Guess where in Europe patients wait the longest for new and innovative medicines? 0 14

Despite the emergence of new drugs and therapy methods, many medications still remain unevenly accessible across different countries in Europe.

A new report from the European Federation of Pharmaceutical Industries and Associations (EFPIA) examines how long it takes for medicines to become available in European Union countries and how these timelines differ from country to country.

In Europe, the availability of medicines continues to decline. By 2025, only 28% of drugs were fully reimbursed by public healthcare systems, compared to 42% in 2019.

At the same time, the differences between countries remain quite striking.

As noted in the report, in some countries, patients wait approximately seven times longer for access to the same medicines than in others: from five to 37 months.

Where do patients wait the longest?

According to EFPIA, the median time between the granting of a marketing authorization for a drug and its actual market availability in European countries is 532 days.

However, waiting times vary significantly. While in Germany new medicines become available on average 56 days after approval, patients in Latvia have to wait ten times longer (560 days), and in Romania, patients wait the longest - 1201 days.

Following Germany in terms of speed of new drug market entry are Switzerland, Serbia, Austria, and Denmark, although the number of available medicines in these countries varies.

The longest wait for medicines occurs in Romania, Portugal, Lithuania, and Croatia.

"Typically, patients in Northern and Western European countries gain access to new treatments within 100–500 days after drug approval, while in Southern and Eastern Europe, the wait is from 500 to 900 days," the report states.

In which countries are more medicines available?

Long waiting times and delays in market entry are not the only barriers for patients in Europe. The actual number of available medicines also varies significantly.

Not all countries offer the same set of medicines, especially when it comes to innovative therapies and orphan drugs—medications intended for the treatment of rare diseases.

In 2019, the level of full availability reached 42%, but by 2025, it has dropped to 28% across Europe. The share of drugs fully covered by public reimbursement systems has significantly decreased, and nearly one-fifth of medicines are now provided only under limited conditions.

The EFPIA report analyzes 168 innovative drugs approved by the European Medicines Agency between 2021 and 2024.

During the same period, 156 of these drugs appeared on the market in Germany, while only 22 were available in Malta.

Among EU countries, the highest numbers were recorded in Austria (143 drugs), Italy (133), and Spain (116).

At the opposite end are Latvia (25), Romania (28), and Hungary (35).

How does Europe compare to other regions?

EFPIA also warns that European regulatory procedures are slower than in several other countries, primarily the United States, causing the region to lag behind.

Based on data from IQVIA, a company that collects and analyzes medical information and clinical research worldwide, EFPIA also publishes a quarterly review assessing the extent to which new drugs approved in the U.S. have been or will be approved by other global regulators, including the European Medicines Agency and China's NMPA.

From 2021 to 2025, the European Medicines Agency approved 231 new active substances, the U.S. Food and Drug Administration approved 253, and China approved 296.

Only a small portion of these drugs has been approved in all regions. The report notes that there are many drugs in China and the U.S. that have not received approval in other countries, and new data indicates that the number of drugs approved in the U.S. but absent in Europe is growing.

Of the 526 drugs approved by the U.S. Food and Drug Administration between 2016 and 2025, 193 (37%) did not receive EMA approval.

"Even considering the European Commission's proposals to simplify regulatory procedures in the EU, the data shows that Europe is lagging in drug approval speed and is unlikely to catch up quickly," warns EFPIA.