Supplement to June 15, 2011 ா Volume 91 Number 11S Transplantation The Official Journal of the Transplantation Society www.transplantjournal.com

Contents

- Note from the Secretariat ...... S27

- The Madrid Resolution on and Transplantation ...... S29

- Executive Summary ...... S32

- Report of the Madrid Consultation Part 1: European and Universal Challenges in Organ Donation and Transplantation, Searching for Global Solutions ...... S39

- Report of the Madrid Consultation Part 2: Reports from the Working Groups ...... S67

- Working Group 1: Assessing Needs for Transplantation...... S67

- Working Group 2: System Requirements for the Pursuit of Self-Sufficiency ...... S71

- Working Group 3: Meeting Needs through Donation ...... S73

- Working Group 4: Monitoring Outcomes in the Pursuit of Self-Sufficiency ...... S75

- Working Group 5: Fostering Professional Ownership of Self-Sufficiency in the Emergency Department and Intensive Care Unit ...... S80

- Working Group 6: The Role of Public Health and Society in the Pursuit of Self-Sufficiency ...... S82

- Working Group 7: Ethics of the Pursuit of Self-Sufficiency ...... S87

- Working Group 8: Effectiveness in the Pursuit of Self-Sufficiency - Achievements and Opportunities ...... S89

- Appendix 1: Expanded report on System Requirements for the Pursuit of Self-Sufficiency (Working Group 2) ...... S94

- Appendix 2: The Critical Pathway for Organ Donation after Death ...... S102

- Glossary of Terms ...... S111 Participants Organizers: Steffen Groth and Luc Noe¨l, WHO; Rafael Matesanz and Beatriz Dominguez-Gil, ONT; Jeremy Chapman and Francis Delmonico, TTS. Working Group Leaders: Group 1: Assessing Needs for Transplantation; Christian Jacquelinet (France), Adeera Levin (Canada), Jha Vivekanand (India); Group 2: System Requirements for The Pursuit Of Self-Sufficiency, Curie Ahn (Korea), Martin Alejandro Torres (Argen- tina), Jose´ Ramo´nNu´n˜ez (Spain); Group 3: Meeting Needs through Donation: Francis Delmonico (United States), Beatriz Dominguez-Gil (Spain), Faissal Shaheen (Saudi Arabia); Group 4: Monitoring Outcomes in the Pursuit of Self-Sufficiency: John Gill (Canada), Axel Rahmel (The Netherlands), Naoshi Shinozaki (Japan); Group 5: Fostering Emergency Department and IC Professional Ownership of Self-Sufficiency: Alexander Capron (United States), Alex Manara (United Kingdom), Gerry O’Callaghan (Australia); Group 6: The Role of Public Health and Society in the Pursuit Of Self-Sufficiency: Jeremy Chapman (Australia), Gregorio Obrador (Mexico), Harjit Singh (Malaysia); Group 7: Ethics of the Pursuit of Self-Sufficiency: Nikola Biller Andorno (Switzerland), Rudolf Garcia-Gallont (Guatemala), Farhat Moazam (Pakistan); Group 8: Effectiveness in the Pursuit of Self-Sufficiency, Achievements, and Opportunities: Luc Noe¨l (WHO), Chris Rudge (United Kingdom), Anantharaman Vathsala (Singapore). Rapporteurs of the Consultation: Beatriz Dominguez-Gil (Spain); Martı´ Manyalich (Spain); Dominique Martin (Australia); Sarah White (Australia), Lead Rapporteur and Editor. Other participants: Carmel Joseph Abela (Malta), Maria Joao Aguiar (Portugal), Adewale Akinsola (Nigeria), Mustafa Al-Mousawi (Kuwait), Ine´s A´ lvarez Saldı´as (Uruguay), Manuel Arias Rodriguez (Spain), Tamar Ashkenazi (Israel), Gloria Ashuntantang (Cameroon), Danica Avsec-Letonja (Slovenia), Mohamed Salah Ben Ammar (Tunisia), Pavel Brezovsky´ (Czech Republic), Mirela Busˇic (Croatia), Mar Carmona (WHO), Leen Coene (Belgium), Elisabeth Coll (Spain), Fiona Constable (WHO), Filip Danninger (Slovak Republic), Gabriel Danovitch (United States), Miguel A´ ngel De Frutos Sanz (Spain), Francisco Jose´ Del Rı´o (Spain), Roser Deulofeu (Spain), Visist Dhitavat (Thailand), Jose´ Luis Di Fabio (WHO), Boucar Diouf (Senegal), Peter Doyle (United Kigdom), Valter Duro Garcia (Brazil), Teodora Dzhaleva (Bulgaria), Ehtuish Ehtuish (Libyan Arab Jamahiriya), Linda Ezekiel (Tanzania), Serguei Gautier (Russian Federation), Gayatri Ghadiok (WHO), Athina Gompou (Greece), Carl Groth (Sweden), Niels Grunnet (Denmark), Sudhir Gupta (India), Valentina Hafner (WHO), Mohamed Hilal Abdou (Egypt), Arnt Jakobsen (Norway), Gu¨nter Kirste (Germany), Anni Ku¨u¨svek (Estonia), Tong Kiat Kwek (Singapore), George Kyriakides (Cyprus), Ko Kyung Soon (Republic Of Korea), Mirjana Lausevic (Serbia), Alan Leichtman (United States), Sveinn Magnu´ sson (Iceland), Beatriz Mahillo (Spain), P.G. Mahipala (Sri Lanka), Rui Maio (Portugal), Terence P. Mangan (Ireland), Rosario Marazuela (Spain), Trevor B. McCartney (Jamaica), Geeta Mehta (WHO), Nabila Metwalli (WHO), Marina Minina (Russian Federation), Fernando Morales Billini (Dominican Republic), Enrique Moreno (Spain), Ferdinand Mu¨ehlbacher (Austria), Elmi Muller (South Africa), Alessandro Nanni Costa (Italy), Howard M. Nathan (USA), Jean-Bosco Ndihokumbayo (WHO), Alejandro Nin˜o Murcia (Colombia), Gerry O’Callaghan (Australia), Kevin O’Connor (United States), Izaaq Odongo (Kenya), Freda O’Neill (Ireland), Arie Oosterlee (The Netherlands), Marie- Odile Ott (Council Of Europe), Ole Øyen (Norway), Anna Pavlou (European Commission), Ferenc Perner (Hungary), Lola Perojo (Spain), Francesco Procaccio (Italy), Rosana Reis Nothen (Brazil), Oleg Reznik (Russian Federation), S. Adibul Hasan Rizvi (Pakistan), Jose´ Luis Rojas (Chile), John Rosendale (United States), Wojciech Rowinski (Poland), Rafail Rozental (Latvia), Bassam Saeed (Syrian Arab Republic), Kaija Salmela (Finland), Jacinto Sa´nchez Iba´n˜ez (Spain), Manav Saxena (Singapore), Hans J. Schlitt (The Netherlands), Vijay Sharma (Nepal), Rakesh Kumar Srivastava (India), Endang Susalit (Indonesia), Zoltán Szabo´ (Hungary), Shiro Takahara (Japan), Annika Tibell (Sweden), George Tsoulfas (Greece), Andre´s Valdivieso Lo´pez (Spain), Koenraad Vandewoude (Belgium), Ernie Vera (Philippines), Andi Wahyuningsih (Indonesia), Haibo Wang (People’s Republic of China), Lori J. West (United States), Daniel Wikler (United States), Liu Yongfeng (People’s Republic of China), Kimberly Young (Canada), Victor-Gheorghe Zota (Romania), Gerson Zafalon (Brazil), Zhongyang Shen (People’s Republic Of China).

© WORLD HEALTH ORGANIZATION 2011. All rights reserved. The World Health Organization has granted the publisher permission for the reproduction of this supplement. Copyright in the typographical arrangement, design, and layout resides with the publisher Lippincott Williams & Wilkins. The authors alone, whether they are staff members of the World Health Organization or not, are responsible for the views expressed in this publication, and they do not necessarily represent the decisions, policy or views of the World Health Organization. Third WHO Global Consultation on Organ Donation and Transplantation: Striving to Achieve Self-Sufficiency, March 23–25, 2010, Madrid, Spain

NOTE FROM THE SECRETARIAT as the optimal approach to prevent The Third World Health Organization (WHO) unethical practices in organ transplantation such as com- Global Consultation on Organ Donation and Transplan- mercialism, organ trafficking, and transplant tourism. The tation was organized by the WHO, The Transplantation aim of the Madrid meeting was to identify the factors nec- Society (TTS), and the Organizacio´n Nacional de Tras- essary to best meet population needs for transplantation plantes (ONT). The partnership among the three organi- and to propose practical and immediate recommendations zations made the best of their complementarities, and the for society, health authorities, and international organiza- utmost recognition and gratitude go to Rafael Matesanz tions. Striving for self-sufficiency has the potential to (Director, ONT), Beatriz Domínguez-Gil (Medical Offi- impact health systems from the delivery of preventive in- cer, ONT), Jeremy Chapman (President, TTS), and Francis terventions to tertiary medical services; at a societal scale, Delmonico (Director of Medical Affairs, TTS) for their self-sufficiency promotes community values such as soli- respective roles in advancing this significant and industri- darity and reciprocity. The outcomes of the Consultation ous collaboration. The main goal of the Consultation was establish the practical, ethical, and philosophical ground to discuss the concept of national self-sufficiency in organ on which self-sufficiency may be understood and illumi- donation and transplantation and to outline strategies by nate the path to greater global equity in access to trans- which this goal might be achieved. plantation, most critically with respect to the central role The Consultation took place at a critical moment for of donation from deceased donors. transplantation both at the European Union (EU) and at a Prior to the Consultation, eight working groups were global level. The draft Directive on Quality and Safety formed. Group members were chosen to represent a variety of Standards of Human Organs Intended for Transplantation background and expertise, including representatives of health was discussed at the European Council and the European authorities and clinicians with different specialties and geo- Parliament. “Trilogues” including the European Commis- graphical origins, to provide an interdisciplinary understanding sion were about to start, and there was a political will to of key issues relating to organ donation and transplantation. reach a first-reading agreement on the legal text. This first- Three individuals within each group were designated to lead the reading agreement was finally reached in May 2010, the preparation of an aide memoire in advance of the Consulta- Directive to be transposed to the national legislation of tion. These documents were discussed and refined during the the 27 EU Member States (MS) in the following 2 years. meeting and were put forward for wider discussion in a ple- The Consultation also preceded the discussion by the nary session. The body of evidence collated in these docu- World Health Assembly (WHA) of the updated WHO ments by the participants of the Consultation, and the recom- Guiding Principles for Human Cell, Tissue and Organ mendations contained therein, form the basis of the Madrid Transplantation following their endorsement by the Exec- Resolution. The Madrid Resolution (1) identifies the com- utive Board of WHO in January 2009. In May 2010, the mon challenges facing transplantation in all countries and 63rd World Health Assembly endorsed the Guiding Prin- acknowledges the unique issues of particular societies and ciples through Resolution 63.22. This resolution urged regions and (2) provides a diverse body of recommendations MS, inter alia, “to strengthen national and multinational to governments, international organizations, and healthcare authorities and/or capacities to provide oversight, organi- professionals for the successful pursuit of the goal of self- zation and coordination of donation and transplantation sufficiency in organ donation and transplantation. activities, with special attention to maximize donation This report of the Third WHO Global Consultation on from deceased persons and to protect the health and wel- Organ Donation and Transplantation is structured in three fare of living donors with appropriate healthcare services parts. First, the final Madrid Resolution and Executive Summary and long-term follow-up.” The resolution, therefore, are presented, which crystallize the central recommendations to echoes the main conclusions of the Third WHO Global emerge from the Consultation. Second, the proceedings of all Consultation on Organ Donation and Transplantation. plenary sessions are summarized to provide a global overview of In July 2008, the Declaration of Istanbul on Organ current challenges and a comprehensive report on the status of Trafficking and Transplant Tourism was promulgated transplantation activities in 2010. Third, the eight aide memoires by TTS and the International Society of Nephrology (ISN). of the working groups are presented in full, with supplementary The Declaration recognizes the importance of self-sufficiency in information in related annexes. This report is intended as an immediate resource for policy makers and as a guide for practical © World Health Organization 2011. All rights reserved. initiatives. It is hoped that the challenges described will also in- The World Health Organization has granted the publisher permission for the spire further work in this emerging and important field with reproduction of this supplement. Copyright in the typographical arrange- implications for healthcare systems. ment, design, and layout resides with the publisher Lippincott Williams & Wilkins. The Third WHO Global Consultation hence ad- ISSN 0041-1337/0-2000/00-27 dressed the concept of self-sufficiency in organs for trans- DOI: 10.1097/TP.0b013e3182190b29 plantation in a comprehensive way for the first time. The

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Madrid Resolution recognizes that organ donation and Shaheen, Naoshi Shinozaki, Harjit Singh, Martin Alejandro transplantation are more than a good gesture and a medi- Torres, and Anantharaman Vathsala. cal service and must involve all citizens. The pursuit of We would also like to acknowledge the efficacy and self-sufficiency relies on a communal appreciation of the wisdom of those who accepted the task of chairing ses- value of organ donation after death. It is an example of the sions: Gu¨nter Kirste, Jeremy Chapman, Peter Doyle, Carl- public health and community values of reciprocity and Gustav Groth, Rafael Matesanz, Enrique Moreno, Arie solidarity; moreover, it is the only safeguard against the Oosterlee, and Jean-Marc Spieser. Special thanks are owed temptation of yielding to trade in human organs. to Beatriz Domínguez-Gil, Martí Manyalich, Dominique The Secretariat wishes to acknowledge the close and Martin, and Sarah White, rapporteurs of the Consultation, fruitful collaboration between the co-organizers of the who captured the main features and products of the Con- consultation, the invaluable support of the Government of sultation and prepared the present report. Sarah White put Spain, at the time holding the Presidency of the Council of together and edited the present report and deserves the Ministers of the EU and the decisive contribution of the thanks of all involved in the consultation. European Commission Directorate General for Health and The preparation and the logistics of the meeting, so Consumer Policy (DG SANCO). The concepts and prepa- essential to its success, owes much to Lola Perojo and the ration for this meeting were brought together from May ONT team; Filomena Picciano and her team at TTS office; 2009 onward by Alex Capron, Jeremy Chapman, Francis and Mar Carmona, Fiona Constable and Chris Faivre-Pierret at Delmonico, Beatriz Domínguez-Gil, and Dominique Mar- WHO to whom we want to express our gratitude. This tin, and we are very grateful to them for their hard work. report represents the views of the participants not neces- We are indebted to the leaders of the working groups sarily those of WHO. All the participants in the consulta- for their dedication and talent in preparing and developing tion should be thanked for their active participation and the basis for this consultation: Curie Ahn, Nikola Biller- their will to achieve consensus. The report was submitted Andorno, Alex Capron, Jeremy Chapman, Francis Del- to all participants for comment. We are grateful to them monico, Beatriz Domínguez-Gil, Rudolf Garcia, John Gill, for their input. Any error or omissions are, of course, our Christian Jacquelinet, Vivekanand Jha, Adeera Levin, Alex responsibility not theirs. Manara, Farhat Moazam, Jose Ramo´nNu´n˜ez, Gregorio Ob- Luc Noël, Coordinator, WHO, Department of Essential rador, Gerry O’Callaghan, Axel Rahmel, Chris Rudge, Faissal Health Technologies (HSS/EHT/CPR). © 2011 Lippincott Williams & Wilkins S29

The Madrid Resolution on Organ Donation and Transplantation National Responsibility in Meeting the Needs of Patients, Guided by the WHO Principles

he Third Global Consultation on Organ Donation and Declaration of Istanbul, in particular emphasizing voluntary TTransplantation was organized by the WHO in collabo- donation, non-commercialization, maximization of dona- ration with the ONT and TTS and supported by the European tion from the deceased, support for living kidney donation, Commission. The Consultation, held in Madrid on March 23 and meeting the needs of the local population in preference to to 25, 2010, brought together 140 government officials, ethi- “transplant tourists.” cists, and representatives of international scientific and med- This new paradigm calls for the development of a ical bodies from 68 countries. comprehensive strategic framework for policy and practice, Participants in the Madrid Consultation urged the directed at the global challenges created by an increasing in- WHO, its MS, and professionals in the field to regard organ cidence of chronic diseases and a shortage of organs for trans- donation and transplantation as a part of every nation’s re- plantation. Self-sufficiency advocates national accountability sponsibility to meet the health needs of its population in a for the establishment of an effective planning context for dis- comprehensive manner and address the conditions leading to eases treatable through organ transplantation and character- transplantation from prevention to treatment. Donation ized by adequate capacity management, regulatory control, from deceased persons, as a consequence of death determined and an appropriate normative environment (Fig. 1). by neurologic criteria (brain death) or by circulatory criteria (circulatory death), was affirmed as the priority source of 1. National capacity management involves: (a) development organs and as having a fundamental role in maximizing the of an adequate and appropriate healthcare infrastructure therapeutic potential of transplantation. and workforce consistent with the country’s level of devel- Every country, in light of its own level of economic and opment and economic capacity; (b) adequate and appro- health system development, should progress toward the priate financing of organ donation and transplantation global goal of meeting patients’ needs based on the resources programme; and (c) management of need by investment obtained within the country, for that country’s population, in chronic disease prevention and vaccination. and through regulated and ethical regional or international 2. National regulatory control consists of (a) adequate cooperation when needed. The strategy of striving for self- legislation, covering declaration of death, organ pro- sufficiency encompasses the following features: actions curement, fair and transparent allocation, consent, es- should (1) begin locally, (2) include broad public health mea- tablishment of transplant organizations, and penalties sures both to decrease the disease burden in a population and for organ trafficking and commercialization; (b) regu- to increase the availability of organ transplantation, (3) en- lations covering procedures for , re- hance cooperation among the stakeholders involved, and (4) imbursement, and allocation rules; and (c) systems for be carried out based on the WHO Guiding Principles and the monitoring and evaluation, including traceability and

FIGURE 1. Schematic representation of the concept of national accountability in meeting the donation and transplanta- tion needs of the population. CKD-chronic kidney disease; CVD-cardiovascular disease; COPD-chronic obstructive pulmo- nary disease. S30 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

surveillance, and for enabling evaluation of programme IMPLEMENTING SELF-SUFFICIENCY: performance. RECOMMENDATIONS FROM THE 3. National authorities need to lead normative change, MADRID CONSULTATION from a perception of organ donation as a matter of the The human right to health and dignity includes the recogni- rights of donor and recipient to one of responsibility tion of all human needs for transplantation. While self-sufficiency is across all levels of society, through unambiguous legis- conceived as a common global goal, the capacity to meet patients’ lation, committed support, and ongoing education and needs should be found primarily within each country’s own re- public information campaigns. Meeting needs of pa- sources, involving regulated regional or international cooperation tients while avoiding the harms of transplant tourism when appropriate. The requirements of organ donation and and commercial donation from living persons is an eth- transplantation programmes with respect to resourcing, proper ical imperative that relies on the assumption of a collec- organization, regulation and the oversight of procurement, pro- tive responsibility for donation after death by all citizens cessing and transplantation of human body components from and residents, thereby contributing to the common living and deceased persons are matters that rightly come under good of transplantation for all. the responsibility of governments, as outlined in Resolution WHA57.18. The health of all populations will benefit from a Consistent with the political and ethical obligations of comprehensive response to diseases contributing to end- governments toward their citizens, the pursuit of self- stage organ failure, from prevention to access to effective sufficiency promotes the health and protects the interests of organ transplantation programmes made possible by a suf- populations. Although the practical implementation of self- ficient supply of donor organs. There is also a strong eco- sufficiency will vary for different countries, influenced by eco- nomic imperative to improve rates of transplantation and nomic factors, health sector development, and existing health therefore organ donation: is less priorities, the inherent values of the self-sufficiency paradigm costly to provide than dialysis, and therefore, maximizing and the WHO Guiding Principles on human cells, tissues and rates of kidney transplantation would significantly reduce organs should guide organ donation and transplantation policy overall expenditure on renal replacement therapies. Kid- and practice in all contexts. The following overarching aspects of ney transplantation also results in better survival and qual- self-sufficiency were identified during The Madrid Consultation ity of life outcomes and enables greater productivity and as subject to specific recommendations: community participation. The perception of organ transplantation as an expensive and luxury clinical prac- Preventing the Need for Transplantation and tice is invalid; rather it is cost effective, mainstream, and a Increasing Organ Availability Are National cardinal feature of comprehensive health services. Beyond Responsibilities the unmistakable medical benefits to patients affected by end-stage organ failure, organ transplantation is a key to • Organ donation and transplantation have a role in the the challenge facing healthcare providers worldwide of un- national health policies of all countries, regardless of sustainable expenditures on dialysis services and has po- current transplant capability. tential to generate further practical consequences for • Of equal importance to infrastructure and professional health systems. development in organ donation and transplantation is From a public perspective, the pursuit of self-sufficiency sustained investment in prevention to reduce future relies on a communal appreciation of the value of organ do- needs for transplantation, through intervention in the nation after death. The concept of donating human body major risk factors for end-stage organ failure and the parts to save the life of another as a civic gesture is one that development of health systems able to meet the chal- should be taught at school alongside health education to de- lenges of chronic diseases such as diabetes, cardiovascu- crease the need for transplants. The pursuit of self-sufficiency lar disease (CVD), and hepatitis. in organs for transplantation exemplifies the public health • National transplantation legislation consistent with the WHO and community values of equity, transparency, reciprocity, Guiding Principles is fundamental. It provides adequate pro- and solidarity, while it is the only safeguard against the temp- tection from exploitation and unethical practices and elimi- tation of yielding to trade in human organs. nates legislative impediments constraining the science and In preparation for and during the meeting in Madrid, medicine of donation from deceased persons. eight Working Groups identified specific goals and challenges • Public support for organ donation necessitates norma- and proposed solutions and recommendations from a num- tive change. To this end, education of the public should ber of perspectives. The Working Groups identified the com- begin in school, emphasizing individual and community mon challenges faced by both developing and developed ethical values such as solidarity and reciprocity. Self- countries, the unique issues of particular societies and re- sufficiency is founded in three main ethical premises: gions, and provided a rich and extensive set of recommenda- • The human right to health encompasses transplanta- tions directed at governments, international organizations, tion and disease prevention. and healthcare professionals regarding how to best maximize • Organs should be understood as a social resource; donations from deceased persons (including the develop- equity must therefore govern both procurement ment of The Critical Pathway for organ donation; Fig. 2) and and allocation. how to successfully progress toward meeting the needs of • Organ donation should be perceived as a civic patients. responsibility. © 2011 Lippincott Williams & Wilkins S31

FIGURE 2. The critical pathway for organ donation. This figure was published in Transplant Int 2011; 24: 373–378. The figure has been reproduced with permission granted by Wiley-Blackwell.

Donation and Transplantation Reflect international benchmarking, identify regions in need of Comprehensive Health Care data, guide national policy making, and enable research. • The critical functions of oversight, maintenance of pro- Opportunities to Donate Should Be Provided in fessional standards and ethics, regulation, policy setting, as Many Circumstances of Death as Possible and monitoring and evaluation of organ donation and transplantation programmes are most effectively man- • The critical pathway provides a framework for the pro- aged by a National Transplant Organization (NTO). cess of donation from deceased persons, which will aid • Data registries are necessary for operational support global harmonization of practice. (waiting list management and organ allocation) and for • The key to self-sufficiency is maximizing donation from monitoring and surveillance of practices and outcomes. deceased persons: facilitating donation in as many cir- • Monitoring and surveillance should encompass the cumstances of death as possible, maximizing the out- following data: national prevalence and incidence of comes from each donor, and optimizing the results of end-stage organ failure and diseases contributing to transplantation. Donation after both brain death and end-stage organ failure (need); availability of related in- circulatory death should be regarded as ethically proper. frastructure and access to organ replacement therapies; Organ donation from living persons should be encouraged outcomes of organ replacement therapy; acceptance as complementary to donation after death, by providing onto transplant waiting lists and time to receipt of an appropriate regulatory frameworks and donor care. organ; organ donation practices, standards and activities; • Physicians and nurses involved in acute care have a central practices, standards and activities in organ donation from role in identifying possible donors and facilitating donation living persons; and outcomes of transplantation (patient after death, and therefore should be supported by the nec- and survival). International harmonization of such essary educational, technical, legal and ethical tools to as- metrics would facilitate comparisons between systems and sume leadership in this regard within their facility. S32 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

Executive Summary

PREAMBLE 6. The role of public health and society In response to the global disparities in access to trans- 7. Ethics plantation, a growing demand for organs, and the self-evident 8. Measuring progress harms of transplant tourism, a meeting of 140 representatives Each group was led by three individuals, who in of international scientific and medical bodies, government advance of the meeting, worked together to guide the prepa- officials, and ethicists was held in Madrid, Spain, on March 23 ration of a draft document for discussion and refinement to 25, 2010. This Third Global Consultation was organized by during the meeting. The outcomes of the working groups the WHO, TTS and ONT, and supported by the European were also discussed in a plenary session. The final eight doc- Commission. The purpose of the meeting was to call for a uments produced by the working groups complete the Ma- global goal of national responsibility in satisfying organ do- drid Resolution on Organ Donation and Transplantation and nation and transplantation needs, with sufficiency based on are based on a large body of evidence collected by participants resources obtained within a country for that country and before the consultation and reflecting their particular experi- through regulated and ethical regional or international coop- ences representing 68 nations. The Madrid Resolution identi- eration, when needed. The concept of a national responsibil- fies the common challenges faced by both developing and ity encompasses the following features: (1) action should developed countries, and the unique issues of particular soci- begin locally (not precluding international cooperation); (2) eties and regions, and provides a diverse body of recommen- strategies should be targeted to decrease the transplantation dations to governments, international organizations, and needs of a population and increasing organ availability, and healthcare professionals regarding how to successfully meet should enhance cooperation between stakeholders involved; the needs of patients. This document represents an immedi- (3) these strategies must be based on solid ethical principles: ate resource for policy makers and guide for practical initia- solidarity, voluntary donation, and non-commercialization tives. It is hoped that the Madrid Resolution will also inspire (1); and (4) strategies should be tailored to the local realities. new work in this emerging and important field. The Third WHO Global Consultation carries forward the principles laid out in the WHO Guiding Principles for Human The Resolution Cell, Tissue and Organ Transplantation, and the Declaration of Istanbul on Organ Trafficking and Transplant Tourism (1, 2). Meeting the needs of patients with respect to organ do- nation and transplantation is a national responsibility that The WHO Guiding Principles articulate the importance of pur- should be met primarily through a country’s own resources, suing national or subregional self-sufficiency in organs for trans- with specific regulated and ethical regional or international plantation, in particular through increased efforts to promote cooperation when appropriate. National accountabilities can donation after death. The Declaration of Istanbul further states be broadly defined as the creation of a national planning con- that “Jurisdictions, countries and regions should strive to text for chronic diseases treatable through organ transplanta- achieve self-sufficiency in organ donation by providing a suffi- tion that encompasses capacity control, regulatory control, cient number of organs for residents in need from within the and determination of the appropriate ethical environments. country or through regional cooperation.” The goal of the Ma- drid consultation was to confront the self-sufficiency paradigm 1. National capacity control involves: (a) development of from a practical perspective, developing a comprehensive strate- adequate and appropriate healthcare infrastructure and gic framework for policy and practice directed at the global chal- workforce development, consistent with development lenges of a shortage of organs for transplantation and unmet level and economic capacity; (b) adequate and appro- patient needs. Therefore, the Madrid Resolution expresses both priate financing of organ donation and transplantation a pledge to progress in satisfying organ donation and transplan- programmes; and (c) management of need by invest- tation needs, and a roadmap of how this may be achieved. ment in chronic disease prevention and vaccination. It was the intent that the consultation process should be 2. National regulatory control consists of: (a) adequate comprehensive and holistic, encompassing different perspec- legislation, covering declaration of death, organ pro- tives studied and discussed during the meeting. Eight differ- curement, fair and transparent allocation, consent, ent working groups were convened, with group members establishment of transplant organizations, penalty of chosen to represent a variety of different clinical experiences organ trafficking, and commercialization; (b) regula- and geographical regions, and to provide an interdisciplinary tion covering procedures for organ procurement, re- understanding of the issues. The eight groups identified spe- imbursement, and allocation rules; (c) systems for cific goals and challenges, and proposed solutions and recom- monitoring and evaluation, including traceability mendations with respect to the following topics: and surveillance, and enabling evaluation of pro- gramme performance. 1. Assessing needs for transplantation 3. National authorities need to lead normative change, 2. System requirements from organ donation as a right of donor and recipient to 3. Meeting needs through donation a responsibility across all levels of society, through edu- 4. Monitoring outcomes cation, unambiguous legislation, and committed sup- 5. Fostering professional ownership in the emergency de- port. Meeting needs of patients while avoiding the partment (ED) and intensive care unit (ICU) harms of transplant tourism and commercial donation © 2011 Lippincott Williams & Wilkins S33

from living persons is an ethical imperative that relies e. Create or support infrastructure and allotment of re- on collective responsibility for donation after death, sources for all aspects of needs assessment. thereby contributing to the common good of transplan- tation for all. The WHO Guiding Principles for Human 5. With respect to needs assessment in transplantation, Cell, Tissue and Organ Transplantation provide the WHO should: foundation for all efforts toward progress in meeting a. Identify as a resolution that all countries shall have the transplantation needs. ability to assess their needs for transplantation by 2020; b. Identify and outline the need for the use of a core min- imum dataset by which international comparisons will Recommendations become meaningful. Informing The Resolution are the detailed recommen- dations of the eight working groups convened as a part of the 6. Professional societies and healthcare providers should: Third WHO Global Consultation on organ donation and a. Ensure consistency of definitions and use of metrics transplantation. The key recommendations of these working with respect to registry data; groups are as follows: b. Support identification of organ failure as a strategic priority; Recommendations With Respect to Assessment of c. Foster international enquiry, collaboration, and devel- Transplantation Needs opment in the area of needs assessment; d. Promote and support education relating to needs as- 1. True need for transplantation cannot be defined by avail- sessment, including technical advice regarding meth- ability of treatment. Instead assessment of need must be odologies, data interpretation, and applications; multifactorial and take into account: e. Promote scientific enquiry in the area of needs assess- a. True incidence of end-stage organ failure, irrespective ment, including validation studies; of treatment availability (in all age groups and for all f. Ensure linkages with governmental agencies and policy organs). makers to support translation of research. b. Complexity of conditions and the drivers of need. c. Nonmedical factors (e.g., economic, cultural, attitudi- Recommendations With Respect to Systems and nal, competing health priorities) that modify actual Organization transplant needs within that setting. 1. Clear and unambiguous legislative and regulatory frame- works are the foundation on which successful systems for 2. Internationally consistent definitions, data, and tools organ donation and transplantation, based on ethical and need to be developed to accurately and comprehen- transparent practices with respect to organ procurement, sively measure transplantation needs, thereby enabling recovery, allocation and transplantation, are built. Gov- a broader understanding of the issues facing different ernments should therefore: countries and facilitating the identification of global a. Enact transplantation legislation consistent with the solutions. WHO Guiding Principles. Legislation should address: • 3. An international registry of organ donation and trans- Standards for determining and declaring death; • Organ procurement from deceased and living persons; plantation should be established. The following national- • level data should be made available for this purpose: Fair and transparent allocation to wait-listed patients, based on medical criteria; a. National prevalence and incidence of end-stage organ • failure and of diseases contributing to end-stage organ Respect for the wishes of the deceased concerning failure. consent; • Establishment of transplant organizations; b. Availability of treatment for end-stage organ failure • (transplant and non-transplant). Prohibition of organ trafficking and commercialization. c. Waiting-list statistics, including “true” wait times. Governments should also: d. Progression and outcomes of organ dysfunction. b. Incorporate donation and transplantation into national e. Referral to organ replacement therapy (assist devises health policies as a priority; and transplantation). c. Support donation after death; f. Time to workup, time to acceptance onto the waiting d. Invest in basic infrastructure and professional training; list, and time to receipt of an organ. e. Create a national waiting list and comprehensive regis- try of donors and recipients; 4. All countries should have the ability to assess their needs f. Create the necessary systems for ongoing regulation and for transplantation. Governments should: oversight to ensure transparency and facilitate review of a. Support the identification of organ failure or replacement progress and the implementation of new strategic poli- needs as a priority for public health improvement; cies; b. Allocate resources to registry development (opera- g. Lead public awareness of organ transplantation and tional and surveillance/monitoring) and furthermore commit to public education. create a registry for conditions leading to the need for organ transplantation; 2. NTOs responsible for coordination and oversight, ethical c. Invest in prevention programmes to reduce needs; practice, regulation, policy setting, maintenance of na- d. Ensure the equity principle is applied in needs tional data registries, and data protection are essential. assessment; Core functions are to include: S34 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

a. Surveillance of practices, standards, and outcomes in approach should be adopted with explicitly defined ac- organ donation and transplantation; tions, roles, and responsibilities across the entire process. b. Assurance of ethically proper organ procurement and The Critical Pathway for organ donation is to be consid- allocation, transparency of all organ donation and ered a general framework of reference for systematizing transplantation processes, and traceability of donated the deceased donation process. The objectives of The Crit- human materials; ical Pathway are as follows: c. Standardization of procedures and performance manage- a. To provide a common systematic approach to the pro- ment of Organ Procurement Organizations (OPOs), re- cess of donation from deceased persons, both for DBD lated non-government organizations (NGOs), individual and DCD. transplantation centers, ethics committees, and transplant b. To create common triggers to facilitate the prospective teams; identification and referral of the possible deceased or- d. Regulation and management of the reimbursement of gan donor and precipitate the deceased donation reasonable and verifiable expenses incurred by the living process. donor, and reimbursement of hospitals that incur costs c. To provide common procedures to estimate the poten- in donating or procuring organs; tial of organ donation from deceased persons and eval- e. Oversight of the division of responsibilities across uate performance in the deceased donation process. all organizations involved in organ donation and transplantation; 3. With respect to organ donation from deceased persons, f. Public endorsement of organ donation and transplanta- governments should: tion and support of the process with mass media educa- a. Eliminate legislative impediments constraining the tion and promotion. medicine and science of donation from deceased per- sons and organ transplantation; 3. When organization is based on OPOs, these organizations b. Provide adequate support (including financial sup- manage procurement activities independently of hospital port) for organ donation from deceased persons and transplant units, subject to government approval and transplantation programmes; regulation. The nature of OPOs will vary according to c. Ensure equitable access to transplantation therapies different national requirements and realities, although the and transparency of the system; essential functions are the same in every setting, which are d. Through a NTO (see Recommendations with respect as follows: to Systems and Organization, number 2) provide over- a. Surveillance and detection of possible/potential donors sight and ensure the development and implementation at every acute care hospital. of the following: b. Donor management for the recovery of viable organs. • The Critical Pathway; c. Coordination of procurement, through a designated • Protocols for all steps of the process of donation after Organ Procurement Coordinator (OPC). death, especially timely identification and referral; • Appointment of trained professionals, including donor 4. Performance is dependent on successful integration and coordinators, who are accountable for performance; coordination across systems. All countries performing • A data registry for ongoing evaluation of donation transplantation need to organize a unified coordination processes, estimation of the potential of donation that regulates organ donation and transplantation pro- from deceased persons, evaluation of overall perfor- cesses. In addition, international coordination facilitates mance, identification of areas for improvement, and cross-border exchange of organs, information and re- factors critical to success; search, and it is critical to combat organ trafficking and • Professional training and promotion of a national transplant tourism. culture of donation.

Recommendations With Respect to Organ Donation 4. With respect to donation from deceased persons, the 1. Countries and jurisdictions should aim to maximize WHO should: donation from deceased persons, maximize the out- a. Promote the international implementation of The come from each deceased donor, and optimize results Critical Pathway; of transplantation. b. Monitor the collection of relevant data assessing per- a. Donation from deceased persons is a requirement; formance in organ donation for international transplantation activity cannot rely on living donors. benchmarking; b. Both donation after brain death (DBD) and donation c. Foster regional cooperation in organ sharing that pre- after circulatory death (DCD) are to be considered. serves equity between donor and recipient popula- c. Countries should enable transplants from living do- tions, and the efficient transplantation of otherwise nors, as complementary to donation from deceased discarded organs. persons, by providing appropriate ethical and legal frameworks and donor care. 5. With respect to organ donation from deceased and living persons, healthcare professions should: 2. Donation after death is a process, at any stage of which a. Make every effort to maximize the number of organs losses of potential donors may occur. Therefore, to maxi- recovered and transplanted; mize donation from deceased persons, an organizational b. Support and promote DCD; © 2011 Lippincott Williams & Wilkins S35

c. Present the option of donation from living persons to c. Facilitate development of an International Data Group families, with all practices in the donation of organs for the ongoing collection of data that will empower from living persons consistent with the principles of individual countries and regions in the pursuit of The Declaration of Istanbul. self-sufficiency. Recommendations With Respect to Monitoring of Recommendations With Respect to Fostering Emergency Outcomes in the Pursuit of Self-Sufficiency and Intensive Care Department Professional Ownership of Organ Donation 1. The purpose of registering data on transplant activities and outcomes is to identify areas in need of improvement; 1. Organ donation is a different process than organ trans- to enable system transparency, equity, and compliance; plantation and requires different skills and personnel to and to monitor system improvement both longitudinally maximize its potential. Possible and potential deceased within a given system and between systems through inter- donors are found in the ICUs and increasingly in EDs. national benchmarking. Registries should be not only Physicians and nurses involved in acute care need to be concerned with donors and recipients but also with infra- aware of their critical role in identifying possible and po- structure availability. They are a tool for quality assurance tential donors and to be engaged in the development of and policy making, and registry data may furthermore be programmes for organ donation from deceased persons. used to raise awareness of the need for organ donation Therefore, the pursuit of self-sufficiency requires ICU and among the lay public and policy makers. ED doctors and nurses to: a. Be aware of the need for organ donation and therefore 2. In all countries/regions, data should ideally be collected in want to facilitate it; the following areas: b. Know how to facilitate organ donation and have the a. Available infrastructure (hospital and organizational); educational, technical, legal and ethical tools to do so; b. Regulatory oversight and health policy; c. Be supported by their colleagues, hospitals and health c. Current and likely future needs for transplantation; authorities in facilitating organ donation; d. Access to the waiting list and to transplantation; d. Be recognized as experts in this area and in educating e. Waiting-list outcomes; their colleagues; f. Travel for transplantation and transplant tourism; e. Take the lead in enabling their facility to provide this g. Organ donation from deceased persons; service, including appropriate counseling for families. h. Organ donation from living persons; and i. Outcomes of transplantation (patient and graft survival). 2. To foster professional ownership of self-sufficiency in the ED and ICU, governments should: 3. Two complementary data collection systems are proposed: a. Under legal, ethical, and medical frameworks for prac- a. A national/regional system, which has operational tice, include: functions (allocation) and monitoring and evaluation. • Standards for determining death, enacted by the leg- b. An international system with a global perspective, un- islature, and accepted by the profession and public; der an International Data Group. The International • Evidence-based tests and methods that physicians Data Group would establish standardized definitions/ can readily use to apply these standards in the ED metrics, provide assistance to national/regional regis- and ICU; tries, facilitate comparisons between systems and inter- • Clear statements, at institutional and governmental national benchmarking, identify regions in need of levels, regarding the responsibility of various care data, guide individual nations and systems, and facili- providers to donors and recipients. tate research into special patient groups where small b. Provide unambiguous guidance ensuring that indi- patient numbers would otherwise be restrictive. vidual medical staff involved in acute care are not 4. With respect to monitoring, governments should: personally or legally vulnerable when aiding the or- a. Support national/regional registries with infrastruc- gan donation process. ture and human resources; b. Establish responsibility for operation and governance 3. Professional bodies should: of this registry; a. Provide training and guidance for Emergency/Inten- c. Facilitate cooperation between government and NGOs sive Care nurses and physicians, covering: • in monitoring outcomes and disseminating informa- The need for organ donation and the importance of tion to the scientific community, the public, and policy the role of acute care physicians and nurses; makers; and • Identification of possible and potential donors; d. Use registry data to assess the impact of policy change • Death determination; and inform the need and direction of new legislation • Protocols on how treatment decisions (e.g., for pa- and policy. tients with severe neurologic injuries) relate to donor status and to alternative (circulatory/respiratory and 5 Professionals and professional societies should: neurologic) bases for determining death; a. Provide content expertise; • Protocols on how to manage the dying process for pa- b. Cooperate on the consistency of data elements across tients whose deaths will be determined on circulatory/ the continuum of organ failure (i.e., chronic kidney respiratory or neurological grounds, and on post-death disease, dialysis, and transplantation); and maintenance of body; S36 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

