VersionNo. 005
Assisted Reproductive Treatment Regulations 2009
S.R. No. 177/2009
Version incorporating amendments as at
30 October 2014
table of provisions
RegulationPage
1
RegulationPage
1Objective
2Authorising provision
3Commencement
4Definition
5Form of consent to treatment procedure
6Counselling prior to treatment procedure
7Form of donor's consent
8Counselling prior to donation
9Counselling prior to surrogacy arrangement
10Prescribed costs actually incurred that may be reimbursed to the surrogate mother
11Counselling prior to posthumous use of gametes or embryos
12Disposal of embryos
13Register kept by registered ART provider
13ARegister of pre-1988 donor treatment procedures to be kept by registered ART Provider
14Register kept by doctor carrying out artificial insemination
15Central Register kept by the Registrar
16Fee for applications for information
17Requirements for entries in the Voluntary Register
18Information and documents to be provided for ART registration
______
SCHEDULES
SCHEDULE 1—Consent to Carrying out a Treatment Procedure
SCHEDULE 2—Consent to Donation of Gametes or embryos
SCHEDULE 3—Information to be Recorded in Register Kept
by Registered ART Provider
1Information relating to donors of gametes and embryos kept
or stored by a registered ART provider
2Information relating to disposal by the registered ART
provider of any gametes or embryos formed outside the body
of a woman
3Information relating to each woman on whom a donor
treatment procedure is carried out by a registered ART
provider and the partner, if any, of each woman
4Information relating to each donor treatment procedure
carried out on a woman by the registered ART provider
5Information relating to the use of donor gametes or donor embryos in a treatment procedure carried out by a registered ART provider
6Information relating to sex selection in a treatment procedure carried out by a registered ART provider
7Information relating to gametes or embryos transferred to or
from the registered ART provider or doctor
8Information relating to collection and storage of gametes or embryos by registered ART provider
9Information relating to consent and withdrawal of consent to
the storage and removal from storage of gametes or embryos
10Information relating to transfer into or out of Victoria of donor gametes or donor embryos that have been or are stored or kept
by a registered ART provider
11Information relating to consent or withdrawal of consent for a treatment procedure carried out by a registered ART provider
12Information relating to donor's consent and withdrawal of consent
13Information relating to outcome of a donor treatment procedure
14Information relating to each child born as a result of a donor treatment procedure carried out by the registered ART provider
SCHEDULE 3A—Information to be Recorded in Register of Pre1988 Donor Treatment Procedures Kept
by Registered Art Provider
1Information relating to donors of gametes used in pre-1988
donor treatment procedures
2Information relating to each woman on whom a pre-1988
donor treatment procedure was carried out by a registered
ART provider and the partner, if any, of each woman
3Information relating to outcome of pre-1988 donor treatment procedures
4Information relating to each pre-1988 donor treatment
procedure carried out on a woman by the registered ART provider
5Information relating to the use of donor gametes in a
pre-1988 donor treatment procedure carried out by a
registered ART provider
6Information relating to each child born as a result of a
pre-1988 donor treatment procedure carried out by the
registered ART provider
SCHEDULE 4—Information to be Recorded in Register Kept by a Doctor Carrying Out Artificial Insemination using donor sperm
1Information in relation to each artificial insemination carried
out by a doctor using donor sperm
2Information in relation to the donor
3Information in relation to a woman who is artificially inseminated using donor sperm and of her partner, if any
4Information about a child born as a result of an artificial insemination carried out by a doctor using donor sperm
5Information in relation to consent or withdrawal of consent to artificial insemination
6Information relating to donor's consent or withdrawal of
consent
SCHEDULE 5—Information to be Kept in Central Register
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ENDNOTES
1. General Information
2. Table of Amendments
3. Explanatory Details
1
VersionNo. 005
Assisted Reproductive Treatment Regulations 2009
S.R. No. 177/2009
Version incorporating amendments as at
30 October 2014
1
S.R. No. 177/2009
Assisted Reproductive Treatment Regulations 2009
1Objective
The objective of these Regulations is to prescribe various matters necessary to give effect to the Assisted Reproductive Treatment Act 2008.
2Authorising provision
These Regulations are made under section 124 of the Assisted Reproductive Treatment Act 2008.
