The Spanish Association of Orphan and Ultra-Orphan Drug Laboratories (AELMHU) has made public the full text of its Annual Report on Access to Orphan Drugs (OMH) in Spain, a study that confirms that 2022 was a very hopeful year for patients with rare diseases (RD) at the European level, while in Spain delays in the approval of these treatments continue to increase.

Thus, before the upcoming commemoration of the World Day for Rare Diseases, AELMHU makes an assessment of its access indicators, warning that "we are facing a decisive year for the pharmaceutical industry in our country", since important projects such as the new Law on Guarantees and Rational Use of Medicines, the new European Regulation on Rare Diseases, the new Pharmaceutical Strategy for Europe, the Strategic Plan for the Pharmaceutical Industry 2023-2025 or the Spanish presidency of the Council of the EU are planned.