New South Wales: Assisted Reproductive Technology Act 2007 (NSW)

Assisted Reproductive Technology Act 2007 No 69 An Act relating to the regulation of assisted reproductive technology services, the registration of assisted reproductive technology service providers and the prohibition of commercial surrogacy; and for other purposes. Part 1 Preliminary 1 Name of Act This Act is the Assisted Reproductive Technology Act 2007. 2 Commencement This Act commences on a day or days to be appointed by proclamation. 3 Objects of Act The objects of this Act are— (a) to prevent the commercialisation of human reproduction, and (b) to protect the interests of the following persons— (i) a person born as a result of ART treatment, (ii) a person providing a gamete for use in ART treatment or for research in connection with ART treatment, (iii) a woman undergoing ART treatment. 4 Definitions (1) In this Act— adult means a person who is not a child. approved form means a form approved by the Secretary. ART provider means a person who provides ART services and includes a registered ART provider, but does not include a person who provides ART services on behalf of a registered ART provider either under contract or in the course of the person's employment by the registered ART provider. ART service means any one or more of the following services, treatments or procedures that is provided for fee or reward or provided in the course of a business (whether or not for profit)— (a) an ART treatment, (b) the storage of gametes and embryos for use in ART treatment, (c) the obtaining of a gamete from a gamete provider for use in ART treatment or for research in connection with ART treatment. ART treatment means assisted reproductive technology treatment, being any medical treatment or procedure that procures or attempts to procure pregnancy in a woman by means other than sexual intercourse, and includes artificial insemination, in-vitro fertilisation, gamete intrafallopian transfer and any related treatment or procedure that is prescribed by the regulations. central register means the central register established under Part 3. certificate of authority means the certificate of authority issued to an inspector by the Secretary under Part 5. child means a person who is under the age of 18 years and not married. Department means the Ministry of Health. donated embryo—see section 4B. donated gamete—see section 4B. donor means the gamete provider from whom a donated gamete has been obtained. embryo means the single entity formed by the combination of a human sperm and a human ovum until the time it is implanted in the body of a woman. exercise a function includes perform a duty. full name, in relation to a gamete provider who is a donor, includes each name by which the gamete provider is or has been known. function includes a power, authority or duty. gamete means a human sperm or a human ovum. Note— Section 8 (b) of the Interpretation Act 1987 provides that in any Act or instrument a reference to a word or expression in the singular form includes a reference to the word or expression in the plural form. gamete provider, in relation to a gamete, means the individual from whom the gamete has been obtained and, in relation to an embryo, means an individual from whom a gamete used to create the embryo was obtained. health services provider means any of the following— (a) an ART provider or a person that has at any time been an ART provider, (b) a registered medical practitioner, a person who has at any time been a registered medical practitioner or a person who, at any time before the repeal of the Medical Practice Act 1992, was registered as a medical practitioner under that Act, (c) a public health organisation within the meaning of the Health Services Act 1997, (d) a private health facility within the meaning of the Private Health Facilities Act 2007, (e) any person or body of a class prescribed by the regulations. identifying information means information that identifies the individual to whom the information relates. inspector means a person appointed as an inspector under Part 5. non-identifying information means information that does not identify the individual to whom the information relates. obtain a gamete from a gamete provider includes receive a gamete from a gamete provider. offspring of a person means an individual to whom the person is a biological parent and includes an individual born as a result of ART treatment using the person's donated gamete. parent of a child means a person having parental responsibility for the child. parental responsibility, in relation to a child, means all the duties, powers, responsibilities and authority which, by law, parents have in relation to their children. premises includes any land or building and part of any land or building. record includes a book, account, deed, writing, document and any other source of information compiled, recorded or stored in written form, or on micro-film, or by electronic process, or in any other manner or by any other means. registered ART provider means a person registered by the Secretary under Division 1 of Part 2 as an ART provider and whose registration is in force. relevant medical history of a donor means any medical history or genetic test results of the donor or the donor's family that are relevant to the future health of any of the following— (a) persons undergoing ART treatment using the donated gamete, (b) offspring born as a result of the treatment, (c) descendants of such offspring. Secretary means the Secretary of the Department. seized item means anything seized by an inspector under Part 5. spouse of a person means— (a) a person to whom the person is legally married (including a husband or wife of the person), or (b) the person's de facto partner, but if more than one person would so qualify as a spouse, means only the latest person to so qualify. Note— "De facto partner" is defined in section 21C of the Interpretation Act 1987. surrogacy arrangement has the same meaning as it has in the Surrogacy Act 2010. Note— The Interpretation Act 1987 contains definitions and other provisions that affect the interpretation and application of this Act. (2) (Repealed) (3) Notes included in this Act do not form part of this Act. 4A References to ART treatment involving gametes A reference in this Act to ART treatment involving the use of a gamete includes a reference to ART treatment involving the use of an embryo created from a gamete. 4B References to "donated gametes" and "donated embryos" (1) A reference in this Act to a donated gamete— (a) is a reference to a gamete donated by a gamete provider for use by a person other than the gamete provider or the gamete provider's spouse, and (b) includes a reference to a gamete used to create a donated embryo (whether or not the gamete was originally obtained from the gamete provider as a donated gamete and whether or not the embryo was originally created for use as a donated embryo). (2) A reference in this Act to a donated embryo is a reference to an embryo donated after its creation for use by a person who is not— (a) one of the gamete providers from whom the gametes used to create the embryo were obtained, or (b) the spouse of one of those gamete providers. 