3Commencement
These Regulations come into operation on 1January 2010.
4Definition
In these Regulations—
the Act means the Assisted Reproductive Treatment Act 2008.
5Form of consent to treatment procedure
For the purposes of section 10(1)(a) of the Act, the prescribed form is the form set out in Schedule1.
6Counselling prior to treatment procedure
For the purposes of section 13 of the Act, the following matters are prescribed—
(a)the options or choices available to the particular woman and her partner, if any;
(b)the possible outcomes of a treatment procedure;
(c)any issue or concern raised by the woman or her partner, if any, in relation to the treatment procedure;
(d)advising children about their donor origins and rights to information;
(e)the Central Register and the information required to be kept in the Central Register;
(f)issues relating to the use of donated gametes or embryos in the treatment procedure;
(g)issues relating to genetic siblings who share a common genetic parent but are raised in different families.
7Form of donor's consent
r. 7
For the purposes of section 17(1)(a) of the Act, the prescribed form is the form set out in Schedule2.
8Counselling prior to donation
For the purposes of section 18 of the Act, the following matters are prescribed—
(a)the requirements of the Act in relation todisclosing the identity of the donor to the Registrar and disclosing informationto donor-conceived children if they seek that information;
(b)any issue or concern raised by the donor in relation to the donation, for example—
(i) the possible impact of donation on the donor's partner, if any;
(ii)the possible impact of donation on the donor's children, if any.
9Counselling prior to surrogacy arrangement
r. 9
For the purposes of section 43(a) of the Act, the following matters are prescribed—
(a)the implications of surrogacy for the relationship between—
(i) if there are 2 commissioning parents, the commissioning parents; and
(ii)if the surrogate mother has a partner, the surrogate mother and her partner; and
(iii)the commissioning parent and the surrogate mother; and
(iv)all parties to the surrogacy; and
(v) if donor gametes or embryos are to be used, the donor and the donor's partner, if any, and all parties to the surrogacy;
(b)the implications of surrogacy for any existing children of the surrogate mother or the commissioning parent;
(c)the possibility of medical complications for the surrogate mother or the child;
(d)the possibility of any party deciding not to proceed with the surrogacy;
(e)the attitudes of all parties towards the conduct of the pregnancy;
(f)the attitudes of all parties to investigation of a genetic abnormality, the possibility of termination of pregnancy or other complications;
(g)the need for the parties to agree on a process for resolving disputes—
(i) relating to the pregnancy; or
(ii)arising during the pregnancy;
(h)if there are 2 commissioning parents, the commissioning parents' intentions for care of the child if one of them dies;
(i) possible grief reactions on the part of the surrogate mother and her partner, if any;
(j)ways of telling the child about surrogacy;
(k)attitudes toward an ongoing relationship between the surrogate mother, her family and the child.
10Prescribed costs actually incurred that may be reimbursed to the surrogate mother
r. 10
For the purposes of section 44(2) of the Act, the following costs areprescribed—
(a)any reasonable medical expenses associated with the pregnancy or birth that are not recoverable under Medicare, health insurance or another scheme;
(b)anylegal advice obtained for the purposes of section 43(c) of the Act;
(c)travel costs related to the pregnancy or birth.
11Counselling prior to posthumous use of gametes or embryos
For the purposes of section 48 of the Act, the following mattersare prescribed—
(a)the grieving process;
(b)the possible impact on the child to be born as a result of the treatment procedure.
12Disposal of embryos
r. 12
For the purposes of section 34(2)(b) of the Act, an embryo must be disposed of by allowing the embryo to stand in its container, at room temperature, in a secure area for a period of not less than 24 hours.
13Register kept by registered ART provider
For the purposes of section 49(1) of the Act, the prescribed information is the information listed in Schedule 3.
Reg.13A insertedby S.R. No. 192/2014 reg.5.
13ARegister of pre-1988 donor treatment procedures to be kept by registered ART Provider
For the purposes of section 49A of the Act, the prescribed information is the information listed in Schedule 3A.
14Register kept by doctor carrying out artificial insemination
For the purposes of section 50(2) of the Act, the prescribed information is the information listed in Schedule 4.
15Central Register kept by the Registrar
(1)For the purposes of section 53(b) of the Act, the prescribed information is the information set out in Schedule 5.
