Scientists in Reproductive Technology (SIRT) presentation- the import and export of gametes and embryos
Sunday, August 31, 2014
Today I presented to the Scientists in Reproductive Technology or SIRT conference in Brisbane. SIRT represents the scientists who run the nation’s IVF labs. I was asked to present about the import and export of gametes and embryos. Here is my paper:
Scientists in Reproductive Technology meeting, Brisbane, 31 August 2014
Should I stay or should I go?
By Stephen Page[1]
Harrington Family Lawyers
With apologies to The Clash, like other areas in the seemingly chaotically regulated assisted reproductive technologies/surrogacy, there is a minefield of laws and procedures concerning the import and export of gametes, whether in sperm, eggs or embryos.
Overseas Export/Import Regimes
To be able to export from here or to import to here, gametes and embryos must go to or come from somewhere else.
I will not presume to cover overseas regulations, other than to say that they have to be considered before any decision is made to import or export.
Currently for example:
· it is next to impossible to import a couple’s own embryos from India, as clients of mine have discovered; and
· at the time of writing, Thailand has cracked down on surrogacy, egg donation and gender selection, so the prospect of importing or exporting there is looking dubious.
Checklist for importing
· Complied with Human Cloning Act?
· NHMRC
· State requirements: NSW, Victoria, SA, WA
Checklist for exporting
· Comply with Human Cloning Act
· Internal volume of the container is less than 50ml?
· Not animal reproductive material?
· NHMRC
· State requirements: NSW, Victoria, SA, WA
The Human Cloning Act
There is a raft of legislation which makes it an offence to import or export a prohibited embryo. I will call this legislation the Human Cloning Act. There is both Commonwealth legislation and mirror State and ACT legislation2. There is no separate legislation in the Northern Territory.
Section 20 of the Prohibition of Human Cloning for Reproduction Act 2002 (Cth) provides:
(1) A person commits an offence if the person intentionally imports an embryo into Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo. Maximum penalty: imprisonment for 15 years.
(2) A person commits an offence if the person intentionally exports an embryo from Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo. Maximum penalty: imprisonment for 15 years…
(4) In this section:
‘Prohibited embryo’ means:
(a) A human embryo created by a process other than the fertilisation of a human egg by human sperm; or
(b) A human embryo created outside the body of a woman, unless the intention of the person that created the embryo was to attempt to achieve pregnancy in the particular woman; or
(c) A human embryo that contains genetic material provided by more than 2 persons; or
(d) A human embryo that has been developing outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended; or
(e) A human embryo created using pre-cursor cells taken from a human embryo or a human fetus; or
(f) A human embryo that contains a human cell (within the meaning of section 15) whose gene name has been altered in such a way that the alteration is heritable by human descendants or the human whose cell was altered; or
(g) A human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; or
(h) A chimeric embryo or a hybrid embryo.”
The term “human embryo” is defined as meaning by section 8 of that Act:
“A discrete entity that has arisen from either:
(a) The first mitotic division when fertilisation of a human oocyte by human sperm is complete; or
(b) Any other process that initiates organised development of a biological entity with an altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears;
and has not yet reached 8 weeks of development since the first mitotic division.”
“Hybrid embryo” means in the same section:
(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; 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.”
As I said there is matching State and ACT legislation. Under the operation of our constitution and the ACT self-government laws when there is Commonwealth legislation governing the field, then that Commonwealth legislation prevails over the State or ACT laws. Unusually with this legislation the State laws operate in tandem. Section 24 of the Prohibition of Human Cloning for Reproduction Act 2002 (Cth) provides:
“This Act is not intended to exclude the operation of any law of a State[2], to the extent that the law of the State is capable of operating concurrently with this Act.
Whilst the State laws mirror Commonwealth provisions to make it an offence, for example, to engage in the commercial trading in human eggs, human sperm or human embryos, the offence of import or export remains solely a Commonwealth offence.
Customs Regulations
Specific customs regulations regulate when certain embryos can be imported or exported. Regulation 5 l (2) of the Customs (Prohibited Imports) Regulations 1956 (Cth) provide:
“The importation into Australia of viable material derived from human embryo clones is prohibited unless:
(a) The Minister or an authorised person has granted permission in writing; and
(b) The permission is produced to a Collector at or before the time of importation.”
Sub regulation 1 defines these terms:
“’Authorised’ person means a person authorised in writing by the Minister for this regulation.
‘Human embryo clone’ has the meaning given by section 8 of the Prohibition of Human Cloning for Reproduction Act 2002.
‘Minister’ means the Minister administering the Prohibition of Human Cloning for Reproduction Act 2002.
‘Viable material’ means living tissue and cells.”
Therefore it is important to establish that any genetic material that has been imported is not a human embryo clone. This will be established, presumably, by a declaration to Australian Customs.
There is a mirror provision for the export of human embryo clones. Regulation 8A (2) of the Customs (Prohibited Exports) Regulations 1958 (CTH) provides:
“The exportation from Australia of viable material derived from human embryo clones is prohibited unless:
(a) The Minister or an authorised person is granted permission in writing; and
(b) The permission mentioned in paragraph (a) is produced to a collector at or before the time of exportation.”
