Governance of Emerging Biotechnologies: Lessons from Two Chinese Cases

This article refers to:

Developing a Reflexive, Anticipatory, and Deliberative Approach to Unanticipated Discoveries: Ethical Lessons from iBlastoids

This article is referred to by:

Response to Open Peer Commentaries on “Developing a Reflexive, Anticipatory, and Deliberative Approach to Unanticipated Discoveries: Ethical Lessons from iBlastoids”

Ankeny et al. (2022) focuses on the recent creation of “iBlastoids” and defends the need for reflexive, anticipatory, and deliberative approaches in the domain of emerging and potentially contentious scientific research. Since the governance of technologies is becoming increasingly transnational and global, in this commentary, we observe two major events that have occurred in the recent human genome editing history in China. They are intended to provide a complementary and supportive viewpoint to the target article through case analyses.

THE CASE OF JUNJIU HUANG

On April 18, 2015, a team of Chinese researchers led by Junjiu Huang at Sun Yat-sen University in Guangzhou, published the world’s first report of human embryos altered by gene editing in the journal Protein & Cell. In this study, the team modified the gene responsible for β-thalassaemia, using the CRISPR/Cas9 technique. The news sparked a global debate regarding the ethical use of such tools (“365 days: Nature’s 10.” 2015).

Scholars opposing this view have called for a moratorium on germline gene editing. As gene editing in embryos could have an unpredictable effect on future generations, some scientists regarded the editing of human germline cells as an ethical “red line” for the fear of a slippery slope toward unethical or unsafe uses of the technique (Cyranoski and Reardon 2015).

However, these embryos could provide a more meaningful model for answering many basic scientific questions unrelated to clinical applications as compared to models using animals or adult human cells. Moreover, Huang had chosen spare embryos (those that could not progress to a live birth) from fertility clinics to avoid ethical concerns (Cyranoski and Reardon 2015). It has been argued that moratorium may be unrealistic, and modifying germline cells for research purposes could be acceptable.

This event had increased the urgency of starting a conversation about such issues and nucleated several high-powered forums to deliberate on the scientific, ethical, legal, social, and governance issues associated with human genome editing research; this includes the International Summit on Human Gene Editing held from December 1, 2015 to December 3, 2015, in Washington DC (“365 days: Nature’s 10” 2015). After three days of conducting thoughtful discussions, the organizing committee for the summit reached a statement on human gene-editing research and its potential applications. The consensus is that gene editing is not yet ready to alter human embryos for reproductive purposes, but “intensive basic and preclinical research is clearly needed and should proceed, subject to appropriate legal and ethical rules and oversight” (Olson et al. 2016). According to the statement, the type of research that Huang’s team did should not be banned. In 2015, Huang was recognized by Nature journal as one of the top ten people who mattered that year (“365 days: Nature’s 10.” 2015).

Admittedly, it would be helpful to both scientists and stakeholders if they could anticipate the ethical issues before initiating their research to promote early discussion, consultation, and regulation. However, as Ankeny et al. (2022) noted, anticipatory governance has largely not gained traction in the bioethical domain. Although there are various governance principles or frameworks on emerging technologies, little information is available on how to translate such calls and discussions into actual practice (Nelson, Selin, and Scott 2021). Therefore, due to the characteristics of uncertainty, complexity, and the controversy surrounding emerging biotechnology, we believe that when ambiguous or outdated regulations cannot fit and guide the emerging and contentious research, timely and effective response to the new problem is an important complement to the ideal reflexive, anticipatory, and deliberative approaches.

THE CASE OF HE JIANKUI

On November 25, 2018, two days before the Second International Summit on Human Genome Editing in Hong Kong, He Jiankui, a researcher at Southern University of Science and Technology in Shenzhen, China, had announced in a YouTube video that he had helped make the world’s first genome-edited babies. The announcement immediately provoked shock and outrage around the world. On November 26, 2018, 122 Chinese scientists posted a strongly worded statement on social media condemning He’s behavior; China’s National Health Commission immediately called on its local authorities to investigate He (Greely 2019).

At the Hong Kong genome-editing summit, He presented the details of his work and defended that the goal of his experiment was to confer HIV resistance to the babies by using CRISPR/Cas9 to edit the CCR5 gene. Furthermore, He felt “proud” of his work and claimed that he aims to prepare the technique for global use. “Do you see your friends or relatives who may have a disease? They need help; for millions of families with inherited disease or infectious disease, if we have this technology we can help them,” he said in the question-and-answer session (Cyranoski 2018).

The overwhelming conclusion is that He’s experiment was unethical and premature and violated both international norms and Chinese law. According to the statement released in the 2015 Washington summit, it would be “irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is a broad societal consensus about the appropriateness of the proposed application.” At present, these conditions have not yet been met (Krimsky 2019; Olson et al. 2016). China’s Regulations on Human Assisted Reproduction explicitly prohibits the genetic manipulation of human gametes, zygotes, and embryos for reproductive purposes. In addition, as it would potentially put the twins at unknown risks, He’s behavior went against Confucius’s principle of “ren” (benevolence, humaneness, and love) in traditional Chinese culture (Lei et al. 2019; Zhang et al. 2021).

In late 2018, when Nature journal named its top 10 people who mattered in science, He was described as “CRISPR rogue” and appeared on the list. (Gibney et al. 2018). On December 30, 2019, he was sentenced to 3 years in prison by Shenzhen Nanshan District People’s Court and was also fined RMB three million (around $430,000) (Cyranoski 2020).

We agree with Ankeny et al. (2022) that reflexive, anticipatory, and deliberative processes are needed for researchers in the domain of emerging and contentious scientific research, in collaboration with interdisciplinary scholars, regulators, and various publics, among others. Given the failure of self-regulation by scientists embodied in the He Jiankui case, researchers should anticipate the risks and possible outcomes of their work and consider its relevant potential ethical, social, and legal implications. Furthermore, collaboration with an interdisciplinary team could promote greater attention to multiple perspectives on the research and better understand and address oppositional views from stakeholders; collaboration with regulators would help shape policies in a deliberative manner and allow regulations to be more effectively applied in emerging areas of science. However, public engagement will be an area of concern in the future because it is much more limited than desirable in the governance process (Nelson, Selin, and Scott 2021).

Overall, the analysis of the two cases in this commentary has the following two-fold aim. We wish to not only provide recommendations for the governance of emerging biotechnologies, but also complement and support the authors’ viewpoint in the target article from a cross-country perspective.

DISCLOSURE STATEMENT

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This work was supported by the National Key R&D Program of China [Grant No. 2018YFC0114500]; and Medical Science and Technology Program of Henan Province [Grant No. LHGJ20200025].