PRESS RELEASES

10-2019
AELMHU presents data on access to orphan drugs in Spain

"The Spanish Association of Orphan and Ultra Orphan Medicinal Products Laboratories (AELMHU) has presented data on access to orphan drugs authorised by the European Medicines Agency (EMA) in Spain.

The data show that only 54% of orphan medicinal products with marketing authorisation from the European Union, which as of the date of the analysis maintain the orphan designation, are finally marketed in Spain, i.e. 58 out of 108. Furthermore, based on these data, the time elapsed from the assignment of the National Code to the actual marketing has worsened by 3.8 months more (mean) and 3.5 months more (median), compared to the data for 2018. However, despite this increase, as of September 2019, more orphan medicines have been marketed (10) than in the whole of 2018 (8)."