{"id":"C2004A01081","name":"Prohibition of Human Cloning for Reproduction Act 2002","slug":"prohibition-of-human-cloning-for-reproduction-act-2002","collection":"act","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":"144 of 2002","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":24979,"registerId":"commonwealth-C2004A01081-current","compilationNumber":null,"startDate":"2026-04-01","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"## Part 1—Preliminary","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Short title","content":"#### 1 Short title\n\n  This Act may be cited as the Prohibition of Human Cloning for Reproduction Act 2002.","sortOrder":1},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 Commencement\n\n  (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table.\n\n```html\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:344.85pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commencement information</span></p></td></tr><tr><td style=\"width:74.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:68.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:74.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Provision(s)</span></p></td><td style=\"width:180.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commencement</span></p></td><td style=\"width:68.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Date/Details</span></p></td></tr></thead><tbody><tr><td style=\"width:74.35pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1.</span><span> </span><span>Sections</span><span> </span><span>1 and 2 and anything in this Act not elsewhere covered by this table</span></p></td><td style=\"width:180.7pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>The day on which this Act receives the Royal Assent</span></p></td><td style=\"width:68.4pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span><span> </span><span>December 2002</span></p></td></tr><tr><td style=\"width:74.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>2.</span><span> </span><span>Sections</span><span> </span><span>3 to 26 and Schedule</span><span> </span><span>1</span></p></td><td style=\"width:180.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>The 28th day after the day on which this Act receives the Royal Assent</span></p></td><td style=\"width:68.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span><span> </span><span>January 2003</span></p></td></tr></tbody></table>\n```\n\n> Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent.\n\n  (2) Column 3 of the table is for additional information that is not part of this Act. This information may be included in any published version of this Act.","sortOrder":2},{"sectionNumber":"3","sectionType":"section","heading":"Object of Act","content":"#### 3 Object of Act\n\n  The object of this Act is to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos by prohibiting certain practices.","sortOrder":3},{"sectionNumber":"4","sectionType":"section","heading":"Operation of Act","content":"#### 4 Operation of Act\n\n  (1) This Act applies as follows:\n    (a) to things done, or omitted to be done, by constitutional corporations;\n    (b) to things done, or omitted to be done, in the course of constitutional trade or commerce;\n    (c) to matters within the legislative power of the Commonwealth under paragraph 51(xxix) of the Constitution;\n    (d) to the Commonwealth and Commonwealth authorities;\n    (e) for purposes relating to the collection, compilation, analysis and dissemination of statistics;\n    (f) to matters within the legislative power of the Commonwealth under paragraph 51(xxxix) of the Constitution, so far as it relates to the matters mentioned in paragraphs (a) to (e) of this subsection.\n\n> Note: See also section 28B of the Research Involving Human Embryos Act 2002 in relation to mitochondrial donation licences.\n\n  (2) In this section:\n\n> constitutional corporation means a trading, foreign or financial corporation within the meaning of paragraph 51(xx) of the Constitution.\n\n> constitutional trade or commerce means trade or commerce:\n\n    (a) between Australia and places outside Australia; or\n    (b) among the States; or\n    (c) by way of the supply of services to the Commonwealth or to a Commonwealth authority.","sortOrder":4},{"sectionNumber":"5","sectionType":"section","heading":"Act to bind the Crown","content":"#### 5 Act to bind the Crown\n\n  (1) This Act binds the Crown in each of its capacities.\n  (2) Nothing in this Act renders the Crown liable to be prosecuted for an offence.","sortOrder":5},{"sectionNumber":"6","sectionType":"section","heading":"External Territories","content":"#### 6 External Territories\n\n  This Act extends to every external Territory.","sortOrder":6},{"sectionNumber":"8","sectionType":"section","heading":"Definitions","content":"#### 8 Definitions\n\n  (1) In this Act:\n\n> animal does not include a human.\n\n> chimeric embryo means:\n\n    (a) a human embryo into which a cell, or any component part of a cell, of an animal has been introduced; or\n    (b) a thing declared by the regulations to be a chimeric embryo.\n\n> Commonwealth authority means the following:\n\n    (a) a body corporate established for a public purpose by or under an Act;\n    (b) a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together:\n    (i) the Commonwealth;\n    (ii) a body covered by paragraph (a);\n    (iii) a body covered by either of the above subparagraphs.\n\n> excess ART embryo means a human embryo that:\n\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:\n    (i) the woman for whom it was created; and\n    (ii) her spouse (if any) at the time the embryo was created.\n\n> general licence has the same meaning as in Part 2 of the Research Involving Human Embryos Act 2002.\n\n> human embryo means a discrete entity that has arisen from either:\n\n    (a) the first mitotic division when fertilisation of a human oocyte by a human sperm is complete; or\n    (b) any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears;\n  and has not yet reached 8 weeks of development since the first mitotic division.\n\n> human embryo clone means a human embryo that is a genetic copy of another living or dead human, but does not include a human embryo created by the fertilisation of a human egg by human sperm.\n\n> human sperm includes human spermatids.\n\n> hybrid embryo means:\n\n    (a) an embryo created by the fertilisation of a human egg by animal sperm; or\n    (b) an embryo created by the fertilisation of an animal egg by human sperm; or\n    (c) a human egg into which the nucleus of an animal cell has been introduced; or\n    (d) an animal egg into which the nucleus of a human cell has been introduced; or\n    (e) a thing declared by the regulations to be a hybrid embryo.\n\n> mitochondrial donation licence means any of the following licences issued under section 28J of the Research Involving Human Embryos Act 2002:\n\n    (a) a pre‑clinical research and training licence;\n    (b) a clinical trial research and training licence;\n    (c) a clinical trial licence;\n    (d) a clinical practice research and training licence;\n    (e) a clinical practice licence.\n\n> mitochondrial donation technique has the same meaning as in Part 2 of the Research Involving Human Embryos Act 2002.\n\n> NHMRC Licensing Committee means the Committee established under section 13 of the Research Involving Human Embryos Act 2002.\n\n> precursor cell means a cell that has the potential to develop into a human egg or human sperm.\n\n> spouse, in relation to a person, includes a de facto partner of the person within the meaning of the Acts Interpretation Act 1901.\n\n> State includes the Australian Capital Territory and the Northern Territory.\n\n> woman means a female human.\n\n  (2) For the purposes of establishing that a human embryo clone is a genetic copy of a living or dead human:\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  (3) For the purposes of the definition of human embryo in subsection (1), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n  (4) For the purposes of the definition of human embryo clone in subsection (1), 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  (5) For the purposes of paragraph (b) of the definition of excess ART embryo, a human embryo is excess to the needs of the persons mentioned in that paragraph at a particular time if:\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.\n  (6) A reference in this Act to an embryo (including a human embryo) is a reference to a living embryo.\n  (7) A reference in this Act to a human egg is a reference to a human oocyte.\n  (8) A reference in this Act to a human embryo does not include a reference to:\n    (a) a hybrid embryo; or\n    (b) a human embryonic stem cell line.","sortOrder":7},{"sectionNumber":"Part 2","sectionType":"part","heading":"Prohibited practices","content":"## Part 2—Prohibited practices","sortOrder":8},{"sectionNumber":"9","sectionType":"section","heading":"Offence—placing a human embryo clone in the human body or the body of an animal","content":"#### 9 Offence—placing a human embryo clone in the human body or the body of an animal\n\n  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.\n\nPenalty: Imprisonment for 15 years.\n\n> Note: 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 14.","sortOrder":9},{"sectionNumber":"10","sectionType":"section","heading":"Offence—importing or exporting a human embryo clone","content":"#### 10 Offence—importing or exporting a human embryo clone\n\n  (1) A person commits an offence if the person intentionally imports a human embryo clone into Australia.\n\nPenalty: Imprisonment for 15 years.\n\n  (2) A person commits an offence if the person intentionally exports a human embryo clone from Australia.\n\nPenalty for contravention of this subsection: Imprisonment for 15 years.","sortOrder":10},{"sectionNumber":"11","sectionType":"section","heading":"No defence that human embryo clone could not survive","content":"#### 11 No defence that human embryo clone could not survive\n\n  It is not a defence to an offence under section 9 or 10 that the human embryo clone did not survive or could not have survived.","sortOrder":11},{"sectionNumber":"12","sectionType":"section","heading":"Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman or the purposes of a mitochondrial donation licence","content":"#### 12 Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman or the purposes of a mitochondrial donation licence\n\n  (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 either or both of the following apply:\n    (a) the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman;\n    (b) the creation of the embryo by the person is permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n  (2) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (1) of this section.","sortOrder":12},{"sectionNumber":"13","sectionType":"section","heading":"Offence—creating or developing a human embryo by fertilisation that contains genetic material provided by more than 2 persons","content":"#### 13 Offence—creating or developing a human embryo by fertilisation that contains genetic material provided by more than 2 persons\n\n  A person commits an offence if:\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; and\n    (c) the creation or development of the human embryo by the person is not permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.","sortOrder":13},{"sectionNumber":"14","sectionType":"section","heading":"Offence—developing a human embryo outside the body of a woman for more than 14 days","content":"#### 14 Offence—developing a human embryo outside the body of a woman for more than 14 days\n\n  A person commits an offence if the person intentionally develops a human embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended.\n\nPenalty: Imprisonment for 15 years.","sortOrder":14},{"sectionNumber":"15","sectionType":"section","heading":"Offence—heritable alterations to genome","content":"#### 15 Offence—heritable alterations to genome\n\n  (1) A person commits an offence if:\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; and\n    (c) the alteration of the genome by the person is not permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n  (2) In this section:\n\n> human cell includes a human embryonal cell, a human fetal cell, human sperm or a human egg.","sortOrder":15},{"sectionNumber":"16","sectionType":"section","heading":"Offence—collecting a viable human embryo from the body of a woman","content":"#### 16 Offence—collecting a viable human embryo from the body of a woman\n\n  A person commits an offence if the person removes a human embryo from the body of a woman, intending to collect a viable human embryo.\n\nPenalty: Imprisonment for 15 years.","sortOrder":16},{"sectionNumber":"17","sectionType":"section","heading":"Offence—creating a chimeric embryo","content":"#### 17 Offence—creating a chimeric embryo\n\n  A person commits an offence if the person intentionally creates a chimeric embryo.\n\nPenalty: Imprisonment for 15 years.","sortOrder":17},{"sectionNumber":"18","sectionType":"section","heading":"Offence—developing a hybrid embryo","content":"#### 18 Offence—developing a hybrid embryo\n\n  A 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.\n\nPenalty: Imprisonment for 15 years.","sortOrder":18},{"sectionNumber":"19","sectionType":"section","heading":"Offence—placing of an embryo","content":"#### 19 Offence—placing of an embryo\n\n  (1) A person commits an offence if the person intentionally places a human embryo in an animal.\n\nPenalty: Imprisonment for 15 years.\n\n  (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.\n\nPenalty: Imprisonment for 15 years.\n\n  (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.\n\nPenalty for contravention of this subsection: Imprisonment for 15 years.","sortOrder":19},{"sectionNumber":"20","sectionType":"section","heading":"Offence—importing, exporting or placing a prohibited embryo","content":"#### 20 Offence—importing, exporting or placing a prohibited embryo\n\n  (1) A person commits an offence if the person intentionally imports an embryo into Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo.\n\nPenalty: Imprisonment for 15 years.