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REGULATION OF RESEARCH INVOLVING HUMAN EMBRYOS AND ASSISTED REPRODUCTIVE TECHNOLOGY BILL 2003

        Queensland




REGULATION OF RESEARCH
    INVOLVING HUMAN
 EMBRYOS AND ASSISTED
      REPRODUCTIVE
  TECHNOLOGY BILL 2003

 


 

 

Queensland REGULATION OF RESEARCH INVOLVING HUMAN EMBRYOS AND ASSISTED REPRODUCTIVE TECHNOLOGY BILL 2003 TABLE OF PROVISIONS Section Page PART 1--PRELIMINARY 1 Short title . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2 Commencement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 3 Object of Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 4 Act binds all persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 6 Meaning of "reckless" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 PART 3--REGULATION OF CERTAIN USES INVOLVING EXCESS ART EMBRYOS Division 1--Interpretation 21 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 22 Meaning of excess ART embryo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Division 2--Offences 23 Offence--use of excess ART embryo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 24 Offence--use of embryo that is not an excess ART embryo. . . . . . . . . . . . . 11 25 Offence--breaching a licence condition . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Division 3--Embryo Research Licensing Committee of the NHMRC 26 Functions of committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

 


 

2 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 27 Powers of committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Division 4--Licensing system 28 Person may apply for licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 29 Determination of application by committee . . . . . . . . . . . . . . . . . . . . . . . . . 12 30 Notification of decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 31 Period of licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 32 Licence is subject to conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 33 Variation of licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 34 Suspension or revocation of licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 35 Surrender of licence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 36 Notification of variation, suspension or revocation of licence . . . . . . . . . . . 16 Division 5--Reporting and confidentiality 37 NHMRC Licensing Committee to make certain information publicly available ......................................... 17 38 Confidential commercial information may only be disclosed in certain circumstances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Division 6--Review provisions 39 Meaning of terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 40 Review of decisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 PART 4--MONITORING POWERS 41 Appointment of inspectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 42 Identity card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 43 Powers available to inspectors for monitoring compliance. . . . . . . . . . . . . . 21 44 Monitoring powers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 45 Power to secure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 46 Inspector must produce identity card on request. . . . . . . . . . . . . . . . . . . . . . 23 47 Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 48 Compensation for damage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 PART 5--MISCELLANEOUS Division 1--Review of Act 49 Review of operation of Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

 


 

3 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 Division 2--Matters about offences 50 Attempts to commit offences against this Act. . . . . . . . . . . . . . . . . . . . . . . . 25 51 Crimes and summary offences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 52 Limitation on time for starting summary proceedings . . . . . . . . . . . . . . . . . 25 Division 3--Regulations 53 Regulation-making power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 PART 6--AMENDMENT OF THIS ACT 54 Act amended in pt 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 55 Amendment of various sections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 SCHEDULE . . . . . . . . . . . . . . . . . . . . . . . . 27 DICTIONARY

 


 

 

2003 A BILL FOR An Act to regulate certain activities involving the use of human embryos, and for related purposes

 


 

s1 6 s4 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 The Parliament of Queensland enacts-- 1 PART 1--PRELIMINARY 2 1 Short title 3 This Act may be cited as the Regulation of Research Involving Human 4 Embryos and Assisted Reproductive Technology Act 2003. 5 2 Commencement 6 (1) This Act, other than part 61 commences on a day to be fixed by 7 proclamation. 8 (2) Part 6 commences on whichever of the following days applies-- 9 (a) 5 April 2005; 10 (b) if the Council of Australian Governments declares an earlier day 11 by notice in the gazette--that earlier day. 12 3 Object of Act 13 The object of this Act is to address concerns, including ethical concerns, 14 about scientific developments in relation to human reproduction and the 15 utilisation of human embryos by regulating activities that involve the use of 16 certain human embryos created by assisted reproductive technology. 17 4 Act binds all persons 18 (1) This Act binds all persons, including the State, and, as far as the 19 legislative power of the Parliament permits, the Commonwealth and the 20 other States. 21 (2) Nothing in this Act makes the Commonwealth or a State liable to be 22 prosecuted for an offence. 23 1 Part 6 (Amendment of this Act)

 


