Research On The Case Approval System Of Human Gene Editing In China

In recent years,the rapid development of human gene editing technology has provided us with new possibilities for deeper understanding and modification of human genes,which is of great significance in the field of life science and medicine.However,while human gene editing technology is advancing by leaps and bounds,its technical uncertainty and lack of rigor in review and supervision have also caused multi-dimensional risks,mainly including:ethical risks,technical risks,safety risks,social risks,etc.Since the implementation of research or treatment related to human gene editing technology should have obtained the corresponding administrative license,these risks should have been prevented and resolved by corresponding legal means.However,in recent years,a series of human gene editing activities,including the "gene-edited baby" incident of He Jiankui’s team,have exposed major flaws in China’s current review mode of human gene editing research or treatment behavior.That is,the current review mode of human gene editing research or treatment activities in China is extremely chaotic and useless,and there is no approval system for human gene editing case projects.Specifically,the relevant administrative laws and regulations are incomplete,the subject of review is unknown,the review principles are missing,the review standards are vague,the review procedures are incomplete,and there is a lack of effective legal supervision and remedies.Therefore,in order to prevent and resolve the multi-dimensional risks that may be brought by human gene technology,this paper puts forward some reasonable suggestions for the problems that arise in the current review mode of human gene editing in China,combined with China’s specific national conditions and the useful experience of the United Kingdom and other foreign countries,the core of which is to construct a case-by-case approval system for human gene editing in China,that is,the approval subject classifies and approves different types of human gene editing in accordance with strict approval standards,and on the basis of ensuring the pre-procedure of ethical review.The specific behavior of carrying out human editing case studies will be included in the scope of administrative licensing,and a case approval system for human gene editing in China will be constructed.Specifically,it includes: speeding up relevant legislation: establishing a special system of administrative laws and regulations for human gene editing;Clarify the subject of approval:establish an administrative approval mechanism led by the "Human Gene and Embryology Administration";Establish the principles of approval: the principle of human dignity,the principle of objectivity and justice,the principle of privacy protection,the principle of informed consent,the principle of proportionality,and the principle of public interest;Clear approval criteria: safety standards and necessity criteria;Improve the approval process:establish a categorical approval procedure-for different types of human gene editing,according to different strict levels,and strengthen the operability of the approval process in practice;Strengthen legal supervision and remedial measures.Finally,guide relevant personnel in China to carry out human gene editing research or treatment activities scientifically and rationally,and ensure the healthy development of biological science and technology such as human gene editing technology in China,especially to reserve reasonable space for the development of germline and embryonic human gene editing.