Solid Organ Transplant Litigation at One of Europe's Largest University Hospitals.

Due to its intrinsic complexity and the principle of collective solidarity that governs it, solid organ transplantation (SOT) seems to have been spared from the increase in litigation related to medical activity. Litigation relating to solid organ transplantation that took place in the 29 units of the Assistance Publique-Hôpitaux de Paris and was the subject of a judicial decision between 2015 and 2022 was studied. A total of 52 cases of SOT were recorded, all in adults, representing 1.1% of all cases and increasing from 0.71% to 1.5% over 7 years. The organs transplanted were 25 kidneys (48%), 19 livers (37%), 5 hearts (9%) and 3 lungs (6%). For kidney transplants, 11 complaints (44%) were related to living donor procedures and 6 to donors. The main causes of complaints were early post-operative complications in 31 cases (60%) and late complications in 13 cases (25%). The verdicts were in favour of the institution in 41 cases (79%). Solid organ transplants are increasingly the subject of litigation. Although the medical institution was not held liable in almost 80% of cases, this study makes a strong case for patients, living donors and their relatives to be better informed about SOT.

An Ethics Committee's Evaluation of Normothermic Regional Perfusion (NRP) in 2018-Unsatisfactory Answers Then-and Now.

An adult university hospital ethics committee evaluated a proposed TA-NRP protocol in the fall of 2018. The protocol raised ethical concerns about violation of the Uniform Determination of Death Act and the prohibition known as the Dead Donor Rule, with potential resultant legal consequences. An additional concern was the potential for increased mistrust by the community of organ donation and transplantation. The ethics committee evaluated the responses to these concerns as unable to surmount the ethical and legal boundaries and the ethics committee declined to endorse the procedure. These concerns endure.

Assessment of Knowledge of Legal Provisions on Organ Donation and Transplantation amongst Healthcare Workers in Nigeria: A Cross-sectional Study.

BACKGROUND: Advancements in the medical field have made organ transplantation an attractive treatment option for patients when indicated. Shortage of organs and commodification of organs are major challenges encountered in organ donation and transplantation. These could potentially breed unethical practices, if the process is not well regulated. AIM: The aim of this study was to assess the knowledge of healthcare workers (HCWs) on the legal provisions regulating organ donation and transplantation in Nigeria. METHODOLOGY: This cross-sectional study was conducted amongst physicians and nurses across Nigeria. Knowledge of legal provisions on organ donation and transplantation was assessed using a validated questionnaire that had 21 questions derived from the National Health Act. Each correctly answered question was given 1 point with a total obtainable score of 21 points. A score of ≥14 points was classified as good knowledge. P <0.05 was considered significant. RESULTS: A total of 836 physicians and nurses with a mean age of 37.61 ± 9.78 years participated in the study. Females and physicians constituted 53.3% and 62.9% of the respondents, respectively. The mean knowledge score of the respondents was 9.70 ± 2.91 points. Eighty-three (9.9%) respondents had a good knowledge score. There was a significantly higher proportion of male HCWs (P < 0.037) and older HCWs (P = 0.017) with good knowledge of legal provisions. On logistic regression, age was the only factor found to be associated with good knowledge of legal provision (adjusted odds ratio: 3.92; confidence interval: 1.33-11.59; P = 0.01). CONCLUSION: The overall knowledge of legal provisions on organ donation and transplant was very poor amongst HCWs in Nigeria. There is a need to educate them on these provisions to curb unethical practices.

A Comprehensive Analysis of Litigation in Organ Transplantation for Allegations of Insufficient Policy Coverage, Discrimination and Malpractice.

Introduction: Transplantation is a field with unique medical and administrative challenges that involve an equally diverse array of stakeholders. Expectantly, the litigation stemming from this field should be similarly nuanced. There is a paucity of comprehensive reviews characterizing this medicolegal landscape. Design: The Caselaw Access Project Database was used to collect official court briefs of 2053 lawsuits related to kidney, liver, heart, lung, and pancreas transplantation. A thematic analysis was undertaken to characterize grounds for litigation, defendant type, and outcomes. Cases were grouped into policy, discrimination, poor or unsuccessful outcome, or other categories. Results: One hundred sixty-four court cases were included for analysis. Cases involving disputes over policy coverage were the most common across all organ types (N = 55, 33.5%). This was followed by poor outcomes (N = 51, 31.1%), allegations of discrimination against prison systems and employers (N = 37, 22.6%) and other (N = 21, 12.8%). Defendants involved in discrimination trials won with the greatest frequency (N = 29, 90.62%). Defendants implicated in policy suits won 65.3% (N = 32), poor outcomes 62.2% (N = 28), and other 70% (N = 14). Of the 51 cases involving poor outcomes, plaintiffs indicated lack of informed consent in 23 (45.1%). Conclusion: Reconsidering the informed consent process may be a viable means of mitigating future legal action. Most discrimination suits favoring defendants suggested previous concerns of structural injustices in transplantation may not be founded. The prevalence of policy-related cases could be an indication of financial burden on patients. Future work and advocacy will need to substantiate these concerns and address change where legal recourse falls short.

