Commonwealth: Research Involving Human Embryos Act 2002 (Cth)

Research Involving Human Embryos Act 2002 No. 145, 2002 Compilation No. 9 Compilation date: 14 October 2024 Includes amendments: Act No. 39, 2024 About this compilation This compilation This is a compilation of the Research Involving Human Embryos Act 2002 that shows the text of the law as amended and in force on 14 October 2024 (the compilation date). The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law. Uncommenced amendments The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Editorial changes For more information about any editorial changes made in this compilation, see the endnotes. Modifications If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law. Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes. Contents Part 1—Preliminary 1 Short title 2 Commencement 3 Object of Act 4 Operation of Act 5 Act to bind the Crown 6 External Territories 7 Definitions Part 2—Regulation of the use of excess ART embryos and other material Division 1—Interpretation 8 Definitions 9 Meaning of excess ART embryo Division 2—Offences 10 Offence—use of excess ART embryo 10A Offence—use of other embryos 10B Offence—certain activities involving use of human eggs 11 Offence—use of embryo that is not an excess ART embryo 11A Offence—use of material created under mitochondrial donation licence 12 Offence—breaching a general licence or mitochondrial donation licence condition 12A Person not liable for conduct purportedly authorised Division 3—Embryo Research Licensing Committee of the NHMRC 13 Establishment of Committee 14 Functions of Committee 15 Powers of Committee 16 Membership of Committee 17 Terms of appointment 18 Annual report 19 Reports to Parliament Division 4—General licences 20 Applying for a general licence 21 Determination of application by Committee 22 Notification of decision 23 Period of a general licence 24 Conditions of general licences 25 Variation of a general licence 26 Suspension or revocation of a general licence 27 Surrender of a general licence 28 Notification of variation, suspension or revocation of a general licence Division 4A—Mitochondrial donation licences Subdivision A—Kinds of mitochondrial donation licences and what they authorise 28A Kinds of mitochondrial donation licences 28B Carrying out activities authorised by mitochondrial donation licences 28C What a pre‑clinical research and training licence authorises 28D What a clinical trial research and training licence authorises 28E What a clinical trial licence authorises 28F What a clinical practice research and training licence authorises 28G What a clinical practice licence authorises Subdivision B—Applying for a mitochondrial donation licence 28H Applying for a mitochondrial donation licence Subdivision C—Determining applications for mitochondrial donation licences 28J Determination of application by Committee 28K Notification of decision 28L Matters to be specified in a mitochondrial donation licence 28M Period of a mitochondrial donation licence Subdivision D—Conditions of mitochondrial donation licences 28N Conditions of mitochondrial donation licences generally 28P Additional condition of clinical trial licences and clinical practice licences—Committee approval before creation or placement of embryo 28Q Other conditions of clinical trial licences and clinical practice licences Subdivision E—Ongoing requirements for holders of mitochondrial donation licences 28R Clinical trial licences and clinical practice licences—information about donors and children 28S Clinical trial licences and clinical practice licences—requirement for ongoing monitoring protocols and to notify adverse events 28T Record‑keeping obligations for all holders of mitochondrial donation licences Subdivision F—Variation, suspension, revocation and surrender 28U Variation of a mitochondrial donation licence 28V Suspension or revocation of a mitochondrial donation licence 28W Surrender of a mitochondrial donation licence 28X Notification of variation, suspension or revocation of a mitochondrial donation licence Division 5—Protection and disclosure of information 29 NHMRC Licensing Committee to make certain information publicly available 29A Mitochondrial Donation Donor Register 30 Confidential commercial information may only be disclosed in certain circumstances Division 6—Review provisions 31 Meaning of terms 32 Review of decisions Part 3—Monitoring powers 33 Appointment of inspectors 34 Identity card 35 Powers available to inspectors for monitoring compliance 36 Monitoring powers 37 Power to secure 37A Monitoring warrants 37B Details of warrant to be given to occupier etc. 37C Announcement before entry 37D Occupier entitled to be present during search 38 Inspector must produce identity card on request 39 Consent 40 Compensation for damage 41 Extended operation of Part Part 4—Commonwealth/State arrangements 42 Operation of State laws 43 Conferral of functions on Commonwealth officers and bodies 44 When duty imposed 45 Review of certain decisions Part 5—Miscellaneous Division 1—Arrangements relating to clinical trials of mitochondrial donation techniques 46 Arrangements relating to clinical trials of mitochondrial donation techniques 46A Terms and conditions relating to clinical trial arrangements 46B Minister or Secretary may delegate powers in relation to arrangements 46C Relationship of this Division with the Public Governance, Performance and Accountability Act 2013 46D Executive power of the Commonwealth Division 2—Other miscellaneous matters 47 Interaction with the Gene Technology Act 2000 47A Immunity from civil actions relating to mitochondrial donation licences 47B Review of operation of Act every 7 years 48 Regulations Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history An Act to regulate certain activities involving the use of human embryos, and for related purposes Part 1—Preliminary 1 Short title This Act may be cited as the Research Involving Human Embryos Act 2002. 2 Commencement (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table. Commencement information Column 1 Column 2 Column 3 Provision(s) Commencement Date/Details 1. Sections 1 and 2 and anything in this Act not elsewhere covered by this table The day on which this Act receives the Royal Assent 19 December 2002 2. Sections 3 to 9 The 28th day after the day on which this Act receives the Royal Assent 16 January 2003 3. Sections 10 to 12 At the end of the period of 6 months beginning on the day on which this Act receives the Royal Assent 19 June 2003 4. Sections 13 to 48 The 28th day after the day on which this Act receives the Royal Assent 16 January 2003 Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent. (2) Column 3 of the table is for additional information that is not part of this Act. This information may be included in any published version of this Act. 3 Object of Act The object of this Act is to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos by regulating activities that involve the use of certain human embryos created by assisted reproductive technology or by other means. 