A bill approved by the House of Representatives this week would make it difficult for U.S. drug companies to contract with five major Chinese biotechnology companies. Academic researchers say they, too, would be hampered. The new rules could threaten projects that rely on sequencing in China or involve Chinese scientists who use services or machines from the companies. It would also cut off one source of genome sequencers used in U.S. labs.
The Senate is considering a similar measure, raising the odds the rule could become law. “It could have a chilling effect on science,” says Gene Robinson, director of the Carl R. Woese Institute for Genomic Biology at the University of Illinois Urbana-Champaign.
Known as the Biosecure Act, the legislation would prevent federal funds from going to biotech companies linked to five “foreign adversaries”: China, Russia, Iran, North Korea, and Cuba. It bans purchases from five specific Chinese companies—BGI, MGI, WuXi Biologics, Wu Xi AppTec, and Complete Genomics—beginning in 2032. It would also prevent federal funds from going to other organizations that use services and equipment from the companies. The White House Office of Management and Budget would update the list of companies of concern at least once a year.
The act’s proponents argue that the named biotech companies are stealing intellectual property from U.S. biotech equipmentmakers or are directing health and genetic data to centers affiliated with the Chinese Communist Party (CCP) and other adversaries. “This bill is a necessary step towards protecting Americans’ sensitive health care data from the CCP before these companies become more embedded in the U.S. economy, university systems, and federal contracting base,” said Representative James Comer (R–KY) on the House floor before the bill passed 306 to 81 with broad bipartisan support.
The biggest impact, says Aaron Cummings, a lobbyist with Crowell & Moring, is likely to be felt by U.S. biotech and pharmaceutical companies. Beyond genome sequencing, Chinese firms such as WuXi AppTec provide services that support clinical research, such as manufacturing pharmaceutical ingredients and cell therapies, as well as providing research cell lines. According to a survey released in May by BIO, a biotech industry trade group, 79% of 124 biopharma companies surveyed have at least one Chinese biotech contractor.
Academic scientists, for their part, worry they will be forced to sever valuable research collaborations with Chinese scientists at the companies of concern or with academic groups that use their equipment or services. “This will have implications for our ability to work together with Chinese companies and Chinese laboratories,” Robinson says. The upshot, he says, is that U.S. scientists and institutions might shelve current collaborations and not launch new ones to avoid running afoul of the new rules.
Those projects could include genomics work with plants, animals, or microbes as well as human DNA samples, says Abigail Coplin, an expert on Chinese biotech development at Vassar College. “Researchers across many disciplines will be increasingly reticent to engage their Chinese counterparts,” she says.
Pamela Soltis, a plant geneticist at the University of Florida, notes that such rules could have jeopardized past projects, such as a study of plant evolution patterns in East Asia and North America, which she did in collaboration with BGI researchers and published in 2019. Although addressing concerns over data security and intellectual property are important, Soltis says, “We can’t be putting up barriers to scientists that need to collaborate.”
One current collaboration that could be vulnerable is the Earth BioGenome Project, a 10-year effort among 25 countries to sequence the genomes of all known species. BGI, one of the world’s largest gene sequencing centers, is a central player in that effort. W. John Kress, curator emeritus at the Smithsonian Institution, says he’s concerned the Biosecure Act could force U.S. researchers out of this or other large international projects. “The U.S. risks falling behind and being left out of major international collaborations,” Kress says.
The measure could also limit competition in the lab instrument market, pushing up research costs, says Michael Snyder, a geneticist at Stanford University. Snyder notes that Stanford’s sequencing center recently purchased a DNBSeq-T7 sequencing platform from Complete Genomics, which was significantly cheaper than a rival platform from Illumina, the market leader. If the Complete Genomics machines are forced off the U.S. market, “I think it hurts science,” he says.
Rob Tarbox, vice president for product management and marketing at Complete Genomics, says the law is based on “a flawed premise.” All data produced by the company’s sequencers stay with the owners of the machine, he says. “Even if we wanted the data we are physically unable to obtain it.” Meanwhile, Tarbox notes, the act does nothing to prevent China from obtaining health and genetic data held by U.S. research universities, hospitals, or companies that do clinical or DNA testing. “If you really wanted to protect data, I don’t think this bill does a good job of that.”
Related legislation has already passed a Senate committee, and onlookers say the Senate will likely adopt the House language in a compromise bill that would then go to President Joe Biden for his signature. Or legislators might tack the bill on to a larger piece of legislation, such as the National Defense Authorization Act, that’s more certain to pass. One way or another, Cummings says, “This is likely to pass and have a profound effect on the industry.”
More: https://www.science.org/content/article/bill-targeting-chinese-biotechs-worries-u-s-researchers
