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Australian Capital Territory
Human Cloning and Embryo Research
Act 2004
A2004-22
Republication No 9
Effective: 16 November 2025
Republication date: 16 November 2025
Last amendment made by A2025-29
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About this republication
The republished law
This is a republication of the Human Cloning and Embryo Research Act 2004 (including any
amendment made under the Legislation Act 2001, part 11.3 (Editorial changes)) as in force on
16 November 2025. It also includes any commencement, amendment, repeal or expiry affecting
this republished law to 16 November 2025.
The legislation history and amendment history of the republished law are set out in endnotes 3
and 4.
Kinds of republications
The Parliamentary Counsel’s Office prepares 2 kinds of republications of ACT laws (see the ACT
legislation register at www.legislation.act.gov.au):
• authorised republications to which the Legislation Act 2001 applies
• unauthorised republications.
The status of this republication appears on the bottom of each page.
Editorial changes
The Legislation Act 2001, part 11.3 authorises the Parliamentary Counsel to make editorial
amendments and other changes of a formal nature when preparing a law for republication.
Editorial changes do not change the effect of the law, but have effect as if they had been made by
an Act commencing on the republication date (see Legislation Act 2001, s 115 and s 117). The
changes are made if the Parliamentary Counsel considers they are desirable to bring the law into
line, or more closely into line, with current legislative drafting practice.
This republication does not include amendments made under part 11.3 (see endnote 1).
Uncommenced provisions and amendments
If a provision of the republished law has not commenced, the symbol U appears immediately
before the provision heading. Any uncommenced amendments that affect this republished law
are accessible on the ACT legislation register (www.legislation.act.gov.au). For more
information, see the home page for this law on the register.
Modifications
If a provision of the republished law is affected by a current modification, the symbol M appears
immediately before the provision heading. The text of the modifying provision appears in the
endnotes. For the legal status of modifications, see the Legislation Act 2001, section 95.
Penalties
At the republication date, the value of a penalty unit for an offence against this law is $160 for an
individual and $810 for a corporation (see Legislation Act 2001, s 133).
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Australian Capital Territory
Human Cloning and Embryo Research
Act 2004
Contents
Page
Part 1 Preliminary
1 Name of Act 2
2 Dictionary 2
3 Notes 2
4 Offences against Act—application of Criminal Code etc 2
5 Object of Act 3
6 Meaning of human embryo 3
7 Meaning of human embryo clone 4
Section 1 - Human Cloning and Embryo Research Act 2004 - Human Cloning and Embryo Research Act 2004 | Zoe
Contents
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Part 2 Prohibited practices
Division 2.1 Practices that are completely prohibited
8 Offence—placing human embryo clone in human body or body of an
animal 5
9 No defence that human embryo clone could not survive 5
10 Offence—creating human embryo for purpose other than achieving
pregnancy in woman 5
11 Offence—creating or developing human embryo by fertilisation that
contains genetic material provided by more than 2 people 6
12 Offence—developing human embryo outside body of woman for more
than 14 days 6
13 Offence—heritable alterations to genome 6
14 Offence—collecting viable human embryo from body of woman 7
15 Offence—creating chimeric embryo 7
16 Offence—developing hybrid embryo 7
17 Offence—placing of embryo 7
18 Offence—importing, exporting or placing prohibited embryo 8
19 Offence—commercial trading in human eggs, human sperm or human
embryos 9
Division 2.2 Practices that are prohibited unless authorised by
licence
20 Offence—creating human embryo other than by fertilisation, or
developing embryo 10
21 Offence—creating or developing human embryo containing genetic
material provided by more than 2 people 10
22 Offence—using precursor cells from human embryo or human fetus to
create human embryo, or developing such an embryo 11
22A Offence—creating hybrid embryo 11
Part 3 Regulation of the use of excess ART
embryos, other embryos and human eggs
Division 3.1 Interpretation for pt 3
23 Definitions for pt 3 13
24 Meaning of excess ART embryo 15
Contents
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Division 3.2 Offences
25 Offence—use of excess ART embryo 16
25A Offence—use of other embryos 17
25B Offence—certain activities involving use of human eggs 18
26 Offence—use of embryo that is not excess ART embryo 18
27 Offence—breaching licence condition 19
27A Person not liable for conduct purportedly authorised 19
Division 3.3 Embryo research licensing committee of NHMRC
28 Functions of committee 20
Division 3.4 Licensing system
29 Person may apply for licence 20
30 Committee decision on application 21
31 Notification of decision 22
32 Period of licence 23
33 Licence is subject to conditions 23
34 Variation of licence 25
35 Suspension or revocation of licence 25
36 Surrender of licence 26
37 Notice of variation, suspension or revocation of licence 26
Division 3.5 Reporting and confidentiality
38 NHMRC licensing committee to make certain information publicly
available 26
39 Confidential commercial information may only be disclosed in certain
circumstances 27
Division 3.6 Review provisions
40 Definitions for div 3.6 29
41 Review of decisions 30
Part 4 Monitoring powers
42 Appointment of inspectors 32
43 Identity card 32
44 Powers available to inspectors for monitoring compliance 33
45 Monitoring powers 33
46 Power to secure 35
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46A Monitoring warrants 35
46B Details of warrant to be given to occupier etc 37
46C Announcement before entry 37
46D Occupier entitled to be present during search 37
47 Inspector must produce identity card on request 37
48 Consent 38
49 Compensation for damage 38
Part 5 Miscellaneous
49A Court to notify director-general of offence 39
50 Reports to Legislative Assembly 39
51 Report on operation of Act 39
52 Determination of fees 39
54 Regulation-making power 39
Dictionary 40
Endnotes
1 About the endnotes 43
2 Abbreviation key 43
3 Legislation history 44
4 Amendment history 46
5 Earlier republications 56
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Human Cloning and Embryo Research
Act 2004
An Act to prohibit human cloning for reproduction and other unacceptable
practices associated with reproductive technology and to regulate certain
activities involving the use of human embryos
Part 1 Preliminary
Section 1
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Part 1 Preliminary
1 Name of Act
This Act is the Human Cloning and Embryo Research Act 2004.
2 Dictionary
The dictionary at the end of this Act is part of this Act.
Note 1 The dictionary at the end of this Act defines certain terms used in this
Act, and includes references (signpost definitions) to other terms defined
elsewhere in this Act.
For example, the signpost definition ‘human embryo—see section 6.’
means that the term ‘human embryo’ is defined that section.
Note 2 A definition in the dictionary (including a signpost definition) applies to
the entire Act unless the definition, or another provision of the Act,
provides otherwise or the contrary intention otherwise appears (see
Legislation Act, s 155 and s 156 (1)).
3 Notes
A note included in this Act is explanatory and is not part of this Act.
Note See Legislation Act, s 127 (1), (4) and (5) for the legal status of notes.
4 Offences against Act—application of Criminal Code etc
Other legislation applies in relation to offences against this Act.
Note 1 Criminal Code
The Criminal Code, ch 2 applies to all offences against this Act (see
Code, pt 2.1).
The chapter sets out the general principles of criminal responsibility
(including burdens of proof and general defences), and defines terms used
for offences to which the Code applies (eg conduct, intention,
recklessness and strict liability).
Note 2 Penalty units
The Legislation Act, s 133 deals with the meaning of offence penalties
that are expressed in penalty units.
Preliminary Part 1
Section 5
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5 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—
(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.
6 Meaning of human embryo
(1) In this Act:
human embryo means a discrete entity that has arisen from either—
(a) the first mitotic division when fertilisation of a human oocyte by
a human sperm is complete; or
(b) any other process that initiates organised development of a
biological entity with a human nuclear genome or altered human
nuclear genome that has the potential to develop up to, or
beyond, the stage at which the primitive streak appears;
and has not yet reached 8 weeks of development since the first mitotic
division.
