Version No. 020
Infertility Treatment Act 1995
Act No. 63/1995
Version incorporating amendments as at 16 October 2003
table of provisions
SectionPage
1
SectionPage
Part 1—Preliminary
1.Purposes
2.Commencement
3.Definitions
4.Interpretation
5.Guiding principles
5A.Act to bind the Crown
Part 2—Treatment Procedures
Division 1—General
6.Fertilisation procedures
7.Donor insemination
Division 2—General requirements for treatment procedures
8.Persons who may undergo treatment procedures
9.Requirements as to consent
10.Information
11.Counselling
Division 3—Requirements for donors
12.Donation of gametes or embryos
13.Consent of spouse of donor
14.Requirements as to consent
15.Objection by later spouse
16.Counselling requirements
17.Requirements as to the giving and receiving of information
18.Identified donors
19.Requirements as to consent to use of gamete etc. from
identified donor
Division 4—Requirements for donor treatment procedures
20.Circumstances in which donor procedure may be used
21.Information and advice
Part 2A—Regulation of Certain Uses Involving Excess Art Embryos
Division 1—Interpretation
21A.Definitions
21B.Meaning of excess ART embryo
Division 2—Offences
21C.Offence—use of excess ART embryo
21D.Offence—use of embryo that is not an excess ART embryo
21E.Offence—breaching a licence condition
Division 3—Embryo Research Licensing Committee of the
NHMRC
21F.Functions of Committee
21G.Powers of Committee
Division 4—Licensing System
21H.Person may apply for licence
21I.Determination of application by Committee
21J.Notification of decision
21K.Period of licence
21L.Licence is subject to conditions
21M.Variation of licence
21N.Suspension or revocation of licence
21O.Surrender of licence
21P.Notification of variation, suspension or revocation of licence
Division 5—Reporting and Confidentiality
21Q.NHMRC Licensing Committee to make certain information publicly available
21R.Confidential commercial information may only be disclosed
in certain circumstances
Division 6—Review provisions
21S.Meaning of terms
21T.Review of decisions
Division 7—Monitoring Powers
21U.Powers available to inspectors for monitoring compliance
21V.Monitoring powers
21W.Power to secure
21X.Inspector must produce identity card on request
21Y.Consent
21Z.Compensation for damage
Part 3—Research
Division 1—Offences
22.Research
23.Places for research
24.Ban on destructive research on non-excess ART embryos
25.Authority must not approve destructive research on non-excess ART embryos
26.Authority must not approve certain research on oocytes in the process of fertilisation
Division 2—Preliminary Requirements for Research Involving Embryos
27.Consent to research involving embryos
28.Consent of spouse of donor
29.Requirements as to consent
30.Objection by later spouse
31.Counselling requirements
32.Information requirements
Division 3—Repealed
33.Repealed
Division 4—Preliminary requirements for other research involving gametes
34.Consent to research using gametes
35.Requirements as to consent
Division 5—Application of Part
35A.Meaning of "research" in this Part
Part 4—Procedures Relating to Consents
36.Approved form to be used
37.Withdrawal of consent
38.Lapsing of consent
Part 4A—Prohibited Practices
Division 1—Human Cloning
38A.Offence—creating a human embryo clone
38B.Offence—placing a human embryo clone in the human body
or the body of an animal
38C.Offence—importing or exporting a human embryo clone
38D.No defence that human embryo clone could not survive
Division 2—Other Prohibited Practices
38E.Offence—creating a human embryo other than by fertilisation,
or developing such an embryo
38F.Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman
38G.Offence—creating or developing a human embryo containing genetic material provided by more than 2persons
38H.Offence—developing a human embryo outside the body of a woman for more than 14 days
38I.Offence—using precursor cells from a human embryo or a human foetus to create a human embryo, or developing such
an embryo
38J.Offence—heritable alterations to genome
38K.Offence—collecting a viable human embryo from the body of
a woman
38L.Offence—creating a chimeric or hybrid embryo
38M.Offence—placing of an embryo
38N.Offence—importing, exporting or placing a prohibited embryo
