Sex equity in organ donation and access to transplantation represents a key priority of the European Committee on Organ Transplantation of the Council of Europe (CD-P-TO). To increase our knowledge on sex-related differences in transplantation in the Council of Europe Member States, a specifically designed questionnaire was distributed to the CD-P-TO countries. Results confirm that, irrespective of the organ, males represent the majority of patients on the transplant waiting list. For all organs except for heart the time spent on the waiting list was shorter for men compared to women. Women represent the majority of living kidney donors (58%), whilst males are the major source of livers from living donation (54%). Across all organ types, men received 64% of deceased donor organs and 58% of living donor organs. We have found sex-related differences in transplantation activities conducted in the Council of Europe Member States. However, these may be the consequence of the higher incidence of some diseases in men, organ size mismatch, or the greater difficulty in finding immunologically compatible donors in women. At this stage, the CD-P-TO will continue its monitoring activity on this highly relevant topic and possibly extend its commitment beyond sex to include gender related aspects.
BACKGROUND:Solid organ transplantation has evolved globally as an established and life-saving treatment for patients with end-stage organ failure. METHODS:Since 2007, the Global Observatory on Donation and Transplantation (GODT), an initiative of the World Health Organization in collaboration with the Organización Nacional de Trasplantes (Spain), collects data and reports on the activity of World Health Organization member states in regard to solid organ donation, transplantation, and waitlisting. This ongoing effort provides insights into transplant activities in countries with different healthcare systems and practices, economic and cultural contexts, and local disease burdens. RESULTS:This annual report presents activities for the year 2024 and summarizes the developments from a global, regional, and country-specific perspective. This report includes information from 92 countries that submitted their data to the GODT by October 29, 2025. Descriptive statistics were applied to analyze and present key indicators. CONCLUSIONS:A record 173 727 solid organ transplants were performed worldwide in 2024, representing the highest number ever reported to the GODT. This corresponds to a 2% global increase compared with 2023, largely driven by a rise in deceased donations, particularly the expansion of donations after the circulatory determination of death, which accounted for 28% of all deceased donation activity in 2024 (total deceased donations: 47 180). Despite these achievements on a global scale, the data also indicate that major challenges persist, including a continued shortage of organs and pronounced geographical disparities in access to transplantation.
Therapies derived from substances of human origin (SoHOs) such as organs, cells, and tissues provide life-saving or life-changing treatment for millions of people worldwide each year. However, many people lack timely access to SoHO-based therapies because of insufficient supplies of these exceptional health resources and/or broader barriers in access to healthcare. Despite well-established governmental commitments to promote health equity in general and equity of access to SoHOs in particular, information about inequities in access to most SoHO-based therapies is scarce. Furthermore, the issue of equitable allocation of SoHO-based therapies has received little attention from policymakers and ethicists, except in the context of organ allocation for transplantation. Consequently, the extent and nature of potential inequities within and between countries are largely unknown, and few sources of guidance are available to support progress toward equity in global access to SoHO-based therapies. We present here the findings of an international ethics working group convened in preparation for the 2023 Global Summit on Convergence in Transplantation, organized in Santander, Spain. The group sought to assess potential gaps in knowledge about inequities involving SoHO-based therapies, to elucidate systemic factors that may influence access to these therapies, and to consider how policies and frameworks governing access to and allocation of SoHO-based therapies may promote equity when it is necessary to define boundaries in access because of insufficiency of supply. In discussing these challenges, we also outline several recommendations for action by governments and health authorities.
The avoidance of financial gain in the human body is an international ethical standard that underpins efforts to promote equity in donation and transplantation and to avoid the exploitation of vulnerable populations. The avoidance of financial loss due to donation of organs, tissues, and cells is also now recognized as an ethical imperative that fosters equity in donation and transplantation and supports the well-being of donors and their families. Nevertheless, there has been little progress in achieving financial neutrality in donations in most countries. We present here the findings of an international ethics working group convened in preparation for the 2023 Global Summit on Convergence in Transplantation, held in Santander, Spain, which was tasked with formulating recommendations for action to promote financial neutrality in donation. In particular, we discuss the potential difficulty of distinguishing interventions that address donation-related costs from those that may act as a financial incentive for donation, which may inhibit efforts to cover costs. We also outline some practical strategies to assist governments in designing, implementing, and evaluating policies and programs to support progress toward financial neutrality in donation.