Sub-regulation 1 defines these terms:
“’Authorised person’ means a person authorised in writing by the Minister for this regulation.
‘Minister’ means the Minister administering the prohibition of Human Cloning for Reproduction Act 2002.
‘Viable material’ means living tissue and cells.”
It is possible that the permission for the import and export may specify conditions or requirements including a time requirement and can be revoked: regulation 8A(3), (4), (5), Customs (Prohibited Exports) Regulations 1958 (Cth) regulation 5L(3), (4), (5) of the Customs (Prohibited Imports) Regulations 1956 (Cth).
Regulation 8 of the Customs (Prohibited Exports) 1958 (Cth) deals with the exportation of goods specified in Schedule 6 (Human Substances).
Sub regulation (2) provides:
“The exportation from Australia of goods specified in Schedule 6 is prohibited unless:
(a) Permission to export the goods has been granted under this regulation and is in force;
(b) The permission is produced to the Collector.”
Schedule 6 of the Customs (Prohibited Exports) Regulations 1958 (Cth) provides as to goods the exportation of which is prohibited if permission is not granted under Regulation 8:
| Item | Description of Goods |
| 1. | Human body fluids, organs and other tissue: (a) Including a part or constituent of material of that kind, if the internal volume of the immediate container in which the material is packed exceeds 50ml; and (b) Excluding viable material derived from human embryo clones. |
| 2. | A substance derived from human blood. |
In other words sperm, eggs and embryos can be exported without permission if the internal volume of the immediate container in which the material is packed is 50ml or less.
I note that the container for an embryo is typically 0.3ml and that for sperm is typically a maximum of 1-2ml.[3]
Schedule 1AA of the Customs Regulations 1926 (Cth) provides for tier 1 and tier 2 goods. Item 8 provides:
“Goods specified in item 1 of schedule 6 to the Customs (Prohibited Exports) Regulations 1958 (human body fluids, organs and other tissue) of regulation 179AA of the Customs Regulations 1926 (Cth), for section 233BAB(1) of the Act [being the Customs Act 1901 (Cth)] the goods specified in column 2 of an item in Part 2 of Schedule 1AA constitute tier 2 goods.”
Section 233BAB(1) provides, relevantly:
(1) The regulations may provide that …
(j) other specified goods;
constitute tier 2 goods.
(2) The regulations must not specify an item for the purpose of subsection (1) unless:
(a) Its importation is prohibited, either absolutely or on condition, by the Customs (Prohibited Imports) Regulations; or
(b) Its exportation is prohibited, either absolutely or on condition, by the Customs (Prohibited Exports) Regulations.”
A breach of the regulation has a maximum penalty of a fine not exceeding 2500 penalty units or imprisonment for 10 years or both.[4] Absolute or strict liability applies.[5]
Animal sperm, eggs and embryos
It is important that Australian Customs are aware that the items are not animal products. Section 9A of the Export Control Act 1982 (Cth) provides, relevantly:
(1) “The regulations may provide for the preparation, implementation, variation, suspension and cancellation of approved export programs…
(2) An approved export program is a program of activities to be undertaken by an accredited veterinarian, or an authorised officer, for the purpose of insuring the health and welfare of eligible live animals, or the health and condition of eligible animal reproductive material, in the course of export activities.
(3) Without limiting subsection (2), the activities to be undertaken may take place within or outside Australia and may include:
(a) Monitoring the health and welfare of the eligible live animals or the health and condition of the eligible animal reproductive material; and
(b) Examining, testing or treating the eligible or live animals or eligible animal reproductive material …
There are then provisions for the regulations as to which countries the eligible animal reproductive material may be exported or the type that may be involved.[6] Generally the export of animal reproductive material is prohibited.[7]
It is therefore important to ensure that so far as the export of sperm, eggs or embryos are concerned the declarations are in place to ensure that they are not eligible animal reproductive material within the meaning of section 9A(2) of the Export Control Act 1982 (Cth).
NHMRC
As a mandatory condition of their licencing, Australian IVF Units are subject to the NHMRC Guidelines[8].
Guideline 6.5 provides:
“Do not trade in human gametes
Gamete donation must be altruistic. Commercial trading in human gametes and/or the use of direct or indirect inducements must not be undertaken (see paragraph 17.21.2).”
Guideline 17.21.2 provides:
“There should be no payments or other inducements for the donation of gametes, gonadal tissue or cell…. Research that is subject to these guidelines. The reimbursement of reasonable out-of-pocket expenses associated with the procedures is acceptable. In research to which these guidelines apply, reimbursement does not cover compensation, compensation for time.”
The requirement under Guidelines 6.2 is that gametes overseas must meet “all the relevant conditions of these guidelines”. Aside from being an open identity donation this brings into question two further steps:
(a) What of commercial donors overseas?
(b) The nature of counselling provided to donors overseas.
