Human Reproductive Technology Act 1991 (WA)

Western Australia Human Reproductive Technology Act 1991 Western Australia Human Reproductive Technology Act 1991 Contents Part 1 — Preliminary Division 1 — Introduction 1. Short title 3 2. Commencement 3 3. Terms used and application 3 3A. Term used: human embryo 12 4. Objects of this Act 13 5. Administration of this Act 14 Division 2 — Specific offences 5A. Application 17 6. Unlicensed practices 17 7. Offences relating to reproductive technology 18 Part 2 — The Council 8. Establishment of Council 20 9. Nominations, and recommendations, for membership 21 10. Committees 22 11. Delegation by Council 23 12. Relationship of Council to Minister 25 13. Powers, and relationship to Council, of CEO 26 14. Functions of Council 28 Part 3 — The Code of Practice Division 1 — Compilation of the Code 15. Concept of Code of Practice 32 16. Implementation of Code of Practice 34 17. Matters which shall be dealt with in Code 36 18. Matters which may be dealt with in Code 36 19. Principles to be embodied in Code 38 20. Principles applicable to projects of research 39 21. Code and directions, generally 40 Division 2 — Consents 22. Consents, generally 42 23. When procedures may be carried out 46 24. Storage 47 Division 3 — Rights of control, etc. 25. Rights in relation to gametes 49 26. Control, dealing and disposal in relation to an egg in process of fertilisation or an embryo 50 Part 4 — Licensing, etc. Division 1 — Licensing 27. Licences, and person responsible 53 28. Exemptions relating to artificial insemination 55 28A. Exemptions relating to storage of certain embryos 56 29. Applications, generally 56 30. Interim authorisations and transitional directions 59 Division 2 — Directions and conditions 31. Directions, generally 61 32. Terms, conditions and directions specifically applicable 62 33. Conditions applicable to all licences and exemptions 63 34. Contravention of condition or direction 66 35. Notice and coming into operation of directions and conditions 66 Division 3 — Suspension or cancellation, and disciplinary action 36. Suspension or cancellation of licence or exemption, other than on disciplinary grounds 67 36A. Referring to SAT a matter leading to section 36(2a) notice 68 37. Summary determinations 69 38. Disciplinary action 70 39. Matters that may be subject of disciplinary action 70 40. Penalties 72 41. Effect on pending procedures 75 Division 4 — State Administrative Tribunal powers 42. Reviews 76 43. Restraint of continuing contravention 77 Division 5 — Information 44. Records of procedures 78 45. Registers of identity 81 46. Access to information 82 47. Annual returns etc. 83 48. Exchange of information 84 49. Confidentiality 84 50. False or misleading statements and records 87 Division 6 — Supervision, etc. 51. Supervision 88 52. Licensee liable for act of employee etc. 90 53. Offences by bodies corporate and partnerships 91 Part 4A — Prohibited practices Division 1 — General 53A. Object of this Part 93 53B. Terms used 93 Division 2 — Human cloning 53C. Offence — creating human embryo clone 95 53D. Offence — placing human embryo clone in human body or body of an animal 95 53E. Offence — importing or exporting human embryo clone 95 53F. No defence that human embryo clone could not survive 96 Division 3 — Other prohibited practices 53G. Offence — creating human embryo other than by fertilisation, or developing such an embryo 96 53H. Offence — creating human embryo for purpose other than achieving pregnancy in woman 96 53I. Offence — creating or developing human embryo containing genetic material provided by more than 2 persons 97 53J. Offence — developing human embryo outside body of woman for more than 14 days 97 53K. Offence — using precursor cells from human embryo or human fetus to create human embryo, or developing such an embryo 97 53L. Offence — heritable alterations to genome 98 53M. Offence — collecting viable human embryo from body of woman 98 53N. Offence — creating chimeric or hybrid embryo 98 53O. Offence — placing of an embryo 99 53P. Offence — importing, exporting or placing prohibited embryo 99 53Q. Offence — commercial trading in human eggs, human sperm or human embryos 101 Division 4 — Review of Part 53R. Review of Part 102 Part 4B — Regulation of certain uses involving excess ART embryos Division 1 — General 53S. Object of this Part 103 53T. Terms used 104 Division 2 — Performance of functions 53U. Functions not affected by State laws 107 53V. Extent to which functions are conferred 107 Division 3 — Offences 53W. Offence — use of excess ART embryo 107 53X. Offence — breaching licence condition 109 Division 4 — Embryo Research Licensing Committee of the NHMRC 53Y. Functions of Committee 110 53Z. Powers of Committee 110 Division 5 — Licensing system 53ZA. Person may apply for licence 110 53ZB. Determination of application by Committee 111 53ZC. Notification of decision 112 53ZD. Period of licence 113 53ZE. Licence is subject to conditions 113 53ZF. Variation of licence 114 53ZG. Suspension or revocation of licence 115 53ZH. Surrender of licence 115 53ZI. Notification of variation, suspension, revocation or surrender of licence 115 Division 6 — Reporting and confidentiality 53ZJ. NHMRC Licensing Committee to make certain information publicly available 116 53ZK. Confidential commercial information may only be disclosed in certain circumstances 116 