The Madrid Resolution on Organ Donation andTransplantation

National Responsibility in Meeting the Needs ofPatients, Guided by the WHO Principles

The Third Global Consultation on Organ Donation andTransplantation was organized by the WHO in collabo-

ration with the ONT and TTS and supported by the EuropeanCommission. The Consultation, held in Madrid on March 23to 25, 2010, brought together 140 government officials, ethi-cists, and representatives of international scientific and med-ical bodies from 68 countries.

Participants in the Madrid Consultation urged theWHO, its MS, and professionals in the field to regard organdonation and transplantation as a part of every nation’s re-sponsibility to meet the health needs of its population in acomprehensive manner and address the conditions leading totransplantation from prevention to treatment. Donationfrom deceased persons, as a consequence of death determinedby neurologic criteria (brain death) or by circulatory criteria(circulatory death), was affirmed as the priority source oforgans and as having a fundamental role in maximizing thetherapeutic potential of transplantation.

Every country, in light of its own level of economic andhealth system development, should progress toward theglobal goal of meeting patients’ needs based on the resourcesobtained within the country, for that country’s population,and through regulated and ethical regional or internationalcooperation when needed. The strategy of striving for self-sufficiency encompasses the following features: actionsshould (1) begin locally, (2) include broad public health mea-sures both to decrease the disease burden in a population andto increase the availability of organ transplantation, (3) en-hance cooperation among the stakeholders involved, and (4)be carried out based on the WHO Guiding Principles and the

Declaration of Istanbul, in particular emphasizing voluntarydonation, non-commercialization, maximization of dona-tion from the deceased, support for living kidney donation,and meeting the needs of the local population in preference to“transplant tourists.”

This new paradigm calls for the development of acomprehensive strategic framework for policy and practice,directed at the global challenges created by an increasing in-cidence of chronic diseases and a shortage of organs for trans-plantation. Self-sufficiency advocates national accountabilityfor the establishment of an effective planning context for dis-eases treatable through organ transplantation and character-ized by adequate capacity management, regulatory control,and an appropriate normative environment (Fig. 1).

1. National capacity management involves: (a) developmentof an adequate and appropriate healthcare infrastructureand workforce consistent with the country’s level of devel-opment and economic capacity; (b) adequate and appro-priate financing of organ donation and transplantationprogramme; and (c) management of need by investmentin chronic disease prevention and vaccination.

2. National regulatory control consists of (a) adequatelegislation, covering declaration of death, organ pro-curement, fair and transparent allocation, consent, es-tablishment of transplant organizations, and penaltiesfor organ trafficking and commercialization; (b) regu-lations covering procedures for organ procurement, re-imbursement, and allocation rules; and (c) systems formonitoring 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.

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surveillance, and for enabling evaluation of programmeperformance.

3. National authorities need to lead normative change,from a perception of organ donation as a matter of therights of donor and recipient to one of responsibilityacross all levels of society, through unambiguous legis-lation, committed support, and ongoing education andpublic information campaigns. Meeting needs of pa-tients while avoiding the harms of transplant tourismand commercial donation from living persons is an eth-ical imperative that relies on the assumption of a collec-tive responsibility for donation after death by all citizensand residents, thereby contributing to the commongood of transplantation for all.

The health of all populations will benefit from acomprehensive response to diseases contributing to end-stage organ failure, from prevention to access to effectiveorgan transplantation programmes made possible by a suf-ficient supply of donor organs. There is also a strong eco-nomic imperative to improve rates of transplantation andtherefore organ donation: kidney transplantation is lesscostly to provide than dialysis, and therefore, maximizingrates of kidney transplantation would significantly reduceoverall expenditure on renal replacement therapies. Kid-ney transplantation also results in better survival and qual-ity of life outcomes and enables greater productivity andcommunity participation. The perception of organtransplantation as an expensive and luxury clinical prac-tice is invalid; rather it is cost effective, mainstream, and acardinal feature of comprehensive health services. Beyondthe unmistakable medical benefits to patients affected byend-stage organ failure, organ transplantation is a key tothe challenge facing healthcare providers worldwide of un-sustainable expenditures on dialysis services and has po-tential to generate further practical consequences forhealth systems.

From a public perspective, the pursuit of self-sufficiencyrelies on a communal appreciation of the value of organ do-nation after death. The concept of donating human bodyparts to save the life of another as a civic gesture is one thatshould be taught at school alongside health education to de-crease the need for transplants. The pursuit of self-sufficiencyin organs for transplantation exemplifies the public healthand community values of equity, transparency, reciprocity,and solidarity, while it is the only safeguard against the temp-tation of yielding to trade in human organs.

