The National Court (Audiencia Nacional) has ruled that orphan drugs cannot be included in reference price orders on the grounds that it would negatively affect the objective of European Union (EU)-level legislation designed to promote the research, development and marketing of orphan drugs. In doing so, the Court has annulled the inclusion of the orphan drug Onivyde (irinotecan) in the reference price system.
Sources:
www.diariofarma.com, “Los medicamentos huérfanos deben ser excluidos de la OPR, dicta la AN”, 13th January 2022