Version No. 010 Infertility Treatment Act 1995 Act No. 63/1995 Version incorporating amendments as at 1 January 1998 TABLE OF PROVISIONS Section Page PART 1—PRELIMINARY 1. 2. 3. 4. 5. 1 Purposes Commencement Definitions Interpretation Guiding principles 1 2 2 8 9 PART 2—TREATMENT PROCEDURES 11 Division 1—General 11 6. 7. Fertilisation procedures Donor insemination 11 11 Division 2—General requirements for treatment procedures 8. 9. 10. 11. Persons who may undergo treatment procedures Requirements as to consent Information Counselling Division 3—Requirements for donors 12. 13. 14. 15. 16. 17. 18. 19. Donation of gametes, zygotes or embryos Consent of spouse of donor Requirements as to consent Objection by later spouse Counselling requirements Requirements as to the giving and receiving of information Identified donors Requirements as to consent to use of gamete etc. from identified donor Division 4—Requirements for donor treatment procedures i 12 12 13 13 14 14 14 16 18 19 20 20 21 22 23 Section 20. 21. Page Circumstances in which donor procedure may be used Information and advice 23 25 PART 3—RESEARCH 26 Division 1—Offences 26 22. 23. 24. 25. 26. Research Places for research Ban on destructive research on embryos Authority must not approve destructive research on embryos Authority must not approve certain research on zygotes 26 27 27 28 29 Division 2—Preliminary requirements for research involving zygotes, embryos or the formation of zygotes 29 27. 28. 29. 30. 31. 32. Consent to research involving zygotes or embryos or the formation of zygotes Consent of spouse of donor Requirements as to consent Objection by later spouse Counselling requirements Information requirements Division 3—Requirements for research involving parthenogenesis 33. Power of Authority to impose requirements Division 4—Preliminary requirements for other research involving gametes 34. 35. Consent to research using gametes Requirements as to consent PART 4—PROCEDURES RELATING TO CONSENTS 36. 37. 38. Approved form to be used Withdrawal of consent Lapsing of consent 29 30 31 31 32 33 33 33 34 34 34 36 36 36 36 PART 5—OFFENCES 38 Division 1—Prohibited procedures 38 39. 40. 41. 42. 43. 44. Alteration of constitution of a gamete, zygote or embryo Transfer of gametes, zygotes or embryos used for research Ban on procedures involving gametes produced by children Ban on procedures involving oocytes derived from a foetus Ban on procedures involving gametes of people known to be dead Ban on use of zygotes or embryos removed from the body ii 38 38 39 39 39 40 Section 45. 46. 47. 48. 49. 50. Page Ban on mixing human and animal gametes etc. Ban on mixing gametes, zygotes or embryos from more than one person Ban on cloning Ban on certain experimental procedures Formation of embryos and zygotes Ban on sex selection Division 2—Storage 51. 52. 53. 54. 55. Storing gametes Storing zygotes or embryos Removal of zygotes or embryos from storage Places of storage Ban on use of gametes, zygotes or embryos not stored at licensed centre 44 44 46 47 47 48 Import or export of gametes, zygotes and embryos No compensation for gamete donation False or misleading information PART 6—SURROGATE MOTHERHOOD 59. 60. 61. 41 42 42 42 43 44 Division 3—General offences 56. 57. 58. 40 Surrogacy Surrogacy—advertising Surrogacy agreements void 48 49 50 51 51 51 52 PART 7—RECORDS AND ACCESS TO INFORMATION 53 Division 1—Records 53 62. 63. 64. 65. 66. 67. 68. 69. 70. Register to be kept for licensed centre Register to be kept by doctor carrying out donor insemination Information to be given to the Authority by licensed centres Information to be given to the Authority by doctors not at licensed centres Information to be given under section 64 and 65 Information to be given to the Authority about births by other persons Authority to keep a central register Authority to correct central register Inspection of Registers Division 2—Information to be given by licensed centres and doctors iii 53 55 57 58 58 59 61 61 61 62 Section 71. 72. 73. Page Information recorded by licensed centre or doctor which is to be given to persons undergoing donor treatment procedures 62 Information recorded by licensed centre or doctor which is to be given to donors 64 Information about pregnancy, birth or transfer 66 Division 3—Information to be given from central register 74. 75. 76. 77. 78. 79. 80. 81. 82. Application by parents for information contained on central register Authority to give information about donor to parents Application by donor for information about persons born as a result of donor treatment procedures and parents of such persons Authority to give information about person born as a result of a donor treatment procedure Authority to give information about parents Application by person born as a result of a donor treatment procedure or descendant for information about donor Authority to give information about donor to person born as the result of a procedure Counselling not applicable in certain circumstances Donor treatment procedure information register Division 4—General provisions 83. 84. 85. 86. 87. 88. 89. 90. 91. 92. 67 67 68 69 70 71 73 73 74 75 76 Information Waiver of fees Disclosure of information to a medical practitioner Records of information given Consent Authority may refuse to give information Confidentiality—information which may identify Confidentiality—non-identifying information Closure of court or tribunal Exemption from Freedom of Information Act 1982 76 76 76 77 77 77 78 82 84 84 PART 8—LICENCES, APPROVALS AND DESIGNATED OFFICERS 86 Division 1—Licensing of places 86 93. 94. 95. 96. 97. Licence application—hospitals and day procedure centres Licence application—research institutions Designation of principal doctor or principal scientist Licence applications—general procedure Authority may grant or refuse licence Division 2—Approval to carry out research 98. Application for approval to carry out research iv 86 86 87 88 88 89 89 Section Page 99. Approval by Authority to carry out research 100. Report of results of research to Authority Division 3—Approval of persons carrying out treatment procedures or research 101. Application for approval of doctor or scientist 102. Authority may grant or refuse approval Division 4—Approved counsellors Division 5—General provisions about licences, approvals and exemptions 111. 112. 113. 114. 115. 116. 117. 118. 91 91 92 93 103. Application for approval of counsellors 104. Authority may grant or refuse approval 105. 106. 107. 108. 109. 110. 90 91 Form and content of licence or approval Power of Authority to impose conditions Provision of information Variation of conditions of licences or approvals under this Part Variation of approvals and exemptions under Part 5 Offence of failing to comply with terms etc. of licence or approval Duration and renewal of licence or approval Application for renewal Suspension of licence, approval or exemption Immediate suspension Cancellation of licence, approval or exemption Orders Notification about approvals and licences Notification to Minister Division 6—Designated officers 93 93 93 94 94 95 95 96 96 97 97 98 99 99 101 105 105 106 119. Designated officers for licensed centres 120. If no designated officer appointed 106 106 PART 9—INFERTILITY TREATMENT AUTHORITY 108 Division 1—Constitution of the Authority 108 121. 122. 123. 124. 125. 126. 127. 128. 129. Establishment of Authority Powers, functions, duties and consultation requirements Membership Terms of office Resignation and removal Chairperson and Deputy Chairperson Acting member Payment of members Procedure of Authority v 108 108 110 111 111 111 112 112 113 Section 130. 131. 132. 133. 134. 135. Page Effect of vacancy or defect Member's interests Immunity Engagement or employment of persons Delegation Committees Division 2—Supplementary Powers 113 114 114 115 115 116 116 136. Powers of Authority in relation to fees 116 Division 3—Reporting and financial provisions 117 137. Report to Minister 138. Infertility Treatment Authority Fund 139. Investment powers 117 118 119 PART 10—Repealed 120 140–148. Repealed 120 PART 11—REVIEW OF DECISIONS 149. Review of decisions 120 120 PART 12—GENERAL 122 150. Decisions by Authority not reviewable 151. No action if gametes used without knowing consent withdrawn or lapsed 152. Conscientious objections 153. Record of consent or objection and withdrawal of consent or objection 154. Transfer of documents 155. Authorised officers 156. Powers and duties of members of Authority and authorised officers 157. Offence to obstruct or hinder 158. Additional liability for offences 159. Application of Public Records Act 1973 160. Prohibition on destruction of documents 161. Evidence 162. Search warrants 125 126 126 127 127 127 128 163. Indictable offences 164. Supreme Court—limitation of jurisdiction 130 130 PART 13—REGULATIONS 122 122 122 123 124 125 132 165. Regulations 132 vi Section Page PART 14—REPEALS, AMENDMENTS AND TRANSITIONAL PROVISIONS 137 Division 1—Repeals and amendments 137 166. 167. 168. 169. Repeals Amendment of Health Act 1958 Amendment of Human Tissue Act 1982 Amendment of Magistrates' Court Act 1989 62. Infertility Treatment Act 170. Amendment of Status of Children Act 1974 Division 2—Transitional provisions 171. 172. 173. 174. 175. 176. 177. 178. 179. 180. 181. 182. 183. 184. 185. 186. 187. 188. 189. 190. 191. 192. 193. 194. 195. 196. 197. 198. 199. Definitions General transitional provision Regulations Donations Consents Eligibility for fertilisation procedures Eligibility to undergo donor insemination Eligibility—research procedures Partial compliance Identified donors under section 16 of the repealed Act Recording and disclosing information—general Registers and records Recording and giving information Access to information Gametes, zygotes and embryos in storage Application of time limits for storage of zygotes and embryos Removal from storage Use of stored gametes, zygotes and embryos Approval of research procedures Approval of counsellors Approval of premises Review of Ministerial decisions Ministerial directions Abolition of former Committee Repealed Exemptions Existing immunity not affected Superseded references Further savings and transitional provisions ═══════════════ 137 137 137 138 138 138 142 142 145 145 145 146 148 148 149 150 152 153 159 160 161 164 164 165 165 165 166 166 169 169 170 171 170 171 172 173 NOTES 175 1. General Information 175 vii Section Page 2. Table of Amendments 176 3. Explanatory Details 177 viii Version No. 010 Infertility Treatment Act 1995 Act No. 63/1995 Version incorporating amendments as at 1 January 1998 The Parliament of Victoria enacts as follows: PART 1—PRELIMINARY 1. Purposes The main purposes of this Act are— (a) to regulate the use of in-vitro and other fertilisation procedures and donor insemination procedures; (b) to regulate access to information about treatment procedures carried out under this Act and the Infertility (Medical Procedures) Act 1984; (c) to regulate research using human gametes, zygotes and embryos; (d) to promote research into the incidence and causes of infertility; (e) to make provisions with respect to surrogacy agreements; S. 1(f) amended by No. 37/1997 s. 5(1)(a). (f) to establish the Infertility Treatment Authority; (g) to repeal the Infertility (Medical Procedures) Act 1984 and amend various other Acts. 3-30/12/97 1 Infertility Treatment Act 1995 Act No. 63/1995 s. 2 2. Commencement (1) This Part (except section 5) comes into operation on the day on which this Act receives the Royal Assent. (2) Section 170 is deemed to have come into operation on 1 July 1988. (3) The remaining provisions of this Act come into operation on a day or days to be proclaimed. (4) If a provision referred to in sub-section (3) does not come into operation before 1 January 1998, it comes into operation on that day. S. 3 amended by No. 37/1997 s. 6(1). 3. Definitions (1) In this Act— "approval" means an approval granted or renewed by the Authority under section 40, 51, 52 or 56 or Part 8; "approved research" means research for which approval has been given by the Authority under Division 2 of Part 8; "artificial insemination" means a procedure of transferring sperm without also transferring an oocyte into the vagina, cervical canal or uterus of a woman; "authorised officer" means an authorised officer under Part 12; "Authority" means the Infertility Treatment Authority established under Part 9; "central register" means the register kept by the Authority under section 68; "clone" means to form, outside the human body, a human embryo that is genetically identical to another human embryo or person; 3-30/12/97 S. 2(4) substituted by No. 37/1997 s. 4. 2 Infertility Treatment Act 1995 Act No. 63/1995 s. 3 * S. 3(1) def. of "Committee" repealed by No. 37/1997 s. 5(1)(b). * * * * "day procedure centre" has the same meaning as in the Health Services Act 1988; S. 3(1) def. of "de facto relationship" inserted by No. 37/1997 s. 6(2). "de facto relationship" means the relationship of a man and a woman who are living together as husband and wife on a genuine domestic basis, although not married; "denominational hospital" has the same meaning as in the Health Services Act 1988; "designated officer" in relation to a licensed centre means a person appointed, employed or engaged for that centre under Division 6 of Part 8; "doctor" means a registered medical practitioner under the Medical Practice Act 1994; "donor" means a person who has given a consent under section 12, 27 or 34 or who consents to his or her gametes being used in research under section 22(2); "donor embryo" means an embryo in respect of which consent has been given under section 12 or 27; "donor gametes" means donor sperm or a donor oocyte; "donor insemination" means artificial insemination with donor sperm; "donor oocyte" means an oocyte in respect of which consent has been given under section 12, 27 or 34; 3-30/12/97 3 Infertility Treatment Act 1995 Act No. 63/1995 "donor sperm" means sperm in respect of which consent has been given under section 12, 27 or 34; "donor treatment procedure" means a treatment procedure where donor gametes or a donor zygote or a donor embryo is used; "donor zygote" means a zygote in respect of which consent has been given under section 12 or 27; "embryo" means any stage of human embryonic development at and from syngamy; "exemption" means an exemption under section 56; "fertilisation procedure" means— (a) the medical procedure of transferring to the body of a woman a zygote formed outside the body of any woman; or (b) the medical procedure of transferring to the body of a woman an embryo formed outside the body of any woman; or (c) the medical procedure of transferring— (i) an oocyte, without also transferring sperm, to the body of a woman; or (ii) sperm (other than by artificial insemination) to the body of a woman; or (iii) an oocyte and sperm to the body of a woman; "gamete" means an oocyte or sperm; 3-30/12/97 4 s. 3 Infertility Treatment Act 1995 Act No. 63/1995 s. 3 "husband", in relation to a woman who is living with a man in a de facto relationship, means the man with whom she is living in that de facto relationship; S. 3(1) def. of "husband" inserted by No. 37/1997 s. 6(2). "licensed centre" means a place in respect of which a licence under Part 8 is in force; "licensee" in relation to a licensed centre, means the person who is the holder of the licence; "oocyte" means an ovum from a woman but does not include a parthenogenetic oocyte; "parthenogenesis" means cell division in an oocyte which only involves the chromosomes of an oocyte; "parthenogenetic oocyte" means an oocyte in which parthenogenesis has occurred or is occurring; "private hospital" has the same meaning as in the Health Services Act 1988; "proprietor" in relation to a private hospital or day procedure centre, has the same meaning as in the Health Services Act 1988; "public hospital" has the same meaning as in the Health Services Act 1988; "research" includes— (a) an experimental procedure or clinical trial; and (b) the activities referred to in section 22(2)(a) and (b); "Secretary" means— (a) in relation to any act to which section 6(3) of the Health Act 1958 applies, the body corporate established by section 6 of that Act; or 3-30/12/97 5 Infertility Treatment Act 1995 Act No. 63/1995 s. 3 (b) in any other case, the Department Head (within the meaning of the Public Sector Management Act 1992) of the Department of Health and Community Services; "sperm" means sperm from a man; "spouse"— (a) in relation to a man who is living with a woman in a de facto relationship, means the woman with whom he is living in that de facto relationship; (b) in relation to a woman who is living with a man in a de facto relationship, means the man with whom she is living in that de facto relationship; "store" means— (a) to freeze an oocyte, zygote, embryo, or sperm; or (b) to otherwise preserve an oocyte, zygote, embryo, or sperm by a prescribed method; "surrogacy agreement" means an agreement, arrangement or understanding, whether formal or informal, under which— (a) a woman agrees (whether or not for payment or reward) with another person to become or try to become pregnant, with the intention— (i) that a child born as a result of the pregnancy is to be treated as the child, not of her, but of another person or persons (whether by adoption, agreement or otherwise); or 3-30/12/97 6 S. 3(1) def. of "spouse" inserted by No. 37/1997 s. 6(2). Infertility Treatment Act 1995 Act No. 63/1995 s. 3 (ii) of transferring custody or guardianship in a child born as a result of the pregnancy to another person or persons; or (iii) that the right to care for a child born as result of the pregnancy be permanently surrendered to another person or persons; (b) a pregnant woman agrees (whether or not for payment or reward) with another person— (i) that a child born as a result of the pregnancy is to be treated as a child, not of her, but of another person or persons (whether by adoption, agreement or otherwise); or (ii) to transfer custody or guardianship in a child born as a result of the pregnancy to another person or persons; or (iii) that the right to care for a child born as a result of the pregnancy be permanently surrendered to another person or persons; "syngamy" means that stage of development of a fertilised oocyte where the chromosomes derived from the male and female pronuclei align on the mitotic spindle; "treatment procedure" means— 3-30/12/97 7 Infertility Treatment Act 1995 Act No. 63/1995 s. 4 (a) artificial insemination of a woman with sperm from a man who is not the husband of the woman; or (b) a fertilisation procedure; "university" means a body listed in Schedule 1 to the Tertiary Education Act 1993; "wife", in relation to a man who is living with a woman in a de facto relationship, means the woman with whom he is living in that de facto relationship; S. 3(1) def. of "wife" inserted by No. 37/1997 s. 6(2). "zygote" means the stages of human development from the commencement of penetration of an oocyte by sperm up to but not including syngamy. (2) If a man or woman living in a de facto relationship is also married, a reference in this Act to a husband, wife or spouse of such a man or woman (as the case requires) does not include a reference to the husband or wife to whom the man or woman is married. 4. Interpretation (1) In this Act, unless the contrary intention appears, a reference to— (a) a kind of procedure; or (b) a kind of fertilisation procedure; or (c) a kind of treatment procedure; or (d) a procedure, fertilisation procedure or treatment procedure of a particular kind— includes— (e) the nature or type of procedure or transfer; and 3-30/12/97 8 S. 3(2) inserted by No. 37/1997 s. 6(3). Infertility Treatment Act 1995 Act No. 63/1995 s. 5 (f) whether the procedure involves the use of a donor oocyte or donor sperm, or a zygote or embryo formed from sperm or an oocyte of a donor (or both); and (g) in relation to a consent, objection or withdrawal of consent or objection of a donor or his or her spouse, whether— (i) a gamete, zygote or embryo may be used in a treatment procedure to be carried out on a woman who is not the donor or the spouse of the donor; and (ii) a gamete, zygote or embryo may be used in such a procedure to be carried out on any woman, or only on a named woman. S. 4(2) amended by No. 37/1997 s. 19(a). (2) In sections 62, 63, 66 and 82 and in any prescribed provision, unless the contrary intention appears, a reference to the husband of a woman who has undergone a treatment procedure, fertilisation procedure, donor treatment procedure, artificial insemination or donor insemination includes a reference to a man who was the woman's husband when the procedure was carried out. 5. Guiding principles (1) It is Parliament's intention that the following principles be given effect in administering this Act, carrying out functions under this Act, and in the carrying out of activities regulated by this Act— (a) the welfare and interests of any person born or to be born as a result of a treatment procedure are paramount; (b) human life should be preserved and protected; 3-30/12/97 9 Infertility Treatment Act 1995 Act No. 63/1995 (c) the interests of the family should be considered; (d) infertile couples should be assisted in fulfilling their desire to have children. (2) These principles are listed in descending order of importance and must be applied in that order. _______________ 3-30/12/97 10 s. 5 Infertility Treatment Act 1995 Act No. 63/1995 s. 6 PART 2—TREATMENT PROCEDURES Division 1—General 6. Fertilisation procedures A person may only carry out a fertilisation procedure if— (a) he or she is a doctor who is approved under Part 8 to carry out a fertilisation procedure of the kind carried out; and (b) he or she is satisfied that the requirements of Divisions 2, 3 and 4 and section 36 have been met; and (c) the procedure is carried out at a place licensed under Part 8 for the carrying out of that kind of fertilisation procedure. Penalty: 480 penalty units or 4 years imprisonment or both. 7. Donor insemination (1) A person may only carry out artificial insemination of a woman using sperm from a man who is not the husband of the woman at a place other than a hospital or centre licensed under Part 8 for the carrying out of donor insemination if he or she— (a) is a doctor who is approved under Part 8 to carry out donor insemination; and (b) is satisfied that the requirements of Divisions 2, 3 and 4 and section 36 have been met. Penalty: 480 penalty units or 4 years imprisonment or both. (2) A person may only carry out artificial insemination of a woman using sperm from a man 3-30/12/97 11 Infertility Treatment Act 1995 Act No. 63/1995 s. 8 who is not the husband of the woman at a place that is a hospital or centre licensed under Part 8 for the carrying out of donor insemination— (a) if— (i) he or she is a doctor who is approved under Part 8 to carry out donor insemination; or (ii) the woman on whom the insemination is to be carried out is in the charge of a doctor who is approved under Part 8 to carry out donor insemination; and (b) in either case, that doctor is satisfied that the requirements of Divisions 2, 3 and 4 and section 36 have been met. Penalty: 480 penalty units or 4 years imprisonment or both. Division 2—General requirements for treatment procedures 8. Persons who may undergo treatment procedures (1) A woman who undergoes a treatment procedure must— (a) be married and living with her husband on a genuine domestic basis; or (b) be living with a man in a de facto relationship. (2) Before a woman undergoes a treatment procedure she and her husband must consent to the carrying out of the kind of procedure to be carried out. (3) Before a woman undergoes a treatment procedure— (a) a doctor must be satisfied, on reasonable grounds, from an examination or from treatment he or she has carried out that the 3-30/12/97 12 S. 8(1) substituted by No. 37/1997 s. 7. Infertility Treatment Act 1995 Act No. 63/1995 s. 9 woman is unlikely to become pregnant from an oocyte produced by her and sperm produced by her husband other than by a treatment procedure; or (b) a doctor, who has specialist qualifications in human genetics, must be satisfied, from an examination he or she has carried out, that if the woman became pregnant from an oocyte produced by her and sperm produced by her husband, a genetic abnormality or a disease might be transmitted to a person born as a result of the pregnancy. 9. Requirements as to consent (1) A consent under section 8— (a) must be in writing; and (b) must specify that the woman and her husband have consented to undergo the kind of treatment procedure specified in the consent; and (c) must not have been withdrawn or have lapsed when the procedure takes place. (2) The person giving the consent must lodge the consent or cause the consent to be lodged— (a) with the designated officer of the licensed centre where the procedure is to take place; or (b) if the procedure is to take place at a place other than a licensed centre, with the doctor in charge of the woman's case. 10. Information (1) Before a woman consents to undergo a treatment procedure the doctor in charge of the woman's case must give to the woman and her husband— 3-30/12/97 13 Infertility Treatment Act 1995 Act No. 63/1995 (a) a list of counsellors who have been approved under Part 8 to give counselling to women undergoing treatment procedures and their husbands; and (b) enough information about the procedure and the alternatives to the procedure to enable the woman and her husband to make an informed decision about whether or not to undergo the procedure. (2) Before a woman undergoes a treatment procedure, she and her husband must give the prescribed information required to be recorded in the Register under section 62 or 63 for women undergoing treatment procedures and their husbands. 11. Counselling (1) Before a woman consents to undergo a treatment procedure, she and her husband must have received counselling (including counselling in relation to the prescribed matters) from a counsellor who has been approved under Part 8 to give counselling to women undergoing treatment procedures and their husbands. (2) Before a woman undergoes a treatment procedure, the doctor in charge of that woman's case must take all reasonable steps to ensure that a counsellor who has been approved under Part 8 to give counselling to women undergoing treatment procedures and their husbands is available to give further counselling to the woman and her husband after the procedure is carried out. Division 3—Requirements for donors 12. Donation of gametes, zygotes or embryos 3-30/12/97 14 s. 11 Infertility Treatment Act 1995 Act No. 63/1995 s. 12 (1) Sperm is not to be used in a treatment procedure to be carried out on a woman who is not the wife of the man who produced the sperm, unless, before the sperm is used, that man consented to the use of the sperm in the kind of procedure proposed. (2) An oocyte produced by a woman must not be used in a treatment procedure to be carried out on another woman unless, before the oocyte is used, the woman who produced the oocyte consented to the use of the oocyte in the kind of procedure proposed. (3) A zygote or embryo must not be used in a treatment procedure to be carried out on a woman, if the sperm used to form the zygote or embryo is not the sperm of the husband of that woman, unless— (a) before the zygote or embryo is formed, the man who produced the sperm consented to the use of the sperm to form a zygote or embryo to be used in the kind of procedure proposed; or (b) the sperm has already been used to form a zygote or embryo outside the body of a woman to be transferred to the wife of the man who produced the sperm or to another woman and— (i) the zygote or embryo is not required to be transferred to the body of that woman; and (ii) that man has consented to the use of the zygote or embryo in the kind of procedure proposed. (4) A zygote or embryo must not be used in a treatment procedure to be carried out on a woman 3-30/12/97 15 Infertility Treatment Act 1995 Act No. 63/1995 s. 13 if another woman produced the oocyte used to form the zygote or embryo, unless— (a) before the zygote or embryo is formed, the woman who produced the oocyte consented to the use of the oocyte to form a zygote or embryo to be used in the kind of procedure proposed; or (b) the oocyte has already been used to form a zygote or embryo outside the body of a woman to be transferred to the woman who produced the oocyte or to another woman and— (i) the zygote or embryo is not required to be transferred to the body of that woman; and (ii) the woman who produced the oocyte has consented to the use of the zygote or embryo in the kind of procedure proposed. (5) A zygote or embryo must not be used in a treatment procedure to be carried out on a woman if the zygote or embryo has been formed from sperm produced by a man who is not the woman's husband and an oocyte produced by another woman unless the requirements of sub-sections (3) and (4) are met. 13. Consent of spouse of donor (1) If a donor who gives a consent under section 12 is, at the time consent is given, married or living in a de facto relationship, the oocyte, sperm, zygote, or embryo in respect of which consent has been given must not be used unless the spouse of the donor also consented to the kind of treatment procedure to be carried out. 3-30/12/97 16 S. 13(1) amended by No. 37/1997 s. 8(a). Infertility Treatment Act 1995 Act No. 63/1995 s. 13 (2) If— S. 13(2) amended by No. 37/1997 s. 8(b). (a) the spouse of a donor has consented under sub-section (1); and (b) the donor and that spouse divorce after the spouse has given that consent; and (c) a procedure which has been consented to is to be carried out after that divorce— this Act applies to that procedure as if the donor was not, at the time the donor gave consent, married or living in a de facto relationship. (3) For the purposes of sub-section (2) a donor and spouse divorce— (a) when a decree of dissolution of the marriage becomes absolute under the Family Law Act 1975 of the Commonwealth; or (b) on the granting of a decree of nullity in respect of the marriage by the Family Court of Australia; or S. 13(3)(c) amended by No. 37/1997 s. 8(c). (c) on the dissolution or annulment of the marriage in accordance with the law of a place outside Australia, but only if that dissolution or annulment is recognised in Australia under the Family Law Act 1975 of the Commonwealth; or S. 13(3)(d) inserted by No. 37/1997 s. 8(c). (d) in the case of a de facto relationship, when the donor and spouse cease to live together as husband and wife on a genuine domestic basis. S. 13(4) amended by No. 37/1997 s. 8(d). (4) This section does not apply if the zygote or embryo is formed from gametes of a woman and a man who are married to each other or are living together in a de facto relationship (as the case requires) and who have both consented under section 12. 