\n\n  (2) A person commits an offence if the person intentionally exports an embryo from Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo.\n\nPenalty: Imprisonment for 15 years.\n\n  (3) 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, unless:\n    (a) the embryo is a prohibited embryo under paragraph (a), (c) or (f) of the definition of that expression in subsection (4); and\n    (b) the placement of the embryo by the person is permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n  (4) In this section:\n\n> prohibited embryo means:\n\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 15) 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.\n  (5) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (3) of this section.","sortOrder":20},{"sectionNumber":"21","sectionType":"section","heading":"Offence—commercial trading in human eggs, human sperm or human embryos","content":"#### 21 Offence—commercial trading in human eggs, human sperm or human embryos\n\n  (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.\n\nPenalty: Imprisonment for 15 years.\n\n  (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.\n\nPenalty: Imprisonment for 15 years.\n\n  (3) In this section:\n\n> reasonable expenses:\n\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:\n    (i) does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo; and\n    (ii) includes, but is not limited to, expenses relating to the storage or transport of the embryo.\n\n> 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.","sortOrder":21},{"sectionNumber":"22","sectionType":"section","heading":"Offence—creating a human embryo other than by fertilisation, or developing such an embryo","content":"#### 22 Offence—creating a human embryo other than by fertilisation, or developing such an embryo\n\n  A person commits an offence if:\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 general licence or permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 10 years.\n\n> Note 1: The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 14.\n\n> Note 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 9 and 20.","sortOrder":22},{"sectionNumber":"23","sectionType":"section","heading":"Offence—creating or developing a human embryo containing genetic material provided by more than 2 persons","content":"#### 23 Offence—creating or developing a human embryo containing genetic material provided by more than 2 persons\n\n  A person commits an offence if:\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 general licence or permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 10 years.\n\n> Note 1: The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 14.\n\n> Note 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 20.","sortOrder":23},{"sectionNumber":"23A","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":"#### 23A Offence—using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo\n\n  A person commits an offence if:\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 general licence, and the person knows or is reckless as to that fact.\n\nPenalty: Imprisonment for 10 years.","sortOrder":24},{"sectionNumber":"23B","sectionType":"section","heading":"Offence—creating a hybrid embryo","content":"#### 23B Offence—creating a hybrid embryo\n\n  (1) A person commits an offence if the person intentionally creates a hybrid embryo.\n\nPenalty: Imprisonment for 10 years.\n\n  (2) A person commits an offence if the person intentionally develops a hybrid embryo.\n\nPenalty: Imprisonment for 10 years.\n\n  (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 general licence.\n\n> Note: A general licence to create or develop a hybrid embryo can only be issued under section 21 of the Research Involving Human Embryos Act 2002:\n\n    (a) for the purposes of testing sperm quality in an accredited ART centre—up to, but not including, the first mitotic division; or\n    (b) in the case of hybrid embryo created by introducing the nucleus of a human cell into an animal egg—for not longer than 14 days.","sortOrder":25},{"sectionNumber":"23BA","sectionType":"section","heading":"Person not liable for conduct purportedly authorised","content":"#### 23BA Person not liable for conduct purportedly authorised\n\n  (1) To avoid doubt, a person is not criminally responsible for a licence offence in respect of particular conduct if:\n    (a) the conduct by the person is purportedly authorised by a provision of a general licence or a mitochondrial donation 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.\n  (2) In this section:\n\n> general licence includes a purported general licence.\n\n> licence offence means:\n\n    (a) for a general licence—an offence against section 22, 23, 23A or 23B; or\n    (b) for a mitochondrial donation licence—an offence against section 12, 13 or 15, subsection 20(3), or section 22 or 23.\n\n> mitochondrial donation licence includes a purported mitochondrial donation licence.","sortOrder":26},{"sectionNumber":"23C","sectionType":"section","heading":"Regulations under Customs Act","content":"#### 23C Regulations under Customs Act\n\n  The Minister who administers the Customs Act 1901 must take all reasonable steps to ensure that regulations are made, within 6 months after the commencement of this section, permitting, subject to appropriate conditions or restrictions, the import and export of human embryonic stem cell lines which have been derived from human embryo clones using practices consistent with Australian legislation.","sortOrder":27},{"sectionNumber":"Part 3","sectionType":"part","heading":"Commonwealth/State arrangements","content":"## Part 3—Commonwealth/State arrangements","sortOrder":28},{"sectionNumber":"24","sectionType":"section","heading":"Operation of State laws","content":"#### 24 Operation of State laws\n\n  This Act is not intended to exclude the operation of any law of a State, to the extent that the law of the State is capable of operating concurrently with this Act.","sortOrder":29},{"sectionNumber":"Part 4","sectionType":"part","heading":"Review provision and regulations","content":"An Act to prohibit human cloning for reproduction and other unacceptable practices associated with reproductive technology, and for related purposes\n\n## Part 1—Preliminary\n\n#### 1 Short title\n\n  This Act may be cited as the Prohibition of Human Cloning for Reproduction Act 2002.\n\n#### 2 Commencement\n\n  (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table.\n\n```html\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:344.85pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commencement information</span></p></td></tr><tr><td style=\"width:74.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:68.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:74.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Provision(s)</span></p></td><td style=\"width:180.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commencement</span></p></td><td style=\"width:68.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Date/Details</span></p></td></tr></thead><tbody><tr><td style=\"width:74.35pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1.</span><span> </span><span>Sections</span><span> </span><span>1 and 2 and anything in this Act not elsewhere covered by this table</span></p></td><td style=\"width:180.7pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>The day on which this Act receives the Royal Assent</span></p></td><td style=\"width:68.4pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span><span> </span><span>December 2002</span></p></td></tr><tr><td style=\"width:74.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>2.</span><span> </span><span>Sections</span><span> </span><span>3 to 26 and Schedule</span><span> </span><span>1</span></p></td><td style=\"width:180.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>The 28th day after the day on which this Act receives the Royal Assent</span></p></td><td style=\"width:68.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span><span> </span><span>January 2003</span></p></td></tr></tbody></table>\n```\n\n> Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent.\n\n  (2) Column 3 of the table is for additional information that is not part of this Act. This information may be included in any published version of this Act.\n\n#### 3 Object of Act\n\n  The object of this Act is to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos by prohibiting certain practices.\n\n#### 4 Operation of Act\n\n  (1) This Act applies as follows:\n    (a) to things done, or omitted to be done, by constitutional corporations;\n    (b) to things done, or omitted to be done, in the course of constitutional trade or commerce;\n    (c) to matters within the legislative power of the Commonwealth under paragraph 51(xxix) of the Constitution;\n    (d) to the Commonwealth and Commonwealth authorities;\n    (e) for purposes relating to the collection, compilation, analysis and dissemination of statistics;\n    (f) to matters within the legislative power of the Commonwealth under paragraph 51(xxxix) of the Constitution, so far as it relates to the matters mentioned in paragraphs (a) to (e) of this subsection.\n\n> Note: See also section 28B of the Research Involving Human Embryos Act 2002 in relation to mitochondrial donation licences.\n\n  (2) In this section:\n\n> constitutional corporation means a trading, foreign or financial corporation within the meaning of paragraph 51(xx) of the Constitution.\n\n> constitutional trade or commerce means trade or commerce:\n\n    (a) between Australia and places outside Australia; or\n    (b) among the States; or\n    (c) by way of the supply of services to the Commonwealth or to a Commonwealth authority.\n\n#### 5 Act to bind the Crown\n\n  (1) This Act binds the Crown in each of its capacities.\n  (2) Nothing in this Act renders the Crown liable to be prosecuted for an offence.\n\n#### 6 External Territories\n\n  This Act extends to every external Territory.\n\n#### 8 Definitions\n\n  (1) In this Act:\n\n> animal does not include a human.\n\n> chimeric embryo means:\n\n    (a) a human embryo into which a cell, or any component part of a cell, of an animal has been introduced; or\n    (b) a thing declared by the regulations to be a chimeric embryo.\n\n> Commonwealth authority means the following:\n\n    (a) a body corporate established for a public purpose by or under an Act;\n    (b) a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together:\n    (i) the Commonwealth;\n    (ii) a body covered by paragraph (a);\n    (iii) a body covered by either of the above subparagraphs.\n\n> excess ART embryo means a human embryo that:\n\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:\n    (i) the woman for whom it was created; and\n    (ii) her spouse (if any) at the time the embryo was created.\n\n> general licence has the same meaning as in Part 2 of the Research Involving Human Embryos Act 2002.\n\n> human embryo means a discrete entity that has arisen from either:\n\n    (a) the first mitotic division when fertilisation of a human oocyte by a human sperm is complete; or\n    (b) any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears;\n  and has not yet reached 8 weeks of development since the first mitotic division.\n\n> human embryo clone means a human embryo that is a genetic copy of another living or dead human, but does not include a human embryo created by the fertilisation of a human egg by human sperm.\n\n> human sperm includes human spermatids.\n\n> hybrid embryo means:\n\n    (a) an embryo created by the fertilisation of a human egg by animal sperm; or\n    (b) an embryo created by the fertilisation of an animal egg by human sperm; or\n    (c) a human egg into which the nucleus of an animal cell has been introduced; or\n    (d) an animal egg into which the nucleus of a human cell has been introduced; or\n    (e) a thing declared by the regulations to be a hybrid embryo.\n\n> mitochondrial donation licence means any of the following licences issued under section 28J of the Research Involving Human Embryos Act 2002:\n\n    (a) a pre‑clinical research and training licence;\n    (b) a clinical trial research and training licence;\n    (c) a clinical trial licence;\n    (d) a clinical practice research and training licence;\n    (e) a clinical practice licence.\n\n> mitochondrial donation technique has the same meaning as in Part 2 of the Research Involving Human Embryos Act 2002.\n\n> NHMRC Licensing Committee means the Committee established under section 13 of the Research Involving Human Embryos Act 2002.\n\n> precursor cell means a cell that has the potential to develop into a human egg or human sperm.\n\n> spouse, in relation to a person, includes a de facto partner of the person within the meaning of the Acts Interpretation Act 1901.\n\n> State includes the Australian Capital Territory and the Northern Territory.\n\n> woman means a female human.\n\n  (2) For the purposes of establishing that a human embryo clone is a genetic copy of a living or dead human:\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  (3) For the purposes of the definition of human embryo in subsection (1), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n  (4) For the purposes of the definition of human embryo clone in subsection (1), 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  (5) For the purposes of paragraph (b) of the definition of excess ART embryo, a human embryo is excess to the needs of the persons mentioned in that paragraph at a particular time if:\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.\n  (6) A reference in this Act to an embryo (including a human embryo) is a reference to a living embryo.\n  (7) A reference in this Act to a human egg is a reference to a human oocyte.\n  (8) A reference in this Act to a human embryo does not include a reference to:\n    (a) a hybrid embryo; or\n    (b) a human embryonic stem cell line.\n\n## Part 2—Prohibited practices\n\n#### 9 Offence—placing a human embryo clone in the human body or the body of an animal\n\n  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.\n\nPenalty: Imprisonment for 15 years.\n\n> Note: 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 14.