Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Act 2003
In ForceQLD
Jurisdiction
Queensland
Act Number
7 of 2003
Collection
act
Plain English Summary
8/10 complexity
The Act makes a range of embryo‑related activities criminal (for example placing cloned embryos, creating chimeras or heritable genome edits, developing embryos beyond 14 days, or commercial trading) and sets penalties up to 15 years. It also creates a licence regime run by the NHMRC Licensing Committee to allow limited research or ART uses subject to consent, conditions and HREC approval (s3; ss7–20A,28–37).
Practical effect: researchers and ART centres bear licensing, consent, reporting and inspection burdens; the Committee, HRECs and magistrates exercise key discretion over authorisations and warrants (ss29–34,32,43–45A).
This Act establishes criminal prohibitions and a licensing regime governing work with human embryos, certain non‑standard embryos, and human gametes. It does two mechanical things: first, it prescribes a set of absolute criminal prohibitions (part 2) on activities such as placing a human embryo clone into a human or animal, creating embryos outside the body except to achieve pregnancy in a specified woman, developing embryos outside a woman for more than 14 days, making heritable genome alterations, creating chimeric or hybrid embryos, removing viable embryos from a woman with an intent to collect them, and commercial trading in eggs, sperm or embryos (see ss 7-17). Many of those prohibitions carry maximum custodial penalties up to 15 years (see ss 7-17).
Second, the Act creates a licensing and oversight framework for certain otherwise prohibited activities (part 3). The NHMRC Licensing Committee decides licence applications (ss 26-29), and licences may authorise limited uses of excess ART embryos, creation or use of embryos by means other than fertilisation, creation of embryos containing genetic material from more than two persons, creation using precursor cells from embryos or fetuses, limited research on fertilisation up to the first mitotic division for ART training, and narrow hybrid embryo use for sperm testing in accredited ART centres (ss 28-29). Licences are subject to conditions including written "proper consent" as defined by NHMRC guidelines and reporting to the Committee (s 32). The Committee must publish a public database of licences, while protecting confidential commercial information (s 37; s 38). Inspectors are empowered to monitor compliance, including entry with consent or warrant, search, seizure and copying of records, and securing items pending a warrant (ss 41-48; ss 45-45A). The Act also sets review and appeal routes for licensing decisions via the Administrative Review Tribunal where declared reviewable under regulations made under the corresponding Commonwealth Act (ss 39-40). The object of the law is stated as addressing ethical concerns about scientific developments related to human reproduction and embryos, by prohibiting certain practices and regulating others (s 3). Commencement provisions and amendment notes are provided, including the staged commencement of part 6 division 1 (s 2).
Current sections
Direct links to the current provisions in Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Act 2003.
79
pt.1
Preliminary
Preliminary
sec.1
Short title
sec.1 Short title
This Act may be cited as the Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Act 2003 .
s 1 amd 2007 No. 45 s 4
sec.2
Commencement
sec.2 Commencement
This Act, other than part 6 , division 1 , commences on a day to be fixed by proclamation.
Part 6 , division 1 , commences on whichever of the following days applies—
5 April 2005;
if the Council of Australian Governments declares an earlier day by notice in the gazette—that earlier day.
(sec.2-ssec.1) This Act, other than part 6 , division 1 , commences on a day to be fixed by proclamation.
(sec.2-ssec.2) Part 6 , division 1 , commences on whichever of the following days applies— 5 April 2005; if the Council of Australian Governments declares an earlier day by notice in the gazette—that earlier day.
(a) 5 April 2005;
(b) if the Council of Australian Governments declares an earlier day by notice in the gazette—that earlier day.
sec.3
Object of Act
sec.3 Object of Act
The object of this Act is to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos—
by prohibiting certain practices; and
by regulating activities that involve the use of certain human embryos created by assisted reproductive technology or by other means.
s 3 amd 2007 No. 45 s 5
(a) by prohibiting certain practices; and
(b) by regulating activities that involve the use of certain human embryos created by assisted reproductive technology or by other means.
sec.4
Act binds all persons
sec.4 Act binds all persons
This Act binds all persons, including the State, and, as far as the legislative power of the Parliament permits, the Commonwealth and the other States.
Nothing in this Act makes the Commonwealth or a State liable to be prosecuted for an offence.
(sec.4-ssec.1) This Act binds all persons, including the State, and, as far as the legislative power of the Parliament permits, the Commonwealth and the other States.
(sec.4-ssec.2) Nothing in this Act makes the Commonwealth or a State liable to be prosecuted for an offence.
sec.5
Definitions
sec.5 Definitions
The dictionary in the schedule defines particular words used in this Act.
For the purposes of establishing that a human embryo clone is a genetic copy of a living or dead human—
it is sufficient to establish that the set of genes in the nuclei of the cells of the living or dead human has been copied; and
it is not necessary to establish that the copy is an identical genetic copy.
For the purposes of the definition human embryo in the schedule, in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.
For the purposes of the definition human embryo clone in the schedule, a human embryo that results from the technological process known as embryo splitting is taken not to be created by a process of fertilisation of a human egg by human sperm.
A reference in this Act to an embryo (including a human embryo) is a reference to a living embryo.
A reference in this Act to a human egg is a reference to a human oocyte.
A reference in this Act to a human embryo does not include a reference to—
a hybrid embryo; or
a human embryonic stem cell line.
The following provisions of the Acts Interpretation Act 1954 do not apply to a reference to a spouse in this Act—
section 32DA (6)
schedule 1 , definition spouse .
s 5 amd 2007 No. 45 s 6 ; 2013 No. 39 s 110 (1) sch 3 pt 1
(sec.5-ssec.1) The dictionary in the schedule defines particular words used in this Act.
(sec.5-ssec.2) For the purposes of establishing that a human embryo clone is a genetic copy of a living or dead human— it is sufficient to establish that the set of genes in the nuclei of the cells of the living or dead human has been copied; and it is not necessary to establish that the copy is an identical genetic copy.
(sec.5-ssec.3) For the purposes of the definition human embryo in the schedule, in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.
(sec.5-ssec.4) For the purposes of the definition human embryo clone in the schedule, a human embryo that results from the technological process known as embryo splitting is taken not to be created by a process of fertilisation of a human egg by human sperm.
(sec.5-ssec.5) A reference in this Act to an embryo (including a human embryo) is a reference to a living embryo.
(sec.5-ssec.6) A reference in this Act to a human egg is a reference to a human oocyte.
(sec.5-ssec.7) A reference in this Act to a human embryo does not include a reference to— a hybrid embryo; or a human embryonic stem cell line.
(sec.5-ssec.8) The following provisions of the Acts Interpretation Act 1954 do not apply to a reference to a spouse in this Act— section 32DA (6) schedule 1 , definition spouse .
(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
(b) it is not necessary to establish that the copy is an identical genetic copy.
(a) a hybrid embryo; or
(b) a human embryonic stem cell line.
• section 32DA (6)
• schedule 1 , definition spouse .
sec.6
Meaning of reckless
sec.6 Meaning of reckless
A person is reckless in relation to a circumstance if—
the person is aware of a substantial risk that the circumstance exists or will exist; and
having regard to the circumstances known to the person, it is unjustifiable to take the risk.
A person is reckless in relation to a result if—
the person is aware of a substantial risk that the result will happen; and
having regard to the circumstances known to the person, it is unjustifiable to take the risk.
It is a question of fact as to whether taking a risk is unjustifiable.
(sec.6-ssec.1) A person is reckless in relation to a circumstance if— the person is aware of a substantial risk that the circumstance exists or will exist; and having regard to the circumstances known to the person, it is unjustifiable to take the risk.
(sec.6-ssec.2) A person is reckless in relation to a result if— the person is aware of a substantial risk that the result will happen; and having regard to the circumstances known to the person, it is unjustifiable to take the risk.
(sec.6-ssec.3) It is a question of fact as to whether taking a risk is unjustifiable.
(a) the person is aware of a substantial risk that the circumstance exists or will exist; and
(b) having regard to the circumstances known to the person, it is unjustifiable to take the risk.
(a) the person is aware of a substantial risk that the result will happen; and
(b) having regard to the circumstances known to the person, it is unjustifiable to take the risk.
pt.2
Prohibited practices
Prohibited practices
pt.2-div.1
Practices that are completely prohibited
Practices that are completely prohibited
sec.7
Offence—placing a human embryo clone in the human body or the body of an animal
sec.7 Offence—placing a human embryo clone in the human body or the body of an animal
A person commits an offence if the person intentionally places a human embryo clone in the body of a human or the body of an animal.
Maximum penalty—15 years imprisonment.
It is not a defence to an offence under subsection (1) that the human embryo clone did not survive or could not have survived.
The development of a human embryo (including a human embryo clone) outside the body of a woman for more than 14 days is prohibited by section 10 .
s 7 sub 2007 No. 45 s 7
(sec.7-ssec.1) A person commits an offence if the person intentionally places a human embryo clone in the body of a human or the body of an animal. Maximum penalty—15 years imprisonment.
(sec.7-ssec.2) It is not a defence to an offence under subsection (1) that the human embryo clone did not survive or could not have survived. The development of a human embryo (including a human embryo clone) outside the body of a woman for more than 14 days is prohibited by section 10 .
sec.8
Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman
sec.8 Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman
A person commits an offence if the person intentionally creates a human embryo by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, unless the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman.
Maximum penalty—15 years imprisonment.
A defendant does not bear the burden of proving any matter in subsection (1) .
s 8 sub 2007 No. 45 s 7
(sec.8-ssec.1) A person commits an offence if the person intentionally creates a human embryo by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, unless the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman. Maximum penalty—15 years imprisonment.
(sec.8-ssec.2) A defendant does not bear the burden of proving any matter in subsection (1) .
sec.9
Offence—creating or developing a human embryo by fertilisation that contains genetic material provided by more than 2 persons
sec.9 Offence—creating or developing a human embryo by fertilisation that contains genetic material provided by more than 2 persons
A person commits an offence if—
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
the human embryo contains genetic material provided by more than 2 persons.
Maximum penalty—15 years imprisonment.
s 9 sub 2007 No. 45 s 7
(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
(b) the human embryo contains genetic material provided by more than 2 persons.
sec.10
Offence—developing a human embryo outside the body of a woman for more than 14 days
sec.10 Offence—developing a human embryo outside the body of a woman for more than 14 days
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.
Maximum penalty—15 years imprisonment.
s 10 sub 2007 No. 45 s 7
sec.11
Offence—heritable alterations to genome
sec.11 Offence—heritable alterations to genome
A person commits an offence if—
the person alters the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered; and
in altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered.
Maximum penalty—15 years imprisonment.
In this section—
human cell includes a human embryonal cell, a human fetal cell, human sperm and a human egg.
s 11 sub 2007 No. 45 s 7
(sec.11-ssec.1) A person commits an offence if— the person alters the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered; and in altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered. Maximum penalty—15 years imprisonment.
(sec.11-ssec.2) In this section— human cell includes a human embryonal cell, a human fetal cell, human sperm and a human egg.
(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
(b) in altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered.
sec.12
Offence—collecting a viable human embryo from the body of a woman
sec.12 Offence—collecting a viable human embryo from the body of a woman
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.
Maximum penalty—15 years imprisonment.
s 12 sub 2007 No. 45 s 7
sec.13
Offence—creating a chimeric embryo
sec.13 Offence—creating a chimeric embryo
A person commits an offence if the person intentionally creates a chimeric embryo.
Maximum penalty—15 years imprisonment.
s 13 sub 2007 No. 45 s 7
sec.14
Offence—developing a hybrid embryo
sec.14 Offence—developing a hybrid embryo
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.
Maximum penalty—15 years imprisonment.
s 14 sub 2007 No. 45 s 7
sec.15
Offence—placing of an embryo
sec.15 Offence—placing of an embryo
A person commits an offence if the person intentionally places a human embryo in an animal.
Maximum penalty—15 years imprisonment.
A person commits an offence if the person intentionally places a human embryo in the body of a human, other than in a woman’s reproductive tract.
Maximum penalty—15 years imprisonment.
A person commits an offence if the person intentionally places an animal embryo in the body of a human for any period of gestation.
Maximum penalty—15 years imprisonment.
s 15 sub 2007 No. 45 s 7
(sec.15-ssec.1) A person commits an offence if the person intentionally places a human embryo in an animal. Maximum penalty—15 years imprisonment.
(sec.15-ssec.2) A person commits an offence if the person intentionally places a human embryo in the body of a human, other than in a woman’s reproductive tract. Maximum penalty—15 years imprisonment.
(sec.15-ssec.3) A person commits an offence if the person intentionally places an animal embryo in the body of a human for any period of gestation. Maximum penalty—15 years imprisonment.
sec.16
Offence—placing a prohibited embryo
sec.16 Offence—placing a prohibited embryo
A person commits an offence if the person intentionally places an embryo in the body of a woman knowing that, or reckless as to whether, the embryo is a prohibited embryo.
Maximum penalty—15 years imprisonment.
In this section—
prohibited embryo means—
a human embryo created by a process other than the fertilisation of a human egg by human sperm; or
a human embryo created outside the body of a woman, unless the intention of the person who created the embryo was to attempt to achieve pregnancy in a particular woman; or
a human embryo that contains genetic material provided by more than 2 persons; or
a human embryo that has been developing outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended; or
a human embryo created using precursor cells taken from a human embryo or a human fetus; or
a human embryo that contains a human cell (within the meaning of section 11 ) whose genome has been altered in such a way that the alteration is heritable by human descendants of the human whose cell was altered; or
a human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; or
a chimeric embryo or a hybrid embryo.
s 16 sub 2007 No. 45 s 7
(sec.16-ssec.1) A person commits an offence if the person intentionally places an embryo in the body of a woman knowing that, or reckless as to whether, the embryo is a prohibited embryo. Maximum penalty—15 years imprisonment.
(sec.16-ssec.2) In this section— prohibited embryo means— a human embryo created by a process other than the fertilisation of a human egg by human sperm; or a human embryo created outside the body of a woman, unless the intention of the person who created the embryo was to attempt to achieve pregnancy in a particular woman; or a human embryo that contains genetic material provided by more than 2 persons; or a human embryo that has been developing outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended; or a human embryo created using precursor cells taken from a human embryo or a human fetus; or a human embryo that contains a human cell (within the meaning of section 11 ) whose genome has been altered in such a way that the alteration is heritable by human descendants of the human whose cell was altered; or a human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; or a chimeric embryo or a hybrid embryo.
(a) a human embryo created by a process other than the fertilisation of a human egg by human sperm; or
(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
(c) a human embryo that contains genetic material provided by more than 2 persons; or
(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
(e) a human embryo created using precursor cells taken from a human embryo or a human fetus; or
(f) a human embryo that contains a human cell (within the meaning of section 11 ) whose genome has been altered in such a way that the alteration is heritable by human descendants of the human whose cell was altered; or
(g) a human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; or
(h) a chimeric embryo or a hybrid embryo.
sec.17
Offence—commercial trading in human eggs, human sperm or human embryos
sec.17 Offence—commercial trading in human eggs, human sperm or human embryos
A person commits an offence if the person intentionally gives or offers valuable consideration to another person for the supply of a human egg, human sperm or a human embryo.
Maximum penalty—15 years imprisonment.