3-30/12/97 17 Infertility Treatment Act 1995 Act No. 63/1995 14. Requirements as to consent (1) A consent under section 12 or 13— (a) must be in writing; and (b) must specify that the donor and, if the case so requires, the donor's spouse, have consented to the use of the oocyte, sperm, zygote or embryo, as the case so requires, in a treatment procedure of a particular kind on a woman other than the donor or the wife of the donor; and (c) must not have been withdrawn or have lapsed when the procedure takes place. (2) A consent under section 12 or 13 may specify that the gamete, zygote or embryo may only be used in a treatment procedure to be carried out on a specified woman. (3) A person giving consent to the use of sperm or an oocyte produced by that person or the spouse of that person must lodge the consent or cause the consent to be lodged— (a) if the donation is made— (i) at a licensed centre, with the designated officer of the licensed centre; or (ii) at a place other than a licensed centre, with a doctor approved under Part 8 to carry out donor insemination and who carries out donor insemination at that place; or (b) where the sperm or oocyte is kept or stored; or (c) in accordance with the regulations. 3-30/12/97 18 s. 14 Infertility Treatment Act 1995 Act No. 63/1995 s. 15 (4) A person giving consent to the use of a zygote or embryo formed from sperm or an oocyte produced by that person or the spouse of that person must lodge the consent or cause the consent to be lodged with the designated officer of the licensed centre where the zygote or embryo is kept or stored. 15. Objection by later spouse (1) If— S. 15(1)(a) substituted by No. 37/1997 s. 9(a). (a) after the donor has given consent under section 12 in respect of an oocyte, sperm, zygote or embryo, the donor marries or commences living in a de facto relationship; and (b) the spouse of the donor objects to the use of the oocyte, sperm, zygote or embryo in any treatment procedure, or a treatment procedure of a particular kind or in a particular case— the oocyte, sperm, zygote or embryo must not be used in any treatment procedure, or in a treatment procedure of the particular kind or in a particular case, as the case requires. (2) An objection— (a) must be in writing; and (b) must be lodged— (i) at the place where the consent of the donor was lodged; or (ii) at the place where the sperm, oocyte, zygote or embryo to which the consent relates is kept or stored or where it is to be used; or (iii) in accordance with the regulations. 3-30/12/97 19 Infertility Treatment Act 1995 Act No. 63/1995 s. 16 (3) An objection may be withdrawn at any time. (4) The withdrawal of an objection— (a) must be in writing; and (b) must be lodged— (i) at the place where the objection was lodged; or (ii) at the place where the sperm, oocyte, zygote or embryo to which the consent relates is kept or stored or where it is to be used; or (iii) in accordance with the regulations. (5) An objection by a spouse of a donor lapses if the person who made it ceases to be married to the donor or ceases to live in a de facto relationship with the donor (as the case requires). 16. Counselling requirements Before a person gives consent under section 12 or 13, he or she must have received counselling (including counselling in relation to the prescribed matters) from a counsellor who has been approved under Part 8 to give counselling to persons giving consent under section 12 or 13. 17. Requirements as to the giving and receiving of information At the time at which a donor gives consent under section 12, he or she— (a) must give the prescribed information required to be recorded in the Register under section 62 or 63 in relation to donors of gametes, zygotes or embryos which are to be used in treatment procedures; and 3-30/12/97 20 S. 15(5) amended by No. 37/1997 s. 9(b). Infertility Treatment Act 1995 Act No. 63/1995 s. 18 (b) must be advised, in writing— (i) of the rights of any person born as a result of a donor treatment procedure, the parents of that person and any other persons to information under Division 3 of Part 7; and (ii) as to the nature of the information about the donor which is recorded in the central register; and (iii) as to the donor's rights to obtain information under Divisions 2 and 3 of Part 7; and (iv) as to the existence and function of the register kept under section 82. 18. Identified donors (1) Sperm, an oocyte, a zygote or an embryo from a named donor may only be used in a treatment procedure if, before the procedure takes place— (a) the woman who is to undergo the procedure and her husband have requested that it be used; and (b) the donor and the spouse of the donor (if any) have consented to its use in the procedure, knowing that the donor has been identified; and (c) the woman and her husband, the donor and the spouse of the donor (if any) have received counselling as to its use from a counsellor approved under Part 8 to give counselling about the use of sperm, oocytes, zygotes or embryos from named donors. (2) A request under sub-section (1) must be— 3-30/12/97 21 Infertility Treatment Act 1995 Act No. 63/1995 s. 19 (a) in writing; and (b) made to the doctor who is to carry out the procedure, or, in the case of donor insemination, if the procedure is not to be carried out by a doctor, the doctor in charge of the woman's case. (3) In this section, "spouse", in relation to a donor, means a person who was, at the time the donor gave consent under sub-section (1)(b), married to the donor or living in a de facto relationship with the donor. 19. Requirements as to consent to use of gamete etc. from identified donor (1) A consent under section 18(1)(b)— (a) must be in writing; and (b) must specify that the donor and the spouse of the donor (if any) have consented to the use of the sperm, oocyte, zygote or embryo (as the case may be); and (c) must acknowledge that the person is aware that the donor has been identified; and (d) must not have been withdrawn or have lapsed when the procedure takes place. (2) A person giving consent under section 18(1)(b), where the consent relates to the use of gametes in the treatment procedure, must lodge the consent or cause the consent to be lodged— (a) if the consent is given— (i) at a licensed centre, with the designated officer of the licensed centre; or (ii) at a place other than a licensed centre, with a doctor approved under Part 8 to carry out donor insemination; or 3-30/12/97 22 S. 18(3) substituted by No. 37/1997 s. 10. Infertility Treatment Act 1995 Act No. 63/1995 s. 20 (b) where the gametes are kept or stored; or (c) in accordance with the regulations. (3) A person giving consent under section 18(1)(b), if the consent relates to the use of a zygote or an embryo in the treatment procedure, must lodge the consent or cause the consent to be lodged with the designated officer of the licensed centre where the zygote or embryo is kept or stored. S. 19(4) substituted by No. 37/1997 s. 11. (4) In this section, "spouse", in relation to a donor, means a person who was, at the time the donor gave consent under section 18(1)(b), married to the donor or living in a de facto relationship with the donor. Division 4—Requirements for donor treatment procedures 20. Circumstances in which donor procedure may be used (1) A treatment procedure must not be carried out on a woman involving the use of sperm produced by a man who is not the woman's husband or of a zygote or embryo formed from an oocyte produced by that woman and sperm produced by a man who is not her husband unless— (a) the woman is unlikely to become pregnant from the sperm of her husband or from a zygote or an embryo formed from his sperm; or (b) if the woman became pregnant from the sperm of her husband or from a zygote or an embryo formed from his sperm, a genetic abnormality or a disease might be transmitted to a person born as a result of that pregnancy. 3-30/12/97 23 Infertility Treatment Act 1995 Act No. 63/1995 (2) A treatment procedure must not be carried out on a woman involving the use of a zygote or embryo formed from sperm of the woman's husband and an oocyte produced by another woman or of an oocyte produced by another woman unless— (a) the woman who is to undergo the procedure is unlikely to become pregnant from an oocyte produced by her or from a zygote or an embryo formed from an oocyte produced by her; or (b) if the woman who is to undergo the procedure became pregnant from an oocyte produced by her or from a zygote or an embryo formed from an oocyte produced by her, a genetic abnormality or a disease might be transmitted to a person born as a result of that pregnancy. (3) A treatment procedure must not be carried out on a woman involving the use of both sperm produced by a man who is not the woman's husband and an oocyte produced by another woman, or a zygote or embryo formed from sperm produced by a man who is not the woman's husband and an oocyte produced by another woman unless— (a) the woman who is to undergo the procedure is unlikely to become pregnant from both the sperm of her husband and an oocyte produced by her or from a zygote or an embryo formed from such sperm and such an oocyte; or (b) if the woman who is to undergo the procedure became pregnant from both the sperm of her husband and an oocyte produced by her or from a zygote or an embryo formed from such sperm and such an 3-30/12/97 24 s. 20 Infertility Treatment Act 1995 Act No. 63/1995 s. 21 oocyte, a genetic abnormality or a disease might be transmitted to a person born as a result of that pregnancy from the use of both the sperm and the oocyte. 21. Information and advice Before a woman undergoes a donor treatment procedure, she and her husband must be advised, in writing— (a) of the rights of any person born as a result of that procedure, the donor and any other persons to information under Division 3 of Part 7; and (b) as to the nature of the information about the woman and her husband which is recorded in the central register; and (c) as to the effect of section 67; and (d) as to the woman's and her husband's rights to obtain information under Divisions 2 and 3 of Part 7; and (e) as to the existence and function of the register kept under section 82. _______________ 3-30/12/97 25 Infertility Treatment Act 1995 Act No. 63/1995 PART 3—RESEARCH Division 1—Offences 22. Research (1) A person may only— (a) carry out research, outside the body of a woman, involving the formation of a zygote; or (b) carry out research, outside the body of a woman, involving a zygote or embryo— if— (c) he or she is— (i) a doctor or scientist who has been approved under Part 8 to carry out that kind of research; or (ii) a person working under the direction and supervision of a doctor or scientist who has been approved under Part 8 to carry out that kind of research and who is responsible for the carrying out of that research; and (d) the research is approved research; and (e) the research is conducted in accordance with the approval; and (f) he or she is satisfied that the requirements of Division 2 and section 36 have been met. Penalty: 480 penalty units or 4 years imprisonment or both. (2) A person may only— 3-30/12/97 26 s. 22 Infertility Treatment Act 1995 Act No. 63/1995 s. 24 23 (a) bring about or attempt to bring about parthenogenesis in an oocyte outside the body of a woman; or S. 22(2)(a) amended by No. 37/1997 s. 20(a). (b) form or attempt to form a parthenogenetic oocyte or a parthenogene outside the body of a woman; or (c) carry out research on a parthenogenetic oocyte or parthenogene outside the body of a woman— if— (d) the research is approved research; and (e) the research is carried out in accordance with the approval; and (f) he or she is satisfied that the requirements of the Authority under Division 3 have been met. Penalty: 480 penalty units or 4 years imprisonment or both. (3) A person may only carry out research, outside the body of a woman, involving the use of an oocyte or sperm, which is not research under sub-section (1) or (2), if he or she is satisfied that the requirements of Division 4 and section 36 have been met. Penalty: 240 penalty units or 2 years imprisonment or both. 23. Places for research A person may only undertake approved research described in section 22 at a place licensed for the purpose under Part 8. Penalty: 480 penalty units or 4 years imprisonment or both. 24. Ban on destructive research on embryos 3-30/12/97 27 Infertility Treatment Act 1995 Act No. 63/1995 A person must not carry out research, outside the body of a woman, involving the use of an embryo— (a) if the embryo is unfit for transfer to a woman; or (b) in the case of an embryo which is fit for transfer to a woman, if the research would— (i) harm the embryo; or (ii) make the embryo unfit for transfer to a woman; or (iii) reduce the likelihood of a pregnancy resulting from the transfer of the embryo. Penalty: 480 penalty units or 4 years imprisonment or both. 25. Authority must not approve destructive research on embryos The Authority must not approve the carrying out of research outside the body of a woman involving the use of an embryo if it considers that— (a) the embryo is unfit for transfer to a woman; or (b) in the case of an embryo which is fit for transfer to a woman, the research would— (i) harm the embryo; or (ii) make the embryo unfit for transfer to a woman; or (iii) reduce the likelihood of a pregnancy resulting from transfer of the embryo; or (iv) otherwise be an offence under this Act. 3-30/12/97 28 Infertility Treatment Act 1995 Act No. 63/1995 s. 26 26. Authority must not approve certain research on zygotes The Authority must not approve the carrying out of research involving the formation or use of a zygote if the research proposes that the zygote continue to develop to syngamy. Division 2—Preliminary requirements for research involving zygotes, embryos or the formation of zygotes 27. Consent to research involving zygotes or embryos or the formation of zygotes (1) Research involving the formation of a zygote must not be carried out unless— (a) before the zygote is formed, each person who produced a gamete to be used in the research consented to the use of the gamete in the particular procedure which the person who is to conduct the research intends to carry out; and (b) the research will be carried out in accordance with the terms of each consent. (2) Research involving a zygote or an embryo under section 22(1)(b) must not be carried out unless— (a) the zygote or embryo was formed for use in a treatment procedure; and (b) in relation to a zygote, the zygote is not required for use in a treatment procedure; and (c) before the research begins, each person who produced a gamete which was used to form the zygote or embryo consented to the use of the zygote or embryo for the carrying out of the particular procedure which the person 3-30/12/97 29 Infertility Treatment Act 1995 Act No. 63/1995 s. 28 who is to conduct the research intends to carry out; and (d) the research will be carried out in accordance with the terms of each consent. 28. Consent of spouse of donor (1) If a donor who gives a consent under section 27 is, at the time consent is given, married or living in a de facto relationship, the research must not be carried out unless the spouse of the donor also consented to the use of the gamete, zygote or embryo (as the case requires) in the particular procedure to be carried out. S. 28(1) amended by No. 37/1997 s. 12(a). (2) If— S. 28(2) amended by No. 37/1997 s. 12(b). (a) the spouse of a donor has consented under sub-section (1); and (b) the donor and that spouse divorce after the spouse has given that consent; and (c) a procedure which has been consented to is to be carried out after that divorce— this Act applies to that procedure as if the donor was not, at the time the donor gave consent, married or living in a de facto relationship. (3) For the purposes of sub-section (2) a donor and spouse divorce— (a) when a decree of dissolution of the marriage becomes absolute under the Family Law Act 1975 of the Commonwealth; or (b) on the granting of a decree of nullity in respect of the marriage by the Family Court of Australia; or (c) on the dissolution or annulment of the marriage in accordance with the law of a place outside Australia, but only if that 3-30/12/97 30 S. 28(3)(c) amended by No. 37/1997 s. 12(c). Infertility Treatment Act 1995 Act No. 63/1995 s. 29 dissolution or annulment is recognised in Australia under the Family Law Act 1975 of the Commonwealth; or S. 28(3)(d) inserted by No. 37/1997 s. 12(c). (d) in the case of a de facto relationship, when the donor and spouse cease to live together as husband and wife on a genuine domestic basis. 29. Requirements as to consent (1) A consent under section 27 or 28— (a) must be in writing; and (b) must specify that the donor and, if the case so requires, the donor's spouse, have consented to the particular use of the gamete, zygote or embryo, as the case so requires, in the research; and (c) must not have been withdrawn or have lapsed when the gamete, zygote or embryo is used for the research. (2) A person giving consent under section 27 or 28, must lodge the consent or cause the consent to be lodged with the designated officer of the licensed centre at which the research is to take place. S. 29(3) inserted by No. 37/1997 s. 13. (3) In this section, "spouse", in relation to a donor, means a person who was, at the time the donor gave consent under section 27 or 28, married to the donor or living in a de facto relationship with the donor. 30. Objection by later spouse S. 30(1) amended by No. 37/1997 s. 14(a). (1) If, after a donor has given consent under section 27, he or she marries or commences living in a de facto relationship, the oocyte, sperm, zygote or embryo in respect of which consent has been given must not be used in the research if that 3-30/12/97 31 Infertility Treatment Act 1995 Act No. 63/1995 s. 31 spouse objects to the use of the oocyte, sperm, zygote or embryo. (2) An objection— (a) must be in writing; and (b) must be lodged— (i) at the place where the consent of the donor was lodged; or (ii) at the place where the sperm, oocyte, zygote or embryo to which the consent relates is kept or stored or where it is to be used; or (iii) in accordance with the regulations. (3) An objection may be withdrawn at any time. (4) The withdrawal of an objection— (a) must be in writing; and (b) must be lodged— (i) at the place where the objection was lodged; or (ii) at the place where the sperm, oocyte, zygote or embryo to which the consent relates is kept or stored or where it is to be used; or (iii) in accordance with the regulations. (5) An objection by a spouse of a donor lapses if the person who made it ceases to be married to the donor or ceases to live in a de facto relationship with the donor (as the case requires). 31. Counselling requirements Before a person gives consent under section 27 or 28, that person must have received counselling, including counselling in relation to the prescribed matters, from a counsellor who has been approved 3-30/12/97 32 S. 30(5) amended by No. 37/1997 s. 14(b). Infertility Treatment Act 1995 Act No. 63/1995 s. 32 under Part 8 to give counselling to people who propose to give consent under section 27 or 28. 32. Information requirements (1) Before a person gives consent under section 27, he or she— (a) must give the prescribed information required to be recorded in the Register under section 62, for donors of gametes, zygotes or embryos to be used for research; and (b) must be given enough information about the proposed research from the doctor or scientist carrying out the research to enable him or her to make an informed decision about whether to consent. (2) Before a person gives consent under section 28, he or she must be given enough information about the proposed research from the doctor or scientist carrying out the research to enable him or her to make an informed decision about whether to consent. Division 3—Requirements for research involving parthenogenesis 33. Power of Authority to impose requirements (1) The Authority may specify requirements in relation to approved research under section 22(2) regarding— (a) the consent of a person whose gametes are to be used in the research, and the consent of such a person's spouse, and where those consents are to be lodged; (b) objections by a spouse in relation to the use of a person's gametes in such research; (c) the lapsing of such consents or objections; 3-30/12/97 33 Infertility Treatment Act 1995 Act No. 63/1995 (d) the withdrawal of such consents and objections; (e) counselling and the provision of information to a person whose gametes are to be used and of his or her spouse in relation to such research; and (f) any other matter, including the application of a provision of this Act or the regulations, with any necessary modifications, to such research or to a parthenogenetic oocyte or parthenogene, that the Authority considers relevant. (2) The requirements imposed under sub-section (1) may be of general or limited application. Division 4—Preliminary requirements for other research involving gametes 34. Consent to research using gametes Research involving the use of a gamete (which is not research under section 22(1) or (2)) must not be carried out unless— (a) before the gamete is used for research, the person who produced the gamete consented to the use of the gamete for the purpose of research or for the carrying out of the particular procedure which the person who is to conduct the research intends to carry out; and (b) the research will be carried out in accordance with the terms of that consent. 35. Requirements as to consent 3-30/12/97 34 s. 35 34 Infertility Treatment Act 1995 Act No. 63/1995 (1) A consent under section 34— (a) must be in writing; and (b) must specify that the donor has consented to the use of the gamete for the particular research or for research generally; and (c) must not have been withdrawn or have lapsed when the procedure using the gamete takes place. (2) A person giving consent under section 34 must lodge the consent or cause the consent to be lodged in accordance with the regulations. _______________ 3-30/12/97 35 Infertility Treatment Act 1995 Act No. 63/1995 PART 4—PROCEDURES RELATING TO CONSENTS 36. Approved form to be used (1) If the Authority has approved a form for the giving of consent, a person giving consent under Part 2 or 3 must give it on the approved form. (2) The Authority may approve a different form according to place, class of person, type of procedure or other circumstance. 37. Withdrawal of consent (1) A person who gives a consent under Part 2 or 3 may withdraw it at any time before the procedure or action consented to is carried out. (2) A withdrawal of consent under this section must be in writing. (3) A person withdrawing a consent must lodge the withdrawal or cause the withdrawal to be lodged as soon as practicable— (a) at the place where the consent was lodged; or (b) at the place where the sperm, oocyte, zygote or embryo to which the consent relates is kept or stored or where it is to be used; or (c) in accordance with the regulations. 38. Lapsing of consent (1) In the case of donor gametes, the consent of the donor and the spouse (if any) of the donor given under Part 2 or Part 3 lapses— (a) 10 years after it has been given; or (b) if any lesser period has been specified in the consent by the person who gave the consent, at the end of that period. 3-30/12/97 36 s. 36 Infertility Treatment Act 1995 Act No. 63/1995 s. 38 (2) In the case of a donor zygote or donor embryo, the consent of each donor and the spouse (if any) of each donor under Part 2 or Part 3 lapses— (a) 5 years after it has been given; or (b) if any lesser period has been specified in the consent by the person who gave the consent, at the end of that period. _______________ 3-30/12/97 37 Infertility Treatment Act 1995 Act No. 63/1995 PART 5—OFFENCES Division 1—Prohibited procedures 39. Alteration of constitution of a gamete, zygote or embryo (1) A person must not alter the genetic constitution of a gamete which is intended to be used in a treatment procedure or to form a zygote or embryo. Penalty: 480 penalty units or 4 years imprisonment or both. (2) A person must not alter the genetic, pro-nuclear or nuclear constitution of a zygote or an embryo except to alter the somatic cells for therapeutic purposes. Penalty: 480 penalty units or 4 years imprisonment or both. 40. Transfer of gametes, zygotes or embryos used for research (1) A person must not transfer to the body of a woman— (a) a gamete or zygote used for research; or (b) an embryo formed from a zygote or gamete used for research; or (c) a zygote formed from a gamete used for research; or (d) an embryo used for research— unless that person has first obtained the approval of the Authority to do so, and conducts the 3-30/12/97 38 s. 39 Infertility Treatment Act 1995 Act No. 63/1995 s. 43 41 transfer in accordance with the terms and conditions of the approval. Penalty: 240 penalty units or 2 years imprisonment or both. (2) An approval under sub-section (1) must be in writing and is subject to any terms and conditions the Authority sees fit to impose. 