{"id":"qld:act-2003-007","name":"Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Act 2003","slug":"research-involving-human-embryos-and-prohibition-of-human-cloning-for-reproduction-act-2003","collection":"act","jurisdiction":"qld","status":"in_force","isInForce":true,"actNumber":"7 of 2003","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":46776,"registerId":"qld-act-2003-007-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"pt.1","sectionType":"part","heading":"Preliminary","content":"# Preliminary","sortOrder":0},{"sectionNumber":"sec.1","sectionType":"section","heading":"Short title","content":"### sec.1 Short title\n\nThis Act may be cited as the Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Act 2003 .\ns 1 amd 2007 No. 45 s 4","sortOrder":1},{"sectionNumber":"sec.2","sectionType":"section","heading":"Commencement","content":"### sec.2 Commencement\n\nThis Act, other than part 6 , division 1 , commences on a day to be fixed by proclamation.\nPart 6 , division 1 , commences on whichever of the following days applies—\n5 April 2005;\nif the Council of Australian Governments declares an earlier day by notice in the gazette—that earlier day.\n(sec.2-ssec.1) This Act, other than part 6 , division 1 , commences on a day to be fixed by proclamation.\n(sec.2-ssec.2) Part 6 , division 1 , commences on whichever of the following days applies— 5 April 2005; if the Council of Australian Governments declares an earlier day by notice in the gazette—that earlier day.\n- (a) 5 April 2005;\n- (b) if the Council of Australian Governments declares an earlier day by notice in the gazette—that earlier day.","sortOrder":2},{"sectionNumber":"sec.3","sectionType":"section","heading":"Object of Act","content":"### sec.3 Object of Act\n\nThe object of this Act is to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos—\nby prohibiting certain practices; and\nby regulating activities that involve the use of certain human embryos created by assisted reproductive technology or by other means.\ns 3 amd 2007 No. 45 s 5\n- (a) by prohibiting certain practices; and\n- (b) by regulating activities that involve the use of certain human embryos created by assisted reproductive technology or by other means.","sortOrder":3},{"sectionNumber":"sec.4","sectionType":"section","heading":"Act binds all persons","content":"### sec.4 Act binds all persons\n\nThis Act binds all persons, including the State, and, as far as the legislative power of the Parliament permits, the Commonwealth and the other States.\nNothing in this Act makes the Commonwealth or a State liable to be prosecuted for an offence.\n(sec.4-ssec.1) This Act binds all persons, including the State, and, as far as the legislative power of the Parliament permits, the Commonwealth and the other States.\n(sec.4-ssec.2) Nothing in this Act makes the Commonwealth or a State liable to be prosecuted for an offence.","sortOrder":4},{"sectionNumber":"sec.5","sectionType":"section","heading":"Definitions","content":"### sec.5 Definitions\n\nThe dictionary in the schedule defines particular words used in this Act.\nFor the purposes of establishing that a human embryo clone is a genetic copy of a living or dead human—\nit is sufficient to establish that the set of genes in the nuclei of the cells of the living or dead human has been copied; and\nit is not necessary to establish that the copy is an identical genetic copy.\nFor the purposes of the definition human embryo in the schedule, in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\nFor the purposes of the definition human embryo clone in the schedule, a human embryo that results from the technological process known as embryo splitting is taken not to be created by a process of fertilisation of a human egg by human sperm.\nA reference in this Act to an embryo (including a human embryo) is a reference to a living embryo.\nA reference in this Act to a human egg is a reference to a human oocyte.\nA reference in this Act to a human embryo does not include a reference to—\na hybrid embryo; or\na human embryonic stem cell line.\nThe following provisions of the Acts Interpretation Act 1954 do not apply to a reference to a spouse in this Act—\nsection 32DA (6)\nschedule 1 , definition spouse .\ns 5 amd 2007 No. 45 s 6 ; 2013 No. 39 s 110 (1) sch 3 pt 1\n(sec.5-ssec.1) The dictionary in the schedule defines particular words used in this Act.\n(sec.5-ssec.2) For the purposes of establishing that a human embryo clone is a genetic copy of a living or dead human— it is sufficient to establish that the set of genes in the nuclei of the cells of the living or dead human has been copied; and it is not necessary to establish that the copy is an identical genetic copy.\n(sec.5-ssec.3) For the purposes of the definition human embryo in the schedule, in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n(sec.5-ssec.4) For the purposes of the definition human embryo clone in the schedule, a human embryo that results from the technological process known as embryo splitting is taken not to be created by a process of fertilisation of a human egg by human sperm.\n(sec.5-ssec.5) A reference in this Act to an embryo (including a human embryo) is a reference to a living embryo.\n(sec.5-ssec.6) A reference in this Act to a human egg is a reference to a human oocyte.\n(sec.5-ssec.7) A reference in this Act to a human embryo does not include a reference to— a hybrid embryo; or a human embryonic stem cell line.\n(sec.5-ssec.8) The following provisions of the Acts Interpretation Act 1954 do not apply to a reference to a spouse in this Act— section 32DA (6) schedule 1 , definition spouse .\n- (a) it is sufficient to establish that the set of genes in the nuclei of the 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 genetic copy.\n- (a) a hybrid embryo; or\n- (b) a human embryonic stem cell line.\n- • section 32DA (6)\n- • schedule 1 , definition spouse .","sortOrder":5},{"sectionNumber":"sec.6","sectionType":"section","heading":"Meaning of reckless","content":"### sec.6 Meaning of reckless\n\nA person is reckless in relation to a circumstance if—\nthe person is aware of a substantial risk that the circumstance exists or will exist; and\nhaving regard to the circumstances known to the person, it is unjustifiable to take the risk.\nA person is reckless in relation to a result if—\nthe person is aware of a substantial risk that the result will happen; and\nhaving regard to the circumstances known to the person, it is unjustifiable to take the risk.\nIt is a question of fact as to whether taking a risk is unjustifiable.\n(sec.6-ssec.1) A person is reckless in relation to a circumstance if— the person is aware of a substantial risk that the circumstance exists or will exist; and having regard to the circumstances known to the person, it is unjustifiable to take the risk.\n(sec.6-ssec.2) A person is reckless in relation to a result if— the person is aware of a substantial risk that the result will happen; and having regard to the circumstances known to the person, it is unjustifiable to take the risk.\n(sec.6-ssec.3) It is a question of fact as to whether taking a risk is unjustifiable.\n- (a) the person is aware of a substantial risk that the circumstance exists or will exist; and\n- (b) having regard to the circumstances known to the person, it is unjustifiable to take the risk.\n- (a) the person is aware of a substantial risk that the result will happen; and\n- (b) having regard to the circumstances known to the person, it is unjustifiable to take the risk.","sortOrder":6},{"sectionNumber":"pt.2","sectionType":"part","heading":"Prohibited practices","content":"# Prohibited practices","sortOrder":7},{"sectionNumber":"pt.2-div.1","sectionType":"division","heading":"Practices that are completely prohibited","content":"## Practices that are completely prohibited","sortOrder":8},{"sectionNumber":"sec.7","sectionType":"section","heading":"Offence—placing a human embryo clone in the human body or the body of an animal","content":"### sec.7 Offence—placing a human embryo clone in the human body or the body of an animal\n\nA person commits an offence if the person intentionally places a human embryo clone in the body of a human or the body of an animal.\nMaximum penalty—15 years imprisonment.\nIt is not a defence to an offence under subsection (1) that the human embryo clone did not survive or could not have survived.\nThe development of a human embryo (including a human embryo clone) outside the body of a woman for more than 14 days is prohibited by section 10 .\ns 7 sub 2007 No. 45 s 7\n(sec.7-ssec.1) A person commits an offence if the person intentionally places a human embryo clone in the body of a human or the body of an animal. Maximum penalty—15 years imprisonment.\n(sec.7-ssec.2) It is not a defence to an offence under subsection (1) that the human embryo clone did not survive or could not have survived. The development of a human embryo (including a human embryo clone) outside the body of a woman for more than 14 days is prohibited by section 10 .","sortOrder":9},{"sectionNumber":"sec.8","sectionType":"section","heading":"Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman","content":"### sec.8 Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman\n\nA person commits an offence if the person intentionally creates a human embryo by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, unless the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman.\nMaximum penalty—15 years imprisonment.\nA defendant does not bear the burden of proving any matter in subsection (1) .\ns 8 sub 2007 No. 45 s 7\n(sec.8-ssec.1) A person commits an offence if the person intentionally creates a human embryo by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, unless the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman. Maximum penalty—15 years imprisonment.\n(sec.8-ssec.2) A defendant does not bear the burden of proving any matter in subsection (1) .","sortOrder":10},{"sectionNumber":"sec.9","sectionType":"section","heading":"Offence—creating or developing a human embryo by fertilisation that contains genetic material provided by more than 2 persons","content":"### sec.9 Offence—creating or developing a human embryo by fertilisation that contains genetic material provided by more than 2 persons\n\nA person commits an offence if—\nthe person intentionally creates or develops a human embryo by a process of the fertilisation of a human egg by a human sperm outside the body of a woman; and\nthe human embryo contains genetic material provided by more than 2 persons.\nMaximum penalty—15 years imprisonment.\ns 9 sub 2007 No. 45 s 7\n- (a) the person intentionally creates or develops a human embryo by a process of the fertilisation of a human egg by a human sperm outside the body of a woman; and\n- (b) the human embryo contains genetic material provided by more than 2 persons.","sortOrder":11},{"sectionNumber":"sec.10","sectionType":"section","heading":"Offence—developing a human embryo outside the body of a woman for more than 14 days","content":"### sec.10 Offence—developing a human embryo outside the body of a woman for more than 14 days\n\nA person commits an offence if the person intentionally develops a human embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended.\nMaximum penalty—15 years imprisonment.\ns 10 sub 2007 No. 45 s 7","sortOrder":12},{"sectionNumber":"sec.11","sectionType":"section","heading":"Offence—heritable alterations to genome","content":"### sec.11 Offence—heritable alterations to genome\n\nA person commits an offence if—\nthe person alters the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered; and\nin altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered.\nMaximum penalty—15 years imprisonment.\nIn this section—\nhuman cell includes a human embryonal cell, a human fetal cell, human sperm and a human egg.\ns 11 sub 2007 No. 45 s 7\n(sec.11-ssec.1) A person commits an offence if— the person alters the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered; and in altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered. Maximum penalty—15 years imprisonment.\n(sec.11-ssec.2) In this section— human cell includes a human embryonal cell, a human fetal cell, human sperm and a human egg.\n- (a) the person alters the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered; and\n- (b) in altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered.","sortOrder":13},{"sectionNumber":"sec.12","sectionType":"section","heading":"Offence—collecting a viable human embryo from the body of a woman","content":"### sec.12 Offence—collecting a viable human embryo from the body of a woman\n\nA person commits an offence if the person removes a human embryo from the body of a woman, intending to collect a viable human embryo.\nMaximum penalty—15 years imprisonment.\ns 12 sub 2007 No. 45 s 7","sortOrder":14},{"sectionNumber":"sec.13","sectionType":"section","heading":"Offence—creating a chimeric embryo","content":"### sec.13 Offence—creating a chimeric embryo\n\nA person commits an offence if the person intentionally creates a chimeric embryo.\nMaximum penalty—15 years imprisonment.\ns 13 sub 2007 No. 45 s 7","sortOrder":15},{"sectionNumber":"sec.14","sectionType":"section","heading":"Offence—developing a hybrid embryo","content":"### sec.14 Offence—developing a hybrid embryo\n\nA person commits an offence if the person intentionally develops a hybrid embryo for a period of more than 14 days, excluding any period when development is suspended.\nMaximum penalty—15 years imprisonment.\ns 14 sub 2007 No. 45 s 7","sortOrder":16},{"sectionNumber":"sec.15","sectionType":"section","heading":"Offence—placing of an embryo","content":"### sec.15 Offence—placing of an embryo\n\nA person commits an offence if the person intentionally places a human embryo in an animal.\nMaximum penalty—15 years imprisonment.\nA person commits an offence if the person intentionally places a human embryo in the body of a human, other than in a woman’s reproductive tract.\nMaximum penalty—15 years imprisonment.\nA person commits an offence if the person intentionally places an animal embryo in the body of a human for any period of gestation.\nMaximum penalty—15 years imprisonment.\ns 15 sub 2007 No. 45 s 7\n(sec.15-ssec.1) A person commits an offence if the person intentionally places a human embryo in an animal. Maximum penalty—15 years imprisonment.\n(sec.15-ssec.2) A person commits an offence if the person intentionally places a human embryo in the body of a human, other than in a woman’s reproductive tract. Maximum penalty—15 years imprisonment.\n(sec.15-ssec.3) A person commits an offence if the person intentionally places an animal embryo in the body of a human for any period of gestation. Maximum penalty—15 years imprisonment.","sortOrder":17},{"sectionNumber":"sec.16","sectionType":"section","heading":"Offence—placing a prohibited embryo","content":"### sec.16 Offence—placing a prohibited embryo\n\nA person commits an offence if the person intentionally places an embryo in the body of a woman knowing that, or reckless as to whether, the embryo is a prohibited embryo.\nMaximum penalty—15 years imprisonment.\nIn this section—\nprohibited embryo means—\na human embryo created by a process other than the fertilisation of a human egg by human sperm; or\na human embryo created outside the body of a woman, unless the intention of the person who created the embryo was to attempt to achieve pregnancy in a particular woman; or\na human embryo that contains genetic material provided by more than 2 persons; or\na human embryo that has been developing outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended; or\na human embryo created using precursor cells taken from a human embryo or a human fetus; or\na human embryo that contains a human cell (within the meaning of section 11 ) whose genome has been altered in such a way that the alteration is heritable by human descendants of the human whose cell was altered; or\na human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; or\na chimeric embryo or a hybrid embryo.\ns 16 sub 2007 No. 45 s 7\n(sec.16-ssec.1) A person commits an offence if the person intentionally places an embryo in the body of a woman knowing that, or reckless as to whether, the embryo is a prohibited embryo. Maximum penalty—15 years imprisonment.