4 Operation of Act (1) This Act applies as follows: (a) to things done, or omitted to be done, by constitutional corporations; (b) to things done, or omitted to be done, in the course of constitutional trade or commerce; (c) to matters within the legislative power of the Commonwealth under paragraph 51(xxix) of the Constitution; (d) to the Commonwealth and Commonwealth authorities; (e) for purposes relating to the collection, compilation, analysis and dissemination of statistics; (f) to matters within the legislative power of the Commonwealth under paragraph 51(xxxix) of the Constitution, so far as it relates to the matters mentioned in paragraphs (a) to (e) of this subsection. Note: See also section 28B in relation to mitochondrial donation licences. (2) In this section: constitutional trade or commerce means trade or commerce: (a) between Australia and places outside Australia; or (b) among the States; or (c) by way of the supply of services to the Commonwealth or to a Commonwealth authority. Note: For constitutional corporation, see subsection 7(1). 5 Act to bind the Crown (1) This Act binds the Crown in each of its capacities. (2) Nothing in this Act renders the Crown liable to be prosecuted for an offence. 6 External Territories This Act extends to every external Territory. 7 Definitions (1) In this Act: Commonwealth authority means the following: (a) a body corporate established for a public purpose by or under an Act; (b) a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together: (i) the Commonwealth; (ii) a body covered by paragraph (a); (iii) a body covered by either of the above subparagraphs. constitutional corporation means a trading, foreign or financial corporation within the meaning of paragraph 51(xx) of the Constitution. corresponding State law, in relation to a State, means a law of that State declared by the Minister, by notice in the Gazette, to be a corresponding State law for the purposes of this Act. human embryo means a discrete entity that has arisen from either: (a) the first mitotic division when fertilisation of a human oocyte by a human sperm is complete; or (b) any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears; and has not yet reached 8 weeks of development since the first mitotic division. hybrid embryo means: (a) an embryo created by the fertilisation of a human egg by animal sperm; or (b) an embryo created by the fertilisation of an animal egg by human sperm; or (c) a human egg into which the nucleus of an animal cell has been introduced; or (d) an animal egg into which the nucleus of a human cell has been introduced; or (e) a thing declared by the regulations to be a hybrid embryo. inspector means a person appointed as an inspector under subsection 33(1). NHMRC Licensing Committee means the Committee established by section 13. Secretary means the Secretary of the Department. spouse, in relation to a person, includes a de facto partner of the person within the meaning of the Acts Interpretation Act 1901. State includes the Australian Capital Territory and the Northern Territory. the NHMRC means the National Health and Medical Research Council established by the National Health and Medical Research Council Act 1992. unsuitable for implantation, in relation to a human embryo, means a human embryo that: (a) is diagnosed by preimplantation genetic diagnosis as unsuitable for implantation, in accordance with the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research, issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992, as existing from time to time; or (b) is determined to be unsuitable for implantation in the body of a woman, in accordance with objective criteria specified in guidelines issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 and prescribed by the regulations for the purposes of this paragraph. use includes develop, or development, as the case requires. woman means a female human. (2) For the purposes of the definition of human embryo in subsection (1), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded. (3) A reference in this Act to an embryo (including a human embryo) is a reference to a living embryo. (4) A reference in this Act to a human egg is a reference to a human oocyte. (5) A reference in this Act to a human embryo does not include a reference to: (a) a hybrid embryo; or (b) a human embryonic stem cell line. Part 2—Regulation of the use of excess ART embryos and other material Division 1—Interpretation 8 Definitions In this Part: accredited ART centre means a person or body accredited to carry out assisted reproductive technology by: (a) the Reproductive Technology Accreditation Committee of the Fertility Society of Australia; or (b) if the regulations prescribe another body or other bodies in addition to, or instead of, the body mentioned in paragraph (a)—that other body or any of those other bodies, as the case requires. AHEC means the Australian Health Ethics Committee established by the National Health and Medical Research Council Act 1992. clinical practice licence means a licence referred to in section 28G. clinical practice research and training licence means a licence referred to in section 28F. clinical trial licence means a licence referred to in section 28E. clinical trial research and training licence means a licence referred to in section 28D. confidential commercial information means information that has a commercial or other value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed. disclose, in relation to information, means give or communicate in any way. donor, in relation to a particular use of a mitochondrial donation technique, has the meaning given by subsection 28R(2). engage in conduct means: (a) do an act; or (b) omit to perform an act. excess ART embryo has the meaning given by section 9. general licence means a licence issued under section 21. HREC means a Human Research Ethics Committee. mitochondrial donation licence means: (a) a pre‑clinical research and training licence; or (b) a clinical trial research and training licence; or (c) a clinical trial licence; or (d) a clinical practice research and training licence; or (e) a clinical practice licence. mitochondrial donation technique means a technique, prescribed by the regulations for the purposes of this definition, that: (a) can be used to minimise the risk of a woman's offspring inheriting mitochondria from that woman that would predispose the offspring to mitochondrial disease; and (b) involves using assisted reproductive technology to create a zygote that: (i) has nuclear DNA from the woman and a man; and (ii) contains mitochondria from a human egg of a different woman; and (c) does not involve: (i) intentionally modifying nuclear DNA or mitochondrial DNA; or (ii) using any cell, or any component part of a cell, of an animal; or (iii) creating a chimeric embryo (within the meaning of the Prohibition of Human Cloning for Reproduction Act 2002) or a hybrid embryo. National Statement means the National Statement on Ethical Conduct in Human Research, issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992, as existing from time to time. Note: The National Statement could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au). patient means a woman whose pregnancy is sought to be achieved using a mitochondrial donation technique under a clinical practice licence. Note: For a human embryo to be created for, or placed in the body of, a woman under a clinical practice licence, the NHMRC Licensing Committee must