Version No. 030
Infertility Treatment Act 1995
No. 63 of 1995
Version incorporating amendments as at 12 June 2007
table of provisions
Section Page
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Section Page
Part 1—Preliminary 1
1 Purposes 1
2 Commencement 2
3 Definitions 2
4 Interpretation 12
5 Guiding principles 13
5A Act to bind the Crown 14
Part 2—Treatment Procedures 15
Division 1—General 15
6 Fertilisation procedures 15
7 Donor insemination 15
Division 2—General requirements for treatment procedures 16
8 Persons who may undergo treatment procedures 16
9 Requirements as to consent 17
10 Information 18
11 Counselling 18
Division 3—Requirements for donors 19
12 Donation of gametes or embryos 19
13 Consent of spouse of donor 20
14 Requirements as to consent 21
15 Objection by later spouse 23
16 Counselling requirements 24
17 Requirements as to the giving and receiving of information 24
18 Identified donors 25
19 Requirements as to consent to use of gamete etc. from identified donor 26
Division 4—Requirements for donor treatment procedures 27
20 Circumstances in which donor procedure may be used 27
21 Information and advice 29
Part 2A—Regulation of Certain Uses Involving Excess Art Embryos, other Embryos and Human Eggs 30
Division 1—Interpretation 30
21A Definitions 30
21B Meaning of excess ART embryo 33
Division 2—Offences 33
21C Offence—use of excess ART embryo 33
21CA Offence—use of other embryos 35
21CB Offence—certain activities involving use of human eggs 36
21D Offence—use of embryo that was created by fertilisation and
that is not an excess ART embryo 37
21E Offence—breaching a licence condition 37
21EA Person not liable for conduct purportedly authorised 38
Division 3—Embryo Research Licensing Committee of the NHMRC 38
21F Functions of Committee 38
21G Powers of Committee 38
Division 4—Licensing system 39
21H Person may apply for licence 39
21I Determination of application by Committee 40
21J Notification of decision 42
21K Period of licence 42
21L Licence is subject to conditions 42
21M Variation of licence 45
21N Suspension or revocation of licence 45
21O Surrender of licence 46
21P Notification of variation, suspension or revocation of licence 46
Division 5—Reporting and confidentiality 46
21Q NHMRC Licensing Committee to make certain information publicly available 46
21R Confidential commercial information may only be disclosed
in certain circumstances 47
Division 6—Review provisions 49
21S Meaning of terms 49
21T Review of decisions 50
Division 7—Monitoring powers 51
21U Powers available to inspectors for monitoring compliance 51
21V Monitoring powers 52
21W Power to secure 54
21WA Monitoring warrants 54
21WB Details of warrant to be given to occupier etc. 55
21WC Announcement before entry 56
21WD Occupier entitled to be present during search 56
21X Inspector must produce identity card on request 56
21Y Consent 56
21Z Compensation for damage 57
21ZA Extended operation of Division 57
Part 3—Research 58
Division 1—Offences 58
22 Research 58
23 Places for research 59
24 Ban on destructive research on non-excess ART embryos 59
25 Authority must not approve destructive research on
non-excess ART embryos 60
26 Authority must not approve certain research on oocytes in the process of fertilisation 60
Division 2—Preliminary requirements for research involving embryos 61
27 Consent to research involving embryos 61
28 Consent of spouse of donor 62
29 Requirements as to consent 63
30 Objection by later spouse 63
31 Counselling requirements 64
32 Information requirements 65
Division 3—Repealed 65
33 Repealed 65
Division 4—Preliminary requirements for other research involving gametes 65
34 Consent to research using gametes 65
35 Requirements as to consent 66
Division 5—Application of Part 66
35A Meaning of research in this Part 66
Part 4—Procedures Relating to Consents 67
36 Approved form to be used 67
37 Withdrawal of consent 67
38 Lapsing of consent 67
Part 4A—Prohibited Practices Including Prohibition on Human Cloning for Reproduction 69
Division 1—Practices that are completely prohibited 69
38A Repealed 69
38B Offence—placing a human embryo clone in the human body
or the body of an animal 69
38C Offence—importing or exporting a human embryo clone 69
38D No defence that human embryo clone could not survive 70
38E Repealed 70
38F Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman 70
38G Offence—creating or developing a human embryo by
fertilisation that contains genetic material provided by more
than 2persons 71
38H Offence—developing a human embryo outside the body of a woman for more than 14 days 71
38I Repealed 71
38J Offence—heritable alterations to genome 72
38K Offence—collecting a viable human embryo from the body