(2) However, human embryo does not include a—
(a) hybrid embryo; or
(b) human embryonic stem cell line.
(3) 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.
Part 1 Preliminary
Section 7
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7 Meaning of human embryo clone
(1) In this Act:
human embryo clone means a human embryo that is a genetic copy
of another living or dead human, but does not include a human
embryo created by the fertilisation of a human egg by human sperm.
(2) To establish that a human embryo clone is a genetic copy of a living
or dead human—
(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.
(3) 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.
Prohibited practices Part 2
Practices that are completely prohibited Division 2.1
Section 8
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Part 2 Prohibited practices
Division 2.1 Practices that are completely
prohibited
8 Offence—placing human embryo clone in human body or
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: imprisonment for 15 years.
Note The development of a human embryo (including a human embryo clone)
outside the body of a woman for more than 14 days is prohibited by s 12.
9 No defence that human embryo clone could not survive
It is not a defence to an offence against section 8 that the human
embryo clone did not survive or could not have survived.
10 Offence—creating human embryo for purpose other than
achieving pregnancy in woman
(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: imprisonment for 15 years.
(2) Despite the Criminal Code, section 58 (3), a defendant does not bear
an evidential burden in relation to anything mentioned in
subsection (1).
Part 2 Prohibited practices
Division 2.1 Practices that are completely prohibited
Section 11
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11 Offence—creating or developing human embryo by
fertilisation that contains genetic material provided by
more than 2 people
A person commits an offence if—
(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 people.
Maximum penalty: imprisonment for 15 years.
12 Offence—developing human embryo outside body of
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: imprisonment for 15 years.
13 Offence—heritable alterations to genome
(1) A person commits an offence if—
(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.
Maximum penalty: imprisonment for 15 years.
(2) In this section:
human cell includes a human embryonal cell, a human fetal cell,
human sperm or a human egg.
Prohibited practices Part 2
Practices that are completely prohibited Division 2.1
Section 14
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14 Offence—collecting viable human embryo from body of
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: imprisonment for 15 years.
15 Offence—creating chimeric embryo
A person commits an offence if the person intentionally creates a
chimeric embryo.
Maximum penalty: imprisonment for 15 years.
16 Offence—developing 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: imprisonment for 15 years.
17 Offence—placing of embryo
(1) A person commits an offence if the person intentionally places a
human embryo in an animal.
Maximum penalty: imprisonment for 15 years.
(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: imprisonment for 15 years.
(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: imprisonment for 15 years.
Part 2 Prohibited practices
Division 2.1 Practices that are completely prohibited
Section 18
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18 Offence—importing, exporting or placing prohibited
embryo
(1) A person commits an offence if the person intentionally imports an
embryo into the ACT knowing that, or reckless about whether, the
embryo is a prohibited embryo.
Maximum penalty: imprisonment for 15 years.
(2) A person commits an offence if the person intentionally exports an
embryo from the ACT knowing that, or reckless about whether, the
embryo is a prohibited embryo.
Maximum penalty: imprisonment for 15 years.
(3) A person commits an offence if the person intentionally places an
embryo in the body of a woman knowing that, or reckless about
whether, the embryo is a prohibited embryo.
Maximum penalty: imprisonment for 15 years.
(4) In this section:
prohibited embryo means—
(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 people; 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
Prohibited practices Part 2
Practices that are completely prohibited Division 2.1
Section 19
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(f) a human embryo that contains a human cell (within the meaning
of section 13) 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.
19 Offence—commercial trading in human eggs, human
sperm or human embryos
(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: imprisonment for 15 years.
(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: imprisonment for 15 years.
(3) In this section—
reasonable expenses—
(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 embryo became an excess ART embryo; and
(ii) includes, but is not limited to, expenses relating to the
storage or transport of the embryo.
Part 2 Prohibited practices
Division 2.2 Practices that are prohibited unless authorised by licence
Section 20
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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.
Division 2.2 Practices that are prohibited unless
authorised by licence
20 Offence—creating human embryo other than by
fertilisation, or developing embryo
A person commits an offence if—
(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.
Maximum penalty: imprisonment for 10 years.
Note 1 The development of a human embryo outside the body of a woman for
more than 14 days is prohibited by s 12.
Note 2 The placement in the body of a woman of a human embryo clone, or any
other human embryo created other than by the fertilisation of a human
egg by a human sperm, is prohibited by s 8 and s 18.
21 Offence—creating or developing human embryo
containing genetic material provided by more than 2
people
A person commits an offence if—
(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
Prohibited practices Part 2
Practices that are prohibited unless authorised by licence Division 2.2
Section 22
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(b) the human embryo contains genetic material provided by more
than 2 people; and
(c) the creation or development of the human embryo by the person
is not authorised by a licence.
Maximum penalty: imprisonment for 10 years.
Note 1 The development of a human embryo outside the body of a woman for
more than 14 days is prohibited by s 12.
Note 2 The placement in the body of a woman of a human embryo created other
than by the fertilisation of a human egg by a human sperm is prohibited
by s 18.
22 Offence—using precursor cells from human embryo or
human fetus to create human embryo, or developing
such an embryo
A person commits an offence if—
(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 about that fact.
Maximum penalty: imprisonment for 10 years.
22A Offence—creating hybrid embryo
(1) A person commits an offence if the person intentionally creates a
hybrid embryo.
(2) A person commits an offence if the person intentionally develops a
hybrid embryo.
Part 2 Prohibited practices
Division 2.2 Practices that are prohibited unless authorised by licence
Section 22A
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(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.
Maximum penalty: imprisonment for 10 years.
Regulation of the use of excess ART embryos, other embryos and
human eggs
Part 3
Interpretation for pt 3 Division 3.1
Section 23
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Part 3 Regulation of the use of excess
ART embryos, other embryos
and human eggs
Division 3.1 Interpretation for pt 3
23 Definitions for pt 3
In this part:
accredited ART centre means an entity accredited to carry out
assisted reproductive technology by—
(a) the Reproductive Technology Accreditation Committee of the
Fertility Society of Australia; or
(b) if the regulations prescribe another body or other bodies in
addition to, or instead of, the body mentioned in paragraph (a)—
that other body or any of those other bodies, as the case requires.
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 information means give or communicate the information in
any way.
HREC means a human research ethics committee.
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—
Part 3 Regulation of the use of excess ART embryos, other embryos and
human eggs
Division 3.1 Interpretation for pt 3
Section 23
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(a) the Ethical guidelines on the use of assisted reproductive
technology in clinical practice and research, issued by the CEO
of the NHMRC in 2017 and updated in 2023; or
Note The guidelines are accessible at www.nhmrc.gov.au.
(b) if other guidelines are issued by the CEO of the NHMRC and
prescribed by regulations made for the Research Involving
Human Embryos Act 2002 (Cwlth), section 24 (9), definition of
proper consent—those guidelines, rather than the guidelines
mentioned in paragraph (a).
relevant Territory entity means the entity notified by the Territory to
the chairperson of the NHMRC licensing committee for the Research
Involving Human Embryos Act 2002 (Cwlth), part 2.
responsible person means—
(a) in relation to an excess ART embryo—
(i) each person who provided the egg or sperm from which the
embryo was created; and
(ii) the woman for whom the embryo was created, for the
purpose of achieving her pregnancy; and
(iii) anyone who was the domestic partner of a person
mentioned in subparagraph (i) when the egg or sperm
mentioned in that subparagraph was provided; and
(iv) anyone who was the domestic partner of the woman
mentioned in subparagraph (ii) when the embryo was
created; or
Note For the meaning of domestic partner, see the Legislation
Act, s 169.
