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In 2008 Israel enacted a new law on organ transplantation which granted priority on the waiting list to holders of donor-cards who become patients in need of organ transplantation. This paper offers ethical criticism of the priority system arguing that the "reward" is by necessary also a "punishment". Moreover, because donor-cards have no binding power in Israeli law, the reward/punishment is actually directed at declarations, not actions, and, consequently, violates the freedom of conscience and expression. The reward system is also incompatible with fundamental values of medical ethics and with the very logic of talion, because the law punishes non-signers but not patients who are responsible for the loss of their organs. Lastly, I argue, that because priority on a waiting list is a positional good, it communicates a false message as if donation is an excellence of the few, and it legitimizes a rational choice to prefer wholesomeness of the cadaver to the risk of low rank in the priority list.

Many U.S. states have passed legislation providing leave to organ and bone marrow donors and/or tax benefits for live and deceased organ and bone marrow donations and to employers of donors. We exploit cross-state variation in the timing of such legislation to analyze its impact on organ donations by living and deceased persons, on measures of the quality of the transplants, and on the number of bone marrow donations. We find that these provisions do not have a significant impact on the quantity of organs donated. The leave laws, however, do have a positive impact on bone marrow donations, and the effect increases with the size of the population of beneficiaries and with the generosity of the legislative provisions. Our results suggest that this legislation works for moderately invasive procedures such as bone marrow donation, but these incentives may be too low for organ donation, which is riskier and more burdensome., (Copyright © 2013 Elsevier B.V. All rights reserved.)

A critical controversy surrounds the type of allowable interventions to be carried out in patients who are potential organ donors, in an attempt to improve organ perfusion and successful transplantation. The main goal is to transplant an organ in conditions as close as possible to its physiological live state. "Elective ventilation" (EV), that is, the use of ventilation for the sole purpose of retrieving the organs of patients close to death, is an option which offsets the shortage of organ donation. We have analyzed the legal context of the dying process of the organ donor and the feasibility of EV in the Italian context. There is no legal framework regulating the practice of EV, neither is any real information given to the general public. A public debate has yet to be initiated. In the Italian cultural and legislative scenario, we believe that, under some circumstances (i.e., the expressed wishes of the patient, even in the form of advance directives), the use of EV does not violate the principle of beneficence. We believe that the crux of the matter lies in the need to explore the real determination and will of the patient and his/her orientation towards the specific aim of organ donation.

Over the last 6 decades, organ transplantation has achieved great success to become standard therapy for the treatment of patients with end-stage organ failure. With this success has emerged candidate wait lists that greatly outnumber the current supply of deceased donor organs. The increasing number of candidates and transplants performed has resulted in an organ allocation process that occurs at a local, regional, and sometimes national level. A brief description of the history is presented as well as the methodologies involved in allocation of a donor organ to a single recipient., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Organ transplantation has evolved into the standard of care for patients with end-stage organ failure. Despite considering increasingly complex transplant recipients for organs recovered from donors with increasing comorbid conditions, 1-year patient survival following kidney transplantation is 97% in the United States, whereas liver transplant recipient 1-year survival is 90%. There were 16,485 kidney recipients in the United States in 2012, and 6256 patients who underwent liver transplantation. The intent of this review is to highlight the logistics required for transplantation as well as reviewing the current oversight of transplantation., (Copyright © 2013 Elsevier Inc. All rights reserved.)

We describe the parallel changes that have taken place in recent years in two countries, Israel and The Philippines, the former once an "exporter" of transplant tourists and the latter once an "importer" of transplant tourists. These changes were in response to progressive legislation in both countries under the influence of the Declaration of Istanbul. The annual number of Israeli patients who underwent kidney transplantation abroad decreased from a peak of 155 in 2006 to an all-time low of 35 in 2011 while in the Philippines the annual number of foreign transplant recipients fell from 531 in 2007 to two in 2011. The experience of these two countries provides a "natural experiment" on the potential impact of legal measures to prevent transplant tourism.

