2003
THE LEGISLATIVE ASSEMBLY
FOR THE AUSTRALIAN CAPITAL TERRITORY

(As presented)
(Minister for Health)
Human Cloning and Embryo Research Bill 2003

Contents
	Page
Part 1	Preliminary
	1	Name of Act	2
	2	Commencement	2
	3	Dictionary	2
	4	Notes	2
	5	Offences against Act—application of Criminal Code etc	2
	6	Object of Act	3
	7	Meaning of human embryo	3
	8	Meaning of human embryo clone	3
Part 2	Prohibited practices
Division 2.1	Human cloning
	9	Offence—creating human embryo clone	5
	10	Offence—placing human embryo clone in body of human or animal	5
	11	Offence—importing or exporting human embryo clone	5
	12	No defence that human embryo clone could not survive	5
Division 2.2	Other prohibited practices
	13	Offence—creating human embryo otherwise than by fertilisation etc	6
	14	Offence—creating human embryo for purpose other than achieving pregnancy	6
	15	Offence—creating etc human embryo containing genetic material from more than 2 people	6
	16	Offence—developing human embryo outside body of woman for longer than 14 days	7
	17	Offence—using precursor cells to create human embryo etc	7
	18	Offence—heritable alterations to genome	7
	19	Offence—collecting viable human embryo from woman’s body	8
	20	Offence—creating chimeric or hybrid embryo	8
	21	Offence—placing of embryo	8
	22	Offence—importing, exporting or placing prohibited embryo	9
	23	Offence—commercial trading in human eggs etc	10
Part 3	Regulation of certain uses involving excess ART embryos
Division 3.1	Interpretation for pt 3
	24	Definitions for pt 3	12
	25	Meaning of excess ART embryo	13
Division 3.2	Offences
	26	Offence—use of excess ART embryo	14
	27	Offence—use of embryo that is not excess ART embryo	15
	28	Offence—breaching licence condition	16
Division 3.3	Embryo research licensing committee of NHMRC
	29	Functions of committee	16
Division 3.4	Licensing system
	30	Person may apply for licence	17
	31	Committee decision on application	17
	32	Notification of decision	18
	33	Period of licence	19
	34	Licence is subject to conditions	19
	35	Variation of licence	20
	36	Suspension or revocation of licence	21
	37	Surrender of licence	21
	38	Notice of variation, suspension or revocation of licence	21
Division 3.5	Reporting and confidentiality
	39	NHMRC licensing committee to make certain information publicly available	22
	40	Confidential commercial information may only be disclosed in certain circumstances	22
Division 3.6	Review provisions
	41	Definitions for div 3.6	25
	42	Review of decisions	26
Part 4	Monitoring powers
	43	Appointment of inspectors	27
	44	Identity card	27
	45	Powers available to inspectors for monitoring compliance	28
	46	Monitoring powers	28
	47	Power to secure	30
	48	Inspector must produce identity card on request	30
	49	Consent	30
	50	Compensation for damage	31
Part 5	Miscellaneous
	51	Reports to Legislative Assembly	32
	52	Review of operation of Act	32
	53	Determination of fees	32
	54	Approved forms	33
	55	Regulation-making power	33
	56	Expiry of certain provisions	33
Dictionary		35

2003
THE LEGISLATIVE ASSEMBLY
FOR THE AUSTRALIAN CAPITAL TERRITORY

(As presented)
(Minister for Health)
Human Cloning and Embryo Research Bill 2003

A Bill for
An Act to prohibit human cloning and to regulate certain activities involving the use of human embryos

    

The Legislative Assembly for the Australian Capital Territory enacts as follows:

Part 1	Preliminary
1	Name of Act
This Act is the Human Cloning and Embryo Research Act 2003.
2	Commencement
This Act commences on the day after its notification day.
Note	The naming and commencement provisions automatically commence on the notification day (see Legislation Act, s 75 (1)).
3	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 7.’ 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)).
4	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.
5	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.
6	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.
7	Meaning of human embryo
	(1)	In this Act:
human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro-nuclei or the initiation of its development by other means.
	(2)	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.
8	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.