\n(sec.16-ssec.2) In this section— prohibited embryo means— a human embryo created by a process other than the fertilisation of a human egg by human sperm; or a human embryo created outside the body of a woman, unless the intention of the person who created the embryo was to attempt to achieve pregnancy in a particular woman; or a human embryo that contains genetic material provided by more than 2 persons; or a human embryo that has been developing outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended; or a human embryo created using precursor cells taken from a human embryo or a human fetus; or a human embryo that contains a human cell (within the meaning of section 11 ) whose genome has been altered in such a way that the alteration is heritable by human descendants of the human whose cell was altered; or a human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; or a chimeric embryo or a hybrid embryo.\n- (a) a human embryo created by a process other than the fertilisation of a human egg by human sperm; or\n- (b) a human embryo created outside the body of a woman, unless the intention of the person who created the embryo was to attempt to achieve pregnancy in a particular woman; or\n- (c) a human embryo that contains genetic material provided by more than 2 persons; or\n- (d) a human embryo that has been developing outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended; or\n- (e) a human embryo created using precursor cells taken from a human embryo or a human fetus; or\n- (f) a human embryo that contains a human cell (within the meaning of section 11 ) whose genome has been altered in such a way that the alteration is heritable by human descendants of the human whose cell was altered; or\n- (g) a human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; or\n- (h) a chimeric embryo or a hybrid embryo.","sortOrder":18},{"sectionNumber":"sec.17","sectionType":"section","heading":"Offence—commercial trading in human eggs, human sperm or human embryos","content":"### sec.17 Offence—commercial trading in human eggs, human sperm or human embryos\n\nA person commits an offence if the person intentionally gives or offers valuable consideration to another person for the supply of a human egg, human sperm or a human embryo.\nMaximum penalty—15 years imprisonment.\nA person commits an offence if the person intentionally receives, or offers to receive, valuable consideration from another person for the supply of a human egg, human sperm or a human embryo.\nMaximum penalty—15 years imprisonment.\nIn this section—\nreasonable expenses —\nin relation to the supply of a human egg or human sperm—includes, but is not limited to, expenses relating to the collection, storage or transport of the egg or sperm; and\nin relation to the supply of a human embryo—\ndoes not include any expenses incurred by a person before the time when the embryo became an excess ART embryo within the meaning of section 22 ; and\nincludes, but is not limited to, expenses relating to the storage or transport of the embryo.\nvaluable consideration , in relation to the supply of a human egg, human sperm or a human embryo by a person, includes any inducement, discount or priority in the provision of a service to the person, but does not include the payment of reasonable expenses incurred by the person in connection with the supply.\ns 17 sub 2007 No. 45 s 7\n(sec.17-ssec.1) A person commits an offence if the person intentionally gives or offers valuable consideration to another person for the supply of a human egg, human sperm or a human embryo. Maximum penalty—15 years imprisonment.\n(sec.17-ssec.2) A person commits an offence if the person intentionally receives, or offers to receive, valuable consideration from another person for the supply of a human egg, human sperm or a human embryo. Maximum penalty—15 years imprisonment.\n(sec.17-ssec.3) In this section— reasonable expenses — in relation to the supply of a human egg or human sperm—includes, but is not limited to, expenses relating to the collection, storage or transport of the egg or sperm; and in relation to the supply of a human embryo— does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo within the meaning of section 22 ; and includes, but is not limited to, expenses relating to the storage or transport of the embryo. valuable consideration , in relation to the supply of a human egg, human sperm or a human embryo by a person, includes any inducement, discount or priority in the provision of a service to the person, but does not include the payment of reasonable expenses incurred by the person in connection with the supply.\n- (a) in relation to the supply of a human egg or human sperm—includes, but is not limited to, expenses relating to the collection, storage or transport of the egg or sperm; and\n- (b) in relation to the supply of a human embryo— (i) does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo within the meaning of section 22 ; and (ii) includes, but is not limited to, expenses relating to the storage or transport of the embryo.\n- (i) does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo within the meaning of section 22 ; and\n- (ii) includes, but is not limited to, expenses relating to the storage or transport of the embryo.\n- (i) does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo within the meaning of section 22 ; and\n- (ii) includes, but is not limited to, expenses relating to the storage or transport of the embryo.","sortOrder":19},{"sectionNumber":"pt.2-div.2","sectionType":"division","heading":"Practices that are prohibited unless authorised by a licence","content":"## Practices that are prohibited unless authorised by a licence","sortOrder":20},{"sectionNumber":"sec.18","sectionType":"section","heading":"Offence—creating a human embryo other than by fertilisation, or developing such an embryo","content":"### sec.18 Offence—creating a human embryo other than by fertilisation, or developing such an embryo\n\nA person commits an offence if—\nthe person intentionally creates a human embryo by a process other than the fertilisation of a human egg by a human sperm, or develops a human embryo so created; and\nthe creation or development of the human embryo by the person is not authorised by a licence.\nMaximum penalty—10 years imprisonment.\nThe development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 10 .\nThe placement in the body of a woman of a human embryo clone, or any other human embryo created other than by the fertilisation of a human egg by a human sperm, is prohibited by sections 7 and 16 .\ns 18 sub 2007 No. 45 s 7\n- (a) the person intentionally creates a human embryo by a process other than the fertilisation of a human egg by a human sperm, or develops a human embryo so created; and\n- (b) the creation or development of the human embryo by the person is not authorised by a licence.\n- 1 The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 10 .\n- 2 The placement in the body of a woman of a human embryo clone, or any other human embryo created other than by the fertilisation of a human egg by a human sperm, is prohibited by sections 7 and 16 .","sortOrder":21},{"sectionNumber":"sec.19","sectionType":"section","heading":"Offence—creating or developing a human embryo containing genetic material provided by more than 2 persons","content":"### sec.19 Offence—creating or developing a human embryo containing genetic material provided by more than 2 persons\n\nA person commits an offence if—\nthe person intentionally creates or develops a human embryo by a process other than the fertilisation of a human egg by a human sperm; and\nthe human embryo contains genetic material provided by more than 2 persons; and\nthe creation or development of the human embryo by the person is not authorised by a licence.\nMaximum penalty—10 years imprisonment.\nThe development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 10 .\nThe placement in the body of a woman of a human embryo created other than by the fertilisation of a human egg by a human sperm, is prohibited by section 16 .\ns 19 sub 2007 No. 45 s 7\n- (a) the person intentionally creates or develops a human embryo by a process other than the fertilisation of a human egg by a human sperm; and\n- (b) the human embryo contains genetic material provided by more than 2 persons; and\n- (c) the creation or development of the human embryo by the person is not authorised by a licence.\n- 1 The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 10 .\n- 2 The placement in the body of a woman of a human embryo created other than by the fertilisation of a human egg by a human sperm, is prohibited by section 16 .","sortOrder":22},{"sectionNumber":"sec.20","sectionType":"section","heading":"Offence—using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo","content":"### sec.20 Offence—using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo\n\nA person commits an offence if—\nthe person uses precursor cells taken from a human embryo or a human fetus, intending to create a human embryo, or intentionally develops an embryo so created; and\nthe person engages in activities mentioned in paragraph (a) without being authorised by a licence, and the person knows or is reckless as to that fact.\nMaximum penalty—10 years imprisonment.\ns 20 sub 2007 No. 45 s 7\n- (a) the person uses precursor cells taken from a human embryo or a human fetus, intending to create a human embryo, or intentionally develops an embryo so created; and\n- (b) the person engages in activities mentioned in paragraph (a) without being authorised by a licence, and the person knows or is reckless as to that fact.","sortOrder":23},{"sectionNumber":"sec.20A","sectionType":"section","heading":"Offence—creating a hybrid embryo","content":"### sec.20A Offence—creating a hybrid embryo\n\nA person commits an offence if the person intentionally creates a hybrid embryo.\nMaximum penalty—10 years imprisonment.\nA person commits an offence if the person intentionally develops a hybrid embryo.\nMaximum penalty—10 years imprisonment.\nA person does not commit an offence against subsection (1) or (2) if the creation or development of the hybrid embryo by the person is authorised by a licence.\nA licence to create or use a hybrid embryo can only be issued under section 29 for the purposes of testing sperm quality in an accredited ART centre up to, but not including, the first mitotic division.\ns 20A ins 2007 No. 45 s 7\n(sec.20A-ssec.1) A person commits an offence if the person intentionally creates a hybrid embryo. Maximum penalty—10 years imprisonment.\n(sec.20A-ssec.2) A person commits an offence if the person intentionally develops a hybrid embryo. Maximum penalty—10 years imprisonment.\n(sec.20A-ssec.3) A person does not commit an offence against subsection (1) or (2) if the creation or development of the hybrid embryo by the person is authorised by a licence. A licence to create or use a hybrid embryo can only be issued under section 29 for the purposes of testing sperm quality in an accredited ART centre up to, but not including, the first mitotic division.","sortOrder":24},{"sectionNumber":"pt.3","sectionType":"part","heading":"Regulation of the use of excess ART embryos, other embryos and human eggs","content":"# Regulation of the use of excess ART embryos, other embryos and human eggs","sortOrder":25},{"sectionNumber":"pt.3-div.1","sectionType":"division","heading":"Interpretation","content":"## Interpretation","sortOrder":26},{"sectionNumber":"sec.21","sectionType":"section","heading":"Definitions for pt 3","content":"### sec.21 Definitions for pt 3\n\nIn this part—\naccredited ART centre means an entity accredited to carry out assisted reproductive technology by an entity prescribed under a regulation.\nconfidential commercial information means information that has a commercial or other value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed.\ndisclose , in relation to information, means give or communicate in any way.\nexcess ART embryo has the meaning given by section 22 .\nHREC means a Human Research Ethics Committee.\nlicence means a licence issued under section 29 .\nproper consent , in relation to the use of an excess ART embryo or a human egg, or the creation or use of any other embryo, means consent obtained in accordance with guidelines issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 (Cwlth) and prescribed under a regulation for the purposes of this definition.\ns 21 def proper consent amd 2006 No. 25 s 241 (2) sch 4\nsub 2007 No. 45 s 9 (2) – (3)\nrelevant State body means the person or body notified by the State to the chairperson of the NHMRC Licensing Committee for the purposes of the Commonwealth Act, part 2 .\nresponsible person means—\nin relation to an excess ART embryo—\neach person who provided the egg or sperm from which the embryo was created; and\nthe woman for whom the embryo was created, for the purpose of achieving her pregnancy; and\nany person who was the spouse of a person mentioned in subparagraph (i) at the time the egg or sperm mentioned in that subparagraph was provided; and\nany person who was the spouse of the woman mentioned in subparagraph (ii) at the time the embryo was created; or\nin relation to an embryo other than an excess ART embryo—each person whose reproductive material, genetic material or cell was used, or is proposed to be used, in the creation or use of the embryo; or\nin relation to a human egg—the woman who was the biological donor of the egg.\ns 21 def responsible person sub 2007 No. 45 s 9 (2) – (3)\ns 21 amd 2007 No. 45 s 9 (1)\n- (a) in relation to an excess ART embryo— (i) each person who provided the egg or sperm from which the embryo was created; and (ii) the woman for whom the embryo was created, for the purpose of achieving her pregnancy; and (iii) any person who was the spouse of a person mentioned in subparagraph (i) at the time the egg or sperm mentioned in that subparagraph was provided; and (iv) any person who was the spouse of the woman mentioned in subparagraph (ii) at the time the embryo was created; or\n- (i) each person who provided the egg or sperm from which the embryo was created; and\n- (ii) the woman for whom the embryo was created, for the purpose of achieving her pregnancy; and\n- (iii) any person who was the spouse of a person mentioned in subparagraph (i) at the time the egg or sperm mentioned in that subparagraph was provided; and\n- (iv) any person who was the spouse of the woman mentioned in subparagraph (ii) at the time the embryo was created; or\n- (b) in relation to an embryo other than an excess ART embryo—each person whose reproductive material, genetic material or cell was used, or is proposed to be used, in the creation or use of the embryo; or\n- (c) in relation to a human egg—the woman who was the biological donor of the egg.\n- (i) each person who provided the egg or sperm from which the embryo was created; and\n- (ii) the woman for whom the embryo was created, for the purpose of achieving her pregnancy; and\n- (iii) any person who was the spouse of a person mentioned in subparagraph (i) at the time the egg or sperm mentioned in that subparagraph was provided; and\n- (iv) any person who was the spouse of the woman mentioned in subparagraph (ii) at the time the embryo was created; or","sortOrder":27},{"sectionNumber":"sec.22","sectionType":"section","heading":"Meaning of excess ART embryo","content":"### sec.22 Meaning of excess ART embryo\n\nIn this part—\nexcess ART embryo means a human embryo that—\nwas created, by assisted reproductive technology, for use in the assisted reproductive technology treatment of a woman; and\nis excess to the needs of—\nthe woman for whom it was created; and\nher spouse (if any) at the time the embryo was created.\nFor the purposes of paragraph (b) of the definition excess ART embryo , a human embryo is excess to the needs of the persons mentioned in that paragraph at a particular time if—\neach such person has given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or\neach such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.\n(sec.22-ssec.1) In this part— excess ART embryo means a human embryo that— was created, by assisted reproductive technology, for use in the assisted reproductive technology treatment of a woman; and is excess to the needs of— the woman for whom it was created; and her spouse (if any) at the time the embryo was created.\n(sec.22-ssec.2) For the purposes of paragraph (b) of the definition excess ART embryo , a human embryo is excess to the needs of the persons mentioned in that paragraph at a particular time if— each such person has given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.\n- (a) was created, by assisted reproductive technology, for use in the assisted reproductive technology treatment of a woman; and\n- (b) is excess to the needs of— (i) the woman for whom it was created; and (ii) her spouse (if any) at the time the embryo was created.