Bill targeting Chinese biotechs worries U.S. researchers

A draft 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 American’s 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 AppTech 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 129 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 of 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.”
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针对中国生物技术公司的法案令美国研究人员担忧

本周美国众议院批准的一项法案草案将使美国制药公司难以与五家主要的中国生物技术公司签订合同。学术研究人员表示，他们也会受到阻碍。新规定可能会威胁到那些依赖在中国进行测序或者涉及使用这些公司的服务或设备的中国科学家的项目。这还将切断美国实验室使用的基因测序仪的一个来源。

参议院正在考虑一项类似的措施，这增加了该规则成为法律的可能性。“这可能会对科学产生寒蝉效应，” 伊利诺伊大学厄巴纳 - 香槟分校卡尔・R・沃斯基因组生物学研究所所长吉恩・罗宾逊说。

这项被称为《生物安全法案》的立法将阻止联邦资金流向与五个 “外国对手”（中国、俄罗斯、伊朗、朝鲜和古巴）有关联的生物技术公司。从 2032 年开始，它禁止从五家特定的中国公司 —— 华大基因（BGI）、华大智造（MGI）、药明生物（WuXi Biologics）、药明康德（Wu Xi AppTec）和 Complete Genomics—— 进行采购。它还将阻止联邦资金流向使用这些公司的服务和设备的其他组织。白宫管理与预算办公室将至少每年更新一次关注公司名单。

该法案的支持者认为，被点名的生物技术公司正在窃取美国生物技术设备制造商的知识产权，或者正在将健康和遗传数据导向与中国***（CCP）和其他对手有关联的中心。“在这些公司更深地嵌入美国经济、大学系统和联邦合同基础之前，这项法案是保护美国人敏感医疗保健数据免受中共侵害的必要步骤，” 众议员詹姆斯・科默（R - KY）在该法案以 306 票对 81 票获得两党广泛支持通过之前在众议院发言说。

Crowell & Moring 公司的说客亚伦・卡明斯表示，美国生物技术和制药公司可能会感受到最大的影响。除了基因组测序，像药明康德这样的中国公司还提供支持临床研究的服务，比如生产药物成分和细胞疗法，以及提供研究细胞系。根据生物技术行业贸易组织 BIO 5 月份发布的一项调查，在接受调查的 129 家生物制药公司中，79% 至少有一家中国生物技术承包商。

就学术科学家而言，他们担心自己将被迫切断与关注公司的中国科学家或使用其设备或服务的学术团体之间有价值的研究合作。“这将对我们与中国公司和中国实验室合作的能力产生影响，” 罗宾逊说。他说，结果是美国科学家和机构可能会搁置当前的合作，并且不再开展新的合作，以避免违反新规定。

瓦萨学院中国生物技术发展专家阿比盖尔・科普林说，这些项目可能包括与植物、动物或微生物以及人类 DNA 样本相关的基因组学工作。“许多学科的研究人员将越来越不愿与中国同行接触，” 她说。

佛罗里达大学的植物遗传学家帕梅拉・索尔蒂斯指出，这样的规定可能会危及过去的项目，比如她与华大基因研究人员合作并于 2019 年发表的一项关于东亚和北美植物进化模式的研究。索尔蒂斯说，尽管解决数据安全和知识产权方面的担忧很重要，但 “我们不能给需要合作的科学家设置障碍。”

目前一个可能受到影响的合作项目是地球生物基因组计划，这是 25 个国家为期 10 年的对所有已知物种基因组进行测序的努力。华大基因是世界上最大的基因测序中心之一，在这项工作中发挥着核心作用。史密森学会名誉馆长 W. 约翰・克雷斯说，他担心《生物安全法案》会迫使美国研究人员退出这个或其他大型国际项目。“美国有落后并被排除在主要国际合作之外的风险，” 克雷斯说。

斯坦福大学的遗传学家迈克尔・斯奈德说，该措施还可能限制实验室仪器市场的竞争，推高研究成本。斯奈德指出，斯坦福大学的测序中心最近从 Complete Genomics 购买了一台 DNBSeq - T7 测序平台，它比市场领导者 Illumina 的竞争平台便宜得多。如果 Complete Genomics 的机器被迫退出美国市场，“我认为这会损害科学，” 他说。

Complete Genomics 公司负责产品管理和营销的副总裁罗布・塔博克斯说，这项法律是基于 “一个有缺陷的前提”。他说，该公司测序仪产生的所有数据都归机器所有者所有。“即使我们想要数据，我们在物理上也无法获取。” 同时，塔博克斯指出，该法案并不能阻止中国获取美国研究型大学、医院或进行临床或 DNA 检测的公司持有的健康和遗传数据。“如果你真的想保护数据，我认为这项法案在这方面做得并不好。”

相关立法已经在参议院的一个委员会获得通过，观察人士表示，参议院可能会在一项折衷法案中采用众议院的措辞，然后提交给乔・拜登总统签署。或者立法者可能会把该法案附加到一项更大的立法中，比如《国防授权法案》，这样更有可能获得通过。卡明斯说，不管怎样，“这很可能会获得通过，并对该行业产生深远影响。”

文章大意：

美国众议院本周批准一项法案草案，参议院也在考虑类似措施。《生物安全法案》将阻止联邦资金流向与包括中国在内的五个 “外国对手” 有关联的生物技术公司，从 2032 年起禁止从五家特定中国生物技术公司采购，并禁止联邦资金流向使用这些公司服务和设备的其他组织。该法案的支持者认为被点名的中国生物技术公司存在窃取知识产权等问题，但这可能给美国带来诸多负面影响。
美国生物技术和制药公司受影响较大，学术研究人员也担心被迫切断与中国相关方的合作，许多学科研究人员将不愿与中国同行接触，甚至可能危及一些过去的项目以及像地球生物基因组计划这样的国际合作项目。此外，该措施还可能限制市场竞争、推高研究成本，有相关人士指出该法律存在缺陷，而此法案很可能通过且对行业产生深远影响。