PCBE: Organ Donation Policy

This paper was prepared solely to aid discussion for the September 2006 meeting, and does not represent the official views of the Council or of the United States Government.

Organ Transplantation Policies and Policy Reforms

Organ Donation Policy

Organ Donation Policy

No matter how one frames the issue, the supply of organs is not meeting the demand.� With over ninety thousand people and rising on the organ waiting list, there is widespread interest in finding novel ways to boost the organ supply-ranging from modest reforms of the current system, such as better education about the benefits of organ donation, to more radical proposals, such as organ markets, the redefinition of death, and the retrieval of organs from deceased individuals without their prior consent.� Yet alongside this understandable drive to increase the number of available organs, there is also growing concern that we have inadequate data about the long-term health consequences of being a living donor (see Working Paper #1), and there is renewed debate about whether brain-dead individuals are truly dead (see Working Paper #2).� In our desire to advance the best system for donating, procuring, allocating, and transplanting organs, in other words, we confront the many tensions that exist in seeking the best possible policy in this complicated area of modern medicine.

Three human goods, in particular, seem to guide both our current organ transplantation policies and the myriad calls for reform.� The first and perhaps most obvious good is health-both promoting the health of those who suffer and sometimes die waiting for organs, and protecting the health of those who willingly become living organ donors. Everyone aches at the misery of the sick, perhaps especially so when a remedy (like transplantation) is possible but not available.� And everyone recognizes the major contribution of organ transplantation to the good of human health and the relief of human suffering.� In modern societies, the pursuit of health is an aim that unites even those who disagree about much else.

The second human good is freedom, a principle embodied in the requirement of consent in order to procure organs from both living and deceased donors.� In liberal democracies in general and the United States in particular, individuals are generally free to make their own choices and control their own bodies, including the decision about whether or not to donate their organs.� No one is required to donate their organs, even if such a requirement would improve many lives at a seemingly minimal cost.� In some cases, it seems, the good of freedom preempts the pursuit of health, or at the very least, the right of autonomy preempts the obligation to serve the health of others.

The third human good, perhaps the hardest to define but in some ways the foundation of the others, is human dignity.� Because human beings possess such dignity, they are worthy of care and protection; their health matters to us as an urgent moral concern.� And because human beings possess such dignity, they are entitled to a sphere of personal freedom; only in extreme circumstances would society as a whole contemplate the conscription of an individual's body or body parts.� Yet this distinctly human dignity also, at times, acts as a limitation on the pursuit of health and the scope of freedom: there are some things, we tend to believe, that even free individuals ought never do, such as giving away all one's organs while still living.� Such an act would no doubt help or save the lives of many organ recipients; it would serve the health of many others at the cost of a single self.� Yet such an act, even freely chosen, seems to be beneath our dignity as human beings, and beneath the dignity of the surgeons who would be called upon to perform the lethal act of procurement.� Saving the most lives, it seems, is not the only concern when it comes to medical ethics in general and organ transplantation policy in particular.

Often, in the context of organ transplantation, these three human goods serve one another, as when an individual freely agrees to give his or her organs at death as an act of altruism toward fellow citizens in need.� At times, however, these human goods may come into conflict.� At the very least, we must decide how much weight to give the pursuit of health, whether to preserve or loosen the limits on freedom, and what human dignity really demands of us.� As we consider the range of specific policy proposals in the area of organ transplantation, we need always to reflect on these more fundamental human goods and their relationship to one another.

The purpose of this working paper is to inform Council members of the current policies on organ transplantation and to provide them with a brief sketch of the potential options for policy reform.� It consists of four basic parts.� Part I highlights the most noteworthy laws and regulations of the current system, and explains how these laws and regulations combine to form existing U.S. policy on organ transplantation.� Part II describes recent congressional and regulatory proposals to alter the current system.� Part III briefly surveys the organ transplantation policies that govern in other countries, looking in particular at Spain's version of presumed consent, Sweden's use of mandatory choice, Iran's organ market, and China's practice of organ conscription.� Part IV describes a range of potential policy reforms that the Council might consider for recommendation, from slight adjustments to the current system to more radical changes in its guiding principles and practical workings. This section aims to categorize these various reforms and to offer a preliminary assessment of the strengths and weaknesses of each option.

There are four main kinds of rules governing the organ transplantation process: state laws, federal laws, federal regulations, and United Network for Organ Sharing (UNOS) policies.� The state laws primarily cover issues pertaining to the donation process, such as the criteria for declaring death, the consent requirements for being a donor, the scope of public education programs, and the composition of donor registries.� With a few notable exceptions, these laws do not differ significantly from state to state.� The federal laws primarily outline the processes of organ procurement, allocation, and transplantation by establishing the Organ Procurement and Transplantation Network (OPTN) and guidelines for organ procurement organizations (OPO).� OPTN is the national organization that coordinates, implements, and monitors the organ transplantation system as a whole; OPOs are local or regional organizations responsible for retrieving organs and notifying potential recipients.� The federal law also sets boundaries on how organs might be transferred from one person to another by prohibiting the buying and selling of organs.� The federal regulations expand on the federal laws by describing how the OPTN, OPOs, and transplant hospitals should function.� More specifically, they explain the internal structure of the organizations and the nature of their principal operations.� UNOS rules further define the functions of the OPTN, and describe the policies OPOs and transplant hospitals must follow in order to be members of the OPTN.� Collectively, these laws, regulations, and rules affect every group and every individual involved or potentially involved in the donation, procurement, allocation, and transplantation of organs.� This part of the essay describes in more detail the most significant state laws, federal laws, federal regulations, and UNOS policies.

The widespread uniformity among key state laws is not a result of chance.� In 1968, the National Conference of Commissioners on Uniform State Laws (NCCUSL)¹ disseminated the Uniform Anatomical Gift Act.� The 1968 Act offers a few main clarifications of how the donation process might occur.� It declares who has the right to keep and to use a dead body.� It proclaims that any eighteen year old with a sound mind may donate his or her body after death to be used for medical research or as a source of transplantable tissues and organs.� The Act also defines the priority list of those who might donate the body if the person who died did not declare a preference for or against donation.� By 1972, all fifty states and the District of Columbia had adopted the 1968 Act.²

In 1987, the NCCUSL revisited the issue with the intention of increasing participation in organ donation.� It revised the 1968 Act in a few main ways.� First, the 1987 Act explicitly states that the declaration of a gift does not require any witnesses, whereas the 1968 Act required witnesses for the gift to be valid.� Second, the document of a gift is sufficient for the removal of organs, which means the procurement team does not need the consent of the spouse or the family in addition to the document of gift.� Third, the 1987 Act requires that hospital and medical personnel ask patients upon admittance if they would consider being organ donors. This practice is commonly called "routine inquiry."� Fourth, when a person who is dead did not officially declare an interest or a lack of interest in donating his or her organs upon death, hospital or medical personnel are required to discuss with that person's relatives or surrogates whether or not they would be interested in donating that person's organs.� This practice is commonly referred to as "required request."� Fifth, the 1987 Act permits the removal of organs by medical personnel without explicit consent from a potential donor or from a relative of the donor, so long as the appropriate medical personnel or authorities have made a "reasonable effort" to discover any objection by the donor or the donor's family.� Finally, the 1987 Act forbids the buying and selling of organs, which reiterates the federal ban enacted in 1984.³� Since the promulgation of the 1987 Act, twenty-four states have adopted it.⁴

In general, most states have similar laws regarding organ donation, as a few examples will demonstrate.⁵� Every state recognizes the driver's license as a document of gift.� Every state claims there are two loci of consent, the individual person and that person's family.� Every state declares that an eighteen year old can consent without needing parental permission.� Every state has some form of an organ donation education program.� Most states have a first person consent law, which means the document of gift is sufficient evidence for proceeding with the procurement of organs.⁶� Most states have donor registries.� Either the Department of Motor Vehicles (DMV) provides the local OPO with donor information collected from driver's licenses or the OPO collects the information itself.⁷� Finally, most states subscribe to the same ways of determining death.⁸� These states base their definitions on the NCCUSL's Uniform Determination of Death Act.⁹

