{"id":"a-2004-22","name":"Human Cloning and Embryo Research Act 2004","slug":"human-cloning-and-embryo-research-act-2004","collection":"act","jurisdiction":"act","status":"in_force","isInForce":true,"actNumber":"22 of 2004","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":23729,"registerId":"act-a-2004-22-current","compilationNumber":null,"startDate":"2026-04-01","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Human Cloning and Embryo Research Act 2004","content":"Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nAustralian Capital Territory\nHuman Cloning and Embryo Research\nAct 2004\nA2004-22\nRepublication No 9\nEffective: 16 November 2025\nRepublication date: 16 November 2025\nLast amendment made by A2025-29\n\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nAbout this republication\nThe republished law\nThis is a republication of the Human Cloning and Embryo Research Act 2004 (including any\namendment made under the Legislation Act 2001, part 11.3 (Editorial changes)) as in force on\n16 November 2025. It also includes any commencement, amendment, repeal or expiry affecting\nthis republished law to 16 November 2025.\nThe legislation history and amendment history of the republished law are set out in endnotes 3\nand 4.\nKinds of republications\nThe Parliamentary Counsel’s Office prepares 2 kinds of republications of ACT laws (see the ACT\nlegislation register at www.legislation.act.gov.au):\n• authorised republications to which the Legislation Act 2001 applies\n• unauthorised republications.\nThe status of this republication appears on the bottom of each page.\nEditorial changes\nThe Legislation Act 2001, part 11.3 authorises the Parliamentary Counsel to make editorial\namendments and other changes of a formal nature when preparing a law for republication.\nEditorial changes do not change the effect of the law, but have effect as if they had been made by\nan Act commencing on the republication date (see Legislation Act 2001, s 115 and s 117). The\nchanges are made if the Parliamentary Counsel considers they are desirable to bring the law into\nline, or more closely into line, with current legislative drafting practice.\nThis republication does not include amendments made under part 11.3 (see endnote 1).\nUncommenced provisions and amendments\nIf a provision of the republished law has not commenced, the symbol U appears immediately\nbefore the provision heading. Any uncommenced amendments that affect this republished law\nare accessible on the ACT legislation register (www.legislation.act.gov.au). For more\ninformation, see the home page for this law on the register.\nModifications\nIf a provision of the republished law is affected by a current modification, the symbol M appears\nimmediately before the provision heading. The text of the modifying provision appears in the\nendnotes. For the legal status of modifications, see the Legislation Act 2001, section 95.\nPenalties\nAt the republication date, the value of a penalty unit for an offence against this law is $160 for an\nindividual and $810 for a corporation (see Legislation Act 2001, s 133).\n\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\ncontents 1\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nAustralian Capital Territory\nHuman Cloning and Embryo Research\nAct 2004\nContents\nPage\nPart 1 Preliminary\n1 Name of Act 2\n2 Dictionary 2\n3 Notes 2\n4 Offences against Act—application of Criminal Code etc 2\n5 Object of Act 3\n6 Meaning of human embryo 3\n7 Meaning of human embryo clone 4\n\nContents\nPage\ncontents 2 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 2 Prohibited practices\nDivision 2.1 Practices that are completely prohibited\n8 Offence—placing human embryo clone in human body or body of an\nanimal 5\n9 No defence that human embryo clone could not survive 5\n10 Offence—creating human embryo for purpose other than achieving\npregnancy in woman 5\n11 Offence—creating or developing human embryo by fertilisation that\ncontains genetic material provided by more than 2 people 6\n12 Offence—developing human embryo outside body of woman for more\nthan 14 days 6\n13 Offence—heritable alterations to genome 6\n14 Offence—collecting viable human embryo from body of woman 7\n15 Offence—creating chimeric embryo 7\n16 Offence—developing hybrid embryo 7\n17 Offence—placing of embryo 7\n18 Offence—importing, exporting or placing prohibited embryo 8\n19 Offence—commercial trading in human eggs, human sperm or human\nembryos 9\nDivision 2.2 Practices that are prohibited unless authorised by\nlicence\n20 Offence—creating human embryo other than by fertilisation, or\ndeveloping embryo 10\n21 Offence—creating or developing human embryo containing genetic\nmaterial provided by more than 2 people 10\n22 Offence—using precursor cells from human embryo or human fetus to\ncreate human embryo, or developing such an embryo 11\n22A Offence—creating hybrid embryo 11\nPart 3 Regulation of the use of excess ART\nembryos, other embryos and human eggs\nDivision 3.1 Interpretation for pt 3\n23 Definitions for pt 3 13\n24 Meaning of excess ART embryo 15\n\nContents\nPage\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\ncontents 3\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nDivision 3.2 Offences\n25 Offence—use of excess ART embryo 16\n25A Offence—use of other embryos 17\n25B Offence—certain activities involving use of human eggs 18\n26 Offence—use of embryo that is not excess ART embryo 18\n27 Offence—breaching licence condition 19\n27A Person not liable for conduct purportedly authorised 19\nDivision 3.3 Embryo research licensing committee of NHMRC\n28 Functions of committee 20\nDivision 3.4 Licensing system\n29 Person may apply for licence 20\n30 Committee decision on application 21\n31 Notification of decision 22\n32 Period of licence 23\n33 Licence is subject to conditions 23\n34 Variation of licence 25\n35 Suspension or revocation of licence 25\n36 Surrender of licence 26\n37 Notice of variation, suspension or revocation of licence 26\nDivision 3.5 Reporting and confidentiality\n38 NHMRC licensing committee to make certain information publicly\navailable 26\n39 Confidential commercial information may only be disclosed in certain\ncircumstances 27\nDivision 3.6 Review provisions\n40 Definitions for div 3.6 29\n41 Review of decisions 30\nPart 4 Monitoring powers\n42 Appointment of inspectors 32\n43 Identity card 32\n44 Powers available to inspectors for monitoring compliance 33\n45 Monitoring powers 33\n46 Power to secure 35\n\nContents\nPage\ncontents 4 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n46A Monitoring warrants 35\n46B Details of warrant to be given to occupier etc 37\n46C Announcement before entry 37\n46D Occupier entitled to be present during search 37\n47 Inspector must produce identity card on request 37\n48 Consent 38\n49 Compensation for damage 38\nPart 5 Miscellaneous\n49A Court to notify director-general of offence 39\n50 Reports to Legislative Assembly 39\n51 Report on operation of Act 39\n52 Determination of fees 39\n54 Regulation-making power 39\nDictionary 40\nEndnotes\n1 About the endnotes 43\n2 Abbreviation key 43\n3 Legislation history 44\n4 Amendment history 46\n5 Earlier republications 56\n\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 1\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nAustralian Capital Territory\nHuman Cloning and Embryo Research\nAct 2004\nAn Act to prohibit human cloning for reproduction and other unacceptable\npractices associated with reproductive technology and to regulate certain\nactivities involving the use of human embryos\n\nPart 1 Preliminary\nSection 1\npage 2 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 1 Preliminary\n1 Name of Act\nThis Act is the Human Cloning and Embryo Research Act 2004.\n2 Dictionary\nThe dictionary at the end of this Act is part of this Act.\nNote 1 The dictionary at the end of this Act defines certain terms used in this\nAct, and includes references (signpost definitions) to other terms defined\nelsewhere in this Act.\nFor example, the signpost definition ‘human embryo—see section 6.’\nmeans that the term ‘human embryo’ is defined that section.\nNote 2 A definition in the dictionary (including a signpost definition) applies to\nthe entire Act unless the definition, or another provision of the Act,\nprovides otherwise or the contrary intention otherwise appears (see\nLegislation Act, s 155 and s 156 (1)).\n3 Notes\nA note included in this Act is explanatory and is not part of this Act.\nNote See Legislation Act, s 127 (1), (4) and (5) for the legal status of notes.\n4 Offences against Act—application of Criminal Code etc\nOther legislation applies in relation to offences against this Act.\nNote 1 Criminal Code\nThe Criminal Code, ch 2 applies to all offences against this Act (see\nCode, pt 2.1).\nThe chapter sets out the general principles of criminal responsibility\n(including burdens of proof and general defences), and defines terms used\nfor offences to which the Code applies (eg conduct, intention,\nrecklessness and strict liability).\nNote 2 Penalty units\nThe Legislation Act, s 133 deals with the meaning of offence penalties\nthat are expressed in penalty units.\n\nPreliminary Part 1\nSection 5\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 3\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n5 Object of Act\nThe object of this Act is to address concerns, including ethical\nconcerns, about scientific developments in relation to human\nreproduction and the utilisation of human embryos—\n(a) by prohibiting certain practices; and\n(b) by regulating activities that involve the use of certain human\nembryos created by assisted reproductive technology or by other\nmeans.\n6 Meaning of human embryo\n(1) In this Act:\nhuman embryo means a discrete entity that has arisen from either—\n(a) the first mitotic division when fertilisation of a human oocyte by\na human sperm is complete; or\n(b) any other process that initiates organised development of a\nbiological entity with a human nuclear genome or altered human\nnuclear genome that has the potential to develop up to, or\nbeyond, the stage at which the primitive streak appears;\nand has not yet reached 8 weeks of development since the first mitotic\ndivision.\n(2) However, human embryo does not include a—\n(a) hybrid embryo; or\n(b) human embryonic stem cell line.\n(3) In working out the length of the period of development of a human\nembryo, any period when the development of the embryo is\nsuspended is to be disregarded.\n\nPart 1 Preliminary\nSection 7\npage 4 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n7 Meaning of human embryo clone\n(1) In this Act:\nhuman embryo clone means a human embryo that is a genetic copy\nof another living or dead human, but does not include a human\nembryo created by the fertilisation of a human egg by human sperm.\n(2) To establish that a human embryo clone is a genetic copy of a living\nor dead human—\n(a) it is sufficient to establish that the set of genes in the nuclei of\nthe cells of the living or dead human has been copied; and\n(b) it is not necessary to establish that the copy is an identical\ngenetic copy.\n(3) A human embryo that results from the technological process known\nas embryo splitting is taken not to be created by a process of\nfertilisation of a human egg by human sperm.\n\nProhibited practices Part 2\nPractices that are completely prohibited Division 2.1\nSection 8\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 5\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 2 Prohibited practices\nDivision 2.1 Practices that are completely\nprohibited\n8 Offence—placing human embryo clone in human body or\nbody of an animal\nA person commits an offence if the person intentionally places a\nhuman embryo clone in the body of a human or the body of an animal.\nMaximum penalty: imprisonment for 15 years.\nNote The development of a human embryo (including a human embryo clone)\noutside the body of a woman for more than 14 days is prohibited by s 12.\n9 No defence that human embryo clone could not survive\nIt is not a defence to an offence against section 8 that the human\nembryo clone did not survive or could not have survived.