41. Ban on procedures involving gametes produced by children A person must not use for a treatment procedure or research— S. 41(a) amended by No. 37/1997 s. 15. (a) a gamete produced by a person less than 18 years old; or S. 41(b) amended by No. 37/1997 s. 15. (b) a zygote or an embryo formed from gametes produced by a person less than 18 years old— except in accordance with the regulations. Penalty: 240 penalty units or 2 years imprisonment or both. 42. Ban on procedures involving oocytes derived from a foetus A person must not use oocytes derived from a foetus in a treatment procedure or research. Penalty: 240 penalty units or 2 years imprisonment or both. 43. Ban on procedures involving gametes of people known to be dead 3-30/12/97 39 Infertility Treatment Act 1995 Act No. 63/1995 A person must not— (a) inseminate a woman with sperm from a man known to be dead; or (b) transfer to a woman a gamete from a person known to be dead; or (c) transfer to a woman a zygote or an embryo formed from a gamete from a person known to be dead; or (d) form a zygote with sperm from a man known to be dead; or (e) form a zygote, if the woman who produced the oocyte used to form the zygote is known to be dead. Penalty: 240 penalty units or 2 years imprisonment or both. 44. Ban on use of zygotes or embryos removed from the body A person must not carry out a treatment procedure or research involving the use of a zygote or an embryo removed from the body of a woman. Penalty: 240 penalty units or 2 years imprisonment or both. 45. Ban on mixing human and animal gametes etc. (1) A person must not carry out a procedure involving the mixing of sperm or ova produced by an animal— (a) with a gamete produced by a man or woman; or (b) with a zygote or an embryo formed from the gametes of a man and woman— 3-30/12/97 40 Infertility Treatment Act 1995 Act No. 63/1995 s. 46 unless the procedure is that of mixing animal ova with human sperm and is prescribed by the regulations and is carried out for diagnostic purposes only. Penalty: 480 penalty units or 4 years imprisonment or both. (2) A person must not carry out a procedure involving the insertion of the gene of an animal into— (a) a gamete produced by a man or woman; or (b) a zygote or embryo formed from gametes produced by a man and woman. Penalty: 480 penalty units or 4 years imprisonment or both. 46. Ban on mixing gametes, zygotes or embryos from more than one person (1) A person must not carry out a treatment procedure— (a) using sperm produced by more than one person or oocytes produced by more than one person; or (b) in which more than one zygote or embryo is used if the gametes from which each zygote or embryo is formed are not produced by the same two people; or (c) using a zygote or an embryo formed from the mixing of— (i) an oocyte with sperm produced by more than one man; or (ii) sperm with more than one oocyte, if the oocytes are produced by more than one woman. Penalty: 240 penalty units or 2 years imprisonment or both. 3-30/12/97 41 Infertility Treatment Act 1995 Act No. 63/1995 (2) A person must not form or attempt to form a zygote or embryo outside the body of a woman from sperm produced by more than one man. Penalty: 240 penalty units or 2 years imprisonment or both. 47. Ban on cloning A person must not carry out or attempt to carry out cloning. Penalty: 480 penalty units or 4 years imprisonment or both. 48. Ban on certain experimental procedures A person must not carry out a procedure or research involving— (a) the transfer of a zygote or an embryo into the body of a man or an animal; or (b) the transfer of a parthenogenetic oocyte or parthenogene to the body of a person or an animal. Penalty: 240 penalty units or 2 years imprisonment or both. 49. Formation of embryos and zygotes (1) A person must not knowingly or recklessly form or attempt to form an embryo outside the body of a woman except for the purposes of a treatment procedure to be carried out in accordance with this Act. Penalty: 480 penalty units or 4 years imprisonment or both. 3-30/12/97 42 s. 47 Infertility Treatment Act 1995 Act No. 63/1995 s. 50 (2) A person must not knowingly or recklessly form or attempt to form a zygote outside the body of a woman except for the purposes of— (a) a treatment procedure to be carried out in accordance with this Act; or (b) approved research to be carried out in accordance with this Act. Penalty: 480 penalty units or 4 years imprisonment or both. (3) A person who is not a doctor or scientist who has been approved under Part 8 for the purpose of forming embryos outside the body of a woman must not knowingly or recklessly form or attempt to form an embryo outside the body of a woman. Penalty: 480 penalty units or 4 years imprisonment or both. (4) A person must not knowingly or recklessly form or attempt to form an embryo outside the body of a woman, except at a place licensed for the purpose under Part 8. Penalty: 480 penalty units or 4 years imprisonment or both. 50. Ban on sex selection (1) If a person is carrying out artificial insemination or a treatment procedure, that person must not— (a) use a gamete, zygote or embryo; or (b) perform the procedure in a particular manner— with the purpose or a purpose of producing or attempting to produce a child of a particular sex. Penalty: 240 penalty units or 2 years imprisonment or both. 3-30/12/97 43 Infertility Treatment Act 1995 Act No. 63/1995 (2) Sub-section (1) does not apply if it is necessary for the child to be of a particular sex so as to avoid the risk of transmission of a genetic abnormality or a disease to the child. Division 2—Storage 51. Storing gametes (1) A person must not cause or permit gametes to remain in storage— (a) if the person knows that the person who produced the gametes has asked for those gametes to be removed; or (b) in any other case— (i) for more than 10 years; or (ii) if the Authority has approved a longer storage period, for more than that approved period. Penalty: 240 penalty units or 2 years imprisonment or both. (2) The Authority may approve in writing a longer storage period if it considers that there are reasonable grounds to do so in the particular case. (3) An approval under sub-section (2) may be subject to conditions. 52. Storing zygotes or embryos (1) A person must not cause or permit a zygote or an embryo to be placed or remain in storage. Penalty: 240 penalty units or 2 years imprisonment or both. (2) Sub-section (1) does not apply if— 3-30/12/97 44 s. 52 51 Infertility Treatment Act 1995 Act No. 63/1995 (a) it is intended to— (i) transfer the zygote or embryo to the body of a woman in a treatment procedure in accordance with this Act; or (ii) use the zygote for the purposes of approved research; and (b) the persons who have produced the gametes from which the zygote or embryo has been formed have consented to its storage for the purpose of later use or transfer. (3) A consent under sub-section (2)(b)— (a) must be in writing; and (b) must be lodged as soon as practicable after the consent has been given with the person storing the zygote or embryo. (4) A person must not cause or permit a zygote or embryo to which sub-section (2) applies to remain in storage— (a) if a person who has consented to storage has specified a period of less than 5 years, after that period; or (b) in any other case, after— (i) 5 years; or (ii) any longer period approved by the Authority. Penalty: 240 penalty units or 2 years imprisonment or both. (5) The Authority may approve in writing a longer period for storage of a zygote or embryo if it 3-30/12/97 45 Infertility Treatment Act 1995 Act No. 63/1995 s. 53 considers that there are reasonable grounds for doing so in the particular case. (6) An approval under sub-section (5) may be subject to conditions. 53. Removal of zygotes or embryos from storage (1) A person must not remove a zygote or an embryo from storage or cause or permit a zygote or an embryo to be so removed unless— (a) it is to be used, in accordance with this Act, in a treatment procedure; or (b) it is to be used, in accordance with this Act, for approved research; or (c) one or both of the persons who produced the gametes from which the zygote or embryo is formed, die; or (d) consent to its removal has been given to the designated officer in writing by both of the persons who produced the gametes from which the zygote or embryo is formed and if either of those persons is, at the time of giving of the consent, married or living in a de facto relationship, the consent of that person's spouse for the removal must also be given to the designated officer in writing; or (e) it is required to be removed by reason of the operation of section 52(4) or Part 14. Penalty: 480 penalty units or 4 years imprisonment or both. (2) A person who removes from storage a zygote or embryo which is not to be used for a treatment 3-30/12/97 46 S. 53(1)(d) amended by No. 37/1997 s. 16. Infertility Treatment Act 1995 Act No. 63/1995 s. 54 procedure or approved research must ensure that— (a) it is not removed from its container (except for the sole purpose of observing the zygote or embryo); and (b) it is disposed of in accordance with the regulations. Penalty: 240 penalty units or 2 years imprisonment or both. 54. Places of storage A person must not— (a) store a zygote or embryo; or (b) store a gamete to be used in a treatment procedure; or (c) store a gamete to be used to form a zygote or an embryo— except at a place licensed for the purpose under this Act. Penalty: 480 penalty units or 4 years imprisonment or both. 55. Ban on use of gametes, zygotes or embryos not stored at licensed centre If an embryo, zygote or gamete has been stored at a place which is not licensed under this Act as a place at which an embryo, zygote or gamete (as the case may be) may be stored, a person must not use, in a treatment procedure— (a) that embryo, zygote or gamete; or (b) an embryo formed from such a zygote or gamete; or (c) a zygote formed from such a gamete. 3-30/12/97 47 Infertility Treatment Act 1995 Act No. 63/1995 Penalty: 240 penalty units or 2 years imprisonment or both. Division 3—General offences 56. Import or export of gametes, zygotes and embryos (1) A person must not— (a) bring a gamete, zygote or embryo into Victoria outside the human body; or (b) take a gamete, zygote or embryo from Victoria outside the human body. Penalty: 240 penalty units or 2 years imprisonment or both. (2) Sub-section (1) does not apply if the gamete, zygote or embryo is brought into or taken from Victoria in accordance with the written approval of the Authority. (3) The Authority's approval under sub-section (2) may apply to a particular case or class of cases and may be subject to conditions imposed by the Authority. (4) If a person has approval under sub-section (2) to bring a gamete, zygote or embryo into Victoria the Authority may exempt a person in relation to— (a) the gamete, zygote or embryo; or (b) the donor of the gamete, zygote or embryo— from compliance with sections 14(3) and (4), 15(2) and (4), 16, 17, 18, 19, 36, 37(3), 52(1)(b) and (3) and 55, Division 1 of Part 7 and any other prescribed provision of the Act or the regulations, if the Authority is satisfied that— (c) similar procedures have taken place outside Victoria; and 3-30/12/97 48 s. 56 Infertility Treatment Act 1995 Act No. 63/1995 s. 57 56 (d) there are special circumstances which warrant the exemption. (5) If a person has approval under sub-section (2) to take a gamete, zygote or embryo from Victoria the Authority may exempt a person in relation to the gamete, zygote or embryo from compliance with sections 49(1) and (2), 52(2) and (3), 53, 89 and 90 and any other prescribed provision of the Act or the regulations, if the Authority is satisfied that— (a) the gamete, zygote or embryo will be used in a manner which is consistent with this Act; and (b) there are special circumstances which warrant the exemption. (6) An exemption granted under this section must be made in writing, and may relate to the whole or a part of a provision, and may be subject to conditions. (7) A person granted an approval or exemption under this section must comply with any condition imposed by the Authority under this section. Penalty: 240 penalty units or 2 years imprisonment or both. 57. No compensation for gamete donation (1) A person must not receive or hold himself or herself out as being willing to receive a payment, reward, benefit or advantage for donating a gamete, zygote or embryo or, in the case of the spouse of such a person, for that spouse's husband or wife making such a donation. Penalty: 50 penalty units. 3-30/12/97 49 Infertility Treatment Act 1995 Act No. 63/1995 (2) A person must not give or offer to give a payment, reward, benefit or advantage to a person for donating a gamete, zygote or embryo or, in the case of the spouse of such a person, for that spouse's husband or wife making such a donation. Penalty: 50 penalty units. (3) Sub-sections (1) and (2) do not apply to— (a) the giving or receiving of an amount, not exceeding an amount calculated at the rate fixed by Order of the Governor in Council and published in the Government Gazette, in respect of expenses incurred by a donor for travelling to or attending the place at which the donation is made; or (b) giving or receiving reimbursement for medical expenses incurred by a donor in connection with a donation. 58. False or misleading information A person must not knowingly or recklessly give false or misleading information or omit to give material information— (a) in an application, consent or request under this Act; or (b) with respect to the giving of information which is required— (i) to be given under this Act; or (ii) to be included in a Register, record or notice under this Act. Penalty: 50 penalty units. _______________ 3-30/12/97 50 s. 58 Infertility Treatment Act 1995 Act No. 63/1995 s. 59 PART 6—SURROGATE MOTHERHOOD 59. Surrogacy A person must not make, give or receive or agree to make, give or receive a payment or reward in relation to or under a surrogacy agreement or the arrangement of a surrogacy agreement or an arrangement to act as a surrogate mother. Penalty: 240 penalty units or 2 years imprisonment or both. 60. Surrogacy—advertising A person must not publish or cause to be published a statement, advertisement, notice or document— (a) to the effect that a person is or may be willing to enter into a surrogacy agreement; or (b) to the effect that a person is seeking another person who is or may be willing to enter into a surrogacy agreement or to act as a surrogate mother or to arrange a surrogacy agreement; or (c) to the effect that a person is or may be willing to arrange a surrogacy agreement; or (d) to the effect that a person is or may be willing to accept any benefit under a surrogacy agreement, whether for himself or herself or for another person; or (e) that is intended or likely to counsel or procure a person to agree to act as a surrogate mother; or (f) to the effect that a person is or may be willing to act as a surrogate mother. 3-30/12/97 51 Infertility Treatment Act 1995 Act No. 63/1995 Penalty: 240 penalty units or 2 years imprisonment or both. 61. Surrogacy agreements void A surrogacy agreement is void whether made before or after the commencement of this section. _______________ 3-30/12/97 52 s. 61 Infertility Treatment Act 1995 Act No. 63/1995 s. 62 PART 7—RECORDS AND ACCESS TO INFORMATION Division 1—Records 62. Register to be kept for licensed centre (1) The licensee of a licensed centre must keep a Register for that centre at the centre or at another place that is specified in the licence for the centre. Penalty: 50 penalty units. (2) The designated officer of a licensed centre must ensure that there is recorded in the Register, in the prescribed manner, the prescribed information in relation to the following— (a) the donors of gametes, zygotes and embryos kept or stored at the centre including any known physical abnormality of each donor; (b) the destruction or disposal at the centre of any gametes, zygotes or embryos formed outside the body of a woman; (c) the formation or attempted formation at the centre of a zygote or embryo outside the body of a woman; (d) each woman who undergoes a treatment procedure at the centre and the husband of that woman including any known physical abnormality of the woman or her husband; (e) any treatment procedure carried out on a woman at the centre; (f) the use of a gamete, zygote or embryo in a treatment procedure or research under Part 3 at the centre; (g) any gametes, zygotes or embryos transferred from the centre to another licensed centre or 3-30/12/97 53 Infertility Treatment Act 1995 Act No. 63/1995 to a doctor who has been approved under Part 8 to carry out donor insemination at a place other than a licensed centre; (h) any gametes, zygotes or embryos, transferred from another licensed centre or a doctor who has been approved under Part 8 to carry out donor insemination at a place other than a licensed centre to the centre; (i) the collection and storage of gametes, zygotes or embryos at the centre; (j) the consents and withdrawals of consent to the storage and removal from storage of gametes, zygotes or embryos at the centre; (k) the bringing into or taking out of the State of any gametes, zygotes or embryos which have been or are stored or kept at the centre; (l) each consent, objection, withdrawal or lapsing of consent or objection given under this Act for a treatment procedure or research under Part 3 carried out at the centre; (m) any amounts paid to donors in respect of donations made at the centre; (n) the outcome of a treatment procedure, if this information is available at the centre or known to the designated officer, including particulars of— (i) a confirmed pregnancy resulting from a treatment procedure carried out at the centre; and (ii) the miscarriage of a pregnancy from a treatment procedure carried out at the centre or the death of an embryo or foetus carried by a woman as a result of 3-30/12/97 54 s. 62 Infertility Treatment Act 1995 Act No. 63/1995 s. 63 a treatment procedure carried out at the centre; (o) a person born as a result of a treatment procedure at the centre, if this information is available at the centre or known to the designated officer, including particulars of— (i) the birth of the person; and (ii) any physical abnormality of the person, identified at or about the time of birth of the person. Penalty: 50 penalty units. (3) The designated officer must ensure that there is recorded in the Register, in the manner determined by the Authority, any information required to be recorded in the Register by a licence condition imposed by the Authority. Penalty: 50 penalty units. 63. Register to be kept by doctor carrying out donor insemination (1) A doctor who has been approved under Part 8 to carry out donor insemination at a place other than a licensed centre must keep a Register at premises specified in the approval. Penalty: 50 penalty units. (2) For each artificial insemination of a woman with sperm from a man who is not the husband of the woman carried out by the doctor at a place other than a licensed centre, the doctor must record in the Register, in the prescribed manner, the prescribed information in relation to the following— (a) the insemination; 3-30/12/97 55 Infertility Treatment Act 1995 Act No. 63/1995 s. 63 (b) the donor of the sperm used in the insemination, including any known physical abnormality of that donor; (c) the woman who is inseminated with the donated sperm and her husband, including any known physical abnormality of that woman or her husband; (d) any amount paid to the donor of sperm in respect of the donation for the insemination; (e) the outcome of the insemination, if this is known to the doctor, including— (i) a confirmed pregnancy resulting from the insemination; and (ii) the miscarriage of a pregnancy resulting from the insemination or the death of an embryo or a foetus carried by a woman as a result of the insemination; and (f) a person born as the result of the insemination, if this is known to the doctor, including particulars of— (i) the birth of the person; and (ii) any physical abnormality of the person, identified at or about the time of birth of the person. Penalty: 50 penalty units. (3) A doctor who has been approved under Part 8 to carry out donor insemination at a place other than a licensed centre must record in the Register kept by the doctor, in the prescribed manner, the prescribed information relating to the following— (a) the destruction or disposal of any sperm; 3-30/12/97 56 S. 63(2)(c) amended by No. 37/1997 s. 19(b). Infertility Treatment Act 1995 Act No. 63/1995 s. 64 (b) each consent, withdrawal or lapsing of consent or objection given under this Act for donor insemination; (c) each objection or withdrawal of objection to the use of the donated sperm; (d) any sperm transferred from the premises where an insemination may be carried out; and (e) any sperm kept at the premises where an insemination is to be carried out. (4) The doctor must record in the Register in the manner determined by the Authority, any information required to be recorded in the Register by a condition imposed on the doctor's approval by the Authority. Penalty: 50 penalty units. 64. Information to be given to the Authority by licensed centres Within one month of the expiration of every prescribed 6 month period, the designated officer of a licensed centre must give to the Authority, in the prescribed manner, the information specified in section 66 with respect to— (a) every birth of a person born as a result of a donor treatment procedure carried out at the centre, which birth becomes known to the designated officer within that 6 month period; (b) every pregnancy which has occurred as a result of a donor treatment procedure carried out at the centre, and which is known to the designated officer within that 6 month period; 3-30/12/97 57 Infertility Treatment Act 1995 Act No. 63/1995 (c) in the circumstances specified in writing by the Authority, every donor treatment procedure carried out at the centre, where the outcome of that procedure is not known by the designated officer; and (d) any other prescribed circumstances. Penalty: 50 penalty units. 65. Information to be given to the Authority by doctors not at licensed centres Within one month of the expiry of every prescribed 6 month period, a doctor who has been approved under Part 8 to carry out donor insemination at a place other than a licensed centre must give to the Authority, in the prescribed manner, the information specified in section 66 with respect to— (a) every birth of a person born as a result of such a donor insemination carried out by the doctor, which birth becomes known to the doctor within that 6 month period; (b) every pregnancy which has occurred as a result of such a donor insemination carried out by the doctor, and which is known to the doctor within that 6 month period; (c) in the circumstances specified in writing by the Authority, every such donor insemination carried out by the doctor, where the outcome of the procedure is not known by the doctor; and (d) any other prescribed circumstances. Penalty: 50 penalty units. 66. Information to be given under section 64 and 65 3-30/12/97 58 s. 65 Infertility Treatment Act 1995 Act No. 63/1995 s. 67 The information to be given under sections 64 and 65 must include the prescribed information in relation to the following— (a) in the case of a birth, the person born as a result of the donor treatment procedure including particulars of any physical abnormality of the person identified at or about the time of his or her birth; (b) in all cases, the donor or donors, including particulars of any known physical abnormality of the donor; S. 66(c) amended by No. 37/1997 s. 19(c). (c) in all cases, the woman who underwent the procedure and her husband, including particulars of any known physical abnormality of either person; and (d) in all cases, the procedure. 67. Information to be given to the Authority about births by other persons (1) If a person has been born as the result of a donor treatment procedure the woman who gave birth or her husband must give written notice in accordance with this section of the birth to the Authority in the prescribed manner. Penalty: 20 penalty units. (2) If a doctor or a registered nurse— (a) attends the birth of a person; and (b) knows that the pregnancy resulted from a donor treatment procedure— the doctor or registered nurse must give written notice of the birth to the Authority in the prescribed manner. Penalty: 20 penalty units. 3-30/12/97 59 Infertility Treatment Act 1995 Act No. 63/1995 (3) A doctor who— (a) attends a woman during pregnancy and is aware that a person has been born as a result of that pregnancy; and (b) knows that the pregnancy resulted from a donor treatment procedure— must give written notice of the birth to the Authority in the prescribed manner. Penalty: 20 penalty units. (4) A notice under sub-section (1), (2) or (3) must include the following— (a) the names of the woman who gave birth and her husband; (b) the name and sex of the person who has been born, and particulars of any physical abnormality of the person identified at or about the time of birth; (c) if— (i) the procedure was performed at a licensed centre, the name of that centre, if known; or (ii) if the procedure was not performed at a licensed centre, the name of the doctor who performed it, if known; (d) any other prescribed information. (5) A person does not commit an offence under this section— (a) if that person reasonably believes that another person has already given a notice 3-30/12/97 60 s. 67 Infertility Treatment Act 1995 Act No. 63/1995 s. 68 under this section which contains all of the information described in sub-section (4); or (b) in prescribed circumstances. 68. Authority to keep a central register The Authority must, in the prescribed manner, keep a central register containing the information given to the Authority under this Division and the prescribed information (if any). 69. Authority to correct central register (1) A person in respect of whom information is recorded in the central register may, at any time, request the Authority to correct or amend any information on the central register which is inaccurate, incomplete, out of date or misleading. (2) A request under sub-section (1)— (a) must be in writing; and (b) must specify the amendment or correction the person wishes to have made and the reasons why the person wishes to have the amendment or correction made. (3) If the Authority is of the opinion that the amendment or correction requested will make the Register more accurate or complete, the Authority must make the amendment or correction to the Register that is necessary in its opinion. (4) The Authority must notify a person who makes a request under this Part of its decision about that request within 30 days of making that decision. 70. Inspection of Registers (1) A person of or over 18 years of age in respect of whom information is kept in a Register under this Division may, at any time during ordinary 3-30/12/97 61 Infertility Treatment Act 1995 Act No. 63/1995 s. 71 business hours, inspect that information if the information does not also relate to someone else. (2) The parent or guardian of a person under 18 years of age in respect of whom information is kept in a Register under this Division may, at any time during ordinary business hours, inspect that information, if the information does not also relate to someone other than the child. Division 2—Information to be given by licensed centres and doctors 71. Information recorded by licensed centre or doctor which is to be given to persons undergoing donor treatment procedures (1) Before a woman undergoes a donor treatment procedure at a licensed centre, the designated officer of the centre must, in writing, offer to give information required to be recorded in the Register kept at the centre to the woman and her husband, about a donor whose gametes or a zygote or embryo formed from his or her gametes are to be or may be used in the procedure. S. 71(1) amended by No. 37/1997 s. 19(d). Penalty: 50 penalty units. (2) Before a woman undergoes a donor treatment procedure at a licensed centre, she and her husband may ask the designated officer to give to them information required to be recorded in the Register about a donor, being either or both of the following— (a) information about the donor (other than information from which the donor will or may be identified); (b) information which will or may identify the donor. 3-30/12/97 62 S. 71(2) amended by No. 37/1997 s. 19(d). Infertility Treatment Act 1995 Act No. 63/1995 s. 71 (3) On receiving a request for information under subsection (2)(a), the designated officer must, in writing give to the woman and her husband any such information recorded in the Register kept at the centre. S. 71(3) amended by No. 37/1997 s. 19(d). Penalty: 50 penalty units. (4) On receiving a request for information under subsection (2)(b), the designated officer must give any such information recorded in the Register kept at the centre, if the donor has first consented to the giving of that information. Penalty: 50 penalty units. (5) Information given under sub-section (4) must be given— (a) in writing; and (b) in accordance with any conditions or limitations imposed by the donor. S. 71(6) amended by No. 37/1997 s. 19(d). (6) Before a woman undergoes a donor insemination at a place other than a licensed centre, the doctor who is to carry out the procedure must, in writing, offer to give information required to be recorded in the Register kept by the doctor to the woman and her husband about the donor of the sperm which is to be or may be used. Penalty: 50 penalty units. S. 71(7) amended by No. 37/1997 s. 19(d). (7) Before a woman undergoes a donor insemination at a place other than a licensed centre, she and her husband may ask the doctor to give to them information required to be recorded in the Register about the donor, being either or both of the following— (a) information about the donor (other than information from which the donor will or may be identified); 3-30/12/97 63 Infertility Treatment Act 1995 Act No. 63/1995 s. 72 (b) information which will or may identify the donor. (8) On receiving a request for information under subsection (7)(a) the doctor must, in writing, give to the woman and her husband any such information recorded in the Register kept by the doctor. S. 71(8) amended by No. 37/1997 s. 19(d). Penalty: 50 penalty units. (9) On receiving a request for information under subsection (7)(b) the doctor must give to the woman and her husband any such information recorded in the Register kept by the doctor if the donor has first consented to the giving of that information. S. 71(9) amended by No. 37/1997 s. 19(d). Penalty: 50 penalty units. (10) Information given under sub-section (9) must be given— (a) in writing; and (b) in accordance with any conditions or limitations imposed by the donor. Penalty: 50 penalty units. 