53ZKA. Annual reports 118 Division 7 — Review provisions 53ZL. Terms used 119 53ZM. Review of decisions 119 Division 8 — Monitoring powers 53ZN. Appointment of inspectors 120 53ZO. Identity card 121 53ZP. Powers available to inspectors for monitoring compliance 121 53ZQ. Monitoring powers 122 53ZR. Power to secure 123 53ZS. Inspector must produce identity card on request 124 53ZT. Consent 124 53ZU. Compensation for damage 124 Division 9 — Expiry 53ZV. Expiry of certain provisions 125 Division 10 — Conscientious objection to use of excess ART embryos 53ZVA. Conscientious objection to use of excess ART embryos 125 Division 11 — Review of Part 53ZW. Review of Part 125 Part 5 — Enforcement Division 1 — Powers of authorised officers 54. Powers of authorised officers 127 55. Entry, search and seizure, by warrant 130 Division 2 — Proceedings 56. Complaints for simple offence 131 57. Averments, and other evidentiary matters 131 Part 6 — Administration Division 1 — Staff 58. Use of staff and facilities of departments, agencies and instrumentalities, and engagement of consultants, etc. 135 59. Staff 136 60A. Public Health Officials 137 Division 2 — Subsidiary legislation 60. Regulations, and subsidiary legislation generally 137 Division 3 — General 61. Review of Act 139 Schedule — Provisions relating to the membership and proceedings of the Council and the annual report on reproductive technology 1. Chair of Council 140 2. Deputies etc. 140 3. Term of office 141 4. Remuneration and leave of members 142 5. Premature vacation of office 143 6. Personal or pecuniary interests 144 7. Meetings and proceedings 146 8. Unanimous resolution may be passed without meeting 147 9. Committees 147 10. Protection of members etc. 148 11. Annual report on reproductive technology 148 Notes Compilation table 150 Defined terms Western Australia Human Reproductive Technology Act 1991 An Act to establish the Western Australian Reproductive Technology Council; to require the compilation of a Code relating to the practice of, the procedures used in, and the ethics governing, human reproductive technology; to make provision with respect to the use of that technology in relation to artificially assisted human conception and for the regulation of certain research; and for related purposes. Preamble Whereas: A. In enacting this legislation Parliament is seeking to give help and encouragement to those eligible persons who wish to be parents. B. Parliament considers that the primary purpose and only justification for the creation of a human embryo in vitro is to assist persons who are unable to conceive children naturally due to medical reasons or whose children are otherwise likely to be affected by a genetic abnormality or a disease, to have children, and this legislation should respect the life created by this process. C. Although Parliament recognises that research has enabled the development of current procedures and that certain research procedures and other uses upon a human embryo may be licit, it does not approve the creation of a human embryo for a purpose other than the implantation in the body of a woman. [Preamble amended: No. 3 of 2002 s. 72; No. 17 of 2004 s. 4.] The Parliament of Western Australia enacts as follows: Part 1 — Preliminary Division 1 — Introduction 1. Short title This Act may be cited as the Human Reproductive Technology Act 1991 1. 2. Commencement The provisions of this Act shall come into operation on such day as is, or days as are respectively, fixed by proclamation and in any event this Act, or so much of it as has not been proclaimed, shall come into operation 18 months after the date upon which it receives the Royal Assent 1. 3. Terms used and application (1) In this Act, unless the contrary intention appears — artificial fertilisation procedure means any — (a) artificial insemination procedure; or (b) in vitro fertilisation procedure; artificial insemination procedure means a procedure where human sperm are introduced, by a non‑coital method, into the reproductive system of a woman but which is not, and is not an integral part of, an in vitro fertilisation procedure; authorised officer means — (a) the CEO; or (b) a person authorised by the CEO, generally or in relation to particular functions, circumstances, or purposes, as may be specified in the relevant certificate issued under section 59(2); (c) in relation to the powers referred to in section 44(3)(c) or 49(4)(b), includes a reference to the CEO as defined in section 3 of the Children and Community Services Act 2004 or an officer as defined in that section authorised in writing by that CEO; (d) in relation to the powers referred to in section 54, a person on whom the powers are conferred by the CEO under section 53ZQ(4); biological parent means a person who — (a) is the source of a human egg or human sperm used in an artificial fertilisation procedure; and (b) is the genetic parent of a human embryo developed, or of a child born, as a consequence of that procedure; CEO has the meaning given by section 3 of the Health Legislation Administration Act 1984; Chairperson means the member appointed to that office under clause 1(1) of the Schedule, and includes a reference to a person acting in that office; Code of Practice or Code means the Code of Practice compiled under section 14(1)(c), as from time to time amended and in force; committee means a committee of the