5 Application of other legislation This Act does not limit or otherwise affect the operation of any of the following— (a) the Status of Children Act 1996, (b) the Mutual Recognition Act 1992 of the Commonwealth, (c) the Trans-Tasman Mutual Recognition Act 1997 of the Commonwealth. Part 2 ART providers Division 1 Registration Note— Section 11 of the Research Involving Human Embryos Act 2002 of the Commonwealth requires a person or body to be accredited by the Reproductive Technology Accreditation Committee of the Fertility Society of Australia or another prescribed body if the person or body intentionally uses a human embryo (other than an excess ART embryo as defined under that Act) outside the body of a woman. 6 ART providers must be registered (1) An ART provider must not provide ART services unless the ART provider is a registered ART provider. (2) A person must not advertise or hold out that the person is a registered ART provider unless the person is a registered ART provider. Maximum penalty—1,000 penalty units in the case of a corporation or 400 penalty units or imprisonment for 2 years, or both, in any other case. 7 Registration (1) A person may apply to the Secretary for registration as an ART provider. (2) An application is to be made in an approved form and be accompanied by the fee (if any) prescribed by the regulations. (3) An application must include the following— (a) the name of the applicant, (b) the address of each premises at which the applicant intends to provide ART services, (c) the name of each registered medical practitioner who is to undertake or supervise ART services provided by the applicant, (d) the name of each person who is to provide counselling services in relation to ART services provided by the applicant, (e) any other matter that is prescribed by the regulations. (4) The Secretary must grant the applicant's registration as an ART provider if an application for registration is duly made. (5) Despite subsection (4), the Secretary must refuse to grant a person registration as an ART provider if the person is prohibited under Part 6 from carrying on a business that provides ART services. (6) Registration as an ART provider takes effect when the Secretary gives the applicant notice of the decision to grant registration and remains in force until cancelled by the Secretary. (7) The Secretary must cancel a person's registration as an ART provider if— (a) the person gives the Secretary notice that the person no longer provides ART services, or (b) the person is prohibited under Part 6 from carrying on a business that provides ART services. (8) A registered ART provider must (within such times as may be prescribed) pay to the Secretary the annual registration fee (if any) prescribed by the regulations. (9) The regulations may prescribe different application fees and annual registration fees for different classes of ART providers, or on the basis of the number of premises at which an ART provider provides ART services, or both. (10) The Secretary may cancel a person's registration as an ART provider if the person fails to pay any fee as required by this section. 8 Notice of change in registered particulars (1) A registered ART provider must give notice to the Secretary of the following events or changes— (a) the ART provider ceasing to provide ART services, (b) any change of premises at which the ART provider provides ART services, (c) any change of registered medical practitioners undertaking or supervising ART services provided by the ART provider, (d) any change in the persons providing counselling services in relation to ART services provided by the ART provider, (e) any other events or changes that are prescribed by the regulations. Maximum penalty—400 penalty units in the case of a corporation or 200 penalty units in any other case. (2) Notice to the Secretary under subsection (1)— (a) is to be given before the end of the next business day after the event or change occurs, and (b) is to be given in an approved form and be accompanied by the fee (if any) prescribed by the regulations. (3) In this section— business day means any day other than a Saturday, a Sunday or a public holiday throughout New South Wales. 9 Register of ART providers (1) The Secretary is to keep a register of all ART providers registered under this Part. (2) The register is to contain the following, for each registered ART provider— (a) the name of the ART provider, (b) the address of each premises at which the ART provider provides ART services, (c) the name of each registered medical practitioner who undertakes or supervises ART services provided by the ART provider, (d) the name of each person who provides counselling services in relation to ART services provided by the ART provider. (3) The register is to contain such other matters and is to be kept in such manner and form as the Secretary may from time to time determine, subject to the regulations. (4) The Secretary is to cause the contents of the register to be made available for inspection free of charge by the public at the Department's head office and on the Department's website on the Internet. Division 2 Provision of ART services 10 Infection control standards The regulations may require an ART provider to meet such infection control standards as may be prescribed by the regulations in relation to any ART services provided by the ART provider. 11 ART services to be undertaken or supervised by a registered medical practitioner An ART provider must ensure that any ART services provided by the ART provider are undertaken by, or under the supervision of, a registered medical practitioner. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. 12 Counselling to be available (1) An ART provider must ensure that counselling services are available to any woman who seeks ART treatment from the ART provider, any spouse of such a woman and any person proposing to provide a gamete to the ART provider. Maximum penalty—50 penalty units in the case of a corporation or 25 penalty units in any other case. (2) The counselling services under subsection (1) must— (a) be available at the place where the ART treatment is provided or, in the case of a person proposing to provide a gamete, at the place where the gamete is to be provided, and (b) (Repealed) (c) be offered before the ART treatment is provided or, in the case of a person proposing to provide a gamete, before the gamete is provided. (2A) An ART provider that has possession of a gamete, or an embryo created using a gamete, that was not originally obtained from the gamete provider as a donated gamete must ensure that counselling services are made available to the gamete provider if the gamete provider proposes to donate the gamete or embryo for use by a person other than the gamete provider or the gamete provider's spouse. (2B) The counselling services under subsection (2A) must— (a) be available at the premises of the ART provider, and (b) be offered before the gamete or embryo is used. (2C) Counselling services under this section must be provided by a person with the qualifications (if any) prescribed by the regulations. (3) Nothing in this section— (a) prevents a person who provides the counselling service from charging a reasonable fee for that service, or (b) requires a person to make use of the counselling service. 13 Provision of information to participants in ART services (1) An ART provider must, in accordance with this section— (a) inform a person specified in Column 1 of the Table to this subsection of the matters specified opposite in Column 2, and (b) obtain confirmation from the person that the person understands those matters, before providing an ART service specified opposite in Column 3. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. Table Column 1 Column 2 Column 3 Person Matters ART service 1 A woman seeking ART treatment that does not use donated gametes Basic list of matters ART treatment to the woman 2 A woman seeking ART treatment that uses donated gametes Extended list of matters ART treatment to the woman 3 A person proposing to provide a gamete (other than as a donated gamete) Basic list of matters Obtaining the gamete from the person 4 A person proposing to provide a donated gamete Extended list of matters Obtaining the gamete from the person 5 A gamete provider from whom the gamete was not originally obtained as a donated gamete Extended list of matters Using the gamete, or an embryo created using the gamete, in providing ART treatment to a person who is not the gamete provider or the gamete provider's spouse (2) The basic list of matters that a person must be informed of under this section is as follows— (a) the availability of counselling services, (b) the effect of a gamete provider's consent under Division 3, and how and until when such a consent may be modified or revoked, (c) any other matter that is prescribed by the regulations. (3) The extended list of matters that a person must be informed of under this section is as follows— (a) the availability of counselling services, (b) the effect of a gamete provider's consent under Division 3, and how and until when such a consent may be modified or revoked, (c) the obligations of the ART provider in relation to obtaining information about the person and the person's offspring, (d) the application of section 62 to the person, including in relation to information provided to the ART provider by the person, (e) the existence of the central register and the information about the person and the person's offspring that will be held on the register, (f) the right of the person to obtain information held on the register about the person, (g) the right of the person and the person's offspring to obtain information held on the register about other persons, (h) the right of other persons to obtain information held on the register about the person and the person's offspring, (i) any other matter that is prescribed by the regulations. (4) Any information required to be provided under this section is to be provided in the approved form (if any). (5) Any confirmation required to be obtained under this section is to be obtained in the approved form (if any). 14 (Repealed) 15 Donated gametes—disclosure of medical information (1) An ART provider may disclose medical information— (a) about a donor— (i) to an adult offspring born as a result of ART treatment using the donor's donated gamete, or (ii) to the parent of an offspring born as a result of ART treatment using the donor's donated gamete, if the offspring is a child, or (iii) to a woman who is pregnant as a result of ART treatment using the donor's donated gamete, or (b) to a donor, about an offspring born as a result of ART treatment using the donor's donated gamete, if a registered medical practitioner has certified in writing that it is necessary to make the disclosure to save a person's life or to warn the person to whom the information is disclosed about the existence of a medical condition that may be harmful to that person or to that person's offspring (including any future offspring of the person). (2) If an ART provider discloses medical information under this section, the disclosure must be made by a registered medical practitioner on behalf of the ART provider. (3) If a disclosure may be made to a person under this section, the disclosure may also be made to a registered medical practitioner who is treating the person. (4) Nothing in this section requires an ART provider to disclose information to any person. 15A Assessment report in relation to surrogacy arrangements (1) An ART provider must not provide treatment to a woman that is intended to assist the woman to achieve pregnancy, and which is sought in connection with a surrogacy arrangement, unless the ART provider has been provided with an assessment report in relation to the surrogacy arrangement. Maximum penalty—100 penalty units in the case of a corporation or 50 penalty units in any other case. (2) A registered medical practitioner who undertakes or supervises the provision of ART services by an ART provider must ensure that any treatment intended to assist a woman to achieve pregnancy, and which is sought in connection with a surrogacy arrangement, is not provided to the woman unless the medical practitioner is satisfied it is appropriate to do so, having regard to an assessment report. (3) Contravention of subsection (2) is not an offence, but may constitute improper conduct by the medical practitioner for the purposes of the Health Practitioner Regulation National Law (NSW). (4) For the purposes of this section, an assessment report is a report by an independent counsellor about the surrogacy arrangement, that is based on interviews with the parties to the surrogacy arrangement. (5) An assessment report must include the independent counsellor's opinion as to whether the parties to the surrogacy arrangement understand the surrogacy arrangement, including the possible outcomes of the surrogacy arrangement, and are suitable persons to enter into or continue with the surrogacy arrangement. (6) An assessment report must address such other matters as the regulations require the report to address. (7) An ART provider or medical practitioner does not contravene this section unless it is proved that the ART provider or medical practitioner knew, or should reasonably have suspected, that the treatment concerned was sought in connection with a surrogacy arrangement. (8) In this section— independent counsellor means a qualified counsellor (within the meaning of the Surrogacy Act 2010) who is not employed or engaged by the ART provider. Division 3 Use of gametes 16 Interpretation In this Division— (a) consent of a gamete provider means the gamete provider's consent given under section 17 in relation to a gamete as modified or revoked in accordance with that section, and (b) a requirement that any matter be consistent with a gamete provider's consent is, if gametes from more than one gamete provider are involved, a requirement that the matter be consistent with each gamete provider's consent. 