A person commits an offence if the person intentionally receives, or offers to receive, valuable consideration from another person for the supply of a human egg, human sperm or a human embryo.
Maximum penalty—15 years imprisonment.
In this section—
reasonable expenses —
in relation to the supply of a human egg or human sperm—includes, but is not limited to, expenses relating to the collection, storage or transport of the egg or sperm; and
in relation to the supply of a human embryo—
does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo within the meaning of section 22 ; and
includes, but is not limited to, expenses relating to the storage or transport of the embryo.
valuable consideration , in relation to the supply of a human egg, human sperm or a human embryo by a person, includes any inducement, discount or priority in the provision of a service to the person, but does not include the payment of reasonable expenses incurred by the person in connection with the supply.
s 17 sub 2007 No. 45 s 7
(sec.17-ssec.1) A person commits an offence if the person intentionally gives or offers valuable consideration to another person for the supply of a human egg, human sperm or a human embryo. Maximum penalty—15 years imprisonment.
(sec.17-ssec.2) A person commits an offence if the person intentionally receives, or offers to receive, valuable consideration from another person for the supply of a human egg, human sperm or a human embryo. Maximum penalty—15 years imprisonment.
(sec.17-ssec.3) In this section— reasonable expenses — in relation to the supply of a human egg or human sperm—includes, but is not limited to, expenses relating to the collection, storage or transport of the egg or sperm; and in relation to the supply of a human embryo— does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo within the meaning of section 22 ; and includes, but is not limited to, expenses relating to the storage or transport of the embryo. valuable consideration , in relation to the supply of a human egg, human sperm or a human embryo by a person, includes any inducement, discount or priority in the provision of a service to the person, but does not include the payment of reasonable expenses incurred by the person in connection with the supply.
(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
(b) in relation to the supply of a human embryo— (i) does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo within the meaning of section 22 ; and (ii) includes, but is not limited to, expenses relating to the storage or transport of the embryo.
(i) does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo within the meaning of section 22 ; and
(ii) includes, but is not limited to, expenses relating to the storage or transport of the embryo.
(i) does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo within the meaning of section 22 ; and
(ii) includes, but is not limited to, expenses relating to the storage or transport of the embryo.
pt.2-div.2
Practices that are prohibited unless authorised by a licence
Practices that are prohibited unless authorised by a licence
sec.18
Offence—creating a human embryo other than by fertilisation, or developing such an embryo
sec.18 Offence—creating a human embryo other than by fertilisation, or developing such an embryo
A person commits an offence if—
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
the creation or development of the human embryo by the person is not authorised by a licence.
Maximum penalty—10 years imprisonment.
The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 10 .
The placement in the body of a woman of a human embryo clone, or any other human embryo created other than by the fertilisation of a human egg by a human sperm, is prohibited by sections 7 and 16 .
s 18 sub 2007 No. 45 s 7
(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
(b) the creation or development of the human embryo by the person is not authorised by a licence.
1 The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 10 .
2 The placement in the body of a woman of a human embryo clone, or any other human embryo created other than by the fertilisation of a human egg by a human sperm, is prohibited by sections 7 and 16 .
sec.19
Offence—creating or developing a human embryo containing genetic material provided by more than 2 persons
sec.19 Offence—creating or developing a human embryo containing genetic material provided by more than 2 persons
A person commits an offence if—
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
the human embryo contains genetic material provided by more than 2 persons; and
the creation or development of the human embryo by the person is not authorised by a licence.
Maximum penalty—10 years imprisonment.
The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 10 .
The placement in the body of a woman of a human embryo created other than by the fertilisation of a human egg by a human sperm, is prohibited by section 16 .
s 19 sub 2007 No. 45 s 7
(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
(b) the human embryo contains genetic material provided by more than 2 persons; and
(c) the creation or development of the human embryo by the person is not authorised by a licence.
1 The development of a human embryo outside the body of a woman for more than 14 days is prohibited by section 10 .
2 The placement in the body of a woman of a human embryo created other than by the fertilisation of a human egg by a human sperm, is prohibited by section 16 .
sec.20
Offence—using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo
sec.20 Offence—using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo
A person commits an offence if—
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
the person engages in activities mentioned in paragraph (a) without being authorised by a licence, and the person knows or is reckless as to that fact.
Maximum penalty—10 years imprisonment.
s 20 sub 2007 No. 45 s 7
(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
(b) the person engages in activities mentioned in paragraph (a) without being authorised by a licence, and the person knows or is reckless as to that fact.
sec.20A
Offence—creating a hybrid embryo
sec.20A Offence—creating a hybrid embryo
A person commits an offence if the person intentionally creates a hybrid embryo.
Maximum penalty—10 years imprisonment.
A person commits an offence if the person intentionally develops a hybrid embryo.
Maximum penalty—10 years imprisonment.
A person does not commit an offence against subsection (1) or (2) if the creation or development of the hybrid embryo by the person is authorised by a licence.
A licence to create or use a hybrid embryo can only be issued under section 29 for the purposes of testing sperm quality in an accredited ART centre up to, but not including, the first mitotic division.
s 20A ins 2007 No. 45 s 7
(sec.20A-ssec.1) A person commits an offence if the person intentionally creates a hybrid embryo. Maximum penalty—10 years imprisonment.
(sec.20A-ssec.2) A person commits an offence if the person intentionally develops a hybrid embryo. Maximum penalty—10 years imprisonment.
(sec.20A-ssec.3) A person does not commit an offence against subsection (1) or (2) if the creation or development of the hybrid embryo by the person is authorised by a licence. A licence to create or use a hybrid embryo can only be issued under section 29 for the purposes of testing sperm quality in an accredited ART centre up to, but not including, the first mitotic division.
pt.3
Regulation of the use of excess ART embryos, other embryos and human eggs
Regulation of the use of excess ART embryos, other embryos and human eggs
pt.3-div.1
Interpretation
Interpretation
sec.21
Definitions for pt 3
sec.21 Definitions for pt 3
In this part—
accredited ART centre means an entity accredited to carry out assisted reproductive technology by an entity prescribed under a regulation.
confidential commercial information means information that has a commercial or other value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed.
disclose , in relation to information, means give or communicate in any way.
excess ART embryo has the meaning given by section 22 .
HREC means a Human Research Ethics Committee.
licence means a licence issued under section 29 .
proper consent , in relation to the use of an excess ART embryo or a human egg, or the creation or use of any other embryo, means consent obtained in accordance with guidelines issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 (Cwlth) and prescribed under a regulation for the purposes of this definition.
s 21 def proper consent amd 2006 No. 25 s 241 (2) sch 4
sub 2007 No. 45 s 9 (2) – (3)
relevant State body means the person or body notified by the State to the chairperson of the NHMRC Licensing Committee for the purposes of the Commonwealth Act, part 2 .
responsible person means—
in relation to an excess ART embryo—
each person who provided the egg or sperm from which the embryo was created; and
the woman for whom the embryo was created, for the purpose of achieving her pregnancy; and
any person who was the spouse of a person mentioned in subparagraph (i) at the time the egg or sperm mentioned in that subparagraph was provided; and
any person who was the spouse of the woman mentioned in subparagraph (ii) at the time the embryo was created; or
in relation to an embryo other than an excess ART embryo—each person whose reproductive material, genetic material or cell was used, or is proposed to be used, in the creation or use of the embryo; or
in relation to a human egg—the woman who was the biological donor of the egg.
s 21 def responsible person sub 2007 No. 45 s 9 (2) – (3)
s 21 amd 2007 No. 45 s 9 (1)
(a) in relation to an excess ART embryo— (i) each person who provided the egg or sperm from which the embryo was created; and (ii) the woman for whom the embryo was created, for the purpose of achieving her pregnancy; and (iii) any person who was the spouse of a person mentioned in subparagraph (i) at the time the egg or sperm mentioned in that subparagraph was provided; and (iv) any person who was the spouse of the woman mentioned in subparagraph (ii) at the time the embryo was created; or
(i) each person who provided the egg or sperm from which the embryo was created; and
(ii) the woman for whom the embryo was created, for the purpose of achieving her pregnancy; and
(iii) any person who was the spouse of a person mentioned in subparagraph (i) at the time the egg or sperm mentioned in that subparagraph was provided; and
(iv) any person who was the spouse of the woman mentioned in subparagraph (ii) at the time the embryo was created; or
(b) in relation to an embryo other than an excess ART embryo—each person whose reproductive material, genetic material or cell was used, or is proposed to be used, in the creation or use of the embryo; or
(c) in relation to a human egg—the woman who was the biological donor of the egg.
(i) each person who provided the egg or sperm from which the embryo was created; and
(ii) the woman for whom the embryo was created, for the purpose of achieving her pregnancy; and
(iii) any person who was the spouse of a person mentioned in subparagraph (i) at the time the egg or sperm mentioned in that subparagraph was provided; and
(iv) any person who was the spouse of the woman mentioned in subparagraph (ii) at the time the embryo was created; or
sec.22
Meaning of excess ART embryo
sec.22 Meaning of excess ART embryo
In this part—
excess ART embryo means a human embryo that—
was created, by assisted reproductive technology, for use in the assisted reproductive technology treatment of a woman; and
is excess to the needs of—
the woman for whom it was created; and
her spouse (if any) at the time the embryo was created.
For the purposes of paragraph (b) of the definition excess ART embryo , a human embryo is excess to the needs of the persons mentioned in that paragraph at a particular time if—
each such person has given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or
each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.
(sec.22-ssec.1) In this part— excess ART embryo means a human embryo that— was created, by assisted reproductive technology, for use in the assisted reproductive technology treatment of a woman; and is excess to the needs of— the woman for whom it was created; and her spouse (if any) at the time the embryo was created.
(sec.22-ssec.2) For the purposes of paragraph (b) of the definition excess ART embryo , a human embryo is excess to the needs of the persons mentioned in that paragraph at a particular time if— each such person has given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.
(a) was created, by assisted reproductive technology, for use in the assisted reproductive technology treatment of a woman; and
(b) is excess to the needs of— (i) the woman for whom it was created; and (ii) her spouse (if any) at the time the embryo was created.
(i) the woman for whom it was created; and
(ii) her spouse (if any) at the time the embryo was created.
(i) the woman for whom it was created; and
(ii) her spouse (if any) at the time the embryo was created.
(a) each such person has given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or
(b) each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.
pt.3-div.2
Offences
Offences
sec.23
Offence—use of excess ART embryo
sec.23 Offence—use of excess ART embryo
A person commits an offence if the person intentionally uses an excess ART embryo, unless—
the use by the person is authorised by a licence; or
the use by the person is an exempt use within the meaning of subsection (2) .
Maximum penalty—5 years imprisonment.
A use of an excess ART embryo by a person is an exempt use for the purposes of subsection (1) if—
the use consists only of—
storage of the excess ART embryo; or
removal of the excess ART embryo from storage; or
transport of the excess ART embryo; or
the use consists only of observation of the excess ART embryo; or
the use consists only of allowing the excess ART embryo to succumb; or
the use is carried out by an accredited ART centre, and—
the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and
the use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or
the use is carried out by an accredited ART centre and is for the purposes of achieving pregnancy in a woman other than the woman for whom the excess ART embryo was created; or
the use is of a kind prescribed under a regulation for the purposes of this paragraph.
A defendant does not bear the burden of proving any matter in subsection (1) or (2) .
In this section—
diagnostic investigation , in relation to an excess ART embryo, means any procedure undertaken on embryos for the sole purpose of diagnostic investigations for the direct benefit of the woman for whom it was created.
observation , in relation to an excess ART embryo, includes taking a photograph of the embryo, or taking a recording of the embryo from which a visual image can be produced.
s 23 amd 2007 No. 45 s 10
(sec.23-ssec.1) A person commits an offence if the person intentionally uses an excess ART embryo, unless— the use by the person is authorised by a licence; or the use by the person is an exempt use within the meaning of subsection (2) . Maximum penalty—5 years imprisonment.
(sec.23-ssec.2) A use of an excess ART embryo by a person is an exempt use for the purposes of subsection (1) if— the use consists only of— storage of the excess ART embryo; or removal of the excess ART embryo from storage; or transport of the excess ART embryo; or the use consists only of observation of the excess ART embryo; or the use consists only of allowing the excess ART embryo to succumb; or the use is carried out by an accredited ART centre, and— the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and the use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or the use is carried out by an accredited ART centre and is for the purposes of achieving pregnancy in a woman other than the woman for whom the excess ART embryo was created; or the use is of a kind prescribed under a regulation for the purposes of this paragraph.
(sec.23-ssec.3) A defendant does not bear the burden of proving any matter in subsection (1) or (2) .
(sec.23-ssec.4) In this section— diagnostic investigation , in relation to an excess ART embryo, means any procedure undertaken on embryos for the sole purpose of diagnostic investigations for the direct benefit of the woman for whom it was created. observation , in relation to an excess ART embryo, includes taking a photograph of the embryo, or taking a recording of the embryo from which a visual image can be produced.
(a) the use by the person is authorised by a licence; or
(b) the use by the person is an exempt use within the meaning of subsection (2) .
(a) the use consists only of— (i) storage of the excess ART embryo; or (ii) removal of the excess ART embryo from storage; or (iii) transport of the excess ART embryo; or
(i) storage of the excess ART embryo; or
(ii) removal of the excess ART embryo from storage; or
(iii) transport of the excess ART embryo; or
(b) the use consists only of observation of the excess ART embryo; or
(c) the use consists only of allowing the excess ART embryo to succumb; or
(d) the use is carried out by an accredited ART centre, and— (i) the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and (ii) the use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or
(i) the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and
(ii) the use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or
(e) the use is carried out by an accredited ART centre and is for the purposes of achieving pregnancy in a woman other than the woman for whom the excess ART embryo was created; or
(f) the use is of a kind prescribed under a regulation for the purposes of this paragraph.
(i) storage of the excess ART embryo; or
(ii) removal of the excess ART embryo from storage; or
(iii) transport of the excess ART embryo; or
(i) the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and
(ii) the use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or
sec.23A
Offence—use of other embryos
sec.23A Offence—use of other embryos
A person commits an offence if—
the person intentionally uses an embryo; and
the embryo is—
a human embryo created by a process other than the fertilisation of a human egg by a human sperm; or
a human embryo created by a process other than the fertilisation of a human egg by a human sperm that contains genetic material provided by more than 2 persons; or
a human embryo created using precursor cells taken from a human embryo or a human fetus; or
a hybrid embryo; and
the use by the person is not authorised by a licence.
Maximum penalty—5 years imprisonment.
The creation or development of embryos mentioned in this section is prohibited under part 2 , unless authorised by a licence.
s 23A ins 2007 No. 45 s 11
(a) the person intentionally uses an embryo; and
(b) the embryo is— (i) a human embryo created by a process other than the fertilisation of a human egg by a human sperm; or (ii) a human embryo created by a process other than the fertilisation of a human egg by a human sperm that contains genetic material provided by more than 2 persons; or (iii) a human embryo created using precursor cells taken from a human embryo or a human fetus; or (iv) a hybrid embryo; and
(i) a human embryo created by a process other than the fertilisation of a human egg by a human sperm; or
(ii) a human embryo created by a process other than the fertilisation of a human egg by a human sperm that contains genetic material provided by more than 2 persons; or
(iii) a human embryo created using precursor cells taken from a human embryo or a human fetus; or
(iv) a hybrid embryo; and
(c) the use by the person is not authorised by a licence.
