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—