Council; Commonwealth Human Embryo Act means the Research Involving Human Embryos Act 2002 of the Commonwealth; condition in relation to a licence or exemption, includes — (a) a limitation, restriction or prohibition; and (b) any other provision of that licence or exemption affecting its operation or the authorisation conferred, whether or not it purports to be expressed by way of a condition; Council means the Western Australian Reproductive Technology Council established by section 8; counselling services include — (a) the screening or assessment of potential participants; and (b) the provision of information; and (c) generally, assisting participants to address personal issues arising from infertility and its treatment; Deputy Chairperson means the member for the time being appointed or selected to that office under clause 1(3) of the Schedule, and includes a reference to a person acting in that office; directions means directions given under Division 2 of Part 4; director, in relation to a body corporate, includes — (a) a member of the board or committee of management of the body corporate; and (b) a person occupying or acting in a position to which paragraph (a) refers, by whatever name the position is called and whether or not validly appointed to occupy or duly authorised to act in the position; and (c) any person in accordance with whose directions or instructions directors of the body corporate are accustomed to act; effective consent is to be construed in accordance with section 22(8); excess ART embryo has the meaning given to that term in section 53T; Executive Officer means the person appointed as the Executive Officer of the Council under section 8(2)(b), and includes a reference to a deputy to that person appointed under clause 2(2) of the Schedule when acting in the place of that person; exemption means — (a) an exemption that is applied for and is not refused, or is specifically issued, under section 28; or (b) an exemption under section 28A; fertilisation, for the purposes of this Act, means the process that commences at the moment of inclusion of a sperm head within the plasma membrane of an egg, and is completed when an embryo is formed; guidelines means, except in section 14(3), the information set out in Part 2 of the Code; human egg means a live human egg; human embryo has the meaning given to that term in section 3A; human gamete means a human egg or a human sperm; human sperm means live human sperm or spermatids; in vitro fertilisation procedure means a procedure, not being a storage procedure, which — (a) is consequent upon the removal of a human egg from the body of a woman, and carried out for one or more of the following purposes — (i) the fertilisation of that egg, within or outside her body; or (ii) the keeping or use of that egg with intent to derive from it a human egg undergoing fertilisation or a human embryo; or (iii) the keeping or use of that human egg undergoing fertilisation or human embryo so derived; or (b) is directed at the introduction into the body of a woman of — (i) a human egg; (ii) a human egg undergoing fertilisation or a human embryo, whether or not fertilisation began outside the body into which it is introduced; or (c) is a procedure in relation to artificially assisted human conception which is prescribed for the purposes of this definition; Institutional Ethics Committee means a body which is recognised by the Council, as having — (a) in relation to ethical matters, the role of overseeing all the aspects of a reproductive technology practice, or of research, carried on by a licensee; and (b) functions, and a composition, complying with requirements of the NHMRC relating to ethical oversight of research involving humans; licence means a licence granted under Part 4; licence supervisor, in relation to a licence or exemption, means the individual under whose supervision the storage or practice authorised is, or is to be, carried on; licensee means a person holding a licence under Part 4 and also includes a reference to — (aa) a person who holds an exemption under section 28A; and (a) a person who is authorised under section 30 to carry on the practice of a licensee; and (b) the licence supervisor, in relation to any licence or exemption; and (c) a person authorised or permitted, in accordance with section 51, to carry on, supervise or manage a reproductive technology practice or specified activities; and (d) a registered medical practitioner to whom an exemption under section 28 applies; and (e) in relation to the duties of keeping, and maintaining the confidentiality of, any record to which this Act relates, a person who as a licensee has, or at any earlier time had, such a duty under this Act in respect of that record; medical practitioner means a person registered under the Health Practitioner Regulation National Law (Western Australia) in the medical profession; member means member of the Council, and includes a reference to a deputy or other person acting in the place of a member; NHMRC means the National Health and Medical Research Council established by the National Health and Medical Research Council Act 1992 of the Commonwealth; NHMRC licence means a licence granted under — (a) section 53ZB; or (b) section 21 of the Commonwealth Human Embryo Act; nominated member means a member of the Council, other than the Executive Officer; participant, in relation to