 

s5 7 s6 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 5 Definitions 1 (1) The dictionary in the schedule defines particular words used in this 2 Act. 3 (3) For the purposes of the definition "human embryo" in the schedule, 4 in working out the length of the period of development of a human embryo, 5 any period when the development of the embryo is suspended is to be 6 disregarded. 7 (5) The following provisions of the Acts Interpretation Act 1954 do not 8 apply to a reference to a spouse in this Act-- 9 section 32DA(6)2 10 section 36, definition "spouse". 11 6 Meaning of "reckless" 12 (1) A person is "reckless" in relation to a circumstance if-- 13 (a) the person is aware of a substantial risk that the circumstance 14 exists or will exist; and 15 (b) having regard to the circumstances known to the person, it is 16 unjustifiable to take the risk. 17 (2) A person is "reckless" in relation to a result if-- 18 (a) the person is aware of a substantial risk that the result will 19 happen; and 20 (b) having regard to the circumstances known to the person, it is 21 unjustifiable to take the risk. 22 (3) It is a question of fact as to whether taking a risk is unjustifiable. 23 2 Acts Interpretation Act 1954, section 32DA (Meaning of "de facto partner")

 


 

s 21 8 s 21 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 PART 3--REGULATION OF CERTAIN USES 1 INVOLVING EXCESS ART EMBRYOS 2 Division 1--Interpretation 3 21 Definitions 4 In this part-- 5 "accredited ART centre" means an entity accredited to carry out assisted 6 reproductive technology by an entity prescribed under a regulation. 7 "confidential commercial information" means information that has a 8 commercial or other value that would be, or could reasonably be 9 expected to be, destroyed or diminished if the information were 10 disclosed. 11 "disclose", in relation to information, means give or communicate in any 12 way. 13 "excess ART embryo" has the meaning given by section 22. 14 "HREC" means a Human Research Ethics Committee. 15 "licence" means a licence issued under section 29. 16 "proper consent", in relation to the use of an excess ART embryo, 17 means-- 18 (a) consent obtained in accordance with the Ethical Guidelines on 19 Assisted Reproductive Technology (1996) issued by the 20 NHMRC; or 21 (b) if other guidelines are issued by the NHMRC under the National 22 Health and Medical Research Council Act 1992 (Cwlth) and 23 prescribed under a regulation for the purposes of this 24 paragraph--consent obtained in accordance with those other 25 guidelines, rather than the guidelines mentioned in paragraph (a). 26 "relevant State body" means the person or body notified by the State to 27 the chairperson of the NHMRC Licensing Committee for the purposes 28 of the Commonwealth Act, part 2. 29 "responsible person", in relation to an excess ART embryo, means-- 30

 


 

s 22 9 s 22 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 (a) each person who provided the egg or sperm from which the 1 embryo was created; and 2 (b) the woman for whom the embryo was created, for the purpose of 3 achieving her pregnancy; and 4 (c) any person who was the spouse of a person mentioned in 5 paragraph (a) at the time the egg or sperm mentioned in that 6 paragraph was provided; and 7 (d) any person who was the spouse of the woman mentioned in 8 paragraph (b) at the time the embryo was created. 9 22 Meaning of excess ART embryo 10 (1) In this part-- 11 "excess ART embryo" means a human embryo that-- 12 (a) was created, by assisted reproductive technology, for use in the 13 assisted reproductive technology treatment of a woman; and 14 (b) is excess to the needs of-- 15 (i) the woman for whom it was created; and 16 (ii) her spouse (if any) at the time the embryo was created. 17 (2) For the purposes of paragraph (b) of the definition "excess ART 18 embryo", a human embryo is excess to the needs of the persons mentioned 19 in that paragraph at a particular time if-- 20 (a) each such person has given written authority for use of the 21 embryo for a purpose other than a purpose relating to the assisted 22 reproductive technology treatment of the woman concerned, and 23 the authority is in force at that time; or 24 (b) each such person has determined in writing that the embryo is 25 excess to their needs, and the determination is in force at that 26 time. 27

 


