Clinical research involving gene editing, gene transfer, or gene regulation could be considered high-risk and overseen by China’s national cabinet, the State Council, if draft regulations posted yesterday (February 26) on the National Health Commission’s website (in Chinese) are adopted.
“The guidelines would require clinical trials involving gene-editing and other experimental life science technologies to be classified as high or low risk, and to obtain approval from government authorities before proceeding,” Bloomberg reports. “Researchers and hospitals found to have flouted the rules will be subject to penalties including a lifetime ban on research work, a revoking of business licenses and criminal investigation, said the draft.”
The proposal comes in the wake of international attention to scientist He Jiankui’s claim to have directed the production of two genetically edited babies. Investigations have revealed that He used banned techniques and may have used government funds to do so.
The Chinese government has said that the experiments go against regulations that prohibit the use of gene-manipulated embryos for reproductive purposes—guidelines released in 2003 concerning in vitro fertilization. But there are no Chinese laws that speak to gene editing in adults; according to Bloomberg, the government merely urges “rigorous supervision” by medical institutions.
The newly proposed regulations, which are open to feedback from the public until March 27, would put more of the oversight burden on health institutions, Bloomberg reports, holding them accountable for clinical trials they host.
The increased oversight may have drawbacks for researchers in the field. Kehkooi Kee, a Tsinghua University researcher who conducts gene editing on stem cells, tells the Associated Press that since late last year when the news of the gene-edited babies broke, he has faced more challenges to getting his research approved, pointing to a mountain of paperwork now required.
“The industry will develop at a slower pace,” Kee tells the AP. “The government will be more cautious with research funds, and private organizations, such as charities and startups, will be less likely to invest.”