(i) a human embryo created by a process other than the fertilisation of a human egg by a human sperm; or
(ii) a human embryo created by a process other than the fertilisation of a human egg by a human sperm that contains genetic material provided by more than 2 persons; or
(iii) a human embryo created using precursor cells taken from a human embryo or a human fetus; or
(iv) a hybrid embryo; and
sec.23B
Offence—certain activities involving use of human eggs
sec.23B Offence—certain activities involving use of human eggs
A person commits an offence if—
the person undertakes research or training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART; and
the person is not authorised by a licence to undertake the research or training.
Maximum penalty—5 years imprisonment.
s 23B ins 2007 No. 45 s 11
(a) the person undertakes research or training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART; and
(b) the person is not authorised by a licence to undertake the research or training.
sec.24
Offence—use of embryo that is not an excess ART embryo
sec.24 Offence—use of embryo that is not an excess ART embryo
A person commits an offence if—
the person intentionally uses, outside the body of a woman, a human embryo—
that was created by fertilisation of a human egg by a human sperm; and
that is not an excess ART embryo; and
the use is not for a purpose relating to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre, and the person knows or is reckless as to that fact.
Maximum penalty—5 years imprisonment.
s 24 amd 2007 No. 45 s 12
(a) the person intentionally uses, outside the body of a woman, a human embryo— (i) that was created by fertilisation of a human egg by a human sperm; and (ii) that is not an excess ART embryo; and
(i) that was created by fertilisation of a human egg by a human sperm; and
(ii) that is not an excess ART embryo; and
(b) the use is not for a purpose relating to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre, and the person knows or is reckless as to that fact.
(i) that was created by fertilisation of a human egg by a human sperm; and
(ii) that is not an excess ART embryo; and
sec.25
Offence—breaching a licence condition
sec.25 Offence—breaching a licence condition
A person commits an offence if the person intentionally engages in conduct, knowing that the conduct contravenes a condition of a licence that applies to the person, or reckless as to whether the conduct contravenes a condition of such a licence.
Maximum penalty—5 years imprisonment.
In this section—
engage in conduct means—
do an act; or
omit to perform an act.
(sec.25-ssec.1) A person commits an offence if the person intentionally engages in conduct, knowing that the conduct contravenes a condition of a licence that applies to the person, or reckless as to whether the conduct contravenes a condition of such a licence. Maximum penalty—5 years imprisonment.
(sec.25-ssec.2) In this section— engage in conduct means— do an act; or omit to perform an act.
(a) do an act; or
(b) omit to perform an act.
sec.25A
Person not liable for conduct purportedly authorised
sec.25A Person not liable for conduct purportedly authorised
To avoid any doubt, it is declared that a person is not criminally responsible for an offence against this part, or section 50 (1) to the extent the attempt relates to an offence against this part, in respect of particular conduct if—
the conduct by the person is purportedly authorised by a provision of a licence; and
the licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and
the person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision.
In this section—
licence includes a purported licence.
s 25A ins 2007 No. 45 s 13
(sec.25A-ssec.1) To avoid any doubt, it is declared that a person is not criminally responsible for an offence against this part, or section 50 (1) to the extent the attempt relates to an offence against this part, in respect of particular conduct if— the conduct by the person is purportedly authorised by a provision of a licence; and the licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and the person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision.
(sec.25A-ssec.2) In this section— licence includes a purported licence.
(a) the conduct by the person is purportedly authorised by a provision of a licence; and
(b) the licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and
(c) the person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision.
pt.3-div.3
Embryo Research Licensing Committee of the NHMRC
Embryo Research Licensing Committee of the NHMRC
sec.26
Functions of committee
sec.26 Functions of committee
The functions of the NHMRC Licensing Committee are—
to perform functions in relation to licences under division 4 ; and
to perform functions in relation to databases under division 5 ; and
to perform such other functions as are conferred on it by this Act or any other law.
(a) to perform functions in relation to licences under division 4 ; and
(b) to perform functions in relation to databases under division 5 ; and
(c) to perform such other functions as are conferred on it by this Act or any other law.
sec.27
Powers of committee
sec.27 Powers of committee
The NHMRC Licensing Committee has power to do all things necessary or convenient to be done for or in connection with the performance of its functions under this Act.
pt.3-div.4
Licensing system
Licensing system
sec.28
Person may apply for licence
sec.28 Person may apply for licence
A person may apply to the NHMRC Licensing Committee for a licence authorising one or more of the following—
use of excess ART embryos;
creation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos;
creation of human embryos other than by fertilisation of a human egg by a human sperm that contain genetic material provided by more than 2 persons, and use of such embryos;
creation of human embryos using precursor cells from a human embryo or a human fetus, and use of such embryos;
research and training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART;
creation of hybrid embryos by the fertilisation of an animal egg by a human sperm, and use of such embryos up to, but not including, the first mitotic division, if—
the creation or use is for the purposes of testing sperm quality; and
the creation or use will occur in an accredited ART centre.
To avoid any doubt, it is declared that subsection (1) (a) , (b) , (c) or (d) does not permit the NHMRC Licensing Committee to authorise any use of an excess ART embryo or other embryo that would result in the development of the embryo for a period of more than 14 days, excluding any period when development is suspended.
An application under subsection (1) —
must be made in accordance with the requirements (if any) specified in writing by the NHMRC Licensing Committee; and
must be accompanied by the fee (if any) prescribed under a regulation.
s 28 amd 2007 No. 45 s 14
(sec.28-ssec.1) A person may apply to the NHMRC Licensing Committee for a licence authorising one or more of the following— use of excess ART embryos; creation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos; creation of human embryos other than by fertilisation of a human egg by a human sperm that contain genetic material provided by more than 2 persons, and use of such embryos; creation of human embryos using precursor cells from a human embryo or a human fetus, and use of such embryos; research and training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART; creation of hybrid embryos by the fertilisation of an animal egg by a human sperm, and use of such embryos up to, but not including, the first mitotic division, if— the creation or use is for the purposes of testing sperm quality; and the creation or use will occur in an accredited ART centre.
(sec.28-ssec.1A) To avoid any doubt, it is declared that subsection (1) (a) , (b) , (c) or (d) does not permit the NHMRC Licensing Committee to authorise any use of an excess ART embryo or other embryo that would result in the development of the embryo for a period of more than 14 days, excluding any period when development is suspended.
(sec.28-ssec.2) An application under subsection (1) — must be made in accordance with the requirements (if any) specified in writing by the NHMRC Licensing Committee; and must be accompanied by the fee (if any) prescribed under a regulation.
(a) use of excess ART embryos;
(b) creation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos;
(c) creation of human embryos other than by fertilisation of a human egg by a human sperm that contain genetic material provided by more than 2 persons, and use of such embryos;
(d) creation of human embryos using precursor cells from a human embryo or a human fetus, and use of such embryos;
(e) research and training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART;
(f) creation of hybrid embryos by the fertilisation of an animal egg by a human sperm, and use of such embryos up to, but not including, the first mitotic division, if— (i) the creation or use is for the purposes of testing sperm quality; and (ii) the creation or use will occur in an accredited ART centre.
(i) the creation or use is for the purposes of testing sperm quality; and
(ii) the creation or use will occur in an accredited ART centre.
(i) the creation or use is for the purposes of testing sperm quality; and
(ii) the creation or use will occur in an accredited ART centre.
(a) must be made in accordance with the requirements (if any) specified in writing by the NHMRC Licensing Committee; and
(b) must be accompanied by the fee (if any) prescribed under a regulation.
sec.29
Determination of application by committee
sec.29 Determination of application by committee
This section applies if a person has made an application under section 28 for a licence.
The NHMRC Licensing Committee must decide, in accordance with this section, whether or not to issue the licence.
The NHMRC Licensing Committee must not issue the licence unless it is satisfied of the following—
that appropriate protocols are in place—
to enable proper consent to be obtained before an excess ART embryo or human egg is used, or other embryo is created or used under the licence (see section 32 (1) (a) ); and
to enable compliance with any restrictions on such consent;
that the activity or project proposed in the application has been assessed and approved by a HREC that is constituted in accordance with, and acting in compliance with, the NHMRC National Statement on Ethical Conduct in Research Involving Humans (1999), as in force from time to time.
In deciding whether to issue the licence, the NHMRC Licensing Committee must have regard to the following—
restricting the number of excess ART embryos, other embryos or human eggs, to that likely to be necessary to achieve the goals of the activity or project proposed in the application;
the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means;
any relevant guidelines, or relevant parts of guidelines, issued by the NHMRC under the National Health and Medical Research Council Act 1992 (Cwlth) and prescribed under a regulation for the purposes of this paragraph;
the HREC assessment of the application mentioned in subsection (3) (c) ;
such additional matters (if any) as are prescribed by a regulation.
s 29 amd 2003 No. 7 s 55 (1) ; 2007 No. 45 s 15
(sec.29-ssec.1) This section applies if a person has made an application under section 28 for a licence.
(sec.29-ssec.2) The NHMRC Licensing Committee must decide, in accordance with this section, whether or not to issue the licence.
(sec.29-ssec.3) The NHMRC Licensing Committee must not issue the licence unless it is satisfied of the following— that appropriate protocols are in place— to enable proper consent to be obtained before an excess ART embryo or human egg is used, or other embryo is created or used under the licence (see section 32 (1) (a) ); and to enable compliance with any restrictions on such consent; that the activity or project proposed in the application has been assessed and approved by a HREC that is constituted in accordance with, and acting in compliance with, the NHMRC National Statement on Ethical Conduct in Research Involving Humans (1999), as in force from time to time.
(sec.29-ssec.4) In deciding whether to issue the licence, the NHMRC Licensing Committee must have regard to the following— restricting the number of excess ART embryos, other embryos or human eggs, to that likely to be necessary to achieve the goals of the activity or project proposed in the application; the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means; any relevant guidelines, or relevant parts of guidelines, issued by the NHMRC under the National Health and Medical Research Council Act 1992 (Cwlth) and prescribed under a regulation for the purposes of this paragraph; the HREC assessment of the application mentioned in subsection (3) (c) ; such additional matters (if any) as are prescribed by a regulation.
(a) that appropriate protocols are in place— (i) to enable proper consent to be obtained before an excess ART embryo or human egg is used, or other embryo is created or used under the licence (see section 32 (1) (a) ); and (ii) to enable compliance with any restrictions on such consent;
(i) to enable proper consent to be obtained before an excess ART embryo or human egg is used, or other embryo is created or used under the licence (see section 32 (1) (a) ); and
(ii) to enable compliance with any restrictions on such consent;
(c) that the activity or project proposed in the application has been assessed and approved by a HREC that is constituted in accordance with, and acting in compliance with, the NHMRC National Statement on Ethical Conduct in Research Involving Humans (1999), as in force from time to time.
(i) to enable proper consent to be obtained before an excess ART embryo or human egg is used, or other embryo is created or used under the licence (see section 32 (1) (a) ); and
(ii) to enable compliance with any restrictions on such consent;
(a) restricting the number of excess ART embryos, other embryos or human eggs, to that likely to be necessary to achieve the goals of the activity or project proposed in the application;
(b) the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means;
(c) any relevant guidelines, or relevant parts of guidelines, issued by the NHMRC under the National Health and Medical Research Council Act 1992 (Cwlth) and prescribed under a regulation for the purposes of this paragraph;
(d) the HREC assessment of the application mentioned in subsection (3) (c) ;
(e) such additional matters (if any) as are prescribed by a regulation.
sec.30
Notification of decision
sec.30 Notification of decision
The NHMRC Licensing Committee must notify its decision on an application for a licence under section 28 to the following—
the applicant;
the HREC that assessed and approved the activity or project proposed in the application as mentioned in section 29 (3) (c) ;
the relevant State body.
If the NHMRC Licensing Committee decides to issue the licence, it must, in addition to issuing the licence to the applicant, give a copy of the licence to the bodies mentioned in subsection (1) (b) and (c) .
(sec.30-ssec.1) The NHMRC Licensing Committee must notify its decision on an application for a licence under section 28 to the following— the applicant; the HREC that assessed and approved the activity or project proposed in the application as mentioned in section 29 (3) (c) ; the relevant State body.
(sec.30-ssec.2) If the NHMRC Licensing Committee decides to issue the licence, it must, in addition to issuing the licence to the applicant, give a copy of the licence to the bodies mentioned in subsection (1) (b) and (c) .
(a) the applicant;
(b) the HREC that assessed and approved the activity or project proposed in the application as mentioned in section 29 (3) (c) ;
(c) the relevant State body.
sec.31
Period of licence
sec.31 Period of licence
A licence—
comes into force on the day specified in the licence, or if no day is specified, on the day on which it is issued; and
remains in force until the day specified in the licence, unless it is suspended, revoked or surrendered before that day.
A licence is not in force throughout any period of suspension.
(sec.31-ssec.1) A licence— comes into force on the day specified in the licence, or if no day is specified, on the day on which it is issued; and remains in force until the day specified in the licence, unless it is suspended, revoked or surrendered before that day.
(sec.31-ssec.2) A licence is not in force throughout any period of suspension.
(a) comes into force on the day specified in the licence, or if no day is specified, on the day on which it is issued; and
(b) remains in force until the day specified in the licence, unless it is suspended, revoked or surrendered before that day.
sec.32
Licence is subject to conditions
sec.32 Licence is subject to conditions
A licence is subject to the condition that before an excess ART embryo or human egg is used, or any other embryo is created or used, as authorised by the licence—
each responsible person in relation to the excess ART embryo, human egg or other embryo must have given proper consent to that creation or use; and
the licence holder must have reported in writing to the NHMRC Licensing Committee that such consent has been obtained, and any restrictions to which the consent is subject.
A licence is subject to the condition that the use of an excess ART embryo or human egg, or the creation or use of any other embryo, must be in accordance with any restrictions to which the proper consent under subsection (1) is subject.
A licence is subject to such other conditions as are specified in the licence.
The conditions specified in the licence may include, but are not limited to, conditions relating to the following—
the persons authorised by the licence to use excess ART embryos or human eggs, or create or use other embryos;
the number of excess ART embryos or human eggs authorised to be used under the licence, or the number of other embryos authorised to be created or used under the licence;
reporting;
monitoring;
information to be given by the licence holder to persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos.
The licence conditions set out in subsections (1) and (2) apply to all persons who are authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos.
Licence conditions specified in the licence apply to—
the licence holder; and
such other persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos, as are specified in the licence.
For the purposes of applying the condition referred to in subsection (1) (a) —
a licence may provide that the guidelines referred to in the definition proper consent apply in a modified form in relation to the use, under the licence, of excess ART embryos that are unsuitable for implantation; and
if a licence so provides, the guidelines as modified by the licence have effect in relation to the giving of consent for the use, under the licence, of the excess ART embryos.
For example, the guidelines could apply to a particular licence in a modified form, to alter the cooling-off period required in relation to the use of excess ART embryos that are unsuitable for implantation.
s 32 amd 2003 No. 7 s 55 (2) ; 2007 No. 45 s 16
(sec.32-ssec.1) A licence is subject to the condition that before an excess ART embryo or human egg is used, or any other embryo is created or used, as authorised by the licence— each responsible person in relation to the excess ART embryo, human egg or other embryo must have given proper consent to that creation or use; and the licence holder must have reported in writing to the NHMRC Licensing Committee that such consent has been obtained, and any restrictions to which the consent is subject.