That said, there are a few exceptions to the uniformity of state laws on organ donation.� The location of the donor laws within the different state codes is one exception worth noting.� Thirty-four states categorize their anatomical gift laws under a title that includes the word "health," but the remainder of the states put their donor laws under a variety of titles.� Louisiana uses the title "Education."� Florida uses the title "Civil Rights."� Colorado and Kentucky put their laws under a title that includes the word "professions."� New Hampshire, Washington, and Wisconsin have their laws under titles that include the phrase "human remains" or "dead bodies."� Alaska, Georgia, Illinois, Indiana, Maryland, Minnesota, Montana, Ohio, Oregon, and Pennsylvania encode their laws under a title that includes the words "estates," "probate," or "property."� It might be worth considering what each of these categories implies about decedents, their worth, and their relation to the living.�

Another exception to the uniformity of state laws on organ donation is the choice of some states to have anatomical gift funds.� Nineteen states currently have gift funds for increasing public awareness about the need for organ donation.� Ohio, which has some of the most donor friendly laws of all the states, uses its fund not only to promote awareness of need but also to support local and statewide programs that publicly recognize donor families for the gift their deceased relative has given.� In addition, Kentucky, Maine, and New York each dedicate a day or a week to publicly recognize organ donors for their sacrifice.� These are the only states that have such programs, though.

There is a final major exception to the uniformity of state laws on organ donation.� A few states have laws that aim to limit or remove the disincentives potentially faced by living organ donors.� A disincentive here means any financial cost the donor might incur during the donation process.� A few states choose to give state employees paid leave while they donate organs.� The leave varies from two days in Colorado; to thirty days in Delaware, D.C., Maryland, Missouri, Utah, and Virginia; to six weeks in Ohio.� While Arkansas does not grant state employees paid leave, it requires that private employers must grant unpaid leave of absence for organ donation, and that if the employer grants paid leave then the employer is entitled to a tax credit of 25% of the regular salary paid to the employee.� Georgia law also grants a tax deduction, but directly to donors for un-reimbursed donation costs of up to $10,000.� Iowa uses 50% of its donor awareness trust fund to cover the costs of living donors, recipients, and transplant candidates.��

As the previous account demonstrates, state laws primarily cover the process of donation, from the education of potential donors, to the consent requirements to be a donor, to donor registries, and finally to determining when a potential donor has died.� While state laws focus mainly on the donation process, federal laws and regulations establish the boundaries of acceptable practice for the procurement, the allocation, and the transplantation of organs.¹⁰

The federal laws on organ transplantation are primarily found in Title 42 of the United States Code, which is called "The Public Health and Welfare."¹¹� This section will describe five of the most important federal laws.¹²� These five laws frame the American system of organ transplantation by establishing the organization that guides the procurement, allocation, and transplantation of organs; by recording the long-term effects of organ transplantation; by restricting how organs might be transferred from one person to another; and by assisting federal employees who become living donors.

Section 6327 of Title 5 of the United States Code declares that an employee of any executive agency shall be entitled to take a leave from work without a loss of pay in order to serve as a bone marrow or an organ donor.� The employee may have seven days of paid leave to serve as a bone marrow donor, or thirty days of paid leave to serve as an organ donor.� The employee may take the paid leave only once per calendar year.� This law supplements those laws at the state level that reduce some of the costs, or disincentives, of organ donation.� It is one of only a few laws at the national level that explicitly addresses the situation of the organ donor and the process of organ donation.

There are two main laws that establish the organizational structure for organ transplantation.� These laws are 42 USC Section 273 and Section 274.� Section 273 explains the guidelines to be a qualified OPO that can receive federal grants.� To be eligible for a federal grant, an OPO must be a nonprofit entity, have an agreement with the HHS Secretary to be reimbursed for the costs of procuring kidneys, have methods to receive payment for non-renal organs provided to transplant centers, have a defined service area that assures effective procurement and equitable allocation, and have met federal regulation performance standards.� The OPO should also have agreements with most of the hospitals in its area to identify potential donors, arrange for the acquisition and the preservation of organs, have a system to allocate the organs in an equitable manner, and participate in the OPTN.

Section 274 establishes the OPTN.� The OPTN serves as the main national body that governs the procurement, allocation, and transplantation of organs in the United States.� The OPTN must be a private nonprofit with a board of directors.� It must establish a national list of people who need organs, and a national system that matches organs and people on the list.� It also must establish any membership criteria and medical criteria for the allocation of organs, maintain a telephone service to aid in the matching of organs with those who are on the list, assist OPOs in the fair nationwide distribution of organs, and carry out studies on how to improve organ procurement and allocation.� The HHS Secretary must contract the establishment and operation of the OPTN.� Since the enactment of this law, the United Network for Organ Sharing (UNOS) has had this contract.

Section 274a establishes the Scientific Registry.� The Registry is a national database on organ transplantation that includes national transplant statistics, transplant center-specific reports, and transplant research resources.� Similar to the case of the OPTN, the Secretary of HHS must contract the development and maintenance of the Registry to another party.� Currently the Arbor Research Collaborative for Health, which was known as the University Renal Research and Education Association until July 4, 2006, administers the Registry.� The Arbor Research Collaborative for Health has conducted a few significant research projects for the Registry.� They are: "Waitlist and Transplant Activity for Liver, Kidney, Heart, and Lung 1995-2004," "Patient Survival Until Five Years After Transplant -- Patient Transplant, 1998-2004," "Living and Deceased Donors -- All Organs, 1995-2004," "Number of ECD & DCD Kidney Donors By Year," "People Living with a Functioning Graft at Year End by Organ, 1995-2005," "One Year Unadjusted Graft Survival by Year," "Living and Deceased Donor Kidney & Liver Transplants," "One Year Unadjusted Patient Survival by Year," "Living and Deceased Donor Kidney & Liver Transplants," "One Year Unadjusted Graft Survival by Year, Heart & Lung," and "One Year Unadjusted Patient Survival by Year, Heart & Lung."¹³� As this list of projects demonstrates, the Scientific Registry offers one of the most comprehensive sources of data on organ transplantation available.

42 USC Sec. 274e prohibits the buying and selling of organs.� Given this law's significance to the current debate, it will appear here in its entirety.

These five laws outline the legal structure for the federal system of organ transplantation.� The majority of this structure focuses on the organizations that procure, allocate, and transplant human organs.� This structure also establishes boundaries for the transferring of organs.� Only those who provide the necessary services involved in transplantation may receive payment for their contributions to the process.� While living donors may receive reimbursement for the costs of giving, organs must be given as gifts and without payment.� Ultimately, however, the federal law is simply a framework and thus necessitates supplementation.� The Department of Health and Human Services has supplemented the law by creating a set of federal regulations on organ transplantation.

Title 42 (Public Health) of the Code of Federal Regulation has two main parts on transplantation.� Part 121 of Title 42 describes the regulations of the OPTN.� These regulations are called the "Final Rule" and were first implemented on October 21, 1999.� The Final Rule has guided the working of the OPTN since that time.� The second part addresses the regulation of OPOs and transplant hospitals, and is found under the heading of the Centers for Medicare and Medicaid Services (CMS).� These rules explain what OPOs and transplant hospitals must do in order to receive Medicare and Medicaid coverage.� One of the most significant rules is that OPOs and transplant hospitals must be members of the OPTN and abide by its policies in order to receive coverage.¹⁵� This section of the working paper will focus on a few of the rules that describe the functions and responsibilities of the OPTN so that the reader might have a better sense of its significance in the organ transplantation process.¹⁶

42 CFR 121.4 lists a few kinds of policy the OPTN Board of Directors is responsible for developing.� The categories are: policies for the just distribution of cadaveric organs, policies for the testing of donors to avoid the spread of infectious diseases, policies that shrink inequities caused by socioeconomic status, and policies regarding the training of transplant surgeons and physicians.� These policy categories assist the implementation of the official mission of the OPTN.

Section 121.5 of the same title explains the rules an OPTN member must obey when including a person on the organ waiting list.� There are three main rules.� The member transplant hospital may list a person only for a designated transplant program.� The transplant hospital must assure that candidates declared for transplantation are listed.� The OPTN member must pay a registration fee to the OPTN for each person it places on the organ waiting list.