\n\n#### 10 Offence—importing or exporting a human embryo clone\n\n  (1) A person commits an offence if the person intentionally imports a human embryo clone into Australia.\n\nPenalty: Imprisonment for 15 years.\n\n  (2) A person commits an offence if the person intentionally exports a human embryo clone from Australia.\n\nPenalty for contravention of this subsection: Imprisonment for 15 years.\n\n#### 11 No defence that human embryo clone could not survive\n\n  It is not a defence to an offence under section 9 or 10 that the human embryo clone did not survive or could not have survived.\n\n#### 12 Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman or the purposes of a mitochondrial donation licence\n\n  (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 either or both of the following apply:\n    (a) the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman;\n    (b) the creation of the embryo by the person is permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n  (2) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (1) of this section.\n\n#### 13 Offence—creating or developing a human embryo by fertilisation that contains genetic material provided by more than 2 persons\n\n  A person commits an offence if:\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; and\n    (c) the creation or development of the human embryo by the person is not permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n#### 14 Offence—developing a human embryo outside the body of a woman for more than 14 days\n\n  A person commits an offence if the person intentionally develops a human embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended.\n\nPenalty: Imprisonment for 15 years.\n\n#### 15 Offence—heritable alterations to genome\n\n  (1) A person commits an offence if:\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; and\n    (c) the alteration of the genome by the person is not permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n  (2) In this section:\n\n> human cell includes a human embryonal cell, a human fetal cell, human sperm or a human egg.\n\n#### 16 Offence—collecting a viable human embryo from the body of a woman\n\n  A person commits an offence if the person removes a human embryo from the body of a woman, intending to collect a viable human embryo.\n\nPenalty: Imprisonment for 15 years.\n\n#### 17 Offence—creating a chimeric embryo\n\n  A person commits an offence if the person intentionally creates a chimeric embryo.\n\nPenalty: Imprisonment for 15 years.\n\n#### 18 Offence—developing a hybrid embryo\n\n  A 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.\n\nPenalty: Imprisonment for 15 years.\n\n#### 19 Offence—placing of an embryo\n\n  (1) A person commits an offence if the person intentionally places a human embryo in an animal.\n\nPenalty: Imprisonment for 15 years.\n\n  (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.\n\nPenalty: Imprisonment for 15 years.\n\n  (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.\n\nPenalty for contravention of this subsection: Imprisonment for 15 years.\n\n#### 20 Offence—importing, exporting or placing a prohibited embryo\n\n  (1) A person commits an offence if the person intentionally imports an embryo into Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo.\n\nPenalty: Imprisonment for 15 years.\n\n  (2) A person commits an offence if the person intentionally exports an embryo from Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo.\n\nPenalty: Imprisonment for 15 years.\n\n  (3) 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, unless:\n    (a) the embryo is a prohibited embryo under paragraph (a), (c) or (f) of the definition of that expression in subsection (4); and\n    (b) the placement of the embryo by the person is permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n  (4) In this section:\n\n> prohibited embryo means:\n\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 15) 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.\n  (5) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (3) of this section.\n\n#### 21 Offence—commercial trading in human eggs, human sperm or human embryos\n\n  (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.\n\nPenalty: Imprisonment for 15 years.\n\n  (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.\n\nPenalty: Imprisonment for 15 years.\n\n  (3) In this section:\n\n> reasonable expenses:\n\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:\n    (i) does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo; and\n    (ii) includes, but is not limited to, expenses relating to the storage or transport of the embryo.\n\n> 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\n#### 22 Offence—creating a human embryo other than by fertilisation, or developing such an embryo\n\n  A person commits an offence if:\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 general licence or permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 10 years.\n\n> Note 1: The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 14.\n\n> Note 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 9 and 20.\n\n#### 23 Offence—creating or developing a human embryo containing genetic material provided by more than 2 persons\n\n  A person commits an offence if:\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 general licence or permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 10 years.\n\n> Note 1: The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 14.\n\n> Note 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 20.\n\n#### 23A Offence—using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo\n\n  A person commits an offence if:\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 general licence, and the person knows or is reckless as to that fact.\n\nPenalty: Imprisonment for 10 years.\n\n#### 23B Offence—creating a hybrid embryo\n\n  (1) A person commits an offence if the person intentionally creates a hybrid embryo.\n\nPenalty: Imprisonment for 10 years.\n\n  (2) A person commits an offence if the person intentionally develops a hybrid embryo.\n\nPenalty: Imprisonment for 10 years.\n\n  (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 general licence.\n\n> Note: A general licence to create or develop a hybrid embryo can only be issued under section 21 of the Research Involving Human Embryos Act 2002:\n\n    (a) for the purposes of testing sperm quality in an accredited ART centre—up to, but not including, the first mitotic division; or\n    (b) in the case of hybrid embryo created by introducing the nucleus of a human cell into an animal egg—for not longer than 14 days.\n\n#### 23BA Person not liable for conduct purportedly authorised\n\n  (1) To avoid doubt, a person is not criminally responsible for a licence offence in respect of particular conduct if:\n    (a) the conduct by the person is purportedly authorised by a provision of a general licence or a mitochondrial donation 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.\n  (2) In this section:\n\n> general licence includes a purported general licence.\n\n> licence offence means:\n\n    (a) for a general licence—an offence against section 22, 23, 23A or 23B; or\n    (b) for a mitochondrial donation licence—an offence against section 12, 13 or 15, subsection 20(3), or section 22 or 23.\n\n> mitochondrial donation licence includes a purported mitochondrial donation licence.\n\n#### 23C Regulations under Customs Act\n\n  The Minister who administers the Customs Act 1901 must take all reasonable steps to ensure that regulations are made, within 6 months after the commencement of this section, permitting, subject to appropriate conditions or restrictions, the import and export of human embryonic stem cell lines which have been derived from human embryo clones using practices consistent with Australian legislation.\n\n## Part 3—Commonwealth/State arrangements\n\n#### 24 Operation of State laws\n\n  This Act is not intended to exclude the operation of any law of a State, to the extent that the law of the State is capable of operating concurrently with this Act.\n\n## Part 4—Review provision and regulations\n\n### Division 1—Review of Act\n\n#### 25 Review of operation of Act every 7 years\n\n  (1) The Minister must cause an independent review of the operation of this Act, in so far as it relates to the use of mitochondrial donation techniques, to be undertaken as soon as possible after the end of:\n    (a) the period of 7 years starting on the commencement of Schedule 1 to the Mitochondrial Donation Law Reform (Maeve’s Law) Act 2022; and\n    (b) each subsequent 7‑year period.\n  (2) A review under this section is to be undertaken by persons chosen by the Minister, with the agreement of each State.\n  (3) The persons undertaking a review under this section must prepare and give to the Minister, for presentation to the Parliament, a report of the review.\n  (4) The report must be given to the Minister within 12 months after the end of the relevant 7‑year period.\n\n> Note: See also section 34C of the Acts Interpretation Act 1901, which contains extra rules about periodic reports.\n\n  (5) The persons undertaking a review under this section must consult:\n    (a) the Commonwealth and the States; and\n    (b) a broad range of persons with expertise in or experience of relevant disciplines;\n  and the views of the Commonwealth, the States and the persons mentioned in paragraph (b) must be set out in the report to the extent that it is reasonably practicable to do so.\n\n### Division 2—Regulations\n\n#### 26 Regulations\n\n  (1) The Governor‑General may make regulations prescribing matters:\n    (a) required or permitted by this Act to be prescribed; or\n    (b) necessary or convenient to be prescribed for carrying out or giving effect to this Act.\n  (2) Before the Governor‑General makes regulations under this Act, the Minister must be satisfied that:\n    (a) the States have been consulted in relation to the proposed regulations; and\n    (b) the proposed regulations have been prepared having regard to views expressed by the States in those consultations.","sortOrder":30},{"sectionNumber":"Division 1","sectionType":"division","heading":"Review of Act","content":"An Act to prohibit human cloning for reproduction and other unacceptable practices associated with reproductive technology, and for related purposes\n\n## Part 1—Preliminary\n\n#### 1 Short title\n\n  This Act may be cited as the Prohibition of Human Cloning for Reproduction Act 2002.\n\n#### 2 Commencement\n\n  (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table.\n\n```html\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:344.85pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commencement information</span></p></td></tr><tr><td style=\"width:74.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:68.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:74.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Provision(s)</span></p></td><td style=\"width:180.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commencement</span></p></td><td style=\"width:68.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Date/Details</span></p></td></tr></thead><tbody><tr><td style=\"width:74.35pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1.</span><span> </span><span>Sections</span><span> </span><span>1 and 2 and anything in this Act not elsewhere covered by this table</span></p></td><td style=\"width:180.7pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>The day on which this Act receives the Royal Assent</span></p></td><td style=\"width:68.4pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span><span> </span><span>December 2002</span></p></td></tr><tr><td style=\"width:74.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>2.</span><span> </span><span>Sections</span><span> </span><span>3 to 26 and Schedule</span><span> </span><span>1</span></p></td><td style=\"width:180.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>The 28th day after the day on which this Act receives the Royal Assent</span></p></td><td style=\"width:68.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span><span> </span><span>January 2003</span></p></td></tr></tbody></table>\n```\n\n> Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent.\n\n  (2) Column 3 of the table is for additional information that is not part of this Act. This information may be included in any published version of this Act.\n\n#### 3 Object of Act\n\n  The object of this Act is to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos by prohibiting certain practices.\n\n#### 4 Operation of Act\n\n  (1) This Act applies as follows:\n    (a) to things done, or omitted to be done, by constitutional corporations;\n    (b) to things done, or omitted to be done, in the course of constitutional trade or commerce;\n    (c) to matters within the legislative power of the Commonwealth under paragraph 51(xxix) of the Constitution;\n    (d) to the Commonwealth and Commonwealth authorities;\n    (e) for purposes relating to the collection, compilation, analysis and dissemination of statistics;\n    (f) to matters within the legislative power of the Commonwealth under paragraph 51(xxxix) of the Constitution, so far as it relates to the matters mentioned in paragraphs (a) to (e) of this subsection.\n\n> Note: See also section 28B of the Research Involving Human Embryos Act 2002 in relation to mitochondrial donation licences.\n\n  (2) In this section:\n\n> constitutional corporation means a trading, foreign or financial corporation within the meaning of paragraph 51(xx) of the Constitution.\n\n> constitutional trade or commerce means trade or commerce:\n\n    (a) between Australia and places outside Australia; or\n    (b) among the States; or\n    (c) by way of the supply of services to the Commonwealth or to a Commonwealth authority.\n\n#### 5 Act to bind the Crown\n\n  (1) This Act binds the Crown in each of its capacities.\n  (2) Nothing in this Act renders the Crown liable to be prosecuted for an offence.\n\n#### 6 External Territories\n\n  This Act extends to every external Territory.\n\n#### 8 Definitions\n\n  (1) In this Act:\n\n> animal does not include a human.\n\n> chimeric embryo means:\n\n    (a) a human embryo into which a cell, or any component part of a cell, of an animal has been introduced; or\n    (b) a thing declared by the regulations to be a chimeric embryo.