of a woman 72
38L Offence—creating a chimeric or hybrid embryo 72
38LA Offence—developing a hybrid embryo 73
38M Offence—placing of an embryo 73
38N Offence—importing, exporting or placing a prohibited embryo 73
38O Offence—commercial trading in human eggs, human sperm or human embryos 75
Division 2—Practices that are prohibited unless authorised by a licence 76
38OA Offence—creating a human embryo other than by fertilisation, or developing such an embryo 76
38OB Offence—creating or developing a human embryo
containing genetic material provided by more than
2persons 77
38OC Offence—using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such
an embryo 78
38OD Offence—creating a hybrid embryo 78
Part 5—Other Miscellaneous Offences 80
Division 1—Prohibited procedures 80
38P Application of Division 80
39 Repealed 80
40 Transfer of gametes or embryos used for research 80
41 Ban on procedures involving gametes produced by children 81
42 Repealed 81
43 Ban on procedures involving gametes of people known to be dead 82
44, 45 Repealed 82
46 Ban on certain procedures 82
47–49 Repealed 83
50 Ban on sex selection 83
Division 2—Storage 84
50A Application of Division 84
51 Storing gametes 84
52 Storing embryos 85
53 Removal of embryos from storage 86
54 Places of storage 87
55 Ban on use of gametes or embryos not stored at licensed centre 88
Division 3—General offences 88
56 Import or export of gametes and embryos 88
57 Repealed 90
58 False or misleading information 90
Part 6—Surrogate Motherhood 91
59 Surrogacy 91
60 Surrogacy—advertising 91
61 Surrogacy agreements void 92
Part 7—Records and Access to Information 93
Division 1—Records 93
62 Register to be kept for licensed centre 93
63 Register to be kept by doctor carrying out donor insemination 95
64 Information to be given to the Authority by licensed centres 97
65 Information to be given to the Authority by doctors not at licensed centres 98
66 Information to be given under section 64 and 65 99
67 Information to be given to the Authority about births by other persons 99
68 Authority to keep a central register 101
69 Authority to correct central register 101
70 Inspection of Registers 101
Division 2—Information to be given by licensed centres and
doctors 102
71 Information recorded by licensed centre or doctor which is to
be given to persons undergoing donor treatment procedures 102
72 Information recorded by licensed centre or doctor which is to
be given to donors 104
73 Information about pregnancy, birth or transfer 106
Division 3—Information to be given from central register 107
74 Application by parents for information contained on central register 107
75 Authority to give information about donor to parents 108
76 Application by donor for information about persons born as a result of donor treatment procedures and parents of such
persons 109
77 Authority to give information about person born as a result
of a donor treatment procedure 110
78 Authority to give information about parents 111
79 Application by person born as a result of a donor treatment procedure or descendant for information about donor 113
80 Authority to give information about donor to person born as
the result of a procedure 113
81 Counselling not applicable in certain circumstances 114
82 Donor treatment procedure information register 115
Division 4—General provisions 116
83 Information 116
84 Waiver of fees 116
85 Disclosure of information to a medical practitioner 116
86 Records of information given 117
87 Consent 117
88 Authority may refuse to give information 117
89 Confidentiality—information which may identify 118
90 Confidentiality—non-identifying information 123
91 Closure of court or tribunal 125
92 Exemption from Freedom of Information Act 1982 125
Part 7A—Pre-1 July 1988 Procedure Information 127
92A Definitions 127
92B Application of Part 127
92C Recording of pre-1 July 1988 information 128
92D Release of information 129
92E Request for release of information 129
92F Authority to comply with wishes of person who provided information 129
92G Authority may give information 129
92H Counselling waived in certain circumstances 130
92I Offences 131
Part 8—Licences, Approvals and Designated Officers 132
Division 1—Licensing of places 132
93 Licence application—hospitals and day procedure centres 132
94 Licence application—research institutions 133
95 Designation of principal doctor or principal scientist 133
96 Licence applications—general procedure 134
97 Authority may grant or refuse licence 135
Division 2—Approval to carry out research 136
98 Application for approval to carry out research 136
99 Approval by Authority to carry out research 137
100 Report of results of research to Authority 137
