PUBLIC POLICY CORNER

Do We Need to Change Our NationalOrgan Donation Policy?

Liver transplantation is the most effective treat-ment for acute or chronic liver failure result-ing from a variety of causes. It has had a pro-

found impact on the survival and quality of life forpatients with advanced liver disease.1 Due to decreasedhospital stays, the costs of liver transplants have stead-ily declined in recent years.2 With the recent availabil-ity of generic immunosuppression medications, thecosts will continue to decrease. While liver transplanta-tions are increasingly associated with improvedoutcomes at lower costs, the supply of donor liverscontinues to be insufficient to meet the demand forliver transplantation in the United States and world-wide. The active waiting list in the United States forliver transplantation as of September 11, 2009, is15,941 individuals. In a typical year, 6000 of thesepatients will receive a deceased donor liver, approxi-mately 250–300 will receive a living donor liver, and1500–2000 will die while waiting to undergo trans-plantation.3 Coupled with a rising incidence of hepa-tocellular carcinoma and the growing epidemic of obe-sity and nonalcoholic fatty liver disease, the gapbetween the supply and demand of liver grafts willonly widen. The shortage of liver grafts is complexand needs to be addressed on multiple levels: preven-tion and early treatment of liver diseases, best utiliza-tion of the donated grafts, as well as increasing organdonation rates. Although a number of factors deter-mine the organ donation rate, many believe that oneof the major factors is the organ donation policy.

Organ Donation Policies

There are three basic different legislative organ don-ation policies: facilitated choice, mandated choice, andpresumed consent.

1. Facilitated Choice. Facilitated choice, the policyadopted in the United States, allows individuals tobecome aware of the option of donation and to choosewhether to donate. Whereas the general policy in theUnited States requires that the donor make an affirma-tive statement during her or his lifetime that she or heis willing to be an organ donor, the regulation oforgan donation is left to states within the limitationsof the federal National Organ Transplant Act, whichwas passed in 1984 and amended in 1988, 1990, and2008. It outlawed the sale of human organs and pro-vided for the establishment of the Task Force onOrgan Transplantation; authorized the Secretary ofHealth and Human Services to make grants for theplanning, establishment, and initial operation of quali-fied Organ Procurement Organizations (OPOs); andestablished the formation of the Organ Procurementand Transplantation Network (OPTN) and ScientificRegistry of Transplant Recipients (SRTR). As a resultof the regulation of organ donation being left to indi-vidual states, there are many inconsistencies amongstate regulations. The Uniform Anatomical Gift Act(UAGA) was revised in 2006 in an effort to addressthe inefficiencies of the system by resolving the dis-crepancies between state laws. In addition to bringinguniformity among states to achieve efficiency, the 2006UAGA aimed to facilitate donations and to update theact to reflect changes in federal law and regulationsgoverning organ donation practices and organ procure-ment and allocation.2. Mandated Choice. Under the policy of man-

dated choice, all consentable adult persons would berequired to declare on driver’s license applications, taxreturns, or official state identification cards whetherthey wish to donate.3. Presumed Consent. The third policy is the pre-

sumed consent, sometimes called ‘‘the dissent solu-tion,’’ which presumes that consent has been givenunless there is evidence to the contrary. Countries suchas Spain, Austria, Sweden, and Israel have all adoptedthe organ donation policy of presumed consent. It hasbeen posited that a policy of presumed consentincreases organ donation rate because countries withpresumed consent (Spain, Austria) are observed tohave higher organ donation rates than countries withfacilitated choice (the United States and the United

Abbreviations: AASLD, American Association for the Study of LiverDiseases; DDC, Donor Designation Collaborative; UAGA, UniformAnatomical Gift Act.Address reprint requests to: Michelle Lai, MD, MPH, Division of

Gastroenterology, Department of Medicine, Beth Israel Deaconess MedicalCenter, Lowry Medical Office Building, 7th Floor, 110 Francis Street, Suite ABoston, MA 02215. E-mail: mlai@caregroup.harvard.edu; fax: 617-632-1125.CopyrightVC 2010 by the American Association for the Study of Liver Diseases.Published online in Wiley InterScience (www.interscience.wiley.com).DOI 10.1002/hep.23556Potential conflict of interest: Nothing to report