SARS-CoV-2 infection represents a new challenge for solid organ transplantation (SOT) with evolving recommendations. A cross-sectional survey was performed (February–June 2024) to describe practices among Member States of the Council of Europe (COE) on the use of organs from deceased donors with resolved or active SARS-CoV-2 infection. Overall, 32 out of 47 Member States with a transplant program participated in the study. Four (12.5%) countries did not use organs from deceased donors either with resolved or with active SARS-CoV-2 infection and 8 (25%) countries accepted organs only from deceased donors with resolved SARS-CoV-2 infection. Donor evaluation for SARS-CoV-2 included universal screening with standard PCR testing on respiratory specimens generally (61.4%) performed within 24 h prior to organ recovery. Further microbiological, immunological and radiological investigations varied. Most waitlisted patients receiving organs from a deceased donor with active (94.5%) or resolved (61.5%) SARS-CoV-2 infection were preferred to have natural, vaccine-induced or hybrid SARS-CoV-2 immunity. Most countries did not require recipients to undergo specific anti-SARS-CoV-2 treatment as pre-exposure (0%), post-exposure prophylaxis (15.4%) or modification of immunosuppression regimen (24%). This study highlights similarities and heterogeneities in the management of SARS-CoV-2 positive donors between COE countries, and a potential to safely expand donors’ pool.
Trafficking in human organs, cells, and tissues has long been a source of concern for health authorities and professionals, and several international ethical guidance documents and national laws have affirmed the prohibition of trade in these substances of human origin (SoHOs). However, despite considerable attention to the issue of organ trafficking, this remains a substantial and widespread problem internationally. In contrast, trafficking in cells, tissues, and medical products derived from SoHOs has received comparatively little attention, and the extent and nature of such trafficking remain largely unknown. Consequently, as part of the 2023 Global Summit on Convergence in Transplantation held in Santander, Spain, an ethics working group was assigned the task of formulating actionable recommendations to support the prevention of trafficking in all SoHOs. In reporting on this work, we review factors that may influence the persistent trafficking of SoHOs, explore the potential difficulties associated with the collection and reporting of data about suspected trafficking activities, and argue that more practical and consistent guidance, training, and regulatory frameworks are needed internationally to support effective reporting, sharing of data, and collaborative responses to suspected trafficking cases. We also discuss the importance of psychosocial evaluation of living donors as a strategy to detect and prevent organ trafficking and strive to advance the implementation of this well-established recommendation by outlining minimum standards for psychosocial evaluation of living donors.
Physical examination (PE) of donors is essential to identify potential risks to the safety and efficacy of donated organs and tissues and is mandatory in the EU. However, no detailed guidance is available as to how PE should be performed. Health authorities (HA) and health professionals (HP) in member states of the European Committee on Organ Transplantation of the Council of Europe (CD-P-TO) and observer countries completed surveys relating to the regulatory requirements for PE and the professional practice of PE in their countries for organ and tissue donors. The HA survey addressed regulatory aspects, and the HP survey addressed professional practices, training, and respondents' opinions on the value of PE. These surveys revealed significant inter-country variation in the regulatory approach to PE and the performance of PE by professionals. Most respondents opined that PE was important and yielded valuable information in identifying contraindications to donation. There is no consensus at a regulatory or professional level as to how PE should be performed on organ and tissue donors. There is a requirement for agreed best practice guidelines in this area.
Background. Organ, tissue, and cell donation and transplantation legislation and policies vary substantially worldwide, as do performance outcomes in various jurisdictions. Our objective was to create expert, consensus guidance that links evidence and ethical concepts to legislative and policy reform for tissue and cell donation and transplantation systems. Methods. We identified topic areas and recommendations through consensus, using nominal group technique. The proposed framework was informed by narrative literature reviews and vetted by the project’s scientific committee. The framework was presented publicly at a hybrid virtual and in-person meeting in October 2021 in Montréal, Canada, where feedback provided by the broader Forum participants was incorporated into the final manuscript. Results. This report has 13 recommendations regarding critical aspects affecting the donation and use of human tissues and cells that need to be addressed internationally to protect donors and recipients. They address measures to foster self-sufficiency, ensure the respect of robust ethical principles, guarantee the quality and safety of tissues and cells for human use, and encourage the development of safe and effective innovative therapeutic options in not-for-profit settings. Conclusions. The implementation of these recommendations, in total or in part, by legislators and governments would benefit tissue transplantation programs by ensuring access to safe, effective, and ethical tissue- and cell-based therapies for all patients in need.
