The leader of Europe’s top drug regulatory body issued a stark warning Wednesday that the continent stands at a pivotal moment for maintaining access to breakthrough medications, as American pricing strategies continue to disrupt the global pharmaceutical landscape.
Emer Cooke, who heads the European Medicines Agency, addressed concerns at a pharmaceutical conference in Barcelona, Spain, noting that new drug introductions across Europe have plummeted by more than one-third following the implementation of President Trump’s pricing initiative last May.
“I think we’re at a very critical point at the moment,” Cooke stated during the Reuters Pharma Europe 2026 gathering.
“Everybody’s struggling with what the impacts of the U.S. policy on pricing will be. And that’s not just on pricing, it’s on where you do your clinical trials, where you market, where you launch.”
The Trump administration’s “most-favored-nation” approach seeks to reduce American drug costs by tying them to the lower prices paid by other developed nations, particularly European countries. However, industry experts report this strategy has prompted pharmaceutical companies to either seek higher European prices or postpone product launches there entirely.
Bill Coyle, who leads biopharma operations at consulting firm ZS, explained the industry’s reluctance at the conference: “MFN is creating a huge hesitation to launch here in Europe if it exposes price in the U.S., which, of course, is the major driver of profit for the entire industry.”
When questioned about pharmaceutical companies’ claims that European markets no longer provide sufficient financial returns, Cooke revealed she recently hosted senior industry executives at the EMA to explore ways the regulatory body could better support innovation and accelerate drug approvals.
Despite the challenges, Cooke emphasized Europe’s strengths as the world’s second-largest pharmaceutical market with comprehensive healthcare coverage, describing it as being in a “very strong place in terms of access” while advocating for coordinated purchasing negotiations across EU member states.
The pharmaceutical sector has increasingly criticized European regulators, arguing that companies now prefer investing and conducting research in the United States and China over Europe, where drug prices remain lower, regulatory processes more complex, and innovation incentives less compelling.
Cooke pushed back against these criticisms, highlighting ongoing European reform efforts including new pharmaceutical legislation covering joint procurement mechanisms for newly approved medications and a comprehensive life sciences strategy emphasizing innovation and market competitiveness.
“We have a lot of very positive things going on in Europe,” she emphasized.
Regarding upcoming regulatory decisions, Cooke indicated that European approval for the first in a new class of weight-loss medications would come “very soon,” suggesting action within weeks or months before the summer institutional slowdown period.
Two oral weight-loss drugs from Eli Lilly and competitor Novo Nordisk, which could significantly impact the profitable weight management market, have already received U.S. approval for launch this year.
Addressing recent upheaval at the U.S. Food and Drug Administration since Trump’s second term began, Cooke noted that Europe has begun attracting American scientific professionals.
“I think we’re getting some already – quietly,” she disclosed.
While maintaining that FDA relationships remain solid, Cooke acknowledged that leadership transitions have required the EMA to establish new working relationships with American counterparts.
The interview also covered European initiatives to address medication shortages and the importance of training EMA personnel in responsible artificial intelligence use, ensuring human oversight remains central to regulatory decision-making processes.