\n\n> Commonwealth authority means the following:\n\n    (a) a body corporate established for a public purpose by or under an Act;\n    (b) a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together:\n    (i) the Commonwealth;\n    (ii) a body covered by paragraph (a);\n    (iii) a body covered by either of the above subparagraphs.\n\n> excess ART embryo means a human embryo that:\n\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:\n    (i) the woman for whom it was created; and\n    (ii) her spouse (if any) at the time the embryo was created.\n\n> general licence has the same meaning as in Part 2 of the Research Involving Human Embryos Act 2002.\n\n> human embryo means a discrete entity that has arisen from either:\n\n    (a) the first mitotic division when fertilisation of a human oocyte by a human sperm is complete; or\n    (b) any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears;\n  and has not yet reached 8 weeks of development since the first mitotic division.\n\n> human embryo clone means a human embryo that is a genetic copy of another living or dead human, but does not include a human embryo created by the fertilisation of a human egg by human sperm.\n\n> human sperm includes human spermatids.\n\n> hybrid embryo means:\n\n    (a) an embryo created by the fertilisation of a human egg by animal sperm; or\n    (b) an embryo created by the fertilisation of an animal egg by human sperm; or\n    (c) a human egg into which the nucleus of an animal cell has been introduced; or\n    (d) an animal egg into which the nucleus of a human cell has been introduced; or\n    (e) a thing declared by the regulations to be a hybrid embryo.\n\n> mitochondrial donation licence means any of the following licences issued under section 28J of the Research Involving Human Embryos Act 2002:\n\n    (a) a pre‑clinical research and training licence;\n    (b) a clinical trial research and training licence;\n    (c) a clinical trial licence;\n    (d) a clinical practice research and training licence;\n    (e) a clinical practice licence.\n\n> mitochondrial donation technique has the same meaning as in Part 2 of the Research Involving Human Embryos Act 2002.\n\n> NHMRC Licensing Committee means the Committee established under section 13 of the Research Involving Human Embryos Act 2002.\n\n> precursor cell means a cell that has the potential to develop into a human egg or human sperm.\n\n> spouse, in relation to a person, includes a de facto partner of the person within the meaning of the Acts Interpretation Act 1901.\n\n> State includes the Australian Capital Territory and the Northern Territory.\n\n> woman means a female human.\n\n  (2) For the purposes of establishing that a human embryo clone is a genetic copy of a living or dead human:\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  (3) For the purposes of the definition of human embryo in subsection (1), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n  (4) For the purposes of the definition of human embryo clone in subsection (1), 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  (5) For the purposes of paragraph (b) of the definition of excess ART embryo, a human embryo is excess to the needs of the persons mentioned in that paragraph at a particular time if:\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.\n  (6) A reference in this Act to an embryo (including a human embryo) is a reference to a living embryo.\n  (7) A reference in this Act to a human egg is a reference to a human oocyte.\n  (8) A reference in this Act to a human embryo does not include a reference to:\n    (a) a hybrid embryo; or\n    (b) a human embryonic stem cell line.\n\n## Part 2—Prohibited practices\n\n#### 9 Offence—placing a human embryo clone in the human body or the body of an animal\n\n  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.\n\nPenalty: Imprisonment for 15 years.\n\n> Note: 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 14.\n\n#### 10 Offence—importing or exporting a human embryo clone\n\n  (1) A person commits an offence if the person intentionally imports a human embryo clone into Australia.\n\nPenalty: Imprisonment for 15 years.\n\n  (2) A person commits an offence if the person intentionally exports a human embryo clone from Australia.\n\nPenalty for contravention of this subsection: Imprisonment for 15 years.\n\n#### 11 No defence that human embryo clone could not survive\n\n  It is not a defence to an offence under section 9 or 10 that the human embryo clone did not survive or could not have survived.\n\n#### 12 Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman or the purposes of a mitochondrial donation licence\n\n  (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 either or both of the following apply:\n    (a) the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman;\n    (b) the creation of the embryo by the person is permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n  (2) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (1) of this section.\n\n#### 13 Offence—creating or developing a human embryo by fertilisation that contains genetic material provided by more than 2 persons\n\n  A person commits an offence if:\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; and\n    (c) the creation or development of the human embryo by the person is not permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n#### 14 Offence—developing a human embryo outside the body of a woman for more than 14 days\n\n  A person commits an offence if the person intentionally develops a human embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended.\n\nPenalty: Imprisonment for 15 years.\n\n#### 15 Offence—heritable alterations to genome\n\n  (1) A person commits an offence if:\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; and\n    (c) the alteration of the genome by the person is not permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n  (2) In this section:\n\n> human cell includes a human embryonal cell, a human fetal cell, human sperm or a human egg.\n\n#### 16 Offence—collecting a viable human embryo from the body of a woman\n\n  A person commits an offence if the person removes a human embryo from the body of a woman, intending to collect a viable human embryo.\n\nPenalty: Imprisonment for 15 years.\n\n#### 17 Offence—creating a chimeric embryo\n\n  A person commits an offence if the person intentionally creates a chimeric embryo.\n\nPenalty: Imprisonment for 15 years.\n\n#### 18 Offence—developing a hybrid embryo\n\n  A 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.\n\nPenalty: Imprisonment for 15 years.\n\n#### 19 Offence—placing of an embryo\n\n  (1) A person commits an offence if the person intentionally places a human embryo in an animal.\n\nPenalty: Imprisonment for 15 years.\n\n  (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.\n\nPenalty: Imprisonment for 15 years.\n\n  (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.\n\nPenalty for contravention of this subsection: Imprisonment for 15 years.\n\n#### 20 Offence—importing, exporting or placing a prohibited embryo\n\n  (1) A person commits an offence if the person intentionally imports an embryo into Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo.\n\nPenalty: Imprisonment for 15 years.\n\n  (2) A person commits an offence if the person intentionally exports an embryo from Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo.\n\nPenalty: Imprisonment for 15 years.\n\n  (3) 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, unless:\n    (a) the embryo is a prohibited embryo under paragraph (a), (c) or (f) of the definition of that expression in subsection (4); and\n    (b) the placement of the embryo by the person is permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n  (4) In this section:\n\n> prohibited embryo means:\n\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 15) 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.\n  (5) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (3) of this section.\n\n#### 21 Offence—commercial trading in human eggs, human sperm or human embryos\n\n  (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.\n\nPenalty: Imprisonment for 15 years.\n\n  (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.\n\nPenalty: Imprisonment for 15 years.\n\n  (3) In this section:\n\n> reasonable expenses:\n\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:\n    (i) does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo; and\n    (ii) includes, but is not limited to, expenses relating to the storage or transport of the embryo.\n\n> 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\n#### 22 Offence—creating a human embryo other than by fertilisation, or developing such an embryo\n\n  A person commits an offence if:\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 general licence or permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 10 years.\n\n> Note 1: The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 14.\n\n> Note 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 9 and 20.\n\n#### 23 Offence—creating or developing a human embryo containing genetic material provided by more than 2 persons\n\n  A person commits an offence if:\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 general licence or permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 10 years.\n\n> Note 1: The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 14.\n\n> Note 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 20.\n\n#### 23A Offence—using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo\n\n  A person commits an offence if:\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 general licence, and the person knows or is reckless as to that fact.\n\nPenalty: Imprisonment for 10 years.\n\n#### 23B Offence—creating a hybrid embryo\n\n  (1) A person commits an offence if the person intentionally creates a hybrid embryo.\n\nPenalty: Imprisonment for 10 years.\n\n  (2) A person commits an offence if the person intentionally develops a hybrid embryo.\n\nPenalty: Imprisonment for 10 years.\n\n  (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 general licence.\n\n> Note: A general licence to create or develop a hybrid embryo can only be issued under section 21 of the Research Involving Human Embryos Act 2002:\n\n    (a) for the purposes of testing sperm quality in an accredited ART centre—up to, but not including, the first mitotic division; or\n    (b) in the case of hybrid embryo created by introducing the nucleus of a human cell into an animal egg—for not longer than 14 days.\n\n#### 23BA Person not liable for conduct purportedly authorised\n\n  (1) To avoid doubt, a person is not criminally responsible for a licence offence in respect of particular conduct if:\n    (a) the conduct by the person is purportedly authorised by a provision of a general licence or a mitochondrial donation 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.\n  (2) In this section:\n\n> general licence includes a purported general licence.\n\n> licence offence means:\n\n    (a) for a general licence—an offence against section 22, 23, 23A or 23B; or\n    (b) for a mitochondrial donation licence—an offence against section 12, 13 or 15, subsection 20(3), or section 22 or 23.\n\n> mitochondrial donation licence includes a purported mitochondrial donation licence.\n\n#### 23C Regulations under Customs Act\n\n  The Minister who administers the Customs Act 1901 must take all reasonable steps to ensure that regulations are made, within 6 months after the commencement of this section, permitting, subject to appropriate conditions or restrictions, the import and export of human embryonic stem cell lines which have been derived from human embryo clones using practices consistent with Australian legislation.\n\n## Part 3—Commonwealth/State arrangements\n\n#### 24 Operation of State laws\n\n  This Act is not intended to exclude the operation of any law of a State, to the extent that the law of the State is capable of operating concurrently with this Act.\n\n## Part 4—Review provision and regulations\n\n### Division 1—Review of Act\n\n#### 25 Review of operation of Act every 7 years\n\n  (1) The Minister must cause an independent review of the operation of this Act, in so far as it relates to the use of mitochondrial donation techniques, to be undertaken as soon as possible after the end of:\n    (a) the period of 7 years starting on the commencement of Schedule 1 to the Mitochondrial Donation Law Reform (Maeve’s Law) Act 2022; and\n    (b) each subsequent 7‑year period.\n  (2) A review under this section is to be undertaken by persons chosen by the Minister, with the agreement of each State.\n  (3) The persons undertaking a review under this section must prepare and give to the Minister, for presentation to the Parliament, a report of the review.\n  (4) The report must be given to the Minister within 12 months after the end of the relevant 7‑year period.\n\n> Note: See also section 34C of the Acts Interpretation Act 1901, which contains extra rules about periodic reports.\n\n  (5) The persons undertaking a review under this section must consult:\n    (a) the Commonwealth and the States; and\n    (b) a broad range of persons with expertise in or experience of relevant disciplines;\n  and the views of the Commonwealth, the States and the persons mentioned in paragraph (b) must be set out in the report to the extent that it is reasonably practicable to do so.\n\n### Division 2—Regulations\n\n#### 26 Regulations\n\n  (1) The Governor‑General may make regulations prescribing matters:\n    (a) required or permitted by this Act to be prescribed; or\n    (b) necessary or convenient to be prescribed for carrying out or giving effect to this Act.