China’s high-tech industrialization policy, known as Made in China 2025, purports to take the country to the front ranks of advanced manufacturing in aerospace, robotics, clean energy, transportation and the life sciences. But the transformation into a global biotech and pharmaceutical dynamo might prove more challenging than making robots or self-driving cars.
That is because China lacks a good regulatory and ethical review process, a serious problem highlighted last November when scientist He Jiankui gave the world an unwelcome surprise. He announced that he had edited the genes of twin girls at the embryo stage with the aim of enhancing their resistance to HIV—an experiment with the potential to produce a host of genetic and health problems that could be passed on to the twins’ offspring.
The rogue nature of He’s actions brought a wave of condemnation from inside and outside the country, but the experiment was by no means an outlier. China stands out from other technologically advanced countries because of its headlong embrace of new biological and medical developments that raise weighty ethical and human-rights issues.
After He went public, the Wall Street Journal reported that other Chinese researchers working with CRISPR-Cas9 gene editing, the same technique used for the twins (but, in these instances, not in embryos), had lost track of the people who had participated in their study. The Journal also documented earlier this year accusations that Uighur Muslims, practitioners of Falun Gong, Tibetan Buddhists and “underground” Christians have had organs forcibly removed for transplants. In addition, animal research on the feasibility of head transplants and spinal cord reattachment has been carried out in China—a head transplant on a living human volunteer has even been discussed.
He’s gene editing of embryos appears to have pushed Chinese authorities to act. Although China lacks firm regulations on the practice, tinkering with the twins’ genes violated its guidelines on human-assisted reproduction, and the scientist was fired from a Chinese university and left a start-up company he founded. China has also begun to open up a process of national self-scrutiny that could put the country on a sturdier foundation of ethical safeguards more in line with international norms. A May commentary in Nature by four bioethicists from Chinese universities and institutes laid out both the problem and a series of solutions with extraordinary clarity and forthrightness. The authors assert China is at a crossroads requiring “substantial changes to protect others from the potential effects of reckless human experimentation.”
The article criticized Chinese science culture as beset by jigong jinli: a motivation to seek “quick successes and short-term gains.” Lei Ruipeng of Huazhong University of Science and Technology in Wuhan and three co-authors from other institutions called for better regulation, stringent penalties and clear codes of conduct for research that involves gene editing, stem cells, mitochondrial transfer, neurotechnologies, synthetic biology, nanotechnology and xenotransplantation. They want these codes to supersede the fragmented framework of oversight responsibilities currently apportioned among different government ministries. Policy makers seem to be edging in the same direction: in February the National Health Commission put out draft regulations that propose stricter controls on gene editing.
The bioethicists also suggest a registry that tracks clinical trials and collects ethics evaluations for studies using new medical technologies. They advocate other measures such as dissemination of regulations by a national organization and ethics education for everyone from scientists to the general public. And they call for an end to discrimination of people with disabilities based on the rationale that they are inferior or a societal burden, an attitude biasing any attempt to formulate a set of ethical principles.
China is not the only country that has lagged at some point in developing a regulatory infrastructure to address experiments on humans. In the U.S., the 1978 Belmont Report set out ethics guidelines for human research subjects in the aftermath of the 40-year Tuskegee experiment, which tracked the progress of syphilis in untreated black men who were, unforgivably, not told clearly that they had the disease. As the Nature commentary’s authors point out, the field of bioethics has only a 30-year history in China. He’s regrettable decision to edit the genes of twin sisters could serve as the impetus to spur the nation toward a profound rethinking of its public policy on human research—a necessary prerequisite before China can responsibly become a biotech colossus.