38O.Offence—commercial trading in human eggs, human sperm or human embryos
Part 5—Other Miscellaneous Offences
Division 1—Prohibited procedures
38P.Application of Division
39.Repealed
40.Transfer of gametes or embryos used for research
41.Ban on procedures involving gametes produced by children
42.Repealed
43.Ban on procedures involving gametes of people known to be dead
44, 45.Repealed
46.Ban on certain procedures
47–49.Repealed
50.Ban on sex selection
Division 2—Storage
50A.Application of Division
51.Storing gametes
52.Storing embryos
53.Removal of embryos from storage
54.Places of storage
55.Ban on use of gametes or embryos not stored at licensed centre
Division 3—General offences
56.Import or export of gametes and embryos
57.Repealed
58.False or misleading information
Part 6—Surrogate Motherhood
59.Surrogacy
60.Surrogacy—advertising
61.Surrogacy agreements void
Part 7—Records and Access to Information
Division 1—Records
62.Register to be kept for licensed centre
63.Register to be kept by doctor carrying out donor insemination
64.Information to be given to the Authority by licensed centres
65.Information to be given to the Authority by doctors not at licensed centres
66.Information to be given under section 64 and 65
67.Information to be given to the Authority about births by other persons
68.Authority to keep a central register
69.Authority to correct central register
70.Inspection of Registers
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
72.Information recorded by licensed centre or doctor which is
to be given to donors
73.Information about pregnancy, birth or transfer
Division 3—Information to be given from central register
74.Application by parents for information contained on central register
75.Authority to give information about donor to parents
76.Application by donor for information about persons born
as a result of donor treatment procedures and parents of such persons
77.Authority to give information about person born as a result
of a donor treatment procedure
78.Authority to give information about parents
79.Application by person born as a result of a donor treatment procedure or descendant for information about donor
80.Authority to give information about donor to person born
as the result of a procedure
81.Counselling not applicable in certain circumstances
82.Donor treatment procedure information register
Division 4—General provisions
83.Information
84.Waiver of fees
85.Disclosure of information to a medical practitioner
86.Records of information given
87.Consent
88.Authority may refuse to give information
89.Confidentiality—information which may identify
90.Confidentiality—non-identifying information
91.Closure of court or tribunal
92.Exemption from Freedom of Information Act 1982
Part 7A—Pre-1 July 1988 Procedure Information
92A.Definitions
92B.Application of Part
92C.Recording of pre-1 July 1988 information
92D.Release of information
92E.Request for release of information
92F.Authority to comply with wishes of person who provided information
92G.Authority may give information
92H.Counselling waived in certain circumstances
92I.Offences
Part 8—Licences, Approvals and Designated Officers
Division 1—Licensing of places
93.Licence application—hospitals and day procedure centres
94.Licence application—research institutions
95.Designation of principal doctor or principal scientist
96.Licence applications—general procedure
97.Authority may grant or refuse licence
Division 2—Approval to carry out research
98.Application for approval to carry out research
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
103.Application for approval of counsellors
104.Authority may grant or refuse approval
Division 5—General provisions about licences, approvals and exemptions
104A.Application of Part
105.Form and content of licence or approval
106.Power of Authority to impose conditions
107.Provision of information
108.Variation of conditions of licences or approvals under this Part
109.Variation of approvals and exemptions under Part 5
110.Offence of failing to comply with terms etc. of licence or approval
110A.Formation of embryos
111.Duration and renewal of licence or approval
112.Application for renewal
113.Suspension of licence, approval or exemption