\n  (2) Before the Governor‑General makes regulations under this Act, the Minister must be satisfied that:\n    (a) the States have been consulted in relation to the proposed regulations; and\n    (b) the proposed regulations have been prepared having regard to views expressed by the States in those consultations.","sortOrder":31},{"sectionNumber":"25","sectionType":"section","heading":"Review of operation of Act every 7 years","content":"#### 25 Review of operation of Act every 7 years\n\n  (1) The Minister must cause an independent review of the operation of this Act, in so far as it relates to the use of mitochondrial donation techniques, to be undertaken as soon as possible after the end of:\n    (a) the period of 7 years starting on the commencement of Schedule 1 to the Mitochondrial Donation Law Reform (Maeve’s Law) Act 2022; and\n    (b) each subsequent 7‑year period.\n  (2) A review under this section is to be undertaken by persons chosen by the Minister, with the agreement of each State.\n  (3) The persons undertaking a review under this section must prepare and give to the Minister, for presentation to the Parliament, a report of the review.\n  (4) The report must be given to the Minister within 12 months after the end of the relevant 7‑year period.\n\n> Note: See also section 34C of the Acts Interpretation Act 1901, which contains extra rules about periodic reports.\n\n  (5) The persons undertaking a review under this section must consult:\n    (a) the Commonwealth and the States; and\n    (b) a broad range of persons with expertise in or experience of relevant disciplines;\n  and the views of the Commonwealth, the States and the persons mentioned in paragraph (b) must be set out in the report to the extent that it is reasonably practicable to do so.","sortOrder":32},{"sectionNumber":"Division 2","sectionType":"division","heading":"Regulations","content":"An Act to prohibit human cloning for reproduction and other unacceptable practices associated with reproductive technology, and for related purposes\n\n## Part 1—Preliminary\n\n#### 1 Short title\n\n  This Act may be cited as the Prohibition of Human Cloning for Reproduction Act 2002.\n\n#### 2 Commencement\n\n  (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table.\n\n```html\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:344.85pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commencement information</span></p></td></tr><tr><td style=\"width:74.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:68.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:74.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Provision(s)</span></p></td><td style=\"width:180.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commencement</span></p></td><td style=\"width:68.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Date/Details</span></p></td></tr></thead><tbody><tr><td style=\"width:74.35pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1.</span><span> </span><span>Sections</span><span> </span><span>1 and 2 and anything in this Act not elsewhere covered by this table</span></p></td><td style=\"width:180.7pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>The day on which this Act receives the Royal Assent</span></p></td><td style=\"width:68.4pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span><span> </span><span>December 2002</span></p></td></tr><tr><td style=\"width:74.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>2.</span><span> </span><span>Sections</span><span> </span><span>3 to 26 and Schedule</span><span> </span><span>1</span></p></td><td style=\"width:180.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>The 28th day after the day on which this Act receives the Royal Assent</span></p></td><td style=\"width:68.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span><span> </span><span>January 2003</span></p></td></tr></tbody></table>\n```\n\n> Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent.\n\n  (2) Column 3 of the table is for additional information that is not part of this Act. This information may be included in any published version of this Act.\n\n#### 3 Object of Act\n\n  The object of this Act is to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos by prohibiting certain practices.\n\n#### 4 Operation of Act\n\n  (1) This Act applies as follows:\n    (a) to things done, or omitted to be done, by constitutional corporations;\n    (b) to things done, or omitted to be done, in the course of constitutional trade or commerce;\n    (c) to matters within the legislative power of the Commonwealth under paragraph 51(xxix) of the Constitution;\n    (d) to the Commonwealth and Commonwealth authorities;\n    (e) for purposes relating to the collection, compilation, analysis and dissemination of statistics;\n    (f) to matters within the legislative power of the Commonwealth under paragraph 51(xxxix) of the Constitution, so far as it relates to the matters mentioned in paragraphs (a) to (e) of this subsection.\n\n> Note: See also section 28B of the Research Involving Human Embryos Act 2002 in relation to mitochondrial donation licences.\n\n  (2) In this section:\n\n> constitutional corporation means a trading, foreign or financial corporation within the meaning of paragraph 51(xx) of the Constitution.\n\n> constitutional trade or commerce means trade or commerce:\n\n    (a) between Australia and places outside Australia; or\n    (b) among the States; or\n    (c) by way of the supply of services to the Commonwealth or to a Commonwealth authority.\n\n#### 5 Act to bind the Crown\n\n  (1) This Act binds the Crown in each of its capacities.\n  (2) Nothing in this Act renders the Crown liable to be prosecuted for an offence.\n\n#### 6 External Territories\n\n  This Act extends to every external Territory.\n\n#### 8 Definitions\n\n  (1) In this Act:\n\n> animal does not include a human.\n\n> chimeric embryo means:\n\n    (a) a human embryo into which a cell, or any component part of a cell, of an animal has been introduced; or\n    (b) a thing declared by the regulations to be a chimeric embryo.\n\n> Commonwealth authority means the following:\n\n    (a) a body corporate established for a public purpose by or under an Act;\n    (b) a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together:\n    (i) the Commonwealth;\n    (ii) a body covered by paragraph (a);\n    (iii) a body covered by either of the above subparagraphs.\n\n> excess ART embryo means a human embryo that:\n\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:\n    (i) the woman for whom it was created; and\n    (ii) her spouse (if any) at the time the embryo was created.\n\n> general licence has the same meaning as in Part 2 of the Research Involving Human Embryos Act 2002.\n\n> human embryo means a discrete entity that has arisen from either:\n\n    (a) the first mitotic division when fertilisation of a human oocyte by a human sperm is complete; or\n    (b) any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears;\n  and has not yet reached 8 weeks of development since the first mitotic division.\n\n> human embryo clone means a human embryo that is a genetic copy of another living or dead human, but does not include a human embryo created by the fertilisation of a human egg by human sperm.\n\n> human sperm includes human spermatids.\n\n> hybrid embryo means:\n\n    (a) an embryo created by the fertilisation of a human egg by animal sperm; or\n    (b) an embryo created by the fertilisation of an animal egg by human sperm; or\n    (c) a human egg into which the nucleus of an animal cell has been introduced; or\n    (d) an animal egg into which the nucleus of a human cell has been introduced; or\n    (e) a thing declared by the regulations to be a hybrid embryo.\n\n> mitochondrial donation licence means any of the following licences issued under section 28J of the Research Involving Human Embryos Act 2002:\n\n    (a) a pre‑clinical research and training licence;\n    (b) a clinical trial research and training licence;\n    (c) a clinical trial licence;\n    (d) a clinical practice research and training licence;\n    (e) a clinical practice licence.\n\n> mitochondrial donation technique has the same meaning as in Part 2 of the Research Involving Human Embryos Act 2002.\n\n> NHMRC Licensing Committee means the Committee established under section 13 of the Research Involving Human Embryos Act 2002.\n\n> precursor cell means a cell that has the potential to develop into a human egg or human sperm.\n\n> spouse, in relation to a person, includes a de facto partner of the person within the meaning of the Acts Interpretation Act 1901.\n\n> State includes the Australian Capital Territory and the Northern Territory.\n\n> woman means a female human.\n\n  (2) For the purposes of establishing that a human embryo clone is a genetic copy of a living or dead human:\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  (3) For the purposes of the definition of human embryo in subsection (1), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n  (4) For the purposes of the definition of human embryo clone in subsection (1), 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  (5) For the purposes of paragraph (b) of the definition of excess ART embryo, a human embryo is excess to the needs of the persons mentioned in that paragraph at a particular time if:\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.\n  (6) A reference in this Act to an embryo (including a human embryo) is a reference to a living embryo.\n  (7) A reference in this Act to a human egg is a reference to a human oocyte.\n  (8) A reference in this Act to a human embryo does not include a reference to:\n    (a) a hybrid embryo; or\n    (b) a human embryonic stem cell line.\n\n## Part 2—Prohibited practices\n\n#### 9 Offence—placing a human embryo clone in the human body or the body of an animal\n\n  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.\n\nPenalty: Imprisonment for 15 years.\n\n> Note: 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 14.\n\n#### 10 Offence—importing or exporting a human embryo clone\n\n  (1) A person commits an offence if the person intentionally imports a human embryo clone into Australia.\n\nPenalty: Imprisonment for 15 years.\n\n  (2) A person commits an offence if the person intentionally exports a human embryo clone from Australia.\n\nPenalty for contravention of this subsection: Imprisonment for 15 years.\n\n#### 11 No defence that human embryo clone could not survive\n\n  It is not a defence to an offence under section 9 or 10 that the human embryo clone did not survive or could not have survived.\n\n#### 12 Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman or the purposes of a mitochondrial donation licence\n\n  (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 either or both of the following apply:\n    (a) the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman;\n    (b) the creation of the embryo by the person is permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n  (2) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (1) of this section.\n\n#### 13 Offence—creating or developing a human embryo by fertilisation that contains genetic material provided by more than 2 persons\n\n  A person commits an offence if:\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; and\n    (c) the creation or development of the human embryo by the person is not permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n#### 14 Offence—developing a human embryo outside the body of a woman for more than 14 days\n\n  A person commits an offence if the person intentionally develops a human embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended.\n\nPenalty: Imprisonment for 15 years.\n\n#### 15 Offence—heritable alterations to genome\n\n  (1) A person commits an offence if:\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; and\n    (c) the alteration of the genome by the person is not permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n  (2) In this section:\n\n> human cell includes a human embryonal cell, a human fetal cell, human sperm or a human egg.\n\n#### 16 Offence—collecting a viable human embryo from the body of a woman\n\n  A person commits an offence if the person removes a human embryo from the body of a woman, intending to collect a viable human embryo.\n\nPenalty: Imprisonment for 15 years.\n\n#### 17 Offence—creating a chimeric embryo\n\n  A person commits an offence if the person intentionally creates a chimeric embryo.\n\nPenalty: Imprisonment for 15 years.\n\n#### 18 Offence—developing a hybrid embryo\n\n  A 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.\n\nPenalty: Imprisonment for 15 years.\n\n#### 19 Offence—placing of an embryo\n\n  (1) A person commits an offence if the person intentionally places a human embryo in an animal.\n\nPenalty: Imprisonment for 15 years.\n\n  (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.\n\nPenalty: Imprisonment for 15 years.\n\n  (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.\n\nPenalty for contravention of this subsection: Imprisonment for 15 years.\n\n#### 20 Offence—importing, exporting or placing a prohibited embryo\n\n  (1) A person commits an offence if the person intentionally imports an embryo into Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo.\n\nPenalty: Imprisonment for 15 years.\n\n  (2) A person commits an offence if the person intentionally exports an embryo from Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo.\n\nPenalty: Imprisonment for 15 years.\n\n  (3) 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, unless:\n    (a) the embryo is a prohibited embryo under paragraph (a), (c) or (f) of the definition of that expression in subsection (4); and\n    (b) the placement of the embryo by the person is permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 15 years.\n\n  (4) In this section:\n\n> prohibited embryo means:\n\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 15) 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.\n  (5) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (3) of this section.\n\n#### 21 Offence—commercial trading in human eggs, human sperm or human embryos\n\n  (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.\n\nPenalty: Imprisonment for 15 years.\n\n  (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.\n\nPenalty: Imprisonment for 15 years.\n\n  (3) In this section:\n\n> reasonable expenses:\n\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:\n    (i) does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo; and\n    (ii) includes, but is not limited to, expenses relating to the storage or transport of the embryo.