Constitutional and Legal Framework for the Use of CRISPR-Cas9 Technologies: China’s Experience

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.