lexgenLex GeneticaLex Genetica3034-16393034-1647МГЮА10.17803/lexgen-2025-4-3-54-72lexgen-80Research ArticleLex Genetica: сравнительно-правовые исследованияLex Genetica: Comparative Legal AnalysisКонституционно-правовая база использования технологий CRISPR-Cas9: опыт КитаяConstitutional and Legal Framework for the Use of CRISPR-Cas9 Technologies: China’s ExperienceДородоноваН. В.DorodonovaN. V.

Наталия В. Дородонова, кандидат юридических наук, доцент кафедры конституционного и муниципального права

Москва

Natalia V. Dorodonova, Candidate of Science (Law), Associate Professor of the Department of Constitutional and Municipal Law

Moscow

nvdorodonova@msal.ruРыбаковаО. С.RybakovaO. S.

Ольга С. Рыбакова, кандидат юридических наук, доцент кафедры конституционного и муниципального права

Москва

Olga S. Rybakova, Candidate of Science (Law), Associate Professor of the Department of Constitutional and Municipal Law

Moscow

Университет имени О.Е. Кутафина (МГЮА)Kutafin Moscow State Law University (MSAL)202513102025435472Copyright © Дородонова Н.В., Рыбакова О.С., 20252025Дородонова Н.В., Рыбакова О.С.Dorodonova N.V., Rybakova O.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://lexgen.msal.ru/jour/article/view/80

Цель: Целью данной статьи является рассмотрение эволюции правового регулирования фундаментальных и доклинических исследований по редактированию генома человека в Китайской Народной Республике с 1990 по 2025 г. Редактирование генома человека является одним из наиболее сложных в правовом и этическом отношении направлений современной биомедицины. В статье представлен анализ опыта правового регулирования использования технологий CRISPR/Cas9 в Китайской Народной Республике (КНР), где эти технологии прошли определенный этап эволюционного развития, сопровождавшийся формированием национальной нормативной правовой базы, направленной на обеспечение баланса между научным прогрессом и биоэтическими ограничениями.Методология: В исследовании использованы общенаучные и специальные когнитивные методы, включающие правовой анализ и синтез, системный, сравнительно-правовой, логический и историко-правовой методы.Результаты: В исследовании проанализирована деятельность ключевых государственных органов (Национальная комиссия по здравоохранению (NHC), Министерство науки и технологий (MoST), Национальный этический комитет по науке и технологиям (NECST)), обеспечивающих системный подход к реализации государственной политики в области здравоохранения, разработке и применению технологий редактирования генома, развитию науки в этой области, этическому управлению научными и технологическими исследованиями, включая редактирование генома человека. В работе представлен детальный анализ эволюции национального законодательства Китайской Народной Республики в области применения технологий редактирования генома человека: законов, нормативных актов, этических стандартов, процессуальных протоколов, регламентирующих исследования по генетическим модификациям с использованием человеческих гамет, эмбрионов и половых клеток. Авторами выявлена тенденция ужесточения правового режима редактирования генома в период с 2018 г. по настоящее время, что вызвано как стремительным развитием технологий (CRISPR-Cas9), так и делом Хэ Цзянькуя. Анализ таких документов, как «Меры этической экспертизы исследований в области естественных наук и медицины с участием людей» (2023), «Пробные меры этической экспертизы научной и технологической деятельности» (2023), «Этические принципы редактирования генома человека» (2024), подчеркивает важность требований к содержанию этической экспертизы, основанной на соблюдении прав человека. В статье анализируются законодательные нововведения, предусматривающие уголовную ответственность за незаконную имплантацию генно-инженерных технологий, клонирование эмбрионов, незаконный сбор и контрабанду генетических ресурсов человека.Выводы: Исследования в области редактирования генов человека должны основываться на понимании этических и правовых аспектов клинической практики и разработке адекватных механизмов нормативного контроля. Стремительное развитие генно-инженерных технологий обусловливает необходимость научного осмысления правового регулирования отношений, возникающих в связи с использованием технологий CRISPR-Cas9, прежде всего с позиций соблюдения прав человека, пределов вмешательства в геном и определения правового статуса геномной и генетической информации. В соответствии с целью использования научного прогресса на благо общества чрезвычайно важна сбалансированная оценка взаимодействия инноваций и рисков при редактировании генома человека.

Objective To examine the evolution of the legal regulation of basic and preclinical human genome editing research in the People’s Republic of China from 1990 to 2025. Human genome editing is one of the most legally and ethically controversial areas of modern biomedicine. The experience of legal regulation in the field of CRISPR/ Cas9 technologies in the People's Republic of China (PRC) is analyzed. Here, the evolution of these technologies has been accompanied by the formation of a national regulatory framework aimed at ensuring a balance between scientific progress and bioethical restrictions.Methodology General and specific scientific methods were used, including legal analysis and synthesis, along with the methods of systems, logical-structural and historical-legal analysis.Results The activities of China’s state bodies (National Health Commission (NHC), Ministry of Science and Technology (MoST), National Ethics Committee for Science and Technology (NECST) in the field of public health policy were analyzed. These bodies ensure the development and application of genome editing technologies, the ethical management of scientific and technological research in this area, including human genome editing. The evolution of China’s national legislation in the field of application of human genome editing technologies was analyzed, including laws, regulations, ethical standards, procedural protocols governing research on genetic modifications using human gametes, embryos and germ cells. The trend toward tightening the legal regime for genome editing in the period from 2018 to the present was noted, which was caused by both the rapid development of technologies (CRISPR-Cas9, base editing) and the He Jiankui case. The new version of the “Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings” (2023), “Trial Measures for Scientific and Technological Ethics Review” (2023), “Ethical Guidelines for Human Genome Editing” (2024) were analyzed. These documents reflect strengthening requirements for the content of ethical review based on respect for human rights. Legislative innovations that provide for criminal liability for illegal implantation of genetic engineering, embryo cloning, illegal collection and smuggling of human genetic resources were outlined.Conclusions Research in the field of human gene editing should be based on understanding the ethical and legal aspects of clinical practice and the development of adequate mechanisms for regulatory control. The rapid development of genetic engineering technologies determines the need for scientific understanding of the legal regulation of relations arising in connection with the use of CRISPR-Cas9 technologies, primarily from the standpoint of respect for human rights, the limits of intervention in the genome, and determining the legal status of genomic and genetic information. In accordance with the principle of using scientific progress for the benefit of society, a balanced assessment of the interaction of innovations and risks in human genome editing is extremely important.

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The authors declare that there are no conflicts of interest present.