Recently released guidelines argue for "a scientific and technological ethics system with Chinese characteristics". This could put China out of step with the rest of the world in areas like data and animal experimentation, says Jeroen Groenewegen-Lau.
Guidelines released in late March by China’s State Council, the country’s top governing body, state something that might sound surprising to outsiders: that research ethics should reflect national identity. China’s insistence on ‘a scientific and technological ethics system with Chinese characteristics’ risks upsetting international collaboration in areas where this has been relatively uncontroversial, such as healthcare and life sciences.
These new guidelines started being drafted after the scandal around gene edited human embryos. In 2018, physicist He Jiankui, associate professor at Southern University of Science and Technology in Shenzhen, announced the birth of twins he said were resistant to HIV as a major breakthrough, ignoring the ethical implications for the lives of the two children and the risk of introducing edited genes into the human population.
At the time, the state reasserted control by sending He to prison for three years. This a typical response. After hundreds of thousands of babies were injected with defective diphtheria-pertussis-tetanus vaccines in 2018, the company responsible Changchun Changsheng Biotech was fined and forced into bankruptcy. In these and similar cases, official supervisors received much lighter punishments.
Projecting trustworthiness to underpin China’s emergence as a science and technology superpower
Projecting trustworthiness is important to underpin China’s emergence as a science and technology superpower, which requires international collaboration in a broad range of areas. In medical research, China has in recent years succeeded in becoming a major location for multi-regional clinical trials. Participation in these trials gives China’s pharma sector the international exposure needed to become globally competitive.
Multinationals are attracted to China by the promise of market access, ethnically different populations, local research talent, government support, and the presence of large hospital groups that can quickly recruit thousands of patients. But there are likely less savoury reasons that explain why they have flocked to China: lax regulatory oversight and the absence of independent patient advocacy groups.
The concerns of the US Food and Drug Administration and others have focused on data quality. In March, the US pharmaceutical company Eli Lilly was denied approval in the US for its cancer immunotherapy Tyvyt (sintilimab) – which has been on the market in China since 2019 - because the patients it was trialed on in China were too dissimilar from US patients.
More generally, both ethics and data quality issues are exacerbated by the lack of experience in China with international standards for medical trials before 2017, when the country officially joined the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). This move signified the end of decades of market protection, which had deprived the population of access to the world’s best treatments.
Animal testing as an area of divergence between China and much of the rest of the world
An area of divergence between China and much of the rest of the world is animal testing. Debate has erupted in and outside China, for instance around experiments in Kunming creating rhesus monkeys with human brain genes in 2019, or a particularly cruel experiment creating pregnant male rats in 2021 that involved transplanting a uterus and tying together the blood flows of male and female rats. These are just the excesses. Fueled by eagerness to approach the global cutting edge in biotechnology and other frontiers, China’s officially approved animal testing facilities grew 4.5% in 2020, to reach 1,665.
Experimenting on monkeys will give China an edge in areas like neuroscience, argued the Economist in 2021. At least one high-profile German based researcher, Nikos Logothetis, moved his lab to China to continue research on monkey brains. In November 2021, Reuters exposed a University of Copenhagen professor, Guojie Zhang, who had been testing experimental drugs preventing brain damage in monkeys exposed to extremely high altitudes in China in conjunction with the People’s Liberation Army.
To be fair to China, the latest guidelines call for the “replacement, reduction and refinement” of research animals, endorsing a policy widely adopted in the rest of the world. But this comes second to furthering human prosperity, including economic and social advances, as well as a sense of security.
By contrast, the US and Europe are moving to phase out animal testing completely. Such a ban would logically need to be complimented with a ban on animal testing for imports, otherwise the west would simply export the problem. Ultimately, this could mean that European patients miss out on the best treatments.
Research ethics-related laws avoid creating hurdles for domestic development
The research ethics-related laws that Beijing has issued in recent years—the Biosecurity Law (2020), the Science and Technology Progress Law (2021) and various data regulations—carefully avoid creating hurdles for domestic development, and for the state in particular. As a result, compliance is often something others do—private tech firms and foreigners. Collecting human genetic resources is fine for the Ministry of Public Security, starting in Tibet and Xinjiang. The same goes for facial recognition and other surveillance technologies, although there have been some successful challenges: in 2020 a court in Hangzhou ruled that a local zoo could not collect the facial recognition data of a legal professor, Guo Bing.
Thanks to these societal debates, China’s research ethics will improve. But without a clear vision and a more principled division of responsibilities, China’s universities and public research institutes will continue to push the boundaries to deliver on national technological ambitions. Beijing seems to accept the occasional scandal as the cost of progress. The true solution to the problem - empowering independent watchdogs, media and patient groups - would contradict the ruling party’s governing principles. So for now, enforcement relies on public shaming and punishing extreme cases.
Academics in China know that the country needs to flesh out its new ethics principles. In 2021, 32.6% of China’s researchers said their institutes had not properly handled ethics issues over the last year, according to a survey by the Chinese Association of Science and Technology, a party-affiliated organisation. 42.9% of scientists found punishments for ethics violations too light, 51.8% did not know whether their institutions had an ethics review committee and only 28.5% felt that credibility and ethics issues were sufficiently taught in higher education.
Foreign firms and institutions in China should expect closer scrutiny, especially if their R&D is deemed high-risk. A list of high-risk areas is stipulated by the latest guidelines. The Chinese guidelines might also prompt European policymakers to consider their own ethical position—on topics like animal testing, facial recognition and genetically modified organisms, but more so on international collaborations with countries that have different, often more permissive ethical standards.
This article was first published by Science Business on April 5, 2022.