\n\n> 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\n#### 22 Offence—creating a human embryo other than by fertilisation, or developing such an embryo\n\n  A person commits an offence if:\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 general licence or permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 10 years.\n\n> Note 1: The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 14.\n\n> Note 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 9 and 20.\n\n#### 23 Offence—creating or developing a human embryo containing genetic material provided by more than 2 persons\n\n  A person commits an offence if:\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 general licence or permitted under section 28B of the Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).\n\nPenalty: Imprisonment for 10 years.\n\n> Note 1: The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 14.\n\n> Note 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 20.\n\n#### 23A Offence—using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo\n\n  A person commits an offence if:\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 general licence, and the person knows or is reckless as to that fact.\n\nPenalty: Imprisonment for 10 years.\n\n#### 23B Offence—creating a hybrid embryo\n\n  (1) A person commits an offence if the person intentionally creates a hybrid embryo.\n\nPenalty: Imprisonment for 10 years.\n\n  (2) A person commits an offence if the person intentionally develops a hybrid embryo.\n\nPenalty: Imprisonment for 10 years.\n\n  (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 general licence.\n\n> Note: A general licence to create or develop a hybrid embryo can only be issued under section 21 of the Research Involving Human Embryos Act 2002:\n\n    (a) for the purposes of testing sperm quality in an accredited ART centre—up to, but not including, the first mitotic division; or\n    (b) in the case of hybrid embryo created by introducing the nucleus of a human cell into an animal egg—for not longer than 14 days.\n\n#### 23BA Person not liable for conduct purportedly authorised\n\n  (1) To avoid doubt, a person is not criminally responsible for a licence offence in respect of particular conduct if:\n    (a) the conduct by the person is purportedly authorised by a provision of a general licence or a mitochondrial donation 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.\n  (2) In this section:\n\n> general licence includes a purported general licence.\n\n> licence offence means:\n\n    (a) for a general licence—an offence against section 22, 23, 23A or 23B; or\n    (b) for a mitochondrial donation licence—an offence against section 12, 13 or 15, subsection 20(3), or section 22 or 23.\n\n> mitochondrial donation licence includes a purported mitochondrial donation licence.\n\n#### 23C Regulations under Customs Act\n\n  The Minister who administers the Customs Act 1901 must take all reasonable steps to ensure that regulations are made, within 6 months after the commencement of this section, permitting, subject to appropriate conditions or restrictions, the import and export of human embryonic stem cell lines which have been derived from human embryo clones using practices consistent with Australian legislation.\n\n## Part 3—Commonwealth/State arrangements\n\n#### 24 Operation of State laws\n\n  This Act is not intended to exclude the operation of any law of a State, to the extent that the law of the State is capable of operating concurrently with this Act.\n\n## Part 4—Review provision and regulations\n\n### Division 1—Review of Act\n\n#### 25 Review of operation of Act every 7 years\n\n  (1) The Minister must cause an independent review of the operation of this Act, in so far as it relates to the use of mitochondrial donation techniques, to be undertaken as soon as possible after the end of:\n    (a) the period of 7 years starting on the commencement of Schedule 1 to the Mitochondrial Donation Law Reform (Maeve’s Law) Act 2022; and\n    (b) each subsequent 7‑year period.\n  (2) A review under this section is to be undertaken by persons chosen by the Minister, with the agreement of each State.\n  (3) The persons undertaking a review under this section must prepare and give to the Minister, for presentation to the Parliament, a report of the review.\n  (4) The report must be given to the Minister within 12 months after the end of the relevant 7‑year period.\n\n> Note: See also section 34C of the Acts Interpretation Act 1901, which contains extra rules about periodic reports.\n\n  (5) The persons undertaking a review under this section must consult:\n    (a) the Commonwealth and the States; and\n    (b) a broad range of persons with expertise in or experience of relevant disciplines;\n  and the views of the Commonwealth, the States and the persons mentioned in paragraph (b) must be set out in the report to the extent that it is reasonably practicable to do so.\n\n### Division 2—Regulations\n\n#### 26 Regulations\n\n  (1) The Governor‑General may make regulations prescribing matters:\n    (a) required or permitted by this Act to be prescribed; or\n    (b) necessary or convenient to be prescribed for carrying out or giving effect to this Act.\n  (2) Before the Governor‑General makes regulations under this Act, the Minister must be satisfied that:\n    (a) the States have been consulted in relation to the proposed regulations; and\n    (b) the proposed regulations have been prepared having regard to views expressed by the States in those consultations.","sortOrder":33},{"sectionNumber":"26","sectionType":"section","heading":"Regulations","content":"#### 26 Regulations\n\n  (1) The Governor‑General may make regulations prescribing matters:\n    (a) required or permitted by this Act to be prescribed; or\n    (b) necessary or convenient to be prescribed for carrying out or giving effect to this Act.\n  (2) Before the Governor‑General makes regulations under this Act, the Minister must be satisfied that:\n    (a) the States have been consulted in relation to the proposed regulations; and\n    (b) the proposed regulations have been prepared having regard to views expressed by the States in those consultations.","sortOrder":34}],"analysis":{"kimi_summary":{"_metrics":{"completionTokens":892},"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":true,"description":"The original 2002 Act focused on prohibiting human cloning and unacceptable embryo practices. The 2022 amendments (Mitochondrial Donation Law Reform (Maeve's Law) Act 2022) significantly expanded the scope by creating a detailed licensing framework for mitochondrial donation techniques — effectively permitting certain previously prohibited activities under strict conditions. This transformed the Act from a purely prohibitory statute to one that also regulates and permits specific therapeutic interventions, requiring new review mechanisms (7-yearly reviews specifically for mitochondrial donation) and extensive cross-referencing to the companion Research Involving Human Embryos Act 2002."},"complexity_factors":["Extensive cross-referencing to the Research Involving Human Embryos Act 2002 (definitions, licensing schemes, and section 28B exceptions)","Multiple overlapping offence categories with similar elements but different penalties (15 years vs 10 years)","Technical scientific definitions including 'mitotic division', 'primitive streak', 'nuclear genome', and 'precursor cells'","Nested exceptions within exceptions — particularly the mitochondrial donation licence framework added by 2022 amendments","Conditional mental elements ('intentionally', 'knowing that, or reckless as to whether') that vary by offence","Special evidentiary rules reversing normal Criminal Code burdens in sections 12 and 20","Complex definition of 'prohibited embryo' with 8 separate categories in section 20(4)"],"plain_english_summary":"**What this law does**\n\nThis Act bans human cloning for reproduction and other ethically controversial practices involving human embryos, eggs, and sperm. It creates serious criminal offences (up to 15 years imprisonment) for activities that Parliament considers unacceptable in reproductive technology.\n\n**Who it affects**\n\n- **Scientists and fertility clinics** — anyone conducting research or treatment involving human embryos\n- **Medical professionals** — involved in assisted reproductive technology (ART)\n- **Patients** — seeking fertility treatment\n- **Researchers** — working with stem cells, embryos, or genetic material\n\n**What is banned (key prohibitions)**\n\n| Offence | Penalty |\n|---------|---------|\n| Placing a cloned human embryo in a human or animal | 15 years |\n| Importing or exporting human embryo clones | 15 years |\n| Creating embryos outside a woman's body for purposes other than achieving pregnancy (with limited exceptions) | 15 years |\n| Creating embryos with genetic material from more than 2 people | 15 years |\n| Developing embryos outside a woman's body for more than 14 days | 15 years |\n| Making heritable genetic changes (changes passed to descendants) | 15 years |\n| Removing viable embryos from a woman's body | 15 years |\n| Creating \"chimeric embryos\" (human embryos with animal cells) | 15 years |\n| Developing \"hybrid embryos\" (human-animal combinations) beyond 14 days | 15 years |\n| Placing human embryos in animals or in humans outside the reproductive tract | 15 years |\n| Commercial trading in human eggs, sperm, or embryos | 15 years |\n| Creating embryos by methods other than egg-sperm fertilisation (without a licence) | 10 years |\n\n**Important exceptions**\n\n- **Mitochondrial donation** — The Act was amended in 2022 to allow licences for mitochondrial donation techniques (a procedure to prevent inherited mitochondrial disease), with strict safeguards\n- **Research licences** — Some activities can be authorised under a \"general licence\" from the NHMRC Licensing Committee under the *Research Involving Human Embryos Act 2002*\n- **Reasonable expenses** — Paying for collection, storage, and transport costs is allowed; only \"valuable consideration\" (profit or inducements) is banned\n\n**Why it matters**\n\nThis law draws ethical boundaries around rapidly advancing reproductive and genetic science. It aims to prevent exploitation, protect human dignity, and ensure Australia doesn't become a destination for reproductive practices banned elsewhere — while allowing carefully regulated research that may lead to treatments for disease."},"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"},"issue_detection":{"absurdities":[{"type":"circular_definition","section":"8(1) definition of 'human embryo clone' and 8(2)","severity":"high","reasoning":"The definition of 'human embryo clone' relies on the concept of 'genetic copy' to convey precision, but s.8(2)(b) drains that concept of its ordinary meaning by negating the requirement for identity. The result is a criminal prohibition whose outer boundary is undefined — regulators and courts cannot determine how much genetic divergence is permissible before an embryo ceases to be a 'clone'. This creates impossible compliance for scientists and prosecutors alike.","confidence":0.88,"description":"A 'human embryo clone' is defined as a 'genetic copy' of another human, but subsection 8(2) explicitly states it is NOT necessary to establish that the copy is an 'identical genetic copy'. This means a non-identical genetic copy qualifies as a 'genetic copy' for purposes of criminal liability, rendering the word 'copy' semantically void and potentially capturing embryos with significant genetic divergence from any source human."},{"type":"circular_definition","section":"8(1) definition of 'human embryo' and 8(8)(a)","severity":"medium","reasoning":"A hybrid embryo under paragraph (d) of the hybrid embryo definition — an animal egg with a human nucleus — possesses a human nuclear genome and initiates organised development, satisfying the substantive limb of 'human embryo' under s.8(1)(b). The Act then carves it out via s.8(8)(a). While Parliament's intent is clear, the definitional structure is logically circular: an entity both meets and is excluded from the same definition simultaneously, creating interpretive difficulty about which provisions apply when an embryo straddles both categories.","confidence":0.75,"description":"Section 8(1) defines 'human embryo' to include entities arising from 'any other process that initiates organised development of a biological entity with a human nuclear genome'. Section 8(8)(a) then expressly excludes hybrid embryos from the definition of 'human embryo'. However, a hybrid embryo created by introducing a human cell nucleus into an animal egg (s.8(1) definition of 'hybrid embryo' para (d)) would itself have a human nuclear genome and could satisfy the s.8(1) 'human embryo' definition — yet it is simultaneously excluded. This creates a classification paradox."},{"type":"impossible_compliance","section":"Section 23C","severity":"high","reasoning":"The Act simultaneously (a) criminalises creating and importing human embryo clones with 15-year penalties, and (b) mandates that the Minister facilitate regulations permitting import/export of products derived from human embryo clones consistent with Australian law. No stem cell line derived from a human embryo clone could have been produced consistent with Australian law because Australian law prohibits producing it. The section either demands facilitation of the fruits of criminality or is internally incoherent. Even reading 'consistent with' as referring to foreign practices consistent with Australian ethical standards doesn't resolve the paradox, as the Act provides no such standard.","confidence":0.85,"description":"Section 23C requires the Minister to ensure regulations permitting import/export of stem cell lines 'derived from human embryo clones using practices consistent with Australian legislation' are made within 6 months of commencement. This is self-referentially impossible: Australian legislation (this very Act) prohibits the creation, import and export of human embryo clones (ss.9, 10, 22). Stem cell lines derived from human embryo clones could not have been created using 'practices consistent with Australian legislation' because those practices are criminally prohibited by the same Act."