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.

Uterine transplantation: legal and regulatory implications in England.

Uterus transplantation (UTx) is fast evolving from an experimental to a clinical procedure, combining solid organ transplantation with assisted reproductive technology. The commencement of the first human uterus transplant trial in the United Kingdom leads us to examine and reflect upon the legal and regulatory aspects closely intertwined with UTx from the process of donation to potential implications for fertility treatment and the birth of the resultant child. As the world's first ephemeral transplant, the possibility of organ restitution requires consideration and is discussed herein. TWEETABLE ABSTRACT: Uterine transplantation warrants a closer look at the legal frameworks on fertility treatment and transplantation in England.

Canadian Society of Transplantation White Paper: Ethical and Legal Considerations for Alcohol and Cannabis Use in Solid Organ Listing and Allocation.

Alcohol and cannabis use as a contraindication to organ transplantation is a controversial issue. Until recently, patients in Canada with alcohol-associated liver disease were required to demonstrate abstinence for 6 mo to receive a liver transplant. There is no equivalent rule that is applied consistently for cannabis use. There is some evidence that alcohol and cannabis use disorder pretransplant could be associated with worse outcomes posttransplantation. However, early liver transplantation for patients with alcohol-associated liver disease in France and in the United States has led to challenges of the 6-mo abstinence rule in Canada in the media. It has also resulted in several legal challenges arguing that the rule violates human rights laws regarding discrimination in the provision of medical services and that the rule is also unconstitutional (this challenge is still before the court). Recent legalization of cannabis use for adults in Canada has led to questions about the appropriateness of limiting transplant access based on cannabis use. The ethics committee of the Canadian Society of Transplantation was asked to provide an ethical analysis of cannabis and alcohol abstinence policies. Our conclusions were as follows: neither cannabis use nor the 6-mo abstinence rule for alcohol use should be an absolute contraindication to transplantation, and transplant could be offered to selected patients, further research should be conducted to ensure evidence-based policies; and the transplant community has a duty not to perpetuate stigma associated with alcohol and cannabis use disorders.

Islets Transplantation at a Crossroads - Need for Urgent Regulatory Update in the United States: Perspective Presented During the Scientific Sessions 2021 at the American Diabetes Association Congress.

Clinical islet allotransplantation has been successfully regulated as tissue/organ for transplantation in number of countries and is recognized as a safe and efficacious therapy for selected patients with type 1 diabetes mellitus. However, in the United States, the FDA considers pancreatic islets as a biologic drug, and islet transplantation has not yet shifted from the experimental to the clinical arena for last 20 years. In order to transplant islets, the FDA requires a valid Biological License Application (BLA) in place. The BLA process is costly and lengthy. However, despite the application of drug manufacturing technology and regulations, the final islet product sterility and potency cannot be confirmed, even when islets meet all the predetermined release criteria. Therefore, further regulation of islets as drugs is obsolete and will continue to hinder clinical application of islet transplantation in the US. The Organ Procurement and Transplantation Network together with the United Network for Organ Sharing have developed separately from the FDA and BLA regulatory framework for human organs under the Human Resources & Services Administration to assure safety and efficacy of transplantation. Based on similar biologic characteristics of islets and human organs, we propose inclusion of islets into the existing regulatory framework for organs for transplantation, along with continued FDA oversight for islet processing, as it is for other cell/tissue products exempt from BLA. This approach would reassure islet quality, efficacy and access for Americans with diabetes to this effective procedure.

The Clinical Conundrum of Cannabis: Current Practices and Recommendations for Transplant Clinicians: An Opinion of the Immunology/Transplantation PRN of the American College of Clinical Pharmacy.