\n10 Offence—creating human embryo for purpose other than\nachieving pregnancy in woman\n(1) A person commits an offence if the person intentionally creates a\nhuman embryo by a process of the fertilisation of a human egg by a\nhuman sperm outside the body of a woman, unless the person’s\nintention in creating the embryo is to attempt to achieve pregnancy in\na particular woman.\nMaximum penalty: imprisonment for 15 years.\n(2) Despite the Criminal Code, section 58 (3), a defendant does not bear\nan evidential burden in relation to anything mentioned in\nsubsection (1).\n\nPart 2 Prohibited practices\nDivision 2.1 Practices that are completely prohibited\nSection 11\npage 6 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n11 Offence—creating or developing human embryo by\nfertilisation that contains genetic material provided by\nmore than 2 people\nA person commits an offence if—\n(a) the person intentionally creates or develops a human embryo by\na process of the fertilisation of a human egg by a human sperm\noutside the body of a woman; and\n(b) the human embryo contains genetic material provided by more\nthan 2 people.\nMaximum penalty: imprisonment for 15 years.\n12 Offence—developing human embryo outside body of\nwoman for more than 14 days\nA person commits an offence if the person intentionally develops a\nhuman embryo outside the body of a woman for a period of more than\n14 days, excluding any period when development is suspended.\nMaximum penalty: imprisonment for 15 years.\n13 Offence—heritable alterations to genome\n(1) A person commits an offence if—\n(a) the person alters the genome of a human cell in such a way that\nthe alteration is heritable by descendants of the human whose\ncell was altered; and\n(b) in altering the genome, the person intended the alteration to be\nheritable by descendants of the human whose cell was altered.\nMaximum penalty: imprisonment for 15 years.\n(2) In this section:\nhuman cell includes a human embryonal cell, a human fetal cell,\nhuman sperm or a human egg.\n\nProhibited practices Part 2\nPractices that are completely prohibited Division 2.1\nSection 14\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 7\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n14 Offence—collecting viable human embryo from body of\nwoman\nA person commits an offence if the person removes a human embryo\nfrom the body of a woman, intending to collect a viable human\nembryo.\nMaximum penalty: imprisonment for 15 years.\n15 Offence—creating chimeric embryo\nA person commits an offence if the person intentionally creates a\nchimeric embryo.\nMaximum penalty: imprisonment for 15 years.\n16 Offence—developing hybrid embryo\nA person commits an offence if the person intentionally develops a\nhybrid embryo for a period of more than 14 days, excluding any\nperiod when development is suspended.\nMaximum penalty: imprisonment for 15 years.\n17 Offence—placing of embryo\n(1) A person commits an offence if the person intentionally places a\nhuman embryo in an animal.\nMaximum penalty: imprisonment for 15 years.\n(2) A person commits an offence if the person intentionally places a\nhuman embryo in the body of a human, other than in a woman’s\nreproductive tract.\nMaximum penalty: imprisonment for 15 years.\n(3) A person commits an offence if the person intentionally places an\nanimal embryo in the body of a human for any period of gestation.\nMaximum penalty: imprisonment for 15 years.\n\nPart 2 Prohibited practices\nDivision 2.1 Practices that are completely prohibited\nSection 18\npage 8 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n18 Offence—importing, exporting or placing prohibited\nembryo\n(1) A person commits an offence if the person intentionally imports an\nembryo into the ACT knowing that, or reckless about whether, the\nembryo is a prohibited embryo.\nMaximum penalty: imprisonment for 15 years.\n(2) A person commits an offence if the person intentionally exports an\nembryo from the ACT knowing that, or reckless about whether, the\nembryo is a prohibited embryo.\nMaximum penalty: imprisonment for 15 years.\n(3) A person commits an offence if the person intentionally places an\nembryo in the body of a woman knowing that, or reckless about\nwhether, the embryo is a prohibited embryo.\nMaximum penalty: imprisonment for 15 years.\n(4) In this section:\nprohibited embryo means—\n(a) a human embryo created by a process other than the fertilisation\nof a human egg by human sperm; or\n(b) a human embryo created outside the body of a woman, unless\nthe intention of the person who created the embryo was to\nattempt to achieve pregnancy in a particular woman; or\n(c) a human embryo that contains genetic material provided by\nmore than 2 people; or\n(d) a human embryo that has been developing outside the body of a\nwoman for a period of more than 14 days, excluding any period\nwhen development is suspended; or\n(e) a human embryo created using precursor cells taken from a\nhuman embryo or a human fetus; or\n\nProhibited practices Part 2\nPractices that are completely prohibited Division 2.1\nSection 19\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 9\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(f) a human embryo that contains a human cell (within the meaning\nof section 13) whose genome has been altered in such a way that\nthe alteration is heritable by human descendants of the human\nwhose cell was altered; or\n(g) a human embryo that was removed from the body of a woman\nby a person intending to collect a viable human embryo; or\n(h) a chimeric embryo or a hybrid embryo.\n19 Offence—commercial trading in human eggs, human\nsperm or human embryos\n(1) A person commits an offence if the person intentionally gives or\noffers valuable consideration to another person for the supply of a\nhuman egg, human sperm or a human embryo.\nMaximum penalty: imprisonment for 15 years.\n(2) A person commits an offence if the person intentionally receives, or\noffers to receive, valuable consideration from another person for the\nsupply of a human egg, human sperm or a human embryo.\nMaximum penalty: imprisonment for 15 years.\n(3) In this section—\nreasonable expenses—\n(a) in relation to the supply of a human egg or human sperm—\nincludes, but is not limited to, expenses relating to the collection,\nstorage or transport of the egg or sperm; and\n(b) in relation to the supply of a human embryo—\n(i) does not include any expenses incurred by a person before\nthe embryo became an excess ART embryo; and\n(ii) includes, but is not limited to, expenses relating to the\nstorage or transport of the embryo.\n\nPart 2 Prohibited practices\nDivision 2.2 Practices that are prohibited unless authorised by licence\nSection 20\npage 10 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nvaluable consideration, in relation to the supply of a human egg,\nhuman sperm or a human embryo by a person, includes any\ninducement, discount or priority in the provision of a service to the\nperson, but does not include the payment of reasonable expenses\nincurred by the person in connection with the supply.\nDivision 2.2 Practices that are prohibited unless\nauthorised by licence\n20 Offence—creating human embryo other than by\nfertilisation, or developing embryo\nA person commits an offence if—\n(a) the person intentionally creates a human embryo by a process\nother than the fertilisation of a human egg by a human sperm, or\ndevelops a human embryo so created; and\n(b) the creation or development of the human embryo by the person\nis not authorised by a licence.\nMaximum penalty: imprisonment for 10 years.\nNote 1 The development of a human embryo outside the body of a woman for\nmore than 14 days is prohibited by s 12.\nNote 2 The placement in the body of a woman of a human embryo clone, or any\nother human embryo created other than by the fertilisation of a human\negg by a human sperm, is prohibited by s 8 and s 18.\n21 Offence—creating or developing human embryo\ncontaining genetic material provided by more than 2\npeople\nA person commits an offence if—\n(a) the person intentionally creates or develops a human embryo by\na process other than the fertilisation of a human egg by a human\nsperm; and\n\nProhibited practices Part 2\nPractices that are prohibited unless authorised by licence Division 2.2\nSection 22\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 11\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(b) the human embryo contains genetic material provided by more\nthan 2 people; and\n(c) the creation or development of the human embryo by the person\nis not authorised by a licence.\nMaximum penalty: imprisonment for 10 years.\nNote 1 The development of a human embryo outside the body of a woman for\nmore than 14 days is prohibited by s 12.\nNote 2 The placement in the body of a woman of a human embryo created other\nthan by the fertilisation of a human egg by a human sperm is prohibited\nby s 18.\n22 Offence—using precursor cells from human embryo or\nhuman fetus to create human embryo, or developing\nsuch an embryo\nA person commits an offence if—\n(a) the person uses precursor cells taken from a human embryo or a\nhuman fetus, intending to create a human embryo, or\nintentionally develops an embryo so created; and\n(b) the person engages in activities mentioned in paragraph (a)\nwithout being authorised by a licence, and the person knows or\nis reckless about that fact.\nMaximum penalty: imprisonment for 10 years.\n22A Offence—creating hybrid embryo\n(1) A person commits an offence if the person intentionally creates a\nhybrid embryo.\n(2) A person commits an offence if the person intentionally develops a\nhybrid embryo.\n\nPart 2 Prohibited practices\nDivision 2.2 Practices that are prohibited unless authorised by licence\nSection 22A\npage 12 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(3) A person does not commit an offence against subsection (1) or (2) if\nthe creation or development of the hybrid embryo by the person is\nauthorised by a licence.\nMaximum penalty: imprisonment for 10 years.\n\nRegulation of the use of excess ART embryos, other embryos and\nhuman eggs\nPart 3\nInterpretation for pt 3 Division 3.1\nSection 23\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 13\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 3 Regulation of the use of excess\nART embryos, other embryos\nand human eggs\nDivision 3.1 Interpretation for pt 3\n23 Definitions for pt 3\nIn this part:\naccredited ART centre means an entity accredited to carry out\nassisted reproductive technology by—\n(a) the Reproductive Technology Accreditation Committee of the\nFertility Society of Australia; or\n(b) if the regulations prescribe another body or other bodies in\naddition to, or instead of, the body mentioned in paragraph (a)—\nthat other body or any of those other bodies, as the case requires.\nconfidential commercial information means information that has a\ncommercial or other value that would be, or could reasonably be\nexpected to be, destroyed or diminished if the information were\ndisclosed.\ndisclose information means give or communicate the information in\nany way.\nHREC means a human research ethics committee.\nproper consent, in relation to the use of an excess ART embryo or a\nhuman egg, or the creation or use of any other embryo, means consent\nobtained in accordance with—\n\nPart 3 Regulation of the use of excess ART embryos, other embryos and\nhuman eggs\nDivision 3.1 Interpretation for pt 3\nSection 23\npage 14 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(a) the Ethical guidelines on the use of assisted reproductive\ntechnology in clinical practice and research, issued by the CEO\nof the NHMRC in 2017 and updated in 2023; or\nNote The guidelines are accessible at www.nhmrc.gov.au.\n(b) if other guidelines are issued by the CEO of the NHMRC and\nprescribed by regulations made for the Research Involving\nHuman Embryos Act 2002 (Cwlth), section 24 (9), definition of\nproper consent—those guidelines, rather than the guidelines\nmentioned in paragraph (a).\nrelevant Territory entity means the entity notified by the Territory to\nthe chairperson of the NHMRC licensing committee for the Research\nInvolving Human Embryos Act 2002 (Cwlth), part 2.