 41F(1) and (2)\n\n13 Disclosure about birth parents and gamete providers—the Act, s 41F(1) and (2)\n\n> The Secretary must, on application by a relevant person, disclose the following information held on the central register about each birth parent, or gamete provider under the surrogacy arrangement, of the relevant person—\n> \n> > (a) residential address,\n> \n> > (b) date of birth,\n> \n> > (c) place of birth,\n> \n> > (d) ethnicity and physical characteristics,\n> \n> > (e) medical history or genetic test results in relation to the following persons that are relevant to the future health of the relevant person or the relevant person’s descendants—\n> > \n> > > (i) the birth parent,\n> > \n> > > (ii) the gamete provider,\n> > \n> > > (iii) members of the birth parent’s family,\n> > \n> > > (iv) members of the gamete provider’s family.\n> \n> Note—\n> \n> The Act, section 41F also requires the name of the birth parent or gamete provider to be given. Information may be disclosed under section 41F only to a person who is an adult.","sortOrder":15},{"sectionNumber":"14","sectionType":"section","heading":"Disclosure about biological siblings—the Act, s 41F(3)(a)","content":"#### 14 Disclosure about biological siblings—the Act, s 41F(3)(a)\n\n14 Disclosure about biological siblings—the Act, s 41F(3)(a)\n\n> The Secretary must, on application by a relevant person, disclose the sex and year of birth of each of the relevant person’s biological siblings.","sortOrder":16},{"sectionNumber":"15","sectionType":"section","heading":"Disclosure to birth parent and gamete provider—the Act, s 41G(1)(a)","content":"#### 15 Disclosure to birth parent and gamete provider—the Act, s 41G(1)(a)\n\n15 Disclosure to birth parent and gamete provider—the Act, s 41G(1)(a)\n\n> The Secretary must, on application by a birth parent, or a gamete provider under a surrogacy agreement, of a relevant person, disclose the sex and year of birth of the relevant person.","sortOrder":17},{"sectionNumber":"Part 4","sectionType":"part","heading":"Miscellaneous","content":"# Part 4 Miscellaneous\n\nPart 4 Miscellaneous","sortOrder":18},{"sectionNumber":"15A","sectionType":"section","heading":"Donations—maximum number of families—the Act, s 27","content":"#### 15A Donations—maximum number of families—the Act, s 27\n\n15A Donations—maximum number of families—the Act, s 27\n\n> > (1) For the Act, section 27(1A)(b), the following classes of women are prescribed—\n> > \n> > > (a) women who, before the relevant date, have an embryo of the woman or the woman’s spouse held in storage by a registered ART provider,\n> > \n> > > (b) women who, before the relevant date, reserved the use of a gamete held in storage before the relevant date by a registered ART provider,\n> > \n> > > (c) women who—\n> > > \n> > > > (i) before the relevant date, reserved the use of a particular donor’s gamete held outside of the State, and\n> > > \n> > > > (ii) no more than 3 months before the relevant date, commenced preliminary treatment with a registered ART provider for the purposes of receiving ART treatment using the gamete.\n> \n> > (2) The exemptions set out in subsection (1)(a)–(c) do not apply unless the registered ART provider who is to provide ART treatment to the woman—\n> > \n> > > (a) informs the woman that offspring of the donor may have been born to more than 5 women, and\n> > \n> > > (b) gives the information before using the embryo or gamete to provide ART treatment to the woman.\n> \n> > (3) The exemptions set out in subsection (1)(a)–(c) apply only in relation to the embryos and gametes referred to in the paragraphs.\n> \n> > (4) In this section—\n> > \n> > relevant date means 1 October 2025.\n> \n> **s 15A:** Ins 2025 (555), Sch 1.","sortOrder":19},{"sectionNumber":"15B","sectionType":"section","heading":"Records—the Act, s 31","content":"#### 15B Records—the Act, s 31\n\n15B Records—the Act, s 31\n\n> For the Act, section 31(1)(e), an ART provider must keep records of all steps taken by the ART provider to ensure compliance with the Act, section 27(1) for each woman who was given ART treatment using a donated gamete.\n> \n> **s 15B:** Ins 2025 (555), Sch 1.","sortOrder":20},{"sectionNumber":"16","sectionType":"section","heading":"Secretary must take into account psychological report—the Act, s 40A(3)","content":"#### 16 Secretary must take into account psychological report—the Act, s 40A(3)\n\n16 Secretary must take into account psychological report—the Act, s 40A(3)\n\n> > (1) In forming an opinion under the Act, section 40A(3) that contact between the applicant and the person whose information is proposed to be disclosed is justified, the Secretary must take into account a report that—\n> > \n> > > (a) has been prepared by—\n> > > \n> > > > (i) a medical practitioner with expertise in mental health, or\n> > > \n> > > > (ii) a psychologist, and\n> > \n> > > (b) considers whether the contact is justified to protect the welfare and best interests of the applicant and the person whose information is proposed to be disclosed.