(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
Regulation of the use of excess ART embryos, other embryos and
human eggs
Part 3
Interpretation for pt 3 Division 3.1
Section 24
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(c) in relation to a human egg—the woman who was the biological
donor of the egg.
unsuitable for implantation—a human embryo is unsuitable for
implantation if it—
(a) is diagnosed by preimplantation genetic diagnosis as unsuitable
for implantation, in accordance with the Ethical guidelines on
the use of assisted reproductive technology in clinical practice
and research, issued by the CEO of the NHMRC in 2017 and
updated in 2023; or
Note The guidelines are accessible at www.nhmrc.gov.au.
(b) is determined to be unsuitable for implantation in the body of a
woman, in accordance with objective criteria specified in
guidelines issued by the CEO of the NHMRC and prescribed by
regulations made for the Research Involving Human Embryos
Act 2002 (Cwlth), section 7 (1), definition of unsuitable for
implantation, paragraph (b).
use includes develop.
Note If an Act defines a term, other parts of speech and grammatical forms of
the term have a corresponding meaning (see Legislation Act, s 157).
24 Meaning of excess ART embryo
(1) In this Act:
excess ART embryo means a human embryo that—
(a) was created, by assisted reproductive technology, for use in the
assisted reproductive technology treatment of a woman; and
(b) is excess to the needs of—
(i) the woman for whom it was created; and
(ii) her domestic partner (if any) when the embryo was created.
Note For the meaning of domestic partner, see Legislation Act, s 169.
Part 3 Regulation of the use of excess ART embryos, other embryos and
human eggs
Division 3.2 Offences
Section 25
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(2) For subsection (1) (b), a human embryo is excess to the needs of the
people mentioned in that paragraph at a particular time if—
(a) each of the people 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 of the people has declared in writing that the embryo is
excess to their needs, and the declaration is in force at that time.
Division 3.2 Offences
25 Offence—use of excess ART embryo
(1) A person commits an offence if the person intentionally uses an
excess ART embryo, unless—
(a) the use by the person is authorised by a licence; or
(b) the use by the person is an exempt use.
Maximum penalty: imprisonment for 5 years.
(2) Despite the Criminal Code, section 58 (3), a defendant does not bear
an evidential burden in relation to anything mentioned in this section.
(3) 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.
exempt use—a use of an excess ART embryo by a person is an
exempt use if—
(a) the use consists only of—
(i) storage of the excess ART embryo; or
(ii) removal of the excess ART embryo from storage; or
Regulation of the use of excess ART embryos, other embryos and
human eggs
Part 3
Offences Division 3.2
Section 25A
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(iii) transport of the excess ART embryo; or
(iv) observation of the excess ART embryo; or
(v) allowing the excess ART embryo to succumb; or
(b) the use is carried out by an accredited ART centre, and—
(i) the excess ART embryo is not suitable (based only on its
biological fitness for implantation) to be placed in the body
of the woman for whom it was created; 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
(c) the use is carried out by an accredited ART centre and is for the
purpose of achieving pregnancy in a woman other than the
woman for whom the excess ART embryo was created; or
(d) the use is prescribed under the regulations.
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.
25A Offence—use of other embryos
A person commits an offence if—
(a) the person intentionally uses an embryo; and
(b) the embryo is—
(i) a human embryo created by a process other than the
fertilisation of a human egg by a human sperm; or
(ii) a human embryo created by a process other than the
fertilisation of a human egg by a human sperm that
contains genetic material provided by more than 2 people;
or
Part 3 Regulation of the use of excess ART embryos, other embryos and
human eggs
Division 3.2 Offences
Section 25B
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(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.
Maximum penalty: imprisonment for 5 years.
Note The creation or development of embryos mentioned in this section is
prohibited under pt 2, unless authorised by a licence.
25B Offence—certain activities involving use of human eggs
A person commits an offence if—
(a) the person undertakes research or training involving the
fertilisation of a human egg by a human sperm up to, but not
including, the first mitotic division, outside the body of a woman
for the purposes of research or training in ART; and
(b) the person is not authorised by a licence to undertake the
research or training.
Maximum penalty: imprisonment for 5 years.
26 Offence—use of embryo that is not excess ART embryo
A person commits an offence if—
(a) the person intentionally uses, outside the body of a woman, a
human embryo—
(i) that was created by fertilisation of a human egg by a human
sperm; and
(ii) that is not an excess ART embryo; and
(b) the use is not for a purpose relating to the assisted reproductive
technology treatment of a woman carried out by an accredited
ART centre, and the person knows or is reckless about that fact.
Maximum penalty: imprisonment for 5 years.
Regulation of the use of excess ART embryos, other embryos and
human eggs
Part 3
Offences Division 3.2
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27 Offence—breaching licence condition
(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 about whether the
conduct contravenes a condition of such a licence.
Maximum penalty: imprisonment for 5 years.
(2) In this section:
engage in conduct means—
(a) do an act; or
(b) omit to perform an act.
27A Person not liable for conduct purportedly authorised
(1) To remove any doubt, a person is not criminally responsible for an
offence against this part in relation to particular conduct if—
(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.
(2) In this section:
licence includes a purported licence.
Part 3 Regulation of the use of excess ART embryos, other embryos and
human eggs
Division 3.3 Embryo research licensing committee of NHMRC
Section 28
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Division 3.3 Embryo research licensing committee
of NHMRC
28 Functions of committee
The functions of the NHMRC licensing committee are—
(a) to exercise functions in relation to licences under division 3.4
(Licensing system); and
(b) to exercise functions in relation to databases under division 3.5
(Reporting and confidentiality); and
(c) to exercise the other functions (if any) that are given to it under
this Act or any other law.
Division 3.4 Licensing system
29 Person may apply for licence
(1) A person may apply to the NHMRC licensing committee for a licence
authorising one or more of the following:
(a) use of excess ART embryos;
(b) creation of human embryos other than by fertilisation of a
human egg by a human sperm, and use of such embryos;
(c) creation of human embryos other than by fertilisation of a
human egg by a human sperm that contain genetic material
provided by more than 2 people, 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;
Regulation of the use of excess ART embryos, other embryos and
human eggs
Part 3
Licensing system Division 3.4
Section 30
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(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.
(2) To remove any doubt, subsection (1) (a), (b), (c) and (d) do not permit
the NHMRC licensing committee to authorise any use of an excess
ART embryo or other embryo that would result in the development
of the embryo for a period of more than 14 days, excluding any period
when development is suspended.
(3) An application under subsection (1) must be made in accordance with
the written requirements (if any) of the NHMRC licensing committee.
30 Committee decision on application
(1) This section applies if a person has made an application under
section 29 for a licence.
(2) The NHMRC licensing committee must decide, in accordance with
this section, whether or not to issue the licence.
(3) The NHMRC licensing committee must not issue the licence unless
it is satisfied of the following:
(a) that appropriate protocols are in place—
(i) to enable proper consent to be obtained before an excess
ART embryo or human egg is used, or other embryo is
created or used, under the licence (see section 33 (1) (a));
and
(ii) to enable compliance with any restrictions on the consent;
Part 3 Regulation of the use of excess ART embryos, other embryos and
human eggs
Division 3.4 Licensing system
Section 31
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(b) that the activity or project proposed in the application has been
assessed and approved by a HREC that is constituted in
accordance with, and acting in compliance with, the NHMRC
National Statement on Ethical Conduct in Research Involving
Humans (1999), as in force from time to time.
