An Act to regulate certain activities involving the use of human embryos, and for related purposes
Part 1—Preliminary
1 Short title [see Note 1]
This Act may be cited as the Research Involving Human Embryos Act 2002.
2 Commencement [see Note 1]
(1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table.
Commencement information |
Column 1 | Column 2 | Column 3 |
Provision(s) | Commencement | Date/Details |
1. Sections 1 and 2 and anything in this Act not elsewhere covered by this table | The day on which this Act receives the Royal Assent | 19 December 2002 |
2. Sections 3 to 9 | The 28th day after the day on which this Act receives the Royal Assent | 16 January 2003 |
3. Sections 10 to 12 | At the end of the period of 6 months beginning on the day on which this Act receives the Royal Assent | 19 June 2003 |
4. Sections 13 to 48 | The 28th day after the day on which this Act receives the Royal Assent | 16 January 2003 |
Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent.
(2) Column 3 of the table is for additional information that is not part of this Act. This information may be included in any published version of this Act.
3 Object of Act
The object of this Act is to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos by regulating activities that involve the use of certain human embryos created by assisted reproductive technology.
4 Operation of Act
(1) This Act applies as follows:
(a) to things done, or omitted to be done, by constitutional corporations;
(b) to things done, or omitted to be done, in the course of constitutional trade or commerce;
(c) to matters within the legislative power of the Commonwealth under paragraph 51(xxix) of the Constitution;
(d) to the Commonwealth and Commonwealth authorities;
(e) for purposes relating to the collection, compilation, analysis and dissemination of statistics;
(f) to matters within the legislative power of the Commonwealth under paragraph 51(xxxix) of the Constitution, so far as it relates to the matters mentioned in paragraphs (a) to (e) of this subsection.
(2) In this section:
constitutional corporation means a trading, foreign or financial corporation within the meaning of paragraph 51(xx) of the Constitution.
constitutional trade or commerce means trade or commerce:
(a) between Australia and places outside Australia; or
(b) among the States; or
(c) by way of the supply of services to the Commonwealth or to a Commonwealth authority.
5 Act to bind the Crown
(1) This Act binds the Crown in each of its capacities.
(2) Nothing in this Act renders the Crown liable to be prosecuted for an offence.
6 External Territories
This Act extends to every external Territory.
7 Definitions
(1) In this Act:
Commonwealth authority means the following:
(a) a body corporate established for a public purpose by or under an Act;
(b) a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together:
(i) the Commonwealth;
(ii) a body covered by paragraph (a);
(iii) a body covered by either of the above subparagraphs.
corresponding State law, in relation to a State, means a law of that State declared by the Minister, by notice in the Gazette, to be a corresponding State law for the purposes of 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.
inspector means a person appointed as an inspector under subsection 33(1).
NHMRC Licensing Committee means the Committee established by section 13.
spouse, in relation to a person, includes a person who, although not legally married to the person, is living with the person as the person’s spouse on a bona fide domestic basis.
State includes the Australian Capital Territory and the Northern Territory.
the NHMRC means the National Health and Medical Research Council established by the National Health and Medical Research Council Act 1992.
woman means a female human.
(2) For the purposes of the definition of human embryo in subsection (1), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.
Part 2—Regulation of certain uses involving excess ART embryos
Division 1—Interpretation
8 Definitions
In this Part:
accredited ART centre means a person or body 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.
AHEC means the Australian Health Ethics Committee established by the National Health and Medical Research Council Act 1992.
confidential commercial information means information that has a commercial or other value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed.
disclose, in relation to information, means give or communicate in any way.
excess ART embryo has the meaning given by section 9.
HREC means a Human Research Ethics Committee.
licence means a licence issued under section 21.
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 CEO of the NHMRC; or
(b) if other guidelines are issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 and prescribed by the regulations for the purposes of this paragraph—consent obtained in accordance with those other guidelines, rather than the guidelines mentioned in paragraph (a).
relevant State body means a person or body notified by a State to the Chairperson of the NHMRC Licensing Committee for the purposes of this Part.
responsible person, in relation to 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) any person who was the spouse of a person mentioned in paragraph (a) at the time the egg or sperm mentioned in that paragraph was provided; and
(d) any person who was the spouse of the woman mentioned in paragraph (b) at the time the embryo was created.
