OBJECTIVES: The primary objective of this analysis was to compare the time to reimbursement (TTR) of orphan drugs (ODs) in five European countries: France, Germany, Italy, Spain and the United Kingdom (UK). METHODS: A panel of 54 ODs with new active substances was created by selecting those approved by the EMA in the last 5 years. The dates of national reimbursement for these were also collected in each country from respective national authorities. TTR was defined as a difference between the date of the national approval/commercialization and the EC decision. RESULTS: The mean difference time to reimbursement varied considerably across countries, ranging in Germany from immediate reimbursement available after launch, “real time launch” 99 days (median 37) to 559 days (median 552) in Spain, passing through 281 days (median 227) in France, 463 days (median 350) in UK and 458 days (median 417) in Italy. Even within each single country ranges between min and max time to reimbursement were highly heterogeneous: 72-902 days for France; 67-1078 days for Italy; 132-1390 days for Spain; 135 - 1168 days for UK. Although drug's launch in Germany is possible immediately after the EC decision, ODs were commercialized within a timeframe of 7-826 days. The overall percentage of reimbursed drugs ranged from 51% in Spain to 95% in Germany; 68% in UK, 72% in Italy and 91% in France. CONCLUSIONS: Our analysis demonstrates a wide difference in TTR timelines, related to a great heterogeneity of assessment procedures applied across Europe. Current data also show that patients in Germany and France, compared to Italy, Spain and UK, have a faster access to ODs.