Muller, Elmi1; Muller, Willem J2; Assche, Kristof Van4; Fraga, Marta Lopez3; Martin, Dominique5 Author Information
Haematopoietic progenitor cell donation from bone marrow and mobilised peripheral blood obtained from related and unrelated donors is an established procedure. The donation process in general has proven to be safe, but in rare cases severe and even fatal events have been reported. The present study aimed at providing a description of the current situation of donor protection measures in Council of Europe member states. A specific questionnaire was developed to compile information on donation activities, graft sources, legal frameworks, donor protection measures, collection of donor outcome data, and long-term follow-up of paediatric and adult related and unrelated donors. The outcome of this survey served as a basis for elaborating the Recommendation CM/Rec(2020)6 of the Committee of Ministers to member States on establishing harmonised measures for the protection of haematopoietic progenitor cell donors.
The primary aim of this study was to describe regulations and practices concerning the family approach to discuss donation, specifically after the neurological determination of death, one of the most challenging steps in the donation pathway. A secondary objective was to assess the impact of legislation on consent rates for organ donation. The Council of Europe surveyed 39 member states about national regulations, practices, and consent rates; 34 replied. Opt-out legislation is present in 19, opt-in in 9 and a mixed system in six countries. An opt-out register is kept by 24 countries and an opt-in register by 18 countries, some keeping both. The mean consent rate was 81.2% of all family approaches. Most countries regulate how death using neurological criteria is confirmed (85.3%), while regulation of other aspects of the deceased donation pathway varies: the timing of informing the family about brain death (47.1%) and organ donation (58.8%), the profile of professional who discusses both topics with the family (52.9% and 64.7%, respectively) and the withdrawal of treatment after brain death (47.1%). We also noted a mismatch between what regulations state and what is done in practice in most countries. We suggest possible reasons for this disparity.
The brain-based determination of death ("brain death") is now widely accepted throughout the world. It states that the irreversible cessation of brain functions is the fundamental criterion for human death. The recent World Brain Death Project provided a comprehensive cataloguing of all aspects of brain death including its medical and legal acceptance throughout the world.1 Organ donation after the brain-based determination of death (DBDD) currently accounts for the majority of multiorgan donations internationally. Organ donation after the circulatory determination of death (DCDD) has grown worldwide since the Institute of Medicine of the United States endorsed the practice of controlled DCDD in 20002 and a US national conference on DCDD in 2005 standardized its practice.3 DCDD donations are expanding but remain fewer than the number of DBDD donations. DCDD donor death determination requires the permanent absence of systemic circulation. When systemic circulation is absent, brain circulation ceases. The essential feature of the unified brain-based concept of death is that permanent cessation of systemic circulation produces permanent cessation of brain circulation and neuronal perfusion resulting in permanent cessation of brain functions. Thus, the determination of death by circulatory criteria is consistent with the determination of death by neurologic criteria. In situ normothermic regional perfusion (NRP) is emerging as a component of organ recovery procedures in controlled DCDD. Controlled DCDD is practiced in hospitalized patients after the planned withdrawal of life-sustaining therapy (WLST). NRP uses extracorporeal membrane oxygenation to reestablish circulation to specific regions of the body following death determination. The circulation reestablished may be restricted to the abdominal cavity (A-NRP) or may also include the thoracic cavity (TA-NRP). NRP reportedly improves organ utilization and recipient outcomes comparable with those of organs from DBDD donors,4,5 but it also raises complex medical, ethical, and legal questions that must be resolved.6-8 DCDD donor death determination requires the permanent absence of systemic circulation but NRP protocols reestablish systemic circulation. This situation raises the principal question in NRP: if resumption of circulation by NRP contradicts the conditions of the death declaration, how can a donor be declared dead by permanent cessation of circulation? The use of the unified brain-based concept of death resolves the dilemma by clarifying that the relevant circulation that must cease is circulation to the brain.9,10 If NRP is effectively restricted to ensure no circulation to the brain, thereby preventing brain perfusion and function, NRP fulfills the requirements of donor death determination and respects the dead donor rule. Ensuring that circulation to the brain has ceased permanently and will not be restarted allows donors to be declared dead based on the permanent cessation of brain functions despite the restoration of regional circulation to the abdomen or thorax. DEATH DETERMINATION IN DONATION AFTER CIRCULATORY DETERMINATION OF DEATH Under current DCDD protocols, a declaration of death requires determining that the potential organ donor's circulation has ceased permanently. Three conditions establish permanent cessation of systemic circulation: (1) circulation has ceased completely, as evidenced by intra-arterial pressure monitoring, electrocardiography, or echocardiography; (2) no circulation persists beyond the time interval during which autoresuscitation has been reported to occur; and (3) no intervention is made to restore circulation after death has been declared.11 If these conditions are