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.

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.

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.

Early impact of COVID-19 on transplant center practices and policies in the United States.

COVID-19 is a novel, rapidly changing pandemic: consequently, evidence-based recommendations in solid organ transplantation (SOT) remain challenging and unclear. To understand the impact on transplant activity across the United States, and center-level variation in testing, clinical practice, and policies, we conducted a national survey between March 24, 2020 and March 31, 2020 and linked responses to the COVID-19 incidence map. Response rate was a very high 79.3%, reflecting a strong national priority to better understand COVID-19. Complete suspension of live donor kidney transplantation was reported by 71.8% and live donor liver by 67.7%. While complete suspension of deceased donor transplantation was less frequent, some restrictions to deceased donor kidney transplantation were reported by 84.0% and deceased donor liver by 73.3%; more stringent restrictions were associated with higher regional incidence of COVID-19. Shortage of COVID-19 tests was reported by 42.5%. Respondents reported a total of 148 COVID-19 recipients from <1 to >10 years posttransplant: 69.6% were kidney recipients, and 25.0% were critically ill. Hydroxychloroquine (HCQ) was used by 78.1% of respondents; azithromycin by 46.9%; tocilizumab by 31.3%, and remdesivir by 25.0%. There is wide heterogeneity in center-level response across the United States; ongoing national data collection, expert discussion, and clinical studies are critical to informing evidence-based practices.

Evolving ethical issues with advances in uterus transplantation.

While uterus transplantation was once considered only a theoretical possibility for patients with uterine factor infertility, researchers have now developed methods of transplantation that have led to successful pregnancies with multiple children born to date. Because of the unique and significant nature of this type of research, it has been undertaken with collaboration not only with scientists and physicians but also with bioethicists, who paved the initial path for research of uterus transplantation to take place. As the science of uterus transplantation continues to advance, so too must the public dialogue among obstetrician/gynecologists, transplant surgeons, bioethicists, and other key stakeholders in defining the continued direction of research in addition to planning for the clinical implementation of uterus transplantation as a therapeutic option. Given the rapid advances in this field, the time has come to revisit the fundamental questions raised at the inception of uterus transplantation and, looking forward, determine the future of this approach given emerging data on the procedure's impact on individuals, families, and society.

Assessment of Somatic Support Process for Pregnant Brain Death Patients Occurring in a Transition Country Between Asia and Europe from Medical, Ethical, Legal and Religious Aspects.

In spite of the fact that brain death during pregnancy is not a common occurrence, it is an important ethical problem for all cultures and religions can have a significant influence on the donation decision after brain death. Therefore, this study aimed to present the case of a pregnant patient developing brain death which occurred in our intensive care unit and to compare the medical, ethical and legal problems relating to pregnant cases developing brain death with 24 cases in the literature. A 21-year-old 19-week pregnant case with gestational diabetes was monitored in the anesthesia intensive care unit and developed brain death due to intracranial mass and intraventricular hemorrhage. Though brain death is a situation well understood by organ transplant professionals, brain death developing in pregnant patients still involves many medical, ethical and legal problems.

[Compulsory organ donation-a controversial topic]. / Verpflichtung zur Organspende ­ ein kontroverses Thema.

The number of organ donations in Germany has continuously fallen in recent years. The proposed Transplantation Act stipulates that every German citizen is considered an organ donor if he/she has not objected during his/her lifetime. This proposal has received wide approval, but also much criticism. The German Society for Urology, the German Society for Surgery, the German Society for Nephrology and the German Transplantation Society have all spoken out in press releases in favor of the introduction of an opt out (presumed consent) solution. The German Bundestag will decide on the proposed bill in autumn.

The VA Transplant Program: A rebuttal to criticism and a look to the future.

The Department of Veterans Affairs (VA) Transplant Program was established decades ago, is well resourced, and provides timely and high quality solid organ transplant care and services to a Nation of Veterans. In the past few years, the VA Transplant Program has received criticism that can be characterized as follows: the location of VA Transplant Centers (VATCs) requires Veterans to travel considerable distances for transplant care and services; the National Surgery Office (NSO) that provides oversight limits the number of active VATCs; Veterans Health Administration (VHA) policy limits referral of Veterans to non-VA transplant centers (community care); and the VA Transplant Program does not provide living donor transplant procedures. The MISSION Act of 2018 (Public Law 115-182) was enacted in part to address these themes by promoting community care and living donation. This article provides perspective regarding the VA Transplant Program and rebuttal to stated criticism: Travel to a transplant center is not isolated to the VA; the NSO does not limit VATC activation; current VHA policy authorizes community care; and the VA Transplant Program currently performs living donor procedures. The MISSION Act, as intended, has the potential to decrease referrals to the VA Transplant Program by 30%.

