Guidelines for the import and export of
donor gametes and embryos produced
from donor gametes
Effective: 28 October 2015
1.
Requirements of the Law
The Assisted Reproductive Treatment Act 2008 (Vic) (Act) prohibits taking donated gametes, or embryos
produced from donated gametes, into or out of Victoria without the written approval of the Victorian
Assisted Reproductive Authority (VARTA). Accordingly, approval must be obtained from VARTA before:
• the import of donor gametes, or embryos produced from donor gametes, into Victoria from interstate or
overseas;
• the export of donor gametes, or embryos produced from donor gametes, out of Victoria but within
Australia; and
• the export of donor gametes, or embryos produced from donor gametes, overseas.
In deciding whether or not to grant approval for a person to take gametes or embryos out of Victoria, the
Authority is required to have regard to whether the purpose and way in which the gametes or embryos will
be used outside Victoria is consistent with the purpose and way they could be used in Victoria.
The Act sets out a comprehensive range of requirements regarding the use of donor gametes in treatment
procedures in Victoria. In particular:
• Part 2, Division 3 outlines the requirements regarding donors, including consent, counselling and giving
and receiving of information;
• Sections 20 and 21 deals with the withdrawal or lapsing of consent;
•
Part 6 of the Act deals with registers and access to information.
Certain procedures are banned, including using donated gametes to produce more than 10 families.
VARTA may impose conditions and may exempt applicants from compliance with certain provisions. VARTA
may also approve a particular class as well as individual applications on a case-by-case basis.
Guidelines for the import and export of donor gametes and
embryos produced from donor gametes
The Prohibition of Human Cloning for Reproduction Act 2002 (Cth) also applies, making it an offence to
intentionally give, receive or offer to give or receive valuable consideration for the supply of a human egg,
human sperm or a human embryo. In this context:
• "reasonable expenses":
o
(a) in relation to the supply of a human egg or human sperm - includes, but is not limited to,
expenses relating to the collection, storage or transport of the egg or sperm; and
o
(b) in relation to the supply of a human embryo:

(i) does not include any expenses incurred by a person before the time when the
embryo became an excess ART embryo; and

(ii) includes, but is not limited to, expenses relating to the storage or transport of the
embryo.
• "valuable consideration", in relation to the supply of a human egg, human sperm or a human embryo by
a person, includes any inducement, discount or priority in the provision of a service to the person, but
does not include the payment of reasonable expenses incurred by the person in connection with the
supply.
2.
The Process
In the normal course, applications to VARTA for approval must be made by the recipient of the donor
gametes, or embryos produced from donor gametes, on the prescribed form, which is available from VARTA
or can be downloaded from VARTA’s website at www.varta.org.au.
In some instances, supporting information is required as described on the form, such as where information
about quality assurance certification for an overseas clinic, or payment details for an overseas donor are
required.
Applicants are reminded that section 38 of the Act makes it an offence to knowingly or recklessly give
false or misleading information or not to give material information relating to an application or with
respect to any information required to be given under the Act.
Please note: Original signatures must be provided on the application submitted to VARTA. Photocopied,
faxed or emailed forms will not be accepted. Donor information, including the donor code, must also be
included on the application. Final approval for import or export will not be granted until this information is
provided.
Following receipt of all the required information each application will be considered on its merits, within the
context of the guidelines set out below. VARTA will notify the applicants and the registered ART provider of
the outcome of the application.
3.
The Criteria
The following is not an exhaustive list, but is intended to provide information in relation to some of the
considerations which VARTA will have regard to in considering applications for the import or export of donor
gametes, or embryos produced from donor gametes.
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Guidelines for the import and export of donor gametes and
embryos produced from donor gametes
3.1
Import Criteria
As a requirement for approval to import donor gametes or embryos produced from donor gametes, in the
normal course VARTA will require the following criteria to be met:
3.1.1 Transferring clinic
If the donor gametes, or embryos produced from donor gametes, are to be imported from overseas, the
overseas clinic /organisation must be accredited or licensed under a relevant accreditation, licensing or
quality assurance scheme acceptable to VARTA. Such schemes include ISO 9001 accreditation, licensing by
the Human Fertilisation and Embryology Authority (HFEA) in the United Kingdom, or FDA Human Cell and
Tissue Establishment Registration in the United States. A copy of the clinic’s accreditation, licence or
equivalent evidence must be provided with the application. Applicants can obtain this information from
the clinic.
3.1.2 Consent
The donor must consent to the import. Donor consent is usually obtained by the clinic at the time of
collection of personal information. The transferring accredited/licenced ART provider must ensure that any
consent or withdrawal of consent relevant to the gametes or embryo is transferred to the Victorian registered
ART provider.