(4) In deciding whether to issue the licence, the NHMRC licensing
committee must have regard to the following:
(a) restricting the number of excess ART embryos, other embryos
or human eggs, to that likely to be necessary to achieve the goals
of the activity or project proposed in the application;
(b) the likelihood of significant advance in knowledge or
improvement in technologies for treatment as a result of the use
of excess ART embryos or human eggs, or the creation or use of
other embryos, proposed in the application, that could not
reasonably be achieved by other means;
(c) any relevant guidelines, or relevant parts of guidelines, issued
by the CEO of the NHMRC under the National Health and
Medical Research Council Act 1992 (Cwlth) and prescribed by
regulations made for the Research Involving Human Embryos
Act 2002 (Cwlth), section 21 (4) (c);
(d) the HREC assessment of the application mentioned in
subsection (3) (b);
(e) the additional matters (if any) prescribed under the regulations.
31 Notification of decision
(1) The NHMRC licensing committee must notify its decision on an
application for a licence to the following:
(a) the applicant;
(b) the HREC that assessed and approved the activity or project
proposed in the application as mentioned in section 30 (3) (b);
Regulation of the use of excess ART embryos, other embryos and
human eggs
Part 3
Licensing system Division 3.4
Section 32
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(c) the relevant Territory entity.
(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 entities mentioned in subsection (1) (b) and (c).
32 Period of licence
(1) A licence—
(a) comes into force on the day stated in the licence or, if no day is
stated, on the day it is issued; and
(b) remains in force until the day stated in the licence, unless it is
suspended, revoked or surrendered before that day.
(2) A licence is not in force throughout any period of suspension.
33 Licence is subject to conditions
(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—
(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 the consent has been obtained, and any
restrictions to which the consent is subject.
(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.
(3) A licence is subject to the other conditions (if any) stated in the
licence.
Part 3 Regulation of the use of excess ART embryos, other embryos and
human eggs
Division 3.4 Licensing system
Section 33
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(4) The conditions stated in the licence may include, for example,
conditions relating to the following:
(a) the people 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 people
authorised by the licence to use excess ART embryos or human
eggs, or to create or use other embryos.
(5) The licence conditions mentioned in subsections (1) and (2) apply to
all people who are authorised by the licence to use excess ART
embryos or human eggs, or to create or use other embryos.
(6) Licence conditions stated in the licence apply to—
(a) the licence holder; and
(b) such other people authorised by the licence to use excess ART
embryos or human eggs, or to create or use other embryos as are
stated in the licence.
(7) For the purposes of applying the condition mentioned in
subsection (1) (a)—
(a) a licence may provide that the guidelines mentioned in the
definition of 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
Regulation of the use of excess ART embryos, other embryos and
human eggs
Part 3
Licensing system Division 3.4
Section 34
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(b) if a licence so provides, the guidelines as modified by the licence
have effect in relation to the giving of consent for such creation
or use.
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.
34 Variation of licence
(1) The NHMRC licensing committee may, by written notice given to the
licence holder, vary a licence if the committee believes on reasonable
grounds that it is necessary or desirable to do so.
(2) The NHMRC licensing committee may vary a licence under
subsection (1) on its own initiative or on application by the licence
holder.
(3) Without limiting subsection (1), the NHMRC licensing committee
may vary the licence by stating additional conditions or varying
existing conditions.
(4) The NHMRC licensing committee must not vary a licence in such a
way that, had a person applied under section 29 for the licence as
varied, the committee would not have been permitted under this part
to issue the licence.
35 Suspension or revocation of licence
(1) The NHMRC licensing committee may, by written notice 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.
(2) If a licence holder is convicted of an offence against this Act, the
NHMRC licensing committee must, by written notice given to the
licence holder, revoke each licence held by the licence holder.
Part 3 Regulation of the use of excess ART embryos, other embryos and
human eggs
Division 3.5 Reporting and confidentiality
Section 36
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36 Surrender of licence
A licence holder may surrender a licence by written notice given to
the NHMRC licensing committee.
37 Notice of variation, suspension or revocation of licence
(1) If the NHMRC licensing committee varies, suspends or revokes a
licence, the committee must tell—
(a) the licence holder; and
(b) the HREC and the relevant Territory entity.
(2) The NHMRC licensing committee must also tell the entities
mentioned in subsection (1) (b) if a licence is surrendered.
Division 3.5 Reporting and confidentiality
38 NHMRC licensing committee to make certain information
publicly available
(1) The NHMRC licensing committee must maintain a database
containing the following information in relation to each licence
(including a licence as varied):
(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, and creations 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 the licence was issued;
(f) the period throughout which the licence is to remain in force.
Regulation of the use of excess ART embryos, other embryos and
human eggs
Part 3
Reporting and confidentiality Division 3.5
Section 39
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(2) The database must be made publicly available.
(3) The database may be kept and made publicly available in electronic
form.
(4) Information mentioned in subsection (1) must not disclose
confidential commercial information.
39 Confidential commercial information may only be
disclosed in certain circumstances
(1) A person commits an offence if—
(a) the person discloses confidential commercial information that
the person has only because of exercising functions under this
Act or under the Commonwealth Act; and
(b) the person knows that the information is confidential
commercial information; and
(c) the disclosure is not—
(i) to the Territory, a Territory agency, the Commonwealth, a
Commonwealth authority, a State, or a State agency for this
Act, a corresponding State law or the Commonwealth Act;
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.
Maximum penalty: imprisonment for 2 years.
(2) A person commits an offence if—
(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
Part 3 Regulation of the use of excess ART embryos, other embryos and
human eggs
Division 3.5 Reporting and confidentiality
Section 39
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(c) the disclosure is not—
(i) to the Territory, a Territory agency, the Commonwealth, a
Commonwealth authority, a State, or a State agency for this
Act, a corresponding State law or the Commonwealth Act;
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.
Maximum penalty: imprisonment for 2 years.
(3) In this section:
Commonwealth authority means—
(a) a corporation established for a public purpose under a
Commonwealth Act; or
(b) a company in which a controlling interest is held by any 1 of the
following, or by 2 or more of the following together:
(i) the Commonwealth;
(ii) a corporation covered by paragraph (a);
(iii) an entity covered by subparagraph (i) or (ii).
corresponding State law—see the Commonwealth Act, section 7 (1).
court includes a tribunal, authority or person having power to require
the production of documents or the answering of questions.
State agency means—
(a) a Minister of a State; or
(b) a department of government of a State; or
(c) an instrumentality of a State, including a corporation established
for a public purpose under a law of a State; or
Regulation of the use of excess ART embryos, other embryos and
human eggs
Part 3
Review provisions Division 3.6
Section 40
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(d) a company in which a controlling interest is held by any 1 of the
following, or by 2 or more of the following together:
(i) a State;
(ii) a Minister of a State;
(iii) an entity covered by subparagraph (i) or (ii).
Territory agency means—
(a) a Minister; or
(b) an administrative unit; or
(c) a territory instrumentality; or
(d) a corporation established for a public purpose under a Territory
Act; or
(e) a company in which a controlling interest is held by any one of
the following, or by 2 or more of the following together:
(i) the Territory;
(ii) an entity covered by paragraph (a), (c) or (d);
(iii) an entity covered by subparagraph (i) or (ii).
Note For the definition of confidential commercial information, see s 23.
Division 3.6 Review provisions
40 Definitions for div 3.6
In this division:
Commonwealth administrative review tribunal means the
Administrative Review Tribunal established under the Administrative
Review Tribunal Act 2024 (Cwlth), section 8.
decision—see the Administrative Review Tribunal Act 2024 (Cwlth),
section 4.