The next section, 121.6, describes the requirements and tests for determining the suitability of donated organs.� The OPTN member that is retrieving the organs must guarantee that laboratory tests and clinical examinations of the potential donors are conducted to determine if the donation is safe to receive.� The transplant programs themselves must establish the criteria for accepting a donated organ, and they must provide these criteria to the OPTN.� These tests must also specifically avoid the acquisition of organs from individuals infected with HIV.� It is the responsibility of the OPTN to adopt the necessary standards for this practice.�

42 CFR Sec. 121.7 explains how the OPTN identifies an organ recipient, allocates the organ, and transports it to the recipient.� The OPTN member must use the OPTN computer match program to identify and to rank potential recipients.� The OPTN determines the order of rank of the recipient by using its established organ specific allocation criteria.� The procurement organization arranges for the transportation of the organ to the hospital and assures that the organ is packaged properly.� The transplant hospital has the right to reject the organ, and if it does so, the procurement organization must offer the organ to the next most eligible recipient.

Section 121.8 describes how the Board of Directors should develop allocation policies to guarantee that they are both efficient and just, and allocation performance goals to ensure the best possible use and most equitable allocation of organs.� The policies must be based on sound medical judgment. They must preserve the transplant program's right to decline an organ.� They must be organ specific.� And they must avoid wasting organs.� A few performance goals aimed at ensuring equitable allocation include: the standardization of the criteria for determining the suitability of candidates, the setting of priority rankings expressed through objective and measurable medical criteria, and the allocation of organs over as large a geographic area as possible.

42 CFR Sec. 121.11 describes the recording and reporting requirements of the various groups involved in the transplantation process.� The OPTN and the Scientific Registry, as appropriate, must use a system for managing information about transplant candidates, recipients, and donors.� The OPTN and the Scientific Registry, as appropriate, must submit to the HHS Secretary a report at least once every year on the organ transplantation process.� The OPTN must provide to the Scientific Registry information on transplant candidates and recipients.� They must also provide information to the public on the performance of transplant programs.� OPOs and transplant programs must maintain any records pertaining to each potential donor, each retrieved organ, and each recipient, and submit that information to the OPTN, Scientific Registry, and HHS Secretary when necessary.

Section 121.12 establishes the Advisory Committee on Organ Transplantation (ACOT).� The HHS Secretary may ask for ACOT's opinion on proposed OPTN policies and any other issue the Secretary deems necessary.� Part II of this essay lists a few of the most significant ACOT recommendations.

While federal regulation explains the framework of the OPTN and its relationship with its member OPOs and transplant centers, this regulation is only a small portion of the policy that dictates the responsibility and action of the OPTN and its members.� The United Network for Organ Sharing (UNOS) creates these other policies.¹⁷� UNOS is the organization that administers the OPTN through a contract with HHS.� HHS awarded UNOS the first contract for the management of the OPTN on September 30, 1986, and UNOS has maintained control over the OPTN since that time.� While UNOS and the OPTN are legally distinct, they are in practice the same.� They have the same Board of Directors and the same policies.� Basically, UNOS provides the substance that composes the OPTN.

UNOS has four main functions.� First, it facilitates the transplantation process by ensuring that organs are procured and allocated as quickly and as fairly as possible through the Organ Center.� The Organ Center matches donors to recipients and organizes the distribution process across the country with UNet, a nationwide transplant computer system that the OPOs can access directly or through the Organ Center.� Once the donor organ information is inputted into UNet, it then lists the potential recipients who are ranked according to the standards UNOS has created for each organ type.¹⁸� When a match is made and the potential recipient's transplant hospital agrees to receive the organ, the procuring OPO delivers the organ.�

Second, UNOS stores and disseminates information on organ transplantation.� It collects data on each transplantation in the United States and analyzes that data.� This process is similar to the process performed by the Scientific Registry.� UNOS also promotes the need for organ donation, which is a task it shares with the states.�

Third, UNOS develops policies for the OPTN.� The policy process has multiple steps.� First a UNOS committee develops policy proposals.� Then the committee writes and disseminates an initial brief explaining the need for the proposed policy changes.� Next the committee asks for public comments on the policy proposals.� The committee then responds to the comments by the public and submits a final proposal to the Board of Directors.� The Board votes on the proposal, and if the Board approves the proposal it becomes UNOS/OPTN rule.� The Board can also submit an approved proposal to the Secretary of HHS, and if the Secretary approves the policy it is incorporated into official regulation.�

Fourth, the UNOS Evaluation and Quality Department monitors OPTN members to ensure their compliance with UNOS/OPTN policies.� While some of the UNOS policies become official regulations, many do not and remain "voluntary."¹⁹� That said, OPOs and hospitals must abide by all of the policies if they desire to remain members of the OPTN,²⁰ so the policies are only voluntary if the OPOs or hospitals do not desire to be members of the OPTN.� Most do because of the conditions for receiving Medicare and Medicaid benefits.� So while the policies are officially voluntary, they are in reality mandatory.

There are two main ways to distinguish UNOS membership: the type of member and the region to which it belongs.� There are three different types of members: OPOs, transplant hospitals, and histocompatibility centers, with each member type having its own laws, regulations, and rules that every member must follow.²¹� The members also belong to a specific region, which is based on the members' geographic location.� There are currently eleven regions.²²� While these categories divide the members, UNOS requires that each member obey all of the UNOS rules that apply to it.

These state laws, federal laws, federal regulations, and UNOS policies comprise the bulk of policy on organ transplantation.� The state laws cover primarily the process of donation, from the encouragement of donation at local DMV offices, to documents of gift, to donor registries, to the determination of death.� While a few federal laws address donor issues, they primarily focus on the procurement, allocation, and transplantation of donated organs by establishing the OPTN, which governs these three processes.� The HHS is responsible for creating regulations to guide the functioning of the OPTN, but leaves the details of implementation of the OPTN to UNOS.� UNOS collects data on transplantation; lists potential recipients; makes policies governing the procurement, allocation, and transplantation of organs; and monitors and enforces compliance to its rules and federal regulations.� These four levels of policy govern the practice of organ transplantation both region by region and nationwide.��

These four levels of policy also reveal a few of the main principles and guidelines of the U.S. system of transplantation, each of them serving in different ways the goods of health, freedom, and dignity introduced above.� First, organ donation is a civic good and should be supported; it ameliorates suffering and saves lives.� Second, personal autonomy is central to the American experience and should be emphasized in the consent laws that govern who donates.� Third, the family has needs and wishes that should also be respected in the donation process, especially in the first moments of mourning.� Fourth, citizens have equal political rights, and this equality should be at least partially reflected in the laws that determine the allocation of organs.� Fifth, one important purpose of government is to protect citizens, and thus it should ensure that the transplantation process is both safe and free from coercion.� Finally, all human beings have a certain moral worth, and this worth should be considered when defining how organs are given and taken.� These guidelines, like the goods that they reflect, sometimes support one another and sometimes are in tension with one another.� Each of these guidelines plays an integral role in shaping the current laws, regulations, and rules, as well as in many of the recommendations for policy reform.

While many of the state laws, federal laws, federal regulations, and UNOS rules have proven useful and good, policymakers at all levels are currently considering how to improve existing policy on organ transplantation. This part of the working paper describes the most important policy initiatives and recommendations at three of the four levels of governance: federal bills, regulatory recommendations, and UNOS proposals.²³�

Central to many of these recommendations is the governance of organ donation from living donors.� A couple of the federal bills described below propose to further remove the disincentives a living donor might face, while one bill proposes to expand the possible ways of being a living donor.� A few of the regulatory recommendations argue for better monitoring and oversight of the process of living donation, and one of the two UNOS proposals described below recommends that transplant hospitals should more closely monitor the health of living donors.�

Other significant themes include continued support for the prohibition on the buying and selling of human organs, which is stated in one of the bills and in one of the regulatory recommendations, and the desire to alter the consent laws, the most notable example being the regulatory recommendation that promotes the exploration of presumed consent policies by the states.� The promotion of presumed consent is the only policy recommendation considered in this section that would radically alter the current policy system, though many of these proposals are indeed significant.��

In the 109^th Congress, the House of Representatives and the Senate have so far introduced twelve bills or resolutions that directly address organ transplantation.� The House has introduced seven of these bills or resolutions, the Senate has introduced four, and there is one concurrent resolution.� Three of the bills presented in the House are analogous to bills being presented in the Senate.� Of the twelve, this essay will describe the most noteworthy.²⁴

The Living Organ Donor Job Security Act of 2005 (H.R. 1993) was presented in the House on April 28, 2005.� It intends to amend the Family and Medical Leave Act of 1993 by allowing leave for individuals who provide living organ donations.� The following procedures are included: tests used to determine whether the potential donor is medically suitable; evaluations of the potential donor; pre-transplant outpatient services; postoperative transplantation services; travel connected with the tests, the evaluations, and the services; and recuperation consistent with the type of transplantation.

