We welcome the European Commission’s initiative to amend the European Organ Directive within the framework of the proposed Biotech Act, intended to align it with recent scientific and technological advances, particularly organ manipulations aimed at improving transplant outcomes and human health. However, the amendment introduces a definition of organ processing that raises significant regulatory questions, particularly related to the exclusions it contains, which might allow human organs subjected to genetic or enzymatic manipulation to be regulated as medicinal products or as goods under industrial or commercial legal frameworks. The potential consequences of regulating human organs as medicines are reviewed, and awareness is raised of the risk of undermining the altruistic basis of donation and public trust in organ donation and transplantation systems. Moreover, this shift could jeopardise access to this life-saving therapy and threaten the economic sustainability of healthcare systems. Concurrently, potential risks associated with certain forms of manipulation (e.g., genetic modification of organs) must be rigorously assessed before their incorporation into clinical practice. We propose a distinctly European regulatory model that preserves the intrinsic value of human organs, promotes collaboration between medicines and transplant authorities, and enables biomedical innovation through companies providing services and technical solutions to healthcare systems.
Cuende et al. (Tue,) studied this question.