17 Giving, modifying and revoking consent (1) A gamete provider may give an ART provider that obtains, or proposes to obtain, a gamete from the gamete provider a written notice, in the approved form (if any), setting out the gamete provider's wishes in relation to the gamete (the gamete provider's consent). (2) A gamete provider's consent may address such matters as the uses that may be made of the gamete (or an embryo created using the gamete) and whether the gamete or embryo may be stored, exported from this State or supplied to another ART provider. (3) A gamete provider may modify or revoke his or her consent by giving written notice, in the approved form (if any), of the modification or revocation of consent to— (a) the ART provider that obtained the gamete from the gamete provider, or (b) any ART provider that is, or has ever been, in possession of the gamete or embryo to which the modification or revocation of consent relates. (4) A consent may be modified or revoked at any time up until— (a) in the case of a donated gamete—the gamete is placed in the body of a woman or an embryo is created using the gamete, or (b) in the case of a gamete that is used to create a donated embryo—the embryo is implanted in the body of a woman, or (c) in any other case—the gamete is placed in the body of a woman or an embryo created using the gamete is implanted in the body of a woman. (5) As soon as practicable after an ART provider is given written notice by a gamete provider of the modification or revocation of his or her consent, the ART provider must give written notice of the modification or revocation to any other ART provider to which the ART provider has supplied the gamete or any embryo created using the gamete. (6) As soon as practicable after an ART provider is given written notice by another ART provider of the modification or revocation of a gamete provider's consent, the ART provider must give written notice of the modification or revocation to any other ART provider to which the ART provider has supplied the gamete or any embryo created using the gamete. (7) Except as provided by section 17A, a modification or revocation of consent takes effect in relation to an ART provider as soon as the ART provider is given written notice of the modification or revocation in accordance with this section. (8) A reference in this section to a donated gamete does not include a reference to a gamete that becomes a donated gamete only after being used to create an embryo. 17A Verification of identify of person giving, modifying or revoking consent (1) An ART provider that is given a written notice under section 17 must take the following steps to verify the identity of the person purportedly giving the consent to which the notice relates— (a) the steps (if any) prescribed by the regulations, (b) if there are no steps prescribed by the regulations, reasonable steps. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. (2) A gamete provider's consent has no effect in relation to an ART provider that is required to comply with subsection (1) in connection with that consent until the ART provider so complies. (3) An ART provider that is given a written notice under section 17 (5) or (6) is not required to comply with subsection (1) in connection with the modification or revocation to which the notice relates if the ART provider has reasonable grounds to believe that another ART provider has already complied with subsection (1) in connection with the modification or revocation. (4) In this section, consent includes the modification or revocation of consent. 17B ART provider to take steps to obtain confirmation of consent in certain cases (1) An ART provider must not carry out any of the following activities in respect of a gamete or embryo (other than a donated gamete or donated embryo) unless the ART provider has taken the required steps, in accordance with this section, to obtain confirmation of the gamete provider's consent to the activity concerned— (a) use the gamete to create an embryo outside the body of a woman, (b) provide ART treatment to a woman using the gamete or embryo, (c) supply the gamete or embryo to another person (including an ART provider), (d) export, or cause to be exported, the gamete or embryo from this State. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. (2) The required steps are the steps (if any) prescribed by the regulations or, if there are no steps prescribed by the regulations, reasonable steps. (3) The ART provider must take the required steps no earlier than the period of time, determined in accordance with the regulations, before the activity concerned. (4) An ART provider is not required to comply with this section— (a) if the ART provider knows or believes on reasonable grounds that the gamete provider is deceased, or (b) in any other circumstances prescribed by the regulations. 18 Use of gametes to create embryo outside a woman's body An ART provider must not use a gamete to create an embryo outside the body of a woman except with the consent of the gamete provider and in a manner that is consistent with the gamete provider's consent. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. Note— Section 9 of the Human Cloning for Reproduction and Other Prohibited Practices Act 2003 provides that a person commits an offence if the person intentionally develops a human embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended. 19 Use of gametes or embryos in ART treatment An ART provider must not provide ART treatment to a woman using a gamete except with the consent of the gamete provider and in a manner that is consistent with the gamete provider's consent in relation to— (a) the ART treatment or classes of ART treatment for which the gamete may be used, and (b) the woman or classes of women who may receive ART treatment using the gamete. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. 20 Use of gametes or embryos for research An ART provider must not use a gamete or an embryo for research except with the consent of the gamete provider and in a manner that is consistent with the gamete provider's consent. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. Note— See also the Research Involving Human Embryos Act 2002 of the Commonwealth which regulates research in relation to embryos. 21 Supply of gametes or embryos to another person An ART provider must not supply a gamete or an embryo to another person (including another ART provider) except with the consent of the gamete provider and in a manner that is consistent with the gamete provider's consent. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. 22 Export of gametes or embryos from NSW An ART provider must not export, or cause to be exported, a gamete or an embryo from this State except with the consent of the gamete provider and in a manner that is consistent with the gamete provider's consent. Maximum penalty—400 penalty units in the case of a corporation or 200 penalty units in any other case. 23 Use of gametes or embryos after death of gamete provider An ART provider must not provide ART treatment to a woman using a gamete if the ART provider knows or believes on reasonable grounds that the gamete provider is deceased, unless— (a) the gamete provider has consented to the use of the gamete after his or her death, and (b) the woman receiving the ART treatment has been notified of the death or suspected death of the gamete provider and the date of death (if known), and (c) the woman receiving the ART treatment has given written consent to the provision of the ART treatment using the gamete despite the death or suspected death of the gamete provider. Maximum penalty—400 penalty units in the case of a corporation or 200 penalty units in any other case. Note— The Human Tissue Act 1983 regulates the removal of tissue (including gametes) from a deceased person. 