A new report from the European Federation of Pharmaceutical Industries and Associations (EFPIA) has laid bare the stark inequalities in access to innovative medicines across the continent. While patients in Germany can obtain a newly authorised drug in as little as 56 days, those in Romania face a median wait of 1,201 days — more than three years.
The study, which tracked 168 innovative medicines authorised by the European Medicines Agency (EMA) between 2021 and 2024, found that the overall availability of new treatments is declining. In 2025, only 28% of medicines were fully covered by public reimbursement across Europe, a sharp drop from 42% in 2019. Nearly one-fifth of drugs are now available only under restricted conditions.
Northern and Western Europe Lead, South and East Left Behind
The median time from EMA marketing authorisation to a medicine's availability in a given country now stands at 532 days. But the range is enormous. After Germany, the fastest countries include Switzerland, Serbia, Austria, and Denmark, where patients typically wait between 100 and 500 days. At the other end of the scale, Romania, Portugal, Lithuania, and Croatia impose waits of 500 to 900 days or more.
“Typically, patients in Northern and Western Europe get access to new treatments between 100 and 500 days after market authorisation has been granted, whereas patients in Southern and Eastern Europe wait between 500 and 900 days,” the report notes.
The number of available medicines also varies dramatically. Germany had 156 of the 168 tracked products on the market, while Malta had just 22. Within the EU, Austria (143), Italy (133), and Spain (116) showed the highest numbers. Latvia (25), Romania (28), and Hungary (35) were at the bottom. This disparity is particularly acute for orphan drugs developed to treat rare diseases, which often struggle to gain reimbursement in smaller or poorer markets.
Europe Falling Behind Globally
The EFPIA warns that Europe's regulatory processes are increasingly slow compared to other major markets. Between 2021 and 2025, the EMA approved 231 new active substances, while the US Food and Drug Administration (FDA) approved 253 and China's NMPA approved 296. Among 526 medicines approved by the US FDA from 2016 to 2025, 193 — or 37% — lack EMA approval.
“Even with the European Commission’s proposals to streamline the EU’s regulatory procedures, evidence suggests that Europe is lagging behind in terms of the speed of regulatory approval and that this is unlikely to catch up in the near future,” the EFPIA warned.
The report also highlights that China and the US have many products not approved elsewhere, and the number of drugs available in the US but absent from Europe is growing. This gap has implications for patients with rare or hard-to-treat conditions, who may have to travel abroad or wait years for access.
The findings come as European health systems grapple with budget constraints and rising demand. The decline in full public reimbursement — from 42% to 28% in just six years — suggests that even when drugs are approved, national pricing and reimbursement negotiations can delay or restrict access. The EFPIA's data, drawn from IQVIA, a global health analytics firm, underscores the need for faster, more harmonised processes across the EU's 27 member states and the wider continent, including the UK, Switzerland, Norway, and the Balkans.
For now, the message is clear: where you live in Europe still determines whether you get a new medicine in months or years.