The phrase “reasonable expenses incurred” under the Human Cloning Act is a vague phrase. There have been no prosecutions which means that we have no guidance from the courts as to what it means. When one looks at the ethical ruling of the American Society for Reproductive Medicine[9] it may well be that it is appropriate that US donors be paid in the order of US$5000 and US$10,000. It was acknowledged by the ASRM Ethics Committee that the nature of being an egg donor is much more invasive and much more involved in time as compared to that of being a sperm donor.
It remains unclear whether eggs from commercial egg donors in the United States would be able to be used under the NHMRC guidelines. There’s certainly some argument that they would be available, but as I said it remains somewhat unclear. Each case would be decided on its own merits.
Counselling is covered under 9.3 of the Guidelines, relevantly:
“ART involves complex decision making to and participants may find it an emotional and stressful experience. Clinics must provide readily accessible services from accredited counsellors to support participants in making decisions about their treatment, before, during and after the procedures.
9.3.1 Clinics should therefore provide counselling services, with professionals who have the appropriate training, skills, experience and accreditation necessary for their counselling role.”
It has been suggested that counselling needs to be undertaken for donors, including overseas donors, by ANZICA counsellors only. One wonders if this is actually the requirement and that what may be sufficient is that the overseas counsellor, an accredited counsellor that in that jurisdiction, who is therefore equivalent to an ANZICA counsellor. Can it be seriously suggested, for example, that in the birth place of surrogacy and egg donation, California that psychologists who specialise in this field, day in day out, and are recognised as experts do not have the necessary qualities to provide adequate counselling to prospective donors?
The difficulty, I suppose, is that ordinarily one must be resident in Australia or New Zealand to be eligible to be a member of ANZICth.[10]
To comply with the guidelines it will also be necessary to provide counselling to the donors partner, Guideline 9.4.
One wonders whether any refusal by Australia to recognise United States counsellors in particular would be in breach of the Australia-United States free trade agreement and in particular the cross-border trade in services.[11]
Guideline 13.1 provides:
“Do not undertake or facilitate commercial surrogacy.
It is ethically unacceptable to undertake or facilitate surrogacy pregnancy for commercial purposes. Clinics must not undertake or facilitate commercial surrogacy arrangements.”
Put simply if it is known within a clinic that a patient wishes to have an embryo exported for the purposes of commercial surrogacy overseas then there will be a breach by the clinic of this Guideline, which in turn is a breach of the licencing requirements.
If on the other hand the clinic is not aware of the purpose of the export, for example, it is to a certain clinic in Thailand and it is noted to be for surrogacy but the patient has not advised whether it is for commercial or altruistic surrogacy, then it would be a mistake to presume that the surrogacy is necessarily commercial, and therefore there would be no prohibition within the Guidelines to allowing export.
As I said in my recent presentation to the Fertility Nurses Association of Australasia Conference,[12]ultimately I am of the view that eggs, sperm and embryos can be owned. If they are considered to be those of the intended parents (whether donated or not) they will be owned by them. They are entitled to their property. I do not consider it a “facilitation” of commercial surrogacy to provide to intended parents their eggs, sperm or embryos in such condition that they remain cryopreserved. Any export by those parents would in turn have to comply with any State based rules.
However it may be practical in the post 9/11 world for intended parents to undertake their own export, unless specialist courier companies, who are IATA[13]compliant, are engaged. Embryos do not cope well with being x-rayed.[14] The cost of using a courier carrier depending on the goods and location, can usually be in the range of $1500 – $2000.
Gender Selection
While gender selection is banned in Australia[15], except for medical reasons, if intended parents have created embryos overseas because they wanted to undertake gender selection, to import those embryos is not a breach of any requirements (provided all other criteria of NHMRC and State legislation is met, of course).
NEW SOUTH WALES
In addition to the Ethical Guidelines and the Human Cloning Act, the Assisted Reproductive Technology Act 2007 (NSW) has a number of requirements. Section 22 provides:
“An ART provider must not export, or cause to be ex ported, a gamete or an embryo from this State except with the consent of the gamete provider and in a manner that is consistent with a gamete provider’s consent.
Maximum penalty: 400 penalty units in the case of a corporation or 200 penalty units in any other case.”
“ART provider” is defined in section 4 of the Act as meaning:
“A person who provides ART services includes a registered ART provider, but does not include a person who provides ART services on behalf of a registered ART provider either under contract or in the course of the person’s employment by the Registered ART provider.”
Therefore if you are an employee of a registered ART provider the offence is not committed by you but by your employer – but you could be an accessory to the principal offender, the ART provider, and be charged accordingly.
“Gamete provider” is defined in section 4 of the Act as:
“In relation to a gamete means the individual from whom the gamete has been obtained and in relation to an embryo, means an individual from whom a gamete used to create the embryo was obtained.”
Therefore it is the donor from whom consent is required.
Example
Mitchell and Lara want to have children. They are both infertile. Embryos are created by the Babies R Us fertility clinic using an egg donated by Lara’s sister Sara and an anonymous sperm donor from the United States. Before the embryo can be exported from New South Wales not only will the consent of Mitchell and Lara need to be obtained, but also the written consent of Sara and the American donor.
