China's ethics guidelines – A new era for human genome editing?

Recently, China's National Science and Technology Ethics Committee introduced a new set of ethics guidelines on human genome editing (see BioNews 1247). The guidelines are at least the fourth national level iteration of China's ban on human reproductive genome editing in recent years (following its updates on the Crime Law and Civil Code in 2020, and the ethical review measures in 2023).

It is also the first major publication of the national Ethics Committee since its administrative function was revoked in 2023. Instead of being an 'advisory and coordinating organ' (yishi xietiao jigou) of the State Council, it is currently categorised as an 'academic expert committee'.

As someone who has been researching China's life science policies, I see the new guidelines as a clear indication that the Chinese government is poised to enter a new phase of supporting human genome editing research. But questions remain about whether the latest guidelines will prevent past mistakes from being repeated.

Though an iteration of many of the ethical principles outlined in earlier national policy papers, the new guidelines stand out with two key features. First, they establish a stratified approach for ethical and regulatory supervision, differentiating between somatic and germ cell editing (Articles 2, 4, 5). Second, they emphasise 'advancing human welfare and promoting social prosperity' as the 'primary principle' for genome editing, underscoring a regulatory imperative to harness technology 'to do good' (xiangshan) (Article 3.1).

Furthermore, in contrast to the more restrictive (some practitioners would say 'punishing') tone in previous national policies on research on human genetic materials, the general tone of the new guidelines are unmistakably pro-research and innovation. For example, guidelines emphasise balancing proactionary and precautionary principles (Article 3.3), where 'risk' is primarily limited to scientific and clinical considerations.

This nuanced yet evident policy shift was also confirmed by domestic promotional reports of the guidelines. The emphasis on promoting genome editing research 'to do good' seems refreshing and compelling to a Chinese audience (see Science and Technology Daily, Southern Weekly, and Xinhua New Press). This contrasts the 'political sensitivity' that genome editing research has faced in China since the CRISPR babies scandal in 2018 with international successes such as the recent approvals of gene therapy for sickle cell disease in the USA and UK, as well as other clinical trials for cancer and HIV gene therapies (see BioNews 1216, 1223, 1231 and 1213).

In a domestic interview, Xiaomei Zhai, a prominent ethicist and a key author of the guidelines was unequivocal that the aim was to reaffirm the need to support China's human genomic research with prudence and to 'leave an opening (kouzi)' for 'future clinical research on germline editing'.

The guidelines appear to champion a new era, at least in the domestic discourse on human genome editing. One should also be reminded that the National Science and Technology Ethics Committee was established as an administrative branch under the State Council in the aftermath of the 2018 scandal (see BioNews 1010). Its transition to an academic committee suggests that, from the government's perspective, this task force has completed its mission. Much like its founding, this change also signals that China is entering a new era of ethical governance in research and innovation.

However, I can't help but notice what has been left unsaid, especially in the context that the National Ethics Committee and this guidelines are both part of China's response to the 'CRISPR babies' scandal.

To begin with, although the guidelines and subsequent news articles emphasised the importance of steering genome editing 'to do good,' as an ethics document, it fails to address or acknowledge how the potential for new therapies might exacerbate social stigma and discrimination. Without a culture of inclusive ethical and policy deliberation on the definition of 'good,' clinical innovations may be distorted, worsening the living conditions of vulnerable groups (eg the disabled and rare disease communities).

This omission is particularly evident in the discussion on preventive and therapeutic clinical research on somatic cell gene editing, where evaluation is limited to comparisons with alternative therapies based on 'their safety, effectiveness, accessibility, and health economics factors' (Article 5.2.1).

Mirroring the language of the 2022 Opinion on Strengthening Ethical Governance of Science and Technology issued by the Central Government, the new guidelines also mention establishing 'a reasonable participation mechanism' for stakeholders and the general public. Like in the 2022 Opinion, the scope of engagement is on transparency and data sharing rather than upstream public deliberation on research and its governance.

This silence on the social contention of 'good' is particularly ironic and worrying in the Chinese context. One must not forget that the CRISPR babies scandal involved experimenting with a technological fix to do 'good.' Considering the stifling social stigma and absence of social support, HIV-affected families deemed the clinical risk worth taking. Another example is China's gene therapy against congenital deafness (see BioNews 1242), which, while being a great scientific advancement, raises unsettling ethical questions about what 'good' means in 'eliminating deafness' in a country with over 27 million deaf people but reportedly only one sign language lawyer.

While I can appreciate the guidelines' pro-innovation intention and, to some extent, agree with its tactic of 'leaving an opening' for future germline editing, I am also concerned. Could the guidelines silence on how 'good' should be defined and by whom also potentially 'leave an opening' for further unethical clinical applications with 'good' intentions?

One notable gesture made by the guidelines is the suggestion that researchers working on human genome editing are required to 'undergo specialised ethical training' (Article 4.3). However, the specifics of this training and the qualifications of those who provide it remain unclear, raising enforceability issues. This further underscores the question: without acknowledging the contentious nature of 'good' or engaging with the complexities of the social context, can one truly act ethically to 'advance human welfare and promote social prosperity'?

To be sure, China has made significant progress in improving its legislation and administrative procedures in human genome editing since 2018. It would be a positive development for both China and the world to enter a new era of social and policy deliberation to advance this field.

However, for China's ethical governance to truly enter a new era, it hinges not only on elevating the level of policies or periodically reiterating policy stances, but also requires a shift toward a style of ethical governance that is more inclusive, deliberative, and deeply embedded in the actual lived experiences and contradictions within China.