• How to make donation an understandable and ac- procity, solidarity, and building public willingness to ceptable choice for families of dying patients; support organ donation; • Effective interaction with the OPO and transplanta- b. Community funding for donation and transplantation tion team. through public finance and charitable sources. b. Support the development of academic and scientific research activity in the emergency and intensive care 3. Recommendations for public health: communities to create a professional investment in the a. Reduce demand for transplantation by prevention of best practice approaches that emerge. major risk factors for end-stage organ failure and by developing healthcare systems able to effectively and 4. Hospitals should: equitably meet the challenges of chronic diseases, par- a. Give local ED and ICU staff “ownership” of solving the ticularly diabetes and hypertension; problems and developing protocols for managing the b. Develop awareness and increased willingness of medical care of potential donors; professionals to be involved in the donation and trans- b. Identify individuals within the emergency or intensive plantation process, encourage a stakeholder role for care team who can act as role models or “champions” ICU/ED physicians, and develop specific education to increase the profile of organ donation within that programmes for primary care physicians, nurses, med- facility and provide education to the team on all rele- ical students, and allied health professionals; vant issues; c. Develop culturally sensitive awareness programmes, c. Appoint donor coordinators within hospitals to facili- using public health methodologies to promote trust and tate communications among emergency and intensive strengthen commitment to organ and tissue donation care staff, bereaved families and transplantation in the community; services; d. Increase the efficiency of healthcare systems and trans- d. Include the possibility or potential for organ donation plant programmes by using private and non-govern- in every end-of-life care pathway in the ED/ICU; ment sources of funding as appropriate, and developing e. Improve the interface between the ED/ICU and the synergies between the government and NGOs. local transplant team and responsible National Authority; 4. Recommendations for society: f. Identify strategies to minimize the effects of lack of re- a. Provide regular and consistent normative change com- sources on the conversion of potential donors to actual munication programmes and culturally sensitive donors; awareness programmes directed at community and g. Audit outcomes of the donation process within each faith-based organizations; facility to allow identification of potential areas for im- b. Provide public recognition of donors and their families provement, set achievable targets, and formally recog- and actively manage adverse publicity; nize excellence. c. Ensure all aspects of donation and transplantation are Recommendations With Respect to the Role of Public transparent to the public, and develop educational pro- Health and Society grammes to dispel myths and misconceptions, taking into account the range of community beliefs and values. 1. Roles for public health in the pursuit of self-sufficiency include: 5. In settings where resource limitations and health sector a. Prevention of the frequent causes of end-stage organ development constrain the development of organ dona- failure (diabetes, hypertension, alcohol abuse, hepatitis tion and transplantation programmes, the prevention of B virus [HBV], hepatitis C virus [HCV], coronary ar- end-stage organ failure, within the context of wider public tery disease [CAD], and chronic obstructive pulmonary health goals, is crucial to self-sufficiency. In such settings, disease [COPD]), including primary, secondary, and delivery of transplantation therapy may be approached tertiary prevention; through locally relevant approaches to financing, using b. Promotion of organ donation among health profes- both private and non-governmental sources of funding, sionals and the general public; and developing synergies between governments, NGOs, c. Development of effective healthcare systems capable of and charities. supporting efficient organ procurement, equitable allo- cation, safety and quality, and national disease preven- Recommendations With Respect to Ethics in the Pursuit tion programmes. of Self-Sufficiency 2. The act of donation is itself an individual decision that 1. Self-sufficiency must be supported by normative change, interacts with the social setting and the institutional and reframing organ donation from a matter of the rights of regulatory framework into which an individual is embed- donor and recipient, to a responsibility functioning at all ded. Family refusal, together with failure to identify levels of society (individual, government, professional, possible and potential donors, is the most significant im- etc). The self-sufficiency paradigm is based on three main pediment to increase rates of donation. Roles for society in ethical premises: the pursuit of self-sufficiency include: a. The human right to health requires that governments a. Public education efforts to counter poor awareness, dis- engage in prevention and providing transplantation trust of medicine, and misconceptions about donation services. The responsible administration of scarce re- and transplantation, while instilling notions of reci- sources such as organs also encompasses concerted ac- © 2011 Lippincott Williams & Wilkins S37

tions directed toward prevention of end-stage organ tional/regional transplantation capabilities to progress failure. from one level of capability to the next, in a manner that is b. Organs should be understood as a social resource; consistent with local realties and does not distort existing therefore, equity should govern both procurement and health priorities. Countries/regions evolve toward greater allocation. self-sufficiency in organ donation and transplantation c. Organ donation should be perceived as a civic respon- through incremental achievements in each of the follow- sibility toward fellow citizens; in contrast, organ ing domains: markets and transplant tourism lead to morally unac- a. Resources and professional development for donation ceptable coercion and exploitation. and coordination; b. Legal and regulatory frameworks; 2. In accordance with The Declaration of Istanbul and the c. Resources and professional development for transplant WHO Guiding Principles, self-sufficiency promotes the services; following ethical principles: d. Government and other resources; a. Minimizing harm/reducing suffering—both decreas- e. Community involvement; ing need for transplantation and efforts to maximize f. Assessment and minimization need for organs. the number of organ available for transplantation are emphasized. 3. To enable evolution and achievement in transplantation b. Justice—an equitable distribution of benefit and bur- capability, Governments should: den and the elimination of exploitation are central to a. Acknowledge their responsibilities in managing end- the self-sufficiency paradigm. stage organ failure from prevention to treatment in c. Respect for persons—self-sufficiency avoids undue in- their population and designate a focal point/coordinat- centives while appealing to solidarity and civic respon- ing authority; sibilities toward the community. b. Derive an integrated strategy for the care of patients 3. With respect to ethics and self-sufficiency: with end-stage organ failure, from prevention of organ a. Governments/health authorities should be account- disease and organ failure to replacement therapies includ- able for the ethical integrity of organ donation and ing transplantation, to optimize the use of resources; transplantation systems; c. Include the elements of organ donation and transplan- b. Health professionals should receive training in the tation in their national health plan and assess their own ethical aspects of organ transplantation and be vigi- level of transplantation capability; lant concerning unethical or illegal behavior, and d. Allocate resources, develop infrastructure, and professional societies should foster enquiry on ques- strengthen health systems to support the achieve- tions of culture, values, and ethics relating to self- ment of these goals; sufficiency; e. Report national data on organ donation and transplan- c. Civil society should establish an ethos of social re- tation activities to the Global Observatory on Donation sponsibility and solidarity in meeting the commu- and Transplantation (GODT); nity’s transplantation needs through participation in f. Participate in public education and engage profession- donation after death, necessitating the engagement als, professional societies, NGOs, and the community; of community- and faith-based organizations and g. Foster regional and international cooperation in the NGOs. pursuit of these goals. Overall Recommendations With Respect to Effective 4. To support national/regional efforts to pursue self- Progress in the Pursuit of Self-Sufficiency sufficiency, WHO should: 1. The capability of individual countries/regions to meet a. Urge MS to adopt and implement the principles of the transplantation needs is determined by economic re- Madrid Resolution; sources, systems development, and existing health priori- b. Urge MS to self-assess their level of transplantation ties. The minimum level of transplantation capability is capability, to aid the identification of areas for defined as the presence of a few medical professionals who improvement; have the capability to provide appropriate presurgical and c. Monitor progress in levels of achievement in the pur- postsurgical management of transplant recipients and liv- suit of self-sufficiency across MS: ing donors in a context of no local transplantation activity; d. Align the range of quantifiable indicators collected by maximum capability is defined as a comprehensive multi- the GODT to the framework of the Madrid Resolution; organ transplant programme that provides an adequate e. Develop international standards, guidelines, and supply of transplantable organs to meet the needs of the tools, in collaboration with professional organiza- population. By defining successive levels of capability, the tions, for the advancement of transplantation policy inclusive nature of the self-sufficiency paradigm is and practice; reinforced, and it is possible to describe a framework for evolution and achievement in organ donation and trans- 5. To support national/regional efforts to pursue self- plantation that is adaptable to all contexts. sufficiency, professionals and professional societies should: 2. The pursuit of self-sufficiency involves the development a. Acknowledge their responsibilities with respect to their and implementation of strategies aimed at increasing na- own professional development, adoption of ethical S38 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

practices, maintenance of standards, and training for the value of organ donation. The concept of donating hu- donation and procurement; man body parts to save the life of another as a civic gesture b. International societies should support the establish- is one that should be taught at school as a part of health ment and work of the relevant national societies to fur- education along with promotion of healthy life style. The ther their missions with respect to organ donation and organizational requirements and allocation of resources transplantation; necessary to maximize donation from deceased donors c. Provide professional advice to MS and assistance for and ensure equitable access to transplantation services, the development of standards for accreditation and and the implementation of preventive interventions to al- quality assurance; leviate needs for transplants, mandate the active commit- d. Participate in professional and public education and ment of Government. The benefits to be gained extend way engage other professionals and the public in the ad- beyond the successful transplantation of patients. The pur- vancement of organ donation and transplantation; suit of the goal of ensuring a national responsibility in e. Encourage research, especially clinical research di- satisfying the donation and transplantation needs of a rected at maximizing benefits, minimizing costs, and given population, outlined in the Madrid Declaration, has optimizing resource allocation in organ donation and the capacity to strengthen the public health and commu- transplantation. nity values of reciprocity and solidarity, while it is the only safe guard against the temptation of yielding to trade in CONCLUSIONS human organs. The Madrid Resolution on Organ Donation and Transplantation recognizes that donation and transplanta- REFERENCES tion are more than a good gesture and a medical service. 1. Steering committee of the Istanbul Summit. Organ trafficking and trans- plant tourism and commercialism. The Declaration of Istanbul. Lancet, For patient needs to be met, all citizens and residents must 2008; 372: 5. Available at: http//www.declarationofistanbul.org. be involved. From a public perspective, national attempts 2. WHO Guiding Principles; WHA 63.22/2010 Available at: http:// to meet patient needs rely on a communal appreciation of www.who.int/transplantation/en/. © 2011 Lippincott Williams & Wilkins S39

Report of the Madrid Consultation Part 1: European and Universal Challenges in Organ Donation and Transplantation, Searching for Global Solutions

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

From the Declaration of Istanbul on Organ Trafficking and Transplant Tourism:

Principles …Jurisdictions, countries, and regions should strive to achieve self-sufficiency in organ donation by providing a sufficient numner of organs for residents in need from within the country or through regional cooperation. a. Collaborations between countries is not inconsistent with national self- sufficiency as long as the collaboration protects the vulnerable, promotes equality between donor and recipient populations, and does not violate these principles. b.Treatment of patients from outside the country or jurisdiction is only acceptable if it does not undermine a country’s ability to provide transplant services for its own population. Proposals …Governments, in collaboration with health-care institutions, professionals, and non-governmental organizations, should take appropriate actions to increase deceased organ donation. Measures should be taken to remove obstacles and disincentives to deceased organ donation. In countries without established deceased organ donation or transplantation, national legislation should be enacted that would initiate deceased organ donation and create transplantation infrastructure, so as to fulfill each country’s deceased donor potential. In all countries in which deceased organ donation has been initiated, the therapeutic potential of deceased organ donation and transplantation should be maximized. Countries with well-established deceased donor transplant programmes are encouraged to share information, expertise, and technology with countries seeking to improve their organ donation efforts… S40 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011 lenges and initiatives in organ donation and transplantation in rapid and substantial progress. For example, in Norway, 70% the EU, including a presentation of the European legislative of patients with end-stage kidney disease receive a kidney framework on quality and safety aspects of organ donation and transplant as their first line of treatment (http://www. transplantation (The Directive on Quality and Safety Standards nephro.no/nnr/AARSM2008.pdf). Regardless of the current of Human Organs Intended for Transplantation) and its associ- challenges facing the pursuit of self-sufficiency in some coun- ated Action Plan; (3) introduction of the concept of self-suffi- tries, the ultimate goal remains both desirable and relevant to ciency in organ donation and transplantation and discussion of those suffering organ failure throughout the world and will its role within the agenda of the WHO, followed by an examina- inspire efforts that strive ever closer to its achievement. tion of the responsibilities of health authorities and professional The optimization of donation after death constitutes the societies in furthering the pursuit of self-sufficiency; and (4) a foundation of the pursuit of self-sufficiency. The potential of global overview of the current state of affairs in organ donation patients who die with viable and functional organs at the time of and transplantation, with representation from each of the six death is sufficient to meet all transplant needs—if only all oppor- WHO regions. tunities for donation could be enabled. Crucially, all societies In the context of organ donation and transplantation, must begin by engaging as early as possible with the concept of “self-sufficiency” refers to the adequate and equitable provision death in the context of respective social, religious, and cultural of transplantation services and human organs to satisfy the or- values and customs, so that public discussion and education can gan transplantation needs of a given population, using resources address concerns and promote the development of responsible obtained from within that population or provided through re- policies concerning donation after death. To maximize the gional cooperation. There was extended discussion during the therapeutic potential of donation from deceased persons, Madrid Consultation regarding the ability of the term self- such policies must recognize donation after death as ethi- sufficiency to adequately capture the full implications of cally proper, including the recovery of organs from both what is involved in satisfying the organ transplantation needs of those who have died as determined by neurologic criteria populations. In particular, there was concern that the impor- (DBD) and after the irreversible cessation of circulation tant role of ethical and regulated regional or international and respiration (DCD). Although DCD is currently not cooperation in some jurisdictions, and the globally collabor- performed in all jurisdictions, it is ethically proper as the ative nature of the pursuit of self-sufficiency, would not be dead donor rule that organ recovery is not the cause of satisfactorily conveyed in the subsequent use of the term. death is affirmed by this donation pathway. In the weeks and months after the Madrid Consulta- In the face of divisive market forces that invoke urgent tion, it became evident that self-sufficiency appropriately en- needs for transplantation as an imperative to legitimize organ capsulates the conception of donation and transplantation sales, the global community must take action and promote a that we intended to promote. Scientific and professional so- greater level of community involvement in transplantation cieties include self-sufficiency in the agenda of their con- and donation activities. The tragic phenomenon of trans- gresses, and representatives of MS used it during the last plant tourism should be replaced by a united global effort WHA. The term functions as intended; striving toward self- to reframe the human experience of death as a potential sufficiency is a rallying standard for a new paradigm in the con- opportunity to participate in a vital communal endeavor ception of organ donation and transplantation that: that saves lives. Some countries already demonstrate significant prog- • Is applicable at jurisdictional level, where the authority ress toward self-sufficiency. The success of the Spanish Model and power of health policy implementation lies, and of Organ Donation in achieving 20 years of sustained in- where agreements between small countries with respect creases in rates of organ donation is internationally recog- to regional cooperation are made; nized, and Spain already has a comprehensive strategic plan • Is inclusive of all those in need of transplantation, and to further increase organ donation after death to a rate of 40 also places the burden of donation on all, whenever donors per million population (3). Elsewhere, transplanta- medically and ethically possible; tion laws prohibiting organ sales are being introduced, re- • Promotes societal values and community ethical flecting a growing political resolve to end the practices of principles; organ trafficking and transplant tourism. The Madrid Reso- • Promotes integrated end-stage organ failure manage- lution is a significant step toward a universal approach to ment, from public health education and primary pre- organ donation and transplantation and an international vention to organ replacement therapies; commitment to the pursuit of self-sufficiency. Significantly, • Has relevance to low- and middle-income countries by the Madrid Resolution also offers a roadmap of the way for- emphasizing that successful implementation of efficient ward that has relevance in all contexts and can be adapted to and effective interventions are possible in all contexts local realities. without an unjustifiable distortion of existing public health priorities; • Prioritizes the development of donation from deceased OFFICIAL OPENING persons. Trinidad Jime´nez Garcı´a-Herrera, Minister of Health Reluctance to invoke the pursuit of self-sufficiency may and Social Policy, Spain welcomes the attendees to the Ma- also be due to a fear of creating impossible hope in promoting drid Conference on Organ Donation and Transplantation the goal of meeting all needs for transplantation. However, and gives the floor to participants for the official opening. although the achievement of self-sufficiency may currently be Isabel de la Mata, Public Health Advisor, European Com- a remote goal in many societies, in others, there is evidence of mission recalls the previous Spanish Presidency of the EU, during © 2011 Lippincott Williams & Wilkins S41 which a Conference on Tissues and Cells was held. Discussions increasing organ donation rates should also be recognized. It began laying the groundwork for the development of the Direc- is to be expected that this Conference brings us a step further tive and its subsequent approval. The debate about the Directive toward an efficient, high-quality, organ donation and trans- on Quality and Safety Standards of Human Organs Intended for plantation scheme for the whole EU. Transplantation and the Action Plan started back in 2008, thanks to the efforts of the European Commission and the MS. The Commission intends to find a balance between the require- Round Table Ministries of Health ments for quality and safety of organs, tissues, and cells, and recognition of the different organizational approaches in place Country Benefits of a Common European Strategy in the EU. The Spanish Presidency will exert maximum efforts to Trinidad Jime´nez Garcı´a-Herrera, Minister of Health and get a first-reading agreement on this Directive in June 2010, and Social Policy, Spain presents participants to this round table. to see the maximum benefits for patients derived from this po- Ana Marı´aTeodoro Jorge, Minister of Health, Portugal litical initiative, along with the Action Plan. expresses the deep support of Portugal for a common Euro- Steffen Groth, Director Essential, Health Technolo- pean strategy. Portugal has evolved from 19 donors per mil- gies, WHO refers to the 57th World Health Assembly Res- lion population in 1996, to 31 donors per million population olution on Human Organ and Tissue Transplantation. As a in 2009. This improvement has been possible because of sev- consequence of this Resolution, many countries have con- eral different actions, including the introduction of trans- demned the commercialization of the human body and plant coordinators in ICUs and the training of professionals organ trafficking. This trade is inconsistent with the most in donation and transplantation. In this regard, the work car- basic human values and contravenes the Universal Decla- ried out by the University of Barcelona and its Transplant ration of Human Rights and the spirit of the WHO Con- Procurement Management Course is to be acknowledged, stitution. Although consensus is being built regarding the another example of the close cooperation between Spain and ethical principles guiding organ donation and transplan- Portugal in the field of donation and transplantation over tation, the insufficient number of organs available to meet recent years. Transplantation saves lives and improves the transplantation needs remains a challenge. Self-sufficiency quality of life of patients, but the shortage of organs within the in transplantation is to be understood as a community EU is a reality, and efforts are to be made for the pursuit of this responsibility. Every person could be a potential organ new concept of self-sufficiency. In this regard, instruments recipient, so every person should recognize him or for the promotion of international cooperation are necessary, herself as a potential organ donor after death. The WHO including those which allow an active exchange of organs aim for this conference is making the concept of self- between countries, while preserving the quality and safety of sufficiency possible. the organs transplanted. Jeremy R. Chapman, President of TTS thanks the Span- Annette Widmann-Mauz, State Parliament Secretary, ish Ministry of Health, the European Commission, the WHO, Germany stresses the fact that the number of patients on the and Dr. Francis Delmonico from TTS for making this Con- waiting list for a transplant far exceeds the number of donors. ference possible and for their dedication, which are making MS must work together to increase donation; hence, cooper- donation and transplantation progress and bringing im- ation between MS is necessary. The Directive on Quality and mense benefits for patients. Safety Standards of Human Organs Intended for Transplanta- Jo Leinen, Chair of the Committee on the Environ- tion of the European Parliament and of the Council foresees the ment, Public Health and Food Safety, European Parliament establishment of a network of MS competent authorities and sets stresses the timeliness of the Conference, because the EU is down the importance of organ exchange between countries, as immersed in debate concerning the Directive on Quality actively performed by European organizations, in particular Eu- and Safety Standards of Human Organs Intended for rotransplant or Scandiatransplant. The Directive also includes Transplantation. There are wide variations between MS in provisions to ensure a uniform level of quality and safety of or- rates of donation after death, and the shortage of organs is gans. At the same time, the Directive provides flexibility to MS a major factor affecting transplantation programmes. The with regards to the details of transposition to national legislation. Committee of Environment, Public Health, and Food Germany is supportive of this Directive and particularly empha- Safety of the European Parliament has just voted on two sizes the importance of two articles: #13, relating to the voluntary reports concerning the Directive, and the Action Plan, the and unpaid nature of donation, two basic principles which also latter aiming to achieve a better cooperation between MS help to guarantee the safety and quality of organs and #15, reg- in the field. The Directive includes the principle of voluntary, ulating the protection of the living donors. The Directive will unpaid donation and specifies measures for the protection of bring undisputed advantages for EU countries and immense the living donor, issues of paramount importance for the Par- benefits for their patients. liament. Given the need to match donors with recipients, the Melinda Medgyaszai, State Secretary, Hungary un- relevance of cross-border exchange of organs is also to be derlines the danger of organ trafficking and the impor- emphasized. tance of both initiatives, the Directive and the Action Plan, Spain is a good example of success in significantly in- in contributing to the prevention of trafficking related to creasing the number of deceased organ donors. It has been transplantation. The need to increase organ availability is proven that such increase is linked to the introduction of also essential, while respecting the quality and safety stan- certain organizational measures that enable the system to dards of organs for transplantation, as provided for within identify potential donors and maximize their conversion into the Directive. In this regard, the importance of everyone’s actual donors. The role of public awareness and opinion in solidarity is to be underlined. S42 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

Trinidad Jiménez García-Herrera Spanish Minister of Health and Social Policy

“Ministers, Parliamentarians, and Health Authorities from different countries from the five continents who have come to this Conference, from WHO, from the EU and from the Council of Europe, transplant professionals, coordinators and directors of the different transplantation organizations, members of TTS, dear friends from Latin America participants to the 6 th Edition of the MASTER ALIANZA, members of the patients´ associations, dear friends all:

It is a pleasure for me to welcome you to this MADRID CONFERENCE ON ORGAN DONATION AND TRANSPLANTATION, organized by the Spanish Presidency of the EU and assembling relevant personalities from health-care administrations and the field of organ donation and transplantation from the five continents, which will make Madrid be considered the WORLD CAPITAL OF TRANSPLANTATION during the next three days.

The main objective for today´s meeting is very clear: to foster a decisive collaborative strategy on donation and transplantation among the MS of the EU, which should lead us to build the biggest structure of the world in this field, covering 500 million people with the highest standards of quality on one hand, and the highest quantity on the other in terms of access to these therapies on which so many lives depend.

With this purpose, already announced at the end of 2008, two initiatives of the European Commission are on the table for which the Spanish Presidency is giving maximum support. Above all, the support provided to the project of a European Directive on standards of quality and safety of human organs intended for transplantation is to be highlighted. The process is well advanced at the Council as well as at the Parliament and we are sincerely hoping a first-reading agreement.

As a perfect complement to the Directive, the Action Plan intends to promote cooperation on organ donation and transplantation among all MS. One single example can exemplify the importance of this collaboration: if rates of donation from deceased persons in the EU, currently at 18.1 donors per million population, reached those of countries with the highest performance, the lives of more than 20,000 people either with no chance at present of a vital organ transplant or otherwise condemned to chronic dialysis would be saved every year.

As you well know, Spain is very proud of its transplantation system, which allows our country to lead the world in the expression of solidarity that is organ donation. This has been possible since the beginning of the nineties, after the creation of the Spanish National Transplant Organization, ONT. Over the years since, we have developed a long experience of cooperation with other countries, either in a bilateral form with those requesting collaboration or through international organizations.

We have chaired the Commission of Transplantation of the Council of Europe for seven years, bringing about the development of most of the documents on which the current projects of the Commission are based. We believe that now is the time for the EU to implement these initiatives for cooperation, from which thousands of European citizens will benefit.

Yet the scarcity of organs for transplantation is a global problem, and any European strategy should be placed in a universal context. That is why this European Conference serves as an opening for a Global Consultation on donation and transplantation, organized with the WHO and TTS. The objectives are very clear: to progress in the pursuit of self-sufficiency in organ donation and to combat transplant tourism. I would like to give my warmest welcome to all the members of the different tourism. I would like to give my warmest welcome to all the members of the different entities, with my sincere wish for you to have fruitful work days among us and to go back to your countries with the best of impressions.

ONT is a WHO collaborative center, and its cooperative activities with countries from the five continents to promote organ donation are long-standing and have led to promising results. To provide an example, the case of Latin America should be mentioned. ONT, in close collaboration with the Pan American Health Organization, contributed to the creation of the Latin American Council on Donation and Transplantation five years ago. This entity has been decisive for the regulation and development of donation in all Latin American countries, with a very significant increase in organ donation rates of 20% in the past five years, and a training programme already delivered to more than 200 coordinators from Spanish and Portuguese speaking countries. About to finish the MASTER ALIANZA next Friday, some of the professionals trained as transplant coordinators in Spain are among us today.

To summarize, I believe that these working days that are about to start are the culmination of the Spanish approach to international cooperation in the transplantation field and will become a point of reference in worldwide collaboration. It is necessary to provide global solutions to universal problems, and Spain is prepared to contribute with the best of its experience in this area through ONT. I assure you that no effort has been spared in this endeavor and that we will continue doing our best to save lives around the world thanks to the universal expression of solidarity that is organ donation and transplantation.

THE MADRID CONFERENCE ON ORGAN DONATION AND TRANSPLANTATION is open.” © 2011 Lippincott Williams & Wilkins S43

Koenraad Vandewoude, Social Integration Responsible, ing years because of the epidemics of diabetes and arterial Belgium refers to the Belgium Transplantation Law enacted in hypertension, along with the ageing of the population. A sec- 1986, which already established the principles of altruistic dona- ond significant challenge is ensuring the safety and quality of tion and non-commercialization and provided for a presumed the organs available for transplantation. Risks are associated consent policy. In Belgium, organ allocation is performed with the use of organs. Both infectious and neoplasic diseases through . Belgium welcomes the Commission’s have been transmitted from donors to recipients through the proposal for a Directive on Quality and Safety Standards of Hu- transplantation of a solid organ. Risks may be minimized man Organs Intended for Transplantation, especially those pro- with an appropriate evaluation of the potential deceased or- visions related to the voluntary and unpaid nature of donation, gan donor. the characterization of donors and organs, and the foreseen pos- The diversity of organ donation and transplantation sibility of building national registries for transplanted patients. activities in the EU is highlighted by data collected by several All these elements are essential to ensure the quality of the organs EU-funded projects and data consortia, in particular the Im- and the safety of transplant recipients. proving the Knowledge and Practices in Organ Donation Janez Remskar, Transplant Coordinator, Slovenia (DOPKI) project (www.dopki.eu). Opting-in and opting-out stresses the importance of European and International coop- consent policies coexist in addition to variable organizational eration for Slovenia, a small country with a population of only approaches. For example, not all EU countries have a NTO in 2 million. The National Transplant Network was created in place, and several are part of supranational organ exchange 1998, including 10 procurement hospitals and a single trans- organizations, as Eurotransplant and Scandiatransplant. plant center; therefore, it was not possible for the country to There are huge disparities in activities in donation from de- work alone. Slovenia started to work with Eurotransplant in ceased persons, with Spain, where the number of deceased 2000 and enacted its national Law on Donation and Trans- donors evolved from 550 to 1600 over the years from 1989 to plantation that same year. A new law has been adopted in 2009, as an international benchmark. The evolution of rates 2010, under which the policy of presumed consent is estab- of donation after death in Spain is not the result of the lished. It is expected that this new policy will be of benefit for implementation of what could be considered “classical patients and their relatives, and will make easier the work of approaches” in response to organ shortage, that is, promo- professionals. Because of the immense benefits expected from this tional campaigns or registries of intention to donate. Nor is it European initiative, Slovenia highly supports the upcoming Euro- because of a progressive swell of support from the population pean Directive on Quality and Safety Standards of Human Organs toward organ donation (a survey performed on a representa- Intended for Transplantation. tive sample of the Spanish population showed similar percentages indicating support in 1993 vs. 1999 vs. 2006). Current Challenges in Organ Donation and Instead, the critical determinants of the success of the Spanish Transplantation in the EU Model of Organ Donation have been the organizational Session Chairs improvements implemented: a coordination network, in- Gu¨nter Kirste house transplant coordinators (mostly critical care physi- Director, Deutsche Stiftung Organtransplantation, cians who assume the coordination role on a part-time Germany basis), ONT as a support agency, a continuous brain death Enrique Moreno audit, training of healthcare professionals, close engage- Head of Department of General and Digestive Surgery, ment with the media, and reimbursement of procurement Hospital 12 de Octubre, Spain activities. Variation in mortality rates attributable to traffic Organ Shortages and Disparities in Access to accidents and cerebrovascular diseases in the EU do not ap- Transplantation in Europe parently justify the regional differences in donation from de- Rafael Matesanz ceased persons nor is there evidence of a correlation between Director, ONT, Spain the proportions of people who report that they would be Approximately 100,000 solid organ transplants are per- likely to donate their organs after death and achieved rates formed annually worldwide (of which almost 70,000 are kid- of donation from deceased persons (http://ec.europa.eu/ ney transplant procedures), providing excellent results in public_opinion/archives/ebs/ebs_272d_en.pdf), suggesting terms of survival and quality of life. Acute and chronic rejec- that a positive public attitude toward donation is not the ma- tion of organs represents an important barrier in the devel- jor determinant of success. In EU countries where increasing opment of transplantation services, which have been partially rates of donation after death are being achieved, many of overcome with advances in immunosuppression. The main these donations are coming from aged donors in the 60ϩ and obstacle to further development is a shortage of organs: data 70ϩ age categories, less frequently considered as potential from both Europe and the United States show waiting list donors in other countries. Another factor influencing dispar- growth far outstripping growth in incident transplantation ities in deceased donation activity in the EU is the significant rates. In the EU, approximately 60,000 patients were on the variation in uptake of DCD, with DCD not permitted by law waiting list for a kidney, a liver, a heart, or a lung at the end of in several jurisdictions, whereas in others, the necessary ex- 2008, whereas only approximately 25,000 procedures of this pertise is not available. In the United States, observed in- nature were performed during that entire year. It is estimated creases in organ donation rates evident since 2003 have af- that 12 EU patients die each day while waiting for an organ. A fected both DBD and DCD. In contrast, rates of donation progressive increase in the demand for organs for transplan- from deceased persons have stabilized in the EU during the tation, particularly for kidneys, is expected to occur in com- same period of time, with the implication that this is in part S44 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011 because of a lack of uptake of DCD in the region. Moreover, must be understood as a dynamic process, with risk levels other specific strategies such as the United States Organ Do- assessed before recovery (through medical history, exter- nation Breakthrough Collaborative have helped the US prog- nal examination, biochemical, serologic, and tool tests), ress in improving rates of donation from deceased persons in confirmed or modified during recovery (through histol- recent years. ogy, biomolecular tests, palpation, and inspection), and The work carried out by the Council of Europe in the reassessed during transplantation (through back-table European setting is to be recognized, with more than 14 rec- surgery and autopsy). ommendations produced, along with an excellent informa- In pretransplant recipient management, the critical tive tool on donation and transplantation activities and issues in quality of care are the provision of dishomoge- waiting list data: the Newsletter Transplant (available at: neous information to patients, inadequate or poor infor- http://www.ont.es/publicaciones/Paginas/Publicaciones.aspx). mation on possible therapeutic options, different criteria These recommendations, in particular the European Consensus for screening and admission, different composition and Document entitled “Meeting the Organ Shortage” have inspired management of waiting list, and dishomogeneous or non- the draft European Directive on Quality and Safety Standards of transparent allocation criteria. Consequences are confu- Human Organs Intended for Transplantation and the Action sion, comparison with other experiences, preclusion of Plan. Intraregional European partnerships have also produced choices, conditioning of healthcare pathway, patients successful outcomes, for example, the cooperation between Italy moving from one transplantation center to the other, per- and the Slovak Republic. Although extensive efforts for harmo- ception of inequalities whether justified or not, and high nization in Europe have been made, there is still a long way to go. variation of waiting list satisfaction indexes, and risk of The upcoming Directive and the Action Plan represent an excel- ethics violations and a lack of system transparency. lent opportunity to move to a new EU situation where rates of The management of the transplanted patient is the start of donation from deceased persons evolve to the levels of the a new process, with two important factors influencing its quality: Southern countries, and rates of donation from living persons to the failure to identify the person responsible for follow-up (re- those of Northern countries, while respecting the ethical frame- sulting in the consequences of a discontinuous physician-patient work laid out in the WHO Guiding Principles for Human Cell, relationship, possible “differences” in follow-up approach and Tissue and Organ Transplantation. Through the establishment difficulty in operational coordination between general practitio- of common standards of quality and safety for EU countries, it is ner and specialist), and the alternation of interlocutors (with also expected that the exchange of organs between MS will be behavioral differences in prescriptions and patient health care, facilitated, both better serving the needs of patients with partic- possible duplication of physician interventions, and nonperson- ular transplantation needs and simultaneously avoiding the loss alized management of follow-up). of organs not to be used locally for different reasons, that is, the Results of the DG SANCO survey on quality and safety lack of a specific transplantation programme. of organs for transplantation were presented at the Venice Conference in 2003. No specific legal or technical provision regulated the traceability (14%), procurement (46.4%) and Safety and Quality Systems in Organ Transplantation in transplantation (32.1%) centers, and the storage of serum Europe samples (32.1%) of a significant percentage of EU countries. Alessandro Nanni Costa In addition, risk assessment guidelines vary from country to Director, Centro Nazionale Trapianti, Italy country, and there is a need for clear protocols concerning the Although safety and quality systems in transplantation utilization of organs from donors with conditions such as have been recommended over the years, standards in this re- neoplasia or history of tumor, positive viral markers for HCV gard are highly variable among European countries. A com- and HBV, known risky behaviors for viral infections or prehensive approach to safety and quality in organ donation emerging infectious diseases, among others (4). Protocols are and transplantation must extend from the moment of donor also generally absent concerning upper age limits for donors. identification through to the follow-up of recipients, and The evaluation of the acceptability of an organ is not absolute cover all clinical, logistical, and decision-making aspects of but is relative to the specific donor risk factor(s) in question the donation and transplantation process. This comprehen- and the type of organ(s) being evaluated. The complexity of sive approach should include: this evaluation process gives rise to situations that are not always foreseeable and cannot be captured in a reference • Donor management: identification, diagnosis, referral, guide. Therefore, the transplantation process needs the sup- first assessment, maintenance, family interview, recipi- port of on-call infectious disease specialists for accurate and ent selection, organ recovery, second assessment, trans- adequate risk assessment. Ultimately, transplantation of or- plant, and follow-up; gans from a high-risk donor cannot be justified in nonlife- • Pretransplant recipient management: diagnosis, indication threatening circumstances. for transplantation, clinical and immunologic assessment, inclusion in the waiting list, admission and treatment, pe- Communication of the European Commission: Policy riodic testing, selection for transplantation, summoning, Options and Impact Assessment preparation, transplant, and follow-up; Isabel de la Mata • Transplanted patient management. Principal Advisor in Public Health, DG Health & Consumers, In donor management, timing is a critical factor in- European Commission fluencing quality, and its optimization relies on decentral- Action of the EU in the field of human organs intended ized assessment and diagnostics. Thus, donor assessment for transplantation are based on the power conferred through © 2011 Lippincott Williams & Wilkins S45

‘ The intended increase in the number of donors and available organs for transplantation cannot be achieved at any price’ (DOPKI Newsletter 2009, available at: http://www.dopki.eu/Newsletter2009.pdf)

article 168 (a) of the Lisbon Treaty, which allows the 3. Exchange of best practices in programmes for the do- Union to establish: “Measures setting high standards of nation of organs from living persons among EU MS. quality and safety of organs and substances of human ori- Support registers of living donors. gin, blood, and blood derivatives; these measures shall not 4. Improve the knowledge and communication skills of prevent any MS from maintaining or introducing more health professionals and patient support groups on or- stringent protective measures.” gan transplantation. Any legislative process in the EU has the following steps: 5. Facilitate the identification of organ donors across Eu- • rope and cross-border donation in Europe. Problem identification; 6. Enhance the organizational models of organ donation • Open consultation; • and transplantation in the EU MS. Impact assessment; 7. Promote EU-wide agreements on various aspects of • Commission proposal; • transplantation medicine. Co-decision procedure: Council & European 8. Facilitate the interchange of organs between national Parliament. authorities. In 2004, the Commission issued the following statement: 9. Evaluation of post-transplant results. “The important differences between organ transplantation and 10. Promote a common accreditation system for organ do- the use of other human substances such as blood, tissues, and nation/procurement and transplantation programmes. cells mean that a specific approach for organs to ensure safety and quality is necessary. Such an approach in the current The Directive intends to set down minimum quality situation characterized by shortage of organs has to bal- and safety requirements of human organs intended for trans- ance two factors: the need for organs’ transplantation, plantation for EU MS. It excludes blood and blood compo- which is usually a matter of life and death, with the need to nents, tissues, and cells and organs of animal origin, and it ensure high standards of quality and safety. The Commis- covers the donation, procurement, testing, preservation, sion believes that before considering any proposal, it is transport, and transplantation of organs. Main elements of necessary to conduct a thorough scientific evaluation of the Directive are: the establishment of authority or author- the situation regarding organ transplantation. The Com- ities for national oversight, the authorization of procure- mission will present a report on the conclusions of the ment and transplantation activities, the establishment of analysis it undertakes as soon as possible.” National Quality Programs, ensuring the traceability of In 2006, an Open Consultation was held with expert par- organs, the reporting of serious adverse events and reac- ticipation from MS, NTOs, Members of the European Parlia- tions, the protection of the living donor, and ensuring a ment, the Pharmaceutical Industry, Patient Associations, and complete characterization of the donor and organ(s) to Medical and Surgical Associations. In 2007, the Commission enable the transplant team to undertake an appropriate published the document “Communication on Organ Donation and individual risk assessment. and Transplantation: Policy Actions at EU Level.” From this point forward, the European Commission, together with the The Initiatives of the EU in the Field of Organ MS, commenced work on legislation in this field. The open con- Donation and Transplantation sultation allowed current problems and challenges in the field of Session Chairs donation and transplantation in the EU to be defined. Several Arie Oosterlee policy options were weighed-up to confront the predefined Director, Eurotransplant International Foundation (EIF) problems, along with an assessment of the clinical and economic Jean-Marc Spieser impacts of each of these options. From this in-depth analysis, the Head of Department of Biological Standardization final best option consisted of (1) an Action Plan for MS to work European Directorate for the Quality of Medicines & Health- on from 2009 to 2015; and (2) a flexible Directive on Quality and Care, Council of Europe Safety Standards of Human Organs Intended for Transplanta- tion, for which approval is foreseen to occur under the Spanish European Legislative Framework on Quality and Safety Presidency of the Council of the EU (January to June 2010). Aspects of Organ Donation and Transplantation: The The Action Plan identifies 10 priority actions, which are European Directive grouped under three challenges: to increase organ availability, Miroslav Mikolásik make transplantation systems more efficient and accessible, and Member of the European Parliament improve quality and safety in the donation and transplantation The regulatory approach of this proposed Directive based process. The priority actions are as follows: on a framework model ensures that legislation is laid down to 1. Promote the role of donor transplant coordinators in ev- deal with key aspects of organ donation and transplantation, ery hospital where there is a potential for organ donation. while not prescribing detailed policy measures that are the pre- 2. Promote quality improvement programme in every hos- rogative of MS. The Directive will ensure that the necessary qual- pital where there is a potential for organ donation. ity and safety structures are in place, facilitating the conditions S46 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011 for organ exchange and ensuring high standards of quality and for limiting that reimbursement to “making good the ex- safety for all patients in Europe. The Directive, given its binding penses and inconveniences related to donation.” Conditions nature, will support and trigger the implementation of key pri- for such reimbursement would be then established by MS. ority actions of the Action Plan. 3. Data protection: the implementation of the proposed The specific issues that have provoked particular inter- organ donation and transplantation scheme requires est during Parliamentary debate, giving rise to a set of pro- the processing of personal data relating to health of the posed amendments in the Parliament report, are as follows: organs, donors, and recipients by authorized organiza- 1. Voluntary and unpaid donation: when the act of donation tions and healthcare professionals of the different MS. is not voluntary or foresees financial gain, the quality of the These data are deemed sensitive and fall under the strict donation process can be jeopardized, because improving rules of data protection on special categories of data. the quality of life or saving the life of a person is not the 4. Donation from living persons: to ensure that the principles main, and the unique objective to be achieved. Hence, of voluntary and unpaid donation are maintained, some these are core principles in this new legislative framework. issues regarding donation from living persons have raised 2. Protection of living donor: information provided to and by concerns at the Parliament. Not aiming at limiting do- thedonorwithregardstodonationandaproperevaluationof nation from living persons who are not close relatives, the donor are essential to minimize the risks for both donors the Parliament would like to make clear the need to and recipients. Reimbursement to the living donor has been a carefully examine and confirm the absolute altruistic subject of debate in the Parliament, with a specific proposal nature of donation under these circumstances.

Box 1

The European Directive and The Action Plan: Key Points

The European Directive

• The Directive is primarily concerned with ensuring a high level of human health protection throughout the EU by establishing common minimum standards of quality and safety of human organs intended for transplantation.

• The Directive will establish the obligation of MS to designate one (or more than one) competent authority responsible for the implementation of the provisions set down in this Directive. A network of competent authorities will be subsequently coordinated by the European Commission, laying the grounds for the biggest organization related to donation and transplantation worldwide and covering a population of about 500 million people. • The need to create a quality and safety framework, including transparent procedures for the adequate development of the process of donation and transplantation is set down in the Directive, along with the capability of control or auditing the activities. MS will also be required to establish systems for the authorization of organ procurement and transplantation, and specific requirements will be set down for the exchange of organs with third countries. • A system for reporting serious adverse events and reactions is to be developed by every MS, which should also assure a system for traceability, while respecting confidentiality and data protection rules. • The respect for principles consistently supported over the years by the WHO, the Council of Europe, and the EU is to be maintained. Donation is to be a voluntary and unpaid act, and the protection of the live donor is to be ensured. These principles imply the respect for fundamental human values but are also essential to not jeopardize the safety and quality of the process of donation and transplantation, the legal basis under which the Directive is built.

• The debate on the Directive is now being held, with such issues raised from the perspective of citizens, patients, and professional as the establishment of limits to donation from living persons, the inclusion of technical aspects in the legal text, and the consideration of a mandatory post-transplant follow-up registry. • After its approval, MS will have 2 years to transpose the Directive into their national law. Along with the pursuit of increased quality and safety of organs for transplantation, benefits expected include the facilitation of organ exchange between MS and the creation of an effective system to combat organ trafficking.

The Action Plan

• The Directive is supported and complemented by the Action Plan on organ donation. The Action Plan sets out common objectives, agreed quantitative, and qualitative indicators for monitoring performance and benchmarking strategies, protocols for regular reporting, and identification of best practices, with the goal of increasing the number of organs available for transplantation.

• The Action Plan will promote a number of initiatives aimed at increasing organ donation through organizational changes that have proven effective in some MS(i.e., promoting the figure of the transplant coordinator or implementing quality assurance programmes in the deceased donation process). It will also help MS to evaluate the performance of their transplant systems and exchange best practices to improve them. © 2011 Lippincott Williams & Wilkins S47

Box 1 cont.

Challenges for the European Union in organ donation and transplantation

• The shortage of organs to cover the transplantation needs of the population is a European and a universal challenge. The disparity between supply and demand for organs means that many patients die or deteriorate whilst waiting for an organ, with an estimated 12 patients dying on the waiting list each day in the EU. As a result, a minority of patients are induced to seek alternative solutions outside of recognized ethical principles, usually in the form of transplant tourism.

• Although belonging to a common context, EU MS exhibit important differences in donation and transplantation activities. Variability in rates of donation after death between EU MS is not seemingly due to differences in mortality rates or in the public support to organ donation. On the contrary, differences in the organizational approach to donation from deceased persons might be the underlying reason for this variation. Donation from living persons also shows a different level of development between European countries.

• Specific types of organ transplantation, such as the heart or lung, are not performed consistently across Europe. In many instances, there is a significant scope to improve the number of organs recovered per donor, although for some countries a lack of the necessary expertise to support cardiothoracic transplantation is the barrier to the expansion of heart or lung donation and other transplantation programmes.

• Europe demonstrates several examples of multinational ambition and corporation in organ donation and transplantation. However, with greater interregional cooperation and greater exchange of organs across borders, there is an emerging need for common safety and quality standards in transplantation at the EU level. On their own, these common standards could foster crossborder exchange of organs, which would increase the chances of transplantation for patients with very particular needs (pediatric, highly sensitized, and urgencies), and provide the opportunity of using surplus organs (because of the lack of an appropriate recipient or that of a specific transplant programme locally).

• A review of current knowledge and recommendations for quality and safety practices in organ donation and transplantation is needed, followed by an evidence-based update of these recommendations that develops clear protocols concerning the utilization of organs from donors with risk-related conditions or behaviors.

• Better risk prediction is urgently needed concerning the outcomes of transplants from expanded criteria donors and nonstandard risk donors. This would be facilitated by international coordination of monitoring and surveillance data from organ donation and transplant registries, and universal best practice in data registration. European cooperation would be enhanced by the formation of a Europe-wide registry of organ donation and transplantation policy, practice, and outcomes similar to the UNOS/SRTR.

• Efforts for harmonization, both in terms of donation and transplantation activities and in terms of quality and safety between European countries, have been pursued by the Council of Europe for years, and by the EU, through dedicated collaborative actions. However, there is still a challenging scenario where much remains to be done.

• In the diverse landscape just described and after a period of consultation and evaluation of different policy options, the European Commission intends to promote two complementary initiatives: a common legal framework to ensure common quality and safety standards for human organs intended for transplantation (the Directive) and an Action Plan integrating different actions targeted not only to ensure quality and safety but also to increase organ availability and to make the transplantation systems more efficient and accessible.