The Living Organ Donor Tax Credit Act of 2005 (H.R. 2474) was presented in the House on May 19, 2005.� It intends to amend the Internal Revenue Code of 1986 to provide a credit to living individuals who donate organs.� During the taxable year when the transplantation occurs, the donor can receive the credit sum of the un-reimbursed costs and of any lost wages as long as the credit does not exceed $5,000.

The Gift of Life Congressional Medal Act of 2006 (H.R. 4753, S. 2283) was presented in the House and in the Senate on February 14, 2006.� It intends to establish a congressional commemorative medal for organ donors and their families.� The entity controlling the OPTN (currently UNOS) must establish an application process that requires the relevant OPO to submit documentation supporting eligibility.

The Living Kidney Organ Donation Clarification Act (S. 2306) was presented in the Senate on February 16, 2006.� It intends to amend the National Organ Transplant Act to clarify that kidney paired donation and kidney list donation do not involve the transfer of a human organ for valuable consideration.

House Resolution 794, which was presented on May 3, 2006, recognizes the 17^th anniversary of the massacre in Tiananmen Square.� It describes China's policy of harvesting organs from executed prisoners as "barbaric."� It calls for the Chinese government to "end organ harvesting and ensure that its organ donor programs proceed only on a purely transparent, voluntary, and non-commercial basis."

The Advisory Committee on Organ Transplantation (ACOT) was created by 42 CFR 121.12.� Its task is to advise the HHS Secretary on organ donation, procurement, allocation, and transplantation.� One of its most important functions is to advise the Secretary on "ways to maximize Federal efforts to increase living and deceased organ donation nationally."²⁵� It also reviews OPTN policies submitted to the Secretary.� ACOT has a list of 42 recommendations to the Secretary that it produced during annual meetings from 2002 through 2005.� This section will list 20 of these recommendations that seem most noteworthy.²⁶� The recommendations will be repeated verbatim from the ACOT Summary Recommendations to the Secretary.²⁷

Recommendation 1: That the following ethical principles and informed consent standards be implemented for all living donors. The person who gives consent to becoming a live organ donor must be:

Recommendation 2: That each institution that performs living donor transplantation provide an independent donor advocate to ensure that the informed consent standards and ethical principles described above are applied to the practice of all live organ donor transplantation.

Recommendation 3: That a database of health outcomes for all live donors be established and funded through and under the auspices of the U.S. Department of Health and Human Services.

Recommendation 4: That serious consideration be given to the establishment of a separate resource center for living donors and their families.

Recommendation 5: That the present preference in OPTN allocation policy-given to prior living organ donors who subsequently need a kidney-be extended so that any living organ donor would be given preference as a candidate for any organ transplant, should one become needed.

Recommendation 7: That a process be established that would verify the qualifications of a center to perform living donor liver or lung transplantation.

Recommendation 9: That research be conducted into the causes of existing disparities in organ transplant rates and outcomes, with the goal of eliminating those disparities.

Recommendation 10:� That legislative strategies be adopted that will encourage medical examiners and coroners not to withhold life-saving organs and tissues from qualified organ procurement organizations.

Recommendation 11:� That the secretary of HHS, in concert with the Secretary of Education, should recommend to states that organ and tissue donation be included in core curriculum standards for public education as well as in the curricula of professional schools, including schools of education, schools of medicine, schools of nursing, schools of law, schools of public health, schools of social work, and pharmacy schools.

Recommendation 15:� That the following measure be added to the CMS conditions of participation: hospitals shall notify organ procurement organizations prior to the withdrawal of life support to a patient, so as to determine that patient's potential for organ donation.� If it is determined that the patient is a potential donor, the OPO shall reimburse the hospital for appropriate costs related to maintaining that patient as a potential donor.

Recommendation 19:� That the primary principle in organ donation be honoring the donor's wishes and fulfilling the donor's intent.� This principle is known as donor designation.

Recommendation 20:� That updated provisions of the Uniform Anatomical Gift Act with respect to donor rights be fully implemented in all states where the UAGA has been adopted, and that those or substantially similar provisions be enacted in all other states.

ACOT specifically recommends that every OPO and hospital in a state that has enacted the UAGA, as amended, should be educated in the implications and enforcement of the UAGA.� ACOT further recommends that OPOs and hospitals in states that have not adopted the amendments to the UAGA, or substantially similar provisions, should work with their state legislatures to enact laws that enforce the donor designation model.

ACOT recommends that a comprehensive review and updating of the laws governing anatomical gifts take place in each state and that all states be encouraged to adopt laws intended to uphold the intent of donors.

Recommendation 22:� That the use of split livers be encouraged as a matter of national policy.

Recommendation 26:� That Section 105 of Senator Frist's bill (S. 573) be endorsed, so as to make clear that the term "valuable consideration," in the National Organ Transplant Act of 1984, does not include familial, emotional, psychological, or physical benefit to an organ donor or recipient.

Recommendation 29:� HHS should fund necessary research initiatives, and convene a national consensus conference, updating the criteria involved in end of life issues related to the determination of death in the context of organ donation and transplantation.� The three specific areas for review would be brain death, cardiac death, and imminent death.

Recommendation 30:� HHS should review the results of the research conducted and national consensus conference convened in response to Recommendation 29 and seek to resolve the many reimbursement issues related to the determination of death in the context of organ donation and transplantation.� These deal with determination of brain death, cardiac death, and imminent death, particularly with regard to ECD organs.� CMS and other appropriate HHS agencies should also review their procedures with regard to living donors to ensure that living donors are fully reimbursed, and further that living donors are not disadvantaged with respect to their other insurance needs.

Recommendation 36:� The Advisory Committee on Organ Transplantation (ACOT) recommends that the Secretary of Health and Human Services (HHS) seek authority to identify and exclude certain practices from the definition of "valuable consideration" in section 301(a) of the National Organ Transplant Act, as amended.

The Secretary's authority should be limited to legitimate and beneficial practices that are intended to increase the supply of human organs, without creating a commercial market for the purchase or sale of human organs or posing a risk of coercion of a potential donor or donor family.� In addition, the Secretary should be required to obtain an appropriate independent ethical evaluation before excluding any practice from the prohibition on valuable consideration.

ACOT has concluded that a process to limit the scope of "valuable consideration" would encourage the development of ethical practices to increase the supply of human organs and provide certainty to the transplant community about the scope of permissible activities.� Regulatory authority is both more flexible and more responsive to innovation than an expanded statutory list of practices that are not included in the term "valuable consideration."� The notice and comment period will provide an opportunity for public and professional input into any proposed regulation.

ACOT, therefore, recommends that Section 301 of the National Organ Transplant Act be amended in its entirety to read as follows:

Recommendation 37:� The ACOT recommends that the Secretary of HHS encourage states to undertake demonstration projects to test the feasibility of adopting a model of presumed consent to organ donation.

Recommendation 41:� The ACOT recommends that the Secretary of HHS direct the OPTN to develop allocation policy pertaining to nondirected, living-donor organs.

Recommendation 42:� ACOT recommends to the Secretary that the OPTN be asked to expeditiously consider all issues associated with the development of a registry for matching living donors and recipients, paying particular attention to informed consent and the monitoring of long-term outcomes of the donors.

