Lawmakers Propose Export Controls for Clinical Trials With Chinese Military Hospitals
The leaders of the House Select Committee on China urged the Commerce Department Jan. 9 to update its regulations to require U.S. biopharmaceutical entities to obtain an export license before working with a Chinese military hospital for clinical trials.
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In a letter to Commerce Secretary Gina Raimondo, Reps. John Moolenaar, R-Mich., and Raja Krishnamoorthi, D-Ill., the committee’s chairman and ranking member, respectively, along with Rep. Neal Dunn, R-Fla., a committee member, said the Bureau of Industry and Security could include the new requirement in its proposed rule, unveiled in July, to expand export controls to military and intelligence end users (see 2407250032). They would specifically update the definition of a “military end user” to include Chinese military medical infrastructure with which a U.S. person is seeking to conduct a clinical trial.
The lawmakers said their proposed restriction is needed to ensure China’s military does not obtain U.S. biotechnology. They said their recommendation is consistent with the Biden administration’s approach of requiring U.S. companies to conduct due diligence and prove they are not doing business that would harm national security or human rights.
“Furthermore, the burden of such a control would not be heavy; based on previous data on clinical trials over the last decade, we would expect only several dozen of these license applications a year to be submitted to BIS due to the small number of hospitals and institutions that are directly operated by the” People’s Liberation Army (PLA), the letter says. The lawmakers also believe the biopharmaceutical industry would seek alternative, non-PLA medical infrastructure in China with which to conduct clinical trials if faced with restrictions on working with the PLA.
Commerce had no immediate comment on the letter.