Washington, DC [US], January 11 : US lawmakers and industry leaders are calling for stricter export control regulations to prevent US biopharmaceutical companies from collaborating with China's military on biotechnology initiatives.
The call comes as part of ongoing concerns over China's (PRC) strategic efforts to advance its biotech capabilities, including the potential for US technology to be leveraged for military and intelligence purposes.
In a letter addressed to Gina Raimondo, the US Secretary of Commerce, a coalition of policymakers and experts argued that the US government should implement export controls on US companies engaging with China's People's Liberation Army (PLA) medical institutions.
These institutions have been linked to hundreds of clinical trials over the past decade, raising alarms over the potential transfer of sensitive data and intellectual property to military-linked entities.
The proposal builds on recent regulatory efforts by the U.S. Department of Commerce's Bureau of Industry and Security (BIS), which issued a notice of proposed rulemaking on July 29, 2024, aimed at expanding export controls on military and intelligence end-users. Lawmakers view this as an opportunity to update and strengthen controls to prevent US biotechnology from falling into the hands of the PLA.
"The competition between the United States and China in biotechnology is a matter of national security, public health, and economic prosperity," the letter states.
It cites the PRC's 14th Five-Year Plan, which emphasizes the importance of biotechnology for national power and military success. The letter further underscores concerns voiced by Chinese military officials about the potential for biotechnology to produce "synthetic pathogens" that could be used in warfare.
The letter also highlights the growing concern over US biopharmaceutical companies working directly with PLA medical institutions such as the Academy of Military Medical Sciences (AAMS), which is currently on the U.S. Department of Commerce's Entity List. These collaborations, the letter argues, expose valuable US proprietary data to a military regime with explicit ambitions to leverage biotechnology for strategic gain.
While current export controls do not restrict the chemical compounds of drugs or related intellectual property, the letter calls for more specific language in the proposed rule to require a licensing process for US entities seeking to conduct clinical trials with PLA medical institutions. The authors recommend broadening the definition of "Military End User" to include medical facilities operated by the national armed services of China, making such collaborations subject to stricter oversight.
The proposal has garnered support from key industry stakeholders who argue that regulating clinical trials with PLA-linked institutions would help protect U.S. technological innovations and safeguard American national security interests. The letter suggests that only a small number of such licenses would be necessary each year, based on existing data, as few PLA-run hospitals are involved in clinical trials.
"We are hopeful that the US biopharmaceutical industry will prioritize partnerships with non-PLA medical institutions in China if regulatory restrictions are implemented," the letter added. "These actions would not only protect US national security but also ensure that US technologies are not exploited for military purposes."
As the US government considers the regulatory changes, industry leaders and lawmakers are eager to engage with the Department of Commerce to discuss the details of the proposed rule and how it could be further refined to address the evolving threats posed by China's biotechnology ambitions.
Notably, US continues to grapple with the implications of its ongoing technological rivalry with China, with biotechnology emerging as a crucial front in the battle for global dominance in science and security.
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