Summary
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.
The access of non‐resident patients to the deceased donor waiting list (DDWL) poses different challenges. This study shows the different policies in place in the European setting and discuss its ethical and legal implications.
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.
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.
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.
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.
The 2018 Edition of the Declaration of Istanbul on Organ Trafficking and Transplant Tourism (DoI) provides an updated set of principles and definitions to guide policymakers and health professionals ...working in organ donation and transplantation. A draft of the new edition was circulated to the public and transplant professionals through an online consultation process, which also sought feedback on a draft explanatory article that explained the principles and discussed some of their practical implications. Both drafts were revised in response to feedback from participants in the consultation. We present here the discussion article, which is intended to assist stakeholders in applying the principles of the DoI by providing more detailed information about the meaning and potential implications of implementing the DoI in various contexts.
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.
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.
Many nations are able to prosecute transplant-related crimes committed in their territory, but transplant recipients, organ sellers and brokers, and transplant professionals may escape prosecution by ...engaging in these practices in foreign locations where they judge the risk of criminal investigation and prosecution to be remote.
The Declaration of Istanbul Custodian Group convened an international working group to evaluate the possible role of extraterritorial jurisdiction in strengthening the enforcement of existing laws governing transplant-related crimes across national boundaries. Potential practical and ethical concerns about the use of extraterritorial jurisdiction were examined, and possible responses were explored.
Extraterritorial jurisdiction is a legitimate tool to combat transplant-related crimes. Further, development of a global registry of transnational transplant activities in conjunction with a standardized international referral system for legitimate travel for transplantation is proposed as a mechanism to support enforcement of national and international legal tools.
States are encouraged to include provisions on extraterritorial jurisdiction in their laws on transplant-related crimes and to collaborate with professionals and international authorities in the development of a global registry of transnational transplant activities. These actions would assist in the identification and evaluation of illicit activities and provide information that would help in developing strategies to deter and prevent them.
Summary
After more than 120 hand‐upper extremity and 37 face transplant procedures performed worldwide, vascularized composite allotransplantation (VCA) now falls under the scope of organ transplant ...legislation in Europe and the United States. While in the USA, VCA has been considered as standard care since 2014, VCA in Europe is still performed through clinical research trials, except in United Kingdom. However, after two decades of favourable experience with upper extremity transplantation (UET), professionals in Europe are proposing hand allotransplantation as “controlled standard” care, as opposed to face transplantation (FT), which is still a challenging activity. The European Committee on Organ Transplantation (CD‐P‐TO) has elaborated a position paper to provide recommendations concerning regulatory aspects for UET and FT. It is aimed at Health Authorities in charge of the oversight – and coordination – of organ donation and transplantation, and at professional groups to help them manage such complex and costly programs dedicated to properly selected patients.
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