met, the permanence criterion is fulfilled, the donor is validly declared dead, and the subsequent recovery of donated organs does not violate the dead donor rule.11 Although legal standards differ among jurisdictions, physicians who follow DCDD protocols can be confident that they are acting in accordance with standards accepted around the world that have long equated death with permanent cessation of systemic circulation.8 In controlled DCDD protocols, a minimum of 5 min of absent circulation establishes that the heart will not restart spontaneously and that circulatory cessation is permanent. This controlled DCDD death standard was recommended by the Institute of Medicine2 and is in common use in the United States and in most European countries.12 The 5-min standard has been confirmed by a large prospective observational study of autoresuscitation, in which death was determined by circulatory criteria following WLST, in which the longest interval reported between asystole and autoresuscitation was 4 min and 24 s.13 THE UNIFIED BRAIN-BASED DEATH DETERMINATION IN DCDD There is a widespread medical acceptance that human death can be declared on the basis of the permanent cessation of brain functions, defined as the permanent loss of the capacity for consciousness, of the capacity to breathe, and of all brain stem reflexes.1,14 The permanent cessation of brain functions can be caused by primary brain pathology, such as traumatic head injury, stroke, or meningitis, or by hypoxic–ischemic brain damage secondary to the loss of brain perfusion during circulatory arrest. The unified brain-based concept of death provides that when the cessation of brain function results from circulatory arrest, the relevant circulation which has ceased is that of the brain.9,10 In applying the unified brain-based concept of death to the determination of death in DCDD, permanent cessation of systemic circulation initially causes brain circulation to cease. Permanent cessation of brain circulation results in the permanent absence of neuronal perfusion, which results in the permanent cessation of brain functions. Thus, the unified brain-based concept of death provides that, in DCDD, the permanent cessation of systemic circulation leads to the permanent cessation of brain functions.9,10 Physiologic studies of patients dying following WLST show that cessation of brain activity closely correlates with cessation of systemic circulation. The electroencephalogram becomes isoelectric within 30 s of cardiac arrest resulting in absent circulation to the brain15 and can occur even sooner when WLST is followed by severe hypotension and hypoxemia before cardiac arrest.16,17 Cessation of brain circulation triggers a physiologic cascade: cessation of brain perfusion leading to cessation of brain neuronal activity leading to cessation of brain function. After 5 min of complete cessation of brain circulation, death can be declared on the grounds that brain circulatory cessation is permanent and, therefore, the cessation of brain functions is permanent. Permanence is established when the interval during which autoresuscitation can occur has elapsed and no resuscitative intervention will be attempted. A physiologic function that ceases irreversibly means that the function cannot be restored. A physiologic function that ceases permanently means that the function will not be restored.18 From its inception, the determination of brain death has confirmed the irreversible cessation of brain functions. The testing that enables a formal brain death determination is a retrospective assessment of brain functions that had ceased previously (they cannot be restored). The determination of death by circulatory criteria is a prospective (real time) assessment that requires only the permanent absence of circulation to the brain to ensure the permanent absence of brain functions. According to the unifying brain-based concept of death, the permanent cessation of circulation to the brain enables a valid determination of death because it results in the permanent cessation of brain functions (see Figure 1). Cessation of brain functions is the true endpoint of the brain-based concept of death, which is the consequence of the permanent cessation of circulation to the brain.FIGURE 1.: Brain functions are time dependent on circulation to the brain.After circulation has ceased permanently, direct testing of brain functions would be the ideal method to prove its absence. But for technical reasons, electrophysiological assessment of brain function is not feasible in the DCDD donor, particularly the assessment of brain stem functions. Therefore, in DCDD protocols, the cessation of circulation to the brain is used as a surrogate for the cessation of brain functions. This practice is justified by the strict causal relationship between brain function and circulation that exists when brain circulation ceases: brain function cannot continue in the absence of brain circulation. However, the mere presence of measurable brain circulation does not necessarily imply the presence of brain functions because detected blood flow may not achieve the necessary perfusion threshold to allow brain functions. Yet, the presence of brain blood flow indicates that brain functions remain possible. These precise thresholds are currently unknown. THE GOAL OF TA-NRP IS TO RESTORE CIRCULATION TO THORACIC AND ABDOMINAL ORGANS NRP has been added to DCDD protocols after the declaration of death as an in situ preservation strategy to reperfuse organs, reduce warm ischemic damage, and allow organs to be better assessed before being recovered for transplantation. In A-NRP, the aorta is clamped or blocked to restrict circulation to the abdominal organs, whereas TA-NRP requires stapling of the aortic arch vessels. The purpose of the arch vessel or abdominal aortic clamping is to exclude blood flow to the brain and restrict blood flow to only those organs being recovered for transplantation. When TA-NRP is initiated, mechanical