Report of the Madrid Consultation: Part 1: European and universal challenges in organ donation and transplantation, searching for global solutions.

Introduction During the past 50 years, the transplantation of human organs, tissues, and cells has become a worldwide practice that has extended and greatly enhanced the quality of hundreds of thousands of lives. Transplantation is the best and most cost-effective treatment for end-stage kidney failure and remains the only available treatment for persons with end-stage failure of other solid organs. Continuous improvements in medical technology, particularly with respect to organ and tissue rejection, have led to increased demand for organs and tissues. Despite substantial expansion in organ donation from deceased persons in recent years and greater reliance on donation from living persons, the availability of organs and tissues for transplantation remains insufficient to meet demand. Global activities in organ donation and transplantation are highly variable, resulting in gross inequities in access to transplantation therapies. Where transplantation services are available, the great shortage of available organs in most jurisdictions means that many people in need are excluded from waiting lists, others deteriorate or die while awaiting transplantation, and some turn to desperate alternatives such as organ sales and transplant tourism. These unethical practices are addressed in The Declaration of Istanbul on Organ Trafficking and Transplant Tourism and in the WHO Guiding Principles for Human Cell, Tissue and Organ Transplantation (1, 2). For the governments of most high-income countries, the consequence of organ shortages has been a vast and escalating expenditure on kidney dialysis, despite dialysis therapy being more costly and associated with poorer outcomes than kidney transplantation. Given the manifest harms of transplant commercialization, global disparities in access to transplantation, the growing demand for organs, and the enormity of costs associated with dialysis provision, there is an urgent need for new strategic approaches toward these challenges that are capable of equitably meeting the organ transplant needs of populations in reliable, sustainable, efficient, and effective ways that do not compromise ethical principles. The Third WHO Global Consultation on Organ Donation and Transplantation (Madrid, March 23–25, 2010) brought together 140 representatives of international scientific and medical bodies, government officials, and ethicists, with the goal of confronting these shared challenges and developing a comprehensive strategic response (the Madrid Resolution). The theme of the conference, “Striving to Achieve Self-Sufficiency,” refers to the practical and ethical requirement for jurisdictions, countries, and regions to take action to both reduce transplantation needs and optimize the resources available to meet them. The many facets— both practical and policy based— of the pursuit of self-sufficiency were the focus of working group discussions. Broad representation from different countries, clinical backgrounds, and disciplines enabled a holistic appreciation of the issues. Each working group produced detailed recommendations that are reproduced in full in Part II of this report. Part I presents a comprehensive background to these recommendations, being an account of the proceedings and plenary presentations of the Consultation. Proceedings were in four main parts: (1) a Round Table of European Ministries of Health to discuss the benefits of a common European strategy toward organ donation and transplantation; (2) a presentation of current chal-