9 Meaning of excess ART embryo
(1) In this Part:
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 spouse (if any) at the time the embryo was created.
(2) For the purposes of paragraph (b) of the definition of excess ART embryo, a human embryo is excess to the needs of the persons mentioned in that paragraph at a particular time if:
(a) each such person has given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or
(b) each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.
Division 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 within the meaning of subsection (2).
Maximum penalty: Imprisonment for 5 years.
(2) A use of an excess ART embryo by a person is an exempt use for the purposes of subsection (1) 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
(b) the use consists only of observation of the excess ART embryo; or
(c) the use consists only of allowing the excess ART embryo to succumb; or
(d) the use is carried out by an accredited ART centre, and:
(i) the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and
(ii) the use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or
(e) the use is carried out by an accredited ART centre and is for the purposes of achieving pregnancy in a woman other than the woman for whom the excess ART embryo was created; or
(f) the use is of a kind prescribed by the regulations for the purposes of this paragraph.
(3) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (1) or (2) of this section.
(4) In subsection (2):
diagnostic investigation, in relation to an excess ART embryo, means any procedure undertaken on embryos for the sole purpose of diagnostic investigations for the direct benefit of the woman for whom it was created.
observation, in relation to an excess ART embryo, includes taking a photograph of the embryo, or taking a recording of the embryo from which a visual image can be produced.
11 Offence—use of embryo that is not an 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 as to that fact.
Maximum penalty: Imprisonment for 5 years.
12 Offence—breaching a 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 as to 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—Embryo Research Licensing Committee of the NHMRC
13 Establishment of Committee
(1) The Embryo Research Licensing Committee of the NHMRC (the NHMRC Licensing Committee) is established by this section.
(2) The NHMRC Licensing Committee is taken to be a Principal Committee within the meaning of the National Health and Medical Research Council Act 1992, other than for the purposes of the following provisions of that Act:
(a) sections 5D and 5E;
(b) section 35;
(c) section 41;
(d) section 80;
(e) subsections 82(1C) and (2).
(3) This section has effect despite the definition of Principal Committee in section 4 of the National Health and Medical Research Council Act 1992.
(4) The regulations may make provision for and in relation to the disclosure of members’ interests in matters being considered by the NHMRC Licensing Committee.
(5) Section 42A of the National Health and Medical Research Council Act 1992 does not have effect in relation to the NHMRC Licensing Committee at any time when regulations under subsection (4) are in force.
14 Functions of Committee
The functions of the NHMRC Licensing Committee are:
(a) to perform functions in relation to licences under Division 4; and
(b) to perform functions in relation to databases under Division 5; and
(c) to perform such other functions as are conferred on it by this Act or any other law.
15 Powers of Committee
The NHMRC Licensing Committee has power to do all things necessary or convenient to be done for or in connection with the performance of its functions.
16 Membership of Committee
(1) The NHMRC Licensing Committee consists of the following members:
(a) a member of AHEC;
(b) a person with expertise in research ethics;
(c) a person with expertise in a relevant area of research;
(d) a person with expertise in assisted reproductive technology;
(e) a person with expertise in a relevant area of law;
(f) a person with expertise in consumer health issues relating to disability and disease;
(g) a person with expertise in consumer issues relating to assisted reproductive technology;
(h) a person with expertise in the regulation of assisted reproductive technology;
(i) a person with expertise in embryology.
(2) The Minister must appoint the members of the NHMRC Licensing Committee.
(3) Before appointing a member, the Minister must:
(a) seek nominations from the States and from such bodies as are prescribed by the regulations for the purpose;
(b) consult, and have regard to the views expressed by, the States on the proposed appointment; and
(c) be satisfied upon receipt of a written declaration by the member proposed to be appointed that the member proposed does not have a direct or indirect pecuniary interest in a body that undertakes uses of excess ART embryos, being an interest of a kind that could conflict with the proper performance of the member’s functions.
(4) The Minister must appoint one of the members, other than the member mentioned in paragraph (1)(a), as the Chairperson of the NHMRC Licensing Committee.