\nresponsible person means—\n(a) in relation to an excess ART embryo—\n(i) each person who provided the egg or sperm from which the\nembryo was created; and\n(ii) the woman for whom the embryo was created, for the\npurpose of achieving her pregnancy; and\n(iii) anyone who was the domestic partner of a person\nmentioned in subparagraph (i) when the egg or sperm\nmentioned in that subparagraph was provided; and\n(iv) anyone who was the domestic partner of the woman\nmentioned in subparagraph (ii) when the embryo was\ncreated; or\nNote For the meaning of domestic partner, see the Legislation\nAct, s 169.\n(b) in relation to an embryo other than an excess ART embryo—\neach person whose reproductive material, genetic material or\ncell was used, or is proposed to be used, in the creation or use of\nthe embryo; or\n\nRegulation of the use of excess ART embryos, other embryos and\nhuman eggs\nPart 3\nInterpretation for pt 3 Division 3.1\nSection 24\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 15\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(c) in relation to a human egg—the woman who was the biological\ndonor of the egg.\nunsuitable for implantation—a human embryo is unsuitable for\nimplantation if it—\n(a) is diagnosed by preimplantation genetic diagnosis as unsuitable\nfor implantation, in accordance with the Ethical guidelines on\nthe use of assisted reproductive technology in clinical practice\nand research, issued by the CEO of the NHMRC in 2017 and\nupdated in 2023; or\nNote The guidelines are accessible at www.nhmrc.gov.au.\n(b) is determined to be unsuitable for implantation in the body of a\nwoman, in accordance with objective criteria specified in\nguidelines issued by the CEO of the NHMRC and prescribed by\nregulations made for the Research Involving Human Embryos\nAct 2002 (Cwlth), section 7 (1), definition of unsuitable for\nimplantation, paragraph (b).\nuse includes develop.\nNote If an Act defines a term, other parts of speech and grammatical forms of\nthe term have a corresponding meaning (see Legislation Act, s 157).\n24 Meaning of excess ART embryo\n(1) In this Act:\nexcess ART embryo means a human embryo that—\n(a) was created, by assisted reproductive technology, for use in the\nassisted reproductive technology treatment of a woman; and\n(b) is excess to the needs of—\n(i) the woman for whom it was created; and\n(ii) her domestic partner (if any) when the embryo was created.\nNote For the meaning of domestic partner, see Legislation Act, s 169.\n\nPart 3 Regulation of the use of excess ART embryos, other embryos and\nhuman eggs\nDivision 3.2 Offences\nSection 25\npage 16 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(2) For subsection (1) (b), a human embryo is excess to the needs of the\npeople mentioned in that paragraph at a particular time if—\n(a) each of the people has given written authority for use of the\nembryo for a purpose other than a purpose relating to the assisted\nreproductive technology treatment of the woman concerned, and\nthe authority is in force at that time; or\n(b) each of the people has declared in writing that the embryo is\nexcess to their needs, and the declaration is in force at that time.\nDivision 3.2 Offences\n25 Offence—use of excess ART embryo\n(1) A person commits an offence if the person intentionally uses an\nexcess ART embryo, unless—\n(a) the use by the person is authorised by a licence; or\n(b) the use by the person is an exempt use.\nMaximum penalty: imprisonment for 5 years.\n(2) Despite the Criminal Code, section 58 (3), a defendant does not bear\nan evidential burden in relation to anything mentioned in this section.\n(3) In this section:\ndiagnostic investigation, in relation to an excess ART embryo, means\nany procedure undertaken on embryos for the sole purpose of\ndiagnostic investigations for the direct benefit of the woman for\nwhom it was created.\nexempt use—a use of an excess ART embryo by a person is an\nexempt use if—\n(a) the use consists only of—\n(i) storage of the excess ART embryo; or\n(ii) removal of the excess ART embryo from storage; or\n\nRegulation of the use of excess ART embryos, other embryos and\nhuman eggs\nPart 3\nOffences Division 3.2\nSection 25A\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 17\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(iii) transport of the excess ART embryo; or\n(iv) observation of the excess ART embryo; or\n(v) allowing the excess ART embryo to succumb; or\n(b) the use is carried out by an accredited ART centre, and—\n(i) the excess ART embryo is not suitable (based only on its\nbiological fitness for implantation) to be placed in the body\nof the woman for whom it was created; and\n(ii) the use forms part of diagnostic investigations conducted\nin connection with the assisted reproductive technology\ntreatment of the woman for whom the excess ART embryo\nwas created; or\n(c) the use is carried out by an accredited ART centre and is for the\npurpose of achieving pregnancy in a woman other than the\nwoman for whom the excess ART embryo was created; or\n(d) the use is prescribed under the regulations.\nobservation, in relation to an excess ART embryo, includes taking a\nphotograph of the embryo, or taking a recording of the embryo from\nwhich a visual image can be produced.\n25A Offence—use of other embryos\nA person commits an offence if—\n(a) the person intentionally uses an embryo; and\n(b) the embryo is—\n(i) a human embryo created by a process other than the\nfertilisation of a human egg by a human sperm; or\n(ii) a human embryo created by a process other than the\nfertilisation of a human egg by a human sperm that\ncontains genetic material provided by more than 2 people;\nor\n\nPart 3 Regulation of the use of excess ART embryos, other embryos and\nhuman eggs\nDivision 3.2 Offences\nSection 25B\npage 18 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(iii) a human embryo created using precursor cells taken from\na human embryo or a human fetus; or\n(iv) a hybrid embryo; and\n(c) the use by the person is not authorised by a licence.\nMaximum penalty: imprisonment for 5 years.\nNote The creation or development of embryos mentioned in this section is\nprohibited under pt 2, unless authorised by a licence.\n25B Offence—certain activities involving use of human eggs\nA person commits an offence if—\n(a) the person undertakes research or training involving the\nfertilisation of a human egg by a human sperm up to, but not\nincluding, the first mitotic division, outside the body of a woman\nfor the purposes of research or training in ART; and\n(b) the person is not authorised by a licence to undertake the\nresearch or training.\nMaximum penalty: imprisonment for 5 years.\n26 Offence—use of embryo that is not excess ART embryo\nA person commits an offence if—\n(a) the person intentionally uses, outside the body of a woman, a\nhuman embryo—\n(i) that was created by fertilisation of a human egg by a human\nsperm; and\n(ii) that is not an excess ART embryo; and\n(b) the use is not for a purpose relating to the assisted reproductive\ntechnology treatment of a woman carried out by an accredited\nART centre, and the person knows or is reckless about that fact.\nMaximum penalty: imprisonment for 5 years.\n\nRegulation of the use of excess ART embryos, other embryos and\nhuman eggs\nPart 3\nOffences Division 3.2\nSection 27\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 19\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n27 Offence—breaching licence condition\n(1) A person commits an offence if the person intentionally engages in\nconduct, knowing that the conduct contravenes a condition of a\nlicence that applies to the person, or reckless about whether the\nconduct contravenes a condition of such a licence.\nMaximum penalty: imprisonment for 5 years.\n(2) In this section:\nengage in conduct means—\n(a) do an act; or\n(b) omit to perform an act.\n27A Person not liable for conduct purportedly authorised\n(1) To remove any doubt, a person is not criminally responsible for an\noffence against this part in relation to particular conduct if—\n(a) the conduct by the person is purportedly authorised by a\nprovision of a licence; and\n(b) the licence or the provision is invalid, whether because of a\ntechnical defect or irregularity or for any other reason; and\n(c) the person did not know, and could not reasonably be expected\nto have known, of the invalidity of the licence or the provision.\n(2) In this section:\nlicence includes a purported licence.\n\nPart 3 Regulation of the use of excess ART embryos, other embryos and\nhuman eggs\nDivision 3.3 Embryo research licensing committee of NHMRC\nSection 28\npage 20 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nDivision 3.3 Embryo research licensing committee\nof NHMRC\n28 Functions of committee\nThe functions of the NHMRC licensing committee are—\n(a) to exercise functions in relation to licences under division 3.4\n(Licensing system); and\n(b) to exercise functions in relation to databases under division 3.5\n(Reporting and confidentiality); and\n(c) to exercise the other functions (if any) that are given to it under\nthis Act or any other law.\nDivision 3.4 Licensing system\n29 Person may apply for licence\n(1) A person may apply to the NHMRC licensing committee for a licence\nauthorising one or more of the following:\n(a) use of excess ART embryos;\n(b) creation of human embryos other than by fertilisation of a\nhuman egg by a human sperm, and use of such embryos;\n(c) creation of human embryos other than by fertilisation of a\nhuman egg by a human sperm that contain genetic material\nprovided by more than 2 people, and use of such embryos;\n(d) creation of human embryos using precursor cells from a human\nembryo or a human fetus, and use of such embryos;\n(e) research and training involving the fertilisation of a human egg\nby a human sperm up to, but not including, the first mitotic\ndivision, outside the body of a woman for the purposes of\nresearch or training in ART;\n\nRegulation of the use of excess ART embryos, other embryos and\nhuman eggs\nPart 3\nLicensing system Division 3.4\nSection 30\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 21\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(f) creation of hybrid embryos by the fertilisation of an animal egg\nby a human sperm, and use of such embryos up to, but not\nincluding, the first mitotic division, if—\n(i) the creation or use is for the purposes of testing sperm\nquality; and\n(ii) the creation or use will occur in an accredited ART centre.\n(2) To remove any doubt, subsection (1) (a), (b), (c) and (d) do not permit\nthe NHMRC licensing committee to authorise any use of an excess\nART embryo or other embryo that would result in the development\nof the embryo for a period of more than 14 days, excluding any period\nwhen development is suspended.\n(3) An application under subsection (1) must be made in accordance with\nthe written requirements (if any) of the NHMRC licensing committee.\n30 Committee decision on application\n(1) This section applies if a person has made an application under\nsection 29 for a licence.\n(2) The NHMRC licensing committee must decide, in accordance with\nthis section, whether or not to issue the licence.\n(3) The NHMRC licensing committee must not issue the licence unless\nit is satisfied of the following:\n(a) that appropriate protocols are in place—\n(i) to enable proper consent to be obtained before an excess\nART embryo or human egg is used, or other embryo is\ncreated or used, under the licence (see section 33 (1) (a));\nand\n(ii) to enable compliance with any restrictions on the consent;\n\nPart 3 Regulation of the use of excess ART embryos, other embryos and\nhuman eggs\nDivision 3.4 Licensing system\nSection 31\npage 22 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(b) that the activity or project proposed in the application has been\nassessed and approved by a HREC that is constituted in\naccordance with, and acting in compliance with, the NHMRC\nNational Statement on Ethical Conduct in Research Involving\nHumans (1999), as in force from time to time.