Bioethical and legal considerations in increasing the supply of transplantable organs: from UAGA to "Baby Fae"

In the last 35 years, organ transplant technology has advanced greatly. The major problem associated with organ transplantation is organ availability, and not surgery-related mortality. This article examines current organ procurement procedures and technologies, legislative responses to the scarcity of transplantable organs, as well as the psychological barriers to organ donation. Issues of fairness in the allocation of scarce economic and social resources, the role of religion and ethics in organ donation and transplantation decision, and the impact of the media are also considered.     

Rational rejection? The ethical complications of assessing organ transplant candidates in the United Kingdom and the United States

The practice of allocating scarce organs in medicine is an ethical minefield. Due to the organ shortage, organ procurement agencies in both the United Kingdom and the United States are placed in the unenviable position of having to choose a limited number of patients to compete equally for life-saving treatment. They do this by composing multidisciplinary transplant teams, which must evaluate transplant candidates and their complex range of personal, medical, environmental, psychiatric and financial characteristics. During the candidate assessment process, such teams may often be torn between their moral duty to save those who are most in need, considerations of efficiency, and the battle against forming moral judgments about particular candidates. Several ethical approaches can be adopted by transplant teams during the decision-making process, but do these ideologies provide adequate justification for their sometimes controversial decisions? This article provides a detailed examination of the ethical principles available to transplant teams in the United Kingdom and the United States, and the effect that these principles have on assessment procedures, organ allocation protocols, transplant candidates and their prospects.     

Obtaining replacements: the organizational framework of organ procurement

In the last ten years there has grown up, in the United States, the most extensive organ procurement system in the world. This system, consisting of approximately 120 organ procurement agencies, retrieved 4435 cadaveric kidneys for transplant purposes in 1981. The nation's organ procurement agencies vary greatly in terms of size, organizational structure, and effectiveness. On average, those agencies not formally part of a transplant hospital appear to be the more effective. This can be accounted for by their superior operational flexibility and their pursuit of a "marketing" strategy. Success in organ procurement requires that medical professionals in non-transplant hospitals, and the potential donors' families, be motivated to assist in the organ procurement process.     

The rise and decline of Israel’s participation in the global organ trade: causes and lessons

Why would a country choose to actively take part in the illicit organ trade, and later reverse course and cease that participation? The article answers this question with respect to Israel, where patients in need of a transplant received public funds to allow them to purchase organs abroad. I argue that the Israeli policy of financing “transplant tourism” resulted from the pleas of desperate patients facing a local organ shortage, combined with cost-saving considerations. Yet pressures from the Israeli and international medical community, together with media reports, led to a legislative prohibition on the trade in organs—a prohibition that has sharply reduced the outflow of patients. The article highlights the main influences that motivated Israel’s policy change, including concerns for the country’s international reputation, and offers lessons for other countries where organ trafficking flourishes.     

Malpractice issues in heart transplantation

As organ transplantation procedures become accepted as standard medical practice, it is anticipated that the frequency of liability claims against transplant care providers will increase. This article examines current statutory and common law analyses of malpractice issues in transplantation, with particular attention given to issues of informed consent as they arise both for the organ donor and donee.     

National Association of Medical Examiners position paper on the medical examiner release of organs and tissues for transplantation

The medical examiner community plays a key role in the organ and tissue procurement process for transplantation. Since many, if not most, potential organ or tissue donors fall under medicolegal jurisdiction, the medical examiner bears responsibility to authorize or deny the procurement of organs or tissues on a case-by-case basis. This responsibility engenders a basic dichotomy for the medical examiner's decision-making process. In cases falling under his/her jurisdiction, the medical examiner must balance the medicolegal responsibility centered on the decedent with the societal responsibility to respect the wishes of the decedent and/or next of kin to help living patients. Much has been written on this complex issue in both the forensic pathology and the transplantation literature. Several studies and surveys of medical examiner practices, as well as suggested protocols for handling certain types of cases, are available for reference when concerns arise that procurement may potentially hinder medicolegal death investigation. It is the position of the National Association of Medical Examiners (NAME) that the procurement of organs and/or tissues for transplantation can be accomplished in virtually all cases, without detriment to evidence collection, postmortem examination, determination of cause and manner of death, or the conducting of criminal or civil legal proceedings. The purpose of this position paper is to review the available data, the arguments for and against medical examiner release, and to encourage the release of organs and tissues in all but the rarest of circumstances.     

Public Good, Private Protections: Competing Values in German Transplantation Law

Organ transplantation has become almost routine practice in many industrialized countries. Policy, ethical, and legal debates tend to center on fairness of allocation rules or alternatives to promote greater numbers of donations. There are also certain beliefs about the use of bodily materials that are often presumed to be homogenous across Euro–American societies. In Germany, however, the idea of using the bodies of some for the good of others, and the right to proclaim some bodies dead for large–scale medical and political purposes is highly charged. This is due to the historical context of medical experimentation, selection, and euthanasia under National Socialism, and the former East German socialist policies which intervened in the private lives and bodies of citizens. This article is based on an ethnography of organ procurement practices during the period when German policymakers struggled with writing a transplant law. Active public resistance revealed deep concern about state intervention in private matters and amplified the growing unrest over definitions of moral community in a changing, post–reunification society. The article shows how public disputes about health policy become a way through which societies deal with other social conflicts.     

