The proposed restrictions will ‘help ensure U.S. biotechnology does not fall into the hands’ of the Chinese regime, said lawmakers.
A bipartisan group of lawmakers has asked the U.S. government to consider new rules restricting U.S. biotech companies from conducting clinical trials with entities linked to the Chinese military.
In a Jan. 9 letter to Commerce Secretary Gina Raimondo, the House Select Committee on the Chinese Communist Party said the proposed restrictions will “help ensure U.S. biotechnology does not fall into the hands of the PRC,” referring to the acronym of communist China’s official name, the People’s Republic of China.
The letter, signed by Reps. John Moolenaar (R-Mich.) and Raja Krishnamoorthi (D-Ill.), chair and ranking member of the committee, respectively, along with Rep. Neal Dunn (R-Fla.), said biotech competition between the United States and the PRC “will not only have implications for our national and economic security, but also for the future of healthcare and the security of American medical data.”
The letter cites Beijing’s 14th Five-Year Plan—which “identifies dominance in biotechnology as critical to ’strengthen the PRC’s science and technological power’ and calls to deepen military-civil science and technology collaboration in the sector”—and a publication by a former president of the Chinese military’s National Defense University, which discussed the potential to create new synthetic pathogens that are “more toxic, more contagious, and more resistant.”
The lawmakers praised the proposals issued by the Bureau of Industry and Security in July 2024 to expand export controls to military and intelligence end users as “a welcome update.” They suggested the measures could be further strengthened by requiring a license to conduct clinical trials with medical institutions linked to the People’s Liberation Army (PLA).
“Specifically, we recommend updating the definition of ‘Military End User’ to state medical infrastructure owned or operated by the national armed services of the PRC and other countries as appropriate constitutes a military end-use if a U.S. person is seeking to engage with the institution to conduct a clinical trial,” they added.
The Epoch Times reached out to the Commerce Department for comment and did not receive a response by publication time.
The letter is a sign of growing concern over China’s role in the biotechnology industry.
In August 2024, the same committee wrote to the Food and Drug Administration (FDA), asking the agency to ensure that U.S. clinical trials are not contributing to human rights abuses in China’s Xinjiang region or aiding the transfer of U.S. critical intellectual property to the PLA.
Citing official data, the letter said U.S. biopharmaceutical companies over the past decade had run hundreds of clinical trials that had at least one Chinese military entity among the research partners and conducted trials in hospitals in Xinjiang, “where the Chinese Communist Party (CCP) is engaged in genocide of the Uyghur population.”
In a response letter to the lawmakers dated Jan. 2, the FDA Acting Associate Commissioner for Legislative Affairs Laura Paulos said protections are in place for trial participants.
“Given concerns regarding the human rights abuses occurring in the Xinjiang Uyghur Autonomous Region, FDA has publicly reiterated that (legislation) requires clinical trials to obtain the legally effective, informed consent of human subjects,” she wrote.
In response to concerns about intellectual property theft and technology transfer, Paulos referred the lawmakers to “appropriate U.S. federal agency partners.”
In addition to clinical trials, the committee has asked the Department of Defense (DOD) to add several Chinese biotech companies to its list of companies allegedly linked to the Chinese military. Two of these companies, Origincell and MGI Group, were added to the updated list on Jan. 7, along with dozens of others in sectors such as artificial intelligence, the Internet of Things, drones, and shipping.
The DOD also included BGI Group, the parent company of MGI and BGI Genomics, which was previously designated as a Chinese military company, and another BGI subsidiary, Forensic Genomics International.
Reuters contributed to this report.