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Kingdom). Rithalia et al. recently published their find-ings from a systematic review of five studies comparingdonation rates before and after the introduction oflegislation for presumed consent and four good-qualitystudies comparing donation rates in countries withand without presumed consent systems.4 The fivestudies comparing donation rates before and after theintroduction of legislation for presumed consent exam-ined organ donation rates in Austria, Belgium, andSingapore. They all showed an increase in organ dona-tion rates following the introduction of presumed con-sent. For example, in Austria, there was an increase of5.5 donors per million population (from 4.6 to 10.1donors per million population) in the 4 years after theintroduction of presumed consent. The study alsofound that infrastructure changes, including full-timetransplant coordinators, accounted for an even moresignificant increase in donation rate to 27.2 per mil-lion (in the 5 years after the changes).The studies comparing donation rates in countries

with and without presumed consent systems found anassociation between presumed consent legislation andhigher organ donation rates. The increase in organdonation from the effect of the presumed consentlegislation varied between studies from a 20%–30%increase to 2.7 more donors per million population inone study and 6.1 more donors per million popula-tion. There was evidence that factors other than pre-sumed consent contributed to the variation in organdonation rates, such as road traffic accidents, the num-ber of transplant centers, gross domestic product percapita, and health expenditure per capita.

Recent Efforts to Address Low OrganDonation Rate in the United States

In recent years, there have been efforts to addressthe organ shortfalls with some success. The organ don-ation rate in the United States has increased from 21donors per million residents in the late 1990s to 26donors per million residents in the year 2006. In

2006, the Revised UAGA was passed to ‘‘facilitatedonations and modernize the act to reflect changes infederal law and regulations governing organ procure-ment and allocation as well as changes in organ dona-tion practices.’’ The Donor Designation Collaborative(DDC) was also launched by the nonprofit organiza-tion Donate Life during that same year. The collabora-tive is a national effort to improve donation rates byhelping states create new donor registries or improveexisting donor registries, and by encouraging stateteams to test, adopt, and share best practices thatmeasurably increase the number of registered donors.The DDC has set a goal of 100 million designateddonors and at least 50% donor designation rate.Donor registries are established to collect and main-

tain a list of citizens who have chosen either to donateor not to donate their organs. Although the concept ofdonor registries has been around for more than a dec-ade, most states did not create donor registries untilthe early 2000s. In addition, donor registries varyfrom state to state in design and also in effectiveness.Unfortunately, the mere existence of a registry is notenough. Registry systems must be effective in order torecord and act on the decisions made by individualswho before their deaths committed to becoming organand tissue donors. Currently, there are two main typesof donor registries in the United States: (1) ‘‘first-per-son consent’’ registries, which record legally bindingdecisions of registered organ, eye, and tissue donorswhose choice can only be revoked by that individualand (2) ‘‘intent’’ registries that document one’s wish todonate, but ultimately the family remains responsiblefor authorizing the donation. The DDC Faculty cameup with a list of Effective Registry Design Criteria,which is currently met by only 25 states and the Dis-trict of Columbia (Table 1).5

In addition, any such registry must protect individ-ual privacy and the individual’s ability to control thecollection, use, disclosure of, and access to his or herhealth information for purposes other than registra-tion. Provisions must be in place to ensure that the de-cision is adequately informed and that registrants canwithdraw from the registry without penalty.Although the DDC has made impressive headway

thus far (see Table 2), there is still much work to bedone. A recent online survey of 5100 adults in the

Table 1. Effective Registry Design Criteria(Put Forth by the DDC)

1. Donor designation is considered legally binding consent

2. Includes consent for tissue donation

3. Individuals can enroll through a dedicated Web site

4. DMV enrolls donors via driver’s license and ID card applications

and renewals

5. No follow-up step required for DMV or online enrollment

6. DMV exports donor records to registry database

7. Organ, eye, and tissue recovery agencies can effectively access

donor designations

Table 2. Progress by the Donor Designation Collaborative

DDC Goal set in 2006 Achieved by end of 2008

100 million designated donors 79.7 million designated donors

50% donor designation rate 36.3%–38.2% donor designation rate

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United States, conducted by Survey Sampling Interna-tional for Donate Life America in partnership withAstellas Pharma US Inc., revealed that misperceptionscontinue to serve as barriers that prevent the publicfrom registering donation decisions. Important surveystatistics include:

• 51 percent of Americans wish to donate all orsome of their organs and tissue.

• Another 26 percent are undecided.

• 58 percent erroneously believe that it is possiblefor a person to recover from brain death.