24 Use of gametes or embryos provided more than 5 years ago (1) An ART provider must not provide ART treatment using a gamete obtained from a gamete provider more than 5 years before the provision of the ART treatment, unless the ART provider has taken reasonable steps to establish whether the gamete provider is alive. Maximum penalty—400 penalty units in the case of a corporation or 200 penalty units in any other case. (2) Despite subsection (1) an ART provider is not required to take reasonable steps to establish whether the gamete provider is alive if— (a) the ART provider (or another ART provider that supplied the gamete used in the ART treatment) has been contacted by the gamete provider less than 5 years before the provision of the ART treatment, or (b) the ART provider knows or believes on reasonable grounds that the gamete provider is deceased. (3) For the purpose of subsection (1), reasonable steps include— (a) obtaining from the Registrar of Births, Deaths and Marriages a certificate under section 49 of the Births, Deaths and Marriages Registration Act 1995 as to whether the death of the gamete provider has been recorded in the Register kept under that Act, and (b) completing such other inquiries as may be prescribed by the regulations for the purpose of establishing whether the gamete provider is alive. (4) The Registrar of Births, Deaths and Marriages must not reject an application made under section 47 of the Births, Deaths and Marriages Registration Act 1995 for the purposes of this section if the application is made in an appropriate form and is accompanied by the fee (if any) prescribed under that Act. (5) A reference in this section to the supply of a gamete includes a reference to the supply of an embryo created using the gamete. 25 Storage of gametes or embryos (1) An ART provider must not store a gamete or an embryo except with the consent of the gamete provider and in a manner that is consistent with the gamete provider's consent. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. (2) If a gamete provider's consent authorises storage of a gamete or an embryo but does not specify a period for which the gamete or embryo may be stored, the gamete provider's consent is, for the purpose of this section, taken not to authorise storage of the gamete or embryo. (3) An ART provider must not store a gamete or an embryo for any longer than the shortest of the following periods— (a) the period (if any) of proposed storage of which the ART provider has given written notice to the gamete provider (whether before or after the gamete was obtained), (b) the period authorised by the gamete provider's consent or, if there is more than one gamete provider, the shorter of the periods authorised by the gamete providers' consents, (c) in the case of a donated gamete, the period of 15 years from the date the gamete was obtained from the donor plus any additional period that may be authorised by the Secretary under section 26, (d) in the case of an embryo created using a donated gamete, or a donated embryo, the period of 15 years from the date the embryo was created plus any additional period that may be authorised by the Secretary under section 26. Maximum penalty—100 penalty units in the case of a corporation or 50 penalty units in any other case. 26 Donated gametes or embryos—time limit on use (1) An ART provider must not provide the following ART treatment without the written authorisation of the Secretary— (a) ART treatment using a donated gamete (but not ART treatment referred to in paragraph (b)) if the gamete was obtained from the donor more than 15 years before the provision of the ART treatment, (b) ART treatment using an embryo created from a donated gamete, or using a donated embryo, if the embryo was created more than 15 years before the provision of the ART treatment. Maximum penalty—400 penalty units in the case of a corporation or 200 penalty units in any other case. (2) The Secretary must not give an authorisation under subsection (1) unless the Secretary is satisfied that there are reasonable grounds for doing so having regard to any relevant guidelines issued by the Secretary from time to time. 27 Donated gametes or embryos—maximum number of families (1) An ART provider must not provide ART treatment using a donated gamete if the treatment is likely to result in offspring of the donor being born, whether or not as a result of ART treatment, to more than 5 women (or such lesser number as may be specified in the donor's consent), including the donor and any current or former spouse of the donor. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. (1A) This section does not prevent the provision of ART treatment using a donated gamete to a woman if— (a) the woman or the spouse of the woman is the parent of a child born as a result of ART treatment using a donated gamete from the same donor, or (b) the woman belongs to a class of women prescribed by the regulations for the purposes of this section. (2) It is a defence to a prosecution under this section if an ART provider establishes that the ART provider exercised due diligence to prevent the contravention. (3) Due diligence is not established if the ART provider failed to take any of the following steps to prevent the contravention— (a) searching records held by the ART provider, (b) making reasonable inquiries of the donor, (c) requesting information from any other ART provider that the first ART provider has reason to believe obtained or has been supplied with a gamete of the donor or an embryo created using a gamete of the donor. (4) An ART provider must provide the following information in relation to a donor if requested to do so by a registered ART provider for the purposes of complying with this section— (a) information in relation to the number of women who have given birth to offspring as a result of ART treatment, provided by the ART provider, using a gamete of the donor, (a1) the number of women who are pregnant as a result of ART treatment provided by the ART provider using a gamete of the donor, but not including women referred to in paragraph (a), (a2) the number of women for whom an embryo has been created as a result of ART treatment provided by the ART provider using a gamete of the donor and placed in storage, but not including women referred to in paragraph (a) or (a1), (a3) the number of women of whom the ART provider is aware who have given birth to offspring of the donor other than as a result of ART treatment, but not including women referred to in paragraph (a), (a1) or (a2), (b) the details of any other ART providers that have been supplied with a gamete of the donor, or an embryo created using a gamete of the donor, (c) any other matter that is prescribed by the regulations. Maximum penalty—100 penalty units in the case of a corporation or 50 penalty units in any other case. (5) The Secretary is to provide to an ART provider relevant information that is on the central register if— (a) the ART provider makes an application in an approved form for the information, or (b) the Secretary is of the opinion that provision of the information to the ART provider may be necessary to prevent offspring of a donor being born to more than 5 women. (6) Section 41 (Fees) applies to an application under subsection (5) in the same way as it applies to an application under Division 2 of Part 3. (7) Subject to the regulations, the Secretary may— (a) give relevant information to an interstate government agency or interstate ART provider in the circumstances prescribed by the regulations, and (b) authorise an ART provider to give relevant information to an interstate government agency or interstate ART provider in the circumstances prescribed by the regulations. (8) The regulations may— (a) provide for the kinds of relevant information that may not be given to an interstate government agency or an interstate ART provider, and (b) prescribe, or authorise the Secretary to impose, conditions on the giving of relevant information to an interstate government agency or interstate ART provider. (9) In this section— interstate ART provider means a person who— (a) provides ART services in another State or Territory, and (b) is prescribed by the regulations. interstate government agency means a Minister or head of a government department in another State or Territory who— (a) has similar functions to the Secretary under this Act, and (b) is prescribed by the regulations. relevant information means the information in relation to a donor specified in subsection (4). 