\n- (i) the woman for whom it was created; and\n- (ii) her spouse (if any) at the time the embryo was created.\n- (i) the woman for whom it was created; and\n- (ii) her spouse (if any) at the time the embryo was created.\n- (a) each such person has given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or\n- (b) each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.","sortOrder":28},{"sectionNumber":"pt.3-div.2","sectionType":"division","heading":"Offences","content":"## Offences","sortOrder":29},{"sectionNumber":"sec.23","sectionType":"section","heading":"Offence—use of excess ART embryo","content":"### sec.23 Offence—use of excess ART embryo\n\nA person commits an offence if the person intentionally uses an excess ART embryo, unless—\nthe use by the person is authorised by a licence; or\nthe use by the person is an exempt use within the meaning of subsection (2) .\nMaximum penalty—5 years imprisonment.\nA use of an excess ART embryo by a person is an exempt use for the purposes of subsection (1) if—\nthe use consists only of—\nstorage of the excess ART embryo; or\nremoval of the excess ART embryo from storage; or\ntransport of the excess ART embryo; or\nthe use consists only of observation of the excess ART embryo; or\nthe use consists only of allowing the excess ART embryo to succumb; or\nthe use is carried out by an accredited ART centre, and—\nthe excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and\nthe use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or\nthe use is carried out by an accredited ART centre and is for the purposes of achieving pregnancy in a woman other than the woman for whom the excess ART embryo was created; or\nthe use is of a kind prescribed under a regulation for the purposes of this paragraph.\nA defendant does not bear the burden of proving any matter in subsection (1) or (2) .\nIn this section—\ndiagnostic investigation , in relation to an excess ART embryo, means any procedure undertaken on embryos for the sole purpose of diagnostic investigations for the direct benefit of the woman for whom it was created.\nobservation , in relation to an excess ART embryo, includes taking a photograph of the embryo, or taking a recording of the embryo from which a visual image can be produced.\ns 23 amd 2007 No. 45 s 10\n(sec.23-ssec.1) A person commits an offence if the person intentionally uses an excess ART embryo, unless— the use by the person is authorised by a licence; or the use by the person is an exempt use within the meaning of subsection (2) . Maximum penalty—5 years imprisonment.\n(sec.23-ssec.2) A use of an excess ART embryo by a person is an exempt use for the purposes of subsection (1) if— the use consists only of— storage of the excess ART embryo; or removal of the excess ART embryo from storage; or transport of the excess ART embryo; or the use consists only of observation of the excess ART embryo; or the use consists only of allowing the excess ART embryo to succumb; or the use is carried out by an accredited ART centre, and— the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and the use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or the use is carried out by an accredited ART centre and is for the purposes of achieving pregnancy in a woman other than the woman for whom the excess ART embryo was created; or the use is of a kind prescribed under a regulation for the purposes of this paragraph.\n(sec.23-ssec.3) A defendant does not bear the burden of proving any matter in subsection (1) or (2) .\n(sec.23-ssec.4) In this section— diagnostic investigation , in relation to an excess ART embryo, means any procedure undertaken on embryos for the sole purpose of diagnostic investigations for the direct benefit of the woman for whom it was created. observation , in relation to an excess ART embryo, includes taking a photograph of the embryo, or taking a recording of the embryo from which a visual image can be produced.\n- (a) the use by the person is authorised by a licence; or\n- (b) the use by the person is an exempt use within the meaning of subsection (2) .\n- (a) the use consists only of— (i) storage of the excess ART embryo; or (ii) removal of the excess ART embryo from storage; or (iii) transport of the excess ART embryo; or\n- (i) storage of the excess ART embryo; or\n- (ii) removal of the excess ART embryo from storage; or\n- (iii) transport of the excess ART embryo; or\n- (b) the use consists only of observation of the excess ART embryo; or\n- (c) the use consists only of allowing the excess ART embryo to succumb; or\n- (d) the use is carried out by an accredited ART centre, and— (i) the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and (ii) the use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or\n- (i) the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and\n- (ii) the use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or\n- (e) the use is carried out by an accredited ART centre and is for the purposes of achieving pregnancy in a woman other than the woman for whom the excess ART embryo was created; or\n- (f) the use is of a kind prescribed under a regulation for the purposes of this paragraph.\n- (i) storage of the excess ART embryo; or\n- (ii) removal of the excess ART embryo from storage; or\n- (iii) transport of the excess ART embryo; or\n- (i) the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and\n- (ii) the use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or","sortOrder":30},{"sectionNumber":"sec.23A","sectionType":"section","heading":"Offence—use of other embryos","content":"### sec.23A Offence—use of other embryos\n\nA person commits an offence if—\nthe person intentionally uses an embryo; and\nthe embryo is—\na human embryo created by a process other than the fertilisation of a human egg by a human sperm; or\na human embryo created by a process other than the fertilisation of a human egg by a human sperm that contains genetic material provided by more than 2 persons; or\na human embryo created using precursor cells taken from a human embryo or a human fetus; or\na hybrid embryo; and\nthe use by the person is not authorised by a licence.\nMaximum penalty—5 years imprisonment.\nThe creation or development of embryos mentioned in this section is prohibited under part 2 , unless authorised by a licence.\ns 23A ins 2007 No. 45 s 11\n- (a) the person intentionally uses an embryo; and\n- (b) the embryo is— (i) a human embryo created by a process other than the fertilisation of a human egg by a human sperm; or (ii) a human embryo created by a process other than the fertilisation of a human egg by a human sperm that contains genetic material provided by more than 2 persons; or (iii) a human embryo created using precursor cells taken from a human embryo or a human fetus; or (iv) a hybrid embryo; and\n- (i) a human embryo created by a process other than the fertilisation of a human egg by a human sperm; or\n- (ii) a human embryo created by a process other than the fertilisation of a human egg by a human sperm that contains genetic material provided by more than 2 persons; or\n- (iii) a human embryo created using precursor cells taken from a 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.\n- (i) a human embryo created by a process other than the fertilisation of a human egg by a human sperm; or\n- (ii) a human embryo created by a process other than the fertilisation of a human egg by a human sperm that contains genetic material provided by more than 2 persons; or\n- (iii) a human embryo created using precursor cells taken from a human embryo or a human fetus; or\n- (iv) a hybrid embryo; and","sortOrder":31},{"sectionNumber":"sec.23B","sectionType":"section","heading":"Offence—certain activities involving use of human eggs","content":"### sec.23B Offence—certain activities involving use of human eggs\n\nA person commits an offence if—\nthe person undertakes research or training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART; and\nthe person is not authorised by a licence to undertake the research or training.\nMaximum penalty—5 years imprisonment.\ns 23B ins 2007 No. 45 s 11\n- (a) the person undertakes research or training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART; and\n- (b) the person is not authorised by a licence to undertake the research or training.","sortOrder":32},{"sectionNumber":"sec.24","sectionType":"section","heading":"Offence—use of embryo that is not an excess ART embryo","content":"### sec.24 Offence—use of embryo that is not an excess ART embryo\n\nA person commits an offence if—\nthe person intentionally uses, outside the body of a woman, a human embryo—\nthat was created by fertilisation of a human egg by a human sperm; and\nthat is not an excess ART embryo; and\nthe use is not for a purpose relating to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre, and the person knows or is reckless as to that fact.\nMaximum penalty—5 years imprisonment.\ns 24 amd 2007 No. 45 s 12\n- (a) the person intentionally uses, outside the body of a woman, a human embryo— (i) that was created by fertilisation of a human egg by a human sperm; and (ii) that is not an excess ART embryo; and\n- (i) that was created by fertilisation of a human egg by a human sperm; 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 technology treatment of a woman carried out by an accredited ART centre, and the person knows or is reckless as to that fact.\n- (i) that was created by fertilisation of a human egg by a human sperm; and\n- (ii) that is not an excess ART embryo; and","sortOrder":33},{"sectionNumber":"sec.25","sectionType":"section","heading":"Offence—breaching a licence condition","content":"### sec.25 Offence—breaching a licence condition\n\nA person commits an offence if the person intentionally engages in conduct, knowing that the conduct contravenes a condition of a licence that applies to the person, or reckless as to whether the conduct contravenes a condition of such a licence.\nMaximum penalty—5 years imprisonment.\nIn this section—\nengage in conduct means—\ndo an act; or\nomit to perform an act.\n(sec.25-ssec.1) A person commits an offence if the person intentionally engages in conduct, knowing that the conduct contravenes a condition of a licence that applies to the person, or reckless as to whether the conduct contravenes a condition of such a licence. Maximum penalty—5 years imprisonment.\n(sec.25-ssec.2) In this section— engage in conduct means— do an act; or omit to perform an act.\n- (a) do an act; or\n- (b) omit to perform an act.","sortOrder":34},{"sectionNumber":"sec.25A","sectionType":"section","heading":"Person not liable for conduct purportedly authorised","content":"### sec.25A Person not liable for conduct purportedly authorised\n\nTo avoid any doubt, it is declared that a person is not criminally responsible for an offence against this part, or section 50 (1) to the extent the attempt relates to an offence against this part, in respect of particular conduct if—\nthe conduct by the person is purportedly authorised by a provision of a licence; and\nthe licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and\nthe person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision.\nIn this section—\nlicence includes a purported licence.\ns 25A ins 2007 No. 45 s 13\n(sec.25A-ssec.1) To avoid any doubt, it is declared that a person is not criminally responsible for an offence against this part, or section 50 (1) to the extent the attempt relates to an offence against this part, in respect of particular conduct if— the conduct by the person is purportedly authorised by a provision of a licence; and the licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and the person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision.\n(sec.25A-ssec.2) In this section— licence includes a purported licence.\n- (a) the conduct by the person is purportedly authorised by a provision of a licence; and\n- (b) the licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and\n- (c) the person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision.","sortOrder":35},{"sectionNumber":"pt.3-div.3","sectionType":"division","heading":"Embryo Research Licensing Committee of the NHMRC","content":"## Embryo Research Licensing Committee of the NHMRC","sortOrder":36},{"sectionNumber":"sec.26","sectionType":"section","heading":"Functions of committee","content":"### sec.26 Functions of committee\n\nThe functions of the NHMRC Licensing Committee are—\nto perform functions in relation to licences under division 4 ; and\nto perform functions in relation to databases under division 5 ; and\nto perform such other functions as are conferred on it by this Act or any other law.\n- (a) to perform functions in relation to licences under division 4 ; and\n- (b) to perform functions in relation to databases under division 5 ; and\n- (c) to perform such other functions as are conferred on it by this Act or any other law.","sortOrder":37},{"sectionNumber":"sec.27","sectionType":"section","heading":"Powers of committee","content":"### sec.27 Powers of committee\n\nThe NHMRC Licensing Committee has power to do all things necessary or convenient to be done for or in connection with the performance of its functions under this Act.","sortOrder":38},{"sectionNumber":"pt.3-div.4","sectionType":"division","heading":"Licensing system","content":"## Licensing system","sortOrder":39},{"sectionNumber":"sec.28","sectionType":"section","heading":"Person may apply for licence","content":"### sec.28 Person may apply for licence\n\nA person may apply to the NHMRC Licensing Committee for a licence authorising one or more of the following—\nuse of excess ART embryos;\ncreation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos;\ncreation of human embryos other than by fertilisation of a human egg by a human sperm that contain genetic material provided by more than 2 persons, and use of such embryos;\ncreation of human embryos using precursor cells from a human embryo or a human fetus, and use of such embryos;\nresearch and training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART;\ncreation of hybrid embryos by the fertilisation of an animal egg by a human sperm, and use of such embryos up to, but not including, the first mitotic division, if—\nthe creation or use is for the purposes of testing sperm quality; and\nthe creation or use will occur in an accredited ART centre.\nTo avoid any doubt, it is declared that subsection (1) (a) , (b) , (c) or (d) does not permit the NHMRC Licensing Committee to authorise any use of an excess ART embryo or other embryo that would result in the development of the embryo for a period of more than 14 days, excluding any period when development is suspended.\nAn application under subsection (1) —\nmust be made in accordance with the requirements (if any) specified in writing by the NHMRC Licensing Committee; and\nmust be accompanied by the fee (if any) prescribed under a regulation.\ns 28 amd 2007 No. 45 s 14\n(sec.28-ssec.1) A person may apply to the NHMRC Licensing Committee for a licence authorising one or more of the following— use of excess ART embryos; creation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos; creation of human embryos other than by fertilisation of a human egg by a human sperm that contain genetic material provided by more than 2 persons, and use of such embryos; creation of human embryos using precursor cells from a human embryo or a human fetus, and use of such embryos; research and training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART; creation of hybrid embryos by the fertilisation of an animal egg by a human sperm, and use of such embryos up to, but not including, the first mitotic division, if— the creation or use is for the purposes of testing sperm quality; and the creation or use will occur in an accredited ART centre.\n(sec.28-ssec.1A) To avoid any doubt, it is declared that subsection (1) (a) , (b) , (c) or (d) does not permit the NHMRC Licensing Committee to authorise any use of an excess ART embryo or other embryo that would result in the development of the embryo for a period of more than 14 days, excluding any period when development is suspended.\n(sec.28-ssec.2) An application under subsection (1) — must be made in accordance with the requirements (if any) specified in writing by the NHMRC Licensing Committee; and must be accompanied by the fee (if any) prescribed under a regulation.