(sec.32-ssec.2) A licence is subject to the condition that the use of an excess ART embryo or human egg, or the creation or use of any other embryo, must be in accordance with any restrictions to which the proper consent under subsection (1) is subject.
(sec.32-ssec.4) A licence is subject to such other conditions as are specified in the licence.
(sec.32-ssec.5) The conditions specified in the licence may include, but are not limited to, conditions relating to the following— the persons authorised by the licence to use excess ART embryos or human eggs, or create or use other embryos; the number of excess ART embryos or human eggs authorised to be used under the licence, or the number of other embryos authorised to be created or used under the licence; reporting; monitoring; information to be given by the licence holder to persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos.
(sec.32-ssec.6) The licence conditions set out in subsections (1) and (2) apply to all persons who are authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos.
(sec.32-ssec.7) Licence conditions specified in the licence apply to— the licence holder; and such other persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos, as are specified in the licence.
(sec.32-ssec.8) For the purposes of applying the condition referred to in subsection (1) (a) — a licence may provide that the guidelines referred to in the definition proper consent apply in a modified form in relation to the use, under the licence, of excess ART embryos that are unsuitable for implantation; and if a licence so provides, the guidelines as modified by the licence have effect in relation to the giving of consent for the use, under the licence, of the excess ART embryos. For example, the guidelines could apply to a particular licence in a modified form, to alter the cooling-off period required in relation to the use of excess ART embryos that are unsuitable for implantation.
(a) each responsible person in relation to the excess ART embryo, human egg or other embryo must have given proper consent to that creation or use; and
(b) the licence holder must have reported in writing to the NHMRC Licensing Committee that such consent has been obtained, and any restrictions to which the consent is subject.
(a) the persons authorised by the licence to use excess ART embryos or human eggs, or create or use other embryos;
(b) the number of excess ART embryos or human eggs authorised to be used under the licence, or the number of other embryos authorised to be created or used under the licence;
(c) reporting;
(d) monitoring;
(e) information to be given by the licence holder to persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos.
(a) the licence holder; and
(b) such other persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos, as are specified in the licence.
(a) a licence may provide that the guidelines referred to in the definition proper consent apply in a modified form in relation to the use, under the licence, of excess ART embryos that are unsuitable for implantation; and
(b) if a licence so provides, the guidelines as modified by the licence have effect in relation to the giving of consent for the use, under the licence, of the excess ART embryos. Note— For example, the guidelines could apply to a particular licence in a modified form, to alter the cooling-off period required in relation to the use of excess ART embryos that are unsuitable for implantation.
sec.33
Variation of licence
sec.33 Variation of licence
The NHMRC Licensing Committee may, by notice in writing given to the licence holder, vary a licence if the committee believes on reasonable grounds that it is necessary or desirable to do so.
The NHMRC Licensing Committee may vary a licence under subsection (1) on its own initiative or on application by the licence holder.
Without limiting subsection (1) , the NHMRC Licensing Committee may vary the licence by specifying additional conditions or varying existing conditions.
The NHMRC Licensing Committee must not vary a licence in such a way that, had a person applied under section 28 for the licence as varied, the committee would not have been permitted by this part to issue the licence.
(sec.33-ssec.1) The NHMRC Licensing Committee may, by notice in writing given to the licence holder, vary a licence if the committee believes on reasonable grounds that it is necessary or desirable to do so.
(sec.33-ssec.2) The NHMRC Licensing Committee may vary a licence under subsection (1) on its own initiative or on application by the licence holder.
(sec.33-ssec.3) Without limiting subsection (1) , the NHMRC Licensing Committee may vary the licence by specifying additional conditions or varying existing conditions.
(sec.33-ssec.4) The NHMRC Licensing Committee must not vary a licence in such a way that, had a person applied under section 28 for the licence as varied, the committee would not have been permitted by this part to issue the licence.
sec.34
Suspension or revocation of licence
sec.34 Suspension or revocation of licence
The NHMRC Licensing Committee may, by notice in writing given to the licence holder, suspend or revoke a licence if the committee believes on reasonable grounds that a condition of the licence has been breached.
If a licence holder is convicted of an offence under this Act, the NHMRC Licensing Committee must, by notice in writing given to the licence holder, revoke each licence held by the licence holder.
(sec.34-ssec.1) The NHMRC Licensing Committee may, by notice in writing given to the licence holder, suspend or revoke a licence if the committee believes on reasonable grounds that a condition of the licence has been breached.
(sec.34-ssec.2) If a licence holder is convicted of an offence under this Act, the NHMRC Licensing Committee must, by notice in writing given to the licence holder, revoke each licence held by the licence holder.
sec.35
Surrender of licence
sec.35 Surrender of licence
A licence holder may surrender a licence by written notice given to the NHMRC Licensing Committee.
sec.36
Notification of variation, suspension or revocation of licence
sec.36 Notification of variation, suspension or revocation of licence
If the NHMRC Licensing Committee varies, suspends or revokes a licence, the committee must notify—
the licence holder; and
the HREC and the relevant State body.
The NHMRC Licensing Committee must also notify the bodies mentioned in subsection (1) (b) if a licence is surrendered.
(sec.36-ssec.1) If the NHMRC Licensing Committee varies, suspends or revokes a licence, the committee must notify— the licence holder; and the HREC and the relevant State body.
(sec.36-ssec.2) The NHMRC Licensing Committee must also notify the bodies mentioned in subsection (1) (b) if a licence is surrendered.
(a) the licence holder; and
(b) the HREC and the relevant State body.
pt.3-div.5
Reporting and confidentiality
Reporting and confidentiality
sec.37
NHMRC Licensing Committee to make certain information publicly available
sec.37 NHMRC Licensing Committee to make certain information publicly available
The NHMRC Licensing Committee must maintain a database containing the following information in relation to each licence (including a licence as varied)—
the name of the person to whom the licence was issued;
a short statement about the nature of the uses of excess ART embryos or human eggs, or creation or uses of other embryos, that are authorised by the licence;
any conditions to which the licence is subject;
the number of ART embryos or human eggs authorised to be used under the licence, and the number of other embryos authorised to be created or used under the licence;
the date on which the licence was issued;
the period throughout which the licence is to remain in force.
The database is to be made publicly available.
The database may be kept and made publicly available in electronic form.
Information mentioned in subsection (1) must not be such as to disclose confidential commercial information.
The database may form part of the database maintained by the NHMRC Licensing Committee under the Commonwealth Act, section 29 .
s 37 amd 2007 No. 45 s 17
(sec.37-ssec.1) The NHMRC Licensing Committee must maintain a database containing the following information in relation to each licence (including a licence as varied)— the name of the person to whom the licence was issued; a short statement about the nature of the uses of excess ART embryos or human eggs, or creation or uses of other embryos, that are authorised by the licence; any conditions to which the licence is subject; the number of ART embryos or human eggs authorised to be used under the licence, and the number of other embryos authorised to be created or used under the licence; the date on which the licence was issued; the period throughout which the licence is to remain in force.
(sec.37-ssec.2) The database is to be made publicly available.
(sec.37-ssec.3) The database may be kept and made publicly available in electronic form.
(sec.37-ssec.4) Information mentioned in subsection (1) must not be such as to disclose confidential commercial information.
(sec.37-ssec.5) The database may form part of the database maintained by the NHMRC Licensing Committee under the Commonwealth Act, section 29 .
(a) the name of the person to whom the licence was issued;
(b) a short statement about the nature of the uses of excess ART embryos or human eggs, or creation or uses of other embryos, that are authorised by the licence;
(c) any conditions to which the licence is subject;
(d) the number of ART embryos or human eggs authorised to be used under the licence, and the number of other embryos authorised to be created or used under the licence;
(e) the date on which the licence was issued;
(f) the period throughout which the licence is to remain in force.
sec.38
Confidential commercial information may only be disclosed in certain circumstances
sec.38 Confidential commercial information may only be disclosed in certain circumstances
A person commits an offence if—
the person discloses confidential commercial information that the person has only because of performing duties or functions under this part, or under this part and the Commonwealth Act; and
the person knows that the information is confidential commercial information; and
the disclosure is not made—
for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or
by order of a court; or
with the consent of each person to whom the information has a commercial or other value.
Maximum penalty—2 years imprisonment.
A person commits an offence if—
the person discloses confidential commercial information that the person has only because of a disclosure permitted under subsection (1) or this subsection; and
the person knows that the information is confidential commercial information; and
the disclosure is not made—
for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or
by order of a court; or
with the consent of each person to whom the information has a commercial or other value.
Maximum penalty—2 years imprisonment.
In this section—
court includes a tribunal, authority or person having power to require the production of documents or the answering of questions.
State agency means the following—
a State;
a Minister of a State;
a department or a department of Government of another State;
an instrumentality of a State, including a body corporate established for a public purpose under a law of a State;
a company in which a controlling interest is held by any 1 of the following persons, or by 2 or more of the following persons together—
a State;
a Minister of a State, or a State instrumentality mentioned in paragraph (d) ;
a person or body covered by subparagraph (i) or (ii) .
(sec.38-ssec.1) A person commits an offence if— the person discloses confidential commercial information that the person has only because of performing duties or functions under this part, or under this part and the Commonwealth Act; and the person knows that the information is confidential commercial information; and the disclosure is not made— for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or by order of a court; or with the consent of each person to whom the information has a commercial or other value. Maximum penalty—2 years imprisonment.
(sec.38-ssec.2) A person commits an offence if— the person discloses confidential commercial information that the person has only because of a disclosure permitted under subsection (1) or this subsection; and the person knows that the information is confidential commercial information; and the disclosure is not made— for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or by order of a court; or with the consent of each person to whom the information has a commercial or other value. Maximum penalty—2 years imprisonment.
(sec.38-ssec.3) In this section— court includes a tribunal, authority or person having power to require the production of documents or the answering of questions. State agency means the following— a State; a Minister of a State; a department or a department of Government of another State; an instrumentality of a State, including a body corporate established for a public purpose under a law of a State; a company in which a controlling interest is held by any 1 of the following persons, or by 2 or more of the following persons together— a State; a Minister of a State, or a State instrumentality mentioned in paragraph (d) ; a person or body covered by subparagraph (i) or (ii) .
(a) the person discloses confidential commercial information that the person has only because of performing duties or functions under this part, or under this part and the Commonwealth Act; and
(b) the person knows that the information is confidential commercial information; and
(c) the disclosure is not made— (i) for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or (ii) by order of a court; or (iii) with the consent of each person to whom the information has a commercial or other value.
(i) for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or
(ii) by order of a court; or
(iii) with the consent of each person to whom the information has a commercial or other value.
(i) for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or
(ii) by order of a court; or
(iii) with the consent of each person to whom the information has a commercial or other value.
(a) the person discloses confidential commercial information that the person has only because of a disclosure permitted under subsection (1) or this subsection; and
(b) the person knows that the information is confidential commercial information; and
(c) the disclosure is not made— (i) for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or (ii) by order of a court; or (iii) with the consent of each person to whom the information has a commercial or other value.
(i) for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or
(ii) by order of a court; or
(iii) with the consent of each person to whom the information has a commercial or other value.
(i) for the purposes of this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth) , to a State agency, the Commonwealth or a Commonwealth authority; or
(ii) by order of a court; or
(iii) with the consent of each person to whom the information has a commercial or other value.
(a) a State;
(b) a Minister of a State;
(c) a department or a department of Government of another State;
(d) an instrumentality of a State, including a body corporate established for a public purpose under a law of a State;
(e) a company in which a controlling interest is held by any 1 of the following persons, or by 2 or more of the following persons together— (i) a State; (ii) a Minister of a State, or a State instrumentality mentioned in paragraph (d) ; (iii) a person or body covered by subparagraph (i) or (ii) .
(i) a State;
(ii) a Minister of a State, or a State instrumentality mentioned in paragraph (d) ;
(iii) a person or body covered by subparagraph (i) or (ii) .
(i) a State;
(ii) a Minister of a State, or a State instrumentality mentioned in paragraph (d) ;
(iii) a person or body covered by subparagraph (i) or (ii) .
pt.3-div.6
Review provisions
Review provisions
sec.39
Definitions for div 6
sec.39 Definitions for div 6
In this division—
Administrative Appeals Tribunal ...
s 39 def Administrative Appeals Tribunal om 2024 No. 47 s 78 sch 2
Administrative Review Tribunal means the Administrative Review Tribunal established by the Administrative Review Tribunal Act 2024 (Cwlth) .
s 39 def Administrative Review Tribunal ins 2024 No. 47 s 78 sch 2
decision has the same meaning as in the Administrative Review Tribunal Act 2024 (Cwlth) .
s 39 def decision amd 2024 No. 47 s 78 sch 2
eligible person , in relation to a decision of the NHMRC Licensing Committee, means—
in relation to a decision under section 29 not to issue a licence—the applicant for the licence; or
in relation to a decision in respect of the period throughout which the licence is to be in force under section 31 —the licence holder; or
in relation to a decision to specify a licence condition under section 32 (4) —the licence holder; or
in relation to a decision to modify guidelines under section 32 (8) in respect of a licence—the licence holder; or
in relation to a decision to vary or refuse to vary a licence under section 33 —the licence holder; or
in relation to a decision to suspend or revoke a licence under section 34 —the person who was the licence holder immediately before the suspension or revocation.
s 39 def eligible person amd 2007 No. 45 s 18 (2)
s 39 amd 2007 No. 45 s 18 (1)
(a) in relation to a decision under section 29 not to issue a licence—the applicant for the licence; or
(b) in relation to a decision in respect of the period throughout which the licence is to be in force under section 31 —the licence holder; or
(c) in relation to a decision to specify a licence condition under section 32 (4) —the licence holder; or
(ca) in relation to a decision to modify guidelines under section 32 (8) in respect of a licence—the licence holder; or
(d) in relation to a decision to vary or refuse to vary a licence under section 33 —the licence holder; or
(e) in relation to a decision to suspend or revoke a licence under section 34 —the person who was the licence holder immediately before the suspension or revocation.
sec.40
Review of decisions
sec.40 Review of decisions
An eligible person may apply to the Administrative Review Tribunal for review of any of the following decisions of the NHMRC Licensing Committee if the decision is declared by the regulations made under the Commonwealth Act to be a reviewable State decision for the purposes of section 45 of that Act—
a decision under section 29 not to issue a licence;
a decision in respect of the period throughout which the licence is to be in force under section 31 ;
a decision to specify a licence condition under section 32 (4) ;
a decision to modify guidelines under section 32 (8) in respect of a licence;
a decision to vary or refuse to vary a licence under section 33 ;
a decision to suspend or revoke a licence under section 34 .
This section has effect subject to the Administrative Review Tribunal Act 2024 (Cwlth) .
The Administrative Review Tribunal Act 2024 (Cwlth) , other than part 7 , and the regulations in force under that Act apply as laws of the State for the review of a decision under subsection (1) .
