From Status to Conduct: China’s Civil Law Regulation of Human Embryo Gene Editing

The 2018 “He Jiankui Affair” exposed structural deficiencies in China’s biotechnology oversight regarding conduct characterization and rights protection. This study argues that the prior legal framework focused predominantly on the ontology-based “status” of embryos—a static approach that proved inadequate when confronting disruptive technologies. With the promulgation of the Civil Code, China has achieved a paradigm shift toward “conduct-based regulation,” bypassing metaphysical disputes over the legal nature of embryos to establish a pragmatic governance framework centered on the protection of personality rights. To further refine this system, this article proposes strengthening the top-level oversight mechanism anchored by the National Science and Technology Ethics Committee, integrated with a tiered regulation model that fosters synergy between “hard law” enforcement and “soft law” guidance based on risk levels. Building upon this, a dynamic, full-lifecycle regulatory path should be established through specialized legislation to cover the spectrum from laboratory R&D to clinical application. By deepening public participation and international coordination to address global regulatory disparities, China can balance technological innovation with ethical boundaries, ensuring that biotechnological advancements remain within the trajectory of the rule of law.