Since the beginning of the pandemic, international scientific research cooperation with China has plummeted. Between navigating border closures, obstacles to equipment access, and increasingly tense domestic political climates, researchers worldwide have encountered a “chilling effect” in life sciences research and development when it comes to working with China. Scientists in the United States are reluctant to start new or continuing existing collaborations with their Chinese peers.
But the largest block to Sino-global public health collaboration is China’s own legislative push against it. Since 2015, China has initiated a series of reforms in biotechnology that has securitized the industry to an extreme.
The National Security Law that year reserved China’s right to “improve the handling of public health, public safety, and other types of outbreaks that affect national security and social stability,” linking biosafety to national security. In 2016, the State Council’s “Guiding Opinions on the Application and Development of Big Data in Healthcare” labeled biomedical data an “important, foundational strategic state resource.” The same year, amendments to human genetic resource (HGR) governance introduced “safeguarding national security” as a core government mandate in the field.
Last year, China released two highly awaited legislative updates that have constrained the transfer of data abroad and effectively codified national security imperatives into HGR research. In March 2022, the Ministry of Science and Technology (MoST) released draft implementation rules on the Administrative Regulations on Human Genetic Resources for public comment. The draft rules require the initiation of a security review if HGR of “specific areas” or “important genetic families” are collected, if genome sequencing information is collected for over 500 people, and if any other data compiled harms public health, national security, or societal public interests.
Although China has attempted to regulate HGR research that has “socially harmful effects” as far back as 2012, the draft rules’ new measures represent a sharp turn into the security domain. Between the draft rules’ revised security review mechanism, increased penalties on violators, and the legal systemization of China’s “full and complete sovereignty” over genetic data since the 2020 Biosecurity Law, genetic research and related governance has fully transitioned into a national security priority.
What’s more, under the Measures for Security Assessment of Outbound Data Transfers from the Cyberspace Administration of China, a security assessment is triggered if any “important data” or “sensitive personal information” of over 10,000 people is released overseas. As genetic research is intrinsically grounded in personal health data and sensitive DNA resources, observers have noted that the CAC Security Measures will disproportionately impact pharmaceutical firms and health researchers already subject to MoST regulation and HGR measures.
Although both legislations’ recency provides limited insight into government enforcement, Chinese scientists have publicly noted the challenges of research cooperation in the last several years. Shuhua Xu, a geneticist from Fudan University, told Nature last May that while he supports HGR regulations in principle, recent changes have prevented him from undertaking research initiatives with U.S. colleagues. In one specific example, his requests to share data on the origins of a set of DNA variants found in Tibetan populations were rejected by MoST in the last several years. While MoST does not explain the rationale behind research proposal rejections, studying the HGR of Tibetans, a genetically distinct population from Han Chinese, may both trigger security reviews as per the draft rules’ stipulations on “specific areas” and “important genetic families.”
Xu is not the only researcher to have seemingly non-threatening academic research sidelined by MoST in recent years. In 2015 and 2016, high-profile genetic research projects between the University of Oxford and Peking University as well as the University of California Los Angeles and Shanghai Jiaotong University were approved, respectively undertaking studies on the foundations of depression in Han Chinese women and the genetic basis of psychosis in Han Chinese.
With proposed scopes of 20,000 samples for the SJU-UCLA project and more than 5,000 samples from Oxford across more than 23 provinces, each project ranked among China’s largest genome sequencing research efforts at the time, but the SJU-UCLA project in its proposal did not even involve the outbound transfer of genetic data abroad, reports found.
Yet, by 2018, both projects were sidelined by MoST pursuant to HGR regulations, marking the first time regulators had publicly revoked international cooperative research licenses for HGR projects. Although MoST did not provide reasoning for these cancellations, as studies on mental illnesses could potentially be perceived as a threat to domestic order, the project may have been canceled on these grounds.
This new regulatory environment in genetic research has become impossible for researchers and institutions alike to predict. Since both new legislation pieces were approved in 2022, very few international genetic research cooperation projects have proceeded – a cancer project between Beijing and Amsterdam researchers was the first to pass new security strictures in January 2023. In the words of UCLA researcher Jonathan Flint, this tightening of China’s regulatory landscape will only amount to China being “left out of the human genetics community.”
These changes in biotechnology governance, however, stem in part from past experiences. In 1996, Harvard geneticist Xiping Xu directed a partnership with Anhui Medical College to collect large-scale DNA samples of Chinese citizens with the goal of identifying susceptibility genes for asthma, obesity, schizophrenia, and other illness predispositions. It was of the first projects of its kind in the country.
Despite the promise of the project – Xu recorded an unprecedented 95 percent volunteerism rate for taking local blood samples – investigative reports would find that the research may have skirted internationally recognized standards of informed consent. Samples were collected in rural towns with over 70 percent illiteracy rates. Residents later told media outlets that they were coerced into the project and did not understand where their samples would be sent. Some were even promised medical care for their conditions, but researchers never followed up.
Xu’s research ignited fear in the Chinese population of foreign exploitation, starting a so-called “gene war” between China and the West. In response, MoST and the Ministry of Health (now the National Health Commission) banned foreign genetic data collection in China for a year and established the 1998 Interim Measures for the Administration of Human Genetic Resources. The interim measures to this day prevent foreign entities from independently collecting, storing, or transferring HGR without a Chinese partner and government permit.
The trend of securitization in joint genetic research not only has diminished global scientific innovation and limited people-to-people ties, but it has real world implications for geopolitical competition. In both China and the United States, genetic research is increasingly being wielded as a tool of national interest – U.S. National Security Advisor Jake Sullivan called biotechnology a “force multiplier” for U.S. economic growth last fall, stating that leadership in the industry is a “national security imperative.” President Joe Biden’s 2022 executive order to boost U.S. biotechnology manufacturing was implemented with the purpose of mitigating the risk of “falling behind” China in the sector globally. Some have gone as far to call biotechnology the United States’ latest “national security obsession” in the wake of the addition of several units of Chinese genetics giant BGI Group to the Entity List earlier this month.
On the Chinese side, the same anxieties can be observed. Tsinghua University Center for International Security and Strategy outlined China-U.S. biotechnology decoupling as a potential top risk for China’s security environment in 2023. The State Council declared that its recently proposed restructuring of MoST would accelerate “high-level scientific and technological self-reliance.” Accordingly, the Australian Strategic Policy Institute has indicated China is far outpacing U.S. innovation in synthetic biology and biological manufacturing – both outputs of genetic research.
This mirroring security competition has nearly locked in within the biotechnology sector, damaging research ties, cross-border trade, and vigilance toward global health issues. “Securitization efforts on both sides not only poison the atmosphere for bilateral cooperation in scientific research but also create hurdles for the sharing of samples and other genetic resources, which is crucial for the global preparation for the next major disease outbreak,” said Yanzhong Huang, senior fellow at the Council on Foreign Relations.
Unfortunately, the pace of securitization in genetic research shows no signs of slowing down. Without tangible collaboration to put a “floor” under research in critical emerging technologies, genetic research and biotechnology may become the next “zero-sum game” between the United States and China.