(5) The Minister must not appoint a person:
(a) as the Chairperson under subsection (4); or
(b) as the member mentioned in paragraph (1)(h);
unless a majority of the States agree with that appointment.
(6) In appointing the members of the NHMRC Licensing Committee, the Minister must have regard to the desirability of ensuring that the Committee as a whole comprises members from different States.
17 Terms of appointment
(1) A member of the NHMRC Licensing Committee holds office on a part‑time basis.
(2) A member holds office for a period not exceeding 3 years that is specified in the instrument of appointment, but is eligible for reappointment.
18 Annual report
(1) A report under section 83 of the National Health and Medical Research Council Act 1992 must, in addition to the matters set out in that section, include details relating to the operations of the NHMRC Licensing Committee.
(2) The NHMRC Licensing Committee must give written details relating to its operations to the CEO of the NHMRC for the purposes of subsection (1).
19 Reports to Parliament
(1) The NHMRC Licensing Committee may at any time cause a report about matters relating to the Committee’s functions to be tabled in either House of the Parliament.
(2) The NHMRC Licensing Committee must give a copy of the report to the Minister and to each State.
(3) The NHMRC Licensing Committee must cause a report to be tabled in either House of Parliament on or before:
(a) 30 June of each year; and
(b) 31 December of each year; and
(c) any other time required by either House of Parliament;
that must include information about:
(d) the operation of this Act; and
(e) the licences issued under this Act.
Division 4—Licensing system
20 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):
(a) must be made in accordance with the requirements (if any) specified in writing by the NHMRC Licensing Committee; and
(b) must be accompanied by the fee (if any) prescribed by the regulations.
21 Determination of application by Committee [see Note 1]
(1) This section applies if a person has made an application under section 20 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 paragraph 24(1)(a)); and
(ii) to enable compliance with any restrictions on such 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 such use is authorised only in respect of an embryo created before 5 April 2002 (see subsection 24(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, which 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 and prescribed by the regulations for the purposes of this paragraph;
(d) the HREC assessment of the application mentioned in paragraph (3)(c);
(e) such additional matters (if any) as are prescribed by the regulations.
22 Notification of decision
(1) The NHMRC Licensing Committee must notify its decision on an application for a licence under section 20 to the following:
(a) the applicant;
(b) the HREC that assessed and approved the activity or project proposed in the application as mentioned in paragraph 21(3)(c);
(c) the relevant State body in relation to the State in which the use is to occur.
(2) If the NHMRC Licensing Committee decides to issue the licence, it must, in addition to issuing the licence to the applicant, give a copy of the licence to the bodies mentioned in paragraphs (1)(b) and (c).
23 Period of licence
(1) A licence:
(a) comes into force on the day specified in the licence, or if no day is specified, on the day on which it is issued; and
(b) remains in force until the day specified in the licence, unless it is suspended, revoked or surrendered before that day.
(2) A licence is not in force throughout any period of suspension.
24 Licence is subject to conditions [see Note 1]
(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 such 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 such use is authorised only in respect of an embryo created before 5 April 2002.
(4) A licence is subject to such other conditions as are specified in the licence.
(5) The conditions specified in the licence may include, but are not limited to, conditions relating to the following:
(a) the persons authorised by the licence to use excess ART embryos;
(b) the number of excess ART embryos in respect of which use is authorised by the licence;
(c) reporting;
(d) monitoring;
(e) information to be given by the licence holder to persons authorised by the licence to use excess ART embryos.
(6) The licence conditions set out in subsections (1), (2) and (3) apply to all persons who are authorised by the licence to use excess ART embryos.
(7) Licence conditions specified in the licence apply to:
(a) the licence holder; and
(b) such other persons authorised by the licence to use excess ART embryos as are specified in the licence.
25 Variation of licence
(1) The NHMRC Licensing Committee may, by notice in writing given to the licence holder, vary a licence if the Committee believes on reasonable grounds that it is necessary or desirable to do so.
(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 specifying 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 20 for the licence as varied, the Committee would not have been permitted by this Part to issue the licence.