5. Death certification and consent: two additional amend- and Safety Standards of Human Organs Intended for Trans- ments are worth mention: (1) “MS shall ensure that plantation. The report prepared by the Parliament on the organs are not removed from a deceased person unless Action Plan stresses once again the principle of voluntary and that person has been certified dead in accordance with unpaid donation and demands MS put in place punitive mea- national law”; and (2) “No organ removal may be car- sures against organ trafficking. It also opens discussions ried out on a person who under national law does not about donation from living persons and welcomes the estab- have the capacity to consent it.” lishment of rules of quality and safety for all MS. The Proposal for a Directive on Standards of Quality The Action Plan: Promoting the Cooperation Between EU and Safety of Human Organs Intended for Transplantation Member States was voted in the Environment, Public Health and Food Safety Andre´s Perello´ Commission of the European Parliament on the May 16, 2009, Member of the European Parliament and the result was a unanimous vote in favor. The spirit of the The main motivation for the implementation of an Ac- Parliament suggests a first-reading agreement on next May 2010. tion Plan on organ donation is the need to increase the rate of Consistency in the debate concerning the key aspects of transplantation overall and to reduce the disparities in the the Directive and the Action Plan should be maintained in the rates of donation and transplantation among EU MS, Parliament. Because donation from living persons, developed through cooperation and sharing of best practices. The Ac- under solid ethical principles, is a necessary component of strat- tion Plan is developed in parallel to the Directive on Quality egies to confront organ shortages, restrictions to donation from S48 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011 living persons in the EU that are currently being considered During the 1970’s, end-stage kidney failure patients could potentially inflate problems with respect to organ traffick- were able to survive on the basis of reasonably widespread ing and transplant tourism. Desperate patients may be driven to access to dialysis. Organ donation and transplantation did search for alternatives outside of the legal and ethical framework not have a legal basis yet in Spain, and the public knowledge of that we pursue. The Action Plan should aim to increase donation this option was scarce. ALCER was created in 1976 and rates in the EU while fostering solidarity as the way to avoid strongly supported the development of a Transplant Law in violations of fundamental human values. Spain during the period 1977 to 1978. Our Transplant Law was finally enacted in 1979. The Patient’s Perspective During the 1980’s, organ donation remained scarce, and Terence P. Mangan the patients’ association put pressure on society and politicians. Chairman, European Heart Lung Transplant Federation, It was the time to consider the need for a National Coordinating Ireland Organization. It was in 1989 that, in response to this pressure, Differences in donation and transplantation activities, ONT was created. The need for a NTO has been put forward most particularly for thoracic organs, become evident in the internationally as a basic element for a deceased donation analysis of available data in Europe, even when comparing system to be effectively established and consolidated. countries with a similar capacity to perform transplantation. ALCER continues acting in support of donation and trans- Heart and activities are highly variable plantation through many activities, making evident the ex- and differently developed between countries even with simi- tent to which patient associations are stakeholders with a lar overall rates of donation after death. In many instances, specific contribution to make to the pursuit of self- suffi- there is significant scope to improve the number of organs ciency in transplantation. ALCER is now engaged in activ- recovered and transplanted per donor, although for some ities such as the provision of information to patients and countries there is a lack of the necessary expertise to support their relatives about donation from living persons, and in cardiothoracic transplantation. Refusals to consent to organ updating patients about initiatives that may help them to donation after death are a key factor in the variation in dona- improve their quality of life and life expectancy. tion and transplantation rates in Europe. In this context, the importance of the European Donation Day to raise awareness Transplant Professionals’ Perspective of the importance of organ donation after death among the gen- Ferdinand Mu¨ehlbacher eral public is to be highlighted. However, there also needs to be a Head, Division of Transplant, Medical University of Vienna- focus on the way the approach to organ donation is made, that is, Austria who asks, what to say, how to say it, and when to say it. The pillars Three European Regulatory bodies in the field of dona- of our activities should be the equal access to high quality trans- tion and transplantation currently coexist: (1) the Council of plant services in MS, the professional and timely post-transplant Europe (47 MS) that has produced several recommendations; care, and maintenance and the right to appropriate post-trans- (2) the EU (27 MS), acting on the basis of article 168͓a͔ of the plant immunosuppressive drugs and medication. Lisbon Treaty (previous 152a of the Amsterdam Treaty), now releasing the Directive and the Action Plan; and (3) National Alejandro Toledo Governments producing the corresponding national legisla- President, Federacio´n Nacional de Asociaciones para la Lucha tion. The Council of Europe has been working on issues of contra las Enfermedades Renales, Federadción Nacional de safety and quality of transplantation for several years and has Asociaciones para la Lucha contra las Enfermedades Renales produced a guide to safety and quality assurance for organs, tis- (ALCER), Spain sues and cells containing information on basic principles for quality management, selection of donors, organ procurement and preservation, tissue and cell procurement, tissue establish- Reflection ments, and transplantation practices (http://www.coe.int/t/ You are the warm sun on my face dg3/health/Source/GuideSecurity2_en.pdf). The last edition The gentle wind on my back included an addendum on “Criteria for preventing the trans- You are the song in my heart mission of neoplastic diseases in organ donation.” This guide The music in my soul is a reference document for European countries. You are the promise of spring Donation and transplantation, whether of organs, tissues, And the glory of autumn or cells, is not without some risk for the living donor, the recip- You are my future And my past ient, and the healthcare professionals involved. Donor risks can You are my Donor be broadly categorized into those relating to the function of the And I am humbled transplanted organ and those concerning the transmission of diseases (tumor, viral, or bacterial infections or metabolic disor- ders). Donor risk factors relating to organ function are age, race, height, body mass index, cause of death [cerebrovascular acci- dent (CVA) and trauma], DBD vs. DCD (controlled vs. uncon- trolled),typeofgraft(fullsize,split,andreducedsize),coldischemia time, steatosis, inotropic support, electrolytes (natremia), local re- covery, histology grading, laboratory data, and surgical judgment. Several issues are still under debate. Anti-HCV, anti-hepatitis B core antigen, and hepatitis B surface antigen prevalence varies according © 2011 Lippincott Williams & Wilkins S49 to the presence or absence of risk behavior, according to the Center creased demand for human organs, tissues, and cells. Despite for Disease Control and Prevention, Atlanta, USA (CDC) (5). The considerable achievements in donation, demand continues to reduction of the so-called window period is possible through the use outstrip supply, especially with respect to solid organs for of the nucleic acid tests. However, currently, there is no sufficient transplantation. Approximately 100,000 organs are trans- evidence to recommend the universal prospective screening of or- planted globally each year, however, given an estimated gan donors for HIV, HCV, and HBV by nucleic acid tests. burden of end-stage organ disease affecting upward of one Donor-derived diseases have also been a subject of re- million individuals, this accounts for less than 10% of global search. Through a dedicated initiative, the United Network need (7). The 90% of people with end-stage organ failure who for Organ Sharing (UNOS) recorded information on donor- do not have hope of a transplant will die from their disease or, derived diseases in organ transplantation, recently published in the case of end-stage kidney failure, be dependent on on- for the years 2005 to 2007 (6). Both infections and malignan- going and costly dialysis therapy. In many regions of the cies were reported as having been transmitted. world, affected persons lack access to basic healthcare ser- The EU Directive on Quality and Safety Standards of Hu- vices in which their need for transplantation would be rec- man Organs Intended for Transplantation and the Action Plan ognized, let alone met. For those who hope to receive a are focused on increasing the availability of organs, developing transplant, the implications of the scarcity of human ma- more efficient and accessible transplant systems, and improving terials for transplantation are that: (1) individuals in need the quality and safety of the organs transplanted. However, three may not be registered on transplant waiting lists, because outstanding issues are identified, from the professionals’ point of inclusion criteria are influenced by the availability of or- view, as not being adequately addressed by the Directive in its gans for transplantation; (2) wait-listed persons may die current form. These are: while awaiting transplantation; and (3) some individuals, facing desperate situations, may seek to obtain an organ by 1. The concept of self-sufficiency, and a requirement for engaging in practices such as transplant tourism, organ MS to do their utmost to improve organ donation, trafficking, or transplant commercialism. should be covered at least be in the preamble. These unethical practices exploit the poorest and most 2. Although safety and quality measures are considered in the vulnerable groups in society, undermine altruistic donation, Commission proposal, no medical details should appear compound socioeconomic disparities in the utilization of trans- in a law. On the contrary, the current annex should make plantation, violate the most basic of human values, contravene reference to “the best medical practice,” with recommen- the Universal Declaration of Human Rights, and have been re- dations produced every 2 years by a scientific-based body pudiated by international institutions and professional societies. (i.e., Council of Europe CD-P-TO, ESOT, or a specific Ex- The global shortage of organs, tissues, and cells for transplanta- pert Group at the Commission). tion must therefore be met by strongly regulated environments 3. A European Registry for the surveillance of donors and to ensure safety, quality, efficacy, and ethical practice in all as- recipients is essential to monitor and evaluate quality pects of organ donation and transplantation programmes. outcomes. Although a follow-up registry for the living Health authorities should promote donation and transplanta- donor is foreseen in the Directive, there is no specific tion motivated by the needs of recipients and the benefits to provision for the follow-up of transplant recipients. A the community, and any measures to encourage donation registry similar to the UNOS/Scientific Registry of should respect the rights of donors and foster social recogni- Transplant Recipients (SRTR) database in the United tion of the altruistic nature of donation. These issues have States should be a goal for Europe. Currently, we are been the subject of successive WHO Resolutions concerning limited to extracting conclusions from the US registry organ donation and transplantation (WHA 40.13/1987; while acknowledging the expected differences between WHA 42.20/1989; WHA 44.25/1991; WHA 57.18/2004). the US and the EU populations. Since their adoption by the WHA nearly 20 years ago, the WHO Guiding Principles for Human Cell, Tissue and These gaps in the Directive present future challenges Organ Transplantation have played an important role in in- for the EU and should be the subject of ongoing improve- fluencing legislation, national policies, and professional ments to this framework. codes and practices in the donation and transplantation of human organs (WHA44.25). These Principles are concerned The Pursuit of Self-Sufficiency: A Global with maximizing the benefits of transplantation by address- Challenge ing the needs of recipients, protecting donors and recipients Session Chairs at all stages of the organ donation and transplantation pro- Peter Doyle cess, and ensuring the dignity of all involved. In response to Independent Medical Advisor, United Kingdom improvements in transplantation medicine and science, and Carl-Gustav Groth evolving practices and perceptions regarding organ and tissue Professor Emeritus, Karolinska Institute, Sweden transplantation, a consultative process was commenced in 2004 to update these Principles. Proposed revisions were the Donation and Transplantation in the WHO Agenda subject of a global consultation held in Geneva in October Luc Noe¨l 2007. Revised Guiding Principles, reformulated to cover Coordinator, Clinical Procedures, Essential Health Technolo- practices identified since the original resolution was adopted gies, WHO in 1991, were endorsed by the 124 Executive Boards of the Rapid medical advancements and the demonstrated WHO in January 2009 (Document EB124/15). The revised success of transplantation procedures have significantly in- Principles articulate a strengthened commitment to the S50 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011 safety, quality, and efficacy of donation and transplantation quence of the global shortage of human materials for trans- procedures and the human materials used, and request trans- plantation, concomitant with the need for effective legal parency in the organization and performance of donation frameworks and regulatory systems is the need to increase and transplantation activities. They call for prohibition of sufficiency in the supply of organs, tissues, and cells for trans- commercialization of cells, tissues, and organs for transplan- plantation. Thus, the Declaration of Istanbul states that “Ju- tation and pay particular attention to the protection of vul- risdictions, countries, and regions should strive to achieve nerable populations. The priorities of the Principles are to self-sufficiency in organ donation by providing a sufficient protect living donors, patients, individuals, and society, number of organs for residents in need from within the coun- to foster public trust in transplantation and donation and to try or through regional cooperation.” combat organ trafficking. The WHO Guiding Principles for Wide international variation in transplantation activity Human Cell, Tissue, and Organ Transplantation therefore (Figs. 3 and 4) not only reflects vast global inequity in access encourage proper respect for human body parts and their to transplantation but also demonstrates the capacity of dif- donors, and for the patients receiving donated cells, tissues ferent approaches to the delivery of organ donation and and organs, and provide a framework for the development of transplantation programmes to produce better outcomes. fair and equitable transplant services. For most high-income countries, current models of service Global commitment to the WHO Guiding Principles delivery have not met the needs of patients, and there is scope and to the eradication of the international trade in human for significant progress in the provision of transplantation. tissues and organs is gathering momentum. China, Pakistan, The high prevalence of chronic diseases contributing to end- the Philippines, Colombia, and Egypt, countries which were stage organ failure such as chronic kidney disease, estimated major destinations for transplant tourism, have each begun to to affect 10% to 15% of adult populations (10–13), and the introduce transplantation legislation prohibiting organ sales. global epidemic of diabetes (14) underscore the need for ac- China implemented the State Council Law on Human Organ tion. There are also compelling economic arguments for self- Transplantation in May 2007, which prohibits financial com- sufficiency, taking the example of Japan where approximately pensation for donors, prioritizes transplantation for Chinese US $15 billion is now spent annually on providing treatment citizens over foreign nationals, and articulates consent pro- to more than a quarter of a million individuals requiring cesses and donor rights (8). This legislation also establishes maintenance hemodialysis (15). minimal requirements that medical institutions must fulfill In addition to disparities in transplantation activity, ex- to be approved to perform transplantation. Transplant tour- tensive international variation in the relative proportion of ism in China has been markedly reduced since the introduc- deceased vs. living donors is also apparent (Fig. 4), demon- tion of this legislation, and China is now seeking to formulate strating widespread underutilization of the resource of de- legislation concerning brain death, to support the develop- ceased donor organs. Unrelenting growth of unmet demand ment of ethical organ donation from deceased persons. for transplantation, and a perceived inability to successfully The Philippines introduced a Presidential ban on Foreigner develop deceased donation, have led to a trend toward invok- Transplantation in April 2008, and The Philippine Society of ing payment as the easiest approach to a greater supply of Nephrology report that access to commercial kidney transplan- human materials and proposals of market-based solutions, tation by foreign nationals has been significantly reduced (9). In which rely on deceased or living donors sourced from domes- 2009, Colombia introduced a Resolution prohibiting transplan- tic, or from foreign, populations. Such proposals present a tation to foreigners while Colombian patients remain on the growing challenge to the basic principles of equality of human waiting list. In March 2010, Egypt passed a transplantation law beings and integrity of the human body. banning organ trafficking, restricting donation from living per- Responding to the need for action, a global network of sons to family members, and permitting regulated donation health authorities, scientific and professional societies, and ex- from deceased persons. Also in March 2010, Pakistan signed into perts, drawn from every region of the globe and level of develop- law the Ordinance on Human Cell and Tissue Transplantation, ment, has formed with the support of the WHO and is working prohibiting the sale of organs and providing for organ donation to advance a common global attitude to transplantation and after death. models of service provision that can meet recipient needs while These efforts are strongly supported by the WHO and preserving the dignity of donors. A comprehensive framework by professional societies. In May 2008, an international meet- for policy and practice directed at the global challenge of satisfy- ing of representatives of scientific and medical bodies, gov- ing organ donation and transplantation needs, consistent with ernment officials, social scientists, and ethicists, convened by the WHO Guiding Principles for Human Cell, Tissue and Organ TTS and ISN, produced the Declaration of Istanbul on Organ Transplantation, was developed by this network through a con- Trafficking and Transplant Tourism (1). The Declaration of sultative process. The extensive recommendations of participant Istanbul urges every country to implement legal and profes- working groups are given in full in Part II of this report. sional frameworks governing the recovery of organs from de- ceased and living donors and the practice of transplantation Self-Sufficiency as a New Paradigm: Definition and that are consistent with international standards of transplan- Significance tation policy and practice. The Declaration also calls for the Luc Noe¨l transparent regulatory oversight of organ donation and Coordinator, Clinical Procedures, Essential Health Technolo- transplantation practices, intended to ensure donor and re- gies, WHO cipient safety, enforcement of standards, and the prohibition Dominique Martin of unethical practices. As organ sales, transplant tourism, and Centre for Applied Philosophy and Public Ethics, The Uni- trafficking in organ donors are largely an undesirable conse- versity of Melbourne, Australia © 2011 Lippincott Williams & Wilkins S51

FIGURE 3. Global transplantation activity in 2008. Map shows solid organs transplanted per million population. Data from (7).

FIGURE 4. Transplanted organs per million population in 2008, for the 50 most active countries globally. Data are taken from (7).

Self-sufficiency in organ donation and transplantation donations and to address the most urgent needs of patients. means equitably meeting the transplantation needs of a given Therefore, self-sufficiency may be pursued at an individual population, using resources from within that population. Al- country level or through mutually beneficial regional organ though each country will strive to develop a sufficient supply exchange networks and international collaborative efforts of cells, tissues, and organs from donors within that country, (16). The concept of pursuing self-sufficiency is founded in regional cooperation may be necessary to effectively use all concerns for equity in access to health care, transparent justice S52 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011 in the distribution of burdens and benefits of transplantation complications of organ removal, which may be physical, and donation, solidarity in the recognition of a common goal social, financial, or psychologic. The highest possible level and responsibilities, and respect for the human right to of protection of living donors must be ensured, which re- health and dignity. The pursuit of self-sufficiency is a multifac- quires maximizing donation from deceased donors, so that eted enterprise that has four main objectives: effective commit- the need for living donors be kept to a minimum. Dona- ment from governments, community involvement, prevention tion after death is also considerably more effective than of end-stage organ failure, and the identification and utilization donation from living persons; a single deceased donor may of all possible deceased donors. provide upward of three organs for transplantation (18). The pursuit of self-sufficiency is a national responsibil- An average deceased donor in the United States has been ity and begins at a jurisdictional level. The active commit- estimated to provide an additional 30.8 life years shared ment of government is required to produce the legislative between 2.9 recipients (19). Optimal utilization of de- framework necessary to combat unethical practices, allow de- ceased donor potential requires the existence of appropri- ceased donation programmes to grow, promote equity, and ate legislative and organizational frameworks, effective uphold the importance of organ donation in the community. coordinating authorities, and community awareness of the Governments also have a critical role in the authorization and importance of organ donation and participation as regis- oversight of organ donation and transplantation pro- tered donors. Public education, including health educa- grammes. At the same time, the pursuit of self-sufficiency is a tion in school curricular, will contribute to awareness and public project, based on the community-oriented values of support this objective. reciprocity, solidarity, equity, and voluntary donation. The pursuit of self-sufficiency offers a framework for Community involvement is essential to successful trans- approaching the challenge of organ shortages that is plantation programmes, which depend on public partici- grounded in community participation and intersectoral and pation at every level. All members of the population need interdisciplinary cooperation. The scope of this goal encom- to be engaged as participants in the development of an passes disease prevention, legislation and regulation, imple- organ donation culture, and as stakeholders in the goal of mentation of organizational infrastructure, donation, and universal access to the benefits of transplantation. To this public education, as complementary elements of a compre- end, transplantation authorities have a responsibility to hensive strategic approach to the needs of patients and the build organ procurement systems and transplant pro- community at large. Self-sufficiency also frames organ dona- grammes that are endorsed by society and are transparent tion and transplantation in a broader health services context in their outcomes and processes. and is strongly concerned with health equity and ethical prac- Meeting the needs of patients not only means providing tice. Adopting the goal of self-sufficiency emphasizes that ac- access to transplantation but also investing in the prevention of cess to transplantation should not be the prerogative of a end-stage organ failure. Significant global variation in incidence privileged few but rather that transplantation programmes of end-stage organ disease, for example, a 3-fold difference should be a feature of comprehensive and well-organized in the incidence of end-stage kidney disease in Norway public healthcare systems. Enhancing collaboration between compared with the United States, clearly demonstrates the the different agencies and organizations working in areas that potential of prevention to reduce transplantation needs influence transplantation needs and resources will optimize (10). Prevention is inherent to the objectives of Transplan- the efficiency, efficacy, and quality of healthcare services pro- tation Authorities and professionals and must be vided and has the potential to greatly advance the goals of supported as such. Furthermore, minimization of trans- transplantation medicine and of public health. plantation needs through prevention is the only feasible approach to self-sufficiency in resource-poor settings The Pursuit of Self-Sufficiency as a Global Objective where cost and infrastructure requirements preclude the development of transplantation services. An example of an The Role and Responsibilities of Health Authorities in the effective prevention programme running on limited re- Pursuit of Self-Sufficiency sources has been underway for several years in rural India The human right to health and dignity implies a right and has had demonstrated success in reducing mean blood to the recognition of all human needs for transplantation. pressure and blood glucose in the target population (17). Therefore, practically and ethically, self-sufficiency must be Prevention of end-stage organ failure starts with primary conceived as a common global goal. Action, however, begins prevention: promotion of healthy lifestyles and basic pre- locally. The intrinsic requirements of organ donation and ventive interventions including vaccination. transplantation programmes in terms of resources, organiza- In addition to concerted efforts in prevention, the tion, and regulation are responsibilities of the State, and the pursuit of self-sufficiency requires the development of procurement of human body components from living and effective deceased donation programmes, complemented deceased persons rightly falls under State jurisdiction. Fur- by organ donation from living persons. Identifying and thermore, governing authorities have political and ethical ob- mobilizing potential resources to maximize donation from ligations to promote the health and protect the interests of deceased persons, through transparent and ethical prac- their citizens, for which there is a reciprocal duty of citizens to tices that respect society’s values and universal human contribute to shared public goods such as transplantation. rights and principles, is a priority. Only certain types of That is, all members of society who stand to benefit from organs can be donated by living donors, moreover living organ donation have a duty to participate in organ donation organ donors face a variety of risks ranging from the im- after death, where eligible to do so. A corollary of this is that plications of undergoing eligibility testing to the potential persons and populations who are excluded from a potential © 2011 Lippincott Williams & Wilkins S53

Box 2

Special report from India: Dr. Rakesh Kumar Srivastava, Director General of Health Services, Ministry of Health and Family Welfare, Government of India

Transplantation in India faces significant challenges with respect to the large burden of end-stage organ failure in the country, a lack of necessary infrastructure, organization and coordination of health services, low awareness and negative attitudes toward organ donation, and the costs of treatment. The incidence of end-stage kidney disease in India is estimated to be 150 to 175 per million population per year (or between 150,000 and 175,000 cases) and is attributable to diabetes in 30 to 40% of patients (20,21). Liver failure affects approximately 50,000 persons per year, with HBV as one of the common causes. Heart failure similarly affects approximately 50,000 persons per year. To meet this burden of disease, India has 180 renal centers, 25 liver centers, and 10 cardiac centers for transplantation, staffed with 160 renal surgeons, 25 liver surgeons, and few cardiac surgeons. Of these facilities, approximately two thirds are located in South India, and 80% are in the private sector.

Organizational challenges include uncoordinated trauma care, the absence of a national coordinating network to provide oversight and regulation of organ donation and transplantation activities, and underdevelopment of public-private partnerships that could improve access to transplantation services. In addition, multitude donor cards have been introduced by multiple agencies with a lack of organization of these and other activities in organ donation. A lack of awareness about organ donation and transplantation is found at both the public and professional level, and religious reservations and negative attitudes toward organ donation are pervasive. Finally, the direct and indirect financial costs of transplantation surgery and maintenance are prohibitive. For example, the cost of immunosuppression using tacrolimus, steroid, and mycophenolate is US 350 to 400 per month, or nearly US 5000 per year (21). Transplantation is, however, achieved at much lower cost than in high-income countries, in particular through the use of generic immunosuppressants. Also, insurance schemes do exist that may assist with the cost of treatment for some patients.

India passed the Transplantation of Human Organs Act (THOA) in 1994. This legislation introduced regulation of transplantation for therapeutic purposes, legal acceptance of brain death, and prohibition of commercial dealings in human materials with penalties in the event of violations of the law. In recent years, the provisions of the Act have been the focus of a national consultation process intended to introduce legislative reforms that will improve rates of donation from deceased persons and support living-related transplantation. Plans for reform to the Act include a renaming to “The Transplantation of Human Organs and Tissues Act,” inclusion of grandparents and grandchildren in the definition of near relatives, recognition of procurement centers, approval of paired donor exchanges, making it mandatory for the treating staff to request relatives of brain-dead patients for organ donation, and mandatory creation of transplant coordinator positions in all hospitals performing transplantation. Further reforms include accreditation of laboratories, simplification of brain-death certification committees, the establishment of a National Transplant Registry, revisions to forms and procedures, and greater regulation surrounding women, minors, and foreign nationals.

Currently, India performs approximately 4000 kidney transplants per year, 250 liver transplants, 10 heart transplants, and 25,000 corneal transplants. Kidney transplantation activity is predominantly based on living donors. With the aim of improving organ availability and increasing transplantation, the government is planning to start the National Organ Transplant Programme (NOTP). The objectives of the NOTP are to minimize end-stage organ failure, treat end-stage organ disease patients, promote organ donation from deceased persons, centralize organ procurement and distribution systems, and strengthen transplantation infrastructure and coordination on a national scale (11). In this capacity, the NOTP is establishing new facilities for transplantation, strengthening existing facilities, conducting training activities, and is establishing a National Tissue and Biomaterial Centre. Additional strategic activities of the NOTP include an information, education and communication campaign concerning the legal provisions of the THOA and organ donation, and activities aimed at reducing the costs of transplantation. Other recent organizational achievements for organ donation and transplantation programmes in India include the beginnings of public-private partnerships, the growth of state-based and other networks, for example, an Armed Forces Organ Retrieval and Transplant Authority, reform of the donor card system, and increasing advocacy for donation after death through media engagement, involvement of key opinion leaders, celebrity endorsements and public events such as World Kidney Day.

Finally, India is also taking steps toward managing its population Organization and activities of the proposed National burden of diseases contributing to end-stage organ failure. Despite limited Organ Transplantation Programme of India budgetary support for public health, several comprehensive prevention • Maintaining waiting list initiatives have been implemented. Examples include the National Rural NOPDO • Transplant registry Health Mission and the National Programme for Prevention and Control of • Co-ordination for procurement Diabetes, Cardiovascular Diseases and Stroke. Additional initiatives include • Dissemination of information • Creating awareness an integrated disease surveillance programme, introduction of universal HBV SOPDO vaccination, a tobacco law and programme initiative, and a national alcohol • Training activities policy. Intersectoral health promotion efforts will also contribute to decreasing • Follow-up • Monitoring of transplantation the burden of these diseases. Zonal • To operate various schemes • Data management

• Retrieval centers • Transplant centers • Diagnostic centers and labs • Public interface NOPDO: National Organ Procurement and Donation Organization SOPO: State Organ Procurement and Donation Organization S54 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

Box 3

Special report from China: Professor JieFu Huang, Vice Minister, Ministry of Health, Peoples’ Republic of China

Today, China performs the second largest number of organ transplants in the world at a rate of approximately10,000 transplants per year. Nearly, all forms of transplantation are performed in China: transplantation of kidneys commenced in 1969, followed by in 1989, liver in 1993, small intestine in 1994, and heart and lung in 2003. Achievements for organ donation and transplantation programmes in China include the development of basic and clinical research, standardization of transplantation techniques, the rapid expansion of clinical applications, training of a large number of skilled young medical professionals, international knowledge exchange and cooperation, and significant improvements in post-transplantation survival rates and patient management.

However, the development of organ donation and transplantation in China has also experienced problems, most particularly with respect to commercialization of organs, transplant tourism, and an overreliance on organs obtained from executed prisoners, a source of deceased donor organs that is not consistent with international ethics and standards of practice. These problems are compounded by scarcity in the supply of organs available for transplantation and the lack of a national system for organ donation and allocation that is subject to appropriate oversight and regulation. There are approximately 1 million end-stage kidney disease patients on maintenance dialysis and approximately 300,000 terminal liver disease patients requiring organ transplantation in China. The lack of a legal, sustainable, and sufficient donor pool to meet the needs of this vast number of end-stage organ failure patients is the greatest challenge for facing transplantation programmes in China. Organ procurement, allocation, and recipient selection are currently hospital based without centralized standards or a transparent registry system. Regulations have lagged behind medical progress, with transplantation therefore expanding in an unregulated manner (8). Some hospitals trade with illegal organ agencies and sell organs to foreigners for profit. The illegal trade in human organs that has emerged in China has created a tremendous profit chain that runs contrary to the principle of equity and the goal of building a harmonious society.

Ethical organ transplantation is not possible without the development of ethical organ donation processes and a regulated organ allocation system. Donation of organs from deceased individuals must be dependent on the good will of individuals and families in a system of voluntary donation with informed consent, moving away from the current system in which more than 90% of grafts are obtained from executed prisoners. Additional safeguards introduced to protect the rights of row inmates include the requirement for written consent to organ removal from the donor and the right to review of all death sentences by the Supreme People’s Court. The long-term goal for social development is to abolish the death penalty; however, until such a time, regulations are needed to protect the individual rights of prisoners and to separate transplantation programmes from the prison system (8).

Since the implementation of the Regulation on Human Organ Transplantation in May 2007, which introduced bans on transplant tourism and established an accreditation system for clinical transplantation services, a significant decrease in liver transplants to foreign nationals has been reported, with the number of liver transplants in non-Chinese patients decreasing from 624 in 2006, to 2 approved cases in 2009. Under the accreditation system, which provides a framework of baseline requirements and guidelines, only 163 hospitals have been granted a license to perform organ transplantation. Since the enforcement of the Regulation, the certificates of seven accredited hospitals have been revoked, and eight physicians’ licenses have been suspended. Reforms have also had the effect of decreasing the number of deceased donor transplants being performed in Chinese citizens and have prompted a dramatic increase in living-related kidney and over the past 2 to 3 years. In addition, driven by the scarcity of available organs and by profiteering by organ brokers, organs sales by the poor and vulnerable are increasing. The future development of organ transplantation in China requires that a National Organ Transplantation Work Scheme, P.R. China national transplantation programme be established that provides oversight, is responsible for the implementation and monitoring of organ procurement and Establish a scientific Scientific Registries for transplantation programmes, and is able to increase administrative efficiency based policy-making 5 Organ Transplantation process by maintaining a balance of authority between central and provincial governments. The National Organ Transplantation Work Scheme outlines a Quality assurance systematic project plan for the development of China’s organ transplant system, Accreditation System for Accreditation systems for conceived within a broader context of healthcare reform and development. 4 Clinical Transplantation hospitals/professionals (163 certified hospitals) Establish guidelines for The Scheme involves five goals: promote voluntary donation; enable efficient clinical practice organ procurement and utilization; ensure equity, justice, and transparency in

Ensure equality, justice allocation; establish quality assurance processes and establish a scientific 3 China Organ Allocation and transparency registry for organ transplantation. Registries will inform the policy- making and Sharing System National Waiting List Organ processes of the National Organ Transplantation Committee (OTC) and help Matching System to ensure the highest professional standards in the delivery of transplant services. National Organ Ensure effective use of Internationally recognized medical criteria regarding patient priority ranking, Procurement Organization 2 transplantable organs System (OPOs) organ matching, allocation, and sharing principles will be adopted by the OTC and specialist committees. OTC policy states that “National waiting list and Establish a donor organ allocation systems shall be established to address medical needs of National Organ Donation registration system 1 Campaign Promote organ donation patients and ensure the principles of equality, justice and transparency.” Voluntarism To support the implementation of these policies, The Ministry of Health has developed the China Organ Allocation and Sharing Computer Network. China is planning additional regulations for this new phase in transplantation. Working Conferences have generated initiatives concerning brain death (Beijing, April 2008) and organ donation (Shanghai, August 2009). Most recently, the Red Cross Society of China, together with the Ministry of Health, commenced a pilot programme of DCD. Launched in March 2010, this programme involves public education, a campaign to register donors, and provides guidelines for organ allocation. DCD potentially offers a means to expand the donor pool in a practical and ethical way, thereby reducing the demand pressures driving the illegal or gan trade and the overreliance on unethical organ sources. With the support of the Red Cross Society of China, China is working toward building an effective and ethical deceased donation programme, based on the principle of altruism, which balances the demand for organs against a framework of values acceptable to Chinese society. ■ © 2011 Lippincott Williams & Wilkins S55 share in the unique benefits of transplantation must be pro- clinical practice of transplantation, designed to improve tected from practices that outsource the burden of organ patient outcomes through greater competence and perfor- donation. Similarly, the burden of donation should not be mance of its members, the medical community, and the unjustly imposed on particular members or groups within a general community. population. In all circumstances, the duty to donate is limited TTS acts as consultative technical body to its members by the right not to be harmed. and Sections, to national and regional societies and their The practical implementation of self-sufficiency strategies country affiliates, to governmental and non-governmental will vary for different populations; however, the inherent values organizations, to related international societies such as the of the self-sufficiency paradigm and the key elements of the Global Alliance for Transplantation, and to international or- WHO Guiding Principles should guide policy and be reflected in ganizations such as the WHO. In this capacity, TTS provides practice in all contexts. The pursuit of self-sufficiency and the expertise in establishing deceased donor programmes and ad- adoption of ethical practices in organ procurement and trans- vises on standards of care for living donors. TTS actively sup- plantation are mutually reinforcing. Approaches to self-suffi- ports the work of the WHO by implementing the resolutions ciency that uphold the interests and well-being of all members of of the WHA as they apply to the fields of cell, tissue, and organ a population will naturally conform to principles of justice, harm transplantation. minimization, and respect for human dignity. A key mission of TTS is to take measures to protect the Countries with low economic and health sector de- poorest and vulnerable groups from transplant tourism and velopment may lack much of the basic infrastructure re- the sale of tissues and organs, including attention to the wider quired for the development of domestic organ donation problem of international trafficking in human tissues and and transplantation programmes, such as transplant sur- organs. The Declaration of Istanbul arose from concerns geons, intensive care facilities, suitable storage facilities, shared by TTS, the ISN, and the WHO regarding the ongoing and adequate diagnostic services. However, the pursuit of problems of international organ trafficking and the global self-sufficiency is not conditional on a particular level of shortage of organs for transplantation. TTS is now leading resources. Indeed, national approaches to self-sufficiency task forces that are systematically assisting professional orga- should be conceived within the context of the wider nizations, scientific journals, pharmaceutical companies, pa- healthcare system, be consistent with public health goals, tients, and governments with the objective of promulgating and must take account of the immediate needs of the pop- and implementing the Declaration of Istanbul. The mandate ulation and available resources. Achievements in the pur- of these task forces is to: suit of self-sufficiency should be celebrated with respect to relevant benchmarks that acknowledge the relative re- • Reach colleagues through professional organizations source constraints and the unique challenges facing dona- and assist with practical implementation of the princi- tion and transplantation in different populations. For ex- ples of the Declaration of Istanbul; ample, the successful implementation of a public health • Ensure all possible relevant organizations are contacted to programme to prevent a disease that contributes to the facilitate communication with the Declaration of Istanbul need for transplantation in one country should be consid- Custodian Group (DICG) and provide suggestions regard- ered as important as an increase in donation rates in an- ing activities following endorsement; other. Progress toward self-sufficiency will take time, but • Communicate the details of the Declaration of Istanbul the potential benefits extend well beyond organ donation to national and institutional review boards, ethics com- and transplantation to include practical consequences for mittees, and ethics review organizations; health systems and the reinforcement of societal values of • Assist medical and scientific journals in (a) requesting equity, transparency, solidarity, and social justice. that authors of articles relating to clinical organ trans- plantation disclose whether the clinical and research ac- The Crucial Contribution of Health Professionals to the tivities being reported conform with the principles of the Pursuit of Self-Sufficiency Declaration of Istanbul, and (b) establishing editorial Jeremy Chapman processes for determining the appropriateness of accept- President, TTS ing presentations on clinical transplantation, based on Francis Delmonico the disclosure of their conformance with the principles Director of Medical Affairs, TTS of the Declaration of Istanbul; Health professionals have a crucial contribution to • Communicate the details of the Declaration of Istanbul to make to the pursuit of self-sufficiency as the medical interface sponsors and funders of clinical transplantation research; with patients, as advocates for patients, and in developing • Integrate into all clinical transplantation trials, adoption and exchanging technical expertise. Global leadership in of the Principles of the Declaration of Istanbul, alongside the field of transplantation medicine is provided by TTS. the Declaration of Helsinki and Good Clinical Practice The Society has specific responsibilities in the develop- Guidelines; ment of the science and clinical practice of transplantation, • Respond to knowledge about individual patients subject in scientific communication among physicians and re- to transplant tourism, commercialism, and trafficking; searchers, in supporting the continuing education of pro- • Promote the welfare of individual donors and recipients fessionals engaged in transplantation, and in providing in the global environment; guidance to professionals on ethical practice. Contributing • Provide an annual report on regional and national to the pursuit of self-sufficiency, TTS aims to provide a organ trafficking and tourism and other develop- comprehensive education programme in the science and ments related to the Declaration of Istanbul (such as S56 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

new legislation, criminal proceedings against trans- donor is an actual donor from whom at least one organ has plant centers, and professionals); been transplanted into a recipient. • Coordinate the work of DICG Emissaries through defining • DCD: a potential DCD donor is a person for whom their terms of reference, collating information from the the withdrawal of life support is planned because fur- Emissaries and providing communication to the DICG; ther treatment would be futile; yet brain death has not • Engage governments to endorse principles of the Declara- occurred, usually because the patient is spontaneously tion of Istanbul and to persuade them of the value of incor- taking a breath. After the withdrawal of life support, porating the principles into clinical practice; the cessation of circulatory and respiratory functions • Distinguish actions required by Governments both with is anticipated within a timeframe (up to 2 hr) that will and without transplantation services with respect to enable recovery of a viable organ. If the patient does both citizens and foreigners; not die within that period, organ recovery is not per- • Communicate with Ministries of Health and empha- formed. A potential DCD donor is also defined as the size the role of the Declaration of Istanbul as a profes- person whose circulatory and respiratory functions sional ethical standard fully consistent with the WHO have ceased and resuscitative maneuvers are not to be Guiding Principles for Human Cell, Tissue, and Or- attempted or continued. An eligible DCD donor is a gan Transplantation. medically suitable person who has been declared dead In addition, TTS is currently undertaking efforts to col- based on the irreversible absence of circulatory and lect data concerning cross-border transplant procedures, to respiratory functions as stipulated by the law of the ensure that these are regulated and comply with agreed qual- relevant jurisdiction, within an appropriate time- ity and safety standards. TTS, along with its Sections, associ- frame that organ recovery is possible. The remainder ated agencies, and members, has a central role in the pursuit of the critical pathway for eligible DCD donors is the of self-sufficiency and is committed to provide ongoing lead- same as for DBD donors. ership in working toward this goal. Application of the critical pathway algorithm in clinical practice may identify specific reasons why a potential organ The Critical Pathway: the Process of Donation From donor has not been converted into a utilized donor. Avoid- Deceased Donors able disruption of the critical pathway includes: (1) failure to Francis Delmonico identify a potential or eligible donor; (2) failure to complete Director of Medical Affairs, TTS brain death diagnosis because of lack of resources or person- A structured deceased donor management algorithm is a nel able to make the diagnosis; (3) failure to declare circula- useful tool by which countries with existing deceased donation tory death within the appropriate timeframe; (4) logistical programmes may evaluate performance in the utilization of problems, for example, the lack of a recovery team; (5) inabil- possible deceased organ donors. It also provides a frame- ity to identify a compatible recipient; (6) damage to organs work for policy in countries seeking to develop effective made during their recovery; (7) inadequate perfusion of or- transplantation programmes from the ground up. A criti- gans or thrombosis; or (8) consent is denied by the donor or cal pathway for organ donation is presented in Figure 2. his or her family. An essential step in the critical pathway is The essential features of this critical pathway are as follows: the notification of organ donation personnel. Referral may occur when the pathway establishes a possible deceased organ • A possible deceased organ donor is a patient with devas- donor, when a potential DBD or DCD donor is identified, or tating brain injury or lesion or a person with a circula- when eligibility of the potential DBD is established. Alterna- tory failure, who is apparently medically suitable for tively the family themselves may raise the possibility of organ organ donation. The critical pathway is designed to ret- donation. rospectively, and prospectively, consistently assess this The critical pathway for organ donation is a core outcome specific patient population. Patients may only become of the Madrid Consultation. Evaluation of the performance of donors after death, and organ recovery must not cause organ donation and transplantation programmes should take death. The identification and referral of a possible donor account of this pathway and the goal of recovering as many or- is the role of the treating physician. gans as possible by converting possible and potential donors to • DBD and DCD are both to be considered under the crit- utilized donors. There are some clear immediate barriers to this ical pathway. goal, for example, the fact that DCD is not legally accepted in • DBD: on recognition of a possible deceased donor by the some countries in Europe. Adoption of the clinical pathway in treating physician responsible for the patient, the possi- clinical decision making and its use as a reference for policy mak- ble donor becomes a potential donor when his or her ers will facilitate the development of deceased donation pro- clinical condition fulfils death by neurologic criteria. grammes that optimize efficiency and efficacy in the recovery Once the potential donor is declared dead, he or she is and transplantation of deceased donor organs. considered an eligible donor if medically suitable for organ donation. An actual donor is a consented eligible donor in Global Status Report on Organ Donation and whom an incision has been made with the intent of organ Transplantation: Current Activities and Progress recovery or an organ has been recovered. If a malignancy is in the Pursuit of Self-Sufficiency discovered during the operative procedure (or any other contraindication to organ donation is noted), the organ European Region recovery procedure may be discontinued. The patient may Valentina Hafner still, however, be categorized as a deceased donor. A utilized WHO Regional Office for Europe © 2011 Lippincott Williams & Wilkins S57

The European region is the global leader in organ do- this goal. The promotion of organ donation and transplan- nation from deceased persons. Of the 31,628 solid organ tation across the European region necessitates a public transplants reported in the region in 2008 (40.5 per million health perspective, to avoid potential distortionary im- population), 85% were from deceased donors (7) (Fig. 5). Yet pacts on national health priorities. Increased attention these figures conceal significant variation in organ donation needs to be given to health promotion, disease prevention, and transplantation activity across the region; Europe en- early treatment, and diagnosis of conditions potentially compasses both the highest performing deceased donor leading to organ failure and other transplant needs, mini- programme in the world (Spain), and multiple MS with no mizing the gap between demand and availability. transplantation activity or infrastructure. Despite this varia- The Chisinau Statement of 2009 (25) extends European tion, the pursuit of self-sufficiency in organ donation and collaboration and knowledge sharing on issues of quality, transplantation is conceived as a shared European ambition. safety, and access to transplantation services, based on eth- The WHO Guiding Principles (22), the EU’s regulatory ical principles and respect for human dignity, to the newly framework (23), and the protocols developed by the Council independent states of Armenia, Belarus, Georgia, Kazakh- of Europe (24), guide consistency in European regulatory stan, Kyrgyzstan, Republic of Moldova, Tajikistan, and Uz- frameworks and processes and promote a common attitude bekistan. Most of these states now have specific transplant legis- toward transplantation issues. European cooperation is con- lation, although not all have established a transplantation cerned mainly with the dissemination of best practice in reg- authority. As MS develop their national transplantation pro- ulated organ donation and transplantation environment- grammes, European collaboration is expected to provide s,and protection of vulnerable populations and elimination ongoing support in the form of practical assistance and of transplant tourism. technical advice to ensure quality of care, regional net- The provision of safe, effective, and sufficient trans- working, and opportunities for regular consultation to plantation services across the European region faces sev- benchmark status, map progress, share concerns, and pro- eral challenges. Uneven health service development, and duce solutions. political, organizational, and cultural diversity across MS translates into differences in legislative backgrounds, vari- ation in donor and recipient management, and differences African Region in public perceptions toward organ donation and trans- Jean-Bosco Ndihokumbwayo plantation. This adds to potential epidemiologic threats WHO Regional Office for Africa (4) and pressure on health service delivery because of Transplantation activity in the 46 MS of the African region growing cross-border movement. The aim of European is minimal and is typically confined to kidney transplantation cooperation and collaboration in the development of pro- from living donors. Activity in the 6 countries that conduct fessional capacity, galvanization of political will, and pro- transplantation (Algeria, Kenya, Mauritius, Nigeria, Ghana, and motion of public awareness is, ultimately, to develop organ South Africa) ranges from 305 organs transplanted in South donation and transplantation programmes across the Eu- Africa during 2008, to 1 kidney transplanted in Ghana (7). ropean region that maximize transplantation rates and are South Africa alone performs transplants from deceased do- simultaneously based on understanding and respect of nors, although Algeria is beginning to develop its own ethical principles, human dignity, and social justice. deceased donor programme. Demand for organs in the Effective national legal frameworks consistent with African region is great and is growing, driven by an the WHO Guiding Principles are essential component of increasing prevalence of chronic diseases, especially hyper- tension, and by the enormous regional burden of infec- tious risk factors for end-stage organ disease, including HBV and HIV. Coordinated, sustained approaches to the prevention of noncommunicable diseases (NCDs) in the region are absent, reflecting low awareness and minimal allocation of funds to support prevention efforts (26). Therefore, the gap between demand and capacity to pro- vide transplantation is rapidly widening. The scarcity of transplantation in Africa corresponds with the limited capacity of health systems in the region to deliver resource-intensive transplantation programmes. Additional barriers to provision of transplantation in the African region include the lack of access to affordable im- munosuppressive drugs and to adequate diagnostic ser- vices, including imaging, pathology, and histocompatibil- ity laboratories. Such challenges are compounded by an absence of oversight and regulation of organ donation and FIGURE 5. Distribution of transplantation activities in transplantation activities, and a legislative and regulatory each World Health Organization region in 2008. Propor- vacuum that leaves populations vulnerable to exploitation. tions attributable to deceased donors (DD) and living Low- and middle-income countries constitute easy targets donors (LD) are shown. Value labels give overall rate (ab- for the exploitation of poor and vulnerable individuals solute transplants performed). when they lack legal protection. The magnitude of these S58 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

Country study: Russian Federation Sergey Gautier Director, National Research Center of Transplantology and Artificial Organs President, Russian Transplantation Society

Despite the introduction of a Federal Transplantation Law based on the WHO Guiding Principles for Human Cell, Tissue and Organ Transplantation and adoption of presumed consent in 1992, and the availability of a legal definition of brain death since 1987, organ donation and transplantation in the Russian Federation remained at a critically low level until 2006. The annual rate of kidney transplantation did not exceed 3.0 per million population, and for other organs, the transplantation rate did not exceed 1.0 per million population (27, 28). However, a number of organizational, legislative, economic, and educational changes have resulted in recent positive trends in transplantation rates. Russia has 34 transplant centers located in 19 cities, of which 33, 8, 5, and 3 perform kidney, liver, heart, and pancreas transplantation, respectively. Almost all transplant centers are located on the European side of the country; therefore, organ donation and transplantation activity occurs in only 14 of 84 regions in the Federation. Furthermore, it is the 41.6 million residents of these 14 regions (29.3% of the total population) comprise the potential deceased donor pool for the entire country. The mean rate of donation from deceased persons in these 14 regions is 8.8 donations per million population, decreasing to 2.6 donations per million population when the whole population is considered.

From 2006 to 2008, there was a marked increase in the deceased donor rate in these 14 regions. The total number of utilized deceased donors reached 381 in 2009, an increase of more than 60% since 2006 (27). There was also a 39% increase in the 12 months from 2008 to 2009 in the number of living kidney and liver transplants. Contributing to increases in the rate of donation from deceased persons has been increases in the both rate of brain death diagnosis and in the rate of multiorgan procurement. A lack of extrarenal transplantation programmes in the majority of transplant centers, however, has meant that multiorgan procurement has already begun to plateau. DCD accounts for approximately 50% of kidney transplants.

There is a need for greater popularization of organ donation in the Russian Federation, for dissemination of information about the process of organ donation, and for public reassurance concerning the successful results of transplantation procedures. The Federation consists of 500 different nationalities, each with individual cultural attitudes toward organ donation, and therefore, engagement with religious and other community leaders is necessary to overcome a widespread lack of awareness concerning organ donation and transplantation in the population. Poor awareness and information extends to medical professionals; medical education needs to be improved to provide specific teaching on principles of organ donation, organ procurement, and organ sharing. There is also a need to settle unresolved legal questions and to improve regulation and coordination at the federal level. The Russian Transplantation Society is working with the developing a federal transplant coordination system and nationwide database and registry. Pediatric deceased donation and informed consent for parents remains an unsettled legal area.