\n(4) In deciding whether to issue the licence, the NHMRC licensing\ncommittee must have regard to the following:\n(a) restricting the number of excess ART embryos, other embryos\nor human eggs, to that likely to be necessary to achieve the goals\nof the activity or project proposed in the application;\n(b) the likelihood of significant advance in knowledge or\nimprovement in technologies for treatment as a result of the use\nof excess ART embryos or human eggs, or the creation or use of\nother embryos, proposed in the application, that could not\nreasonably be achieved by other means;\n(c) any relevant guidelines, or relevant parts of guidelines, issued\nby the CEO of the NHMRC under the National Health and\nMedical Research Council Act 1992 (Cwlth) and prescribed by\nregulations made for the Research Involving Human Embryos\nAct 2002 (Cwlth), section 21 (4) (c);\n(d) the HREC assessment of the application mentioned in\nsubsection (3) (b);\n(e) the additional matters (if any) prescribed under the regulations.\n31 Notification of decision\n(1) The NHMRC licensing committee must notify its decision on an\napplication for a licence to the following:\n(a) the applicant;\n(b) the HREC that assessed and approved the activity or project\nproposed in the application as mentioned in section 30 (3) (b);\n\nRegulation of the use of excess ART embryos, other embryos and\nhuman eggs\nPart 3\nLicensing system Division 3.4\nSection 32\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 23\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(c) the relevant Territory entity.\n(2) If the NHMRC licensing committee decides to issue the licence, it\nmust, in addition to issuing the licence to the applicant, give a copy\nof the licence to the entities mentioned in subsection (1) (b) and (c).\n32 Period of licence\n(1) A licence—\n(a) comes into force on the day stated in the licence or, if no day is\nstated, on the day it is issued; and\n(b) remains in force until the day stated in the licence, unless it is\nsuspended, revoked or surrendered before that day.\n(2) A licence is not in force throughout any period of suspension.\n33 Licence is subject to conditions\n(1) A licence is subject to the condition that before an excess ART\nembryo or human egg is used, or any other embryo is created or used,\nas authorised by the licence—\n(a) each responsible person in relation to the excess ART embryo,\nhuman egg or other embryo must have given proper consent to\nthat creation or use; and\n(b) the licence holder must have reported in writing to the NHMRC\nlicensing committee that the consent has been obtained, and any\nrestrictions to which the consent is subject.\n(2) A licence is subject to the condition that the use of an excess ART\nembryo or human egg, or the creation or use of any other embryo,\nmust be in accordance with any restrictions to which the proper\nconsent under subsection (1) is subject.\n(3) A licence is subject to the other conditions (if any) stated in the\nlicence.\n\nPart 3 Regulation of the use of excess ART embryos, other embryos and\nhuman eggs\nDivision 3.4 Licensing system\nSection 33\npage 24 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(4) The conditions stated in the licence may include, for example,\nconditions relating to the following:\n(a) the people authorised by the licence to use excess ART embryos\nor human eggs, or create or use other embryos;\n(b) the number of excess ART embryos or human eggs authorised\nto be used under the licence, or the number of other embryos\nauthorised to be created or used under the licence;\n(c) reporting;\n(d) monitoring;\n(e) information to be given by the licence holder to people\nauthorised by the licence to use excess ART embryos or human\neggs, or to create or use other embryos.\n(5) The licence conditions mentioned in subsections (1) and (2) apply to\nall people who are authorised by the licence to use excess ART\nembryos or human eggs, or to create or use other embryos.\n(6) Licence conditions stated in the licence apply to—\n(a) the licence holder; and\n(b) such other people authorised by the licence to use excess ART\nembryos or human eggs, or to create or use other embryos as are\nstated in the licence.\n(7) For the purposes of applying the condition mentioned in\nsubsection (1) (a)—\n(a) a licence may provide that the guidelines mentioned in the\ndefinition of proper consent apply in a modified form in relation\nto the use, under the licence, of excess ART embryos that are\nunsuitable for implantation; and\n\nRegulation of the use of excess ART embryos, other embryos and\nhuman eggs\nPart 3\nLicensing system Division 3.4\nSection 34\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(b) if a licence so provides, the guidelines as modified by the licence\nhave effect in relation to the giving of consent for such creation\nor use.\nExample\nThe guidelines could apply to a particular licence in a modified form, to alter the\ncooling-off period required in relation to the use of excess ART embryos that are\nunsuitable for implantation.\n34 Variation of licence\n(1) The NHMRC licensing committee may, by written notice given to the\nlicence holder, vary a licence if the committee believes on reasonable\ngrounds that it is necessary or desirable to do so.\n(2) The NHMRC licensing committee may vary a licence under\nsubsection (1) on its own initiative or on application by the licence\nholder.\n(3) Without limiting subsection (1), the NHMRC licensing committee\nmay vary the licence by stating additional conditions or varying\nexisting conditions.\n(4) The NHMRC licensing committee must not vary a licence in such a\nway that, had a person applied under section 29 for the licence as\nvaried, the committee would not have been permitted under this part\nto issue the licence.\n35 Suspension or revocation of licence\n(1) The NHMRC licensing committee may, by written notice given to the\nlicence holder, suspend or revoke a licence if the committee believes\non reasonable grounds that a condition of the licence has been\nbreached.\n(2) If a licence holder is convicted of an offence against this Act, the\nNHMRC licensing committee must, by written notice given to the\nlicence holder, revoke each licence held by the licence holder.\n\nPart 3 Regulation of the use of excess ART embryos, other embryos and\nhuman eggs\nDivision 3.5 Reporting and confidentiality\nSection 36\npage 26 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n36 Surrender of licence\nA licence holder may surrender a licence by written notice given to\nthe NHMRC licensing committee.\n37 Notice of variation, suspension or revocation of licence\n(1) If the NHMRC licensing committee varies, suspends or revokes a\nlicence, the committee must tell—\n(a) the licence holder; and\n(b) the HREC and the relevant Territory entity.\n(2) The NHMRC licensing committee must also tell the entities\nmentioned in subsection (1) (b) if a licence is surrendered.\nDivision 3.5 Reporting and confidentiality\n38 NHMRC licensing committee to make certain information\npublicly available\n(1) The NHMRC licensing committee must maintain a database\ncontaining the following information in relation to each licence\n(including a licence as varied):\n(a) the name of the person to whom the licence was issued;\n(b) a short statement about the nature of the uses of excess ART\nembryos or human eggs, and creations or uses of other embryos,\nthat are authorised by the licence;\n(c) any conditions to which the licence is subject;\n(d) the number of ART embryos or human eggs authorised to be\nused under the licence, and the number of other embryos\nauthorised to be created or used under the licence;\n(e) the date the licence was issued;\n(f) the period throughout which the licence is to remain in force.\n\nRegulation of the use of excess ART embryos, other embryos and\nhuman eggs\nPart 3\nReporting and confidentiality Division 3.5\nSection 39\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 27\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(2) The database must be made publicly available.\n(3) The database may be kept and made publicly available in electronic\nform.\n(4) Information mentioned in subsection (1) must not disclose\nconfidential commercial information.\n39 Confidential commercial information may only be\ndisclosed in certain circumstances\n(1) A person commits an offence if—\n(a) the person discloses confidential commercial information that\nthe person has only because of exercising functions under this\nAct or under the Commonwealth Act; and\n(b) the person knows that the information is confidential\ncommercial information; and\n(c) the disclosure is not—\n(i) to the Territory, a Territory agency, the Commonwealth, a\nCommonwealth authority, a State, or a State agency for this\nAct, a corresponding State law or the Commonwealth Act;\nor\n(ii) by order of a court; or\n(iii) with the consent of each person to whom the information\nhas a commercial or other value.\nMaximum penalty: imprisonment for 2 years.\n(2) A person commits an offence if—\n(a) the person discloses confidential commercial information that\nthe person has only because of a disclosure permitted under\nsubsection (1) or this subsection; and\n(b) the person knows that the information is confidential\ncommercial information; and\n\nPart 3 Regulation of the use of excess ART embryos, other embryos and\nhuman eggs\nDivision 3.5 Reporting and confidentiality\nSection 39\npage 28 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(c) the disclosure is not—\n(i) to the Territory, a Territory agency, the Commonwealth, a\nCommonwealth authority, a State, or a State agency for this\nAct, a corresponding State law or the Commonwealth Act;\nor\n(ii) by order of a court; or\n(iii) with the consent of each person to whom the information\nhas a commercial or other value.\nMaximum penalty: imprisonment for 2 years.\n(3) In this section:\nCommonwealth authority means—\n(a) a corporation established for a public purpose under a\nCommonwealth Act; or\n(b) a company in which a controlling interest is held by any 1 of the\nfollowing, or by 2 or more of the following together:\n(i) the Commonwealth;\n(ii) a corporation covered by paragraph (a);\n(iii) an entity covered by subparagraph (i) or (ii).\ncorresponding State law—see the Commonwealth Act, section 7 (1).\ncourt includes a tribunal, authority or person having power to require\nthe production of documents or the answering of questions.\nState agency means—\n(a) a Minister of a State; or\n(b) a department of government of a State; or\n(c) an instrumentality of a State, including a corporation established\nfor a public purpose under a law of a State; or\n\nRegulation of the use of excess ART embryos, other embryos and\nhuman eggs\nPart 3\nReview provisions Division 3.6\nSection 40\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 29\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(d) a company in which a controlling interest is held by any 1 of the\nfollowing, or by 2 or more of the following together:\n(i) a State;\n(ii) a Minister of a State;\n(iii) an entity covered by subparagraph (i) or (ii).\nTerritory agency means—\n(a) a Minister; or\n(b) an administrative unit; or\n(c) a territory instrumentality; or\n(d) a corporation established for a public purpose under a Territory\nAct; or\n(e) a company in which a controlling interest is held by any one of\nthe following, or by 2 or more of the following together:\n(i) the Territory;\n(ii) an entity covered by paragraph (a), (c) or (d);\n(iii) an entity covered by subparagraph (i) or (ii).\nNote For the definition of confidential commercial information, see s 23.\nDivision 3.6 Review provisions\n40 Definitions for div 3.6\nIn this division:\nCommonwealth administrative review tribunal means the\nAdministrative Review Tribunal established under the Administrative\nReview Tribunal Act 2024 (Cwlth), section 8.\ndecision—see the Administrative Review Tribunal Act 2024 (Cwlth),\nsection 4.\n\nPart 3 Regulation of the use of excess ART embryos, other embryos and\nhuman eggs\nDivision 3.6 Review provisions\nSection 41\npage 30 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\neligible person, in relation to a decision of the NHMRC licensing\ncommittee, means:\n(a) in relation to a decision under section 30 not to issue a licence—\nthe applicant for the licence; or\n(b) in relation to a decision about the period throughout which the\nlicence is to be in force under section 32—the licence holder; or\n(c) in relation to a decision to state a licence condition under\nsection 33 (3)—the licence holder; or\n(d) in relation to a decision to modify guidelines under\nsection 33 (7) in relation to a licence—the licence holder; or\n(e) in relation to a decision to vary or refuse to vary a licence under\nsection 34—the licence holder; or\n(f) in relation to a decision to suspend or revoke a licence under\nsection 35—the person who was the licence holder immediately\nbefore the suspension or revocation.