\n- (a) use of excess ART embryos;\n- (b) creation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos;\n- (c) creation of human embryos other than by fertilisation of a human egg by a human sperm that contain genetic material provided by more than 2 persons, and use of such embryos;\n- (d) creation of human embryos using precursor cells from a human embryo or a human fetus, and use of such embryos;\n- (e) research and training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART;\n- (f) creation of hybrid embryos by the fertilisation of an animal egg by a human sperm, and use of such embryos up to, but not including, the first mitotic division, if— (i) the creation or use is for the purposes of testing sperm quality; and (ii) the creation or use will occur in an accredited ART centre.\n- (i) the creation or use is for the purposes of testing sperm quality; and\n- (ii) the creation or use will occur in an accredited ART centre.\n- (i) the creation or use is for the purposes of testing sperm quality; and\n- (ii) the creation or use will occur in an accredited ART centre.\n- (a) must be made in accordance with the requirements (if any) specified in writing by the NHMRC Licensing Committee; and\n- (b) must be accompanied by the fee (if any) prescribed under a regulation.","sortOrder":40},{"sectionNumber":"sec.29","sectionType":"section","heading":"Determination of application by committee","content":"### sec.29 Determination of application by committee\n\nThis section applies if a person has made an application under section 28 for a licence.\nThe NHMRC Licensing Committee must decide, in accordance with this section, whether or not to issue the licence.\nThe NHMRC Licensing Committee must not issue the licence unless it is satisfied of the following—\nthat appropriate protocols are in place—\nto enable proper consent to be obtained before an excess ART embryo or human egg is used, or other embryo is created or used under the licence (see section 32 (1) (a) ); and\nto enable compliance with any restrictions on such consent;\nthat the activity or project proposed in the application has been assessed and approved by a HREC that is constituted in accordance with, and acting in compliance with, the NHMRC National Statement on Ethical Conduct in Research Involving Humans (1999), as in force from time to time.\nIn deciding whether to issue the licence, the NHMRC Licensing Committee must have regard to the following—\nrestricting the number of excess ART embryos, other embryos or human eggs, to that likely to be necessary to achieve the goals of the activity or project proposed in the application;\nthe likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means;\nany relevant guidelines, or relevant parts of guidelines, issued by the NHMRC under the National Health and Medical Research Council Act 1992 (Cwlth) and prescribed under a regulation for the purposes of this paragraph;\nthe HREC assessment of the application mentioned in subsection (3) (c) ;\nsuch additional matters (if any) as are prescribed by a regulation.\ns 29 amd 2003 No. 7 s 55 (1) ; 2007 No. 45 s 15\n(sec.29-ssec.1) This section applies if a person has made an application under section 28 for a licence.\n(sec.29-ssec.2) The NHMRC Licensing Committee must decide, in accordance with this section, whether or not to issue the licence.\n(sec.29-ssec.3) The NHMRC Licensing Committee must not issue the licence unless it is satisfied of the following— that appropriate protocols are in place— to enable proper consent to be obtained before an excess ART embryo or human egg is used, or other embryo is created or used under the licence (see section 32 (1) (a) ); and to enable compliance with any restrictions on such consent; that the activity or project proposed in the application has been assessed and approved by a HREC that is constituted in accordance with, and acting in compliance with, the NHMRC National Statement on Ethical Conduct in Research Involving Humans (1999), as in force from time to time.\n(sec.29-ssec.4) In deciding whether to issue the licence, the NHMRC Licensing Committee must have regard to the following— restricting the number of excess ART embryos, other embryos or human eggs, to that likely to be necessary to achieve the goals of the activity or project proposed in the application; the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means; any relevant guidelines, or relevant parts of guidelines, issued by the NHMRC under the National Health and Medical Research Council Act 1992 (Cwlth) and prescribed under a regulation for the purposes of this paragraph; the HREC assessment of the application mentioned in subsection (3) (c) ; such additional matters (if any) as are prescribed by a regulation.\n- (a) that appropriate protocols are in place— (i) to enable proper consent to be obtained before an excess ART embryo or human egg is used, or other embryo is created or used under the licence (see section 32 (1) (a) ); and (ii) to enable compliance with any restrictions on such consent;\n- (i) to enable proper consent to be obtained before an excess ART embryo or human egg is used, or other embryo is created or used under the licence (see section 32 (1) (a) ); and\n- (ii) to enable compliance with any restrictions on such consent;\n- (c) that the activity or project proposed in the application has been assessed and approved by a HREC that is constituted in accordance with, and acting in compliance with, the NHMRC National Statement on Ethical Conduct in Research Involving Humans (1999), as in force from time to time.\n- (i) to enable proper consent to be obtained before an excess ART embryo or human egg is used, or other embryo is created or used under the licence (see section 32 (1) (a) ); and\n- (ii) to enable compliance with any restrictions on such consent;\n- (a) restricting the number of excess ART embryos, other embryos or human eggs, to that likely to be necessary to achieve the goals of the activity or project proposed in the application;\n- (b) the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means;\n- (c) any relevant guidelines, or relevant parts of guidelines, issued by the NHMRC under the National Health and Medical Research Council Act 1992 (Cwlth) and prescribed under a regulation for the purposes of this paragraph;\n- (d) the HREC assessment of the application mentioned in subsection (3) (c) ;\n- (e) such additional matters (if any) as are prescribed by a regulation.","sortOrder":41},{"sectionNumber":"sec.30","sectionType":"section","heading":"Notification of decision","content":"### sec.30 Notification of decision\n\nThe NHMRC Licensing Committee must notify its decision on an application for a licence under section 28 to the following—\nthe applicant;\nthe HREC that assessed and approved the activity or project proposed in the application as mentioned in section 29 (3) (c) ;\nthe relevant State body.\nIf the NHMRC Licensing Committee decides to issue the licence, it must, in addition to issuing the licence to the applicant, give a copy of the licence to the bodies mentioned in subsection (1) (b) and (c) .\n(sec.30-ssec.1) The NHMRC Licensing Committee must notify its decision on an application for a licence under section 28 to the following— the applicant; the HREC that assessed and approved the activity or project proposed in the application as mentioned in section 29 (3) (c) ; the relevant State body.\n(sec.30-ssec.2) If the NHMRC Licensing Committee decides to issue the licence, it must, in addition to issuing the licence to the applicant, give a copy of the licence to the bodies mentioned in subsection (1) (b) and (c) .\n- (a) the applicant;\n- (b) the HREC that assessed and approved the activity or project proposed in the application as mentioned in section 29 (3) (c) ;\n- (c) the relevant State body.","sortOrder":42},{"sectionNumber":"sec.31","sectionType":"section","heading":"Period of licence","content":"### sec.31 Period of licence\n\nA licence—\ncomes into force on the day specified in the licence, or if no day is specified, on the day on which it is issued; and\nremains in force until the day specified in the licence, unless it is suspended, revoked or surrendered before that day.\nA licence is not in force throughout any period of suspension.\n(sec.31-ssec.1) A licence— comes into force on the day specified in the licence, or if no day is specified, on the day on which it is issued; and remains in force until the day specified in the licence, unless it is suspended, revoked or surrendered before that day.\n(sec.31-ssec.2) A licence is not in force throughout any period of suspension.\n- (a) comes into force on the day specified in the licence, or if no day is specified, on the day on which it is issued; and\n- (b) remains in force until the day specified in the licence, unless it is suspended, revoked or surrendered before that day.","sortOrder":43},{"sectionNumber":"sec.32","sectionType":"section","heading":"Licence is subject to conditions","content":"### sec.32 Licence is subject to conditions\n\nA licence is subject to the condition that before an excess ART embryo or human egg is used, or any other embryo is created or used, as authorised by the licence—\neach responsible person in relation to the excess ART embryo, human egg or other embryo must have given proper consent to that creation or use; and\nthe licence holder must have reported in writing to the NHMRC Licensing Committee that such consent has been obtained, and any restrictions to which the consent is subject.\nA licence is subject to the condition that the use of an excess ART embryo or human egg, or the creation or use of any other embryo, must be in accordance with any restrictions to which the proper consent under subsection (1) is subject.\nA licence is subject to such other conditions as are specified in the licence.\nThe conditions specified in the licence may include, but are not limited to, conditions relating to the following—\nthe persons authorised by the licence to use excess ART embryos or human eggs, or create or use other embryos;\nthe number of excess ART embryos or human eggs authorised to be used under the licence, or the number of other embryos authorised to be created or used under the licence;\nreporting;\nmonitoring;\ninformation to be given by the licence holder to persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos.\nThe licence conditions set out in subsections (1) and (2) apply to all persons who are authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos.\nLicence conditions specified in the licence apply to—\nthe licence holder; and\nsuch other persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos, as are specified in the licence.\nFor the purposes of applying the condition referred to in subsection (1) (a) —\na licence may provide that the guidelines referred to in the definition proper consent apply in a modified form in relation to the use, under the licence, of excess ART embryos that are unsuitable for implantation; and\nif a licence so provides, the guidelines as modified by the licence have effect in relation to the giving of consent for the use, under the licence, of the excess ART embryos.\nFor example, the guidelines could apply to a particular licence in a modified form, to alter the cooling-off period required in relation to the use of excess ART embryos that are unsuitable for implantation.\ns 32 amd 2003 No. 7 s 55 (2) ; 2007 No. 45 s 16\n(sec.32-ssec.1) A licence is subject to the condition that before an excess ART embryo or human egg is used, or any other embryo is created or used, as authorised by the licence— each responsible person in relation to the excess ART embryo, human egg or other embryo must have given proper consent to that creation or use; and the licence holder must have reported in writing to the NHMRC Licensing Committee that such consent has been obtained, and any restrictions to which the consent is subject.\n(sec.32-ssec.2) A licence is subject to the condition that the use of an excess ART embryo or human egg, or the creation or use of any other embryo, must be in accordance with any restrictions to which the proper consent under subsection (1) is subject.\n(sec.32-ssec.4) A licence is subject to such other conditions as are specified in the licence.\n(sec.32-ssec.5) The conditions specified in the licence may include, but are not limited to, conditions relating to the following— the persons authorised by the licence to use excess ART embryos or human eggs, or create or use other embryos; the number of excess ART embryos or human eggs authorised to be used under the licence, or the number of other embryos authorised to be created or used under the licence; reporting; monitoring; information to be given by the licence holder to persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos.\n(sec.32-ssec.6) The licence conditions set out in subsections (1) and (2) apply to all persons who are authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos.\n(sec.32-ssec.7) Licence conditions specified in the licence apply to— the licence holder; and such other persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos, as are specified in the licence.\n(sec.32-ssec.8) For the purposes of applying the condition referred to in subsection (1) (a) — a licence may provide that the guidelines referred to in the definition proper consent apply in a modified form in relation to the use, under the licence, of excess ART embryos that are unsuitable for implantation; and if a licence so provides, the guidelines as modified by the licence have effect in relation to the giving of consent for the use, under the licence, of the excess ART embryos. For example, the guidelines could apply to a particular licence in a modified form, to alter the cooling-off period required in relation to the use of excess ART embryos that are unsuitable for implantation.\n- (a) each responsible person in relation to the excess ART embryo, human egg or other embryo must have given proper consent to that creation or use; and\n- (b) the licence holder must have reported in writing to the NHMRC Licensing Committee that such consent has been obtained, and any restrictions to which the consent is subject.\n- (a) the persons authorised by the licence to use excess ART embryos or human eggs, or create or use other embryos;\n- (b) the number of excess ART embryos or human eggs authorised to be used under the licence, or the number of other embryos authorised to be created or used under the licence;\n- (c) reporting;\n- (d) monitoring;\n- (e) information to be given by the licence holder to persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos.\n- (a) the licence holder; and\n- (b) such other persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos, as are specified in the licence.\n- (a) a licence may provide that the guidelines referred to in the definition proper consent apply in a modified form in relation to the use, under the licence, of excess ART embryos that are unsuitable for implantation; and\n- (b) if a licence so provides, the guidelines as modified by the licence have effect in relation to the giving of consent for the use, under the licence, of the excess ART embryos. Note— For example, the guidelines could apply to a particular licence in a modified form, to alter the cooling-off period required in relation to the use of excess ART embryos that are unsuitable for implantation.","sortOrder":44},{"sectionNumber":"sec.33","sectionType":"section","heading":"Variation of licence","content":"### sec.33 Variation of licence\n\nThe NHMRC Licensing Committee may, by notice in writing given to the licence holder, vary a licence if the committee believes on reasonable grounds that it is necessary or desirable to do so.\nThe NHMRC Licensing Committee may vary a licence under subsection (1) on its own initiative or on application by the licence holder.\nWithout limiting subsection (1) , the NHMRC Licensing Committee may vary the licence by specifying additional conditions or varying existing conditions.\nThe NHMRC Licensing Committee must not vary a licence in such a way that, had a person applied under section 28 for the licence as varied, the committee would not have been permitted by this part to issue the licence.\n(sec.33-ssec.1) The NHMRC Licensing Committee may, by notice in writing given to the licence holder, vary a licence if the committee believes on reasonable grounds that it is necessary or desirable to do so.\n(sec.33-ssec.2) The NHMRC Licensing Committee may vary a licence under subsection (1) on its own initiative or on application by the licence holder.\n(sec.33-ssec.3) Without limiting subsection (1) , the NHMRC Licensing Committee may vary the licence by specifying additional conditions or varying existing conditions.