Unlike some of the federal bills and certainly quite a few of the ACOT recommendations, recent UNOS proposals are relatively modest.� Since the beginning of the year, UNOS committees have recommended ten policy changes.� Most of these policy recommendations would involve subtle alterations to current policy.� A couple proposals would require somewhat more significant transformations.� Here we describe the two most significant recommendations.²⁸�

Proposal 1 (2/27/06): Currently a few regions have a system of paybacks, where the region that receives a liver from another region must "payback" the giving region with a liver.� The payback system supposedly promotes the regional sharing of livers.� This proposal argues that such a system is outdated by new protocols and it recommends the disbanding of the payback system.

Proposal 2 (5/19/06): This proposal recommends that transplant centers report organ function failure of living donors and living donor deaths within 72 hours of awareness of the event.� Currently the collection of this information occurs six months and one year after the transplantation.� The committee members desire that the information be made available in a more timely fashion.

The federal bills, ACOT recommendations, and UNOS proposals described above provide some insight into the general direction of U.S. policy reform.� The federal bills primarily aim to support living donation, perhaps as a means to increase the organ supply.� The Living Organ Donor Job Security Act and the Living Organ Donor Tax Credit Act propose to remove some of the disincentives that might discourage or at least increase the difficulty of living donation.� The Gift of Life Congressional Medal Act proposes to provide an incentive to donate by appealing to the potential donor's sense of honor.� The Living Kidney Organ Donation Clarification Act proposes to exclude paired donation and list donation from the meaning of valuable consideration.� These bills aim at making living donation less costly, more rewarding, and easier.�

But Congress is not committed to every imaginable way of increasing the organ supply. House Resolution 794 states that certain practices of providing more organs are inappropriate by calling for the Chinese government to "ensure that its organ donor programs proceed only on a purely transparent, voluntary, and non-commercial basis."� Thus prohibiting the conscription and the purchase of organs trumps Congress' desire to increase the organ supply.

ACOT shares Congress' desire to continue to ban the purchase of organs.� But its recommendations also focus on a few other important donation issues, namely improving the process of living donation, increasing public awareness about the need to donate, and promoting experimentation with presumed consent laws.� Recommendations 1, 2, 3, and 42 very clearly express ACOT's concern for living donors.� Recommendation 1 calls for improving informed consent standards for living donors; Recommendation 2 proposes that transplant centers have living donor advocates to protect the rights and represent the interests of the donors; Recommendation 3 argues for the creation of a database of living donors; and Recommendation 42 calls for the OPTN to consider how to create a registry that would match living donors and recipients.� These recommendations respect the need for more organs, but they also seek to protect the health and well-being of those who donate.��

ACOT also understands the need for an informed public.� In Recommendation 11 it proposes that the HHS Secretary and the Secretary of Education suggest to the states that they include a section on organ donation in their public school curriculum.� Better education certainly equals more informed citizens, but hopefully also more willingness to donate organs.�

In Recommendation 37, ACOT introduces the only policy proposal that would clearly lead to a significant change in the guiding principles and governing framework of the current system.� It states that the HHS Secretary should urge states to test the feasibility of "presumed consent" laws.� As mentioned in Part I, most states have "first person consent" laws.� A few states give the family members of a deceased person some legal authority to determine if they would like to donate their dead family member's organs.� Both kinds of laws are "opt-in" policies, in which donation occurs only by request and only with the explicit permission to donate. (There is a partial exception to this general rule in some state laws.� This exception is explained more fully below; see footnote 42.)� Presuming that the lack of declaration means that the deceased person intends to donate would be a radical alteration of the current practice by transforming the "opt-in" policies to "opt-out" policies.� Such a policy shift would alter the current policy by removing some of the responsibility of the individual or the family to choose to donate and placing that power in the hands of the government.�

It is also worth noting that Recommendation 37 involves a process typically left to the states.� But it is not the only recommendation to do so.� ACOT's recommendations cover public education, first person consent laws, donor rights, and the determination of death.� All of these issues are integral parts of the process of donation.� While ACOT never explicitly says that the national government should address these issues instead of the states, its status as an HHS advisory body suggests a possible expanded scope for national governance and oversight of the transplantation process.�

Perhaps the most difficult ACOT proposal to evaluate is Recommendation 36, which calls for an amendment to the federal law prohibiting the sale of an organ for "valuable consideration."� On the one hand, this recommendation seems to affirm the existing ban on the buying and selling of human organs.� Yet it also seems interested in making room for incentives that would boost the organ supply without creating a "commercial" organ market.� The scope of this suggested change would thus depend upon how the term "commercial" is interpreted.

Like ACOT, UNOS is also concerned about the health of living donors, as Proposal 2 from May 19, 2006, demonstrates.� In this proposal, UNOS calls for better monitoring of instances when a living donor's health fails.� UNOS recognizes that living donors compose a significant part of the donor pool and that the needs of these donors should be more formally considered through established rules.�

In general, these proposals would not radically alter the current organ transplantation policy.� Yet especially with the ACOT recommendations on presumed consent and valuable consideration, they might plant the seeds for more significant changes in current practice.� In Part IV, we will consider a much wider range of potential policy reforms. Before doing so, we consider in Part III a few organ transplantation policies in other countries that differ significantly from our own policies.��

Before discussing a sample of countries with alternative organ policies, it is worth noting that the United States policy on organ transplantation is fairly similar to that of most other democracies in which organ transplantations occur.� The precise laws of these countries are of course different from U.S. law, but they share many of the same guidelines.� Most countries' laws reflect a belief that organ donation is a public good that should be supported and increased.� Many countries have some form of first person consent laws, where individual citizens freely decide if they would like to be living donors and freely determine the fate of their organs after death.� Many countries' laws respect the wishes of the families of the deceased and request the family's consent if a family member who died did not declare a clear desire to donate or not donate.� Many countries do not permit or support the buying or the selling of organs.� And many countries protect their citizens from coercion to donate.²⁹��

Nevertheless, a few countries have vastly different policies on organ transplantation than the United States, and these policies imply a different set of guidelines. Considering a few of these approaches will provide a broader perspective from which to evaluate United States policy.� This section briefly describes Spain's presumed consent law, Sweden's mandatory choice law, Iran's organ market, and China's policy of organ conscription.³⁰

Spain is widely perceived in the transplant community as having one of the best organ donation programs in the world,³¹ and many analysts believe that its presumed consent law accounts for part of its success.� As mentioned above, presumed consent in the organ donation context means that the government and procurement organizations may assume that citizens are willing to donate their organs at death if they do not state otherwise.� There are two main kinds of presumed consent laws: "Strong" presumed consent laws rely solely on the individual citizen to declare himself or herself a non-donor. "Weak" presumed consent laws allow the family members of a decedent to opt-out if they desire to do so.� Spain has a weak presumed consent law, where hospital staff members always approach the surviving family members-not to request permission to procure organs, but to see if they would prefer not to allow procurement to proceed as it normally would.³²

In the spring of 1996 the Swedish health authority, Socialstyrelsen, distributed enough pamphlets about organ donation to reach Sweden's entire population.� The pamphlets specifically requested to know whether or not each individual would like to donate his or her organs at death.� In the summer of that year Sweden began implementing a law that required each citizen to decide whether or not they wish to donate, and what was a request in the spring became a command in the summer.� This statute is commonly referred to as Sweden's "mandatory choice" law.³³� We cannot say what the precise effect of this law has been, but we do know that Sweden ranks relatively low in donation rates compared to other Western countries.³⁴��

Iran's transplant program is one of the most active in the Middle East.� Unlike most other countries in the world, the vast majority of organs come from non-related living donors.³⁵� And unlike in most other countries, many of these donors receive payment for their body parts-typically kidneys-which are legally bought and sold.� In Iran, donors are actually vendors. The Charity Association for the Support of Kidney Patients and the Charity Foundation for Special Diseases are the two nongovernmental organizations that organize and monitor the organ trade.� They match donors to recipients, and provide the donors with a specific sum of money for the donation.³⁶� Without this source of kidneys from living donors, the organ supply would probably drastically diminish, in part because of significant disagreement among Islamic scholars over the guidelines for cadaveric donation.³⁷

In July 2006, China banned the buying and selling of human organs.³⁸� Presumably this ban might affect the Chinese policy of routinely harvesting organs from prisoners, or at least those organs that the government is selling.� The policy of organ conscription has its roots in the 1983 "Strike Hard" campaign, which announced that China would begin executing common criminals.� With this new supply of decedents, China then created the "Rules Concerning the Utilization of Corpses or Organs from Corpses from Executed Criminals" law the following year.� This law claims that the government can use a prisoner's organs if that prisoner consents to donate.³⁹� In November 2005, at a World Health Organization meeting, the vice minister of China's Ministry of Health disclosed that 95% of organs transplanted in hospitals in China come from executed criminals, with the other 5% coming from living donors.⁴⁰� The first percentage is shockingly high, and given China's human rights record one might rightly doubt that most prisoners who surrender their organs freely consent to donation.� This doubt explains why many organ transplantation scholars refer to the Chinese system as organ conscription.