Cannabis, or marijuana, comprises many compounds with varying effects. It has become a treatment option for chronic diseases and debilitating symptoms, and evidence suggests that it has immunomodulatory and antiinflammatory properties. Transplant centers are more frequently facing issues about cannabis, as indications and legalization expand. As of February 2020, 33 states and the District of Columbia have legalized medical cannabis, and 14 have legalized recreational cannabis. Moreover, 8 states have passed legislation prohibiting the denial of transplant listing solely based on cannabis use. Studies demonstrate the potential for significant pharmacokinetic and pharmacodynamic interactions between cannabis and immunosuppression. Additionally, safety concerns include increased risk of myocardial infarction, ischemic stroke, tachyarrhythmias, malignancy, neurocognitive deficits, psychosis, other neuropsychiatric disorders, cannabis use disorder, respiratory symptoms, and infection. A recent retrospective database study found a negative association between documented cannabis use disorder and graft survival, but little additional evidence exists evaluating this relationship. In the absence of robust clinical data, transplant centers need a clear, reasoned, and systematic approach to cannabis. The results of our national survey, unfortunately, found little consensus among institutions. As both recreational and medicinal cannabis become more ubiquitous nationwide, transplant centers will need to develop comprehensive policies to address its use.

Deceased Organ Donation in Syria: Challenges and Solutions.

The first living-donor kidney transplant in Syria was performed 41 years ago; by 2019, 5407 renal transplants had been performed there. Three heart transplants from deceased donors were performed in the late 1980s; cardiac transplant activities have since discontinued. In 2003, a new, national Syrian legislation was enacted authorizing the use of organs from living unrelated donors and from deceased donors. This important law was preceded by another big stride in this regard: 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 enactment of this law, 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. Kidney transplants continued at comparable rates until 2010, before the beginning of the political crisis in 2011. Four decades after the first successful kidney transplant in Syria, however, patients needing an organ transplant must rely on living donors only. Moreover, 17 years after the law authorizing use of organs from deceased donors, a program is still not in place in Syria, and additional improvement of the legal framework is needed. The war, limited resources, and lack of public awareness about the importance of organ donation and transplant appear to be major 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.

Ethical Issues Raised by the Media Portrayal of Adolescent Transplant Refusals.

Cases of adolescents in organ failure who refuse solid organ transplant are not common, but several have been discussed in the media in the United States and the United Kingdom. Using the framework developed by Buchanan and Brock for surrogate decision-making, I examine what role the adolescent should morally play when deciding about therapy for life-threatening conditions. I argue that the greater the efficacy of treatment, the less voice the adolescent (and the parent) should have. I then consider how refusals of highly effective transplant cases are similar to and different from refusals of other lifesaving therapies (eg, chemotherapy for leukemia), which is more commonly discussed in the media and medical literature. I examine whether organ scarcity and the need for lifelong immunosuppression justify differences in whether the state intervenes when an adolescent and his or her parents refuse a transplant. I argue that the state, as parens patriae, has an obligation to provide the social supports needed for a successful transplant and follow-up treatment plan, although family refusals may be permissible when the transplant is experimental or of low efficacy because of comorbidities or other factors. I conclude by discussing the need to limit media coverage of pediatric treatment refusals.

Uncontrolled Donation After Circulatory Death: A Unique Opportunity.

Uncontrolled donation after circulatory death (uDCD) refers to donation from persons who die following an unexpected and unsuccessfully resuscitated cardiac arrest. Despite the large potential for uDCD, programs of this kind only exist in a reduced number of countries with a limited activity. Barriers to uDCD are of a logistical and ethical-legal nature, as well as arising from the lack of confidence in the results of transplants from uDCD donors. The procedure needs to be designed to reduce and limit the impact of the prolonged warm ischemia inherent to the uDCD process, and to deal with the ethical issues that this practice poses: termination of advanced cardiopulmonary resuscitation, extension of advanced cardiopulmonary resuscitation beyond futility for organ preservation, moment to approach families to discuss donation opportunities, criteria for the determination of death, or the use of normothermic regional perfusion for the in situ preservation of organs. Although the incidence of primary nonfunction and delayed graft function is higher with organs obtained from uDCD donors, overall patient and graft survival is acceptable in kidney, liver, and lung transplantation, with a proper selection and management of both donors and recipients. Normothermic regional perfusion has shown to be critical to achieve optimal outcomes in uDCD kidney and liver transplantation. However, the role of ex situ preservation with machine perfusion is still to be elucidated. uDCD is a unique opportunity to improve patient access to transplantation therapies and to offer more patients the chance to donate organs after death, if this is consistent with their wishes and values.