\n41 Review of decisions\n(1) An eligible person may apply to the Commonwealth administrative\nreview tribunal for review of the following decisions of the NHMRC\nlicensing committee:\n(a) a decision under section 30 not to issue a licence;\n(b) a decision about the period throughout which the licence is to be\nin force under section 32;\n(c) a decision to state a licence condition under section 33 (3);\n(d) a decision to modify guidelines under section 33 (7) in relation\nto a licence;\n(e) a decision to vary or refuse to vary a licence under section 34;\n(f) a decision to suspend or revoke a licence under section 35.\n\nRegulation of the use of excess ART embryos, other embryos and\nhuman eggs\nPart 3\nReview provisions Division 3.6\nSection 41\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 31\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(2) This section has effect subject to the Administrative Review Tribunal\nAct 2024 (Cwlth).\n\nPart 4 Monitoring powers\nSection 42\npage 32 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 4 Monitoring powers\n42 Appointment of inspectors\n(1) The chairperson of the NHMRC licensing committee may, by\ninstrument in writing, appoint any of the following as inspectors:\n(a) a person who is appointed or employed by the Territory;\n(b) a person who is appointed or employed by a State;\n(c) a person who is appointed or employed by the Commonwealth.\n(2) The Legislation Act, part 19.3 (Appointments) does not apply to\nappointments under this section.\n(3) In exercising functions as an inspector, an inspector must comply\nwith any directions of the chairperson of the NHMRC licensing\ncommittee.\n(4) The chairperson of the NHMRC licensing committee must not\nappoint a person as an inspector under subsection (1) unless the\nchairperson is satisfied that the person has appropriate skills and\nexperience.\n43 Identity card\n(1) The chairperson of the NHMRC licensing committee must issue an\nidentity card to an inspector.\n(2) The identity card must contain a recent photograph of the inspector.\n(3) If a person to whom an identity card has been issued ceases to be an\ninspector, the person must return the identity card to the chairperson\nof the NHMRC licensing committee as soon as practicable.\nMaximum penalty: 1 penalty unit.\n\nMonitoring powers Part 4\nSection 44\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 33\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(4) An inspector must carry their identity card at all times when\nexercising functions as an inspector.\n44 Powers available to inspectors for monitoring compliance\n(1) To find out whether this Act has been complied with, an inspector\nmay—\n(a) enter any premises; and\n(b) exercise the monitoring powers set out in section 45.\nNote A reference to an Act includes a reference to the statutory instruments\nmade or in force under the Act, including regulations (see Legislation\nAct, s 104).\n(2) An inspector is not authorised to enter premises under subsection (1)\nunless—\n(a) the occupier of the premises has consented to the entry; or\n(b) the premises are premises where the occupier of the premises is\ncarrying out activities authorised by a licence issued under\nsection 30, and the entry is at a reasonable time; or\n(c) the entry is made under a warrant under section 46A.\n45 Monitoring powers\n(1) The monitoring powers that an inspector may exercise under\nsection 44 (1) (b) are as follows:\n(a) to search the premises and anything on the premises;\n(b) to inspect, examine, take measurements of, conduct tests on, or\ntake samples of, any human embryo, other embryo, human egg\nor thing on the premises that relates to this Act;\n(c) to take photographs, make video or audio recordings or make\nsketches of the premises or anything on the premises;\n(d) to inspect any book, record or document on the premises;\n\nPart 4 Monitoring powers\nSection 45\npage 34 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(e) to take extracts from or make copies of any such book, record or\ndocument;\n(f) to take onto the premises the equipment and materials that the\ninspector requires to exercise powers in relation to the premises;\n(g) in addition to the powers mentioned in paragraphs (a) to (f), if\nthe inspector was authorised to enter the premises by a warrant\nunder section 46A—to require any person in or on the premises\nto—\n(i) answer any questions put by the inspector; and\n(ii) produce any book, record or document requested by the\ninspector.\nNote The Legislation Act, s 170 and s 171 deal with the application of the\nprivilege against self-incrimination and client legal privilege.\n(2) For this part, monitoring powers include the power to operate\nequipment at premises to see whether—\n(a) the equipment; or\n(b) a disk, tape or other storage device that—\n(i) is at the premises; and\n(ii) can be used with the equipment or is associated with it;\ncontains information that is relevant to deciding whether there has\nbeen compliance with this Act.\nNote A reference to an Act includes a reference to the statutory instruments\nmade or in force under the Act, including regulations (see Legislation\nAct, s 104).\n\nMonitoring powers Part 4\nSection 46\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 35\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(3) If the inspector, after operating equipment at the premises, finds that\nthe equipment, or that a disk, tape or other storage device at the\npremises, contains information mentioned in subsection (2), the\ninspector may—\n(a) operate equipment or facilities at the premises to put the\ninformation in documentary form and copy the document\nproduced; or\n(b) if the information can be transferred to a tape, disk or other\nstorage device that—\n(i) is brought to the premises; or\n(ii) is at the premises and the use of which has been agreed to\nin writing by the occupier of the premises;\noperate the equipment or other facilities to copy the information\nto the storage device, and remove the storage device from the\npremises.\n46 Power to secure\nIf an inspector, during a search of premises, believes on reasonable\ngrounds that there is at the premises a human embryo, another\nembryo, a human egg or a thing that may provide evidence of the\ncommission of an offence against this Act, the monitoring powers\ninclude securing the embryo, the egg or the thing while a warrant to\nseize it is obtained (whether by the inspector or by another person).\n46A Monitoring warrants\n(1) An inspector may apply to a magistrate for a warrant under this\nsection in relation to premises.\n\nPart 4 Monitoring powers\nSection 46A\npage 36 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(2) Subject to subsection (3), the magistrate may issue the warrant if the\nmagistrate is satisfied by information on oath that it is reasonably\nnecessary that 1 or more inspectors should have access to the\npremises for the purposes of finding out whether this Act has been\ncomplied with.\nNote 1 Oath includes affirmation, and take an oath includes make an affirmation\n(see Legislation Act, dict, pt 1).\nNote 2 A reference to an Act includes a reference to the statutory instruments\nmade or in force under the Act, including any regulation (see Legislation\nAct, s 104).\n(3) The magistrate must not issue the warrant unless the inspector or\nsomeone else has given to the magistrate, either orally or by affidavit,\nany further information the magistrate requires about the grounds on\nwhich the issue of the warrant is being sought.\n(4) The warrant must—\n(a) authorise 1 or more inspectors (whether or not named in the\nwarrant) with the assistance and force that is necessary and\nreasonable—\n(i) to enter the premises; and\n(ii) to exercise the powers set out in section 45 in relation to\nthe premises; and\n(b) state whether the entry is authorised to be made at any time of\nthe day or night or during stated hours of the day or night; and\n(c) state the day (not more than 15 days after the issue of the\nwarrant) on which the warrant ceases to have effect; and\n(d) state the purpose for which the warrant is issued.\n\nMonitoring powers Part 4\nSection 46B\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 37\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n46B Details of warrant to be given to occupier etc\n(1) If a warrant under section 46A is being executed and the occupier of\nthe premises or another person who apparently represents the\noccupier is present at the premises, the inspector must make available\nto that person a copy of the warrant.\n(2) The inspector must identify themself to that person.\n(3) The copy of the warrant mentioned in subsection (1) need not include\nthe signature of the magistrate who issued the warrant.\n46C Announcement before entry\nAn inspector must, before entering premises under a warrant—\n(a) announce that they are authorised to enter the premises; and\n(b) give any person at the premises an opportunity to allow entry to\nthe premises.\n46D Occupier entitled to be present during search\n(1) If a warrant under section 46A is being executed and the occupier of\nthe premises, or another person who apparently represents the\noccupier is present at the premises, the person is entitled to observe\nthe search being conducted.\n(2) The right to observe the search being conducted ceases if the person\nimpedes the search.\n(3) This section does not prevent 2 or more areas of the premises being\nsearched at the same time.\n47 Inspector must produce identity card on request\nAn inspector is not entitled to exercise any powers under this part in\nrelation to premises if—\n(a) the occupier of the premises has required the inspector to\nproduce their identity card for inspection by the occupier; and\n\nPart 4 Monitoring powers\nSection 48\npage 38 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(b) the inspector fails to comply with the requirement.\n48 Consent\n(1) Before obtaining the consent of a person for section 44 (2) (a), the\ninspector must tell the person that they may refuse consent.\n(2) An entry of an inspector with the consent of a person is not lawful\nunless the person voluntarily consented to the entry.\n49 Compensation for damage\n(1) The owner of equipment or other facilities is entitled to compensation\nfor damage to the equipment or other facilities if—\n(a) the damage was caused to the equipment or other facilities\nbecause of it being operated by an inspector as mentioned in this\npart; and\n(b) the damage was caused because insufficient care was exercised\nby the inspector operating the equipment or other facilities.\n(2) In deciding the amount of compensation payable, regard is to be had\nto whether the occupier of the premises and any employee or agent of\nthe occupier, if they were available at the time, had provided any\nwarning or guidance as to the operation of the equipment or other\nfacilities that was appropriate in the circumstances.\n\nMiscellaneous Part 5\nSection 49A\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 39\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 5 Miscellaneous\n49A Court to notify director-general of offence\nIf a person is convicted or found guilty of an offence against this Act,\nthe registrar or other proper officer of the court must notify the\ndirector-general in writing.\n50 Reports to Legislative Assembly\nAs soon as practicable (but within 6 sitting days) after receiving a\ncopy of a report from the NHMRC licensing committee under the\nCommonwealth Act, section 19, the Minister must present a copy of\nthe report to the Legislative Assembly.\n51 Report on operation of Act\n(1) This section applies to—\n(a) a report of the review mentioned in the Prohibition of Human\nCloning for Reproduction Act 2002 (Cwlth), section 25; and\n(b) a report of the review mentioned in the Research Involving\nHuman Embryos Act 2002 (Cwlth), section 47B.\n(2) The Minister must present a copy of the report to the Legislative\nAssembly as soon as practicable after it is tabled in a house of the\nCommonwealth Parliament.