For this section, a reference in a provision of the Administrative Review Tribunal Act 2024 (Cwlth) , as the provision applies as a law of this State, to the whole or part of part 7 of that Act is taken to be a reference to the whole or part of that part as it has effect as a law of the Commonwealth.
s 40 amd 2007 No. 45 s 19 ; 2024 No. 47 s 78 sch 2
(sec.40-ssec.1) An eligible person may apply to the Administrative Review Tribunal for review of any of the following decisions of the NHMRC Licensing Committee if the decision is declared by the regulations made under the Commonwealth Act to be a reviewable State decision for the purposes of section 45 of that Act— a decision under section 29 not to issue a licence; a decision in respect of the period throughout which the licence is to be in force under section 31 ; a decision to specify a licence condition under section 32 (4) ; a decision to modify guidelines under section 32 (8) in respect of a licence; a decision to vary or refuse to vary a licence under section 33 ; a decision to suspend or revoke a licence under section 34 .
(sec.40-ssec.2) This section has effect subject to the Administrative Review Tribunal Act 2024 (Cwlth) .
(sec.40-ssec.3) The Administrative Review Tribunal Act 2024 (Cwlth) , other than part 7 , and the regulations in force under that Act apply as laws of the State for the review of a decision under subsection (1) .
(sec.40-ssec.4) For this section, a reference in a provision of the Administrative Review Tribunal Act 2024 (Cwlth) , as the provision applies as a law of this State, to the whole or part of part 7 of that Act is taken to be a reference to the whole or part of that part as it has effect as a law of the Commonwealth.
(a) a decision under section 29 not to issue a licence;
(b) a decision in respect of the period throughout which the licence is to be in force under section 31 ;
(c) a decision to specify a licence condition under section 32 (4) ;
(ca) a decision to modify guidelines under section 32 (8) in respect of a licence;
(d) a decision to vary or refuse to vary a licence under section 33 ;
(e) a decision to suspend or revoke a licence under section 34 .
pt.4
Monitoring powers
Monitoring powers
sec.41
Appointment of inspectors
sec.41 Appointment of inspectors
The chairperson of the NHMRC Licensing Committee may, by instrument in writing, appoint any of the following persons as inspectors—
a person who is appointed or employed by the State;
a person who is appointed or employed by the Commonwealth.
In exercising powers or performing functions as an inspector, an inspector must comply with any directions of the chairperson of the NHMRC Licensing Committee.
The chairperson of the NHMRC Licensing Committee must not appoint a person as an inspector under subsection (1) unless he or she is satisfied that the person has appropriate skills and experience.
(sec.41-ssec.1) The chairperson of the NHMRC Licensing Committee may, by instrument in writing, appoint any of the following persons as inspectors— a person who is appointed or employed by the State; a person who is appointed or employed by the Commonwealth.
(sec.41-ssec.2) In exercising powers or performing functions as an inspector, an inspector must comply with any directions of the chairperson of the NHMRC Licensing Committee.
(sec.41-ssec.3) The chairperson of the NHMRC Licensing Committee must not appoint a person as an inspector under subsection (1) unless he or she is satisfied that the person has appropriate skills and experience.
(a) a person who is appointed or employed by the State;
(b) a person who is appointed or employed by the Commonwealth.
sec.42
Identity card
sec.42 Identity card
The chairperson of the NHMRC Licensing Committee must issue an identity card to an inspector.
The identity card—
must be in the form prescribed by the regulations under the Commonwealth Act; and
must contain a recent photograph of the inspector.
If a person to whom an identity card has been issued ceases to be an inspector, the person must return the identity card to the chairperson of the NHMRC Licensing Committee as soon as practicable.
Maximum penalty—1 penalty unit.
An inspector must carry his or her identity card at all times when exercising powers or performing functions as an inspector.
(sec.42-ssec.1) The chairperson of the NHMRC Licensing Committee must issue an identity card to an inspector.
(sec.42-ssec.2) The identity card— must be in the form prescribed by the regulations under the Commonwealth Act; and must contain a recent photograph of the inspector.
(sec.42-ssec.3) If a person to whom an identity card has been issued ceases to be an inspector, the person must return the identity card to the chairperson of the NHMRC Licensing Committee as soon as practicable. Maximum penalty—1 penalty unit.
(sec.42-ssec.4) An inspector must carry his or her identity card at all times when exercising powers or performing functions as an inspector.
(a) must be in the form prescribed by the regulations under the Commonwealth Act; and
(b) must contain a recent photograph of the inspector.
sec.43
Powers available to inspectors for monitoring compliance
sec.43 Powers available to inspectors for monitoring compliance
For the purpose of finding out whether this Act has been complied with, an inspector may—
enter any premises; and
exercise the monitoring powers set out in section 44 .
An inspector is not authorised to enter premises under subsection (1) unless—
the occupier of the premises has consented to the entry; or
the premises are premises at which the occupier of the premises is carrying out activities authorised by a licence issued under section 29 , and the entry is at a reasonable time; or
the entry is made under a warrant under section 45A .
s 43 amd 2007 No. 45 s 20
(sec.43-ssec.1) For the purpose of finding out whether this Act has been complied with, an inspector may— enter any premises; and exercise the monitoring powers set out in section 44 .
(sec.43-ssec.2) An inspector is not authorised to enter premises under subsection (1) unless— the occupier of the premises has consented to the entry; or the premises are premises at which the occupier of the premises is carrying out activities authorised by a licence issued under section 29 , and the entry is at a reasonable time; or the entry is made under a warrant under section 45A .
(a) enter any premises; and
(b) exercise the monitoring powers set out in section 44 .
(a) the occupier of the premises has consented to the entry; or
(b) the premises are premises at which the occupier of the premises is carrying out activities authorised by a licence issued under section 29 , and the entry is at a reasonable time; or
(c) the entry is made under a warrant under section 45A .
sec.44
Monitoring powers
sec.44 Monitoring powers
The monitoring powers that an inspector may exercise under section 43 (1) (b) are as follows—
to search the premises and any thing on the premises;
to inspect, examine, take measurements of, conduct tests on, or take samples of, any human embryo, other embryo, human egg or thing on the premises that relates to this Act;
to take photographs, make video or audio recordings or make sketches of the premises or any thing on the premises;
to inspect any book, record or document on the premises;
to take extracts from or make copies of any such book, record or document;
to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises;
in addition to the powers mentioned in paragraphs (a) to (f) , if the inspector was authorised to enter the premises by a warrant under section 45A —to require any person in or on the premises to—
answer any questions put by the inspector; and
produce any book, record or document requested by the inspector.
For the purposes of this part, monitoring powers include the power to operate equipment at premises to see whether—
the equipment; or
a disk, tape or other storage device that—
is at the premises; and
can be used with the equipment or is associated with it;
contains information that is relevant to determining whether there has been compliance with this Act.
If the inspector, after operating equipment at the premises, finds that the equipment, or that a tape, disk or other storage device at the premises, contains information mentioned in subsection (2) , the inspector may—
operate equipment or facilities at the premises to put the information in documentary form and copy the document so produced; or
if the information can be transferred to a tape, disk or other storage device that—
is brought to the premises; or
is at the premises and the use of which has been agreed to in writing by the occupier of the premises;
operate the equipment or other facilities to copy the information to the storage device, and remove the storage device from the premises.
s 44 amd 2007 No. 45 s 21
(sec.44-ssec.1) The monitoring powers that an inspector may exercise under section 43 (1) (b) are as follows— to search the premises and any thing on the premises; to inspect, examine, take measurements of, conduct tests on, or take samples of, any human embryo, other embryo, human egg or thing on the premises that relates to this Act; to take photographs, make video or audio recordings or make sketches of the premises or any thing on the premises; to inspect any book, record or document on the premises; to take extracts from or make copies of any such book, record or document; to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises; in addition to the powers mentioned in paragraphs (a) to (f) , if the inspector was authorised to enter the premises by a warrant under section 45A —to require any person in or on the premises to— answer any questions put by the inspector; and produce any book, record or document requested by the inspector.
(sec.44-ssec.2) For the purposes of this part, monitoring powers include the power to operate equipment at premises to see whether— the equipment; or a disk, tape or other storage device that— is at the premises; and can be used with the equipment or is associated with it; contains information that is relevant to determining whether there has been compliance with this Act.
(sec.44-ssec.3) If the inspector, after operating equipment at the premises, finds that the equipment, or that a tape, disk or other storage device at the premises, contains information mentioned in subsection (2) , the inspector may— operate equipment or facilities at the premises to put the information in documentary form and copy the document so produced; or if the information can be transferred to a tape, disk or other storage device that— is brought to the premises; or is at the premises and the use of which has been agreed to in writing by the occupier of the premises; operate the equipment or other facilities to copy the information to the storage device, and remove the storage device from the premises.
(a) to search the premises and any thing on the premises;
(b) to inspect, examine, take measurements of, conduct tests on, or take samples of, any human embryo, other embryo, human egg or thing on the premises that relates to this Act;
(c) to take photographs, make video or audio recordings or make sketches of the premises or any thing on the premises;
(d) to inspect any book, record or document on the premises;
(e) to take extracts from or make copies of any such book, record or document;
(f) to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises;
(g) in addition to the powers mentioned in paragraphs (a) to (f) , if the inspector was authorised to enter the premises by a warrant under section 45A —to require any person in or on the premises to— (i) answer any questions put by the inspector; and (ii) produce any book, record or document requested by the inspector.
(i) answer any questions put by the inspector; and
(ii) produce any book, record or document requested by the inspector.
(i) answer any questions put by the inspector; and
(ii) produce any book, record or document requested by the inspector.
(a) the equipment; or
(b) a disk, tape or other storage device that— (i) is at the premises; and (ii) can be used with the equipment or is associated with it;
(i) is at the premises; and
(ii) can be used with the equipment or is associated with it;
(i) is at the premises; and
(ii) can be used with the equipment or is associated with it;
(a) operate equipment or facilities at the premises to put the information in documentary form and copy the document so produced; or
(b) if the information can be transferred to a tape, disk or other storage device that— (i) is brought to the premises; or (ii) is at the premises and the use of which has been agreed to in writing by the occupier of the premises; operate the equipment or other facilities to copy the information to the storage device, and remove the storage device from the premises.
(i) is brought to the premises; or
(ii) is at the premises and the use of which has been agreed to in writing by the occupier of the premises;
(i) is brought to the premises; or
(ii) is at the premises and the use of which has been agreed to in writing by the occupier of the premises;
sec.45
Power to secure
sec.45 Power to secure
If an inspector, during a search of premises, believes on reasonable grounds that there is at the premises a human embryo, another embryo, a human egg or a thing that may afford evidence of the commission of an offence against this Act, the monitoring powers include securing the embryo, the egg or the thing pending the obtaining of a warrant by anyone to seize it.
s 45 amd 2007 No. 45 s 22
sec.45A
Monitoring warrants
sec.45A Monitoring warrants
An inspector may apply to a magistrate for a warrant under this section in relation to premises.
Subject to subsection (3) , the magistrate may issue the warrant if the magistrate is satisfied by information on oath or affirmation that it is reasonably necessary that one or more inspectors should have access to the premises for the purpose of finding out whether this Act has been complied with.
The magistrate must not issue the warrant unless the inspector or some other person has given to the magistrate, either orally or by affidavit, such further information (if any) as the magistrate requires concerning the grounds on which the issue of the warrant is being sought.
The warrant must—
authorise one or more inspectors (whether or not named in the warrant) with such assistance and by such force as is necessary and reasonable—
to enter the premises; and
to exercise the powers set out in section 44 in relation to the premises; and
state whether the entry is authorised to be made at any time of the day or night or during specified hours of the day or night; and
specify the day (not more than 15 days after the issue of the warrant) on which the warrant ceases to have effect; and
state the purpose for which the warrant is issued.
s 45A ins 2007 No. 45 s 23
(sec.45A-ssec.1) An inspector may apply to a magistrate for a warrant under this section in relation to premises.
(sec.45A-ssec.2) Subject to subsection (3) , the magistrate may issue the warrant if the magistrate is satisfied by information on oath or affirmation that it is reasonably necessary that one or more inspectors should have access to the premises for the purpose of finding out whether this Act has been complied with.
(sec.45A-ssec.3) The magistrate must not issue the warrant unless the inspector or some other person has given to the magistrate, either orally or by affidavit, such further information (if any) as the magistrate requires concerning the grounds on which the issue of the warrant is being sought.
(sec.45A-ssec.4) The warrant must— authorise one or more inspectors (whether or not named in the warrant) with such assistance and by such force as is necessary and reasonable— to enter the premises; and to exercise the powers set out in section 44 in relation to the premises; and state whether the entry is authorised to be made at any time of the day or night or during specified hours of the day or night; and specify the day (not more than 15 days after the issue of the warrant) on which the warrant ceases to have effect; and state the purpose for which the warrant is issued.
(a) authorise one or more inspectors (whether or not named in the warrant) with such assistance and by such force as is necessary and reasonable— (i) to enter the premises; and (ii) to exercise the powers set out in section 44 in relation to the premises; and
(i) to enter the premises; and
(ii) to exercise the powers set out in section 44 in relation to the premises; and
(b) state whether the entry is authorised to be made at any time of the day or night or during specified hours of the day or night; and
(c) specify the day (not more than 15 days after the issue of the warrant) on which the warrant ceases to have effect; and
(d) state the purpose for which the warrant is issued.
(i) to enter the premises; and
(ii) to exercise the powers set out in section 44 in relation to the premises; and
sec.45B
Details of warrant to be given to occupier etc.
sec.45B Details of warrant to be given to occupier etc.
If a warrant under section 45A is being executed and the occupier of the premises or another person who apparently represents the occupier is present at the premises, the inspector must make available to that person a copy of the warrant.
The inspector must identify himself or herself to that person.
The copy of the warrant referred to in subsection (1) need not include the signature of the magistrate who issued the warrant.
s 45B ins 2007 No. 45 s 23
(sec.45B-ssec.1) If a warrant under section 45A is being executed and the occupier of the premises or another person who apparently represents the occupier is present at the premises, the inspector must make available to that person a copy of the warrant.
(sec.45B-ssec.2) The inspector must identify himself or herself to that person.
(sec.45B-ssec.3) The copy of the warrant referred to in subsection (1) need not include the signature of the magistrate who issued the warrant.
sec.45C
Announcement before entry
sec.45C Announcement before entry
An inspector must, before entering premises under a warrant—
announce that he or she is authorised to enter the premises; and
give any person at the premises an opportunity to allow entry to the premises.
s 45C ins 2007 No. 45 s 23
(a) announce that he or she is authorised to enter the premises; and
(b) give any person at the premises an opportunity to allow entry to the premises.
sec.45D
Occupier entitled to be present during search
sec.45D Occupier entitled to be present during search
If a warrant under section 45A is being executed and the occupier of the premises or another person who apparently represents the occupier is present at the premises, the person is entitled to observe the search being conducted.
The right to observe the search being conducted ceases if the person impedes the search.
This section does not prevent 2 or more areas of the premises being searched at the same time.
s 45D ins 2007 No. 45 s 23
(sec.45D-ssec.1) If a warrant under section 45A is being executed and the occupier of the premises or another person who apparently represents the occupier is present at the premises, the person is entitled to observe the search being conducted.
(sec.45D-ssec.2) The right to observe the search being conducted ceases if the person impedes the search.
(sec.45D-ssec.3) This section does not prevent 2 or more areas of the premises being searched at the same time.
sec.46
Inspector must produce identity card on request
sec.46 Inspector must produce identity card on request
An inspector is not entitled to exercise any powers under this part in relation to premises if—
the occupier of the premises has required the inspector to produce his or her identity card for inspection by the occupier; and
the inspector fails to comply with the requirement.
