The European Organ Donation Framework: a medico-legal cartography of consent, governance, and traceability

This article examines how European consent systems for deceased organ donation are evolving, arguing that the focus on opt-in versus opt-out consent systems overshadows the governance structures determining how consent is obtained at the bedside. Through legal analysis, it shows that the impact of opt-out schemes—often described as presumed consent schemes—depends on the usability of organ donation registers, evidence of the deceased’s wishes, family influence, and documentation accuracy. While opt-out regimes are widespread and often operationally ‘soft’ (family-centred at the bedside), they generate a number of issues from a human rights perspective. The article introduces a medico-legal taxonomy connecting legal default rules, the design of organ donor registers, and family decisions about donation, suggesting a practical model for ‘soft harmonisation’ that respects national constitutional choices. Central to this is a European Consent Status Summary and six governance pillars to improve transparency, interoperability, and traceability without forcing a single consent model. This approach aims to reduce litigation, support cross-border organ exchanges, and build public trust by ensuring that, wherever they exist, the deceased’s recorded or reliably reconstructed wishes are identified and given primacy in the transplantation process, regardless of the applicable consent default.