Similarly section 21 of the Act has the same effect. It provides:
“An ART provider must not supply a gamete or an embryo to another person (including another ART provider) except with the consent of the gamete provider and in a manner that is consistent with the gamete provider’s consent.
Maximum penalty: 800 penalty units in the case of a corporation or 400 penalty units in any other case.”
By an IVF clinic exporting eggs, sperm or embryos either interstate or overseas will almost invariably mean that there is also a supply of the gametes or embryos to another person. There are two further limitations in New South Wales that don’t prevent the import of eggs, sperm or embryos, but potentially prevent their use:
· Under section 24 there is a general prohibition on the use of embryos provided more than 5 years before although there is the ability to see if the consent of the gamete provider is still given or steps are taken to ascertain if the gamete provider is alive.
· An ART provider must not store a gamete or an embryo for any longer than:
§ That consented to in writing by the gamete provider
§ If there are two gamete providers – the shortest period of consent; or
§ No greater than ten years from when the gamete was obtained from the donor plus any additional period that may be authorised by the Director General of New South Wales Health.
· There is a maximum offspring from donated gametes of no more than 5 families i.e. 5 women being treated: section 27.
· The Assisted Reproductive Technology Act 2007(NSW), s.17 provides for the giving of consent from a gamete provider in written form. The consent can be modified or revoked at any time until the gamete is placed in the body of a woman or an embryo is created using the gamete[16], s.18 provides that an ART provider must not use a gamete to create an embryo outside the body of a woman except with the consent of the gamete provider and in a manner that is consistent with the gamete provider’s consent, for which there is a maximum penalty of 400 penalty units for a person and 800 penalty units for a corporation.
· Similarly there is an offence for providing ART treatment to a woman using a gamete except with the consent of the gamete provider and in a manner that is consistent with the gamete provider’s consent.[17]
· Similarly it is an offence to export or to cause to export from New South Wales a gamete or an embryo except with the consent of the gamete provider and in a manner that is consistent with the gamete provider’s consent[18].
VICTORIA
Assisted Reproductive Treatment Act 2008 (Vic):
In essence under the Assisted Reproductive Treatment Act 2008 (Vic) you need the approval of VARTA to export or import if there are donor gametes. Section 36 provides:
(1) “A person must not –
(a) Bring donor gametes, or an embryo produced from donor gametes, into Victoria; or
(b) Take donor gametes or embryo produced from donor gametes, from Victoria.
Penalty, 240 penalty units or 2 years imprisonment or both.
(2) Subsection (1) does not apply if gametes or embryo are brought into or taken from Victoria in accordance with the written approval of the authority.
(3) In deciding whether or not to grant approval under subsection (2) for a person to take gametes or an embryo from Victoria, the Authority must have regard to the following –
(a) Whether the purpose for which the gametes or embryo will be used outside of Victoria is consistent with the purpose for which it could be used in Victoria;
(b) Whether the way in which the gametes or embryo will be used outside Victoria is consistent with the way in which it could be used in Victoria.
(4) An approval granted under subsection (2) –
(a) May apply to a particular case or class of cases; and
(b) May be subject to conditions imposed by the Authority.
(5) A person given approval under this section must comply with any condition imposed by the Authority on the approval.
Penalty: 240 penalty units or 2 years imprisonment or both.”
The key to the section is that the gametes must be donor gametes. Approval is not required from VARTA if you are seeking to take your own gametes into or out of Victoria.
The VARTA website[19]states:
“Import or export of your own gametes or embryos
If you are considering moving your own gametes or embryos interstate or overseas you will need to contact your clinic to determine how this will be done. If you wish to bring your own gametes or embryos into Victoria from interstate or overseas, you will need to contact your interstate/ overseas clinic as well as the destination clinic in Victoria to let them know of your intentions and to organise the transport of the gametes or embryos.”
As is quite clear, if the intended parents own gametes or embryos in which there are no donor gametes or embryos are involved, VARTA approval is not required.
The website states:
“When considering an application for import of donor gametes or embryos produced from donor gametes, the Authority must give consideration to how the donor gametes were obtained. Commercial trading in human eggs, sperm or embryos is an offence under the Prohibition of Human Cloning for Reproduction Act 2008 in Victoria and donors can only be compensated for reasonable expenses incurred in making the donation.”
VARTA has helpfully published guidelines.[20]
Importing to Victoria
First up, a prescribed form is required, which can be downloaded from VARTA’s website at www.varta.org.au.
VARTA sets out its requirement to be able to import donor gametes or embryos:
“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.
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 interstate or overseas clinic is responsible for ensuring that this counselling occurs and must return a 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 registered Victorian ART provider where the donor gametes, or embryos produced from donor 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 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 on the donor.
3.1.5 Information for register. The applicant must sign a declaration indicating that they will notify the relevant clinic 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 are 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 obtained the donor gametes to obtain this information. In certain circumstances supporting documents may be required to demonstrate compliance.”
Again a form is required. The guidelines set out the requirement.
Exporting from Victoria
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:
3.21 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 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 donor gametes and ensure 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 or has not been asked for consent, 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.
