A few weeks before the celebration of World Day for Rare Diseases, the Spanish Association of Orphan and Ultra Orphan Drug Laboratories (AELMHU) publishes the results of its Annual Access Report, which analyzes all orphan medicinal products (OMPs) with a trade name, which have a European orphan designation in force as of December 31, 2023. In it, the Association analyzes in detail the situation of orphan products in Europe and their availability for patients with rare diseases (RD) in Spain.

According to the data available for 2023, at the European level there has been a decrease both in the number of new orphan designations, from 29 in 2022 to 19, and in the number of new commercial authorizations, from 24 in 2022 to 12. However, in this same period, Spain has improved its access data, increasing the number of orphan drugs financed and reducing the times for their financing, thus contributing to improve the decrease that has occurred in recent years.

In 2023, 21 new orphan drugs were financed, 12 more than in the previous year, bringing the total number of orphan drugs financed by the National Health System (NHS) to 78, out of 147 with marketing authorization from the European Medicines Agency (EMA), i.e. 53%.

See the full content of the Press Release in the attached document.