Transplant advocacy in the era of the human immunodeficiency virus organ policy equity act.

In 2013, the Human Immunodeficiency Virus Organ Policy Equity (HOPE) Act was passed to permit the conduct of research on the transplantation of organs from donors infected with human immunodeficiency virus (HIV) into recipients who are HIV-positive. The HOPE Act workshop had many objectives including the discussion of the ethical issues involved in HIV-positive to HIV-positive transplantation, the informed consent process, and the role of independent advocates in the context of HIV to HIV transplantation. As of 2018, 22 transplant hospitals are approved, or undergoing approval, to perform HIV-positive to HIV-positive transplant surgeries, and this number is expected to grow. This study aims to: (i) briefly review the history and research of HIV+ transplantation prior to the HOPE Act, (ii) describe the ethical principles supporting the HOPE Act, (iii) characterize the informed consent process, and (iv) provide guidance regarding the role of independent advocates in the context of HIV-positive to HIV-positive transplantation.

When politics meets science: What impact might Brexit have on organ donation and transplantation in the United Kingdom?

Brexit may lead to major political, societal, and financial changes-this has significant implications for a tax revenue funded healthcare system such as the United Kingdom's (UK) National Health Service. The complex relationship between European Union (EU) legislation and clinical practice of organ donation and transplantation is poorly understood. However, it is unclear what impact Brexit may have on organ donation and transplantation in the UK and EU. This work aims to describe the current legislative interactions affecting organ donation and transplantation regulation and governance within the UK and EU. We consider the potential impact of Brexit on the practical aspects of transplantation such organ-sharing networks, logistics, and the provision of health care for transplant patients when traveling to the EU from the UK and vice versa, as well as personnel, and research. Successful organ donation and transplantation practices rely on close collaboration and co-operation across Europe and throughout the United Kingdom. The continuation of such relationships, despite the proposed legislative change, will remain a vital and necessary component for the ongoing success of transplantation programs.

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.

[LEGAL REGULATION OF TRANSPLANTOLOGY AT THE PRESENT STAGE: UKRAINIAN ISSUE AND EXPERIENCE OF FOREIGN STATES].

The objective of the research is to analyze the legal regulation in the transplantology field at the present stage in Ukraine. To address identified challenges, the author investigates the foreign countries experience and suggests ways of improving certain mechanism for legal regulation in the field of organ transplantation and anatomical materials. The empiric material of the study included a wide range of legal instruments regulating this sphere of legal relationships, information regarding the problems of their application, statistics, expert analysis of Ukrainian and foreign researchers. Methodological mechanism of current research includes such methods: systematic, logical and formal, structural-functional, comparative. The research found that the most world's successful model for the organization of transplantation is in Spain. Additionally, the criteria for the reception of such a model are singled out as well as certain aspects of their application in Ukraine are analyzed. Particularly, the most important criteria are: universal and general territorial proliferation of national health systems; relevant economic resources (special attention is paid to the fact that transplantation is not a medicine of luxury, and an adequate compensation to hospitals for transplantation operations should serve as a main economic aspect); an adequate and necessary number of doctors and nurses; the availability of advanced technical options for medical mechanical ventilation (air conditioning of dead bodies). The research led to the following overall findings. Due to the rapid development of medical and biological sciences, there is an urgent need on further investigation of legal, moral and ethical, general medical aspects of transplantation with subsequent proposals for improving legislation in the field of human organs transplantation and other anatomical materials. At the same time, development of appropriate legislation by complex groups of cross-disciplinary specialists and experts (in medicine, biology, law and bioethics) is the key to legal regulation effectiveness.

Ethical and medico-legal remarks on uterus transplantation: may it solve uterine factor infertility?