72. Information recorded by licensed centre or doctor which is to be given to donors 3-30/12/97 (1) A donor may ask the designated officer of a licensed centre at which a donor treatment procedure is proposed to be carried out, for any information required to be recorded in the Register kept at the centre, if his or her gametes, or a zygote or embryo formed from such gametes, are to be used in the procedure, about the woman on whom the procedure is proposed to be carried out and her husband, being either or both of the following— S. 72(1) amended by No. 37/1997 s. 19(d). (a) information about that woman or her husband (other than information from which the woman or her husband will or may be S. 72(1)(a) amended by No. 37/1997 s. 19(d). 64 Infertility Treatment Act 1995 Act No. 63/1995 s. 72 identified); and S. 72(1)(b) amended by No. 37/1997 s. 19(d). (b) information which will or may identify that woman or her husband. (2) On receiving a request for information under subsection (1)(a) the designated officer must, in writing, give to the donor any such information recorded in the Register kept at the centre. Penalty: 50 penalty units. S. 72(3) amended by No. 37/1997 s. 19(d). (3) On receiving a request for information under subsection (1)(b) the designated officer must give any such information recorded in the Register kept at the centre, if the woman and her husband have first consented to the giving of that information. Penalty: 50 penalty units. (4) Information given under sub-section (3) must be given— (a) in writing; and S. 72(4)(b) amended by No. 37/1997 s. 19(d). (b) in accordance with any conditions or limitations imposed by the woman or her husband. S. 72(5) amended by No. 37/1997 s. 19(d). (5) A donor may ask a doctor who proposes to carry out a donor insemination at a place other than a licensed centre using sperm from that donor for information required to be recorded in the Register kept by the doctor about the woman who is to or may undergo the insemination and her husband, being either or both of the following— S. 72(5)(a) amended by No. 37/1997 s. 19(d). (a) information about that woman or her husband (other than information from which the woman or her husband will or may be identified); 3-30/12/97 65 Infertility Treatment Act 1995 Act No. 63/1995 (b) information which will or may identify that woman or her husband. (6) On receiving a request for information under subsection (5)(a) the doctor must, in writing, give to the donor any such information recorded in the Register kept by the doctor. s. 73 S. 72(5)(b) amended by No. 37/1997 s. 19(d). Penalty: 50 penalty units. (7) On receiving a request for information under subsection (5)(b), the doctor must give any such information recorded in the Register kept at the centre, if the woman and her husband have first consented to the giving of that information. S. 72(7) amended by No. 37/1997 s. 19(d). Penalty: 50 penalty units. (8) Information given under sub-section (7) must be given— (a) in writing; and (b) in accordance with any conditions or limitations imposed by the woman or her husband. 73. Information about pregnancy, birth or transfer (1) A donor may ask the designated officer of a licensed centre where gametes of the donor or a zygote or an embryo formed from gametes of the donor may have been used in a treatment procedure at the centre whether or not a pregnancy has occurred or a person has been born as a result of such a procedure. (2) On receiving a request under sub-section (1), the designated officer must, in writing, advise the donor, as to whether or not, to the designated officer's knowledge, a pregnancy has occurred or a person has been born as a result of such a procedure. 3-30/12/97 66 S. 72(8)(b) amended by No. 37/1997 s. 19(d). Infertility Treatment Act 1995 Act No. 63/1995 s. 74 (3) A donor may ask a doctor who carries out donor insemination at a place other than a licensed centre who may have used sperm from the donor in such a procedure as to whether or not a pregnancy has occurred or a person has been born as a result of such a procedure. (4) On receiving a request under sub-section (3), the doctor must, in writing, advise the donor as to whether or not, to the doctor's knowledge, a pregnancy has occurred or a person has been born as a result of such a procedure. (5) At the request of a donor, the designated officer of a licensed centre where the donor's gametes were stored or kept or donated, or a doctor who may have kept or received the donor's gametes must, if the gametes or a zygote or embryo formed from the gametes have been transferred to another place, give to the donor the name of the doctor to whom or the licensed centre or other place to which the gametes, zygote or embryo have been transferred. Penalty applying to this section: 50 penalty units. Division 3—Information to be given from central register 74. Application by parents for information contained on central register (1) The parents or guardian of a person born as a result of a donor treatment procedure may apply to the Authority for information required to be recorded in the central register about a donor whose gametes were used in the procedure or whose gametes were used to form a zygote or an embryo used in the procedure, being either or both of the following— 3-30/12/97 67 Infertility Treatment Act 1995 Act No. 63/1995 (a) information about the donor (other than information from which the donor will or may be identified); (b) information which will or may identify the donor. (2) An application under this section must— (a) be in writing; and (b) be in the prescribed form and accompanied by the prescribed fee. 75. Authority to give information about donor to parents (1) On receiving an application for information under section 74(1)(a) the Authority must give, in writing, any such information recorded in the central register to the applicant, if the Authority is satisfied that the applicant has been offered counselling about the potential consequences of the disclosure of that information from a counsellor who has been approved under Part 8 to give counselling to persons applying for information under section 74. (2) On receiving an application under section 74(1)(b) the Authority must give, in writing, any such information recorded in the central register to the applicant— (a) if the donor has first consented to the giving of that information; and (b) if the information is given in accordance with any conditions or limitations imposed by the donor; and (c) if the Authority is satisfied that the applicant has received counselling about the potential consequences of the disclosure of that information from a counsellor who has been approved under Part 8 to give counselling to 3-30/12/97 68 s. 75 Infertility Treatment Act 1995 Act No. 63/1995 s. 76 persons applying for information under section 74. (3) The Authority must make reasonable efforts to find the person whose consent is required under sub-section (2). (4) Before seeking the consent for the giving of information to an applicant under sub-section (2), the Authority must advise the person whose consent is required that he or she may need counselling and provide him or her with the names of counsellors approved under Part 8 to give counselling to persons in respect of whom an application has been made under section 74. (5) If a person consents to the giving of the information under sub-section (2), before the information is given the Authority must make reasonable efforts to advise that person that the information is about to be given. 76. Application by donor for information about persons born as a result of donor treatment procedures and parents of such persons (1) A donor may apply to the Authority for information required to be recorded in the central register about any person born as a result of a treatment procedure, and a parent or the parents of any such person, if gametes produced by the donor, or a zygote or an embryo formed from gametes produced by the donor were used in the treatment procedure, being any or all of the following— (a) information about the person born as a result of the procedure (other than information from which the person will or may be identified); 3-30/12/97 69 Infertility Treatment Act 1995 Act No. 63/1995 (b) information which will or may identify the person born as a result of the procedure; (c) information about a parent or both parents (other than information from which either or both of them will or may be identified); (d) information which will or may identify either or both of the parents. (2) An application under this section must— (a) be in writing; and (b) be in the prescribed form and accompanied by the prescribed fee. 77. Authority to give information about person born as a result of a donor treatment procedure (1) On receiving an application for information under section 76(1)(a) the Authority must give, in writing, any such information recorded in the central Register to the applicant, if the Authority is satisfied that the applicant has been offered counselling about the potential consequences of the disclosure of that information from a counsellor approved under Part 8 to give counselling to persons applying for information under 76. (2) On receiving an application for information under section 76(1)(b) the Authority must give, in writing, any such information recorded in the central register to the applicant— (a) if— (i) in the case of a person who is under 18 years of age, both parents or a guardian of that person have first consented to the giving of that information; or (ii) in the case of a person who has attained the age of 18 years, the person has 3-30/12/97 70 s. 77 Infertility Treatment Act 1995 Act No. 63/1995 s. 78 consented to the giving of that information; and (b) if the information is given in accordance with any conditions or limitations imposed by each person who has consented; and (c) if the Authority is satisfied that the applicant has received counselling about the potential consequences of the disclosure of the information from a counsellor approved under Part 8 to give counselling to persons applying for information under 76. (3) The Authority must make reasonable efforts to find a person whose consent is required under sub-section (2). (4) Before seeking consent to the giving of information to an applicant under sub-section (2), the Authority must advise a person whose consent is required that he or she may need counselling and provide the person with the names of counsellors approved under Part 8 to give counselling to a person in respect of whom an application has been made under section 76. (5) If a person consents to the giving of the information under sub-section (2), before the information is given the Authority must make reasonable efforts to advise that person that the information is about to be given. 78. Authority to give information about parents (1) On receiving an application for information under section 76(1)(c) the Authority must give, in writing, any such information recorded in the central register to the applicant, if the Authority is satisfied that the applicant has been offered counselling about the potential consequences of the disclosure of that information from a 3-30/12/97 71 Infertility Treatment Act 1995 Act No. 63/1995 counsellor who has been approved under Part 8 to give counselling to persons applying for information under section 76. (2) On receiving an application for information under section 76(1)(d) the Authority must give, in writing, any such information recorded in the central register about a parent to the applicant— (a) if the person has first consented to the giving of that information; and (b) if information would also identify the person born as the result of a donor treatment procedure and the person is over 18 years of age, that person has consented to the giving of that information; and (c) if information will or may also identify the other parent, that parent has also consented to the giving that information; and (d) if the information is given in accordance with any conditions or limitations imposed by each person who has consented; and (e) if the Authority is satisfied that the applicant has received counselling about the potential consequences of the disclosure of the information from a counsellor who has been approved under Part 8 to give counselling to persons applying for information under section 76. (3) The Authority must make reasonable efforts to find a person whose consent is required under sub-section (2). (4) Before seeking consent to the giving of information to an applicant under sub-section (2), the Authority must advise a person whose consent is required that he or she may need counselling and provide the person with the names of 3-30/12/97 72 s. 78 Infertility Treatment Act 1995 Act No. 63/1995 s. 79 counsellors approved under Part 8 to give counselling to a person in respect of whom an application has been made under 76. (5) If a person consents to the giving of the information under sub-section (2), before the information is given the Authority must make reasonable efforts to advise that person that the information is about to be given. 79. Application by person born as a result of a donor treatment procedure or descendant for information about donor (1) A person who is or may have been born as the result of a donor treatment procedure or who is the descendant of such a person may, on attaining the age of 18 years, apply to the Authority for information required to be recorded in the central register about a donor whose gametes were used in the procedure or whose gametes were used to form a zygote or embryo used in the procedure, being either or both of the following— (a) information about the donor (other than information from which the donor will or may be identified); (b) information which will or may identify the donor. (2) An application under this section must— (a) be in writing; and (b) be in the prescribed form and accompanied by the prescribed fee. 80. Authority to give information about donor to person born as the result of a procedure (1) On receiving an application for information under section 79(1)(a) the Authority must give, in writing, any such information recorded in the 3-30/12/97 73 Infertility Treatment Act 1995 Act No. 63/1995 central register to the applicant, if the Authority is satisfied that the applicant has been offered counselling about the potential consequences of the disclosure of that information from a counsellor who has been approved under Part 8 to give counselling to persons applying for information under section 79. (2) On receiving an application for information under section 79(1)(b), the Authority must— (a) give, in writing, any such information recorded in the central register to the applicant if it is satisfied that the applicant has received counselling about the potential consequences of the disclosure of the information from a counsellor who has been approved under Part 8 to give counselling to persons applying for information under section 79; and (b) prior to the giving of the information make reasonable efforts— (i) to advise the donor that the information is about to be given; and (ii) to advise the donor that he or she may need counselling and provide the donor with the names of counsellors approved under Part 8 to give counselling to persons in respect of whom applications have been made under section 79. 81. Counselling not applicable in certain circumstances The Authority may waive a requirement in this Division requiring it to be satisfied that an applicant for information has received counselling if it is satisfied that the applicant is already aware 3-30/12/97 74 s. 81 Infertility Treatment Act 1995 Act No. 63/1995 s. 82 of the substance of the information to be given and that counselling is not appropriate. 82. Donor treatment procedure information register (1) The Authority shall establish and maintain a donor treatment procedure information Register. (2) There shall be entered in the Register— (a) the names and addresses of persons, including— (i) persons born as a result of donor treatment procedures; (ii) the descendants of persons born as a result of donor treatment procedures; (iii) donors; (iv) women who have undergone donor treatment procedures and their husbands; and (v) the relatives of persons described in this section— who have requested the Authority in writing to so enter their names and addresses; and (b) in relation to each person so registered, the wishes of the person in relation to— (i) obtaining information about another person whose name is, or may in the future be, entered in the Register; or (ii) another person whose name is, or may in the future be, entered in the Register obtaining information about him or her. (3) The Authority shall from time to time publicise the establishment and purpose of the Register. 3-30/12/97 75 Infertility Treatment Act 1995 Act No. 63/1995 (4) The Authority shall upon the request of a person whose name is entered in the Register, amend or cancel the entry relating to that person, or give the person a copy of the entry. (5) The Register is not part of the central register. (6) The Register shall be kept in accordance with the regulations. Division 4—General provisions 83. Information Any reference to the giving of information which will or may identify a person in this Act or the regulations means the giving, disclosing or publication of information from which a person will or may be identified, directly or indirectly. 84. Waiver of fees The Authority may waive or reduce, in a particular case or class of cases, fees that would otherwise be payable to it under this Part or the regulations. 85. Disclosure of information to a medical practitioner If a person has applied for information under this Part or the regulations, and the person to whom the application has been made considers that the disclosure of information which is of a medical or psychiatric nature to the applicant might be prejudicial to the physical or mental health or well-being of the applicant, the person to whom the application has been made may decide not to disclose that information to the applicant but to disclose it instead to a medical practitioner nominated by the applicant. 3-30/12/97 76 s. 83 Infertility Treatment Act 1995 Act No. 63/1995 s. 86 86. Records of information given A person who gives any information under this Division or Division 2 or 3 or the regulations must keep a record of the person to whom the information has been given and of the information given. Penalty: 50 penalty units. 87. Consent (1) In this Division, Divisions 2 and 3 and the regulations, if consent is required to be given and the person to whom the consent relates is dead, the consent may be given by the senior available next of kin of that person, within the meaning of the Human Tissue Act 1982. (2) In this Division and the regulations, if consent is required to be given and the person to whom the consent relates is a person under the age of 18 years, the consent may be given by both parents of the child or by the child's guardian. (3) In this Division, Divisions 2 and 3 and the regulations, when information may only be given with consent, information must not be given if that consent is subsequently withdrawn in writing prior to the giving of the information. 88. Authority may refuse to give information If an application for information about a person under the age of 18 years has been made under this Part or the regulations which requires the consent of the parent or guardian of that person, and if that person has advised the Authority that he or she does not want the information to be given by the Authority, the Authority may refuse the application. 3-30/12/97 77 Infertility Treatment Act 1995 Act No. 63/1995 89. Confidentiality—information which may identify (1) A listed person must not, except to the extent necessary— (a) to carry out functions under this Act or any other Act or regulations made under this Act or any other Act; or (b) to give any information he or she is expressly authorised, permitted or required to give under this or any other Act (other than section 141(3) of the Health Services Act 1988) or regulations made under this Act or any other Act— give to any other person, whether directly or indirectly, any information acquired by reason of being a listed person if— (c) a person who is or has been a donor, or a woman who is to undergo, or may undergo, a treatment procedure or who has undergone a treatment procedure or a man who is or has been the husband of such a person, or a person who was born as a result of a treatment procedure, will or may be identified from that information; or (d) the information is the name or address entered in the Register kept under section 82 in relation to a person not referred to in paragraph (c). Penalty: 50 penalty units. (2) Sub-section (1) does not apply— (a) subject to sub-sections (5), (6) and (7), to the giving of information with the prior consent in writing of the person about whom the information relates and any other person who 3-30/12/97 78 s. 89 Infertility Treatment Act 1995 Act No. 63/1995 s. 89 will or may be identified from the giving of that information; or (b) to the giving of information to a court or tribunal in the course of legal proceedings; or (c) to the giving of information pursuant to an order of a court or tribunal made under another Act or law; or (d) to the giving of information as described in section 141(3)(d), (f) or (ga) of the Health Services Act 1988 in relation to all of the persons referred to in sub-section (1)(c); or (e) to the giving of information as described in section 141(3)(c) of the Health Services Act 1988 in relation to a patient who is a woman that is to undergo, or may undergo, a treatment procedure or who has undergone a treatment procedure or who is the husband of such a woman; or (f) to the giving of information with the consent of the Minister and in accordance with the conditions specified by the Minister, if the Minister is of the opinion that it is in the public interest that the information be so given; or (g) to the giving of information to the extent reasonably required to enable the enforcement or investigation of the criminal law; or (h) where the information relates to a woman who is to undergo, or may undergo, a treatment procedure or who has undergone a treatment procedure or to the husband of such a woman, the giving of information where it is reasonably required for the 3-30/12/97 79 Infertility Treatment Act 1995 Act No. 63/1995 medical treatment of the woman or her husband; or (i) to the giving of information to another listed person to the extent necessary to carry out any procedure, research or other activity authorised or regulated by this Act. (3) In this section— "listed person" means— (a) the licensee of a licensed centre and any person who is or has been a member or officer of the governing body of that licensee; or (b) a person who— (i) is or has been involved in the management of, engaged or employed at or worked for or at a licensed centre; or (ii) is or has been a doctor approved under Part 8 to carry out donor insemination at a place other than a licensed centre or any person who is or has been engaged or employed by or worked for or with such a doctor; or (c) a person who is or had been a designated officer or an approved doctor, scientist or counsellor; or (d) any person who carries out or has carried out or is or has been involved in the carrying out of— (i) a treatment procedure, whether or not at a licensed centre; or (ii) research under Part 3 at a licensed centre; or 3-30/12/97 80 s. 89 Infertility Treatment Act 1995 Act No. 63/1995 s. 89 (iii) anything authorised to be done under this Act; (iv) any other function under this Act; or (e) the Authority established under this Act or any person who is or has been a member of that Authority or employed or engaged to assist the Authority to carry out its functions; or S. 89(3)(f) repealed by No. 37/1997 s. 5(1)(c). * * * * * (g) any person who is or has been an authorised officer; or (h) any person who is or has been involved in the administration of this Act or any corresponding previous enactment. (4) A reference to any other Act or to a regulation made under any other Act in sub-section (1) does not include a reference to— (a) a provision which requires or permits the giving of information with the consent of the person to whom the information relates or the consent of the senior available next of kin of that person, if he or she has died, or of the consent of a parent or guardian of such a person; or (b) the Freedom of Information Act 1982 or a regulation made under that Act, except to the extent provided for in section 92. (5) Consent cannot be given by a person under subsection (2)(a) to the giving of information to another person— 3-30/12/97 81 Infertility Treatment Act 1995 Act No. 63/1995 (a) where that other person has made or may make an application for that information under Divisions 2 or 3 or the regulations in relation to that person; or (b) in the prescribed circumstances. (6) Consent cannot be given under sub-section (2)(a) by a person described in sub-section (1)(c) to the giving of the entry in the Register kept under section 82 in relation to the address of that person, or to the giving of that person's current address, to another person who has made or may make an application for information in relation to that person under Division 3 or the regulations, unless the person who is seeking the information has made such an application under the relevant provisions or the regulations (as the case may be) and has been given the name of the person to be identified in accordance with the Act or the regulations. (7) To the extent that information will or may identify both a person who was born as a result of a treatment procedure and any other person described in sub-section (1), the information may be given under sub-section (2)(a) if— (a) the person to whom the information relates was born as a result of the procedure, and has attained the age of 18 years; and (b) that person consents to the giving of the information— notwithstanding that the other person who will or may be identified does not consent. 90. Confidentiality—non-identifying information (1) A listed person (within the meaning of section 89) must not give to another person, directly or 3-30/12/97 82 s. 90 89 Infertility Treatment Act 1995 Act No. 63/1995 indirectly, any information acquired by reason of being a listed person which can be the subject matter of an application under Divisions 2 or 3 or the regulations (other than information from which a person will or may be identified), where that person can make or has made an application for that information under Divisions 2 or 3 or the regulations, except in accordance with those provisions or section 184, or to the extent necessary— (a) to carry out other functions under this Act or any other Act or a regulation made under this Act or any other Act; or (b) to give information he or she is otherwise expressly authorised, permitted or required to give under this or any other Act or a regulation made under this Act or any other Act. Penalty: 50 penalty units. (2) Sub-section (1) does not apply to— (a) the giving of information with the consent of the Minister and in accordance with the conditions specified by the Minister, if the Minister is of the opinion that it is in the public interest that the information be so given; or (b) the giving of information pursuant to an order of a court or tribunal made under another Act or law. (3) A reference to any other Act or to a regulation made under any other Act in sub-section (1) does not include a reference to the Freedom of Information Act 1982 or a regulation made under that Act, except to the extent provided for in section 92. 3-30/12/97 83 Infertility Treatment Act 1995 Act No. 63/1995 91. Closure of court or tribunal (1) If, in a matter before a court or tribunal, evidence is proposed to be given of any information referred to in section 89(1)(c) or (d), the court or tribunal, in addition to any other powers the court or tribunal may have, if it is of the opinion that it is necessary to do so because it is appropriate to protect the privacy of the person to whom the information relates, may— (a) order that the whole or any part of the proceedings be heard in closed session; or (b) order that only persons specified by it may be present during the whole or any part of the proceedings; or (c) make an order prohibiting the publication of a report of the whole or any part of the proceedings or of any information derived from the proceedings. (2) If an order has been made under this section, the court or tribunal must cause a copy of it to be posted on a door of, or in another conspicuous place at, the place at which the court or tribunal is being held. (3) A person must not contravene an order made and posted under this section. Penalty: 50 penalty units. 