Fifty years of organ transplants: the successes and the failures

More than fifty years have now passed since the first successful human organ transplant. During that time, substantial progress has been made in both surgical techniques and immunosuppressive drug therapy. As a result, transplant success rates have improved dramatically, and thousands of recipients of kidneys, hearts, livers, and lungs have been granted both longer and healthier lives. At the same time, however, many more thousands of patients have died while waiting in vain for a cadaveric donor organ to become available due to a severe and persistent shortage of such organs. That shortage, in turn, is directly attributable to the National Organ Transplant Act of 1984, which proscribes payment to potential organ donors, even if that would increase supply. This atavistic policy and the shortage and deaths it has spawned provides a stirring example of the tendency for public policy to lag behind technological advancement, particularly in the medical field. But the tide of medical opinion may be turning on this issue, and some form of donor payments may soon emerge.     

Non-Heart-Beating Organ Donation: A Defense of the Required Determination of Death

The family of a patient who is unconscious and respirator-dependent has made a decision to discontinue medical treatment. The patient had signed a donor card. The family wants to respect this decision, and agrees to non-heart-beating organ donation. Consequently, as the patient is weaned from the ventilator, he is prepped for organ explantation. Two minutes after the patient goes into cardiac arrest, he is declared dead and the transplant team arrives to begin organ procurement. At the time retrieval begins, it is not certain that the patient's brain is dead or that cardiac function cannot be restored. Procurement follows uneventfully, and two transplantable kidneys are retrieved .     

The organization of organ procurement

The American organ procurement system has improved and matured in the last five years. At the same time, the basic challenges facing it have remained substantially the same because the moral and legal framework of the system has not changed. Success at organ procurement continues to depend on the voluntary cooperation of medical professionals and the families of potential organ donors. The generosity of the American public is so great that the primary challenge facing organ procurement agencies is obtaining cooperation from hospitals and medical professionals. This calls for a "marketing" orientation aimed at those hospitals and professionals who are most likely to treat potential donors. The last five years have seen a more general acceptance of this appreciation of the central task of organ procurement. As a result, the overall effectiveness of the system has improved, as measured by the number of organs procured on a per capita basis and by the number of multiorgan donors obtained. Much of this improvement can be attributed to the diffusion of organizational techniques and approaches, and this diffusion has been encouraged by the involvement of national organizations and public bodies in the organ procurement community. The system remains uneven in its effectiveness and further improvement is possible. It is also possible that the next general round of improvement will result from the application of businesslike information management and marketing techniques.     

Public and private regulation of organ transplantation: liver allocation and the final rule

The allocation of cadaveric organs for transplantation in the United States is governed by a process of private regulation. Through the Organ Procurement and Transplantation Network (OPTN), stakeholders and public representatives determine the substantive content of allocation rules. Between 1994 and 2000 the U.S. Department of Health and Human Services conducted a rule making to define more clearly the public and private roles in the determination of organ allocation policy. Several prominent liver transplant centers that were losing market share as a result of the proliferation of transplant centers used the rule making as a vehicle for challenging the local priority for organ allocation inherent in the OPTN rules. The process leading to the final rule provides a window on the politics of organ allocation. It also facilitates an assessment of the strengths and weaknesses of private rule making. Overall, private rule making appears to be relatively effective in tapping the technical expertise and tacit knowledge of stakeholders to allow for the adaptation of rules in the face of changing technology and information. However, the particular system of representation employed may give less influence to some stakeholders than they would have in public regulatory arenas, giving them an incentive to seek public rule making as a remedy for their persistent losses within the framework of private rule making.     

Medicare and Medicaid programs; conditions for coverage for organ procurement organizations (OPOs). Final rule

This rule finalizes the February 4, 2005 proposed rule entitled "Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs)." It establishes new conditions for coverage for organ procurement organizations (OPOs) that include multiple new outcome and process performance measures based on organ donor potential and other related factors in each service area of qualified OPOs. Our goal is to improve OPO performance and increase organ donation. In addition, this final rule re-certifies these 58 OPOs from August 1, 2006 through July 31, 2010 and provides an opportunity for them to sign agreements with the Secretary that will begin on August 1, 2006 and end on January 31, 2011. New agreements are needed so that the Medicare and Medicaid Programs can continue to pay them for their organ procurement activities after July 31, 2006.     

Medicare and Medicaid programs; conditions of coverage for organ procurement organizations--HCFA. Interim final rule with comment

This interim final rule with comment sets forth changes to the conditions of coverage for organ procurement organizations (OPOs). It redefines an OPO service area, revises the qualifications for the Board of Directors, specifies the assistance to be provided by an OPO to hospitals in establishing and implementing protocols governing organ procurement activity, requires an OPO to establish criteria for allocating organs, and requires an OPO to ensure that tests are performed on prospective organ donors to prevent the acquisition of organs that are infected with the etiologic agent for Acquired Immune Deficiency Syndrome. These changes are required by the Health Omnibus Programs Extension Act of 1988 (Public Law 100-607) and the Transplant Amendments Act of 1990 (Public Law 101-616). We also clarify the distinction between certification and designation and amend the criteria with respect to compliance with performance standards, change of ownership, and termination procedures.     

