On the Need to Change the Model of Supervision over Substances of Human Origin from the Perspective of Regulation (EU) 2024/1938: Polish and Serbian Examples

Abstract

Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on Standards of Quality and Safety for Substances of Human Origin Intended for Human Application and Repealing Directives 2002/98/EC and 2004/23/EC provides a new legal framework, after almost 20 years, in which issues concerning the quality and safety of substances of human origin (SoHOs) as well as the safety of SoHO donors will be settled. One of these is the way the institutions supervising the implementation of the provisions of the Regulation are shaped. New requirements addressed to the SoHO competent authority must be met by August 2027. Hence the particular challenge facing EU Member States is adapting their own organizational solutions regarding the transplant system in a way that meets the requirements of the Regulation. Using the examples of legal and organizational solutions adopted in Poland and Serbia, the authors try to assess their performance from the perspective of the expectations of the EU legislation.