(a) the occupier of the premises has required the inspector to produce his or her identity card for inspection by the occupier; and
(b) the inspector fails to comply with the requirement.
sec.47
Consent
sec.47 Consent
Before obtaining the consent of a person for the purposes of section 43 (2) (a) , the inspector must inform the person that he or she may refuse consent.
An entry of an inspector by virtue of the consent of a person is not lawful unless the person voluntarily consented to the entry.
(sec.47-ssec.1) Before obtaining the consent of a person for the purposes of section 43 (2) (a) , the inspector must inform the person that he or she may refuse consent.
(sec.47-ssec.2) An entry of an inspector by virtue of the consent of a person is not lawful unless the person voluntarily consented to the entry.
sec.48
Compensation for damage
sec.48 Compensation for damage
The owner of equipment or other facilities is entitled to compensation for damage to the equipment or other facilities if—
the damage was caused to the equipment or other facilities as a result of it being operated by an inspector as mentioned in this part; and
the damage was caused as a result of insufficient care being exercised by the inspector operating the equipment or other facilities.
In determining the amount of compensation payable, regard is to be had to whether the occupier of the premises and his or her employees and agents, if they were available at the time, had provided any warning or guidance as to the operation of the equipment or other facilities that was appropriate in the circumstances.
(sec.48-ssec.1) The owner of equipment or other facilities is entitled to compensation for damage to the equipment or other facilities if— the damage was caused to the equipment or other facilities as a result of it being operated by an inspector as mentioned in this part; and the damage was caused as a result of insufficient care being exercised by the inspector operating the equipment or other facilities.
(sec.48-ssec.2) In determining the amount of compensation payable, regard is to be had to whether the occupier of the premises and his or her employees and agents, if they were available at the time, had provided any warning or guidance as to the operation of the equipment or other facilities that was appropriate in the circumstances.
(a) the damage was caused to the equipment or other facilities as a result of it being operated by an inspector as mentioned in this part; and
(b) the damage was caused as a result of insufficient care being exercised by the inspector operating the equipment or other facilities.
pt.5
Miscellaneous
Miscellaneous
pt.5-div.1
Review of Act
Review of Act
sec.49
Further review of operation of Act
sec.49 Further review of operation of Act
The Minister must cause a review of the operation of this Act as amended by the Research Involving Human Embryos and Prohibition of Human Cloning Amendment Act 2007 to be undertaken as soon as possible after the third anniversary of the day on which that Act commenced.
The review must cover the scope and operation of parts 2 and 3 taking into account the following—
developments in assisted reproductive technology, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research;
developments in embryonic stem cell research, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research;
community standards;
a brief analysis of international developments and legislation relating to the use of human embryos and related research;
an analysis of research resulting from the licenses granted;
an analysis of any research or clinical practice that has been prevented as a result of legislative restrictions.
The review may be undertaken as part of the reviews under the Commonwealth Act, section 47A and the Prohibition of Human Cloning for Reproduction Act 2002 (Cwlth) , section 25A .
s 49 sub 2007 No. 45 s 24
(sec.49-ssec.1) The Minister must cause a review of the operation of this Act as amended by the Research Involving Human Embryos and Prohibition of Human Cloning Amendment Act 2007 to be undertaken as soon as possible after the third anniversary of the day on which that Act commenced.
(sec.49-ssec.2) The review must cover the scope and operation of parts 2 and 3 taking into account the following— developments in assisted reproductive technology, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research; developments in embryonic stem cell research, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research; community standards; a brief analysis of international developments and legislation relating to the use of human embryos and related research; an analysis of research resulting from the licenses granted; an analysis of any research or clinical practice that has been prevented as a result of legislative restrictions.
(sec.49-ssec.3) The review may be undertaken as part of the reviews under the Commonwealth Act, section 47A and the Prohibition of Human Cloning for Reproduction Act 2002 (Cwlth) , section 25A .
(a) developments in assisted reproductive technology, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research;
(b) developments in embryonic stem cell research, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research;
(c) community standards;
(d) a brief analysis of international developments and legislation relating to the use of human embryos and related research;
(e) an analysis of research resulting from the licenses granted;
(f) an analysis of any research or clinical practice that has been prevented as a result of legislative restrictions.
pt.5-div.2
Matters about offences
Matters about offences
sec.50
Attempts to commit offences against this Act
sec.50 Attempts to commit offences against this Act
A person who attempts to commit an offence against this Act commits an offence.
Maximum penalty—the maximum penalty for committing the offence attempted to be committed.
The Criminal Code, section 4 , applies to subsection (1) .
(sec.50-ssec.1) A person who attempts to commit an offence against this Act commits an offence. Maximum penalty—the maximum penalty for committing the offence attempted to be committed.
(sec.50-ssec.2) The Criminal Code, section 4 , applies to subsection (1) .
sec.51
Crimes and summary offences
sec.51 Crimes and summary offences
The following offences are crimes—
an offence mentioned in part 2 or in part 3 , division 2 ;
an offence against section 50 (1) , if the offence attempted to be committed is a crime.
The offender can not be arrested without warrant.
Any other offence against this Act is a summary offence.
(sec.51-ssec.1) The following offences are crimes— an offence mentioned in part 2 or in part 3 , division 2 ; an offence against section 50 (1) , if the offence attempted to be committed is a crime.
(sec.51-ssec.2) The offender can not be arrested without warrant.
(sec.51-ssec.3) Any other offence against this Act is a summary offence.
(a) an offence mentioned in part 2 or in part 3 , division 2 ;
(b) an offence against section 50 (1) , if the offence attempted to be committed is a crime.
sec.52
Limitation on time for starting summary proceedings
sec.52 Limitation on time for starting summary proceedings
A proceeding for a summary offence against this Act by way of summary proceeding under the Justices Act 1886 must start—
within 1 year after the commission of the offence; or
within 6 months after the offence comes to the complainant’s knowledge, but within 2 years after the commission of the offence.
(a) within 1 year after the commission of the offence; or
(b) within 6 months after the offence comes to the complainant’s knowledge, but within 2 years after the commission of the offence.
pt.5-div.3
Regulations
Regulations
sec.53
Regulation-making power
sec.53 Regulation-making power
The Governor in Council may make regulations under this Act.
pt.6
Saving provisions
Saving provisions
sec.54
Saving provision
sec.54 Saving provision
If—
at any time before the commencement of this section, a person made an application under sub section 28 (1) for a licence; and
immediately before that commencement, the NHMRC Licensing Committee had not decided the application;
then the person is taken, on and from that commencement, to have applied for the licence under sub section 28 (1) of the amended Act.
To avoid any doubt, it is declared that a licence issued under section 29 that was in force immediately before the commencement of this section continues in force after that commencement.
In this section—
amended Act means this Act as amended by the Research Involving Human Embryos and Prohibition of Human Cloning Amendment Act 2007 .
s 54 ins 2007 No. 45 s 25
(sec.54-ssec.1) If— at any time before the commencement of this section, a person made an application under sub section 28 (1) for a licence; and immediately before that commencement, the NHMRC Licensing Committee had not decided the application; then the person is taken, on and from that commencement, to have applied for the licence under sub section 28 (1) of the amended Act.
(sec.54-ssec.2) To avoid any doubt, it is declared that a licence issued under section 29 that was in force immediately before the commencement of this section continues in force after that commencement.
(sec.54-ssec.3) In this section— amended Act means this Act as amended by the Research Involving Human Embryos and Prohibition of Human Cloning Amendment Act 2007 .
(a) at any time before the commencement of this section, a person made an application under sub section 28 (1) for a licence; and
(b) immediately before that commencement, the NHMRC Licensing Committee had not decided the application;
Source text: opening excerpt
Sourced from Queensland Legislation (legislation.qld.gov.au), CC BY 4.0.
pt.1 Preliminary
Preliminary
sec.1 Short title
sec.1 Short title
This Act may be cited as the Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Act 2003 .
s 1 amd 2007 No. 45 s 4
sec.2 Commencement
sec.2 Commencement
This Act, other than part 6 , division 1 , commences on a day to be fixed by proclamation.
Part 6 , division 1 , commences on whichever of the following days applies—
5 April 2005;
if the Council of Australian Governments declares an earlier day by notice in the gazette—that earlier day.
(sec.2-ssec.1) This Act, other than part 6 , division 1 , commences on a day to be fixed by proclamation.
(sec.2-ssec.2) Part 6 , division 1 , commences on whichever of the following days applies— 5 April 2005; if the Council of Australian Governments declares an earlier day by notice in the gazette—that earlier day.
(a) 5 April 2005;
(b) if the Council of Australian Governments declares an earlier day by notice in the gazette—that earlier day.
sec.3 Object of Act
sec.3 Object of Act
The object of this Act is to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos—
by prohibiting certain practices; and
by regulating activities that involve the use of certain human embryos created by assisted reproductive technology or by other means.
s 3 amd 2007 No. 45 s 5
(a) by prohibiting certain practices; and
(b) by regulating activities that involve the use of certain human embryos created by assisted reproductive technology or by other means.
sec.4 Act binds all persons
sec.4 Act binds all persons
This Act binds all persons, including the State, and, as far as the legislative power of the Parliament permits, the Commonwealth and the other States.
Nothing in this Act makes the Commonwealth or a State liable to be prosecuted for an offence.
(sec.4-ssec.1) This Act binds all persons, including the State, and, as far as the legislative power of the Parliament permits, the Commonwealth and the other States.
(sec.4-ssec.2) Nothing in this Act makes the Commonwealth or a State liable to be prosecuted for an offence.
sec.5 Definitions
sec.5 Definitions
The dictionary in the schedule defines particular words used in this Act.
For the purposes of establishing that a human embryo clone is a genetic copy of a living or dead human—
it is sufficient to establish that the set of genes in the nuclei of the cells of the living or dead human has been copied; and
it is not necessary to establish that the copy is an identical genetic copy.
For the purposes of the definition human embryo in the schedule, in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.
For the purposes of the definition human embryo clone in the schedule, a human embryo that results from the technological process known as embryo splitting is taken not to be created by a process of fertilisation of a human egg by human sperm.
A reference in this Act to an embryo (including a human embryo) is a reference to a living embryo.
A reference in this Act to a human egg is a reference to a human oocyte.
A reference in this Act to a human embryo does not include a reference to—
a hybrid embryo; or
a human embryonic stem cell line.
The following provisions of the Acts Interpretation Act 1954 do not apply to a reference to a spouse in this Act—
section 32DA (6)
schedule 1 , definition spouse .
s 5 amd 2007 No. 45 s 6 ; 2013 No. 39 s 110 (1) sch 3 pt 1
(sec.5-ssec.1) The dictionary in the schedule defines particular words used in this Act.
(sec.5-ssec.2) For the purposes of establishing that a human embryo clone is a genetic copy of a living or dead human— it is sufficient to establish that the set of genes in the nuclei of the cells of the living or dead human has been copied; and it is not necessary to establish that the copy is an identical genetic copy.
(sec.5-ssec.3) For the purposes of the definition human embryo in the schedule, in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.
(sec.5-ssec.4) For the purposes of the definition human embryo clone in the schedule, a human embryo that results from the technological process known as embryo splitting is taken not to be created by a process of fertilisation of a human egg by human sperm.
(sec.5-ssec.5) A reference in this Act to an embryo (including a human embryo) is a reference to a living embryo.
(sec.5-ssec.6) A reference in this Act to a human egg is a reference to a human oocyte.
(sec.5-ssec.7) A reference in this Act to a human embryo does not include a reference to— a hybrid embryo; or a human embryonic stem cell line.
(sec.5-ssec.8) The following provisions of the Acts Interpretation Act 1954 do not apply to a reference to a spouse in this Act— section 32DA (6) schedule 1 , definition spouse .
Main concepts
The Act uses a set of technical definitions and legal thresholds that determine whether activity is prohibited, licensable, or exempt. Key definitional and conceptual points in the text are:
Human embryo and exclusions, development timing: the schedule (referred to in s 5) contains definitions used throughout the Act. The Act clarifies that references to an embryo are to a living embryo, and any suspended period of development is disregarded when working out the length of development (s 5). It also explicitly excludes hybrid embryos and human embryonic stem cell lines from the statutory meaning of human embryo for particular purposes (s 5).
Excess ART embryo: an "excess ART embryo" is defined in pt 3 as an embryo created by assisted reproductive technology (ART) for a woman’s treatment that is excess to the needs of the woman and her spouse at the time the embryo was created, determined either by written authority for another use or written determination that it is excess (s 22). That definition controls which embryos are eligible for uses subject to the licensing scheme.
Prohibited embryo: s 16 provides an enumerated list of embryo types that are "prohibited" for placement into a woman, including embryos created other than by fertilisation, embryos created outside the body unless intended to achieve pregnancy in a particular woman, embryos with genetic material from more than two persons, embryos developed outside a woman for more than 14 days, embryos created using precursor cells taken from an embryo or fetus, embryos containing heritable genome alterations (per s 11), embryos removed from a woman with intent to collect a viable embryo, chimeric embryos and hybrid embryos (s 16(2)).
Mental element: many offences require intention, others require the actor to "know or be reckless" (see ss 20, 25). The Act defines "reckless" for both circumstances and results as awareness of a substantial risk and that taking the risk is unjustifiable, which is a question of fact (s 6).
Licence as exception: part 3 permits specified otherwise prohibited activities if authorised by a licence issued by the NHMRC Licensing Committee, subject to conditions and HREC approval (ss 28-29, 32). The Committee must be satisfied proper consent protocols exist and the activity has HREC approval in accordance with the NHMRC National Statement (s 29(3)).
Time limit on embryo development: the Act makes it an offence to develop a human embryo outside the body of a woman for more than 14 days, excluding suspended periods (s 10). Licences cannot authorise development beyond 14 days (s 28(1A)).
Confidentiality and transparency: the NHMRC Licensing Committee must maintain a public database with licence names, scope, conditions and numbers of embryos or eggs authorised, while confidential commercial information is to be excluded from disclosure and its unauthorised disclosure is criminalised (ss 37-38).
Interaction with NHMRC guidance and Commonwealth law: "proper consent" is defined by NHMRC guidelines under the National Health and Medical Research Council Act 1992 and prescribed by regulation (s 21). The Act explicitly interoperates with the Commonwealth Prohibition of Human Cloning Act 2002 and the Commonwealth Act governing licensing, with several provisions making cross references (for example s 37(5); ss 25A, 40).
These core concepts drive legal status: who may legally do what, where licences authorise departures from the prohibitions, and how oversight, consent and reporting link to HREC and NHMRC mechanisms.
Who it affects
The Act directly and indirectly affects several discrete categories of actors in medical research, clinical ART, and government oversight:
Researchers and licence applicants: any person or entity seeking to create or use embryos in ways covered by the licensing provisions must apply to the NHMRC Licensing Committee (s 28). Licence holders are subject to conditions, reporting obligations and potential criminal liability for contraventions (ss 32, 25).
Assisted reproductive technology centres and clinicians: accredited ART centres are specifically referenced as eligible to carry out some exempt uses (for example diagnostic investigations, storage, transport, observation, and certain transfers to achieve pregnancy in other women under s 23(2)). Section 28(1)(f) also permits authorised hybrid embryo creation limited to accredited ART centres for sperm testing up to the first mitotic division.
