Five years after introduction of an opt-out consent system for organ donation; lessons learned from England and the Netherlands.

Five years after changing from opt-in to opt-out consent systems in England and the Netherlands, we examine the impact on donor registrations, consent rates, donor numbers, and reflect on lessons learned. Opt-out legislation was implemented in May 2020 in England and July 2020 in the Netherlands. In England, 44% of the population is now registered; 40% recording an opt-in decision and 4% an opt-out decision. In the Netherlands, mandated donor registration resulted in the entire adult population having their decision recorded: "Yes, I want to be a donor" (34%), "No objection" (24%), or "No, I don't want to be a donor" (31%), while 11% leave the "Decision to next of kin". Despite these structural changes, the consent categories created by opt-out legislation ("deemed" consent in England and "No objection" in the Netherlands) remain challenging in practice, with fewer than 50% of families agreeing to donation. In England, the family consent rate declined from 69% to 57% between 2020 and 2025 and the donor numbers remain below pre-pandemic levels. In contrast, the Netherlands experienced a modest increase in family consent rates and donor numbers compared to the opt-in consent system. Opt-out legislation provides an important policy framework, but sustained system-level commitment remains essential.