Part 3 Regulation of the use of excess ART embryos, other embryos and
human eggs
Division 3.6 Review provisions
Section 41
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eligible person, in relation to a decision of the NHMRC licensing
committee, means:
(a) in relation to a decision under section 30 not to issue a licence—
the applicant for the licence; or
(b) in relation to a decision about the period throughout which the
licence is to be in force under section 32—the licence holder; or
(c) in relation to a decision to state a licence condition under
section 33 (3)—the licence holder; or
(d) in relation to a decision to modify guidelines under
section 33 (7) in relation to a licence—the licence holder; or
(e) in relation to a decision to vary or refuse to vary a licence under
section 34—the licence holder; or
(f) in relation to a decision to suspend or revoke a licence under
section 35—the person who was the licence holder immediately
before the suspension or revocation.
41 Review of decisions
(1) An eligible person may apply to the Commonwealth administrative
review tribunal for review of the following decisions of the NHMRC
licensing committee:
(a) a decision under section 30 not to issue a licence;
(b) a decision about the period throughout which the licence is to be
in force under section 32;
(c) a decision to state a licence condition under section 33 (3);
(d) a decision to modify guidelines under section 33 (7) in relation
to a licence;
(e) a decision to vary or refuse to vary a licence under section 34;
(f) a decision to suspend or revoke a licence under section 35.
Regulation of the use of excess ART embryos, other embryos and
human eggs
Part 3
Review provisions Division 3.6
Section 41
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(2) This section has effect subject to the Administrative Review Tribunal
Act 2024 (Cwlth).
Part 4 Monitoring powers
Section 42
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Part 4 Monitoring powers
42 Appointment of inspectors
(1) The chairperson of the NHMRC licensing committee may, by
instrument in writing, appoint any of the following as inspectors:
(a) a person who is appointed or employed by the Territory;
(b) a person who is appointed or employed by a State;
(c) a person who is appointed or employed by the Commonwealth.
(2) The Legislation Act, part 19.3 (Appointments) does not apply to
appointments under this section.
(3) In exercising functions as an inspector, an inspector must comply
with any directions of the chairperson of the NHMRC licensing
committee.
(4) The chairperson of the NHMRC licensing committee must not
appoint a person as an inspector under subsection (1) unless the
chairperson is satisfied that the person has appropriate skills and
experience.
43 Identity card
(1) The chairperson of the NHMRC licensing committee must issue an
identity card to an inspector.
(2) The identity card must contain a recent photograph of the inspector.
(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.
Monitoring powers Part 4
Section 44
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(4) An inspector must carry their identity card at all times when
exercising functions as an inspector.
44 Powers available to inspectors for monitoring compliance
(1) To find out whether this Act has been complied with, an inspector
may—
(a) enter any premises; and
(b) exercise the monitoring powers set out in section 45.
Note A reference to an Act includes a reference to the statutory instruments
made or in force under the Act, including regulations (see Legislation
Act, s 104).
(2) An inspector is not authorised to enter premises under subsection (1)
unless—
(a) the occupier of the premises has consented to the entry; or
(b) the premises are premises where the occupier of the premises is
carrying out activities authorised by a licence issued under
section 30, and the entry is at a reasonable time; or
(c) the entry is made under a warrant under section 46A.
45 Monitoring powers
(1) The monitoring powers that an inspector may exercise under
section 44 (1) (b) are as follows:
(a) to search the premises and anything 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 anything on the premises;
(d) to inspect any book, record or document on the premises;
Part 4 Monitoring powers
Section 45
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(e) to take extracts from or make copies of any such book, record or
document;
(f) to take onto the premises the equipment and materials that the
inspector requires to exercise 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 46A—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.
Note The Legislation Act, s 170 and s 171 deal with the application of the
privilege against self-incrimination and client legal privilege.
(2) For this part, monitoring powers include the power to operate
equipment at premises to see whether—
(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;
contains information that is relevant to deciding whether there has
been compliance with this Act.
Note A reference to an Act includes a reference to the statutory instruments
made or in force under the Act, including regulations (see Legislation
Act, s 104).
Monitoring powers Part 4
Section 46
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(3) If the inspector, after operating equipment at the premises, finds that
the equipment, or that a disk, tape or other storage device at the
premises, contains information mentioned in subsection (2), the
inspector may—
(a) operate equipment or facilities at the premises to put the
information in documentary form and copy the document
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.
46 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 provide evidence of the
commission of an offence against this Act, the monitoring powers
include securing the embryo, the egg or the thing while a warrant to
seize it is obtained (whether by the inspector or by another person).
46A Monitoring warrants
(1) An inspector may apply to a magistrate for a warrant under this
section in relation to premises.
Part 4 Monitoring powers
Section 46A
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(2) Subject to subsection (3), the magistrate may issue the warrant if the
magistrate is satisfied by information on oath that it is reasonably
necessary that 1 or more inspectors should have access to the
premises for the purposes of finding out whether this Act has been
complied with.
Note 1 Oath includes affirmation, and take an oath includes make an affirmation
(see Legislation Act, dict, pt 1).
Note 2 A reference to an Act includes a reference to the statutory instruments
made or in force under the Act, including any regulation (see Legislation
Act, s 104).
(3) The magistrate must not issue the warrant unless the inspector or
someone else has given to the magistrate, either orally or by affidavit,
any further information the magistrate requires about the grounds on
which the issue of the warrant is being sought.
(4) The warrant must—
(a) authorise 1 or more inspectors (whether or not named in the
warrant) with the assistance and force that is necessary and
reasonable—
(i) to enter the premises; and
(ii) to exercise the powers set out in section 45 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 stated hours of the day or night; and
(c) state 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.
Monitoring powers Part 4
Section 46B
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46B Details of warrant to be given to occupier etc
(1) If a warrant under section 46A 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.
(2) The inspector must identify themself to that person.
(3) The copy of the warrant mentioned in subsection (1) need not include
the signature of the magistrate who issued the warrant.
46C Announcement before entry
An inspector must, before entering premises under a warrant—
(a) announce that they are authorised to enter the premises; and
(b) give any person at the premises an opportunity to allow entry to
the premises.
46D Occupier entitled to be present during search
(1) If a warrant under section 46A 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.
(2) The right to observe the search being conducted ceases if the person
impedes the search.
(3) This section does not prevent 2 or more areas of the premises being
searched at the same time.
47 Inspector must produce identity card on request
An inspector is not entitled to exercise any powers under this part in
relation to premises if—
(a) the occupier of the premises has required the inspector to
produce their identity card for inspection by the occupier; and
Part 4 Monitoring powers
Section 48
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(b) the inspector fails to comply with the requirement.
48 Consent
(1) Before obtaining the consent of a person for section 44 (2) (a), the
inspector must tell the person that they may refuse consent.
(2) An entry of an inspector with the consent of a person is not lawful
unless the person voluntarily consented to the entry.
49 Compensation for damage
(1) The owner of equipment or other facilities is entitled to compensation
for damage to the equipment or other facilities if—
(a) the damage was caused to the equipment or other facilities
because of it being operated by an inspector as mentioned in this
part; and
(b) the damage was caused because insufficient care was exercised
by the inspector operating the equipment or other facilities.
(2) In deciding the amount of compensation payable, regard is to be had
to whether the occupier of the premises and any employee or agent of
the occupier, 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.
Miscellaneous Part 5
Section 49A
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Part 5 Miscellaneous
49A Court to notify director-general of offence
If a person is convicted or found guilty of an offence against this Act,
the registrar or other proper officer of the court must notify the
director-general in writing.
50 Reports to Legislative Assembly
As soon as practicable (but within 6 sitting days) after receiving a
copy of a report from the NHMRC licensing committee under the
Commonwealth Act, section 19, the Minister must present a copy of
the report to the Legislative Assembly.
