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There is an ancient proverb, "If the body is skinned, the parents will not dare to hurt it." With the development of medical technology, the application of gene editing technology has entered the public eye, but human gene editing also poses certain challenges to human ethics and laws.
In November 2018, the world's first gene-edited infant immunized against AIDS had an impact that far exceeded the biomedical industry.
On November 30, 2019, the case was publicly pronounced at the Shenzhen Nanshan District People’s Court in the first instance. The defendant He XX and others were sentenced in accordance with the law for illegally performing human embryo gene editing and reproductive medical activities for the purpose of reproduction. The three have constituted the crime of illegal medical practice and have been investigated for criminal responsibility according to law.
In addition to severe criminal penalties, how does the highest national legislature characterize such behaviors and how to regulate such behaviors?
The relevant person in charge of the Civil Law Office of the Legal Work Committee of the Standing Committee of the National People's Congress recalled that in April 2019, the second review draft of the Personal Rights of the Civil Code submitted to the Standing Committee of the National People's Congress for deliberation was the first review of medical and scientific research activities such as human genes and human embryos. Provisions are made: laws, administrative regulations and relevant state regulations shall be observed, human health shall not be endangered, and ethics shall not be violated.
During the review of the draft, some people believed that to engage in such activities, it should also be emphasized that public interests should not be harmed.
On August 22, 2019, the third review draft of the Personal Rights of the Civil Code was submitted to the 12th meeting of the 13th National People's Congress Standing Committee for deliberation.
The third-review draft adopted the above suggestions and clearly stated: Those engaged in medical and scientific research activities related to human genes and human embryos should abide by laws, administrative regulations and relevant national regulations, and must not endanger human health, violate ethics and morals, and must not harm Public Interest.
"Regulatory issues related to research on human genes and human embryos are indeed very important. The inclusion of this content in the third review manuscript is very targeted." On August 23, 2019, the third review draft of the draft of the Civil Code was reviewed in groups. At that time, Chen Zhu, vice chairman of the Standing Committee of the National People's Congress, said in his speech that at present, the issue of gene editing of embryonic stem cells is of particular concern. The technology itself is not fully mature, and there are hidden dangers in safety. Gene editing is also very important for which diseases. In particular, gene editing of embryonic stem cells may affect the safety of the human genome and have a great impact on human health and basic ethics in the future. Therefore, my country must have clear prohibitions on genetic manipulation of embryonic stem cells.
In May 2020, the Civil Code approved by the Third Session of the Thirteenth National People’s Congress passed three “nots” to add three “law locks” to gene editing to minimize and reduce the personality of natural persons. Rights, ethics, and public interests. Specifically, gene editing may pose three centuries of challenges to civil law.
Specifically, Article 109 clearly stipulates in the form of a special article: medical and scientific research activities related to human genes and human embryos shall abide by laws, administrative regulations and relevant national regulations, and shall not endanger human health or violate Ethics and morals must not harm the public interest.
The above-mentioned person in charge said that this is the first time that my country has clearly stipulated medical and scientific research activities related to human genes and human embryos at the legal level. The purpose is to make my country's medical and scientific research activities related to human genes and human embryos comply with bioethics standards, to ensure that internationally recognized bioethics standards and my country's relevant regulations are respected and observed, and to promote the orderly development of these activities. Prior to this, relevant issues were regulated by documents issued by relevant departments such as "Guiding Principles of Human Embryonic Stem Cell Research Ethics," "Management Measures for Stem Cell Clinical Research," "Measures for Ethical Review of Biomedical Research Involving Humans," and other relevant departments. These documents have legal status. Low, there is a gap with the major social impact of issues such as gene editing. The Civil Code clearly stipulates this, and it is timely. (Chen Yu)
[Responsible editor: Cai Lin]