The Spanish Association of Orphan and Ultra-Orphan Drug Laboratories (AELMHU) has published its Report on Access to Orphan Medicinal Products in Spain for the second four-month period of 2025, with data up to August 31.
This publication, which is published both each four-month period and annually, provides a detailed analysis of orphan-designated products with trade names in the European Union and Spain, as well as their availability for patients with rare diseases.
In the second four-month period of the year, the European Medicines Agency (EMA) granted orphan designation to 9 new drugs. In addition, 8 treatments have received marketing authorization, 2 have obtained the National Code in Spain and 14 have received funding from the National Health System (SNS).
At the European level, a total of 221 drugs with orphan designation and trade name have already been identified, of which 156 have marketing authorization.
Meanwhile, in Spain 135 drugs have a national code and 104 are financed by the SNS, although 57% are financed with restrictions (limitations in the authorized indications or with some indication not financed).
As for the 31 orphan drugs with a National Code, but without funding in Spain, 17 have an express resolution of no funding and 14 are under study or have not yet submitted a request for funding.
The report also shows the time that elapses between the assignment of the National Code to the drug and its incorporation into the SNS. So far this year, this period has averaged 24 months, compared to the 23 months recorded at the end of last year. For AELMHU, this figure highlights the need for all the agents involved to continue working together to speed up access to these drugs for all patients with rare diseases.
The sources consulted in the preparation of this report include the EMAthe Community Register of Orphan Medicinal Products, the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) and the Ministry of Health..
Consult here the complete infographic.
Infographics_report quarterly access 2_ 2025_AELMHU