26 Suspension or revocation of licence
(1) The NHMRC Licensing Committee may, by notice in writing given to the licence holder, suspend or revoke a licence if the Committee believes on reasonable grounds that a condition of the licence has been breached.
(2) If a licence holder is convicted of an offence under this Act or the Prohibition of Human Cloning Act 2002, the NHMRC Licensing Committee must, by notice in writing given to the licence holder, revoke each licence held by the licence holder.
27 Surrender of licence
A licence holder may surrender a licence by written notice given to the NHMRC Licensing Committee.
28 Notification of variation, suspension or revocation of licence
(1) If the NHMRC Licensing Committee varies, suspends or revokes a licence, the Committee must notify:
(a) the licence holder; and
(b) the HREC and the relevant State body to which the NHMRC Licensing Committee notified its decision on the application for the licence under section 22.
(2) The NHMRC Licensing Committee must also notify the bodies mentioned in paragraph (1)(b) if a licence is surrendered.
Division 5—Reporting and confidentiality
29 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 respect of which use is authorised by the licence;
(e) the date on which the licence was issued;
(f) the period throughout which the licence is to remain in force.
(2) The database is to 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 be such as to disclose confidential commercial information.
30 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 performing duties or functions under this Act or under a corresponding State law; and
(b) the person knows that the information is confidential commercial information; and
(c) the disclosure is not:
(i) to the Commonwealth, a Commonwealth authority or a State agency in the course of carrying out duties or functions under this Act or under a corresponding State law; 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 Commonwealth, a Commonwealth authority or a State agency in the course of carrying out duties or functions under this Act or under a corresponding State law; 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:
court includes a tribunal, authority or person having power to require the production of documents or the answering of questions.
State agency means the following:
(a) the Crown in right of a State;
(b) a Minister of a State;
(c) a State Government department;
(d) an instrumentality of a State, including a body corporate established for a public purpose by or under a law of a State;
(e) a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together:
(i) the Crown in right of a State;
(ii) a person or body covered by paragraph (b) or (d);
(iii) a person or body covered by either of the above subparagraphs.
Note: For the definition of confidential commercial information, see section 8.
Division 6—Review provisions
31 Meaning of terms
In this Division:
decision has the same meaning as in the Administrative Appeals Tribunal Act 1975.
eligible person, in relation to a decision of the NHMRC Licensing Committee, means:
(a) in relation to a decision under section 21 not to issue a licence—the applicant for the licence; or
(b) in relation to a decision in respect of the period throughout which the licence is to be in force under section 23—the licence holder; or
(c) in relation to a decision to specify a licence condition under subsection 24(4)—the licence holder; or
(d) in relation to a decision to vary or refuse to vary a licence under section 25—the licence holder; or
(e) in relation to a decision to suspend or revoke a licence under section 26—the person who was the licence holder immediately before the suspension or revocation.
32 Review of decisions
(1) An eligible person may apply to the Administrative Appeals Tribunal for review of the following decisions of the NHMRC Licensing Committee:
(a) a decision under section 21 not to issue a licence;
(b) a decision in respect of the period throughout which the licence is to be in force under section 23;
(c) a decision to specify a licence condition under subsection 24(4);
(d) a decision to vary or refuse to vary a licence under section 25;
(e) a decision to suspend or revoke a licence under section 26.
(2) This section has effect subject to the Administrative Appeals Tribunal Act 1975.
Part 3—Monitoring powers
33 Appointment of inspectors
(1) The Chairperson of the NHMRC Licensing Committee may, by instrument in writing, appoint any of the following persons as inspectors:
(a) a person who is appointed or employed by the Commonwealth;
(b) a person who is appointed or employed by a State.
(2) In exercising powers or performing functions as an inspector, an inspector must comply with any directions of the Chairperson of the NHMRC Licensing Committee.
(3) The Chairperson of the NHMRC Licensing Committee must not appoint a person as an inspector under subsection (1) unless he or she is satisfied that the person has appropriate skills and experience.
34 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 form prescribed by the regulations; 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 powers or performing functions as an inspector.
35 Powers available to inspectors for monitoring compliance
(1) For the purpose of finding out whether this Act or the regulations have been complied with, an inspector may:
(a) enter any premises; and
(b) exercise the monitoring powers set out in section 36.