The Philippine government officially responded to the Declaration of Istanbul on Organ Trafficking and the related WHO Guidelines on organ transplantation by prohibiting all transplants to foreigners using Filipino organs. However, local tourists have escaped the regulatory radar, leaving a very wide gap in efforts against human trafficking and transplant tourism. Authorities need to deal with the situation seriously, at a minimum, by issuing clear procedures for verifying declarations of kinship or emotional bonds between donors and recipients. Foreigners who come to the country for transplants with same-nationality donors constitute a problem that is replicated in many transplant centers around the world. Also, emotionally related living donors continue to pose challenges for ethics committees, especially because of the realities associated with the existence of extended families. Those who find themselves facing these issues need to be armed with clear protocols for going through the process of verifying documents and individual declarations assiduously. There is also a need for international referral mechanisms at least to ensure that governments are aware when their citizens travel for transplant so they can take steps they consider suitable to address the vulnerabilities of exploited persons.

Increasing the number of organ transplants is a priority for most governments. While potential new legislation for donor registration, such as the Welsh Government white paper on establishing an opt-out system for Welsh residents, is the focus of most ethical and legal scrutiny, there are also other approaches to increase the number of patients receiving organ transplants. The then National Institute for Health and Care Excellence (NICE) published guidance on this issue in 2011, but subsequent debate in this journal has suggested that the guidance was presumptuous and might encourage unethical practice. This paper addresses these concerns and concludes that the NICE guidance provides a legal, ethical and clinically relevant way forward in a complex and developing public health issue.

: HHS is issuing this final rule (herein referred to as ``this rule'') to add vascularized composite allografts (VCAs) as specified herein to the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network (OPTN) (herein referred to as the OPTN final rule). When it enacted the National Organ Transplant Act in 1984, Congress included a definition of the term organ and authorized the Secretary to expand this definition by regulation. The Secretary has previously exercised this authority and expanded the statutory definition of organ. Prior to this rule, the OPTN final rule defined covered organs as ``a human kidney, liver, heart, lung, or pancreas, or intestine (including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract). Blood vessels recovered from an organ donor during the recovery of such organ(s) are considered part of an organ with which they are procured for purposes of this part if the vessels are intended for use in organ transplantation and labeled `For use in organ transplantation only.' '' This rule also includes a corresponding change to the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984, as amended (NOTA).

By 2005, human organ trafficking, commercialization, and transplant tourism had become a prominent and pervasive influence on transplantation therapy. The most common source of organs was impoverished people in India, Pakistan, Egypt, and the Philippines, deceased organ donors in Colombia, and executed prisoners in China. In response, in May 2008, The Transplantation Society and the International Society of Nephrology developed the Declaration of Istanbul on Organ Trafficking and Transplant Tourism consisting of a preamble, a set of principles, and a series of proposals. Promulgation of the Declaration of Istanbul and the formation of the Declaration of Istanbul Custodian Group to promote and uphold its principles have demonstrated that concerted, strategic, collaborative, and persistent actions by professionals can deliver tangible changes. Over the past 5 years, the Declaration of Istanbul Custodian Group organized and encouraged cooperation among professional bodies and relevant international, regional, and national governmental organizations, which has produced significant progress in combating organ trafficking and transplant tourism around the world. At a fifth anniversary meeting in Qatar in April 2013, the DICG took note of this progress and set forth in a Communiqué a number of specific activities and resolved to further engage groups from many sectors in working toward the Declaration's objectives.

