基因编辑技术医疗应用的行政法规控

 通过比较分析、规范分析和价值分析，发现基因编辑技术医疗的民事法、刑事法规控路径存在明显不足，需以行政法加以补强。通过对生命宪制理论的研究发现，基因编辑技术医疗应用的规控依赖科学行政。以科学行政规控基因编辑医疗，建议在立法上要科学厘定基因编辑医疗的概念，完善基因编辑技术医疗应用规制的技术规范，设置科学公平的处罚条款。同时要提高规范层级，形成全面、系统和专门的基因编辑技术法；在行政监管上，建议实行综合审查下的个案许可制度，同时强化行政监管的开放性，改革基因编辑伦理审查机制。在行政司法上，要建构公正的基因编辑行政纠纷解决机制，确立合理的基因编辑行政司法裁判基本原则，适用正确的利益平衡裁判方法，吸纳人民陪审，引入专家证人等。

Legal regulation for medical application of gene editing technology

There are obvious deficiencies in the medical risk regulation and control of the gene editing technology through the civil law and the criminal law, and the reinforcement must be made by the administrative law. From the perspective of the constitutional theory of life, the medical application of the gene editing technology needs to be regulated and controlled through a scientific administrative approach. It is suggested to regulate the medical application of the gene editing technology by the scientific administration. To achieve this goal, the concept of the gene editing medical treatment needs to be defined scientifically; the technical rules on the regulation of the medical application of the gene editing technology need to be improved; the penalty provisions need to be set scientifically and fairly. In addition, it is necessary to improve the legislative level and to form a comprehensive, systematic and special technical regulations for the gene editing. In terms of the administrative supervision, it is suggested to give individual case permission under a comprehensive review. And we should strengthen the openness of the administrative supervision and reform the mechanism of the ethical review. As for the administrative justice, a fair administrative dispute resolution system for the gene editing is necessary with reasonable basic principles for the dispute adjudication, the appropriate methods of a balancing of interests, the people jury system and the experts as the witness play big roles in the system.