American Society of Transplant Surgeons Normothermic Regional Perfusion Standards: Ethical, Legal, and Operational Conformance.

BACKGROUND: The American Society of Transplant Surgeons convened a multidisciplinary working group to address operational, ethical, and legal considerations surrounding normothermic regional perfusion (NRP) procurement. METHODS: The working group, comprising members from American Society of Transplant Surgeons and AST across various disciplines including transplant surgery, hepatology, critical care, and bioethics, collaborated to formulate recommendations and guidance for NRP procurement. RESULTS: The following topics were identified by the group as essential standards that need to be addressed for ethical, legal, and operational conformance: terminology; conceptualization of death in the context of NRP; and communication, logistics, and training and competency. CONCLUSIONS: Fourteen recommendations that support the ethical and legal acceptability of NRP in the United States and set expectations for the conduct of NRP procedures are provided.

Road To Deceased Donor Transplantation in Egypt.

In Egypt, there is presently a growing need to have a deceased donor transplant program. Egypt conducted its first kidney transplant from a living donor in 1976 and a first partial liver transplant in 2001. Since 2009, the Egyptian Health Authorities Combat Transplant Tourism in concordance with ethics codes and the Declaration of Istanbul Custodian Group has been in place. The Egyptian Transplantation Law of 2011 mentions that organs could be procured from deceased donors based on a will and on family consent. This law has had many critics, including religious authorities who have stressed that organs cannot be taken from a person with brain death because, in their view, life ends with death of all organs. Many intensivists disagree over the definition of death. In addition, the media has communicated contradicting and sometimes misleading health care information. Mummification is rooted in pharos practice and linked to religious beliefs. The ancient Egyptians believed that, by burying the deceased with their organs, they may rejoin with them in the afterlife. Since 2019, the transplant community in Egypt has started collaborations with international transplant organizations and campaigns with doctors and celebrities to donate their organs after death, which have stressed that a deceased donor program could help against end-stage organ mortality. In November 2022, after communications with politicians, President Abdelfattah El Sisi directed the government to establish a regional center for organ transplantation, which aimed to be the biggest in the Middle East and North Africa region. The new center will be part of a new medical city that would replace Nasser Medical Institution in Cairo, Egypt. The Ministry of Health issued an official form to be signed by a person before his death, accepting use of organs, to give hope and support to other patients in need.

Donation and Equitable Access to Organ, Tissue, and Cell Transplants: A Brazilian Perspective on the Strategy and Plan of Action 2019-2030.

OBJECTIVE: To position the Brazilian Transplant System within the context of the 4 Strategic Lines of Action proposed by the Pan-American Health Organization. METHOD: A specialist analysis was conducted through comparative analyses of the 4 Strategic Lines of Action, objectives, and indicators outlined in the Action Plan, along with the donation and transplantation system in accordance with Brazilian transplantation law. Subsequent to an in-depth review of the document issued by the health authority, a series of meetings involving 8 specialists in organ donation and transplantation were conducted. During these meetings, discussions were carried out with the objective of numerically interpreting each strategy presented in the document, and recommendations constructed. RESULTS: Four strategies were evaluated and only 2 of them the third (81,3%) and the fourth (90%) do not achieve the indicators to complete the objective related to equitable access to organ, tissue, and cell transplants in Brazil. CONCLUSION: The recommendations developed carry importance, as they are innovative and contribute to the establishment of priorities when shaping public policies. The report not only highlights indicators that were not satisfactorily met but also provides insights into the recommendations formulated to improve those indicators that have already been achieved and to work toward achieving those that have not yet been realized. Additionally, these recommendations can justify actions and establish priorities for research efforts in the field.

Transplantation in the Context of Migration and Refugees: A Summary of the DICG and TTS Ethics Committee Workshop, Buenos Aires, Argentina, September 2022.

Global conflicts and humanitarian crises have resulted in an unprecedented number of refugees and migrants. This challenges the limited resources of health care systems and jeopardizes the availability of transplant care for these deserving migrants and refugees. This was the basis for a workshop held during the Congress of the Transplantation Society (Buenos Aires, 2022). We elaborate on the proceedings of the workshop entitled "Transplantation in the Context of Migration and Refugees," organized by the Ethics Committee of The Transplantation Society and Declaration of Istanbul Custodian Group. Transplant providers from around the world shared strategies of how each region has responded to providing access to care for refugees and migrants in need of transplant services. The potential exploitation of this vulnerable group leading to illicit organ removal was addressed for each region. The Transplantation Society, Declaration of Istanbul Custodian Group, and global transplant community should continue to focus on the status of refugees and migrants and collaborate on strategies to provide access to transplant care for this deserving population. Global cooperation will be essential to provide vigilant oversight to prevent exploitation of this vulnerable population.

Organ Donation in Syria.