28 Use of gametes to create embryo with close family member (1) An ART provider must not use a gamete to create an embryo (whether inside or outside the body of a woman) if the ART provider knows that the gamete provider is a close family member of the other person whose gamete is to be used to create the embryo. Maximum penalty—1,000 penalty units in the case of a corporation or 400 penalty units or imprisonment for 2 years, or both, in any other case. (2) In this section— close family member means a parent, son, daughter, sibling (including a half-brother or half-sister), grandparent or grandchild, being such a family member from birth. 29 Provision of ART treatment to a child (1) An ART provider must not— (a) provide ART treatment to a child, or (b) obtain a gamete from a child for use in ART treatment or for research in connection with ART treatment. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. (2) An ART provider does not contravene this section if— (a) a registered medical practitioner has certified that there is a reasonable risk of the child becoming infertile before becoming an adult, and (b) the ART provider obtains a gamete from the child for the purpose of storing the gamete for the child's future benefit. (3) Despite section 25, a gamete obtained from a child, by an ART provider under subsection (2), must be stored by the ART provider until such time as the child becomes an adult and is able to provide his or her consent in relation to the gamete. Note— Nothing in this section affects any other legal obligation a registered medical practitioner may have in relation to the medical treatment of a child. Division 4 Records 30 Collection of information (1) An ART provider must not obtain a gamete from a gamete provider unless the ART provider has obtained the following information— (a) the full name of the gamete provider, (b) the residential address of the gamete provider, (c) the date of birth of the gamete provider, (d) the place of birth of the gamete provider, (e) the ethnicity and physical characteristics of the gamete provider, (f) the relevant medical history of the gamete provider, (g) the sex and year of birth of each offspring of the gamete provider, (h) the name of each ART provider who has previously obtained a donated gamete from the gamete provider and the date on which the gamete was obtained. (2) An ART provider must not use a gamete or an embryo for any purpose (including in the provision of ART treatment) unless the ART provider has obtained the information specified in subsection (1) in relation to the gamete or gametes used to create the embryo. (2A) An ART provider is only required to obtain the information specified in subsection (1) (d)–(h) if the gamete is a donated gamete. (3) An ART provider must not use a gamete in the provision of ART treatment to a woman unless the ART provider has obtained the following information— (a) the full name, residential address and date of birth of the woman, (b) any other information about the woman, the woman's spouse (if any) and any offspring of the woman that the regulations may require the ART provider to obtain. (4) An ART provider must not provide treatment to a woman that is intended to assist the woman to achieve pregnancy if the ART provider knows, or should reasonably suspect, that the woman intends to achieve pregnancy through ART treatment provided by a person other than a registered ART provider, unless the ART provider has obtained— (a) the information required under subsection (1) in relation to the gamete (or the gametes used to create the embryo) that the woman will use to achieve pregnancy, and (b) the information required under subsection (3) in relation to the woman, the woman's spouse (if any) and any offspring of the woman. (5) An ART provider that provides ART treatment to a woman using a donated gamete must take reasonable steps to find out from the woman, no earlier than 1 month and no later than 4 months after the treatment, whether or not she is pregnant as a result of the treatment. (6) The ART provider is not required to take those steps if the ART provider knows that the woman is not pregnant as a result of the treatment. (7) The ART provider must take further reasonable steps to find out from the woman, no earlier than 10 months and no later than 15 months after the ART treatment— (a) whether or not an offspring was born as a result of the treatment, and (b) the full name, sex and date of birth of the offspring. (8) The ART provider is not required to take those steps if the ART provider— (a) is informed by the woman earlier than 10 months after the treatment that an offspring was born as a result of the treatment and the woman informs the ART provider of the full name, sex and date of birth of the offspring, or (b) knows that no offspring was born as a result of the treatment. Maximum penalty—200 penalty units in the case of a corporation or 100 penalty units in any other case. 31 Records to be kept by ART provider (1) An ART provider must keep a record in relation to each of the following in an approved form— (a) for any gamete or embryo that is in the ART provider's possession— (i) the information required to be obtained under section 30 (1) or (2), and (ii) the provenance of any such gamete or embryo (including the provenance of the gametes used to create the embryo), and (iii) the gamete provider's consent (within the meaning of Division 3) in relation to any such gamete or embryo, and (iv) the uses that have been made of any such gamete or embryo, including exporting the gamete or embryo from this State or supplying the gamete or embryo to another ART provider, and (v) the period during which any such gamete or embryo has been in storage, (b) for each woman who is provided ART treatment by the ART provider— (i) the full name, residential address and date of birth of the woman, and (ii) any other information required to be obtained under section 30 (3) about the woman, the woman's spouse (if any) and any offspring of the woman, (b1) for each woman who has been provided ART treatment by the ART provider using a donated gamete— (i) whether or not the woman is or has been pregnant, up until at least 1 month after the treatment, as a result of the treatment, or (ii) if the ART provider does not know whether or not the woman is or has been pregnant, up until at least 1 month after the treatment, as a result of the treatment—information to that effect, (c) for each offspring known by the ART provider to have been born as a result of ART treatment provided by the ART provider— (i) the full name, sex and date of birth of the offspring, and (ii) the full name of the woman who gave birth to the offspring, and (iii) if the offspring