Russian legislation

Embryo research

Research on human embryos is vitally important to advance in the treatment of infertility and for further development of ART and embryology in general. Russia is one of the countries with the most permissive legislation in the world as for embryo research. 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. There is no any specific federal law or regulation regarding embryo research in Russia. The only 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 deals with basic aspects of IVF, AI, gamete and embryo donation, surrogacy, PGD, but it does not even mention embryo research.

So creation of embryos in vitro for research purposes is not forbidden, as well as use of embryos left after successful IVF procedure for scientific purposes. Written informed consent for ovarian stimulation and further use of embryos is always mandatory. Cryopreservation of embryos is allowed and sometimes even recommended. 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.

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).

Reproductive human cloning is not oficially prohibited in Russia, but there is a temporary 5 year ban on reproductive 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 reproductive 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 reproductive cloning. This ban expires in June, 2007.

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 a fertile age has the right to artificial fertilization and implantation of 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 personality constitute medical secret. A woman has 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.

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.