\n(sec.33-ssec.4) The NHMRC Licensing Committee must not vary a licence in such a way that, had a person applied under section 28 for the licence as varied, the committee would not have been permitted by this part to issue the licence.","sortOrder":45},{"sectionNumber":"sec.34","sectionType":"section","heading":"Suspension or revocation of licence","content":"### sec.34 Suspension or revocation of licence\n\nThe NHMRC Licensing Committee may, by notice in writing given to the licence holder, suspend or revoke a licence if the committee believes on reasonable grounds that a condition of the licence has been breached.\nIf a licence holder is convicted of an offence under this Act, the NHMRC Licensing Committee must, by notice in writing given to the licence holder, revoke each licence held by the licence holder.\n(sec.34-ssec.1) The NHMRC Licensing Committee may, by notice in writing given to the licence holder, suspend or revoke a licence if the committee believes on reasonable grounds that a condition of the licence has been breached.\n(sec.34-ssec.2) If a licence holder is convicted of an offence under this Act, the NHMRC Licensing Committee must, by notice in writing given to the licence holder, revoke each licence held by the licence holder.","sortOrder":46},{"sectionNumber":"sec.35","sectionType":"section","heading":"Surrender of licence","content":"### sec.35 Surrender of licence\n\nA licence holder may surrender a licence by written notice given to the NHMRC Licensing Committee.","sortOrder":47},{"sectionNumber":"sec.36","sectionType":"section","heading":"Notification of variation, suspension or revocation of licence","content":"### sec.36 Notification of variation, suspension or revocation of licence\n\nIf the NHMRC Licensing Committee varies, suspends or revokes a licence, the committee must notify—\nthe licence holder; and\nthe HREC and the relevant State body.\nThe NHMRC Licensing Committee must also notify the bodies mentioned in subsection (1) (b) if a licence is surrendered.\n(sec.36-ssec.1) If the NHMRC Licensing Committee varies, suspends or revokes a licence, the committee must notify— the licence holder; and the HREC and the relevant State body.\n(sec.36-ssec.2) The NHMRC Licensing Committee must also notify the bodies mentioned in subsection (1) (b) if a licence is surrendered.\n- (a) the licence holder; and\n- (b) the HREC and the relevant State body.","sortOrder":48},{"sectionNumber":"pt.3-div.5","sectionType":"division","heading":"Reporting and confidentiality","content":"## Reporting and confidentiality","sortOrder":49},{"sectionNumber":"sec.37","sectionType":"section","heading":"NHMRC Licensing Committee to make certain information publicly available","content":"### sec.37 NHMRC Licensing Committee to make certain information publicly available\n\nThe NHMRC Licensing Committee must maintain a database containing the following information in relation to each licence (including a licence as varied)—\nthe name of the person to whom the licence was issued;\na short statement about the nature of the uses of excess ART embryos or human eggs, or creation or uses of other embryos, that are authorised by the licence;\nany conditions to which the licence is subject;\nthe number of ART embryos or human eggs authorised to be used under the licence, and the number of other embryos authorised to be created or used under the licence;\nthe date on which the licence was issued;\nthe period throughout which the licence is to remain in force.\nThe database is to be made publicly available.\nThe database may be kept and made publicly available in electronic form.\nInformation mentioned in subsection (1) must not be such as to disclose confidential commercial information.\nThe database may form part of the database maintained by the NHMRC Licensing Committee under the Commonwealth Act, section 29 .\ns 37 amd 2007 No. 45 s 17\n(sec.37-ssec.1) The NHMRC Licensing Committee must maintain a database containing the following information in relation to each licence (including a licence as varied)— the name of the person to whom the licence was issued; a short statement about the nature of the uses of excess ART embryos or human eggs, or creation or uses of other embryos, that are authorised by the licence; any conditions to which the licence is subject; the number of ART embryos or human eggs authorised to be used under the licence, and the number of other embryos authorised to be created or used under the licence; the date on which the licence was issued; the period throughout which the licence is to remain in force.\n(sec.37-ssec.2) The database is to be made publicly available.\n(sec.37-ssec.3) The database may be kept and made publicly available in electronic form.\n(sec.37-ssec.4) Information mentioned in subsection (1) must not be such as to disclose confidential commercial information.\n(sec.37-ssec.5) The database may form part of the database maintained by the NHMRC Licensing Committee under the Commonwealth Act, section 29 .\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 embryos or human eggs, or creation or uses of other embryos, that 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 used under the licence, and the number of other embryos authorised to be created or used under the licence;\n- (e) the date on which the licence was issued;\n- (f) the period throughout which the licence is to remain in force.","sortOrder":50},{"sectionNumber":"sec.38","sectionType":"section","heading":"Confidential commercial information may only be disclosed in certain circumstances","content":"### sec.38 Confidential commercial information may only be disclosed in certain circumstances\n\nA person commits an offence if—\nthe person discloses confidential commercial information that the person has only because of performing duties or functions under this part, or under this part and the Commonwealth Act; and\nthe person knows that the information is confidential commercial information; and\nthe disclosure is not made—\nfor the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or\nby order of a court; or\nwith the consent of each person to whom the information has a commercial or other value.\nMaximum penalty—2 years imprisonment.\nA person commits an offence if—\nthe person discloses confidential commercial information that the person has only because of a disclosure permitted under subsection (1) or this subsection; and\nthe person knows that the information is confidential commercial information; and\nthe disclosure is not made—\nfor the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or\nby order of a court; or\nwith the consent of each person to whom the information has a commercial or other value.\nMaximum penalty—2 years imprisonment.\nIn this section—\ncourt includes a tribunal, authority or person having power to require the production of documents or the answering of questions.\nState agency means the following—\na State;\na Minister of a State;\na department or a department of Government of another State;\nan instrumentality of a State, including a body corporate established for a public purpose under a law of a State;\na company in which a controlling interest is held by any 1 of the following persons, or by 2 or more of the following persons together—\na State;\na Minister of a State, or a State instrumentality mentioned in paragraph (d) ;\na person or body covered by subparagraph (i) or (ii) .\n(sec.38-ssec.1) A person commits an offence if— the person discloses confidential commercial information that the person has only because of performing duties or functions under this part, or under this part and the Commonwealth Act; and the person knows that the information is confidential commercial information; and the disclosure is not made— for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or by order of a court; or with the consent of each person to whom the information has a commercial or other value. Maximum penalty—2 years imprisonment.\n(sec.38-ssec.2) A person commits an offence if— the person discloses confidential commercial information that the person has only because of a disclosure permitted under subsection (1) or this subsection; and the person knows that the information is confidential commercial information; and the disclosure is not made— for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or by order of a court; or with the consent of each person to whom the information has a commercial or other value. Maximum penalty—2 years imprisonment.\n(sec.38-ssec.3) In this section— court includes a tribunal, authority or person having power to require the production of documents or the answering of questions. State agency means the following— a State; a Minister of a State; a department or a department of Government of another State; an instrumentality of a State, including a body corporate established for a public purpose under a law of a State; a company in which a controlling interest is held by any 1 of the following persons, or by 2 or more of the following persons together— a State; a Minister of a State, or a State instrumentality mentioned in paragraph (d) ; a person or body covered by subparagraph (i) or (ii) .\n- (a) the person discloses confidential commercial information that the person has only because of performing duties or functions under this part, or under this part and the Commonwealth Act; and\n- (b) the person knows that the information is confidential commercial information; and\n- (c) the disclosure is not made— (i) for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or (ii) by order of a court; or (iii) with the consent of each person to whom the information has a commercial or other value.\n- (i) for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or\n- (ii) by order of a court; or\n- (iii) with the consent of each person to whom the information has a commercial or other value.\n- (i) for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or\n- (ii) by order of a court; or\n- (iii) with the consent of each person to whom the information has a commercial or other value.\n- (a) the person discloses confidential commercial information that the person has only because of a disclosure permitted under subsection (1) or this subsection; and\n- (b) the person knows that the information is confidential commercial information; and\n- (c) the disclosure is not made— (i) for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or (ii) by order of a court; or (iii) with the consent of each person to whom the information has a commercial or other value.\n- (i) for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or\n- (ii) by order of a court; or\n- (iii) with the consent of each person to whom the information has a commercial or other value.\n- (i) for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or\n- (ii) by order of a court; or\n- (iii) with the consent of each person to whom the information has a commercial or other value.\n- (a) a State;\n- (b) a Minister of a State;\n- (c) a department or a department of Government of another State;\n- (d) an instrumentality of a State, including a body corporate established for a public purpose under a law of a State;\n- (e) a company in which a controlling interest is held by any 1 of the following persons, or by 2 or more of the following persons together— (i) a State; (ii) a Minister of a State, or a State instrumentality mentioned in paragraph (d) ; (iii) a person or body covered by subparagraph (i) or (ii) .\n- (i) a State;\n- (ii) a Minister of a State, or a State instrumentality mentioned in paragraph (d) ;\n- (iii) a person or body covered by subparagraph (i) or (ii) .\n- (i) a State;\n- (ii) a Minister of a State, or a State instrumentality mentioned in paragraph (d) ;\n- (iii) a person or body covered by subparagraph (i) or (ii) .","sortOrder":51},{"sectionNumber":"pt.3-div.6","sectionType":"division","heading":"Review provisions","content":"## Review provisions","sortOrder":52},{"sectionNumber":"sec.39","sectionType":"section","heading":"Definitions for div 6","content":"### sec.39 Definitions for div 6\n\nIn this division—\nAdministrative Appeals Tribunal ...\ns 39 def Administrative Appeals Tribunal om 2024 No. 47 s 78 sch 2\nAdministrative Review Tribunal means the Administrative Review Tribunal established by the Administrative Review Tribunal Act 2024 (Cwlth) .\ns 39 def Administrative Review Tribunal ins 2024 No. 47 s 78 sch 2\ndecision has the same meaning as in the Administrative Review Tribunal Act 2024 (Cwlth) .\ns 39 def decision amd 2024 No. 47 s 78 sch 2\neligible person , in relation to a decision of the NHMRC Licensing Committee, means—\nin relation to a decision under section 29 not to issue a licence—the applicant for the licence; or\nin relation to a decision in respect of the period throughout which the licence is to be in force under section 31 —the licence holder; or\nin relation to a decision to specify a licence condition under section 32 (4) —the licence holder; or\nin relation to a decision to modify guidelines under section 32 (8) in respect of a licence—the licence holder; or\nin relation to a decision to vary or refuse to vary a licence under section 33 —the licence holder; or\nin relation to a decision to suspend or revoke a licence under section 34 —the person who was the licence holder immediately before the suspension or revocation.\ns 39 def eligible person amd 2007 No. 45 s 18 (2)\ns 39 amd 2007 No. 45 s 18 (1)\n- (a) in relation to a decision under section 29 not to issue a licence—the applicant for the licence; or\n- (b) in relation to a decision in respect of the period throughout which the licence is to be in force under section 31 —the licence holder; or\n- (c) in relation to a decision to specify a licence condition under section 32 (4) —the licence holder; or\n- (ca) in relation to a decision to modify guidelines under section 32 (8) in respect of a licence—the licence holder; or\n- (d) in relation to a decision to vary or refuse to vary a licence under section 33 —the licence holder; or\n- (e) in relation to a decision to suspend or revoke a licence under section 34 —the person who was the licence holder immediately before the suspension or revocation.","sortOrder":53},{"sectionNumber":"sec.40","sectionType":"section","heading":"Review of decisions","content":"### sec.40 Review of decisions\n\nAn eligible person may apply to the Administrative Review Tribunal for review of any of the following decisions of the NHMRC Licensing Committee if the decision is declared by the regulations made under the Commonwealth Act to be a reviewable State decision for the purposes of section 45 of that Act—\na decision under section 29 not to issue a licence;\na decision in respect of the period throughout which the licence is to be in force under section 31 ;\na decision to specify a licence condition under section 32 (4) ;\na decision to modify guidelines under section 32 (8) in respect of a licence;\na decision to vary or refuse to vary a licence under section 33 ;\na decision to suspend or revoke a licence under section 34 .\nThis section has effect subject to the Administrative Review Tribunal Act 2024 (Cwlth) .\nThe Administrative Review Tribunal Act 2024 (Cwlth) , other than part 7 , and the regulations in force under that Act apply as laws of the State for the review of a decision under subsection (1) .\nFor this section, a reference in a provision of the Administrative Review Tribunal Act 2024 (Cwlth) , as the provision applies as a law of this State, to the whole or part of part 7 of that Act is taken to be a reference to the whole or part of that part as it has effect as a law of the Commonwealth.\ns 40 amd 2007 No. 45 s 19 ; 2024 No. 47 s 78 sch 2\n(sec.40-ssec.1) An eligible person may apply to the Administrative Review Tribunal for review of any of the following decisions of the NHMRC Licensing Committee if the decision is declared by the regulations made under the Commonwealth Act to be a reviewable State decision for the purposes of section 45 of that Act— a decision under section 29 not to issue a licence; a decision in respect of the period throughout which the licence is to be in force under section 31 ; a decision to specify a licence condition under section 32 (4) ; a decision to modify guidelines under section 32 (8) in respect of a licence; a decision to vary or refuse to vary a licence under section 33 ; a decision to suspend or revoke a licence under section 34 .\n(sec.40-ssec.2) This section has effect subject to the Administrative Review Tribunal Act 2024 (Cwlth) .