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A Bill for an Act to regulate certain activities involving the use of human embryos, to prohibit human cloning and other unacceptable practices associated with reproductive technology, and for related purposes
For authoritative information on the progress of bills and on amendments proposed to them, please see the House of Representatives Votes and Proceedings, and the Journals of the Senate as available on the Parliament House website.
Introduced HR 27 Jun 2002

Research Involving Embryos and Prohibition of Human Cloning Bill 2002
First Reading

2002

The Parliament of the

Commonwealth of Australia

HOUSE OF REPRESENTATIVES

Presented and read a first time

Research Involving Embryos and Prohibition of Human Cloning Bill 2002

No. , 2002

(Prime Minister)

A Bill for an Act to regulate certain activities involving the use of human embryos, to prohibit human cloning and other unacceptable practices associated with reproductive technology, and for related purposes

Contents

Part 1--Preliminary       1

1       Short title 1

2       Commencement 2

3       Object of Act 2

4       Operation of Act 3

5       Act to bind the Crown 3

6       External Territories 4

7       Definitions 4

Part 2--Prohibited practices       7

Division 1--Human cloning       7

8       Offence--creating a human embryo clone 7

9       Offence--placing a human embryo clone in the human body or the body of an animal 7

10       Offence--importing or exporting a human embryo clone 7

11       No defence that human embryo clone could not survive 7

Division 2--Other prohibited practices       8

12       Offence--creating a human embryo other than by fertilisation, or developing such an embryo 8

13       Offence--creating a human embryo for a purpose other than achieving pregnancy in a woman 8

14       Offence--creating or developing a human embryo containing genetic material provided by more than 2 persons 8

15       Offence--developing a human embryo outside the body of a woman for more than 14 days 9

16       Offence--using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo 9

17       Offence--heritable alterations to genome 9

18       Offence--collecting a viable human embryo from the body of a woman 10

19       Offence--creating a chimeric or hybrid embryo 10

20       Offence--placing of an embryo 10

21       Offence--importing, exporting or placing a prohibited embryo 11

22       Offence--commercial trading in human eggs, human sperm or human embryos 12

Part 3--Regulation of certain uses involving excess ART embryos       13

Division 1--Interpretation       13

23       Definitions 13

24       Meaning of excess ART embryo 14

Division 2--Offences       16

25       Offence--use of excess ART embryo 16

26       Offence--use of embryo that is not an excess ART embryo 17

27       Offence--breaching a licence condition 17

Division 3--Embryo Research Licensing Committee of the NHMRC       19

28       Establishment of Committee 19

29       Functions of Committee 19

30       Powers of Committee 20

31       Membership of Committee 20

32       Terms of appointment 21

33       Annual report 21

34       Reports to Parliament 21

Division 4--Licensing system       22

35       Person may apply for licence 22

36       Determination of application by Committee 22

37       Notification of decision 23

38       Period of licence 23

39       Licence is subject to conditions 24


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40       Variation of licence 25

41       Suspension or revocation of licence 25

42       Surrender of licence 26

43       Notification of variation, suspension or revocation of licence 26

Division 5--Reporting and confidentiality       27

44       NHMRC Licensing Committee to make certain information publicly available 27

45       Confidential commercial information may only be disclosed in certain circumstances 27

Division 6--Review provisions       30

46       Meaning of terms 30

47       Review of decisions 30

Part 4--Monitoring powers       32

48       Appointment of inspectors 32

49       Identity card 32

50       Powers available to inspectors for monitoring compliance 33

51       Monitoring powers 33

52       Power to secure 34

53       Inspector must produce identity card on request 34

54       Consent 35

55       Compensation for damage 35

Part 5--Commonwealth/State arrangements       36

56       Operation of State laws 36

57       Conferral of functions on Commonwealth officers and bodies 36

58       When duty imposed 37

59       Review of certain decisions 38

Part 6--Sunset clause, review provision and regulations       39

Division 1--Repeal       39

60       Repeal of paragraphs 36(3)(b) and 39(1)(c) and subsection 39(3) 39

Division 2--Review of Act       40

61       Review of operation of Act 40

Division 3--Regulations       41

62       Regulations 41

Schedule 1--Consequential amendment       42

Gene Technology Act 2000       42

A Bill for an Act to regulate certain activities involving the use of human embryos, to prohibit human cloning and other unacceptable practices associated with reproductive technology, and for related purposes

The Parliament of Australia enacts:

Part 1--Preliminary

1 Short title
        This Act may be cited as the Research Involving Embryos and Prohibition of Human Cloning Act 2002.

2 Commencement
       (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


2. Sections 3 to 24

The 28th day after the day on which this Act receives the Royal Assent


3. Sections 25 to 27

At the end of the period of 6 months beginning on the day on which this Act receives the Royal Assent


4. Sections 28 to 62

The 28th day after the day on which this Act receives the Royal Assent


5. Schedule 1

The 28th day after the day on which this Act receives the Royal Assent


Note: 
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     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:

       (a) by prohibiting certain practices; and

       (b) 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:

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) a thing declared by the regulations to be a chimeric embryo.

