The availability of medicines in Spain

In the European Union (EU) procedures for the authorization of medicinal products are applied to incorporate new medicinal products and their successive amendments under the same conditions in all Member States. However, the effective marketing of medicinal products differs, and the intended harmonization based on a single authorization valid for the whole EU is fragmented by the subsequent intervention of the Member States responsible for price and reimbursement. The difference in the availability of medicines affects patients when the product is not effectively marketed. Spain was in an intermediate position in the EU, however, the latest published data indicate a clear deterioration in the availability of new medicines, moving it away from countries such as Germany, France or Italy. On the other hand, apart from innovations, there is another group of medicines with availability problems. They are medicines considered essential in therapeutics and that have been marketed for years with a continuous erosion of their prices, reducing their marketing viability. The AEMPS has qualified in May 2022 as strategic medicines some of these medicines, essential from a therapeutic point of view and, at the same time, vulnerable in relation to their supply. The intention of this paper is to revise the causes that most influence the availability of medicines in Spain and the changes that could favor their better access, both with respect to new medicines and strategic medicines. Keywords: availability of medicine; access to medicines; strategic medicine; critical medicines