While the accounts of the practices of these four nations are very brief, they highlight a few major differences from the U.S. system, and in doing so help define more clearly the boundaries of our national organ policies, most especially concerning the role of the government in questions involving organ donation.� In the United States, the choice to donate is left to the individual person or to that person's family, and the decision that the person or the family makes is to opt-in to the donation system, not to opt-out.� These guidelines severely limit the government's power in determining who will donate.� In systems that conscript donors (like China) or presume that donors consent when they do not declare otherwise (like Spain), the government plays a much larger role in the determination process.� The same can be said for mandatory choice laws (as in Sweden): a government that sponsors this type of law forces its citizens to make a decision, whereas in the U.S. system the government offers every citizen the choice to declare themselves potential donors but does not require an explicit declaration of one's intentions.

As for the limits concerning the giving of an organ, the U.S. distinguishes between "gifting" and "selling."� By not permitting the buying and selling of organs, the U.S. system declares that gifting is the only way organs can be procured.� Thus, unlike the case of consent, the U.S. government is arguably more involved than some other nations by legally prohibiting organ commerce.� A more libertarian system would permit both forms of organ exchange-giving and vending-and leave individuals free to decide for themselves, without government interference, whether selling a body part made personal sense.

Clearly the U.S. government's role in the organ transplantation process is fairly complex, but it is not arbitrary.� Our laws reflect our liberal democratic principles, though not simply in a libertarian way.� These guiding principles aim to protect personal autonomy, respect the needs of the family, recognize the equality of American citizens, defend the inherent worth of human life, and promote the pursuit of health.� But it is also worth remembering that the current system reflects certain judgments about the relevant meaning of and proper balance among these principles.� Those who seek to modify current policy, whether in a limited or a dramatic way, would alter how we understand and how we balance the human goods that govern the system.� We turn now to the range of potential policy reforms.��

As the preceding overview should make clear, organ donation, procurement, allocation, and transplantation is a complex matter, both at the level of clinical practice and of public policy.� This section aims to provide an analytical survey of a range of possible policy reforms.� It focuses primarily (though not exclusively) on reforms at the level of public policy, not clinical practice, and in particular (though again, not exclusively) on those policy reforms that would require changes in state or federal law.� Some important areas of reform are specifically not addressed-including changes in organ allocation policy aimed at reducing organ waste and promoting equitable distribution (addressed in Working Paper #3), new protections for living donors to ensure that all procedures meet an acceptable level of safety (addressed in Working Paper #1), and efforts to expand the pool of deceased donors by establishing protocols for donation after uncontrolled cardiac death (addressed in Working Paper #2).� In addition to changes at the policy level, this section will explore, albeit all too briefly, various scientific and medical efforts to develop clinical alternatives to transplantation.

The potential policy reforms surveyed here are broken down into eight thematic categories: (1) the expansion of education programs; (2) the removal of disincentives for living donation; (3) the use of expanded criteria donors; (4) the promotion of organ exchanges; (5) the alteration of donor consent laws; (6) the legal and clinical redefinition of death; (7) the creation of new rewards or incentives for donation; and (8) the promotion of medical alternatives to transplantation.� Each policy reform is described in terms of its larger aims and its effect on existing policies and regulations.� Then, briefly, the strengths and weaknesses of each proposed reform are evaluated.

For the past few decades, education and outreach about the benefits of organ donation-the "gift of life," as it is regularly called-have been promoted, supported, or undertaken by the federal government, state governments, and myriad private organizations.� These efforts could be significantly expanded.� National campaigns might take the form of an "organ donor awareness day," where the President and Congress issue proclamations or commemoratives explaining the need for and virtues of organ donation.� Congress might promote an extensive publicity program that targets communities throughout the country that have low donation rates.� States might have similar programs, and they might further expand their education efforts at their DMVs, public schools, and driver's education courses.� Local communities might also sponsor donor awareness events, such as parades or carnivals.� One might even make the education campaign more aggressive-by declaring organ donation a national duty, or shaming those who do not register as organ donors as "wasting the gift of life."

The strength of this policy option is that it recognizes the need for more organs and the current ignorance of this need by many American citizens, yet it does not require vast changes in the practical workings and ethical guidelines of the current system.� The weakness of this policy is that it is seen by many as an inadequate means of significantly boosting the organ supply.� Numerous education programs are already in place, and while surely useful and valuable, it seems unlikely to many observers that more education alone will drastically change donation behavior.

Disincentives are the financial costs a potential organ donor might incur during the process of living donation.� Some of the most significant disincentives are: lost pay and forgone advancement due to missed work; the costs of transportation, from the initial visit to determine eligibility for donation to the final trip home after transplantation and recovery; lodging and perhaps food during these trips; and any other financial costs directly related to the donation process.�

Already, the federal government and a few states have laws that aim to ease the economic burden of being a living donor.� These laws mainly apply to government employees and typically only reduce a portion of the donation costs.� A more comprehensive policy would cover most, if not all, of the financial costs incurred during the donation process.� It might do so by providing expanded benefits for government employees, tax credits to private employers who offer organ donor benefits to their employees, or direct grants or tax credits to the donors themselves.� The federal government explicitly excludes such forms of reimbursement from the meaning of "valuable consideration," so policy reforms in this area would not encroach on forbidden practices.

This policy presupposes that living organ donation is a public good, or at least a useful means of supplying organs to those who need them.� It aims to use public funds and public law to help altruistic individuals help others in need, yet it does so without undermining the system and spirit of organ "gifting."� It recognizes that giving an organ involves a grave personal sacrifice, and that we should not make donation to a loved one impossible for those who could not bear the burden of lost pay or the extra out-of-pocket expenses.

The potential weakness of this policy is that the line between removing disincentives and creating new incentives might become murky.� In the name of reducing the burden of organ gifting, such a policy introduces money and payment into the mix; donors get paid for being donors, even if they are not paid for the organs themselves.� To remove a disincentive is to create an incentive to donate, albeit a very small one.� Moreover, covering such costs through the public purse would add to the overall expense of organ transplantation to taxpayers, and there might be better ways to invest public funds even if the goal is to promote more organ donation.

One way to expand the potential pool of organ donors is to loosen the health criteria for being a donor at death.� Already, as discussed in greater detail in Working Paper #3 on organ allocation, we use both "standard donors" who meet the strictest standards of eligibility and "expanded criteria donors" who meet a looser, more discretionary standard.� The UNOS Board of Directors defines the eligible dead donor as an individual who is 70 years or younger and meets a very extensive list of health requirements.⁴¹ There are two main ways of expanding this definition.� First, the age limit might be increased to 75 or 80.� Second, some of the health requirements imposed on potential donors might be reduced.� Serious diseases such as AIDS would still disqualify the use of organs, but less severe conditions might not.�

Expanding the criteria would require specific changes in the rules governing organ transplantation.� UNOS would need to change its definition of eligible death, but given that the current definition is not federal regulation or law, Congress and the Department of Health and Human Services would not need to change any of their policies.� There might, however, need to be some updates of the informed consent policies, letting recipients of older, less healthy organs know of the increased risks of receiving such organs.� In addition, the rules of allocation might need to be altered to accommodate this new tier of organs.

