Do we need to change our national organ donation policy?
Authors: Michelle Lai
Journal: Hepatology (2010)

Liver transplantation is the most effective treatment for acute or chronic liver failure resulting from a variety of causes. It has had a profound impact on the survival and quality of life for patients with advanced liver disease.1 Due to decreased hospital stays, the costs of liver transplants have steadily declined in recent years.2 With the recent availability of generic immunosuppression medications, the costs will continue to decrease. While liver transplantations are increasingly associated with improved outcomes at lower costs, the supply of donor livers continues to be insufficient to meet the demand for liver transplantation in the United States and worldwide. The active waiting list in the United States for liver transplantation as of September 11, 2009, is 15,941 individuals. In a typical year, 6000 of these patients will receive a deceased donor liver, approximately 250–300 will receive a living donor liver, and 1500–2000 will die while waiting to undergo transplantation.3 Coupled with a rising incidence of hepatocellular carcinoma and the growing epidemic of obesity and nonalcoholic fatty liver disease, the gap between the supply and demand of liver grafts will only widen. The shortage of liver grafts is complex and needs to be addressed on multiple levels: prevention and early treatment of liver diseases, best utilization of the donated grafts, as well as increasing organ donation rates. Although a number of factors determine the organ donation rate, many believe that one of the major factors is the organ donation policy. AASLD, American Association for the Study of Liver Diseases; DDC, Donor Designation Collaborative; UAGA, Uniform Anatomical Gift Act. There are three basic different legislative organ donation policies: facilitated choice, mandated choice, and presumed consent. Facilitated choice, the policy adopted in the United States, allows individuals to become aware of the option of donation and to choose whether to donate. Whereas the general policy in the United States requires that the donor make an affirmative statement during her or his lifetime that she or he is willing to be an organ donor, the regulation of organ donation is left to states within the limitations of the federal National Organ Transplant Act, which was passed in 1984 and amended in 1988, 1990, and 2008. It outlawed the sale of human organs and provided for the establishment of the Task Force on Organ Transplantation; authorized the Secretary of Health and Human Services to make grants for the planning, establishment, and initial operation of qualified Organ Procurement Organizations (OPOs); and established the formation of the Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). As a result of the regulation of organ donation being left to individual states, there are many inconsistencies among state regulations. The Uniform Anatomical Gift Act (UAGA) was revised in 2006 in an effort to address the inefficiencies of the system by resolving the discrepancies between state laws. In addition to bringing uniformity among states to achieve efficiency, the 2006 UAGA aimed to facilitate donations and to update the act to reflect changes in federal law and regulations governing organ donation practices and organ procurement and allocation. Under the policy of mandated choice, all consentable adult persons would be required to declare on driver's license applications, tax returns, or official state identification cards whether they wish to donate. The third policy is the presumed consent, sometimes called "the dissent solution," which presumes that consent has been given unless there is evidence to the contrary. Countries such as Spain, Austria, Sweden, and Israel have all adopted the organ donation policy of presumed consent. It has been posited that a policy of presumed consent increases organ donation rate because countries with presumed consent (Spain, Austria) are observed to have higher organ donation rates than countries with facilitated choice (the United States and the United Kingdom). Rithalia et al. recently published their findings from a systematic review of five studies comparing donation rates before and after the introduction of legislation for presumed consent and four good-quality studies comparing donation rates in countries with and without presumed consent systems.4 The five studies comparing donation rates before and after the introduction of legislation for presumed consent examined organ donation rates in Austria, Belgium, and Singapore. They all showed an increase in organ donation rates following the introduction of presumed consent. For example, in Austria, there was an increase of 5.5 donors per million population (from 4.6 to 10.1 donors per million population) in the 4 years after the introduction of presumed consent. The study also found that infrastructure changes, including full-time transplant coordinators, accounted for an even more significant increase in donation rate to 27.2 per million (in the 5 years after the changes). The studies comparing donation rates in countries with and without presumed consent systems found an association between presumed consent legislation and higher organ donation rates. The increase in organ donation from the effect of the presumed consent legislation varied between studies from a 20%–30% increase to 2.7 more donors per million population in one study and 6.1 more donors per million population. There was evidence that factors other than presumed consent contributed to the variation in organ donation rates, such as road traffic accidents, the number of transplant centers, gross domestic product per capita, and health expenditure per capita. In recent years, there have been efforts to address the organ shortfalls with some success. The organ donation rate in the United States has increased from 21 donors per million residents in the late 1990s to 26 donors per million residents in the year 2006. In 2006, the Revised UAGA was passed to "facilitate donations and