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.


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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.

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.

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 by the regulations to be a hybrid embryo.

inspector means a person appointed as an inspector under subsection 48(1).

NHMRC Licensing Committee means the Committee established by section 28.

precursor cell means a cell that has the potential to develop into a human egg or human sperm.

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 establishing 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) 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.

       (4) For the purposes of the definition of human embryo clone in subsection (1), 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 1--Human cloning

8 Offence--creating a human embryo clone
        A person commits an offence if the person intentionally creates a human embryo clone.

Maximum penalty:       Imprisonment for 15 years.

9 Offence--placing a human embryo clone in the human body or the body of an animal
        A person commits an offence if the person intentionally places a human embryo clone in the body of a human or the body of an animal.

Maximum penalty:       Imprisonment for 15 years.

10 Offence--importing or exporting a human embryo clone
       (1) A person commits an offence if the person intentionally imports a human embryo clone into Australia.

        Maximum penalty: Imprisonment for 15 years.

       (2) A person commits an offence if the person intentionally exports a human embryo clone from Australia.

Maximum penalty:       Imprisonment for 15 years.


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11 No defence that human embryo clone could not survive
        It is not a defence to an offence under section 8, 9 or 10 that the human embryo clone did not survive or could not have survived.

Division 2--Other prohibited practices

12 Offence--creating a human embryo other than by fertilisation, or developing such an embryo
        A person commits an offence if the person intentionally creates a human embryo by a process other than the fertilisation of a human egg by human sperm, or intentionally develops a human embryo so created.

Maximum penalty:       Imprisonment for 10 years.

13 Offence--creating a human embryo for a purpose other than achieving pregnancy in a woman
       (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 subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (1) of this section.

14 Offence--creating or developing a human embryo containing genetic material provided by more than 2 persons
        A person commits an offence if the person intentionally creates or develops a human embryo containing genetic material provided by more than 2 persons.

Maximum penalty:       Imprisonment for 10 years.

15 Offence--developing a human embryo outside the body of a woman for more than 14 days
        A person commits an offence if the person intentionally develops a human embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended.

Maximum penalty:       Imprisonment for 10 years.

16 Offence--using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo
        A person commits an offence if the person uses precursor cells taken from a human embryo or a human fetus, intending to create a human embryo, or intentionally develops an embryo so created.

Maximum penalty:       Imprisonment for 10 years.

17 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 fetal cell, human sperm or a human egg.

18 Offence--collecting a viable human embryo from the body of a woman
        A person commits an offence if the person removes a human embryo from the body of a woman, intending to collect a viable human embryo.

Maximum penalty:       Imprisonment for 10 years.

19 Offence--creating a chimeric or hybrid embryo
       (1) A person commits an offence if the person intentionally creates a chimeric embryo.


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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.

20 Offence--placing of an 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.

21 Offence--importing, exporting or placing a prohibited embryo
       (1) A person commits an offence if the person intentionally imports an embryo into Australia knowing that, or reckless as to 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 Australia knowing that, or reckless as to 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 as to whether, the embryo is a prohibited embryo.

Maximum penalty:       Imprisonment for 10 years.

       (4) In this section:

prohibited embryo means:

       (a) a human embryo created by a process other than the fertilisation of a human egg by human sperm; or

       (b) a human embryo created outside the body of a woman, unless the intention of the person who created the embryo was to attempt to achieve pregnancy in a particular woman; or

       (c) a human embryo that contains genetic material provided by more than 2 persons; or

       (d) a human embryo that has been developing outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended; or

       (e) a human embryo created using precursor cells taken from a human embryo or a human fetus; or

       (f) a human embryo that contains a human cell (within the meaning of section 17) 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.

22 Offence--commercial trading in human eggs, human sperm or human embryos
       (1) A person commits an offence if the person intentionally gives or offers valuable consideration to another person for the supply of a human egg, human sperm or a human embryo.

Maximum penalty:       Imprisonment for 10 years.

       (2) A person commits an offence if the person intentionally receives, or offers to receive, valuable consideration from another person for the supply of a human egg, human sperm or a human embryo.

Maximum penalty:       Imprisonment for 10 years.

       (3) In this section:

reasonable expenses:

       (a) in relation to the supply of a human egg or human sperm--includes, but is not limited to, expenses relating to the collection, storage or transport of the egg or sperm; and

       (b) in relation to the supply of a human embryo:

       (i) does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo within the meaning of section 24; and

       (ii) includes, but is not limited to, expenses relating to the storage or transport of the embryo.

valuable consideration, in relation to the supply of a human egg,

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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 1--Interpretation

23 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 24.

