Trump administration proposes new curbs on China biotech deals
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The Trump administration officially made biotechnology a national security concern late Thursday, proposing to subject certain deals with Chinese life sciences companies to new screening requirements or prohibit them altogether.
Why it matters: Western drug giants have invested tens of billions of dollars in Chinese biotechs to bolster their product pipelines, and the rule could impose significant limitations on such transactions.
- Biotech would join semiconductors, AI and quantum computing among the sensitive technologies subject to added scrutiny under the proposal.
Driving the news: The Treasury Department late Thursday proposed updating rules for implementing the Comprehensive Outbound Investment National Security (COINS) Act, which Congress passed last year.
- The law requires notification of certain U.S. investments in countries of concern like China, Cuba, Iran and North Korea and allows some transactions to be blocked.
- The concern is investments could be used to create biological weapons or brain-computer interfaces for surveillance, or to make U.S. supply chains overly dependent on a country.
- Violators would be subject to civil penalties and possible divestment from a prohibited technology.
What's inside: The proposal suggests defining "prohibited technologies" within biotech to include pharmaceutical compounds and their delivery systems, which would mean "small molecules, polymers, vaccines, blood and blood components, allergenics, cell and gene therapies, and monoclonal antibodies or other recombinant therapeutic proteins."
- It also includes brain-computer interfaces, biomanufacturing equipment and other life sciences technology and tools.
- The proposal lists acquisitions of equity interest, certain debt financing and entrance into a joint venture among the transactions that would be targeted.
The big picture: Biotech has quickly emerged as a technology that can be used for both good and bad purposes.
- That means that while breakthroughs are opening a world of new possibilities for patients, they also pose terrifying new risks.
- The Treasury Department said that it's trying to strike a balance between encouraging promising innovation and protecting national security interests.
- "It is necessary to place restrictions in this sector in the interest of protecting U.S. national security; at the same time, the Treasury Department recognizes that restrictions may potentially have countervailing effects on national security to the extent restrictions lead to significant public health risks or harm U.S. businesses in this sector," per the proposal, which will be subject to public comment.
Between the lines: What's not specifically mentioned in that list of transactions are licensing deals, one of the most common types of transactions that Big Pharma companies are striking with Chinese biotechs.
- "I think licensing is going to be largely OK," said Raymond James analyst Chris Meekins after a first read of the rule.
What they're saying: "The administration is correct that biotechnology is a strategic technology industry for the United States. We need policies and initiatives that maintain and advance our global leadership in biotech, particularly as we compete with China," Biotechnology Innovation Organization CEO John Crowley said in a statement.
- "We cannot restrict our way to success. As Treasury considers comments on the proposed rule, we need to ensure that we do not have an overly broad approach that would create uncertainty for innovators and investors, and that may unintentionally risk weakening U.S. biotech competitiveness."
- Caitlin Frazer, executive director of the National Security Commission on Emerging Biotechnology, said the announcement was "a prudent step that aligns with NSCEB's bipartisan goals of retaining, and in some cases regaining, American leadership in biotechnology."