modernize the act to reflect changes in federal law and regulations governing organ procurement and allocation as well as changes in organ donation practices." The Donor Designation Collaborative (DDC) was also launched by the nonprofit organization Donate Life during that same year. The collaborative is a national effort to improve donation rates by helping states create new donor registries or improve existing donor registries, and by encouraging state teams to test, adopt, and share best practices that measurably increase the number of registered donors. The DDC has set a goal of 100 million designated donors and at least 50% donor designation rate. Donor registries are established to collect and maintain a list of citizens who have chosen either to donate or not to donate their organs. Although the concept of donor registries has been around for more than a decade, most states did not create donor registries until the early 2000s. In addition, donor registries vary from state to state in design and also in effectiveness. Unfortunately, the mere existence of a registry is not enough. Registry systems must be effective in order to record and act on the decisions made by individuals who before their deaths committed to becoming organ and tissue donors. Currently, there are two main types of donor registries in the United States: (1) "first-person consent" registries, which record legally binding decisions of registered organ, eye, and tissue donors whose choice can only be revoked by that individual and (2) "intent" registries that document one's wish to donate, but ultimately the family remains responsible for authorizing the donation. The DDC Faculty came up with a list of Effective Registry Design Criteria, which is currently met by only 25 states and the District of Columbia (Table 1).5 In addition, any such registry must protect individual privacy and the individual's ability to control the collection, use, disclosure of, and access to his or her health information for purposes other than registration. Provisions must be in place to ensure that the decision is adequately informed and that registrants can withdraw from the registry without penalty. 51 percent of Americans wish to donate all or some of their organs and tissue. Another 26 percent are undecided. 58 percent erroneously believe that it is possible for a person to recover from brain death. 51 percent incorrectly believe doctors may not try as hard to save their lives or are unsure they will, if they know they wish to be a donor. 44 percent mistakenly think that in the United States there is a black market in which people can buy or sell organs and tissue for transplant. 23 percent of people who say they are undecided, reluctant, or do not wish to donate their organs and tissue are not sure they would be acceptable donors. Liver transplantation improves survival and quality of life in many patients with acute and chronic liver disease. Although organ donation rates have been increasing in the United States in recent years, the current supply of donor livers in the United States continues to be insufficient to meet the demand for liver transplantation, as evidenced by the long waiting list and thousands of patients dying on the waiting list. It is still too early to see if recent efforts by the DDC to increase donor designation rates and in establishing effective donor registries will translate to higher organ donation rates. A recent survey reveals significant public misperceptions serve as barriers to registering as organ donors. Public education is needed to address these misperceptions. There is some data that a policy of presumed consent increases organ donation rate. However, implementation of such a policy needs to have built-in mechanisms to guarantee free and informed decision-making, especially in disadvantaged populations such as the illiterate and non-English-speaking populations. To be ethically acceptable, presumed consent would require intensive, sustained educational efforts to inform individuals and families of their right to opt out of the system by registering an objection to donation. Collaborate with the American Liver Foundation, Donate Life America, and other foundations and professional societies to promote public awareness to address public misperceptions regarding organ donation. Work with governmental and nongovernmental agencies in increasing donor registration through a variety of opportunities, such as during driver's education and licensing, during advance-care planning, and in connection with work-based, faith-based, school-based, and community-based initiatives. Encourage state governments, organ procurement organizations, and the Health Resources and Service Administration to set up effective state donor registries and to provide national access to a system that is updated daily and that can be quickly and easily accessed 24 hours a day by relevant healthcare professionals. Advocate for demonstration projects to test the feasibility of adopting a model of presumed consent by participating in governmental and nongovernmental committees such as the United Network for Organ Sharing and Donate Life America. Prior to acceptance of this policy nationwide, we need to perform demonstration projects to test the feasibility of adopting a model of presumed consent to organ donation and collect data before and after the implementation of the projects to study their impact. These recommendations reflect the goal of the AASLD to identify issues and affect change in public policy related to liver health and disease and its strategies of actively monitoring policy issues related to organ allocation.6 We propose that these recommendations be considered for adoption by the AASLD for implementation through its member committees, including clinical research, ethics, National Institutes of Health liaison, public policy, surgery, and liver transplantation committees. Increasing the organ donation rate is vital to meet the demand for liver transplantation, thereby decreasing the long waiting list and the number of patients dying on the waiting list.