be satisfied that there is a particular risk of the woman's offspring inheriting mitochondria from the woman that would predispose the offspring to mitochondrial disease: see paragraph 28P(4)(a). permitted technique for a mitochondrial donation licence of a particular kind means a mitochondrial donation technique that is declared by the regulations to be a permitted technique for a mitochondrial donation licence of that kind. pre‑clinical research and training licence means a licence referred to in section 28C. proper consent: (a) for the purposes of Division 4 (general licences) of Part 2—has the meaning given by subsection 24(9); and (b) for the purposes of Division 4A (mitochondrial donation licences) of Part 2—has the meaning given by subsection 28N(8). relevant State body means a person or body notified by a State to the Chairperson of the NHMRC Licensing Committee for the purposes of this Part. responsible person: (a) for the purposes of Division 4 (general licences) of Part 2—has the meaning given by subsection 24(9); and (b) for the purposes of Division 4A (mitochondrial donation licences) of Part 2—has the meaning given by subsection 28N(8). trial participant means a woman whose pregnancy is sought to be achieved using a mitochondrial donation technique under a clinical trial licence. Note: For a human embryo to be created for, or placed in the body of, a woman under a clinical trial licence, the NHMRC Licensing Committee must be satisfied that there is a particular risk of the woman's offspring inheriting mitochondria from the woman that would predispose the offspring to mitochondrial disease: see paragraph 28P(4)(a). 9 Meaning of excess ART embryo (1) In this Part: excess ART embryo means a human embryo that: (a) was created, by assisted reproductive technology, for use in the assisted reproductive technology treatment of a woman; and (b) is excess to the needs of: (i) the woman for whom it was created; and (ii) her spouse (if any) at the time the embryo was created. (2) For the purposes of paragraph (b) of the definition of excess ART embryo, a human embryo is excess to the needs of the persons mentioned in that paragraph at a particular time if: (a) each such person has given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or (b) each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time. Division 2—Offences 10 Offence—use of excess ART embryo (1) A person commits an offence if the person intentionally uses an excess ART embryo, unless: (a) the excess ART embryo is created other than by using a mitochondrial donation technique and the use of the embryo by the person is authorised by a general licence; or (aa) the excess ART embryo is created using a mitochondrial donation technique and the use of the embryo by the person is permitted under section 28B (carrying out activities authorised by mitochondrial donation licences); or (b) the use by the person is an exempt use within the meaning of subsection (2). Penalty: Imprisonment for 5 years. (2) A use of an excess ART embryo by a person is an exempt use for the purposes of subsection (1) if: (a) the use consists only of: (i) storage of the excess ART embryo; or (ii) removal of the excess ART embryo from storage; or (iii) transport of the excess ART embryo; or (b) the use consists only of observation of the excess ART embryo; or (c) the use consists only of allowing the excess ART embryo to succumb; or (d) the use is carried out by an accredited ART centre, and: (i) the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and (ii) the use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or (e) the use is carried out by an accredited ART centre, and: (i) the use is for the purposes of achieving pregnancy in a woman other than the woman for whom the excess ART embryo was created; and (ii) the excess ART embryo was not created using a mitochondrial donation technique as permitted under section 28B (carrying out activities authorised by mitochondrial donation licences); or (f) the use is of a kind prescribed by the regulations for the purposes of this paragraph. (3) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (1) or (2) of this section. (4) In subsection (2): diagnostic investigation, in relation to an excess ART embryo, means any procedure undertaken on embryos for the sole purpose of diagnostic investigations for the direct benefit of the woman for whom it was created. observation, in relation to an excess ART embryo, includes taking a photograph of the embryo, or taking a recording of the embryo from which a visual image can be produced. 10A Offence—use of other embryos A person commits an offence if: (a) the person intentionally uses an embryo; and (b) the embryo is: (i) a human embryo created by a process other than the fertilisation of a human egg by a human sperm; or (ii) a human embryo created by a process other than the fertilisation of a human egg by a human sperm that contains genetic material provided by more than 2 persons; or (iii) a human embryo created using precursor cells taken from a human embryo or a human fetus; or (iv) a hybrid embryo; and (c) the use by the person is not authorised by a general licence or, if subparagraph (b)(i) or (ii) applies, permitted under section 28B (carrying out activities authorised by mitochondrial donation licences). Penalty: Imprisonment for 5 years. Note: The creation or development of embryos mentioned in this section is prohibited under Part 2 of the Prohibition of Human Cloning for Reproduction Act 2002, unless authorised by a general licence under this Act, or if subparagraph (b)(i) or (ii) applies, permitted under section 28B of this Act. 10B Offence—certain activities involving use of human eggs A person commits an offence if: (a) the person undertakes research or training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in assisted reproductive technology; and (b) neither of the following apply: (i) the person is authorised to undertake the research or training by a general licence; (ii) the person is permitted under section 28B to undertake the research or training because of a pre‑clinical research and training licence, a clinical trial research and training licence or a clinical practice research and training licence. Penalty: Imprisonment for 5 years. 11 Offence—use of embryo that is not an excess ART embryo A person commits an offence if: (a) the person intentionally uses, outside the body of a woman, a human embryo: (i) that was created by fertilisation of a human egg by a human sperm; and (ii) that is not an excess ART embryo; and (b) the use is not for a purpose relating to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre, and the person knows or is reckless as to that fact; and (c) the use by the person is not permitted under section 28B (carrying out activities authorised by mitochondrial donation licences). Penalty: Imprisonment for 5 years. 11A Offence—use of material created under mitochondrial donation licence A person commits an offence if: (a) the person intentionally uses any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence; and (b) the use of the material by the person is not permitted under section 28B (carrying out activities authorised by mitochondrial donation licences). Penalty: Imprisonment for 5 years. 