The Spanish Association of Orphan and Ultra-Orphan Drug Laboratories (AELMHU) has published itsReport on Access to Orphan Drugsin Spain for thefirst four months of 2026, with data through April 30.
This publication, whichis issued both quarterly and annually, provides a detailed analysis of orphan-designated products with trade names in the European Union and Spain, as well as their availability to patients with rare diseases.
In the first four months of the year, theEuropean Commission granted marketing authorization to seven new orphan drugs. In Spain, six have been assigned a National Code, andthree have received fundingto be included in the National Health System (SNS) coverage.
At the European level, there are already a total of163 orphan drugs with marketing authorization. Of these,141 have a national code(87% of the total authorized at the European level) and106 are covered by the Spanish National Health System (SNS), although 59% are covered with restrictions (limitations on authorized indications or with some indications not covered).
As forthe 35 orphan drugs with a National Code but without funding in Spain, 24 have been expressly denied funding, and 11 are under review or have not yet submitted a request for funding.
The report also detailsthe time that elapses between the assignment of the National Code to a drug and its inclusion in the National Health System (SNS). So far this year,this timeframe stands at 22 months on average, compared to the 23 months recorded at the end of last year. For AELMHU, this data highlights the need for all stakeholders to continue working together toexpedite access to these medicationsfor all patients with rare diseases.
The AELMHU report also details the progress of advanced therapies for the treatment of rare diseases. Currently,18 advanced therapies have marketing authorization in Europe; of these,9 are covered by the Spanish National Health System (SNS), and15 already have a national code in Spain.
The sources consulted in preparing this report include the EMA, the Community Register of Orphan Drugs, and the Spanish Agency for Medicines and Health Products (AEMPS), and the Ministry of Health.