 

s 23 10 s 23 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 Division 2--Offences 1 23 Offence--use of excess ART embryo 2 (1) A person commits an offence if the person intentionally uses an 3 excess ART embryo, unless-- 4 (a) the use by the person is authorised by a licence; or 5 (b) the use by the person is an exempt use within the meaning of 6 subsection (2). 7 Maximum penalty--5 years imprisonment. 8 (2) A use of an excess ART embryo by a person is an exempt use for the 9 purposes of subsection (1) if-- 10 (a) the use consists only of-- 11 (i) storage of the excess ART embryo; or 12 (ii) removal of the excess ART embryo from storage; or 13 (iii) transport of the excess ART embryo; or 14 (b) the use consists only of observation of the excess ART embryo; 15 or 16 (c) the use consists only of allowing the excess ART embryo to 17 succumb; or 18 (d) the use is carried out by an accredited ART centre, and-- 19 (i) the excess ART embryo is not suitable to be placed in the 20 body of the woman for whom it was created where the 21 suitability of the embryo is determined only on the basis of 22 its biological fitness for implantation; and 23 (ii) the use forms part of diagnostic investigations conducted in 24 connection with the assisted reproductive technology 25 treatment of the woman for whom the excess ART embryo 26 was created; or 27 (e) the use is carried out by an accredited ART centre and is for the 28 purposes of achieving pregnancy in a woman other than the 29 woman for whom the excess ART embryo was created; or 30 (f) the use is of a kind prescribed under a regulation for the purposes 31 of this paragraph. 32

 


 

s 24 11 s 25 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 (3) A defendant does not bear an evidential burden in relation to any 1 matter in subsection (1) or (2). 2 (4) In this section-- 3 "diagnostic investigation", in relation to an excess ART embryo, means 4 any procedure undertaken on embryos for the sole purpose of 5 diagnostic investigations for the direct benefit of the woman for whom 6 it was created. 7 "observation", in relation to an excess ART embryo, includes taking a 8 photograph of the embryo, or taking a recording of the embryo from 9 which a visual image can be produced. 10 24 Offence--use of embryo that is not an excess ART embryo 11 A person commits an offence if-- 12 (a) the person intentionally uses, outside the body of a woman, a 13 human embryo that is not an excess ART embryo; and 14 (b) the use is not for a purpose relating to the assisted reproductive 15 technology treatment of a woman carried out by an accredited 16 ART centre, and the person knows or is reckless as to that fact. 17 Maximum penalty--5 years imprisonment. 18 25 Offence--breaching a licence condition 19 (1) A person commits an offence if the person intentionally engages in 20 conduct, knowing that the conduct contravenes a condition of a licence that 21 applies to the person, or reckless as to whether the conduct contravenes a 22 condition of such a licence. 23 Maximum penalty--5 years imprisonment. 24 (2) In this section-- 25 "engage in conduct" means-- 26 (a) do an act; or 27 (b) omit to perform an act. 28

 


 

s 26 12 s 29 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 Division 3--Embryo Research Licensing Committee of the NHMRC 1 26 Functions of committee 2 The functions of the NHMRC Licensing Committee are-- 3 (a) to perform functions in relation to licences under division 4; and 3 4 (b) to perform functions in relation to databases under division 5;4 5 and 6 (c) to perform such other functions as are conferred on it by this Act 7 or any other law. 8 27 Powers of committee 9 The NHMRC Licensing Committee has power to do all things necessary 10 or convenient to be done for or in connection with the performance of its 11 functions under this Act. 12 Division 4--Licensing system 13 28 Person may apply for licence 14 (1) A person may apply to the NHMRC Licensing Committee for a 15 licence authorising use of excess ART embryos. 16 (2) An application under subsection (1)-- 17 (a) must be made in accordance with the requirements (if any) 18 specified in writing by the NHMRC Licensing Committee; and 19 (b) must be accompanied by the fee (if any) prescribed under a 20 regulation. 21 29 Determination of application by committee 22 (1) This section applies if a person has made an application under 23 section 28 for a licence. 24 3 Division 4 (Licensing system) 4 Division 5 (Reporting and confidentiality)

 


