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[Poster] The new EU regulation on SoHO: strengthening the protection of donors, recipients and offspring
Abstract
The European Union (EU) regulation 2024/1938 on standards of quality and safety for Substances of Human Origin (SoHO) intended for human application was adopted on 13 June 2024 in order to solve issues that were not (sufficiently) addressed by the previous EU directives on blood (Directive 2002/98/EC) and tissues and cells (Directive 2004/23/EC). Among them, an extensive evaluation of the EU legislation led by the European Commission highlighted that they were avoidable risks for donors and for children born from donated gametes, and that patients were not fully protected from avoidable risks. Methods: This study is based on an analysis of the preparatory documents and of the final adopted version of the EU regulation on SoHO regarding the protection of SoHO donors, recipients and offspring. It combines legal and biomedical sciences approaches as well as fundamental and practical analysis in order to clarify and discuss the new EU legal measures targeting the protection of SoHO donors, recipients and offspring.
Poster
Authors
Aurélie Mahalatchimy, EuroGCT Deputy coordinator and WP4 leader; UMR 7318 DICE CERIC, Aix-Marseille University, Centre National de la Recherche Scientifique, Marseille, Provence-Alpes-Côte d’Azur, France
Valentin Roby, EuroGCT information officer on Ethical, Legal and Societal Issues
Christian Chabannon, Professor of Molecular Biology, MD, Centre de Thérapie Cellulaire. Institut Paoli-Calmettes Comprehensive Cancer Center & module Biothérapies du Centre d’Investigations Cliniques de Marseille, Inserm CBT-1409 –AMU –AP-HM -IPC
To be cited as:
A. MAHALATCHIMY, V. ROBY, C. CHABANNON, The new EU regulation on SoHO: strengthening the protection of donors, recipients and offspring, 52nd EBMT Annual Meeting, 22-25 March 2026, Madrid, Spain. (POSTER).