Europe Pharmaceutical Access at a Critical Crossroads Amid U.S. Pricing Policies
Europe Pharmaceutical Access is at a “very critical point,” according to Emer Cooke, Executive Director of the European Medicines Agency (EMA). The number of new drug launches in Europe has fallen by more than a third since U.S. President Donald Trump’s “most-favored-nation” (MFN) drug pricing policy took effect in May 2025. By linking U.S. medicine prices to the lowest rates paid in other wealthy nations, the policy has led pharmaceutical companies to delay European launches or demand higher prices to safeguard their core U.S. market, creating hesitation across clinical trials, marketing, and launch decisions.
Launch Collapse Exposes Pricing Contagion Risk
The most striking finding is the sharp drop in European drug launches—exceeding one-third—directly triggered by the MFN policy. Cooke warns that the policy’s influence now reaches far beyond pricing, affecting where companies choose to run clinical trials and which markets they prioritise. Bill Coyle, global head of biopharma at ZS, highlights the “huge hesitation to launch here in Europe if it exposes price in the U.S.,” the industry’s primary profit centre. As a result, Europe’s traditionally lower prices now risk contaminating the higher U.S. pricing environment, causing companies to deprioritise the continent despite it being the world’s second-largest pharmaceutical market.
EU Must Flex Collective Muscle
Europe possesses a powerful universal healthcare infrastructure and is advancing regulatory reforms, yet fragmented national decision-making continues to weaken its bargaining power. Cooke is calling for “more Europe,” urging expanded EU-level authority—especially joint procurement negotiations among multiple countries—to strengthen negotiating leverage and speed up patient access to new medicines.
This push is backed by the EU Pharmaceutical Package, politically agreed in late 2025 and set for implementation in 2026, which broadens joint procurement, bolsters supply security, and adds incentives for innovation. Cooke’s recent high-level meetings with industry leaders at EMA headquarters underscore active efforts to sustain innovation while accelerating Europe Pharmaceutical Access.
HEOR Must Adapt to Geopolitical Pricing Realities
The decline in new launches threatens timely availability of breakthrough therapies in oncology, rare diseases, chronic conditions, and obesity, potentially worsening health outcomes and driving up long-term costs. From a Health Economics and Outcomes Research (HEOR) perspective, there is an urgent need to measure not only direct price effects but also the opportunity costs of delayed launches, including lost quality-adjusted life years and increased disease burden.
Cooke’s call for unified procurement and stronger EU coordination offers a pathway to improve cost-effectiveness while preserving innovation incentives. As Cooke’s mandate runs until April 2027, stakeholders will watch closely to see whether EU member states translate these recommendations into concrete policy that secures both patient access and industry investment.