Such a policy is rooted in the principle that in some cases the risks of an imperfect organ are preferable to waiting for a higher quality organ.� Such a policy would potentially make transplantation available to individuals who would likely never receive an organ otherwise.� Given that these organs would be less desirable than standard criteria organs, those at the top of the waiting list might reject them, believing that a slightly longer wait time will lead to a longer lasting/better performing organ.� If this scenario in fact happens, transplant centers might give these less healthy organs to the elderly, including those whose other health problems make them marginal candidates for transplantation.�

The major weakness of this policy is that by increasing the age and loosening the health requirements of potential donors, we risk harming those whom we desire to help.� We also risk introducing new layers confusion into the allocation system, with doctors and patients forced to decide, under pressure, whether to take a less healthy organ now or hope for a better organ later.� For some, even considering such an expanded criteria proposal demonstrates the need to consider more aggressive ways of expanding the pool of healthy donors.

One possible way to expand the donor pool is to promote and facilitate organ exchanges. In some cases, an individual wishes to act as a living donor for a loved one, but cannot do so because he or she is not biologically compatible with the intended recipient.� An organ exchange would permit the living donor to give his or her organ to someone else in exchange for the intended recipient receiving an organ from another source.� There are two main forms of such exchanges: list donations and paired exchanges.

A list donation occurs when Donor A desires to give a kidney to Recipient A, but the two individuals are not biologically compatible.� Instead, Donor A gives a kidney to someone on the general kidney list, and in exchange Recipient A receives a compatible kidney from the list.� Depending on how such a policy is enacted, Recipient A could receive a certain number points to improve his or her list ranking, meaning he or she would get a kidney earlier but not immediately.� Or the intended recipient could be moved up to the top of the list, meaning that he or she would get the next publicly available kidney.

Some transplant hospitals across the country currently practice list donation, but its legal status is somewhat ambiguous.� While the law is presently silent on list donation, competing interpretations exist.� Some believe that list donation might be considered a form of "valuable consideration," because the donor receives a "reward" for donating (i.e., the donor's desired recipient moves up the waiting list).� Others believe that this form of exchange is a type of dual gifting, a creative form of altruism that does not involve "valuable consideration" as defined by the law.� The Living Kidney Organ Donation Clarification Act, mentioned above, would clarify that list donation does not involve valuable consideration and does not violate existing law in any way.

The promotion of list donation might involve not simply ensuring its protection under the law, but establishing protocols to encourage this practice by making potential donors aware of this alternative means of helping a loved one.� The case for list donation is that it allows two patients to be helped instead of one; it adds a donor to the donor pool who would not donate otherwise-a donor whose only motivation to give is helping a particular person in need.� It is a way to strengthen community, by binding individuals to one another in overlapping acts of altruism

The argument against list donation is that it gives an unfair advantage to those who have willing donors-though, of course, this situation is always the case, given that those with compatible living donors do not need to wait on the list.� The specific difference here is that the desired recipient gets an organ from the public list, and it is possible, in certain cases, that this form of exchange would disadvantage those at the top of the list who are not potential recipients of Donor A's organ but who are potential recipients of the organ that might end up going to Recipient A.� In addition, some might see list donation as a form of trading, no different than commerce even if money is not involved.� This practice would mean reducing the body and its parts to objects of trade; as such, the meaning of gifting is blurred or ultimately lost.

A paired exchange is similar to list donation, but it involves two living donors instead of one living donor and a kidney from the list.� In other words: Donor A gives to Intended Recipient B, and Donor B gives to Intended Recipient A.� Paired exchanges can also occur among multiple pairs of donors and recipients.� For example: the donor from pair A has a kidney that matches the recipient of pair B.� The donor of pair B has a kidney that matches the recipient of pair C.� And the donor of pair C has a kidney that matches the recipient of pair A.� Each donor can then offer a kidney to a compatible recipient, allowing three donations to occur instead of (in some cases) none at all.

The legal implications of paired donation are very similar to those of list donation.� Many transplant centers throughout the nation are currently practicing paired donation, but confusion still exists on whether or not paired donation involves the transfer of organs for "valuable consideration."� The moral arguments are also similar: to some, this is a form of creative altruism that allows many individuals to benefit; to others, it transforms gifting into exchange and body parts into objects of trade.� With paired exchanges, however, there is not even the possibility of disadvantaging anyone on the waiting list, given that no publicly available organs are used.� Moreover, the fact that all the donors are living makes it possible for them to know one another, and thus to see one another as engaged in interconnected acts of generosity.

This category includes a range of policy options that would modify or fundamentally alter the ways of consenting to organ donation.� While any typology is an oversimplification, there seem to be five main kinds of consent laws: (1) first person consent, which is when one becomes an organ donor only by explicit personal consent; (2) family consent, which is when the surviving family members give explicit permission for a deceased loved one to be an organ donor; (3) mandatory choice, which is when the government requires every adult citizen to use his or her right to consent by declaring himself or herself either a donor or a non-donor; (4) presumed consent, which is when the government assumes that organs can be procured from the deceased unless the individual or the family expresses the explicit desire to "opt out"; and (5) organ conscription, which is when the government procures organs, from the dead or even the living, without the individual having any real choice to opt out.� In the United States, as we have seen, current policy centers on first person consent, with surviving families almost always consulted, both when the deceased person's wishes are unknown and even when the decedent's desire to be a donor is clear.⁴²� In what follows, we survey each of these policies, beginning with where we are and then exploring the range of possible reforms.

Most states, as we have seen, have first person consent laws.� Simply put, these laws stipulate that the individual person has the sole authority to choose whether or not to donate his or her organs.� Legally, neither the family nor the state can trump the person's decision to donate or not donate.� But sometimes there is a difference between law and practice.� In the case of a living individual who wishes to donate a "non-essential" organ,⁴³ the legality of first person consent is typically upheld, so long as the consenting individual is deemed to understand the risks and benefits of donation and is deemed medically eligible to donate.� In the case of donation after death, however, the situation is somewhat more complicated from the perspective of consent.� When a declared donor dies, most procurement teams still consult the surviving family members and do not procure the decedent's organs if the family objects.� In those cases in which the deceased person is not a declared donor, surrogates must decide on his or her behalf-whether by seeking to discern what they believe the deceased person would have wanted, or by doing what they believe themselves to be right.� The most complicated cases involve situations in which it is unclear who speaks for the deceased, or when there seem to be no family members or surrogates at all to speak for the deceased.� In the latter case, some states will not procure organs without explicit family consent; other states have the option to proceed with procurement after making a reasonable effort to get consent.

First person consent is described here as a policy "option" in the United States precisely because it is not always strictly enforced.� To strictly enforce such a policy in the context of deceased donation would not change the law or governing principles of the current system, but it would alter prevailing practice: specifically, in those rare cases when the deceased person wished to donate but the surviving family does not, it would mandate that the family's objections be overridden and the decedent's organs be procured.� It would strengthen even further the respect for personal autonomy that is so central to the current system, at the possible expense of violating the wishes of those in mourning. (Such a strict first person consent policy, one should note, might also invite the creation of a "non-donor registry," so that individuals who wish not to have their organs procured at death can make their desires legally clear.)

One might argue that the strength of a first person consent policy is that organ donation is treated always as a personal choice-freely embraced as a good by the one who gives, without explicit coercion by others.� It enshrines the principle that individuals do not belong to others, and that neither the state nor anyone else can take one's body parts without the individual willingly seeking to give them and explicitly authorizing their being taken.� First person consent laws solidify the individual person's rights over his or her own body even after death, by respecting the person's autonomous wishes about the handling of his or her mortal remains.�

One might argue that the weakness of first person consent laws is that they push the principle of autonomy too far, neglect the needs of others, and forget the larger context in which individual persons live.� This context consists of family, friends, and fellow citizens-family and friends who need to accept the death of the one who has died, and fellow citizens whose very lives sometimes hang in the balance as they wait for transplantable organs.� Only by balancing the autonomy of individual persons and the needs of others can family and community be preserved.��

As just explored, the surviving family plays a central role-arguably the central role-in actually deciding whether a deceased loved one's organs are donated.� To enshrine what is standard practice into an explicit, legally sanctioned policy would give family members the final say about whether organs are procured, even in those cases in which the deceased person is a registered organ donor.� Such a law would, in a sense, make registering as an organ donor a signal of one's desires rather than a binding legal contract. In those rare cases when an individual's wishes and a family's wishes come into conflict, the will of the living family members would prevail.