12 Offence—breaching a general licence or mitochondrial donation licence condition A person commits an offence if the person intentionally engages in conduct, knowing that the conduct contravenes a condition of a general licence or mitochondrial donation licence that applies to the person, or reckless as to whether the conduct contravenes a condition of such a licence. Penalty: Imprisonment for 5 years. 12A Person not liable for conduct purportedly authorised (1) To avoid doubt, a person is not criminally responsible for a licence offence in respect of particular conduct if: (a) the conduct by the person is purportedly authorised by a provision of a general licence or mitochondrial donation licence; and (b) the licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and (c) the person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision. (2) In this section: general licence includes a purported general licence. licence offence means: (a) for a general licence—an offence against section 10, 10A, 10B or 12; or (b) for a mitochondrial donation licence—an offence against: (i) section 10; or (ii) section 10A, in so far as it applies because of subparagraph (b)(i) or (ii) of that section; or (iii) section 10B in so far as it applies to a pre‑clinical research and training licence, a clinical trial research and training licence or a clinical practice research and training licence; or (iv) section 11, 11A or 12. mitochondrial donation licence includes a purported mitochondrial donation licence. Division 3—Embryo Research Licensing Committee of the NHMRC 13 Establishment of Committee (1) The Embryo Research Licensing Committee of the NHMRC (the NHMRC Licensing Committee) is established by this section. (2) The NHMRC Licensing Committee is taken to be a Principal Committee within the meaning of the National Health and Medical Research Council Act 1992, other than for the purposes of the following provisions of that Act: (a) sections 5D and 5E; (b) section 35; (c) section 41; (d) section 80; (e) subsections 82(1C) and (2). (3) This section has effect despite the definition of Principal Committee in section 4 of the National Health and Medical Research Council Act 1992. (4) The regulations may make provision for and in relation to the disclosure of members' interests in matters being considered by the NHMRC Licensing Committee. (5) The following provisions do not have effect in relation to the NHMRC Licensing Committee at any time when regulations under subsection (4) are in force: (a) section 42A of the National Health and Medical Research Council Act 1992; (b) section 29 of the Public Governance, Performance and Accountability Act 2013 (which deals with the duty to disclose interests) and any rules made for the purposes of that section. 14 Functions of Committee The functions of the NHMRC Licensing Committee are: (a) to perform functions in relation to general licences under Division 4; and (aa) to perform functions in relation to mitochondrial donation licences under Division 4A; and (b) to perform functions in relation to databases under section 29; and (c) to perform such other functions as are conferred on it by this Act or any other law. 15 Powers of Committee The NHMRC Licensing Committee has power to do all things necessary or convenient to be done for or in connection with the performance of its functions. 16 Membership of Committee (1) The NHMRC Licensing Committee consists of the following members: (a) a member of AHEC; (b) a person with expertise in research ethics; (c) a person with expertise in a relevant area of research; (d) a person with expertise in assisted reproductive technology; (e) a person with expertise in a relevant area of law; (f) a person with expertise in consumer health issues relating to disability and disease; (g) a person with expertise in consumer issues relating to assisted reproductive technology; (h) a person with expertise in the regulation of assisted reproductive technology; (i) a person with expertise in embryology. (2) The Minister must appoint the members of the NHMRC Licensing Committee. (3) Before appointing a member, the Minister must: (a) seek nominations from the States and from such bodies as are prescribed by the regulations for the purpose; (b) consult, and have regard to the views expressed by, the States on the proposed appointment; and (c) be satisfied upon receipt of a written declaration by the member proposed to be appointed that the member proposed does not have a direct or indirect pecuniary interest in a body that undertakes uses of excess ART embryos or human eggs, or creation or uses of other embryos, being an interest of a kind that could conflict with the proper performance of the member's functions. (4) The Minister must appoint one of the members, other than the member mentioned in paragraph (1)(a), as the Chairperson of the NHMRC Licensing Committee. (5) The Minister must not appoint a person: (a) as the Chairperson under subsection (4); or (b) as the member mentioned in paragraph (1)(h); unless a majority of the States agree with that appointment. (6) In appointing the members of the NHMRC Licensing Committee, the Minister must have regard to the desirability of ensuring that the Committee as a whole comprises members from different States. (7) It is the intention of the Parliament that any vacancy on the NHMRC Licensing Committee be filled as soon as possible. (8) If there is a vacancy in the membership of the NHMRC Licensing Committee for a period of 3 months the Minister must, within 3 sitting days of the expiration of that 3 months, table in each House of the Parliament a written statement of reasons for the failure to fill the vacancy. 17 Terms of appointment (1) A member of the NHMRC Licensing Committee holds office on a part‑time basis. (2) A member holds office for a period not exceeding 3 years that is specified in the instrument of appointment, but is eligible for reappointment. 18 Annual report (1) The annual report prepared by the CEO of the NHMRC under section 46 of the Public Governance, Performance and Accountability Act 2013 must, in addition to the matters set out in section 83 of the National Health and Medical Research Council Act 1992, include details relating to the operations of the NHMRC Licensing Committee. (2) The NHMRC Licensing Committee must give written details relating to its operations to the CEO of the NHMRC for the purposes of subsection (1). 