Why I worry (differently) about China's biobanks

China's fast rise in the biobanking sector has spurred international concerns.

One prominent example is the Chinese company BGI Group, which manages China National GeneBank. In 2021, Reuters warned that BGI might be accumulating data for military advantages from millions of women around the world through its prenatal test (see BioNews 1103).

More recently, a Washington Post article characterised BGI's purported genetic data collection in Serbia via its portable COVID testing facilities as adding to the fear of 'a DNA arms race'.

These worries are further complicated by souring relations between China and the West, and China's increased restriction over foreign researchers' access to its own genetic databases. In fact, in 2022, the UK Biobank was urged to reevaluate China's access to genetic data of UK citizens, due to concerns of misuse and non-reciprocal data-sharing.

Having studied China's life science governance for two decades, I am also concerned about China's biobanking sector. Yet, I find the dominant military rhetoric trivialises the challenges China's biobanks present, it oversimplifies the expanding field as controlled by a single omnipotent actor (ie, the Chinese central government or its front, such as the BGI). It also diverts attention from more urgent issues that could help reduce, if not prevent, misuse.

Compared to other major scientific powers, there are four key characteristics of China's biobanking sector:

1. China's biobanks had a relatively late start, but experienced a rapid growth spurt over the past decade, driven by national directives.
2. Far from being uniform, the landscape of biobanking in China is unevenly developed, driven by entangled, sometimes conflicting local, national, public and private interests.
3. A significant capacity-building gap renders many biobanks dysfunctional and susceptible to ethics violations and data security breaches.
4. A lag in regulation adds difficulties to quality control and administrative oversight.

China's first biobank was founded in 1994 by the Chinese Academy of Medical Sciences to store immortalised cell lines from different ethic groups. In 2003, China established the National Infrastructure of Chinese Genetic Resources. Regional efforts followed. China's biobank expansion took off in 2011 with the which set building large-scale biobanks and human genetic resource repositories as a national agenda. It was also in 2011 with the 12th Five Year Plan on Biotechnology Development that four Chinese miniseries entrusted BGI to build the China National GeneBank. This national directive on developing biobanking and data-driven innovation was further reinforced by the 13th and the 14th Five Year Plans.

An often ignored fact is that China's biobanking sector is diverse and unevenly equipped. According to an article published in April 2023 in China's High-Tech, a Ministry of Science and Technology journal, there are currently 129 biobanks in China, with 98 hosted by hospitals, 23 hosted by research institutions and eight commercial ones.

In fact, a number of China's leading biobanks are not state-owned or state-run, but are founded through public-private partnership with a commercial company entrusted with the actual operation. But a succession of national framings of biobanks as key to economic competitiveness has also led to perverse conflict between public and private, national and local interests.

A number of academic articles published in China (see He et al, 2017, Gao et al, 2018, Qin et al, 2023 and Zhang et al, 2023) have highlighted the emergence of 'trash biobanks' (laji ku), where the quality of the data collection and sample storage is so poor that effectively render them unusable, and the emergence of 'private or undisclosed biobanks' (si ku), where biomaterials are collected and stored without the intention for public-sharing or without public knowledge or public accountability.

In other words, the field of biobanking in China has become ever more fragmented and diverse over the last decade.

A significant number of new biobanks struggle to operate effectively, due to a lack of trained and dedicated staff, incompatible and poorly enforced data collection, storage and sharing protocols (see Yuan et al 2020 and You et al, 2023). A 2018 survey of 63 key biobanks in China found that 85 percent of the biobanks had less than a 20 percent use rate of their samples. This has raised ethical questions of squandering social and medical resources, but it has also raised concerns of accountability and data security.

What's more worrying is a notable regulatory gap in this field. It was not until 2018 that China introduced the international general standard for biobanking (ISO 20387:2018) to domestic practitioners. In 2019, China launched its first national technical standard for biobanks (GB/T 37864-2019), followed by the national standards on Ethical Requirement of Human Biobanking (GB/T 38736-2020), and on health data security (GB/T 39725-2020). However, administrative loopholes make enforcement difficult. A Shanghai Municipal Health Commission funded study revealed that up to February 2023, only five clinical biobanks in China have received ISO 20387:2018 accreditation, with even fewer contributing clinical labs receiving national or international accreditation.

Considering the four key characteristics mentioned above, it is perhaps not too difficult to understand my point that the dominate media framing misses the wider challenges presented by China's biobanks. Instead of a streamlined military operation, biobanking in China is much more fragmented, with inconsistent regulatory oversight.

This is arguably a thornier issue in terms of potential for misuse. I hasten to add that most of the critiques of China's biobanking sector that I have cited in this comment are articles written by Chinese researchers and published in Chinese academic journals. Contrary to a popular belief that social change can only be driven from the top down, it is domestic academic criticism such as this that has promoted ethical governance in China.

One should also be reminded of the fruitful UK-China collaboration on the China Kadoorie Biobank, one of the world's largest prospective cohort studies, and how it further inspired the founding of the Guangzhou Biobank Cohort Study.

Instead of seeing China's biobanking sector as a state-driven monolithic operation and keeping Chinese scientists at arm's length, we need to have an attentive but differentiated approach to China's development in this field. International exchange and collaboration in this area may be invaluable, to address capacity and regulatory gaps in China.