3.2.4 Information. The applicant must sign a declaration indicating that they will notify the Victorian clinic should a live birth result from the use of donor gametes, or embryos produced from donor 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.
The guidelines also make plain that there is no difference with surrogacy including as to information, counselling, consent and advertising requirements.[21]
The annual returns of VARTA show a largely stable outlook for imports and exports.
Unfortunately in 2011 and 2012 there is not a breakdown between imports and exports.
In 2013 the breakdown was as follows[22]:
IMPORTS AND EXPORTS FROM VICTORIA
2012 – 2013
| Gamete type No. of applications Outcome | |||
| Import | Export | ||
| Donor sperm | 6 | 3 | Approved |
| Donor eggs | 9 | 0 | Approved |
| Donor eggs | 8 | 0 | Pending approval |
| Embryos formed using donor sperm | 4 | 3 | Approved |
| Embryos formed using donor eggs | 1 | 1 | Approved |
| Embryos formed using donor eggs | 1 | 0 | Pending approval |
| Total | 36 |
In Victoria there is a ban on carrying out treatment using gametes or an embryo formed from gametes produced by donor for more than 10 families[23].
(1) “Gametes donated by a person may be used in a treatment procedure only if the person who donated the gametes has consented to the use of the gametes in a treatment procedure of that kind.
(2) An embryo may be used in a treatment procedure only if each of the persons who donated gametes used to create the embryo has consented to the use of the person’s gametes for a treatment procedure of that kind.”
S.17 sets out the formal requirements for the consent and, critically the consent:
“Must not have been withdrawn or have lapsed when the treatment procedure takes place.”[24]
A person who gives consent may withdraw it at any time before the procedure or action consented to is carried out.[25] The withdrawal of consent must be in writing and needs to be given in a particular way:
“A person withdrawing a consent must give the withdrawal or cause the withdrawal to be given as soon as practicable –
(a) to the registered ART provider or doctor to whom the consent was given; or
(b) To the registered ART provider or doctor with whom the sperm, oocyte or embryo to which the consent relates is kept or stored;
(c) In accordance with the regulations.”[26]
There is no provision in the Assisted Reproductive Treatment Regulations 2009 (Vic) for the withdrawal of consent.
Tasmania
Tasmania does not have specific rules about import or export. If a clinic puts together information that could be used in the making of a commercial surrogacy arrangement then an offence would be committed. Section 41 of the Surrogacy Act 2012 (Tas) provides:
“(1) In this section –
Payment means –
(a) payment in money or monies worth other than payment of birth mother’s reasonable surrogacy costs; and
(b) for reward or other material that benefit or advantage, other than payment of any of the birth mother’s reasonable surrogacy costs.
(2) A person must not, for payment, or in anticipation of receiving payment –
(a) Initiate or take part in any negotiations with a view to the making of a surrogacy arrangement; or
(b) offer or agree to negotiate the making of a surrogacy arrangement; or
(c) Compile any information with a view to its use in making, or negotiating the making of, any surrogacy arrangements; or
(d) Knowingly cause another person to do any of the acts referred to in paragraph (a), (b), (c).
Penalty: fine not exceeding 100 penalty units.
South Australia
South Australia does not have specific rules other than NHMRC as to import and export. However, there is one provision of the Assisted Reproductive Treatment Act 1988(SA) that is relevant. That Act provides a process of licencing to be able to provide assisted reproductive treatment. Section 4A of that Act provides:
“The welfare of any child to be born as a consequence of the provision of assisted reproductive treatment in accordance with this Act must be treated as being of paramount importance, and accepted as a fundamental principle in respect of the operation of this Act.”
Western Australia
Section 11 of the Surrogacy Act 2008 (WA) provides:
“(1) A person who provides a service knowing that the service is to facilitate a surrogacy arrangement that is for reward commits a crime except in the circumstances described in subsection (2).
(2) It is not an offence against subsection (1) if the service is a health service provided to the birth mother after she has become pregnant.
Penalty: Imprisonment for 5 years.
Summary conviction penalty: a fine of $12,000 or imprisonment for 1 year.”
To facilitate the export of gametes for commercial surrogacy will be the supply of a “service” and therefore the commissioning of offence by those involved.
It may well be that in Western Australia to supply to the owners of the embryos in circumstances where is known that the embryos would be used for a commercial surrogacy would in turn be committing the offence. It sounds bizarre but it would appear that in Western Australia if a clinic provides to a couple their own embryo they may in some circumstances be committing a criminal offence and therefore refuse to supply them!
Western Australia has, like Victoria, a state regulator, in this case the Reproductive Treatment Council. The relevant legislation is the Human Reproduction Technology Act 1991(WA). Section 15 refers to a Code of Practice. Section 18 provides, relevantly:
(1) “The Code may make provision, and may impose conditions or prohibitions, in relation to the following matters –
f) The donation, use, supply, export from the State, posthumous use, or other dealing in or disposal of, human gametes, human eggs undergoing fertilisation or human embryos by licensees.”
The Code is called “directions” given by the Commissioner of Health[27].
