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Russia: Germline / Embryonic

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Ongoing Research, Regulations In Development

Germline gene editing research is being conducted, but no regulations specifically address germline gene editing for research or clinical purposes.

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

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which human / health products and processes are approved or in development and their regulatory status.

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Human / Health Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Gene and stem cell therapies regulated with minimal restrictions and requirements.
*Determined: No Unique Regulations: Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.

Therapeutic:
Gene editing of adult human cells, including gene therapy and stem cell therapy, that is used to treat and cure disease. Recent breakthroughs include CAR T-cell therapy, which uses patients’ own immune cells to treat their cancer.
Germline:
Gene editing of the human embryo or germline that results in genetic changes that are passed down to the next generation. This type of gene editing is the most controversial because changes are inherited and because it could theoretically be used to create “designer babies”. A Chinese scientist announced in 2018 that he had successfully edited twins that were brought to term. International backlash from the announcement has resulted in China and other countries working to clarify regulations on germline gene editing.

Rating by Country / Region
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Country / RegionTherapeuticGermlineHuman Rating
Japan888
Brazil402
Canada402
Russia1057.5
Argentina513
Israel825
Australia402
China846
US402
Chile412.5
New Zealand402
Ukraine1057.5
Central America111
Paraguay111
Uruguay111
India402
UK444
Mexico804
EU402