 

s 29 13 s 29 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 (2) The NHMRC Licensing Committee must decide, in accordance with 1 this section, whether or not to issue the licence. 2 (3) The NHMRC Licensing Committee must not issue the licence unless 3 it is satisfied of the following-- 4 (a) that appropriate protocols are in place-- 5 (i) to enable proper consent to be obtained before an excess 6 ART embryo is used under the licence (see 7 section 32(1)(a));5 and 8 (ii) to enable compliance with any restrictions on such consent; 9 (b) if the use of an excess ART embryo proposed in the application 10 may damage or destroy the embryo--that appropriate protocols 11 are in place to enable compliance with the condition that such 12 use is authorised only in respect of an embryo created before 13 5 April 2002 (see section 32(3)); 14 (c) that the activity or project proposed in the application has been 15 assessed and approved by a HREC that is constituted in 16 accordance with, and acting in compliance with, the NHMRC 17 National Statement on Ethical Conduct in Research Involving 18 Humans (1999), as in force from time to time. 19 (4) In deciding whether to issue the licence, the NHMRC Licensing 20 Committee must have regard to the following-- 21 (a) restricting the number of excess ART embryos to that likely to be 22 necessary to achieve the goals of the activity or project proposed 23 in the application; 24 (b) the likelihood of significant advance in knowledge or 25 improvement in technologies for treatment as a result of the use 26 of excess ART embryos proposed in the application, which could 27 not reasonably be achieved by other means; 28 (c) any relevant guidelines, or relevant parts of guidelines, issued by 29 the NHMRC under the National Health and Medical Research 30 Council Act 1992 (Cwlth) and prescribed under a regulation for 31 the purposes of this paragraph; 32 5 Section 32 (Licence is subject to conditions)

 


 

s 30 14 s 32 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 (d) the HREC assessment of the application mentioned in 1 subsection (3)(c); 2 (e) such additional matters (if any) as are prescribed by a regulation. 3 30 Notification of decision 4 (1) The NHMRC Licensing Committee must notify its decision on an 5 application for a licence under section 28 to the following-- 6 (a) the applicant; 7 (b) the HREC that assessed and approved the activity or project 8 proposed in the application as mentioned in section 29(3)(c); 9 (c) the relevant State body. 10 (2) If the NHMRC Licensing Committee decides to issue the licence, it 11 must, in addition to issuing the licence to the applicant, give a copy of the 12 licence to the bodies mentioned in subsection (1)(b) and (c). 13 31 Period of licence 14 (1) A licence-- 15 (a) comes into force on the day specified in the licence, or if no day 16 is specified, on the day on which it is issued; and 17 (b) remains in force until the day specified in the licence, unless it is 18 suspended, revoked or surrendered before that day. 19 (2) A licence is not in force throughout any period of suspension. 20 32 Licence is subject to conditions 21 (1) A licence is subject to the condition that before an excess ART 22 embryo is used as authorised by the licence-- 23 (a) each responsible person in relation to the excess ART embryo 24 must have given proper consent to that use; and 25 (b) the licence holder must have reported in writing to the NHMRC 26 Licensing Committee that such consent has been obtained, and 27 any restrictions to which the consent is subject; and 28

 


 

s 33 15 s 33 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 (c) if the licence authorises use of an excess ART embryo that may 1 damage or destroy the embryo--the licence holder must have 2 reported in writing to the NHMRC Licensing Committee that the 3 embryo was created before 5 April 2002. 4 (2) A licence is subject to the condition that the use of an excess ART 5 embryo must be in accordance with any restrictions to which the proper 6 consent under subsection (1) is subject. 7 (3) If a licence authorises the use of an excess ART embryo that may 8 damage or destroy the embryo, the licence is subject to the condition that 9 such use is authorised only in respect of an embryo created before 10 5 April 2002. 11 (4) A licence is subject to such other conditions as are specified in the 12 licence. 13 (5) The conditions specified in the licence may include, but are not 14 limited to, conditions relating to the following-- 15 (a) the persons authorised by the licence to use excess ART 16 embryos; 17 (b) the number of excess ART embryos in respect of which use is 18 authorised by the licence; 19 (c) reporting; 20 (d) monitoring; 21 (e) information to be given by the licence holder to persons 22 authorised by the licence to use excess ART embryos. 23 (6) The licence conditions set out in subsections (1), (2) and (3) apply to 24 all persons who are authorised by the licence to use excess ART embryos. 25 (7) Licence conditions specified in the licence apply to-- 26 (a) the licence holder; and 27 (b) such other persons authorised by the licence to use excess ART 28 embryos as are specified in the licence. 29 33 Variation of licence 30 (1) The NHMRC Licensing Committee may, by notice in writing given 31 to the licence holder, vary a licence if the committee believes on reasonable 32 grounds that it is necessary or desirable to do so. 33

 