Why NOTTO? The National Organ and Tissue Transplant Organisation and Why It Is Crucial to Regulate Organ Donation and Transplantation in India.

OBJECTIVES: This study addresses the establishment of the National Organ and Tissue Transplant Organisation (NOTTO) and its impact on organ donation and transplantation in India. METHODS: Yearly data, 2013 to 2018, from all the states and union territories of India as per the World Health Organization-Global Observatory on Donation and Transplantation (WHO-GODT) format, were analyzed and tabulated. The various national and international legislation, advisories, and reports that mandated establishment of national regulatory bodies were studied. Comparisons were drawn, noting points of similarity and contrast between analogous organizations. RESULTS: In the WHO Madrid Report 2004, the international advisory highlighted the need for a national transplantation agency for effective integrated development of donation and transplantation. Its parallel in India was the 2011 Amendment of the Transplantation of Human Organs Act 1994 to set NOTTO up with its first director in 2014, and also with a national donor and recipient registry to achieve transparent allocation. A challenging task for NOTTO was to collect from all transplant and/or retrieval centers their real-time data of donors, recipients, and transplants in the National Organ and Tissue Transplant Registry (NOTTR). However, NOTTO succeeded in collecting data offline from all 29 states and 7 union territories and submitted to GODT in 2019. There was a greater than 2-fold increase of deceased organ donors from 340 in 2013 (pre-NOTTO) to 875 in 2018 (post-NOTTO). The deceased organ donation rate went up from 0.27 to 0.65, and the total number of transplants went up from 4990 to 10,340 in the same period. All the outcome measures doubled or tripled, establishing the role of NOTTO. Albeit having differences, NOTTO is analogous to the National Transplant Organization of Spain and United Network of Organ Sharing of the United States. CONCLUSION: The 2011 Amendment of THOA 1994 provided the basis for the establishment of NOTTO, which has been crucial in regulating organ donation and transplantation in India with the setting up of the NOTTR in 2015. NOTTO has been instrumental in augmenting all outcomes.

A review of policies and programmes for human organ and tissue donations and transplantations, WHO African Region.

Several resolutions, endorsed by the World Health Assembly and the United Nations General Assembly, articulate the need to improve the availability, quality and safety of organ and tissue donation and transplantation, as well as to prevent and combat trafficking in human organs. Here we assessed the implementation of these resolutions pertaining to organ and tissue donations and transplantations by sending out a questionnaire to all 47 countries in the World Health Organization African Region. From 33 countries that provided data, we identified several obstacles and challenges. Compared to other regions, there are very limited data on organ donation and transplantation. Most countries are lacking legal and regulatory frameworks, since they did not yet establish a specific or comprehensive legislation covering donation and transplantation of human organs and tissues. Countries also have a poor national capacity to perform organ and tissue transplantations and the organization and management of national programmes are weak. Funding, both from domestic and external sources, is insufficient to implement effective transplantations programmes and patients have inadequate financial protection. To address these challenges, we propose that countries and partners should develop and implement policies, strategies, plans and regulatory frameworks for all aspects of organ and tissue donations and transplantations, including fighting against organ trafficking and transplant tourism. Where donation and transplantation programmes exist, stakeholders should develop the skills of human resources, adopt technical standards and quality management procedures to improve donation and transplantation of human organs and tissues.