any artificial fertilisation procedure, means — (a) a person who — (i) undergoes that procedure; or (ii) is the donor, or being a woman is the recipient, of human gametes, of a human egg undergoing fertilisation or of a human embryo used in that procedure; or (b) a person from whom, by reason of this Act, a consent to the carrying out of that procedure is required; person to whom the licence applies is to be construed in accordance with subsection (5); premises includes any land, any vehicle, vessel or aircraft, and any part of premises; procedure means any treatment, course of treatment or cycle of treatment involving reproductive technology, but may also include any part of such treatment or any other service or process which is defined in and described by the Code as constituting for the purposes of this Act a procedure of a specified kind; proprietary company means a proprietary company within the meaning of the Corporations Act 2001 of the Commonwealth; Public Health Official means a person designated by the CEO under section 60A(1); record means — (a) any book, account, document, financial records (within the meaning of the Corporations Act 2001 of the Commonwealth), paper, return, register or other source of information compiled, recorded or stored in written or encoded form or on microfilm, or by electronic or other means or process; and (b) the contents, in a printout or other intelligible format, of records that are kept, by computer or otherwise, in a format that is not readily intelligible; and (c) any other sources of information prescribed for the purposes of this definition; related body corporate, in relation to a specified body corporate, means a body corporate that is, within the meaning of the Corporations Act 2001 of the Commonwealth, related to the specified body corporate; reproductive technology means that branch of medical science which is concerned with — (a) artificial fertilisation procedures; or (b) the keeping or use of human gametes intended for use in an artificial fertilisation procedure, human eggs undergoing fertilisation or human embryos; or (c) other procedures or matters incidental thereto; research means systematic investigations carried out for the primary purpose of adding to general knowledge but includes the carrying out of an experiment, and project of research shall be construed accordingly; Rules means the rules contained in Part 1 of the Code; storage procedure shall be construed in accordance with subsection (4); subsidiary legislation includes the Rules and any direction having legislative effect; summary conviction penalty, in relation to a crime, has the same meaning as that term has in section 5 of The Criminal Code; this Act includes a reference to — (a) the regulations; and (b) the Rules and the guidelines; and (c) such directions as are published in the Gazette; treatment includes medical, surgical and obstetric services; woman means any female human. (2) This Act, other than Part 4A or 4B so far as it relates to the keeping or use of, or any offence relating to, a human egg undergoing fertilisation or a human embryo applies — (a) only to such keeping or use as takes place outside the body of a woman; and (b) only if the egg or the embryo has been or is developed in consequence of an in vitro fertilisation procedure. (3) In this Act, a reference — [(a) deleted] (b) to a human egg, except where the context otherwise indicates, does not include a reference to a human egg undergoing fertilisation; and (c) to a reproductive technology practice or practice includes all activities authorised under a licence issued or exemption granted under this Act, including storage, unless the context otherwise requires; and (d) to the keeping of human sperm, does not include keeping for purposes other than for use in an artificial fertilisation procedure. (4) In relation to human gametes, a human egg undergoing fertilisation or a human embryo a reference in this Act — (a) to keeping, includes storing, whether by cryo‑preservation or in any other way, in such a state as temporarily arrests or suspends metabolic function; and (b) to any human gametes which are or a human egg or embryo which is, stored, means kept in such a state, and store and storage shall be construed accordingly. (5) References in this Act to a "person to whom the licence applies" are to — (a) the licensee; and (b) the licence supervisor; and (c) any person designated in a notice given to the CEO by the licensee or the licence supervisor, as a person to whom the licence applies; and (d) any person acting under the direction of the licensee, the licence supervisor or of the person so designated. (6) In this Act a reference to what is "proper" or "suitable" shall be construed having regard to any relevant provision of the Code. (7) A requirement in this Act to provide or produce a record includes, where the record is not written or not written in the English language, a requirement that any person having the power to do so provide or produce a statement written in the English language supported by details of any encoding involved, setting forth such of the particulars in the record as are not written or are not written in the English language in such a manner as to allow for verification. (8) Where directions are published in the Gazette those directions are to be taken to be subsidiary legislation to which