Note From the Secretariat

The Third World Health Organization (WHO) Global Consultation on Organ Donation and Transplantation was organized by the WHO, The Transplantation Society (TTS), and the Organización Nacional de Trasplantes (ONT). The partnership among the three organizations made the best of their complementarities, and the utmost recognition and gratitude go to Rafael Matesanz (Director, ONT), Beatriz Domínguez-Gil (Medical Officer, ONT), Jeremy Chapman (President, TTS), and Francis Delmonico (Director of Medical Affairs, TTS) for their respective roles in advancing this significant and industrious collaboration. The main goal of the Consultation was to discuss the concept of national self-sufficiency in organ donation and transplantation and to outline strategies by which this goal might be achieved. The Consultation took place at a critical moment for transplantation both at the European Union (EU) and at a global level. The draft Directive on Quality and Safety Standards of Human Organs Intended for Transplantation was discussed at the European Council and the European Parliament. “Trilogues” including the European Commission were about to start, and there was a political will to reach a first-reading agreement on the legal text. This first-reading agreement was finally reached in May 2010, the Directive to be transposed to the national legislation of the 27 EU Member States (MS) in the following 2 years. The Consultation also preceded the discussion by the World Health Assembly (WHA) of the updated WHO Guiding Principles for Human Cell, Tissue and Organ Transplantation following their endorsement by the Executive Board of WHO in January 2009. In May 2010, the 63rd World Health Assembly endorsed the Guiding Principles through Resolution 63.22. This resolution urged MS, inter alia, “to strengthen national and multinational authorities and/or capacities to provide oversight, organization and coordination of donation and transplantation activities, with special attention to maximize donation from deceased persons and to protect the health and welfare of living donors with appropriate healthcare services and long-term follow-up.” The resolution, therefore, echoes the main conclusions of the Third WHO Global Consultation on Organ Donation and Transplantation. In July 2008, the Declaration of Istanbul on Organ Trafficking and Transplant Tourism was promulgated by TTS and the International Society of Nephrology (ISN). The Declaration recognizes the importance of self-sufficiency in organ transplantation as the optimal approach to prevent unethical practices in organ transplantation such as commercialism, organ trafficking, and transplant tourism. The aim of the Madrid meeting was to identify the factors necessary to best meet population needs for transplantation and to propose practical and immediate recommendations for society, health authorities, and international organizations. Striving for self-sufficiency has the potential to impact health systems from the delivery of preventive interventions to tertiary medical services; at a societal scale, self-sufficiency promotes community values such as solidarity and reciprocity. The outcomes of the Consultation establish the practical, ethical, and philosophical ground on which self-sufficiency may be understood and illuminate the path to greater global equity in access to transplantation, most critically with respect to the central role of donation from deceased donors. Prior to the Consultation, eight working groups were formed. Group members were chosen to represent a variety of background and expertise, including representatives of health authorities and clinicians with different specialties and geographical origins, to provide an interdisciplinary understanding of key issues relating to organ donation and transplantation. Three individuals within each group were designated to lead the preparation of an aide memoire in advance of the Consultation. These documents were discussed and refined during the meeting and were put forward for wider discussion in a plenary session. The body of evidence collated in these documents by the participants of the Consultation, and the recommendations contained therein, form the basis of the Madrid Resolution. The Madrid Resolution (1) identifies the common challenges facing transplantation in all countries and acknowledges the unique issues of particular societies and regions and (2) provides a diverse body of recommendations to governments, international organizations, and healthcare professionals for the successful pursuit of the goal of self-sufficiency in organ donation and transplantation. This report of the Third WHO Global Consultation on Organ Donation and Transplantation is structured in three parts. First, the final Madrid Resolution and Executive Summary are presented, which crystallize the central recommendations to emerge from the Consultation. Second, the proceedings of all plenary sessions are summarized to provide a global overview of current challenges and a comprehensive report on the status of transplantation activities in 2010. Third, the eight aide memoires of the working groups are presented in full, with supplementary information in related annexes. This report is intended as an immediate resource for policy makers and as a guide for practical initiatives. It is hoped that the challenges described will also inspire further work in this emerging and important field with implications for healthcare systems. The Third WHO Global Consultation hence addressed the concept of self-sufficiency in organs for transplantation in a comprehensive way for the first time. The Madrid Resolution recognizes that organ donation and transplantation are more than a good gesture and a medical service and must involve all citizens. The pursuit of self-sufficiency relies on a communal appreciation of the value of organ donation after death. It is an example of the public health and community values of reciprocity and solidarity; moreover, it is the only safeguard against the temptation of yielding to trade in human organs. The Secretariat wishes to acknowledge the close and fruitful collaboration between the co-organizers of the consultation, the invaluable support of the Government of Spain, at the time holding the Presidency of the Council of Ministers of the EU and the decisive contribution of the European Commission Directorate General for Health and Consumer Policy (DG SANCO). The concepts and preparation for this meeting were brought together from May 2009 onward by Alex Capron, Jeremy Chapman, Francis Delmonico, Beatriz Domínguez-Gil, and Dominique Martin, and we are very grateful to them for their hard work. We are indebted to the leaders of the working groups for their dedication and talent in preparing and developing the basis for this consultation: Curie Ahn, Nikola Biller- Andorno, Alex Capron, Jeremy Chapman, Francis Delmonico, Beatriz Domínguez-Gil, Rudolf Garcia, John Gill, Christian Jacquelinet, Vivekanand Jha, Adeera Levin, Alex Manara, Farhat Moazam, Jose Ramón Núñez, Gregorio Obrador, Gerry O'Callaghan, Axel Rahmel, Chris Rudge, Faissal Shaheen, Naoshi Shinozaki, Harjit Singh, Martin Alejandro Torres, and Anantharaman Vathsala. We would also like to acknowledge the efficacy and wisdom of those who accepted the task of chairing sessions: Günter Kirste, Jeremy Chapman, Peter Doyle, Carl-Gustav Groth, Rafael Matesanz, Enrique Moreno, Arie Oosterlee, and Jean-Marc Spieser. Special thanks are owed to Beatriz Domínguez-Gil, Martí Manyalich, Dominique Martin, and Sarah White, rapporteurs of the Consultation, who captured the main features and products of the Consultation and prepared the present report. Sarah White put together and edited the present report and deserves the thanks of all involved in the consultation. The preparation and the logistics of the meeting, so essential to its success, owes much to Lola Perojo and the ONT team; Filomena Picciano and her team at TTS office; and Mar Carmona, Fiona Constable and Chris Faivre-Pierret at WHO to whom we want to express our gratitude. This report represents the views of the participants not necessarily those of WHO. All the participants in the consultation should be thanked for their active participation and their will to achieve consensus. The report was submitted to all participants for comment. We are grateful to them for their input. Any error or omissions are, of course, our responsibility not theirs. Luc Noël,Coordinator, WHO, Department of Essential Health Technologies (HSS/EHT/CPR).