Part 2	Prohibited practices
Division 2.1	Human cloning
9	Offence—creating human embryo clone
A person commits an offence if the person intentionally creates a human embryo clone.
Maximum penalty:  imprisonment for 15 years.
10	Offence—placing human embryo clone in body of human or 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.
11	Offence—importing or exporting human embryo clone
	(1)	A person commits an offence if the person intentionally imports a human embryo clone into the ACT.
Maximum penalty:  imprisonment for 15 years.
	(2)	A person commits an offence if the person intentionally exports a human embryo clone from the ACT.
Maximum penalty:  imprisonment for 15 years.
12	No defence that human embryo clone could not survive
It is not a defence to an offence against section 9, section 10 or section 11 that the human embryo clone did not survive or could not have survived.
Division 2.2	Other prohibited practices
13	Offence—creating human embryo otherwise than by fertilisation etc
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 human sperm, or intentionally develops a human embryo so created.
Maximum penalty:  imprisonment for 10 years.
14	Offence—creating human embryo for purpose other than achieving pregnancy 
	(1)	A person commits an offence if the person intentionally creates a human embryo 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 10 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).
15	Offence—creating etc human embryo containing genetic material from more than 2 people
A person commits an offence if the person intentionally creates or develops a human embryo containing genetic material provided by more than 2 people.
Maximum penalty:  imprisonment for 10 years.
16	Offence—developing human embryo outside body of woman for longer 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 longer than 14 days, excluding any period when development is suspended.
Maximum penalty:  imprisonment for 10 years.
17	Offence—using precursor cells to create human embryo etc
A person commits an offence if the person uses precursor cells taken from a human embryo or a human foetus, intending to create a human embryo, or intentionally develops an embryo so created.
Maximum penalty:  imprisonment for 10 years.
18	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 10 years.
	(2)	In this section:
human cell includes a human embryonal cell, a human foetal cell, human sperm and a human egg.
19	Offence—collecting viable human embryo from woman’s body
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 10 years.
20	Offence—creating chimeric or hybrid embryo
	(1)	A person commits an offence if the person intentionally creates a chimeric embryo.
Maximum penalty:  imprisonment for 10 years.
	(2)	A person commits an offence if the person intentionally creates a hybrid embryo.
Maximum penalty:  imprisonment for 10 years.
21	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 10 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 10 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 10 years.
22	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 10 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 10 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 10 years.
	(4)	In this section:
human cell includes a human embryonal cell, a human foetal cell, human sperm and a human egg.
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 containing 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 longer than 14 days, disregarding any period when development is suspended; or
	(e)	a human embryo created using precursor cells taken from a human embryo or foetus; or
	(f)	a human embryo containing a human cell 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.
23	Offence—commercial trading in human eggs etc
	(1)	A person commits an offence if the person intentionally gives or offers valuable consideration to someone else for the supply of a human egg, human sperm or a human embryo.
Maximum penalty:  imprisonment for 10 years.
	(2)	A person commits an offence if the person intentionally receives, or offers to receive, valuable consideration from someone else for the supply of a human egg, human sperm or a human embryo.
Maximum penalty:  imprisonment for 10 years.
	(3)	In this section:
reasonable expenses—
	(a)	in relation to the supply of a human egg or human sperm—includes, for example, 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)	includes, for example, expenses relating to the storage or transport of the embryo; but
	(ii)	does not include any expenses incurred by a person before the embryo became an excess ART embryo.
Note	An example is part of the Act, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).
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.