Import into Western Australia
Where there are no donor gametes, approval of the Reproductive Technology Council is not required. In other words, approval is only required if there are donor gametes. Guidelines 6.1 to 6.3 provide:
6.1“Import of reproductive material generally.
In addition to requirements in relation to import of donated material under the Act the (Customs Prohibited Imports) regulations 1956(Cth) apply to the import of embryos to Australia.
A person whom the licence applies may only accept gametes, embryos or eggs undergoing fertilisation from outside the State if –
(a) Their gametes are to be used in an artificial fertilisation procedure;
(b) The embryo or egg undergoing fertilisation is to be used in an artificial fertilisation procedure;
(c) The material is to be used in a research project that has been approved by the Council; or
(d) The embryo is an excess ART embryo that is to be used under an NHMRC licence.
6.2 Import of donated reproductive material.
Except as approved under direction of 6.3, a person whom the licence applies must not, without the approval of the Council, accept from outside the State for use of an artificial fertilisation procedure, gametes, embryos or eggs undergoing fertilisation where donation of human reproductive material has been involved, if the information that would be required under the Act for the registers, had the donated human reproductive material been collected in this State, is not available to him/her.
6.3 Council may approve import without information for registers.
The council may, on compassionate grounds, approve the import of donated gametes, embryos or eggs undergoing fertilisation where the required information is not available.”
The Reproductive Technology Council has published a quick reference guide as to the import and export of gametes or embryos[28].
The RTC states:
“Transfers from an overseas clinic to a clinic in Western Australia may require additional information before accepting the gametes or embryos. This may include information about:
· Laboratory standards;
· Screening for infectious diseases;
· Standards for quarantine
Import where donation is involved:
There are additional requirements where the import of gametes or embryos involve donation:
· The provision of donor identifying information.
· The donor/s must not have been paid for their donation, but they have received reasonable expenses (altruistic donation).
· The counselling of the people involved in the donation must be equivalent to the counselling standards for WA
· Compliance with the WA requirement of a five family limit for each donor including families in other States and overseas.
· Consent with reference to the HRT Act – Ss.22(1),(3), (6-9) and Direions 3.1, 3.5, 3.9, 4.2, 7.1.
Application to the Reproductive Technology Council to import gametes or embryos is only required when any of the above requirements cannot be met. The RTC may approve, on compassionate grounds, the import of gametes or embryos where the required donor identifying information is not available, or whether the five family limited has been exceeded.”
Export from WA
The directions state:
“6.4 Export of embryos for prohibited uses. Note: In addition to requirements in relation to export of donated material under the Act, the Customs (Prohibited Exports) Regulations 1958 (Cth) apply to the export of embryos from Australia.
A person to whom the licence applies must not permit or facilitate the export from the State of an embryo for a use will not be permitted under the Act.
6.5 Export of donated gametes, embryos or eggs undergoing fertilisation for use in an artificial fertilisation procedure. A person to whom the licence applies must not, without the approval of the Council, permit or facilitate the export from the State for the use in an artificial fertilisation procedure, gametes, embryos or eggs undergoing fertilisation where a donation of human reproductive material has been involved.
6.6 Council may approve exported donated gametes, embryos or eggs undergoing fertilisation for use in an artificial fertilisation procedure. The Council may approve the export for use in artificial fertilisation procedure of donated gametes, embryos or eggs undergoing fertilisation to an approved person who has given a written undertaking using Form 10 in Schedule 1, to provide the licensee with the information that would be required for the registers, had the donated material being used within this State. Where the undertaking to provide information is not completed within a reasonable time, the approval of the Council to export may be withdrawn and the failure to comply with the undertaking may be taken into consideration in any future application for approval to export to that person.
6.7 Transfer of excess ART embryos. The licensee must ensure that if an excess ART embryo is transferred to another person, that person –
(a) is the holder of a storage licence;
(b) has been granted exemption under section 28A of the Act; or
(c) is the holder of an NHMRC licence that authorises the use of the excess ART embryo. It is also a requirement of Western Australia generally for gametes not to be stored for longer than 15 years: direction 6.8, 6.9.”
There is a minimum age for donation of 18 years: direction 7.1 and a requirement of sperm from close relatives not to be used: 7.3, 7.4
There is a limit of 5 recipient families: 8.1 and 8.2.
The RTC quick reference guide as to export states:
“Transfers of gametes and embryos to an overseas clinic may require providing additional information to the receiving clinic. This may include information about:
· Laboratory standards;
· Screening for infectious diseases;
· Standards for quarantine.
Where the export involves embryos, the clinic must not allow export for use that would not be permitted in WA. This means, for example, that the clinic cannot export embryos for use in a commercial surrogacy arrangement as surrogacy for reward is illegal in WA.
Export where donation is involved that additional requirements for the export of gametes or embryos involves donation.
The clinic must seek approval from the RTC for the export of eggs, sperm or embryos where donation has been involved. Conditions for approval may include:
· The provision of information about the use and outcome of the donation.
· Provision of donor-identifying information.
· Compliance with the limit of 5 families per donor including families in other states or overseas.