},{"type":"other","section":"Section 17 vs Section 23B","severity":"medium","reasoning":"The asymmetry between the chimeric embryo prohibition (absolute, 15 years) and hybrid embryo prohibition (10 years, licence-defeasible) appears internally inconsistent. Both involve mixing human and animal genetic material. The Act permits licensed hybrid embryo research up to 14 days but provides zero authorised pathway for chimeric embryo research. This is arguably arbitrary and creates a regulatory gap that may impede legitimate science without logical justification from within the Act's own framework.","confidence":0.78,"description":"Section 17 makes creating a chimeric embryo a criminal offence carrying 15 years imprisonment with no exceptions whatsoever. Section 23B makes creating or developing a hybrid embryo an offence of only 10 years imprisonment, but provides a complete defence via general licence. There is no equivalent licence defence for chimeric embryo creation under s.17. The Act therefore treats chimeric embryo creation as categorically worse than hybrid embryo creation with zero pathway for authorised research, despite chimeric embryos potentially having significant legitimate research applications comparable to hybrid embryos."},{"type":"other","section":"Section 8(4) — embryo splitting deeming provision","severity":"low","reasoning":"In-vitro embryo splitting is the target of s.8(4), but the provision does not limit itself to artificial splitting. Natural twinning is also embryo splitting. A naturally-split embryo would be a 'genetic copy' of its twin and, by s.8(4), not created by fertilisation — technically meeting the definition of 'human embryo clone' in s.8(1). While prosecutorial discretion would prevent absurd prosecutions, the definitional structure inadvertently captures natural twins, which cannot have been Parliament's intent.","confidence":0.65,"description":"Section 8(4) deems that a human embryo produced by embryo splitting is 'taken not to be created by a process of fertilisation of a human egg by human sperm' for the purposes of the human embryo clone definition. Natural identical twins arise from embryo splitting and are genetic copies of each other. This deeming provision would technically classify one of a pair of naturally-occurring twins as a 'human embryo clone' of the other, since they are genetic copies not created by fertilisation under this deeming rule."},{"type":"impossible_compliance","section":"Section 16","severity":"medium","reasoning":"The actus reus is the physical removal of any embryo; the mens rea is intent to collect a viable one. The offence is therefore committed upon removal with the relevant intent, regardless of viability outcome. A fertility specialist removing a failing embryo who simultaneously hoped it would prove viable could theoretically satisfy both elements. There is no medical necessity or therapeutic purpose defence on the face of s.16, unlike the licensed exceptions in other sections.","confidence":0.72,"description":"Section 16 creates an offence of removing a human embryo from the body of a woman 'intending to collect a viable human embryo'. This means the offence is entirely intent-based. A person who removes an embryo for legitimate medical purposes (e.g., ectopic pregnancy surgery) but holds a concurrent subjective intention to collect a viable embryo would commit the offence, even if the clinical purpose is therapeutic. More absurdly, a person who removes a non-viable embryo while intending to collect a viable one commits the offence even though no viable embryo was or could be collected."},{"type":"other","section":"Section 25(1)","severity":"low","reasoning":"The section heading says 'Review of operation of Act every 7 years' but the substance reviews only one narrow amendment area (mitochondrial donation). This means the cloning prohibitions, chimeric embryo prohibitions, hybrid embryo prohibitions, commercial trading prohibitions and all other core provisions receive no mandatory parliamentary oversight review. This is a structural absurdity — the review provision for a prohibition Act reviews everything except the prohibitions.","confidence":0.82,"description":"Section 25 mandates an independent review of the operation of 'this Act' but then immediately limits the review scope to 'in so far as it relates to the use of mitochondrial donation techniques'. The Act's primary subject matter — prohibition of human cloning for reproduction — is entirely excluded from mandatory review. The review mechanism created for oversight of the Act does not actually review the Act's core purpose."}],"contradictions":[{"severity":"high","section_a":"Section 9 — placing a human embryo clone in the body of a human (15 years, absolute prohibition)","section_b":"Section 20(3) — exception permitting placement of prohibited embryos under mitochondrial donation licence","confidence":0.78,"description":"Section 9 absolutely prohibits placing a human embryo clone in a human body with no exceptions. Section 20(3) creates an exception permitting placement of a 'prohibited embryo' in a woman's body where authorised by a mitochondrial donation licence under s.28B of the Research Involving Human Embryos Act 2002. A human embryo clone is a 'prohibited embryo' under s.20(4)(a) (embryo created other than by fertilisation). It is also a 'prohibited embryo' under potentially s.20(4)(b). The mitochondrial donation licence exception in s.20(3) does not apply to s.20(4)(b) embryos but does apply to s.20(4)(a) embryos — which could include clones. This creates a tension where s.9 absolutely prohibits what s.20(3) may conditionally permit."},{"severity":"medium","section_a":"Section 17 — creating a chimeric embryo (15 years, no exceptions)","section_b":"Section 20(4)(h) and Section 20(3) — chimeric embryo as prohibited embryo with mitochondrial donation licence exception","confidence":0.65,"description":"Section 17 absolutely prohibits creating a chimeric embryo with no licence exception. Section 20(4)(h) defines a chimeric embryo as a 'prohibited embryo'. Section 20(3) then creates an exception for placing prohibited embryos in a woman's body where authorised by a mitochondrial donation licence — and this exception applies to embryos prohibited under paras (a), (c) or (f), not (h). However, the prohibited embryo definition at s.20(4)(h) includes chimeric embryos, and the interplay between the absolute creation prohibition in s.17 and the placement framework in s.20 is structurally dissonant: you can never lawfully create one, but the Act's placement offence regime acknowledges their possible existence by categorising them."},{"severity":"medium","section_a":"Section 13 — creating embryo by fertilisation with genetic material from more than 2 persons (15 years)","section_b":"Section 23 — creating embryo other than by fertilisation with genetic material from more than 2 persons (10 years)","confidence":0.85,"description":"The identical prohibited outcome — a human embryo containing genetic material from more than 2 persons — attracts a 15-year maximum sentence if achieved by fertilisation (s.13) but only a 10-year maximum if achieved by non-fertilisation processes (s.23). This is internally contradictory in policy terms: the more conventional and less technologically exotic method of achieving the same prohibited result is punished 50% more severely. The Act provides no rational basis within its text for this sentencing disparity."},{"severity":"medium","section_a":"Section 21(1)-(2) — prohibition on commercial trading in human embryos (15 years)","section_b":"Section 21(3) definition of 'reasonable expenses' for human embryo supply","confidence":0.8,"description":"Section 21 prohibits giving or receiving 'valuable consideration' for supply of a human embryo, but the definition of 'valuable consideration' expressly excludes 'reasonable expenses'. The definition of 'reasonable expenses' for embryo supply expressly excludes expenses incurred before the embryo became an 'excess ART embryo'. This means that ALL storage, creation and IVF costs incurred while the embryo was being created and maintained — which constitute the overwhelming majority of costs — are excluded from 'reasonable expenses' and cannot be recouped. Anyone who donates an excess ART embryo and is reimbursed for the substantial pre-excess costs commits an offence, making the 'reasonable expenses' carve-out largely illusory and commercially impossible to operationalise."},{"severity":"medium","section_a":"Section 5(1) — Act binds the Crown","section_b":"Section 5(2) — Crown not liable to prosecution","confidence":0.82,"description":"Section 5(1) states the Act binds the Crown 'in each of its capacities', creating an unqualified obligation. Section 5(2) then immunises the Crown from prosecution for offences. This is a structural contradiction: binding the Crown to a regime composed entirely of criminal offences while simultaneously immunising the Crown from the only enforcement mechanism creates a binding with no teeth. Commonwealth agencies could theoretically engage in prohibited conduct (e.g., creating chimeric embryos, commercial trading in embryos) with complete impunity, directly contradicting the binding in s.5(1)."},{"severity":"low","section_a":"Section 18 — developing a hybrid embryo for more than 14 days (10 years)","section_b":"Section 23B(2) — developing a hybrid embryo (10 years, but licence-defeasible)","confidence":0.68,"description":"Section 18 prohibits developing a hybrid embryo for more than 14 days with no licence exception on its face. Section 23B(2) prohibits developing a hybrid embryo generally but provides a complete licence defence under s.23B(3). A general licence under the Research Involving Human Embryos Act 2002 (per the Note to s.23B) can authorise hybrid embryo development for up to 14 days. These two sections overlap on the conduct of developing a hybrid embryo, but s.18 provides no licence exception while s.23B(3) does. If a person develops a hybrid embryo for exactly 14 days under a general licence, they may be acquitted under s.23B but the same conduct potentially constitutes the s.18 offence (if 'more than 14 days' is read as including day 14 under certain counting methods). More significantly, the existence of two separate offence provisions for the same conduct with different exception structures creates uncertainty about which section governs."}]},"summary":{"complexity_score":8,"scope_assessment":{"changed":true,"description":"The original 2002 Act was narrowly focused on prohibiting human reproductive cloning and a defined set of unacceptable embryo practices. Over time, the scope has meaningfully expanded through amendments. Most significantly, the Mitochondrial Donation Law Reform (Maeve's Law) Act 2022 introduced an entirely new category of permitted activity — mitochondrial donation techniques — with its own licensing regime, carve-outs from multiple offence provisions, and a new 7-year review cycle. This represents a substantive broadening of the Act beyond its original prohibitory intent into actively facilitating (under controlled conditions) a new reproductive technology. The addition of offences covering hybrid embryos (sections 23B) and precursor cells (section 23A) also expanded the prohibition side beyond the original cloning focus."},"complexity_factors":["Highly technical scientific terminology requiring precise legal definitions (e.g., 'first mitotic division', 'human nuclear genome', 'primitive streak', 'mitochondrial donation technique', 'precursor cells', 'spermatids')","Multiple interlocking offence provisions with different penalty tiers (15 years vs 10 years) and overlapping subject matter requiring careful cross-referencing","Extensive carve-outs and exceptions dependent on licences issued under a separate Act (Research Involving Human Embryos Act 2002), making the law impossible to understand in isolation","Complex constitutional law underpinning — the Act's scope is defined by reference to multiple heads of Commonwealth constitutional power (corporations power, trade and commerce, external affairs, etc.), limiting who the federal law can reach","The 'prohibited embryo' definition in section 20 has eight distinct sub-categories with different rules and exceptions applying to each","Amendments introducing mitochondrial donation (Maeve's Law 2022) have layered additional exceptions and licence types throughout existing offence provisions, creating a patchwork structure","The distinction between absolutely prohibited conduct and conditionally prohibited conduct (subject to licensing) requires careful parsing throughout","Cross-references to multiple external instruments: the Research Involving Human Embryos Act 2002, the Criminal Code, the Acts Interpretation Act 1901, the Customs Act 1901","Definitional complexities — e.g., a 'human embryo clone' is defined to exclude embryos created by fertilisation yet embryo splitting is explicitly brought back in; 'human embryo' excludes hybrid embryos and stem cell lines"],"plain_english_summary":"## What This Law Does\n\nThis Act is Australia's federal law banning human cloning and a range of other controversial practices involving human embryos (the earliest stage of human development, from fertilisation up to 8 weeks). It sets out a long list of things that are **absolutely forbidden** — and backs them up with serious criminal penalties of up to **15 years in prison**.\n\n## Who Does It Affect?\n\nThis law primarily affects:\n- **Scientists and medical researchers** working with human embryos, eggs, or sperm\n- **IVF (in vitro fertilisation) clinics** and fertility specialists\n- **Biotech companies** involved in reproductive technology\n- **Anyone** who might attempt to import or export cloned embryos\n\nFor most ordinary Australians, this law operates in the background — it's unlikely to directly affect your day-to-day life unless you work in reproductive medicine or research.\n\n## What Is Banned?