\n(sec.40-ssec.3) The Administrative Review Tribunal Act 2024 (Cwlth) , other than part 7 , and the regulations in force under that Act apply as laws of the State for the review of a decision under subsection (1) .\n(sec.40-ssec.4) For this section, a reference in a provision of the Administrative Review Tribunal Act 2024 (Cwlth) , as the provision applies as a law of this State, to the whole or part of part 7 of that Act is taken to be a reference to the whole or part of that part as it has effect as a law of the Commonwealth.\n- (a) a decision under section 29 not to issue a licence;\n- (b) a decision in respect of the period throughout which the licence is to be in force under section 31 ;\n- (c) a decision to specify a licence condition under section 32 (4) ;\n- (ca) a decision to modify guidelines under section 32 (8) in respect of a licence;\n- (d) a decision to vary or refuse to vary a licence under section 33 ;\n- (e) a decision to suspend or revoke a licence under section 34 .","sortOrder":54},{"sectionNumber":"pt.4","sectionType":"part","heading":"Monitoring powers","content":"# Monitoring powers","sortOrder":55},{"sectionNumber":"sec.41","sectionType":"section","heading":"Appointment of inspectors","content":"### sec.41 Appointment of inspectors\n\nThe chairperson of the NHMRC Licensing Committee may, by instrument in writing, appoint any of the following persons as inspectors—\na person who is appointed or employed by the State;\na person who is appointed or employed by the Commonwealth.\nIn exercising powers or performing functions as an inspector, an inspector must comply with any directions of the chairperson of the NHMRC Licensing Committee.\nThe chairperson of the NHMRC Licensing Committee must not appoint a person as an inspector under subsection (1) unless he or she is satisfied that the person has appropriate skills and experience.\n(sec.41-ssec.1) The chairperson of the NHMRC Licensing Committee may, by instrument in writing, appoint any of the following persons as inspectors— a person who is appointed or employed by the State; a person who is appointed or employed by the Commonwealth.\n(sec.41-ssec.2) In exercising powers or performing functions as an inspector, an inspector must comply with any directions of the chairperson of the NHMRC Licensing Committee.\n(sec.41-ssec.3) The chairperson of the NHMRC Licensing Committee must not appoint a person as an inspector under subsection (1) unless he or she is satisfied that the person has appropriate skills and experience.\n- (a) a person who is appointed or employed by the State;\n- (b) a person who is appointed or employed by the Commonwealth.","sortOrder":56},{"sectionNumber":"sec.42","sectionType":"section","heading":"Identity card","content":"### sec.42 Identity card\n\nThe chairperson of the NHMRC Licensing Committee must issue an identity card to an inspector.\nThe identity card—\nmust be in the form prescribed by the regulations under the Commonwealth Act; and\nmust contain a recent photograph of the inspector.\nIf a person to whom an identity card has been issued ceases to be an inspector, the person must return the identity card to the chairperson of the NHMRC Licensing Committee as soon as practicable.\nMaximum penalty—1 penalty unit.\nAn inspector must carry his or her identity card at all times when exercising powers or performing functions as an inspector.\n(sec.42-ssec.1) The chairperson of the NHMRC Licensing Committee must issue an identity card to an inspector.\n(sec.42-ssec.2) The identity card— must be in the form prescribed by the regulations under the Commonwealth Act; and must contain a recent photograph of the inspector.\n(sec.42-ssec.3) If a person to whom an identity card has been issued ceases to be an inspector, the person must return the identity card to the chairperson of the NHMRC Licensing Committee as soon as practicable. Maximum penalty—1 penalty unit.\n(sec.42-ssec.4) An inspector must carry his or her identity card at all times when exercising powers or performing functions as an inspector.\n- (a) must be in the form prescribed by the regulations under the Commonwealth Act; and\n- (b) must contain a recent photograph of the inspector.","sortOrder":57},{"sectionNumber":"sec.43","sectionType":"section","heading":"Powers available to inspectors for monitoring compliance","content":"### sec.43 Powers available to inspectors for monitoring compliance\n\nFor the purpose of finding out whether this Act has been complied with, an inspector may—\nenter any premises; and\nexercise the monitoring powers set out in section 44 .\nAn inspector is not authorised to enter premises under subsection (1) unless—\nthe occupier of the premises has consented to the entry; or\nthe premises are premises at which the occupier of the premises is carrying out activities authorised by a licence issued under section 29 , and the entry is at a reasonable time; or\nthe entry is made under a warrant under section 45A .\ns 43 amd 2007 No. 45 s 20\n(sec.43-ssec.1) For the purpose of finding out whether this Act has been complied with, an inspector may— enter any premises; and exercise the monitoring powers set out in section 44 .\n(sec.43-ssec.2) An inspector is not authorised to enter premises under subsection (1) unless— the occupier of the premises has consented to the entry; or the premises are premises at which the occupier of the premises is carrying out activities authorised by a licence issued under section 29 , and the entry is at a reasonable time; or the entry is made under a warrant under section 45A .\n- (a) enter any premises; and\n- (b) exercise the monitoring powers set out in section 44 .\n- (a) the occupier of the premises has consented to the entry; or\n- (b) the premises are premises at which the occupier of the premises is carrying out activities authorised by a licence issued under section 29 , and the entry is at a reasonable time; or\n- (c) the entry is made under a warrant under section 45A .","sortOrder":58},{"sectionNumber":"sec.44","sectionType":"section","heading":"Monitoring powers","content":"### sec.44 Monitoring powers\n\nThe monitoring powers that an inspector may exercise under section 43 (1) (b) are as follows—\nto search the premises and any thing on the premises;\nto inspect, examine, take measurements of, conduct tests on, or take samples of, any human embryo, other embryo, human egg or thing on the premises that relates to this Act;\nto take photographs, make video or audio recordings or make sketches of the premises or any thing on the premises;\nto inspect any book, record or document on the premises;\nto take extracts from or make copies of any such book, record or document;\nto take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises;\nin addition to the powers mentioned in paragraphs (a) to (f) , if the inspector was authorised to enter the premises by a warrant under section 45A —to require any person in or on the premises to—\nanswer any questions put by the inspector; and\nproduce any book, record or document requested by the inspector.\nFor the purposes of this part, monitoring powers include the power to operate equipment at premises to see whether—\nthe equipment; or\na disk, tape or other storage device that—\nis at the premises; and\ncan be used with the equipment or is associated with it;\ncontains information that is relevant to determining whether there has been compliance with this Act.\nIf the inspector, after operating equipment at the premises, finds that the equipment, or that a tape, disk or other storage device at the premises, contains information mentioned in subsection (2) , the inspector may—\noperate equipment or facilities at the premises to put the information in documentary form and copy the document so produced; or\nif the information can be transferred to a tape, disk or other storage device that—\nis brought to the premises; or\nis at the premises and the use of which has been agreed to in writing by the occupier of the premises;\noperate the equipment or other facilities to copy the information to the storage device, and remove the storage device from the premises.\ns 44 amd 2007 No. 45 s 21\n(sec.44-ssec.1) The monitoring powers that an inspector may exercise under section 43 (1) (b) are as follows— to search the premises and any thing on the premises; to inspect, examine, take measurements of, conduct tests on, or take samples of, any human embryo, other embryo, human egg or thing on the premises that relates to this Act; to take photographs, make video or audio recordings or make sketches of the premises or any thing on the premises; to inspect any book, record or document on the premises; to take extracts from or make copies of any such book, record or document; to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises; in addition to the powers mentioned in paragraphs (a) to (f) , if the inspector was authorised to enter the premises by a warrant under section 45A —to require any person in or on the premises to— answer any questions put by the inspector; and produce any book, record or document requested by the inspector.\n(sec.44-ssec.2) For the purposes of this part, monitoring powers include the power to operate equipment at premises to see whether— the equipment; or a disk, tape or other storage device that— is at the premises; and can be used with the equipment or is associated with it; contains information that is relevant to determining whether there has been compliance with this Act.\n(sec.44-ssec.3) If the inspector, after operating equipment at the premises, finds that the equipment, or that a tape, disk or other storage device at the premises, contains information mentioned in subsection (2) , the inspector may— operate equipment or facilities at the premises to put the information in documentary form and copy the document so produced; or if the information can be transferred to a tape, disk or other storage device that— is brought to the premises; or is at the premises and the use of which has been agreed to in writing by the occupier of the premises; operate the equipment or other facilities to copy the information to the storage device, and remove the storage device from the premises.\n- (a) to search the premises and any thing on the premises;\n- (b) to inspect, examine, take measurements of, conduct tests on, or take samples of, any human embryo, other embryo, human egg or thing on the premises that relates to this Act;\n- (c) to take photographs, make video or audio recordings or make sketches of the premises or any thing on the premises;\n- (d) to inspect any book, record or document on the premises;\n- (e) to take extracts from or make copies of any such book, record or document;\n- (f) to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises;\n- (g) in addition to the powers mentioned in paragraphs (a) to (f) , if the inspector was authorised to enter the premises by a warrant under section 45A —to require any person in or on the premises to— (i) answer any questions put by the inspector; and (ii) produce any book, record or document requested by the inspector.\n- (i) answer any questions put by the inspector; and\n- (ii) produce any book, record or document requested by the inspector.\n- (i) answer any questions put by the inspector; and\n- (ii) produce any book, record or document requested by the inspector.\n- (a) the equipment; or\n- (b) a disk, tape or other storage device that— (i) is at the premises; and (ii) can be used with the equipment or is associated with it;\n- (i) is at the premises; and\n- (ii) can be used with the equipment or is associated with it;\n- (i) is at the premises; and\n- (ii) can be used with the equipment or is associated with it;\n- (a) operate equipment or facilities at the premises to put the information in documentary form and copy the document so produced; or\n- (b) if the information can be transferred to a tape, disk or other storage device that— (i) is brought to the premises; or (ii) is at the premises and the use of which has been agreed to in writing by the occupier of the premises; operate the equipment or other facilities to copy the information to the storage device, and remove the storage device from the premises.\n- (i) is brought to the premises; or\n- (ii) is at the premises and the use of which has been agreed to in writing by the occupier of the premises;\n- (i) is brought to the premises; or\n- (ii) is at the premises and the use of which has been agreed to in writing by the occupier of the premises;","sortOrder":59},{"sectionNumber":"sec.45","sectionType":"section","heading":"Power to secure","content":"### sec.45 Power to secure\n\nIf an inspector, during a search of premises, believes on reasonable grounds that there is at the premises a human embryo, another embryo, a human egg or a thing that may afford evidence of the commission of an offence against this Act, the monitoring powers include securing the embryo, the egg or the thing pending the obtaining of a warrant by anyone to seize it.\ns 45 amd 2007 No. 45 s 22","sortOrder":60},{"sectionNumber":"sec.45A","sectionType":"section","heading":"Monitoring warrants","content":"### sec.45A Monitoring warrants\n\nAn inspector may apply to a magistrate for a warrant under this section in relation to premises.\nSubject to subsection (3) , the magistrate may issue the warrant if the magistrate is satisfied by information on oath or affirmation that it is reasonably necessary that one or more inspectors should have access to the premises for the purpose of finding out whether this Act has been complied with.\nThe magistrate must not issue the warrant unless the inspector or some other person has given to the magistrate, either orally or by affidavit, such further information (if any) as the magistrate requires concerning the grounds on which the issue of the warrant is being sought.\nThe warrant must—\nauthorise one or more inspectors (whether or not named in the warrant) with such assistance and by such force as is necessary and reasonable—\nto enter the premises; and\nto exercise the powers set out in section 44 in relation to the premises; and\nstate whether the entry is authorised to be made at any time of the day or night or during specified hours of the day or night; and\nspecify the day (not more than 15 days after the issue of the warrant) on which the warrant ceases to have effect; and\nstate the purpose for which the warrant is issued.\ns 45A ins 2007 No. 45 s 23\n(sec.45A-ssec.1) An inspector may apply to a magistrate for a warrant under this section in relation to premises.\n(sec.45A-ssec.2) Subject to subsection (3) , the magistrate may issue the warrant if the magistrate is satisfied by information on oath or affirmation that it is reasonably necessary that one or more inspectors should have access to the premises for the purpose of finding out whether this Act has been complied with.\n(sec.45A-ssec.3) The magistrate must not issue the warrant unless the inspector or some other person has given to the magistrate, either orally or by affidavit, such further information (if any) as the magistrate requires concerning the grounds on which the issue of the warrant is being sought.\n(sec.45A-ssec.4) The warrant must— authorise one or more inspectors (whether or not named in the warrant) with such assistance and by such force as is necessary and reasonable— to enter the premises; and to exercise the powers set out in section 44 in relation to the premises; and state whether the entry is authorised to be made at any time of the day or night or during specified hours of the day or night; and specify the day (not more than 15 days after the issue of the warrant) on which the warrant ceases to have effect; and state the purpose for which the warrant is issued.\n- (a) authorise one or more inspectors (whether or not named in the warrant) with such assistance and by such force as is necessary and reasonable— (i) to enter the premises; and (ii) to exercise the powers set out in section 44 in relation to the premises; and\n- (i) to enter the premises; and\n- (ii) to exercise the powers set out in section 44 in relation to the premises; and\n- (b) state whether the entry is authorised to be made at any time of the day or night or during specified hours of the day or night; and\n- (c) specify the day (not more than 15 days after the issue of the warrant) on which the warrant ceases to have effect; and\n- (d) state the purpose for which the warrant is issued.