\n> \n> > (2) The report must—\n> > \n> > > (a) be obtained by the applicant at the applicant’s cost, and\n> > \n> > > (b) accompany the application.","sortOrder":21},{"sectionNumber":"17","sectionType":"section","heading":"Time within which notice to applicant must be given—the Act, s 41U(1)","content":"#### 17 Time within which notice to applicant must be given—the Act, s 41U(1)\n\n17 Time within which notice to applicant must be given—the Act, s 41U(1)\n\n> For the Act, section 41U(1), the time prescribed is 28 days.","sortOrder":22},{"sectionNumber":"18","sectionType":"section","heading":"Information to be given to Secretary—the Act, s 41U(3)(b)","content":"#### 18 Information to be given to Secretary—the Act, s 41U(3)(b)\n\n18 Information to be given to Secretary—the Act, s 41U(3)(b)\n\n> An ART provider must, when giving the Secretary information about a donor under the Act, section 41U, also give the Secretary identifying information that the ART provider has about—\n> \n> > (a) each woman who has undergone ART treatment using a gamete donated by the donor, and\n> \n> > (b) each offspring born as a result of the ART treatment.","sortOrder":23},{"sectionNumber":"19","sectionType":"section","heading":"Information to be given in response to written direction—the Act, s 41V(1)(d)","content":"#### 19 Information to be given in response to written direction—the Act, s 41V(1)(d)\n\n19 Information to be given in response to written direction—the Act, s 41V(1)(d)\n\n> > (1) The Secretary may require a person to give the Secretary information about—\n> > \n> > > (a) a woman who has undergone ART treatment using a gamete donated by a specified donor, and\n> > \n> > > (b) offspring born as a result of the ART treatment.\n> \n> > (2) A reference to information in subsection (1) includes identifying information.","sortOrder":24},{"sectionNumber":"20","sectionType":"section","heading":"Savings","content":"#### 20 Savings\n\n20 Savings\n\n> > An act, matter or thing that, immediately before the repeal of the [Assisted Reproductive Technology Regulation 2014](/view/html/repealed/current/sl-2014-0555), had effect under that regulation continues to have effect under this regulation.","sortOrder":25}],"analysis":{"summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"Insufficient substantive content was provided to assess whether the regulation's scope changed from its original intent. The document only contains website navigation, version history, and status metadata — no operative provisions were included. No scope change can be confirmed or denied on the available material."},"complexity_factors":["Only metadata and administrative information was provided — the operative legal provisions (the actual rules) are absent from the supplied text, making substantive analysis impossible","ART law as a subject matter is inherently complex, involving intersecting areas of medical law, family law, privacy, and ethics","The regulation has been amended multiple times in a short period (three versions in under 14 months), suggesting the underlying rules are evolving and potentially intricate","Staged repeal mechanism adds a temporal complexity layer that practitioners must track","The parent Act framework (which this regulation sits under) would add further complexity if the full legislative scheme were analysed"],"plain_english_summary":"This NSW regulation governs assisted reproductive technology (ART) — IVF, artificial insemination, egg freezing and surrogacy‑related procedures — setting the rules clinics and patients must follow. It affects people undergoing fertility treatment, donors, donor‑conceived people, fertility clinics and medical professionals.\n\nIt matters because ART rules shape consent, record‑keeping, donor rights and clinic practices, directly influencing family formation and the rights and experiences of patients and donor‑conceived people."},"issue_detection":{"absurdities":[],"contradictions":[]},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This is a replacement regulation that largely mirrors the structure and intent of the 2014 version it replaces. The 2024 version maintains the same core scope covering ART provider registration, fees, standards, and the central register for surrogacy information. The 2025 amendments (sections 15A and 15B) added specific provisions about donor limits and record-keeping, but these represent targeted additions rather than scope creep beyond the regulation's original purpose of operationalising the Assisted Reproductive Technology Act 2007."},"complexity_factors":["Multiple cross-references to parent Act (Assisted Reproductive Technology Act 2007) and Commonwealth legislation","Nested definitions with multiple levels of indentation (e.g., 'ART legislation' definition spans 4 levels)","Conditional exemptions in section 15A with temporal cut-off dates and notification requirements","Dual registration systems (state registration vs federal accreditation) creating parallel compliance tracks","Information disclosure rules vary by recipient type (relevant person, birth parent, gamete provider) with different data elements for each","Incorporation of external documents by reference (infection control standards, ethical guidelines) that change 'as in force from time to time'"],"plain_english_summary":"This regulation sets the rules for how assisted reproductive technology (ART) — like IVF and sperm/egg donation — is provided in New South Wales. It covers who can run fertility clinics, what they must tell the government, and how information about donors and surrogacy is kept and shared.