COINS Act Regulations Undermine American Leadership

The United States is the global leader in biopharmaceutical research and development.  This position is crucial to the economy and giving patients access to new medicines well before they are available in foreign countries.  Unfortunately, steps are being taken to put this leadership at risk and push research and development overseas.

On October 22, 2026, the Department of the Treasury announced a notice of proposed rulemaking (NRPM) to implement the Comprehensive Outbound Investment National Security (COINS) Act of 2025, which was included in the Fiscal Year 2026 National Defense Authorization Act and was signed into law on December 15, 2025.  The COINS Act imposes restrictions on outbound investments in sensitive technologies like semiconductors, microelectronics, quantum information technologies and artificial intelligence.  But the NRPM expanded the restrictions to biotechnology.  In a press release accompanying the NPRM, Treasury Secretary Scott Bessent stated that the proposed regulations would “prevent our adversaries from using U.S. investment to develop critical technologies that threaten U.S. national security.”  Congress did not state that biotechnology is one of those critical technologies.

Adding biotechnology to the list of industries covered by the COINS Act will harm patients and give China a leg up in pharmaceutical innovation.  American companies regularly engage with companies in China and elsewhere to develop commercial agreements like licensing and asset acquisition, co-development and co-commercialization, and vendor services.  These agreements expand the field for discovering and delivering life-saving medicines and therapies for American patients.

The inclusion of biotechnology would give Chinese companies more control over these technologies and medicines.  At the same time, European countries would be able to access more newly developed Chinese medicines, undermining American competitiveness and innovation.

Protecting national security, especially in new and emerging technologies, is a laudable goal but including biotechnology in these regulations, which was outside the original intent of the COINS Act, would harm patients and is unrelated to the national security interests identified by Congress in the legislation.  America is and must remain as the global leader in the pharmaceutical industry and the new, overly broad regulations that would take effect if the NRPM is approved, will undermine that leadership position and harm both patients and the economy.