There is no specific federal law regarding all aspects of assisted reproduction in Russia. Different laws with completely different concepts have been in preparation for years – but were never placed before the State Duma – lower chamber of Russian parliament. As for the moment one of the most important legal document as for assisted reproduction is Article 35 of the Russian Federation Citiziens’ Health Protection Law (22.07.1993 № 5487-I), “Artificial fertilization and implantation of embryo”: Each grown-up woman of fertile age has the right to artificial fertilization and implantation of an embryo. Artificial fertilization of a woman and implantation of embryo are carried out in establishments that have been licensed for that, upon getting a written consent of spouses (single woman). Information about carried-out artificial fertilization and implantation of embryo, as well as donor identity constitute medical secret. A woman has a right to information about a procedure of artificial fertilization and implantation of embryo, about medical and legal aspects of its consequences, about medical-genetic check-up, physical aspect and nationality of a donor, given by a doctor carrying out a medical intrusion.
Another document that regulates ART in Russia is Order 67th of the RF Ministry for Health (Reg. №4452 24.04.03 RF Justice Ministry). This regulation that deals with basic aspects of IVF, AI, gamete and embryo donation, surrogacy, PGD must be followed by all IVF clinics. Not more that 3 embryos at a time can be transferred, but normally Russian embryologists transfer not more than 2 embryos. Cryopreservation of embryos is allowed. Generally speaking, the legal situation concerning ART is very favorable, embryo research is allowed, gamete and embryo donation permitted on a commercial level. Single women can be treated by known or anonymous donor insemination. Gestational surrogacy is an option for officially married couples and single women. There is no such concept as gay and lesbian marriage in Russia, it is not acknowledged by the law, so lesbian couples are not mentioned in the law and such patients can be treated as single women.
Research on embryos in vitro is allowed. There are no any specific restrictions as for experiments on a human embryo imposed by any law or act. No ethics committee approval is required.
Gamete donation is officially allowed by Order №67 of the Russian Federation Ministry for Health. All persons involved should give their written informed consent for the donation procedure. Donors do not assume parental responsibilities. Birth of 20 children from the same donor per 800 000 residents in such or another region is sufficient reason to stop any further use of a specific donor in this region. Commercial donation was permitted by the federal law “On transplantation of human organs (tissues)” (22.12.1992 № 4179-1,). In its Article 1 the law forbids commercial deals with all human organs (tissues). But its Article 2 stands that this quite restrictive law has nothing to do with organs and tissues related to human reproduction, and even explicitly singles out human gametes and embryos. According to Article 35 of the Russian Federation Citiziens’ Health Protection Law (22.07.1993 № 5487-I), donor personality constitutes medical secret. Normally it is guaranteed by the clinic. To avoid identification clinics provide recipients with very little information about donors (just matching characteristics based on phenotype description). But recipients always can choose between known and anonymous donation. Offspring doesn’t have the right to know the identity of the donor (donors).
Anonymous oocyte donor should be from 20 to 35 years; must have a healthy child of her own; no pronounced phenotype manifestations; somatic health.
Oocyte donation can be performed only after getting from a donor a written informed consent for superovulation induction and for ovarian puncture. The legal mother is the woman who gives birth to the child.
According to the Order 67th of the RF Ministry for Health there has to be a medical indication for IVF with donated oocytes, such as: absence of oocytes, caused by natural menopause, premature ovarian failure syndrome, specific states of health typical for post-ovarian ectomy period, post-radiotherapy period or post-chemotherapy period, as well as abnormal development (gonad dysgenesis, Shereshevsky-Turner syndrome, etc.); oocytal functional inferiority in female patients suffering gender-specific hereditary diseases (hemophilia, Duchesne myodystrophy, Х-linked ichthyosis, Charcot-Marie-Trusseau peroneal myotrophy, etc.); repeated IVF attempts with no success, when the ovaries were insufficiently responsive to inducement of superovulation, and when obtained embryos repeatedly were of poor quality, so that no pregnancy could be achieved after their transfer.
Donated sperm can be used both for IVF and AI. It’s allowed to use donated sperm in the following cases: infertility; ejaculatory & sexual disorders or unfavorable medico-genetic prognosis for men and absence of sexual partner for women.
It is permitted to use donated sperm from any medical facility with a sperm bank. It is permitted to use frozen/thawed donated sperm only, after obtaining of repeated (6 months after the sperm is taken) negative results of tests for HIV, syphilis and hepatitis. Use of frozen/thawed sperm makes it possible to prevent any contraction of HIV, syphilis, hepatitis and other infections; and avoid personal meeting between the donor and the recipient.
Requirements for sperm donors: age between 20 to 40 years; absence of any deviations in normal organometric and phenotype characteristics.
Embryo donors can be IVF program patients, who still have, after completing their families (childbirth), some non-used cryopreserved embryos in the bank. If donating patients have voluntary given a written informed consent for donation, these embryos can be donated to infertile married couples or single women (recipients).
Embryos for donation can also be obtained through fertilization of donated oocytes with donated sperm. According to Article 35 of the Russian Federation Citiziens’ Health Protection Law (22.07.1993 № 5487-I), donors personality constitutes medical secret.
The patients should always be informed that expected success rate of program involving use of cryopreserved embryos left after IVF program is lower than in case embryos obtained from donated gametes are used. The recipients should also be provided with donor phenotypic portraits.
It’s allowed to use donated embryos in the following cases: absence of oocytes; unfavorable medico-genetic prognosis; if poor quality embryos were repeatedly obtained, and their transfer produced no pregnancy; if it is not possible to collect or use the husband’s sperm in combination with the above mentioned factors (or any other factors). Single women can apply for embryo donation without any medical indications.