(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 at which the occupier of the premises is carrying out activities authorised by a licence issued under section 21, and the entry is at a reasonable time.
36 Monitoring powers
(1) The monitoring powers that an inspector may exercise under paragraph 35(1)(b) are as follows:
(a) to search the premises and any thing on the premises;
(b) to inspect, examine, take measurements of, conduct tests on, or take samples of, any human embryo or thing on the premises that relates to this Act;
(c) to take photographs, make video or audio recordings or make sketches of the premises or any thing on the premises;
(d) to inspect any book, record or document on the premises;
(e) to take extracts from or make copies of any such book, record or document;
(f) to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises.
(2) For the purposes of 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 determining whether there has been compliance with the Act or the regulations.
(3) If the inspector, after operating equipment at the premises, finds that the equipment, or that a tape, disk or other storage device at the premises, contains information mentioned in subsection (2), the inspector may:
(a) operate equipment or facilities at the premises to put the information in documentary form and copy the document so produced; or
(b) if the information can be transferred to a tape, disk or other storage device that:
(i) is brought to the premises; or
(ii) is at the premises and the use of which has been agreed to in writing by the occupier of the premises;
operate the equipment or other facilities to copy the information to the storage device, and remove the storage device from the premises.
37 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 afford evidence of the commission of an offence against this Act, the monitoring powers include securing the embryo or thing pending the obtaining of a warrant (whether by the inspector or by another person) to seize it.
38 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.
39 Consent
(1) Before obtaining the consent of a person for the purposes of paragraph 35(2)(a), the inspector must inform the person that he or she may refuse consent.
(2) An entry of an inspector by virtue of the consent of a person is not lawful unless the person voluntarily consented to the entry.
40 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 as a result of it being operated by an inspector as mentioned in this Part; and
(b) the damage was caused as a result of insufficient care being exercised by the inspector operating the equipment or other facilities.
(2) Compensation is payable out of money appropriated by the Parliament.
(3) In determining the amount of compensation payable, regard is to be had to whether the occupier of the premises and his or her employees and agents, if they were available at the time, had provided any warning or guidance as to the operation of the equipment or other facilities that was appropriate in the circumstances.
41 Extended operation of Part
A reference in this Part to this Act includes a reference to the Prohibition of Human Cloning Act 2002, and a reference in this Part to the regulations includes a reference to regulations made under the Prohibition of Human Cloning Act 2002.
Part 4—Commonwealth/State arrangements
42 Operation of State laws
This Act is not intended to exclude the operation of any law of a State, to the extent that the law of the State is capable of operating concurrently with this Act.
43 Conferral of functions on Commonwealth officers and bodies
(1) A corresponding State law may confer functions, powers and duties on the following:
(a) the NHMRC Licensing Committee;
(b) a Commonwealth authority;
(c) an officer of the Commonwealth or a Commonwealth authority.
(2) If a function, power or duty is conferred on a person or body under subsection (1), the person or body may perform the function or duty or exercise the power, as the case requires.
(3) Subsection (1) does not authorise the conferral of a function or power, or the imposition of a duty, by a corresponding State law to the extent to which:
(a) the conferral or imposition, or the authorisation, would contravene any constitutional doctrines restricting the duties that may be imposed on a Commonwealth body, officer or authority; or
(b) the authorisation would otherwise exceed the legislative power of the Commonwealth.
(4) This Act is not intended to exclude or limit the operation of a corresponding State law that confers any functions or powers, or imposes any duties, on the NHMRC Licensing Committee, a Commonwealth officer or a Commonwealth authority to the extent to which that law:
(a) is consistent with subsections (1) and (2); and
(b) is capable of operating concurrently with this Act.
44 When duty imposed
(1) This section applies if a corresponding State law purports to impose a duty on the following:
(a) the NHMRC Licensing Committee;
(b) a Commonwealth authority;
(c) an officer of the Commonwealth or a Commonwealth authority.
(2) The duty is taken not to be imposed by this Act (or any other law of the Commonwealth) to the extent to which:
(a) imposing the duty is within the legislative powers of the State concerned; and
(b) imposing the duty by the corresponding State law is consistent with the constitutional doctrines restricting the duties that may be imposed on a Commonwealth body, officer or authority.