ventilation is also restarted. The donor's heart is assessed for transplantation suitability after the resumption of sinus rhythm and cardiac contractions. The restarted donor heart provides circulation to perfuse thoracic and abdominal organs and also provides an opportunity to assess the heart's functional suitability for transplantation. But do these techniques succeed in totally excluding brain circulation? POTENTIAL INADEQUACIES OF CLAMPING THE AORTIC ARCH VESSELS TA-NRP Brain circulation may not be completely excluded by arch vessel clamping because of potential collateral arterial circulation to the brain and the dynamics of brain circulatory autoregulation. Brain circulation is a robust system of direct and collateral arteries distributed by the aorta. Blood flow proceeds from the arch to the brain through the carotid and vertebral arteries that ultimately form the Circle of Willis. At the level of the medulla, the vertebral arteries give off branches that merge to form the anterior spinal artery. The anterior spinal artery distributes blood flow to the spinal cord and brain from collateral supply derived from branches from the aorta in cervical (C1–T3), thoracic (T4–T8), and lumbar regions (T9 to the conus medullaris) via the spinal artery of Adamkiewicz. That artery can direct blood flow cephalad toward the collateral branches along the spinal cord if the circulation to the brain is impaired through the major arch routes of blood flow. Clamping of the brain's main arteries may stimulate collateral circulation to the brain by cerebral autoregulation in the presence of the cephalad arterial blood flow generated by NRP.19 Current human data are insufficient to assure zero brain blood flow during in situ NRP, although animal models are reassuring.20 A recent TA-NRP experiment in a small sample of pigs found that clamping of the arch vessels prevented brain activity as assessed by electroencephalogram, evoked potentials, cerebral blood flow, and oxygen uptake.21 But because of the uncertainty that complete cessation of blood flow to the brain results by only clamping the arch vessels, current protocols in the United Kingdom and Spain have added the step of severing the arch vessels distal to the clamps and draining or aspirating blood from the cephalad ends of the severed vessels while exposed to atmospheric pressure.22 This technical maneuver is intended to divert any possible collateral blood flow away from the brain. For a unified brain-based circulatory determination of death to be valid in NRP, it is essential that all brain circulation has ceased completely and is not restored by NRP or any other means. Animal and human studies must be performed to reassure that brain circulation is eliminated completely when TA-NRP is incorporated into controlled DCDD protocols. These studies could also inform the best methods of clinical direct brain monitoring during TA-NRP. To resolve the clinical uncertainty over restoring circulation to the brain, studies, such as those planned in the United Kingdom and Spain, should be conducted to assess brain blood flow during TA-NRP, for example, by contrast angiography. Given that brain monitoring is not sufficiently sensitive to detect functioning, particularly in areas difficult to examine, like the brain stem, one must assume that the presence of brain perfusion indicates the potential for brain functioning. RECOMMENDATIONS TO DEVELOP AN INTERNATIONAL CONSENSUS ON A UNIFIED BRAIN-BASED CONCEPT OF DEATH WHEN NRP IS IMPLEMENTED International Professional Societies That Develop Medical Standards Should Work to Achieve a Consensus on the Unified Brain-based Concept of Death The unified brain-based concept of death is applicable to both DBDD and DCDD although the clinical criteria for death determination are distinct. The brain-based concept of death provides that the permanent absence of brain functions is achieved by the permanent absence of circulation to the brain.23 Determining death by the permanent cessation of brain functions is consistent with the medical standards for determining death outside the context of organ donation.1 If circulation to the brain ceases completely and permanently, no brain function can continue. Establishing international professional consensus on the unified brain-based concept of death will provide a framework for TA-NRP DCDD policy and practice, thereby promoting public trust and addressing potential barriers to opportunities for donation and transplantation. Such a consensus has been accomplished previously by international expert collaboratives on death determination based on solid scientific evidence.1,14,24 Future clinical and laboratory research should determine if any residual brain circulation exceeds the threshold for neuronal perfusion necessary for brain functions, even when the most restrictive vascular blocking techniques of NRP protocols are implemented. Protocols of DCDD Organ Recovery, Especially With In Situ Organ Preservation Using TA-NRP, Must Ensure the Permanent Absence of Circulation to the Brain Current protocols in TA-NRP must be validated to provide assurance that the techniques to stop or divert collateral blood flow to the brain are experimentally proven and clinically effective. Programs using TA-NRP before such validation is available should consider implementing a system of brain monitoring using sensitive techniques to provide reassurance in the complete and continued absence of brain functions during TA-NRP–assisted organ recovery.25 The Surgical Recovery Maneuvers Used to Prevent Circulation to the Brain During NRP Must Be Legally, Ethically, and Socially Acceptable Discussions between qualified organ donation professionals and potential donor families should include information about the aims, methods, and technical maneuvers of NRP protocols that are sufficient to allow family members and surrogates to make informed decisions about authorizing organ donation. Transparency in these conversations ensures