GEOPOLITICS AND STRATEGIC COMPETITION BEHIND U.S.-CHINA GENOMIC DATA POLICIES

Zijing Yang, Stanford LLM ’25, CLB student fellow

A new rule issued by the Department of Justice of the United States (the “DOJ”) on “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons” (the “Rule”) took effect on April 8, 2025.[1] The Rule identifies China (including Hong Kong and Macau), Russia, Cuba, Iran, Venezuela, and North Korea as “countries of concern,” and prohibits and restricts certain data transactions involving the transfer or access to bulk human genomic data by those countries of concern or covered persons.

Over the past few years, genomic data has emerged as a strategic asset at the intersection of biotechnology, national security and global competitiveness. Both the U.S. and China have increasingly recognized the value and sensitivity of large-scale human genomic data and prompted the development of regulatory frameworks aimed at governing their use and transfer.

New U.S. Rule on Human Genomic Data Transfers

The new U.S. Rule was promulgated in response to the Executive Order 14117 issued by then President of the U.S., Joe Biden on February 28, 2024, which describes an unusual and extraordinary threat to the national security and foreign policy of the U.S. posed by the continuing effort of certain countries of concern to access American’s sensitive personal data and U.S. government-related data.[2]

The Rule, restricting the transfer of bulk human genomic data, certain other human ‘omics data and other sensitive data to China and other countries of concern, is allegedly driven by long-standing national security concerns.

It is worth noting that U.S. national security concerns over the transfer of human genomic data are primarily rooted in economic, not military, considerations. Genetic-based weapons are regarded by experts as a distant prospect, at best.[3] Moreover, the U.S., as a multiethnic country, faces lower risk of gene-targeting being used as a military threat. The real concern is that China could gain long-term economic advantages through the large-scale collection of human genomic data from the U.S.

Several national security strategies and congressional reports have emphasized that China is increasing efforts to obtain valuable U.S. datasets in biotechnology and genomics to enhance its artificial intelligence (AI) capabilities.[4] From the U.S. perspective, large-scale genomic data, when combined with AI and machine learning, could significantly strengthen a country’s competitiveness in critical areas such as healthcare and advanced technologies.[5] To address perceived regulatory gaps, the U.S. is taking steps to limit the outflow of sensitive data in order to protect its technological edge and broader national interests.

China’s Early Controls on Human Genetic Data

Across the Pacific, China has long regarded its domestic human genetic data as a strategic resource and has imposed restrictions on its transfer to foreign entities, a regulatory approach that dates back as early as 1998. Under China’s legal framework, human genetic data is classified as part of “human genetic resources,” and its collection, storage, use, and provision to foreign parties are subject to a series of regulatory controls.

China’s legislative efforts regarding the management of human genetic resources emerged against the background of what was then referred to as a “gene war” in the early 21^st century. Around 1996, several U.S.-based gene-hunting teams, drawn by the low cost of collecting biological samples and the large, genetically divers population, began traveling in China in search of genes related to complex diseases[6], which raised strong concerns among Chinese scientists. In July 1997, renowned Chinese geneticist Jiazhen Tan wrote a letter to Zemin Jiang, then President of the People’s Republic of China, expressing concerns over the status of China’s gene engineering industry and urging the government to take effective measures to protect China’s human genetic resources while accelerating the development of the domestic gene-based pharmaceutical industry. This advocacy directly led to the promulgation of China’s first regulatory framework in this area. In 1998, China’s Ministry of Science and Technology (the “MOST”) and the former Ministry of Health jointly issued the Interim Measures for the Administration of Human Genetic Resources (the “Interim Measures”), marking the country’s first institutional effort to strengthen the protection and regulated use of human genetic resources.

Following its implementation in 1998, the Interim Measures remained largely dormant for over a decade, with no public enforcement actions or legislative developments during that time. However, beginning in 2010, the MOST began introducing more detailed rules to strengthen oversight. The MOST also made public six administrative penalties between 2015 and 2018 for violations under the Interim Measures, which include cases such as BGI Group transmitting human genetic data abroad via the Internet without prior authorization; WuXi AppTec exporting human serum disguised as canine serum; and AstraZeneca transferring leftover samples from an approved project to external partners and conducting research activities beyond the approved scope, which were all subject to administrative sanctions.

Starting 2019, China’s legislative authorities have promulgated a series of new rules replacing the Interim Measures. The current regulatory framework for human genetic resources in China is composed of the Biosecurity Law passed in 2020, the Regulation on the Administration of Human Genetic Resources issued in 2019, and the Implementation Rules for the Regulation on the Administration of Human Genetic Resources issued in 2023.

Escalating U.S.-China Competition in Biotech and Gene Sequencing

The United States has long been the global leader in genomic research and data resources, serving as a dominant force in the global life sciences data ecosystem. The U.S. has led the Human Genome Project and invested heavily in basic research as early as the 1990s, establishing some of the world’s earliest biological databases and gene sequencing industries. Relying on leading sequencing companies such as Illumina and critical genomic databases, along with sustained research funding and international collaborations, the U.S. continues to attract genetic data from populations worldwide, and maintains global leadership in its scientific output.