\n52 Determination of fees\n(1) The Minister may, in writing, determine fees for this Act.\n(2) A determination is a disallowable instrument.\n54 Regulation-making power\nThe Executive may make regulations for this Act.\n\nDictionary\npage 40 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nDictionary\n(see s 3)\nNote 1 The Legislation Act contains definitions and other provisions relevant to\nthis Act.\nNote 2 For example, the Legislation Act, dict, pt 1, defines the following terms:\n• corporation\n• entity\n• exercise\n• functions\n• State\n• under.\naccredited ART centre—see section 23.\nanimal does not include a human.\nchimeric embryo means—\n(a) a human embryo into which a cell, or any component part of a\ncell, of an animal has been introduced; or\n(b) anything declared under the regulations to be a chimeric\nembryo.\nCommonwealth Act means the Research Involving Human Embryos\nAct 2002 (Cwlth).\nCommonwealth administrative review tribunal—see section 40.\nconfidential commercial information—see section 23.\ndecision, for division 3.6 (Review provisions)—see section 40.\ndisclose information, for part 3 (Regulation of the use of excess ART\nembryos, other embryos and human eggs)—see section 23.\neligible person, for division 3.6 (Review provisions)—see section 40.\nembryo means a living embryo, and includes a human embryo.\nexcess ART embryo—see section 24.\n\nDictionary\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 41\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nHREC—see section 23.\nhuman egg means a human oocyte.\nhuman embryo—see section 6.\nhuman embryo clone—see section 7.\nhuman sperm includes human spermatids.\nhybrid embryo means—\n(a) an embryo created by the fertilisation of a human egg by animal\nsperm; or\n(b) an embryo created by the fertilisation of an animal egg by human\nsperm; or\n(c) a human egg into which the nucleus of an animal cell has been\nintroduced; or\n(d) an animal egg into which the nucleus of a human cell has been\nintroduced; or\n(e) a thing declared under the regulations to be a hybrid embryo.\ninspector means a person appointed as an inspector under section\n42 (1).\nlicence means a licence issued under section 30 (Committee decision\non application).\nNHMRC licensing committee means the committee established by\nthe Research Involving Human Embryos Act 2002 (Cwlth),\nsection 13.\nNHMRC means the National Health and Medical Research Council\nestablished by the National Health and Medical Research Council\nAct 1992 (Cwlth).\nprecursor cell means a cell that has the potential to develop into a\nhuman egg or human sperm.\n\nDictionary\npage 42 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nproper consent, for part 3 (Regulation of the use of excess ART\nembryos, other embryos and human eggs)—see section 23.\nrelevant Territory entity, for part 3 (Regulation of the use of excess\nART embryos, other embryos and human eggs)—see section 23.\nresponsible person, for part 3 (Regulation of the use of excess ART\nembryos, other embryos and human eggs)—see section 23.\nunsuitable for implantation, for part 3 (Regulation of the use of\nexcess ART embryos, other embryos and human eggs)—see\nsection 23.\nuse, for part 3 (Regulation of the use of excess ART embryos, other\nembryos and human eggs)—see section 23.\nwoman means a female human.\n\nEndnotes\nAbout the endnotes 1\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 43\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nEndnotes\n1 About the endnotes\nAmending and modifying laws are annotated in the legislation history and the\namendment history. Current modifications are not included in the republished law\nbut are set out in the endnotes.\nNot all editorial amendments made under the Legislation Act 2001, part 11.3 are\nannotated in the amendment history. Full details of any amendments can be\nobtained from the Parliamentary Counsel’s Office.\nUncommenced amending laws are not included in the republished law. The details\nof these laws are underlined in the legislation history. Uncommenced expiries are\nunderlined in the legislation history and amendment history.\nIf all the provisions of the law have been renumbered, a table of renumbered\nprovisions gives details of previous and current numbering.\nThe endnotes also include a table of earlier republications.\n2 Abbreviation key\nA = Act NI = Notifiable instrument\nAF = Approved form o = order\nam = amended om = omitted/repealed\namdt = amendment ord = ordinance\nAR = Assembly resolution orig = original\nch = chapter par = paragraph/subparagraph\nCN = Commencement notice pres = present\ndef = definition prev = previous\nDI = Disallowable instrument (prev...) = previously\ndict = dictionary pt = part\ndisallowed = disallowed by the Legislative r = rule/subrule\nAssembly reloc = relocated\ndiv = division renum = renumbered\nexp = expires/expired R[X] = Republication No\nGaz = gazette RI = reissue\nhdg = heading s = section/subsection\nIA = Interpretation Act 1967 sch = schedule\nins = inserted/added sdiv = subdivision\nLA = Legislation Act 2001 SL = Subordinate law\nLR = legislation register sub = substituted\nLRA = Legislation (Republication) Act 1996 underlining = whole or part not commenced\nmod = modified/modification or to be expired\n\nEndnotes\n3 Legislation history\npage 44 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n3 Legislation history\nThis Act was made as the Human Embryo (Research) Act 2004 A2004-22. It was\nrenamed by sch 1, amdt 1.2 as the Human Cloning and Embryo Research Act 2004\non the commencement of the Human Cloning (Prohibition) Act 2004 (see\nA2004-22 s 41).\nHuman Cloning and Embryo Research Act 2004 A2004-22\nnotified LR 7 April 2004\ns 1, s 2 commenced 7 April 2004 (LA s 75 (1))\nremainder commenced 8 April 2004 (s 2)\nas amended by\nHuman Cloning and Embryo Research Amendment Act 2008 A2008-8\nnotified LR 17 April 2008\ns 1, s 2 commenced 17 April 2008 (LA s 75 (1))\nremainder commenced 18 April 2008 (s 2)\nStatute Law Amendment Act 2019 A2019-42 sch 3 pt 3.14\nnotified LR 31 October 2019\ns 1, s 2 commenced 31 October 2019 (LA s 75 (1))\nsch 3 pt 3.14 commenced 14 November 2019 (s 2 (1))\nStatute Law Amendment Act 2021 A2021-12 sch 3 pt 3.25\nnotified LR 9 June 2021\ns 1, s 2 commenced 9 June 2021 (LA s 75 (1))\nsch 3 pt 3.25 commenced 23 June 2021 (s 2 (1))\nAssisted Reproductive Technology Act 2024 A2024-7 s 135\nnotified LR 28 March 2024\ns 1, s 2 commenced 28 March 2024 (LA s 75 (1))\ns 135 commenced 28 September 2024 (s 2 (2) and LA s 79)\nHealth Legislation Amendment Act 2025 A2025-16 sch 1 pt 1.4\nnotified LR 26 May 2025\ns 1, s 2 commenced 26 May 2025 (LA s 75 (1))\nsch 1 pt 1.4 commenced 2 June 2025 (s 2)\n\nEndnotes\nLegislation history 3\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 45\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nStatute Law Amendment Act 2025 A2025-29 sch 3 pt 3.48, sch 4\npt 4.94\nnotified LR 6 November 2025\ns 1, s 2 commenced 6 November 2025 (LA s 75 (1))\nsch 3 pt 3.48, sch 4 pt 4.94 commenced 16 November 2025 (s 2 (1),\n(9))\n\nEndnotes\n4 Amendment history\npage 46 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n4 Amendment history\nLong title\ntitle sub A2004-22 amdt 1.1; A2008-8 s 4\nName of Act\ns 1 sub A2004-22 amdt 1.2\nDictionary\ns 2 orig s 2 om LA s 89 (4)\n(prev s 3) renum R1 LA (see A2004-22 amdt 1.10)\nNotes\ns 3 orig s 3 renum as s 2\n(prev s 4) renum R1 LA (see A2004-22 amdt 1.10)\nOffences against Act—application of Criminal Code etc\ns 4 orig s 4 renum as s 3\n(prev s 5) renum R1 LA (see A2004-22 amdt 1.10)\nObject of Act\ns 5 orig s 5 renum as s 4\n(prev s 6) sub A2004-22 amdt 1.3\nrenum R1 LA (see A2004-22 amdt 1.10)\nam A2008-8 s 5\nMeaning of human embryo\ns 6 orig s 6 renum as s 5\n(prev s 7) renum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 6\nMeaning of human embryo clone\ns 7 orig s 7 renum as s 6\n(prev s 7A) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 8 by A2004-22 amdt 1.11\nrenum R1 LA (see A2004-22 amdt 1.10)\nMeaning of human embryo clone\ns 7A renum as s 7\nProhibited practices\npt 1A hdg renum as pt 2 hdg\nHuman cloning\ndiv 1A.1 hdg renum as div 2.1 hdg\nOther prohibited practices\ndiv 1A.2 hdg renum as div 2.2 hdg\n\nEndnotes\nAmendment history 4\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 47\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nProhibited practices\npt 2 hdg orig pt 2 hdg renum as pt 3 hdg\n(prev pt 1A hdg) reloc from Human Cloning (Prohibition) Act\n2004 A2004-21 pt 2 hdg by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nPractices that are completely prohibited\ndiv 2.1 hdg orig div 2.1 hdg renum as div 3.1 hdg\n(prev div 1A.1 hdg) reloc from Human Cloning (Prohibition) Act\n2004 A2004-21 div 2.1 hdg by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nOffence—placing human embryo clone in human body or body of an animal\ns 8 orig s 8 renum as s 23\n(prev s 9) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 9 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nNo defence that human embryo clone could not survive\ns 9 orig s 9 renum as s 24\nprev s 9 (as reloc from A2004-21 s 9) renum as s 8\n(prev s 10) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 10 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nOffence—creating human embryo for purpose other than achieving\npregnancy in woman\ns 10 orig s 10 renum as s 25\nprev s 10 (as reloc from A2004-21 s 10) renum as s 9\n(prev s 11) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 11 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nOffence—creating or developing human embryo by fertilisation that contains\ngenetic material provided by more than 2 people\ns 11 orig s 11 renum as s 26\nprev s 11 (as reloc from A2004-21 s 11) renum as s 10\n(prev s 12) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 12 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\n\nEndnotes\n4 Amendment history\npage 48 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nOffence—developing human embryo outside body of woman for more than\n14 days\ns 12 orig s 12 renum as s 27\nprev s 12 (as reloc from A2004-21 s 12) renum as s 11\n(prev s 13) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 13 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nOffence—developing human embryo outside body of woman for more than\n14 days\ns 13 orig s 13 renum as s 28\nprev s 13 (as reloc from A2004-21 s 13) renum as s 12\n(prev s 14) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 14 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nam A2019-42 amdt 3.21\nOffence—collecting viable human embryo from body of woman\ns 14 orig s 14 renum as s 29\nprev s 14 (as reloc from A2004-21 s 14) renum as s 13\n(prev s 15) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 15 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nOffence—creating chimeric embryo\ns 15 orig s 15 renum as s 30\nprev s 15 (as reloc from A2004-21 s 15) renum as s 14\n(prev s 16) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 16 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nOffence—developing hybrid embryo\ns 16 orig s 16 renum as s 31\nprev s 16 (as reloc from A2004-21 s 16) renum as s 15\n(prev s 17) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 17 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\n\nEndnotes\nAmendment history 4\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 49\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nOffence—placing of embryo\ns 17 orig s 17 renum as s 32\nprev s 17 (as reloc from A2004-21 s 17) renum as s 16\n(prev s 18) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 18 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nOffence—importing, exporting or placing prohibited embryo\ns 18 orig s 18 renum as s 33\nprev s 18 (as reloc from A2004-21 s 18) renum as s 17\n(prev s 19) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 19 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nam A2019-42 amdt 3.22\nOffence—commercial trading in human eggs, human sperm or human\nembryos\ns 19 orig s 19 renum as s 34\nprev s 19 (as reloc from A2004-21 s 19) renum as s 18\n(prev s 20) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 20 