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China set to introduce gene-editing regulation following CRISPR-baby furore

The draft rules mean that anyone who manipulates human genes in adults or embryos is responsible for adverse outcomes.

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He Jiankui speaks during an interview at a laboratory in Shenzhen

He Jiankui's controversial gene-editing experiments on embryos have lead to tighter regulations in China.Credit: Mark Schiefelbein/AP/Shutterstock

China is poised to introduce a new regulation on gene editing in humans. A draft of the country’s new civil code lists human genes and embryos in a section on personality rights to be protected. Experiments on genes in adults or embryos that endanger human health or violate ethical norms can accordingly be seen as a violation of a person’s fundamental rights.

Lawyers say the regulation would mean that anyone who manipulates genes in humans is responsible for what happens to a person. “The law makes clear that those who do research with human genes and embryos cannot endanger human health or violate ethics,” says Zhang Peng, a criminal-law scholar at Beijing Wuzi University.

China has been revising its civil code — the overarching legal framework that governs non-criminal disputes in areas such as marriage, inheritance and personal rights — since 2002. The latest draft was submitted last month to the country’s chief legislative body, the Standing Committee of the National People’s Congress, and is likely to be adopted next March.

The inclusion of gene editing in the latest draft of the new civil code was a last-minute addition, however — prompted by uproar over gene-editing experiments carried out last November by Chinese biophysicist He Jiankui. He claimed to have done experiments on human embryos that resulted in twin girls whose DNA had been engineered to make them less susceptible to contracting HIV. The controversial experiments drew condemnation in China and internationally, and led to He’s sacking from the Southern University of Science and Technology in Shenzhen in January. He was also censured by Chinese authorities, but it was not clear whether he had broken any of the country’s laws.

The revised civil code places experiments using human genes or embryos under the section of the code that ensures a person’s right to physical well-being, freedom, privacy and dignity. It is the first time that regulations relating to genomes have been included in the civil code, says Zhang.

If the new code had been in effect when He was considering his experiments, it might have dissuaded him, says Zhang. Even if He’s work did make the twin girls less likely to get HIV, it’s possible that he inadvertently increased their susceptibility to other infectious diseases. But there’s also a danger that his experiments made unintended modifications in their genomes, as often happens in gene-editing experiments in the laboratory, leaving the twins vulnerable to genetic diseases. Under these regulations, such gene-editing experiments would be illegal, says Zhang.

In March, the health ministry also drafted regulations that would require scientists to get approval before editing human embryos, and would impose penalties for those who broke the rules.

doi: 10.1038/d41586-019-01580-1
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