92. Exemption from Freedom of Information Act 1982 (1) Subject to sub-sections (2) and (3), for the purposes of the Freedom of Information Act 1982, a document is an exempt document if— (a) it contains information (whether or not that information is kept in a Register under this Part) about or provided by a person as— (i) a donor or the spouse of a donor; or 3-30/12/97 84 s. 91 Infertility Treatment Act 1995 Act No. 63/1995 s. 92 (ii) a woman who is to undergo, or may undergo, a treatment procedure or who has undergone a treatment procedure; or (iii) a person who is or has been the husband of a woman referred to in paragraph (ii); or (iv) a person who was born as a result of a treatment procedure; or (b) it is the Register, or part of the Register, under section 82. (2) A document is not an exempt document under sub-section (1)(a) to the extent that it only contains information— (a) about or provided by the applicant and no other person; or (b) about or provided by one person only and the applicant is that person's guardian. (3) A document that contains information about or provided by a person referred to in sub-section (1)(a) (other than information from which that person will or may be identified) is not an exempt document in the prescribed circumstances. _______________ 3-30/12/97 85 Infertility Treatment Act 1995 Act No. 63/1995 PART 8—LICENCES, APPROVALS AND DESIGNATED OFFICERS Division 1—Licensing of places 93. Licence application—hospitals and day procedure centres An application may be made by— (a) a public hospital; or (b) a denominational hospital, or, if the hospital is not a legal person, a nominee of the hospital who is a legal person; or (c) the proprietor of a private hospital or day procedure centre, or, if the proprietor is not a legal person, a nominee of the proprietor who is a legal person— to the Authority for a licence for all or any of the following activities at the premises of the hospital or centre— (d) the carrying out of treatment procedures or treatment procedures of a particular kind; (e) the forming of an embryo outside the body of a woman; (f) the storage of gametes, zygotes or embryos; (g) the undertaking of approved research of the kind described in section 22(1)(a) or (b). 94. Licence application—research institutions An application may be made by— (a) a university; or (b) any other research or educational institution or institution where research is undertaken, or the proprietor of such an institution, or the 3-30/12/97 86 s. 93 Infertility Treatment Act 1995 Act No. 63/1995 s. 95 governing body of such an institution, where the institution, proprietor or governing body is a legal person; or (c) in relation to an institution described in paragraph (b), where the institution, proprietor and governing body are not legal persons, a nominee of the proprietor or governing body who is a legal person— to the Authority for a licence for either or both of the following activities at premises of the university or institution— (d) the undertaking of approved research of the kind described in section 22(1)(a) or (b); (e) the storage of gametes, zygotes or embryos. 95. Designation of principal doctor or principal scientist (1) On an application under section 93(g) or 94(d) or sub-section (2) or (3) of this section, the Authority, after considering nominations from the applicant, must designate a doctor or scientist approved under Division 3 to carry out research or a person who has applied to be such a doctor or scientist to be the principal doctor or principal scientist responsible for the undertaking of the approved research at the premises to which the application relates. (2) If, during the course of the licence, the principal doctor or principal scientist dies, resigns, is suspended or ceases to be a approved under Division 3 to carry out research, the licensee must, within 14 days after that event, apply to the Authority to designate another doctor or scientist who has been approved under Division 3 to carry out research to be the principal doctor or principal scientist or to be that doctor or scientist during the period of suspension, as the case requires. 3-30/12/97 87 Infertility Treatment Act 1995 Act No. 63/1995 (3) If, during the course of the licence, the licensee wishes to make any other change in the principal doctor or principal scientist, the licensee must first apply to the Authority to designate another doctor or scientist to be the principal doctor or principal scientist. 96. Licence applications—general procedure (1) An application for a licence must— (a) be in writing; and (b) specify the activities for which the licence is sought; and (c) be in the form determined by the Authority and accompanied by the fee determined by the Authority. (2) The Authority may require the applicant to provide further information or material in respect of the application and may, with the consent of the applicant, enter and inspect any premises in respect of which a licence application has been made. (3) The Authority may refuse to consider an application for a licence until the information or material requested under sub-section (2) is provided. (4) The Authority may refuse to grant an application for a licence if the applicant refuses to consent to an entry or inspection of premises under subsection (2). 97. Authority may grant or refuse licence (1) The Authority may grant or refuse to grant a licence to the applicant. (2) The Authority may determine a fee that is payable by the applicant prior to the issuing of a licence. 3-30/12/97 88 s. 96 Infertility Treatment Act 1995 Act No. 63/1995 s. 98 (3) A licence authorises the carrying out of the activities specified in the licence at the premises specified in the licence. (4) The Authority must not— (a) grant a licence in relation to an activity described in section 93(g) or 94(d) unless it is satisfied that, if a person has been designated under section 95 who was not, at the time a scientist approved under Division 3 to carry out research or a doctor approved under Division 3 to carry out research, that person has been granted approval under Division 3 to carry out research; or (b) grant a licence in relation to an activity described in section 93(d), (e) or (g) or 94(d) unless it is satisfied that the applicant, in order to approve and monitor the licensed activities at the premises to be licensed, has established an ethics committee, or is able to use the services of an ethics committee established by another licensee; or (c) grant a licence unless it is satisfied that there are facilities at the premises to be licensed which are appropriate for the carrying out of the activities for which the licence is sought. Division 2—Approval to carry out research 98. Application for approval to carry out research (1) A doctor or scientist who has been approved under Division 3 to carry out research may apply to the Authority for approval to carry out research of the kind described in section 22(1)(a) or (b). (2) A doctor or scientist may apply to the Authority for approval to carry out research of the kind described in section 22(2)(a), (b) or (c). 3-30/12/97 89 Infertility Treatment Act 1995 Act No. 63/1995 s. 99 (3) An application under this section must— (a) be in writing; and (b) be in the form determined by the Authority and accompanied by the fee determined by the Authority; and (c) specify the research proposed to be carried out, and the premises at which it is to be carried out. (4) The Authority may require the applicant to provide further information or material in respect of the application and may, with the consent of the applicant, enter and inspect any premises in respect of which the application has been made. (5) The Authority may refuse to consider an application for approval until the information or material requested under sub-section (4) is provided. (6) The Authority may refuse to grant an application for approval if the applicant refuses to consent to an entry or inspection of premises under subsection (3). * * * * * S. 98(7)(8) repealed by No. 37/1997 s. 5(1)(d). 99. Approval by Authority to carry out research (1) The Authority may grant or refuse an application for approval under section 98. * * * * * (3) The Authority may determine a fee that is payable by the applicant prior to the issue of an approval. 3-30/12/97 90 S. 99(1) amended by No. 37/1997 s. 5(1)(e)(i). S. 99(2) repealed by No. 37/1997 s. 5(1)(e)(ii). Infertility Treatment Act 1995 Act No. 63/1995 s. 100 (4) An approval authorises the holder or a person working under the direction or supervision of the holder to carry out the research specified in the approval at the premises specified in the approval. 100. Report of results of research to Authority (1) A doctor or scientist who has received the approval of the Authority under this Division must— (a) if the research does not go on for more that 12 months, report the results of that research to the Authority as soon as possible after completing that research; or (b) if the research goes on for more than 12 months, report the results of that research to the Authority, at the intervals determined by the Authority and advised in writing to the doctor or scientist. Penalty: 50 penalty units. S. 100(2) repealed by No. 37/1997 s. 5(1)(f). * * * * * Division 3—Approval of persons carrying out treatment procedures or research 101. Application for approval of doctor or scientist (1) A doctor may apply to the Authority for approval— (a) to carry out treatment procedures of a particular kind; or (b) to form an embryo outside the body of a woman; or 3-30/12/97 91 Infertility Treatment Act 1995 Act No. 63/1995 (c) to carry out and be responsible for the carrying out of approved research under section 22(1). (2) A scientist of an institution may apply to the Authority for approval— (a) to carry out and be responsible for the carrying out of approved research under section 22(1); or (b) to form an embryo outside the body of a woman. (3) An application under this section must— (a) be in writing; and (b) be in the form determined by the Authority and accompanied by the fee determined by the Authority. (4) The Authority may require the applicant to provide further information or material in respect of the application. (5) The Authority may refuse to consider an application for a licence until the information or material requested under sub-section (4) is provided. 102. Authority may grant or refuse approval (1) The Authority may grant or refuse an application for approval under section 101. (2) The Authority may determine a fee that is payable by the applicant prior to the issue of the approval. (3) An approval authorises the holder to carry out the activities specified in the approval. (4) In relation to donor insemination, an approval must specify whether or not the doctor may carry out donor insemination at a place other than a licensed centre. 3-30/12/97 92 s. 102 Infertility Treatment Act 1995 Act No. 63/1995 s. 103 Division 4—Approved counsellors 103. Application for approval of counsellors (1) A person who wishes to be an approved counsellor may apply to the Authority for approval under this Division. (2) The application must— (a) be in writing; and (b) in the form approved by the Authority and accompanied by the fee determined by the Authority. (3) The Authority may require an applicant to provide further information or material in respect of an application. (4) The Authority may refuse to consider an application for approval until the information or material requested under sub-section (2) is provided. 104. Authority may grant or refuse approval (1) The Authority may grant or refuse an application for approval under section 103. (2) The Authority may determine a fee that is payable by the applicant prior to the issue of the approval. (3) An approval authorises the holder to act as an approved counsellor— (a) for the kinds of treatment procedures, research or other circumstances specified in the approval; (b) for the classes of people specified in the approval. Division 5—General provisions about licences, approvals and exemptions 3-30/12/97 93 Infertility Treatment Act 1995 Act No. 63/1995 105. Form and content of licence or approval (1) A licence or approval under this Part must be in writing. (2) A licence or approval must specify— (a) the matters required to be specified by this Part; and (b) any conditions, limitations or restrictions— (i) prescribed for that class of licences or approvals; or (ii) imposed under section 106 or 107; and (c) any other prescribed information. 106. Power of Authority to impose conditions (1) In an approval or a licence granted or renewed under this Part, the Authority may impose conditions, limitations or restrictions. (2) The matters about which the Authority may impose conditions, limitations or restrictions include but are not limited to all or any of the following— (a) the collection, use, storage and removal from storage of gametes and the formation, use or storage of embryos and zygotes; (b) the manner in which procedures ancillary to the performance of treatment procedures are to be carried out; (c) the manner in which approved research or treatment procedures are to be carried out; (d) the manner in which diagnostic services related to infertility or treatments regulated by this Act for genetic abnormality or disease may be performed; 3-30/12/97 94 s. 105 Infertility Treatment Act 1995 Act No. 63/1995 s. 107 (e) the obtaining of information under Parts 2, 3 and 7; (f) counselling required by this Act; (g) the manner in which research under section 22(3) is performed by doctors or scientists approved to perform research under Division 3 or at a place licensed under Division 1; (h) the provision of information by doctors under Parts 2 and 3. 107. Provision of information It is a condition of each licence or approval or exemption that the licensee or approval holder or exemption holder must, at the written direction of the Authority, provide to the Authority in the form and at the intervals specified in the direction— (a) copies of or extracts from any information which the licensee or approval holder or exemption holder is required to record under this Act; and (b) any other information relating to activities at the licensed centre or the premises of the approved person or the premises where the research or approved or exempt activity is carried out which the Authority considers relevant to the carrying out of the Authority's functions under this Act. 108. Variation of conditions of licences or approvals under this Part (1) The Authority may, by notice in writing given to the licensee or approval holder, vary any condition, limitation or restriction of the licence or an approval under Part 8. 3-30/12/97 95 Infertility Treatment Act 1995 Act No. 63/1995 (2) The Authority cannot under this section vary a prescribed condition, limitation or restriction included in the licence or approval. (3) Before varying a condition, limitation or restriction of the licence or approval, the Authority must allow the licensee or approval holder the opportunity to make written submissions. (4) The Authority must have regard to any submissions made under sub-section (3) and may have regard to any other relevant matters. 109. Variation of approvals and exemptions under Part 5 (1) An approval or exemption under sections 40, 51, 52, or 56 or the terms or conditions of such an approval or exemption may be amended or varied by the Authority, by notice in writing given to the holder of the approval or exemption. (2) Before making an amendment or variation under this section, the Authority must allow the approval or exemption holder the opportunity to make written submissions. (3) The Authority must have regard to any submissions made under sub-section (2) and may have regard to any other relevant matters. 110. Offence of failing to comply with terms etc. of licence or approval A person to whom a licence or approval has been granted or renewed under this Part or section 51 or 52 must— (a) comply with the terms, conditions, limitations or restrictions of the licence or approval; or 3-30/12/97 96 s. 109 Infertility Treatment Act 1995 Act No. 63/1995 s. 111 (b) if the condition, limitation or restriction must be complied with by another person, take reasonable steps to ensure that the term, condition or restriction is complied with. Penalty: 240 penalty units or 2 years imprisonment or both. 111. Duration and renewal of licence or approval (1) If the Authority determines that a fee is payable by an applicant as described in section 97(2), 99(3), 102(2) or 104(2), the licence or approval in question does not take effect until the fee is paid and the licence or approval is issued. (2) A licence or approval continues in force for the period determined by the Authority and specified in the licence or approval, which may be either— (a) for that licence or approval; or (b) for the class of licences or approvals of which that licence or approval is one. (3) A licence or approval granted under Division 1, 3 or 4 may be renewed. 112. Application for renewal (1) An application for renewal of a licence or approval— (a) must be made to the Authority, in the time specified by the Authority, before the existing licence or approval expires; and (b) must be made in the form determined by the Authority; and (c) must be accompanied by the fee determined by the Authority; (d) must comply in all other respects with the requirements for an application for a licence or approval under this Part. 3-30/12/97 97 Infertility Treatment Act 1995 Act No. 63/1995 (2) Subject to sub-section (4), sections 95, 96(2), (3) and (4), 97, 101(4) and (5), 102, 103 (3) and (4) and 104 and the prescribed provisions (if any) apply to the renewal of a licence or approval. (3) This Division and any other provision of this Act or the regulations that relates to a licence or approval applies to a licence or approval that has been renewed, unless the contrary intention appears. (4) The Authority may grant a temporary renewal even if it is not satisfied that a renewal is appropriate, pending the outcome of an investigation, inquiry or other matter commenced or under consideration by the Authority, prior to the expiry of the approval or licence; and for this purpose that investigation, inquiry or other matter or consideration may continue to apply, so that the Authority may consider whether to suspend or revoke the renewed licence or approval. 113. Suspension of licence, approval or exemption (1) The Authority may, by notice in writing given to the licensee or the approval holder or exemption holder, suspend a licence or approval or exemption granted or renewed under this Part or section 56, either in whole or in part if the Authority is satisfied that there are reasonable grounds to do so. (2) Before suspending a licence or approval, the Authority must allow the licensee, approval holder or exemption holder the opportunity to make written submissions. (3) The Authority must have regard to any written submissions made under sub-section (2). (4) A suspension under this section has effect— 3-30/12/97 98 s. 113 Infertility Treatment Act 1995 Act No. 63/1995 s. 115 114 (a) from the time at which notice of it is given to the licensee, approval holder or exemption holder; and (b) for the period determined by the Authority. 114. Immediate suspension (1) Despite section 113, the Authority may suspend a licence, approval or exemption referred to in that provision without allowing the licensee, approval holder or exemption holder an opportunity to make submissions if— (a) the Authority is of the opinion that there is an overriding public interest which requires the licence, approval or exemption to be suspended immediately; and (b) the Authority has obtained the Minister's approval to do so. (2) A suspension under sub-section (1)— (a) has effect from the time at which notice of it is given to the licensee, approval holder or exemption holder; and (b) remains in force for that period, determined by the Authority, which must be no longer than is reasonably necessary to safeguard the public interest for which the suspension was imposed. (3) At any time during the period of the suspension, the Authority must allow the licensee, approval holder or exemption holder to make written submissions about the suspension. (4) The Authority may revoke the suspension at any time, and must have regard to any submissions made under sub-section (3) in determining whether or not to do so. 115. Cancellation of licence, approval or exemption 3-30/12/97 99 Infertility Treatment Act 1995 Act No. 63/1995 (1) The Authority may, by notice in writing, given to the licensee, approval holder or exemption holder cancel a licence or approval or exemption, either in whole or in part if— (a) the Authority is satisfied that there are reasonable grounds to do so; or (b) without limiting the generality of paragraph (a)— (i) in the case of a licence, a person has been found guilty of an offence against this Act, the regulations, the Infertility (Medical Procedures) Act 1984 or the regulations under that Act, at the licensed centre (whether before or after the commencement of this section); or (ii) in the case of an approval or exemption, the approved person or a person acting under his or her supervision or any other holder of an approval or exemption has been found guilty of an offence against this Act, the regulations, the Infertility (Medical Procedures) Act 1984, or the regulations under that Act (whether before or after the commencement of this section); or (iii) in the case of a licence or approved research, a person has breached this Act, the regulations, the Infertility (Medical Procedures) Act 1984 or the regulations under that Act, at the premises which are the subject of the licence or approval (whether before or after the commencement of this section); or 3-30/12/97 100 Infertility Treatment Act 1995 Act No. 63/1995 s. 116 (iv) in the case of an approval or exemption, the approved person or a person acting under his or her supervision, or any other holder of an approval or exemption has breached this Act, the regulations, the Infertility (Medical Procedures) Act 1984 or the regulations under that Act (whether before or after the commencement of this section); or (v) there has been a breach (whether or not before or after the commencement of this section) of a condition, limitation, restriction or term of a licence, approval or an exemption or a breach of a term or condition of an approval given under the Infertility (Medical Procedures) Act 1984. (2) Before cancelling a licence or approval, the Authority must allow the licensee, approval holder or exemption holder the opportunity to make written submissions. (3) The Authority must have regard to any written submissions made under sub-section (2). (4) A cancellation under this section has effect from the time at which notice of it is given to the licensee, approval holder or exemption holder. 116. Orders (1) If the Authority cancels or suspends a licence, the Authority, having first obtained the Minister's approval may, by notice in writing given to the former licensee, make any order that the Authority thinks fit in relation to all or any of the following— 3-30/12/97 101 Infertility Treatment Act 1995 Act No. 63/1995 (a) the appointment of an administrator to carry out the functions of the licensee in relation to any activities affected by the cancellation or suspension; (b) the continuation of any treatment procedures affected by the cancellation or suspension; (c) the manner of dealing with gametes, zygotes or embryos stored at any place for treatment procedures or for research, and the transfer of gametes, zygotes or embryos so stored to a licensed centre; (d) the directions to be given about the transfer of research or treatment procedures affected by the cancellation or suspension to the person who has agreed to accept the transfer; (e) the keeping and transfer of records; (f) any other matter that the Authority considers relevant. (2) If the Authority cancels or suspends an approval under Division 2, the Authority, having first obtained the Minister's approval may, by notice in writing given to the licensee or the holder of the approval to carry out the research, make any order that the Authority thinks fit in relation to all or any of the following— (a) the appointment of an administrator to carry out the functions of the licensee or holder of the approval in relation to research affected by the cancellation or suspension; (b) the manner of dealing with, and the transfer of, gametes, zygotes, embryos, parthenogenetic oocytes or parthenogenes stored or kept at any place for research; (c) the directions to be given about the transfer of research affected by the cancellation or 3-30/12/97 102 s. 116 Infertility Treatment Act 1995 Act No. 63/1995 s. 116 suspension to the person who has agreed to accept the transfer; (d) the keeping and transfer of records; (e) any other matter that the Authority considers relevant. (3) If the Authority cancels or suspends an approval under Division 3, the Authority, having first obtained the Minister's approval, may, by notice in writing given to the person whose approval has been cancelled or suspended, make any order that the Authority thinks fit in relation to all or any of the following— (a) the appointment of another person to carry out the functions of the person whose approval has been cancelled or suspended in relation to any activities affected by the cancellation or suspension; (b) the continuation of any treatment procedures or research affected by the cancellation or suspension; (c) the directions to be given about the transfer of research or treatment procedures affected by the cancellation or suspension to the person who has agreed to accept the transfer; (d) the keeping and transfer of records; (e) any other matter that the Authority considers relevant. (4) If the Authority cancels or suspends an approval or exemption under section 40 or 56, the Authority, having first obtained the Minister's approval, may, by notice in writing given to the person whose approval or exemption has been suspended or cancelled, make any order that the Authority thinks fit. 3-30/12/97 103 Infertility Treatment Act 1995 Act No. 63/1995 (5) An order under this section may be subject to any conditions imposed by the Authority. (6) A person or body to whom an order made under this section applies must comply with that order and its conditions. Penalty: 50 penalty units. (7) An order under this section must be published in the Government Gazette. (8) An administrator appointed by an order under this section has all the powers and may exercise any of the duties of the licensee in relation to the activities in respect of which the appointment is made. (9) If an administrator is appointed by an order under this section the Governor in Council may, on the recommendation of the Minister, by Order in Council published in the Government Gazette, make the administrator the governing body of the hospital, centre, university or other institution for the purpose of, and only to the extent necessary, to enable the carrying out of the activities specified in the order. (10) If an administrator is made the governing body of a hospital, centre, university or other institution as described in sub-section (9)— (a) the administrator has all the powers, may exercise any of the duties, and is subject to the duties, of the governing body of the hospital, centre, university, or other institution for the purpose of, and only to the extent necessary, to enable the carrying out of the activities specified in the order; and (b) the pre-existing governing body of the hospital, centre, university or other institution ceases to have any power as a governing body in relation to those activities 3-30/12/97 104 s. 116 Infertility Treatment Act 1995 Act No. 63/1995 s. 117 and cannot override any directions given by the administrator regarding those activities, but will otherwise continue to exist as the governing body and have all its powers. 117. Notification about approvals and licences (1) The Authority must, in accordance with the regulations— (a) give written notice of each approval, renewal of approval or variation, suspension or cancellation of approval under this Part to the licensee of each licensed centre; and (b) give written notice of each approval under Division 2 and 4 to a doctor approved to carry out donor insemination at a place other than a licensed centre; and (c) publish notice of each licence or approval granted under this Part, or renewal, variation, suspension or cancellation of such an approval or licence, in the Government Gazette. (2) If requested by the Authority in writing, the designated officer of each licensed centre must give written notice of any notice given to the licensee under sub-section (1) to each doctor and scientist who has been approved under Division 3 or who is working at the centre. Penalty: 50 penalty units. 