 

s 34 16 s 36 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 (2) The NHMRC Licensing Committee may vary a licence under 1 subsection (1) on its own initiative or on application by the licence holder. 2 (3) Without limiting subsection (1), the NHMRC Licensing Committee 3 may vary the licence by specifying additional conditions or varying 4 existing conditions. 5 (4) The NHMRC Licensing Committee must not vary a licence in such a 6 way that, had a person applied under section 28 for the licence as varied, 7 the committee would not have been permitted by this part to issue the 8 licence. 9 34 Suspension or revocation of licence 10 (1) The NHMRC Licensing Committee may, by notice in writing given 11 to the licence holder, suspend or revoke a licence if the committee believes 12 on reasonable grounds that a condition of the licence has been breached. 13 (2) If a licence holder is convicted of an offence under this Act or the 14 Prohibition of Human Cloning Act 2003, the NHMRC Licensing 15 Committee must, by notice in writing given to the licence holder, revoke 16 each licence held by the licence holder. 17 35 Surrender of licence 18 A licence holder may surrender a licence by written notice given to the 19 NHMRC Licensing Committee. 20 36 Notification of variation, suspension or revocation of licence 21 (1) If the NHMRC Licensing Committee varies, suspends or revokes a 22 licence, the committee must notify-- 23 (a) the licence holder; and 24 (b) the HREC and the relevant State body. 25 (2) The NHMRC Licensing Committee must also notify the bodies 26 mentioned in subsection (1)(b) if a licence is surrendered. 27

 


 

s 37 17 s 38 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 Division 5--Reporting and confidentiality 1 37 NHMRC Licensing Committee to make certain information 2 publicly available 3 (1) The NHMRC Licensing Committee must maintain a database 4 containing the following information in relation to each licence (including 5 a licence as varied)-- 6 (a) the name of the person to whom the licence was issued; 7 (b) a short statement about the nature of the uses of excess ART 8 embryos that are authorised by the licence; 9 (c) any conditions to which the licence is subject; 10 (d) the number of excess ART embryos in respect of which use is 11 authorised by the licence; 12 (e) the date on which the licence was issued; 13 (f) the period throughout which the licence is to remain in force. 14 (2) The database is to be made publicly available. 15 (3) The database may be kept and made publicly available in electronic 16 form. 17 (4) Information mentioned in subsection (1) must not be such as to 18 disclose confidential commercial information. 19 (5) The database may form part of the database maintained by the 20 NHMRC Licensing Committee under the Commonwealth Act, section 29. 21 38 Confidential commercial information may only be disclosed in 22 certain circumstances 23 (1) A person commits an offence if-- 24 (a) the person discloses confidential commercial information that the 25 person has only because of performing duties or functions under 26 this part, or under this part and the Commonwealth Act; and 27 (b) the person knows that the information is confidential commercial 28 information; and 29 (c) the disclosure is not made-- 30

 


 

s 38 18 s 38 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 (i) for the purposes of this Act, a corresponding State law, the 1 Commonwealth Act or the Prohibition of Human Cloning 2 Act 2002 (Cwlth), to a State agency, the Commonwealth or 3 a Commonwealth authority; or 4 (ii) by order of a court; or 5 (iii) with the consent of each person to whom the information 6 has a commercial or other value. 7 Maximum penalty--2 years imprisonment. 8 (2) A person commits an offence if-- 9 (a) the person discloses confidential commercial information that the 10 person has only because of a disclosure permitted under 11 subsection (1) or this subsection; and 12 (b) the person knows that the information is confidential commercial 13 information; and 14 (c) the disclosure is not made-- 15 (i) for the purposes of this Act, a corresponding State law, the 16 Commonwealth Act or the Prohibition of Human Cloning 17 Act 2002 (Cwlth), to a State agency, the Commonwealth or 18 a Commonwealth authority; or 19 (ii) by order of a court; or 20 (iii) with the consent of each person to whom the information 21 has a commercial or other value. 22 Maximum penalty--2 years imprisonment. 23 (3) In this section-- 24 "court" includes a tribunal, authority or person having power to require the 25 production of documents or the answering of questions. 26 "State agency" means the following-- 27 (a) a State; 28 (b) a Minister of a State; 29 (c) a department or a department of Government of another State; 30 (d) an instrumentality of a State, including a body corporate 31 established for a public purpose under a law of a State; 32

 