\n- (i) to enter the premises; and\n- (ii) to exercise the powers set out in section 44 in relation to the premises; and","sortOrder":61},{"sectionNumber":"sec.45B","sectionType":"section","heading":"Details of warrant to be given to occupier etc.","content":"### sec.45B Details of warrant to be given to occupier etc.\n\nIf a warrant under section 45A is being executed and the occupier of the premises or another person who apparently represents the occupier is present at the premises, the inspector must make available to that person a copy of the warrant.\nThe inspector must identify himself or herself to that person.\nThe copy of the warrant referred to in subsection (1) need not include the signature of the magistrate who issued the warrant.\ns 45B ins 2007 No. 45 s 23\n(sec.45B-ssec.1) If a warrant under section 45A is being executed and the occupier of the premises or another person who apparently represents the occupier is present at the premises, the inspector must make available to that person a copy of the warrant.\n(sec.45B-ssec.2) The inspector must identify himself or herself to that person.\n(sec.45B-ssec.3) The copy of the warrant referred to in subsection (1) need not include the signature of the magistrate who issued the warrant.","sortOrder":62},{"sectionNumber":"sec.45C","sectionType":"section","heading":"Announcement before entry","content":"### sec.45C Announcement before entry\n\nAn inspector must, before entering premises under a warrant—\nannounce that he or she is authorised to enter the premises; and\ngive any person at the premises an opportunity to allow entry to the premises.\ns 45C ins 2007 No. 45 s 23\n- (a) announce that he or she is authorised to enter the premises; and\n- (b) give any person at the premises an opportunity to allow entry to the premises.","sortOrder":63},{"sectionNumber":"sec.45D","sectionType":"section","heading":"Occupier entitled to be present during search","content":"### sec.45D Occupier entitled to be present during search\n\nIf a warrant under section 45A is being executed and the occupier of the premises or another person who apparently represents the occupier is present at the premises, the person is entitled to observe the search being conducted.\nThe right to observe the search being conducted ceases if the person impedes the search.\nThis section does not prevent 2 or more areas of the premises being searched at the same time.\ns 45D ins 2007 No. 45 s 23\n(sec.45D-ssec.1) If a warrant under section 45A is being executed and the occupier of the premises or another person who apparently represents the occupier is present at the premises, the person is entitled to observe the search being conducted.\n(sec.45D-ssec.2) The right to observe the search being conducted ceases if the person impedes the search.\n(sec.45D-ssec.3) This section does not prevent 2 or more areas of the premises being searched at the same time.","sortOrder":64},{"sectionNumber":"sec.46","sectionType":"section","heading":"Inspector must produce identity card on request","content":"### sec.46 Inspector must produce identity card on request\n\nAn inspector is not entitled to exercise any powers under this part in relation to premises if—\nthe occupier of the premises has required the inspector to produce his or her identity card for inspection by the occupier; and\nthe inspector fails to comply with the requirement.\n- (a) the occupier of the premises has required the inspector to produce his or her identity card for inspection by the occupier; and\n- (b) the inspector fails to comply with the requirement.","sortOrder":65},{"sectionNumber":"sec.47","sectionType":"section","heading":"Consent","content":"### sec.47 Consent\n\nBefore obtaining the consent of a person for the purposes of section 43 (2) (a) , the inspector must inform the person that he or she may refuse consent.\nAn entry of an inspector by virtue of the consent of a person is not lawful unless the person voluntarily consented to the entry.\n(sec.47-ssec.1) Before obtaining the consent of a person for the purposes of section 43 (2) (a) , the inspector must inform the person that he or she may refuse consent.\n(sec.47-ssec.2) An entry of an inspector by virtue of the consent of a person is not lawful unless the person voluntarily consented to the entry.","sortOrder":66},{"sectionNumber":"sec.48","sectionType":"section","heading":"Compensation for damage","content":"### sec.48 Compensation for damage\n\nThe owner of equipment or other facilities is entitled to compensation for damage to the equipment or other facilities if—\nthe damage was caused to the equipment or other facilities as a result of it being operated by an inspector as mentioned in this part; and\nthe damage was caused as a result of insufficient care being exercised by the inspector operating the equipment or other facilities.\nIn determining the amount of compensation payable, regard is to be had to whether the occupier of the premises and his or her employees and agents, if they were available at the time, had provided any warning or guidance as to the operation of the equipment or other facilities that was appropriate in the circumstances.\n(sec.48-ssec.1) The owner of equipment or other facilities is entitled to compensation for damage to the equipment or other facilities if— the damage was caused to the equipment or other facilities as a result of it being operated by an inspector as mentioned in this part; and the damage was caused as a result of insufficient care being exercised by the inspector operating the equipment or other facilities.\n(sec.48-ssec.2) In determining the amount of compensation payable, regard is to be had to whether the occupier of the premises and his or her employees and agents, if they were available at the time, had provided any warning or guidance as to the operation of the equipment or other facilities that was appropriate in the circumstances.\n- (a) the damage was caused to the equipment or other facilities as a result of it being operated by an inspector as mentioned in this part; and\n- (b) the damage was caused as a result of insufficient care being exercised by the inspector operating the equipment or other facilities.","sortOrder":67},{"sectionNumber":"pt.5","sectionType":"part","heading":"Miscellaneous","content":"# Miscellaneous","sortOrder":68},{"sectionNumber":"pt.5-div.1","sectionType":"division","heading":"Review of Act","content":"## Review of Act","sortOrder":69},{"sectionNumber":"sec.49","sectionType":"section","heading":"Further review of operation of Act","content":"### sec.49 Further review of operation of Act\n\nThe Minister must cause a review of the operation of this Act as amended by the Research Involving Human Embryos and Prohibition of Human Cloning Amendment Act 2007 to be undertaken as soon as possible after the third anniversary of the day on which that Act commenced.\nThe review must cover the scope and operation of parts 2 and 3 taking into account the following—\ndevelopments in assisted reproductive technology, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research;\ndevelopments in embryonic stem cell research, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research;\ncommunity standards;\na brief analysis of international developments and legislation relating to the use of human embryos and related research;\nan analysis of research resulting from the licenses granted;\nan analysis of any research or clinical practice that has been prevented as a result of legislative restrictions.\nThe review may be undertaken as part of the reviews under the Commonwealth Act, section 47A and the Prohibition of Human Cloning for Reproduction Act 2002 (Cwlth) , section 25A .\ns 49 sub 2007 No. 45 s 24\n(sec.49-ssec.1) The Minister must cause a review of the operation of this Act as amended by the Research Involving Human Embryos and Prohibition of Human Cloning Amendment Act 2007 to be undertaken as soon as possible after the third anniversary of the day on which that Act commenced.\n(sec.49-ssec.2) The review must cover the scope and operation of parts 2 and 3 taking into account the following— developments in assisted reproductive technology, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research; developments in embryonic stem cell research, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research; community standards; a brief analysis of international developments and legislation relating to the use of human embryos and related research; an analysis of research resulting from the licenses granted; an analysis of any research or clinical practice that has been prevented as a result of legislative restrictions.\n(sec.49-ssec.3) The review may be undertaken as part of the reviews under the Commonwealth Act, section 47A and the Prohibition of Human Cloning for Reproduction Act 2002 (Cwlth) , section 25A .\n- (a) developments in assisted reproductive technology, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research;\n- (b) developments in embryonic stem cell research, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research;\n- (c) community standards;\n- (d) a brief analysis of international developments and legislation relating to the use of human embryos and related research;\n- (e) an analysis of research resulting from the licenses granted;\n- (f) an analysis of any research or clinical practice that has been prevented as a result of legislative restrictions.","sortOrder":70},{"sectionNumber":"pt.5-div.2","sectionType":"division","heading":"Matters about offences","content":"## Matters about offences","sortOrder":71},{"sectionNumber":"sec.50","sectionType":"section","heading":"Attempts to commit offences against this Act","content":"### sec.50 Attempts to commit offences against this Act\n\nA person who attempts to commit an offence against this Act commits an offence.\nMaximum penalty—the maximum penalty for committing the offence attempted to be committed.\nThe Criminal Code, section 4 , applies to subsection (1) .\n(sec.50-ssec.1) A person who attempts to commit an offence against this Act commits an offence. Maximum penalty—the maximum penalty for committing the offence attempted to be committed.\n(sec.50-ssec.2) The Criminal Code, section 4 , applies to subsection (1) .","sortOrder":72},{"sectionNumber":"sec.51","sectionType":"section","heading":"Crimes and summary offences","content":"### sec.51 Crimes and summary offences\n\nThe following offences are crimes—\nan offence mentioned in part 2 or in part 3 , division 2 ;\nan offence against section 50 (1) , if the offence attempted to be committed is a crime.\nThe offender can not be arrested without warrant.\nAny other offence against this Act is a summary offence.\n(sec.51-ssec.1) The following offences are crimes— an offence mentioned in part 2 or in part 3 , division 2 ; an offence against section 50 (1) , if the offence attempted to be committed is a crime.\n(sec.51-ssec.2) The offender can not be arrested without warrant.\n(sec.51-ssec.3) Any other offence against this Act is a summary offence.\n- (a) an offence mentioned in part 2 or in part 3 , division 2 ;\n- (b) an offence against section 50 (1) , if the offence attempted to be committed is a crime.","sortOrder":73},{"sectionNumber":"sec.52","sectionType":"section","heading":"Limitation on time for starting summary proceedings","content":"### sec.52 Limitation on time for starting summary proceedings\n\nA proceeding for a summary offence against this Act by way of summary proceeding under the Justices Act 1886 must start—\nwithin 1 year after the commission of the offence; or\nwithin 6 months after the offence comes to the complainant’s knowledge, but within 2 years after the commission of the offence.\n- (a) within 1 year after the commission of the offence; or\n- (b) within 6 months after the offence comes to the complainant’s knowledge, but within 2 years after the commission of the offence.","sortOrder":74},{"sectionNumber":"pt.5-div.3","sectionType":"division","heading":"Regulations","content":"## Regulations","sortOrder":75},{"sectionNumber":"sec.53","sectionType":"section","heading":"Regulation-making power","content":"### sec.53 Regulation-making power\n\nThe Governor in Council may make regulations under this Act.","sortOrder":76},{"sectionNumber":"pt.6","sectionType":"part","heading":"Saving provisions","content":"# Saving provisions","sortOrder":77},{"sectionNumber":"sec.54","sectionType":"section","heading":"Saving provision","content":"### sec.54 Saving provision\n\nIf—\nat any time before the commencement of this section, a person made an application under sub section 28 (1) for a licence; and\nimmediately before that commencement, the NHMRC Licensing Committee had not decided the application;\nthen the person is taken, on and from that commencement, to have applied for the licence under sub section 28 (1) of the amended Act.\nTo avoid any doubt, it is declared that a licence issued under section 29 that was in force immediately before the commencement of this section continues in force after that commencement.\nIn this section—\namended Act means this Act as amended by the Research Involving Human Embryos and Prohibition of Human Cloning Amendment Act 2007 .\ns 54 ins 2007 No. 45 s 25\n(sec.54-ssec.1) If— at any time before the commencement of this section, a person made an application under sub section 28 (1) for a licence; and immediately before that commencement, the NHMRC Licensing Committee had not decided the application; then the person is taken, on and from that commencement, to have applied for the licence under sub section 28 (1) of the amended Act.\n(sec.54-ssec.2) To avoid any doubt, it is declared that a licence issued under section 29 that was in force immediately before the commencement of this section continues in force after that commencement.\n(sec.54-ssec.3) In this section— amended Act means this Act as amended by the Research Involving Human Embryos and Prohibition of Human Cloning Amendment Act 2007 .\n- (a) at any time before the commencement of this section, a person made an application under sub section 28 (1) for a licence; and\n- (b) immediately before that commencement, the NHMRC Licensing Committee had not decided the application;","sortOrder":78}],"analysis":{"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":true,"description":"The Act as presented has expanded from a primarily prohibitory statute into a regulatory framework that permits narrowly specified research activities under licence. The original text (Research Involving Human Embryos and Prohibition of Human Cloning Act 2003) set strict prohibitions; subsequent amendments (noted in the text, e.g. 2007 insertions) added a licensing route (ss 28–34) allowing certain activities that were otherwise offences (creation/use of embryos by non‑fertilisation, use of precursor cells, creation/use of hybrid embryos in tightly circumscribed circumstances). The amendments therefore changed scope by converting some absolute prohibitions into conditional permissions subject to NHMRC committee approval, public reporting and inspector oversight (ss 28–37, 41–46). This change concentrates lawful research authority in licence-holders and the NHMRC Licensing Committee while retaining criminal sanctions for unlicensed activity (Parts 2 and 3)."},"complexity_factors":["Multiple high‑penalty criminal offences with overlapping definitions (Parts 2 and 3: ss 7–20A, 23–25) creating layered prohibitions and licence exceptions","Extensive defined terms and an external dictionary/schedule (s 5, ss 21–22) that feed into many substantive rules","Licensing regime with discretionary criteria and procedural steps (ss 28–29, 32) and licence lifecycle rules (ss 31–36)","Numerous cross-references to NHMRC guidelines, the Commonwealth Act and HREC requirements, linking federal, state and administrative rules (ss 21, 29, 37)","Nested exceptions and exemptions (e.g. exempt uses of excess ART embryos in s 23(2) and modified consent rules in s 32(8))","Detailed monitoring and enforcement powers including consent-based entry, warrant process, inspection powers and seizure (ss 41–46, 45A–45D)","Public database obligations balanced against confidentiality protections (ss 37–38) requiring factual line-drawing","Appeal/review pathway via Administrative Review Tribunal and regulatory designations of reviewable decisions (ss 39–40)","Multiple temporal and commencement provisions and amendment history embedded in text (s 2, ss 54, and amendment notes), increasing interpretive complexity","Interplay between criminal, regulatory and administrative sanctions (ss 50–51, penalties ranging from summary offences to 15 years imprisonment)"],"plain_english_summary":"**What this law does (mechanics)\n\n- Establishes a set of criminal prohibitions about creating, placing, trading in and developing certain kinds of embryos (including cloned, chimeric, hybrid embryos and embryos with heritable genomic changes). (see Parts 2 and 3 — e.g. ss 7–16, 11)\n- Keeps a bright legal line: many activities are automatically criminal unless a licence authorising that specific activity has been issued by the NHMRC Licensing Committee (s 18–20A, s 28). Licences can permit research uses that would otherwise be offences, but always subject to conditions (ss 28–34, 32). \n- Creates a licensing regime administered by the NHMRC Licensing Committee: who can apply, what the committee must be satisfied of before issuing a licence (consent protocols, Human Research Ethics Committee (HREC) approval), and what factors the committee must consider (s 28–29, s 32).