Washington, DC [US]: US lawmakers and industry leaders are urging tighter export control regulations to curb collaborations between American biopharmaceutical companies and China’s military-linked biotechnology institutions. This comes amid heightened concerns over China’s strategic efforts to bolster its biotech capabilities, potentially leveraging US technology for military and intelligence purposes.
In a letter addressed to US Secretary of Commerce Gina Raimondo, policymakers and experts called for expanded export controls targeting US entities engaging with the People’s Liberation Army (PLA) medical institutions. These facilities, including the Academy of Military Medical Sciences (AAMS), are linked to hundreds of clinical trials and are currently on the U.S. Department of Commerce’s Entity List.
Key Concerns Highlighted
- Data and IP Transfer Risks: Collaborations with PLA-linked institutions risk exposing sensitive data and intellectual property to China’s military.
- Biotechnology as a National Security Concern: China’s 14th Five-Year Plan underscores biotechnology as a critical tool for national power, including potential military applications such as synthetic pathogens.
- Expanding Export Controls: The lawmakers proposed updating the definition of “Military End User” to include medical facilities operated by the PLA, making US collaborations with these institutions subject to stricter licensing processes.
Proposed Measures
The letter builds on a July 29, 2024, proposed rule by the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) aimed at expanding controls on military and intelligence end-users. Key recommendations include:
- Requiring Licenses: US entities conducting clinical trials with PLA medical institutions must obtain specific licenses.
- Narrowing Collaborations: Encouraging the biopharmaceutical industry to prioritize partnerships with non-PLA entities in China.
- Strengthening Oversight: Enhancing the scrutiny of partnerships to protect US innovations and national security.
Support from Industry Stakeholders
The proposal has garnered support from biopharmaceutical leaders, who believe it would safeguard American technological advances while preventing their misuse for military purposes. The letter suggests that the regulatory change would not significantly impact industry operations, as few PLA-run hospitals are currently involved in clinical trials.
Broader Implications
The move reflects the intensifying US-China rivalry, with biotechnology emerging as a critical area of competition. The letter emphasizes the dual stakes of national security and economic prosperity, urging swift regulatory action to address evolving threats.
As the Department of Commerce reviews the proposal, lawmakers and industry leaders are keen to collaborate on refining the rules to ensure they effectively address the risks posed by China’s growing ambitions in biotechnology.