HREC means a Human Research Ethics Committee.

licence means a licence issued under section 36.

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 the Chairperson of the NHMRC Licensing Committee specifies, by notice in the Gazette, other guidelines issued by the NHMRC--consent obtained in accordance with those other guidelines.

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.

24 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


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25 Offence--use of excess ART embryo
       (1) A person commits an offence if the person intentionally uses an excess ART embryo, unless:

       (a) the use by the person is authorised by a licence; or

       (b) the use by the person is an exempt use 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; 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 (1):

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.

26 Offence--use of embryo that is not an excess ART embryo
       (1) 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 person is not using the embryo as part of an ART program carried out by an accredited ART centre, and the person knows or is reckless as to that fact.

Maximum penalty:       Imprisonment for 5 years.

       (2) In this section:

ART program means an assisted reproductive technology program carried out in accordance with:

       (a) the Code of Practice for Centres Using Assisted Reproductive Technology issued by the Reproductive Technology Accreditation Committee of the Fertility Society of Australia, as in force from time to time; or

`       (b) such other code or document as is prescribed by the regulations in addition to, or instead of, the code mentioned in paragraph (a), as in force from time to time.

27 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


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28 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) section 10;

       (b) section 35;

       (c) section 80;

       (d) subsection 82(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) A determination by the NHMRC under paragraph 38(b)(vi) 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.

29 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.

30 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.

31 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; and

       (b) consult, and have regard to the views expressed by, the States on the proposed appointment.

       (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

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the Committee as a whole comprises members from different States.

32 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.

33 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 NHMRC for the purposes of subsection (1).

34 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.

Division 4--Licensing system

35 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.

36 Determination of application by Committee
       (1) This section applies if a person has made an application under section 35 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 39(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 39(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) the number of excess ART embryos 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 NHMRC;


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       (d) the HREC assessment of the application mentioned in paragraph (3)(c);

       (e) such additional matters (if any) as are prescribed by the regulations.

37 Notification of decision
       (1) The NHMRC Licensing Committee must notify its decision on an application for a licence under section 35 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 36(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).

38 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.

39 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 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 embyro 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.

40 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

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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 35 for the licence as varied, the Committee would not have been permitted by this Part to issue the licence.

41 Suspension or revocation of licence
        The NHMRC Licensing Committee may, by notice in writing given to the licence holder, suspend or revoke a licence if the Committee believes on reasonable grounds that a condition of the licence has been breached.

42 Surrender of licence
        A licence holder may surrender a licence by written notice given to the NHMRC Licensing Committee.

43 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 37.

       (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

44 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.

45 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

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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 23.

Division 6--Review provisions

46 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 36 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 38--the licence holder; or

       (c) in relation to a decision to specify a licence condition under subsection 39(4)--the licence holder; or

       (d) in relation to a decision to vary or refuse to vary a licence under section 40--the licence holder; or

       (e) in relation to a decision to suspend or revoke a licence under section 41--the person who was the licence holder immediately before the suspension or revocation.

47 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 36 not to issue a licence;

       (b) a decision in respect of the period throughout which the licence is to be in force under section 38;

       (c) a decision to specify a licence condition under subsection 39(4);

       (d) a decision to vary or refuse to vary a licence under section 40;

       (e) a decision to suspend or revoke a licence under section 41.

       (2) This section has effect subject to the Administrative Appeals Tribunal Act 1975.

Part 4--Monitoring powers

48 Appointment of inspectors

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       (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.

49 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.

50 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 51.

       (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 36, and the entry is at a reasonable time.

51 Monitoring powers
       (1) The monitoring powers that an inspector may exercise under paragraph 50(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

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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.

52 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.

53 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.

54 Consent
       (1) Before obtaining the consent of a person for the purposes of paragraph 50(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.

55 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.

Part 5--Commonwealth/State arrangements

56 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.

57 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

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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.

58 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 57 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 57.

59 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

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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 6--Sunset clause, review provision and regulations

Division 1--Repeal

60 Repeal of paragraphs 36(3)(b) and 39(1)(c) and subsection 39(3)
        Paragraphs 36(3)(b) and 39(1)(c) and subsection 39(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

61 Review of operation of Act
       (1) 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 is to be undertaken by persons chosen by the NHMRC, with the agreement of each State.

       (3) The persons undertaking the review must give the Council of Australian Governments a written report of the review before the third anniversary of the day on which this Act received the Royal Assent.

       (4) The persons undertaking the review must consider and report on the scope and operation of Parts 2 and 3 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.

       (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.

Division 3--Regulations

62 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.

Schedule 1--Consequential amendment

Gene Technology Act 2000

1 Sections 192B, 192C and 192D

Repeal the sections.


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