Australian Capital Territory

Human Embryo (Research) Act 2004
A2004-22
    
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	3
	6	Object of Act	3
	7	Meaning of human embryo	3
Part 2	Regulation of certain uses involving excess ART embryos
Division 2.1	Interpretation for pt 2
	8	Definitions for pt 2	4
	9	Meaning of excess ART embryo	6
Division 2.2	Offences
	10	Offence—use of excess ART embryo	6
	11	Offence—use of embryo that is not excess ART embryo	8
	12	Offence—breaching licence condition	8
Division 2.3	Embryo research licensing committee of NHMRC
	13	Functions of committee	9
Division 2.4	Licensing system
	14	Person may apply for licence	9
	15	Committee decision on application	9
	16	Notification of decision	11
	17	Period of licence	11
	18	Licence is subject to conditions	11
	19	Variation of licence	13
	20	Suspension or revocation of licence	13
	21	Surrender of licence	14
	22	Notice of variation, suspension or revocation of licence	14
Division 2.5	Reporting and confidentiality
	23	NHMRC licensing committee to make certain information publicly available	14
	24	Confidential commercial information may only be disclosed in certain circumstances	15
Division 2.6	Review provisions
	25	Definitions for div 2.6	17
	26	Review of decisions	18
Part 3	Monitoring powers
	27	Appointment of inspectors	19
	28	Identity card	19
	29	Powers available to inspectors for monitoring compliance	20
	30	Monitoring powers	20
	31	Power to secure	22
	32	Inspector must produce identity card on request	22
	33	Consent	22
	34	Compensation for damage	23
Part 4	Miscellaneous
	35	Reports to Legislative Assembly	24
	36	Review of operation of Act	24
	37	Determination of fees	24
	38	Approved forms	25
	39	Regulation-making power	25
	40	Expiry of certain provisions	25
	41	Legislation amended—sch 1	26
Schedule 1	Amendments	27
Part 1.1	Amendments of this Act	27
Part 1.2	Amendments of the Human Cloning (Prohibition) Act 2004	29
Dictionary		30

Australian Capital Territory

Human Embryo (Research) Act 2004
A2004-22

An Act 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 Embryo (Research) Act 2004.
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 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.

Part 2	Regulation of certain uses involving excess ART embryos
Division 2.1	Interpretation for pt 2
8	Definitions for pt 2
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 15 (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.
9	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 2.2	Offences
10	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.
11	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.
12	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 2.3	Embryo research licensing committee of NHMRC
13	Functions of committee
The functions of the NHMRC licensing committee are—
	(a)	to exercise functions in relation to licences under division 2.4 (Licensing system); and
	(b)	to exercise functions in relation to databases under division 2.5 (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 2.4	Licensing system
14	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 37 for this section.
15	Committee decision on application
	(1)	This section applies if a person has made an application under section 14 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 18 (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 18 (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.
16	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 15 (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).
17	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.
18	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.
19	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 14 for the licence as varied, the committee would not have been permitted under this part to issue the licence.
20	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.
21	Surrender of licence
A licence holder may surrender a licence by written notice given to the NHMRC licensing committee.
22	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 2.5	Reporting and confidentiality
23	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.
24	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
	(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 8.
Division 2.6	Review provisions
25	Definitions for div 2.6
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 15 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 17—the licence holder; or
	(c)	in relation to a decision to state a licence condition under section 18 (4)—the licence holder; or
	(d)	in relation to a decision to vary or refuse to vary a licence under section 19—the licence holder; or
	(e)	in relation to a decision to suspend or revoke a licence under section 20—the person who was the licence holder immediately before the suspension or revocation.
26	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 15 not to issue a licence;
	(b)	a decision about the period throughout which the licence is to be in force under section 17;
	(c)	a decision to state a licence condition under section 18 (4);
	(d)	a decision to vary or refuse to vary a licence under section 19;
	(e)	a decision to suspend or revoke a licence under section 20.
	(2)	This section has effect subject to the Administrative Appeals Tribunal Act 1975 (Cwlth).

