REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot93810.21518/1561-5936-2020-4-5-6-6-15Original ArticleProspects for further development of biobanks and genetic research: ethical implicationsNadelyaevaI. I.noemail@neicon.ruNational Research Institute of Public Health named after N.A. Semashko041220204-661518032022Copyright © 2020,2020In early 2019, the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor) developed and presented a draft federal law on human biological and genetic data as directed by Order of the President of the Russian Federation No. Pr-295 of December 1, 2017. It is believed that after adoption of the document, two federal laws, On Personal Data and On the Protection of Consumers’ Rights, will be immediately amended at one time.In so doing, the state makes attempts to lay the groundwork for a national control system in the area of human biomaterials. The international law has established regulatory practice in this area, while several problems remain unresolved.biobanksgenetic researchhuman bio-samplescollectionmedical institutionslegal regulationбиобанкигенетические исследованиябиообразцы человекасбормедицинские учрежденияправовое регулирование[Проект федерального закона. Федеральный портал проектов нормативных правовых актов 2019. Available at: https:// regulation.gov.ru/p/87215.][Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Available at: https://eur-lex.europa.eu/LexUriServ/.][Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. Available at: https://eur-lex.europa.eu/LexUriServ/.][Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. Available at: https://eur- lex.europa.eu/LexUriServ/.][Biobank Act. Available at: https://www.finlex.fi/en/laki/ kaannokset/2012/en20120688.pdf.][Biobanks in Medical Care Act (SFS 2002:297). Available at: http://www.codex.vr.se/en/manniska4.shtml.][The Biobanks and Health Databanks Act. Available at: https://www.government.is/media/velferdarraduneyti-media/media/ acrobat-enskar_sidur/Biobanks-Act-as-amended-2015.pdf.][The Health Research Act 2008 (Helseforskningsloven). Available at: http://app.uio.no/ub/ujur/oversatte-lover/data/lov-20080620-044-eng.pdf.][Human Genes Research Act. Available at: https://www.riigiteataja.ee/en/eli/531102013003/consolide.][Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free move- ment of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). Available at: https://eur-lex.europa.eu/ legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679.][WMA declaration of Taipei on ethical considerations regarding health databases and biobanks. Available at: https://www.wma.net/ policies-post/wma-declaration-of-taipei-on-ethical-consider- ations-regarding-health-databases-and-biobanks/.][Конвенция о защите прав и достоинства человека в связи с применением достижений биологии и медицины: Конвенция о правах человека и биомедицине. Available at: https://www.coe. int/ru/web/conventions/full-list/-/conventions/treaty/164.][International Database on the Legal and Socio-Ethical Aspects of Population Genetics. Available at: http://www.popgen.info/.][Genetics Home Reference. Available at: https://ghr.nlm.nih.gov/.][EuroGentest. Available at: http://www.eurogentest.org/index.php?id=160.][B3Africa - Bridging Biobanking and Biomedical Research across Europe and Africa. Available at: http://www.b3africa.org/.][Хельсинкская декларация Всемирной медицинской ассоциации. Available at: http://acto-russia.org/index. php?option=com_content&task=view&id=21. WMA declaration of Reykjavik - ethical considerations regarding the use of genetics in health care. Available at: https://www.wma. net/policies-post/wma-statement-on-genetics-and-medicine/. 2020;(4-5-6) | REMEDIUM]