Despite recent improvements, transplant activity in the Russian Federation remains vastly insufficient compared with population needs. There is a significant and unrealized potential of donation from deceased persons, meaning that the preconditions exist for considerable growth of solid organ transplantation with greater development of regional and federal coordination systems for organ donation and transplantation. Key challenges in the pursuit of self-sufficiency will be to extend organ procurement to include a greater proportion of the population and to build support for organ donation and transplantation among medical professionals.■

problems in the African region is not well known, consis- eral medicine, while also contributing to improved quality tent with a general opacity surrounding regional activities, of medical education and of tertiary care at large. practices, and outcomes in organ donation and transplan- Few countries in the African region have established tation in the absence of reliable data. specific transplantation legislation under national health Collaboration between African countries, or be- laws or any form of regulatory oversight with respect to tween Africa and other regions/international agencies, for organ donation and transplantation. Currently, 5 of 46 the purpose of enhancing knowledge, skills, and resources, MS in the African region have transplantation legislation is currently limited. Greater regional and international in place (South Africa, Algeria, Mali, Senegal, and Coˆte collaboration and cooperation might contribute meaning- d’Ivoire). Hence, the African region faces the simultaneous fully to the future of organ donation and transplantation in challenges of a large vulnerable population lacking legal the African region by: (1) providing technical support and protection from exploitation, an expanding population in training; (2) supporting efforts to identify affordable need of organs, and an absence of many of the essential drugs, equipment, and consumables; (3) consulting on services necessary to meet minimal standards for the pro- oversight, organization, and coordination of organ dona- vision of transplantation services. Although the extent of tion and transplantation programmes; and (4) facilitating organ trafficking and related forms of exploitation in the regional cooperation in the development of deceased do- region is unknown, the combination of these factors has nor transplantation. Development of greater expertise in potential to jeopardize patients, medical teams, and trans- the practice of transplantation and increased resourcing of plantation services. There is therefore a critical need for transplantation services in African countries with existing improved regulation and oversight of all aspects of trans- transplant programmes have the potential to produce an- plantation in the region, so that risks to patients and com- cillary benefits for the health services, including improve- munities may be controlled. For African countries, the first ments in pathology and imaging services, surgery, and gen- steps toward self- sufficiency will be to raise political © 2011 Lippincott Williams & Wilkins S59

Country study: Nigeria Adewale Akinsola Nephrologist and Head of Renal Unit, Department of Medicine, Obafemi Awolowo University

Nigeria is the most populous country in West Africa, with a population of 150 million, comprised predominantly of young adults. Communicable diseases, particularly tuberculosis, malaria, and HIV, are highly prevalent. Like most countries in the region, Nigeria faces a concurrent, growing burden of noncommunicable disease. Hypertension is found in approximately 10% of adults, and rates of diabetes mellitus are increasing (29). Community-based studies estimate a prevalence of chronic kidney disease as high as18% to 20% (30), and there has been a surge in the representation of chronic kidney disease among hospital admissions over recent years (21, 24 Arogundade and Barsoum 2008).

Hypertension is the biggest single case of chronic kidney disease in Nigeria, as in most of sub-Saharan Africa, followed by glomerulonephritis (including secondary glomerulonephritis related to malaria, HIV, filariasis, schistosomiasis, HBV, HCV, and SLE). Currently, only approximately 5% of chronic kidney disease is attributable to diabetes mellitus (26). Other contributing risk factors include analgesic intake, the use of herbal and alternative medicine, poor access to health care, and a reluctance to seek out health services. End-stage kidney disease in Nigeria is predominately a disease of young adults (30–40 years) from low socioeconomic background. Presentation is typically late in the course of disease progression and is accompanied by a high comorbidity burden (31). Poor access to treatment means mortality is more than 95% (32).

Primary health care in Nigeria provides free immunization and basic services, including maternal/child health care, subsidized by the government. Tertiary health care is available in specialist/teaching hospitals located near major cities. Government funds cover staff and equipment only; all costs of treatment are covered by the patient. Nigeria has had a national health insurance scheme for about 5 years, which covers less than 1% of the population for primary andsome secondary care services, but not for tertiary services such as dialysis or organ transplantation. Nonetheless, the provision of dialysis services through both public and private facilities has seen rapid growth in recent times. The maintenance dialysis population in Nigeria is estimated to be between 500 and 600 patients; however, this reflects only 5% to 10% of population of patients actually requiring dialysis (>6000). These are patients who are able to afford more than 2 months of dialysis through personal funds or sponsorship by government agencies or private organizations. Prevention programmes targeted at the causes of end-stage organ disease currently do not exist in Nigeria. Strengthening primary health care to include detection of chronic disease risk factors for the prevention of chronic disease and end-stage organ failure is an important goal. Adequate population studies and national registries are also needed to generate reliable data on end-stage organ failure and its treatment.

Transplantation activities are confined to a small programme based on living donors. Kidney transplantation was commenced in 2001, and Nigeria now has 4 transplant centers with a combined capacity to perform approximately 30 to 40 transplants per year More than 90% of transplanted organs come from living related donors, and first year survival of patients transplanted in Nigeria is approximately 95%. In 2008, total transplantation activity consisted of 14 kidney transplants from living donors. Transplantation facilities, equipment, and trained personnel are severely limited, as are diagnostic services and expertise. The huge cost of medications and laboratory and radiologic investments adversely affect the quality of immunosuppression, ongoing graft management, and patient management and workup. Legislative and regulatory frameworks are absent, as are competent authorities responsible for oversight of transplant activities, practices, and donor and recipient outcomes.

The expansion of transplantation activity in Nigeria depends on addressing these regulatory and resource deficits. Public-private partnerships for sustainable financing of transplantation services are needed. Financing needs also to provide for subsidization of individuals unable to afford the expense of transplantation, to promote greater equity access to treatment. Expansion of national medical insurance may also be appropriate. Regional and international collaboration has an important role in building technical capacity and in the development of deceased donor transplant programmes in Nigeria. Finally, increasing population awareness of organ donation and transplantation is necessary to support organ procurement and to address adverse sociocultural attitudes regarding medical interventionl, which can lead to delayed presentation and difficulties for graft maintenance. ■ awareness of these challenges and to sensitize national au- garding the importance of organ donation. Donation after death thorities to the critical importance of legal frameworks, is rare because of social reservations and ongoing debates sur- based on the WHO Guiding Principles. rounding brain death; therefore, transplant activity in the region predominantly involves kidney and partial liver transplants Eastern Mediterranean Region from living donors. Waiting lists for organ transplantation are Nabila Metwalli growing rapidly, but in the absence of significant investment in WHO Regional Office for the Eastern Mediterranean transplantation services or access to organs from deceased do- The Eastern Mediterranean region, extending from Af- nors, many patients have sought alternative solutions in the ghanistan to Morocco and including some African countries form of commercial transplantation. The region contains coun- with complex emergencies such as Sudan, Somalia, and Dji- tries with significant problems in terms of organ trafficking, both bouti, is full of diversity. Concerning organ donation and trans- documented and undocumented; wealthy individuals who need plantation, challenges for the region include unevenly distrib- organs for transplantation import the vendors from poor MS. The uted wealth, and consequently healthcare infrastructure, WHO,withthecooperationofdedicatedindividualsinthefield,has minimal interest in prevention of chronic disease, and low been able to introduce legislation against this practice in a few MS awareness among medical professionals and communities re- and is very proud of the results. Implementation is yet to follow. S60 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

Country study: Egypt Mohamed Hilal El Sahel Teaching Hospital

Egypt commenced living donor kidney transplantation in 1980, introducing liver transplantation from living donors in 2002. An extremely high burden of end-stage liver disease and hepatocellular carcinoma is found in the Egyptian population. It is estimated that 42,000 individuals are currently in need of a kidney or liver transplant [ vs. 1280 transplants performed in 2008; (7)]. The national government has introduced a comprehensive primary prevention strategy to control the spread of HCV; however, it is estimated that the number in need of transplants will exceed 100,000 by 2020 years based on the current population burden of HCV infection.

Disagreement over the definition of brain death, questions of social injustice, and ethical debates concerning the ownership of organs prevented the legalization of donation after death in Egypt until 2010. As the only hope for Egyptian patients with end-stage organ failure of disease has helped to inflate the problem of a compatible living donor, the large, unmet burden of disease has helped to inflate the problem of commercial organ sales in the country, and Egypt has become a regional hub for organ trafficking. The passing of a transplantation law prohibiting organ trafficking, legalizing donation from deceased persons, and coordinating donation from living persons by the Egyptian Parliament in March 2010 represents a significant step both toward addressing the transplantation needs of the Egyptian population and bringing an end to wide spread trafficking. The Egyptian law stipulates that a License for Organ Transplantation will only be issued to adequately equipped facilities that are able to comply with strict standards and adhere to rigorous inspections from the High Committee of Organ Transplantation. It is intended that this new legal framework will be the foundation of an organ donation and transplantation programme characterized by transparency, legality, donor and recipient safety, equity in access to transplantation therapy, and a national culture of organ donation.

In 2010, Egypt is at a crossroads in organ donation and transplantation. Immediate challenges are to establish organizations responsible for organ procurement, construct a formal waiting list, and begin to generate community support for donation after death. Subsequent needs include the articulation of organ allocation criteria, construction of a donor and recipient registry, building depth of experience in brain death diagnosis, and the promotion of an organ donation culture within the health system.■

Responding to the obligations of WHO MS with re- Iran are also now moving toward expanding deceased dona- spect to effective national oversight, accountability, and tion programmes. the protection of vulnerable groups from transplant tour- The foundations are in place for unprecedented na- ism (WHA 57.18/2004) is an important challenge facing tional efforts to maximize organ donation from deceased the Eastern Mediterranean region. Prevention of an inter- persons in the Eastern Mediterranean region. These efforts national trade in organs has been gathering momentum, will be met by ongoing challenges of regulation, organiza- including significant recent progress in instituting regula- tion, and coordination, and by the need to firmly establish tory and legal frameworks consistent with The Declaration public awareness and community support through ongoing of Istanbul. Saudi Arabia, Kuwait, Tunisia, and Morocco campaigns and effective media engagement. Appropriate mod- have led the region in the regulation and technical devel- els of organization and financing need to be developed that in- opment of organ donation and transplantation. In March corporate public and private healthcare providers in locally 2010, transplantation law was also passed in Egypt. This appropriate, regulated organ donation and transplantation sys- law bans the commercial trafficking of organs, restricts tems that are transparent and acceptable to the community. Pro- donation from living persons to family members, permits cedures for evaluating and making determinations on new regulated deceased donation, and undertakes to finance developments of legal, ethical, or religious concern, for example transplant procedures for low-income patients. Also in DCD, may also facilitate the continuing advancement of de- March 2010, President Asif Ali Zardardi of Pakistan signed ceased donor programmes within the region. into law a bill prohibiting the sale of organs and providing for organ donation to occur after death (http://www. South East Asian Region emro.who.int/pressreleases/2010/no2.htm). Mehta Geeta Antipathy toward donation after death has been a ma- WHO Regional Office for South-East Asia jor challenge in the Eastern Mediterranean region. Religious The South East Asian region is home to approximately leaders are now leading normative change and building com- 25% of the world’s population and approximately 30% of the munity support for donation after death by advocating organ global burden of disease. Communicable diseases, especially transplantation, from both living and deceased donors, as tuberculosis and HIV, are highly prevalent. However, it is being upheld by the Quran as a charitable and life-saving act. chronic diseases—CVD, cancer, chronic lung disease, and Registration as a potential deceased donor is being encour- diabetes—that are the leading cause of death in the region. aged on the basis of religion, motivation to be a participant in This dual chronic and infectious disease burden is com- a responsible society, and a responsibility to contribute to pounded by high neonatal and maternal mortality, and by the greater equity by increasing the donor pool, so that access to complex challenges of emerging diseases such as endemic transplantation is possible across all sectors of society (a re- avian influenza. Epidemiologic data on end-stage organ fail- jection of an allegorical notion of “pharos and slaves”). Do- ure for the region is sparse. India (33) and Thailand (34) nation from deceased persons is currently performed in report an incidence of end-stage kidney failure of approxi- Tunisia, Iran, Saudi Arabia, Lebanon, and Kuwait, with these mately 150 to 175 cases per million population per year, countries soon to be joined by Egypt and Pakistan. Syria and higher than the incidence of end-stage kidney disease re- © 2011 Lippincott Williams & Wilkins S61 ported by most European countries. Glomerulonephritis and Significant heterogeneity is also found with respect to the interstitial diseases, associated with communicable diseases utilization of organs from deceased donors in the Western Pa- and environmental toxins, were historically the most com- cific region. Transplantation in Viet Nam, Mongolia, Philip- mon causes of end-stage kidney failure in the South East pines, Japan, the Republic of Korea, and Singapore is based pre- Asian Region but are now being taken over by diabetes, which dominantly on organs from living donors. Only in Australia, is rapidly emerging as the single most common cause of kid- New Zealand, and China, do deceased donors outnumber liv- ney failure in the region (33, 35). ing donors. The shortage of organs from deceased donors is a Of the 11 South East Asia region MS, six (Indonesia, India, key challenge in the pursuit of self-sufficiency in the Western Thailand, Sri Lanka, Myanmar, and Nepal) are currently en- Pacific region. Despite high economic development and gaged in transplantation activity and have national plans for or- long-established transplantation programmes, Australia and gan donation and transplantation programmes at varying stages New Zealand achieve rates of deceased donation consistently of implementation. More than 220 health facilities in the region below the global average (39). In Japan, where the burden of perform solid organ transplantation, of which 65% are in the end-stage kidney disease is among the largest in the world (34), private sector. Approximately 7000 kidneys, 300 livers, and 10 debate concerning the definition of brain death has impeded hearts are transplanted each year, with the majority of this activ- the development of deceased donation. Other donation- ity taking place in India, followed by Indonesia, Thailand, and Sri related issues that present ongoing challenges in the region Lanka (7). However, 94% of kidneys and 70% of livers trans- include allocation processes, traceability of organs, and trans- planted in South East Asia are obtained from living donors. parency of procurement and transplantation. There is a scope Thailand alone has a significant deceased donation pro- for greater regional cooperation, including collaboration to gramme. The high burden of end-stage organ disease in share technical capacity and to meet training needs, improved South East Asia, combined with undeveloped deceased dona- laboratory coordination, and development of common qual- tion programmes, together contribute to a vast disparity be- ity and safety systems. Registries and databases for donor tween the need for organs and access to transplantation in the matching, surveillance of adverse events, and monitoring of region and tempt unethical practices. Although the major- organ donation and transplantation activities are well-established in ity of MS have established legal frameworks regulating some MS but underdeveloped in others. Finally, a tacit community donation and transplantation, commercialization and acceptance of transplant tourism and commercial organ transplan- trafficking continue to be reported. tation exists that has not yet been adequately addressed through The pursuit of greater self-sufficiency in organ dona- legislative and regulatory frameworks. tion and transplantation for the South East Asian region first Greater self-sufficiency in organ donation and trans- requires that national plans for organ donation and trans- plantation in the Western Pacific requires principally that plantation programmes be extended to include the develop- national legal frameworks be strengthened and imple- ment of deceased donation. As in other regions, the successful mented, consistent with the WHO Guiding Principles for expansion of organ donation and transplantation pro- Human Cell, Tissue, and Organ Transplantation, and that grammes relies on widespread community awareness of the deceased donation programmes be developed as a matter importance of organ donation and participation as registered of priority. donors. It will be necessary to build on legal frameworks to ensure adequate regulation of all donation and transplanta- American Region tion practices and to combat the persistence of unethical Jose´ Luis Di Fabio practice in the sector. Finally, public-private partnerships WHO Regional Office for the Americas should be promoted as an appropriate and sustainable Transplantation activities in the American region are method of financing organ donation transplantation in highly variable. Rates of organ donation from deceased persons emerging economies, able to promote greater equity in access range from 6.29 deceased donors per million population for to transplantation by persons in need. Latin America as a whole to 26.3 donors per million population in the United States. Within Latin America, there is a large diver- sity in transplantation activity, influenced by variability with re- Western Pacific Region spect to economic factors, political commitment to transplanta- Gayatri Ghadiok tion programmes, and the organization of healthcare systems. WHO Regional Office for the Western Pacific Countries that have had the benefit of continuous government Of the 27 MS of the Western Pacific region, 10 have commitment to organ donation and transplantation pro- transplantation facilities (Australia, NZ, China, Korea, Viet grammes, such as Uruguay, Chile, Columbia, Cuba, Argentina, Nam, Philippines, Japan, Mongolia, Singapore, and Malay- and Brazil, demonstrate the highest rates of organ donation and sia). Organ donation and transplantation involving foreign transplantation in the region, and have shown systematic, ongo- donors and recipients traveling for this purpose is permitted ing improvements for the past 5 to 10 years (43, 42). by some countries in the region, although this is closely reg- Latin America serves as a model for international ulated. The Western Pacific is highly heterogeneous with re- cooperation and collaboration in the sharing of knowl- spect to economic development, accounting for much of the edge, skills, and resources. Training of transplant coordi- variability in the distribution of transplantation activity, al- nators from Latin American countries by Spain in the early though this variation also presents opportunities for coun- 90s established a precedent of Iberoamerican cooperation tries seeking to develop organ donation and transplantation for the development of donation and transplantation pro- programmes (most recently Fiji) to draw on long-established grammes in Latin America. This exchange of knowledge regional expertise in transplantation. and skills has been progressively formalized, and in 2005, S62 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

Country study: Thailand Visist Dhitavat Thai Red Cross Organ Donation Center Thailand’s Organ Donation Centre was established under the Thai Red Cross Society in 1994. Founded in 1893, the Thai Red Cross Society is the oldest, non-governmental, non-profit organization in Thailand. In addition to overseeing organ donation and transplantation activities, the Thai Red Cross Society is responsible for the National Blood Bank and . These organizations, with a common goal of obtaining cells, tissues and organs for transplantation, also share common laboratory support in HLA typing and microbiology. The policies of the Organ Donation Centre have been developed in accordance with recommendations outlined by the Thai Medical Council, the WHO Guiding Principles, and the ethics committee of The Transplantation Society. These governing policies are; first, to promote an understanding of organ donation after death among the public and health professionals to have enough organs for transplantation in the country; second, to allocate organs fairly and without financial gain; and third, to optimize efficiency in the utilization of donated organs. The specific functions of the Centre incorporate almost all aspects of the organ donation and transplantation process, including maintenance of an organ donation registry and a national waiting list, organ matching and allocation, organ preservation and transport, coordination between donors and recipient hospitals, donor family care, increasing public awareness of the critical need for organs, and maintenance of a Heart Valve Bank (36–38).

The Organ Donation Centre has been responsible for extensive public awareness campaigns to promote understanding and greater support for organ donation and transplantation in Thailand. Multimedia campaigns, employing film and television advertising, print media, television programming, celebrity endorsements, poster campaigns, handbills, lecture tours, and exhibitions, have been used in the effort to raise awareness and to address specific topics such as brain death, organ donation and Buddhism, the shortage of available organs, the process of organ donation, and the efficacy of transplantation. In addition, the venerable Buddhist monk Phra Phromkunaporn (Prayuth Payutto) has written on the merits on organ donation to address misconceptions regarding donation and transplantation in the predominantly Buddhist Thai population. Events have been used to raise the profile of organ donation, including “The Organ Donation Day,” an annual event during which the Organ Donation Centre organizes religious ceremonies to honor donors and publishes a booklet with words contributed from recipients and from donors’ families. Private enterprises have also contributed to awareness campaigns, producing phone cards, and stamps printed with messages affirming the value of organ donation. The Organ Donation Centre also provides training in transplant coordination, donor management, and organ recovery and conducts visits to provincial hospitals to educate professionals on the donation process and on the importance of transplantation. Education is also extended to medical and nursing students. Currently, Thailand has 638 transplant coordinators across 131 hospitals. The country has 31 kidney transplant centers, 10 liver transplant centers, and 5 heart transplant centers, of which 17 are located in private hospitals and 29 in government hospitals. However, although transplant waiting lists have more than doubled since 2001, the number of deceased donors has remained less than 100 per annum, fluctuating according to changes in public confidence and disturbances in healthcare operations affecting organ donation (36–38). There is approximately an 80% refusal rate from families approached regarding donation after death. The major obstacles to improve the rate of donation after death in Thailand are the lack of an appropriate legislative framework, the lack of governmental and public health policies supporting organ donation and transplantation, poor awareness among medical professionals of the value of organ donation, and refusal of consent by families of potential donors. Solutions will require a commitment from the Ministry of Health to increase donation from deceased persons and the introduction of a legal definition of brain death as a priority.■ the XV Iberoamerican Summit of the Heads of State and Gov- tion, coordination, and regulation of organ donation and trans- ernment ratified a proposal to create the Red/Consejo Ibe- plantation, the development of data registries, the systematic roamericano de Donacio´n y Trasplante, with the mandate to high-quality training of transplant coordinators, and an increas- improve organ donation and transplant programmes in Latin ing equity of access to organ transplantation are enormous American through international linkage with ONT and via pro- achievements for the region. motion of intraregional cooperation and collaboration. Red/ Consejo Iberoamericano de Donacio´n y Trasplante has devel- Key Points and Summary oped numerous recommendations for implementation at the A global overview of current activities in organ dona- national level and has also developed an ongoing human re- tion and transplantation demonstrates that, despite wide sources training programme (the Master Alianza). As of March variation in health service capacity, legislative background 2010, more than 180 transplant coordinators from across Latin and cultural perceptions relating to organ donation, the chal- America had been trained in Spanish hospitals in all aspects of lenges confronting individual countries with respect to the the coordination of organ donation and transplantation and had pursuit of self-sufficiency are often shared in common. Al- returned to their respective countries to apply their expertise. though the characteristics of successful organ donation and Supported by a strong network of collaborations and an transplantation programmes may differ from country to coun- active exchange of information, experience, training, and re- try, the factors essential for progress toward self-sufficiency are sources, Latin America has managed to address many of the affirmed in all contexts, regardless of local realities. challenges that in other regions act as barriers to the effective Essential for every country is a commitment to: (1) re- delivery of organ donation and transplantation programmes. ducing need through disease prevention and (2) establishing Recent years have seen several Latin American countries achieve legislative frameworks based on respect of ethical principles, considerable success in their organ donation and transplan- human dignity, and social justice. Profound social and eco- tation programmes. The existence of appropriate and effec- nomic changes in low- and middle-income countries, accom- tive legal frameworks in most Latin American countries, the panied by rapidly changing patterns of diet and exercise, are emergence of strong national organizations for the promo- promoting escalating rates of CVD, diabetes, and other chronic © 2011 Lippincott Williams & Wilkins S63

Country study: Singapore Anantharaman Vathsala National University of Singapore, Department of Medicine

Singapore conducted its first corneal transplant in 1964, followed by the first kidney transplant from a deceased donor in 1970 and first kidney transplant from a living-related donor in 1976. Legislation was introduced in 1973 in the form of the Medical Therapy, Education and Research Act and was followed by the introduction of the Human Organ Transplant Act in 1987, which subsequently has undergone several amendments reflecting developments of a scientific or social nature relevant to the Act. Transplantation law in Singapore provides for the removal of organs from the bodies of deceased persons for transplantation purposes and prohibits trade in organs. Presumed consent has been gradually phased-in, incorporating different sections of the population in a step-wise fashion. The 1987 Act provided for the removal of kidneys from persons who had died from accidents only and exempted Muslims and persons more older than 60 years from the provisions of the Act; in 2004, the Act was amended to allow organ donation from all deaths and to provide for liver, heart, and corneal in addition to kidney donation; in 2008, Muslims were included in presumed consent, and; in 2009, the upper age limit for organ recovery was removed. There is now a recognized need for Singapore to focus on the development of “soft skills,” to fully realize the potential of the country’s established legislative framework and existing transplantation infrastructure. The “Live On” programme has been developed to address public education and community motivation, policy development and implementation, engagement of the government and public agencies, and in innovations in practice. Public awareness of the importance of organ donation is the target of an annual SGD1.5 million media campaign that involves the distribution of an information booklet to all households, the utilization of news media, and campaigns directed at youth (such as short story competition and use of social networking websites). There is evidence that this programme is having a positive effect on attitudes towards organ donation, with 64% of people surveyed responding that they now support organ donation more than they did before to the roll-out of the programme. Concerns for living donor welfare and for financial hardship incurred by donors and recipients have prompted a number of organizational and legislative developments in recent years. Singapore has established a Donor Care Registry to monitor the long-term health outcomes of all donors, for life. Counseling and education are provided to all potential living donors, who must also go through a “cooling off” period before proceeding with donation. Amendments have been made to the policies of national health providence fund (Medishield) to exempt living donors from exclusions or premium loading. In addition, the Human Organ Transplant Act has been revised to include provision for the defraying or reimbursing of (1) costs or expenses or loss of earnings directly attributable to organ donation and (2) costs for medical care or insurance protection incurred as a consequence of organ donation. The Singaporean National Kidney Foundation has established the NKF Fund for needy donors, which provides annual medical follow-up and insurance protection covering hospitalization and surgery, death, disability, and critical illness. At the same time, legislation prohibiting the buying or selling of organs is being widened to prohibit advertisements relating to buying or selling of organs and to introduce stricter penalties for organ trading syndicates and middlemen. Singapore’s first organ trading case was prosecuted in August 2008, and ensuring ethical practice in organ donation and transplantation is a priority. Currently, a living donor organ transplant can only be carried out following the approval of the hospital’s Transplant Ethics Committee. The incidence of end-stage kidney disease in Singapore has remained stable at 150 to 175 per million population for the past decade. During the same period, however, the rate of kidney transplantation has also remained relatively static at 25 to 40 transplants per million population per year (40). It is hoped that comprehensive chronic disease prevention programmes will complement efforts to increase the transplantation rate by reducing rates of end-stage organ failure. Programmes include the Integrated Screening Programme, which screens for diabetes, hypertension, and hyperlipidemia in the general community, the Pre-Diabetes Intervention Programme, and the Chronic Disease Management Programme. The Pre-Diabetes Intervention Programme, in which individuals with impaired fasting glucose are referred to nurse educators for assessment, counseling, and follow-up, has already been shown to be effective in decreasing mean blood glucose level in programme participants. Therefore, backed by a detailed legislative framework, Singapore is pursuing a composite approach to self-sufficiency that places emphasis on both successfully reducing demand for organs and increasing the transplantation rate.■ diseases. This epidemiologic transition will alter the nature of the come traditional cultural, legislative, and organizational demand for health services in those countries affected, with barriers to the development of deceased donation pro- global implications for organ donation and transplantation. grammes. There is a central role for international cooper- Where there is a high burden of end-stage organ failure, ation and collaboration in facilitating these efforts, combined with undeveloped deceased donation and an ab- through the sharing of knowledge, skills and resources, sence of regulation, there is also the temptation of uneth- data sharing, training programmes, and advocacy on issues ical practices. The importance of legislative frameworks, of shared concern. Increasing access to transplantation consistent with the WHO Guiding Principles, cannot be globally by maximizing donation from deceased persons, understated. However, it must be noted that regulation is complemented by donation from living persons, through ineffectual unless adequate resources are channeled into its practices that respect society’s values and universal human implementation, which requires political commitment, rights and principles, is central to future progress in the pur- and that legislation can only bring about the desired suit of self-sufficiency. change when it is sanctioned by public attitudes. A need to engage communities to build awareness concerning the Closure of the Meeting and Closing Remarks importance of organ donation and the benefits of trans- Participants agreed on adopting a Resolution stress- plantation was identified in all regions. ing a national responsibility to meet the needs of patients Finally, the current era in transplantation is seeing with respect to organ transplantation, as guided by the the beginnings of widespread international efforts to over- WHO Guiding Principles for Human Cell, Tissue, and Or- S64 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

Country study: Uruguay Inés Alvarez Instituto Nacional de Donación y Trasplante

Uruguay has some of the highest reported rates of end-stage organ failure in the American region but is also the highest performing country with regards to organ donation and transplantation in Latin America. Significantly, the majority of transplanted organs in Uruguay come from deceased donors (deceased donor rate of 19.1 donors per million population). The first kidney transplant in Uruguay was performed in 1969; regulation of transplantation activity followed in 1971. Initial legislation defined consent and prohibited trafficking and commercialization, while subsequent amendments have addressed donation from non related, living persons, definitions of circulatory and brain death, and (41). A nationally integrated health system provides universal healthcare coverage. Since 1980, access to transplantation has similarly been free and universal. Financing of organ donation and transplantation is based on regulated private systems with public assistance. Uruguay also established a separate national donor registry and tissue bank, responsible for typing and allocation, early in the development of their programme to facilitate quality control, and also to ensure transparency to the wider community. One of the strengths of Uruguay’s organ donation and transplantation programme has been the incorporation of community values. There is a community perception of equity of access, real possibilities of transplantation, and transparency of allocation systems (41). On this foundation, Uruguay has sought to increase rates of donation from deceased persons by aligning organ procurement practices with the Spanish model. Transplantation is governed by a publicly financed, national governmental organization, responsible for regulation, implementation of national policy, procurement management, and monitoring and quality control of organ donation and transplantation practices in Uruguay (Instituto Nacional de Donación y Trasplante de Células, Tejidos y Órganos, INDT). Since the introduction in 2000 of hospital-based transplant coordinators under INDT, actualized donor rates have more than doubled ( 42). In 2006, a quality assurance programme was introduced to analyze theoretical national capacity for deceased donation, to monitor donation and transplantation practices, and to evaluate for improvement. Recent emphasis has also been placed on improving professional awareness and on public education, promoting a donation culture across the community. Uruguay has also benefitted from a strategic focus on regional cooperation and linkages, with Brazil and RCDIT in particular, and from an emphasis on specialist training and continuing medical education, reflecting the core values of the Uruguayan organ donation and transplantation programme: sharing, discussion, and consensus. Central to the pursuit of self-sufficiency in Uruguay are public education, the promotion of a donation culture, ongoing professional training in both the medical and communication aspects of organ donation and transplantation, and fostering of best-practice in the detection of potential donors.■

Box 4

Common challenges in the pursuit of self-sufficiency

From low-income countries to high-income countries, many of the challenges facing organ donation and transplantation are shared in common. Successfully addressing these mutual challenges will often involve similar strategies and in some cases will depend on international cooperation and collaboration. These common challenges are as follows: • The growing demand for organs affects low-, middle- and high-income countries alike, with need far outstripping current transplant capacity in the majority of countries. • The global burden of diseases contributing to end-stage organ failure is immense, and therefore, organ donation and transplantation efforts must be complemented by sustained and comprehensive public health approaches to the prevention of diabetes, hypertension, cardiovascular disease, HBC, HCV, and chronic pulmonary disease. • Reliable epidemiologic data on rates of end-stage organ failure are not available; hence, appreciation of actual transplantation need is currently not possible. • Registries for the purpose of monitoring organ donation and transplantation activities must be comprehensive and accurate. National surveillance systems that monitor adverse events in transplant recipients and complications in live donors are critical. • A minimal set of legal provisions concerning the removal of human material for therapeutic purposes from deceased and living donors is essential to protect the vulnerable from exploitation; however, unregulated settings persist. • Ongoing regulatory improvement is a requirement for all regions. National bodies responsible for oversight of organ donation and transplantation activities are commonly absent. • Low-income countries are uniquely challenged to provide diagnostic services (imaging, pathology, and histocompatibility laboratories) and by the unaffordability of immunosuppressive drugs. International support is needed to address these issues. • Achieving transparency in allocation practices and equity in access to transplantation is a challenge wherever there is disparity between the number of patients in need and the number of organs available for transplantation. It is particularly challenging in settings where inequity is entrenched within the broader health system. • Financing of organ donation and transplantation must seek to make effective use of private and nongovernmental funds and public-private partnerships in a locally appropriate manner. • Promotion of transplantation and the expansion of deceased donation must avoid distortion of existing health priorities in disease prevention and be commensurate with local realities. © 2011 Lippincott Williams & Wilkins S65

Box 5

Shared goals on the pathway to self-sufficiency Repeatedly identified across all regions of the globe are a common set of factors essential to the successful pursuit of self-sufficiency in organ donation and transplantation. These are: • Regional/international cooperation for the exchange of knowledge, skills and, resources. • Political sensitization to the need for adequate legislative frameworks based on the WHO Guiding Principles for Human Cell, Tissue and Organ Transplantation. • National regulation and oversight of organ donation and transplantation. • Community awareness of the importance of organ donation and participation in efforts to increase rates of transplantation. • A culture of organ donation within the medical community. • Access to national and international databases that cover all aspects of organ donation and transplantation, from population need, to long-term donor and recipient outcomes. • Processes for quality assurance, monitoring the gap between potential and achieved donation. • Incorporation of community values in organ donation and transplantation programmes; normative change led by political, religious, and community leaders. • International cooperation in specialist training and continuing medical education. • Sufficiently transparent financing, organ procurement, and allocation processes that the public, as potential donors themselves, are satisfied that the system is not being used to generate financial rewards, and is otherwise free from unethical or inequitable practices. • National and international commitment to prevention. gan Transplantation, and acknowledging that meeting the hance cooperation between the different stakeholders needs of patients necessitates a comprehensive approach that involved. addresses the conditions leading to transplantation from pre- From a public perspective, the pursuit of self-sufficiency vention to treatment. Strategies for the pursuit of self-sufficiency relies on a communal appreciation of the value of organ do- within individual countries should be adapted to the respec- nation after death. The concept of donating human body tive level of economic and health system development, with parts to save the life of another as a civic gesture is one that the pace of progress from one level of transplantation capa- should be taught at school as a part of health education to bility to the next commensurate with local resource availabil- decrease needs in transplants. The pursuit of self-sufficiency ity and competing health priorities. Transplantation pro- in organs for transplantation exemplifies the public health grammes should use resources obtained within a given and community values of reciprocity and solidarity, whereas country for that country’s population or, when necessary, it is the only safe guard against the temptation of yielding to resources may be obtained by regulated and ethical regional trade in human organs. or international cooperation. The consultation was officially concluded by Dr Jose´ This new paradigm advances a comprehensive stra- Martinez Olmos at 14:35 on the March 25, 2010. tegic framework for policy and practice directed at the global challenges of an increasing incidence of chronic NCDs, a shortage of organs for transplantation, and unmet REFERENCES patient needs. From this perspective, donation and trans- 1. Steering committee of the Istanbul Summit. Organ trafficking and trans- plantation services are to be recognized as an integral com- plant tourism and commercialism. 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Part 2: Reports From the Working Groups

WORKING GROUP 1: ASSESSING NEEDS plantation in different countries, internationally applicable FOR TRANSPLANTATION metrics are required, which will support a consistent global Leaders: Christian Jacquelinet, Vivekanand Jha, and approach to transplantation needs assessment. Through the Adeera Levin comparison of a common set of key indicators, it is possible to Members: Manuel Arias, Gloria Ashuntantang, Saeed establish the notion that end-stage organ failure and trans- Bassam, Eemi Vera, Sveinn Magnusson, Rosario Marazuela, plantation are indeed global issues; thus, the assessment of Nabila Metwalli, Ferdinand Muehlbacher, Kaija Salmela, and needs across regions and political and geographical boundaries, Zhong Yang Shen. based on a framework of internationally applicable metrics, should stimulate comparisons, discussions, and ultimately com- A Common Framework for the Accurate mon solutions to similar problems. Assessment of Transplantation Needs In an attempt to move toward sustainability and self- The Requirement for Common Metrics and sufficiency with respect to organ donation and transplanta- Definitions tion, nations must use a common framework and set of The requirement for common metrics and definitions metrics. The goal of defining these metrics is that by doing so, has several aspects: a broader understanding of the gaps and issues facing differ- ent countries will be more apparent. Solution generation and a. A need for the clear identification of need according to dissemination may be facilitated if we start with a greater standard definitions: global understanding of the issues that currently exist. • We strongly advocate for inclusivity of case reporting. Organ transplantation is the part of a continuum of care That is, all cases of (incident) end-stage organ failure must and health, which commences with recognition of risk factors, be documented irrespective of treatment availability, documentation of chronic conditions, and management of end- cause, or eligibility/availability of organ replacement (true stage organ failure, which includes identification of the optimal need). The availability of treatments introduces bias and treatment of that organ failure. Thus, a better understanding of must be acknowledged as a limitation of current metrics organ transplantation requires an appreciation of the interaction available and in current use around the world. Reporting between population needs, healthcare systems, and the availabil- of true need will help to focus public and political atten- ity of living and deceased donors as a source of grafts. It is well tion on the problem of insufficient donor organs available recognized that organ availability varies widely between and to meet transplantation needs. within countries, because of different combinations of cultural, • Organ failure in all age groups and of all organs so as to ethical, religious, social, organizational, and practical issues. Fur- ensure a true reflection of societal burden of illness. thermore, the care and outcomes of patients with failing organs varies depending on the organ affected. b. A need for the clear identification of drivers of need: this Strategies for greater self-sufficiency in organ donation includes the identification of the number of individuals and transplantation must be informed by the accurate assess- with multiple conditions to highlight the complexity of ment of the needs of populations. Therefore, recognizing the conditions, and the linkage between multiple organ dys- diversity of outcomes, situations, and challenges facing trans- function and end-stage organ failure within individuals.

Key Points • The application of an internationally consistent framework to the assessment of transplantation needs will enable a broader understanding of the issues facing different countries, and facilitate the identification of global solutions. Yet there is currently a paucity of the necessary metrics, tools, and definitions required to make standardized needs assessment possible. • An international organ transplantation registry, using common definitions and metrics, should be established. For the purposes of this registry, the following national-level data should be made available: (i) true incidence and prevalence of end-stage organ failure, reported annually, (ii) availability of treatment for end-stage organ failure, (iii) waiting-list statistics, (iv) data relating to the identification of organ dysfunction and progression to organ failure, (v) referral to organ replacement therapy (transplant and non transplant), and (vi) time for workup, time to acceptance onto waiting list, and time to receipt of an organ. • Governments should: (i) support identification of transplantation needs as a priority for public health improvement; (ii) create a registry for conditions leading to the need for organ transplantation; (iii) invest in prevention programmes; (iv) ensure the equity principle is applied in need assessment; and (v) create or support infrastructure and allotment of resources for all aspects of need assessment.

• The WHO should: (i) identify as a resolution that all countries shall have the ability to assess their needs for transplantation by 2020; (ii) identify and outline the need for a core minimum data set by which international comparisons will become meaningful. • Professional societies and their members should: (i) ensure consistency in definitions and use of terms; (ii) support identification of organ failure /dysfunction as a strategic priority for the organization; (iii) foster international cooperation and intra-societal cooperation; (iv) support education concerning technical issues in needs assessment; (v) promote scientific enquiry in the area of needs assessment; and (vi) ensure linkages with governmental agencies and policy makers for translation of research into policy. S68 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011 c. A need for the clear identification of factors that may im- International Data Requirements pede ability to define true need: there is a need to system- It is imperative that we are able to identify needs- atically identify and document the nonmedical factors related data that are relevant (to the pursuit of self-sufficiency (e.g., economic, social, competing needs, bias, and atti- at a national level) and thus would ask that the following tudes) that influence the ability to conduct an accurate information be available to all: needs assessment with respect to organ transplantation or the prevalence/incidence and treatment of end-stage or- a. By country, and as appropriate by region: • gan failure itself. Prevalence and incidence of end-stage organ failure, • Prevalence and incidence of particular diseases contrib- uting to end-stage organ failure, An International Registry for Organ • Transplantation Availability of treatment for organ failure (transplant and non-transplant); To appreciate the international scope of challenges fac- ing organ transplantation, an international registry of trans- b. Waiting lists have different purposes and start times; thus, plantation need using common definitions and metrics it would be of value to determine “true” wait times for should be established. The development of common metrics organ replacement therapy (especially organ transplanta- relating to organ transplantation, and the reporting of these tion therapy); data to a central international registry, is intended to enrich c. Wait lists keep growing because patients are not taken off currently available international data, and to harmonize re- despite being obviously unsuitable for transplantation, porting practices so as to permit a more cohesive global un- which needs to be recognized and factored in; derstanding of needs for organ transplantation. General d. A uniform method of tracking chronic organ failure points: would be of value, specifically a uniform tracking of key time points in the trajectory of disease; a. Uniform data based on the true incidence of condition(s) e. Data relating to the identification of organ dysfunction should be forthcoming on an annual basis from each country. and the progression of organ dysfunction; b. The documentation of the availability of organ replace- f. Referral to organ replacement therapy (includes assist de- ment therapies should serve as a measure of “other re- vices, and transplantation); sources” available but should not be used to define need. g. Time for workup, time to acceptance onto waiting list Comparison between countries who do and do not have (living donor or deceased as applicable), and time to re- supportive therapies available [e.g., dialysis and left ven- ceipt of organ. tricle assist device (LVAD)] should be of value. c. Mortality and morbidity statistics should be used to esti- In the context of international data comparisons, it is mate theoretical needs for organ transplantation. also relevant to consider: (1) what methods of successful d. Supplementary data from population-based, prospective, needs prevention currently exist in the different regions? (2) or cross-sectional studies, or from other cohort studies, Does the presence or absence of formal structures impact on would support the findings from mortality data. the availability of data or resources? Any programme that e. A set of useful indicators to inform needs assessment aims to prevent end-stage organ failure will directly impact should be established in the absence of formal registries of on the population need for transplantation, as needs will be transplantation need (and to ensure an understanding of favorably affected by the success of such programmes. Imple- the continuum of care and health in organ failure). mentation of early detection and prevention programmes also strengthen data collection efforts and hence would make Key indicators include: possible a more accurate assessment of the affected popula- • tion. The need for prevention is more acute in countries with High-risk conditions (incidence and prevalence) leading to limited resources (though organ replacement therapy is ex- organ failure; pensive everywhere). This would need support from the • Organ failure (all age groups/all organs); • health policy makers. Outcomes of patients with respect to With respect to current international prevention - movement through stages of diseases (complex)—risk strategies: factors, early identification, end-stage organ failure, and replacement; • Need to recognize the existence of such programmes, their - dynamic nature of chronic conditions adds complexity scope, implementation methodology, and success. Exam- to data capture; ples include those among the Aboriginal population in Australia, Dharan (Nepal), and Chennai (India). Others • individuals who have received organ replacement therapy, may also exist in South America and Africa, but formal for example, the location of therapy delivered (inside vs. documentation of these need to be undertaken. outside country); • There is a need to document variability across regions. • variability between and within regions with regards to • To impress the planners, metric needs to be developed that - Acceptance criteria to organ replacement therapy, would enable the estimation of the projected cost savings - Attitudes/nonmedical factors determining uptake of from prevention programmes. various therapies. The current state of data availability around the • Economic factors driving resource availability (equipment/ world should form phase 1 of the international assessment facilities). of transplantation needs, collated as an “information avail- © 2011 Lippincott Williams & Wilkins S69 ability world map,” which documents the availability or transplantation are assessed should be adaptable to all non-availability of data on the indicators described earlier. contexts, reflecting differing realities with respect to This map would inform an understanding the “gaps” in health system development and competing public “needs assessment” itself. (Note that the ideal source health priorities and thus empowering the stepwise of these data would be national/regional registries, but development of organ donation and transplantation other sources, such as smaller cross-sectional studies and systems in all nations, commensurate with the pace of representative population cohorts also have utility for this development. purpose.) c. Large variability across and within regions in their willingness to invest or allocate resources to informa- Metrics or Milestones: How Do We Know We Are Getting tion collection and a systematic approach to needs There? assessment. a. Create world map describing the current state with re- d. The fact that, despite the proposed need for uniformity gards to ability to capture any data concerning the need of definitions and essential data elements across re- for transplantation. This will allow benchmarking of the gions, this has not yet been achieved even in the devel- current state and methods of data monitoring and surveil- oped world where data are more easily obtained and lance abilities for reporting change/improvements. This greater resources exist with respect to registries and data map may be used to: collection tools. • Determine change by updating the map on an annual e. A paucity of human resources (trained medical and basis; other professionals) to assist in all aspects of needs as- • Identify areas of particular need. sessment and treatment of organ failure—be it care, documentation, evaluation, and implementation. b. Road map/process, by which increasing data collection f. Difficulties in facilitating collaboration between various will inform transplantation needs worldwide, should be stakeholders in the pursuit of common goals within constructed: countries or regions because of political, economic, or • Describing key elements of need assessment in hierar- other barriers. chal manner (information that will be pivotal in inform- g. There is a need to identify opportunities for interre- ing change); gional or national collaborations where local resources • Acknowledging regional variation in timelines to achieve would not support an independent programme. This this; would lead to improved outcomes and standardization • Acknowledging strategies that foster international col- of processes. It is recognized that given the diversity of laboration (in data collection, dissemination, and pos- international issues, these collaborations may vary over sibly transplantation process itself). time, organ types, and situations. c. Showcase examples of successful meeting of needs for transplantation do exist, for example, Iceland. Such ex- Responses amples may be considered as case studies and reviewed for Given the challenges above, the following responses are elements that exist within that community that have en- suggested: abled it to achieve its current state; use as a benchmark against which to map the progress of other countries a. Each country or region should have the ability to: based on key indicators. • Assess the incidence and prevalence of conditions that d. Compare and contrast elements in each of the different may lead to end-stage organ failure or the need for organ situations of organ transplant success (excellent, moder- replacement therapy (transplantation), noting that ate, and poor), so as to confirm the importance of each of prevalence is confounded by availability of therapies/ the elements required for “needs assessment.” survival outcomes/competing risks and is also relevant as a proxy indicator of need; Responding to the Challenges of Transplantation • Assess the ability to accurately project progression of Needs Assessment diseases and predict future incidence and prevalence of Challenges end-stage organ failure (future needs); • There are a set of recognized challenges to the imple- Assess the ability to deliver treatments to delay or pre- mentation of these goals which include, but are not limited to: vent conditions that lead to need for transplantation (management of current and future needs); a. A lack of clear definition as to who or what or when or • Describe the nature and performance of current struc- where the responsibility for needs assessment (data col- tures and organizations (or lack thereof) responsible for lection and dissemination) lies within regions and addressing the need for organs for transplantation countries. (transplantation rates and waiting lists); b. Competing needs in different regions or countries per- • Describe accurately outcomes of patients with organ taining to the “human condition.” In those countries dysfunction/failure/transplanted and non-transplanted. where infection, infant mortality, poverty, war, and starvation are key concerns on a day-to-day basis, organ b. Current state assessment: transplantation needs must be regarded within the con- • It is important to acknowledge the variability of the ca- text of existing health and social priorities. At the same pacity of individual countries or regions to identify those time, the framework by which achievements in organ in need; S70 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