In recent years, however, there has been a growing acknowledgment within the U.S. of the challenges posed by China in this area. In February 2021, the U.S. National Counterintelligence and Security Center released a report titled “China’s Collection of Genomic and Other Healthcare Data from America: Risks to Privacy and U.S. Economic and National Security” (the “NCSC Report”), which warned of the multiple risks posed by China’s large-scale collection of medical and genomic data globally, especially targeting the U.S.[7] The NCSC Report noted that the Chinese government regards bulk personal data, including genomic data, as a strategic commodity and is vigorously developing emerging industries centered on biotechnology, AI, and precision medicine through policy guidance and financial support.[8]

It is true that, over the past decade, many Chinese companies have significantly expanded their presence in the global market. The competition between U.S.’s Illumina and China’s BGI in the field of genomic sequencing stands out as a notable example. While the American gene sequencing giant Illumina has long maintained a dominant market position, BGI’s rapid development in recent years has made it a strong competitor in the global gene sequencing technology sector. The competition between Illumina and BGI has even led to legislative actions in the U.S. and China. The U.S. BIOSECURE Act passed in September 2024 explicitly identifies certain Chinese biotechnology companies including BGI as potential threats to the U.S. national security, and restricts cooperation between U.S. government agencies or companies and any foreign biotech firms deemed to pose such a threat. As a direct counteraction, China’s Ministry of Commerce placed Illumina, Inc. on its Unreliable Entity List on February 4, 2025, and subsequently banned the export of Illumina’s sequencing machines to China a month later.

On the other hand, the Chinese government has also recognized genomic data as a crucial strategic resource for advancing its independent innovation in biotechnology. Since 2011, China has started to establish the China National GeneBank in Shenzhen, which is positioned as a major scientific infrastructure serving national strategy, dedicated to storing, reading, and sharing global biological genetic resource data to support innovation in life sciences research and the biotech industry. The motivation behind China’s establishment of a national gene bank is easy to infer. In the past, China has long relied on foreign gene databases. In order to ensure the security and development of its own biological genetic data, China has decided to build its own national gene bank.

Impact of U.S.-China Genomic Data Legislation on Business and Research

Under the new Rule, a wide range of commercial transactions in the life sciences sector could face severe restrictions. For example, collaborations, licensing or technology transfer transactions between U.S. and Chinese entities that involve the transfer of clinical trial data, biospecimens, or sensitive health information collected in the U.S. may be deemed restricted or even prohibited data transactions under the Rule.

While the newly introduced Rule has placed compliance pressures on commercial transactions, their impact on scientific research may be even more significant. Since April 2025, the U.S. National Institutes of Health (NIH) has officially prohibited researchers from countries of concerns, including China, from accessing 21 of its controlled databases, such as dbGaP, TCGA, SEER, and others.[9] All these platforms are critical resources for global life sciences research, offering critical data in fields like human genetics, disease phenotypes, cancer rates and treatment outcomes, and neurodegenerative diseases.

The sudden restriction of access to these databases has posed substantial challenges for many Chinese researchers who rely on NIH’s databases for research in areas such as genetic diseases, tumor mechanisms, and precision medicine. This move not only affects the flow of data for international collaboration but also highlights the growing importance of life sciences data as a strategic resource in the context of global technological competition. In addition to restricting data access, the NIH’s decision includes halting ongoing projects involving researchers from countries of concerns.[10] This has reduced opportunities for international cooperation and may require joint projects that depended on U.S. data resources to be restructured or even canceled. As a result, Chinese research institutions will need to seek alternative data sources, potentially leading to higher research costs and longer timelines, or gaps in certain research fields.

From a technical perspective, the U.S. blockade can potentially affect one of the most vulnerable aspects of China’s current research system, which is access to high-quality foundational data. While China has made progress in developing life sciences databases, there are still major gaps in data standardization, integration, sharing, and international recognition. Compared to NIH, China’s domestic databases currently fall short in terms of data coverage and user ecosystem, and it will be challenging for China to close this gap in the short term. In the long run, this policy could pose a significant challenge to China’s ability and global competitiveness in research and development of innovative drugs.

Looking Ahead

The active legislation from both the U.S. and China on human genomic data in recent years is not a set of standalone policies, but reflects both countries’ growing strategic competition in this domain, underscoring how human genomic data is increasingly viewed not just as a commercial resource but also as a strategic national asset. As the U.S. and China each take steps to secure their own genomic resources, their policies are likely to shape the future of innovation, cooperation, and competition within the global biotech sector.

 

[1] U.S. Dep’t of Just., Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment (May 7, 2024), https://www.justice.gov/nsd/media/1382521/dl.

[2] Exec. Order No. 14,117, 89 Fed. Reg. 15,421 (2024).

[3] Joby Warrick & Cate Brown, China’s Quest for Human Genetic Data Spurs Fears of a DNA Arms Race, Wash. Post (Sept. 21, 2023), https://www.washingtonpost.com/world/interactive/2023/china-dna-sequencing-bgi-covid/.

[4] Supra note 1, at 2.

[5] Id.

[6] S.W. Guo, China’s “Gene War of the Century” and Its Aftermath: The Contest Goes On, 51 Minerva 485 (2013), https://doi.org/10.1007/s11024-013-9237-7.

[7] National Counterintelligence and Security Center, China’s Collection of Genomic and Other Healthcare Data from America: Risks to Privacy and U.S. Economic and National Security (Feb. 3, 2021), https://www.dni.gov/files/NCSC/documents/SafeguardingOurFuture/NCSC_China_Genomics_Fact_Sheet_2021revision20210203.pdf.

[8] Id.

[9] Meredith Wadman, Researchers from China and Five Other “Countries of Concern” Barred from NIH Databases, Science (Apr. 10, 2025), https://www.science.org/content/article/researchers-china-and-five-other-countries-concern-barred-nih-databases.

[10] Id.