\n\nThe following are **absolutely prohibited** (15 years jail):\n- **Reproductive cloning** — creating a genetic copy of a human and implanting it to create a baby\n- Importing or exporting human embryo clones\n- Creating IVF embryos for any purpose *other than* trying to achieve a pregnancy (you can't create embryos just for research using standard IVF)\n- Growing an embryo outside the womb for **more than 14 days**\n- Making **heritable genetic changes** (i.e., gene edits that would be passed on to future generations) — think CRISPR-style edits on embryos\n- Creating **chimeric embryos** (mixing human and animal cells together in an embryo)\n- Placing a human embryo inside an animal, or an animal embryo inside a human\n- **Buying or selling** eggs, sperm, or embryos (though reimbursing reasonable out-of-pocket expenses is allowed)\n- Collecting a viable embryo from a woman's body\n\nSome activities carry a slightly lower penalty of **10 years jail**, such as creating embryos through non-standard means (e.g., cloning techniques) without a licence, creating part-human/part-animal embryos (\"hybrid embryos\") without a licence, or using foetal cells to create embryos without a licence.\n\n## Important Exceptions — Licensed Research\n\nNot everything is an outright ban. Some of the above activities **can be done legally if you hold the right licence** from the NHMRC Licensing Committee (a government body that oversees embryo research). For example:\n- Researchers with a **general licence** can create embryos by non-standard means (like cloning techniques) for approved research\n- **Mitochondrial donation** — a medical technique that helps women with certain genetic diseases have healthy children by using a small amount of DNA from a donor egg — is now permitted under special licences (added by the *Maeve's Law* reforms in 2022)\n- Hybrid embryos can be created in limited circumstances (e.g., to test sperm quality at fertility clinics, but only up to a very early stage of development)\n\nIf someone acts under a licence that later turns out to be technically invalid through no fault of their own, they won't face criminal prosecution.\n\n## The Mitochondrial Donation Addition\n\nA significant update came through the *Mitochondrial Donation Law Reform (Maeve's Law) Act 2022*, which carved out carefully controlled exceptions for mitochondrial donation techniques. This is a procedure that can prevent inherited diseases passed through mitochondria (tiny energy-producing structures in cells). The law now requires an independent review every 7 years to assess how this is working.\n\n## State Laws Still Apply\n\nThis is a federal law but it **doesn't override State laws** — States can have their own additional rules on top of this, and they do (most States have mirror legislation).\n\n## Bottom Line\n\nAustralia takes a firm \"yes to carefully regulated fertility treatment and approved research, **no** to reproductive cloning and ethically unacceptable practices\" approach. The penalties are severe, reflecting how seriously Parliament treats these issues."},"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":true,"description":"The Act as presented includes express carve‑outs and cross‑references that narrow some original prohibitions by allowing activities authorised under licences in the Research Involving Human Embryos Act 2002 (notably mitochondrial donation licences and general licences). Examples: s 12(1)(b), s 13(c) and s 15(c) permit certain conduct if authorised under section 28B of the Research Involving Human Embryos Act 2002; s 22 and s 23B(3) similarly permit conduct authorised by a general licence. The Act also incorporates a statutory review mechanism specifically tied to the commencement of Schedule 1 to the Mitochondrial Donation Law Reform (Maeve’s Law) Act 2022 (s 25). Those features indicate the current scope is not an absolute, unconditional ban but a prohibition subject to a licensing and review architecture introduced (or made explicit) after the original enactment."},"complexity_factors":["Extensive technical definitions that determine offence scope (s 8: human embryo, clone, hybrid, chimeric embryo, precursor cell, excess ART embryo).","Multiple, detailed criminal offences with differing maxima (s 9–23B) and cross‑references to another Act for authorised exceptions (Research Involving Human Embryos Act 2002, cited in s 12(1)(b), s 13(c), s 15(c), s 22, s 23B(3)).","Layered temporal and developmental thresholds (14‑day limit for ex‑vivo development in s 14; 8‑week upper bound in the human embryo definition in s 8(1); suspended development periods disregarded in s 8(3)).","Mixed mens rea standards: offences require intent, knowledge or recklessness in places (e.g. s 9, s 10, s 20), and evidentiary allocations are specifically altered (s 12(2), s 20(5)).","Intergovernmental and jurisdictional design — application to constitutional corporations and interstate/international trade (s 4), extension to external Territories (s 6), and a non‑exclusion clause for State laws (s 24).","Administrative and regulatory requirements that require State consultation and Ministerial satisfaction before regulations (s 26) and a statutory duty on the Customs Minister (s 23C).","Procedural safe‑harbour for those relying on licences that are invalid but reasonably believed valid (s 23BA), adding interpretive complexity for licence holders and regulators.","Periodic review process tied to later legislative change (Maeve’s Law reference in s 25), which layers temporal obligations onto the regulatory regime."],"plain_english_summary":"What this law does, in plain steps\n\n- Creates criminal offences for a range of activities involving human embryos, embryo clones, hybrid embryos and chimeric embryos, and for certain genetic manipulations and commercial trading in human gametes or embryos. Many offences carry a maximum penalty of 15 years’ imprisonment; some carry 10 years (see s 9–23B).\n\n- Defines key terms used to apply those offences (for example: what counts as a human embryo, a human embryo clone, a hybrid embryo, a chimeric embryo, precursor cell, excess ART embryo) so the prohibitions are tied to those technical definitions (see s 8).\n\n- Limits the Act’s reach to conduct within Commonwealth legislative power and to activity by constitutional corporations, interstate or international trade/service supply, the Commonwealth and Commonwealth authorities, and extends to external Territories (s 4, s 6).\n\n- Provides that the Act binds the Crown but does not make the Crown liable to criminal prosecution (s 5).\n\n- Requires regulatory instruments and intergovernmental consultation: the Governor‑General may make regulations (s 26) and the Minister must seek State agreement on certain rules (s 26(2)); the Customs minister must pursue regulations permitting, subject to conditions, the import/export of human embryonic stem cell lines derived from embryo clones consistent with Australian law (s 23C).\n\nHow it works mechanically (who decides, who pays, and what changes in behaviour)\n\n- Who decides: Ministers, the Governor‑General (for regulations) and licensing bodies established under the Research Involving Human Embryos Act 2002 (referred to here as general licences and mitochondrial donation licences) determine what otherwise‑prohibited activities may be authorised (see cross‑references in s 12(1)(b), s 13(c), s 15(c), s 22 and s 23B(3)). The NHMRC Licensing Committee is referenced by definition (s 8). Independent reviewers are appointed by the Minister (with State agreement) for periodic review duties (s 25).\n\n- Who pays / bears cost: persons and organisations carrying out embryo research or assisted‑reproduction activities face the compliance burden of avoiding prohibited conduct or securing licences where permitted. Criminal penalties (imprisonment) function as the primary enforcement cost; indirect costs include licence application and compliance administration, adjusted procedures to avoid prohibited practices (record keeping, proof of intent, lab controls), and possible relocation of work offshore if activities cannot be authorised domestically.\n\n- Behavioural changes required: clinics, researchers and traders must avoid creating or using embryos in ways the Act defines as prohibited (examples include placing a human embryo clone in a body (s 9), importing/exporting embryo clones (s 10), creating embryos for non‑pregnancy purposes without permitted licence (s 12), developing embryos outside a woman beyond 14 days (s 14), heritable genome edits (s 15), creating chimeric or hybrid embryos except where a general licence applies (s 17, s 18, s 23B), and commercial trading for valuable consideration except reasonable expenses (s 21)). They must rely on licences expressly authorised in the Research Involving Human Embryos Act 2002 where the Act permits.\n\nOfficial purpose claim and the practical trade‑offs\n\n- The Act states its object is to address (including ethical) concerns about scientific developments in human reproduction and use of embryos by prohibiting certain practices (s 3). That is the stated rationale rather than a factual finding about effects.\n\n- Practical trade‑offs visible in the text:\n  - Concentrated obligations and enforcement: the Act imposes criminal sanctions on identifiable actors (researchers, clinicians, importers/exporters, suppliers) (see the offence provisions s 9–23B). This concentrates costs on those who perform or authorise the activities.\n  - Regulatory carve‑outs and administrative control: several prohibitions are subject to express exceptions where activities are authorised by licences under the Research Involving Human Embryos Act 2002 (see s 12(1)(b), s 13(c), s 15(c), s 22, s 23). That channels some activity into a licensing regime, shifting decision‑making to regulators and imposing administrative compliance costs on applicants.\n  - Enforcement and evidentiary design choices: the Act removes some potential defences (e.g. it is not a defence that an embryo clone could not survive; s 11) and explicitly states that defendants do not bear an evidential burden for certain matters (s 12(2), s 20(5)), affecting litigation strategy and proof burdens.\n  - Jurisdictional complexity: the Act applies to constitutional corporations and interstate/international trade and contemplates concurrent State laws (s 4, s 24), so enforcement and regulatory coordination involve Commonwealth/State interaction.\n\nCosts, incentives and implementation risks\n\n- Compliance burden and costs: entities that work with embryos or gametes must invest in compliance systems, licence applications where relevant, and documentation of intent (because many offences hinge on intent or knowledge). The commercial‑trading ban (s 21) allows reimbursement of reasonable expenses but prohibits valuable consideration, so organisations must structure donor payments and record keeping to fit that exception.\n\n- Incentives: strong criminal penalties create a deterrent against experimental or commercial activity outside the licence framework. At the same time, the licence exceptions create an incentive to seek formal authorisation rather than operate covertly.\n\n- Implementation risks: technical determinations the Act requires (for example, whether an embryo “contains genetic material provided by more than 2 persons,” whether a genome alteration is heritable, or whether embryo development exceeded 14 days excluding suspended periods) may be scientifically complex and litigation‑prone (see definitions and s 8, s 14, s 15). Cross‑agency and intergovernmental coordination is required (s 26, s 25) and could delay or complicate rulemaking and licensing decisions.\n\nPotential substitution effects and opportunity costs\n\n- Research and services that fall within prohibitions but are permitted elsewhere may move offshore if licensing is unavailable or too slow, producing an opportunity cost for domestic scientific activity. Conversely, the licensing route preserves a domestic channel for some techniques (see the multiple references to activities permitted under section 28B of the Research Involving Human Embryos Act 2002 in s 12, s 13, s 15 and others).\n\nKey cross‑references and procedural safeguards in the Act\n\n- Licence exceptions: s 12(1)(b), s 13(c), s 15(c), s 22, s 23B(3) link prohibited activities to permissions under the Research Involving Human Embryos Act 2002 (mitochondrial donation licences and general licences).\n- Licence invalidity safe‑harbour: s 23BA protects a person from licence offences where the conduct was purportedly authorised by an invalid licence and the person did not know (and could not reasonably be expected to know) of the invalidity.\n- Customs regulation duty: s 23C directs the Customs minister to pursue regulations permitting import/export of certain human embryonic stem cell lines under conditions.\n- Periodic review: s 25 requires independent seven‑yearly reviews (with State agreement) of the Act insofar as it relates to mitochondrial donation techniques, and a report to Parliament.\n- Regulatory rule‑making: s 26 requires State consultation before regulations are made.\n\nBottom line (mechanical effect)\n\nThe Act makes a detailed set of reproductive and embryo‑related practices criminal offences, defines the technical scope of those offences, and channels any permitted exceptions into a licensing and regulatory regime (cross‑referencing the Research Involving Human Embryos Act 2002). It assigns enforcement and rule‑making roles to Commonwealth ministers and licensing bodies, places heavy criminal penalties on prohibited conduct, and builds in procedural features (licence exceptions, evidentiary rules, review cycles, and State consultation requirements) that shape compliance costs, administrative discretion and the likely behaviour of researchers, clinicians and commercial actors. (See especially s 3, s 4, s 8, s 9–23B, s 23BA, s 23C, s 25 and s 26.)"}},"importantCases":[],"_links":{"self":"/api/acts/prohibition-of-human-cloning-for-reproduction-act-2002","history":"/api/acts/prohibition-of-human-cloning-for-reproduction-act-2002/history","analysis":"/api/acts/prohibition-of-human-cloning-for-reproduction-act-2002/analysis","conflicts":"/api/acts/prohibition-of-human-cloning-for-reproduction-act-2002/conflicts","importantCases":"/api/acts/prohibition-of-human-cloning-for-reproduction-act-2002/important-cases","documents":"/api/acts/prohibition-of-human-cloning-for-reproduction-act-2002/documents"}}