public trust in the system of organ donation. Some commentators have emphasized the desirability of pursuing ex situ normothermic perfusion because it avoids the ethical and legal issues of in situ NRP while providing many of its benefits.26 However, this alternative is associated with substantially higher costs and has its own limits in countries where legislation requires an observation period longer than the 5-min standard for the declaration of death. To support the development of best practices for communicating with potential donors and families, studies of donor families and hospital personnel should be conducted to explore their attitudes and understanding of TA-NRP. Transparency in these conversations ensures public trust in the system of organ donation. We are encouraged by the efforts of the Canadian panel that has adopted the unified brain-based concept of death into a national clinical practice guideline for death determination after the arrest of circulation and brain functions.27 Their rationale and recommendations can serve as a model worldwide, particularly where TA-NRP is implemented. Alignment between NRP protocols and prevailing clinical, ethical, and legal standards remains necessary.7,8
Background. Transplant therapy is considered the best and often the only available treatment for thousands of patients with organ failure that results from communicable and noncommunicable diseases. The number of annual organ transplants is insufficient for the worldwide need. Methods. We elaborate the proceedings of the workshop entitled "The Role of Science in the Development of International Standards of Organ Donation and Transplantation," organized by the Pontifical Academy of Sciences and cosponsored by the World Health Organization in June 2021. Results. We detail the urgency and importance of achieving national self-sufficiency in organ transplantation as a public health priority and an important contributor to reaching relevant targets of the United Nations Agenda for Sustainable Development. It details the elements of a global action framework intended for countries at every level of economic development to facilitate either the establishment or enhancement of transplant activity. It sets forth a proposed plan, by addressing the technical considerations for developing and optimizing organ transplantation from both deceased and living organ donors and the regulatory oversight of practices. Conclusions. This document can be used in governmental and policy circles as a call to action and as a checklist for actions needed to enable organ transplantation as treatment for organ failure.
In this issue of Transplantation, Braun et al1 deal with a highly sensitive and challenging issue—travel for liver transplantation (LT) to and from the United States—to assess the fitness of the current United Network for Organ Sharing citizenship classification and describe noncitizen patients on the LT waiting list (WL) and recipient populations. Their results are compelling, highlighting the limitations of the current classification system and significant disparities in the access to and outcomes following LT according to citizenship and residency status. Travel for transplantation is a complex phenomenon. Although in certain instances unethical and linked to transplant tourism, as defined by the Declaration of Istanbul,2 there are legitimate reasons for traveling to receive an organ transplant abroad, including personal or family reasons (eg, citizenship and family/social support in another country), transnational cooperation agreements, or transplant services for related donor–recipient pairs from countries without fully developed programs. Therefore, an in-depth study of the phenomenon is essential to better understand its suitability under concrete and limited circumstances and the potential risks. The Final Rule, a US national policy governing deceased donor organ transplantation, suggests that organs should be allocated to patients, regardless of citizenship or residency status, by prioritizing medical necessity3; however, patient demand for organs in the United States outstrips supply by 400%, and each year, around 5% of waitlisted patients die awaiting a transplant.4 This inability to satisfy transplantation needs is not uncommon: in the European Union-28, 7% of patients on the LT WL died during 2020.5 Transplantation of nonresidents may, therefore, undermine self-sufficiency and affect the resident population’s chances of accessing this life-saving therapy. Furthermore, it can entail a futile use of those invaluable organs if adequate posttransplant care of the nonresident recipients cannot be guaranteed once they return to their country of origin. Nevertheless, countries may feel compelled to provide transplant services to nonresidents in certain situations, including those already present in their jurisdiction suffering a sudden life-threatening condition requiring a transplant or refugees, asylum-seekers, and minors without other access to transplant care. In such cases, a balance must be struck between providing compassionate health care to nonresidents and meeting obligations of resident patients’ needs while preventing the consequences of transplant tourism. Countries may also provide transplant services to nonresidents under transnational cooperation agreements—transparent arrangements, usually reciprocity-based, whereby the origin country contributes to the deceased donor pool of the other country and commits to the development of a local transplant program. Recent efforts to understand the dimensions of travel for transplantation and its impact on organ allocation in the United States involve requesting transplant programs to provide patient citizenship and residency data to the United Network for Organ Sharing during waitlisting; however, the reportable data have been oversimplified, requiring no verification or audit, undermining their value and the relevance of findings. Braun et al show that more