• It is important to recognize the diversity of resources 4. Ensure the equity principle is applied in need assess- available across the world and that strategies for increas- ment (irrespective of access and resources). ing organ donation rates will vary depending on those 5. Create or support infrastructure and allotment of resources resources; for all aspects of need assessment (human and tools). • The need for transplantation (vis a vis “other replace- ment therapies”) may differ in different parts of the The WHO should: world depending on: 1. Identify as a resolution in the WHA that all countries - patient demographics (e.g., need may be greater in shall have the ability to assess their needs for transplan- countries where patients are younger or there is large tation by 2020 (which would include the capacity for population growth, or higher life expectancy), data collection and information sharing). - availability of complimentary adjunct therapies for 2. Identify and outline the need for use a core minimum organ dysfunction, dataset by which international comparisons will be- - availability of human and physical resources (trained come meaningful (Table 1). professionals medical and nonmedical). c. Unanswered questions: Professional societies and their members (healthcare • Does the legal framework of a country impact need as- providers) should: sessment? For example, a country may not have a legal 1. Ensure consistent definitions and use of terms in data framework that permits donation from deceased per- collection. sons. This will change the assessment with respect to the 2. Support identification of organ failure/dysfunction as a achievability of organ donation from all appropriate strategic priority for the organization (for instance in sources. research, core mission, and advocacy). Recommendations and Solutions 3. Foster international cooperation and intrasocietal co- The following set of solutions and recommendations is operation to ensure that data are available for the pur- defined according to organization/stakeholder. Note that pose of the evaluation of transplantation needs. each stakeholder is important to the process and the success 4. Promote and support education about needs assess- of the strategy. ment issues (methods, importance, and application). Governments should: 5. Promote scientific enquiry in the area of needs assess- ment (validation). 1. Support identification of organ failure/replacement 6. Ensure linkages with governmental agencies and policy mak- needs as a priority for public health improvement. ers (translational research: bench to bedside to policy). 2. Create a registry for conditions leading to the need for organ transplantation (all organs and all ages). Patient groups should: 3. Invest in prevention programmes as the strategy to re- duce needs (requires identification of at risk and early 1. Be involved in public health initiatives and policy. disease patients). 2. Be involved in educational programmes for peers/fam-

TABLE 1. Draft template for the assessment of needs for transplantation Stages: potential to Assessment of potential needs Tools for assessment actual needs (data requirements) (mechanisms) Action/purpose (results) Stage 1: diseases Estimation of disease prevalence Population studies Identification of opportunities for contributing to organ and incidence prevention failure Chronic disease assessment Registries Future planning to ensure needs Coexistence of multiple diseases Cohort studies are met (potential needs) Stage 2: organ failure/ Identification of patients with Education of primary healthcare Early intervention to manage health conditions organ failure/dysfunction professionals organ failure and delay needs requiring organ for transplantation replacement therapy Reporting Planning for future management Stage 3: end-stage organ Identification of transplantation Wait-listing/registering Transplantation failure candidates (actual needsa) candidates Identification of those unsuitable Referral to appropriate specialists Provision of alternate therapies for transplantation Stage 4: transplantation Registration of transplant Routine follow-up and Analysis of success in meeting recipients monitoring of outcomes needs, preventing needs, measuring benefits to recipients, etc.

a The accuracy of the measurement of “actual needs” will be influenced by numerous factors. We suggest mechanisms for monitoring accuracy, for example, through auditing of provinces and comparisons with national data, be developed in conjunction with other data requirements for this enterprise. © 2011 Lippincott Williams & Wilkins S71

ilies and society to ensure value of registration and data • Traceability of all organs, collection well understood by all. • Monitoring and auditing of transplantation procedures, using a transplant registry, WORKING GROUP 2: SYSTEM • Education of health professionals and the general public REQUIREMENTS FOR THE PURSUIT OF about transplantation and the importance of organ dona- SELF-SUFFICIENCY tion, including media engagement. Leaders: Ahn Curie, Martin Alejandro Torres, and Essential organizational structures: Jose Ramo´nNu´n˜ez Members: Maria Joao Aguiar, Mirela Busic, Jose´ Luis • NTO, Di Fabio, Peter Doyle, Mohamed Hilal, Marie Odile Ott, • Hospital transplantation programmes, Ferenc Perner, R.K. Srivastava, Zolta´n Szabo´, Annika Ti- • OPOs, bell, Liu Yong Feng, and Kimberly Young • An allocation system, • Traceability and surveillance systems, Essential Requirements and Key Functions of • Data registries. Organ Donation and Transplant Systems To achieve self-sufficiency, it is necessary to both min- System Requirements imize the need for transplantation and maximize the utility of available resources through efficient organ procurement, Legislative and Regulatory Frameworks successful transplantation, and optimal graft survival. This Clear legislative and regulatory frameworks are an essen- requires a number of specific systems, structural, organiza- tial system requirement to ensure ethical and transparent tional, and regulatory developments (Fig. 6). practices in organ procurement, retrieval, allocation, and transplantation. Specific requirements are as follows: Essential requirements for system development: a. Legislation: clear definition of brain death and circulatory • Government support, • death is necessary to enable donation from deceased per- Appropriate legislative, regulatory, and ethical frame- sons, together with legislation governing the procurement works, and transparent allocation of organs and the establish- • Adequate healthcare infrastructure, • ment of OPOs. Legislation should also cover prevention Adequate resources for programmes, including the long- of organ trafficking and commercialism and formal pro- term care of patients, cedures for consenting donors. Critical areas for legisla- • Independent oversight, • tion are: Share knowledge and experience with other system models. • Declaration of death; Key responsibilities of organ donation and transplantation • Organ procurement (deceased and living); systems: • Fair and transparent allocation principles; • Consent; • Organ procurement, • Establishment of transparent organizations; • Establishment and maintenance of a transplant recipient • Prohibition of organ trafficking and commercialism. waiting list, • Allocation of organs, b. Regulation and oversight: regulatory bodies are needed to • Exchange and transportation of organs both nationally and monitor practices, standards, and outcomes of organ do- internationally, nation and transplantation programmes and, therefore, • Approval of transplant teams and institutions, must be informed by comprehensive surveillance and • Safety and quality standards for organs, data collection. Regulatory oversight should guide ethical

Key Points • Legislation must cover death declaration, consent, procurement, and allocation and must govern organ donation and transplantation practice in accordance with the WHO Guiding Principles. • Regulatory bodies must establish ethically proper organ procurement and allocation processes, review existing practices, and standardize procedures and oversee performance. • Proper legislation and regulation enhance progress toward self-sufficiency and enable policy making for improved organ donation; for example, countries may adopt “presumed consent” or “required request” by legislative/regulatory processes. • National Transplant Organizations should be the highest authority in organ transplantation, responsible for maintaining transparency of programmes, monitoring and surveillance, policy setting and innovation to increase the donor pool; for example, utilization of expanded criteria donors and donation after circulatory death. • Organ Procurement Organizations may enhance progress toward self-sufficiency by optimizing processes in the identification and management of potential donors: for example, critical pathways, education, death audits, mandatory reporting of potential donors, quality management, and coordination. • Effective coordination of local, regional, and national systems involved in organ donation and transplantation is fundamental. Each country that performs transplantation requires a unified national coordination network that supports the entire system, through the oversight and regulation of organ distribution, transport, waiting lists, information dissemination, and policy implementation. S72 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

FIGURE 6. Flow diagram of system requirements supporting successful organ donation and transplantation programmes.

standards, development of policy, and quality manage- Hospital Transplant Programmes ment. Essential areas for regulation and oversight include: Well-organized and professional hospital transplant • Organ procurement procedures; programmes are essential to self-sufficiency. • Development of new policies and introduction of new procedures; a. Hospital transplant programmes require specialist per- • Reimbursement policies; sonnel (transplant surgeons, transplantation physicians, an- • Eligibility of living donors and consent processes; esthesiologists, and transplantation coordinators) and infra- • Quality assurance systems (control/audit and profes- structure (intensive and high dependency care unit, sional education and training); hemodialysis unit, and transplantation laboratory). • Allocation rules. b. Organ procurement by authorized OPO: the OPO is a separate organization, which may operate within the hos- Key National, Provincial, or Regional Organizations pital’s transplant center or outside the hospital setting. a. The NTO: the NTO must have regulatory functions and c. A centralized hospital transplantation management team: re- provide oversight to all activities in organ donation and sponsible for regulation and oversight, encompassing a brain transplantation. They may also be responsible for the death determination team, the hospital ethical committee, management of waiting lists, matching, and allocation and centralized oversight of education and quality control. and the maintenance of comprehensive registries that d. Hospital efforts to expand the donor pool: evidence-based enable collation and analysis of data concerning the cur- strategies for enhanced organ availability and utilization rent status of organ donation, transplantation, and graft should be pursued as appropriate, including expanded survival, to monitor trends, evaluate performance, and criteria donors (ECDs), DCD, and desensitization proto- inform policy (see also Working Group 4). cols (see Working groups 3 and 5). b. OPOs: the functions of the OPO include surveillance to Coordination Systems detect potential donors, donor management (medical Multiple systems functioning at local, regional, and na- management before and after brain death), and pro- tional (and sometimes international) levels are involved in organ curement of organs (including donor assessment, as- donation and transplantation, necessitating an overarching sys- certainment of consent, support to donor families, tem for coordination. National coordination systems provide a clinical care of the donor, and liaison with surgical support agency for the entire organ donation and transplanta- teams). May be centralized and government led, or be tion system, responsible for organ distribution, transport orga- under non-governmental authority; may be hospital- nization, waiting-list maintenance, information distribution, based OPOs (HOPOs) or independent OPOs (IOPOs). and any actions that can contribute to improved outcomes. In- IOPOs operate outside the hospital setting and provide ternational coordination facilitates cross-border exchange of or- services to multiple transplant centers. gans, information, and research and is critical for combating c. National donation promotion programmes: governmen- organ trafficking and transplant tourism. tal and NGOs have an important role in promoting com- munity support for donation after death. This is achieved System Challenges largely through public education to increase awareness, by a. Challenges for legislation: engaging in public relations through the media and by act- • Legislation absent or inadequate. ing as a consumer advocate group (see Working Group 6). Donation promotion may also extend to the promotion of b. Challenges relating to government support for key ethically acceptable living donor programmes. organizations: © 2011 Lippincott Williams & Wilkins S73

• Lack of NTO, Examples and References • Lack of control over the system or corruption, An expanded report on the system requirements for • No assessment of national needs or existence of dona- self-sufficiency in organ donation and transplantation, with tion and transplant registries, detailed examples and references is provided in Appendix 1. • Lack of system integration or professional consensus, • Lack of adequate financial support (understanding true WORKING GROUP 3: MEETING NEEDS costs associated with diagnosis and treatment is essential THROUGH DONATION to building the business case for funding) • Competing governmental or health priorities. Leaders: Francis Delmonico, Beatriz Domínguez-Gil, and Faissal Shaheen Members: Carmel J. Abela, Mustafa Al-Mousawi, Vi- c. Challenges for healthcare systems: sist Dhitavat, Valter Duro, Marina Minina, Elmi Muller, • Lack of professional expertise in transplantation medi- Alessandro Nanni Costa, Howard M. Nathan, Kevin cine and systems management, O’Connor, Oleg Reznik, John David Rosendale, Jacinto • Difficulties in identifying potential donors, managing Sa´nchez, George Tsoulfas, and Haibo Wang their care, and procuring organs, • Special additional contributors to the critical pathway Lack of hospital infrastructures for management of po- for organ donation: Alexander Capron, Jeremy Chapman, tential donors, Zhonghua Klaus Chen, Leen Coene, Serguei Gautier, John • Lack of coordinated in-hospital procurement team, • Gill, Tomonori Hasegawa, Vivekanand Jha, Guenter Kirste, Inadequate healthcare system/resources/funding, Tong Kiat Kwek, Bernard Loty, Martí Manyalich, Rafael • Inequitable access to health care, Ј • Matesanz, Luc Noel, Gerry O Callaghan, Rutger Ploeg, Chris Lack of follow-up of living donors. Rudge, Ellen Sheehy, Sam D. Shemie, Annika Tibell, Anan- tharaman Vathsala, and Kimberly Young d. Challenges relating to public awareness and education: • Poor public knowledge or understanding about dona- Organ Donation as a Critical Element in the tion and transplantation, Pursuit of Self-Sufficiency • Absence of school education programmes regarding Countries or jurisdictions should aim to maximize dona- the importance of organ donation and transplanta- tion from deceased persons, maximize the outcome from each tion, deceased donor (organs transplanted per donor), and optimize • Discomfort and inexperience of medical students and results of transplantation. Countries or jurisdictions should also professionals regarding death diagnosis or transplanta- aim to enable transplants from living donors by providing an tion and donation procedures. ethical and legal framework and appropriate donor care. e. Challenges for societies: a. Donation from deceased persons is a requirement, be- • Lack of public solidarity and trust, cause transplantation activity cannot rely only on the • Misconceptions concerning organ donation and living donors. Both DBD and DCD are to be considered. b. Donation from living persons is a necessary component transplantation, in the pursuit of self-sufficiency. • Cultural and religious perceptions or lack of awareness of brain death and donation, Challenges and Obstacles to Maximizing Organ • Negative media attitudes. Donation Activities Recommendations and Solutions for Legislation and Government Governments • Legislative frameworks concerning transplantation 1. Incorporation of donation and transplantation into na- are absent in certain countries. Nine (9%) of 99 coun- tional health policies as a priority. tries reporting to the GODT do not have yet a legisla- 2. Investment in basic infrastructure and legislative frame- tive framework for donation and transplantation. works required for transplantation. Two of the nine countries with no specific legislation 3. Adoption of WHO Guiding Principles for Human Cell, on donation and transplantation reported kidney and Tissue, and Organ Transplantation. liver transplantation activity in 2008; (1) 4. Creation of necessary systems for regulation and • Regulatory oversight of donation and transplantation activi- oversight, to ensure transparency and facilitate re- ties is also absent in several countries. Of those countries re- view of progress and implementation of new strate- porting to the GODT, 15.3% had no official body nor other gies for success. designated organization overseeing and coordinating dona- 5. Incorporate education regarding donation and trans- tion and transplantation activities at a national level; plantation into school curricula and medical education. • Legislative impediments, such as the prohibition of 6. Support for deceased donation programmes. DCD or other specific limitations to donation from de- 7. Creation of national registries, responsible for the ceased persons (e.g., viral diseases) are contained within maintenance of the transplant waiting list, and the on- the legislative frameworks on organ donation and trans- going registration of data on deceased and living donor plantation in some countries. activity, transplantation activity, transplant outcomes, • Inadequate support (including financial support) for dona- and follow-up of recipients and donors. tion and transplantation activities in the healthcare agenda. S74 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

Key Points • Countries should aim to maximize deceased donation, maximize the outcome from each deceased donor (organs transplanted per donor), and optimize the results of transplantation. • Deceased donation is a requirement, to be complemented by transplants from living donors. Both donation after brain death and donation after circulatory death are to be considered. • The Critical Pathway for organ donation is to be considered a general framework of reference for systematizing the deceased donation process. • Governments should: (i) establish legal frameworks that support and regulate the development of the medicine and science of donation and transplantation, and ensure quality, transparency, and equity of processes; (ii) support donation and transplantation in the health care agenda, allocating adequate financial resources for the development of the required infrastructure, organizational systems, technical expertise, and data registries for ongoing evaluation of programmes, and (iii) promote a culture of donation by engaging with the general public and health professionals to increase awareness and understanding, and to overcome misconceptions and cultural/religious barriers. • The support of health professionals is critical to efforts to maximize organ recovery and transplantation. • The WHO has a role in promoting implementation of the critical pathway, monitoring international data for benchmarking, and fostering regional cooperation for efficient organ sharing practices.

Public Attitudes and Media Recommendations and Solutions • Cultural and religious barriers; Governments Should: • Misunderstanding of brain death, circulatory death, and 1. Create a legislative framework to enable and regulate donation procedures. donation and transplantation; • Public mistrust of the organ donation process; 2. Eliminate legislative impediments that might constrain the • Social inequities that undermine consent for donation; medicine and science of organ donation and transplantation; populations or certain groups within a given population 3. Provide adequate support (including financial support) with no access to transplantable organs are reluctant to for donation and transplantation in the healthcare agenda; support donation after death; 4. Ensure social equality in the access of patients to transplan- • Misconceptions by the media and inadequate reportage tation therapies and in the distribution of organs, while of the benefits of organ transplantation. ensuring the transparency of the system; 5. Establish an authority to oversee the process of donation Support From Healthcare Professionals and transplantation. This authority should ensure the de- • A lack or inadequacy of knowledge, understanding, and velopment of a systematic approach to the process of do- support concerning organ donation and transplantation nation from deceased persons and be responsible for: on the part of healthcare professionals, particularly for identification and referral of possible donors; a. The systematic implementation of processes for donation • Intensive care professionals not recognizing or support- from deceased persons, according to local realities with re- ing donation as a part of end of life care; spect to legislation, cultural/religious beliefs, and technical • Insufficient family care. capability. The Critical Pathway (Fig. 2) is to be considered a general framework of reference for systematizing the pro- Organization and Systems cess of organ donation from deceased persons; • Lack of a designated authority to oversee the process of b. Appointment of qualified and trained professionals, donation and transplantation; including donor coordinators, to take specific re- • Lack of OPO(s) with appropriately trained personnel; sponsibilities in every step of the process and be ac- • Lack of the basic infrastructure necessary for develop- countable for performance; ment of a deceased donation programme in resource- c. Definition of protocols for each step in the process of poor environments; donation from deceased persons as described in the • Limited availability of mechanical ventilation and inten- Critical Pathway, consistent with the local legal frame- sive care resources; work. This would include the timely identification and • Lack of protocols for the determination of death; referral of possible deceased organ donors to the appro- • Lack of technical expertise to recover organs from de- priate authority or organization. Recommendations in ceased donors; this regard are provided in Appendix 2. • The availability of DBD may be limited; d. Development of a quality assurance programme, in- • Lack of systematic approach to the process of donation from cluding a data registry, for a continuous evaluation of deceased persons, limiting the ability to realize the potential of organ donation and transplantation processes. This organ donation from deceased persons particularly in terms of programme should estimate the potential of donation the number of organs transplanted per donor. from deceased persons, evaluate overall performance in - Failure to identify or refer potential deceased donors is the deceased donation process, identify areas for im- to be considered the main limitation. provement, and ascertain factors critical to success in - Other reasons why a potential donor does not become each step of the deceased donation process, that is: a utilized donor are specified in Appendix 2. • Identification and referral © 2011 Lippincott Williams & Wilkins S75

• Consent Council of Europe. Recommendation Rec(2006)15 of the • Evaluation of medical suitability Committee of Ministers to member states: On the back- • Donor maintenance ground, functions and responsibilities of a National Trans- • Organ recovery plantation Organization (NTO). Available at: https://wcd. • Organ preservation coe.int/wcd/ViewDoc.jsp?idϭ1062653&SiteϭCOE. Accessed • Organ transportation to transplant center on April 15, 2011. • Organ transplantation Council of Europe. Recommendation Rec(2006)16 of the e. Development of a training programme for those pro- Committee of Ministers to member states: On quality im- provement programmes for organ donation. Available at: fessionals direct or indirectly involved in the process ϭ ϭ of donation from deceased persons. https://wcd.coe.int/wcd/ViewDoc.jsp?id 1062721&Site CM. f. Promotion of a culture of donation by engaging the general Accessed on: April 15, 2011. public, specific groups (religious leaders, coroners, media, Council of Europe. Recommendation Rec(2005)11 on the and academics), and healthcare professionals. role and training of key organ donation professionals (trans- plant “donor coordinators”). Available at: https://wcd.coe. The WHO Should: int/wcd/ViewDoc.jsp?idϭ870643. Accessed on April 15, 2011. 1. Promote the implementation of the Critical Pathway Commission of the European Communities. Communication and related recommendations. from the Commission: Action plan on Organ Donation and 2. Monitor the collection of relevant data, assess interna- Transplantation (2009–2015): Strengthened Cooperation be- tional performance in donation from deceased persons tween Member States. Available at: http://ec.europa.eu/ for the purposes of benchmarking, and facilitate the ex- health/ph_threats/human_substance/oc_organs/docs/organs_ change of knowledge and experiences among countries, action_en.pdf. Accessed on April 15, 2011. as described in more detail in Appendix 2. US organ donation breakthrough collaborative. Avail- 3. Foster regional cooperation in sharing of organs that pre- able at: http://www.ihi.org/IHI/Topics/Improvement/ serves equity between donor and recipient populations and Improvement Methods/ImprovementStories/Organ the efficient transplantation of otherwise discarded organs. Donation BreakthroughCollaborative.htm. Accessed on April 15, 2011. Healthcare Professionals Should: REFERENCE 1. Support the process of organ donation; 1. Organ donation and transplantation: Activities, laws and organization. 2. Identify and refer possible deceased organ donors in a 2008 Report of the Global Observatory on Donation and Transplantation. timely manner; this particularly applies to intensive and World Health Organization and Organizacio’n Nacional de Trasplantes, emergency care physicians (see Working Group 5); March 2010. Available at: http://www.transplant-observatory.org/ 3. Make every effort to maximize the number of organs recovered and transplanted; WORKING GROUP 4: MONITORING 4. Promote the recovery of organs from DCD. OUTCOMES IN THE PURSUIT OF SELF- SUFFICIENCY Donation From Living Persons: Leaders: John Gil, Axel Rahmel, and Naoshi Shinozaki 1. Healthcare professionals should present the option of Members: Pavel Brezovsky, Mar Carmona, Elisabeth donation from living persons to families of individuals Coll, Rui Maio, Jean Bosco Ndihokumbayo, Lausevic Mirjana, with organ failure. Arie Oosterlee, Jose´ Luis Rojas, Shiro Takahara, Andre´s Val- 2. The practice of donation from living persons should be divieso, and Lori J. West consistent with the principles of Istanbul Declaration Data Monitoring in the Pursuit of Self-Sufficiency on organ trafficking and transplant tourism. Self-sufficiency means satisfaction of the transplantation Related Policy References and Guidelines needs of a given population, using resources obtained from within that population. Importantly, populations may be de- Steering Committee of the Istanbul Summit. Organ traf- fined by national or regional boundaries. The availability of re- ficking and transplant tourism and commercialism: The liable data on population needs with respect to transplantation, Declaration of Istanbul. Lancet 2008; 372: 5. on the availability of organs from deceased and living donors, on Delmonico F; Council of the Transplantation Society. A patient access to transplantation, and on transplantation out- report of the Amsterdam Forum on the Care of the Live comes is of crucial importance in this framework. Only with this Kidney Donor: Data and Medical Guidelines. Transplanta- information it is possible to develop and determine the impact of tion 2005; 79(6 suppl): S53. policies and initiatives in the pursuit of self-sufficiency. Ethics Committee of the Transplantation Society. The con- Areas of Relevance for Data Collection in the sensus statement of the Amsterdam Forum on the Care of Self-Sufficiency Framework the Live Kidney Donor. Transplantation 2004; 78: 491. Matesanz R, Dominguez-Gil B. Strategies to optimize de- Available Infrastructure ceased organ donation. Transplant Rev 2007; 4: 177. a. Intensive care capacity Meeting the organ shortage: Current status and strategies • ICUs, beds, and ventilators for improvement of organ donation. A European consen- sus document. Available at: www.coe.int/t/dg3/health/ b. Treatment of end-stage disease Source/organshortage_en.doc. Accessed on April 15, 2011 • Dialysis units and availability of other bridge therapies S76 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

Key Points • The pursuit of self-sufficiency is supported by data collection for the purposes of monitoring population needs, organ availability, access to transplantation, transplantation outcomes, and the broader policy/ regulatory environment and systems supporting organ donation and transplantation programmes. • In all countries/regions, data should be collected on the following: (i) available infrastructure (hospital and organizational); (ii) regulatory oversight and health policy; (iii) current and likely future needs for transplantation; (iv) access to the waiting list and to transplantation; (v) waiting list outcomes; (vi) travel for transplantation and transplant tourism; (vii) organ donation from deceased persons; (viii) organ donation from living persons; and (ix) outcomes of transplantation (patient and graft survival). In each of these areas, a minimum dataset should be defined, based on common definitions and standard metrics, to facilitate international comparisons, benchmarking, and the identification of key performance indicators. • Governments should: (i) support national/regional data registries with infrastructure and human resources; (ii) establish responsibility for operation and governance of this registry; (iii) facilitate cooperation between government and NGOs in monitoring outcomes and disseminating information to the scientific community, the public and policy makers; and (iv) use registry data to assess the impact of policy change and inform the need and direction of new legislation and policy. • Professionals and Professional Societies should: (i) provide content expertise; (ii) cooperate on the consistency of data elements across the continuum of organ failure (i.e., CKD, dialysis,and transplantation); and (ii) facilitate development of an International Data Group for the ongoing collection of data that will empower individual countries and regions in the pursuit of self-sufficiency. • This International Data Group should: (i) establish standardized definitions/metrics; (ii) provide/help to establish data registries in all countries/regions involved in organ donation and transplantation; (iii) perform international benchmarking and disseminate effective strategies and details of best practice; and (iv) conduct international studies to address specific data deficiencies. c. Transplantation services gan donation and transplantation in accordance with interna- • Transplant units and transplant programmes tional standards is fundamental to self-sufficiency. An inventory • Transplant surgeons of health policies governing organ donation and transplant prac- • Living donor paired exchange, capacity to treat ABO tices would provide useful information regarding the status of incompatible and highly sensitized patients organ donation and transplantation in a given country or region. d. Donation services Furthermore, availability of international standards and policies • Coordinators governing donation and transplantation would facilitate identi- • OPOs fication of best practice in the pursuit of self-sufficiency. An inventory of infrastructure (material and human Need for Transplantation resources) required to support organ donation and transplanta- tion will permit comparisons between countries or regions with Underlying diseases, current (and future) demand for a similar gross domestic product (GDP) and should assist coun- transplantation (see also Working Group 1) tries or regions in advocating for necessary resources. Sharing of • Incidence or prevalence of underlying diseases such as this information could facilitate international or regional initia- HCV and diabetes mellitus (DM; this information could tives for shared infrastructure developments (i.e., a human leu- be obtained by International Classification of Diseases kocyte antigen [HLA] laboratory or a training programme). (ICD) codes, data from pharmaceutical companies re- Similarly, a longitudinal assessment of infrastructure over time garding sales and use of specialized therapeutics), in a region would help demonstrate the extent to which a coun- • Use of bridge therapies (e.g., dialysis register, mechani- try or region is improving. This effort would be advanced by the cal heart support), establishment of standardized “tiers” of infrastructure, that is, • Deaths from end-stage organ failure (renal and non- “minimal/essential, desirable, and optimal.” renal organs) from national death registry, Health Policies • Population burden of renal and non-renal end organ failure. a. Regulatory oversight Organ transplantation needs are correlated with the number • Registration of transplant centers of individuals suffering end-stage organ failure. If information on theincidenceofunderlyingdiseasesisnotavailable,deathratesfrom b. Financing (public/private) end-stage organ failure might be a more easily accessible parameter. c. Recognition and prevention of end-stage organ failure Withthisinformation,thedemandfororgantransplantationcanbe d. Transplantation • estimated, but perhaps more importantly, areas where preventative Donation and organ recovery strategies might lead to a reduced need for transplantation can be e. Selection of candidates for transplantation identified. Cooperation between NGOs could support information • Indications and contraindications for transplantation, sharing in this area; for example, there is significant overlap between guidelines for transplant referral and acceptance cardiorenal diseases and diabetes and therefore cooperation • Legislation governing practice of organ donation after death between NGOs focused on these specific diseases should be • Deceased donor organ allocation policies encouraged. Kidney transplantation is cost effective in com- parison with dialysis but is still an extremely expensive and re- f. Living donor transplantation source-intensive intervention. The cost of caring for patients with • Legislation governing practice of living donor transplantation end-stage failure of other organs would be useful in advocating for Information regarding the existence of legislation and reg- the investment of resources in prevention. The societal costs includ- ulatory oversight to ensure safety and the ethical practice of or- ing lost wages, taxes, etc. and would also be useful to capture. © 2011 Lippincott Williams & Wilkins S77

Access to the Waiting List and Transplantation Assessment of transplant tourism activity is an indirect indicator of sufficiency. a. Number of registrations on the waiting list (absolute number and per million population) Organ Donation ● Basic demographic data on patients registered on the waiting list and comparison to population with end- a. Identifying potential DBD and DCD donors in the hos- stage organ failure. pital, converting potential donors to actual donors (see also Working Group 3). b. Derived indicators b. Identification of steps in donation process (identifica- ● Proportion of patients with end-stage organ failure that tion of potential donors, approach, consent, organ re- are wait listed; covery, utilization, and organ discard). ● Time to transplantation from any donor source from c. Selection of donors, including risk management. outset of end organ failure. d. Characterization of the donor—part of a meaningful assess- ment of system performance and transplant outcomes. c. Characteristics of transplanted individuals (compared with those of general population or, if available, popula- Outcome of Transplantation—Patient and Graft Survival tion with end organ failure). a. Graft survival and patient survival Patients should have equal access to the waiting list and to b. Complications transplantation. The criteria for registration on the waiting list • Organ function—measured by glomerular filtration should be transparent and medically based. Documenting com- rate for kidney transplant recipients, measures of organ pliance with agreed guidelines should be prioritized. Comparing function in non-renal organs are not defined patient groups with an underlying disease in the population with • Tumor, infection, etc. those registered on the waiting list would allow monitoring of access to the waiting list. In countries or regions where the avail- c. Derived: influence of donor characterization, derived ability of bridge therapies (i.e., dialysis) and deceased donor from selection of donors (see Organ Donation, part c). transplantation is limited, waiting lists will be a poor indicator of d. Derived: influence of recipient characterization, derived access to transplantation. In these regions, the characteristics of from selection of recipients (see Access to the Waiting List transplanted individuals in relation to the characteristics of the and Transplantation) general population, or the population with end-stage organ fail- e. Benefit generated by transplantation ure if these data are available, will provide some indication of the • Life years from transplant concept nature of access to transplantation. • Reducing the need for retransplantation The available donor organs should be used in an effec- Waiting List Outcomes tive way, and optimal allocation policies and recipient man- a. Number of drop outs, deaths, and transplants (deceased/ agement can increase the long-term benefit. living donors, absolute number/ per million population). b. Differences in waiting times, preemptive listing, and Living Donor Transplantation time to wait listing. a. Access to living donor transplantation c. Proportion of preemptive kidney transplants. • Preemptive living donor transplantation d. Outcomes for special patient groups (high urgency pa- tients, highly immunized patients, and children). b. Outcome of living donor transplantation e. Compliance/deviation from rules governing organ • Living donor follow-up: documentation of policies for do- allocation. nor follow-up; mechanisms to identify negative outcomes in living donors (e.g., end-stage organ failure). Monitoring longitudinal changes in time to transplan- • Recipient follow-up (graft and patient survival): similar tation, waiting time until transplantation, and death on the to deceased donor transplant follow-up. waiting list reflect both allocation policies and the availability of donor organs. The efficacy and fairness of an allocation and In living donor transplantation, not only do the recip- transplant system become especially evident when looking at ient outcomes need to be monitored, at least as important is special patient groups experiencing biologic barriers to trans- for donor outcomes to be monitored. plantation. Transparent reporting of organ allocation rules and compliance with such rules is an essential component of Establishment of Data Systems/Registries: any organ donation and transplant system. Standardization, Technical And Legal Requirements, and Quality Assurance Travel for Transplant, Transplant Governance and Oversight for the Registry Tourism—Transplantation Outside the Population a. National policies/oversight to ensure adequate data col- a. Occurrences in the population of delisting from the lection, data integrity, and security • waiting list without transplantation. Objectives of registries have to be defined at a b. Need for post-transplant therapy without registration – National level (national health authorities and national of a transplant. medical societies) S78 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

– International level (WHO and international medical • Data collection and delivery to the registry (directly or societies) indirectly) • Data analyses, reporting b. Registry steering group/oversight body • Mandate and terms of reference b. National and regional registries contribution to an inter- national registry should be free of charge. c. Policies • Access to the data has to be defined on national and on Recommendations and Solutions an international level Overarching recommendations: • Rules for data exchange have to be established 1. In all countries or regions data should be collected on the need d. Accountability/registry performance for transplantation/burden of end-stage organ disease. • Internal and external audits/performance reporting • 2. In all countries, whether or not there is an existing transplant Transparency programme, information on (the potential for) organ dona- Clear ownership of the data, including the rights on re- tion from deceased persons should be collected. porting combined with established data privacy measures, is not 3. In countries with existing transplant activities, data on only a legal obligation in most countries but are also mandatory waiting lists, transplantation activities, and transplant out- to establish and maintain trust in the system. Ongoing assess- comes should be registered. ment of registry performance is necessary to ensure transpar- 4. In each of these areas, a minimum dataset with common ency, compliance with governing principles, and the attainment definitions, allowing international comparisons and in- of objectives. formation exchange, should be defined. 5. The minimum dataset shall include standard methods/ metrics by which to measure the sufficiency of organ transplant Structure of Registries, Organization of Data Delivery to programmes and identify the key performance indicators rele- or Collection by Registry, and Quality Assurance vant to monitor progress towards self-sufficiency. These include: a. Responsibility for data delivery/acquisition has to be a. Need for transplantation, clearly assigned. b. Organ donation (deceased/living), b. Multiple methods of data delivery (based on local infra- c. Access to transplantation, structure and needs). d. Outcome of transplantation, c. Secure data transfer consistent with national data pro- e. Transplant tourism. tection regulations. d. Quality and timeliness of the data has to be assured, Governments should: reinforced by auditing processes. e. Standardized registry maintenance policies have to be in 1. Support the development and operation of national place. or regional registries. This includes investment devel- opment of infrastructure and human resources. 2. Establish responsibility for the operation and gover- Data Elements nance of the national or regional registry. a. Identification of essential data elements 3. Ensure cooperation between bodies responsible for • Harmonization with existing national and international clinical care and those in charge of the registry. registries 4. Support national or regional registry participation in international data initiatives. b. Modular system with different tiers of data with increas- 5. Facilitate cooperation between government agencies ing complexity (required vs. optional data elements, ad- and NGOs to avoid duplication of efforts and promote aptation to national needs and capabilities) the sharing of resources and data. • Age appropriate data elements have to be included (rec- 6. Ensure information is accessible by all stakeholders (scien- ognizing pediatric patients) tific community, public, and policy makers). Reporting has to be adapted for each of these groups, with the com- c. Identification of derived key performance indicators with mon aim of uniting the lay public, engaging policy makers, corresponding metrics for benchmarking. and improving scientific knowledge. Individual data elements need to be defined taking into 7. Ensure data acquisition to assess impact of policy change and account the availability of the data and the purpose to be inform the need and direction of new legislation or policy. achieved by collecting this information. The set of relevant and 8. Facilitate the development of an International Data measurable factors may be different in the developing and the Group for the ongoing collection of data that will em- developed world. A comparison between countries (bench- power individual countries and regions in the pursuit of marking) will only be possible if common definitions are used. self-sufficiency.

Financing of the Registry Professional societies should: a. Financing of the registry has to be established by national 1. Provide content expertise necessary to support collec- health authorities tion of national and international data relevant to the • Maintenance of the registry pursuit of self-sufficiency. © 2011 Lippincott Williams & Wilkins S79

2. Cooperate to ensure consistency of data elements across Prospective National Registry POLKARD HF. Transplant the continuum of organ failure [i.e., chronic kidney dis- Proc 2009; 41: 3161. ease (CKD), dialysis, and transplantation]. Cusumano A, Garcia Garcia G, Di Gioia C, et al; on behalf of the 3. Advocate for appropriate national or regional Latin American Registry of Dialysis and Transplantation. The infrastructure. Latin American Dialysis and Transplantation Registry (RLDT) 4. Support development of national or regional policies. Annual Report 2004. Ethn Dis 2006; 16(suppl 2): S2. 5. Facilitate development of an International Data Group for the ongoing collection of data that will empower Organ Donation individual countries and regions in the pursuit of self-sufficiency. Coppen R, Friele RD, Gevers SKM, et al. The impact of Recommendations for an International Data Group: donor policies in Europe: A steady increase, but not every- where. BMC Health Serv Res 2008; 8: 235. 1. Establish standardized definitions or metrics. 2. Define “tiers” of data. 3. Provide/help to establish data registries in all coun- Transplant Outcome tries/regions involved in organ donation and trans- plantation. Burra P, Senzolo M, Adam R, et al. Liver transplantation 4. Showcase international success stories and disseminate for alcoholic liver disease in Europe: A study from the effective strategies and details of best practice relating to ELTR (European Liver Transplant Registry). Am J Trans- organ donation and transplantation. plant 2010; 10: 138. 5. Organize and conduct international studies to address Mailey B, Buchberg B, Prendergast C, et al. A disease-based com- specific data deficiencies. parison of liver transplantation outcomes. Am Surg 2009; 75: 901. 6. Publish global information and international compari- Herlenius G, Wilczek HE, Larsson M, et al. Ten years of sons relevant to the aim of sufficiency. international experience with liver transplantation for fa- 7. Facilitate cooperation between international NGOs. milial amyloidotic polyneuropathy: Results from the Fa- 8. Support national/regional efforts to achieve self-sufficiency. milial Amyloidotic Polyneuropathy World Transplant Registry. Transplantation 2004; 77: 64. Patient groups should: Gidding HF, Topp L, Middleton M, et al. The epidemiology 1. Lobby policy makers for necessary resources. of hepatitis C in Australia: Notifications, treatment uptake 2. Ensure common messages are being delivered to the lay and liver transplantations, 1997–2006. J Gastroenterol public and policy makers. Hepatol 2009; 24: 1648. 3. Ensure patient need is the primary consideration of pol- Vathsala A; for the Asian Transplant Registry. Immunosup- icies and legislation. pression use in renal transplantation from Asian transplant centers: A preliminary report from the Asian Transplant Reg- Examples and References istry. Transplant Proc 2004; 36: 1868. Singhal AK, Sheng X, Drakos SG, et al. Impact of donor Demand for Transplantation and Access to cause of death on transplant outcomes: UNOS Registry Transplantation Analysis. Transplant Proc 2009; 41: 3539. ERA-EDTA Registry Annual Report 2007. Academic Med- Close N, Alejandro R, Hering B, et al; for the CITR Inves- ical Center, Department of Medical Informatics, Amster- tigators. Second annual analysis of the Collaborative Islet dam, The Netherlands, 2009. Transplant Registry. Transplant Proc 2007; 39: 179. Cusumano AM, Gonza´lez Bedat MC. Chronic kidney dis- Gentil Govantes MA, Rodriguez-Benot A, Sola E, et al. ease in Latin America: Time to improve screening and de- Trends in kidney transplantation outcome: The Andalu- tection. Clin J Am Soc Nephrol 2008; 3: 594. sian Kidney Transplant Registry, 1984–2007. Transplant Zoccali C, Kramer A, Jager K. The databases: renal replace- Proc 2009; 41: 1583. ment therapy since 1989-the European Renal Association and European Dialysis and Transplant Association (ERA- EDTA). Clin J Am Soc Nephrol 2009; 4(suppl 1): S18. Living Donor Transplantation White SL, Chadban SJ, Jan S, et al. How can we achieve global equity in provision of renal replacement therapy? Arau´ jo CCV, Balbi E, Pacheco-Moreira LF, et al. Evalua- WHO Bull 2008; 86: 229. tion of living donor liver transplantation: Causes for exclu- Woodle ES, Gupta M, Buell JF, et al. Prostate cancer prior sion. Transplant Proc 2010; 42: 424. to solid organ transplantation: The Israel Penn Interna- Manauis MN, Pilar KA, Lesaca R, et al. A national programme tional Transplant Tumor Registry Experience. Transplant for nondirected kidney donation from living unrelated donors: Proc 2005; 37: 958. The Philippine experience. Transplant Proc 2008; 40: 2100. Neil N, Walker DR, Sesso R, et al. Gaining efficiencies: Re- sources and demand for dialysis around the globe. Value Data Selection Health 2009; 12: 73. Zielin´ ski T, Browarek A, Zembala M, et al; on behalf of Data Harmonization on Transplantation Activities and POLKARD HF investigators. Risk stratification of patients Outcomes; Editorial Group for a Global Glossary Geneva, with severe heart failure awaiting : June 7–8, 2007. S80 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

Structure of a Registry and ICUs. Doctors and nurses need to become aware of their responsibilities to the broader community and the relevance of Dickinson DM, Bryant PC, Williams MC, et al. Transplant their skills to organ donation; further, they must have confidence data: sources, collection and caveats. Am J Transpl 2004; to support the delivery of this service. Healthcare professionals 4(suppl 9): 13 who participate in this work deserve to have their skills and en- Dickinson DM, Dykstra DM, Levine GN, et al. Transplant deavors recognized by their peers, policy makers, funders, and data: Sources, collection and research considerations, 2004. the community. Am J Transplant 2005; 5(4 pt 2): 850. Shroff S. Indian Transplant Registry: www.transplantin- Conditions for Self-Sufficiency dia.com. Transplant Proc 2007; 39: 711. Mahdavi-Mazdeh M, Heidary Rouchi A, Rajolani H, et al. a. ICU and ED doctors and nurses are aware of the need Transplantation Registry in Iran. Transplant Proc 2008; 40: 126. for organ donation and therefore want to facilitate it; b. ICU and ED doctors and nurses know how to facilitate Aims of a Registry organ donation and have the educational, technical, le- gal, and ethical tools to do so; Coppen R, Friele RD, Gevers SKM, et al. The impact of c. ICU and ED doctors and nurses are supported by their donor policies in Europe: A steady increase, but not ev- colleagues, hospitals, and health authorities in facilitat- erywhere. BMC Health Serv Res 2008; 8: 235. ing organ donation; Budiani-Saberi DA, Delmonico FL. Organ trafficking and d. Identified doctors and nurses in EDs and ICUs are rec- transplant tourism: A commentary on the global realities. ognized as experts in this area and in educating their Am J Transplant 2008; 8: 925. colleagues about it; e. These doctors and nurses are expected to take the lead in enabling their ED or ICU to provide this service, includ- ing appropriate counseling for families. WORKING GROUP 5: FOSTERING PROFESSIONAL OWNERSHIP OF SELF- Goals for Each Country/Region SUFFICIENCY IN THE EMERGENCY DEPARTMENT AND INTENSIVE CARE UNIT Barriers to achieving Goals 1 and 2: Leaders: Alexander Capron, Alex Manara, and Gerry • ICU/ED physicians and nurses are not aware of the ex- O’Callaghan tent of the need for organs and the crucial role the ICU Members: Wahyuningsih Andi, Danica Avsec- can play in meeting that need; Letonija, Gabriel Danovitch, Francisco Del Rio, Ehtuish • ICU/ED physicians and nurses do not see organ dona- Ehtuish, Steffen Groth, Niels Grunnet, Anni Kuusvek, Tong tion as a part of their responsibility in caring for patients Kiat Kwek, Ko Kyung-Soon, PG Mahipala, Francesco Pro- (potential donors) and families; caccio, and Victor-Gheorghe Zota • ICU/ED physicians and nurses believe that respond- ing to need for organs would represent a conflict of interest with their obligations to dying patients; The Critical Role of Emergency Department and • ICU/ED physicians are not familiar or comfortable with Intensive Care Unit Professionals determining death in donors or are not, or do not feel, Organ donation is a distinct, time-critical medical process competent to perform relevant tests; that provides individuals with end-stage organ failure access to • Specific resources or expertise are not always available in transplantation and its life saving, and life changing, benefits. a timely manner to support the diagnosis of brain death Transplant programmes can rely on living-related donors to (e.g., cerebral angiography); meet some of the need for donated kidneys, but self-sufficient • ICU/ED physicians and nurses are not compensated or re- donation programmes require a robust system of donation from warded for the time spent in facilitating organ donation; deceased persons (not only hearts, livers, and lungs but also kid- • Limited ICU/ED resources restrict the ability of physi- neys). The majority of deceased donor organs originate in EDs cians and nurses to be involved in organ donation; and ICUs, but in most countries currently, organs are obtained • ICU/ED physicians and nurses face, or believe they will from only a small minority of ED and ICU patients who would face, difficult ethical and legal issues in caring for poten- be potential donors. tial organ donors; For a country (or region) to achieve self-sufficiency in or- • Organ procurement staff are not available in a timely fashion gan donation, health professionals (principally physicians and to interact with ICU/ED patients and their families; nurses) involved in acute health care need to be aware of their • The country lacks adequate infrastructure/resources to indispensable role in identifying potential donors, in using their procure and use organs for transplantation. expertise in the medical management of these critically ill, dying Barriers to achieving Goal 3: patients in a manner that allows and facilitates donation, and in encouraging the families of these patients to consider donation • Cultural factors in a country preclude using techniques and supporting them as they do so. that work in EDs and ICUs elsewhere; To be successful, organ procurement programmes must, • Organizational factors (from national to institutional therefore, seek to engage healthcare professionals in planning level) interfere with importing techniques that work in and executing organ donation in their facilities, especially in EDs other EDs and ICUs; © 2011 Lippincott Williams & Wilkins S81

Key Points • The majority of deceased-donor organs originate in EDs and ICUs. Hence the pursuit of self-sufficiency requires ICU and ED doctors and nurses to: (i) be aware of the need for organ donation and are motivated to facilitate it; (ii) know how to facilitate organ donation and have the educational, technical, legal, and ethical tools to do so; (iii) be supported by their colleagues, hospitals, and health authorities in facilitating organ donation; (iv) have identified doctors and nurses in EDs and ICUs recognized as experts in this area, who take the lead in enabling their ED or ICU to provide this service, including appropriate counselling for families; and (v) be involved in the development of protocols for organ donation within their ICU/ED. • Goals for each country/region with respect to the pursuit of self-sufficiency in the ED and ICU are that: (i) every death in ICU of a potential donor will lead to a timely decision regarding donation; (ii) every death in an ED of a potential donor will lead to a timely decision regarding donation; (iii) each country will be offered solutions that can be customized to apply to the specific circumstances of its EDs and ICUs. • Governments should develop clear legal and ethical frameworks to guide ICU and ED professionals in the care of potential donors, including: (i) standards for determining death that are enacted by the legislature and accepted by the public; (ii) tests and methods that physicians can readily use to apply these standards; and (iii) clear statements regarding the responsibility of various care providers to donors and recipients, ensuring individual intensivists and ED physicians are not vulnerable when facilitating organ donation processes. • National Professional Bodies should: (i) provide clear protocols on how treatment decisions relate to donor status and to alternative (circulatory/respiratory and neurologic) bases for determining death; (ii) provide clear protocols on how to manage dying process for patients whose deaths will be determined on circulatory/respiratory or neurologic grounds, as and on post-death maintenance of body; and (iii) educate nurses and physicians on how to make donation an understandable and acceptable choice for families. • Hospitals should: (i) facilitate local ED/ICU staff “ownership” of potential donor management; (ii) identify champions of organ donation within the ICU/ED team; (iii) appoint donor coordinators within hospitals to facilitate communications amongst ICU/ED staff, families and transplant authorities; (iv) include the possibility for organ donation in every end-of-life care pathway within the ICU and ED; (v) improve the interface with the local transplant team and responsible national authority; (vi) identify strategies to optimize available resources for the conversion of potential donors to actual donors; and (vii) audit outcomes of the donation process.