· Effective consent:
§ Minimum of 18 years of age.
§ Awareness of the legal requirements, and the rights and responsibilities of donors and the recipient.
§ Consent of partners (if any).
The receiving clinic must submit a written undertaking (form 10) to provide the recipient identifying information to the exporting clinic and the Department of Health Reproductive Technology Registers…
There are also further requirements:
§ Customs (Prohibited Imports) Amendment Regulations 2003 (1) – Statutory Rule 2003 No.18, Customs (Prohibited Exports ) Amendment Regulations 2003 (No. 1) – Statutory Rule No. 17 and Customs Amendment Regulations 2003 (No. 1);
§ NHMRC (2007) Ethical Guidelines in the Use of Assisted Reproductive Technology in Clinical Practice and Research 2004 (it was revised in 2007 but take into account the changes in legislation).
§ Prohibition of Human Cloning Act 2002 (Human Cloning Act 2002)
§ Research involving human embryos Act 2002
§ Statutory rule 16.
The link to the Customs Notice is No 13 of 2003 which merely reflects the Customs (Prohibited Imports) Regulations 1956 and the Customs (Prohibited Exports) Regulations 1958 by which the import regulations were amended to prohibit absolutely importation of living tissue and cells (viable material) derived from human embryo clones and the export regulations were amended to prohibit absolutely the export of human embryos for a period of 12 months.
I note that the restriction of the absolute prohibition on any export is not the current position.
The Human Reproductive Technology Act 1991 (WA), s.22 sets out the provisions for consents, which need to be in writing and can be withdrawn at any time provided the gametes have not been used or the egg or embryo has not been used[29].
Section 22 provides:
“ (1) For the purposes of the licence condition referred to in section 33(2)(e) —
(a) The gametes of a person shall not be used, or for such a use be received by a licensee or participant, unless —
(i) there is an effective consent, by that person, to the gametes being so used; and
(ii) the gametes are used in accordance with that consent;
(b) The gametes of a person shall not be kept in storage unless —
(i) there is an effective consent, by that person, to the storage; and
(ii) the gametes are stored in accordance with that consent;
(c) The gametes of a person shall not be used in an in vitro fertilisation procedure unless there is an effective consent, by that person, to any human egg undergoing fertilisation or human embryo thereby derived being used for a consequential purpose authorised by this Act;
(d) Where the development of an egg undergoing fertilisation or a human embryo was brought about by an in vitro fertilisation procedure it shall not be kept in storage unless —
(i) there is an effective consent, by each person from whose gametes the egg or embryo was derived, to the storage; and
(ii) the egg or embryo is stored in accordance with that consent;
(e) Where the development of a human egg undergoing fertilisation or a human embryo was brought about by an in vitro fertilisation procedure, it shall not be used for any purpose, or for such a purpose be received by a licensee or participant, unless —
(i) There is an effective consent, by each person from whose gametes the egg or embryo was derived, to the use for that purpose; and
(ia) In the case of a use outside the body of a woman, there is an effective consent to the use for that purpose by the woman on whose behalf it is being developed and her spouse or de facto partner, if any; and
(ib) In the case of implantation in the body of a woman, there is an effective consent to the implantation by the woman and her spouse or de facto partner, if any; and
(ii) The purpose is authorised by this Act; and
(iii) That egg or embryo is used in accordance with that consent, and the Code may make further provision in relation to such, or related, matters.
(2) Where a consent is given in general terms to the use or storage of human gametes separately, whether human eggs or human sperm, that consent shall be taken to relate to the use or storage of any of those eggs or sperm, and also to any human egg undergoing fertilisation or human embryo derived from the use of the human gametes, for any purpose, save that —
(a) Any such consent may be given subject to specific conditions in its terms; and
(b) Notwithstanding subsection (4) or that a human egg undergoing fertilisation or a human embryo, may have developed which is derived from the use of human gametes the subject of any particular consent, in so far as it relates to any human egg or human sperm that has not been used that consent may be varied or withdrawn, but where a human egg in the process of fertilisation, or a human embryo, has been developed from any human gametes the consent thereafter to be required is not a consent to the use of those human gametes but a specific consent relating to that particular egg undergoing fertilisation or embryo only.
(3) The terms of any effective consent may from time to time be varied or the consent withdrawn, unless subsection (4) applies, by notice given by the person who gave the consent to the person keeping the human gametes, human eggs undergoing fertilisation or human embryos to which the consent is relevant.
(4) The terms of any effective consent to the use of any human gametes, a human egg undergoing fertilisation or a human embryo cannot be varied, and such consent cannot be withdrawn, once the gametes have, or that egg or embryo has, been used.
(5) A consent to the use of a human egg undergoing fertilisation or a human embryo must specify the purposes for which the egg or embryo may be used and may specify conditions subject to which the egg or embryo shall or shall not be used.