needs to be done to increase transparency, maximize the value of the data, and improve the fairness of the system. Although travel for LT to the United States remains relatively limited—approximately 1% of the LT WL and recipient populations are nonresidents—the implications may be severe and profoundly unfair as a scarce and life-saving organ is diverted to a cohort that does not contribute to the deceased donor pool to the detriment of the resident population which does. There are also significant differences in access to LT and posttransplant outcomes among US citizen, noncitizen nonresident (NC-NR), and noncitizen resident (NC-R) patients. Compared with US citizens, NC-NR patients are more likely to proceed to transplant and have better unadjusted survival afterward. These patients are overwhelmingly highly educated White males from the Middle East and are predominantly insured by foreign governments, privately insured, or self-insured. They undergo transplant in regions with shorter waiting times and have lower disease severity. Notably, NC-NR patients receive the highest proportion of living donor grafts (8.3%), which is a practice with separate issues (eg, confirming the validity of donor–recipient relationships, ensuring proper long-term care of donors, or in other settings, safety concerns when donor–recipient pairs travel to countries with emerging programs and low healthcare-related costs)6 but should, in our view, have been excluded from the present study to better ascertain the impact of travel for transplantation on self-sufficiency and the national deceased donor WL. In addition, US citizens listed in several centers were excluded from the comparator population, although they were likely similar to the NC-NR patient cohort in terms of resources and access to services and information. In contrast, NC-R patients—who contribute to the national donor pool and to society at large—are less likely to proceed to transplant and more likely to die on the WL or be removed for becoming too sick, even with significantly better survival than US citizens following transplantation. The authors suggest that the US system is not providing its resident population equal access to LT because citizenship status and geographical region cause disparities in access, with NC-NR and NC-R patients unevenly distributed across the United States. Although compelling, these data should be interpreted with caution, as the US health system is not universally accessible, comprising publicly and privately funded schemes and programs providing different services to patients depending on their insurance. It is possible that unequal access to transplantation is actually rooted in inherent healthcare system disparities primarily affecting NC-R patients. Indeed, NC-R LT recipients in this study were predominantly Asian or Hispanic and were with less access to higher education and largely publicly insured. Finally, the study reports a small number of candidates removed from official US WLs for pursuing transplants abroad. These data are difficult to interpret because of the lack of relevant details, such as patient citizenship, but they come primarily from region 5 (New Mexico through California), which has notoriously long waiting times and high Model for End-stage Liver Disease scores. This demonstrates that self-sufficiency is key to preventing transplant tourism.7 In any instance, what becomes clear is that fair, straightforward, and transparent criteria for access of NC-NR and NC-R patients to transplantation are paramount to national transplant systems worldwide. Criteria should not be defined by individual physicians or transplant centers. National policies tailored to individual countries should ensure equal access to transplantation and commitment to provide timely transplantation therapy to residents. The first step toward transparency and equitable access to transplantation is to accurately account for the movement of persons seeking a transplant across jurisdictions.6,8,9 Although, according to the study by Braun et al, travel for transplantation may seem marginal in the United States, the commitment of the country to shed light on this phenomenon, and hopefully continue refining the exercise in the future, should be commended and set an example for others. The transplant community must report accurate data on their operational delivery of transplant care; if not, they risk losing public trust.10
Discrepancies in donation and transplantation by sex and gender have previously been reported. However, whether such differences are invariably the inevitable, unintended outcome of a legitimate process has yet to be determined. The European Committee on Organ Transplantation of the Council of Europe (CD-P-TO) is the committee that actively promotes the development of ethical, quality and safety standards in the field of transplantation in Europe. Whilst the ultimate objective is to shed light on the processes underlying potential gender inequities in transplantation, our initial goal was to represent the distribution by sex among organ donors and recipients in the CD-P-TO Member States and observer countries. Our survey confirms previous evidence that, in most countries, men represent the prevalent source of deceased donors (63.3% in 64 countries: 60.7% and 71.9% for donation after brain and circulatory death, respectively). In contrast, women represent the leading source of organs recovered from living kidney and liver donors (61.1% and 51.2% in 55 and 32 countries, respectively). Across countries, most recovered organs are transplanted into men (65% in 57 countries). These observations may be explained, at least in part, by the higher burden of certain diseases in men, childbearing related immune sensitization in women, and donor-recipient size mismatch. Future research should establish whether gender-related socially-constructed roles and socioeconomic status may play a detrimental role reducing the access of women to transplantation.