Part 3	Monitoring powers
    
27	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.
28	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.
29	Powers available to inspectors for monitoring compliance
	(1)	To find out whether this Act or the Human Cloning (Prohibition) Act 2004 has been complied with, an inspector may—
	(a)	enter any premises; and
	(b)	exercise the monitoring powers set out in section 30.
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 15, and the entry is at a reasonable time.
30	Monitoring powers
	(1)	The monitoring powers that an inspector may exercise under section 29 (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 or the Human Cloning (Prohibition) Act 2004;
	(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 or the Human Cloning (Prohibition) Act 2004.
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.
31	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 or the Human Cloning (Prohibition) Act 2004, 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).
32	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.
33	Consent
	(1)	Before obtaining the consent of a person for section 29 (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.
34	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 4	Miscellaneous
35	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.
36	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 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 review mentioned in the Commonwealth Act, section 47.
37	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.
38	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.
39	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.
40	Expiry of certain provisions
	(1)	This section applies to the following provisions:
·	section 15 (3) (b)
·	section 18 (1) (c)
·	section 18 (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.
41	Legislation amended—sch 1
	(1)	Despite section 2 (Commencement), this section commences on the later of the following:
	(a)	the commencement of the Human Cloning (Prohibition) Act 2004;
	(b)	the commencement of this Act.
	(2)	On the commencement of this section, this Act is taken to be amended in accordance with schedule 1, part 1.1.
	(3)	Schedule 1, part 1.2 amends the Human Cloning (Prohibition) Act 2004.
	(4)	On the commencement of this section, the Human Cloning (Prohibition) Act 2004 (as amended by this Act) is repealed.
	(5)	This section and schedule 1 expire at the end of 6 months after the commencement of this Act if the Human Cloning (Prohibition) Act 2004 has not commenced before then.
	(6)	To remove any doubt, subsection (4) does not affect the operation of the Legislation Act, section 89 (Automatic repeal of certain laws and provisions).

Schedule 1	Amendments
(see s 41)
Part 1.1	Amendments of this Act
[1.1]	Long title
substitute
An Act to prohibit human cloning and other unacceptable practices associated with reproductive technology and to regulate certain activities involving the use of human embryos
[1.2]	Section 1
substitute
1	Name of Act
This Act is the Human Cloning and Embryo Research Act 2004.
[1.3]	Section 6
substitute
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.
[1.4]	Section 29 (1)
omit
or the Human Cloning (Prohibition) Act 2004
[1.5]	Section 30 (1) (b)
omit
or the Human Cloning (Prohibition) Act 2004
[1.6]	Section 30 (2)
omit
or the Human Cloning (Prohibition) Act 2004
[1.7]	Section 31
omit
or the Human Cloning (Prohibition) Act 2004
[1.8]	Section 36 (2)
before
part 2
insert
part 1A and
[1.9]	Section 36 (3)
substitute
	(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.
[1.10]	Act—renumbering
renumber provisions when Act next republished under Legislation Act
Part 1.2	Amendments of the Human Cloning (Prohibition) Act 2004
[1.11]	Section 8
relocate to this Act as section 7A
[1.12]	Part 2
relocate to this Act as part 1A
[1.13]	Dictionary definitions (other than definitions of excess ART embryo, human embryo and woman)
relocate to this Act, dictionary

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 8.
Commonwealth Act means the Research Involving Human Embryos Act 2002 (Cwlth).
Commonwealth administrative appeals tribunal—see section 25.
confidential commercial information—see section 8.
decision, for division 2.6 (Review provisions)—see section 25.
disclose information, for part 2 (Regulation of certain uses involving excess ART embryos)—see section 8.
eligible person, for division 2.6 (Review provisions)—see section 25.
excess ART embryo—see section 9.
HREC—see section 8.
human embryo—see section 7.
inspector means a person appointed as an inspector under section 27 (1).
licence, for part 2 (Regulation of certain uses involving excess ART embryos)—see section 8.
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).
proper consent, for part 2 (Regulation of certain uses involving excess ART embryos)—see section 8.
relevant Territory entity, for part 2 (Regulation of certain uses involving excess ART embryos)—see section 8.
responsible person, for part 2 (Regulation of certain uses involving excess ART embryos)—see section 8.
woman means a female human.

Endnotes
1	Presentation speech
	Presentation speech made in the Legislative Assembly on 30 March 2004.
2	Notification
	Notified under the Legislation Act on 7 April 2004.
3	Republications of amended laws
	For the latest republication of amended laws, see www.legislation.act.gov.au.

I certify that the above is a true copy of the Human Embryo (Research) Bill 2004 which was passed by the Legislative Assembly on 1 April 2004.

Clerk of the Legislative Assembly

© Australian Capital Territory 2004