While medicines and novel therapies emerge and new treatments are being discovered, many medicines are still not equally available across Europe.
A new report by the European Federation of Pharmaceutical Industries and Associations (EFPIA) looked at the time it takes for medicines to become available in the European Union and the differences between countries.
Medicines are becoming less and less available in Europe. In 2025, only 28% of medicines were fully covered by public reimbursement, compared to 42% in 2019.
The differences between countries are also stark.
Patients in certain European countries can wait about seven times longer than patients in other countries to get access to the same medicine, from as little as five months to 37 months, the report found.
Where do patients wait the most?
According to EFPIA, the median time to availability is 532 days, between the marketing authorisation of a certain medicine and the date of availability in European countries.
The wait time varies widely between countries. While German patients have medicines available in the market 56 days after authorisation, those in Romania have to wait for 1,201 days.
After Germany, Switzerland, Serbia, Austria, and Denmark are the fastest countries, despite the number of available medicines varying between them.
Medicines take longer to be available in Romania, Portugal, Lithuania, and Croatia.
“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 found.
What countries have more available medicines?
Long waits and delayed market entries are not the only barriers patients face in Europe when they want to access medicines. The number of products available also varies widely.
Not all countries offer the same medicines, especially when it comes to innovative therapies and orphan drugs – those developed to treat rare diseases.
In 2019, the rate of full availability was 42%, while in 2025, this fell to 28% across Europe. The share of medicines fully available on public reimbursement has declined substantially, and nearly one-fifth of medicines are now available under restricted conditions.
The EFPIA’s report tracked 168 innovative medicines authorised by the European Medicines Agency between 2021 and 2024.
In the same period of time, Germany had 156 of those products in the market, while Malta had 22.
Austria (143), Italy (133), and Spain (116) showed the highest numbers across the European Union.
Latvia (25), Romania (28), and Hungary (35) are at the other end of the scale.
How does Europe compare to other regions?
The EFPIA also warns that the European regulatory process is slower than some international processes, particularly that of the United States, which causes the region to lag.
Using IQVIA, a global health data, analytics, and clinical research company, the EFPIA has also published a quarterly tracker analysing the extent to which new medicines approved by the US were, or will be approved by other global regulatory agencies, including the European Medicines Agency and the Chinese NMPA.
In the period 2021-2025, the EMA approved 231 new active substances while the US Food and Drug Administration approved 253. China approved 296.
Only a fraction of medicines are approved in all regions. The report notes that China and the US have many products not approved elsewhere, with new evidence showing that the number of products approved in the US and absent from Europe is growing.
Among 526 medicines approved by the US FDA from 2016 to 2025, 193 (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.