Preimplantation diagnosis and sex selection are allowed only when there is a risk of giving birth to children with hereditary pathologies (gene mutations or chromosomal anomalities), as an alternative method for prenatal diagnosis - to prevent gender-linked hereditary diseases. The principal advantage of preimplantation diagnosis is that it offers an opportunity to avoid invasive intervention into embryo/fetus egg and to interrupt the pregnancy in case any pathology is found.
Embryo reduction can be performed to prevent various obstetrical and perinatal complications associated with multiple pregnancy (3 or more embryos). Embryonic/fetal reduction can be performed only after the pregnant woman has given her written informed consent for that. Specific number of embryos to be reduced is precised by the woman upon her doctor’s advice. Embryo reduction can not be performed if there is a danger of pregnancy interruption or acute inflammatory diseases, wherever located (as of the procedure date).
Gestational surrogacy
Gestational surrogacy is absolutely legal in Russia, but it is an option only for officially married couples and single women. No specific permission from any regulatory body is required for that. According to the Order 67th of the RF Ministry for Health (Reg. №4452 24.04.03 RF Justice Ministry) there has to be a medical indication for surrogacy: absence of uterus (congenital or acquired); uterine cavity or cervix deformity due to congenital malformations or to any diseases; uterine cavity synechia, which cannot be treated; somatic diseases contraindicating any child bearing; repeatedly failed IVF attempts when high-quality embryos were repeatedly obtained and their transfer was not followed by pregnancy.
The prospective surrogate should be between 20 - 35 years old. She must be mentally and physically healthy and have at least one healthy child of her own. The surrogate may have no relation to the commissioning parents. The maritial status of the surrogate is irrelevant.
Donorgametes or donorembryos might be used in surrogacy programmes. There are no restrictions as for the use of surrogate mother’s gametes for surrogacy programs, so she could donate her own oocytes for the IVF (not AI) program as well.
A written informed consent of all parties (prospective parents and surrogate) participating in the surrogacy program is mandatory.
Commissioning parents are considered the child’s legal parents only after getting a consent of the surrogate for that. No adoption is required. It’s regulated by the Article 51 of the Russian Federation Family Code (29.12.1995 №223 Federal Law), “Entry of Parents of Child in Book of Birth Registrations”, Clause 4: Persons who are married to one another and who have given their consent in written form to the implantation of an embryo in another woman for the purpose of bearing may be entered as parents of the child only with the consent of the woman who gave birth to the child (surrogate mother). After the entry of parents in the book of birth registrations is made, the surrogate loses all rights to motherhood. According to the Article 52 of the Russian Federation Family Code, Contesting Fatherhood(of Motherhood), Clause 3: A spouse has given consent in the procedure established by a law in written form to the application of the method of artificial insemination or to the implantation of an embryo shall not have the right when contesting fatherhood to refer to these circumstances. Spouses who have given consent to the implantation of an embryo in another woman, and also a surrogate mother (Article 51(4), paragraph two, of the present Code) shall not have the right when contesting motherhood and fatherhood after the making of the entry of parents in the book of birth registrations to refer to these circumstances.
The surrogate can get remuneration for her service and be compensated for actual expenses as well.
A written surrogate parenting contract between parties is not mandatory, but if done, it’s enforceable as for parties financial responsibility only. If the surrogate changes her mind and would like to keep the baby, the contract would be considered unenforceable and cannot be used as evidence in a proceeding to determine who gets custody of the child.
Public opinion is surrogacy-friendly, recent cases of a famous singer and a business-woman that both openly used services of gestational surrogates received very positive news coverage.
Traditional surrogacy
Traditional surrogacy is not mentioned in the law, so the child born as the result of artificial insemination pursuant to a traditional surrogacy program is deemed to be the child of the surrogate mother and commissioning biological father. If traditional surrogate is married, her husband would be the legal father of this child. To avoid it according to the article 48, clause 3 of the Family Code of the Russian Federation the fatherhood of biological father should be established by means of filing a joint statement of the intended biological father and biological (“surrogate”) mother of the child in an agency for the registry of acts of civil status. If biological father is married, step-parent adoption will be necessary to get the intended mother’s name listed on the child’s birth certificate instead of the surrogate’s name.
Human cloning is not oficially prohibited in Russia, but there is a 5 year ban on human cloning. This ban was imposed according to the Russian Federation law № 54 FZ “On temporary prohibition of human cloning” adopted by the State Duma (Russian parliament) on April 19th, 2002 and signed by Russian President Vladimir Putin on May 20th, 2002. The law imposed temporary ban only on creation of “a human being, genetically identical to another one, dead or alive, by means of implantation of a nucleus of a human somatic cell into a female gamete preliminary deprived of its nucleus” on the territory of the Russian Federation. So only reproductive cloning of humans is prohibited. The law also explicitly forbids import and export of cloned human embryos in and out of the national territory for the same period of five years.
The law applies to human cloning only. It explicitly says that cloning of other living beings is allowed. Persons flouting the law will be prosecuted in accordance with the federal legislation. In the meantime, neither the Criminal nor Administrative Codes of the Russian Federation provide any punishment (neither imprisonment nor penalty) for human cloning. This ban expires in June, 2007.
This overview of Russian legislation was prepared by
Konstantin Svitnev
svitnev@jurconsult.ru
Russian Legislation
Embryo research
Donor anonymity
Family code (russian language)
Order 67
Order 67 (russian language)