The Spanish Association of Orphan and Ultra-Orphan Medicines Laboratories (AELMHU) has conducted a study on access to HMPs in Spain, in comparison with the most relevant countries in Europe. The study reveals a significant decrease in the number of HMMHs that have obtained funding and price in the last four years, and shows a change in trend that distances Spain from the ratios identified for other European countries, with respect to effective access to these therapeutic innovations. Specifically, the study reveals that of the 94 new HMPs approved by the EMA since 2002, with orphan drug designation in force, only 51 have been marketed in Spain, just over half.