Donors, patients and "responsible persons": the Act gives rights and duties to responsible persons. For excess ART embryos, a responsible person includes each person who provided the egg or sperm, the woman for whom the embryo was created for pregnancy, spouses at the time of provision or creation, and for other embryos each person whose reproductive or genetic material was used (s 21 def responsible person). Proper consent from these people is a licence precondition (s 32(1)). The definition of excess ART embryo in s 22 depends on written authorities or written determinations from the relevant persons.
Bodies that assess ethics and oversight: Human Research Ethics Committees (HRECs) are required to assess and approve licensable activities, in conformity with the NHMRC National Statement on Ethical Conduct in Research Involving Humans (s 29(3)). The NHMRC Licensing Committee performs licence functions and maintains the public database (ss 26-27, 37).
State and Commonwealth agencies: the Act binds all persons including the State (s 4(1)), but s 4(2) declares nothing in the Act makes the Commonwealth or a State liable to be prosecuted. The Act contemplates information flow between the NHMRC Licensing Committee and "relevant State body" (ss 30, 36), and the database may form part of the Commonwealth database (s 37(5)). Section 38 allows disclosure of confidential commercial information to State agencies, the Commonwealth or Commonwealth authorities in specified circumstances.
Inspectors and enforcement officers: inspectors appointed by the chairperson of the Licensing Committee, and magistrates issuing monitoring warrants, are given powers to enter, search, copy records and secure evidence (ss 41-46, 45A). The chairperson may appoint inspectors from persons appointed or employed by the State or the Commonwealth (s 41).
Commercial entities and intermediaries: section 17 criminalises giving or receiving "valuable consideration" for supply of eggs, sperm or embryos, subject to permitted reimbursement of "reasonable expenses". The section’s definition of valuable consideration includes inducements or priority in provision of services.
Wider public and researchers internationally: publication obligations and public database (s 37) mean that licence activity will be publicly visible, subject to confidential commercial information protection (s 38). The Minister is required to undertake a statutory review of parts 2 and 3 after the 2007 amendments took effect, including analysis of licences granted and research prevented (s 49), which may affect future policy and access.
In short, clinical ART providers, research institutions seeking to work at the margins of the prohibitions, donors and treated women, HRECs and the NHMRC Licensing Committee, and enforcement personnel are the principal affected groups. Those who provide or receive "valuable consideration" for human reproductive materials are criminalised unless only reasonable expenses are paid (s 17).
Key duties and rights
The Act imposes specific duties on licence holders, researchers, ART centres and public officials, and it equally protects certain procedural rights. The main duties and rights are:
Duties on licence holders and applicants
Obtain HREC approval in accordance with the NHMRC National Statement before a licence can be issued (s 29(3)(b)-(c)).
Ensure appropriate protocols are in place to obtain "proper consent" in accordance with NHMRC guidelines and to comply with restrictions on that consent (s 29(3)(a); s 32(1)). Proper consent is a statutory condition for the use of an excess ART embryo, a human egg, or creation or use of another embryo (s 32(1)).
Report in writing to the NHMRC Licensing Committee that proper consent has been obtained and disclose any restrictions attached to that consent before using embryos or eggs as authorised by the licence (s 32(1)(b)).
Comply with licence conditions which may include limits on the persons authorised to carry out work, numerical limits on embryos or eggs, reporting and monitoring, and information to be provided to authorised persons (s 32(4)-(6)).
Keep records and ensure monitoring and reporting obligations so the Licensing Committee can exercise its oversight functions and maintain the public database (ss 32, 37).
Rights and protections for applicants and licence holders
Applicants may seek a licence authorising various activities specified at s 28. The Committee must not issue a licence unless satisfied about consent protocols and HREC approval (s 29(3)).
The Licensing Committee must notify the applicant, the HREC and the relevant State body of its decision on an application, and must give copies of a licence to the HREC and relevant State body if issued (s 30).
Eligible persons have a right to apply for review of certain Committee decisions to the Administrative Review Tribunal when regulations declare decisions reviewable under the Commonwealth Act (s 40). The Act sets out who is an eligible person (s 39).
Protection where reliance on a purported licence was reasonable: s 25A states a person is not criminally responsible for conduct if the conduct was purportedly authorised by a licence, the licence or provision was invalid, and the person did not know and could not reasonably be expected to have known of the invalidity.
Duties on accredited ART centres and clinical providers
Accredited ART centres are identified in definitions and certain exempt uses are reserved to accredited ART centres (s 21; s 23(2)(d)-(e); s 28(1)(f)).
Clinicians and centres must not place certain prohibited embryos in a woman or animal (ss 7, 15, 16).
Duties on inspectors and oversight officers
Inspectors must carry identity cards and comply with directions of the chairperson of the Licensing Committee (ss 41-42; s 46).
Inspectors must inform persons they seek consent from that consent can be refused (s 47); must produce identity cards on request to exercise powers (s 46); must announce authority prior to entry under a warrant (s 45C); and provide a copy of a warrant to the occupier if present (s 45B).
Confidentiality duties and rights
The Licensing Committee must maintain a public database but exclude confidential commercial information (s 37(1)-(4)).
Unauthorised disclosure of confidential commercial information obtained through duties under part 3 is a criminal offence carrying up to two years imprisonment, with limited carve outs for disclosure to State agencies, Commonwealth authorities, courts, or with affected persons’ consent (s 38).
Specific substantive prohibitions as duties to refrain
Persons must not engage in the activities criminalised in part 2 and in part 3 division 2 unless authorised by licence or subject to an exempt use (ss 7-20A; ss 23-24).
The Act therefore colours legal practice and research activity by imposing pre‑conditions of consent, HREC approval and licence conditions, plus oversight and confidentiality duties, while protecting rights to review and a narrow defence for reliance on an invalid licence (s 25A).
Penalties and enforcement
The statute sets a tiered penalty structure, administrative enforcement tools, and criminal procedural rules:
Penalty levels
Maximum penalties for core prohibitions in part 2 are generally 15 years imprisonment for placing human embryo clones in bodies, creating embryos outside the body for not to achieve pregnancy, creating embryos containing genetic material from more than two persons, developing embryos outside the body for more than 14 days, heritable genome alterations, collecting viable embryos from a woman, creating chimeric embryos, developing hybrid embryos beyond permitted windows, various forms of placing embryos in inappropriate bodies, and intentional placement of a prohibited embryo (see ss 7-16). The maximum is often stated as "Maximum penalty,15 years imprisonment."
Some offences are capped at 10 years, for instance creating or developing embryos other than by fertilisation without licence (s 18), creating or developing embryos with genetic material from more than two persons absent a licence (s 19), using precursor cells from an embryo or fetus to create embryos without licence (s 20), and creating or developing hybrid embryos where licensable exceptions do not apply (s 20A).
Offences in part 3 division 2, relating to unauthorised use of excess ART embryos, other embryos, certain activities with human eggs, unauthorised use of embryos that are not excess ART embryos, and breach of licence conditions carry maximum penalties up to five years imprisonment (ss 23-25B). Disclosure of confidential commercial information is a separate offence carrying up to two years imprisonment (s 38).
Attempted offences attract the maximum penalty for the completed offence, and the Criminal Code s 4 applies (s 50).
Enforcement machinery
Criminal enforcement can be effected by police or prosecuting authorities. The Act labels offences in part 2 and part 3 division 2 as crimes (s 51(1)), and states "The offender cannot be arrested without warrant" (s 51(2)). Other offences are summary offences (s 51(3)). Note that the Act itself does not create liability for Commonwealth or State governments to be prosecuted (s 4(2)).
The NHMRC Licensing Committee has administrative enforcement powers: it may vary, suspend or revoke licences on reasonable grounds, and must revoke licences if a licence holder is convicted under the Act (s 34). It may also vary licences on reasonable grounds and must notify relevant parties of variations, suspensions, revocations and surrenders (ss 33, 34, 36).
Inspectors appointed by the Licensing Committee are empowered to enter premises with consent, at reasonable times for licensed activity, or under warrant issued by a magistrate (ss 41, 43, 45A). Powers include searching premises, inspecting and copying documents, taking samples, photographing and operating equipment to obtain data, securing items pending warrant, and seizing information to produce documentary copies (ss 44-45).
Safeguards and obligations on inspectors include carrying and producing identity cards, informing persons of their right to refuse consent to entry, providing copies of warrants during execution, announcing authority before entry under warrant, and allowing occupiers to observe searches unless they impede it (ss 42, 45B, 45C, 45D, 47, 46).
Remedies for damage to equipment caused by inspectors are provided; owners are entitled to compensation if damage results from insufficient care by the inspector (s 48).
Procedural rights and review
Where decisions are reviewable under Commonwealth regulations, eligible persons may apply to the Administrative Review Tribunal for review of defined decisions of the Licensing Committee, including refusal to issue a licence, licence period, specification of licence conditions, variation or suspension or revocation of licences (ss 39-40). The Administrative Review Tribunal Act 2024 applies as a State law for such reviews (s 40).
The enforcement framework therefore mixes criminal sanctions with administrative licensing oversight, monitoring powers subject to warrants and prescribed processes, and administrative review routes for affected parties.
How it interacts with other laws
The Act is written to operate in a cooperative federal regulatory environment and makes multiple cross references to Commonwealth law and NHMRC instruments:
Interaction with Commonwealth prohibitions and the Commonwealth licensing scheme
The Act is enacted alongside and cross‑references the Prohibition of Human Cloning Act 2002 (Cwlth) and the Commonwealth Act governing licensing (referred to repeatedly as the Commonwealth Act). The NHMRC Licensing Committee may carry out functions that align with the Commonwealth licensing scheme and databases may form part of the Commonwealth database (s 26-29; s 37(5)). Disclosure of confidential commercial information is permitted for the purposes of "this Act, a corresponding State law, the Commonwealth Act or the Prohibition of Human Cloning Act 2002 (Cwlth)" to a State agency or Commonwealth authority (s 38(1)(c)). The review regime in s 40 operates only where regulations made under the Commonwealth Act declare the Committee decision to be a reviewable State decision for the Commonwealth Act’s purposes.
Relationship with NHMRC guidelines and HRECs
"Proper consent" for use of embryos or eggs for licensable purposes is defined by guidelines issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 and prescribed under regulation (s 21 def proper consent; s 32(1)). The Committee must be satisfied that the activity has been assessed and approved by an HREC constituted in accordance with, and acting in compliance with, the NHMRC National Statement on Ethical Conduct in Research Involving Humans (s 29(3)(b)-(c)). Thus ethical guidance and HREC approval are embedded prerequisites for licence issuance.
Administrative Review and Federal administrative law
The Act makes licensing decisions subject to administrative review where the decision is declared reviewable under Commonwealth Act regulations (s 40). The Administrative Review Tribunal Act 2024 applies, other than part 7, as a law of the State for review (s 40(3)).
State sovereignty clause and prosecution
The Act binds all persons including the State (s 4(1)) but expressly states that nothing in the Act makes the Commonwealth or a State liable to be prosecuted for an offence (s 4(2)). That carve‑out preserves executive immunity for the Commonwealth and States as regards criminal sanctions in this Act.
Criminal Code and attempts
Attempts are governed by the Criminal Code; s 50(2) specifically applies the Criminal Code s 4.
Regulatory instruments and governor‑in‑council regulations
The Governor in Council may make regulations under this Act (s 53). Regulations are envisaged to prescribe fees for licences (s 28(2)), to prescribe accredited ART centres, and to prescribe uses and other matters referred to in ss 21, 29 and 28.
Data sharing and confidentiality
The Licensing Committee’s database is to be publicly available, but information that would disclose confidential commercial information must be excluded (s 37(3)-(4)). The Act permits limited information sharing with State or Commonwealth agencies and courts (s 38).
Overall, the Act is designed to dovetail with Commonwealth prohibitions, NHMRC guidance and HREC processes, while retaining State administrative mechanics for licensing, inspection and review. The Act contains multiple cross‑references that require implementers to consult NHMRC guidelines, Commonwealth legislation and regulations to determine the practical legal obligations.
Amendment history
The text provided contains multiple amendment annotations. The Act originated as the Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Act 2003, and has been amended several times. The in‑text amendment markers indicate the following:
2007 amendments: Numerous sections show "sub 2007 No. 45 s 7" or "amd 2007 No. 45 s 15" etc. For example, s 1 contains "s 1 amd 2007 No. 45 s 4", s 3 "s 3 amd 2007 No. 45 s 5", s 5 "s 5 amd 2007 No. 45 s 6", s 7-20A reflect 2007 substitution or insertion notes "sub 2007 No. 45 s 7" or "ins 2007 No. 45 s 7". Part 3 licensing provisions and definitions were amended or expanded in 2007 (see ss 21, 28-33 with "amd 2007 No. 45" annotations).
2006 amendment: s 21 def proper consent is annotated "s 21 def proper consent amd 2006 No. 25 s 241 (2) sch 4", indicating the definition of "proper consent" was amended in 2006 to reference NHMRC guidelines as defined under the NHMRC Act.
2013 amendment: s 5 notes "2013 No. 39 s 110 (1) sch 3 pt 1", indicating an amendment in 2013 to the definitions provisions.
2024 amendment and administrative review update: s 39 def Administrative Appeals Tribunal has "om 2024 No. 47 s 78 sch 2" and insertion of "Administrative Review Tribunal" is noted "s 39 def Administrative Review Tribunal ins 2024 No. 47 s 78 sch 2". The Administrative Review Tribunal Act 2024 is incorporated into the review provisions in s 40, and s 40 has "amd 2007 No. 45 s 19 ; 2024 No. 47 s 78 sch 2". The changes reflect restructuring of administrative review mechanisms.
Commencement changes: s 2 provides staged commencement for part 6 division 1 on 5 April 2005, or earlier if Council of Australian Governments declared.
Saving provision insertion: s 54 was inserted by 2007 No. 45 s 25 to deal with transitional licence applications and continuation of licences.
The Act text embeds amendment notations adjacent to the relevant sections. The Minister is required to cause a statutory review of operations as amended by the 2007 Amendment Act to be undertaken as soon as possible after the third anniversary of that Amendment Act’s commencement, with specified review scope (s 49 sub 2007 No. 45 s 24). The Act’s amendment history therefore shows iterative changes to definitions, licensing details and administrative review processes, and incorporation of NHMRC guidelines as legally material instruments.
Users should consult the consolidated statute and the statutory instruments (regulations, NHMRC guidelines) and the Commonwealth Acts referenced for the current operative text and any further amendments after the ones shown in the text provided.
Litigation history
The Act text supplied does not refer to any judicial decisions or litigation outcomes. It establishes statutory appeal and review routes rather than judicial interpretations within the text itself. Specifically:
The Act creates administrative review routes for eligible persons to the Administrative Review Tribunal for specified Licensing Committee decisions where regulations under the Commonwealth Act declare them reviewable (ss 39-40). Those provisions provide an administrative channel, not a record of litigation.
There are no cases cited or described in the statute text. The Act does not annotate or summarise any judicial applications, constitutional challenges, or case law.
Because the Act classifies core offences as crimes and specifies that offenders "cannot be arrested without warrant" for those crimes (s 51(2)), relevant criminal prosecutions, if commenced, would generate litigation; none are recorded in the Act text.