Note: If this subsection applies, the duty will be taken to be imposed by force of the corresponding State law (the Commonwealth having consented under section 43 to the imposition of the duty by the corresponding State law).
(3) If, to ensure the validity of the purported imposition of the duty, it is necessary that the duty be imposed by a law of the Commonwealth (rather than by force of the corresponding State law), the duty is taken to be imposed by this Act to the extent necessary to ensure that validity.
(4) If, because of subsection (3), this Act is taken to impose the duty, it is the intention of the Parliament to rely on all powers available to it under the Constitution to support the imposition of the duty by this Act.
(5) The duty is taken to be imposed by this Act in accordance with subsection (3) only to the extent to which imposing the duty:
(a) is within the legislative power of the Commonwealth; and
(b) is consistent with the constitutional doctrines restricting the duties that may be imposed on a Commonwealth body, officer or authority.
(6) To avoid doubt, neither this Act (nor any other law of the Commonwealth) imposes a duty on the NHMRC Licensing Committee, a Commonwealth officer or a Commonwealth authority to the extent to which imposing such a duty would:
(a) contravene any constitutional doctrine restricting the duties that may be imposed on a Commonwealth body, officer or authority; or
(b) otherwise exceed the legislative power of the Commonwealth.
(7) Subsections (1) to (6) do not limit section 43.
45 Review of certain decisions
(1) Application may be made to the Administrative Appeals Tribunal for review of a reviewable State decision.
(2) A decision made by the NHMRC Licensing Committee in the performance of a function or the exercise of a power conferred by a corresponding State law is a reviewable State decision for the purposes of this section if:
(a) the law under which the decision was made provides for review by the Administrative Appeals Tribunal; and
(b) the decision is declared by the regulations to be a reviewable State decision for the purposes of this section.
(3) For the purposes of this section, the Administrative Appeals Tribunal Act 1975 has effect as if a corresponding State law were an enactment.
Part 5—Sunset clause, review provision and regulations
Division 1—Repeal
46 Repeal of paragraphs 21(3)(b) and 24(1)(c) and subsection 24(3) [see Note 1]
Paragraphs 21(3)(b) and 24(1)(c) and subsection 24(3) are repealed on whichever of the following days applies:
(a) 5 April 2005;
(b) if the Council of Australian Governments declares an earlier day by notice in the Gazette—that earlier day.
Division 2—Review of Act
47 Review of operation of Act
(1) The CEO of the NHMRC must cause an independent review of the operation of this Act to be undertaken as soon as possible after the second anniversary of the day on which this Act received the Royal Assent.
(2) The review must be:
(a) undertaken by the persons who undertake the Prohibition of Human Cloning Act review; and
(b) undertaken concurrently with the Prohibition of Human Cloning Act review.
(3) The persons undertaking the review must give to the Council of Australian Governments and both Houses of the Parliament a written report of the review. The report must accompany the report of the Prohibition of Human Cloning Act review.
(4) The persons undertaking the review must consider and report on the scope and operation of this Act 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.
(5) The report must contain recommendations about amendments (if any) that should be made to this Act, having regard to the matters mentioned in subsection (4).
(6) The persons undertaking the review must consult:
(a) the Commonwealth and the States; and
(b) a broad range of persons with expertise in or experience of relevant disciplines;
and the views of the Commonwealth, the States and the persons mentioned in paragraph (b) must be set out in the report to the extent that it is reasonably practicable to do so.
(7) In this section:
Prohibition of Human Cloning Act review means the review mentioned in section 25 of the Prohibition of Human Cloning Act 2002.
Division 3—Regulations
48 Regulations
(1) The Governor‑General may make regulations prescribing matters:
(a) required or permitted by this Act to be prescribed; or
(b) necessary or convenient to be prescribed for carrying out or giving effect to this Act.
(2) Before the Governor‑General makes regulations under this Act, the Minister must be satisfied that:
(a) the States have been consulted in relation to the proposed regulations; and
(b) the proposed regulations have been prepared having regard to views expressed by the States in those consultations.
