Russia has no explicit regulations directly addressing the germline gene editing of embryos for research or clinical purposes, but supports the World Health Organization position against making changes to the human germline. Russia is not party to the 1997 European-based Oviedo Convention, which bans modifying the human germline.
There are laws that prohibit human genetic engineering in most circumstances, but it is unclear whether or how the rules apply to germline gene editing. The laws prohibit the creation of human embryos for the purposes of producing biomedical cell products. Russia’s regulations on assisted reproduction do not explicitly address gene editing.
Denis Rebrikov, a researcher from the Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, created an international furor in 2019, when he controversially announced he intended to follow in the footsteps of Chinese scientist He Jiankui in using CRISPR to edit embryos to prevent passing HIV from parent to child.
The Russian health ministry stated that it views any clinical use of gene editing technologies on human embryos premature. The Russian Academy of Sciences’ vice president for medical sciences said that until proof of safety for gene editing is shown in experiments with human embryos, “there should be no clinical activity whatsoever.”
Rebrikov subsequently decided to switch from the HIV gene to a gene that, when mutated, causes a form of congenital deafness. He then announced that he has started to edit genes in eggs donated by women who can hear in order to learn how to edit eggs from deaf couples to avoid the genetic mutation that impairs hearing. He claims to have permission from a local review board to do his research, but that this does not allow transfer of gene-edited eggs into the womb and subsequent pregnancy, and Roebrikov said he does not plan to do that until he receives full regulatory approval.
Products/Research
- Embryos with edited gene to avoid deafness: Denis Rebrikov, from the Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, edited normal eggs to study how to allow some deaf couples to give birth to children without one of the most common genetic causes of hearing loss.
- HIV-resistant embryos: Rebrikov announced in 2019 that he was considering implanting gene-edited embryos into women to create embryos resistant to HIV. An international uproar greeted his announcement and the research has been put on hold.
Regulatory Timeline
2019: Russian health ministry issues statement that any clinical use of genome-editing technologies on human embryos is “premature” and fully supports the World Health Organization position against making changes to the human germline.
2016: Russia’s Federal Law No. 180 on Biomedical Products prohibits the creation of human embryos for the purposes of producing biomedical cell products.
2014: Russia modifies civil code to prohibit the patentability of the various methods of modifying the human germline.
2012: Decree on artificial reproductive technologies does not allow genetically modified embryos to be implanted.
2003: Russian Federation Ministry of Healthcare publishes ‘On Use of Assisted Reproductive Technologies for Infertility Treatment for Female and Male Patients’, which outlines rules for artificial reproductive technologies.
1993: Basic Law of the Russian Federation as for Citizens’ Health Protection enacted, which allows for assisted reproduction.
NGO Reaction
The Russian Orthodox Church published a preliminary position saying that while gene editing has the potential to prevent inherited illnesses and conditions, it should be prohibited if an embryo’s viability is threatened. Some prominent Russian bioethicists, including Elena Grebenshchikova from the Russian Academy of Science’s Institute of Scientific Information for Social Sciences, strongly endorsed the Russian ministry’s restrictions on Rebrikov’s now-delayed plans to implant a gene edited embryo.
Additional Resources
- Genetic Literacy Project’s FAQ on gene editing
- Library of Congress summary of Russia gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
- The Regulation of Genome Editing and Human Reproduction Under International Law, EU Law and Comparative Law