the Interpretation Act 1984 applies, but not to be regulations within the meaning or for the purposes of section 42 of that Act. (9) For the purposes of this Act, a person occupies a position of authority in a body if that person — (a) where the body is a body corporate, is a director; or (b) exercises or exerts, or is in a position to exercise or exert, control or substantial influence over the body in the conduct of its affairs; or (c) manages, or is deemed to manage, the business of the practice to be carried on under a licence, or, where a body corporate is a proprietary company, if that person is a shareholder in that proprietary company. (9a) Nothing in this Act, or in a licence, authorisation or approval under this Act, authorises or permits the use of a human embryo for technical or commercial purposes in the testing, creation or manufacture of cosmetic products such as lipstick, mascara, face moisturising creams and other like beauty products. (10) This Act binds the Crown. [Section 3 amended: No. 57 of 1997 s. 75; No. 10 of 2001 s. 108; No. 17 of 2004 s. 5; No. 18 of 2004 s. 4; No. 34 of 2004 Sch. 2 cl. 14; No. 55 of 2004 s. 522 and 540; No. 28 of 2006 s. 266 and 270(1); No. 22 of 2008 Sch. 3 cl. 28; No. 35 of 2010 s. 95; No. 19 of 2016 s. 157.] 3A. Term used: human embryo (1) In this Act — human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means. (2) 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. [Section 3A inserted: No. 17 of 2004 s. 6.] 4. Objects of this Act (1) Generally, the objects of this Act are — (a) to regulate, and to provide guidance in, the use of reproductive technology by — (i) the establishment of the Council, with the functions referred to in section 14; and (ii) the compilation and implementation of a Code of Practice; and (iii) the imposition of licensing requirements; and (iv) the enforcement of this Act; and (b) to ensure adherence to standards in the practice of reproductive technology that are proper and suitable; and (c) to allow beneficial developments in reproductive technology, but to discourage, and if required to prohibit, developments or procedures that are not both proper and suitable; and (d) to ensure — (i) that artificial fertilisation procedures may only be carried out for the benefit of persons who, in accordance with this Act, are eligible to be so treated; and (ii) that the participants are adequately assessed medically as to the need for any procedure, and counselled and informed as to its implications; and (iii) that the welfare of participants is properly promoted; and (iv) that the prospective welfare of any child to be born consequent upon a procedure to which this Act relates is properly taken into consideration; and (e) to require that equity, welfare and general standards prevailing in the community are taken into account in the practice of reproductive technology; and (f) to provide a forum whereby — (i) debate by the community on reproductive technology issues may be conducted; and (ii) proper standards to evaluate and monitor reproductive technology can be determined, established and maintained; and (iii) policy decisions may be made about reproductive technology, on an informed basis. (1a) The particular objects of Part 4A are set out in section 53A. (2) The particular objects of Part 4B are set out in section 53S. [Section 4 amended: No. 17 of 2004 s. 7; No. 18 of 2004 s. 5.] 5. Administration of this Act (1) Subject to the Minister, the administration of this Act is vested in the CEO who — (a) shall be responsible for the implementation of the licensing system set out in Part 4; and (b) may give directions to licensees. (2) The Western Australian Reproductive Technology Council established under section 8 shall — (a) compile the Code of Practice; and (b) advise the Minister, generally; and (c) advise the CEO on licensing and disciplinary matters, but shall give effect to instructions given by the Minister under section 12(3) and, if the CEO is empowered under section 13 to discharge functions of the Council, shall assist the CEO in so doing. (3) The Code of Practice shall be compiled and implemented in accordance with Part 3. (4) Regulations made under this Act shall have effect notwithstanding any inconsistency with the Code of Practice, but the Minister shall not recommend the making of regulations in relation to any matter in respect of which a Rule is, or could be, made under the Code unless, in the opinion of the Minister — (a) the making of the regulation is necessary to ensure the coming into operation of a provision which is required to have effect sooner than the procedure set out in section 16 would permit; or (b) the regulation is required for the purposes of section 13(2). (5) Directions given by the CEO shall have effect, except to the extent of any inconsistency with the regulations or the Code, in accordance with section 31. (6) A report on the use of human reproductive technology in the State during the preceding financial year shall be furnished annually by the Council to the CEO who shall thereafter submit the annual report required by clause 11 of the Schedule to the Minister who shall, within 14 sitting days after the submission of that report, cause copies of it to be laid before each House of Parliament. (7) For parliamentary purposes, and for the conduct of the public business of the Minister, the Minister is