This article investigates the impact of legal determinants of cadaveric and living donor organ transplantation rates using panel data on legislative, procedural and managerial aspects of organ transplantation and procurement, government health expenditures, enrollment rates, religious beliefs, legal systems and civil rights and liberties for 62 countries over a 2-year period. Under living donor organ transplantation, we found that guaranteeing traceability of organs by law or performing psychiatric evaluation to living donors has a sizeable, negative impact on living transplant rates once the remaining determinants of living transplantation have been controlled for. Under cadaveric transplantation, our findings do not suggest an unequivocal and positive association between presumed consent, donor registries and cadaveric transplant rates. However, legally requiring family consent or maintaining written procurement standards for deceased donors has a sizeable, negative impact on cadaveric transplant rates. The latter finding suggests that informing families rather than asking for consent may be an effective strategy to raise procurement rates while respecting patient autonomy. Finally, we confirm that predominantly non-Christian countries have significantly higher living but lower cadaveric transplant rates., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Publication is one of the primary rewards in the academic research community and is the first step in the dissemination of a new discovery that could lead to recognition and opportunity. Because of this, the publication of research can serve as a tacit endorsement of the methodology behind the science. This becomes a problem when vulnerable populations that are incapable of giving legitimate informed consent, such as prisoners, are used in research. The problem is especially critical in the field of transplant research, in which unverified consent can enable research that exploits the vulnerabilities of prisoners, especially those awaiting execution. Because the doctrine of informed consent is central to the protection of vulnerable populations, we have performed a historical analysis of the standards of informed consent in codes of international human subject protections to form the foundation for our limit and ban recommendations: (1) limit the publication of transplant research involving prisoners in general and (2) ban the publication of transplant research involving executed prisoners in particular., (Copyright © 2013 American Association for the Study of Liver Diseases.)

Purpose of Review: This article conveys early findings with respect to changes in patient and graft survival since Centers for Medicare & Medicaid Services (CMS) regulations for Medicare coverage of solid organ transplantation became effective on 28 June 2007., Recent Findings: Programmes cited by CMS for subpar outcomes have strong incentives to improve performance and have risen to the challenge. Adult kidney programmes that entered into System Improvement Agreements or were approved for mitigating factors by CMS, for which there is a 2-year postsurvey tracking period (N = 15), improved their standardized mortality ratio (SMR) for 1-year posttransplant patient survival from 2.05 to 1.17 on average. Volume in some of those programmes tended to decline, whereas national volume increased. Nationally, average donor risk across U.S. adult kidney transplant programmes increased approximately 6% from CY2001 through CY2010. Average recipient risk also increased. Despite increased risk profiles, national survival rates for all organ types continued to increase from 2007 through 2010., Summary: People who receive transplants from programmes cited by CMS for subpar outcomes tend to have much improved prospects for posttransplant survival. Individuals waitlisted in those programmes may face lower odds of receiving a transplant, at least temporarily, due to the tendency of such programmes to reduce volume as they regroup to improve their outcomes.

The Japanese Organ Transplant Law was amended, and the revised law took effect in July 2010 to overcome extreme donor shortage and to increase the availability of donor organs from brain-dead donors. It is now possible to procure organs from children. The year 2011 was the first year that it was possible to examine the results of this first extensive revision of the Japanese Organ Transplant Law, which took effect in 1997. Currently, seven transplant centers, including Tohoku, Dokkyo, Kyoto, Osaka, Okayama, Fukuoka and Nagasaki Universities, are authorized to perform lung transplantation in Japan, and by the end of 2011, a total of 239 lung transplants had been performed. The number of transplants per year and the ratio of brain-dead donor transplants increased dramatically after the revision of the Japanese Organ Transplant Law. The survival rates for lung transplant recipients registered with the Japanese Society for Lung and Heart-lung Transplantation were 93.3 % at 1 month, 91.5 % at 3 months, 86.3 % at 1 year, 79.0 % at 3 years, and 73.1 % at 5 years. The survival curves for brain-dead donor and living-donor lung transplantation were similar. The survival outcomes for both brain-dead and living-donor lung transplants were better than those reported by the International Society for Heart and Lung Transplantation. However, donor shortage remains a limitation of lung transplantation in Japan. The lung transplant centers in Japan should continue to make a special effort to save critically ill patients waiting for lung transplantation.

