In the wake of the gene-edited-baby scandal, scientists and institutions could face tough penalties for breaking the rules.
China’s health ministry has issued draft regulations that will restrict the use of gene editing in humans, just three months after Chinese researcher He Jiankui announced that twin girls had been born with edited genomes. The proposal includes severe penalties for those who break the rules. If approved, scientists say the policy could have gains and drawbacks for research.
The draft regulations, issued by the National Health Commission on 26 February, state that gene editing in any type of cell that will end up in humans, including embryos, will need the commission’s approval, as will other high-risk biomedical procedures.
The regulations come in response to He’s claim, in late November, that he used the gene-editing technology CRISPR–Cas9 to alter the genomes of embryos — a process known as germline editing — to make them resistant to HIV. He then implanted the edited embryos into women. News that twin girls had been born as a result of these experiments prompted an international outcry about He’s use of a risky and unproven technology.