3.1.3 Counselling and information
The donor must be counselled by a counsellor who provides services for a Victorian registered ART provider
and provided with prescribed information about the Victorian system. The purpose is to ensure that the
donor is aware of the rights of various parties under the Victorian system and legal requirements in relation
to record-keeping. The Victorian receiving clinic is responsible for ensuring that this counselling occurs and
must return a receiving clinic declaration to VARTA stating that it has taken place. Such counselling may be
done via telephone where distance makes this appropriate.
3.1.4 Identifying information
Identifying information about the donor must be lodged with the Victorian registered ART provider where
the donated gametes, or embryos produced from donated gametes, are to be stored, to enable the
registration of a live birth on the Victorian Central Register. The interstate or overseas clinic must return a
transferring clinic declaration to VARTA stating that they will forward this information to the registered ART
provider in Victoria. Victorian registered ART providers may not use imported donor gametes, or
embryos produced from donor gametes, for treatment unless they have received identifying information
about the donor.
3.1.5 Information for register
The applicant must sign a declaration indicating that they will notify the Victorian registered ART provider
should a live birth result from the use of donor gametes, or embryos produced from donor gametes, within
Australia. VARTA, in partnership with the Victorian Registry of Births, Deaths and Marriages, may monitor
approvals which have been granted to determine if notification has occurred in the event of a live birth.
3.1.6 No consideration
As noted earlier, Australian legislation makes it an offence to give, receive or offer to give or receive valuable
consideration for the supply of a human egg, sperm or an embryo, however payment of reasonable expenses
is permitted. Details must be provided in the application about whether the applicant paid for the donor
gametes and how much was paid to the donor for the donation. If applicants do not have this information,
they should contact the Victorian registered ART provider or the interstate or overseas clinic from which they
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Guidelines for the import and export of donor gametes and
embryos produced from donor gametes
obtained the donor gametes to obtain this information. In certain circumstances supporting documents may
be required to demonstrate compliance.
3.2
Export Criteria
As a requirement for approval to export donor gametes or embryos produced from donor gametes, in the
normal course VARTA will require the following criteria to be met:
3.2.1 Licenced/Accredited clinic
If the donor gametes, or embryos produced from donor gametes, are to be exported overseas, the overseas
clinic must be accredited or licensed under a relevant accreditation, licensing or quality assurance scheme
acceptable to VARTA. Such schemes include for example, ISO 9001 accreditation, licensing by the Human
Fertilisation and Embryology Authority (HFEA) in the United Kingdom, or FDA Human Cell and Tissue
Establishment Registration in the United States. A copy of the clinic’s accreditation, licence or equivalent
evidence must be provided with the application. Applicants can obtain this information from the clinic.
3.2.2 Counselling
The applicant (recipient) must be counselled by a counsellor who provides services for a Victorian registered
ART provider and must make a declaration confirming that they have been counselled by such a person.
3.2.3 Consent
The donor must consent to the export. It is the Victorian registered ART provider’s responsibility to obtain
donor consent for the export of his/her gametes or embryos produced from his/her gametes, and to ensure
that this consent is current. Donor consent is usually obtained by the clinic at the time of collection of
personal information.
If the donor has not consented, it would be unlawful to export his/her gametes, or embryos produced from
his/her gametes, in such circumstances. Any conditions attached to the consent, must be complied with. The
Victorian registered ART provider must ensure that any consent or withdrawal of consent relevant to the
gametes is transferred to the accredited/licenced receiving clinic.
The Victorian registered provider must make all reasonable efforts to give the donor written notice of the
name of the accredited/licenced ART provider to whom the gametes or embryo has been transferred.
3.2.4 Information for register
The applicant must sign a declaration indicating that they will notify the Victorian clinic should a live birth
result from the use of donated gametes, or embryos produced from donated gametes. VARTA, in
partnership with the Victorian Registry of Births, Deaths and Marriages, may monitor approvals which have
been granted to determine if notification has occurred in the event of a live birth.
3.3
Surrogacy Treatment
The requirements of the legislation in relation to surrogacy are outlined in part 4 of the Act, and part 2
division 3 of the Act also applies.
Where an application for the export of donor gametes or embryos produced from donor gametes relates to
their use in a surrogacy arrangement, all of the requirements of the Act must be met, including the
information, counselling, consent and advertising requirements outlined in part 2, division 3 and part 4. The
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Guidelines for the import and export of donor gametes and
embryos produced from donor gametes
prohibitions on giving valuable consideration for the supply of a human egg, human sperm or a human
embryo under the Prohibition of Human Cloning for Reproduction Act 2002 (Cth) also apply.
4.
More Information
For more information about the import or export of donor gametes, or embryos produced from donor
gametes, please contact the Victorian Assisted Reproductive Treatment Authority:
Level 30, 570 Bourke Street, Melbourne VIC 3000
Phone: (03) 8601 5250 Email: [email protected]
Fax: (03) 8601 5277
Web: www.varta.org.au
Version History
Date Effective
Superseded version
28 October 2015
15 October 2014
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