The economics and ethics of markets for human organs

In 1984, federal legislation outlawing payment for human organs for transplantation was adopted after only cursory discussion of the underlying policy issues. More considered analysis suggests that this prohibition may be overly broad. It appears possible to design suitably regulated market-type approaches to the acquisition and allocation of cadaveric organs (and perhaps of organs from living donors as well) that will be neither unduly offensive to ethical sensibilities nor easily abused and that may yield significant improvements over the existing system of organ procurement, which presents important ethical and practical problems of its own. Moreover, whatever ultimate judgment we reach concerning the merits of markets for transplantable organs, analysis of the sources of the initial moral resistance to the commercialization that lies behind measures such as the 1984 legislation offers insights into the respective roles of market and nonmarket institutions in general.     

双肺移植引发医疗纠纷的思考

器官移植对于挽救终末期器官功能衰竭病人的生命具有重要意义，但是在没有充分权衡移植手术利弊的情况下，对患者施行移植技术尚不成熟的双肺移植手术，进行探索性试验的医疗行为违背了生命伦理学和医生的职业道德，医患双方由此发生医疗纠纷也是不可避免的。在司法实践中，由于法律之间的冲突，使医疗纠纷案件的处理陷入了困境，要想使医疗纠纷步入良性、理性处理的轨道，应建立多元化纠纷解决机制或者制定一部位阶较高，专门调整医疗损害赔偿法律关系的法律。     

The law and economics of organ procurement

This paper presents an economic analysis of the organ procurement system in the U.S. and examines proposals to alleviate the shortage of transplantable organs. The paper's principal conclusions are: (1) Although non-market solutions deserve the highest priority, demand increases fueled by improvements in transplant technology will probably make some market-based solution necessary in the future. (2) Quality deterioration and coercion will not necessarily be worrisome problems under a market-based procurement system.     

Government's role in organ transplantation policy

This paper initially considers ways of thinking about organ transplantation: Should it be treated as a catastrophic disease or as an ordinary and accepted medical procedure? The analysis then shifts to the role the government has played in influencing organ transplantation policy. The federal government's involvement initially stemmed from its role as payer for end-stage renal disease services. In recent years, the rationale for intervention has changed, and the mechanism for implementing regulatory oversight has shifted to a private network run for the government by the United Network for Organ Sharing (UNOS). The government has delegated much policymaking authority to UNOS, although the author demonstrates that this is not required by the applicable legislation. The article raises questions about the relationship between UNOS and the federal government, about potential conflicts between UNOS guidelines and state laws under the Uniform Anatomical Gift Act, and about the ideological stance undergirding much of current federal policy in the organ transplantation arena.     

Modified cardiectomy: documenting sudden cardiac death in hearts selected for valve allograft procurement

Medical examiners frequently deny requests by tissue procurement organizations for heart valves intended for allograft transplantation. Most of these denials are in cases of sudden apparent natural death, often where a cardiac cause is suspected. The basis of denial in these cases is that the heart must be removed and the valves procured off site under sterile conditions. This prevents the medical examiner from determining and documenting the cause of death. A dissection technique was therefore devised to increase the number of heart valves available for allograft transplantation and to simultaneously allow the pathologist to document a cardiac cause of sudden death. Interagency procedures, the dissection technique, and case summaries are provided.     

Laypeople's ethical concerns about a New Israeli organ transplantation prioritization policy aimed to encourage organ donor registration among the public

A new policy recently enacted in Israel promises preferred status in receiving organs for transplantation to individuals who register to be organ donors and to their close family members. Proponents believe it will increase the supply of organs for transplantation from the deceased. Ethical issues were raised in government committees appointed to discuss the policy before its approval, but discussions among laypeople were not solicited. This study aimed to elicit laypeople's views about the policy by conducting thirteen group interviews and thirty-six individual interviews. Participants included religious and nonreligious people, immigrants, and Arabs. Some participants thought the law would contribute to fairness by prioritizing those willing to give, but others articulated ethical concerns that were not emphasized by scholars, in particular that the policy would add to the erosion of social solidarity, increase divisiveness, and enable people to abuse the system. Mistrust in the health care system emerged as a prominent reason for not registering as an organ donor. Implications about the importance of transparency in the organ transplantation system as a basis for an information campaign, social norms regarding organ donation, and the public's involvement in policy issues on organ donation are discussed.     

Blood vessels recovered with organs and intended for use in organ transplantation. Direct final rule

The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) are amending their regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products (HCT/Ps) (FDA regulation). We (HRSA and FDA) are taking this action to provide that blood vessels recovered with organs and intended for use in organ transplantation are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We believe that this change will eliminate the unnecessary burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). We are issuing these amendments directly as a final rule because they are noncontroversial, and there is little likelihood that we will receive any significant adverse comments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.