19 Reports to Parliament (1) The NHMRC Licensing Committee may at any time cause a report about matters relating to the Committee's functions to be tabled in either House of the Parliament. (2) The NHMRC Licensing Committee must give a copy of the report to the Minister and to each State. (3) The NHMRC Licensing Committee must cause a report to be tabled in either House of Parliament on or before: (a) 30 June of each year; and (b) 31 December of each year; and (c) any other time required by either House of Parliament; that must include information about: (d) the operation of this Act; and (e) the general licences and mitochondrial donation licences issued under this Act. (4) A report under this section must not include information about any of the following matters unless the NHMRC Licensing Committee considers that the information does not identify, and is not reasonably capable of being used to identify, any person: (a) approvals under subsection 28P(3) (including applications for such approvals and the outcomes of those applications); (b) births of children as a result of pregnancies achieved using a mitochondrial donation technique under a clinical trial licence or a clinical practice licence; (c) adverse events notified to the NHMRC Licensing Committee under paragraph 28S(3)(a). Division 4—General licences 20 Applying for a general licence (1) A person may apply to the NHMRC Licensing Committee for a licence (a general licence) authorising one or more of the following: (a) use of excess ART embryos; (b) creation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos; (c) creation of human embryos other than by fertilisation of a human egg by a human sperm that contain genetic material provided by more than 2 persons, and use of such embryos; (d) creation of human embryos using precursor cells from a human embryo or a human fetus, and use of such embryos; (e) research and training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in assisted reproductive technology; (f) creation of hybrid embryos by the fertilisation of an animal egg by a human sperm, and use of such embryos up to, but not including, the first mitotic division, if: (i) the creation or use is for the purposes of testing sperm quality; and (ii) the creation or use will occur in an accredited ART centre. (1A) To avoid doubt, paragraphs (1)(a), (b), (c) and (d) do not permit the NHMRC Licensing Committee to authorise any use of an excess ART embryo or other embryo that would result in the development of the embryo for a period of more than 14 days, excluding any period when development is suspended. (1B) Subsection (1) does not permit the NHMRC Licensing Committee to authorise: (a) any activity that involves the use of a mitochondrial donation technique; or (b) the use of any material created, developed or produced under a mitochondrial donation licence. (2) An application under subsection (1): (a) must be made in accordance with the requirements (if any) specified in writing by the NHMRC Licensing Committee; and (b) must be accompanied by the fee (if any) prescribed by the regulations. 21 Determination of application by Committee (1) This section applies if a person has made an application under section 20 for a general licence. (2) The NHMRC Licensing Committee must decide, in accordance with this section, whether or not to issue the licence. (3) The NHMRC Licensing Committee must not issue the licence unless it is satisfied of the following: (a) that appropriate protocols are in place: (i) to enable proper consent to be obtained before an excess ART embryo or human egg is used, or other embryo is created or used under the licence (see paragraph 24(1)(a)); and (ii) to enable compliance with any restrictions on such consent; (c) that the activity or project proposed in the application has been assessed and approved by a HREC that is constituted in accordance with, and acting in compliance with, the National Statement. (4) In deciding whether to issue the licence, the NHMRC Licensing Committee must have regard to the following: (a) restricting the number of excess ART embryos, other embryos or human eggs, to that likely to be necessary to achieve the goals of the activity or project proposed in the application; (b) the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means; (c) any relevant guidelines, or relevant parts of guidelines, issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 and prescribed by the regulations for the purposes of this paragraph; (d) the HREC assessment of the application mentioned in paragraph (3)(c); (e) such additional matters (if any) as are prescribed by the regulations. 22 Notification of decision (1) The NHMRC Licensing Committee must notify its decision on an application for a general licence under section 20 to the following: (a) the applicant; (b) the HREC that assessed and approved the activity or project proposed in the application as mentioned in paragraph 21(3)(c); (c) the relevant State body in relation to the State in which the use is to occur. (2) If the NHMRC Licensing Committee decides to issue the licence, it must, in addition to issuing the licence to the applicant, give a copy of the licence to the bodies mentioned in paragraphs (1)(b) and (c). 23 Period of a general licence (1) A general licence: (a) comes into force on the day specified in the licence, or if no day is specified, on the day on which it is issued; and (b) remains in force until the day specified in the licence, unless it is suspended, revoked or surrendered before that day. (2) A general licence is not in force throughout any period of suspension. 24 Conditions of general licences (1) A general licence is subject to the condition that before an excess ART embryo or human egg is used, or any other embryo is created or used, as authorised by the licence: (a) each responsible person in relation to the excess ART embryo, human egg or other embryo must have given proper consent to that creation or use; and (b) the licence holder must have reported in writing to the NHMRC Licensing Committee that such consent has been obtained, and any restrictions to which the consent is subject. (2) A general licence is subject to the condition that the use of an excess ART embryo or human egg, or the creation or use of any other embryo, must be in accordance with any restrictions to which the proper consent under subsection (1) is subject. (4) A general licence is subject to such other conditions as are specified in the licence. (5) The conditions specified in the licence may include, but are not limited to, conditions relating to the following: (a) the persons authorised by the licence to use excess ART embryos or human eggs, or create or use other embryos; (b) the number of excess ART embryos or human eggs authorised to be used under the licence, or the number of other embryos authorised to be created or used under the licence; (c) reporting; (d) monitoring; (e) information to be given by the licence holder to persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos. (6) The licence conditions set out in subsections (1) and (2) apply to all persons who are authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos. (7) Licence conditions specified in the licence apply to: (a) the licence holder; and (b) such other persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos as are specified in the licence. (8) For the purposes of applying the condition referred to in paragraph (1)(a): (a) a general licence may provide that the guidelines referred to in the definition of proper consent in subsection (9) apply in a modified form in relation to the use, under the licence, of excess ART embryos that are unsuitable for implantation; and (b) if a general licence so provides, the guidelines as modified by the licence have effect in relation to the giving of consent for such creation or use. Note: For example, the guidelines could apply to a particular licence in a modified form, to alter the cooling‑off period required in relation to the use of excess ART embryos that are unsuitable for implantation. (9) In this Division: proper consent, in relation to the use of an excess ART embryo or a