 

s 39 19 s 39 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 (e) a company in which a controlling interest is held by any 1 of the 1 following persons, or by 2 or more of the following persons 2 together-- 3 (i) a State; 4 (ii) a Minister of a State, or a State instrumentality mentioned in 5 paragraph (d); 6 (iii) a person or body covered by subparagraph (i) or (ii). 7 Division 6--Review provisions 8 39 Meaning of terms 9 In this division-- 10 "Administrative Appeals Tribunal" means the Administrative Appeals 11 Tribunal established by the Administrative Appeals Tribunal Act 1975 12 (Cwlth). 13 "decision" has the same meaning as in the Administrative Appeals 14 Tribunal Act 1975 (Cwlth). 15 "eligible person", in relation to a decision of the NHMRC Licensing 16 Committee, means-- 17 (a) in relation to a decision under section 29 not to issue a 18 licence--the applicant for the licence; or 19 (b) in relation to a decision in respect of the period throughout which 20 the licence is to be in force under section 31--the licence holder; 21 or 22 (c) in relation to a decision to specify a licence condition under 23 section 32(4)--the licence holder; or 24 (d) in relation to a decision to vary or refuse to vary a licence under 25 section 33--the licence holder; or 26 (e) in relation to a decision to suspend or revoke a licence under 27 section 34--the person who was the licence holder immediately 28 before the suspension or revocation. 29

 


 

s 40 20 s 41 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 40 Review of decisions 1 (1) An eligible person may apply to the Administrative Appeals Tribunal 2 for review of any of the following decisions of the NHMRC Licensing 3 Committee if the decision is declared by the regulations made under the 4 Commonwealth Act to be a reviewable State decision for the purposes of 5 section 45 of that Act-- 6 (a) a decision under section 29 not to issue a licence; 7 (b) a decision in respect of the period throughout which the licence 8 is to be in force under section 31; 9 (c) a decision to specify a licence condition under section 32(4); 10 (d) a decision to vary or refuse to vary a licence under section 33; 11 (e) a decision to suspend or revoke a licence under section 34. 12 (2) This section has effect subject to the Administrative Appeals Tribunal 13 Act 1975 (Cwlth). 14 (3) The Administrative Appeals Tribunal Act 1975 (Cwlth), other than 15 part IVA, and the regulations in force under that Act apply as laws of the 16 State for the review of a decision under subsection (1). 17 (4) For this section, a reference in a provision of the Administrative 18 Appeals Tribunal Act 1975 (Cwlth), as the provision applies as a law of the 19 State, to all or any part of part IVA of that Act is taken to be a reference to 20 all or part of that part as it has effect as a law of the Commonwealth. 21 PART 4--MONITORING POWERS 22 41 Appointment of inspectors 23 (1) The chairperson of the NHMRC Licensing Committee may, by 24 instrument in writing, appoint any of the following persons as inspectors-- 25 (a) a person who is appointed or employed by the State; 26 (b) a person who is appointed or employed by the Commonwealth. 27 (2) In exercising powers or performing functions as an inspector, an 28 inspector must comply with any directions of the chairperson of the 29 NHMRC Licensing Committee. 30

 


 

s 42 21 s 43 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 (3) The chairperson of the NHMRC Licensing Committee must not 1 appoint a person as an inspector under subsection (1) unless he or she is 2 satisfied that the person has appropriate skills and experience. 3 42 Identity card 4 (1) The chairperson of the NHMRC Licensing Committee must issue an 5 identity card to an inspector. 6 (2) The identity card-- 7 (a) must be in the form prescribed by the regulations under the 8 Commonwealth Act; and 9 (b) must contain a recent photograph of the inspector. 10 (3) If a person to whom an identity card has been issued ceases to be an 11 inspector, the person must return the identity card to the chairperson of the 12 NHMRC Licensing Committee as soon as practicable. 13 Maximum penalty--1 penalty unit. 14 (4) An inspector must carry his or her identity card at all times when 15 exercising powers or performing functions as an inspector. 16 43 Powers available to inspectors for monitoring compliance 17 (1) For the purpose of finding out whether this Act has been complied 18 with, an inspector may-- 19 (a) enter any premises; and 20 (b) exercise the monitoring powers set out in section 44. 21 (2) An inspector is not authorised to enter premises under subsection (1) 22 unless-- 23 (a) the occupier of the premises has consented to the entry; or 24 (b) the premises are premises at which the occupier of the premises 25 is carrying out activities authorised by a licence issued under 26 section 29,6 and the entry is at a reasonable time. 27 6 Section 29 (Determination of application by committee)

