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2021-03-12 12:05:39 Voices

The latest edition of China’s criminal law formally came into effect March 1. The updated code includes a range of new legal provisions, from making it a crime to insult Communist Party martyrs, to tougher punishments for those who sexually assault certain minors. Scientists, too, have reason to brush up on their legal knowledge: A new section dedicated to “illegal medical practices” was added beneath Article 336, outlawing “the implantation of genetically edited or cloned human embryos into human or animal bodies, or the implantation of genetically edited or cloned animal embryos into human bodies.”

It’s hard not to draw a connection between the new language and China’s 2018 gene-editing scandal. On Nov. 26, 2018, He Jiankui, a researcher at the Southern University of Science and Technology (SUSTech) in Shenzhen, announced in an interview with The Associated Press that his team had helped a Chinese couple give birth to genetically edited twin girls. The father was HIV-positive, and the embryos’ genomes had been edited in an effort to confer genetic resistance to HIV.

The news quickly kicked off a global firestorm: Although gene-editing techniques such as CRISPR have made significant strides over the past decade — to the point where scientists have started experimenting with them to treat rare diseases in humans — scientists remain extremely cautious about directly editing human embryo genomes. There are serious ethical questions around “programming” these embryos, not least because the technique is still not proven to be safe, and there is a risk of accidentally damaging other genes.

Shortly after He’s announcement, The Intellectual — a media outlet influential among Chinese academics — published a joint statement signed by more than 300 scientists denouncing the research done by He’s team. A few days later, He revealed additional information about the experiment at the Second International Summit on Human Genome Editing, including that the gene-editing had gone “off-target.” The summit’s organizing committee stated that He’s project was unreasonably designed, medically unnecessary, and that his treatment of his research subjects did not meet ethical standards.

Given the damage He did to the reputation of Chinese bioscience, public opinion was generally supportive of the court’s decision.

The controversy surrounding the experiment quickly spread from the academic world to the political one. On Nov. 29, 2018, China’s Ministry of Science and Technology sanctioned those involved in the project. In January 2019, SUSTech fired He. The situation eventually escalated to a criminal investigation, and He was sentenced to three years of imprisonment by a Shenzhen court in December 2019.

Given the damage He did to the reputation of Chinese bioscience, public opinion was generally supportive of the court’s decision, but many legal researchers and lawyers felt uneasy. One main cause for concern was how the court’s legal interpretation seemed somewhat far-fetched. The court found that the defendants, including He Jiankui, had “jointly engaged in the illegal genetic editing of human embryos for reproductive purposes and reproductive medical treatment activities, and disturbed the order of medical management, with serious consequences.” This, in the court’s opinion, constituted the crime of offering illegal medical services.

In the view of many legal experts, however, this was an overinterpretation of the law, which at the time said nothing about gene editing and had largely been used to prosecute providers of dangerous medical procedures, not researchers. Did the genetic editing of human embryos really constitute a “medical service”? Should He bear all the blame for what could be seen as a systemic breakdown? And lastly, should the risks in this case, which remain largely theoretical, be defined as “serious consequences”?

Although the new law clears up some of these questions, it was not in effect at the time of He’s experiment. Rather, the prosecutors’ insistence that He be prosecuted seemed less a purely legal decision and more one made to send a clear message of zero tolerance for unethical human embryo experiments.

They got their conviction, and legislators moved quickly to close the legal loophole He’s case exposed, but it’s still worth examining how we got there. All the way back in 2003, China’s Ministry of Science and Technology joined with the then-Ministry of Health to release guidelines on the ethical issues related to human embryonic stem cell research. The guidelines stipulated that researchers may not implant genetically edited embryos into humans. These regulations, as scholars have pointed out, should have been enough to block He’s research.

So why didn’t they? One reason is that a legal document has to be enacted by a powerful authority in order to be effective: Unlike the criminal law, ministry-level guidelines are not always applied evenly, especially in regions China has endowed with greater autonomy to pursue economic goals. Another reason is that legislation rarely keeps up with the speed of science. Consider that the guideline was released in 2003, a decade before CRISPR technology was proven effective. It’s understandable that an older regulation might not carry the same weight as one accounting for the latest scientific advances.

Regulators should set up national ethics committees made up of experts from different fields and backgrounds to oversee consequential or sensitive research projects.

To an extent, overly strict and constantly changing rules will pose a barrier to scientific and technological innovation. However, if left unchecked, new technologies could pose a real threat to human life. What’s needed is a multi-layered regulatory system at once robust enough to deter misconduct and flexible enough not to stand in the way of scientific progress.

Last year’s biosecurity law, which provided a framework for managing “genetic resources,” was a solid step, but more work is needed to shore up ethics review boards, especially for sensitive research. In He’s case, investigators say he forged the ethical review documentation, but many experts have questioned why a local hospital should have the power to approve an experiment of that magnitude in the first place. Regulators should set up national ethics committees made up of experts from different fields and backgrounds to oversee consequential or sensitive research projects.

It’s good that prosecutors won’t need to stretch the law to prosecute offenders like He in the future, but it’d be better if researchers, policymakers, and the public were all on the same page to begin with. Criminal prosecution is an effective, but blunt weapon. What’s needed is a scalpel so Chinese regulators can excise unethical experiments without curbing the country’s ability to innovate.

Translator: David Ball; editors: Cai Yineng and Kilian O’Donnell; portrait artist: Wang Zhenhao.

(Header image: Lee Woodgate/Ikon Image/People Visual)