human egg, or the creation or use of any other embryo, means consent obtained in accordance with guidelines issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 and prescribed by the regulations for the purposes of this definition. responsible person means: (a) in relation to an excess ART embryo: (i) each person who provided the egg or sperm from which the embryo was created; and (ii) the woman for whom the embryo was created, for the purpose of achieving her pregnancy; and (iii) any person who was the spouse of a person mentioned in subparagraph (i) at the time the egg or sperm mentioned in that subparagraph was provided; and (iv) any person who was the spouse of the woman mentioned in subparagraph (ii) at the time the embryo was created; or (b) in relation to an embryo other than an excess ART embryo—each person whose reproductive material, genetic material or cell was used, or is proposed to be used, in the creation or use of the embryo; or (c) in relation to a human egg—the woman who was the biological donor of the egg. 25 Variation of a general licence (1) The NHMRC Licensing Committee may, by notice in writing given to the licence holder, vary a general licence if the Committee believes on reasonable grounds that it is necessary or desirable to do so. (2) The NHMRC Licensing Committee may vary a general licence under subsection (1) on its own initiative or on application by the licence holder. (3) Without limiting subsection (1), the NHMRC Licensing Committee may vary the licence by specifying additional conditions or varying existing conditions. (4) The NHMRC Licensing Committee must not vary a general licence in such a way that, had a person applied under section 20 for the licence as varied, the Committee would not have been permitted by this Division to issue the licence. 26 Suspension or revocation of a general licence (1) The NHMRC Licensing Committee may, by notice in writing given to the licence holder, suspend or revoke a general licence if the Committee believes on reasonable grounds that a condition of the licence has been breached. (2) If a licence holder is convicted of an offence under this Act or the Prohibition of Human Cloning Act 2002, the NHMRC Licensing Committee must, by notice in writing given to the licence holder, revoke each general licence held by the licence holder. 27 Surrender of a general licence A licence holder may surrender a general licence by written notice given to the NHMRC Licensing Committee. 28 Notification of variation, suspension or revocation of a general licence (1) If the NHMRC Licensing Committee varies, suspends or revokes a general licence, the Committee must notify: (a) the licence holder; and (b) the HREC and the relevant State body to which the NHMRC Licensing Committee notified its decision on the application for the licence under section 22. (2) The NHMRC Licensing Committee must also notify the bodies mentioned in paragraph (1)(b) if a general licence is surrendered. Division 4A—Mitochondrial donation licences Subdivision A—Kinds of mitochondrial donation licences and what they authorise 28A Kinds of mitochondrial donation licences There are 5 kinds of mitochondrial donation licences, which are as follows: (a) pre‑clinical research and training licences referred to in section 28C; (b) clinical trial research and training licences referred to in section 28D; (c) clinical trial licences referred to in section 28E; (d) clinical practice research and training licences referred to in section 28F; (e) clinical practice licences referred to in section 28G. 28B Carrying out activities authorised by mitochondrial donation licences (1) A person may carry out an activity as authorised by a pre‑clinical research and training licence, a clinical trial research and training licence or a clinical trial licence (see section 28C, 28D or 28E) if: (a) the licence is in force; and (b) the licence holder is a constitutional corporation. (2) Subsection (1) applies despite a law of a State. (3) A person may carry out an activity as authorised by a clinical practice research and training licence or a clinical practice licence (see section 28F or 28G) in a particular State if: (a) the licence is in force; and (b) carrying out the activity is authorised by a law of that State. 28C What a pre‑clinical research and training licence authorises (1) A pre‑clinical research and training licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence in undertaking research and training for the purpose of doing all of the following: (a) developing the permitted technique specified in the licence for potential future use in a clinical setting as a way to minimise the risk of women's offspring inheriting mitochondria that would predispose them to mitochondrial disease, but without the immediate aim of: (i) conducting a clinical trial; or (ii) using the technique in a clinical practice setting; (b) better understanding the technique, including its safety and efficacy in minimising the risk of women's offspring inheriting mitochondria that would predispose them to mitochondrial disease; (c) building expertise in the technique and how to use it. (2) The activities are as follows: (a) creation of human embryos other than by fertilisation of a human egg by a human sperm, using the permitted technique specified in the licence, and use of such embryos; (b) creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence: (i) by fertilisation of a human egg by a human sperm outside the body of a woman; or (ii) other than by the fertilisation of a human egg by a human sperm; and use of such embryos; (c) creation of human embryos by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, using the permitted technique specified in the licence, and use of such embryos; (d) research and training involving the fertilisation of a human egg by a human sperm up to, including and after the first mitotic division, outside the body of a woman for the purposes of research or training in the use of the permitted technique specified in the licence; (e) use of any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence. (3) A pre‑clinical research and training licence does not authorise any use of a human embryo that would: (a) result in the development of a human embryo for a period of more than 14 days, excluding any period when development is suspended; or (b) involve placing a human embryo into the body of a woman for the purposes of achieving pregnancy in that woman. 