This paper examines questions concerning elective ventilation, contextualised within English law and policy. It presents the general debate with reference both to the Exeter Protocol on elective ventilation, and the considerable developments in legal principle since the time that that protocol was declared to be unlawful. I distinguish different aspects of what might be labelled elective ventilation policies under the following four headings: 'basic elective ventilation'; 'epistemically complex elective ventilation'; 'practically complex elective ventilation'; and 'epistemically and practically complex elective ventilation'. I give a legal analysis of each. In concluding remarks on their potential practical viability, I emphasise the importance not just of ascertaining the legal and ethical acceptability of these and other forms of elective ventilation, but also of assessing their professional and political acceptability. This importance relates both to the successful implementation of the individual practices, and to guarding against possible harmful effects in the wider efforts to increase the rates of posthumous organ donation.

The Organ Transplantation Act, including transplantation of organs from brain-dead donors, entered into force in Korea on February 9, 2000. This article introduces the Organ Transplantation Act, focusing on scope of the Act, determination of brain death, removal of organs from brain-dead or deceased donors, removal from living donors, organ allocation, and prohibition of trade in human organs. Especially, some primary ethical dilemmas surrounding organ allocation arise from the shortage of available organs. The primary ethical problems surrounding organ allocation are as follows. A key purpose of the organ donation incentive system is to increase the number of organ transplants from brain-dead donors. In particular, the priority for kidney patient was allowed in consideration of doctor's strong desire to increase the brain-dead donors. Also, the organ allocation criteria based on the organ donation incentive system appear unfair, especially for the kidney patient, because the criteria do not fit the principles of distributive justice. In the future, the organ donation incentive system itself may need to be reexamined.

Brain death or neurologic death has gradually become recognized as human death over the past decades worldwide. Nevertheless, in Japan, the New York State, and the State of New Jersey, death is declared based not on brain death criteria, but on cardio-pulmonary criteria. In Japan, the 1997 Organ Transplant Law legalized brain death determination exclusively when organs were to be procured from brain-dead patients. Even after 2009 law revision, the default definition of death continued to be based on cardio-pulmonary criteria, despite the criticism. The cases of Japan and the United States provide a good reference as social experiments of appreciating conscientious or religio-cultural dimensions in health care. This text theoretically examines the 1997 organ transplant law of Japan and its 2009 revision, presenting some characteristics of Japan's case compared to American cases and the implications its approach has for the rest of the world. This is an example in which a foreign idea that did not receive widespread support from Japanese citizens was transformed to fit the religio-cultural landscape.

Background: In this article we present an economic evaluation of policies aimed at increasing deceased organ donation in Chile, a developing country that has low donation rates; it had 5.4 donors per million people (pmp) in 2010., Methods: Expert opinions of leading participants in donation and transplantation were analyzed, resulting in a set of local policies aimed at increasing donation rates. Using previous results of reported cost savings of increasing kidney transplantation in Chile, we estimated the net benefits of these policies, as a function of additional donors., Results: The main problem of the Chilean system seems to be the low capability to identify potential donors and a deficit in intensive care unit (ICU) beds. Among considered policies central to increase donation are the following: increasing human and capital resources dedicated to identifying potential donors, providing ICU beds from private centers, and developing an online information system that facilitates procurement coordination and the evaluation of performance at each hospital. Our results show that there is a linear relationship between cost savings and incremental donors pmp. For example, if these policies are capable of elevating donation rates in Chile by 6 donors pmp net estimated cost savings are approximately US $1.9 million. Likewise, considering the effect on patients' quality of life, savings would amount to around $15.0 million dollars per year., Conclusions: Our estimates suggest that these policies have a large cost-saving potential. In fact, considering implementation costs, cost reduction is positive after 4 additional donors pmp, and increasing afterward., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: This survey was conducted to assess the public perception on organ donation and transplantation., Methods: A random sample of the population attending the outpatient clinics in Dhahran Military Hospital, Saudi Arabia, from December 1, 2011, to January 31, 2012, answered a questionnaire related to the above aim., Results: From 582 subjects who answered the questionnaire, 85 were excluded for incoherent answers. From the remaining 497, 77.7% were males and 22.3% females with the age ranging from 18 to 65 years, and the majority was at a secondary or university level of education. More than 90% were aware organ transplantation and donation. From a religious point of view, 68.6% considered it legal to donate organs versus 26.2%. Those who disagreed with the concept of donation believed that one kidney is not enough to survive (50%), and that the remaining kidney may be affected (25.8%), whereas 15.2% expressed fear of the operation. Kidney transplantation was the preferred treatment for 73.2% of respondents and 12.75% were in favor of dialysis. Regarding financial incentive, 14.5% asked for reward from the government, 3.4% believed that the reward should come from the donor, and the majority (82.1%) stated that organ donation should be for the sake of God. Finally, there was a 61.2% willingness of respondents to donate relatives' organs after brain death., Conclusion: The level of awareness about donation and transplantation in our population was found to be satisfactory. Religion was not a bar for organ donation; moreover, financial incentive was not found to be a positive stimulus toward donation because the majority was willing to donate for the sake of God., (Copyright © 2013 Elsevier Inc. All rights reserved.)

