Pharmaceutical companies are putting certain European launches on hold as they weigh possible consequences of U.S. pricing initiatives, industry executives, a trade association official and market data say. The hesitation reflects concern that linking U.S. prescription drug prices to those paid in other countries could lower what the United States pays for new medicines.
White House efforts to reduce the cost of prescription drugs in the United States - where prices have historically been higher than in many other wealthy nations - have focused on tying American costs to international levels, a strategy often referred to as most-favoured-nation pricing. That approach has prompted drugmakers to rethink how and where they introduce medicines, particularly in lower-priced European markets.
Stefan Oelrich, president of the European Federation of Pharmaceutical Industries and Associations and a senior Bayer executive, said the sector is seeing "first signs of delayed introductions into Europe." He described the trend as "a consequence of uncertainty around what that ultimately does to U.S. pricing."
Market research from GlobalData supports the observations of industry officials. According to its analysis, new drug launches in European Union markets dropped by around 35% in the 10 months after President Trump’s executive order on international reference pricing, compared with the previous 10-month period. GlobalData also found that more than 90% of drugs approved in 2025 first launched in the United States, with the majority still not available elsewhere.
Executives and policymakers say the rationale for pausing launches in lower-priced European countries is to avoid anchoring U.S. prices lower for longer. In Europe, national health systems negotiate the prices they will pay, keeping costs relatively low. The U.S. system, by contrast, involves negotiations with insurers, pharmacy benefit managers and other intermediaries, alongside rebates and discounts off list prices.
Pressure on early-access pathways
In France, regulators report that interest from manufacturers in early-access routes - mechanisms that allow patients to receive some medicines before formal marketing approval - has declined. Lionel Collet, head of France’s HAS health authority, said companies increasingly defer decisions on France’s early-access pathway, noting that applications for early access before marketing approval have fallen sharply over the past year.
Collet pointed to a fall in HAS early-access decisions, saying the number fell "to 10 last year from 25 in 2024." He described France as one of Europe’s lowest-priced medicines markets, with prices around a third of those in the United States, and observed that prices set in France and Germany often influence how other European countries price medicines. "Manufacturers all talk to me about Trump, since the autumn. It’s all about the policy in the U.S. and what it means for Europe," Collet said.
Company actions and commentary
Some drugmakers have publicly cited U.S. pricing uncertainty as the reason for changes to their European strategies. Insmed, a U.S. company, said in February it postponed the launch in Germany of its anti-inflammatory medicine Brunspri because of uncertainty over U.S. pricing plans. CEO William Lewis told investors, "We want clarity on the MFN policies," adding: "It seems to us that the prudent thing to do is to sort of put things on hold until we know what that’s going to look like." The drug received European approval in November but had not launched in the region at the time of the comments. Insmed began U.S. sales of the product after FDA approval in August.
The changing dynamic has also drawn pointed public remarks from executives at several large European and Swiss companies. Leaders at Roche, Novartis and AstraZeneca have criticized the way European governments value medicines and have called for higher spending to support innovation. AstraZeneca executive Ruud Dobber warned that Europe risks falling behind the United States and China under current valuation approaches.
Lobby group data cited by industry advocates show Europe spends around 1% of GDP on pharmaceuticals, compared with roughly 2% in the United States and 1.8% in China. The group argues Europe has lost ground in research and development investment, clinical trials and the launching of innovative therapies.
Market withdrawals and investor uncertainty
Beyond delays, a few companies have pulled products from European markets. Amgen withdrew its cholesterol medicine Repatha from Denmark, citing pricing and a "changed environment." Indivior removed addiction treatment drugs Subutex and Suboxone from Sweden and other markets. These moves were reported without direct reference to the U.S. most-favoured-nation policy.
Legal and market professionals say the murkiness around U.S. pricing benchmarks complicates corporate planning and communications with investors. Boston-based healthcare lawyer Ron Lanton described the challenge companies face when forecasting revenues from new launches. "You have to tell your shareholders exactly how much money you expect to earn from this new launch. And none of that’s clear," he said. Lanton argued that the uncertainty has made launching in Europe a slower process, likening it to "playing a game of chess" while wearing a "blindfold." "I’m not surprised that things are going to be launched a lot slower," he added.
Implications for policymakers and markets
The combination of U.S. policy shifts and low European price levels has created a complex strategic challenge for chief executives and health ministers. Manufacturers say they must balance protecting revenue in the United States - a market valued at about $700 billion - with maintaining access and pricing in European systems where governments tightly control costs. That balancing act has led to delays and withdrawals that market data and officials say are already visible across Europe.
As uncertainty persists, company decisions on launch timing and market participation are likely to remain cautious, with potential knock-on effects for patient access, industry revenues and the broader innovation landscape in Europe and the United States.