\n\n**Key things this regulation does:**\n\n- **Sets fees for fertility clinics**: Clinics must pay $3,418 to apply for registration and $2,420 each year to stay registered.\n\n- **Tells clinics what they must disclose**: When applying, clinics must say if they've ever broken ART laws or lost their federal accreditation (official approval to operate).\n\n- **Sets health and safety standards**: Clinics without federal accreditation must follow specific infection control guidelines.\n\n- **Defines who can provide counselling**: Only psychologists, certain psychiatrists and GPs, or eligible social workers can counsel people going through fertility treatment.\n\n- **Creates a central register for surrogacy**: The government keeps detailed records about children born through surrogacy, including information about birth parents and gamete (sperm/egg) providers. When these children become adults, they can apply to learn about their biological origins.\n\n- **Limits how many families can use one donor**: Generally, a donor's gametes can be used for no more than 5 families, with some exceptions for women who already had embryos in storage before October 2025.\n\n- **Protects people's privacy**: Strict rules govern who can access information from the central register and when psychological assessments are needed before contact is allowed.\n\n**Why it matters**: This regulation balances helping people have children through medical assistance with protecting the wellbeing of donors, surrogates, and children born through these arrangements. It ensures clinics operate safely and that people born through surrogacy or donation can eventually learn about their biological heritage."},"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":true,"description":"This regulation expressly replaces the Assisted Reproductive Technology Regulation 2014 (commencing 1 September 2024) and sets out new, specific operational requirements: prescribed fees, expanded data fields for the central surrogacy register, defined disclosure procedures, conditional exemptions for donor limits, mandatory records and procedural steps (including an applicant‑paid psychological report and a 28‑day notice period). Those additions materially narrow and specify compliance duties and administrative processes compared with the prior instrument by turning previously general duties into defined obligations."},"complexity_factors":["Cross‑references to multiple Acts and external instruments (defined 'ART legislation' in s 3; infection control documents referenced in s 8).","Fixed monetary charges and timing obligations (registration application fee in s 4; annual fee and payment timing in s 6).","Detailed application and notification content requirements that allocate who must report what (s 5 and s 7).","Extensive personal and medical data required for the central surrogacy register, including ethnicity, physical characteristics and genetic/medical history (s 12).","Prescribed disclosure regimes with eligibility limits and specific data items for applicants and birth parents/gamete providers (ss 13–15).","Conditional statutory exemptions and preconditions tied to a future date (s 15A), adding transitional complexity.","Mandated recordkeeping obligations tied to specific statutory tests and evidentiary steps (s 15B; s 18).","Procedural requirements that shift costs to applicants (psychological report to be obtained at applicant’s cost in s 16) and set time limits for administrative responses (s 17).","Secretary’s information‑gathering and disclosure powers that involve identifying information and written directions (ss 19; 18), increasing administrative discretion.","Interjurisdictional verification procedure for establishing whether a gamete provider is alive (s 10), adding cross‑jurisdictional process complexity."],"plain_english_summary":"This regulation replaces the 2014 instrument and, from 1 September 2024, sets mandatory fees, registration and notification requirements, infection‑control and counselling qualifications, recordkeeping duties, and detailed rules for a central surrogacy register. It affects ART providers, donors, birth parents, gamete providers and adults born by surrogacy by creating explicit compliance costs, data‑collection and disclosure obligations and procedural steps for applications and information access."}},"importantCases":[],"_links":{"self":"/api/acts/assisted-reproductive-technology-regulation-2024","history":"/api/acts/assisted-reproductive-technology-regulation-2024/history","analysis":"/api/acts/assisted-reproductive-technology-regulation-2024/analysis","conflicts":"/api/acts/assisted-reproductive-technology-regulation-2024/conflicts","importantCases":"/api/acts/assisted-reproductive-technology-regulation-2024/important-cases","documents":"/api/acts/assisted-reproductive-technology-regulation-2024/documents"}}