• 51 percent incorrectly believe doctors may not tryas hard to save their lives or are unsure they will, ifthey know they wish to be a donor.

• 44 percent mistakenly think that in the UnitedStates there is a black market in which people can buyor sell organs and tissue for transplant.

• 23 percent of people who say they are undecided,reluctant, or do not wish to donate their organs andtissue are not sure they would be acceptable donors.

Recommendations for Action

Liver transplantation improves survival and qualityof life in many patients with acute and chronic liverdisease. Although organ donation rates have beenincreasing in the United States in recent years, the cur-rent supply of donor livers in the United States contin-ues to be insufficient to meet the demand for livertransplantation, as evidenced by the long waiting listand thousands of patients dying on the waiting list. Itis still too early to see if recent efforts by the DDC toincrease donor designation rates and in establishingeffective donor registries will translate to higher organdonation rates. A recent survey reveals significant pub-lic misperceptions serve as barriers to registering asorgan donors. Public education is needed to addressthese misperceptions. There is some data that a policyof presumed consent increases organ donation rate.However, implementation of such a policy needs tohave built-in mechanisms to guarantee free andinformed decision-making, especially in disadvantagedpopulations such as the illiterate and non-English-speaking populations. To be ethically acceptable, pre-sumed consent would require intensive, sustained edu-cational efforts to inform individuals and families oftheir right to opt out of the system by registering anobjection to donation.The American Association for the Study of Liver

Diseases (AASLD) and its membership have the op-portunity to take action to increase organ donation

rates, thereby improving survival and quality of life inpatients with end-stage liver disease. With this goal inmind, the Association and its members have severaladvocacy options open to it, including:1. Collaborate with the American Liver Foundation,

Donate Life America, and other foundations and pro-fessional societies to promote public awareness toaddress public misperceptions regarding organdonation.2. Work with governmental and nongovernmental

agencies in increasing donor registration through a va-riety of opportunities, such as during driver’s educationand licensing, during advance-care planning, and inconnection with work-based, faith-based, school-based,and community-based initiatives.3. Encourage state governments, organ procurement

organizations, and the Health Resources and ServiceAdministration to set up effective state donor registriesand to provide national access to a system that isupdated daily and that can be quickly and easilyaccessed 24 hours a day by relevant healthcareprofessionals.4. Advocate for demonstration projects to test the

feasibility of adopting a model of presumed consentby participating in governmental and nongovernmentalcommittees such as the United Network for OrganSharing and Donate Life America. Prior to acceptanceof this policy nationwide, we need to perform demon-stration projects to test the feasibility of adopting amodel of presumed consent to organ donation andcollect data before and after the implementation of theprojects to study their impact.These recommendations reflect the goal of the

AASLD to identify issues and affect change in publicpolicy related to liver health and disease and its strat-egies of actively monitoring policy issues related toorgan allocation.6 We propose that these recommen-dations be considered for adoption by the AASLDfor implementation through its member committees,including clinical research, ethics, National Institutesof Health liaison, public policy, surgery, and livertransplantation committees. Increasing the organ don-ation rate is vital to meet the demand for liver trans-plantation, thereby decreasing the long waiting listand the number of patients dying on the waitinglist.

MICHELLE LAI, MD, MPHDivision of Gastroenterology, Department of Medicine,Beth Israel Deaconess Medical CenterBoston, MA

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References1. Belle SH, Porayko MK, Hoofnagle JH, Lake JR, Zetterman RK.

Changes in quality of life after liver transplantation among adults.National Institute of Diabetes and Digestive and Kidney Diseases(NIDDK) Liver Transplantation Database (LTD). Liver Transpl Surg1997;3:93-104.

2. Best JH, Veenstra DL, Geppert J. Trends in expenditures forMedicare liver transplant recipients. Liver Transpl 2001;7:858-862.

3. Organ Procurement and Transplantation Network. http://optn.transplant.hrsa.gov/latestData/rptData.asp. Accessed February 2010.

4. Rithalia A, McDaid C, Suekarran S, Myers L, Sowden A. Impact of pre-sumed consent for organ donation on donation rates: a systematicreview. BMJ 2009;338:a3162.

5. DonateLifeAmerica, National Donor Designation Report Card 2009.Accessed February 2010.

6. American Association for the Study of Liver Diseases. Strategic plan.www.aasld.org/about/who/Documents/Who%20We%20Are/Strategicplan.pdf. Accessed February 2010.

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