 


 

s 44 22 s 44 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 44 Monitoring powers 1 (1) The monitoring powers that an inspector may exercise under 2 section 43(1)(b) are as follows-- 3 (a) to search the premises and any thing on the premises; 4 (b) to inspect, examine, take measurements of, conduct tests on, or 5 take samples of, any human embryo or thing on the premises that 6 relates to this Act; 7 (c) to take photographs, make video or audio recordings or make 8 sketches of the premises or any thing on the premises; 9 (d) to inspect any book, record or document on the premises; 10 (e) to take extracts from or make copies of any such book, record or 11 document; 12 (f) to take onto the premises such equipment and materials as the 13 inspector requires for the purpose of exercising powers in 14 relation to the premises. 15 (2) For the purposes of this part, monitoring powers include the power to 16 operate equipment at premises to see whether-- 17 (a) the equipment; or 18 (b) a disk, tape or other storage device that-- 19 (i) is at the premises; and 20 (ii) can be used with the equipment or is associated with it; 21 contains information that is relevant to determining whether there has been 22 compliance with this Act. 23 (3) If the inspector, after operating equipment at the premises, finds that 24 the equipment, or that a tape, disk or other storage device at the premises, 25 contains information mentioned in subsection (2), the inspector may-- 26 (a) operate equipment or facilities at the premises to put the 27 information in documentary form and copy the document so 28 produced; or 29 (b) if the information can be transferred to a tape, disk or other 30 storage device that-- 31 (i) is brought to the premises; or 32

 


 

s 45 23 s 48 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 (ii) is at the premises and the use of which has been agreed to in 1 writing by the occupier of the premises; 2 operate the equipment or other facilities to copy the information 3 to the storage device, and remove the storage device from the 4 premises. 5 45 Power to secure 6 If an inspector, during a search of premises, believes on reasonable 7 grounds that there is at the premises a human embryo or a thing that may 8 afford evidence of the commission of an offence against this Act, the 9 monitoring powers include securing the embryo or thing pending the 10 obtaining of a warrant by anyone to seize it. 11 46 Inspector must produce identity card on request 12 An inspector is not entitled to exercise any powers under this part in 13 relation to premises if-- 14 (a) the occupier of the premises has required the inspector to 15 produce his or her identity card for inspection by the occupier; 16 and 17 (b) the inspector fails to comply with the requirement. 18 47 Consent 19 (1) Before obtaining the consent of a person for the purposes of 20 section 43(2)(a),7 the inspector must inform the person that he or she may 21 refuse consent. 22 (2) An entry of an inspector by virtue of the consent of a person is not 23 lawful unless the person voluntarily consented to the entry. 24 48 Compensation for damage 25 (1) The owner of equipment or other facilities is entitled to 26 compensation for damage to the equipment or other facilities if-- 27 7 Section 43 (Powers available to inspectors for monitoring compliance)

 


 

s 49 24 s 49 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 (a) the damage was caused to the equipment or other facilities as a 1 result of it being operated by an inspector as mentioned in this 2 part; and 3 (b) the damage was caused as a result of insufficient care being 4 exercised by the inspector operating the equipment or other 5 facilities. 6 (2) In determining the amount of compensation payable, regard is to be 7 had to whether the occupier of the premises and his or her employees and 8 agents, if they were available at the time, had provided any warning or 9 guidance as to the operation of the equipment or other facilities that was 10 appropriate in the circumstances. 11 PART 5--MISCELLANEOUS 12 Division 1--Review of Act 13 49 Review of operation of Act 14 (1) The Minister must cause a review of the operation of this Act to be 15 undertaken as soon as possible after the second anniversary of the date this 16 section commences. 17 (2) The review must cover the scope and operation of part 3 of this Act 18 taking into account the following-- 19 (a) developments in technology in relation to assisted reproductive 20 technology; 21 (b) developments in medical research and scientific research and the 22 potential therapeutic applications of such research; 23 (c) community standards; 24 (d) the applicability of establishing a National Stem Cell Bank. 25 (3) The review of this Act-- 26 (a) must be undertaken concurrently with the review of the 27 Prohibition of Human Cloning Act 2003 under section 49 of that 28 Act; and 29