Travel for transplantation is a complex phenomenon. Although in certain instances unethical and linked to transplant tourism, there are legitimate reasons for traveling to receive an organ transplant abroad, including family reasons, transnational co-operation agreements or access to better transplant services for related donor–recipient pairs. However, at present, very limited data is available on the international scope of the phenomenon, the profile of donors and recipients, the quality of the transfer of care, the impact on origin and destination countries, and potential risks.In 2016, the Council of Europe established the Network of National Focal Points (NFP) on Travel for Transplantation. This network is composed of reference persons, designated by countries and based at existing national transplantation organisations and/or Ministries of Health, tasked with collecting rigorous and comprehensive data on recipients and/or donors who travelled abroad in the context of a transplant procedure. They are also in charge of increasing awareness among health authorities and healthcare professionals on transplant-related crimes and developing national protocols and codes of conduct to provide an adequate framework within the medical field to prevent, detect and report transplant-related crimes, including the training of healthcare staff likely to encounter them in their professional practice. Importantly, they act as a reference person to exchange and disseminate information at national and international level on transplant-related crimes and help establish multidisciplinary synergies and a multi-agency approach to ensure an effective fight against transplant-related crimes. Currently, 35 countries have designated a NFP, including countries outside the Council of Europe borders. In June 2017, the Registry on International Travel for Transplantation Activity (RITTA) was launched. NFP submit information annually on all patients who received an organ transplant abroad, as well as non-resident donor-recipient pairs who underwent a transplant procedure in the reporting country. Currently, RITTA includes information on 479 transplant procedures, including pseudoanonymized information about recipients, donors, transplant teams, suitability and reasons for referral for transplantation abroad, organ transplanted, status of the recipient on their home country waiting list, quality of the transfer of care, etc. Thanks to this detailed information, the network can analyse the possible legitimacy of the procedures.The international exchange of information on these patients is helping to better understand the phenomenon of travel for transplantation, assess its dimensions and identify possible hotspots of transplant tourism deserving careful investigation by the countries concerned. In addition, it is helping to gain better knowledge of the profile of donors and recipients, the quality of the transfer of recipient care and its impact on post-transplant outcomes. EDQM/Council of Europe Network of National Focal Points on Travel for Transplantation.
The access of non-resident patients to the deceased donor waiting list (DDWL) poses different challenges. The European Committee on Organ Transplantation of the Council of Europe (CD-P-TO) has studied this phenomenon in the European setting. A questionnaire was circulated among the Council of Europe member states to inquire about the criteria applied for non-residents to access their DDWL. Information was compiled from 28 countries. Less than 1% of recipients of deceased donor organs were non-residents. Two countries never allow non-residents to access the DDWL, four allow access without restrictions and 22 only under specific conditions. Of those, most give access to non-resident patients already in their jurisdictions who are in a situation of vulnerability (urgent life-threatening conditions). In addition, patients may be given access: (i) after assessment by a specific committee (four countries); (ii) within the framework of official cooperation agreements (15 countries); and (iii) after patients have officially lived in the country for a minimum length of time (eight countries). The ethical and legal implications of these policies are discussed. Countries should collect accurate information about residency status of waitlisted patients. Transparent criteria for the access of non-residents to DDWL should be clearly defined at national level.
Donation after circulatory death (DCD) has become an accepted practice in many countries and remains a focus of intense interest in the transplant community. The present study is aimed at providing a description of the current situation of DCD in European countries. Specific questionnaires were developed to compile information on DCD practices, activities and post-transplant outcomes. Thirty-five countries completed the survey. DCD is practiced in 18 countries: eight have both controlled DCD (cDCD) and uncontrolled DCD (uDCD) programs, 4 only cDCD and 6 only uDCD. All these countries have legally binding and/or nonbinding texts to regulate the practice of DCD. The no-touch period ranges from 5 to 30 min. There are variations in ante and post mortem interventions used for the practice of cDCD. During 2008-2016, the highest DCD activity was described in the United Kingdom, Spain, Russia, the Netherlands, Belgium and France. Data on post-transplant outcomes of patients who receive DCD donor kidneys show better results with grafts obtained from cDCD versus uDCD donors. In conclusion, DCD is becoming increasingly accepted and performed in Europe, importantly contributing to the number of organs available and providing acceptable post-transplantation outcomes.
The Declaration of Istanbul on Organ Trafficking and Transplant Tourism (DoI) was developed in 2008, at an international summit convened by The Transplantation Society (TTS) and the International Society of Nephrology (ISN).1 At that time, trends in the data available regarding organ trafficking and transplant tourism activities around the world demonstrated relentless growth, fueled by illicit activities in several countries in Asia, Eastern Europe, Latin America, and Africa. These activities often involved patients traveling from other Asian and Latin American countries, as well as from North America, Western Europe, the Middle East, Australia, and New Zealand.