114.Immediate suspension
115.Cancellation of licence, approval or exemption
116.Orders
117.Notification about approvals and licences
118.Notification to Minister
Division 6—Designated officers
119.Designated officers for licensed centres
120.If no designated officer appointed
Part 9—Infertility Treatment Authority
Division 1—Constitution of the Authority
121.Establishment of Authority
122.Powers, functions, duties and consultation requirements
123.Membership
124.Terms of office
125.Resignation and removal
126.Chairperson and Deputy Chairperson
127.Acting member
128.Payment of members
129.Procedure of Authority
130.Effect of vacancy or defect
131.Member's interests
132.Immunity
133.Engagement or employment of persons
134.Delegation
135.Committees
Division 2—Supplementary Powers
136.Powers of Authority in relation to fees
Division 3—Reporting and financial provisions
137.Report to Minister
138.Infertility Treatment Authority Fund
139.Investment powers
Part 10—Repealed155
140–148. Repealed
Part 11—Review of Decisions
149.Review of decisions
Part 12—General
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
163.Indictable offences
164.Supreme Court—limitation of jurisdiction
Part 13—Regulations
165.Regulations
Part 14—Review and Transitional Provisions
Division 1—Review of Parts 2A and 4A
166.Review of operation of Parts 2A and 4A
167–170. Repealed
Division 2—Transitional provisions
171.Definitions
172.General transitional provision
173.Regulations
174.Donations
175.Consents
176.Eligibility for fertilisation procedures
177.Eligibility to undergo donor insemination
178.Eligibility—research procedures
179.Partial compliance
180.Identified donors under section 16 of the repealed Act
181.Recording and disclosing information—general
182.Registers and records
183.Recording and giving information
184.Access to information
185.Gametes, zygotes and embryos in storage
186.Application of time limits for storage of zygotes and embryos
187.Removal from storage
188.Use of stored gametes, zygotes and embryos
189.Approval of research procedures
190.Approval of counsellors
191.Approval of premises
192.Review of Ministerial decisions
193.Ministerial directions
194.Abolition of former Committee
195.Repealed
196.Exemptions
197.Existing immunity not affected
198.Superseded references
199.Further savings and transitional provisions
Division 3—Savings and Transitional Provisions (2003 Act)
200.Definition
201.Status of certain licences and approvals
202.Regulations
203.General transitional provision
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ENDNOTES
1. General Information
2. Table of Amendments
3. Explanatory Details
INDEX211
1
Version No. 020
Infertility Treatment Act 1995
Act No. 63/1995
Version incorporating amendments as at 16 October 2003
1
Infertility Treatment Act 1995
Act No. 63/1995
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;
S. 1(ba) insertedby No. 11/2003 s.4(a).
(ba)to regulate certain activities involving the use of human embryos;
S. 1(bb) insertedby No. 11/2003 s.4(a).
(bb)to prohibit human cloning and certain other practices associated with reproductive technology;
S. 1(c) amendedby No. 11/2003 s.4(b).
(c)to regulate research using human gametes 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;
S. 1(fa) insertedby No. 11/2003 s.4(c).
(fa)to confer functions on the Embryo Research Licensing Committee of the National Health and Medical Research Council;
(g)to repeal the Infertility (Medical Procedures) Act 1984 and amend various other Acts.
2.Commencement
s. 2
(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.
S. 2(4) substituted by No. 37/1997
s. 4.
(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—
S. 3(1) def. of "animal" insertedby No. 11/2003 s.5(1).
"animal" does not include a human;
"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;
S. 3(1) def. of "chimeric embryo" insertedby No. 11/2003 s.5(1).
"chimeric embryo" means—
(a)a human embryo into which a cell, or any component part of a cell, of an animal has been introduced; or
s. 3
(b)a thing declared by the regulations to be a chimeric embryo;
S. 3(1) def. of "clone" repealedby No. 11/2003 s.5(2)(a).
*****
S. 3(1) def. of "Committee" repealed by No. 37/1997
s. 5(1)(b).