The first living donor kidney transplant in Syria was performed 44 years ago; by the end of 2022, 6265 renal transplants had been performed in Syria. Kidney, bone marrow, cornea, and stem cells are the only organs or tissues that can be transplanted in Syria. Although 3 heart transplants from deceased donors were performed in the late 1980s, cardiac transplant activities have since discontinued. In 2003, national Syrian legislation was enacted authorizing the use of organs from living unrelated and deceased donors. This important law was preceded by another big stride: the acceptance by the higher Islamic religious authorities in Syria in 2001 of the principle of procurement of organs from deceased donors, provided that consent is given by a first- or second-degree relative. After the law was enacted, kidney transplant rates increased from 7 per million population in 2002 to 17 per million population in 2007. Kidney transplants performed abroad for Syrian patients declined from 25% in 2002 to <2% in 2007. Rates plateaued through 2010, before the political crisis started in 2011. Forty-four years after the first successful kidney transplant in Syria, patients needing an organ transplant rely on living donors only. Moreover, 20 years after the law authorizing use of organs from deceased donors, a program is still not in place in Syria. The war, limited resources, and lack of public awareness about the importance of organ donation and transplant appear to be factors inhibiting initiation of a deceased donor program in Syria. A concerted and ongoing education campaign is needed to increase awareness of organ donation, change negative public attitudes, and gain societal acceptance. Every effort must be made to initiate a deceased donor program to lessen the burden on living donors and to enable national self-sufficiency in organs for transplant.

Una mirada al origen, funcionamiento y desafíos del nuevo sistema de donación y trasplantes chileno / A peek to the origin, functioning and challenges of the new Chilean transplantation system

Chile made several legal, practical and educational changes to the organ donation and transplant system in recent years, to improve its results. However, studies evaluating these reforms and suggesting further corrections are still pending. Our aim is to assess the new regulations and their reception by both the population and health care providers. Proposals are made to promote the development of a model of Chilean transplantation able to respond to the needs of the population.

Inequidad en trasplantes de órganos: ¿cómo establecer una justicia distributiva? / Inequity in organ transplants: How to establish a distributive justice?

El sistema de salud no redistribuye. Aunque debiera,porque es parte de la política social que se promete como correctivo de los desvíos concentradores de la economía. Pero la equidad no se ha discutido hasta ahora en los trasplantes de órganos, al menos en los sistemas universales como el argentino. Si existen, no encontramos publicaciones que prueben la existencia de inequidad en el proceso donación-trasplante de órganos. Sin embargo, esto se pone a la vista cuando re-elaboran los datos oficiales

Entrega de información y voluntariedad en el consentimiento presunto de la ley de donación de órganos en Chile / Information delivery and voluntariness in presumed consent in the Chilean organ donation law

A principios del año 2010 se reformó en Chile la antigua ley de donación y trasplante de órganos de 1996, instaurando una nueva forma de hacer donantes a los ciudadanos a través del llamado consentimiento presunto. A partir de lo anterior se analiza este concepto en relación a los pilares fundamentales del consentimiento informado; información, voluntariedad y capacidad, enfocado principalmente en los dos primeros. Respecto al principio de voluntariedad es claramente violado ya que actualmente no es necesario que la persona se manifieste para ser donante, sino que es posicionada automáticamente como tal a no ser que escoja lo contrario. Continuando con el análisis, se puede ver como la autoridad ha dejado de lado el principio de información, no poniendo énfasis en éste, a pesar de que la evidencia indica que es una forma efectiva de convencer a pacientes no donantes. La promulgación de la ley debe ser complementada con entrega de información y educación a los distintos sectores cívicos.

In early 2010, in Chile, the law of organ donation and transplantation from 1996 was amend ended, establishing a new form of organ donation to citizens through the presumed consent. From the above, this concept is analyzed according to the fundamental pillars of informed consent; information, voluntariness and capacity, mainly focused on the first two. Regarding the principle of voluntary it is clearly violated, as it is no longer necessary that the person chooses to be a donor if one does not manifest their willingness to not be one. Continuing with the analysis, it can be seen how the authority has neglected the principle of information, not emphasizing it, even though the evidence indicates that it is an effective way to convert non-donors. The enactment of the law must be supplemented by providing information and education to civic sectors.(AU)om the above, this concept is analyzed according to the fundamental pillars of informed consent; information, voluntariness and capacity, mainly focused on the first two. Regarding the principle of voluntary it is clearly violated, as it is no longer necessary that the person chooses to be a donor if one does not manifest their willingness to not be one. Continuing with the analysis, it can be seen how the authority has neglected the principle of information, not emphasizing it, even though the evidence indicates that it is an effective way to convert non-donors. The enactment of the law must be supplemented by providing information and education to civic sectors.

Declaración de Estambul en relación al tráfico de órganos y turismo en trasplante / Istambul Declaration on organ trafficking and transplant tourism

This is a translation into Spanish, done by Mario Uribe, M.D., F.A.C.S., and authorized by the Conference Organization, of the official statements signed by The Transplantation Society, The International Society of Nephrology and the representatives who participated at a WHO sponsored Conference held in Istambul, Turkey, April 30 to May 2, 2008.