Xenotransplantation in the European Union: towards harmonisation and accessibility

Abstract The regulation of xenotransplants in the European Union has undergone significant changes, particularly with the introduction of the Reflection Paper on the Classification of Advanced Therapy Medicinal Products. This paper defines products containing animal cells or tissues for human administration as Advanced Therapeutic Medicinal Products (ATMPs). This regulatory shift extended restrictions on ATMPs to other products like animal cell/tissue transplants. This article examines the implications of this change, exploring concerns about reclassifying procedures currently in clinical practice and neglecting the nature of xenotransplants as transplants rather than medicinal products. It highlights challenges in adopting this classification, including increased costs for healthcare facilities, and sustainability concerns. Recommendations are provided, including creating separate legislation for animal cells, tissues, and organs, refining ATMP classification criteria to exempt products without genome modification, recombinant nucleic acids, substantial manipulation, or intended non-homologous use, and reducing regulatory burdens for minimally manipulated xenotransplants to facilitate access. Engaging experts and stakeholders in decision-making and balancing safety with accessibility and sustainability is advocated. The article emphasizes the need to avoid hindering the clinical translation of xenotransplants and to implement proportionate, science-based legislation that inspires global harmonization while benefiting patients.