Division 3—Approval of persons carrying out treatment proceduresor research 138
101 Application for approval of doctor or scientist 138
102 Authority may grant or refuse approval 139
Division 4—Approved counsellors 139
103 Application for approval of counsellors 139
104 Authority may grant or refuse approval 140
Division 5—General provisions about licences, approvals and exemptions 140
104A Application of Part 140
105 Form and content of licence or approval 140
106 Power of Authority to impose conditions 141
107 Provision of information 142
108 Variation of conditions of licences or approvals under this Part 142
109 Variation of approvals and exemptions under Part 5 143
110 Offence of failing to comply with terms etc. of licence or approval 143
110A Formation of embryos 144
111 Duration and renewal of licence or approval 144
112 Application for renewal 145
113 Suspension of licence, approval or exemption 146
114 Immediate suspension 146
115 Cancellation of licence, approval or exemption 147
116 Orders 149
117 Notification about approvals and licences 152
118 Notification to Minister 153
Division 6—Designated officers 154
119 Designated officers for licensed centres 154
120 If no designated officer appointed 154
Part 9—Infertility Treatment Authority 156
Division 1—Constitution of the Authority 156
121 Establishment of Authority 156
122 Powers, functions, duties and consultation requirements 156
123 Membership 158
124 Terms of office 159
125 Resignation and removal 159
126 Chairperson and Deputy Chairperson 160
127 Acting member 160
128 Payment of members 161
129 Procedure of Authority 161
130 Effect of vacancy or defect 161
131 Member's interests 162
132 Immunity 163
133 Engagement or employment of persons 163
134 Delegation 163
135 Committees 164
Division 2—Supplementary powers 164
136 Powers of Authority in relation to fees 164
Division 3—Reporting and financial provisions 165
137 Report to Minister 165
138 Infertility Treatment Authority Fund 167
139 Investment powers 167
Part 10—Repealed 168
140–148 Repealed 168
Part 11—Review of Decisions 169
149 Review of decisions 169
Part 12—General 171
150 Decisions by Authority not reviewable 171
151 No action if gametes used without knowing consent withdrawn
or lapsed 171
152 Conscientious objections 171
153 Record of consent or objection and withdrawal of consent or objection 172
154 Transfer of documents 173
155 Authorised officers 174
156 Powers and duties of members of Authority and authorised officers 174
157 Offence to obstruct or hinder 175
158 Additional liability for offences 175
159 Application of Public Records Act 1973 176
160 Prohibition on destruction of documents 176
161 Evidence 176
162 Search warrants 177
163 Indictable offences 179
164 Supreme Court—limitation of jurisdiction 179
Part 13—Regulations 181
165 Regulations 181
Part 14—Review and Transitional Provisions 185
Division 1—Review of Parts 2A and 4A 185
166 Review of operation of Parts 2A and 4A 185
167–170 Repealed 186
Division 2—Transitional provisions 186
171 Definitions 186
172 General transitional provision 189
173 Regulations 189
174 Donations 190
175 Consents 191
176 Eligibility for fertilisation procedures 192
177 Eligibility to undergo donor insemination 193
178 Eligibility—research procedures 194
179 Partial compliance 194
180 Identified donors under section 16 of the repealed Act 197
181 Recording and disclosing information—general 198
182 Registers and records 204
183 Recording and giving information 204
184 Access to information 205
185 Gametes, zygotes and embryos in storage 208
186 Application of time limits for storage of zygotes and embryos 208
187 Removal from storage 209
188 Use of stored gametes, zygotes and embryos 209
189 Approval of research procedures 210
190 Approval of counsellors 210
191 Approval of premises 211
192 Review of Ministerial decisions 213
193 Ministerial directions 213
194 Abolition of former Committee 214
195 Repealed 214
196 Exemptions 215
197 Existing immunity not affected 216
198 Superseded references 216
199 Further savings and transitional provisions 218
Division 3—Savings and transitional provisions (2003 Act) 218
200 Definition 218
201 Status of certain licences and approvals 219
202 Regulations 219
203 General transitional provision 219
Division 4—Savings and transitional provisions (2007 Act) 220
204 Definition 220
205 Existing applications for licences 220
206 Existing licences 220
207 Offences 220
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ENDNOTES 222
1. General Information 222
2. Table of Amendments 223
3. Explanatory Details 225
INDEX 226
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Version No. 030
Infertility Treatment Act 1995