A significant gap exists between availability of organs for transplant and patients with end-stage organ failure for whom organ transplantation is the last treatment option. Reasons for this mismatch include inadequate approach to potential donor families and donor loss as a result of refractory cardiopulmonary instability during and after brainstem herniation. Other reasons include inadequate cultural competence and sensitivity when communicating with potential donor families. Clinicians may not have an understanding of the cultural and religious perspectives of Muslim families of critically ill patients who may be approached about brain death and organ donation. This review analyzes Islamic cultural and religious perspectives on organ donation, transplantation, and brain death, including faith-based directives from Islamic religious authorities, definitions of death in Islam, and communication strategies when discussing brain death and organ donation with Muslim families. Optimal family care and communication are highlighted using case studies and backgrounds illustrating barriers and approaches with Muslim families in the United States and in the Kingdom of Saudi Arabia that can improve cultural competence and family care as well as increase organ availability within the Muslim population and beyond.

Progress in transplantation outcomes depends on continuing research into both donor and recipient factors that may enhance graft and patient survival. A system of licencing for transplantation research, introduced by the Human Tissue Act 2004, which separates it from the transplantation process (then exempt from licencing), has damaged this vital activity by a combination of inflexible interpretation of the 2004 Act and fear of criminal liability on the part of researchers. Now, following the European Union (EU) Directive (2010) on standards of quality and safety of human organs intended for transplantation, new UK Regulations have been drafted, which are intended to implement it. These Regulations impose a compulsory licencing system, similar to that for research, on the whole transplantation process. This goes beyond what is required by the Directive and may even have an inhibitory effect similar to that already seen in research. Initial draft Regulations went further, imposing criminal sanctions for breaches. However, following a public consultation process, the Department of Health (DH) has recently stated that, as a result of the overwhelming view of respondents that the proposed licencing system was unnecessary, all sanctions under the final Regulations are now decriminalised, with the sole exception of operating without a licence. While this does not eliminate the negative effect of licencing, it does suggest an awareness of the DH that excessive regulation unnecessarily harms the transplantation process. An opportunity thus arises for the Human Tissue Authority (the regulatory body for both the new licences and research licences under the 2004 Act) to end the current illogical and harmful separation of transplantation and transplantation research by ensuring that all centres licenced for organ donation, retrieval and transplantation are also fully licenced for related research.

: The Government of India has established laws to conduct organ transplantation in India. The Transplantation of Human Organ Act and rules in India were promulgated in 1994 and subsequently amended in 2008 and 2011 to promote organ transplantation, including deceased organ donation, commensurate with the highest ethical principles. We have reviewed in brief the origin and evolution of the Transplantation of Human Organ Act in India with the hope that our experience in developing the laws that govern organ transplantation may be of value for others undertaking or overseeing this life-giving advance.