was born as a result of ART treatment using a donated gamete, the full name and date and place of birth of the donor, (c1) if at least 15 months have passed since the ART provider provided ART treatment to a woman and the ART provider does not know whether or not an offspring has been born as a result of the treatment—information to that effect, (d) any information required to be collected by the ART provider under section 30 (4), (e) any other matter that is prescribed by the regulations. Maximum penalty—100 penalty units in the case of a corporation or 50 penalty units in any other case. (2) The ART provider must retain any records required to be kept under this section for a period of 50 years after the record is made or such other period as may be prescribed by the regulations. Maximum penalty—400 penalty units in the case of a corporation or 200 penalty units in any other case. (3) In this section— provenance of a gamete or an embryo means the particulars of each ART provider that has had possession of the gamete or embryo from the time the gamete was obtained from the gamete provider or from the time the embryo was created. 32 Records may be given to other ART providers If an ART provider supplies a gamete or an embryo to another ART provider, the first ART provider— (a) must give the second ART provider a copy of the gamete provider's consent (within the meaning of Division 3) in relation to the gamete or embryo, and (b) may give the second ART provider a copy of any other information required to be obtained by or under this Act in relation to the gamete or embryo. Part 3 Central register Division 1 Preliminary 32A Establishment of central register (1) The Secretary is to establish and maintain a register called the central register. (2) The Secretary is to enter in the register such information as the Secretary is required to enter in the register by or under this Part. Note— Division 2 requires the Secretary to enter in the register information about ART treatment. Division 3 requires the Secretary to enter in the register information about surrogacy arrangements. 32B Disclosure of information on the central register generally (1) The Secretary may disclose information held on the central register only in accordance with this Part or Part 3A. (2) For the purposes of the provisions of this Part and Part 3A relating to disclosure, the Secretary is entitled to assume that information provided to the Secretary and held on the central register is accurate. (3) Nothing in this section limits section 33D (1). Division 2 Information about ART treatment 32C Objectives of central register—ART treatment The objectives of the central register, in relation to ART treatment, are as follows— (a) to allow access to identifying information and certain non-identifying information about a donor by an adult offspring of the donor (who was born as a result of ART treatment using the donor's donated gamete), (b) to allow access to certain non-identifying information about an adult offspring of a donor by other offspring of the donor and to allow access to identifying information if the adult offspring consents, (c) to allow access to certain non-identifying information about a donor and other offspring of the donor by a parent of a child offspring of the donor (who was born as a result of ART treatment using the donor's donated gamete) and to allow access to identifying information about the donor in limited circumstances, (d) to allow access to certain non-identifying information about an adult offspring of a donor (who was born as a result of ART treatment using the donor's donated gamete) by the donor and to allow access to identifying information if the adult offspring consents, (e) to allow access to certain non-identifying information about a child offspring of a donor (who was born as a result of ART treatment using the donor's donated gamete) by the donor. 33 Mandatory giving of information by ART providers (1) An ART provider that provides ART treatment using a donated gamete must, within 2 months after becoming aware that a live offspring has been born as a result of the treatment, give the Secretary— (a) the records that the ART provider is required to keep under section 31 (1) (a) (i) and (iii) in relation to the gamete and embryo created from that gamete, and (b) the records that the ART provider is required to keep under section 31 (1) (c) in relation to the offspring. Maximum penalty—400 penalty units in the case of a corporation or 200 penalty units in any other case. (1A) An ART provider that provides ART treatment to a woman using a donated gamete must, no earlier than 15 months and no later than 16 months after the treatment, do the following if the ART provider does not know whether or not a live offspring has been born as a result of the treatment— (a) inform the Secretary that the ART provider does not know whether or not a live offspring has been born as a result of the treatment, (b) give the Secretary— (i) the records that the ART provider is required to keep under section 31 (1) (a) (i) and (iii) in relation to the gamete and embryo created from that gamete, and (ii) the full name of the woman. Maximum penalty—400 penalty units in the case of a corporation or 200 penalty units in any other case. (2) The Secretary must enter in the central register any information given to the Secretary under this section. 33A Voluntary giving of information about private ART arrangements (1) In this section— private ART arrangement means ART treatment using a donated gamete that— (a) resulted in the birth of a live offspring, and (b) was not carried out for fee or reward or in the course of a business. (2) The parties to a private ART arrangement, being the donor of the gamete, the woman undergoing ART treatment and any spouse of the woman may, by notice in writing, give the Secretary information about the parties and about the offspring, being information of a kind that an ART provider would be required to give the Secretary under section 33. (3) The notice may be given at any time and must be given in an approved form. (4) The Secretary may require that the notice be accompanied by any documents or other evidence that demonstrates the accuracy of the information contained in the notice. (5) The Secretary may enter in the central register any information given to the Secretary under this section. 33B Voluntary giving of information about personal characteristics of donor (1) A donor may, by notice in writing, give the Secretary information about the personal characteristics of the donor for inclusion on the central register. (2) The notice may be given at any time and must be given in an approved form. (3) The notice may specify restrictions on the disclosure of the information. (4) The Secretary may enter in the central register any information given to the Secretary under this section. 33C Voluntary giving of information by adult offspring of donor (1) An adult offspring of a donor may, by notice in writing, give the Secretary the following information about the offspring for inclusion on the central register— (a) the full name, sex and date of birth of the offspring, (b) the residential address of the offspring. (2) The notice may be given at any time and must be given in an approved form. (3) The notice may specify restrictions on the disclosure of the information. (4) The Secretary may enter in the central register any information given to the Secretary under this section. 