Part 3	Regulation of certain uses involving excess ART embryos
Division 3.1	Interpretation for pt 3
24	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.
licence means a licence issued under section 31 (Committee decision on application).
proper consent, in relation to the use of an excess ART embryo, means—
	(a)	consent obtained in accordance with the Ethical Guidelines on Assisted Reproductive Technology (1996) issued by the NHMRC; or
	(b)	if other guidelines are issued by the NHMRC under the National Health and Medical Research Council Act 1992 (Cwlth) and prescribed under the regulations for this paragraph—consent obtained in accordance with 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, for an excess ART embryo, means—
	(a)	each person who provided the egg or sperm from which the embryo was created; and
	(b)	the woman for whom the embryo was created, for the purpose of achieving her pregnancy; and
	(c)	anyone who was the domestic partner of a person mentioned in paragraph (a) when the egg or sperm mentioned in that paragraph was provided; and
	(d)	anyone who was the domestic partner of the woman mentioned in paragraph (b) when the embryo was created.
Note	For the meaning of domestic partner, see Legislation Act, s 169.
25	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.
	(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
26	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
	(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.
27	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 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.
28	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.
Division 3.3	Embryo research licensing committee of NHMRC
29	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
30	Person may apply for licence
	(1)	A person may apply to the NHMRC licensing committee for a licence authorising use of excess ART embryos.
	(2)	An application under subsection (1) must be made in accordance with the written requirements (if any) of the NHMRC licensing committee.
Note	A fee may be determined under s 53 for this section.
31	Committee decision on application
	(1)	This section applies if a person has made an application under section 30 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 is used under the licence (see section 34 (1) (a)); and
	(ii)	to enable compliance with any restrictions on the consent;
	(b)	if the use of an excess ART embryo proposed in the application may damage or destroy the embryo—that appropriate protocols are in place to enable compliance with the condition that the use is authorised only in relation to an embryo created before 5 April 2002 (see section 34 (3));
	(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.
	(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 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 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 NHMRC under the National Health and Medical Research Council Act 1992 (Cwlth) and prescribed under the regulations for this paragraph;
	(d)	the HREC assessment of the application mentioned in subsection (3) (c);
	(e)	the additional matters (if any) prescribed under the regulations.
32	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 31 (3) (c);
	(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).
33	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.
34	Licence is subject to conditions
	(1)	A licence is subject to the condition that before an excess ART embryo is used as authorised by the licence—
	(a)	each responsible person in relation to the excess ART embryo must have given proper consent to that 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; and
	(c)	if the licence authorises use of an excess ART embryo that may damage or destroy the embryo—the licence holder must have reported in writing to the NHMRC licensing committee that the embryo was created before 5 April 2002.
	(2)	A licence is subject to the condition that the use of an excess ART embryo must be in accordance with any restrictions to which the proper consent under subsection (1) is subject.
	(3)	If a licence authorises the use of an excess ART embryo that may damage or destroy the embryo, the licence is subject to the condition that the use is authorised only in relation to an embryo created before 5 April 2002.
	(4)	A licence is subject to the other conditions (if any) stated in the licence.
	(5)	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;
	(b)	the number of excess ART embryos in relation to which use is authorised by 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.
Note	An example is part of the Act, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).
	(6)	The licence conditions mentioned in subsections (1), (2) and (3) apply to all people who are authorised by the licence to use excess ART embryos.
	(7)	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 as are stated in the licence.
35	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 30 for the licence as varied, the committee would not have been permitted under this part to issue the licence.
36	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.
37	Surrender of licence
A licence holder may surrender a licence by written notice given to the NHMRC licensing committee.
38	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
39	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 that are authorised by the licence;
	(c)	any conditions to which the licence is subject;
	(d)	the number of excess ART embryos in relation to which use is authorised by the licence;
	(e)	the date the licence was issued;
	(f)	the period throughout which the licence is to remain in force.
	(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.
40	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
	(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
	(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
	(a)	a corporation established for a public purpose under a Territory Act; or
	(d)	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 (e);
	(iii)	an entity covered by subparagraph (i) or (ii).
Note	For the definition of confidential commercial information, see s 24.
Division 3.6	Review provisions
41	Definitions for div 3.6
In this division:
Commonwealth administrative appeals tribunal means the Administrative Appeals Tribunal established by the Administrative Appeals Tribunal Act 1975 (Cwlth).
decision has the same meaning as in the Administrative Appeals Tribunal Act 1975 (Cwlth).
eligible person, in relation to a decision of the NHMRC licensing committee, means:
	(a)	in relation to a decision under section 31 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 33—the licence holder; or
	(c)	in relation to a decision to state a licence condition under section 34 (4)—the licence holder; or
	(d)	in relation to a decision to vary or refuse to vary a licence under section 35—the licence holder; or
	(e)	in relation to a decision to suspend or revoke a licence under section 36—the person who was the licence holder immediately before the suspension or revocation.
42	Review of decisions
	(1)	An eligible person may apply to the Commonwealth administrative appeals tribunal for review of the following decisions of the NHMRC licensing committee:
	(a)	a decision under section 31 not to issue a licence;
	(b)	a decision about the period throughout which the licence is to be in force under section 33;
	(c)	a decision to state a licence condition under section 34 (4);
	(d)	a decision to vary or refuse to vary a licence under section 35;
	(e)	a decision to suspend or revoke a licence under section 36.
	(2)	This section has effect subject to the Administrative Appeals Tribunal Act 1975 (Cwlth).

