A Study On The Legality Of Human Germline Genome Editing

In November 2018,the former professor of Southern University of Science and Technology in China,named He Jiankui,announced the birth of a twins named Lulu and Nana,who are immune to AIDS and became the first gene-edited babies in the world.A great disturbance as soon as the news came out,which triggered discussions about gene-edited baby.The technology applied is human germline genome editing,which refers to the addition or deletion of specific DNA fragments of germline genome,in order to achieve modification purpose.At present,CRISPR/Cas9 is the most efficient and simple means to the operation.But there are risks of high off-target rates and irreversible consequences.In addition,germ cells are hereditary which is different from somatic cells,therefore the consequences of off-target will continue in the future generations.The purpose of this paper is to solve the problem of legitimacy and legality of human germline genome editing.This paper discusses the legitimacy reasons of human germline genome editing under the premise of technical safety.In accordance with the purpose,gene editing can be divided into gene therapy and gene enhancement.Although it can not be denied that normality as the boundary between therapy and enhancement is relative,the minimum range of gene therapy still can be defined,which is genetic diseases that seriously affect human health and their normal life.For the purpose of recovering the health of potentials and safeguard their future well-being,this minimum range of it is legitimate.Since at one aspect,germline gene enhancement challenges the concept of "human",violates human dignity,and destroys family ethics in the relationship between parents and children;at another aspect,it may restore eugenics in a new form,destroy social equality and justice,bring the hidden worries of genetic determinism,germline gene enhancement is not legitimate.Then this paper explores the basic position of current law on germline gene editing.Through the combing of legal documents,China is clearly opposed to the clinical application,but lacks of the attitude towards the stages of the basic and preclinical research.Combined with Huang Junjiu affair,it can be seen that China is not opposed to the research in preclinical stage.After that,by means of case analysis,this paper puts He Jiankui affair under the current law to see whether it is legal or not.In the case of He Jiankui,the technology was directly applied to clinical practice,which violated the prohibitive provisions,which was also a flagrant violation of international ethical norms.The experiment process violated the informed consent of participates,evaded the ethical review system,and there were procedural violations.The legal review of the affair also revealed some deficiencies of the current law: the lack of legal norms for germline genome editing;relying on legislation in the fields of human assisted reproduction,genetic resource etc.,which results in a large number of regulatory administrative authorities and overlapped functions;low ranks of legal documents in the form of guidelines and technical norms;the effectiveness of ethical review needs to be improved etc.Finally,this paper put forward some suggestions to improve the current legislation.This paper suggests the principles of human dignity,future health of the potentials,social justice and stability as the criteria to guide the legality judgment.This paper advocate the prohibition of human germline genome editing in clinical application,prohibition of gene enhancement in basic and preclinical research stages,and allow gene therapy in these stages.Considering the development of technology and the evolution of social values,the legality boundary should not be rigid,and a system of periodic reassessment needs to be established.To improve the current legislation,it is suggested to stick precautionary principle to regulate the different research stages and purposes of germline gene editing in different levels.The technical risks and ethical issues involved should be regulated respectively,enhance public participation to improve the scientific and democratic of administrative decision-making,strengthen the procedural control of research projects with ethical review and punish the illegal behavior with blacklisting system.In a word,with the development of technology,the law should not blindly appreciate the brilliant achievements of it,but should review the accompanying technical risks and ethical disputes calmly,and put forward prudent regulatory operations.Legality judgment delimits behavior boundary of technology,and the legitimacy analysis provides a reference for the legalized space of the technology in the future.