Has it been a crime or should it be criminalised? A case study on genome-edited babies and the improvement of criminal statutes in China

The 2018 “gene-edited babies” incident involving He Jiankui elicited widespread global condemnation, and he was subsequently convicted of and sentenced for illegal medical practice. Although several years have passed, impulses and initiatives aimed at advancing the clinical application of human germline genome editing in infants continue to emerge. Consequently, it is essential to re-examine the ethical oversight and legal framework governing this issue, particularly the role of criminal law in addressing safety and broader social concerns. This study employs a comparative legal approach combined with doctrinal legal analysis. It draws on legal and policy documents, case-related reports from official and authoritative media, as well as relevant scholarly literature. The analysis systematically reviews existing ethical guidelines, the applicable legal framework, and, in particular, the criminal provisions derived from relevant jurisprudential domains. By clarifying the key facts of the incident, the study demonstrates that the central issue lies in the clinical application of germline editing, which at the time was not expressly criminalised under Chinese criminal law. It argues that criminalisation was warranted and notes the subsequent enactment, in 2021, of the offence of “illicit implantation of gene-edited or cloned embryos” in Amendment (XI) to the Criminal Law of the People’s Republic of China. However, it contends that this provision remains in need of refinement and advances specific recommendations for its improvement.