La regulación del uso terapéutico de las sustancias de origen humano (SoHO) en el derecho de la Unión Europea: novedades y principales aspectos jurídicos

This study analyses the development and main legal aspects of European Union Law on the therapeutic use of substances of human origin (SoHO). These substances have traditionally included blood, cells and tissues, but recent scientific developments have led to other SoHO being used for therapeutic purposes. The new European Union (EU) concept of SoHO and the definition of its precise material scope of application are key to the development of legislation covering all substances currently used and those that may be used in the future. This is one of the main developments discussed in this study and is laid down in the new Regulation (EU) 2024/1938, which will be generally applicable from 2027 and will replace the previous Blood and Tissues and Cells Directives. In addition to its background and legal nature, the guiding principles of this regulation are analysed, including specially the principle of voluntary and unpaid donation.