*****
S. 3(1) def. of "Common-wealth Act" insertedby No. 11/2003 s.5(1).
"Commonwealth Act" means the Research Involving Human Embryos Act 2002 of the Commonwealth;
S. 3(1) def. of "Common-wealth authority" insertedby No. 11/2003 s.5(1).
"Commonwealth authority" means the following—
(a)a body corporate established for a public purpose by or under a Commonwealth Act;
(b)a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together—
(i)the Commonwealth;
(ii)a body covered by paragraph (a);
(iii)a body covered by either sub-paragraph (i) or (ii);
"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;
s. 3
"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 ofwhich 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 section12, 27 or 34;
"donor sperm" means sperm in respect of which consent has been given under section 12, 27 or 34;
S. 3(1) def. of "donor treatment procedure" amendedby No. 11/2003 s.5(2)(b).
"donor treatment procedure" means a treatment procedure where donor gametes or a donor embryo is used;
S. 3(1) defs of "donor zygote", "embryo" repealedby No. 11/2003 s.5(2)(a).
*****
s. 3
"exemption" means an exemption under section56;
S. 3(1) def. of "fertilisation procedure" amendedby No. 11/2003 s.5(2)(c).
"fertilisation procedure" means—
*****
(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;
S. 3(1) def. of "human embryo" insertedby No. 11/2003 s.5(1).
"human embryo" means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8weeks since the appearance of 2pro-nuclei or the initiation of its development by other means;
S. 3(1) def. of "human embryo clone" insertedby No. 11/2003 s.5(1).
"human embryo clone" means a human embryo that is a genetic copy of another living or dead human, but does not include a human embryo created by the fertilisation of a human egg by human sperm;
s. 3
S. 3(1) def. of "human sperm" insertedby No. 11/2003 s.5(1).
"human sperm" includes human spermatids;
S. 3(1) def. of "husband" inserted by No. 37/1997
s. 6(2).
"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 "hybrid embryo" insertedby No. 11/2003 s.5(1).
"hybrid embryo" means—
(a)an embryo created by the fertilisation of a human egg by animal sperm; or
(b)an embryo created by the fertilisation of an animal egg by human sperm; or
(c)a human egg into which the nucleus of an animal cell has been introduced; or
(d)an animal egg into which the nucleus of a human cell has been introduced; or
(e)a thing declared by the regulations to be a hybrid embryo;
S. 3(1) def. of "inspector" insertedby No. 11/2003 s.5(1).
"inspector" means a person appointed as an inspector under section 33(1) of the Commonwealth Act;
"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;
S. 3(1) def. of "NHMRC Licensing Committee" insertedby No. 11/2003 s.5(1).
"NHMRC Licensing Committee" means the Committee established by section 13 of the Commonwealth Act;
S. 3(1) def. of "oocyte" amendedby No. 11/2003 s.5(2)(d).
"oocyte" means an ovum from a woman;
s. 3
S. 3(1) def. of "oocyte in the process of fertilisation" insertedby No. 11/2003 s.5(1).
"oocyte in the process of fertilisation" means an oocyte at any stage of human development from the commencement of penetration of the oocyte by human sperm up to but not including the appearance of 2 pro-nuclei;
S. 3(1) defs of "partheno-genesis", "partheno-genetic oocyte" repealedby No. 11/2003 s.5(2)(a).
*****
S. 3(1) def. of "precursor cell" insertedby No. 11/2003 s.5(1).
"precursor cell" means a cell that has the potential to develop into a human egg or human sperm;
"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;
S. 3(1) def. of "research" amendedby No. 11/2003 s.5(2)(e)(i)(ii).
"research" includes—
(a)an experimental procedure or clinical trial;
*****
S. 3(1) def. of "Secretary" amended by No. 46/1998
s. 7(Sch. 1).
"Secretary" means—
(a)in relation to any act to which section6(3) of the Health Act 1958 applies, the body corporate established by section 6 of that Act; or
(b)in any other case, the Secretary to the Department of Human Services;
"sperm" means sperm from a man;
S. 3(1) def. of "spouse" inserted by No. 37/1997
s. 6(2).
"spouse"—
s. 3
(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;
S. 3(1) def. of "store" amendedby No. 11/2003 s.5(2)(f).
"store" means—
(a)to freeze an oocyte, embryo, or sperm; or
(b)to otherwise preserve an oocyte, 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
(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—