Uterus transplantation was firstly tested with animal trials sixty-five years ago. Despite several successful attempts in human subjects, the different procedures still lay at the experimental stage, in need of further studies and investigations before they can be considered as standard clinical practices. Uterus transplant cannot be regarded as a life-saving procedure, but rather a method to restore woman ability to procreate, when lost, thus improving her quality of life. Uterus transplant is a complex surgical procedure and presents significant health threats. Medical staff should therefore always obtain informed consent from patients, emphasizing such risks. Before that, women undergoing uterine transplants should be thoroughly informed about the hazards inherent to the procedure and especially about the dangers of immunosuppressant drugs, administered after the surgery which may injure the fetus, eventually formed in the restored organ and even lead to its death, thus nullifying the purpose of the transplant itself. Therefore, the risk-benefit ratio of uterus transplantation needs to be carefully assessed and described.

The current status and future perspectives of organ donation in Japan: learning from the systems in other countries.

The revised Organ Transplant Law came into effect in Japan in July 2010. The law allows for organ procurement from brain-dead individuals, including children, with family consent from subjects who had not previously rejected organ donation. Nevertheless, the number of cadaveric organ donations has not increased as expected. The Spanish Model is widely known as the most successful system in the field of organ donation. The system includes an earlier referral of possible donors to the transplant coordination teams, a new family-based approach and care methods, and the development of additional training courses aimed at specific groups of professionals, which are supported by their corresponding societies. South Korea, a country which neighbors Japan, has recently succeeded in increasing the rates of organ donation by introducing several systems, such as incentive programs, an organ procurement organization, a donor registry, and a system to facilitate potential donor referral. In this review, we present the current status of organ donation in Japan and also explore various factors that may help to improve the country's low donation rate based on the experiences of other developed countries.

The 25th anniversary of the Eurotransplant Acceptable Mismatch program for highly sensitized patients.

In 2014, the Eurotransplant Acceptable Mismatch (AM) program celebrated its 25th anniversary. The AM program was initiated to enhance transplantation of highly sensitized patients awaiting a renal transplant within the Eurotransplant region. Unlike the regular renal transplant allocation, in which the histocompatibility parameters consist of the degree of compatibility with the patient's human leucocyte antigen (HLA) type and the absence of unacceptable antigens, the AM program is based on compatibility of the possible donor with the combination of the patient's HLA type and the acceptable antigens. These acceptable antigens are defined as HLA antigens to which the patient has never made antibodies. This strategy aims at the prediction of a negative cross match. Since the start of the program almost 2000 patients participated and more than 1000 patients were transplanted with excellent transplant outcome, comparable to that of non-immunized transplant recipients within Eurotransplant. Progressive insights have led to fine-tuning of the AM program through the years, as well as to novel initiatives, including a recent consortium study to determine the feasibility of a Europe-wide AM program. The current review will tell the story of the AM program in a historical perspective, but will also provide an open-minded look into the future of transplanting highly sensitized patients.

To achieve national self-sufficiency: recent progresses in deceased donation in Korea.

BACKGROUND: The disparity between patients awaiting transplantation and available organs has widened, and resultant organ shortage became a world crisis. The transplantation community has made considerable progress in national organ donation system in Korea, and significant growth in the number of deceased donors has been witnessed. METHODS: After introduction of the Organ Transplant Act, which was enacted in 2000, transparency was established in organ allocation system in Korea. However, the number of deceased donor dwindled significantly from 162 in 1999 to 36 in 2002. To improve deceased donation, several strategies were pursued, and finally new national organ donation system was established through the amendment of the Organ Transplant Act. RESULTS: Organ incentive system, which was introduced in 2003, failed to increase the number of deceased donors (68 in 2003, 86 in 2004, and 91 in 2005). Monetary incentive to the bereaved family was introduced in 2006 and slightly increased the number of deceased donor (141 in 2006). However, this effect was not long-lasting (148 in 2007). After enforcement of the new Organ Transplant Act, which included nationwide independent organ procurement organization and mandatory report of potential brain death, the number of deceased donors significantly increased, reaching 368 in 2011. The growth continued and the number of deceased donors reached 409 (8.03 pmp) in 2012. CONCLUSION: There has been a significant growth in the number of deceased donors in Korea since the appropriate deceased organ donation system was launched. A comprehensive national program is required to improve deceased donation and achieve self-sufficiency.