28D What a clinical trial research and training licence authorises (1) A clinical trial research and training licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence, at an accredited ART centre, in undertaking research and training for the purpose of doing all of the following in preparation for using the permitted technique specified in the licence in a particular clinical trial: (a) developing protocols for using the technique safely and effectively, in a clinical trial setting, for the purpose of minimising the risk of women's offspring inheriting mitochondria that would predispose them to mitochondrial disease; (b) ensuring that each embryologist nominated under subsection 28H(5) has technical competence in the use of the technique in accordance with those protocols; (c) ensuring that the holder's facilities, equipment, processes and protocols for using the technique are suitable for using the technique in a clinical trial setting. (2) The activities are as follows: (a) creation of human embryos other than by fertilisation of a human egg by a human sperm, using the permitted technique specified in the licence, and use of such embryos; (b) creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence: (i) by fertilisation of a human egg by a human sperm outside the body of a woman; or (ii) other than by the fertilisation of a human egg by a human sperm; and use of such embryos; (c) creation of human embryos by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, using the permitted technique specified in the licence, and use of such embryos; (d) research and training involving the fertilisation of a human egg by a human sperm up to, including and after the first mitotic division, outside the body of a woman for the purposes of research or training in the use of the permitted technique specified in the licence; (e) use of any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence. (3) A clinical trial research and training licence does not authorise any use of a human embryo that would: (a) result in the development of a human embryo for a period of more than 14 days, excluding any period when development is suspended; or (b) involve placing a human embryo into the body of a woman for the purposes of achieving pregnancy in that woman. 28E What a clinical trial licence authorises (1) A clinical trial licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence, at an accredited ART centre, for the purpose of doing both of the following in conducting a clinical trial to determine whether the permitted technique specified in the licence is sufficiently safe and effective to use in a clinical practice setting: (a) creating a human embryo for a trial participant, using the permitted technique specified in the licence, with the intention of minimising the risk of the embryo inheriting mitochondria that would predispose any resulting child to mitochondrial disease; (b) placing the embryo in the body of the trial participant for the purposes of achieving her pregnancy. (2) The activities are as follows: (a) creation of human embryos other than by fertilisation of a human egg by a human sperm, using the permitted technique specified in the licence, and use of such embryos; (b) creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence: (i) by fertilisation of a human egg by a human sperm outside the body of a woman; or (ii) other than by the fertilisation of a human egg by a human sperm; and use of such embryos; (c) alteration of the genome of a human cell (within the meaning of section 15 of the Prohibition of Human Cloning for Reproduction Act 2002) using the permitted technique specified in the licence, in such a way that the alteration is heritable by descendants of the human whose cell was altered; (d) placement in the body of a woman of any of the following kinds of human embryo created using the permitted technique specified in the licence: (i) a human embryo created by a process other than the fertilisation of a human egg by human sperm; (ii) a human embryo that contains genetic material provided by more than 2 persons; (iii) a human embryo that contains a human cell (within the meaning of section 15 of the Prohibition of Human Cloning for Reproduction Act 2002) whose genome has been altered in such a way that the alteration is heritable by descendants of the human whose cell was altered; (e) use of any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence. (3) A clinical trial licence does not authorise any use of a human embryo that would result in the development of the embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended. 28F What a clinical practice research and training licence authorises (1) A clinical practice research and training licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence, at an accredited ART centre, in undertaking research and training for the purpose of doing all of the following in preparation for using the permitted technique specified in the licence in a clinical practice setting: (a) developing protocols for using the technique safely and effectively, in a clinical practice setting, for the purpose of minimising the risk of women's offspring inheriting mitochondria that would predispose them to mitochondrial disease; (b) ensuring that each embryologist nominated under subsection 28H(5) has technical competence in the use of the technique in accordance with those protocols; (c) ensuring that the holder's facilities, equipment, processes and protocols for using the technique are suitable for using the technique in a clinical practice setting. (2) The activities are as follows: (a) creation of human embryos other than by fertilisation of a human egg by a human sperm, using the permitted technique specified in the licence, and use of such embryos; (b) creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence: (i) by fertilisation of a human egg by a human sperm outside the body of a woman; or (ii) other than by the fertilisation of a human egg by a human sperm; and use of such embryos; (c) creation of human embryos by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, using the permitted technique specified in the licence, and use of such embryos; (d) research and training involving the fertilisation of a human egg by a human sperm up to, including and after the first mitotic division, outside the body of a woman for the purposes of research or training in the use of the permitted technique specified in the licence; (e) use of any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence. (3) A clinical practice research and training licence does not authorise any use of a human embryo that would: (a) result in the development of a human embryo for a period of more than 14 days, excluding any period when development is suspended; or (b) involve placing a human embryo into the body of a woman for the purposes of achieving pregnancy in that woman. 28G What a clinical practice licence authorises (1) A clinical practice licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence, at an accredited ART centre, for the purpose of doing both of the following in a clinical practice setting: (a) creating a human embryo for a patient, using the permitted technique specified in the licence, with the intention of minimising the risk of the embryo inheriting mitochondria that would predispose any resulting child to mitochondrial disease; (b) placing the embryo in the body of the patient for the purposes of achieving her pregnancy. (2) The activities are as follows: (a) creation of human embryos other than by fertilisation of a human egg by a human sperm, using the permitted technique specified in the licence, and use of such embryos; (b) creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence: (i) by fertilisation of a human egg by a human sperm outside the body of a woman; or (ii) other than by the fertilisation of a human egg by a human sperm; and use of such embryos; (c) alteration of the genome of a human cell (within the meaning of section 15 of the Prohibition of Human Cloning for Reproduction Act 2002) using the permitted technique specified in the