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Governments throughout the industrialized world make decisions that fundamentally affect the quality and accessibility of medical care. In the United States, despite the absence of universal health insurance, these decisions have great influence on the practice of medicine. InMedical Governance, David Weimer explores an alternative regulatory approach to medical care based on the delegation of decisions about the allocation of scarce medical resources to private nonprofit organizations. He investigates the specific development of rules for the U.S. organ transplant system and details the conversion of a voluntary network of transplant centers to one private rulemaker: the Organ Procurement and Transplantation Network (OPTN). As the case unfolds, Weimer demonstrates that the OPTN is more efficient, nimble, and better at making evidence-based decisions than a public agency; and the OPTN also protects accountability and the public interest more than private for-profit organizations. Weimer addresses similar governance arrangements as they could apply to other areas of medicine, including medical records and the control of Medicare expenditures, making this timely and useful case study a valuable resource for debates over restructuring the U.S. health care system.

This volume examines the issue of human organ trafficking from the perspectives of criminal justice, business, medicine, ethics, philosophy, and theology. It presents case studies of the trafficking of body parts occurring in the U.S. and Mexico, examines the increase in organ harvesting from Chinese prisoners, and describes widespread instances of trafficking in Europe. It discusses the economic ramifications of possible legislation of the sale of body parts and explores ethical issues surrounding the kidney shortage and incentives to promote donation. It also offers arguments for and against compensation for transplant organs from philosophical and religious perspectives.

Professor David Price gives a comprehensive analysis of existing laws and policies governing transplantation practices around the world. He examines the meaning of death, cadaver organ procurement policies, use of living donors, trading in human organs, experimental transplant procedures and xenotransplantation, identifying challenges and strategies, current practices and future developments.

The Council of Europe (CoE) and the European Union (EU) share the same fundamental values, i.e., human rights, democracy and the rule of law, but are separate entities which perform different, yet complementary, roles. The CoE brings together governments from across Europe, and beyond, to agree minimum legal standards in a wide range of areas. CoE monitors how countries apply the standards that they have chosen to sign up to. It provides technical assistance, often working together with the EU. The EU refers to those same European values as a key element of its political and economic integration processes. It often builds upon CoE standards when drawing up legal instruments and agreements which apply to the member states, furthermore, monitoring work in its dealings with neighbouring countries, many of which are CoE member states. At CoE, the European Committee on Organ Transplantation (CD-P-TO) is the steering committee in charge of organ transplantation activities. In the EU, the regulation on Substances of Human Origin (SoHO) was endorsed in 2024. The CoE and the EU thave concluded an agreement expanding their co-operation in the field of SoHO. In the BTC regulation, xenotransplantation is not included.

The 1984 National Organ Transplant Act (NOTA) saw to the establishment of a national Organ Procurement and Transplantation Network (OPTN). As envisaged by the law's congressional sponsors, the Secretary of the US Department of Health and Human Services (HHS) was to institute a \"central registry linking donors and potential recipients.\" In addition, the Secretary was to see to the institution of a \"scientific registry of organ recipients\" as well as \"designate and maintain an identifiable unit in the Public Health Service to coordinate Federal organ transplant programs and policies.\" Forty years later, over 103,000 patients remain on the organ transplant waiting list for an average of 3-5 years during which time 17 die every day. It is against this backdrop that the Senate Committee on Finance (SCF) launched a sustained inquiry in 2020 with an eye towards assessing the status quo and potential remedies thereof. A Health Resources & Services Administration (HRSA) Modernization Initiative followed suit in March 2023. In this Perspective, we review the state of OPTN, discuss its recent oversight by the SCF, and describe its future reform as conceived and enunciated by HRSA.

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.

Deficiencies and shortfalls in the supply of human organs for transplantation and human tissue for research generate policy dilemmas across the world and have often given rise to major and deleterious controversies, such as those relating to organ and tissue retention practices following post-mortem examination. They also create an environment in which illegitimate commercial activities flourish. At the same time, patients are denied the therapy they desperately require and researchers are impeded from carrying out vital work into the causes of, and efficacious treatments for, major illnesses and diseases. David Price sets out a clear and integrated legal and policy framework which emanates from the tissue source but protects the interests of donors and relevant professionals through tailored property entitlements, but without presupposing rights to trade in 'original' materials.

China's aims are to develop an ethical and sustainable organ transplantation system for the Chinese people and to be accepted as a responsible member of the international transplantation community. In 2007, China implemented the Regulation on Human Organ Transplantation, which was the first step towards the establishment of a voluntary organ donation system. Although progress has been made, several ethical and legal issues associated with transplantation in China remain, including the use of organs from executed prisoners, organ scarcity, the illegal organ trade, and transplantation tourism. In this Health Policy article we outline the standards used to define cardiac death in China and a legal and procedural framework for an organ donation system based on voluntary donation after cardiac death that adheres to both China's social and cultural principles and international transplantation standards.

BackgroundThere is currently an inadequate supply of allografts to meet the number of transplant candidates worldwide. A number of controversial policies, including implementation of a presumed consent organ donation system, have been considered to rectify the organ donation crisis.AimsA secondary retrospective data analysis aimed to assess the impact of switching to a presumed consent organ donation model on organ donation rates.MethodsDeceased organ donation rates were compared before and after countries adopted presumed consent.ResultsSix countries met entry criteria. All six countries had an increase in liver donation rates, while 4 out of the six countries had an increase in kidney donation rates. The overall mean (± SD) liver donation rate was 3.23 (± 0.97) per million population (pmp) before the transition and 6.46 (± 1.81) pmp after the transition (p < 0.0001). The overall mean (± SD) kidney donation rate was 17.94 (± 3.34) pmp before the transition and 26.58 (± 4.23) pmp after the transition (p < 0.0001). The percentage increase in liver and kidney donation rates varied among countries, ranging from 28 to 1186%.ConclusionThe transition from explicit to presumed consent was associated with a significant increase in liver donation rates in all countries that met our criteria, while the effect on kidney donation rates was partially realized. Although presumed consent alone is unlikely to explain the increase in donation rates, the adoption of such a policy may prove to be a worthwhile risk for countries experiencing consistently low organ donation rates.