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How to ensure the safe, effective, and ethical use of emerging biotechnologies, such as clustered regularly interspaced short palindromic repeats (CRISPR)-based genome editing, is a global challenge. The occurrence of the “CRISPR babies” in 2018 publicly brought this issue into sharp focus, and led to comprehensive regulatory reforms in China and various countries around the world. The current article analyzes this event-driven regulatory reform in China by elaborating the most salient provisions designed to prevent risk and protect individual rights, public health, and social morality relating to human genome editing in four important sectors of law: biosecurity law, civil code, criminal law and patent law. It highlights that, although regulation is being undertaken, the gaps between the law and advancing technology remain discernible, at both a national and transnational level (i.e., the “double-pacing problem”). Further attention and collaboration will be required to address the ongoing challenges associated with the use of human genome editing.

In December 2019, a Chinese court sentenced Jiankiu He, the scientist who used genome editing to create three babies via in vitro fertilization (IVF), to three years in prison for practicing medicine without a license. The court claimed that He violated Chinese law when he forged ethical review documents and misled doctors into unknowingly implanting genetically altered embryos into two women the previous year. He stated that he had taken a leave from his university prior to starting the clinical stage of his project, and that he financed that part of the study from his own personal savings, therefore seemingly absolving his university and Chinese authorities of any responsibility in the affair. But to many observers, it seems inconceivable that Jiankui He could have engaged in this research without at least tacit government approval. This paper explores the sources of funding for He's experiment, in an attempt to clarify what Chinese authorities knew or should have known – and whether it is conceivable that He could have completed the clinical phase of the project with no direct government knowledge. It then analyzes the roles that China's science policy and scientific culture played in enabling He to act as he did. [ABSTRACT FROM AUTHOR]