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nPractices that are prohibited unless authorised by licence\ndiv 2.2 hdg orig div 2.2 hdg renum as div 3.2 hdg\n(prev div 1A.2 hdg) reloc from Human Cloning (Prohibition) Act\n2004 A2004-21 div 2.2 hdg by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nOffence—creating human embryo other than by fertilisation, or developing\nembryo\ns 20 orig s 20 renum as s 35\nprev s 20 (as reloc from A2004-21 s 20) renum as s 19\n(prev s 21) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 21 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\n\nEndnotes\n4 Amendment history\npage 50 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nOffence—creating or developing human embryo containing genetic material\nprovided by more than 2 people\ns 21 orig s 21 renum as s 36\nprev s 21 (as reloc from A2004-21 s 21) renum as s 20\n(prev s 22) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 22 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nOffence—using precursor cells from human embryo or human fetus to\ncreate human embryo, or developing such an embryo\ns 22 hdg am A2019-42 amdt 3.22\ns 22 orig s 22 renum as s 37\nprev s 22 (as reloc from A2004-21 s 22) renum as s 21\n(prev s 23) reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 s 23 by A2004-22 amdt 1.12\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 7\nam A2019-42 amdt 3.22\nOffence—creating hybrid embryo\ns 22A ins A2008-8 s 7\nRegulation of the use of excess ART embryos, other embryos and human\neggs\npt 3 hdg orig pt 3 hdg renum as pt 4 hdg\n(prev pt 2 hdg) renum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 8\nInterpretation for pt 3\ndiv 3.1 hdg (prev div 2.1 hdg) renum R1 LA (see A2004-22 amdt 1.10)\nDefinitions for pt 3\ns 23 orig s 23 renum as s 38\nprev s 23 (as reloc from A2004-21 s 23) renum as s 22\n(prev s 8) renum R1 LA (see A2004-22 amdt 1.10)\ndef licence om A2008-8 s 9\ndef proper consent sub A2008-8 s 10\nam A2025-16 amdt 1.19, amdt 1.20\ndef responsible person sub A2008-8 s 11\ndef unsuitable for implantation ins A2008-8 s 12\nam A2025-16 amdt 1.21, amdt 1.22\ndef use ins A2008-8 s 12\nMeaning of excess ART embryo\ns 24 orig s 24 renum as s 39\n(prev s 9) renum R1 LA (see A2004-22 amdt 1.10)\nInterpretation for pt 3\ndiv 3.2 hdg (prev div 2.2 hdg) renum R1 LA (see A2004-22 amdt 1.10)\n\nEndnotes\nAmendment history 4\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 51\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nOffence—use of excess ART embryo\ns 25 orig s 25 renum as s 40\n(prev s 10) renum R1 LA (see A2004-22 amdt 1.10)\nOffence—use of other embryos\ns 25A ins A2008-8 s 13\nam A2019-42 amdt 3.22\nOffence—certain activities involving use of human eggs\ns 25B ins A2008-8 s 13\nOffence—use of embryo that is not excess ART embryo\ns 26 orig s 26 renum as s 41\n(prev s 11) renum R1 LA (see A2004-22 amdt 1.10)\nam A2008-8 s 14\nOffence—breaching licence condition\ns 27 orig s 27 renum as s 42\n(prev s 12) renum R1 LA (see A2004-22 amdt 1.10)\nPerson not liable for conduct purportedly authorised\ns 27A ins A2008-8 s 15\nEmbryo research licensing committee of NHMRC\ndiv 3.3 hdg (prev div 2.3 hdg) renum R1 LA (see A2004-22 amdt 1.10)\nFunctions of committee\ns 28 orig s 28 renum as s 43\n(prev s 13) renum R1 LA (see A2004-22 amdt 1.10)\nLicensing system\ndiv 3.4 hdg (prev div 2.4 hdg) renum R1 LA (see A2004-22 amdt 1.10)\nPerson may apply for licence\ns 29 orig s 29 renum as s 44\n(prev s 14) renum R1 LA (see A2004-22 amdt 1.10)\nam A2008-8 s 16; ss renum R3 LA; A2019-42 amdt 3.22;\nA2025-29 amdt 4.94\nCommittee decision on application\ns 30 orig s 30 renum as s 45\n(prev s 15) renum R1 LA (see A2004-22 amdt 1.10)\n(3) (b) exp 5 April 2005 (s 55)\npar renum R2 LA\nam A2008-8 ss 17-20; A2025-16 amdt 1.23, amdt 1.24\nNotification of decision\ns 31 orig s 31 renum as s 46\n(prev s 16) renum R1 LA (see A2004-22 amdt 1.10)\n\nEndnotes\n4 Amendment history\npage 52 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPeriod of licence\ns 32 orig s 32 renum as s 47\n(prev s 17) renum R1 LA (see A2004-22 amdt 1.10)\nLicence is subject to conditions\ns 33 orig s 33 renum as s 48\n(prev s 18) renum R1 LA (see A2004-22 amdt 1.10)\n(1) (c), (3) exp 5 April 2005 (s 55)\nss renum R2 LA\nam A2008-8 ss 21-26\nVariation of licence\ns 34 orig s 34 renum as s 49\n(prev s 19) renum R1 LA (see A2004-22 amdt 1.10)\nSuspension or revocation of licence\ns 35 orig s 35 renum as s 50\n(prev s 20) renum R1 LA (see A2004-22 amdt 1.10)\nSurrender of licence\ns 36 orig s 36 renum as s 51\n(prev s 21) renum R1 LA (see A2004-22 amdt 1.10)\nNotice of variation, suspension or revocation of licence\ns 37 orig s 37 renum as s 52\n(prev s 22) renum R1 LA (see A2004-22 amdt 1.10)\nReporting and confidentiality\ndiv 3.5 hdg (prev div 2.5 hdg) renum R1 LA (see A2004-22 amdt 1.10)\nNHMRC licensing committee to make certain information publicly available\ns 38 orig s 38 renum as s 53\n(prev s 23) renum R1 LA (see A2004-22 amdt 1.10)\nam A2008-8 s 27, s 28\nConfidential commercial information may only be disclosed in certain\ncircumstances\ns 39 orig s 39 renum as s 54\n(prev s 24) renum R1 LA (see A2004-22 amdt 1.10)\nam A2025-29 amdt 3.159\nReview provisions\ndiv 3.6 hdg (prev div 2.6 hdg) renum R1 LA (see A2004-22 amdt 1.10)\nDefinitions for div 3.6\ns 40 orig s 40 renum as s 55\n(prev s 25) renum R1 LA (see A2004-22 amdt 1.10)\ndef Commonwealth administrative appeals tribunal om\nA2025-16 amdt 1.25\ndef Commonwealth administrative review tribunal ins\nA2025-16 amdt 1.26\n\nEndnotes\nAmendment history 4\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 53\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\ndef decision sub A2025-16 amdt 1.27\ndef eligible person am A2008-8 s 29; pars renum R3 LA\nReview of decisions\ns 41 orig s 41 om LA s 89 (3)\n(prev s 26) renum R1 LA (see A2004-22 amdt 1.10)\nam A2008-8 s 30; pars renum R3 LA; A2025-16 amdt 1.28,\namdt 1.29 (as am R8 LA)\nMonitoring powers\npt 4 hdg orig pt 4 hdg renum as pt 5 hdg\n(prev pt 3 hdg) renum R1 LA (see A2004-22 amdt 1.10)\nAppointment of inspectors\ns 42 (prev s 27) renum R1 LA (see A2004-22 amdt 1.10)\nIdentity card\ns 43 (prev s 28) renum R1 LA (see A2004-22 amdt 1.10)\nam A2021-12 amdt 3.59; A2025-29 amdt 3.160\nPowers available to inspectors for monitoring compliance\ns 44 (prev s 29) am A2004-22 amdt 1.4\nrenum R1 LA (see A2004-22 amdt 1.10)\nam A2008-8 s 31\nMonitoring powers\ns 45 (prev s 30) am A2004-22 amdt 1.5, amdt 1.6\nrenum R1 LA (see A2004-22 amdt 1.10)\nam A2008-8 s 32, s 33\nPower to secure\ns 46 (prev s 31) am A2004-22 amdt 1.7\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 34\nMonitoring warrants\ns 46A ins A2008-8 s 35\nDetails of warrant to be given to occupier etc\ns 46B ins A2008-8 s 35\nam A2025-29 amdt 3.161\nAnnouncement before entry\ns 46C ins A2008-8 s 35\nam A2025-29 amdt 3.162\nOccupier entitled to be present during search\ns 46D ins A2008-8 s 35\nInspector must produce identity card on request\ns 47 (prev s 32) renum R1 LA (see A2004-22 amdt 1.10)\nam A2025-29 amdt 3.163\n\nEndnotes\n4 Amendment history\npage 54 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nConsent\ns 48 (prev s 33) renum R1 LA (see A2004-22 amdt 1.10)\nam A2025-29 amdt 3.164\nCompensation for damage\ns 49 (prev s 34) renum R1 LA (see A2004-22 amdt 1.10)\nam A2025-29 amdt 3.165\nMiscellaneous\npt 5 hdg (prev pt 4 hdg) renum R1 LA (see A2004-22 amdt 1.10)\nCourt to notify director-general of offence\ns 49A ins A2024-7 s 135\nReports to Legislative Assembly\ns 50 (prev s 35) renum R1 LA (see A2004-22 amdt 1.10)\nReport on operation of Act\ns 51 (prev s 36) am A2004-22 amdt 1.8, amdt 1.9\nrenum R1 LA (see A2004-22 amdt 1.10)\nsub A2008-8 s 36\nam A2025-16 amdt 1.30, amdt 1.31\nDetermination of fees\ns 52 (prev s 37) renum R1 LA (see A2004-22 amdt 1.10)\nam A2025-29 amdt 4.94\nApproved forms\ns 53 (prev s 38) renum R1 LA (see A2004-22 amdt 1.10)\nom A2021-12 amdt 3.60\nRegulation-making power\ns 54 (prev s 39) renum R1 LA (see A2004-22 amdt 1.10)\nam A2025-29 amdt 4.94\nExpiry of certain provisions\ns 55 (prev s 40) renum R1 LA (see A2004-22 amdt 1.10)\nexp 5 April 2005 (s 55)\nTransitional\npt 10 hdg ins A2008-8 s 37\nexp 18 April 2009 (s 101)\nExisting applications for licences\ns 100 ins A2008-8 s 37\nexp 18 April 2009 (s 101)\nExpiry—pt 10\ns 101 ins A2008-8 s 37\nexp 18 April 2009 (s 101)\nAmendments\nsch 1 om LA s 89 (3)\n\nEndnotes\nAmendment history 4\nR9\n16/11/25\nHuman Cloning and Embryo Research Act 2004\nEffective: 16/11/25\npage 55\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nDictionary\ndict def animal reloc from Human Cloning (Prohibition) Act 2004\nA2004-21 dict by A2004-22 amdt 1.13\ndef chimeric embryo reloc from Human Cloning (Prohibition)\nAct 2004 A2004-21 dict by A2004-22 amdt 1.13\ndef Commonwealth administrative review tribunal am\nR8 LA\ndef disclose sub A2008-8 s 38\ndef embryo ins A2008-8 s 39\ndef human egg ins A2008-8 s 40\ndef human embryo clone reloc from Human Cloning\n(Prohibition) Act 2004 A2004-21 dict by A2004-22 amdt 1.13\ndef human sperm reloc from Human Cloning (Prohibition) Act\n2004 A2004-21 dict by A2004-22 amdt 1.13\ndef hybrid embryo reloc from Human Cloning (Prohibition)\nAct 2004 A2004-21 dict by A2004-22 amdt 1.13\ndef licence sub A2008-8 s 41\ndef precursor cell reloc from Human Cloning (Prohibition) Act\n2004 A2004-21 dict by A2004-22 amdt 1.13\ndef proper consent sub A2008-8 s 42\ndef relevant Territory entity sub A2008-8 s 42\ndef responsible person sub A2008-8 s 42\ndef unsuitable for implantation ins A2008-8 s 43\ndef use ins A2008-8 s 43\n\nEndnotes\n5 Earlier republications\npage 56 Human Cloning and Embryo Research Act 2004\nEffective: 16/11/25\nR9\n16/11/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n5 Earlier republications\nSome earlier republications were not numbered. The number in column 1 refers to\nthe publication order.\nSince 12 September 2001 every authorised republication has been published in\nelectronic pdf format on the ACT legislation register. A selection of authorised\nrepublications have also been published in printed format. These republications are\nmarked with an asterisk (*) in column 1. Electronic and printed versions of an\nauthorised republication are identical.\nRepublication\nNo and date\nEffective Last\namendment\nmade by\nRepublication\nfor\nR1\n8 Apr 2004\n8 Apr 2004–\n5 Apr 2005\nnot amended new Act and\ncommencement of\nHuman Cloning\n(Prohibition) Act\n2004 A2004-21\nR2\n6 Apr 2005\n6 Apr 2005–\n17 Apr 2008\nnot amended commenced expiry\nR3\n18 Apr 2008\n18 Apr 2008–\n18 Apr 2009\nA2008-8 amendments by\nA2008-8\nR4\n19 Apr 2009\n19 Apr 2009–\n13 Nov 2019\nA2008-8 commenced expiry\nR5\n14 Nov 2019\n14 Nov 2019–\n22 June 2021\nA2019-42 amendments by\nA2019-42\nR6\n23 June 2021\n23 June 2021–\n27 Sept 2024\nA2021-12 amendments by\nA2021-12\nR7\n28 Sept 2024\n28 Sept 2024–\n1 June 2025\nA2024-7 amendments by\nA2024-7\nR8\n2 June 2025\n2 June 2025–\n15 Nov 2025\nA2025-16 amendments by\nA2025-16\n© Australian Capital Territory 2025\n\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au","sortOrder":0}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"flash_summary":{"complexity_score":8,"scope_assessment":{"changed":true,"description":"Since its original enactment in 2004 the Act has been amended repeatedly to broaden and specify regulatory coverage and enforcement mechanisms. Amendments have: (a) added and clarified offences (including hybrid and chimeric embryo provisions and commercial trading prohibitions) and tiered penalty levels (Parts 2.1–2.2); (b) embedded a detailed licensing regime tied to NHMRC processes and HREC approvals (Part 3, ss 28–36), expanding the Act from narrow prohibitions to an active licensing structure; (c) introduced a public licence database and confidentiality protections with criminal sanctions (ss 38–39); (d) strengthened monitoring and inspection powers including warrants and inspector appointment rules (Part 4, ss 42–46A); and (e) aligned review and administrative appeal pathways with Commonwealth tribunals (s 41). These changes move the Act beyond a simple prohibition instrument into a complex regulatory framework that manages, permits and monitors specified embryo research under delegated administrative decision-making (see amendment history and the many inserted sections such as ss 22A, 25A–25B, 38–41, 42–46A)."