• The public does not understand or accept the goals of physiology, and interact with OPO and transplant team. organ donation and believes that ethical conflicts exist Specifically, this should cover: when physicians and nurses in EDs and ICUs are in- a. Clear guidance on how treatment decisions are reached volved in organ procurement. (e.g., for patients with severe neurologic injuries) in the context of potential organ donors and on the circula- Recommendations and Solutions tory and neurologic criteria for determining death; Governments should: b. Clear protocols on how to manage dying process for patients whose deaths will be determined on circula- 1. Develop clear legal and ethical frameworks to guide ICU and ED tory or neurologic grounds; professionals in the care of potential donors, including: c. Clear protocols on the optimization of donor physiol- a. Standards for determining death that are enacted by ogy in brain dead donors to maximize the number of the legislature and accepted by the public; organs donated and the quality of those organs; b. Tests and methods that physicians can readily use to d. Education for nurses and physicians on how to make apply these standards in EDs and ICUs; donation an understandable and acceptable choice for c. Clear statements, at institutional and governmental families of dying patients. levels, regarding the responsibility of various care pro- viders to donors and recipients. 2. Support the development of academic and scientific re- 2. Provide clear and unambiguous guidance from the minis- search activity in the emergency and intensive care com- try of health (and other responsible authorities) and hos- munities to create a professional investment in the best pitals to ensure individual intensivists and ED physicians practice approaches that emerge. and nurses are not vulnerable when aiding organ donation Hospitals Should: processes. Professional Bodies should: 1. Give local ED and ICU staff “ownership” of solving the problems and developing protocols for managing the 1. Offer training and guidance for ED and ICU nurses and care of potential donors. physicians on how to identify potential donors, commu- 2. Identify individuals within the ICU or ED team who can nicate with family, determine death, optimize donor act as role models or “champions” to increase the profile of

Goal 1 Every death in ICU of a potential donor will be preceded by a timely decision regarding donation

Goal 2 Every death in an ED of a potential donor will be preceded by a timely decision regarding donation S82 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

Goal 3 Each country will be offered solutions that can be customized to apply to the specific circumstances of its EDs and ICUs

organ donation within individual ICUs and EDs and pro- Examples of Individual ICU Initiatives to Increase vide education for the team on all relevant issues. Donation by Starting NHBD Schemes 3. Appoint donor coordinators within hospitals to facili- tate communications among ICU/ED staff, bereaved Thomas I, Caborn S, Manara AR. Experiences in the families, and transplantation services. development of non-heart beating organ donation 4. Include the possibility or potential for organ donation in ev- scheme in a regional neurosciences intensive care unit. ery end-of-life care pathway within the ICU and ED (Fig. 7). Br J Anesth 2008; 100: 820. 5. Improve the interface between ICUs/EDs and the local Akoh JA, Denton MD, Bradshaw SB, et al. Early results of a transplant team and responsible national authority. controlled non-heart-beating kidney donor programme. 6. Identify strategies to minimize the effects of lack of resources Nephrol Dial Transplant 2009; 24: 1992. on the conversion of potential donors to actual donors. 7. Audit outcomes of the donation process within each Factors Influencing Consent Rates ICU/ED and hospital to allow potential areas for improve- ment to be identified and achievable targets to be set. Simpkin AL, Robertson LC, Barber VS, et al. Modifiable factors influencing relatives’ decision to offer organ do- Examples and References nation: Systematic review. BMJ 2009; 338: b991. ACRE Trial Collaborators. Effect of “collaborative re- Examples of National Guidance on Death Diagnosis questing” on consent rate for organ donation: random- A code of practice for the diagnosis and confirmation of ized controlled trial (ACRE trial). BMJ 2009; 339: b3911. death. Academy of Medical Royal Colleges. Shafer TJ. Improving relatives’ consent to organ donation. The ANZICS Statement on Death and Organ Donation BMJ 2009; 338: b701. [ed. 3]. Australian and New Zealand Intensive Care Society, 2008. Analysis of the Effect of “Presumed Consent”

Examples of National Legal/Ethical Guidance on Issues Kwek TK, Lew TW, Tan HL, et al. The transplantable organ Relevant to Donation shortage in Singapore: Has implementation of presumed consent to organ donation made a difference? Ann Acad Legal issues relevant to non-heartbeating organ donation. Med Singapore 2009; 38: 346. Welsh Assembly Government Department of Health. Organ and tissue donation after death for transplantation: Guidelines for ethical practice for health professionals. WORKING GROUP 6: THE ROLE OF Australian Government National Health and Medical Re- PUBLIC HEALTH AND SOCIETY IN THE search Council. PURSUIT OF SELF-SUFFICIENCY Leaders: Jeremy Chapman, Gregorio Obrador, and Example of Expert Panel Guidance on Diagnosis of Death Harjit Singh Bernat JL, Capron AM, Bleck TP, et al. The circulatory- Members: Adewale Akinsola, Mohamed Salah Ben respiratory determination of death in organ donation. Crit Ammar, Filip Danninger, Roser Deulofeu, Athina Gom- Care Med 2010; 38: 972. pou, Carl Groth, Valentina Hafner, Gunter Kirste, Alan

FIGURE 7. Flow chart for decisions regarding patients with severe neurologic injuries (example). ICU, intensive care unit; GW, General Ward; PVS, Permanent Vegetative State. © 2011 Lippincott Williams & Wilkins S83

Leichtman, Beatriz Mahillo, Freda O’Neill, Anna Pavlou, of NCD-related deaths are attributable to preventable CVD, Koenraad Vandewoude, and Kumar Sharma Vijay DM, cancer, or chronic respiratory disease, with the magnitude of this disease burden a result of two main factors: (1) changing The Relationship Between Public Health and patterns of lifestyle-related risk factors—increased levels of ex- Society and the Pursuit of Self-Sufficiency posure to tobacco use, unhealthy diets, physical inactivity, and Public Health and society are closely interrelated be- the harmful use of alcohol—and (2) issues of access to effective cause: (1) the mission of public health is the fulfillment of and equitable healthcare services, most acutely affecting popula- society’s interest in assuring the conditions in which peo- tions of low- and middle-income countries. ple can be healthy; (2) the substance of public health is These data have important implications. First, NCDs im- organized community efforts aimed at the prevention of disease pose a heavy burden on socioeconomic development and are and the promotion of health; and (3) the organizational frame- closely associated with poverty. Second, CVD, DM, cancer, and work of public health encompasses both activities undertaken chronic respiratory diseases can lead to end-stage organ failure, within the formal structure of government and the associated efforts potentially requiring transplantation. Primary prevention is of of private and voluntary organizations and individuals (1). utmost importance, particularly in the setting of financially con- Public health is to play a key role in the pursuit of self- strained, underdeveloped healthcare systems that are unable to sufficiency by reducing demand through prevention of end- bear the costs and resource requirements of chronic disease stage organ failure potentially leading to transplantation and management. WHO has launched the 2008–2013 Action Plan by promoting donation among health professionals and the for the global strategy for the prevention and control of non- general public. Another contribution of public health is communicable diseases (3) with the aim of reducing the main through the establishment of a well-developed healthcare sys- modifiable risk factors in common for these diseases, specifically tem and transplant programme. unhealthy diets, lack of exercise, tobacco, and harmful use of Society must possess the willingness to promote and alcohol. Secondary and tertiary prevention are also extremely support donation, otherwise there would be no organs to important to reduce the risk of chronic complications and organ transplant. A second societal contribution to the pursuit of failure potentially leading to transplantation. self-sufficiency is in the form of community funding for do- There are numerous examples of successful chronic nation and transplantation through public finance and char- disease prevention strategies around the world. The Kidney itable sources. Table 2 summarizes the roles of public health Early Evaluation programme is a free community screening and society in the pursuit of self-sufficiency. programme aimed at early detection of CKD among high-risk individuals, including those with DM, hypertension, and Role of Public Health family history of DM, hypertension, or CKD. It began in the Prevention of End-Stage Organ Failure United States and now routinely operates in Australia, Japan, Certain causes of end-stage organ failure potentially and Mexico (4–7). Metformin use and lifestyle intervention leading to transplantation are amenable to primary, second- have been associated with reduction in the incidence of type 2 ary, and tertiary prevention (Table 3). diabetes of 31% and 58%, respectively, in a US randomized NCDs are the global leading cause of death, accounting for trial (8). CVD prevention with a multidrug regimen has been approximately 60% of all deaths in 2005, with 80% of NCD- shown to be cost effective in the developing world (9). It is related deaths occurring in low- and middle-income countries recognized that CKD prevention would be most cost -effec- (2). This mortality burden attributable to NCDs is predicted to tive as a part of an integrated strategy targeting chronic vas- continue to increase rapidly in coming years. Approximately half cular diseases (10). An example of this type of integrated in-

Key Points • Public health is to play a key role in self-sufficiency by reducing demand for transplantation through disease prevention, promotion of donation among health professionals and the general public, and contributing to effective and well-developed health systems • The frequency causes of end-stage organ failure (diabetes, hypertension, alcohol abuse, HBV, HCV, CAD, and COPD) must be met by primary, secondary and tertiary prevention. Prevention must address the two principle drivers of this disease burden, (i) lifestyle risk factors – tobacco use, unhealthy diets, physical inactivity, and harmful use of alcohol, and (ii) ineffective and inequitable healthcare services. • Donation education and promotion, drawing on public health methodologies, is necessary to strengthen public commitment to organ and tissue donation, and increase the willingness of medical professionals to be involved in the donation and transplantation process. Society must have a willingness to promote and support donation, else there would be not organs to transplant. • The act of donation is itself an individual decision that interacts with the social setting and the institutional and regulatory framework into which an individual is embedded. Family refusal, together with failure to identify potential donors, is the most significant impediment to increase rates of donation. Public education efforts need to counter poor awareness, distrust of medicine and misconceptions about donation and transplantation, while instilling notions of reciprocity, solidarity, and an appreciation of the uniquely life-saving nature of donation. • In low-income settings, where health sector development constrains the development of organ donation and transplantation, prevention of end-stage organ failure within the context of wider public health goals is crucial to self-sufficiency. Adverse public attitudes and legal restrictions may pose additional obstacles to transplantation, therefore culturally appropriate education and the endorsement of donation and transplantation by community and religious are essential. Service delivery may use both private and non-governmental means of financing, and grow from synergies between governments, NGOs, and charities. S84 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

motion of donation and transplantation among health pro- TABLE 2. Roles of public health and society in the pursuit of self-sufficiency fessionals and the general public. Public health Screening and prevention of end-stage organ Health Professionals failure potentially leading to transplantation Many publications have demonstrated that the willing- Promotion of donation among health professionals and the general public ness of healthcare professionals to participate in the donation - Skills and knowledge development process can improve the donation rate (13, 14). Donation edu- among health professionals cation of health professionals, particularly of transplant coordi- - Promotion of trust in organ donation nators, emergency and ICU doctors, and family practitioners, is throughout the community critical (15). In Spain, transplant coordinators are trained as Development of efficient healthcare systems managers of educational programmes and resources, are re- and transplant programmes sponsible for administrative tasks, and are also in charge of me- - Development of efficient donor dia relations (16). There are also reports of donation education procurement organizations for medical students as a way to enhance the link between phy- - Develop society and medically acceptable sicians and procurement professionals (17–20). recipient selection and organ allocation systems for deceased donor Because nurses are usually the first people among the transplantation healthcare staff to recognize a patient as a potential donor, - Optimize accredited transplant programmes they have an important role in the procurement of organ - Ensure transparency in support of equity and tissue from deceased donors. Educational pro- - Ensure maintenance of safety and quality of grammes can enhance nurses’ knowledge and commit- donation and transplantation ment to the organ donation process and, ultimately, in- - Create national programmes but implement crease the donation rate. In a recent report from Pakistan, them locally knowledge and attitudes toward organ and tissue donation Society Willingness to promote and support organ improved significantly after nurses attended a 1-day work- donation shop on organ donation (21). Consequently, it is of great Community funding through public finance importance for OPOs to offer regular training pro- and charitable sources grammes for all their healthcare staff (22).

General Public TABLE 3. Frequent causes of end-stage organ failure and common risk factors Public attitudes to and awareness of organ donation and transplantation are key elements affecting donation rates. Public End-stage Common risk health methodology applied to donation education pro- organ failure Frequent causes factors grammes consists of assessing the status of donation-related Kidney failure Diabetes hypertension Unhealthy diet public education, identifying existing needs in donation educa- Liver failure Alcohol abuse Lack of exercise tion by applying principles learned from other public health ed- ucation programmes, and identifying roles than can be assumed Hepatitis B virus Tobacco use to help strengthen the public’s commitment to organ and tissue Hepatitis C virus Harmful use of donation (23). A systematic review of the literature yielded eight alcohol elements of effectiveness that could be used to assess donation Heart failure Coronary artery Intravenous education efforts (23). They are the use of: disease drug abuse Hypertension • Formative research, • Lung failure Chronic obstructive Strategic planning, pulmonary disease • Appropriate messages, • Audience-based strategies, • Multiple channels, • Collaboration with other groups in a community, • Evaluation, and tervention has shown success in rural India, achieving blood • pressure and DM targets, and lowering prevalence of CKD at Coordination of information exchange in the transplant an annual cost of US $0.43 per capita of population (11). This field. programme minimized costs by using nonphysician health Oberley (24) examined barriers to donation and as- workers and cheapest available diagnostic tests and drugs. sessed educational materials and programmes, concluding Combination pharmacotherapy, a fixed dose of aspirin, a sta- that grassroots, community-based programmes were essen- tin, an angiotensin-converting enzyme inhibitor, and a di- tial to supplement mass media efforts and that well-re- uretic/␤-blocker, may also have potential as an integrated ap- searched campaigns, targeted to specific audiences, were also proach to chronic vascular disease in low- and middle- key to success. income countries (12). Challenges and Recommendations for Public Health in Promotion of Donation the Pursuit of Self-Sufficiency Public health can help to increase organ donation It is important to note that sustainability of public through education, information, encouragement, and pro- health programmes is driven by the critical processes of sys- © 2011 Lippincott Williams & Wilkins S85 temization and standardization. In particular, improving sus- TABLE 4. Challenges and recommendations for public tainability may require stabilization of organizational re- health in the pursuit of self-sufficiency sources, attention to incentives, and standardization of policies at the national level (25). The Working Group Barriers Solutions and recommendations identified several barriers to public health efforts in the Prevention of end-stage organ failure pursuit self-sufficiency and provided some solutions and Lack of or insufficient Reduce transplant demand by recommendations (Table 4). programmes to prevent preventing end-stage organ failure end-stage organ disease from diabetes, hypertension, Role of Society cirrhosis of the liver, and chronic The act of donation is in itself an individual decision pulmonary disease that requires a depth of understanding that interacts with the Ineffective and Reduce transplant demand by effective social setting and the institutional and regulatory framework inequitable care for and equitable care of chronic into which an individual is embedded. Decisions are influ- chronic diseases diseases, particularly diabetes and enced by regulation (presumed consent), awareness of regu- hypertension lation, and social interactions, such as the ability to count on Promotion of donation others in case of a serious problem, also known as reciprocity Insufficient donation Encourage ICU and Emergency Room (26). Other factors, such as age, race, education, socioeco- education of health ER doctors and residents to assume nomic status, and religion, among others, determine willing- professionals responsibility for organ donation ness to donate one’s own organs and consent to the donation Education of primary care physicians, of those of a relative (27). nurses, medical students, and other allied health professionals Donors, Recipients, and Their Families Insufficient donation Develop culturally sensitive awareness In any society, individuals’ and families’ attitudes education of the general programmes toward donation are critical factors in self-sufficiency. public Use public health methodology Involve communication specialists Families’ refusal of organ donation, together with failure to identify donors, remain the most important impedi- Efficient healthcare systems and transplant programmes ments to improve rates of organ donation from deceased Competing factors and Use private and non-governmental persons in most high-income countries. In a study that resource limitations sources of funding compared donor and nondonor families, donation was Lack of/inadequate Establish synergies between the more likely when the deceased had made his or her dona- transplant programmes government and NGOs/charities because of issues of (e.g., Sindh Institute of Urology tion intentions known and the next-of-kin had more fa- infrastructure, and Transplantation in Karachi, vorable organ donation beliefs, but was less likely when organization, health Pakistan) family members were not in complete agreement about system financing, legal International collaboration donation (28). These findings highlight the need for con- and ethical regulation tinued public education efforts to maximize positive be- of the transplant liefs about organ donation and promote the necessity of process, and high cost sharing donation intentions with others (29, 30). of immunosuppressive Little is known about how best to educate patients and drugs their families about donation from living persons. In a study ICU, intensive care unit; NGO, non-government organization. of living donor kidney transplantation (LDKT), patients were randomized to receive clinic-based (CB) education alone or CB and home-based (CBϩHB) education (31). The latter moting, but also risks adversely affecting, organ donation involved home visits with the patient, family, and other po- (29, 33). Managing adverse publicity is a complex and time- tential donors by one or two trained health educators. When consuming task that must be combined with adequate and compared with CB, more patients in the CBϩHB group had systematic spread of the positive and life-enhancing aspects of living donor inquiries, evaluations and LDKTs (30.4% vs. organ donation and transplantation. Success depends not 52.4%, Pϭ0.013). Both groups demonstrated an increased only on provision of adequate information to the public but LDKT knowledge after the CB education, but CBϩHB led to also on the transparency of donation and transplantation an additional increase in LDKT knowledge and in willing- systems. Direct publicity campaigns are not guaranteed to ness to discuss LDKT with others and a decrease in LDKT positively influence the attitude of the public toward organ concerns. donation and are costly. One cost-effective strategy is that used by the Spanish Model, in which ONT provides infor- The Wider Community mation to the public and the media by means of a 24-hr The messages delivered by public education efforts transplantation hotline and periodic meetings with jour- must be clear, well defined, positive, and essentially shared by nalists, communication experts, and leaders in trans- all those involved in the process of organ donation and trans- plantation. Health professionals, who are responsible for plantation. A Spanish multiethnic national survey docu- identifying potential donors and in some cases approach- mented a significant relationship between the degree to which ing the grieving families, should also be a key target of the public is prepared to accept organ donation, and the con- education efforts (15). viction that transplantation is a good and positive element of Donation education should also target specific groups, health care (32). The mass media can be both useful in pro- such as religious leaders (27) and school students (34). Al- S86 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011 though most clergy are supportive of organ donation, reli- attitudes toward organ donation and transplantation. Ad- gious objections are often cited as a reason for refusal to give verse legislation may also be an obstacle in some countries. consent for donation. School-based education programmes In Nepal, for example, donation from living persons is only concerning organ donation and registration of intent to do- permitted from individuals in direct relation to the recip- nate have been systematically developed in The Netherlands ient from the paternal side, which has brought about a to enable adolescents to make well-informed decisions about disparity in number of recipients and donors. Regulation organ donation (37). Also, donation education for Depart- or organ donation from deceased persons is also lacking in ments of Motor Vehicles clerks, who in several countries serve this country. as gatekeepers to organ donation registration, is an effective As in high-income countries, education about organ way to increase knowledge, attitudes, and beliefs among these donation and transplantation is essential to the pursuit of key individuals and may increase donor registration rates self-sufficiency. The message that transplantation, as the among the public (38, 39). result of donation from a living or deceased donor, is the Public education concerning organ donation and means by which people suffering from end-stage organ transplantation needs to take into account cultural diversity. failure may have hope, should be communicated in a cul- Promoting organ donation and transplantation in a multicul- turally sensitive way to the general public. The role of tural environment represents one of the major challenges teachers, priests, political and social leaders, and celebri- facing the transplant community (40). Different attitudes, ties is crucial in achieving this goal. For organ donation cultures, and values systems mean that a blanket standard after death, trained counselors are required for education approach to organ shortages will not be effective. Promotion of potential donors and relatives. of donation and transplantation should involve a team of Despite these challenges, there are examples of suc- healthcare workers who are sensitive to the values and the cessful transplantation programmes in the developing traditions of individual groups in society, in addition to a world, such as the Sindh Institute of Nephrology and coordinated effort to clear any misconceptions about or- Transplantation in Pakistan (42). This model of govern- gan donation, improve public education and awareness, ment-community partnership receives 40% of its budget and promote communication with the general public. Re- from the government and the rest from the community as spect for cultural diversity and a better understanding of donations. The scheme has been extremely successful in the cultural influences involved will build stronger support providing free medical care and support for thousands of for transplantation and more successful organ donation patients. It has been sustained over the past two decades by campaigns. complete transparency, public audit, and accountability. Overcoming barriers toward organ donation from de- ceased persons in public opinion is a real challenge. Resis- tance to organ donation after death derives from lack of awareness, religious uncertainties, distrust of medicine, hos- tility toward new ideas, and misconceptions about organ TABLE 5. Challenges and recommendations for donation and transplantation. Education should be used to society in the pursuit of self-sufficiency reshape public opinion about the use of organs for transplan- Barriers Solutions and recommendations tation (41). To optimize organ donation in any given society, it is important that the community accept that use of body Lack of awareness Provide regular and consistent behavioral parts is moral and offers a source of health for everybody. The about donation change communication programmes concept that using deceased donor organs implies sharing a Develop culturally sensitive awareness source of health ideally forms a social agreement between all programmes directed to general public, members of society. Suggestions for improving organ short- religious leaders, schools, Department of age include (1) developing an understanding that during Motor Vehicles’ clerks, among others Cultivate community role models and one’s life one is more likely to need to be an organ recipient champions for organ donation and than an organ donor and (2) cadaver organs are an irreplace- transplantation able source of health. Provide public recognition to donors and their families Challenges and Recommendations for Society in the Develop a positive attitude about donation Pursuit of Self-Sufficiency through mass media, films, TV shows, The Working Group identified several challenges for radio programmes, books, and social societies in the pursuit of self-sufficiency and provided some networking sites solutions and recommendations (Table 5). Adverse publicity Actively manage adverse publicity Distrust of Provide adequate information and Challenges of Underdeveloped Healthcare medicine transparency about all aspects of Systems donation and transplantation Limited per capita health expenditure and underde- Misconceptions Develop educational programmes to dispel veloped health care systems affecting capacity for trans- about donation myths about donation and plantation are important challenges facing organ donation and transplantation transplantation and transplantation in low-and middle-income countries. Take into account people’s beliefs and values and the broader sociocultural Additional challenges in these settings may include low context in which they live levels of education, cultural antipathy, and adverse public © 2011 Lippincott Williams & Wilkins S87

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Prog Transplant 2009; 19: 173. 2): S1. 31. Rodrigue JR, Cornell DL, Lin JK, et al. Increasing live donor kidney 6. Obrador GT, Garcia-Garcia G, Villa AR, et al. Prevalence of chronic transplantation: A randomized controlled trial of a home-based edu- kidney disease in the Kidney Early Evaluation Program (KEEP) cational intervention. Am J Transplant 2007; 7: 394. Mexico and comparison with KEEP US. Kidney Int Suppl 2010; 32. Martin A. Donacio´n de o´rganos para trasplante: Aspectos psicosociales. 77(S116): S2. Nefrología 1991; 11: 62. 7. Takahashi S, Okada K, Yanai M. The Kidney Early Evaluation Program 33. Matesanz R, Miranda B. Organ donation—The role of the media and of (KEEP) of Japan: Results from the initial screening period. Kidney Int public opinion. Nephrol Dial Transplant 1996; 11: 2127. Suppl 2010; 77(S116): S17. 34. Baughn D, Rodrigue JR, Cornell DL. Intention to register as organ 8. Diabetes Prevention Program Research Group. Reduction in the inci- donors: A survey of adolescents. Prog Transplant 2006; 16: 260. dence of type 2 diabetes with lifestyle intervention or metformin. 35. Reubsaet A, Brug J, Kitslaar J, et al. The impact and evaluation of two N Engl J Med 2002; 346: 393. school-based interventions on intention to register an organ donation 9. Gaziano T, Opie L, Weinstein M. Cardiovascular disease prevention preference. Health Educ Res 2004; 19: 447. with a multidrug regimen in the developing world: A cost-effectiveness 36. Reubsaet A, Reinaerts EB, Brug J, et al. Process evaluation of a school- analysis. Lancet 2006; 368: 679. based education program about organ donation and registration, and 10. Dirks JH, de Zeeuw D, Agarwal SK, et al. Prevention of chronic kidney the intention for continuance. Health Educ Res 2004; 19: 720. and vascular disease: Toward global health equity—The Bellagio 2004 37. Reubsaet A, Brug J, Nijkamp MD, et al. The impact of an organ dona- Declaration. 2005: S1. tion registration information program for high school students in the 11. Mani MK. Nephrologists sans frontie`res: Preventing chronic kidney Netherlands. Soc Sci Med 2005; 60: 1479. disease on a shoestring. 2006; 70: 821. 38. Rodrigue JR, Cornell DL, Jackson SI, et al. Are organ donation attitudes 12. Wise J. Polypill holds promise for people with chronic disease. Bull and beliefs, empathy, and life orientation related to donor registration World Health Organ 2005; 83: 885. status? Prog Transplant 2004; 14: 56. 39. Harrison TR, Morgan SE, Di Corcia MJ. Effects of information, educa- 13. Simpkin AL, Robertson LC, Barber VS, et al. Modifiable factors influ- tion, and communication training about organ donation for gatekeep- encing relatives’ decision to offer organ donation: Systematic review. ers: Clerks at the Department of Motor Vehicles and organ donor reg- BMJ 2009; 338: b991. istries. Prog Transplant 2008; 18: 301. 14. Andreoni KA: Educating Kidney Transplant Professionals and Candi- 40. Oniscu GC, Forsythe JL. An overview of transplantation in culturally dates May Improve Utilization, Allocation Efficiency and Lifetime Sur- diverse regions. Ann Acad Med Singapore 2009; 38: 365. vival. Am J Transplant. 10:711–712, 2010. 41. Cantarovich F. Public opinion and organ donation suggestions for 15. Williams MA, Lipsett PA, Rushton CH, et al. The physician’s role in overcoming barriers. Ann Transplant 2005; 10: 22. discussing organ donation with families. Crit Care Med 2003; 31: 42. Rizvi SA, Naqvi SA, Hussain Z, et al. Renal transplantation in develop- 1568. ing countries. Kidney Int Suppl 2003; 83: S96. 16. Matesanz R. Factors that influence the development of an organ dona- tion program. Transplant Proc 2004; 36: 739. 17. Essman CC, Lebovitz DJ. Donation education for medical students: Enhancing the link between physicians and procurement professionals. WORKING GROUP 7: ETHICS OF THE Prog Transplant 2005; 15: 124. 18. Feeley TH, Tamburlin J, Vincent DE. An educational intervention on PURSUIT OF SELF-SUFFICIENCY organ and tissue donation for first-year medical students. Prog Trans- Leaders: Nikola Biller Andorno, Rudolf Garcia- plant 2008; 18: 103. Gallont, and Farhat Moazam 19. Deulofeu R, Blanca MA, Twose J, et al. Attitudes and knowledge on Members: Linda Ezekiel, Susalit Endang, Miguel organ and tissue procurement and transplantation of emergency and ´ primary care doctors in Spain. Med Clin 2009; 9: 9. Angel Frutos, Sergei Gautier, George Kyriakides, Terence 20. Manyalich M, Paredes D, Balleste C, et al. The PIERDUB project: In- Mangan, Dominique Martin, Geeta Mehta, Fernando Rau´l ternational Project on Education and Research in Donation at Univer- Morales Billini, Hans H. Schlitt, McCartney Trevor, Daniel sity of Barcelona: Training university students about donation and Wikler, and Gerson Zavalon transplantation. Transplant Proc 2010; 42: 117. 21. Aghayan HR, Arjmand B, Emami-Razavi SH, et al. Organ donation Ethical Foundations workshop—A survey on nurses’ knowledge and attitudes toward organ and tissue donation in Iran. Int J Artif Organs 2009; 32: 739. Self-sufficiency is to be understood as a strategic ap- 22. Bener A, El-Shoubaki H, Al-Maslamani Y. Do we need to maximize the proach rather than as an ethical imperative. It aims to foster knowledge and attitude level of physicians and nurses toward organ the adequate provision of organs and transplantation services donation and transplant? Exp Clin Transplant 2008; 6: 249. to meet the needs of a given population, using resources from 23. Ganikos ML, McNeil C, Braslow JB, et al. A case study in planning for within that population. Responsibly administrating the public health education: The organ and tissue donation experience. Public Health Rep 1994; 109: 626. scarce and precious resource of human organs for transplan- 24. Oberley E. Public education in organ and tissue donation: Review and tation also encompasses actions directed toward the preven- recommendations. Madison, WI, Medical Media Publishing 1992. tion of organ failure. S88 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

The pursuit of self-sufficiency requires a paradigm progress in the pursuit of self-sufficiency needs to be mea- shift, from a perception of organ transplantation as a matter sured by context-dependent benchmarks. Clearly not em- of the rights of a donor and a recipient, to one of responsibil- bracing the pursuit of self-sufficiency would be healthcare ities at the family, community, national, and international systems that: level. It is also important to recognize the profound emo- • tional, psychosocial, and experiential components connected Do not strive to develop capacity to prevent end-stage or- with the act of donating and receiving an organ, in addition to gan failure or provide for the transplantation needs of their traditional clinical and biologic concerns. population (where health system development is sufficient to support transplantation programmes); • Ethical Premises “Outsource” transplantation and provision of organs by sending their citizens to other countries; a. The human right to health requires that countries under- • Encourage organ sales, domestically or to nationals of take measures to prevent end-stage organ failure, and treat other countries. those suffering from end-stage organ failure through the use of transplantation where this is appropriate. Questions and Challenges b. Organs should be understood as a social resource; equity should govern both procurement and allocation. a. Will self-sufficiency encourage an insular attitude rather c. Organ donation should be perceived as a civic re- than global solidarity? sponsibility toward fellow citizens. Organ markets b. Is self-sufficiency an achievable goal for developing and transplant tourism lead to morally unacceptable countries? coercion and exploitation of the disadvantaged. c. Potential abuses. • Organ markets disguised as regional cooperation; Ethical Principles • Domestic financial incentives; In accordance with the Declaration of Istanbul (1), self- • Inequitable allocation or lack of transparent waiting list; sufficiency promotes the following ethical principles: • Unethical practices in the donation of organs from living a. Minimizing harm/reducing suffering: through an em- persons. phasis on the reduction of need for transplants while aiming to maximize the number of organs available for d. Diversity in cultural approaches to death/deceased per- transplantation. sons/dead bodies and related implications for attitudes to- b. Justice: by promoting a more equitable distribution ward donation. of benefit and burden (potential recipients as poten- e. Lack of awareness and education among public and health tial donors and vice versa), and censuring practices professionals. that involve the exploitation of any party. c. Respect for persons: by avoiding undue incentives, Recommendations while appealing to the community-oriented values of Recommendations to Health Authorities solidarity and civic responsability. 1. Acknowledge that the pursuit of self-sufficiency does Self-sufficiency is an aspirational concept, which can be not preclude a collaborative approach, capacity build- implemented in different, locally relevant ways, and therefore ing, or humanitarian assistance;

Key Points • The self-sufficiency paradigm reframes organ transplantation from a matter of the rights of a donor and recipient, to one of responsibilities at the family, community, national, and international level. This paradigm is based on three main ethical premises: (i) the human right to health means that countries should invest in the prevention of end-stage organ failure and in its treatment through maximizing access to transplantation; (ii) organs are a social resource, the management of which must be transparent and equitable; and (iii) organ donation should be perceived as a civic responsibility, in contrast to organ markets and transplant tourism, which lead to morally unacceptable coercion and exploitation of the disadvantaged. • The pursuit of self-sufficiency promotes the ethical principles of minimizing harm/reducing suffering, justice, and respect for persons. • Health authorities should: (i) take responsibility for meeting transplant needs and actions to prevent organ failure; (ii) be accountable for the ethical integrity of the system; and (iii) acknowledge the role for collaborative approaches, capacity building, and humanitarian assistance within the self-sufficiency paradigm. • Health professionals should: (i) receive training in ethical aspects of organ transplantation; (ii) contribute to the education of the public; (iii) maximize the utilization of donated organs; and (iii) be vigilant concerning unethical/illegal behavior and willing to report it to judicial, professional, and human rights bodies. • Professional societies should also foster research on questions of culture, values, and ethics as they relate to self-sufficiency. There is also a need for research in particular reference to the nature of the implementation of self-sufficiency to inform unresolved ethical questions. • Civil society should: (i) establish an ethos of social responsibility and solidarity in meeting transplantation needs through participation in deceased donation; (ii) be sensitive to the needs of both donors recipients; and (iii) engage NGOs, community and faith-based organizations. © 2011 Lippincott Williams & Wilkins S89

2. Take responsibility for meeting transplant needs and lung transplant waiting list in Spain while transplant actions to prevent organ failure; teams in Portugal develop technical expertise. This lead 3. Be accountable for the ethical integrity of the system. to an official agreement between the two countries, whereby the lungs suitable for transplantation in Por- Recommendations to Professionals tugal are offered to the Spanish teams, who take care of organ recovery and subsequent transplantation. 1. Receive training in ethical aspects of organ transplantation; 2. Contribute to the education of the public; REFERENCE 3. Maximize the utilization of donated organs; 1. Steering committee of the Istanbul Summit. Organ trafficking and trans- 4. Be vigilant concerning unethical/illegal behavior and plant tourism and commercialism. The Declaration of Istanbul. Lancet, willing to report it to judicial, professional, and human 2008; 372: 5. Available at: http//www.declarationofistanbul.org. rights bodies.

Recommendations to Civil Society WORKING GROUP 8: EFFECTIVENESS IN THE PURSUIT OF SELF-SUFFICIENCY - 1. Establish an ethos of social responsibility and solidarity in meeting the community’s transplant needs through ACHIEVEMENTS AND OPPORTUNITIES participation in donation after death; Leaders: Luc Noe¨l, Chris Rudge, and Anantharaman 2. Be sensitive to the needs of both the donor and the Vathsala recipient; Members: Ines Alvarez, Tamar Ashkenazi, Teodora 3. Engage NGOs and community- and faith-based Dzhaleva, Gayatri Ghadiok, Sudhir Gupta, Arnt Jakobsen, organizations. Martí Manyalich, Rafael Matesanz, Alejandro Nin˜o Murcia, Izaaq Odongo, Ole Øyen, Adib Rizvi, Wojciech Rowinski, Recommendations to Scientific and Professional Bodies Rafael Rozental, Manav Saxena, and Sarah White and Funding Agencies A Framework for Progress in the Pursuit of 1. Foster research on questions such as: Self-Sufficiency Achieving self-sufficiency is a journey, with the pace of a. How is the pursuit of self-sufficiency consistent with progress dictated by resource availability, systems develop- the values in different cultural and religious contexts? ment, and the extent of national commitment to this goal. b. What are cultural, social, and religious obstacles to Progress may be defined as levels of transplantation capabil- donation after death, and how might they be over- ity, which reflect the evolution and achievements of organ come? donation and transplantation systems. The objectives of spec- c. How does the emphasis on organs as a community ifying levels of transplantation capabilities are as follows: resource impact on motivation to participate in pre- vention programmes/donation after death? a. To ensure that every nation or region has, or acquires, d. How to maintain equity within regional cooperation the necessary attitudes, policies and plans, resources, to preserve mutual benefits and avoid an unbalanced skills, and infrastructure to provide solid organ trans- flow of organs or other related resources from one plantation for its population for the purpose of treating country to another. end-stage organ failure; e. What constitutes an equitable donation pattern? b. To provide tools for every nation or region to self-assess its own progress in the pursuit of self-sufficiency in Examples of Ethical Approaches to Challenges in solid organ transplantation for the purpose of treating the Pursuit of Self-Sufficiency end-stage organ failure; c. To provide tools for nations or regions to identify a. Tanzania: because of a lack of transplantation services in gaps or barriers to progress in the pursuit of self- Tanzania currently, a programme has been arranged to sufficiency; ethically and safely match altruistic living-related kid- d. To identify the resources required by nations or regions ney donors to those requiring transplantation. Donors to resolve gaps or remove barriers that present obstacles and their recipient relatives are flown abroad to India to the attainment of self-sufficiency and to identify pri- where procurement and transplantation is performed at ority interventions in the pursuit of this goal; the cost of the Tanzanian government, and patients e. To provide a framework that has relevance in all con- then return home for follow-up care. This temporary texts, whatever the local reality in terms of economic solution to the problem of unavailable transplantation and health system development, for the stepwise devel- services in Tanzania is highly valued but is neither cost opment of organ donation and transplantation systems effective nor sustainable in the long term. Therefore, toward self-sufficient models. Tanzania is working toward the development of trans- plantation services, so that, in the future, patients and Therefore, by defining stepwise levels of transplanta- donors may receive all their care locally, avoiding the need tion capability, it is possible to construct a roadmap of how to rely on the services of foreign countries (L. Ezekiel, per- individual nations or regions can progress toward self- sonal communication). sufficiency. Progress from one level of transplantation capa- b. Spain—Portugal exchange for lung transplantation: bility to the next requires government commitment toward Portuguese patients have been officially admitted to the developing and implementing policies and programmes, S90 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

Key Points • In the journey toward self-sufficiency, the capability of individual countries/regions to meet transplantation needs is determined by economic resources, systems development, and existing health priorities. By defining successive levels of capability, the inclusive nature of the self-sufficiency paradigm is reinforced, and it is possible to describe a framework for evolution and achievement in organ donation and transplantation that is adaptable to all contexts. • The minimum level of transplantation capability (level 1) is defined as the presence of a few medical professionals who have the capability to provide appropriate presurgical and postsurgical management of transplant recipients and living donors in a context of no local transplantation activity; maximum capability (level 6) is defined as a comprehensive multiorgan transplant programme that provides an adequate supply of transplantable organs to meet the needs of the population. • At every level, the pursuit of self-sufficiency involves the development and implementation of strategies aimed at increasing regional/ national capabilities in each of the following domains: (i) donation and coordination, (ii) legislation and regulation, (iii) transplant services, (iv) government resourcing, (v) community involvement, and (vi) assessment and minimization of needs. With progressive achievements in each of these domains, at a level consistent with local realities, countries/regions evolve toward greater self-sufficiency in organ donation and transplantation. • To enable the evolution of organ donation and transplantation systems toward models of self-sufficiency, governments should: (i) acknowledge their responsibility and address the problem of end-stage organ failure, from prevention to organ replacement therapy, in an integrated manner for the optimal management of resources; (iii) include the elements of organ donation, and transplantation in the national health plan; (iv) allocate adequate resources, develop infrastructure, and strengthen health systems for the achievement of these goals; and (v) foster regional and international cooperation in the pursuit of these goals. • To support these efforts, the WHO should: (i) urge all nations to self-assess their level of transplant achievement; (ii) expand data collection and monitor international progress in the pursuit of self-sufficiency; and (iii) develop international standards, guidelines, and tools for the advancement of transplantation policy and practice. • To support these efforts, healthcare professionals and professional societies should: (i) acknowledge responsibilities with respect to professional development, ethical practices, and maintenance of standards and training in donation, organ procurement and transplantation; (i) encourage research directed at optimizing the benefits and minimizing costs of transplantation; (iii) support the establishment and work of national societies; and (iv) provide professional advice, and assistance in the development of standards for accreditation and quality assurance. commensurate with local resources and competing health with the capacity to provide kidney procurement surgery priorities, within each of six key domains: from living donors, kidney transplantation surgery, and postsurgical management of kidney transplant patients. • Resources and professional development for donation The transplant center follows established standards, guide- and coordination; lines, and care protocols for living kidney donors and kid- • Legal and regulatory frameworks; ney transplant recipients, taking into consideration the • Resources and professional development for transplant relevant international consensus documents, in particular services; the Declaration of Istanbul. The transplant center has de- • Government and other resources; veloped mechanisms for monitoring outcomes for its kid- • Community involvement; ney transplants in key areas including graft and patient • Assessing and minimizing need for organs. survival. This level also defines nations or regions that have Levels of Transplantation Capability begun to assess their needs for organ replacement therapy, including transplantation therapy, by establishing regis- Six levels of achievement within each domain are tries of end-stage kidney disease/liver failure/heart failure defined: (as per country needs). Level 1 This level defines nations or regions that have a few Level 3 medical professionals who have the capability to provide This level defines nations or regions that have one or appropriate pre and postsurgical management of transplant more centers providing clinical kidney transplant services recipients and living donors, taking into consideration guide- within their own borders. The transplant centers have es- lines concerning the care of transplantation patients as devel- tablished standards, guidelines, and care protocols for liv- oped by international consensus, such as the Amsterdam ing kidney donors and kidney transplant recipients, taking Forum on the Care of the Live Kidney Donor and the Van- into consideration the consensus documents developed by couver Forum on Live Donation of Extrarenal Organs. This the Amsterdam and Vancouver Forums on care of the live do- level also defines nations or regions that have begun to assess nor, the Declaration of Istanbul, and the Kidney Disease: Im- their needs for renal replacement therapy, including trans- proving Global Outcomes (KDIGO) Clinical Practice Guide- plantation therapy, by developing a registry of end-stage kid- lines for the Care of Kidney Transplant Recipients. The ney disease. transplant center has developed mechanisms for monitoring outcomes for its kidney transplants in key areas including graft Level 2 and patient survival. This level defines nations or regions that have a clin- This level also defines nations or regions that are ical kidney transplant service within their own borders establishing the framework for a deceased donor kidney © 2011 Lippincott Williams & Wilkins S91 transplant programme within their own borders, includ- per million population and the percentage of incident end- ing legislative developments and training of organ pro- stage kidney disease patients receiving a transplant. curement professionals. Nations and regions with this level of capability have This level furthermore defines nations and regions that, established detailed end-stage organ failure registries for the in addition to the development of end-stage organ failure ongoing evaluation of the need for organ transplantation and registries, have begun to address the risk factors for end stage have developed and implemented preventive interventions to organ failure by identifying their prevalence in the nation and reduce the demand for organs for transplantation. introducing interventions to delay its progression. Level 6 Level 4 This level defines nations or regions that have a com- This level defines nations or regions that have initiated prehensive multiorgan transplant programme that provides deceased donor kidney transplant services within their own an adequate supply of transplantable organs to meet the borders and have capacity to perform kidney procurement needs of its population with end-stage kidney disease, end- surgery from deceased and living donors, kidney transplan- stage liver failure, and end-stage heart failure. Other features tation surgery, and postsurgical management of kidney trans- of such a programme include: plant patients. The nation or region has effected legislation • that covers organ procurement from deceased donors and Death of patients on the transplant wait list(s) is provides high level governance over organ procurement and nonexistent; • Travel for transplantation is nonexistent; transplantation activities. The transplant centers have estab- • lished standards, guidelines, and care protocols for living The system has capacity to provide expertise to assist the kidney donors and kidney transplant recipients, taking into development of transplant programmes in level 1 to 5 nations or regions; consideration the consensus documents developed by the • Amsterdam and Vancouver Forums on care of the live donor, Exchange of organs between programmes, based on es- the Declaration of Istanbul, and KDIGO Clinical Practice tablished guidelines for international cooperation. Guidelines for the Care of Kidney Transplant Recipients. This level also defines nations or regions that have a Recommendations clinical liver and heart transplant service within their own Governments should: borders, with the capabilities to provide liver and heart pro- 1. Acknowledge their responsibilities in managing the curement surgery from deceased donors, liver and heart end-stage organ failure of their population, and desig- transplantation surgery, and postsurgical management of nate a competent authority, responsible for policy liver and heart transplant patients. The transplant center fol- making, regulation, and oversight and coordination lows established standards, guidelines, and care protocols for at a national level; living organ donors and transplant recipients. This level fur- 2. Address the problem of end-stage organ failure, from thermore defines nations or regions that are developing other prevention to organ replacement therapy, in an inte- organ transplant programmes, including lung, pancreas, and grated manner for the optimal management of combined transplant programmes. resources; 3. Include the elements of organ donation and transplan- Level 5 tation in the national health plan; This level defines nations or regions that have an estab- 4. Allocate adequate resources, develop infrastructure, lished multiorgan deceased donor organ transplant pro- and strengthen health systems for the achievement of gramme that is capable of providing kidney, liver, and heart these goals; transplantation for its patients with end-stage kidney disease, 5. Establish appropriate legislation and regulatory end-stage liver failure, and end-stage heart failure. Critical frameworks; elements of legislation and regulation of the various aspects of 6. Report national data on organ donation and transplan- organ donation and transplantation, government commit- tation activities to a global observatory; ment to resourcing infrastructure and developing profes- 7. Foster regional and international cooperation in the sional capacity, governance and oversight by national author- pursuit of these goals; ities, and surveillance and monitoring of organ donation and 8. Participate in public education, engaging communities, transplantation activities are all well established. A national or and NGOs. regional network that optimizes deceased donor organ pro- curement and a framework for organ allocation to patients on The WHO should: a national waiting list is an essential development. Complementary to the deceased donor transplant pro- 1. Urge all nations to self-assess their level of transplant gramme, living donor transplantation is performed to pro- capability, to assist in the identification of areas for vide kidney and liver transplants for a proportion of its end- improvement; stage kidney disease and emergent end-stage liver failure 2. Expand the framework of relevant quantifiable indi- patients, following the standards, guidelines, and care proto- cators in alignment with the GODT (http://www. cols set forth in the Amsterdam and Vancouver Forums. transplant-observatory.org/); Complementing deceased donor kidney transplanta- 3. Monitor international progress in levels of achievement tion with LDKT maximizes the rate of kidney transplantation in the pursuit of self-sufficiency; S92 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