118. Notification to Minister S. 118(1) amended by No. 37/1997 s. 5(1)(g). (1) The Authority must cause the Minister to be notified immediately of— (a) any grant or renewal of a licence, approval or exemption; or (b) any suspension or cancellation of a licence, approval or exemption; or 3-30/12/97 105 Infertility Treatment Act 1995 Act No. 63/1995 (c) any variation of a condition, term, limitation or restriction of a licence, approval or exemption. (2) If requested by the Minister, the Authority must— (a) give reasons for any action taken of which notice has been given under sub-section (1) to the Minister; and (b) give any further information requested by the Minister. (3) When the Minister is notified of the grant under Division 2 of Part 8 of an approval to carry out research, the Minister must cause the notice to be laid before both Houses of Parliament within 14 sitting days after the Minister receives the notice. Division 6—Designated officers 119. Designated officers for licensed centres (1) The licensee of a licensed centre must ensure that at all times a designated officer is appointed, employed or engaged for that centre. Penalty: 50 penalty units. (2) That appointment, employment or engagement must be in writing. (3) The licensee of a licensed centre must notify the Authority and the Secretary immediately— (a) of the appointment, employment or engagement of a designated officer for that centre; or (b) of the cessation of the appointment, employment or engagement of a designated officer for that centre. Penalty: 50 penalty units. 120. If no designated officer appointed 3-30/12/97 106 s. 120 119 Infertility Treatment Act 1995 Act No. 63/1995 If at any time there is no designated officer for a licensed centre— (a) the medical superintendent of the centre (by whatever name known) or if he or she is absent from or not on duty at the centre, a person acting in his or her place; or (b) if there is no position of medical superintendent at the centre, the principal executive officer of the centre (by whatever name known), or if he or she is absent from or not on duty at the centre, a person acting in his or her place— is to perform the functions of the designated officer for the purposes of this Act until a designated officer is appointed. _______________ 3-30/12/97 107 Infertility Treatment Act 1995 Act No. 63/1995 PART 9—INFERTILITY TREATMENT AUTHORITY Division 1—Constitution of the Authority 121. Establishment of Authority (1) There is established an Authority to be called the Infertility Treatment Authority. (2) The Authority— (a) is a body corporate with perpetual succession; and (b) has a common seal; and (c) may sue and be sued in its corporate name; and (d) may acquire, hold and dispose of real and personal property; and (e) may do and suffer all acts and things that a body corporate may, by law, do and suffer. (3) The common seal must be kept as directed by the Authority and must not be used except as authorised by the Authority. (4) All courts must take judicial notice of the seal of the Authority on a document and, until the contrary is proved, must presume that the document was properly sealed. 122. Powers, functions, duties and consultation requirements (1) The Authority has the following functions— (a) to administer the compiling and keeping of records under Part 7 and access to those records; 3-30/12/97 108 s. 121 Infertility Treatment Act 1995 Act No. 63/1995 s. 122 (b) to administer the licensing and approvals systems under this Act and to grant exemptions under this Act; (c) to monitor compliance with licences, approvals and exemptions given under this Act; (d) to consider requests to approve the extension of the maximum storage period for gametes, zygotes or embryos and, if it thinks fit, to approve that extension; (e) to keep under regular review the progress of approved research; (f) to keep records about— (i) programs and activities carried out under this Act; and (ii) programs and procedures relating to infertility carried out outside Victoria; (g) to keep under regular review and, if it thinks fit, to make recommendations to the Minister about its functions, operation or composition; (h) to promote research into the causes of infertility; (i) to approve the bringing of gametes, zygotes or embryos into or the taking of them from the State, and to provide for the exemption from particular provisions of this Act in accordance with section 56; (j) without limiting the generality of the preceding paragraphs, any other functions conferred on the Authority by or under this or any other Act. 3-30/12/97 109 Infertility Treatment Act 1995 Act No. 63/1995 s. 123 (2) The Authority must, without delay, advise the Minister of any of the following matters that come to its notice— (a) a contravention of this Act or the regulations or the Infertility (Medical Procedures) Act 1984 or regulations made under that Act; (b) a breach of a licence, approval or exemption given under this Act or the Infertility (Medical Procedures) Act 1984; (c) a development in— (i) research relating to infertility; or (ii) treatment for infertility— whether in Victoria or elsewhere, which the Authority considers of major importance or views with concern. (3) The Authority has all the powers necessary to enable it to perform its functions. (4) The Authority must have regard to the Minister's advice in carrying out its functions and exercising its powers. * * * * * 123. Membership (1) The Authority is to consist of not more than 7 members nominated by the Minister and appointed by the Governor in Council. (2) In making nominations for appointments to the Authority the Minister must have regard to the need for diversity of expertise and experience and to the need to appoint persons who have the expertise to carry out the functions of the 3-30/12/97 110 S. 122(5) repealed by No. 37/1997 s. 5(1)(h). Infertility Treatment Act 1995 Act No. 63/1995 s. 124 Authority or to ensure that those functions are carried out. 124. Terms of office (1) A member of the Authority holds office— (a) for the period; and (b) on the terms and conditions— specified in his or her instrument of appointment. (2) A member of the Authority is eligible for reappointment. (3) The Public Sector Management Act 1992 (except Part 9 or in accordance with Part 8) does not apply to a member in respect of the office of member. 125. Resignation and removal (1) A member of the Authority may resign the office of member by writing signed by the member and addressed to the Governor in Council. (2) The Governor in Council may at any time remove a member of the Authority from office. (3) If a member of the Authority dies, resigns or is removed from office, the Governor in Council may, in accordance with this Act, on the nomination of the Minister, fill the vacant office. (4) A member appointed under sub-section (3) holds office for the rest of the term of appointment of the member whose place she or he fills. 126. Chairperson and Deputy Chairperson (1) The Governor in Council may appoint members of the Authority to be Chairperson and Deputy Chairperson. 3-30/12/97 111 Infertility Treatment Act 1995 Act No. 63/1995 (2) A person appointed to an office under sub-section (1) holds that office for the term specified in her or his instrument of appointment and is eligible for reappointment. (3) A person appointed to an office under sub-section (1) may resign that office by writing signed by the person and addressed to the Governor in Council. (4) The Governor in Council may at any time remove a person appointed under sub-section (1) from office. (5) A person appointed to an office under sub-section (1) ceases to hold that office on ceasing to be a member of the Authority. 127. Acting member (1) If a member of the Authority is unable to perform the duties or functions of the office, the Governor in Council may appoint a person qualified to be appointed as a member to act as the member during the period of inability. (2) The Governor in Council— (a) subject to this Act, may determine the terms and conditions of appointment of an acting member; and (b) may at any time terminate the appointment. (3) While the appointment of an acting member remains in force, the acting member has and may exercise all the powers and perform all the duties and functions of the member. 128. Payment of members (1) A member or acting member of the Authority, other than a member who is an officer or employee of the public service within the meaning of the Public Sector Management Act 1992, is entitled to receive the fees that are fixed from time 3-30/12/97 112 s. 127 Infertility Treatment Act 1995 Act No. 63/1995 s. 129 to time by the Governor in Council for that member. (2) Each member or acting member of the Authority is entitled to receive the allowances that are fixed from time to time by the Governor in Council. 129. Procedure of Authority (1) The Chairperson or, in the absence of the Chairperson, the Deputy Chairperson, must preside at a meeting of the Authority at which she or he is present. (2) If neither the Chairperson nor Deputy Chairperson are present at a meeting the members present may elect a member to preside at the meeting. (3) The person presiding at a meeting has a deliberative vote and a second or casting vote. (4) A majority of the members of the Authority currently holding office constitutes a quorum. (5) Except as otherwise provided for in this Act or the regulations, the Authority may regulate its own proceedings. 130. Effect of vacancy or defect An act or decision of the Authority is not invalid only because— (a) of a vacancy in its membership; or (b) of a defect or irregularity in the appointment of any of its members; or (c) in the case of an acting member, the occasion for that member so acting had not arisen or had ceased. 3-30/12/97 113 Infertility Treatment Act 1995 Act No. 63/1995 131. Member's interests (1) A member who has— (a) a pecuniary interest in any matter in which the Authority is concerned; or (b) any other substantial interest in any matter in which the Authority is concerned which the member considers might appear to raise a material conflict between his or her private interest and his or her functions as a member of the Authority— must— (c) if the member is present at a meeting of the Authority at which the matter is to be considered, disclose the nature of the interest immediately before the consideration of that matter; or (d) if the member is aware that the matter is to be considered at a meeting of the Authority at which the member does not intend to be present, disclose the nature of the interest to the Chairperson or Deputy Chairperson of the Authority before the meeting is held. (2) The member— (a) may take part in the discussion in the meeting; and (b) must leave the meeting while any vote is taken on a question relating to the matter. 132. Immunity (1) A member of the Authority is not personally liable for anything done or omitted to be done in good faith and without negligence— (a) in the exercise of a power or the discharge of a duty under this Act; or 3-30/12/97 114 s. 131 Infertility Treatment Act 1995 Act No. 63/1995 s. 133 (b) in the reasonable belief that the act or omission was in the exercise of a power or the discharge of a duty under this Act. (2) Any liability resulting from an act or omission that would but for sub-section (1), attach to a member of the Authority attaches instead to the Authority. 133. Engagement or employment of persons The Authority may employ or engage a Chief Executive Officer and any other persons that are necessary for the purposes of the administration of the Authority and the carrying out of its powers and functions. 134. Delegation The Authority may, in writing, with the approval of the Minister and subject to any conditions or limitations the Minister may impose, delegate to— (a) a committee established under section 135, its powers and functions under this Act and the regulations, other than— (i) the power to approve research under Division 2 of Part 8; or (ii) the power to approve under section 40; or (iii) the variation, suspension or revocation of an approval under section 40 or under Division 2 of Part 8; or (iv) the power to appoint authorised officers; or (v) the power to give orders under section 116; or (vi) this power to delegate; and 3-30/12/97 115 Infertility Treatment Act 1995 Act No. 63/1995 (b) a person employed or engaged under section 133, its powers and functions under Part 7, section 184 and the regulations. 135. Committees The Authority may appoint one or more committees of members of the Authority to discharge the Authority's powers, functions and duties. Division 2—Supplementary Powers 136. Powers of Authority in relation to fees (1) In the case of any fee for an application for, or renewal or issue of a licence or approval which the Authority is empowered to fix under this Act— (a) the Authority must determine the fee to be paid; and (b) the Authority may amend or vary such a fee; and (c) the Authority may determine a different fee for a different case or class of case and may allow for the reduction or refund, in whole or in part, of any such fee; and (d) before determining, amending or varying any fee as described in paragraph (a) or (b), the Authority must consult with the Minister; and (e) the Authority must cause any fee it has determined, amended or varied as described in paragraph (a) or (b) to be published in the Government Gazette. (2) In fixing fees under this Act the Authority is entitled to ensure that the amount of money collected in fees under this Act is sufficient to 3-30/12/97 116 s. 135 Infertility Treatment Act 1995 Act No. 63/1995 s. 137 cover the cost to the Authority of its administration and of carrying out its powers, functions and duties under this Act. Division 3—Reporting and financial provisions 137. Report to Minister (1) The Authority must on 30 September in each year report to the Minister on the following matters— (a) the programs under which treatment procedures and research are conducted and under which embryos, gametes and zygotes are stored at licensed centres; and (b) particulars of each program including— (i) the number of treatment procedures carried out under this Act during the year and the nature and outcome of those procedures; and (ii) the number and kind of approvals for research given by the Authority during the year; and (iii) the number of participants in research or treatment procedures carried out at each licensed centre during the year; and (iv) the kinds of research carried out at each licensed centre during the year and the results of that research; and (iv) the number of embryos and zygotes formed at each licensed centre during the year; and (c) the number of licences, approvals and exemptions granted, varied, renewed, suspended or cancelled during the year; and 3-30/12/97 117 Infertility Treatment Act 1995 Act No. 63/1995 (d) any other matter on which the Minister asks the Authority to report. (2) The references to "year"— (a) in sub-section (1)(a) and (b) are to the calendar year prior to the year in which the report is prepared; and (b) in sub-section (1)(c) are to the year ending on the preceding 30 June. (3) The Minister must cause each report made by the Authority under sub-section (1) to be laid before each House of the Parliament before the expiration of the 14th sitting day of that House after the Minister receives the report. 138. Infertility Treatment Authority Fund (1) The Authority must establish and keep an Infertility Treatment Authority Fund. (2) The Authority must pay into the Fund— (a) any money received by it by way of fees paid to or recovered by it; and (b) and any income from the investments of the Fund; and (c) any other money received by the Authority. (3) The Authority may pay out of the Fund— (a) any expenses incurred in its administration or in the carrying out of its functions, powers and duties under this Act; and (b) any payments to be made to members of the Authority under this Act and any payments to be made to other persons by the Authority in the course of the exercise of its powers and functions under this Act; and 3-30/12/97 118 s. 138 Infertility Treatment Act 1995 Act No. 63/1995 s. 139 (c) any other payments recommended by the Authority and approved by the Minister; and (d) any other payments authorised under any other Act. 139. Investment powers The Authority may invest money credited to the Fund that it does not immediately require— (a) in any manner authorised by section 4(1) of the Trustee Act 1958; or (b) in any other manner that the Minister approves. _______________ Pt 10 (Heading and ss 140–148) repealed by No. 37/1997 s. 5(1)(i). * * * _______________ 3-30/12/97 119 * * Infertility Treatment Act 1995 Act No. 63/1995 PART 11—REVIEW OF DECISIONS 149. Review of decisions (1) An application may be made to the Administrative Appeals Tribunal established under the Administrative Appeals Tribunal Act 1984 for the review of a decision of the Authority— (a) to grant or refuse a licence or approval under Part 8, except an approval under Division 2 of Part 8; or (b) to grant or refuse to grant an approval under section 51(2) or 52(5); or (c) to grant or refuse an approval or exemption under section 56; or (d) to impose conditions, limitations or restrictions on a licence or approval or exemption, except an approval under section 40 or Division 2 of Part 8; or (e) to renew or refuse to renew a licence or approval under Part 8; or (f) to vary or refuse to vary a licence, approval, or exemption, except an approval under section 40 or Division 2 of Part 8; or (g) to suspend or cancel a licence, approval or exemption, except an approval under section 40 or Division 2 of Part 8; or or of a failure by the Authority to make such a decision within a reasonable time. (2) An application under sub-section (1) may only be made by a person aggrieved by— (a) the decision of the Authority; or (b) the failure of the Authority to act. 3-30/12/97 120 s. 149 Infertility Treatment Act 1995 Act No. 63/1995 s. 149 (3) If an application is made under sub-section (1)(c) in relation to a decision to suspend a licence or approval— (a) the application does not stay the operation of that decision; and (b) section 46 of the Administrative Appeals Tribunal Act 1984 does not apply to or in relation to that decision. (4) In this section "decision" has the same meaning as in the Administrative Appeals Tribunal Act 1984. _______________ 3-30/12/97 121 Infertility Treatment Act 1995 Act No. 63/1995 s. 150 PART 12—GENERAL 150. Decisions by Authority not reviewable A decision or purported decision of the Authority under section 99(1) or a decision or purported decision of the Authority under section 106 or 107 in relation to an approval under section 99(1) cannot be appealed against, reviewed, challenged, quashed or called in to question on any account in any court or tribunal or before any person acting judicially within the meaning of the Evidence Act 1958. 151. No action if gametes used without knowing consent withdrawn or lapsed If— (a) a person has carried out research under Part 3 or a treatment procedure for which consent was required; and (b) before the research or treatment procedure was carried out, the consent was withdrawn or an objection was made under the Act— no civil or criminal proceeding lies against that person because of the withdrawal of the consent or objection if, at the time the treatment procedure or research was carried out, that person did not know and could not reasonably be expected to have known that the consent had been withdrawn or the objection had been made. 152. Conscientious objections (1) Despite any Act, law or agreement to the contrary a person who has a conscientious objection to research involving the use of gametes, zygotes or embryos or to a treatment procedure does not have to participate in that research or procedure unless 3-30/12/97 122 S. 150 amended by No. 37/1997 s. 5(1)(j)(i)(ii). Infertility Treatment Act 1995 Act No. 63/1995 s. 153 it is necessary to do so because it is likely that a person who is or was a participant in the research or procedure will otherwise die. (2) In any proceedings the burden of proving a conscientious objection is on the person who relies on it. 153. Record of consent or objection and withdrawal of consent or objection (1) Subject to section 154 and the regulations— (a) the designated officer of a licensed centre; and (b) an approved doctor who carries out donor insemination at a place other than a licensed centre; and (c) a prescribed person— must— (d) obtain and keep the original of each consent, withdrawal of consent, objection or withdrawal of objection lodged under Parts 2, 3 or 4 (as the case may be); and (e) ensure that a certified copy of each such consent, withdrawal of consent, objection or withdrawal of objection is given to the person who lodged the consent, withdrawal of consent, objection or withdrawal of objection. Penalty: 50 penalty units. (2) A copy of a document must be certified as a true copy under this section in accordance with the regulations. Penalty: 50 penalty units. 3-30/12/97 123 Infertility Treatment Act 1995 Act No. 63/1995 154. Transfer of documents (1) Subject to the regulations, if a gamete, zygote, embryo, parthenogenetic oocyte or parthenogene is to be or has been transferred from— (a) a licensed centre; or (b) the premises of an approved doctor who carries out donor insemination at a centre other than a licensed centre; or (c) a prescribed place— to another place, the designated officer of the licensed centre referred to in paragraph (a), the approved doctor referred to in paragraph (b), or a prescribed person in relation to a place described in paragraph (c) (as the case may be), must ensure that— (d) a consent, objection or withdrawal of a consent or an objection lodged at that place or forwarded to that place which relates to the gamete, zygote, embryo, parthenogenetic oocyte or parthenogene; and (e) any prescribed information— is also transferred to that other place, in accordance with the regulations. Penalty: 50 penalty units. (2) If a document is transferred under this provision a certified copy must be kept by the designated officer, approved doctor or prescribed person. Penalty: 50 penalty units. (3) A copy of a document must be certified as a true copy under this section in accordance with the regulations. Penalty: 50 penalty units. 3-30/12/97 124 s. 154 Infertility Treatment Act 1995 Act No. 63/1995 s. 155 155. Authorised officers (1) The Authority may, in writing, appoint an employee of the Authority as an authorised officer for the purposes of determining whether or not this Act, or the regulations or a licence, approval or exemption, or the Infertility (Medical Procedures) Act 1984, the regulations or an approval made under that Act, are being or have been complied with. (2) The Authority must issue an identity card to each member of the Authority and to each authorised officer appointed by the Authority. 156. Powers and duties of members of Authority and authorised officers (1) A member of the Authority or an authorised officer may exercise powers under this section only to the extent that it is reasonably necessary to do so for the purpose of determining compliance with this Act, or the regulations, or a licence, approval or exemption, or the Infertility (Medical Procedures) Act 1984, or the regulations or an approval made under that Act. (2) A member of the Authority or an authorised officer with any necessary assistants may enter a licensed centre or premises on which a doctor carries out donor insemination, or premises which are the subject of an approval or exemption at any time during ordinary working hours on any business day and may— (a) inspect the premises or anything found on the premises; and (b) require the production for inspection of any records or other documents or documents containing information required to be kept under this Act or any licence, approval or 3-30/12/97 125 Infertility Treatment Act 1995 Act No. 63/1995 exemption, or under the Infertility (Medical Procedures) Act 1984 or an approval made under that Act; and (c) inspect any documents produced under paragraph (b); (d) take possession of any documents found on the premises or produced under paragraph (b) for so long as is necessary to make copies of or take extracts from those documents. (3) The member or authorised officer must as soon as possible report the results of an inspection under sub-section (2) to the Authority. (4) A member of the Authority or an authorised officer may not exercise any powers under this section if the member or authorised officer fails to produce, on request, his or her identity card for inspection by the occupier of the premises. (5) A member of the Authority or an authorised officer may not take possession of any documents apparently in the custody of a person unless the member or authorised officer makes out and tenders to the person a receipt for the documents taken. 157. Offence to obstruct or hinder A person must not obstruct or hinder a member of the Authority or an authorised officer in carrying out his or her powers or duties under section 156. Penalty: 50 penalty units. 158. Additional liability for offences (1) If a person commits an offence against this Act at a licensed centre the licensee also commits an offence against this section. (2) A person who commits an offence against this section is liable to a penalty— 3-30/12/97 126 s. 157 Infertility Treatment Act 1995 Act No. 63/1995 s. 159 (a) in the case of a body corporate, 500 penalty units; or (b) in any other case, the equivalent penalty to the original offence. (3) It is a defence to a prosecution of a person for an offence under this section to show that the person prosecuted— (a) did not know of and could not reasonably have been aware of or prevented; or (b) had taken reasonable steps to prevent— the commission of the original offence. (4) This section is in addition to, and does not take away from, any other provision of this Act. 159. Application of Public Records Act 1973 The Public Records Act 1973 does not apply to a Register or record required to be kept under Part 7 of this Act. 160. Prohibition on destruction of documents A person must not destroy, remove or cancel a document required to be kept by or under this Act or the regulations unless authorised by this Act to do so. Penalty: 50 penalty units. 161. Evidence In any proceedings under this Act— S. 161(a) amended by No. 37/1997 s. 5(k)(i)(ii). (a) a copy of an order, request, direction, authority, decision, determination or notice made or given under this Act by the Minister or the Authority and signed and certified by the Minister, or sealed and certified by the Authority to be a true copy and to have been so made or given is evidence of the making 3-30/12/97 127 Infertility Treatment Act 1995 Act No. 63/1995 or giving of the order, direction, authority, decision or notice; (b) in the absence of evidence to the contrary, proof is not required of the appointment of a person as an authorised officer under section 155. 162. Search warrants (1) A member of the police force may apply to a magistrate for the issue of a search warrant in relation to particular place if the member of the police force believes on reasonable grounds that there is in that place a particular thing that may be evidence of the commission of an offence against this Act or the regulations or the Infertility (Medical Procedures) Act 1984 or the regulations made under that Act. (2) The Authority may apply to a magistrate for the issue of a search warrant in relation to a particular place if the Authority believes on reasonable grounds that there is in that place a gamete, zygote, embryo, parthenogenetic oocyte or parthenogene, or records, which may indicate that a breach of section 116(6) has occurred. (3) If a magistrate is satisfied by the evidence on oath, whether oral or by affidavit, that there are— (a) in relation to an application under subsection (1), reasonable grounds for believing that there is in that place a particular thing that may be evidence of the commission of an offence against this Act or the regulations or the Infertility (Medical Procedures) Act 1984 or the regulations made under that Act; or (b) in relation to an application under subsection (2), reasonable grounds for believing 3-30/12/97 128 s. 162 Infertility Treatment Act 1995 Act No. 63/1995 s. 162 that there is in that place a gamete, zygote, embryo, parthenogenetic oocyte or parthenogene, or records which may indicate that there has been a breach of section 116(6)— the magistrate may issue a search warrant authorising a member of the police force named in the warrant and any assistants— (c) to enter the place, or the part of the place, named or described in the warrant; and (d) to search for and seize a thing named or described in the warrant. (4) In addition to any other requirement, a search warrant issued under this section must state— (a) the offence or breach suspected; and (b) the place to be searched; and (c) a description of the thing to be searched for; and (d) any conditions to which the warrant is subject; and (e) whether entry is authorised to be made at any time or during stated hours; and (f) a day, not later than 7 days after the issue of the warrant, on which the warrant ceases to have effect. (5) A search warrant must be issued in accordance with the Magistrates' Court Act 1989 and in the form prescribed under that Act. (6) Subject to sub-section (7), the rules to be observed with respect to search warrants in the Magistrates' Court Act 1989 extend and apply to warrants under this section. 