(2)A registered ART provider or doctor who has carried out artificial insemination other than on behalf of a registered ART provider using donor gametes must provide to the Registrar—
(a)the information set out in Schedule 5; and
(b)for the purposes of performing administrative functions relating to the Central Register, the address and telephone number of—
(i) the donor; and
(ii)the woman on whom the treatment procedure was carried out and her partner, if any.
Reg.16 amendedby S.R. No. 192/2014 reg.6.
16Fee for applications for information
r. 16
For the purposes of sections 56(3)(b) and 60A(2)(b) of the Act, the prescribed fee for an application is 518 fee units.
17Requirements for entries in the Voluntary Register
For the purposes of section 71(4) of the Act, the Voluntary Register must be kept in an electronic form that is readily convertible into legible print in the English language.
18Information and documents to be provided for ART registration
For the purposes of section 74(2)(c) of the Act, an application must include the name of the designated officer appointed, employed or engaged by the ART provider.
______
SCHEDULES
Sch. 1
SCHEDULE 1
Regulation 5
Consent to Carrying out a Treatment Procedure
PART A
Consent of woman who will undergo treatment procedure
I, (name of woman who will undergo treatment procedure)
of (address) consent to the following treatment procedure being carried out on me—
artificial insemination;
assisted reproductive treatment.
Signed:
Name: (print name)
Date:
*PART B
Consent of partner of woman who will undergo treatment procedure
I, (name of partner of woman who will undergo treatment procedure)
of (address) consent to the following treatment procedure being carried out on (name of woman who will undergo treatment procedure)—
artificial insemination;
assisted reproductive treatment.
Signed:
Name: (print name)
Date:
PART C
Statement by counsellor
Sch. 1
I, (name of counsellor who provided counselling under section 13 of the Assisted Reproductive Treatment Act 2008) of (address) *have/*have not sighted a criminal records check in relation to (name of woman who will undergo treatment procedure) *and (name of partner of woman who will undergo treatment procedure).
Signed:
Name: (print name)
Date:
*Delete if inapplicable.
______
SCHEDULE 2
Sch. 2
Regulation 7
Consent to Donation of Gametes or embryos
Name(s) of donor(s):
Donation:
*sperm/*oocytes; or
embryos created from donors' sperm and oocytes
*I/*We, (name(s) of donor(s)) of (address(es) of donor(s)) consent to the *gametes donated by me/*embryos donated by us being used in the following treatment procedures—
(specify treatment procedures for which donor's gametes or donors' embryos may be used)
Treatment procedures using *my gametes/*our embryos may be carried out on a maximum of (insert number not exceeding10) women.
This consent lapses—
10 years from the date on which it is given;
OR
at the end of the following period: (insert period not exceeding 10years).
Signed: (signature of each donor)
Name(s): (print name(s))
Date:
*Delete if inapplicable.
______
SCHEDULE 3
Sch. 3
Regulation 13
Information to be Recorded in Register Kept by Registered ART Provider
1Information relating to donors of gametes and embryos kept or stored by a registered ART provider
The following information is required in relation to each donor of gametes, and each person who produced the gametes from which a donated embryo was formed—
(a)the unique donor identifier;
(b)the full name of the donor;
(c)the date of birth of the donor;
(d)the donor's place of birth (suburb or town and country);
(e)the sex of the donor;
(f)any other name by which the donor is or has been known;
(g)the date on which the registered ART provider sightedthe donor's passport, driver licence or other identification bearing the donor's photograph and signature;
(h)the donor's residential address and contact telephone number;
(i) the date and place where the donor produced the gamete;
(j)if the gametes or embryo were not produced at the premises of the registered ART provider, the date on which the gamete or embryo was received by the registered ART provider;
Sch. 3
(k)the ethnic background of the donor's parents and grandparents;
(l)the donor's height;
(m)the donor's build;
(n)the donor's blood group;
(o)anygenetic abnormality of the donor and, if available, any results of tests undertaken in relation to that abnormality;
(p)the number of women who have children conceived using the donor's gametes or an embryo formed from the donor's gametes, including the donor andany current or former partner of the donor;
(q)the total number of children born as a result oftreatment procedures carried out by the registered ART provider using the donor's gametes or embryo formed from his or her gametes;
(r)whether the donor has donated gametes to any other registered ART provider or a doctor.