4. Develop international standards, guidelines, and • Professional Training Group—responsible for profes- tools for the advancement of transplantation policy sional training on organ donation and e-learning virtual and practice. modules; • Managers Training Group—responsible for managers Healthcare professionals and professional societies training on organ donation. should: One hundred twenty-five health professionals were 1. Acknowledge responsibilities with respect to their own trained by the ETPOD project in each of 25 target areas across professional development, ethical practices, mainte- Europe, with this number including 2 senior transplant coor- nance of standards and training in donation, organ pro- dinators (training for trainers), 2 junior transplant coordina- curement, and transplantation; tors (professional training), 1 transplant area manager (organ 2. Encourage research, especially clinical research directed donation quality managers training), and 120 health profes- at optimizing the benefits and minimizing costs of or- sionals involved in donor detection (EOD). gan transplantation; ETPOD in Turkey (communication from Levent 3. International societies should support the establish- Yu¨cetin): eight EOD seminars were held in Ankara be- ment and work of the relevant national societies to fur- tween September and October 2009, with 500 participants. In ther their missions with respect to organ donation and December 2009, eight EOD seminars were held for 1600 par- transplantation; ticipants in I˙stanbul. Another four EOD seminars were held 4. Provide professional advice to MS; in April/May 2010 for 700 participants in I˙zmir. 5. Provide assistance to MS for the development of stan- Evaluation of the impact of ETPOD on organ donation dards for accreditation and quality assurance; rates at national, regional, and local level (communication 6. Participate in public education. from Gloria Pa´ez): to evaluate the effect of ETPOD courses, data on key indicators were collected in 2006 (before project Examples commencement) and again in 2009. The impact of the train- The pursuit of self-sufficiency involves the develop- ing programmes on rates of brain death diagnosis, identifica- ment and implementation of strategic policies and pro- tion of potential donors, refusals, effective donors, and pro- grammes aimed at increasing regional or national levels of cured organs was assessed for each of the target areas. The capability within each of the domains of (1) donation and number of procured organs increased in 19 of the 25 target coordination, (2) legislation/regulation, (3) transplant ser- areas, from 1242 in 2006 to 1483 in 2009 (1). Assessed per vices, (4) government resourcing, (5) community involve- million population, procured organs increased from 43.2 to ment, and (6) assessment and minimization of needs. Exam- 51.8 per million population, whereas brain death diagnoses ples of strategies that have successfully developed capacity for increased from 28.2 to 39.8 per million population. The im- self-sufficiency at a regional or national level are given below: portance of donor coordinators was emphasized in this eval- uation—those target areas which had increased their number of coordinators between the years 2006 and 2009 demon- European Training Programme on Organ Donation strated significantly greater improvements in organ procure- (http://etpod.il3.ub.edu/etpod.html) ment than those target areas with a steady or reduced number The European Training Programme on Organ Dona- of personnel devoted to coordination in 2009 compared with tion (ETPOD) project was conceived with the objectives of: 2006. (1) developing and validating a professional ETPOD that would increase organ donation knowledge and maximize growth of organ donation rates; (2) providing training to Gift of Life Donor Programme (United healthcare professionals from EU countries, to develop States—Communication From Howard Nathan) Transplant Coordinators with the expertise, competencies, Gift of Life (Philadelphia, PA) is an urban-based, non- and motivation in the organ donation process to lead efficient profit OPO/Tissue Recovery/Eye Bank established in 1974 and successful organ donation-procurement programmes; that is the largest in the United States with approximately 34 and (3) to build a solid European collaborative partnership staff in the field, divided between procurement and educa- in the organ donation-transplantation process that will en- tion/marketing professionals, and generating the highest vol- able countries to respond to the growing demand for trans- ume of organ donors in 2009 in US history (439 organ donors plantation by increasing donation rates. Cofunded by the from a population of 10.2 million). European Commission Grant Agreement 2005205, the The Pennsylvania Act 102 was initiated by families project was developed during the period from January whose loved ones died waiting for a transplant. Originally 2007 to December 2009. The execution of the project was drafted as a presumed consent law, the provisions of the Act carried out through four working groups: are as follows:

• Data Base Source Group—responsible for establishing • Routine referral of all deaths to the OPO at or near the the training needs in each target area and for evaluation time of death; of the ETPOD project; • Medical suitability of potential donors determined by • Basic Training Group—responsible for training for OPO personnel; trainers and essentials in organ donation (EOD) training • Family approached by trained requestor/OPO person- programmes; nel with hospital staff; © 2011 Lippincott Williams & Wilkins S93

• Medical record reviews to determine donor potential nation system. This SEUSA programme includes: (1) insti- and missed referrals of all deaths, with provision for fines tution of area coordinators, (2) periodic meetings with for missed referrals. ICU coordinators and hospitals leaders, (3) implementa- Therefore under PA Act 102, routine referral started in tion of technical strategies to better detect all brain and 1994. The law states that hospitals are required to refer all patient heart deaths in ICUs, (4) constitution of an organ and tissues deaths and imminent brain deaths to the OPO in a timely man- procurement team in each ICU, (5) allocation of dedicated fi- ner, so that medical suitability can be evaluated and that the nancial resources direct to the procurement system, and (6) option of organ donation is preserved for families. The standard training courses for members of the procurement teams. Anal- educational message to the hospital staff was to refer all nonre- ysis of data on procurement parameters in 21 ICUs from the coverable, neurologically injured, vent-dependent patients at the ATRC computer network, registered before and after the com- first sign of imminent brain death. Clinical parameters for refer- mencement of the programme, indicated a significant increase ral were not specified, removing barriers to early reporting and during the first 2 years of the Spain Europe USA (SEUSA) pro- encouraging hospital staff to call the OPO as soon as this type of gramme in of the number of brain death assessments and organ patient presented in the emergency room (ER) or ICU. A top donors and a decrease in the refusal rate. down approach to hospital development was adopted, reinforc- However, despite the successes of the first 2 years of ing the early referral message to administrators, physicians, and the programme, organ donation rates in the Apulia region nurse managers on a one-on-one basis. Maintaining the com- remained lower than the Italian national average rate, with mitment to send a coordinator out on site for every referral that indications that potential donors were still not being effec- fit criteria is critical to the routine referral policy. tively identified. Therefore, in January 2009, Apulia intro- Because of the success of PA Act 102 in the Gift of Life duced a Deceased Alert System (DAS), a new monitoring service area, from August 1998, a National Routine Referral and reporting system for brain and circulatory death, policy was introduced whereby all US hospitals were required which functions synergistically with the Registry of Head by Medicare to adopt routine referral as a “condition of par- Injury and the Donor Manager. Under the DAS, when an ticipation.” Over the 15 years since the introduction of the PA ICU patient has a severe acute brain injury or goes into Act 102 for Routine Referral, Gift of Life has experienced a circulatory death, an automated message is sent through doubling in rates of organ donation. These positive outcomes the internet to the ATRC and simultaneously to the mobile extend beyond organ donation; bone donation has increased phone of the local coordinator, who is therefore kept up- in the Gift of Life jurisdiction from 174 donations in 1992, to-date in real time one the presence of a potential donor before the introduction of Routine Referral, to 1026 dona- in the ICU and can therefore initiate appropriate proce- tions in 2009. dures. During the first 5 months of the DAS being opera- tional, actual donors increased by more than 57%. Referral SEUSA (Spain, Europe, United States—Communication of potential donors increased gradually with increasing From M. Paula Go´mez) confidence in the new system, and these initial data indi- In response to low organ donation rates in Apulia, a cate that increasing use of the DAS could significantly re- South-Eastern Italian region, a new international collab- duce losses of potential donors through failure to report. orative strategy to increase donation activity was intro- duced in 2007. This collaboration involves international REFERENCE experts from Spain, Europe and the United States working 1. Ferraro C, Vespasiano F, Ricci A, Caprio M, Di Ciaccio P, Nanni Costa A, Guash X, del Rio M. Impact of ETPOD on organ donation rates at with the Apulia Transplantation Regional Center (ATRC), National, Regional and Local level. Comparative report on organ do- Azienda Ospedaliero—Universitaria Policlinico di Bari, nation rates before and after training implementation. European with the goal of reorganizing the entire regional organ do- Training Programme on Organ Donation [ETPOD], February 2009. S94 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

APPENDIX 1: Expanded Report on System e. Legislation guaranteeing transparency of organ alloca- Requirements for the Pursuit of Self- tion: the criteria for organ allocation should be set in Sufficiency (Working Group 2) accordance with medical utility, mindful of the charac- teristics, and preferences of each region or country and To achieve self-sufficiency, it is necessary to both min- the principle of equity (3). imize the need for transplantation and maximize the utility of f. Presumed consent for donation after death (optional): available resources through efficient organ procurement, legislation may be enacted to establish presumed con- successful transplantation, and optimal graft survival. This sent for organ donation. This may be effective in in- requires a number of specific system-related, structural, or- creasing potential deceased donors, provided there is ganizational, and regulatory developments. social consensus regarding presumed consent (4, 5). For example, in Spain and France if a brain-dead per- son has never expressed his or her intention for do- ESSENTIAL LEGISLATION AND nation, his or her consent is legally presumed (6). In REGULATION Germany and selected other European countries, Legislation from 13 years of age, individuals may draw up a doc- Legislation is necessary to ensure that clear definitions ument rejecting donation of their organs, and there- of brain death and circulatory death exist to allow procure- fore, persons with such a document are considered to ment of organs from deceased donors. It is also required to be objectors to organ donation, and persons without define protocols concerning consent, including presumed such a document, assenters. The presumed approach consent, and the fair and transparent allocation of organs. has contributed to an increased provision of organs for these countries, but the local sociocultural con- Finally, legislation must govern transplantation practice in texts of different counties need to be considered be- accordance with the WHO Guiding Principles. In particular, fore enacting a mandatory system. this means promoting the altruistic character of organ dona- g. Routine Inquiry laws: for example, Required Request tion and prohibiting organ trafficking and commercialism. Legislation introduced in the United States in 1986 re- quires that hospitals or their designees ask families of a. Legislation concerning organ trafficking: consistent patients and potential donors about their wishes con- with the WHO Guiding Principles, each country re- cerning organ donation (7). quires legislation prohibiting organ trafficking and sales to prevent human rights abuses. The export and import Regulation of organs or tissues or cells and transplantation for for- eign patients should also be governed by legislation. Regulatory bodies should monitor the activities of b. Legislation concerning declaration of death: each coun- organ procurement, allocation, and transplantation organi- try performing deceased donor transplantation must le- zations to ensure they take place in accordance with local, gally define brain death, consistent with international regional, and international law and in an ethical and effective standards. There should be legal provision to remove manner. Regulation is necessary for oversight and guidance related to ethical standards, the development of transplanta- organs from a deceased person, in accordance with local tion policies, and quality management in all organ procure- statutes on determination of brain death and circula- ment and transplantation practices. tory death. c. Legislation concerning organ procurement procedures: a. Transplantation ethics organ recovery can only be justified through a strict • Regulatory bodies have an important role in establish- consent process that is guaranteed by autonomy of ing ethically appropriate organ procurement and allo- the donor who is sufficiently informed or in the setting cation processes. of legislated presumed consent to donation after death • Ethics committees, under the local, regional, or na- (1). Organ donation from living persons who are mi- tional regulatory authority, guide (1) organ procure- nors or individuals unable to provide informed consent ment processes such as informed consent, (2) the should be prohibited (2). Although it is hoped that the implementation of new procedures or practices that consent of relatives to donation after death will be ac- have ethical implications, such as DCD, and (3) eligibil- tively sought in all circumstances, in some jurisdictions ity criteria for living donors and approving the relation- where the preferences of relatives may conflict with ship between a potential donor and a recipient. those expressed by the potential deceased donor, the latter may be upheld (This is not the case in all countries. b. Development of transplantation policy In practice, relatives’ wishes are often upheld over do- • Through surveillance and data collection, regulatory nor wishes. See Uniform Anatomical Gift Act, United bodies are able to review existing processes and develop States). more effective transplantation policies. Data relevant to d. Legislation to establish transparent organizational transplantation policies include the reported rate of structures and authorities for the coordination of organ brain deaths in each hospital, factors contributing to donation and transplantation (refer Monitoring and nonprocurement from potential donors, and donor Regulation of Organ Donation and Transplantation, Or- and recipient outcomes. For example, in the United gan Procurement Organizations, National Donation Pro- Statesm a death audit is carried out every year and motion Programmes, Hospital Transplant Programmes). identifies, according to the medical records, whether © 2011 Lippincott Williams & Wilkins S95

potential donors have been missed. All hospitals Coordinator Organization, which also provides con- should have a continuous quality audit programme tinuing education, conducts research, and gives ad- concerning brain deaths to ensure that every brain vice concerning organ procurement processes (13); death patient has been detected and evaluated by the – Spain: the Transplant Procurement Management transplant coordinator. (TPM) curriculum includes family meetings and con- • Regulatory bodies must evaluate and make recommen- sent of organ donation. dations concerning the appropriate standards for age, disease, use of ECDs, and DCD. THE NATIONAL TRANSPLANT • Regulatory bodies must additionally consider, and ORGANIZATION implement where appropriate, innovative strategies National Transplantation Organizations (NTO) em- for increasing the availability of donor organs such as body all processes involved in organ procurement and trans- paired kidney exchange programmes between living plantation at the governmental level. Although they may be donors (8). • responsible for various functions such as the management of Regulatory bodies are also responsible for the develop- waiting lists, matching and allocation, and the maintenance ment of whole-of-system strategic policies to better of comprehensive registries, above all they should ensure meet the transplantation needs of the population. Ex- the implementation of national policy concerning dona- amples of comprehensive strategic policy include: tion and transplantation. Hence, the NTO must have regula- – The Organ Donation Breakthrough Collaborative tory functions and provide effective oversight of all activities (United States): started in 2003 to vitalize organ DBD in organ donation and transplantation, monitor trends and and also promote best practice in organ donation, the performance, and guide informed policy. Breakthrough Collaborative targets hospitals or OPOs with a large potential in terms of DBD. Each Allocation of Organs hospital is encouraged to identify opportunities for There are two models of organ allocation: a centralized improving practice and collaborate with OPOs in the system led by government (e.g., ONT, Korean Network of introduction of new strategies to enhance organ pro- Organ Sharing [KONOS]) or private corporation aggregate curement. After implementing this system, DBD in- run by a non-profit corporation (e.g., UNOS). Regardless of creased by 4% (9–11); the structure of organ allocation bodies, their operation and – The “40 donors per million population plan” (Spain): organization should be intimately connected with the NTO. Spain is trying to increase its rate of organ donation Examples of organ allocation models: from deceased persons to 40 donors per million pop- ulation, by targeting the key areas of (1) detection and a. The EIF, found in 1967, is responsible for the mediation management of brain-dead donors, with specific fo- and allocation of organ donation procedures in Austria, cus on access to ICUs, new forms of hospital manage- Belgium, Croatia, Germany, Luxemburg, the Nether- ment, foreigners and minorities, and evaluation/ lands, and Slovenia (http://www.eurotransplant.org). maintenance of thoracic organ donors; (2) ECDs, b. Agence de la Biomedicine (France) is the public body in looking at aging, donors with positive tests to certain Europe to combine the four allocation region services de viral serologies, and donors with rare diseases; (3) régulation et d’appui (SRA) of organ procurement (http:// special surgical techniques, and (4) DCD. In addi- www.agence-biomedecine.fr/). tion, Spain seeks to open new DCD programmes in c. KONOS: a government controlled system responsible cities with more than 300,000 inhabitants and try- for registry, allocation, and database management for ing to reduce the rate of potential donor families’ three geographic regions (http://www.konos.go.kr/). refusal to 10% (12). d. ONT, Spain: a system of interdependence between dis- tinct/regional based procurement arrangements, which c. Transplantation quality management and professional works as part of a NTO (http://www.ont.es). education e. UNOS (United States): the national UNOS membership is • Regulatory oversight helps to standardize, and maintain divided into 11 geographic regions for procurement, allo- quality in, transplantation performance by promoting cation, and transplantation (http://www.unos.org). uniform procedures and monitoring the performance of each individual transplantation center. To maximize utility, organs are generally allocated based • Regulatory bodies are responsible for ensuring ade- on medical urgency and blood/tissue type matches. Distribution quate education and training of transplant staff, for ex- is usually made first on a local, then regional, and finally national ample: level. Kidney and pancreas allocation is usually made based on a – United States: transplant professionals must demon- point system, using an algorithm that takes into account blood strate the ability to execute their tasks independently group, waiting time, type of HLA match, degree of sensitization, and pass a test hosted by North America Transplant and age. Local patients with the highest points are allocated the

Suggestions for enhancing progress toward self-sufficiency through legislation and regulation:

► Proper legislation and regulation ► Policy making for improved organ donation ► May adopt “presumed consent” or “explicit consent” by legislation or regulation S96 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011 organs in descending order, then they are distributed regionally provided to the EIF and UNOS (DonorNet®) computer in descending point order, and finally nationally, in the same order systems, staff at the hospital where the transplant candi- (14, 15). Liver allocation takes into account degree of medical ur- date is located can share real-time information and show gency, blood group, and time waiting and also used a point-based intention of acceptance in the system, by which allocation system for these factors. Degree of urgency is classified using a scor- and distribution are made. Other examples of registries ing system such as Mayo End-stage Liver Disease score (16–18). and large-scale databases in organ donation and transplan- tation include: Monitoring and Regulation of Organ Donation and Transplantation a. SRTR (United States): supports the ongoing evalua- Registries play a vital role in transplantation systems, tion of the scientific and clinical status of solid organ including maintenance of the organ transplant waiting list transplantation. The SRTR contains current and past and facilitating the allocation of organs from deceased donors information about the full continuum of transplant in accordance with transparent distribution criteria (see activity, from organ donation and waiting-list candi- Working Group 4). They also enable review of the current dates to transplant recipients and survival statistics. status of donation and transplantation, thereby facilitating This information is used to help develop evidence- quality control, evidence-based research, and the develop- based policy, to support analysis of transplant pro- ment of policies that are guided by the best available informa- grammes and OPOs, and to encourage researches on tion concerning the management of patients and their needs. issues of importance to the transplant community Each country performing transplantation should develop a (www.ustransplant.org). registry of organ donation and transplantation activities. b. Collaborative Transplant Study (Europe): with the ac- Transplantation authorities need access to transplanta- tive support of more than 400 transplant centers in 45 tion data for several policy and regulatory purposes. Key ap- countries, the Collaborative Transplant Study is the plications of registry data include: largest international voluntary study in the field of medicine. More than 400,000 datasets for kidney, heart, a. Performance standards: transplant data can be used to lung, liver, and pancreas transplants have been col- assess and set performance standards for transplant lected. This wealth of data has provided invaluable centers. The data can be used to evaluate the number of insights into transplantation-related problems such transplants performed by individual transplant centers as effects of immunosuppressive drugs, long-term and the outcomes at those centers. The data can show toxicity of immunosuppressant, causes of long-term the impact of patient mix on patient and graft survival graft loss, factors influencing patient survival, etc and the effects of race, blood type, and other variables (www.ctstransplant.org). on pretransplant waiting time. c. Sistema Nacional de Informacíon de Procuracíon y b. Legislative and regulatory policy: transplant data are Trasplante (Argentina): run by the National Institute important for setting government policies and passing for Organ Donation and Transplantation Instituto Na- laws related to transplantation. For example, data can cional Central U´nico Coordinador de Ablación e Im- be used to determine the impact of federal OPO regu- plante (INCUCAI), Sistema Nacional de Informacíon lations that require demonstrated ability of each OPO de Procuracíon y Trasplante is an online data system to meet a minimum procurement rate. Data can also be that administrates, manages, and supervises organ, tis- used to determine the effects of cold ischemia time sue, and cell procurement and transplantation activities (time without blood supply to the organ) on graft sur- in the national field. It allows online monitoring of di- vival. Such information can be used to develop optimal alysis registries, waiting lists, procurement procedures, geographic organ sharing policies. and the distribution and allocation of organs and tis- c. Quality control: data can also be used to examine such sues. It also facilitates traceability from donor to recip- issues as accuracy in histocompatibility testing and graft ient and vice versa. The data are used to generate reports survival for specific transplant procedures. about transplant activity from organ donation and wait- d. Internal benchmarking: registry data are also useful for ing-lists patients, to transplant recipients (http:// healthcare professionals and research organizations for www.incucai.gov.ar). improving practices and setting standards. It also helps to facilitate communication with relevant international ORGAN PROCUREMENT ORGANIZATIONS organizations concerned with transplantation. An OPO is an independent organization responsible Best practice with respect to registries consists of, for the process of systematic surveillance for the identifica- where possible, computer-based, real-time sharing of do- tion of potential donors and the procurement of deceased nor information. For example, when donor information is donor organs (19). The identification of potential donors is

To enhance progress towards self sufficiency, NTOs should: Be the main authority for organ transplantation programmes Maintain transparency in organ allocation Maintain a useful national data system Promote innovation to increase the donor pool, including consideration of paired kidney exchange programmes between living donors Develop allocation policies for expanded criteria donors and donation after circulatory death © 2011 Lippincott Williams & Wilkins S97 the starting point of transplantation, and its optimization is responsible for donor detection, screening and possibly the most important process in maximizing the pro- management, organ distribution, and allocation curement of organs for transplantation. coordinating 24 OPOs around the country (www.incucai.gov.ar); Structure of an OPO – Agence de la Biomédecine (France) is a public body In setting up an OPO, its region of jurisdiction/respon- combining the four allocated regions (SRA) for or- sibility will be influenced by population size, geographical gan procurement (www.agence-biomedecine.fr); features, and the number and size of hospitals and transplan- – Deutche Stiftung Organtransplantation (Germany): tation centers available. Limits must be set to ensure the since 1984, Deutche Stiftung Organtransplanta- region is appropriate for management by a central OPO re- tion has conducted identification of potential sponsible for the distribution of organs for transplantation. brain death donors and organ extractions; how- OPOs require the involvement of experts concerned with ever, allocation is executed by Eurotransplant medical administration, clinical management, logistics, (www.dso.de); education and so forth, and the support of a variety of – Korea Organ Donation Agency (KODA): set up in institutions. 2009, KODA is responsible for donor detection, OPOs are divided into two organizational models: screening, and management in each three geo- HOPOs and IOPOs. HOPOs originally served as exclusive graphic regions, working separately from KONOS procurement entities for the transplantation facilities in (www.koda1458.kr); which they were located. IOPOs operate outside the hos- – ONT, Spain: ONT is in charge of the national net- pital setting and provide services to a number of transplant work of OPOs (www.ont.es); centers. IOPOs are usually structured as non-government, – UNOS (United States): under UNOS are 59 OPOs in nonprofit organizations. Regardless of the model, there 11 regions, working with transplant medical institu- should be an approval process involved and oversight pro- tions, laboratories, and civic groups (www.unos.org). vided by appropriate government authorities to ensure Personnel Involved in OPOs transparent management. In both models, procurement activity occurs independently from transplant units, al- a. OPC: OPOs may employ highly trained professionals though transplant surgeons are in charge of organ recov- called procurement coordinators who carry out the or- ery. Decisions about the adoption of a particular system of ganization’s mission (20). The OPC is a key person re- organ procurement should be made with consideration of sponsible for integrating the actions noted above; for each national and regional situation. The following sec- possible donor detection, donor management, working tions review the advantages and disadvantages of both with donor families, hospital staff, and also develop- models. ment of donor detection programmes and protocol etc. Therefore, OPC need to maintain professional a. HOPO qualification by regular education and certification • Advantages: because a HOPO creates no additional eligibility (American Board for Transplant Certifica- costs, it would be suitable for a country with only tion, www.abtc.net, USA; Transplant Procurement one transplantation center or just starting deceased Management, www.tpm.org, Spain). transplantation. b. Physicians and nurses: nephrologists, critical care spe- • Disadvantages: HOPOs are often hampered by fund- cialists, and also other physicians and nurses can engage ing conflicts and inefficiencies. In addition, the identi- in the activities of the OPC. An OPC needs to be able to fication of potential donors is likely to be unsystematic manage both ECDs and DCD. because of the small scale of operations of an HOPO c. Subordinate coordinators: in the case of LifeLink (At- compared with an IOPO. Furthermore, HOPOs are lanta, United States), the roles of the OPC are divided vulnerable to ethical conflicts because of the in-house across a local call center, referral coordinator, desig- nature of their operations. nated coordinator, surgical coordinator, and organ b. IOPO placement coordinator; each department is responsible • Advantages: IOPOs are more effective in organ pro- for specific tasks. Some OPOs may also employ “after- curement than HOPOs, because they have a larger in- care coordinators.” tegrated system and a centralized authority, that can d. Organ donation representative or organ facilitator: this help to provide more consistency of service, minimize person may help to identify potential donors within a inefficiencies, and optimize the potential donor pool facility. In countries with a limited number of OPCs, through large scale programmes of education and sur- designated experts within a hospital may take on the veillance. In the United States, an organ procurement role of organ donation representative. system has evolved gradually from an HOPO- to an e. Team or committee responsible for brain death diagno- IOPO-based system. sis: may include two or three medical specialists includ- • Disadvantages: this system may be financially unviable ing a neurologist. or practically inappropriate in countries lacking mul- f. Organ procurement team: transplant surgeons, tiple transplantation centers. physicians, and medical staff of the OPO work in col- • Examples: laboration with each other. A standardized donor – Instituto Nacional Central Unico Coordinador de management protocol, or a Critical Pathway, for or- Ablacio´n e Implante (INCUCAI, Argentina) is gan donation after death is an important tool to en- S98 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

able the work of the organ procurement team and the effective identification of all possible deceased donors (see also Working Group 3).

The Functions of the OPO a. Surveillance: the detection of potential donors needs to occur at every acute hospital. For example, the Donor Action Programme (www.donoraction.org), originat- ing in Europe, is a quality management programme de- signed to maximize the donation potential of hospi- tals by conducting a diagnostic review of practices, including a medical record review and hospital atti- tude survey, enabling hospitals to identify problems FIGURE 8. Key strategies for adoption by Organ Pro- and find solutions (21). curement Organizations (OPOs) to enhance progress to- b. Donor management: the recovery of viable organs for wards self-sufficiency. transplantation is dependent on appropriate medical management both before and after brain death. The medical team managing the potential donor must an- b. Best practice management of potential deceased donors, ticipate and prevent or detect and treat abnormalities through: that can cause circulatory collapse or permanent dam- • Standardization, development, and implementation of age to otherwise transplantable organs, which ulti- critical pathways for donor management; mately make it possible to recover better functioning • A team approach to donor management, including a and multiple organs without loss (22, 23). member of an OPO; c. Procurement: potential donors should be carefully as- • Real-time reporting of the donor’s condition to trans- sessed to exclude contraindications to donation pend- plantation teams preparing for surgery (25). ing the necessary clinical and legal procedures required c. Optimize organ procurement, through: to establish and certify brain death (24). The relatives • will have to be approached and interviewed to obtain Standardization and development of critical pathways for organ procurement; formal consent or to obtain a social history about the • potential donor. Adequate support for the family from Establishing coordination teams for organ procurement in hospitals; trained staff (preferably a procurement coordinator) at • this time is essential; once consent for donation is fi- Use of state-of-the-art systems to find the fastest and nalized, the procurement coordinator manages the most cost-effective ways of sending and organ from clinical care of the donor together with the hospital one city to another (e.g., Multi-Agent System) (26); donor management team. Donor information is pro- d. Support for the expenses for organ removal and trans- vided to the donor allocation center to find a match plantation, through: for the donated organs. The procurement coordina- • Governmental support for management of potential do- tor also coordinates the organ recovery process with nors and expenses incurred in procurement, and sup- the surgical teams and provides follow-up informa- port for necessary hospital infrastructure. Whatever the tion to the donor family. system, it is essential that socioeconomically disad- vantaged persons should not be denied the opportu- Suggestions for Enhancing Progress Toward nity to donate or the ability to access transplantation. Self-Sufficiency Through OPOs (Fig. 8) e. Improved management for the bereaved, through: a. Optimize identification of potential deceased donors, • Aftercare programmes for relatives of donors (especially in the through: early period, using a letter of thanks, reporting of organ shar- • Instituting quality management programmes, as in the ing, etc., may provide great comfort to the bereaved); example of Donor Action (www.donoraction.org); • Commemorative works such as a memorial park, which • Facilitation of the interaction between the OPC and can encourage positive recognition among relatives of transplantation team in local hospitals; donors and the public. • Assisting hospitals to develop systems for flagging po- tential deceased donors; f. Increase organ procurement from marginal donors, • Provision of education for medical staff throughout the through: hospital, in particular in emergency and ICUs; • Maximal use of ECD and DCD donors; • Conducting death audits, healthcare financing adminis- • Utilization of deceased donor organs from potential co- tration, condition of participations, compliance moni- ronial cases (Unexpected deaths with no obvious cause toring, etc; of death require mandatory reporting to coroners in • Providing official recognition and support to hospitals some countries and often require autopsies. However, to achieve high rate of organ donation; organs could be removed by an organ procurement • Use of mandatory reporting for candidate deceased donors. team after reporting to a medical examiner/coroner’s © 2011 Lippincott Williams & Wilkins S99

office, and the report during the process could be ap- oration with a variety of medical teams and individuals proved as an autopsy report). may play multiple roles in the absence of extended sup- port from OPOs. Education efforts should be supported NATIONAL DONATION PROMOTION by promotion of registration of intent to donate after PROGRAMS death. Organ procurement is not just a matter for health au- f. Relationships with the media: establishing good rela- thorities, OPOs, and specific hospital personnel. The entire tions with the media will facilitate the timely release of medical community and society as a whole need to be aware appropriate information and news into the public do- of this challenge and become involved, indirectly or directly, main. Regular meetings with the media will establish in the process of organ procurement (see Working Group 6). relationships that are crucial in the setting of crises and events that may be negatively influenced in the absence Organization of Donation Promotion of clear messages. g. Hotline: a telephone hotline may be helpful in provid- Public awareness of organ donation should be lead by ing information directly to members of the public and the government and its agencies, in collaboration with rele- to medical professionals. vant NGOs. The resulting coalition of different entities should be coordinated at a national level to ensure consis- tency of messages and reliability of information, although HOSPITAL TRANSPLANT PROGRAMS individual organizations should also strive to maintain spon- To contribute to progress toward self-sufficiency, hos- taneity and creativity in their strategic approaches. NGOs pital transplantation programmes should strive to achieve the contributing to donation awareness may have different focus following goals: of interest, yet synergies between them should be encouraged. • Examples of donation promotion programmes func- Enhancement of graft survival, • tioning at a national level include: Donate Life America, an Increased procurement of organs and enhanced utility NGO founded in 1992 to educate the public about organ, of transplanted organs, • eye, and tissue donation; the Korean Donate Life Network Promotion of medical excellence in transplantation and (KodoNet), also an NGO, and; Donate Life Australia (See donation care, • www.donatelife.org.au), a programme funded by the Fed- Promotion of ethical practice in transplantation and eral Australian Government. donation, • Promotion of education and training of transplant The Role and Potential Activities of National professionals. Donation Promotion Programmes Components of Hospital Transplantation a. Publicity: for example, conduct a nationwide organ do- Programmes (Fig. 9) nation campaign regularly, use specification of intent to donate on driver licenses, introduce donor cards, a. Personnel awareness campaigns, or tokens such as an organ dona- • Medical staff: specialist physicians involved in trans- tion ribbon, donor memorial events such as a “national plantation include transplant surgeons, transplantation Donor Day,” construction of monument or memorial physicians, and anesthesiology staff, who are essential park, etc. for successful operation and management of transplan- b. Information: target all media for regular release of pub- tation patients. lic information, using printouts, broadcasting, radio, • Transplantation coordinators: responsible for ensuring and Internet. that all elements of evaluation and postoperative pro- c. Research: seek feedback from living donors and the cesses are in place (28, 29). Transplant Coordinators families of deceased donors. (TCs) also perform the review and updating of hospital d. Acknowledgment: support the family of deceased do- protocols, quality assessment, quality assurance, data nors, recognize their involvement and share stories and collection, and research. The specific duties of the role experiences. vary for each individual center. e. Education: consistency of educational content is essen- tial, as is the evaluation of the efficacy and quality of b. Facilities education programmes. There is a need to dispel myths • Intensive and high dependency care unit: these are and misconceptions about donation after death and to essential, especially for patients who undergo major target the content and delivery of education pro- heart and lung transplants, and also for deceased do- grammes to the specific characteristics of their intended nor management. audience (27). Education should be delivered at the level • Hemodialysis unit: should be available for patients who of schools, the general public, and medical profession- experience delayed renal graft function or other condi- als. Education concerning the importance of organ do- tions with decreased renal function. nation after death should be delivered iteratively as part • Transplantation laboratory: these perform investiga- of health curricular, from elementary to high school, tions to determine donor and recipient compatibility and include education on brain death. Professional ed- for transplantation, including tissue typing between a ucation is especially important for hospital staff work- donor and a recipient and serum screening panel reactive ing in regional areas, where donation occurs in collab- antibody (PRA)/crossmatching, and also monitor S100 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

FIGURE 9. Essential components of hospital transplant programmes.

related infections including cytomegalovirus, Ep- b. A death determination team (30): a death determination stein-Barr virus, BKV, and team (responsible for determining and declaring brain concentration. In addition, pathology laboratory sup- and circulatory death) should be established to ensure that ports the assessment of graft viability/rejection. the independent determination of death of all potential donors occurs in a transparent and ethical manner consis- c. Organ procurement: hospitals have a variable capacity to tent with local brain death legislation. perform organ procurement. Some may have procure- c. Education and quality control: a team should help to ment facilities and staff available, whereas others may be ensure the ongoing education of medical and nursing able to identify and maintain potential donors but not professionals involved in the transplant programme, perform all (or any) types of procurement. For example: monitoring the quality and effectiveness of educational • Germany: hospitals are divided into three categories. activities to ensure maintenance of the highest possible Category A: University Hospital; category B: hospital standards. that has a neurosurgery unit; category C: hospital that d. A public relations team should also assist in education does not have a neurosurgery unit. initiatives aimed at the general public and coordinate • France: donor hospitals are assigned into three types the release of information about local transplant activ- by Agency de la Biomedicine, the body providing ities to the media. national oversight of organ procurement. Type 1: hospital for donor detection; type 2: hospital for or- Strategies for Adoption by Hospital Transplant gan procurement; and type 3: hospital for both organ Programmes to Enhance Progress Toward procurement and transplantation. Self-Sufficiency Hospitals will require different facilities (e.g., laborato- To achieve self-sufficiency, it is important to expand ries, electroencephalogram machines, sample banks) accord- the donor pool and to improve the outcomes for patients. ing to the category into which they fall. Therefore, it is recommended that hospitals consider imple- menting the following strategies: Management of the Hospital Transplant Programme a. The ECD: a major concern regarding ECD kidneys is poor long-term graft survival. However, recent studies For effective management of the various interrelated have showed 5-year graft survival to be comparable with components and potential challenges of providing transplan- standard grafts, although ECD grafts had slightly worse tation services and procuring organs, it is necessary to have a function. Therefore, utilization of ECD is likely to have management team within transplanting hospitals that is re- a role in achieving self-sufficiency. In the United States, sponsible for oversight of the activities of the transplantation a modified allocation policy for deceased donor kidneys programme. This team should work independently from the was put into place in 2002, whereby transplant candi- transplantation and procurement teams to ensure transparency dates are now asked to indicate whether they are willing and efficacy of regulation and oversight. The Director of the to consider ECD kidneys at the time of placement on the Transplantation Center should work closely with other groups waiting list. ECD kidneys are allocated from this sepa- in and outside of the hospital. Management of transplantation rate supplementary list by waiting time, without consid- programmes at the hospital level needs to incorporate: eration of HLA matching, to a preinformed group of a. An ethics committee (Ethics Committee: American candidates (31). In Spain, policy related to the active use Society of Transplant Surgeons; available at: www. of organs from aged donors was established in 1990, asts.org): the hospital ethics committee will consider resulting in donors aged 60ϩ years now accounting for various ethical issues such as the eligibility of living do- 46.6% of all donors. nors, provide oversight of organ allocation, and also b. DCD: there is still a general reluctance to use DCD for guide the implementation of new procedures or prac- kidney donation and transplantation, because of a rela- tices that have ethical implications, such as DCD. tively high incidence of delayed graft function and pri- © 2011 Lippincott Williams & Wilkins S101

mary nonfunction compared with conventional DBD. International Coordination However, optimal organ preservation and careful selec- International coordination is required to facilitate tion of kidneys from DCD may reduce these risks of cross-border exchange of information and research. It also delayed graft function and primary non-function (32). may enable better efficiencies through regional organ sharing programmes that can avoid discard of usable organs and ad- COORDINATION SYSTEMS dress urgent needs most effectively. International coordina- tion and cooperation also has a critical role in addressing the Multiple systems functioning at the local, regional, and problems of organ trafficking and transplant tourism. Exam- national level are involved in the processes of organ dona- ples of international system coordination in organ donation tion and transplantation, and the effective coordination of and transplantation include: these various systems is fundamental to the pursuit of self- sufficiency. Each country needs to have a national organ do- a. EIF (http://www.eurotransplant.org/): EIF is responsible nation and transplantation coordination system that fits with for the mediation of organ donation procedures and the its particular organizational structures and components. Co- allocation of donated organs across Austria, Belgium, ordination may also extend beyond national borders. Croatia, Germany, Luxemburg, The Netherlands, and Slo- venia. This coordination network incorporates all trans- plant hospitals, tissue-typing laboratories, and hospitals Levels of Coordination in Organ Procurement where donations take place in the participating countries. (Fig. 10) The aims of EIF are to: The institutions involved in the process of organ pro- • Achieve optimal use of available donor organs and curement may operate at three different levels of coordina- tissues; tion (national, regional, and local), each of which should be • Secure a transparent and objective allocation system, systematically integrated. based on medical and ethical criteria; • Assess factors influencing waiting-list mortality and a. Local (hospital level): at this level, the coordination of transplant results; organ procurement involves a physician (assisted by • Support donor procurement and increase the supply one or more nurses), who works on a part-time basis in of donor organs and tissues; the hospital and is responsible for detection and evalu- • Promote scientific research; ation of potential donors, and coordinating the entire • Disseminate and implement EU legislation relevant to donation-transplantation process including family ap- transplantation; proach. The physician is in close relationship with the • Promote, support, and coordinate organ donation and transplant team and the OPC and reports directly to transplantation in the broadest sense. the Hospital Director. Most of the physicians in this role are intensivists, but some other specialists might b. Trans Tasman Exchange (http://www.tsanz.com.au/organal be included. locationprotocols/transtasmanexchangeprinciples.asp): The b. Regional level: regional bodies may help to coordinate Trans Tasman agreement between Australia and New Zea- procurement and transplantation at the local level be- land enables the sharing of organs between these nations’ tween individual hospitals and with state, provincial, or respective populations in particular circumstances. The national organizations, particularly in the context of agreement is mutually beneficial, with organs that cannot large populations or geographical boundaries. For ex- be used in one country being offered to the other, and in ample, there is an administrative office for each of the cases of urgent need, the saving of a life is prioritized with- 17 regions in Spain, which together constitute the out concern for individual nationalities. Concern for eq- National Transplant Commission where technical decisions are made and then communicated to a co- ordinator in the relevant hospital. c. National level: each country that performs transplanta- tion needs to organize a unified coordination network that regulates the organ donation and transplantation process. National coordination systems essentially pro- vide a support agency for the entire organ donation and transplantation system. National coordination is con- cerned with organ distribution, transport organization, waiting list maintenance, general and specialized infor- mation, and any policies or actions that can contribute to improved outcomes in the donation transplantation process. This support is of utmost importance for small hospitals that cannot undertake organ donation pro- cesses independently. Quality control for each institu- tion, establishment of allocation rules, collection and FIGURE 10. Three levels of coordination for national or- analysis of national data, education, and certification gan donation and transplantation programmes and respon- for personnel are all coordinated at a national level. sibilities at each level. S102 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