},"complexity_factors":["Multiple offence categories with different prohibition tiers: absolute prohibitions (Part 2.1), licence-only activities (Part 2.2), and regulated uses with exemptions (Part 3) — many cross-references between parts","Several distinct maximum penalties (15 years, 10 years, 5 years, 2 years) tied to different offences across Parts 2 and 3","Extensive definitions in the Dictionary and s 23 (e.g., human embryo, human embryo clone, hybrid embryo, chimeric embryo, excess ART embryo, proper consent, responsible person, accredited ART centre) that materially change application","Conditional licensing regime requiring HREC approval, NHMRC committee discretion, and detailed licence conditions and variations (ss 29–36, s 30(3)(b), s 33)","Cross‑jurisdictional dependencies and references to Commonwealth legislation and NHMRC instruments (Research Involving Human Embryos Act 2002 (Cwlth); NHMRC guidelines) that import external rules and standards (s 23, s 28, s 38)","Monitoring and enforcement architecture with inspector appointments, identity card rules, voluntary consent entry exceptions, warrant regime and procedural protections (ss 42–49, 46A–46D)","Public database requirement with carve‑outs for confidential commercial information plus separate criminal offences for unauthorised disclosure (s 38–39)","Review/appeal routed to a Commonwealth administrative review tribunal, adding layered administrative law processes (s 41)","Numerous conditional exceptions and technical limits (eg, the 14‑day rule, first mitotic division limits, permitted hybrid embryo uses under licence) creating many edge cases to resolve in practice"],"plain_english_summary":"**What this law does, in plain terms**\n\n- **It bans some practices entirely and tightly controls others.** The Act makes a set of activities involving human embryos and reproductive material criminal offences (with heavy penalties) and permits specified other activities only if authorised by an NHMRC licence or falling within narrow exemptions (see Part 2 and Part 3).  The Act’s stated object is to address ethical and scientific concerns about human reproduction and embryo use by prohibiting certain practices and regulating specified embryo-related activities (s 5).\n\n- **Key outright bans.** The Act makes it a serious criminal offence to do things such as placing a cloned human embryo into a human or animal (s 8), developing a human embryo outside a woman for more than 14 days (s 12), carrying out heritable changes to the human genome (s 13), creating chimeric embryos or developing hybrids beyond certain limits (ss 15–16), collecting a viable embryo from a woman for storage/other use (s 14), and commercial trading in eggs, sperm or embryos (s 19). Maximum penalties for many of these prohibited acts are up to 15 years’ imprisonment (see Parts 2.1 and 2.2). \n\n- **What is controlled by licence.** Activities that are not absolutely banned but may be authorised only by licence include creating embryos by processes other than fertilisation (for example, by somatic cell nuclear transfer) or developing such embryos (s 20), making embryos that contain genetic material from more than two people (s 21), using precursor cells from embryos or fetuses to create embryos (s 22), and certain kinds of hybrid embryo creation and use (s 22A). Licence applications are considered and issued by the NHMRC licensing committee, with specific procedural and ethical safeguards (ss 28–36, 29–31). \n\n- **Regulation of excess ART embryos and other embryo use.** The Act regulates when an embryo created during assisted reproductive technology (ART) treatment becomes an \"excess ART embryo\" and how those embryos may be used. Using an excess ART embryo for research or other purposes is an offence unless authorised by licence or falling within listed \"exempt uses\" (s 25). The Act also criminalises unauthorised use of other non-excess embryos and limits research involving fertilisation up to the first mitotic division unless licensed (ss 25A, 25B, 26). Consent requirements and the definition of \"proper consent\" are tied to NHMRC ethical guidelines (s 23, s 33).\n\n- **Who decides and how decisions are checked.** The NHMRC licensing committee evaluates licence applications and must be satisfied that appropriate consent protocols and HREC (human research ethics committee) approval are in place before issuing a licence (s 30(3)). Licence conditions may limit numbers of embryos used, who may use them, reporting, and monitoring (s 33). Eligible applicants or licence-holders can seek review of particular committee decisions through the Commonwealth administrative review tribunal (s 41).\n\n- **Enforcement, monitoring and confidentiality.** Inspectors appointed by the NHMRC licensing committee have powers to enter premises (with consent, because activities are licenced, or under warrant), inspect material, copy records and take samples (ss 42–46A). The committee must keep a public database of licences (but may exclude confidential commercial information) (s 38). There are criminal penalties for unlawful disclosure of confidential commercial information obtained under the Act (s 39).\n\n**Why it matters (mechanics and practical effects)**\n\n- **Who pays / bears costs.** Regulated entities and researchers (including accredited ART centres) bear the compliance costs: preparing licence applications, securing HREC approval, meeting consent and reporting requirements, maintaining records, and responding to inspections (ss 29–31, 33, 38, 44–46A). Criminal sanctions attach to non-compliance (Parts 2 and 3). The Minister may set fees (s 52).\n\n- **Who decides.** The NHMRC licensing committee has primary decision-making power over licences (s 28–31). Human research ethics committees must assess and approve projects before licence issuance (s 30(3)(b)). Magistrates decide on issuing monitoring warrants (s 46A). The chairperson of the NHMRC licensing committee appoints inspectors (s 42).\n\n- **Behaviour changes the law incentivises.** Researchers and clinics will avoid or seek licences for activities that are otherwise prohibited; many kinds of embryo research must be carefully documented and consented to in accordance with NHMRC guidance (s 23, s 33). The ban on commercial trading in gametes/embryos (s 19) disincentivises market transactions beyond reimbursement of reasonable expenses. The 14‑day developmental limit (s 12) and prohibition on heritable genome edits (s 13) channel research toward non‑germline and short‑term embryo work.\n\n**Implementation, trade‑offs and risks**\n\n- **Administrative discretion and workload.** The Act delegates substantial discretion to the NHMRC licensing committee (ss 28–36), and requires HREC ethical approvals and ongoing reporting (s 30, s 33). This creates an administrative gatekeeper role that concentrates decision power and creates ongoing compliance and monitoring costs for applicants.\n\n- **Cross‑jurisdictional interaction.** The Act is linked to Commonwealth legislation and NHMRC instruments (eg, Research Involving Human Embryos Act 2002 (Cwlth) and NHMRC guidelines) for definitions, consent rules and parts of the licensing framework (s 23, s 28, s 38). That alignment means changes at Commonwealth level or in NHMRC guidance will affect how this Territory Act operates, introducing dependency and coordination requirements.\n\n- **Enforcement intensity vs research flexibility.** Heavy criminal penalties (up to 15 years) and broad inspection powers (ss 8, 12, 13; ss 44–46A) increase enforcement teeth and therefore compliance costs and legal risk for researchers. At the same time, the licensing pathway (Part 3, esp. ss 29–36) preserves a legal route for authorised research that the Act does not absolutely prohibit (e.g. limited hybrid embryo use for sperm testing where licensed—s 29(1)(f)).\n\n- **Concentrated benefits and diffuse costs.** The licensing regime concentrates potential benefits (authorisation to carry out restricted research) among licence-holders and accredited centres, while compliance costs and the risk of criminal sanction are spread across clinics, researchers and potentially donors.\n\n- **Potential for substitution effects.** Strict on‑territory prohibitions (import/export/placement restrictions—s 18) could shift some research off-shore or to jurisdictions with different regulation unless licensing avenues meet researcher demand.\n\n**Technical definitions that matter (examples)**\n\n- \"Human embryo\" is defined with developmental and genomic criteria and excludes hybrid embryos and embryonic stem cell lines (s 6).\n- \"Human embryo clone\" is defined as a genetic copy produced other than by fertilisation (s 7).\n- \"Excess ART embryo\" and \"proper consent\" are tightly defined and linked to NHMRC guidelines (ss 23–24).\n\n**Sections to look at first if you need to act**\n- Prohibitions and penalties: Part 2 (especially ss 8–19).  \n- Licence routes and conditions: Part 3 (ss 29–36), and the NHMRC licensing committee functions (s 28).  \n- Inspection and enforcement: Part 4 (ss 42–49, 46A).  \n- Consent and guidelines: definitions in s 23 and conditions in s 33.\n\n(References in parentheses are to the Act sections cited above.)"},"issue_detection":{"absurdities":[],"contradictions":[]},"kimi_summary":{"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":true,"description":"The legislation has grown significantly beyond its original scope. Originally enacted as the Human Embryo (Research) Act 2004, it was renamed and substantially expanded in 2004 by incorporating the entire Human Cloning (Prohibition) Act 2004 into it. The 2008 amendments further expanded the regulatory framework to include hybrid embryos, research training involving fertilisation up to first mitotic division, and detailed licensing conditions. The 2024-2025 amendments updated references to the new Administrative Review Tribunal and assisted reproductive technology legislation, showing continuous expansion of the regulatory framework to keep pace with scientific developments and federal administrative changes."},"complexity_factors":["Multiple overlapping offence categories with different penalty levels (15 years, 10 years, 5 years, 2 years) depending on the activity and whether licensed","Extensive cross-referencing to Commonwealth legislation (Research Involving Human Embryos Act 2002, NHMRC Act 1992, Administrative Review Tribunal Act 2024)","Complex defined terms including 'human embryo', 'human embryo clone', 'excess ART embryo', 'proper consent', and 'responsible person' with multi-factorial definitions","Nested conditional logic: some activities are prohibited absolutely, others prohibited unless licensed, and others exempt from licensing requirements under specific circumstances","Dual jurisdiction elements: ACT law incorporates federal NHMRC licensing committee functions and Commonwealth administrative review tribunal processes","Multiple amendment layers (2004, 2008, 2019, 2021, 2024, 2025) creating a fragmented legislative history with renumbering and relocation of provisions","Exception to exception structure in Part 3 (exempt uses of excess ART embryos listed in s 25(3))","Technical scientific definitions requiring biological knowledge (mitotic division, primitive streak, precursor cells, chimeric/hybrid embryo distinctions)"],"plain_english_summary":"This Act is the ACT’s principal law on human cloning and embryo research, banning ethically unacceptable practices while allowing tightly regulated scientific work under NHMRC licences. It affects researchers, fertility clinics, patients donating embryos, licensing bodies and inspectors, and aims to protect reproductive ethics, require informed consent and oversight, and keep research responsible yet scientifically viable."}},"importantCases":[],"_links":{"self":"/api/acts/human-cloning-and-embryo-research-act-2004","history":"/api/acts/human-cloning-and-embryo-research-act-2004/history","analysis":"/api/acts/human-cloning-and-embryo-research-act-2004/analysis","conflicts":"/api/acts/human-cloning-and-embryo-research-act-2004/conflicts","importantCases":"/api/acts/human-cloning-and-embryo-research-act-2004/important-cases","documents":"/api/acts/human-cloning-and-embryo-research-act-2004/documents"}}