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.
The commission's proposed regulations include penalties for unapproved use of high-risk biomedical technologies, including fines and blacklisting from grant applications. Existing regulations prohibit gene editing in human embryos that will be used for reproduction, but there are no penalties for breaking the rules. As such, there has been no indication of whether, or how, He will be punished for his experiments, although he has been fired by his university. The regulations also state how unapproved use of these technologies could break existing national laws, which could lead to criminal charges.
The proposed regulations send a clear signal to academics, hospitals, research funding agencies and even investors that they should not get involved in clinical research that could be deemed unethical or illegal, says Tang Li, a science policy researcher at Fudan University in Shanghai, China. “The global scientific community’s opposition to He Jiankui’s experiment has ignited China’s awareness of research ethics.”
Other high-risk procedures that would require approval by the National Health Commission include other types of gene modification, stem-cell technologies, mitochondrial replacement, use of cells from other animal species or synthetic genetic material in humans, and other research projects with highly unpredictable, potentially severe outcomes. Low- to medium-risk research, which is yet to be defined, will need approval only from provincial government authorities. The regulations will not apply to preclinical and basic research, including gene editing of human embryos not being used for reproduction.
State media says the government of Guangdong province, where He was working, found that He’s team had forged ethics documents. Under the proposed rules, people who use false information to, for example, obtain ethical permission for clinical research could be fined between 50,000 and 100,000 yuan (US$7,400–$15,000). Their research permits could be cancelled and they could be banned from research for five years.
A medical institution that uses the restricted technologies for clinical research without approval could also be fined 50,000–100,000 yuan, and could lose the right to apply for clinical research funding for five years. In severe cases, an institution could lose its medical licence. The government would also confiscate an profits that arise from illegal clinical procedures.
Tang says that the government’s tighter oversight of biomedical technologies could slow, or even halt, some research in China. But doing research responsibly is more important than making big scientific breakthroughs, she says.
Jonathan Kimmelman, who studies the ethics and policy of new biomedical technologies at McGill University in Montreal, Canada, says the regulations could increase people’s confidence in Chinese research. “Strict regulations, like those described above, remove some of the fear scientists, sponsors or others might have in collaborating with Chinese scientists working in contentious areas of clinical research,” he says. “The regulations might cut short rogue and short-term-oriented research, while establishing a solid foundation for more sustained and long-term-oriented research activities.”
The draft regulations are open for public comments until 27 March, after which the commission will make its final policy.