 


 

s 50 25 s 52 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 (b) may be undertaken as part of the reviews of the Commonwealth 1 Act and the Prohibition of Human Cloning Act 2002 (Cwlth) 2 mentioned in the Commonwealth Act, section 47. 3 Division 2--Matters about offences 4 50 Attempts to commit offences against this Act 5 (1) A person who attempts to commit an offence against this Act 6 commits an offence. 7 Maximum penalty--the maximum penalty for committing the offence 8 attempted to be committed. 9 (2) The Criminal Code, section 4,8 applies to subsection (1). 10 51 Crimes and summary offences 11 (1) The following offences are crimes-- 12 (a) an offence mentioned in part 3, division 2;9 13 (b) an offence against section 50(1), if the offence attempted to be 14 committed is a crime. 15 (2) The offender can not be arrested without warrant. 16 (3) Any other offence against this Act is a summary offence. 17 52 Limitation on time for starting summary proceedings 18 A proceeding for a summary offence against this Act by way of 19 summary proceeding under the Justices Act 1886 must start-- 20 (a) within 1 year after the commission of the offence; or 21 (b) within 6 months after the offence comes to the complainant's 22 knowledge, but within 2 years after the commission of the 23 offence. 24 8 Criminal Code, section 4 (Attempts to commit offences) 9 Part 3 (Regulation of certain uses involving excess ART embryos), Division 2 (Offences)

 


 

s 53 26 s 55 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 Division 3--Regulations 1 53 Regulation-making power 2 The Governor in Council may make regulations under this Act. 3 PART 6--AMENDMENT OF THIS ACT 4 54 Act amended in pt 6 5 This part amends this Act. 6 55 Amendment of various sections 7 (1) Sections 29(3)(b) and 32(1)(c) and (3)-- 8 omit. 9 (2) Section 32(6), `, (2) and (3)'-- 10 omit, insert-- 11 `and (2)'. 12

 


 

27 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 SCHEDULE 1 DICTIONARY 2 section 5(1) 3 "accredited ART centre", for part 3, see section 21. 4 "Administrative Appeals Tribunal", for part 3, division 6, see section 39. 5 "Commonwealth Act" means the Research Involving Human Embryos 6 Act 2002 (Cwlth). 7 "Commonwealth authority" means the following-- 8 (a) a body corporate established for a public purpose by or under an 9 Act of the Commonwealth; 10 (b) a company in which a controlling interest is held by any 1 of the 11 following persons, or by 2 or more of the following persons 12 together-- 13 (i) the Commonwealth; 14 (ii) a body covered by paragraph (a); 15 (iii) a body covered by subparagraph (i) or (ii). 16 "confidential commercial information", for part 3, see section 21. 17 "corresponding State law" see the Commonwealth Act, section 7(1). 18 "decision", for part 3, division 6, see section 39. 19 "disclose", for part 3, see section 21. 20 "eligible person", for part 3, division 6, see section 39. 21 "excess ART embryo", for part 3, see section 21. 22 "HREC", for part 3, see section 21. 23 "human embryo" means a live embryo that has a human genome or an 24 altered human genome and that has been developing for less than 25 8 weeks since the appearance of 2 pro-nuclei or the initiation of its 26 development by other means. 27 "inspector" means a person appointed as an inspector under section 41(1). 28

 


 

28 Regulation of Research Involving Human Embryos and Assisted Reproductive Technology Bill 2003 SCHEDULE (continued) "licence" , for part 3, see section 21. 1 "NHMRC Licensing Committee" means the committee established by 2 the Commonwealth Act, section 13. 3 "proper consent , for part 3, see section 21. " 4 "reckless" see section 6. 5 "relevant State body , for part 3, see section 21. " 6 "responsible person , for part 3, see section 21. " 7 "spouse" , in relation to a person, includes a person who, although not 8 legally married to the person, is living with the person as the person's 9 spouse on a bona fide domestic basis. 10 "State" includes the Australian Capital Territory and the Northern 11 Territory. 12 "the NHMRC" means the National Health and Medical Research Council 13 established by the National Health and Medical Research Council Act 14 1992 (Cwlth). 15 "woman" means a female human. 16 State of Queensland 2003

 


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