In preparation for and during the meeting in Madrid,eight Working Groups identified specific goals and challengesand proposed solutions and recommendations from a num-ber of perspectives. The Working Groups identified the com-mon challenges faced by both developing and developedcountries, the unique issues of particular societies and re-gions, and provided a rich and extensive set of recommenda-tions directed at governments, international organizations,and healthcare professionals regarding how to best maximizedonations from deceased persons (including the develop-ment of The Critical Pathway for organ donation; Fig. 2) andhow to successfully progress toward meeting the needs ofpatients.

IMPLEMENTING SELF-SUFFICIENCY:RECOMMENDATIONS FROM THE

MADRID CONSULTATIONThe human right to health and dignity includes the recogni-

tion ofall human needs for transplantation. While self-sufficiency isconceived as a common global goal, the capacity to meet patients’needs should be found primarily within each country’s own re-sources, involving regulated regional or international cooperationwhen appropriate. The requirements of organ donation andtransplantation programmes with respect to resourcing, properorganization, regulation and the oversight of procurement, pro-cessing and transplantation of human body components fromliving and deceased persons are matters that rightly come underthe responsibility of governments, as outlined in ResolutionWHA57.18.

Consistent with the political and ethical obligations ofgovernments toward their citizens, the pursuit of self-sufficiency promotes the health and protects the interests ofpopulations. Although the practical implementation of self-sufficiency will vary for different countries, influenced by eco-nomic factors, health sector development, and existing healthpriorities, the inherent values of the self-sufficiency paradigmand the WHO Guiding Principles on human cells, tissues andorgans should guide organ donation and transplantation policyand practice in all contexts. The following overarching aspects ofself-sufficiency were identified during The Madrid Consultationas subject to specific recommendations:

Preventing the Need for Transplantation andIncreasing Organ Availability Are NationalResponsibilities

• Organ donation and transplantation have a role in thenational health policies of all countries, regardless ofcurrent transplant capability.

• Of equal importance to infrastructure and professionaldevelopment in organ donation and transplantation issustained investment in prevention to reduce futureneeds for transplantation, through intervention in themajor risk factors for end-stage organ failure and thedevelopment of health systems able to meet the chal-lenges of chronic diseases such as diabetes, cardiovascu-lar disease (CVD), and hepatitis.

• National transplantation legislation consistent with the WHOGuiding Principles is fundamental. It provides adequate pro-tection from exploitation and unethical practices and elimi-nates legislative impediments constraining the science andmedicine of donation from deceased persons.

• Public support for organ donation necessitates norma-tive change. To this end, education of the public shouldbegin in school, emphasizing individual and communityethical values such as solidarity and reciprocity. Self-sufficiency is founded in three main ethical premises:• The human right to health encompasses transplanta-

tion and disease prevention.• Organs should be understood as a social resource;

equity must therefore govern both procurementand allocation.

• Organ donation should be perceived as a civicresponsibility.

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Donation and Transplantation ReflectComprehensive Health Care

• The critical functions of oversight, maintenance of pro-fessional standards and ethics, regulation, policy setting,and monitoring and evaluation of organ donation andtransplantation programmes are most effectively man-aged by a National Transplant Organization (NTO).

• Data registries are necessary for operational support(waiting list management and organ allocation) and formonitoring and surveillance of practices and outcomes.

• Monitoring and surveillance should encompass thefollowing data: national prevalence and incidence ofend-stage organ failure and diseases contributing toend-stage organ failure (need); availability of related in-frastructure and access to organ replacement therapies;outcomes of organ replacement therapy; acceptanceonto transplant waiting lists and time to receipt of anorgan; organ donation practices, standards and activities;practices, standards and activities in organ donation fromliving persons; and outcomes of transplantation (patientand graft survival). International harmonization of suchmetrics would facilitate comparisons between systems and

international benchmarking, identify regions in need ofdata, guide national policy making, and enable research.

Opportunities to Donate Should Be Provided inas Many Circumstances of Death as Possible

• The critical pathway provides a framework for the pro-cess of donation from deceased persons, which will aidglobal harmonization of practice.

• The key to self-sufficiency is maximizing donation fromdeceased persons: facilitating donation in as many cir-cumstances of death as possible, maximizing the out-comes from each donor, and optimizing the results oftransplantation. Donation after both brain death andcirculatory death should be regarded as ethically proper.Organ donation from living persons should be encouragedas complementary to donation after death, by providingappropriate regulatory frameworks and donor care.

• Physicians and nurses involved in acute care have a centralrole in identifying possible donors and facilitating donationafter death, and therefore should be supported by the nec-essary educational, technical, legal and ethical tools to as-sume leadership in this regard within their facility.

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

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