US Lawmakers Call for Curbs on Clinical Trial Collaborations Linked to Chinese Military
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.
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.”
“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.
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.”
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.