Millions of patients across Europe are waiting longer than ever before to access life-saving medications, according to a sobering new report released on Monday by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the continent’s primary pharmaceutical industry lobby group. The findings arrive at a moment of mounting tension between drugmakers and European governments over pricing policies, with the industry warning that restrictive cost controls are driving away investment and deepening the gap between drug approval and patient access.
According to EFPIA data, the average time it takes for a newly approved drug to become available to a patient in Europe has climbed to 597 days, up significantly from 504 days in 2019. That figure represents nearly 20 months of waiting after regulatory approval before a patient can receive a medication that has already been deemed safe and effective. In some countries, the wait is even longer: patients in Romania, for example, face delays of more than 1,200 days while German patients have access within roughly 56 days of authorization, a disparity that advocates say is unacceptable in a region that prides itself on universal healthcare.
The report, published as part of EFPIA’s annual Patients W.A.I.T. Indicator analysis, also found that only 28 percent of centrally approved medicines are now fully reimbursed across European Union member states, compared to 42 percent in 2019. The trend reflects a broader retreat from patient-centered drug policies, the lobby group argues, with budget pressures and pricing disputes increasingly determining which treatments citizens can access. In some countries, structural barriers, such as external reference pricing, force companies to delay market launches entirely as they wait for a medicine to be reimbursed in enough neighboring countries before they can file locally.
EFPIA’s research, commissioned from Germany’s WifOR Institute in collaboration with Columbia University economist Frank Lichtenberg, examined medicines used to treat cancer, diabetes, and respiratory diseases across 29 European nations between 2014 and 2022. The findings paint a compelling economic case for faster patient access: every euro invested in new medicines generated an estimated €5.67 in wider social and economic benefits. Newer medicines were associated with 1.83 million fewer years of life lost before age 85 and 20.9 million fewer hospital days. The study also linked innovative treatments to €38 billion ($43.4 billion) in workforce productivity gains, €19 billion in savings on informal care activities, and €9 billion in reduced hospital costs.
Pharmaceutical companies have been vocal in recent months about their frustration with European pricing structures. Drugmakers have warned that tighter cost controls risk making the region a less attractive destination for investment and new drug launches, potentially driving innovation to the United States and China. EFPIA noted that Europe has already lost nearly a quarter of its share of global pharmaceutical research and development investment over the past two decades, and urged governments to reframe spending on innovative medicines as long-term investment rather than short-term expenditure.
Adding further complication to the European landscape is the ripple effect of U.S. trade policy. Several pharmaceutical companies have been delaying European launches while they assess the consequences of President Donald Trump’s most-favored-nation pricing policy, which requires drugmakers to offer American patients prices that match those charged in other countries. Because European nations typically pay far less for medicines than the United States, the policy threatens to erode the commercial advantage of the U.S. market. That has prompted some companies to reconsider low-price launches abroad that could affect their American revenues. The result, analysts fear, may be that European patient access deteriorates further as pharmaceutical companies grow more selective about where and when they bring new products to market.
EFPIA has called for concrete structural reforms, including a commitment from EU member states to allow immediate patient access to newly approved medicines while national reimbursement negotiations take place. The organization has also proposed a tiered pricing model designed to ensure that less affluent member states pay proportionally less for medicines, removing a key barrier to equitable access across the bloc. However, for now, millions of patients across Europe remain in a waiting room that keeps getting larger.
