PRESS RELEASES

02-2020
Only half of the orphan drugs approved in Europe are marketed in Spain

"On the occasion of World Rare Disease Day, the Spanish Association of Orphan and Ultra-Orphan Drug Laboratories (AELMHU) has taken stock of the approval and marketing processes for orphan drugs in the European Union and Spain during 2019.

There are currently 103 orphan drugs in Europe, of which only 53 are available in Spain.

The median time to market approval for orphan drugs is 15 months, a slight worsening compared to the previous year.

According to AELMHU's annual report, only 50% of orphan drugs are consistently marketed in Spain.

In this sense, the association reiterates the need for the approval processes for access to orphan drug treatments to be homogeneous throughout the national territory regardless of the autonomous community, and also to increase the number of orphan drugs available to patients in our country".