CRISPR/Cas9人体基因编辑技术运用的法律规制——以基因编辑婴儿事件为例

Legal Regulations on the Application of CRISPR/Cas9 Human Gene-edited Technology——Take the gene-edited babies event as an example

基因编辑是运用生物手段对基因进行修改,人为进行自然选择的一种技术。CRISPR/Cas9基因编辑技术运用于人体基因编辑面临着较大脱靶风险和技术安全隐患。滥用人体生殖细胞基因编辑技术可能会加剧社会分化和不平等,并引发人类基本伦理道德间的冲突,危及人类尊严。域外对人体基因编辑的法律监管较为严格。完善人体基因编辑技术的国内立法过程中,应秉持尊重人类尊严、人类安全、严格监管等原则,遵循《赫尔辛基宣言》等国际条约,强化对人体基因编辑技术临床试验的监管,细化伦理审查委员会的事前和事后监管,并明确人体基因编辑技术的限制领域,必要时可设定民事或刑事责任规范该技术的试验和使用。当然,相关立法也应当为人体基因编辑技术的探索和发展,保留必要、合理的空间。

Gene-edited is a kind of technology that using biological means to modify gene and artificial natural selection.The application of CRISPR/Cas9 gene-edited technology in human gene-edited is faced with great risks of missing the target and some technical security problems.The abuse of human germ cell gene-edited technology may aggravate social differentiation and inequality,as well as cause conflicts between basic human ethics and endanger human dignity.The law regulations on human gene editing of other countries are relatively strict.During the process that perfect the human gene-edited techniques legislation of China,we should uphold principle of respecting human dignity,human security,and strict supervision,follow the international treaties such as The Declaration of Helsinki,strengthen the regulation of gene-edited techniques’clinical trials to human body,refine both the ex ante and ex post supervision of The Ethical Review Committee,clearly limited the field of human gene-edited techniques,and could set civil or criminal liability to manage the trail and use of this technology if necessary.Certainly,relevant legislation should also reserve necessary and reasonable space for the exploration and development of human gene-edited technology.