3-30/12/97 129 Infertility Treatment Act 1995 Act No. 63/1995 s. 163 (7) If a gamete, zygote, embryo, parthenogenetic oocyte or parthenogene or records are seized under a warrant issued following an application by the Authority under sub-section (2), the gamete, zygote, embryo, parthenogenetic oocyte or parthenogene, or records seized must, if the Authority so requests, be taken to the Authority as soon as practicable to enable arrangements to be made for the transfer, use, storage or destruction of the gamete, zygote, embryo, parthenogene or parthenogenetic oocyte or the keeping of the records. 163. Indictable offences (1) An offence under section 6, 7, 22(1) or (2), 23, 24, 39, 45, 47, 49, 53(1) or 54 is an indictable offence. (2) An offence under section 158 is an indictable offence if the original offence is an indictable offence. 164. Supreme Court—limitation of jurisdiction It is the intention of this section to alter or vary section 85 of the Constitution Act 1975 to the extent necessary to prevent the Supreme Court from— (a) entertaining an action in which a decision or purported decision of the Authority under section 99(1) or a decision or purported decision of the Authority under section 106 or 107 in relation to an approval under section 99(1) is sought to be appealed against, reviewed, challenged, quashed or called in question; or (b) entertaining an action of the kind referred to in section 151. _______________ 3-30/12/97 130 S. 164(a) amended by No. 37/1997 s. 5(1)(l)(i)(ii). Infertility Treatment Act 1995 Act No. 63/1995 s. 164 3-30/12/97 131 Infertility Treatment Act 1995 Act No. 63/1995 PART 13—REGULATIONS 165. Regulations (1) The Governor in Council may make regulations for or with respect to any of the following— (a) forms for notices or other documents required under this Act; (b) fees, other than fees fixed by the Authority— (i) for the purposes of this Act; or (ii) payable in relation to applications for information made under the regulations; (c) the terms and conditions to be included in licences (other than licences to undertake approved research) and approvals under this Act; (d) the giving of information for inclusion in records and registers required or permitted to be kept, and notices required or permitted to be given, under this Act; (e) if counselling is required by this Act, the matters which it must address and the form it must take; (f) the giving of information and the keeping of records for the purposes of this Act; (g) limiting, in so far as it is not already provided for in the Act, the persons to whom, conditions under which, and circumstances in which information may be given; (h) specifying, in so far as it is not already provided for in the Act, the conditions under which, and circumstances in which an 3-30/12/97 132 s. 165 Infertility Treatment Act 1995 Act No. 63/1995 s. 165 application may be made for the giving of information (other than information from which a person will or may be identified), and when such information must, or must not, or may be given; (i) specifying, in so far as it is not already provided for in the Act, the conditions under which, and circumstances in which information (other than information from which a person will or may be identified) may be given under section 90; (j) specifying, in so far as it is not already provided for in the Act, the conditions under which, and circumstances in which applications may be made for the giving of information which will or may identify a person, and when such information may, or must, be given with that persons's consent, or when it must not be given; (k) prescribing persons or places where consents or objections or withdrawals of consents or objections under this Act are to be lodged; (l) the disposal of zygotes or embryos removed from storage; (m) the manner of the recording of information in registers and the nature of information to be so recorded; (n) the manner of giving notice of birth to the Authority and the nature of the information to be given in the notice; (o) the manner of keeping the central register, and the register under section 82; (p) specifying, in so far as it is not already provided for in the Act, requirements regarding— 3-30/12/97 133 Infertility Treatment Act 1995 Act No. 63/1995 (i) the transfer of information relating to a gamete, zygote, embryo, parthenogenetic oocyte or parthenogene which has been or is to be transferred from one place to another place; and (ii) the obtaining, keeping of and forwarding of consents, objections or the withdrawal of consents or objections or of certified copies of such documents (including, but not limited to, the circumstances where a consent, objection or withdrawal of a consent or objection relates to more than one gamete, zygote, embryo, parthenogenetic oocyte or parthenogene or activity or procedure); and (iii) the retaining of copies of consents, objections, or the withdrawals of consents or objections, and the certification of such documents; and (iv) specifying, to the extent not already provided for in this Act, requirements regarding the obtaining, keeping or transferring of consents or withdrawals of consents made under the Infertility (Medical Procedures) Act 1984, or other consents or withdrawals of consents in relation to a procedure, research, or a gamete, zygote, embryo, parthenogenetic embryo or parthenogene made prior to the repeal of that Act or of a provision of that Act; (q) in so far as it has not already been provided for in this Act, the use of, storage of, activities relating to, and the keeping of records about parthenogenetic oocytes or parthenogenes; 3-30/12/97 134 s. 165 Infertility Treatment Act 1995 Act No. 63/1995 s. 165 (r) for the purposes of section 181, to— (i) prescribe circumstances in which sections 62, 63, 64, 65 and 66 are not to apply to a matter, procedure, research, person or thing; and (ii) provide alternative powers, functions or duties in such circumstances; (s) penalties, not exceeding 20 penalty units, for breaches of the regulations; (t) generally prescribing any matter or thing required or permitted by this Act to be prescribed or necessary to be prescribed to give effect to this Act. (2) The regulations— (a) may be of general or limited application; and (b) may differ according to differences in time, place and circumstance; and (c) may confer a discretionary authority or impose a duty on, or leave any matter or thing to be determined or approved by, a specified person or class of persons; and (d) may apply, adopt or incorporate any matter contained in any document, code, standard, rule, specification, or method, formulated, issued, prescribed or published by any person whether— (i) wholly or partially or as amended by the regulations; or (ii) as formulated, issued, prescribed or published at the time the regulations are made or at any time before them; or (iii) as formulated, issued, prescribed or published from time to time. 3-30/12/97 135 Infertility Treatment Act 1995 Act No. 63/1995 _______________ 3-30/12/97 136 s. 165 Infertility Treatment Act 1995 Act No. 63/1995 s. 166 PART 14—REPEALS, AMENDMENTS AND TRANSITIONAL PROVISIONS Division 1—Repeals and amendments 166. Repeals (1) Sections 6(3) and (4) of the Infertility (Medical Procedures) Act 1984 are repealed. (2) Part V of the Infertility (Medical Procedures) Act 1984 is repealed. (3) The Infertility (Medical Procedures) Act 1984 is repealed. (4) Section 181 of the Health Services Act 1988 is repealed. 167. Amendment of Health Act 1958 In section 133 of the Health Act 1958— (a) in sub-section (1)(b)(i) for "Infertility (Medical Procedures) Act 1984" substitute "Infertility Treatment Act 1995"; (b) in sub-section (1)(b)(ii) omit "relevant". 168. Amendment of Human Tissue Act 1982 (1) After section 38(2) of the Human Tissue Act 1982 insert— "(3) Sub-section (1) does not apply to the receiving of an amount to which section 57(3) of the Infertility Treatment Act 1995 applies.". (2) After section 39(1) of the Human Tissue Act 1982 insert— "(1A) Sub-section (1) does not apply to the giving of an amount to which section 55(3) of the Infertility Treatment Act 1995 applies.". 3-30/12/97 137 Infertility Treatment Act 1995 Act No. 63/1995 (3) In section 40 of the Human Tissue Act 1982, after "selling or buying of tissue" insert "or the donation of tissue". 169. Amendment of Magistrates' Court Act 1989 In Schedule 4 to the Magistrates' Court Act 1989, after item 61 insert— "62. Infertility Treatment Act Indictable offences under the Infertility Treatment Act 1995.". 170. Amendment of Status of Children Act 1974 (1) After section 10A(2) of the Status of Children Act 1974 insert— '(3) In this Part— "embryo" includes an embryo within the meaning of the Infertility Treatment Act 1995; "ovum in the process of fertilisation" means an ovum at any stage of human development from the commencement of penetration of an ovum by sperm up to but not including syngamy; "semen" includes sperm; "syngamy" has the same meaning as in the Infertility Treatment Act 1995.'. (2) In section 10B(1) of the Status of Children Act 1974 for "The provisions" substitute "Subject to sub-section (3), the provisions". (3) After section 10B(2) of the Status of Children Act 1974 insert— "(3) The amendments made to this Part by the Infertility Treatment Act 1995 apply— 3-30/12/97 138 s. 169 Infertility Treatment Act 1995 Act No. 63/1995 s. 170 (a) in respect of a pregnancy referred to in section 10D or 10E which resulted from a procedure carried out in or outside Victoria whether before or after the commencement of section 170 of the Infertility Treatment Act 1995; and (b) in respect of any child born as a result of a pregnancy referred to in section 10D or 10E resulting from a procedure carried out whether before or after the commencement of section 170 of the Infertility Treatment Act 1995. (4) Nothing in the amendments made to this Part by the Infertility Treatment Act 1995 affects the vesting in possession or in interest of any property that occurred before the date on which that Act received the Royal Assent.". (4) In section 10D(1) of the Status of Children Act 1974, after "womb of a woman" insert ", or otherwise transferring to the body of a woman,". (5) After section 10D(1) of the Status of Children Act 1974 insert— "(1A) A reference in this section to a procedure includes a reference to— (a) the procedure of transferring to the body of a woman, otherwise than by artificial insemination— (i) semen produced by a man other than her husband; or (ii) semen produced by a man other than her husband and an ovum produced by her; and (b) the procedure of transferring to the body of a woman an ovum in the 3-30/12/97 139 Infertility Treatment Act 1995 Act No. 63/1995 process of fertilisation, if the ovum was produced by her and the process of fertilisation commenced outside her body from semen produced by a man other than her husband.". (6) After section 10D(2)(b) of the Status of Children Act 1974 insert— "(c) the husband shall be presumed, for all purposes, to have produced the semen— (i) used in the procedure; or (ii) used for the fertilisation of the ovum used in the procedure; or (iii) used for the fertilisation of the ovum from which the embryo used in the procedure was derived— and to be the father of any child born as a result of the pregnancy; and (d) the man who produced the semen— (i) used in the procedure; or (ii) used for the fertilisation of the ovum used in the procedure; or (iii) used for the fertilisation of the ovum from which the embryo used in the procedure was derived— shall, for all purposes, be presumed not to have produced that semen and not to be the father of any child born as the result of the pregnancy.". (7) In section 10E(1) of the Status of Children Act 1974, after "womb of a woman" insert ", or otherwise transferring to the body of a woman,". (8) After section 10E(1) of the Status of Children Act 1974 insert— 3-30/12/97 140 s. 170 Infertility Treatment Act 1995 Act No. 63/1995 s. 170 "(1A) A reference in this section to a procedure includes a reference to— (a) the procedure of transferring to the body of a woman an ovum produced by another woman, including an ovum in the process of fertilisation, where that process commenced outside the body of the first-mentioned woman; and (b) the procedure of transferring to the body of a woman an ovum produced by another woman and semen— whether any semen transferred, or any semen which is used to fertilise the ovum (if any) is produced by the husband of the firstmentioned woman or by another man.". (9) In section 10E(2)(b) of the Status of Children Act 1974 after "ovum" insert "used in the procedure or". (10) After section 10E(2) of the Status of Children Act 1974 insert— "(e) where the semen used— (i) in the procedure; or (ii) for the fertilisation of the ovum used in the procedure— was produced by the husband of the married woman, the husband shall be presumed, for all purposes, to be the father of any child born as a result of the pregnancy; and (f) where the semen used— (i) in the procedure; or (ii) for the fertilisation of the ovum used in the procedure— 3-30/12/97 141 Infertility Treatment Act 1995 Act No. 63/1995 was produced by a man other than the husband of the married woman— (iii) the husband shall be presumed, for all purposes, to have produced the semen and to be the father of any child born as a result of the pregnancy; and (iv) the man who produced the semen shall be presumed, for all purposes, not to have produced that semen and not to be the father of any child born as a result of the pregnancy.". Division 2—Transitional provisions 171. Definitions (1) In this Division— "donor" (in relation to the repealed Act or to things done before the commencement of Part 2) means— (a) a woman who, under the repealed Act, consented to an oocyte produced by her or a zygote or an embryo formed from such an oocyte being used in a relevant procedure to be carried out on another woman or in a procedure under section 9A of the repealed Act; and (b) a man who, under the repealed Act, consented to his sperm or a zygote or an embryo formed from his sperm being used in a fertilisation procedure to be carried out on a woman who is not his wife or in a procedure under section 9A of the repealed Act; and (c) a man who before the commencement of Part 2 consented to his sperm being used in artificial insemination to be 3-30/12/97 142 s. 171 Infertility Treatment Act 1995 Act No. 63/1995 s. 171 carried out on a woman other than his wife; and (d) a person who has consented to an embryo or zygote being used in an experimental procedure under section 6(3) of the repealed Act; and (e) a person who before the commencement of section 22 consented to his or her gametes being used in research (other than research described in section 22(1) or (2)); and (f) any other person who is a donor for the purposes of the repealed Act including, but not limited to, the persons referred to as a donor in sections 9A, 11, 12, 13 and 13A of that Act; and (g) a prescribed person; "former Committee" means the Standing Review and Advisory Committee established under the repealed Act; "relevant procedure" has the same meaning as in the repealed Act and includes artificial insemination; "repealed Act" means the Infertility (Medical Procedures) Act 1984; "specified procedure" means— (a) a relevant procedure carried out under the repealed Act; or (b) a treatment procedure which is or is to be or may be carried out under this Act, where a consent was given by a woman who is to or may undergo the procedure, or by her husband, or by a 3-30/12/97 143 Infertility Treatment Act 1995 Act No. 63/1995 s. 171 donor or the husband or wife of a donor— (i) under the repealed Act; or (ii) before the commencement of Part 2 (in relation to artificial insemination)— to the carrying out of a fertilisation procedure or artificial insemination or to the use of a gamete, zygote or an embryo in a fertilisation procedure or artificial insemination (as the case may be); or (c) research which is or is to be or may be carried out under this Act where a consent was given to the use of a gamete or a zygote or an embryo for such research— (i) under section 9A of the repealed Act; or (ii) in relation to other research, before the commencement of section 22; or (d) any other prescribed activity which was lawfully commenced before the commencement of this section. (2) Terms (other than terms defined in sub-section (1)) used in this Division and defined in section 3(2) or any other provision of the repealed Act have the same meanings as in that section or provision, unless the contrary intention appears. (3) Unless the contrary intention appears, the definitions of "husband", "spouse" and "wife" in section 3(1) of this Act do not apply to this Division. 3-30/12/97 144 S. 171(3) inserted by No. 37/1997 s. 17(1). Infertility Treatment Act 1995 Act No. 63/1995 s. 172 172. General transitional provision (1) Subject to sub-section (2), this Division does not affect or take away from the operation of the Interpretation of Legislation Act 1984. (2) If a provision of this Division is inconsistent with a provision of the Interpretation of Legislation Act 1984, the provision of this Division prevails. (3) This Division applies despite anything to the contrary in this Act or the repealed Act. S. 173 amended by No. 37/1997 s. 20(b). 173. Regulations The regulations in force under the repealed Act immediately before the commencement of this section have effect, on and from that commencement— (a) to the extent to which regulations to a like effect could be made under this Act, as if made under this Act and may be amended or revoked accordingly; and (b) where a regulation relates to a provision of the repealed Act that is in operation at the commencement of this section or is otherwise continuing to apply, that regulation will also continue to apply to that provision, and may be amended or revoked under the repealed Act, notwithstanding the repeal of an empowering provision under that Act. 174. Donations (1) On the commencement of this section, a gamete, zygote or embryo donated for the purposes of a relevant procedure— (a) to be carried out on another woman, or on the wife of another man (as the case may be); or 3-30/12/97 145 Infertility Treatment Act 1995 Act No. 63/1995 (b) to be carried out under section 9A of the repealed Act— but not used for that procedure at that commencement, must be taken to have been donated for the purpose of a treatment procedure or research under this Act corresponding to that procedure. (2) On the commencement of this section, a gamete donated for the purposes of research of the kind described in section 22(3) but not used for that research at that commencement must be taken to have been donated for the purposes of equivalent research under this Act. (3) Subject to section 181, on the commencement of this section, a person who was the donor of a gamete, zygote or embryo referred to in subsection (1) or (2) must be taken to be a donor of that gamete, zygote or embryo for the purposes of this Act. 175. Consents (1) If, before the commencement of this section— (a) a consent has been given for the purposes of a fertilisation procedure under the repealed Act or for the purposes of artificial insemination using sperm of a donor, by— (i) a donor; or (ii) a donor's spouse; or (iii) a woman who is to undergo the procedure or her husband— and has not been withdrawn at the commencement of this section; and 3-30/12/97 146 s. 175 Infertility Treatment Act 1995 Act No. 63/1995 s. 175 (b) at the commencement of this section the procedure has not been carried out— the consent is deemed, subject to section 180, to be a consent made under and complying with Parts 2 and 4 of this Act to the carrying out of a treatment procedure that corresponds to that procedure, or to the use of a gamete, zygote or embryo in a treatment procedure that corresponds to that procedure. (2) If— (a) a consent has been given for the purposes of a procedure to which section 9A of the repealed Act applies and has not been withdrawn before the commencement of this section; and (b) at the commencement of this section the procedure has not been carried out— the consent is deemed to be a consent made under and complying with Parts 3 and 4 of this Act to the carrying out of that procedure in accordance with Parts 3 and 4. (3) The designated officer of a licensed centre which, before the commencement of this section, was an approved hospital within the meaning of the repealed Act must, subject to the regulations, continue to keep consent documents held at the centre at the commencement of this section and relating to relevant procedures carried out under the repealed Act at the centre before that commencement. (4) If— (a) a consent has been given to the use of a gamete in research (other than research described in section 22(1) or (2)) and has not 3-30/12/97 147 Infertility Treatment Act 1995 Act No. 63/1995 been withdrawn before the commencement of this section; and (b) at the commencement of this section the research has not been carried out— sections 35(2) and 36 do not apply to the consent to the use of that gamete in research under section 34. (5) If sub-section (1) applies so that a consent is deemed to be a consent complying with section 8, 12 or 13, section 10(1) or 17 (as the case may be) does not apply in relation to that consent. 176. Eligibility for fertilisation procedures (1) If all of the requirements of the repealed Act that have to be met before a fertilisation procedure can be carried out under the repealed Act on a woman have been met before the commencement of this section but that procedure has not been carried out at that commencement, a treatment procedure corresponding to that procedure may only be carried out on that woman in accordance with this Act and for that purpose compliance with those requirements is deemed to be compliance with the requirements of Divisions 2, 3 and 4 of Part 2 of this Act. (2) This section does not affect or limit the operation of Division 1 or section 9(1)(c), 10(2), 11(2), 14(1)(c), 15, 21 or 175. 177. Eligibility to undergo donor insemination (1) If— 3-30/12/97 148 s. 177 176 Infertility Treatment Act 1995 Act No. 63/1995 (a) the requirements regarding counselling in section 18 of the repealed Act that have to be met before artificial insemination can be carried out on a woman have been met before the commencement of this section; and (b) the proposed procedure involves the use of sperm from a man who is not the woman's husband— and that procedure has not been carried out at that commencement, the procedure may only be carried out under this Act and for that purpose, section 11(1) is deemed to have been complied with. (2) Section 8(3), Division 3 of Part 2 (except sections 12(1), 14(1) and (2) and 15) and section 20 do not apply to the carrying out of the artificial insemination after commencement of this section in the circumstances outlined in sub-section (1). (3) Sections 13, 14(3) and (4), 16 and 17 only apply to the carrying out of artificial insemination after the commencement of this section in the circumstances outlined in sub-section (1) if the donor consents under section 12 after that commencement. (4) This section does not affect or limit the operation of section 180(4). 178. Eligibility—research procedures (1) If all of the requirements under the repealed Act that have to be met before a procedure to which section 9A of that Act applies can be carried out under the repealed Act have been met before the commencement of this section but at that commencement that procedure has not been carried out, that procedure may only be carried 3-30/12/97 149 Infertility Treatment Act 1995 Act No. 63/1995 out in accordance with Part 3 of this Act and for that purpose compliance with the requirements of those requirements is deemed to be compliance with Divisions 1 and 2 of Part 3. (2) This section does not affect or limit the operation of sections 29(1)(c), 30 or 175. 179. Partial compliance (1) If— (a) one or more, but not all, of the requirements which have to be met for a fertilisation procedure under the repealed Act to be carried out on a woman under that Act have been met before the commencement of this section; and (b) the procedure is to be carried out after that commencement— counselling of— (c) the woman who is to undergo the procedure; or (d) the husband of a woman who is to undergo the procedure; or (e) a donor; or (f) a spouse of a donor— under the repealed Act is deemed to be the equivalent counselling under and in accordance with this Act. (2) If— (a) one or more, but not all, of the requirements which have to be met for a fertilisation procedure under the repealed Act to be carried out on a woman under that Act have been met before the commencement of this section; and 3-30/12/97 150 s. 179 Infertility Treatment Act 1995 Act No. 63/1995 s. 179 (b) the procedure is to be carried out after that commencement; and (c) an assessment of eligibility to undergo a fertilisation procedure following examination or treatment has been conducted under section 10(3)(c) and (d), 11(3)(c) and (d), 12(3)(c) and (d), 13(3)(c) and (d) or 13A(3)(c) and (d) of the repealed Act— and the woman was eligible to undergo a procedure under that section— (d) the woman is deemed to be eligible to undergo a fertilisation procedure under this Act that corresponds to that procedure; and (e) the use of sperm, an oocyte, a zygote or an embryo including sperm, an oocyte, a zygote or an embryo from a donor (as the case may be) as would have been permitted under the repealed Act is permitted in the corresponding procedure under this Act— if, in all other respects, the requirements of this Act (including the requirements in relation to consents under sections 8, 12 and 13) are met. (3) This section does not affect or limit the operation of section 175. (4) If section 175 applies so that a consent is deemed to be a consent complying with section 8, 12 or 13 but the person who has given the consent has not undergone counselling (where counselling is required) under the repealed Act, the counselling referred to in section 11(1) or 16 (as the case may be) in relation to that person must take place before the performance of the procedure to which the consent has been given. (5) Subject to section 189, if one or more, but not all, of the requirements which have to be met for a 3-30/12/97 151 Infertility Treatment Act 1995 Act No. 63/1995 procedure to which section 9A of the repealed Act applies can be carried out under that Act have been met before the commencement of this section, the procedure may only be carried out after that commencement under this Act and for that purpose— (a) a consent which complies with section 9A(2)(b)(iii) or 9A(3)(b) of the repealed Act is deemed to be a consent given under and in accordance with section 27(1)(a) or 28(1) and in accordance with sections 29 and 36; and (b) counselling in compliance with section 9A(2)(b)(iv) or 9A(3)(c) of the repealed Act is deemed to be counselling under and in accordance with section 31; and (c) if a consent has been given as described in paragraph (a)— (i) section 32 does not apply to a person who has given that consent; and (ii) if counselling has not taken place as described in paragraph (b), the counselling described in section 31 must take place before the carrying out of the research. 180. Identified donors under section 16 of the repealed Act (1) Counselling carried out under section 16 of the repealed Act before the commencement of this section is deemed to be counselling under and in accordance with section 18(1)(c), in relation to a procedure to be carried out after that commencement. (2) A request by a woman and her husband under section 16 of the repealed Act prior to the commencement of this section with respect to 3-30/12/97 152 s. 180 Infertility Treatment Act 1995 Act No. 63/1995 s. 181 gametes to be given by a specified person to be used in a relevant procedure is deemed to be a request under section 18(1)(a) and (2), in relation to a procedure to be carried out after that commencement. (3) Section 18(1)(b) does not apply to the carrying out of a fertilisation procedure if a donor has given consent in the circumstances described in section 175(1) and, before the commencement of this section, has undergone counselling under section 16(b) of the repealed Act. (4) Section 18(1)(b) applies to the carrying out of a treatment procedure if— S. 180(4)(a) amended by No. 37/1997 ss 17(2), 20(c). (a) the woman who is to undergo the procedure or her husband (within the meaning of section 3(1) of this Act) knew the identity of a donor before the commencement of this section; and (b) the donor has given or will give consent under section 12. (5) Section 18(1)(b) applies to the carrying out of a fertilisation procedure if a donor has given consent in the circumstances described in section 175(1) and has not undergone counselling under section 16(b) of the repealed Act before the commencement of this section. 