51 Report on operation of Act
(1) This section applies to—
(a) a report of the review mentioned in the Prohibition of Human
Cloning for Reproduction Act 2002 (Cwlth), section 25; and
(b) a report of the review mentioned in the Research Involving
Human Embryos Act 2002 (Cwlth), section 47B.
(2) The Minister must present a copy of the report to the Legislative
Assembly as soon as practicable after it is tabled in a house of the
Commonwealth Parliament.
52 Determination of fees
(1) The Minister may, in writing, determine fees for this Act.
(2) A determination is a disallowable instrument.
54 Regulation-making power
The Executive may make regulations for this Act.
Dictionary
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Dictionary
(see s 3)
Note 1 The Legislation Act contains definitions and other provisions relevant to
this Act.
Note 2 For example, the Legislation Act, dict, pt 1, defines the following terms:
• corporation
• entity
• exercise
• functions
• State
• under.
accredited ART centre—see section 23.
animal does not include a human.
chimeric embryo means—
(a) a human embryo into which a cell, or any component part of a
cell, of an animal has been introduced; or
(b) anything declared under the regulations to be a chimeric
embryo.
Commonwealth Act means the Research Involving Human Embryos
Act 2002 (Cwlth).
Commonwealth administrative review tribunal—see section 40.
confidential commercial information—see section 23.
decision, for division 3.6 (Review provisions)—see section 40.
disclose information, for part 3 (Regulation of the use of excess ART
embryos, other embryos and human eggs)—see section 23.
eligible person, for division 3.6 (Review provisions)—see section 40.
embryo means a living embryo, and includes a human embryo.
excess ART embryo—see section 24.
Dictionary
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HREC—see section 23.
human egg means a human oocyte.
human embryo—see section 6.
human embryo clone—see section 7.
human sperm includes human spermatids.
hybrid embryo means—
(a) an embryo created by the fertilisation of a human egg by animal
sperm; or
(b) an embryo created by the fertilisation of an animal egg by human
sperm; or
(c) a human egg into which the nucleus of an animal cell has been
introduced; or
(d) an animal egg into which the nucleus of a human cell has been
introduced; or
(e) a thing declared under the regulations to be a hybrid embryo.
inspector means a person appointed as an inspector under section
42 (1).
licence means a licence issued under section 30 (Committee decision
on application).
NHMRC licensing committee means the committee established by
the Research Involving Human Embryos Act 2002 (Cwlth),
section 13.
NHMRC means the National Health and Medical Research Council
established by the National Health and Medical Research Council
Act 1992 (Cwlth).
precursor cell means a cell that has the potential to develop into a
human egg or human sperm.
Dictionary
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proper consent, for part 3 (Regulation of the use of excess ART
embryos, other embryos and human eggs)—see section 23.
relevant Territory entity, for part 3 (Regulation of the use of excess
ART embryos, other embryos and human eggs)—see section 23.
responsible person, for part 3 (Regulation of the use of excess ART
embryos, other embryos and human eggs)—see section 23.
unsuitable for implantation, for part 3 (Regulation of the use of
excess ART embryos, other embryos and human eggs)—see
section 23.
use, for part 3 (Regulation of the use of excess ART embryos, other
embryos and human eggs)—see section 23.
woman means a female human.
Endnotes
About the endnotes 1
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Endnotes
1 About the endnotes
Amending and modifying laws are annotated in the legislation history and the
amendment history. Current modifications are not included in the republished law
but are set out in the endnotes.
Not all editorial amendments made under the Legislation Act 2001, part 11.3 are
annotated in the amendment history. Full details of any amendments can be
obtained from the Parliamentary Counsel’s Office.
Uncommenced amending laws are not included in the republished law. The details
of these laws are underlined in the legislation history. Uncommenced expiries are
underlined in the legislation history and amendment history.
If all the provisions of the law have been renumbered, a table of renumbered
provisions gives details of previous and current numbering.
The endnotes also include a table of earlier republications.
2 Abbreviation key
A = Act NI = Notifiable instrument
AF = Approved form o = order
am = amended om = omitted/repealed
amdt = amendment ord = ordinance
AR = Assembly resolution orig = original
ch = chapter par = paragraph/subparagraph
CN = Commencement notice pres = present
def = definition prev = previous
DI = Disallowable instrument (prev...) = previously
dict = dictionary pt = part
disallowed = disallowed by the Legislative r = rule/subrule
Assembly reloc = relocated
div = division renum = renumbered
exp = expires/expired R[X] = Republication No
Gaz = gazette RI = reissue
hdg = heading s = section/subsection
IA = Interpretation Act 1967 sch = schedule
ins = inserted/added sdiv = subdivision
LA = Legislation Act 2001 SL = Subordinate law
LR = legislation register sub = substituted
LRA = Legislation (Republication) Act 1996 underlining = whole or part not commenced
mod = modified/modification or to be expired
Endnotes
3 Legislation history
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3 Legislation history
This Act was made as the Human Embryo (Research) Act 2004 A2004-22. It was
renamed by sch 1, amdt 1.2 as the Human Cloning and Embryo Research Act 2004
on the commencement of the Human Cloning (Prohibition) Act 2004 (see
A2004-22 s 41).
Human Cloning and Embryo Research Act 2004 A2004-22
notified LR 7 April 2004
s 1, s 2 commenced 7 April 2004 (LA s 75 (1))
remainder commenced 8 April 2004 (s 2)
as amended by
Human Cloning and Embryo Research Amendment Act 2008 A2008-8
notified LR 17 April 2008
s 1, s 2 commenced 17 April 2008 (LA s 75 (1))
remainder commenced 18 April 2008 (s 2)
Statute Law Amendment Act 2019 A2019-42 sch 3 pt 3.14
notified LR 31 October 2019
s 1, s 2 commenced 31 October 2019 (LA s 75 (1))
sch 3 pt 3.14 commenced 14 November 2019 (s 2 (1))
Statute Law Amendment Act 2021 A2021-12 sch 3 pt 3.25
notified LR 9 June 2021
s 1, s 2 commenced 9 June 2021 (LA s 75 (1))
sch 3 pt 3.25 commenced 23 June 2021 (s 2 (1))
Assisted Reproductive Technology Act 2024 A2024-7 s 135
notified LR 28 March 2024
s 1, s 2 commenced 28 March 2024 (LA s 75 (1))
s 135 commenced 28 September 2024 (s 2 (2) and LA s 79)
Health Legislation Amendment Act 2025 A2025-16 sch 1 pt 1.4
notified LR 26 May 2025
s 1, s 2 commenced 26 May 2025 (LA s 75 (1))
sch 1 pt 1.4 commenced 2 June 2025 (s 2)
Endnotes
Legislation history 3
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Statute Law Amendment Act 2025 A2025-29 sch 3 pt 3.48, sch 4
pt 4.94
notified LR 6 November 2025
s 1, s 2 commenced 6 November 2025 (LA s 75 (1))
sch 3 pt 3.48, sch 4 pt 4.94 commenced 16 November 2025 (s 2 (1),