\n- Limits embryo development outside a woman to no more than 14 days (s 10) and prohibits intentional placement of a human embryo clone into a human or animal (s 7).\n- Prohibits commercial trading in human eggs, sperm or embryos (payments beyond reasonable expenses are criminalised) (s 17).\n- Requires public publication of basic licence information in a database while protecting confidential commercial information (ss 37–38).\n- Provides monitoring, inspection and enforcement powers for inspectors (appointments, identity cards, entry with consent or warrant, search and seizure powers, ss 41–46, 45A–45D) and penalties for breaches (various sections provide maximum imprisonment terms up to 15 years for the most serious offences).\n\n**Who decides and who pays**\n\n- The NHMRC Licensing Committee decides who may lawfully do activities otherwise criminalised under the Act (ss 26–30). The committee sets licence conditions, can vary, suspend or revoke licences, and must notify applicants and certain state bodies of decisions (ss 29–36).\n- Applicants must follow procedural requirements and pay any fee prescribed by regulation to apply for a licence (s 28). Licence holders and authorised personnel must meet consent, reporting and record-keeping conditions (s 32).\n- Inspectors (appointed by the committee chair) and courts/magistrates enforce the law; penalties are borne by persons who contravene the Act (see particularly Part 2 and Part 3, Division 2 for offences and Part 4 for monitoring powers).\n\n**Who this affects in practice**\n\n- Assisted reproductive technology (ART) clinics and accredited ART centres (regulated entities; accreditation referenced in definitions, s 21).\n- Researchers and research institutions that work with embryos, human eggs, sperm or precursor cells.\n- People who provided gametes or embryos (\"responsible persons\") because their written consent is required before research use (ss 21, 22, 32).\n- Commercial actors: the Act removes the ability to buy or sell gametes/embryos beyond reimbursement of reasonable expenses (s 17).\n- Regulators and state bodies involved in accreditation and notification (s 21, s 30).\n\n**Why it matters (stated purpose and practical implications)\n\n- The Act's stated object is to address ethical concerns about scientific developments in human reproduction and embryo use by prohibiting certain practices and regulating others (s 3). Practically, it replaces a simple \"allowed/forbidden\" approach with a criminal prohibition backed by a licensing route for specified research uses.\n\n- Costs and compliance burden: the licensing, consent, HREC approval and reporting requirements create measurable compliance costs for clinics and researchers (ss 28–32). They must establish protocols, recordkeeping, and submit to inspections (ss 29, 32, 43–44).\n\n- Effects on private enterprise and markets: the prohibition on commercial trading in gametes/embryos (s 17) constrains any market for those biological materials; licences create exclusive legal authority to carry out activities that are otherwise crimes, concentrating direct lawful economic opportunity in license holders (ss 17, 28, 37).\n\n- Incentives and substitution effects: by criminalising a broad set of activities while permitting narrow, authorised research, the Act incentivises researchers to (a) seek licences; (b) pursue alternative non-embryo research methods where licensing is impractical; or (c) relocate research outside its jurisdiction where laws differ. The licensing requirement raises administrative and time costs that can delay projects (ss 28–31).\n\n- Bureaucratic discretion and implementation risk: the NHMRC Licensing Committee has broad judgment (s 29) about scientific merit, number of embryos authorised and consent protocols. That discretion requires robust internal procedures to ensure timely, consistent decisions and creates risk of uneven outcomes across applicants.\n\n- Enforcement and privacy trade-offs: public disclosure of licence-holder names and authorised activities (s 37) increases transparency but is limited by confidentiality protections (s 38). Inspections and warrant powers (ss 43–45A) expand enforcement reach and raise the need for clear operational safeguards.\n\n**Concrete constraints the Act imposes (examples with sections)**\n\n- 14-day embryo culture limit outside a woman (s 10).\n- Ban on placing a human embryo clone into a human or animal (s 7) and broad ban on placing embryos in animals or non-reproductive tracts (s 15–16).\n- Prohibition on creating embryos by fertilisation outside a woman unless intended to achieve pregnancy in a particular woman (s 8).\n- Prohibition on heritable genomic alterations (s 11).\n- Licensing regime for limited exceptions where research is authorised (ss 28–34). \n\n**Trade-offs and opportunity costs**\n\n- The Act centralises decision-making over ethically sensitive research in a licensing committee, which aims to enable targeted research while preventing practices the legislature prohibits. That centralisation reduces legal uncertainty for authorised projects but raises fixed compliance and administrative costs that may disadvantage smaller providers and increase the time-to-start for research projects (ss 28–29, 32).\n- The ban on commercial trading narrows contract freedom and removes a potential revenue stream for donors or intermediaries, potentially reducing supply of donated gametes/embryos and affecting clinic operations (s 17).\n\n(References: object and prohibitions – s 3, Parts 2 and 3: ss 7–20A, 23–25; licensing and conditions – ss 28–36; public database and confidentiality – ss 37–38; monitoring and enforcement – ss 41–48.)"},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"kimi_summary":{"_metrics":{"provider":"moonshot","completionTokens":1824},"content_quality":"ok","complexity_score":7,"scope_assessment":{"changed":true,"description":"The legislation has significantly expanded beyond its original 2003 scope. Originally focused heavily on prohibition of cloning and strict limits on embryo research, the 2007 amendments (Research Involving Human Embryos and Prohibition of Human Cloning Amendment Act 2007) introduced a licensing system permitting previously banned activities including: creation of human embryos by somatic cell nuclear transfer (therapeutic cloning), creation of hybrid embryos for sperm quality testing, and expanded research uses of excess ART embryos. The Act transformed from a primarily prohibitory framework to a regulatory licensing scheme that permits controlled research while maintaining reproductive cloning bans."},"complexity_factors":["Multiple interlocking definitions with recursive references (e.g., 'human embryo' excludes hybrid embryos and stem cell lines, but hybrid embryos are separately defined and partially permitted under limited licences)","Nested exception structure: Section 23 lists exempt uses of excess ART embryos within the offence provision, creating multiple layers of permissibility","Dual prohibition/licensing structure where the same act (e.g., creating embryos by non-fertilisation methods) is prohibited in Part 2 but permitted in Part 3 if licensed, requiring cross-referencing between Parts 2 and 3","Integration with Commonwealth legislation requiring knowledge of the NHMRC Act 1992, Commonwealth Prohibition of Human Cloning Act 2002, and mirror legislation schemes","Multiple amendment layers (2007, 2013, 2024) creating transitional provisions and retrospective application issues (e.g., section 54 saving provisions for pending applications)","Technical scientific terminology requiring specialist knowledge (mitotic division, precursor cells, somatic cell nuclear transfer, embryonal cells)","Complex consent mechanics involving 'responsible persons' definitions that vary by embryo type (excess ART vs other embryos vs human eggs) and spousal rights references","Monitoring powers provisions incorporating Commonwealth warrant procedures and evidentiary rules by reference"],"plain_english_summary":"**What this law is about**\n\nThis is Queensland's legislation that controls scientific research involving human embryos and bans human cloning for reproduction. It operates as part of a national scheme aligned with Commonwealth law.\n\n**Who it affects**\n\n- Scientists and researchers working with human embryos\n- IVF clinics and assisted reproductive technology (ART) centres\n- Anyone handling human eggs, sperm, or embryos\n- The NHMRC (National Health and Medical Research Council) Licensing Committee, which administers the licensing system\n\n**What it does**\n\n**1. Bans certain practices completely**\nThe law makes it a serious crime (up to 15 years in prison) to:\n- Place a cloned human embryo into a woman or animal\n- Create human embryos for purposes other than achieving pregnancy (unless specifically licensed)\n- Create embryos with genetic material from more than two people (without a licence)\n- Grow embryos outside a woman's body for more than 14 days\n- Make heritable genetic changes (changes that can be passed to descendants)\n- Remove viable embryos from a woman's body\n- Create \"chimeric\" embryos (mixing human and animal cells) or \"hybrid\" embryos (animal egg fertilised by human sperm, except for limited sperm testing)\n- Buy or sell human eggs, sperm, or embryos (commercial trading)\n- Place embryos in animals or in humans outside the reproductive tract\n\n**2. Allows some research under strict licences**\nWhile the above activities are generally banned, researchers can apply to the NHMRC Licensing Committee for a licence to:\n- Use \"excess ART embryos\" (leftover embryos from IVF treatment that are no longer needed by the couple who created them)\n- Create embryos using methods other than fertilisation (such as somatic cell nuclear transfer, sometimes called therapeutic cloning)\n- Create hybrid embryos specifically for testing sperm quality in accredited IVF clinics (up to but not including the first cell division)\n\n**3. Requires consent**\nBefore any research use, \"responsible persons\" (typically the people who provided the genetic material or the woman for whom the embryo was created) must give proper consent according to NHMRC guidelines.\n\n**4. Establishes monitoring and enforcement**\n- Authorised inspectors can enter premises with consent, warrants, or during reasonable hours at licensed facilities\n- Inspectors can examine records, take samples, photograph equipment, and secure evidence\n- Breaching licence conditions carries penalties up to 5 years imprisonment\n\n**Why it matters**\n\nThis law attempts to balance medical innovation with ethical boundaries. It allows potentially life-saving research (such as stem cell research) using excess IVF embryos while maintaining strict prohibitions against reproductive cloning and commercial exploitation of human reproductive material. It ensures that embryo research only occurs with proper ethical oversight, informed consent, and transparency through a public database of licences.\n\n**Key terms explained**\n- **Excess ART embryo**: A leftover embryo from IVF treatment that the couple no longer needs for having children\n- **Human embryo clone**: An embryo created with the same genetic makeup as another person (reproductive cloning)\n- **Hybrid embryo**: An embryo created by fertilising an animal egg with human sperm\n- **Chimeric embryo**: An embryo containing both human and animal cells\n- **Proper consent**: Consent obtained according to national ethical guidelines, including cooling-off periods and full disclosure"},"summary":{"complexity_score":8,"scope_assessment":{"changed":true,"description":"The 2007 amendments (Act No. 45 of 2007) materially expanded the original scope. The Act originally focused primarily on prohibiting reproductive cloning and regulating use of excess IVF embryos. The 2007 amendments added entirely new categories of regulated activity: creation of embryos by non-fertilisation methods (e.g., somatic cell nuclear transfer for research cloning), use of precursor cells from embryos or fetuses, research and training involving fertilisation up to the first mitotic division, and the creation/use of hybrid embryos for sperm quality testing. This shifted the Act from a narrower cloning ban with basic IVF embryo oversight into a broader framework regulating a much wider range of reproductive and genetic research technologies."},"complexity_factors":["Dual regulatory framework: the State law operates in parallel with Commonwealth legislation (the Research Involving Human Embryos Act 2002 and Prohibition of Human Cloning Act 2002), requiring readers to cross-reference multiple Acts","Highly technical scientific terminology requiring specialised knowledge (e.g., chimeric embryo, hybrid embryo, precursor cells, mitotic division, oocyte, somatic cell nuclear transfer)","Two-tier offence structure: absolute prohibitions (Part 2 Div 1) versus conditional prohibitions requiring absence of a licence (Part 2 Div 2 and Part 3), with different maximum penalties","Complex definitions with nested exclusions and inclusions (e.g., 'prohibited embryo' has 8 sub-categories; 'excess ART embryo' requires analysis of written authorities and determinations; 'responsible person' has multiple categories depending on embryo type)","Nuanced consent regime: 'proper consent' is defined by reference to external NHMRC guidelines which are themselves subject to modification by individual licences","Layered licensing system involving applications, mandatory criteria, discretionary factors, conditions, variation, suspension, revocation and surrender — each with separate procedural requirements","Intergovernmental complexity: the licensing committee is a Commonwealth body (NHMRC) exercising functions under this State law; review rights depend on Commonwealth regulations declaring decisions 'reviewable State decisions'","Evolving definitions after 2007 amendments significantly restructured Part 2, adding new offence categories and reordering existing ones, making legislative history relevant to interpretation","'Recklessness' given a specific statutory definition that differs subtly from common law, affecting the fault element of multiple offences","Exempt uses under s.23 involve multiple sub-conditions that must be assessed together, including biological fitness determinations that require scientific expertise"],"plain_english_summary":"This Queensland law outlaws reproductive human cloning and several high‑risk embryo practices (with severe penalties) while tightly regulating research on leftover IVF embryos.  \n\nIt affects IVF patients (their written consent is required), researchers and clinics (research needs federal NHMRC licences plus ethics approval), and public bodies — aiming to permit medically valuable embryo research under strict safeguards while preventing cloning and heritable genetic modification."},"issue_detection":{"absurdities":[],"contradictions":[]}},"importantCases":[],"_links":{"self":"/api/acts/research-involving-human-embryos-and-prohibition-of-human-cloning-for-reproduction-act-2003","history":"/api/acts/research-involving-human-embryos-and-prohibition-of-human-cloning-for-reproduction-act-2003/history","analysis":"/api/acts/research-involving-human-embryos-and-prohibition-of-human-cloning-for-reproduction-act-2003/analysis","conflicts":"/api/acts/research-involving-human-embryos-and-prohibition-of-human-cloning-for-reproduction-act-2003/conflicts","importantCases":"/api/acts/research-involving-human-embryos-and-prohibition-of-human-cloning-for-reproduction-act-2003/important-cases","documents":"/api/acts/research-involving-human-embryos-and-prohibition-of-human-cloning-for-reproduction-act-2003/documents"}}