China's Civil Code introduces regulations on human gene editing
China's Civil Code, adopted at the third session of the 13th National People's Congress (NPC) in May 2020, includes tightened provisions on human gene editing to minimize the threats the technology poses to "personality rights," ethics, and public interests.
Article 1009 stipulates that "a medical and scientific research activity related to human genes, embryos, or the like, shall be done in accordance with the relevant provisions of laws, administrative regulations, and the regulations of the State, and shall not endanger human health, offend ethics and morals, or harm public interests."
With the recent developments in new medical technologies, the application of gene editing has drawn significant public attention. Meanwhile, gene editing in humans also poses challenges to ethical norms and laws.
In November 2018, Chinese biophysicist He Jiankui claimed to have completed experiments on human embryos that resulted in babies whose DNA had been engineered to make them less susceptible to contracting HIV. The news prompted a scientific backlash and that was seen far beyond the biomedical sector.
On Nov. 30, 2019, the Nanshan District People's Court of Shenzhen said He had been convicted of illegal medical practice and received three years in jail for illegally carrying out human embryo gene editing intended for reproduction.
China's top legislator also took action to introduce clearer and tougher rules on research involving human genes and embryos.
An official with the Legislative Affairs Commission of the NPC Standing Committee said the second draft of the Civil Code's "personality rights" section was submitted to the meeting of the Standing Committee in April 2019. It stipulates that medical and scientific research activity related to human genes or embryos shall not endanger human health or offend ethics and morals.
When reviewing the second draft, some lawmakers stressed such activity must also not harm public interests. Their suggestion was taken up and the third draft was submitted to the 12th session of the 13th NPC Standing Committee for deliberation on Aug. 22, 2019.
During the session, Chen Zhu, vice chairman of the NPC Standing Committee, emphasized the importance of enacting regulations on research with human genes and embryos, noting that editing genes in human embryos is not yet a mature technology and could present multiple risks.
According to Chen, the provisions in the Civil Code are the first specific regulations on medical and scientific research activity related to human genes and embryos created from a legal perspective.
Before these laws, such activity was regulated by documents issued by relevant departments placed at a relatively low level in the legal hierarchy.
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