(9))
Endnotes
4 Amendment history
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4 Amendment history
Long title
title sub A2004-22 amdt 1.1; A2008-8 s 4
Name of Act
s 1 sub A2004-22 amdt 1.2
Dictionary
s 2 orig s 2 om LA s 89 (4)
(prev s 3) renum R1 LA (see A2004-22 amdt 1.10)
Notes
s 3 orig s 3 renum as s 2
(prev s 4) renum R1 LA (see A2004-22 amdt 1.10)
Offences against Act—application of Criminal Code etc
s 4 orig s 4 renum as s 3
(prev s 5) renum R1 LA (see A2004-22 amdt 1.10)
Object of Act
s 5 orig s 5 renum as s 4
(prev s 6) sub A2004-22 amdt 1.3
renum R1 LA (see A2004-22 amdt 1.10)
am A2008-8 s 5
Meaning of human embryo
s 6 orig s 6 renum as s 5
(prev s 7) renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 6
Meaning of human embryo clone
s 7 orig s 7 renum as s 6
(prev s 7A) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 8 by A2004-22 amdt 1.11
renum R1 LA (see A2004-22 amdt 1.10)
Meaning of human embryo clone
s 7A renum as s 7
Prohibited practices
pt 1A hdg renum as pt 2 hdg
Human cloning
div 1A.1 hdg renum as div 2.1 hdg
Other prohibited practices
div 1A.2 hdg renum as div 2.2 hdg
Endnotes
Amendment history 4
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Prohibited practices
pt 2 hdg orig pt 2 hdg renum as pt 3 hdg
(prev pt 1A hdg) reloc from Human Cloning (Prohibition) Act
2004 A2004-21 pt 2 hdg by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Practices that are completely prohibited
div 2.1 hdg orig div 2.1 hdg renum as div 3.1 hdg
(prev div 1A.1 hdg) reloc from Human Cloning (Prohibition) Act
2004 A2004-21 div 2.1 hdg by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Offence—placing human embryo clone in human body or body of an animal
s 8 orig s 8 renum as s 23
(prev s 9) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 9 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
No defence that human embryo clone could not survive
s 9 orig s 9 renum as s 24
prev s 9 (as reloc from A2004-21 s 9) renum as s 8
(prev s 10) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 10 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Offence—creating human embryo for purpose other than achieving
pregnancy in woman
s 10 orig s 10 renum as s 25
prev s 10 (as reloc from A2004-21 s 10) renum as s 9
(prev s 11) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 11 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Offence—creating or developing human embryo by fertilisation that contains
genetic material provided by more than 2 people
s 11 orig s 11 renum as s 26
prev s 11 (as reloc from A2004-21 s 11) renum as s 10
(prev s 12) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 12 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Endnotes
4 Amendment history
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Offence—developing human embryo outside body of woman for more than
14 days
s 12 orig s 12 renum as s 27
prev s 12 (as reloc from A2004-21 s 12) renum as s 11
(prev s 13) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 13 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Offence—developing human embryo outside body of woman for more than
14 days
s 13 orig s 13 renum as s 28
prev s 13 (as reloc from A2004-21 s 13) renum as s 12
(prev s 14) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 14 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
am A2019-42 amdt 3.21
Offence—collecting viable human embryo from body of woman
s 14 orig s 14 renum as s 29
prev s 14 (as reloc from A2004-21 s 14) renum as s 13
(prev s 15) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 15 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Offence—creating chimeric embryo
s 15 orig s 15 renum as s 30
prev s 15 (as reloc from A2004-21 s 15) renum as s 14
(prev s 16) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 16 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Offence—developing hybrid embryo
s 16 orig s 16 renum as s 31
prev s 16 (as reloc from A2004-21 s 16) renum as s 15
(prev s 17) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 17 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Endnotes
Amendment history 4
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Offence—placing of embryo
s 17 orig s 17 renum as s 32
prev s 17 (as reloc from A2004-21 s 17) renum as s 16
(prev s 18) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 18 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Offence—importing, exporting or placing prohibited embryo
s 18 orig s 18 renum as s 33
prev s 18 (as reloc from A2004-21 s 18) renum as s 17
(prev s 19) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 19 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
am A2019-42 amdt 3.22
Offence—commercial trading in human eggs, human sperm or human
embryos
s 19 orig s 19 renum as s 34
prev s 19 (as reloc from A2004-21 s 19) renum as s 18
(prev s 20) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 20 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Practices that are prohibited unless authorised by licence
div 2.2 hdg orig div 2.2 hdg renum as div 3.2 hdg
(prev div 1A.2 hdg) reloc from Human Cloning (Prohibition) Act
2004 A2004-21 div 2.2 hdg by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Offence—creating human embryo other than by fertilisation, or developing
embryo
s 20 orig s 20 renum as s 35
prev s 20 (as reloc from A2004-21 s 20) renum as s 19
(prev s 21) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 21 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Endnotes
4 Amendment history
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Offence—creating or developing human embryo containing genetic material
provided by more than 2 people
s 21 orig s 21 renum as s 36
prev s 21 (as reloc from A2004-21 s 21) renum as s 20
(prev s 22) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 22 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
Offence—using precursor cells from human embryo or human fetus to
create human embryo, or developing such an embryo
s 22 hdg am A2019-42 amdt 3.22
s 22 orig s 22 renum as s 37
prev s 22 (as reloc from A2004-21 s 22) renum as s 21
(prev s 23) reloc from Human Cloning (Prohibition) Act 2004
A2004-21 s 23 by A2004-22 amdt 1.12
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 7
am A2019-42 amdt 3.22
Offence—creating hybrid embryo
s 22A ins A2008-8 s 7
Regulation of the use of excess ART embryos, other embryos and human
eggs
pt 3 hdg orig pt 3 hdg renum as pt 4 hdg
(prev pt 2 hdg) renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 8
Interpretation for pt 3
div 3.1 hdg (prev div 2.1 hdg) renum R1 LA (see A2004-22 amdt 1.10)
Definitions for pt 3
s 23 orig s 23 renum as s 38
prev s 23 (as reloc from A2004-21 s 23) renum as s 22
(prev s 8) renum R1 LA (see A2004-22 amdt 1.10)
def licence om A2008-8 s 9
def proper consent sub A2008-8 s 10
am A2025-16 amdt 1.19, amdt 1.20
def responsible person sub A2008-8 s 11
def unsuitable for implantation ins A2008-8 s 12
am A2025-16 amdt 1.21, amdt 1.22
def use ins A2008-8 s 12
Meaning of excess ART embryo
s 24 orig s 24 renum as s 39
(prev s 9) renum R1 LA (see A2004-22 amdt 1.10)