2Information relating to disposal by the registered ART provider of any gametes or embryos formed outside the body of a woman
(1)The following information is required in relation to gametes disposed of by the registered ART provider—
(a)the date and place where the gameteswere produced;
(b)theunique donor identifier or unique patient identifierof person who produced the gametes;
Sch. 3
(c)the date of disposal of the gametes.
(2)The following information is required in relation to each embryo formed outside the body of the woman disposed of by the registered ART provider—
(a)the date on which the embryo was formed;
(b)the embryo reference number;
(c)the unique donor identifier or unique patient identifier of persons who produced the gametes used to form the embryo;
(d)the date of disposal of the embryo.
3Information relating to each woman on whom a donor treatment procedure is carried out by a registered ART provider and the partner, if any, of each woman
(1)The following information is required in relation to each woman on whom a donor treatment procedure is carried out by the registered ART provider—
(a)the name of the doctor performing the procedure;
(b)the full name of the woman;
(c)the date of birth of the woman;
(d)the place of birth of the woman (suburb or town and country);
(e)anygenetic abnormality of the woman and, if available, any results of tests undertaken in relation to that abnormality;
(f)if the woman has given birth to a child as a result of a previous treatment procedure—
Sch. 3
(i) the name of the registered ART provider or doctorwho carried out the treatment procedure; and
(ii)if the child was conceived using donor gametes, the unique donor identifier.
(2)If the woman has a partner, the following information is required in relation to her partner—
(a)the full name of the partner;
(b)the date of birth of the partner;
(c)the place of birth of the partner (suburb or town and country);
(d)the partner's gender;
(e)if the partner's gametes will be used in the treatment procedure, any genetic abnormality of the partner and, if available, any results of tests undertaken in relation to that abnormality.
4Information relating to each donor treatment procedure carried out on a woman by the registered ART provider
(1)The following information is required in relation to each donor treatment procedure carried out on a woman by the registered ART provider—
(a)the unique patient identifiers of the woman on whom the treatment procedure is carried out and, if applicable, her partner;
(b)the date of the woman's consent to undergo the treatment procedure and, if applicable, the date of her partner's consent to the treatment procedure;
(c)the date and place where the treatment procedure was carried out;
Sch. 3
(d)the kind of treatment procedure carried out;
(e)the name of the doctor who carried out the treatment procedure;
(f)the date on which the treatment cycle commenced;
(g)in relation to the donor of gametes or embryos used in the treatment procedure—
(i) whetherthe donor was known to thewoman; and
(ii)the date of the donor's consent to use the gametes or embryos in a treatment procedure; and
(iii)the unique donor identifiers for each person who produced the gametes or embryo used; and
(iv)ifa donor embryo is used in the treatment procedure, the embryo reference number;
(h)theoutcome of the treatment procedure.
5Information relating to the use of donor gametes or donor embryos in a treatment procedure carried out by a registered ART provider
(1)The following information is required in relation to each treatment procedure using donor gametes or donor embryos carried out by the registered ART provider—
(a)whether the gametes or embryo used in the treatment procedure were thawed or fresh;
(b)if the gametes or embryo used in the treatment procedure were transferred to the registered ART provider, the date the gametes or embryo were received by the registered ART provider and from whom the gametes or embryowere transferred;
Sch. 3
(c)theoutcome of the treatment procedure.
(2)The following information is required in relation to the formation or attempted formation of an embryo outside the body of a woman by a registered ART provider for the purposes of a donor treatment procedure—
(a)the embryo reference number;
(b)the name of the doctor performing the treatment procedure;
(c)the registered ART provider record number, unique donor identifieror unique patient identifier of the man who produced the sperm or the woman who produced the oocyte;
(d)the date on which the gametes were produced;
(e)the time and date at which the sperm and oocyte were placed together;
(f)the time and date at which fertilisation was confirmed.
6Information relating to sex selection in a treatment procedure carried out by a registered ART provider
The following information is required in relation to each treatment procedure carried out by a registered ART providerusing sex selected embryos—
(a)the number of sex selected embryos used;
(b) if sex selected embryos were used to avoid the risk of transmission of a genetic abnormality or a genetic disease, the particular abnormality or disease;