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.
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.)
- 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.
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.
- 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