Interpretation for pt 3
div 3.2 hdg (prev div 2.2 hdg) renum R1 LA (see A2004-22 amdt 1.10)
Endnotes
Amendment history 4
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Offence—use of excess ART embryo
s 25 orig s 25 renum as s 40
(prev s 10) renum R1 LA (see A2004-22 amdt 1.10)
Offence—use of other embryos
s 25A ins A2008-8 s 13
am A2019-42 amdt 3.22
Offence—certain activities involving use of human eggs
s 25B ins A2008-8 s 13
Offence—use of embryo that is not excess ART embryo
s 26 orig s 26 renum as s 41
(prev s 11) renum R1 LA (see A2004-22 amdt 1.10)
am A2008-8 s 14
Offence—breaching licence condition
s 27 orig s 27 renum as s 42
(prev s 12) renum R1 LA (see A2004-22 amdt 1.10)
Person not liable for conduct purportedly authorised
s 27A ins A2008-8 s 15
Embryo research licensing committee of NHMRC
div 3.3 hdg (prev div 2.3 hdg) renum R1 LA (see A2004-22 amdt 1.10)
Functions of committee
s 28 orig s 28 renum as s 43
(prev s 13) renum R1 LA (see A2004-22 amdt 1.10)
Licensing system
div 3.4 hdg (prev div 2.4 hdg) renum R1 LA (see A2004-22 amdt 1.10)
Person may apply for licence
s 29 orig s 29 renum as s 44
(prev s 14) renum R1 LA (see A2004-22 amdt 1.10)
am A2008-8 s 16; ss renum R3 LA; A2019-42 amdt 3.22;
A2025-29 amdt 4.94
Committee decision on application
s 30 orig s 30 renum as s 45
(prev s 15) renum R1 LA (see A2004-22 amdt 1.10)
(3) (b) exp 5 April 2005 (s 55)
par renum R2 LA
am A2008-8 ss 17-20; A2025-16 amdt 1.23, amdt 1.24
Notification of decision
s 31 orig s 31 renum as s 46
(prev s 16) renum R1 LA (see A2004-22 amdt 1.10)
Endnotes
4 Amendment history
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Period of licence
s 32 orig s 32 renum as s 47
(prev s 17) renum R1 LA (see A2004-22 amdt 1.10)
Licence is subject to conditions
s 33 orig s 33 renum as s 48
(prev s 18) renum R1 LA (see A2004-22 amdt 1.10)
(1) (c), (3) exp 5 April 2005 (s 55)
ss renum R2 LA
am A2008-8 ss 21-26
Variation of licence
s 34 orig s 34 renum as s 49
(prev s 19) renum R1 LA (see A2004-22 amdt 1.10)
Suspension or revocation of licence
s 35 orig s 35 renum as s 50
(prev s 20) renum R1 LA (see A2004-22 amdt 1.10)
Surrender of licence
s 36 orig s 36 renum as s 51
(prev s 21) renum R1 LA (see A2004-22 amdt 1.10)
Notice of variation, suspension or revocation of licence
s 37 orig s 37 renum as s 52
(prev s 22) renum R1 LA (see A2004-22 amdt 1.10)
Reporting and confidentiality
div 3.5 hdg (prev div 2.5 hdg) renum R1 LA (see A2004-22 amdt 1.10)
NHMRC licensing committee to make certain information publicly available
s 38 orig s 38 renum as s 53
(prev s 23) renum R1 LA (see A2004-22 amdt 1.10)
am A2008-8 s 27, s 28
Confidential commercial information may only be disclosed in certain
circumstances
s 39 orig s 39 renum as s 54
(prev s 24) renum R1 LA (see A2004-22 amdt 1.10)
am A2025-29 amdt 3.159
Review provisions
div 3.6 hdg (prev div 2.6 hdg) renum R1 LA (see A2004-22 amdt 1.10)
Definitions for div 3.6
s 40 orig s 40 renum as s 55
(prev s 25) renum R1 LA (see A2004-22 amdt 1.10)
def Commonwealth administrative appeals tribunal om
A2025-16 amdt 1.25
def Commonwealth administrative review tribunal ins
A2025-16 amdt 1.26
Endnotes
Amendment history 4
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def decision sub A2025-16 amdt 1.27
def eligible person am A2008-8 s 29; pars renum R3 LA
Review of decisions
s 41 orig s 41 om LA s 89 (3)
(prev s 26) renum R1 LA (see A2004-22 amdt 1.10)
am A2008-8 s 30; pars renum R3 LA; A2025-16 amdt 1.28,
amdt 1.29 (as am R8 LA)
Monitoring powers
pt 4 hdg orig pt 4 hdg renum as pt 5 hdg
(prev pt 3 hdg) renum R1 LA (see A2004-22 amdt 1.10)
Appointment of inspectors
s 42 (prev s 27) renum R1 LA (see A2004-22 amdt 1.10)
Identity card
s 43 (prev s 28) renum R1 LA (see A2004-22 amdt 1.10)
am A2021-12 amdt 3.59; A2025-29 amdt 3.160
Powers available to inspectors for monitoring compliance
s 44 (prev s 29) am A2004-22 amdt 1.4
renum R1 LA (see A2004-22 amdt 1.10)
am A2008-8 s 31
Monitoring powers
s 45 (prev s 30) am A2004-22 amdt 1.5, amdt 1.6
renum R1 LA (see A2004-22 amdt 1.10)
am A2008-8 s 32, s 33
Power to secure
s 46 (prev s 31) am A2004-22 amdt 1.7
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 34
Monitoring warrants
s 46A ins A2008-8 s 35
Details of warrant to be given to occupier etc
s 46B ins A2008-8 s 35
am A2025-29 amdt 3.161
Announcement before entry
s 46C ins A2008-8 s 35
am A2025-29 amdt 3.162
Occupier entitled to be present during search
s 46D ins A2008-8 s 35
Inspector must produce identity card on request
s 47 (prev s 32) renum R1 LA (see A2004-22 amdt 1.10)
am A2025-29 amdt 3.163
Endnotes
4 Amendment history
page 54 Human Cloning and Embryo Research Act 2004
Effective: 16/11/25
R9
16/11/25
Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au
Consent
s 48 (prev s 33) renum R1 LA (see A2004-22 amdt 1.10)
am A2025-29 amdt 3.164
Compensation for damage
s 49 (prev s 34) renum R1 LA (see A2004-22 amdt 1.10)
am A2025-29 amdt 3.165
Miscellaneous
pt 5 hdg (prev pt 4 hdg) renum R1 LA (see A2004-22 amdt 1.10)
Court to notify director-general of offence
s 49A ins A2024-7 s 135
Reports to Legislative Assembly
s 50 (prev s 35) renum R1 LA (see A2004-22 amdt 1.10)
Report on operation of Act
s 51 (prev s 36) am A2004-22 amdt 1.8, amdt 1.9
renum R1 LA (see A2004-22 amdt 1.10)
sub A2008-8 s 36
am A2025-16 amdt 1.30, amdt 1.31
Determination of fees
s 52 (prev s 37) renum R1 LA (see A2004-22 amdt 1.10)
am A2025-29 amdt 4.94
Approved forms
s 53 (prev s 38) renum R1 LA (see A2004-22 amdt 1.10)
om A2021-12 amdt 3.60
Regulation-making power
s 54 (prev s 39) renum R1 LA (see A2004-22 amdt 1.10)
am A2025-29 amdt 4.94
Expiry of certain provisions
s 55 (prev s 40) renum R1 LA (see A2004-22 amdt 1.10)
exp 5 April 2005 (s 55)
Transitional
pt 10 hdg ins A2008-8 s 37
exp 18 April 2009 (s 101)
Existing applications for licences
s 100 ins A2008-8 s 37
exp 18 April 2009 (s 101)
Expiry—pt 10
s 101 ins A2008-8 s 37
exp 18 April 2009 (s 101)
Amendments
sch 1 om LA s 89 (3)
Endnotes
Amendment history 4
R9
16/11/25
Human Cloning and Embryo Research Act 2004
Effective: 16/11/25
page 55
Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au
Dictionary
dict def animal reloc from Human Cloning (Prohibition) Act 2004
A2004-21 dict by A2004-22 amdt 1.13
def chimeric embryo reloc from Human Cloning (Prohibition)
Act 2004 A2004-21 dict by A2004-22 amdt 1.13
def Commonwealth administrative review tribunal am
R8 LA
def disclose sub A2008-8 s 38
def embryo ins A2008-8 s 39
def human egg ins A2008-8 s 40
def human embryo clone reloc from Human Cloning
(Prohibition) Act 2004 A2004-21 dict by A2004-22 amdt 1.13
def human sperm reloc from Human Cloning (Prohibition) Act
2004 A2004-21 dict by A2004-22 amdt 1.13
def hybrid embryo reloc from Human Cloning (Prohibition)
Act 2004 A2004-21 dict by A2004-22 amdt 1.13
def licence sub A2008-8 s 41
def precursor cell reloc from Human Cloning (Prohibition) Act
2004 A2004-21 dict by A2004-22 amdt 1.13
def proper consent sub A2008-8 s 42
def relevant Territory entity sub A2008-8 s 42
def responsible person sub A2008-8 s 42
def unsuitable for implantation ins A2008-8 s 43
def use ins A2008-8 s 43