Last week, the Office of the United States Trade Representative (USTR) released its 2026 Special 301 Report. The annual report highlights foreign government policies that unfairly limit American innovation.
What’s new: This year’s report marks a significant positive shift in trade enforcement and zeros in on policies that underpin America’s leading biopharmaceutical industry. The report places new focus on unfair pricing and reimbursement policies that previous reports ignored, despite the Special 301 statutory mandate, and prioritizes markets vital to biopharmaceutical innovation. Specifically, the report:
- Includes new language highlighting unreasonable pricing and reimbursement policies in several countries, including Australia, Canada, France, Germany, Italy, Japan, Korea and Spain, that result in other high-income countries not paying their fair share for innovative medicines.
- Designates the European Union as a “Watch List” market for the first time in decades, highlighting concerns over legislative initiatives that weaken intellectual property protections and set a negative global precedent.
- Continues to highlight concerns that countries including Canada, China and Mexico are falling short of their U.S. trade agreement obligations to protect intellectual property.
What’s next: The report should serve as a blueprint for the Administration as it works with other nations to address urgent intellectual property barriers and unfair pricing policies that undervalue innovation. USTR should use trade tools and negotiations to eliminate these policies, including through bilateral agreements modeled on the recent U.S.-UK agreement on pharmaceutical pricing.
Ernest Kawka
Ernest Kawka is PhRMA’s deputy vice president for international intellectual property. Previously, he worked for industry’s international trade association in Geneva, Switzerland focusing on intellectual property and trade policies. He received a law degree from University of New Hampshire School of Law.