For litigation research, practitioners must therefore consult external sources: court databases, prosecutorial records, and legal reporting services, to identify any judicial decisions applying or interpreting this Act. The Act itself provides no litigation history or case law citations.
Gotchas
The Act contains a number of drafting features and interactions that commonly surprise operators. The following are source‑grounded points to watch for:
"Intention" and "recklessness" vary across offences: many prohibitions require that the actor "intentionally" engages in conduct (e.g. ss 7, 8, 9, 10). Some offences add a mens rea of "knows or is reckless as to that fact" (e.g. s 20), and breaches of licence conditions criminalise intentional conduct knowing it contravenes a condition or being reckless as to that fact (s 25). The Act defines "reckless" with a specific two‑element test and declares unjustifiability a question of fact (s 6). Practitioners must map the statutory mental element to evidence strategy.
No defence that an embryo did not survive: s 7(2) explicitly states it is not a defence that the human embryo clone did not survive or could not have survived. That narrows reliance on eventual outcome as a defence.
Narrow definition of "excess ART embryo": s 22 establishes that an embryo is only "excess" if each relevant person has given written authority for non‑treatment use or has determined in writing the embryo is excess. Ambiguity in documentation or missing signatures can convert an embryo from licensable to prohibited if used incorrectly.
Payment and "valuable consideration": s 17 criminalises giving or receiving "valuable consideration" for supply of eggs, sperm or embryos. The definition expressly includes inducements, discounts or priority, but excludes payment of "reasonable expenses". For embryos, "reasonable expenses" excludes costs incurred before the embryo became an excess ART embryo (s 17(3)). Clinics and intermediaries must document expense categories carefully.
Public database and confidential commercial information tension: the Licensing Committee must make licence information publicly available but exclude confidential commercial information (s 37). Unauthorized disclosure of confidential commercial information is a criminal offence carrying up to two years imprisonment, but the Act permits disclosure to State agencies, Commonwealth authorities, courts, or with the consent of each affected person (s 38). Decisions about redaction and whether information is "confidential commercial information" will have operational consequences and potential criminal exposure.
Licences cannot authorise development beyond 14 days: s 10 sets a 14‑day developmental limit for embryos outside a woman, and s 28(1A) clarifies that s 28(1)(a)-(d) licences cannot authorise development beyond 14 days. There is no statutory carve‑out for extensions.
Protection for reasonable reliance on invalid licences is narrow: s 25A provides a defence if conduct was purportedly authorised by a licence, the licence was invalid and the person did not know and could not reasonably be expected to have known of the invalidity. The defence requires showing reasonable expectation of validity; it does not absolve reckless or negligent inattention.
Arrest and procedural oddity: s 51(2) states "The offender can not be arrested without warrant" for offences classified as crimes in s 51(1). Practitioners must reconcile this with general criminal procedure and policing practice; operational impact depends on prosecutorial and police practice and any applicable general criminal procedure legislation.
Interaction with Commonwealth law: licence reviewability depends on Commonwealth Act regulations declaring the decision reviewable for the purposes of section 45 of the Commonwealth Act (s 40). Where that declaration is absent, the review rights in s 40 may not apply, affecting procedural strategy.
HREC and NHMRC dependencies: the Committee must be satisfied that an HREC constituted in accordance with the NHMRC National Statement has approved the project (s 29(3)(c)). Changes to NHMRC guidance or HREC composition requirements have direct legal effect on licenceability.
Strict liability‑adjacent reporting obligations: s 32 makes reporting of consent a condition precedent to use. Failure to report or to obtain consent renders subsequent use criminal under s 23 and related provisions.
These are concrete, statute‑based areas where implementation mistakes carry criminal risk, administrative sanction or both.
How to comply
The Act structures compliance as a sequence of preventive steps, recordkeeping and institutional processes. Below is a practical, section‑referenced checklist for regulated entities and counsel.
Determine whether the activity is prohibited without authorisation
Check part 2 prohibitions (ss 7-16) and part 3 use prohibitions (ss 23-24). If your proposed activity appears in those sections, plan to seek a licence under s 28 or ensure it falls within an express exempt use (s 23(2)).
Pre‑application ethics and consent work
Obtain HREC review and approval in accordance with the NHMRC National Statement. The NHMRC Licensing Committee must be satisfied the activity has HREC approval before issuing a licence (s 29(3)(b)-(c)).
Implement protocols to obtain "proper consent" as defined by NHMRC guidelines under the National Health and Medical Research Council Act 1992. Ensure any cooling‑off period or other NHMRC guideline requirements are reflected in clinical practice and documented (s 21 def proper consent; s 32(1); s 32(8) allows limited modifications by licence).
Prepare the licence application
Use s 28 to determine the scope of the licence needed. Prepare the application in accordance with any written requirements specified by the Committee and include any prescribed fees (s 28(2)).
In the application, justify the number of embryos or eggs sought, demonstrating restriction to that necessary to achieve project goals, as s 29 instructs the Committee to have regard to limiting numbers (s 29(4)(a)).
Provide evidence of likely advances and why the goals could not reasonably be achieved by other means (s 29(4)(b)).
Consent documentation and responsible persons
For excess ART embryos, secure written authority or written determination from each responsible person as defined in s 21 to establish the embryo is excess (s 22).
Prior to use, obtain and document "proper consent" from each responsible person; the licence holder must report in writing that such consent has been obtained and state any restrictions to the NHMRC Licensing Committee (s 32(1)).
Licence conditions and operational controls
Understand that licences will carry conditions, including numerical limits, authorised persons, reporting and monitoring obligations (s 32(4)-(6)). Implement internal SOPs to ensure all authorised personnel comply with licence terms.
If relying on a licence provision that modifies NHMRC guidelines for unsuitable embryos, ensure the licence explicitly records any modified guidelines and observe them (s 32(8)).
Recordkeeping and database considerations
Maintain records sufficient to respond to inspector requests and to meet reporting obligations to the Committee and HRECs. Anticipate that the Committee will list the licence and summary details publicly, excluding confidential commercial information (s 37).
Make a documented assessment whether information is "confidential commercial information" and seek legal advice before disclosing; unauthorised disclosure is a criminal offence (s 38).
Avoid commercial trading exposures
Do not give, offer, receive or offer to receive valuable consideration for supply of human eggs, sperm or embryos (s 17). If reimbursement is intended, ensure it is restricted to "reasonable expenses" as defined, and document expense categories and timing (s 17(3)).
Inspection readiness
Be prepared to admit inspectors with consent, provide identity checks, or respond to warrants (ss 41-47). Ensure staff know that inspectors must produce identity cards on request and must inform individuals they may refuse consent (ss 42, 46-47).
Keep records and devices accessible. If equipment contains relevant information, inspectors may operate it and copy information under specified conditions (s 44(2)-(3)).
Manage risk around developmental limit
Program experimental protocols to ensure no embryo is developed outside a woman for more than 14 days excluding suspended development periods, and ensure licences do not authorise beyond that statutory limit (ss 10, 28(1A)).
Licence change, suspension and review
Monitor licence compliance. If circumstances change, apply to vary the licence, or expect the Licensing Committee may vary or suspend a licence on reasonable grounds (ss 33-34).
If a licence is refused, varied or revoked and reviewability is declared under Commonwealth Act regulations, be ready to seek Administrative Review Tribunal review as an eligible person (ss 39-40).
Document good faith reliance
If relying on a licence that later turns out to be invalid, document the steps taken to verify licence validity and to satisfy HREC and consent requirements. Section 25A provides protection only where the person did not know and could not reasonably be expected to have known the licence was invalid.
Legal oversight and regulatory liaison
Engage counsel to review consent forms, expense schedules, licence applications, public database redactions, and to advise on interplay with Commonwealth law and NHMRC guidelines.
Liaise with the relevant State body and the NHMRC Licensing Committee during application and after issuance, as the Committee is required to notify those bodies (s 30, s 36).
Following these steps, documenting decisions and retaining evidence of HREC approval, proper consent, licence terms and compliance will materially reduce criminal and administrative risk under the Act. Counsel should also track updates to NHMRC guidance, Commonwealth regulations that affect reviewability, and any further statutory amendments.
(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
(b) it is not necessary to establish that the copy is an identical genetic copy.
(a) a hybrid embryo; or
(b) a human embryonic stem cell line.
• section 32DA (6)
• schedule 1 , definition spouse .
sec.6 Meaning of reckless
sec.6 Meaning of reckless
A person is reckless in relation to a circumstance if—
the person is aware of a substantial risk that the circumstance exists or will exist; and
having regard to the circumstances known to the person, it is unjustifiable to take the risk.
A person is reckless in relation to a result if—
the person is aware of a substantial risk that the result will happen; and
having regard to the circumstances known to the person, it is unjustifiable to take the risk.
It is a question of fact as to whether taking a risk is unjustifiable.
(sec.6-ssec.1) A person is reckless in relation to a circumstance if— the person is aware of a substantial risk that the circumstance exists or will exist; and having regard to the circumstances known to the person, it is unjustifiable to take the risk.
(sec.6-ssec.2) A person is reckless in relation to a result if— the person is aware of a substantial risk that the result will happen; and having regard to the circumstances known to the person, it is unjustifiable to take the risk.
(sec.6-ssec.3) It is a question of fact as to whether taking a risk is unjustifiable.
(a) the person is aware of a substantial risk that the circumstance exists or will exist; and
(b) having regard to the circumstances known to the person, it is unjustifiable to take the risk.
(a) the person is aware of a substantial risk that the result will happen; and
(b) having regard to the circumstances known to the person, it is unjustifiable to take the risk.
pt.2 Prohibited practices
Prohibited practices
pt.2-div.1 Practices that are completely prohibited
Practices that are completely prohibited
sec.7 Offence—placing a human embryo clone in the human body or the body of an animal
sec.7 Offence—placing a human embryo clone in the human body or the body of an animal
A person commits an offence if the person intentionally places a human embryo clone in the body of a human or the body of an animal.
Maximum penalty—15 years imprisonment.
It is not a defence to an offence under subsection (1) that the human embryo clone did not survive or could not have survived.
The development of a human embryo (including a human embryo clone) outside the body of a woman for more than 14 days is prohibited by section 10 .
s 7 sub 2007 No. 45 s 7
(sec.7-ssec.1) A person commits an offence if the person intentionally places a human embryo clone in the body of a human or the body of an animal. Maximum penalty—15 years imprisonment.
(sec.7-ssec.2) It is not a defence to an offence under subsection (1) that the human embryo clone did not survive or could not have survived. The development of a human embryo (including a human embryo clone) outside the body of a woman for more than 14 days is prohibited by section 10 .
sec.8 Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman
sec.8 Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman
A person commits an offence if the person intentionally creates a human embryo by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, unless the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman.
Maximum penalty—15 years imprisonment.
A defendant does not bear the burden of proving any matter in subsection (1) .
s 8 sub 2007 No. 45 s 7
(sec.8-ssec.1) A person commits an offence if the person intentionally creates a human embryo by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, unless the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman. Maximum penalty—15 years imprisonment.
(sec.8-ssec.2) A defendant does not bear the burden of proving any matter in subsection (1) .
sec.9 Offence—creating or developing a human embryo by fertilisation that contains genetic material provided by more than 2 persons
sec.9 Offence—creating or developing a human embryo by fertilisation that contains genetic material provided by more than 2 persons
A person commits an offence if—
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
the human embryo contains genetic material provided by more than 2 persons.
Maximum penalty—15 years imprisonment.
s 9 sub 2007 No. 45 s 7
(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
(b) the human embryo contains genetic material provided by more than 2 persons.
sec.10 Offence—developing a human embryo outside the body of a woman for more than 14 days
sec.10 Offence—developing a human embryo outside the body of a woman for more than 14 days
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.
Maximum penalty—15 years imprisonment.
s 10 sub 2007 No. 45 s 7
sec.11 Offence—heritable alterations to genome
sec.11 Offence—heritable alterations to genome
A person commits an offence if—
the person alters the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered; and
in altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered.
Maximum penalty—15 years imprisonment.
In this section—
human cell includes a human embryonal cell, a human fetal cell, human sperm and a human egg.
s 11 sub 2007 No. 45 s 7
(sec.11-ssec.1) A person commits an offence if— the person alters the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered; and in altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered. Maximum penalty—15 years imprisonment.
(sec.11-ssec.2) In this section— human cell includes a human embryonal cell, a human fetal cell, human sperm and a human egg.
(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
(b) in altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered.
sec.12 Offence—collecting a viable human embryo from the body of a woman
sec.12 Offence—collecting a viable human embryo from the body of a woman
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.
Maximum penalty—15 years imprisonment.
s 12 sub 2007 No. 45 s 7
sec.13 Offence—creating a chimeric embryo
sec.13 Offence—creating a chimeric embryo
A person commits an offence if the person intentionally creates a chimeric embryo.
Maximum penalty—15 years imprisonment.
s 13 sub 2007 No. 45 s 7
sec.14 Offence—developing a hybrid embryo
sec.14 Offence—developing a hybrid embryo
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.
Maximum penalty—15 years imprisonment.
s 14 sub 2007 No. 45 s 7
sec.15 Offence—placing of an embryo
sec.15 Offence—placing of an embryo
A person commits an offence if the person intentionally places a human embryo in an animal.
Maximum penalty—15 years imprisonment.
A person commits an offence if the person intentionally places a human embryo in the body of a human, other than in a woman’s reproductive tract.
Maximum penalty—15 years imprisonment.
A person commits an offence if the person intentionally places an animal embryo in the body of a human for any period of gestation.
Maximum penalty—15 years imprisonment.
s 15 sub 2007 No. 45 s 7
(sec.15-ssec.1) A person commits an offence if the person intentionally places a human embryo in an animal. Maximum penalty—15 years imprisonment.
(sec.15-ssec.2) A person commits an offence if the person intentionally places a human embryo in the body of a human, other than in a woman’s reproductive tract. Maximum penalty—15 years imprisonment.
(sec.15-ssec.3) A person commits an offence if the person intentionally places an animal embryo in the body of a human for any period of gestation. Maximum penalty—15 years imprisonment.
sec.16 Offence—placing a prohibited embryo
sec.16 Offence—placing a prohibited embryo
A person commits an offence if the person intentionally places an embryo in the body of a woman knowing that, or reckless as to whether, the embryo is a prohibited embryo.
Maximum penalty—15 years imprisonment.
In this section—
prohibited embryo means—
a human embryo created by a process other than the fertilisation of a human egg by human sperm; or
a human embryo created outside the body of a woman, unless the intention of the person who created the embryo was to attempt to achieve pregnancy in a particular woman; or
a human embryo that contains genetic material provided by more than 2 persons; or
a human embryo that has been developing outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended; or
a human embryo created using precursor cells taken from a human embryo or a human fetus; or
a human embryo that contains a human cell (within the meaning of section 11 ) whose genome has been altered in such a way that the alteration is heritable by human descendants of the human whose cell was altered; or
a human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; or
a chimeric embryo or a hybrid embryo.
s 16 sub 2007 No. 45 s 7
(sec.16-ssec.1) A person commits an offence if the person intentionally places an embryo in the body of a woman knowing that, or reckless as to whether, the embryo is a prohibited embryo. Maximum penalty—15 years imprisonment.
This is an opening excerpt, not the complete document.