Electronic Medical Records & EHRs Can Enhance Healthcare In Africa

The pace of securitization in genetic research is damaging research ties, cross-border trade, and vigilance toward global health issues.

Electronic Medical Records & EHRs Can Enhance Healthcare In Africa

The trend of securitization in joint genetic research has diminished global scientific innovation and limited people-to-people ties, but it has real world implications for geopolitical competition.

International scientific research cooperation with China has plummeted due to border closures, equipment access challenges, and tense domestic political climates. And because of the “chilling effect” of the pandemic, scientists in the United States are hesitant to begin new or continue existing collaborations with their Chinese counterparts.

However, the most significant impediment to Sino-global public health collaboration is China’s own legislative push against it. Since 2015, China has implemented a series of biotechnology reforms that have severely securitized the industry.

That same year, China’s National Security Law reserved the right to “improve the handling of public health, public safety, and other types of outbreaks that affect national security and social stability,” tying biosafety to national security.

Biomedical data was designated as an “important, foundational strategic state resource” in the State Council’s “Guiding Opinions on the Application and Development of Big Data in Healthcare” in 2016. In the same year, amendments to human genetic resources (HGR) governance established “national security” as a core government mandate in the field.

Last year, China issued two long-awaited legislative updates that limited data transfers abroad and effectively codified national security imperatives into HGR research. The Ministry of Science and Technology (MoST) issued draft implementation rules for the Administrative Regulations on Human Genetic Resources for public comment in March 2022.

If HGR from “specific areas” or “important genetic families” is collected, genome sequencing information for more than 500 people is collected, and any other data compiled harms public health, national security, or societal public interests, the draft rules require the initiation of a security review.

Although China attempted to regulate HGR research with “socially harmful effects” as early as 2012, the new measures in the draught rules represent a significant shift in the security domain. With the revised security review mechanism in the draft rules, increased penalties for 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 have officially transitioned into a national security priority.

Furthermore, under the Cyberspace Administration of China’s Measures for Security Assessment of Outbound Data Transfers, a security assessment is triggered if any “important data” or “sensitive personal information” of more than 10,000 people is released overseas.

Because genetic research is inherently based on personal health data and sensitive DNA resources, observers have noted that the CAC Security Measures will have a disproportionate impact on pharmaceutical companies and health researchers, who are already subject to MoST regulation and HGR measures.

Chinese scientists have publicly noted the challenges of research cooperation in the last several years. Shuhua Xu, a geneticist from Fudan University, told Nature that 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. MoST does not explain the rationale behind research proposal rejections, but studying the HGR of Tibetans may trigger security reviews as per the draft rules’ stipulations on “specific areas” and “important genetic families.”

Xu is not the only academic researcher whose seemingly non-threatening research has been sidelined by MoST in recent years. In 2015 and 2016, the University of Oxford and Peking University, as well as the University of California, Los Angeles, and Shanghai Jiaotong University, received funding to conduct studies on the genetic basis of depression in Han Chinese women and the genetic basis of psychosis in Han Chinese.

The SJU-UCLA project and the Oxford project were among China’s largest genome sequencing research efforts at the time, but both were sidelined by MoST due to HGR regulations. MoST did not provide reasoning for these cancellations, but studies on mental illnesses could potentially be perceived as a threat to domestic order.

This new regulatory environment in genetic research has become impossible to predict for both researchers and institutions. Since both new pieces of legislation were approved in 2022, very few international genetic research collaboration projects have moved forward—a cancer project led by Beijing and Amsterdam researchers was the first to implement new security measures in January 2023.

According to UCLA researcher Jonathan Flint, tightening China’s regulatory landscape will only result in the country being “left out of the human genetics community.”

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.

Despite the promise of the project, investigative reports found that the research may have skirted internationally recognized standards of informed consent. Samples were collected in rural towns with over 70 percent illiteracy rates, and residents were coerced into the project and promised medical care.

Xu’s research instilled fear of foreign exploitation in the Chinese people, sparking a “gene war” between China and the West. For a year, the Ministry of Science and Technology and the Ministry of Health prohibited foreign genetic data collection in China and established the 1998 Interim Measures for the Administration of Human Genetic Resources.

These measures prohibit foreign entities from collecting, storing, or transferring HGR without the assistance of a Chinese partner and a government permit.

In both China and the United States, genetic research is increasingly being used as a tool of national interest, with U.S. National Security Advisor Jake Sullivan calling biotechnology a “force multiplier” and President Joe Biden’s 2022 executive order to boost biotechnology manufacturing.

Some have even called biotechnology the United States’ latest “national security obsession” following the addition of several units of Chinese genetics giant BGI Group to the Entity List earlier this month.

China-U.S. biotechnology decoupling is a potential top risk for China’s security environment in 2023. The State Council has proposed restructuring of MoST to accelerate scientific and technological self-reliance, and the Australian Strategic Policy Institute has indicated China is far outpacing the U.S. in innovation in synthetic biology and biological manufacturing.

The pace of securitization in genetic research is damaging research ties, cross-border trade, and vigilance toward global health issues. This has created hurdles for sharing samples and other genetic resources, which is crucial for the global preparation for the next major disease outbreak.

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.