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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">lexrussica</journal-id><journal-title-group><journal-title xml:lang="ru">Lex russica</journal-title><trans-title-group xml:lang="en"><trans-title>Lex Russica</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">1729-5920</issn><issn pub-type="epub">2686-7869</issn><publisher><publisher-name>MSAL</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.17803/1729-5920.2025.219.2.102-111</article-id><article-id custom-type="elpub" pub-id-type="custom">lexrussica-4245</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ГЕНОМ / GENOME</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>GENOME / GENOME</subject></subj-group></article-categories><title-group><article-title>Развитие правового регулирования синтетической биологии: интеграционно-правовой аспект</article-title><trans-title-group xml:lang="en"><trans-title>Development of Legal Regulation of Synthetic Biology: Integration and Legal Aspect</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Нечаева</surname><given-names>Е. К.</given-names></name><name name-style="western" xml:lang="en"><surname>Nechaeva</surname><given-names>E. K.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Нечаева Елена Константиновна, кандидат юридических наук, доцент кафедры интеграционного и европейского права</p><p>д. 9, Садовая-Кудринская ул., г. Москва 125993</p></bio><bio xml:lang="en"><p>Elena K. Nechaeva, Cand. Sci. (Law), Associate Professor, Department of Integration and European Law</p><p>Moscow</p></bio><email xlink:type="simple">eknechaeva@msal.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Некотенева</surname><given-names>М. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Nekoteneva</surname><given-names>M. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Некотенева Мария Владимировна, кандидат юридических наук, доцент кафедры интеграционного и европейского права</p><p>д. 9, Садовая-Кудринская ул., г. Москва 125993</p></bio><bio xml:lang="en"><p>Maria V. Nekoteneva, Cand. Sci. (Law), Associate Professor, Department of Integration and European Law</p><p>Moscow</p></bio><email xlink:type="simple">mvnekoteneva@msal.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кубышкин</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Kubyshkin</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Кубышкин Алексей Викторович, кандидат юридических наук, доцент кафедры медицинского права, старший научный сотрудник НОЦ правового обеспечения биоэкономики и генетических технологий </p><p>д. 9, Садовая-Кудринская ул., г. Москва 125993</p></bio><bio xml:lang="en"><p>Aleksey V. Kubyshkin, Cand. Sci. (Law), Associate Professor, Department of Medical Law, Senior Researcher, Center for Legal Support of Bioeconomics and Genetic Technologies</p><p>Moscow</p></bio><email xlink:type="simple">avkubyshkin@msal.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Московский государственный юридический университет имени О.Е. Кутафина (МГЮА)</institution></aff><aff xml:lang="en"><institution>Kutafin Moscow State Law University (MSAL)</institution></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>18</day><month>02</month><year>2025</year></pub-date><volume>78</volume><issue>2</issue><elocation-id>102–111</elocation-id><permissions><copyright-statement>Copyright &amp;#x00A9; Нечаева Е.К., Некотенева М.В., Кубышкин А.В., 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">Нечаева Е.К., Некотенева М.В., Кубышкин А.В.</copyright-holder><copyright-holder xml:lang="en">Nechaeva E.K., Nekoteneva M.V., Kubyshkin A.V.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://lexrussica.msal.ru/jour/article/view/4245">https://lexrussica.msal.ru/jour/article/view/4245</self-uri><abstract><p>Статья посвящена исследованию правового регулирования общественных отношений в сфере синтетической биологии. Цель статьи — выявить ключевые признаки понятия «синтетическая биология»; провести исследование нормативных правовых актов на глобальном уровне, уровне межгосударственных интеграционных объединений Российской Федерации, которые посвящены регулированию в сфере синтетической биологии; выявить основные аспекты и направления, в которых используется понятие «синтетическая биология»; сформулировать предложения по правовому регулированию соответствующих отношений на уровне Российской Федерации. Проанализированы различные определения понятия «синтетическая биология» в российских и зарубежных доктринальных источниках, а также в международно-правовых документах и документах международных организаций. Проведен анализ нормативного регулирования общественных отношений в сфере синтетической биологии. При исследовании использовались догматический и формально-логический методы, аксиологический подход и метод сравнения. По итогам анализа выделены существенные признаки понятия «синтетическая биология», сделаны выводы об основных аспектах и направлениях, в рамках которых используется данное понятие. Сформулированы предложения по правовому регулированию соответствующих отношений на уровне Российской Федерации, согласно которым целесообразно развивать регулирование применения технологий синтетической биологии для возможного создания патогенных организмов и других угроз в области биобезопасности, при этом регулировать применение технологий синтетической биологии в рамках других направлений нецелесообразно, поскольку соответствующие общественные отношения подпадают под уже существующее регулирование в более общих областях, таких как регулирование научных исследований и регулирование в сфере биотехнологий, биоэкономики, генетических технологий.</p></abstract><trans-abstract xml:lang="en"><p>The paper is devoted to the study of the legal regulation of public relations in the field of synthetic biology. The purpose of the paper is to identify the key features of the concept of «synthetic biology»; to conduct a study of regulatory legal acts at the global level, the level of interstate integration associations, and the Russian Federation, which are devoted to regulation in the field of synthetic biology; to identify the main aspects and directions in which the concept of «synthetic biology» is used; to formulate proposals for the legal regulation of relevant relations at the at the level of the Russian Federation. The various definitions of the concept of «synthetic biology» in Russian and foreign doctrinal sources, as well as in international legal documents and documents of international organizations are analyzed. The analysis of the statutory regulation of public relations in the field of synthetic biology is carried out. The research utilizes dogmatic and formal logical methods, an axiological approach and a method of comparison. Based on the results of the analysis, the essential features of the concept of «synthetic biology» are identified, conclusions are drawn about the main aspects and directions in which this concept is used. Proposals have been formulated for the legal regulation of relevant relations at the level of the Russian Federation, according to which it is advisable to develop regulation of the use of synthetic biology technologies for the possible creation of pathogenic organisms and other threats in the field of biosafety, while regulating the use of synthetic biology technologies in other areas is impractical, since the relevant public relations fall under existing regulation in more general areas — regulation of scientific research and regulation in the field of biotechnology, bioeconomics, and genetic technologies.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>синтетическая биология</kwd><kwd>правовое регулирование</kwd><kwd>биологическое разнообразие</kwd><kwd>международное право</kwd><kwd>генетические технологии</kwd><kwd>биотехнологии</kwd><kwd>биоэкономика</kwd></kwd-group><kwd-group xml:lang="en"><kwd>synthetic biology</kwd><kwd>legal regulation</kwd><kwd>biological diversity</kwd><kwd>international law</kwd><kwd>genetic technologies</kwd><kwd>biotechnologies</kwd><kwd>bioeconomics</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Васильев Р. 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