The Spanish Association of Orphan and Ultra-Orphan Drug Laboratories (AELMHU) has published its Report on Access to Orphan Drugs in Spain for the second four-month period of 2026, with data updated through August 31.
This publication, produced by AELMHU on a quarterly and annual basis, provides an up-to-date overview of the status of orphan drugs with trade names in the European Union and Spain, as well as their availability and accessibility to patients with rare diseases.
From January 1 through August 31, 2026, the European Commission has authorized the marketing of 13 new orphan drugs. In addition, in Spain, 10 have been assigned a National Code, and 5 have secured funding for inclusion in the National Health System (SNS).
With these new additions, the number of orphan drugs with marketing authorization in Europe has risen to 164. In Spain, 141 have a National Code, accounting for 86% of all orphan drugs authorized at the European level, while 105 are covered by the Spanish National Health System (SNS).
However, access to these treatments continues to be subject to certain conditions. Sixty-two percent of the orphan drugs funded by the National Health System (SNS) are subject to restrictions, either due to limitations on authorized indications or because funding is not available for some of these indications.
The AELMHU report focuses particularly on orphan drugs that, despite having a National Code in Spain, are not yet covered by insurance. There are currently 36 such drugs, of which 22 have been expressly denied coverage, while the remaining 14 are under review or have not yet submitted a request for coverage.
Another indicator analyzed is the time elapsed between the assignment of the National Code and the inclusion of the medication in the National Health System’s (SNS) coverage. As of August 3 , 2026, this period averaged 34 months, compared with the 23 months recorded at the end of 2025.
For AELMHU, these figures highlight the need for all stakeholders to continue working in a coordinated manner to streamline processes and facilitate access for patients with rare diseases to the treatments they need.
The 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, 15 have a National Code in Spain, and 9 are covered by the Spanish National Health System (SNS).
The data included in the report come from official sources such as the European Medicines Agency (EMA), the Community Register of Orphan Medicines, the Spanish Agency for Medicines and Health Products (AEMPS), and the Ministry of Health.
Check out the infographic from the Second Quarterly Access Report 2026 to learn more about the evolution of orphan drugs and access to them in Spain.