33D Secretary to ensure accuracy of central register in relation to ART treatment (1) The Secretary is to ensure that, as far as is practicable, the information in the central register is accurate and not misleading and is consistent with the objectives of the register and for these purposes the Secretary may do any one or more of the following— (a) refuse to enter information, or revise information or omit information, (b) retain superseded information (such as a person's former name), (c) add any notes or annotations that the Secretary considers to be appropriate. (1A) The Secretary may, on the Secretary's own initiative, enter in the central register information relating to any of the following persons— (a) a live offspring whom the Secretary has reasonable grounds to be satisfied was born as a result of the provision by an ART provider of ART treatment, on or after 1 January 2010, using a donated gamete, (b) a person whom the Secretary has reasonable grounds to be satisfied is the donor from whom the donated gamete was obtained (the gamete provider), (c) the woman who gave birth to the offspring. (1B) The information that may be entered on the central register under subsection (1A) includes any of the following— (a) the full name, sex and date of birth of the offspring, (b) the full name, residential address, date of birth, ethnicity, physical characteristics and relevant medical history of the gamete provider, (c) the sex and year of birth of each offspring of the gamete provider, (d) the gamete provider's consent (within the meaning of Division 3 of Part 2) relating to the gamete or embryo that the Secretary has reasonable grounds to be satisfied was used in the ART treatment, (e) the full name of the woman who gave birth to the offspring, (f) the full name of the spouse (if any) of that woman, (g) any other matters that are prescribed by the regulations. (1C) Without limiting subsection (1) (c), the Secretary must note in the central register the source of any information entered in the central register under subsection (1A) (including whether the information was obtained in response to a direction under section 34). (2) The Secretary must remove information from the register that has been provided voluntarily by a person if the person applies, in an approved form, to have the information removed and the Secretary is satisfied that the information is not information that is otherwise required to be on the register. 33E Disclosure of information on Secretary's own initiative (1) The Secretary may, on the Secretary's own initiative, disclose information held on the central register that has been revised or entered under section 33D. (2) The Secretary may disclose the information only to a person who would be entitled, if the person made an application under this Part, to be given the information. 34 Direction to answer questions and provide information about donor-conceived births (1) The Secretary may give a health services provider a written direction requiring the provider to answer specified questions, or to furnish any other information specified in the direction, for the purposes of— (a) determining whether or not a live offspring was born as a result of the provision by an ART provider of ART treatment, on or after 1 January 2010, using a donated gamete, or (b) determining whether or not any registrable information in connection with such an offspring has been correctly entered in the central register, or (c) obtaining any registrable information in connection with such an offspring. (2) A direction under this section may require the questions to be answered, or the other information to be furnished, in a specified manner, by a specified time and in a specified form. (3) A person who is given a direction under this section must not, without reasonable excuse, refuse or fail to comply with the direction. Maximum penalty—200 penalty units in the case of a corporation or 100 penalty units in any other case. (4) In this section, registrable information means any of the following— (a) the full name, sex and date of birth of an offspring who was born as a result of the provision by an ART provider of ART treatment using a donated gamete, (b) the full name, residential address, date of birth, ethnicity, physical characteristics and relevant medical history of the gamete provider, (c) the sex and year of birth of each offspring of the gamete provider, (d) the gamete provider's consent (within the meaning of Division 3 of Part 2) relating to the gamete or embryo used in the ART treatment, (e) the full name of the woman who gave birth to the offspring, (f) the full name of the spouse (if any) of that woman, (g) any other matters that are prescribed by the regulations. 35 Information sharing between Secretary and Registrar of Births, Deaths and Marriages about donor-conceived births (1) The Secretary and the Registrar of Births, Deaths and Marriages may share information for the purpose of enabling or assisting the Secretary to ensure the completeness and accuracy of the central register in relation to— (a) live offspring born as a result of ART treatment provided by ART providers using donated gametes, and (b) the donors from whom the gametes were obtained, and (c) the women who gave birth to the offspring, and (d) the spouses (if any) of those women. (2) This section has effect despite any law to the contrary. 36 Disclosure to subject of information (1) The Secretary must, if an application in an approved form is made by any of the following persons, provide to the person a copy of any information about that person held on the central register— (a) a donor, (b) an adult offspring of a donor, (c) a woman who has undergone ART treatment using a donated gamete. (2) The Secretary must, if an application in an approved form is made by the parent of a child who is an offspring of a donor, provide to the parent a copy of any information about the child held on the central register. (3) This section does not authorise disclosure of— (a) information about a person other than the applicant (or, in the case of an application under subsection (2), a person other than the child), or (b) information about the applicant's relationship with other persons (or, in the case of an application under subsection (2), the child's relationship with other persons) unless such information was originally provided by the applicant. 37 Disclosure to offspring (1) The Secretary must, if an application in an approved form is made by a person who is an adult and who was born as a result of ART treatment using a donated gamete, disclose to the person the following information held on the central register— (a) the information referred to in section 30 (1) (a)–(g) about the donor of the donated gamete, (b) any information about the donor that the donor has voluntarily given under section 33B (subject to any restrictions on the disclosure of the information specified by the donor under that section). (2) The Secretary must, if an application in an approved form is made by an adult offspring of a donor, disclose to the offspring the following information held on the central register— (a) the sex and year of birth of each other offspring of the donor, (b) any information about any other offspring of the donor that the other offspring has voluntarily given under section 33C