De nombreuses résolutions approuvées par l'Assemblée mondiale de la Santé et l'Assemblée générale des Nations Unies ont souligné le besoin d'améliorer la disponibilité, la qualité et la sécurité des dons et de transplantations d'organes et de tissus humains, de même que celui d'assurer la prévention et la lutte contre le trafic d'organes. Dans ce document, nous avons étudié la mise en œuvre de ces résolutions relatives aux dons et transplantations d'organes et de tissus, par le biais d'un questionnaire envoyé aux 47 pays appartenant à la région Afrique de l'Organisation mondiale de la Santé. Nous avons identifié de nombreux obstacles et défis dans les 33 pays qui nous ont transmis des données. Par rapport à d'autres régions, il existe très peu d'informations à ce propos. La plupart des pays ne possèdent pas de cadres juridiques et réglementaires car ils n'ont pas encore établi de législation spécifique ou exhaustive couvrant les dons et transplantations d'organes et de tissus. Certains manquent également de moyens au niveau national pour réaliser des greffes d'organes et de tissus, tandis que leur organisation et leur gestion des programmes nationaux sont inadaptées. Tant les fonds provenant de l'intérieur que ceux fournis par l'extérieur ne permettent pas d'instaurer des programmes de transplantation efficaces. Enfin, les patients ne bénéficient pas d'une protection financière suffisante. Afin de pouvoir relever ces défis, nous proposons que ces pays et leurs partenaires développent et appliquent des politiques, stratégies, projets et règles pour tous les aspects liés aux dons et transplantations d'organes et de tissus, y compris la lutte contre le trafic d'organes et le tourisme de la transplantation. Et là où des programmes de dons et de transplantations existent, les intervenants devraient acquérir des compétences en ressources humaines, mais aussi adopter des normes techniques et des procédures de gestion de la qualité afin d'optimiser les dons et transplantations d'organes et de tissus.

Diversas resoluciones que la Asamblea Mundial de la Salud y la Asamblea General de las Naciones Unidas aprobaron articulan la necesidad de mejorar la disponibilidad, la calidad y la seguridad de la donación y el trasplante de tejidos y órganos, así como de prevenir y combatir el tráfico de órganos humanos. En el presente documento se evalúa la implementación de estas resoluciones relacionadas con la donación y el trasplante de tejidos y órganos por medio del envío de un cuestionario a los 47 países de la Región de África de la Organización Mundial de la Salud. De los 33 países que suministraron los datos, se identificaron varios obstáculos y desafíos. En comparación con otras regiones, existen muy pocos datos sobre la donación y el trasplante de órganos. La mayoría de los países carecen de marcos normativos y legales, ya que todavía no han establecido una legislación específica o integral que aborde la donación y el trasplante de tejidos y órganos humanos. Los países también tienen una capacidad nacional deficiente para realizar los trasplantes de tejidos y órganos, además de que la organización y la gestión de los programas nacionales son débiles. El financiamiento, tanto de fuentes nacionales como internacionales, es insuficiente para implementar programas de trasplantes efectivos y los pacientes tienen una protección financiera inadecuada. Para hacer frente a estos desafíos, se propone que los países y los socios elaboren e implementen políticas, estrategias, programas y marcos normativos de todos los aspectos de la donación y el trasplante de tejidos y órganos, incluida la lucha contra el tráfico de órganos y el turismo de trasplantes. Cuando existan programas de donación y trasplante, las partes interesadas deberían desarrollar las habilidades de los recursos humanos y adoptar estándares técnicos y procedimientos de gestión de calidad para mejorar la donación y el trasplante de tejidos y órganos humanos.

Knowledge of Law Students on the Problems of Modern Transplantology Is Good but It Can Always Be Better.

The progress of transplantation in Poland is influenced not only by medical staff, but also by the legislative organ, which approves amendments to the Act of the Collection, Storage and Transplantation of Cells, Tissues and Organs. This is why young lawyers should be aware of the scale of the problem and have current statistics on transplant issues. AIM: To assess the awareness of existing problems in the field of transplantation in Poland among law students. MATERIALS AND METHODS: A survey (with 11 questions) of 209 law students at the University of Bialystok (64% women and 36% men). RESULTS: Of respondents, 32% do not see the difference between dialysis treatment and transplantation, and 47% are convinced that the 5-year survival of dialysis patients is as much as 70% (in fact this number is twice as low). Still, 13% of people consider the stereotype of family consent for organ procurement is necessary. Of law students, 5% indicated that organ trafficking is allowed in Poland, and 41% believe that as many as 5% of people in Poland stated in writing opposition to removal of their organs after death. Fortunately, this number is much smaller (2%). The respondents have current knowledge about the place of Poland in the world in terms of the number of donors. Relatively good results were recorded in questions about medical knowledge. CONCLUSIONS: In most questions, the correct answer obtained the highest score, but it was not an absolute majority. There is a trend among law students for an optimistic approach to statistics and the real problems in transplantology.