By Maggie Fick BARCELONA, April 22 (Reuters) - European Union authorities need a broader remit to secure access to newly approved drugs, including collective procurement negotiations for several
European health chief says EU is at 'a critical point' in ensuring new drug access
Challenges and Developments in European Drug Access
By Maggie Fick
BARCELONA, April 22 (Reuters) - Europe is at a critical juncture for ensuring future access to new drugs as U.S. pricing policies shake the sector, the head of the European Medicines Agency Emer Cooke said on Wednesday, urging regional authorities to work together more closely.
The number of drug launches in Europe has fallen by more than a third, an analysis of data found, potentially hindering patient access to the latest innovative medicines, since U.S. President Donald Trump last May introduced a new drug pricing policy.
Impact of U.S. Drug Pricing Policies
"I think we're at a very critical point at the moment," Cooke told the Reuters Pharma Europe 2026 event in Barcelona, Spain.
"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."
Pressure on Drug Launches and Pricing in Europe
PRESSURE NOT TO LAUNCH IN EUROPE OR TO RAISE PRICES
Trump's "most-favored-nation" policy aims to cut U.S. medicine prices by linking them to lower ones paid in other wealthy countries, including in Europe, but analysts and executives say it has led drugmakers to push for higher prices there or delay launches.
"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," Bill Coyle, global head of biopharma at consulting firm ZS, told the conference.
Industry Concerns and Regulatory Response
Asked about drugmaker complaints Europe no longer offers attractive enough returns, Cooke said she met senior industry leaders at the EMA last week to discuss how the regulator could support innovation and speed medicines to market.
Europe is the second biggest market for pharmaceuticals and has universal healthcare, putting it in a "very strong place in terms of access" overall, Cooke noted, while urging measures such as collective procurement negotiations within the EU.
European regulators have faced growing criticism from the pharmaceuticals industry, which says companies are increasingly likely to invest and conduct research in the United States and China rather than Europe, where prices are lower, regulation burdensome and incentives to innovate weaker.
Cooke defended Europe as a base for business and research. She said the region was working on reforms, including pharmaceutical legislation that covers joint procurement for the bloc to access newly approved drugs and a life sciences strategy focused on innovation and competitiveness.
"We have a lot of very positive things going on in Europe," she said.
Upcoming Decisions and Regulatory Developments
EU Decision on Obesity Pills
EU DECISION ON OBESITY PILLS COMING 'VERY SOON'
Cooke also said in the interview that the EU regulatory review of the first of a new generation of weight-loss pills would be concluded "very soon", indicating it would be in the coming weeks or months ahead of the northern hemisphere summer when institutional decision-making generally slows.
Two new oral drugs by Eli Lilly's LLY.N and rival Novo Nordisk, which could shake up the lucrative weight loss market, have been cleared for a U.S. launch this year.
Transatlantic Regulatory Relations
Referring to upheaval at the U.S. Food and Drug Administration since the start of Trump's second administration last year, Cooke said Europe was also attracting some scientific talent from the United States.
"I think we're getting some already - quietly," she said.
Cooke said ties with the FDA remained strong, but leadership changes meant the EMA was having to build new relationships with counterparts there.
Efforts to Prevent Drug Shortages and Embrace Innovation
In the interview, she also addressed Europe's efforts to prevent drug shortages and said it was important for the EMA to train its staff to use artificial intelligence responsibly, with human oversight and without weakening the judgment needed for regulatory decisions.
(Reporting by Maggie Fick; Writing by Ludwig Burger; Editing by Barbara Lewis and Adam Jourdan)