181. Recording and disclosing information—general (1) Subject to this Division and to the regulations, Divisions 3 and 4 of Part 7, and sections 62(1), 63(1), 68, 69, 70 and 73 and any other prescribed provisions apply to— (a) a relevant procedure carried out under the repealed Act or an experimental procedure carried out under section 6(3) of the repealed Act; and 3-30/12/97 153 Infertility Treatment Act 1995 Act No. 63/1995 (b) a donor who gave a gamete, zygote or an embryo which was used in a procedure referred to in paragraph (a) carried out under the repealed Act, or who gave a gamete or a zygote which was used to form a zygote or an embryo (as the case may be) which was used in such a procedure carried out under the repealed Act; and (c) the husband or wife of a person referred to in paragraph (b); and (d) a woman who underwent a relevant procedure under the repealed Act and her husband; and (e) a person born as a result of the carrying out of a relevant procedure under the repealed Act; and (f) a gamete, zygote or an embryo used in a procedure referred to in paragraph (a) which was carried out under the repealed Act, or which was used to form a zygote or an embryo (as the case may be) which was used in such a procedure carried out under the repealed Act; and (g) information in connection with a procedure carried out under the repealed Act or a person or thing referred to in paragraph (a), (b), (c), (d), (e) or (f). (2) Despite their repeal, sections 19 and 21 of the repealed Act continue to apply in relation to— (a) things required to be done, but not done, prior to the repeal of those provisions; and (b) those things which would have been required to be done but for the repeal of those provisions— but— 3-30/12/97 154 s. 181 Infertility Treatment Act 1995 Act No. 63/1995 s. 181 (c) if information is or was required to be given to the Chief General Manager or to the Secretary of the Department of Health and Community Services under section 19 or 21 of the repealed Act, each section is to be taken— (i) to apply only to a procedure involving the use of a gamete, zygote or an embryo from a donor, and to the birth of a child from such a procedure; and (ii) to provide that the information is to be given to the Authority (rather than to the Chief General Manager or the Secretary) for inclusion in the central register; and (d) if, after the commencement of Part 7, information is required to be kept in a register or written record under section 19 or 21 of the repealed Act, and the approved hospital or medical practitioner to whom the provision applies is subject to section 62 or 63 of this Act, the information must be kept in the equivalent register under those provisions rather than as required under section 19 or 21 of the repealed Act. (3) Subject to this Division and to the regulations, Part 7 applies— (a) if a treatment procedure or research is or may be carried out after the commencement of Part 2, where— (i) a consent or other requirement in relation to a donor, the woman who is to undergo the procedure or her husband or some other person; or 3-30/12/97 155 Infertility Treatment Act 1995 Act No. 63/1995 (ii) any other requirement in relation to that procedure or research— was given or begun or otherwise commenced under the repealed Act or prior to the commencement of Part 2, to— (iii) that treatment procedure or research; and (iv) a donor who has given a gamete, zygote or an embryo which has been or may be used in such a treatment procedure or research or which may be or has been used to form a zygote or an embryo which has been or may be used (as the case may be) in such a treatment procedure or research and the spouse of such a person; and (v) a woman who may undergo or has undergone such a treatment procedure and her husband; and (vi) a person born as a result of such a treatment procedure; and (vii) a gamete, zygote or an embryo used or which may be used in such a treatment procedure or research or which was used or may be used to form a zygote or an embryo which has been or may be used (as the case may be) in such a treatment procedure or research; and (viii) information in connection with a treatment procedure, research, person or thing referred to in sub-paragraph (iii), (iv), (v), (vi) or (vii); and (b) to any information which is not referred to in sub-section (1) which is kept or required to be kept in the register of a hospital or a 3-30/12/97 156 s. 181 Infertility Treatment Act 1995 Act No. 63/1995 s. 181 written record of a doctor under section 19 or 21 of the repealed Act or in the central register under section 22 of that Act. (4) For the purposes of sub-sections (1) and (3), and in addition to section 174, Part 7 applies with any necessary modifications, including the following— (a) a reference to a licensed centre is to include a reference to an approved hospital; and (b) a reference to the central register includes a reference to the central register under section 22 of the repealed Act; (c) a reference to a donor includes a reference to a donor within the meaning of section 171(1); (d) a reference to a treatment procedure includes a reference to a fertilisation procedure or artificial insemination under the repealed Act; and (e) a reference to a donor treatment procedure includes a reference to a fertilisation procedure under the repealed Act using gametes from a donor or a zygote or embryo donated by or formed from a gamete donated by a donor, and to artificial insemination using sperm of a donor. (5) In sub-sections (1)(e) and (3)(f), "information in connection with", includes information about— (a) gametes, zygotes or embryos; and (b) a person who produces gametes; and (c) consents; and (d) the outcome of a procedure, including pregnancy or miscarriage; and 3-30/12/97 157 Infertility Treatment Act 1995 Act No. 63/1995 (e) the birth of a child as a result of a procedure. (6) For the purposes of this section, "listed person" in sections 89(3) and 90 includes, in addition to the persons referred to in section 89(3)— (a) a person who— (i) is or has been involved in the management of, engaged or employed at or worked for or at an approved hospital; or (ii) is or has been a doctor who has carried out artificial insemination at a place other than an approved hospital or any person who is or has been engaged or employed by or worked for or with such a doctor; or (b) a person who is or has been a designated officer or an approved counsellor; or (c) a person who carries out or has carried out or is or has been involved in the carrying out of— (i) a relevant procedure, whether or not at an approved hospital; or (ii) an experimental procedure under section 6(3) of the repealed Act; or (iii) anything authorised to be done under the repealed Act; (iv) any other function under the repealed Act; or (d) the former Committee or any person who is or has been a member of that Committee or who has been employed or engaged to assist that Committee in carrying out its functions; or 3-30/12/97 158 s. 181 Infertility Treatment Act 1995 Act No. 63/1995 s. 182 (e) any person who is or has been involved in the administration of the repealed Act. (7) Section 70 applies to a register or written record kept under section 19 or 21 of the repealed Act if the register or record is not, by virtue of section 182, a register under section 62 and 63. (8) In this section, a reference to information in section 165 includes a reference to— (a) information kept or required to be kept under the repealed Act; and (b) information about a matter, thing or person referred to in sub-section (1) or (3). (9) Despite any other provision in this Division, Part 7 does not apply to a treatment procedure or artificial insemination carried out before 1 July 1988 or to a donor whose gamete, zygote or embryo was used in such a procedure or insemination except— (a) in relation to information required to be recorded in a register or written record under section 19 or 21 of the repealed Act or in the central register under section 22 of the repealed Act; or (b) in the prescribed circumstances. 182. Registers and records (1) A Register existing immediately before the commencement of this section under section 19 of the repealed Act in respect of an approved hospital that becomes a licensed centre by virtue of section 191 forms part of the Register to be kept at that centre under section 62. (2) A written record existing under section 21 of the repealed Act immediately before the commencement of this section and kept by a 3-30/12/97 159 Infertility Treatment Act 1995 Act No. 63/1995 doctor who is an approved doctor under Part 8 forms part of the record to be kept by that doctor under section 63. (3) The central Register existing under section 22 of the repealed Act immediately before the commencement of this section forms part of the central Register kept under section 68 of this Act. 183. Recording and giving information (1) Subject to the regulations, on the commencement of this section information recorded or given before that commencement or given after that commencement in accordance with this Act under a provision of the repealed Act specified in column 1 of the Table as required by that provision or this Act is deemed to be information referred to in, and recorded or given in accordance with, a provision of this Act appearing opposite in column 2 of the Table, to the extent that a provision in column 2 imposes a type of requirement equivalent to the type of requirement imposed under the provision in column 1. (2) The regulations may prescribe further provisions for the purpose of this section. Table Provision of repealed Act Provision of this Act Section 19(2)(a) Section 19(2)(b) Section 19(2)(c) Section 19(2)(d) Section 19(2)(e) Section 62(2)(a) (d) and (i) Section 62(2)(l) Section 62(2)(m) Section 62(2)(b) Section 62(2)(a), (b), (c), (e), (f), (i), (j) and (n) Section 62(2)(b), (c), (f), (g), (i) and (j) Section 62(2)(b), (c), (f) and (i) Section 19(2)(f) Section 19(2)(g) 3-30/12/97 160 s. 183 Infertility Treatment Act 1995 Act No. 63/1995 s. 184 Provision of repealed Act Provision of this Act Section 19(2)(h) Section 19(3)(a) Section 62(2)(d) and (o) Section 64(a) and 66(b) and (c) Section 64(a) and 66(a) Section 154 Section 62(2)(h) Section 71(3) Section 72(2) and 73(5) Section 63(2)(a), (b), (e) and (f) Section 63(2)(c) and (f) Section 65(a) and 66. Section 19(3)(b) Section 19(4)(a) Section 19(4)(b) Section 20(1) Section 20(2) Section 21(a) Section 21(b) Section 21 184. Access to information (1) A request under section 20 (3) of the repealed Act that has not been complied with before the commencement of this section is deemed to be a request made under section 73(1) of this Act. (2) An application under section 23(2) of the repealed Act that has not been dealt with under section 23(3) of that Act before the commencement of this section is deemed to be an application under section 79(1)(a) of this Act and must be forwarded to the Authority. (3) On receiving an application made under section 79(1)(a) by a person— (a) who is or may have been born as the result of a specified procedure in which— (i) a gamete or a zygote or an embryo given by a donor was used; and (ii) the donor gave consent to the use of the gamete, zygote or embryo in relation to such a procedure under the repealed 3-30/12/97 161 Infertility Treatment Act 1995 Act No. 63/1995 Act or prior to the commencement of Part 2; or (b) who is the descendant of a person who has or may have been born as the result of such a specified procedure— the Authority must give, in writing, any such information recorded in the Central Register to the applicant, if the Authority is satisfied that the applicant, has been offered counselling about the potential consequences of the disclosure of that information from a counsellor approved under Part 8 to give counselling to persons applying for information under section 79. (4) On receiving an application made under section 79(1)(b) by a person— (a) who is or may have been born as the result of a specified procedure in which— (i) a gamete or a zygote or an embryo given by a donor was used; and (ii) the donor gave consent to the use of the gamete, zygote or embryo in relation to such a procedure under the repealed Act or prior to the commencement of Part 2; or (b) who is the descendant of a person who has or may have been born as the result of such a specified procedure— the Authority must give, in writing, any such information recorded in the Central Register to the applicant— (c) if the Authority is satisfied that the donor has first consented in writing to the giving of that information; and 3-30/12/97 162 s. 184 Infertility Treatment Act 1995 Act No. 63/1995 s. 184 (d) the information is given in accordance with any conditions or limitations imposed by the donor; and (e) the Authority is satisfied that the applicant has received counselling about the potential consequences of the disclosure of that information from a counsellor approved under Part 8 to give counselling to persons applying for information under section 79; and (f) the donor's consent has not been withdrawn in writing. (5) For the purposes of sub-section (4), the Authority must make reasonable efforts— (a) to find the donor whose consent is required; and (b) before seeking the consent, to advise the donor that he or she may need counselling and provide the donor with the names of counsellors approved under Part 8 to give counselling to a person in respect of whom an application has been made under section 79; and (c) if the donor consents to the giving of the information, before the information is given, to advise the donor that the information is about to be given. (6) Section 80 does not apply to an application to which sub-section (3) or (4) applies or to an application in relation to a treatment procedure or artificial insemination carried out before 1 July 1988. (7) Information or a consent given or required to be given under sub-section (3) or (4) is deemed for the purposes of Part 7 to be information or a 3-30/12/97 163 Infertility Treatment Act 1995 Act No. 63/1995 consent given or required to be given under Division 3 of that Part. (8) Section 81 applies to this section. 185. Gametes, zygotes and embryos in storage (1) A gamete, zygote or embryo which, immediately before the commencement of this section, was in storage may be used in accordance with this Act in a treatment procedure or research. (2) Subject to sections 186, 187, 188, this Division and the regulations, this Act (except section 52) applies to gametes, zygotes and embryos in storage at the commencement of this section. 186. Application of time limits for storage of zygotes and embryos (1) A person must not cause or permit a zygote or embryo in storage at the commencement of section 185 to remain in storage at or after that commencement— (a) if a person who has produced a gamete from which the zygote or embryo was formed has specified in writing a maximum total period of storage of less than five years, after that period; or (b) in any other case, after— (i) five years from the date on which the zygote or embryo was first placed in storage; or (ii) any longer period approved by the Authority. Penalty: 240 penalty units or 2 years imprisonment or both. 3-30/12/97 164 s. 185 Infertility Treatment Act 1995 Act No. 63/1995 s. 189 187 (2) The Authority may approve in writing a longer period of storage under sub-section (1), with or without conditions, if it considers that there are reasonable grounds to do so in the particular case. (3) For the purposes of this Act an approval by the Authority under this section is deemed to be an approval under section 52(4). (4) Sub-section (1)(b)(i) does not apply to a zygote or embryo until the second anniversary of the day on which this Act receives the Royal Assent. (5) Section 51(1)(b)(i) does not apply to a gamete in storage at the commencement of section 185 until the second anniversary of the day on which this Act receives the Royal Assent. 187. Removal from storage If a zygote or embryo is stored at a place that is not an approved hospital at the commencement of this section, section 53(1) does not apply to such a zygote or embryo. 188. Use of stored gametes, zygotes and embryos Section 55 applies to a gamete, zygote or embryo in storage at the commencement of this section, but only in relation to its storage after that commencement. 189. Approval of research procedures (1) In this section "specified approval" means an approval— (a) given by the former Committee under section 9A of the repealed Act; and (b) in force, or varied and in force, immediately before the commencement of this section. (2) On the commencement of this sub-section— 3-30/12/97 165 Infertility Treatment Act 1995 Act No. 63/1995 (a) an approval in force under section 6(3) of the repealed Act ceases to have effect; and (b) a request for approval under that sub-section not determined at the date of commencement of this section lapses. (3) On the commencement of this sub-section a specified approval to which this section applies is deemed to have been given by the Authority under Division 2 of Part 8 and may be varied or cancelled accordingly. (4) Section 22(1)(c) does not apply to the carrying out of research under an approval deemed to have been given by the Authority under sub-section (3). 190. Approval of counsellors (1) An approval of a person as a counsellor— (a) given by the Minister under the repealed Act; and (b) in force, or varied and in force, immediately before the commencement of this section— is deemed to be an approval given by the Authority under Division 4 of Part 8 and may be varied, suspended, or cancelled accordingly. (2) Sub-section (1) does not affect the continuity of the terms and conditions of an approval to which it applies. 191. Approval of premises (1) Subject to sub-section (11), an approval of a public hospital, private hospital or denominational hospital— (a) under section 7 of the repealed Act; and (b) in force, or varied and in force, immediately before the commencement of this section— 3-30/12/97 166 s. 191 Infertility Treatment Act 1995 Act No. 63/1995 is deemed to be a licence granted by the Authority under Division 1 of Part 8 on the same terms and conditions as those applying to the approval, and may be varied or cancelled or renewed accordingly. (2) A licence referred to in sub-section (1) that applies to a public hospital, denominational hospital or private hospital must be taken to authorise the carrying out, by a doctor or other person, of donor insemination but only if the hospital was, immediately before the commencement of this sub-section, approved as a place at which the procedure of artificial insemination may be carried out. (3) Subject to sub-section (4), the prescribed conditions do not apply to a licence referred to in sub-section (1). (4) As soon as practicable after the commencement of this section but not later than the end of 6 months after that commencement of this section the Authority must, in accordance with this Act, vary a licence referred to in sub-section (1)— (a) to include in the licence— (i) the prescribed conditions applying to licences granted after the commencement of this section for activities, and authorising procedures, of the same kind as those covered by the licence to be varied; and (ii) any terms and conditions that the Authority wishes to impose under subsection (5); and 3-30/12/97 167 Infertility Treatment Act 1995 Act No. 63/1995 (b) to remove any inconsistency between the existing terms and conditions of the licence and those included under paragraph (a). (5) Section 106 applies to a licence referred to in subsection (1) for six months after the commencement of this section, so as to empower the Authority to impose conditions during that six month period. (6) Sections 107 and 110 apply to a licence referred to in sub-section (1) as if that licence was granted under Part 8. (7) Sub-section (4) does not apply to an activity at premises which has become subject to a licence granted or renewed under Part 8. (8) If a licence referred to in sub-section (1) refers to a procedure or to a provision of the repealed Act to describe a procedure authorised by the licence, that licence is deemed to authorise the carrying out under this Act of a procedure corresponding to that procedure. (9) A licence referred to in sub-section (1) must be taken to authorise the storage of gametes, zygotes and embryos at the licensed centre. (10) Part 8 does not apply to the variation of a licence under sub-section (4). (11) The Authority must designate a person who is to be the licensee in relation to a licence referred to in sub-section (1) and for that purpose a licensee must be— (a) in relation to a hospital that is a legal person, that hospital; or (b) in relation to a denominational hospital that is not a legal person, a nominee of the hospital who is a legal person; or 3-30/12/97 168 s. 191 Infertility Treatment Act 1995 Act No. 63/1995 s. 192 (c) in relation to a private hospital, the proprietor and, if the proprietor is not a legal person, a nominee of the proprietor who is a legal person— and a licence referred to in sub-section (1) is not deemed to be a licence granted under Division 1 of Part 8 until that designation is made. 192. Review of Ministerial decisions Despite its repeal, Part VI of the repealed Act (as in force immediately before the commencement of this section) continues to apply to a decision of the Minister under that Act. 193. Ministerial directions (1) This Part does not affect the continuity of the status and effect of a direction given under section 7 of the repealed Act and anything required or authorised by the direction that has not been done at the commencement of this section must be done or completed in accordance with that direction and this Act. (2) This Act applies to a zygote or an embryo which, before the commencement of this section, in accordance with section 14(1)(a) of the repealed Act has been made available for use in a relevant procedure but at the commencement has not been used for that procedure. (3) This Act applies if— (a) under section 14(1)(b) of the repealed Act, a direction has been given that a zygote or an embryo be made available for use in a relevant procedure; and (b) at the commencement of this section the procedure has not been carried out— 3-30/12/97 169 Infertility Treatment Act 1995 Act No. 63/1995 s. 194 as if all relevant consents had been given under this Act to the carrying out of a treatment procedure or research corresponding to that procedure. 194. Abolition of former Committee (1) The former Committee is abolished and its members go out of office. (2) The Authority may, in accordance with this Act, continue and complete any thing of a continuing nature commenced by the former Committee. * * * * * S. 194(2) substituted by No. 37/1997 s. 5(2). S. 194(3) repealed by No. 37/1997 s. 5(2). (4) The Authority must prepare the Annual Report that the former Committee would have been required to prepare in accordance with the requirements of section 29(9) of the repealed Act, if that provision had not been repealed. * * * * * 196. Exemptions (1) The Authority may, in writing, with the approval of the Minister exempt a person from all or any of the provisions of this Act (other than section 24) or the regulations or any part of a provision of this Act (other than section 24) or the regulations in respect of— (a) a specified procedure; or (b) a procedure involving the use of a zygote or an embryo referred to in section 193(2) or (3); or (c) anything done in accordance with the repealed Act; or 3-30/12/97 170 S. 195 repealed by No. 37/1997 s. 18. Infertility Treatment Act 1995 Act No. 63/1995 s. 197 196 (d) a continuing matter commenced under the repealed Act but not completed at the commencement of this section. (2) An exemption— (a) may be general or limited in application to any particular case or class of cases; and (b) may be made subject to any conditions that the Authority specifies in the exemption; and (c) may specify who must comply with any conditions of the exemption. (3) A person required to comply with a condition of an exemption must comply with that condition. Penalty: 50 penalty units. (4) The Authority may, in writing, amend or revoke an exemption. (5) As soon as possible after making, amending or revoking an exemption the Authority must give written notice of this to each person to whom it applies or will apply. (6) This section applies despite anything to the contrary in this Division. (7) Without limiting sub-section (1)(d), "continuing matter" under that sub-section includes— (a) a case where section 176, 177, 179 or 180 applies; and (b) a gamete, zygote or embryo in storage before the commencement of this section or section 185. 197. Existing immunity not affected (1) The amendments made to section 133 of the Health Act 1958 by Division 1 do not affect any immunity existing under that section immediately 3-30/12/97 171 Infertility Treatment Act 1995 Act No. 63/1995 before the date of commencement of this subsection. (2) Despite the repeal of section 15(2) or 24 of the repealed Act, those provisions continue to apply to a relevant procedure carried out under that Act. 198. Superseded references (1) On the commencement of this section and unless inconsistent with the context or subject matter, a reference in an Act or regulations (other than this Act) or a document, in relation to a period on or after that commencement— (a) to an approved hospital under the repealed Act is deemed to be a reference to a licensed centre; and (b) to the central Register under the repealed Act is deemed to be a reference to the central Register under Part 7 of this Act; and (c) to a Register under section 19 of the repealed Act is deemed to be a reference to a Register under section 62 of this Act; and (d) except in relation to approving research, to the former Committee is deemed to be a reference to the Committee; and (e) to the former Committee, in relation to approving research, is deemed to be a reference to the Authority; and (f) to a record kept under section 21 of the repealed Act is deemed to be a reference to a record under section 63; and (g) to the designated officer of an approved hospital under the repealed Act is deemed to be a reference to the designated officer of a licensed centre; and 3-30/12/97 172 Infertility Treatment Act 1995 Act No. 63/1995 s. 199 (h) to a fertilisation procedure is deemed to be a reference to a fertilisation procedure under this Act; and (i) to a relevant procedure, other than a procedure under section 9A of the repealed Act, is deemed to be a reference to a treatment procedure; and (j) to an approved counsellor under the repealed Act is deemed to be a reference to a counsellor approved under Part 8 of this Act; and (k) to the repealed Act is deemed to be a reference to this Act; and (l) to the regulations made under the repealed Act is deemed to be a reference to the regulations made under this Act. (2) Regulations may be made prescribing superseded references. 199. Further savings and transitional provisions (1) The regulations may contain provisions of a savings or transitional nature consequent on— (a) the coming into operation of any provision of this Act; or (b) the repeal of any provision of the repealed Act; or (c) the coming into operation of a regulation under this Act; or (d) the revocation of a regulation under the repealed Act. (2) The regulations may provide for the presumed or deemed construction of a consent, assessment of eligibility or other document— 3-30/12/97 173 Infertility Treatment Act 1995 Act No. 63/1995 (a) made under or in relation to the repealed Act; or (b) made before the commencement of section 22 or Part 2. (3) Sub-section (2) does not limit or affect subsection (1). ═══════════════ 3-30/12/97 174 s. 199 Infertility Treatment Act 1995 Act No. 63/1995 Notes NOTES 1. General Information Minister's second reading speech— Legislative Assembly: 4 May 1995 Legislative Council: 6 June 1995 The long title for the Bill for this Act was "A Bill to regulate procedures for the treatment of infertility and research using human reproductive material, to make provisions with respect to surrogacy agreements, to repeal the Infertility (Medical Procedures) Act 1984 and to amend various other Acts and for other purposes.". Constitution Act 1975: Section 85(5) statement: Legislative Assembly: 4 May 1995 Legislative Council: 6 June 1995 Absolute majorities: Legislative Assembly: 20 May 1995 and 1 June 1995 Legislative Council: 7 June 1995 The Infertility Treatment Act 1995 was assented to on 27 June 1995 and came into operation as follows: Sections 1–4 on 27 June 1995: s. 2(1); section 170 on 1 July 1988: s. 2(2); sections 5, 121, 122(1)(g)(j)(2)–(5), 123–136, 138, 139, 165, 199 on 1 September 1995: Government Gazette 31 August 1995 page 2284; rest of Act on 1 January 1998: s. 2(4). 3-30/12/97 175 Infertility Treatment Act 1995 Act No. 63/1995 2. Table of Amendments This version incorporates amendments made to the Infertility Treatment Act 1995 by Acts and subordinate instruments. ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Infertility Treatment (Amendment) Act 1997, No. 37/1997 Assent Date: 3.6.97 Commencement Date: 3.6.97: s. 2 Current State: All of Act in operation ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 3-30/12/97 176 Notes Infertility Treatment Act 1995 Act No. 63/1995 Notes 3. Explanatory Details No entries at date of publication. 3-30/12/97 177
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