Part 4	Monitoring powers
    
43	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.
44	Identity card
	(1)	The chairperson of the NHMRC licensing committee must issue an identity card to an inspector.
	(2)	The identity card—
	(a)	must be in the approved form; and
	(b)	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.
	(4)	An inspector must carry his or her identity card at all times when exercising functions as an inspector.
45	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 46.
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 31, and the entry is at a reasonable time.
46	Monitoring powers
	(1)	The monitoring powers that an inspector may exercise under section 45 (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 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;
	(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.
	(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).
	(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.
47	Power to secure
If an inspector, during a search of premises, believes on reasonable grounds that there is at the premises a human embryo or a thing that may provide evidence of the commission of an offence against this Act, the monitoring powers include securing the embryo or thing while a warrant to seize it is obtained (whether by the inspector or by another person).
Note	A reference to an offence against a Territory law includes a reference to a related ancillary offence, eg attempt (see Legislation Act, s 189).
48	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 his or her identity card for inspection by the occupier; and
	(b)	the inspector fails to comply with the requirement.
49	Consent
	(1)	Before obtaining the consent of a person for section 45 (2) (a), the inspector must tell the person that he or she 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.
50	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 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.

Part 5	Miscellaneous
51	Reports to Legislative Assembly
As soon as practicable 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.
52	Review of operation of Act
	(1)	The Minister must review the operation of this Act as soon as practicable after the 2nd anniversary of the day the Act commences.
	(2)	The review must consider and report on the scope and operation of this Act, part 2 and part 3 taking into account the following:
	(a)	developments in technology in relation to assisted reproductive technology;
	(b)	developments in medical research and scientific research and the potential therapeutic applications of such research;
	(c)	community standards;
	(d)	the applicability of establishing a national stem cell bank.
	(3)	The review may be undertaken as part of the reviews mentioned in the Research Involving Human Embryos Act 2002 (Cwlth), section 47 and the Prohibition of Human Cloning Act 2002 (Cwlth), section 25.
53	Determination of fees
	(1)	The Minister may, in writing, determine fees for this Act.
Note	The Legislation Act contains provisions about the making of determinations and regulations relating to fees (see pt 6.3)
	(2)	A determination is a disallowable instrument.
Note	A disallowable instrument must be notified, and presented to the Legislative Assembly, under the Legislation Act.
54	Approved forms
	(1)	The Minister may, in writing, approve forms for this Act.
Note	For other provisions about forms, see Legislation Act, s 255.
	(2)	If the Minister approves a form for a particular purpose, the approved form must be used for that purpose.
	(3)	An approved form is a notifiable instrument.
Note	A notifiable instrument must be notified under the Legislation Act.
55	Regulation-making power
The Executive may make regulations for this Act.
Note	Regulations must be notified, and presented to the Legislative Assembly, under the Legislation Act.
56	Expiry of certain provisions
	(1)	This section applies to the following provisions:
·	section 31 (3) (b)
·	section 34 (1) (c)
·	section 34 (3)
·	this section.
	(2)	The provisions expire on the earlier of the following:
	(a)	5 April 2005;
	(b)	if an earlier expiry date is fixed by the Minister under subsection (3)—that day.
	(3)	If the Council of Australian Governments declares an expiry date earlier than 5 April 2005 by notice in the Commonwealth Gazette (as mentioned in the Commonwealth Act, section 46), the Minister must, in writing, fix that day as the expiry date.
	(4)	An instrument under subsection (2) is a notifiable instrument.
Note	A notifiable instrument must be notified under the Legislation Act.

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 24.
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 appeals tribunal—see section 41.
confidential commercial information—see section 24.
decision, for division 3.6 (Review provisions)—see section 41.
disclose information, for part 3 (Regulation of certain uses involving excess ART embryos)—see section 24.
eligible person, for division 3.6 (Review provisions)—see section 41.
excess ART embryo—see section 25.
HREC—see section 24.
human embryo—see section 7.
human embryo clone—see section 8.
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 43 (1).
licence, for part 3 (Regulation of certain uses involving excess ART embryos)—see section 24.
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.
proper consent, for part 3 (Regulation of certain uses involving excess ART embryos)—see section 24.
relevant Territory entity, for part 3 (Regulation of certain uses involving excess ART embryos)—see section 24.
responsible person, for part 3 (Regulation of certain uses involving excess ART embryos), see section 24.
woman means a female human.

Endnotes
1	Presentation speech
	Presentation speech made in Legislative Assembly on	2003.
2	Notification
	Notified under the Legislation Act on	2003.
3	Republications of amended laws
	For the latest republication of amended laws, see www.legislation.act.gov.au.

© Australian Capital Territory 2003