entitled — (a) to be furnished by the CEO and the Council with — (i) any report concerning the activities or proceedings of the CEO, the Council or the committees of the Council; and (ii) all information in their respective possession, as the Minister may from time to time require; and (b) to have, and to retain copies of, any record required to be kept, or kept, under this Act, or under any order or resolution of either House of Parliament in relation to this Act, but the Minister shall ensure that the confidentiality of any record or other information to which this Act applies is not thereby prejudiced. (8) For the purposes of subsection (7), the Minister may — (a) request the CEO or the Council to furnish, or to give the Minister access to, information, and to supply records; and (b) make use of the services of any staff of the CEO or of the Council, or of any other person engaged in the administration or enforcement of this Act, for the purposes of obtaining access to information or copies of records, and the Executive Officer is authorised to ensure compliance with any requirement of the Minister made under this section. (9) In this section — information means — (a) any record relating to the functions of the CEO or the Council; (b) any other document or information which relates to the CEO or the Council or to reproductive technology which is in the custody or control of the CEO or of the Council and is specified, or of a description specified, by the Minister; parliamentary purposes means the purpose of — (a) answering a question asked in a House of Parliament; or (b) complying with a written law, or an order or resolution of a House of Parliament, that requires information to be furnished to a House of Parliament; record includes any data that is compiled, recorded, encoded or stored, and any film, tape, disc or other device or medium on which it can or may be found. [Section 5 amended: No. 28 of 2006 s. 270.] Division 2 — Specific offences 5A. Application This Division does not apply in relation to an excess ART embryo except in relation to a use of such an embryo that is an exempt use as defined in section 53W(2). [Section 5A inserted: No. 17 of 2004 s. 8.] 6. Unlicensed practices (1) No person shall cause or permit — (a) any procedure to be carried out related to the storage of — (i) a human egg intended for use in an in vitro fertilisation procedure; or (ii) a human egg undergoing fertilisation; or (iii) a human embryo; or (b) human sperm, having been obtained from different men, to be kept; or (c) an artificial fertilisation procedure, other than an artificial insemination to which section 28(3) applies, to be carried out; or (d) any other use, outside the body of a woman, of a human embryo, if the use is not for a purpose relating to the reproductive technology treatment of the woman, except pursuant to a licence or exemption by which it is authorised under this Act. (2) A person who contravenes subsection (1) commits a crime and is liable to imprisonment for 5 years. Summary conviction penalty: Imprisonment for one year. [(3) deleted] (4) If an offence referred to in subsection (1) is shown to have been committed after the service upon the alleged offender of a notice in the prescribed form signed by the CEO drawing attention to a continuing state of affairs alleged in that notice to contravene subsection (1), the offender is liable to a penalty of $10 000, in addition to the penalty specified in subsection (2) or (3), in respect of each day on which that offence is continued after the service of that notice. (5) It shall not be a defence to proceedings for an offence against this section to allege that the accused believed that what was done was — (a) authorised by a licence or exemption under this Act; or (b) done at the request of, or with the consent of, a participant. [Section 6 amended: No. 17 of 2004 s. 9; No. 84 of 2004 s. 82; No. 28 of 2006 s. 270(1).] 7. Offences relating to reproductive technology (1) A person, whether or not a licensee, must not cause or permit — (a) research to be conducted upon or with a human egg undergoing fertilisation, or any embryo, not being research in respect of which the Council has already granted relevant approval or all requisite specific prior approvals have been sought and obtained under section 20; or (b) a diagnostic procedure to be carried out upon or with a human egg undergoing fertilisation, or any embryo, not being a procedure which is — (i) authorised by the Code; or (ii) specifically approved by the Council. (2) A person who contravenes subsection (1) commits a crime and is liable to imprisonment for 5 years. Summary conviction penalty: Imprisonment for one year. [(3), (4) deleted] (5) A person who — (a) being a licensee, keeps or uses human gametes, a human egg undergoing fertilisation or a human embryo in contravention of this Act; or (b) being a person to whom a licence applies or applied, fails to comply with a direction given for the purpose of section 30(4)(a), commits an offence. Penalty: 2 years imprisonment. [Section 7 amended: No. 17 of 2004 s. 10.] Part 2 — The Council 8. Establishment of Council (1) As soon as is practicable after the coming into operation of this Part, there shall be established a body of persons, to be known as the Western Australian Reproductive Technology Council, which shall have the functions conferred under th