uity is reflected in the distributional methods employed 27. DuBois JM, Anderson EE. Attitudes toward death criteria and organ between the countries. donation among healthcare personnel and the general public. Prog Transplant 2006; 16: 65. 28. Matesanz R, Miranda B, de Felipe C, et al. Ecolucion de la donacion y la REFERENCES actividad transplanstadora en Espana. In: El donante de organos y teji- dos: Evaluacion y manejo. Barcelona, Springer Verlag Iberica 1997. 1. Arnold RM, Siminoff LA, Frader JE. Ethical issues in organ procure- 29. Matesanz R, Dominguez-Gil B. Strategies to optimize deceased organ ment: A review for intensivists. Crit Care Clin 1996; 12: 29. donation. Transplant Rev 2007; 2007: 177. 2. WHO Guiding Principles; WHA 63.22/2010. Available at: http:// 30. Guidelines for the determination of death: report of the medical con- www.who.int/transplantation/en/. sultants on the diagnosis of death to the President’s Commission for 3. Neuberger J, Adams D, MacMaster P, et al. Assessing priorities for the Study of Ethical Problems in Medicine and Biomedical and Behav- allocation of donor liver grafts: survey of public and clinicians. BMJ ioral Research. JAMA 1981; 246: 2184 1998; 317: 172. 31. Merion RM. Expanded criteria donors for kidney transplantation. 4. Rithalia A, McDaid C, Suekarran S, et al. Impact of presumed consent Transplant Proc 2005; 37: 3655. for organ donation on donation rates: A systematic review. BMJ 2009; 32. Steinbrook R. Organ donation after cardiac death. N Engl J Med 2007; 338: a3162. 357: 209. 5. Rithalia A, McDaid C, Suekarran S, et al. A systematic review of pre- 33. Organ Shortage: The Solutions. Proceedings of the 26th Conference on sumed consent systems for deceased organ donation. Health Technol Transplantation and Clinical Immunology, June 13–15, 1994. In: Assess 2009; 13: iii, ix-xi, 1. Touraine JL, Traeger J, Be´tuel H, et al., eds. Dordrecht, Kluwer Aca- 6. Jousset N, Gaudin A, Mauillon D, et al. Organ donation in France: demic Publishers 1995. Legislation, epidemiology and ethical comments. Med Sci Law 2009; 49: 191. 7. Andersen KS, Fox DM. The impact of routine inquiry laws on organ APPENDIX 2: The Critical Pathway for donation. Health Aff (Millwood) 1988; 7: 65. Organ Donation After Death 8. Ross LF, Rubin DT, Siegler M, et al. Ethics of a paired-kidney-exchange program. N Engl J Med 1997; 336: 1752. Assessing the Potential of Donation from 9. U.S.Department of Health and Human Services. The organ donation Deceased Persons and Promoting the breakthrough collaborative: Best practices final report (September Identification of Potential Deceased Organ 2003). Nephrol Nurs J 2003; 30: 529. Donors (Working Group 3) 10. Marks WH, Wagner D, Pearson TC, et al. Organ donation and utiliza- tion, 1995–2004: Entering the collaborative era. Am J Transplant 2006; Self-sufficiency in transplantation is defined as the sat- 6(5 pt 2): 1101. isfaction of the transplantation needs of a given population, 11. Shafer TJ, Wagner D, Chessare J, et al. Organ donation breakthrough by using resources obtained from within that population. collaborative: Increasing organ donation through system redesign. Crit Donation from deceased persons, realized to its maximum Care Nurse 2006; 26: 33, 44; quiz 49. 12. Matesanz R, Marazuela R, Dominguez-Gil B, et al. The 40 donors per therapeutic potential within a given population, is an essen- million population plan: an action plan for improvement of organ tial element of the self-sufficiency paradigm, as already donation and transplantation in Spain. Transplant Proc 2009; 41: 3453. stressed in existing International Standards: 13. Bollinger RR, Heinrichs DR, Seem DL, et al. Organ procurement orga- nization (OPO), best practices. Clin Transplant 2001; 15(suppl 6): 16. • WHO Guiding Principles for Human Cell, Tissue 14. Poli F, Scalamogna M, Cardillo M, et al. An algorithm for cadaver and Organ Transplantation Guiding Principle 3 (1): kidney allocation based on a multivariate analysis of factors impacting on cadaver kidney graft survival and function. Transpl Int 2000; “Donation from deceased persons should be developed to 13(suppl 1): S259. its maximum therapeutic potential” 15. Danovitch GM, Cecka JM. Allocation of deceased donor kidneys: Past, present, and future. Am J Kidney Dis 2003; 42: 882. The principle emphasizes the importance of both tak- 16. Wiesner R, Edwards E, Freeman R, et al. Model for end-stage liver ing the legal and logistical steps needed to develop deceased disease (MELD) and allocation of donor livers. Gastroenterology 2003; donor programmes where they do not exist, and making ex- 124: 91. 17. Coombes JM, Trotter JF. Development of the allocation system for isting programmes as effective and efficient as possible. deceased donor liver transplantation. Clin Med Res 2005; 3: 87. • The Declaration of Istanbul on Organ Trafficking and 18. Jacquelinet C, Audry B, Pessione F, et al. [Rules for allocation of livers for transplantation]. Presse Med 2008; 37: 1782. Transplant Tourism (2): 19. Prottas JM. The organization of organ procurement. J Health Polit “Governments, in collaboration with health-care institu- Policy Law 1989; 14: 41. 20. Matesanz R, Miranda B, Felipe C. Organ procurement and renal trans- tions, professionals, and NGOs, should take appropriate plants in Spain: The impact of transplant coordination. Spanish Na- actions to increase deceased organ donation...In tional Transplant Organization (ONT). Nephrol Dial Transplant 1994; countries without established deceased organ donation 9: 475; discussion 479. or transplantation, national legislation should be enacted 21. Roels L, Cohen B, Gachet C, et al. Joining efforts in tackling the organ that would initiate deceased organ donation and create shortage: The Donor Action experience. Clin Transpl 2002: 111. 22. Frist WH, Fanning WJ. Donor management and matching. Cardiol transplantation infrastructure, so as to fulfill each coun- Clin 1990; 8: 55. try’s deceased donor potential. In all countries in which 23. Wood KE, Becker BN, McCartney JG, et al. Care of the potential organ deceased organ donation has been initiated, the therapeu- donor. N Engl J Med 2004; 351: 2730. tic potential of deceased organ donation and transplanta- 24. Tjabbes H. Donor screening: An overview of current regulation and tion should be maximized.” practices in Europe. Transplant Proc 1996; 28: 2950. 25. DonorNet http://www.donornet2007.net/DonorNet, new webbased application to increase organ placement, launched by UNOS. Trans- A SYSTEMATIC APPROACH TO THE plant News, September 14, 2003; Available at: http://findarticles.com/ PROCESS OF DONATION FROM p/articles/mi_m0YUG/is_17-13/ai_n18617175/ DECEASED PERSONS 26. Moreno A, et al Finding efficient organ transport routes using multi- agent system. Available at: http://citeseerx.ist.psu.edu/viewdoc/ To develop and maximize organ donation activities, an summary?; doi10.1.1.24.3863 organizational approach to donation from deceased persons © 2011 Lippincott Williams & Wilkins S103 should be adopted. Donation from deceased persons is a pro- deaths occurring within a specific setting to identify po- cess (A process is a set of correlated activities, which convert tential donors. an input into an output by generating an added value • A prospective approach, through the systematic identi- [UNIEN ISO 9000:2000]), involving a set of steps at each of fication and referral of persons dying in conditions suit- which losses of potential deceased organ donors can occur. able for organ donation. One of the weakest links of this chain is the failure to identify These strategies have been applied in different settings and subsequently refer potential deceased organ donors. A and have been frequently combined for better estimation of systematic approach to the process of donation from de- the potential of organ donation from deceased persons and ceased persons will help populations to define actions, roles, accurate evaluation of performance. and responsibilities within the process, tailored to their local circumstances. This systematic approach should consider both DBD and DCD. Use of Mortality Data to Estimate the Potential of Donation From Deceased Persons Estimating the Potential of Organ Donation From The use of mortality data is considered an objective, Deceased Persons cheap, and nonlabor intensive approach to the estimation of In the pursuit of self-sufficiency, estimating the poten- the potential of donation from deceased persons. This esti- tial of organ donation from deceased persons within a popu- mation may be based on general mortality data or in-hospital lation is essential. deaths. Some selection criteria may be applied to any of these data, based on the inclusive factors (conditions potentially • It facilitates understanding of the local possibilities for leading to a severe brain injury or circulatory failure) and satisfying the transplantation needs of that population. exclusive factors (absolute medical contraindications to or- • It allows a better comprehension of those factors acting gan donation). These approaches have been used to generate at a hospital, regional, or national level, whatever their nationwide estimations of the potential of donation from de- nature, that affect the potential of donation from de- ceased persons in the United States (5) and the European ceased persons within a given population and hence or- setting (6). gan donation and transplantation outcomes. In the US study, performance was evaluated for each • It is crucial to evaluate performance in the process of of the different UNOS regions based on Donor Extraction donation from deceased persons within a specific geo- Rate, calculated as the number of actual donors aged 1 to graphical location, at a hospital, a regional, or a country 65 years over the number of evaluable deaths (in-hospital level. Performance evaluation is necessary to formulate deaths for ages 1 to 65 years, not medically unsuitable, relevant policies and standards of practice and to discern based on the ICD-9 codes). Notably, results of this study achievable goals for organ donation programmes, were comparable with previous approaches based on a de- through the identification of the best performers and tailed review of medical records of in-hospital deaths (5). critical success factors (benchmarking), and evaluation Coppen et al. recently compared the performance of de- of the effectiveness of implemented strategies. ceased donation processes across several European coun- tries, based on the calculation of ‘Donor Efficiency Rate Evaluation of performance in organ donation, espe- per Proxy’ (actual donors vs. deaths because of cardiovas- cially when comparing countries or regions, has been classi- cular and traffic accidents), as the rate of mortality because cally addressed by comparing numbers of deceased donors of these causes was found to bear a high correlation with per million population. This is a universal, objective, and deceased donation activity (6). easy-to-construct metric of performance. However, it has However, attempts to work with mortality data face been considered flawed, because it assumes that the potential several limitations given that these data are usually not of organ donation from deceased persons is uniform across readily available, death certificate data are restricted by the all jurisdictions under assessment. It fails to capture perfor- inherent problems of underreporting and codification er- mance in the context of rates of mortality under conditions rors, and codification of deaths is not a universally imple- suitable for organ donation. Many local factors will affect this mented practice. final number, including demography, mortality in the con- text of brain injury, accessibility to the hospital, cultural, Prospective Identification and Referral of healthcare system, and organizational factors, among others Potential Donors and Clinical Chart Review (3, 4). Even when severely brain damaged patients are able to Studies of donation potential, based on prospective access a hospital, many other factors will determine whether, identification or clinical chart review, have been performed in if the person finally dies, this occurs under conditions suitable several countries and enable a good comprehension of de- for organ donation. Such factors include, for example, the ceased donation performance in those settings for which es- sufficient availability of intensive care resources or variability timates are available (Fig. 11). in clinical practice in the treatment of neurocritical patients Both methodologies (prospective identification of and in terminal care. potential donors and clinical chart reviews) have the ad- When estimating the potential of organ donation from vantages of being sensitive to local variation in factors that deceased persons, two different, although potentially com- affect the potential of donation in a given population, al- plementary, approaches may be adopted: lowing analysis of an individual’s suitability for organ • A retrospective approach, based on the analysis of mor- donation, and facilitating the identification of areas for tality data or, ideally, through a clinical chart review of improvement in deceased donation processes. However, S104 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

FIGURE 11. Countries with published information on the potential of deceased donation, estimated through prospective identification-referral or clinical chart review (13-33). the fact that these methodologies are not standardized at a actual donors (3). Eligible deaths are communicated prospec- universal level limits international comparisons of de- tively from hospitals to OPOs by self-report, potentially in- ceased donor potential. Table 6 describes in detail the troducing bias because of an underreporting. To gain a better design of a selection of international studies estimating understanding of overall performance, Ojo et al. (3) proposed national donation potential. Notably, the definition of a a complementary Notification Rate metric, according to potential donor varies greatly between these studies. In which the number of eligible deaths was to be compared addition, most of these studies are based on a self-report- against the number of notifiable deaths, this number being ing, prospectively or retrospectively, performed by profes- estimated on the basis of in-hospital mortality data with some sionals in charge of the process of donation from deceased inclusive and exclusive factors (through the analysis of ICD-9 persons. Hence, estimates of donation potential rely on the codes) as mentioned earlier. degree of referral and identification of potential donors, Clinical chart review of deceased persons within a par- which may vary depending on the motivation and experi- ticular setting is considered the gold standard for accuracy in ence of the health professional in charge. Constructing the assessment of donation potential, especially if performed combined indicators of potential of donation from de- by external observers. However, it has been considered costly ceased persons, based on self-reported data on one hand and time consuming by some commentators. Others have and mortality data on the other hand, has been proposed as recommended the systematic and routine performance of a good approach for a more realistic comprehension of the clinical chart reviews by those professionals in charge of the potential of donation and as a metric of performance in deceased donation process, as an essential tool for a continuous donor identification (7). improvement in performance (8, 9). Quality assurance pro- As an example of the application of these methods in grammes based on this approach have been developed in differ- programme evaluation, the performance of different OPOs in ent countries and are considered an essential element of success the United States is evaluated according to Donation Rate, in many models (10). Based largely on self-report, information whereby the number of actual donors meeting a set of eligi- provided by these quality assurance programmes may be com- bility criteria is compared with the number of eligible deaths plemented by external audits of centers or by the construction of (Յ70 years, ultimately legally declared brain dead and with indicators, which combine information collected based on self- no medical contraindications to organ donation). This metric reporting methods with mortality data. represents the performance of a particular OPO with respect Given wide international variation in approaches to or- to the conversion of potential donors, once identified, into gan donation processes, the provision of an internationally © 2011 Lippincott Williams & Wilkins S105

will facilitate the development of consistent, integrated orga- TABLE 6. National estimations of the potential of donation based on the prospective identification and nizational approaches to organ donation, and thus advance referral of potential donors or on a clinical chart review the pursuit of self-sufficiency worldwide. Moreover, com- mon international approaches to donation processes and Ploeg, The Netherlands (29) their evaluation will help to overcome the inherent difficul- Scope 11 hospitals (convenient selection ties of international comparisons, needed for transparency of of different types of hospitals) practices and outcomes, international benchmarking, and Design Prospective assessment mutual learning. Data collection Performed by Physicians declaring death Performed on Hospital deaths THE CRITICAL PATHWAY FOR ORGAN Definition of a potential No MC, below an age threshold DONATION FROM DECEASED PERSONS donor (maximum); diagnosis possibly Objectives leading to BD (optimistic); The principal objective of a Critical Pathway ap- artificial ventilation; and BD declared (realistic) proach to the process of donation from deceased persons is to facilitate the development, and progressive increase, of Inferred national estimates Actual donors, consented donors, and number of hospitals of deceased donation activities globally. This objective is cen- each type tral to the broader goal of self-sufficiency in transplanta- Sheehy, United States (12) tion and may be broken down into the following specific objectives: Scope 25–36 OPOs (convenient selection) a. To provide a common systematic approach to the pro- Design Retrospective clinical chart review cess of donation from deceased persons, both for DBD Data collection and DCD; Performed by Trained staff members of OPOs b. To create common triggers to facilitate the prospective Performed on ICU deaths identification and referral of the potential deceased or- Definition of a potential No absolute MC, aged Յ70 years gan donor and precipitate the deceased donation pro- donor and met criteria for BD cess (action); Inferred national estimates Actual donors, population c. To provide common procedures to estimate the poten- tial of organ donation from deceased persons and to Barber, United Kingdom (14) evaluate performance in the process of donation after Scope All ICU with a potential for DBD death (assessment). Design Retrospective Data collection Methodology Performed by Donor transplant To achieve the objectives above, TTS, WHO, and coordinators/donor liaison nurses/ ONT convened a group of experts, widely representative of some ICU link nurses the different WHO regions, on three different occasions Performed on ICU deaths (Sydney, Australia, August 2008; Geneva, Switzerland, Definition of a potential donor No absolute MC and brain stem March 2009; and Berlin, Germany, October 2009), to draft death declared a Global Consensus Document providing specific recom- Inferred national estimates — mendations in this regard. This draft was finalized during QAP, Spain (2007)a the Third WHO Global Consultation on Organ Donation Scope Donor hospitals (75%, and Transplantation (Madrid, Spain, March 2010) by convenient selection) Working Group 3. Design Retrospective The guidelines provided to the group for the construc- Data collection tion of these recommendations were: Performed by Transplant coordinators a. Recommendations were to be based on the current sci- Performed on ICU deaths entific knowledge, experience from existing running Definition of a potential donor No MC and met criteria for BD procedures and systems, interaction, mutual learning, Inferred national estimates Actual donors and agreement between the different countries; b. Recommendations were to be conceived in a way that a Quality assurance programme in the deceased donation process. ONT website. the methodology should be applicable to every country MC, medical contraindications; BD, brain death; OPO, organ procurement or region, regardless of the level of development of its organization; ICU, intensive care unit; DBD, donation after brain death. healthcare system or the baseline situation of its de- ceased donation activity. During the past year, the draft recommendations with applicable reference framework for systematizing donation regards to the structure of the deceased donation process, from deceased persons, together with guidelines for interna- assessment of the potential of donation from deceased per- tionally consistent methods and metrics for estimation of do- sons, and provision of clinical triggers for the identification nation potential and evaluation of donation performance, and referral of potential donors have been piloted in different S106 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011 settings—India (Dr. Vivekanand Jha), Russia (Dr. Marina suitable for organ donation and is declared dead Minina), Saudi Arabia (Dr. Faisal Shaheen), and South Africa based on neurologic criteria, as stipulated by the law (Dr. Elmi Muller). These pilot experiences have shown the of the relevant jurisdiction. Regarding medical suit- recommendations to be applicable and beneficial in each of ability, it should be acknowledged that medical con- the settings in which they were applied, with increases ditions precluding organ donation might vary be- demonstrated in the identification and referral of potential tween countries according to legal and technical deceased organ donors as a result of implementation. The provisions. The reasons why a potential DBD does not outcomes of these pilot experiences were presented during become eligible for donation might be the following: the combined ISODP-ETCO congress, celebrated in Berlin in (1) failure to identify and subsequently refer the case October 2009. (if this is the point for referral, according to local circumstances); (2) presence of medical conditions precluding organ donation; (3) the diagnosis of brain Recommended Structure for the Process of death cannot be confirmed or completed (i.e., because of Deceased Donation: The Critical Pathway the lack of technical or human resources necessary for con- The process of organ donation from deceased persons firmation); or (4) hemodynamic instability leading to an defined in this project is described under The Critical Path- anticipated cardiac arrest. The three last situations could way for organ donation. Pathways are described for both still be linked to the possibility of controlled or uncon- DBD and DCD. trolled DCD. The process of organ donation from deceased persons • An eligible DBD would become an actual donor after brain developed by the work group is graphically represented in death only after consent has been obtained for organ dona- Figure 2. The processes of DBD and DCD are described tion. Two possible situations define the actual DBD. The below: first situation would be that in which an operating incision has been made with the intent of organ recovery for the a. Possible deceased organ donor purpose of transplantation. In the second situation, the • A possible deceased organ donor is defined as the patient condition of actual donation would be defined when with a devastating brain injury or lesion or the patient at least one organ has been recovered for transplanta- with circulatory failure and apparently medically suit- tion purposes. The evolution from eligible to actual do- able for organ donation nor entails the need to obtain permission for organ do- • Identification of the possible deceased donor and re- nation, although such permission might have been ferral by the treating physician to a key donation per- obtained at an earlier stage during the process, accord- son/OPO should ideally occur as early as possible in ing to the legal framework and practical provisions in the process. For example, in the United States, each place. Also, according to local circumstances, permis- imminent death should be referred to the OPO for sion might be based on the expression of the deceased assessment (where imminent may be understood as during his/her lifetime (i.e., through a specific regis- the time of transition between therapeutic treatments try) or might be obtained from their relatives. Autho- to end-of-life care). However, referral of the possible rization by a coroner or other judicial officer to allow donor might not be acceptable in all local circumstances donation for forensic reasons, if applicable, might also be needed at a certain point. Continuous evalua- (i.e., many countries do not find it acceptable to refer pos- tion of medical suitability for organ donation, hemo- sible donors where death has not yet been established). dynamic maintenance of the donor, organ allocation, Hence, it is accepted that referral might occur later on in and the finally surgical incision and organ recovery the process of donation from deceased persons. It should are all necessary steps in the transition from eligible to be pointed out that referral is understood as the action of actual DBD. Losses because of maintenance problems making the key donation person/OPO aware of the pos- would still be linked to the possibility of uncontrolled sibility of deceased donation, but it does not mean DCD. any other subsequent action. Referral requires, and is • Finally, a utilized donor after brain death would be linked to, the act of identification. the actual DBD from whom at least one organ has • The possible deceased organ donor when defined as the been transplanted, followed by organ allocation and patient with a devastating brain injury represents the com- transplantation itself. Organ damage during recovery, mon starting point of two different pathways that activate anatomical, histologic and functional abnormalities depending on evolution and clinical practice: the process of of the organs detected during or after recovery, inad- DBD and the process of DCD. The possible donor defined equate perfusion/thrombosis of the organs, logistical as the patient with circulatory failure might be the starting problems, and lack of an appropriate recipient are the point of the process of DCD. categorical reasons why an actual DBD does not be- come a utilized DBD. b. The process of DBD • A potential donor after brain death (DBD) is defined as b. The process of DCD a person whose clinical condition is suspected to fulfill • Two conditions deriving from the possible deceased organ brain death criteria. donor could define the potential donor after circulatory • A potential DBD would become an eligible donor af- death. A person whose circulatory and respiratory func- ter brain death if the person is considered medically tions have ceased and in whom resuscitative measures are © 2011 Lippincott Williams & Wilkins S107

not to be attempted or continued would define the first of When should the referral occur? these two conditions. DCD under these particular cir- • For DBD: at a minimum, when the Critical Pathway es- cumstances is so far limited to some specific countries tablishes an eligible donor. (i.e., France, Spain), although possible to be devel- • For DCD: at a minimum, when the Critical Pathway oped in many other settings. identifies a potential donor. • The second condition defining a potential donor after cir- • For DBD and DCD: referral could also occur when the culatory death would be that of the patient in whom the Critical Pathway establishes a possible donor; or cessation of circulatory and respiratory functions is antici- • Referral may also occur when the family requests to pated to occur within a time frame that will enable organ speak with the OPO/key organ donation personnel. recovery. This situation usually applies when withdrawal of life-supporting therapy has been decided on the basis of the ominous prognosis of the patient, pursuant to the family decision, or the request of the family. It should be pointed RECOMMENDED METHODOLOGY FOR out that there are an additional small number of patients THE RETROSPECTIVE ASSESSMENT OF who would fulfill these criteria of potential DCD but with- THE POTENTIAL OF ORGAN DONATION out brain injury, that is, end-stage lung disease patients FROM DECEASED PERSONS with elective withdrawal of ventilatory support or patients Retrospective assessment of the potential of organ with progressive neurodegenerative diseases such as amyo- donation from deceased persons for the purposes of pro- trophic lateral sclerosis with elective withdrawal of life-sus- gramme evaluation must consider all possible donors, po- taining therapy. tential donors, and eligible donors. The basic methodology • A potential DCD would become an eligible donor after for such estimations is based on coded mortality data or circulatory death when the person is considered medically clinical chart review. suitable for donation and has been declared dead based on the irreversible absence of circulatory and respiratory func- Estimating the Number of Possible Deceased tions as stipulated by the law of the relevant jurisdiction, Organ Donors within a time frame that enables organ recovery. The steps The number of possible deceased organ donors, par- required for a potential DCD becoming an eligible DCD ticularly those with a devastating brain injury, may be es- would be: (1) the identification and subsequent referral of timated from the analysis of coded mortality data. This the case for organ donation (if not previously performed); coded mortality data would identify those deaths most (2) the declaration of death by circulatory and respiratory likely to become donor candidates or would identify de- criteria within an appropriate time frame that allows organ ceased patients with a diagnostic code consistent with recovery, (3) the consent to proceed with organ recovery brain injury or lesion. (this may occur before or during the process according to On the basis of mortality data, therefore, the possible local legislation), and (4) evaluation of the medical suitabil- deceased organ donor would be identified as a person dying ity for donation. within a hospital with primary or secondary brain damage, • An eligible DCD would become an actual donor after cir- defined by the presence of at least one of the ICD codes rep- culatory death if an incision has been made for resented in Table 7 among their primary and secondary diag- organ recovery and at least one solid organ has been recov- noses (7). Alternatives to this codified mortality system have ered for the purpose of transplantation. This requires at been applied in other countries (e.g., death with acute cere- least continuous medical evaluation, organ allocation and bral lesion in Italy). recovery. Reasons why an eligible DCD does not become Estimating the number of possible deceased organ donors an actual DCD are as for the process of DBD. on the basis of codified mortality data has the following caveats: • A utilized donor after circulatory death is defined as the • Persons dying with primary or secondary brain dam- actual DCD from whom at least one organ has been trans- age may have not died as a consequence of the brain planted. Organ allocation and transplantation are the con- injury; version steps in this process. The same categorical reasons • The ICD system is not universally applied in all the coun- as those described for the process of DBD justify that an tries, regions, or hospitals, or in all critical care units; actual DCD not be converted to a utilized DCD. • Coded mortality data are not readily available; Recommendations for the Prospective • Contrary to clinical chart review, it does not allow the Identification and Referral of the Potential complementary analysis of the particular reasons why Deceased Organ Donor a potential donor did not become an actual donor, Identification and referral of the potential deceased organ thus mortality data have limited usefulness as a tool donor is one of the most critical steps in the realization of dona- for the evaluation of the performance of deceased do- tion after death. Identification of a potential deceased organ do- nation programmes. nor should be inherently linked to the act of referral to a key donation person/transplant coordinator/OPO specifically ap- Estimating the Number of Potential and Eligible pointed for the activation of the deceased donation process. The Deceased Organ Donors After Brain Death act of referral means informing these key organ donation per- The number of potential and eligible donors, in contrast, sonnel of an individual that could be a possible, a potential or an is necessarily obtained from a clinical chart review. The most eligible organ donor, according to the pathway described above. critical aspect of estimating the number of potential and eligible S108 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

TABLE 7. ICD-9 codes representing the most frequent RECOMMENDATIONS FOR THE causes of brain death EVALUATION OF THE PERFORMANCE IN THE DECEASED DONATION PROCESS ICD-9 Description This section intends to provide a set of definitions and Cranioencephalic traumatisms metrics that represent performance in the deceased donation 800 Fracture of vault of skull process. These metrics, which describe the overall perfor- 801 Fracture of base of skull mance of the system, will facilitate the identification of critical 803 Other and unqualified skull fractures success factors. 804 Multiple fractures involving skull or face with other bones Suggested Additional Definitions 850 Concussion a. Multiorgan donors: donors from whom at least two dif- 851 Cerebral laceration and contusion ferent types of organs have been recovered for the purpose 852 Subarachnoid, subdural, and extradural of transplantation as a solid organ. hemorrhage after injury b. Organs recovered per donor: number of different organs that 853 Other and unspecified intracranial have been recovered from actual donors. To calculate the num- hemorrhage after injury ber of organs recovered, only organs recovered with the inten- 854 Intracranial injury of other and tion of transplantation as a solid organ should be counted. unspecified natures • Number of kidneys recovered: double procurement, 2; Cerebrovascular accidents single procurement, 1. 430 Subarachnoid hemorrhage • Number of livers recovered: exclude if the intention of 431 Intracerebral hemorrhage recovery is not transplantation as a solid organ (i.e., 432 Other and unspecified intracranial hepatocytes). hemorrhage • Number of hearts recovered: exclude if the intention of 433 Occlusion and stenosis of precerebral recovery is not transplantation as a solid organ (i.e., arteries heart valves). 434 Occlusion of cerebral arteries • Number of lungs recovered: double procurement, 2; 436 Acute, but ill-defined, cerebrovascular single procurement, 1. disease • Number of pancreas recovered: exclude if the intention of re- Tumors of the central nervous system covery is not transplantation as a solid organ (i.e., islets). • 191 Malignant neoplasm of brain Number of small bowel procured. 192 Malignant neoplasm of other and c. Organs transplanted per donor: number of different or- unspecified parts of nervous system gans that have been transplanted from actual donors. To 225 Benign neoplasm of brain and other parts calculate the number of organs transplanted, only solid of nervous system organs should be counted. Cerebral anoxia • Number of kidneys transplanted: double transplanta- 348.1 Anoxic brain damage tion, 2; single transplantation, 1. ICD, international classification of disease. • Number of livers transplanted: count one, regardless of specific use of the organ (i.e., split liver transplantation). • Number of hearts transplanted. • Number of lungs transplanted: double transplantation, 2; single transplantation, 1. deceased donors in a particular setting is the evaluation of brain • Number of pancreas transplanted. death, in particular with regard to the identification of the clini- • Number of small bowel transplanted. cal condition of brain death (there is at least one physical exam- ination compatible with brain death) and the declaration of Suggested Metrics of Performance brain death (the diagnosis of brain death has been completed Performance in the deceased donation process may be according to international standards and legally declared). How- represented as indicated in Table 9. ever, as clinical chart review relies on the recording of complete and reliable chart data, for the purposes of appraising whether a Representing Performance at a Regional or at a person fulfils the criteria of brain death, it would be necessary to Country Level According to Different agree on standard minimum data requirements for hospital Availability of Data charts. Two examples of minimum data requirements are pro- The number of possible donors at a regional/country level vided below ([12]; methodology of the Spanish Quality Assur- may be estimated based on a top-down approach to infer the ance Programme in the donation process). performance of the deceased donation processes for a given re- gion or country. Possible methodologies are described below: Metrics to Represent the Potential of Donation a. Living population : deaths within the country/region. Proposed metrics by which to perform comparisons of b. Deaths within the country/region because of selected the potential of donation from deceased persons are outlined pathologies: (crude) deaths because of cerebrovascular in Table 8. accidents and traffic accidents. © 2011 Lippincott Williams & Wilkins S109

Criteria applied by Sheehy et al. to the potential donor after brain death (12): A deceased person for whom evidence of all or any of the following is found in the hospital chart: the absence of spontaneous respiration and two additional brain-stem reflexes, a physician’s note declaring brain death, a flat electroencephalogram, or other brain studies indicating irreversible destruction of the brain.

Criteria applied at the Spanish Quality Assurance Programme in the deceased donation process Four concepts are applied: confirmed brain death, highly probable brain death, possible brain death, and not assessable brain death. 1. Confirmed brain death: For the purposes of the programme, a person will be considered as a confirmed brain death if any of the following circumstances are present: a. All legal requirements are properly reflected in the chart. b. A neurologist or neurosurgeon has explored the dead person and has recorded that brain death has occurred and there is no evidence against this diagnosis. c. ICU physician has recorded that brain death has occurred and there is no evidence against this diagnosis. To define a person as being a highly probable or a possible brain death, the following issues are considered based on the available information in the clinical chart: a. Etiology of the process causing death: It must be one of the known etiologies that cause brain death and must be severe enough to cause it. b. Conditions: absence or no evidence of spontaneous breathing and movements. c. Findings in clinical exploration: • Progressing nonreactive midriasis (de novo nonreactive midriasis in a patient with severe neurologic pathology, in the context of a severe clinical deterioration and which is not explained by drug interference) • Absence of at least one of the following brain-stem reflexes: corneal, oculocephalic, oculovestibular, coughing, and gag. • Negative atropine test. d. Clinical signs: • Abrupt arterial hypotension, other causes apart from brain death having been discarded. • Abrupt polyuria, other causes having been discarded. • Refractory and progressive intracranial hypertension (intracranial hypertension which progresses in the minutes or hours before death, towards limits that provoke a cerebral perfusion pressure of 0 or close to 0 mm Hg, with no response to therapy). 2. Highly probable brain death: Etiology + conditions + 1 finding (at least) in clinical exploration + 1 clinical sign (at least) Etiology + conditions + 2 findings (at least) in clinical exploration 3. Possible brain death: Etiology + conditions + 1 finding in clinical exploration (at least) Etiology + conditions + 1 clinical sign (at least) 4. Finally, brain death will not be assessable in any of the following circumstances: a. Etiology of the process is known, severe and consistent with brain death, in the absence of any more information in the clinical chart or absence of clinical chart. b. Etiology of the process is known, severe, and can lead to brain death, but diagnosis could not be confirmed because of a limitation of the therapeutic effort. c. Etiology of the process is known, severe, and can lead to brain death, but exposure to barbiturics, muscle relaxant drugs at the moment of cardiac arrest is present. d. Infratentorial processes with no legal diagnosis of brain death. Any other situation will be considered as no brain death.

TABLE 8. Proposed metrics to represent the potential TABLE 9. Indicators of performance in the deceased of donation donation process Possible deceased organ donors/hospital deathsϫ100 Actual donors/possible donorsϫ100 Potential donors after brain death/possible deceased organ Actual donors/potential donorsϫ100 donorsϫ100 Actual donors/eligible donorsϫ100 Potential donors after circulatory death/possible deceased organ Multiorgan donors/actual donorsϫ100 ϫ donors 100 Utilized donors/actual donorsϫ100 Potential donors after circulatory death/potential donors after Organs recovered/donor brain deathϫ100 Organs transplanted/donor S110 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

c. In-hospital deaths within the country/region. 14. Barber K, Falvey S, Hamilton C, et al. Potential for organ donation in d. In-hospital deaths within the country/region because of the United Kingdom: Audit of intensive care records. BMJ 2006; 332: selected pathologies: In-hospital deaths with brain in- 1124. 15. Bednarek T. [Application of the donor action program to assess the jury, on the basis of at least one of the ICD-9 codes donating potential of the intensive care unit at the hospital in specified in Table 7 among their primary and secondary Kołobrzeg]. Ann Acad Med Stetin 2004; 50: 11. diagnosis (i.e., possible deceased organ donors). 16. Broomberg CJ, McCurdie FJ, Kahn D. Prospective audit of deaths at a teaching hospital. Transplant Proc 2005; 37: 556. The number of potential and eligible donors for a given 17. Bustos JL, Surt K, Soratti C. Glasgow coma scale 7 or less surveillance region or country could be estimated for countries in which a clin- program for brain death identification in Argentina: Epidemiology and ical chart review is performed at all hospitals meeting some specific outcome. Transplant Proc 2006; 38: 3697. criteria (acute care hospitals, hospitals authorized for organ pro- 18. Christiansen CL, Gortmaker SL, Williams JM, et al. A method for esti- mating solid organ donor potential by organ procurement region. Am J curement). In addition, if information is not available for all Public Health 1998; 88: 1645. hospitals meeting some specific criteria, estimation might 19. Cloutier R, Baran D, Morin JE, et al. Brain death diagnoses and evalu- be performed for a given region/country by inference ac- ation of the number of potential organ donors in Quebec hospitals. Can cording to a given parameter. J Anaesth 2006; 53: 716. 20. Cuende N, Can˜o´n JF, Alonso M, et al. 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GLOSSARY OF TERMS Actual deceased organ Deceased person in whom an operative incision was made with the intent of organ recovery for the purpose of donor transplantation or from whom at least one organ was recovered for the purpose of transplantation (see Critical Pathway) Critical Pathway Working Group, Madrid Consultation Allocation The assignment of human cells, tissues, and organs to a transplant candidate, based on a set of rules WHO Glossary Authorization Authorization, accreditation, designation, licensing or registration, depending on the concepts used and the practices in place in each jurisdiction Adapted from EU Directive 2010 Bank See tissue establishment Brain death Irreversible cessation of cerebral and brain stem function; characterized by absence of electrical activity in the brain, blood flow to the brain, and brain function as determined by clinical assessment of responses. A brain dead person is dead, although his or her cardiopulmonary functioning may be artificially maintained for some time Glossary of UNOS Bridge therapy See organ replacement therapy Certification of death Formal standardization documentation of death WHO Glossary Circulatory death Death resulting from the irreversible cessation of circulatory and respiratory function; an individual who is declared dead by circulatory and respiratory criteria may donate tissues and organs for transplantation Adapted from the WHO Glossary Consent to donation Legally valid permission for removal of human cells, tissues, and organs for transplantation WHO Glossary Death diagnosis Confirmation of death from evidence acquired through clinical investigation or examination, meeting criteria of brain or circulatory death WHO Glossary Distribution Transportation and delivery of cells, tissues or organs intended for human applications, after they have been allocated WHO Glossary Donation Donating human cells, tissues or organs intended for human applications WHO Glossary Donor A human being, living or deceased, who is a source of cells, tissues or organs for the purpose of transplantation WHO Glossary Donor characterization The collection of the relevant information on the characteristics of the donor needed to evaluate his or her suitability for organ donation, in order to undertake a proper risk assessment and minimize the risks for the recipient, and optimize organ allocation EU Directive 2010 Donor evaluation The procedure of determining the suitability of a potential donor, living or deceased, to donate WHO Glossary Donor maintenance The process and critical pathways used to medically care for donors in order to keep their organs viable until organ recovery can occur WHO Glossary Donor safety A minimization of living donor complications or adverse reactions related to donation WHO Glossary Eligible deceased organ A medically suitable person who has been declared dead as stipulated by the law of the relevant jurisdiction, donor based on neurologic criteria or based on the irreversible absence of circulatory and respiratory functions within a time frame that enables organ recovery (see Critical Pathway) Critical Pathway Working Group, Madrid Consultation Ethics committee Committee charged with considering ethical issues related to the process of organ procurement, distribution, transplantation, pre-donation and post-donation, and transplantation care and research for cells, tissues and organs. Such a committee should be at a national level but can also be at a regional or local level WHO Glossary Explicit consent Legally valid permission for removal of human cells, tissues and organs for transplantation, otherwise known as “opting in” WHO Glossary (Continued) S112 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

GLOSSARY OF TERMS Continued Exported/export Human bodies, body parts, cells, tissues or organs for human application, legally procured inside of the national boundary and transported to another country where it is to be further processed or used. Export must be according to local (exporting country) laws, international laws and conventions and receiving country laws WHO Glossary Follow-up Subsequent examinations of a patient, living donor, or recipient, for the purpose of monitoring the results of the donation or transplant, care maintenance and initiating post-donation or post-transplantation interventions WHO Glossary Human cells and tissues Articles containing or consisting of human cells and/or tissues that are intended for implantation, transplantation, for transplantation infusion, or transfer into a human recipient. Examples include, but are not limited to, musculoskeletal tissue (bone, cartilage, and meniscus), skin, soft tissue (tendons, ligaments, nerves, dura mater, fascia lata and amniotic membrane), cardiovascular tissue (heart valves, arteries and veins), ocular tissue (corneas and sclera), bone marrow and hematopoetic stem/progenitor cells derived from peripheral and cord blood and stem cells of any tissue, and reproductive cells/tissues. The following articles are not included in HCTT 1. Vascularized human organs 2. Whole blood or blood components or blood derivative products 3. Secreted or extracted human products, specifically milk, collagen, and cell factors; Cells, tissues and organs derived from animals other than humans WHO Glossary Imported/import Human bodies, body parts, cells, tissues and organs for human application, legally procured outside of the national boundary to which it has been transported for use. Importation must be according to local (receiving country) laws and conventions and supplying country laws WHO Glossary Incompetent person An individual who is unable to make legally valid decisions or is deprived of his or her capacity to decide and/ or understand the implications of his or her actions (e.g., a minor or individual legally declared unable to manage their own affairs) WHO Glossary Living donor A living human being from whom cells, tissues or organs have been removed for the purpose of transplantation. A living donor has one of three possible relationships with the recipient: A/Related 1. Genetically related i. First-degree genetic relative: parent, sibling, offspring ii. Second-degree genetic relative: grandparent, grandchild, aunt, uncle, niece, nephew iii. Other than first- or second-degree relative; for example cousin; 2. Emotionally related: spouse (if not genetically related), in-laws, adopted, friend B/Unrelated: not genetically or emotionally related WHO Glossary Opt-in system See Explicit consent Opt-out system See Presumed consent Organ Differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularization and capacity to develop physiological functions with an important level of autonomy EU Directive 2004 Organ characterization The collection of the relevant information on the characteristics of the organ needed to evaluate its suitability, in order to undertake a proper risk assessment and minimize the risks for the recipient, and optimize organ allocation EU Directive 2010 Organ exchange A non-profit organization, whether public or private, dedicated to national and cross-border organ exchange organization Adapted from EU Directive 2010 Organ replacement Medical treatment for the purpose of prolonging life in the event of end-stage organ failure, including therapy transplantation, renal dialysis, left ventricular assist device, etc. Also called “bridge therapy” where the intention is to sustain life in preparation for transplantation Editorial Group, Madrid Consultation Possible deceased organ A patient with a devastating brain injury or lesion or a patient with circulatory failure who is apparently donor medically suitable for organ donation (see critical pathway) Critical Pathway Working Group, Madrid Consultation Potential deceased A person whose clinical condition is suspected to fulfill brain death criteria or a person whose circulatory and organ donor respiratory functions have ceased and resuscitative measures are not to be attempted or continued or a person in whom the cessation of circulatory and respiratory functions is anticipated to occur within a time frame that will enable organ recovery (see critical pathway) Critical Pathway Working Group, Madrid Consultation (Continued) © 2011 Lippincott Williams & Wilkins S113

GLOSSARY OF TERMS Continued Preemptive The transplantation of an organ to a recipient who has not yet lost all function of that organ and is not transplantation receiving another form of organ replacement therapy, but for whom end-stage organ failure is imminent Editorial Group, Madrid Consultation Preservation The use of chemical agents, alterations in environmental conditions, or other means to prevent or retard biological or physical deterioration of organs from procurement to transplantation EU Directive 2010 Presumed consent Legally valid presumption of permission for removal of cells, tissues and organs for transplantation, in the absence of individual pre-stated refusal of permission. Otherwise known as “opting out” WHO Glossary Processing All operations involved in the preparation, manipulation, preservation and packaging of cells or tissues intended for human application EU Directive 2004 Procurement The process that includes donor identification, evaluation, obtaining consent for donation, donor maintenance and retrieval of cells, tissues, or organs WHO Glossary Procurement Any organization that undertakes or coordinates the procurement of human organs and is authorized to do so organization by the relevant authority Adapted from EU Directive 2010 Recipient The human being into whom allogenic human cells, tissues or organs were transplanted WHO Glossary Regulatory oversight The management or supervision of a group by an outside body in order to control or direct according to rule, principle, or law WHO Glossary Reimbursement Compensation for the costs involved in making donations, including medical expenses and loss of earnings for live donors, on the basis of reasonable and verifiable claims Editorial Group, Madrid Consultation Retrieval or recovery The procedure of removing cells, tissues or organs from a donor for the purpose of transplantation WHO Glossary Self-sufficiency Self-sufficiency in organ donation and transplantation means equitably meeting the transplantation needs of a given population, using resources from within that population or through regional cooperation as required Editorial Group, Madrid Consultation Serious adverse event Any untoward occurrence associated with the procurement, testing, processing, storage, distribution, transplantation procedure itself, or post-transplantation management procedure of cells, tissues, and organs that might lead to the transmission of a communicable disease, to death or life threatening, disabling, or incapacitating conditions for patients or which might result in, or prolong, hospitalization or morbidity WHO Glossary Serious adverse reaction An unintended response, including a communicable disease, in the donor or in the recipient, associated with the procurement, the transplantation procedure itself or post-transplantation management procedure in the human application of cells, tissues, and organs that is fatal, life threatening, disabling, incapacitating or which results in, or prolongs, hospitalization or morbidity WHO Glossary Split liver A split liver transplant is defined when a donor liver is divided into parts and transplanted into more than one recipient WHO Glossary Storage The maintenance of donor cells, tissues or organs under appropriate controlled conditions until transplantation or disposal WHO Glossary Surveillance The systematic ongoing collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary International Health Regulations 2005 Surveillance system (for An established process at a local, regional or national level for the reporting of serious adverse events, serious human cells, tissues and adverse reactions or complications related to donation, and transplantation of cells, tissues, and organs organs for transplantation) WHO Glossary Time on waiting list The time from placement on the waiting list for a transplant until the date of reporting (of a transplant) or until removal (from the waiting list) WHO Glossary (Continued) S114 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011

GLOSSARY OF TERMS Continued Tissue All constituent parts of the human body formed by cells EU Directive 2004 Tissue establishment A tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage, or distribution of human tissues and cells are undertaken. It may also be responsible for procurement or testing of tissues and cells EU Directive 2004 Traceability The ability of an authorized organization to identify and locate all cells, tissues, or organs from all specific donors at any time after donation, linked to all specific recipients and vice versa from recipients to donors. This traceability applies to any step of procurement, allocation, processing, including processing agents, storage, distribution, or disposal at any time after donation WHO Glossary Trafficking (cells, tissues The recruitment, transport, transfer, harboring, or receipt of living or deceased persons or their cells, tissues, or organs) or organs, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, or deception, of the abuse of power or of a position of vulnerability, or of the giving to, or the receiving by, a third party of payments or benefits to achieve the transfer of control over the potential donor, for the purpose of exploitation by the removal of cells, tissues and organs for transplantation WHO Glossary Transplant A policy or practice in which cells, tissues, or organs are treated as a commodity, including by being bought or commercialism sold or used for material gain WHO Glossary Transplant tourism Travel for transplantation when it involves organ trafficking and/or transplant commercialism or if the resources (organs, professionals, and transplant centers) devoted to providing transplant to patients from outside a country undermine the country’s ability to provide transplant services for its own population The Declaration of Istanbul Transplantation The transfer (engraftment) of human cells, tissues or organs from a donor to a recipient with the aim of restoring function(s) in the body. When transplantation is performed between different species, for example, animal to human, it is named xenotransplantation WHO Glossary Transplantation center A healthcare establishment, team or a unit of a hospital or any other body which undertakes the transplantation of human organs, and is authorized to do so by the relevant authority Adapted from EU Directive 2010 Travel for The movement of organs, donors, recipients or transplant professionals across jurisdictional borders for transplantation transplantation purposes The Declaration of Istanbul Utilized deceased organ An actual donor from whom at least one organ was transplanted (see Critical Pathway) donor Critical Pathway Working Group, Madrid Consultation Waiting list The list of candidates registered to receive a human cell, tissue and organ transplant WHO Glossary Waiting list A system (or method) for maintaining a waiting list accuracy and currency, protecting the privacy, and management confidentiality of patients in the waiting list WHO Glossary