(6) A consent to the keeping of any human gametes, a human egg undergoing fertilisation or a human embryo must —
(a) specify the maximum period of storage, if that is to be less than such limit as may be prescribed or may be determined in accordance with section 24(1)(b); and
(b) give instructions as to what is, subject to this Act, to be done with the gametes, the egg or the embryo if the person who gave the consent is unable by reason of incapacity or otherwise to vary the terms of the consent or to withdraw it, and may specify conditions subject to which the gametes, or the egg or embryo, shall or shall not remain in storage.
(7) Before a licensee gives effect to a consent given for the purposes of this Act the licensee shall ensure that each participant has been provided with a suitable opportunity to receive —
(a)Proper counselling about the implications of the proposed procedures; and
(b)Such other relevant and suitable information as is proper or as may be specifically required by the Code or directions, including an explanation of the effect of subsection (3) and subsection (4).
(8)For the purposes of this Act a consent to the use or keeping of any human gametes, a human egg undergoing fertilisation or a human embryo shall not be taken to be effective unless —
(a) It is given in writing; and
(b) Any condition to which it is subject is met; and
(c) It has not been withdrawn; and
(d)Those gametes are, or that egg or embryo is, kept and used in accordance with the consent.
(9) Where a consent required by or under this Act is not given, or is not effective, or is not complied with that matter may be a cause for disciplinary action or proceedings for an offence but does not necessarily affect the rights of any person.
Thank you!
Stephen Page
Harrington Family Lawyers
25 July 2014
Phone: 07 3221 9544
Fax: 07 3221 9969
spage@harringtonfamilylawyers.com
Australian Divorce Blog http://australiandivorce.blogspot.com
Australian Gay and Lesbian Law Blog http://lgbtlawblog.blogspot.com
Australian Surrogacy and Adoption Blog http://surrogacyandadoption.blogspot.com
[1]Stephen Page is a partner of Harrington Family Lawyers, Brisbane. He is an accredited family law specialist He was admitted as a solicitor in 1987, has been an accredited family law specialist since 1996 and is author of the Australian Surrogacy and Adoption Blog.
2Prohibition of Human Cloning for Reproduction Act 2002 (Cth); Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Act 2003 (Qld); Human Cloning and Other Prohibited Practices Act 2003 (NSW); Human Cloning and Embryo Research Act 2004 (ACT); Prohibition of Human Cloning for Reproduction Act 2008 (Vic); Human Cloning for Reproduction and Other Prohibited Practices Act 2003(Tas); Prohibition of Human Cloning for Reproduction Act 2003 (SA); Human Reproductive Technology Act 1991 (WA).
[2]Including the ACT & NT if the latter passes laws: s.8
[3] Conversation with Dr Liz Butler, Life Fertility Clinic, 28 July, 2014
[4] S.223BAB (5,6) Strict liability applies
[5] 233BAB(5A),(5B), (6A), (6B)
[6] Section 9A (4) Export Control Act 1982 (Cth)
[7] Reg 3,Export Control (orders) Regulations 1982(Cth); Item 4.01, Export Control (Animals) Order 2004 (Cth)
[8]National Health and Medical Research Council, Ethical Guidelines in the use of Assisted Reproductive Technology in Clinical Practice and Research (2007). To be able to use any embryos, or conduct research, clinics need to comply with the Guidelines (and RTAC): Research Involving Human Embryos Act 2003 (Cth), ss 8, 10, 11, 21; Research Involving Human Embryos Regulations 2003 (Cth), regulation2.4.
[9] The Ethics Committee of the American Society for Reproductive Medicine, Financial Compensation of Oocyte Donors, American Society for Reproductive Medicine, Birmingham, Alabama, USA 2007
[10] http://www.fertilitysociety.com.au/wp-content/uploads/ANZICA-MEMBERSHIP-CRITERIA.pdf viewed on 28 July 2014.
[11]http://www.dfat.gov.au/fta/ausfta/final-text/chapter_10.html
Viewed on 30 6 2014
[12]Whose gametes are they anyway, 14 June 2014
[13]International Air Transport Association – international regulator of airline safety standards, etc.
[14]Conversation with Dr Liz Butler, Life Fertility Clinic, 28 July, 2014.
[15]NHMRC Guidelines 11 and 12, Assisted Reproduction Treatment Act 2008 (Vic), S.28; possibly Human Reproduction Technology Act 1991 (WA), SS 6(i)(d), 7 (b).
[16]S.17(4).
[17]S.19.
[18]S.22.
[19]http://www.varta.org.au/import-export-of-gametes-embryos/viewed 30 6 2014
[20]Victorian Assisted Reproductive Treatment Authority, Guidelines for the Import and Export of donor gametes and embryos produced from donor gametes, (March 2013).
[21] Guideline 3.3
[22] Source VARTA Annual Report 2013
[23] Section 29
[24]S.17(1)(d).
[25]S.20.
[26]S.20(3).
[27] Viewable at: http://www.slp.wa.gov.au/gazette/GAZETTE.NSF/gazlist/28FA432BECED857B48256F58002444B8/$file/gg201.pdf on 30 6 2014.
[28]http://www.rtc.org.au/clinics/docs/IMPORT_AND_EXPORT_QUICK_REFERENCE_GUIDE.pdf
[29]S.22(5).