licence, in such a way that the alteration is heritable by descendants of the human whose cell was altered; (d) placement in the body of a woman of any of the following kinds of human embryo created using the permitted technique specified in the licence: (i) a human embryo created by a process other than the fertilisation of a human egg by human sperm; (ii) a human embryo that contains genetic material provided by more than 2 persons; (iii) a human embryo that contains a human cell (within the meaning of section 15 of the Prohibition of Human Cloning for Reproduction Act 2002) whose genome has been altered in such a way that the alteration is heritable by descendants of the human whose cell was altered; (e) use of any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence. (2) A clinical practice licence does not authorise any use of a human embryo that would result in the development of the embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended. Subdivision B—Applying for a mitochondrial donation licence 28H Applying for a mitochondrial donation licence (1) A person may, subject to subsections (2) to (7), apply to the NHMRC Licensing Committee for: (a) a pre‑clinical research and training licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28C(2); or (b) a clinical trial research and training licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28D(2); or (c) a clinical trial licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28E(2); or (d) a clinical practice research and training licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28F(2); or (e) a clinical practice licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28G(2). (2) A person cannot apply for any of the following licences unless the person is a constitutional corporation: (a) a pre‑clinical research and training licence; (b) a clinical trial research and training licence; (c) a clinical trial licence. (3) A person cannot apply for a clinical trial licence relating to a particular mitochondrial donation technique unless the person has held a clinical trial research and training licence relating to that technique. (4) A person cannot apply for a clinical practice licence relating to a particular mitochondrial donation technique unless the person has held a clinical practice research and training licence relating to that technique. (5) An application for a mitochondrial donation licence relating to a particular mitochondrial donation technique must nominate one or more embryologists who will be authorised to use the technique under the licence. (6) A single application cannot relate to: (a) more than one kind of mitochondrial donation licence; or (b) more than one permitted technique for a mitochondrial donation licence. (7) An application for a mitochondrial donation licence must: (a) be in the form approved by the NHMRC Licensing Committee; and (b) specify the following: (i) the kind of mitochondrial donation licence; (ii) the permitted technique to which the licence will relate; and (c) be made in accordance with: (i) the requirements specified in the regulations for the purposes of this subparagraph (if any); and (ii) such other requirements (if any) as are specified in writing by the NHMRC Licensing Committee and are not inconsistent with requirements specified under subparagraph (i); and (d) be accompanied by the fee (if any) prescribed by the regulations. (8) A form approved for the purposes of paragraph (7)(a) may require: (a) an application to contain, or be accompanied by, such information as is required by the form; and (b) any such information to be verified by statutory declaration. Subdivision C—Determining applications for mitochondrial donation licences 28J Determination of application by Committee (1) If a person applies under subsection 28H(1) for a mitochondrial donation licence relating to a mitochondrial donation technique that is a permitted technique for the licence, the NHMRC Licensing Committee must decide, in accordance with this section, whether or not to issue the licence. (2) The NHMRC Licensing Committee must not issue the licence unless it is satisfied of the following: (a) that appropriate protocols are in place to enable proper consent to be obtained before any of the following activities are carried out under the licence (see paragraph 28N(1A)(a)): (i) an excess ART embryo, a human egg or a human sperm is used; (ii) a human zygote or a human embryo (other than an excess ART embryo) is created or used; (iii) any material not covered by subparagraph (i) or (ii) of this paragraph is created, developed, produced or used; (aa) that appropriate protocols are in place to enable compliance with any restrictions on such consent; (b) that the activity or project proposed in the application has been assessed and approved by a HREC that is constituted in accordance with, and acting in compliance with, the National Statement. (3) In deciding whether to issue the licence, the NHMRC Licensing Committee must have regard to the following: (a) restricting the number of excess ART embryos, other embryos, or human eggs or zygotes, to that likely to be necessary to achieve the goals of the activity or project proposed in the application; (b) any relevant guidelines, or relevant parts of guidelines, issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 and prescribed by the regulations for the purposes of this paragraph; (c) the HREC assessment of the application mentioned in paragraph (2)(b); (d) whether the applicant has complied with the conditions of any other mitochondrial donation licence. (4) Without limiting section 15, the NHMRC Licensing Committee may also request, and have regard to, advice from any person having appropriate expertise. (5) The NHMRC Licensing Committee must not issue a clinical trial licence, or a clinical practice licence, relating to a particular mitochondrial donation technique unless it is satisfied that: (a) the applicant has in place protocols for using the technique safely and effectively in a clinical trial or in clinical practice (as the case requires) for the purpose of minimising the risk of women's offspring inheriting mitochondria that would predispose them to mitochondrial disease; and (b) each embryologist nominated under subsection 28H(5) has: (i) consented in writing to being so nominated; and (ii) demonstrated technical competence in the use of the technique in accordance with the protocols referred to in paragraph (a) of this subsection; and (iii) understands the embryologist's obligations under this Act; and (c) the applicant's facilities, equipment and processes for using the technique under the licence are suitable for that purpose; and (d) the staff, other than embryologists, who will carry out activities directly connected with the clinical trial or clinical practice (as the case requires) are appropriately qualified, trained and competent to do so; and (e) the applicant is likely to be able to comply with its obligations under section 28R (information about donors and children); and (f) the applicant has protocols in place to ensure that each donor in relation to a use of the technique is aware that any children born as a result of a pregnancy achieved by using the technique will be able to obtain information about the donor in accordance