A Public Resource Compiled by the

Russia: Therapeutic / Stem Cell

Print Friendly, PDF & Email
Russia Flag

Determined: No Unique Regulations*

Gene therapies are regulated as other medical drugs.

No laws specifically regulate gene therapies, but they are regulated through existing medical drug laws. The Ministry of Health is responsible for overseeing clinical trials and medical drug approval. Gene therapies also need to be approved by central and local ethics committees. Stem cell treatments must be administered by certified medical centers that are accredited by the Ministry of Health.

In 2015, Federal Law No. 61-FZ, On the Turnover of Medical Drugs, was amended to add gene therapy to the list of treatments covered by the law.

As of 2017, 10 gene therapy trials had been completed and one gene therapy drug has been approved.

Although there is no legislation directly addressing mitochondrial replacement (aka ‘three-parent baby’), a controversial technique that can help avoid certain mitochondrial genetic diseases, clinics in Russia offer the procedure. (The UK is the only country that has officially approved the procedure.)

Products/Research

  • Peripheral Arterial Disease: The Human Stem Cells Institute received approval in 2011 for a gene therapy drug to treat Peripheral Arterial Disease caused by atherosclerosis (a thickening of artery walls and subsequent reduction of blood flow). The drug was licensed for development in the US and Canada in 2016.
  • Cancer: Russian Academy of Sciences (RAS) Institute of Gene Biology conducted a gene therapy clinical trial to treat some types of melanoma and carcinoma.
  • Cardiovascular disease: Researchers conducted a clinical trial in 2012 to treat chest pain due to heart disease using gene therapy.
  • Nerve injury: Kazan Federal University conducted a clinical trial in 2015 to treat nerve injuries through regeneration using gene therapy.
  • Raynaud’s disease: Human Stem Cell Institute conducted a clinical trial in 2015 to treat Raynaud’s disease, which causes reduced blood flow to the extremities.
  • Bone tissue regeneration: Moscow State University of Medicine and Dentistry conducted clinical trials in 2014, 2017 for bone regeneration using gene therapy.
  • Diabetes complications: Human Stem Cell Institute conducted a clinical trial in 2015 to treat complications of diabetes using gene therapy.
  • Spinal cord injury repair: The Kazan State Medical University and Kazan Federal University studied various possible gene therapy treatments for spinal cord injury in rats.

Regulatory Timeline

2016: Adopts Federal Law No. 180 on Biomedical Products, which defines regulations for the development, trials and registration of cell lines and other biomedical cell products.

2015: Federal Law No. 61-FZ On the Turnover of Medical Drugs amended, clarifying good practices and approval requirements and adding gene therapy as a defined term.

2014: Agreement, Common Principles and Rules of Drug Circulation in the Eurasian Economic Union, signed, which outlines regulations for registration of medical products for their release into circulation within the Eurasian Economic Union.

2010: Adopts Federal Law No. 61-FZ, On the Turnover of Medical Drugs, which defines how medical drugs are tested and approved.

2005: National Standard for Good Clinical Practice goes into effect, which defines international quality standards for clinical trials.

1996: Adopts Federal Law No. 86-FZ, On the State Regulation in the Sphere of Genetic Engineering Activities. The foundational federal law on genetic engineering in Russia establishes state control over the monitoring of genetic engineering, including gene therapies, on human health.

NGO Reaction

None

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.

Globe Map

European Union

Brazil

New Zealand

United States

Australia

Canada

China

United Kingdom

Israel

Argentina

Japan

Mexico

Russia

Chile

Uruguay

Paraguay

India

Africa

Ukraine

Southeast Asia

Central America

Colombia

Norway

Ecuador

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
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

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
Share via

Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

Send this to a friend