This paper reviews the standpoints of Muslim jurists within the Sunni tradition on organ transplantation. Muslim jurists allowed different forms of bone grafts (autograft, allograft and xenograft) for widely broken bones. Ibn Sina in 1037 discussed this subject in Al-Kanoon 1000 years ago. In 1959, the Muftis of Egypt and Tunisia allowed, under specific conditions, corneal transplants from dead persons. Thereafter, many fatwas (jurisprudence) on organ trans-plantation have been issued from different parts of the Muslim world. In Amman, Jordan, the International Islamic Jurist Council recognized brain-death as a recognized sign of death in Islam in October 1986. This paved the way for organ transplantation from brain-dead persons, which started immediately in Saudi Arabia. In 1990 and 2003, the International Islamic Fiqh Academy (IIFA) and the Islamic Fiqh Academy (IFA) issued important fatwas on organ transplantation. By the end of 2008, more than 3600 organs were transplanted from brain-dead persons in Saudi Arabia.

The human body and its parts are widely perceived as matters beyond commercial usage. This belief is codified in several national and European documents. This so-called 'no-property rule' is held to be the default position across the countries of the European Union. However, a closer look at the most pertinent national and European documents, and also current practices in the field, reveals a gradual model of commercialisation of human tissue. In particular, we will argue that the ban on commercialisation of body material is not as strict as it may appear at first sight, leaving room for the commercial practice of tissue procurement and transfer. We argue for more transparent information for patients and tissue donors, an intensified ethical debate on commercialisation practices, and a critical review of current normative principles.

Because of the strict Organ Transplantation Act, only 81 brain dead (BD) organ donations had been performed in Japan for 13 years since 1997. The Act was revised on July 17, 2010, allowing, organs to be donated after BD with consent from the family, if the subject had not denied organ donation previously. This act has lead to an expectation of a 6-7-fold increase in BD donation. The 82 organ procurement coordinators (OPC) in Japan include 32 belonging to the Japanese Organ Network (JOT) and the others to each administrative division. JOT has guideline manuals of standard roles and procedures of OPC during organ procurement from BD and cardiac death donors. To manage the increased organ donations after the revision of the act, we have modified the education system. First, we modified the guideline manuals for OPC to correspond to the revised Transplant Act and governmental guidelines. Second, all OPC gathered in a meeting room to learn the new organ procurement system to deal with the revised Transplant Act and guidelines. Third, a special education program for 2 months was provided for the 10 newcomers. Last, the practical training in each donor case for newcomers was performed by older OPC. Topics of the education program were the revised transplant act and guidelines, family approach to organ donation, BD diagnosis, donor evaluation and management, organ procurement and preservation, allocation system, hospital development and family care. In the future, each OPC will be divided into special categories, such as the donor family OPC, the donor management OPC, and the operating room OPC. Therefore, we need to construct separate special education programs for each category., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: From October 1997 to July 2010, only 86 brain-dead (BD) organ donations were obtained and no organs were retrieved from children under 15 years of age because of the strict Japan Organ Transplantation Act. The Act was revised on July 17, 2010, allowing organs to be donated after BD with family consent., Objective: To manage the increased donations after the revision, the Japan Organ Transplant Network (JOT) employed 10 organ procurement coordinators (OPCs) and modified its education systems. We retrospectively reviewed the modified education programs to evaluate whether they were effective and whether the processes of organ donation were promptly performed after the revision of the Act., Methods: The modifications of education program were: changing OPC to guideline manuals to correspond to the revised Transplant Act; OPCs were taught the new organ procurement system; and a special education program was provided for the 10 newcomers for 2 months., Results: After 12 months of the revision, 58 BD organ donations were accomplished, whereas they had averaged 6.6 in a year before the revision. Two pediatric BD organ donations were accomplished without problem. One priority organ donation to a relative was performed uneventfully. After applying the modified education program, skilled JOT OPCs and leader JOT OPCs increased., Conclusions: To manage increased organ donations after the revision of the Act, the educational system was modified and 58 brain dead organ donations were performed safely., (Copyright © 2012 Elsevier Inc. All rights reserved.)

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., (Copyright © 2012 Elsevier Ltd. All rights reserved.)