Given that most states have first person consent laws, strict family consent laws would alter one of the fundamental guidelines of current policy, though such a legal reform may not actually change what presently happens at the bedside after death.� Moreover, like first person consent laws, organs could only be removed with explicit permission.� The body is given by the family; it does not belong to the community or the state.

One might argue that the strength of such a policy is that it would respect the role of family members in speaking for those who can no longer speak for themselves.� It would respect the needs of the family during the grieving process, and acknowledge that the deceased cannot foresee in life the exact circumstances of their death, and that there might be times when doing what the deceased person claimed to want is not what is best for those who must remember him or her.��

One might argue that the core weakness of this policy is that it weakens autonomy unnecessarily, and authorizes family members to violate the explicit wishes of the person whose mortal remains they were instructed to oversee in a particular way.� By ceding so much authority to the family, some individuals may be denied the right to be donors, and thus the right to have their death redeemed by giving life to those whose organs are failing.� Families do not always have the best interests of the individual members in mind, and this conflict of interests is one reason why the individual person currently has principal rights over his or her body.� And families in grief are not always the most rational decision-makers, whereas a registered donor has made a deliberate decision rather than an emotional decision in crisis.

A mandatory choice law would dictate that citizens must explicitly choose whether or not they are willing to donate their organs.� By law, individuals would be required to assume the status of donors or non-donors, or else to declare explicitly that they wish their surrogates to decide on their behalf at the time of their death.� In a system that has "opt-in" consent policies, like the United States, the person who does not declare an intention leaves the ultimate decision, by default, in the hands of his or her surrogates at death. In a system that has an "opt-out" policy, like Spain, the person who does not declare an intention is presumed to acquiesce.� A mandatory choice law would forbid this lack of explicit decision making.� It would force people to speak autonomously for themselves, yet it would do so by imposing a novel legal obligation upon individuals backed by the force of the state.�

Mandatory choice laws would alter the U.S. system by removing the option not to choose.� With every citizen required to make a determination whether or not to donate, the family in all likelihood would no longer play as central a role, except in those cases when individuals remain silent in violation of the law, or when they explicitly choose to put decision making authority in the hands of others.

The strongest argument for such a law is that by forcing citizens to choose, more citizens will agree to donate.� Combined with public education, mandatory choice will awaken people to the good of organ donation, and engage them in deeper reflection about how they wish to have their bodies cared for after death.� In addition, mandatory choice laws respect the right of the individual person to choose, and simply require that the individual person use that capacity.� Such laws seem to rest on the belief that the decision to donate is more justified if made by individuals themselves rather than left to surrogates by default, who can never fully know what the deceased person would have wanted.

The strongest case against mandatory choice laws is that they would undermine the very end they seek to achieve: instead of expanding the number of donors, they would create a new class of explicit non-donors.� Such laws would unduly impose upon the individual's freedom not to decide, and would expect a decision about donation when many citizens lack adequate understanding of what being a donor really means.� Rationally or irrationally, some people fear that being a designated organ donor will affect the quality of their care either in crisis circumstances (like a heart attack) or at the end of life.� These fears might lead many individuals to opt out of the donation system, whereas their surrogates might have allowed donation after death to occur for those who presently have no legally stated intentions.

Presumed consent means that the government assumes that citizens agree to donate their organs at death unless the individual or the family explicitly declares otherwise.� Such policies vary based upon how easy it is to "opt out" and based on who has the authority to opt out: a hard presumed consent law might permit only the individual, before death, to opt out, meaning that surviving family members would have no authority to prevent organ procurement if their deceased loved one had remained silent.� A softer presumed consent law might authorize surviving family members to opt out, but only if they take the initiative to intervene; or, such a law could require organ procurement agencies to inform family members that organs are being taken, giving them an explicit opportunity to opt out.

Presumed consent in any of these forms would alter the current U.S. system.� Instead of asking the families of deceased individuals who are not registered donors for permission to procure organs, OPOs would inform them of the intention to do so.� It would change our "opt in" system to an "opt out" system.� It would thus give the government more authority over citizens' bodies, by presuming that all individuals wish to surrender their bodies for public use after death.� As William May has written, it would require those families who do not wish to donate to reclaim their loved one's body at the very moment when they must engage in the final acts of saying goodbye.

That said, the U.S. system does already have a limited form of presumed consent.⁴⁴� Section 4 of the 1987 Uniform Anatomical Gift Act asserts that under certain circumstances specific medical personnel may allow OPOs to remove organs from the deceased if they are not able to find an available surrogate to give consent.� Nearly half of all U.S. states have codified the 1987 Act.� This policy clearly conflicts not only with the earlier sections of the 1987 Act on first person consent and family consent, but also with the general consent guidelines for organ transplantation policy.� ��

Presumed consent laws aim at increasing the organ supply, and they assume that ordinary citizens are willing to give up their organs when they die even if they do not explicitly declare an intention to do so.� Unlike conscription, such laws aim to be rooted in a notion of consent-not that the government owns everyone's body at death, but that the government can presume that people wish to have their bodies used to benefit others. Such a law aims to balance the rights of individuals with the good of the community; it preserves the possibility of not giving for reasons of conscience, while presuming that giving one's organs is a civic good in which everyone should desire to participate.� Another argument in favor of presumed consent is that it would allow organ procurement to proceed without burdening the family with such matters in the first moments of their mourning.

The case against presumed consent is that such a policy transfers too much authority to the state.� Consent needs to be given by individuals, not presumed.� Consent requires being informed, whereas many individuals do not understand all that is entailed in being a donor.� Rather than presuming every individual's consent, it is better to allow family members or surrogates to decide on behalf of those who never made their intentions known, and to do so in light of an informed conversation with a designated requester. Such laws would place a special burden on those families who do not wish to donate, by forcing them, as said above, to reclaim the loved one's body in order to say goodbye.

An organ conscription policy would mandate that all available organs be removed from the deceased, regardless of the wishes of individuals or families.� Such a law is not at present being seriously contemplated in the United States, but it is worth noting here to show what might be embraced by those who take the pursuit of health as their only or most important guide to organ policy.� A conscription policy would maximize the number of available organs from deceased donors, and it would eliminate the added complexity of creating donor registries and seeking permission from surviving family members.� It would treat organs as a societal resource that the needy have a right to acquire.� Just as we might conscript individuals to act as soldiers in wartime, we might conscript the newly dead to act as sources of spare parts in the struggle to save or improve the lives of those suffering from organ failure.� It would take something that the dead will never need again to give it to the living who desperately need it.�

One might also contemplate the conscription of kidneys from living donors-for example, by giving every 25-year old a lottery number, subjecting them to basic medical screening, and working one's way down the list of healthy conscripts until everyone who needs an organ has received one.� This would, in effect, shift resources from those who have more than they need (two functioning kidneys) to those who have less than what they need (no functioning kidneys).� From a utilitarian perspective, it might maximize national health.� It would focus on the needs of those who suffer most.

Yet most people find such the prospect of organ conscription ethically indefensible or even abhorrent, because it violates both individual freedom and human dignity.� It turns individuals and their bodies into resources of the state; it transforms organ donation from a generous act of altruism into a mandatory act of surrender; it violates the conscience of those who wish not to be donors; and in the case of conscription from living donors, it would force healthy individuals to put themselves at risk and coerce doctors to perform surgery on healthy, unwilling persons.

The definition of death and its relationship to organ procurement practices is explored at great length in Working Paper #2, so it will be dealt with only briefly here, merely for the sake of completeness.� At present, nearly every state sanctions two standards for declaring someone dead: a neurological standard (death of the whole brain, including the whole brain stem) and a cardiopulmonary standard (permanent cessation of heart and lung functions).� Critics of current practice come from many different directions, but there seem to be four basic alternatives that one might consider as policy options:

1. Cardiopulmonary Definition: Some argue that even those who meet the standard for whole brain death are not dead, or they argue that the condition of brain-dead individuals is too ambiguous to make a confident declaration of death.� They propose, therefore, that all declaration of death be made according to cardiopulmonary criteria alone.

2. Higher Brain Definition: Some argue that those who have lost the higher brain functions, even if they retain some autonomic brain function, are already dead, because they have lost all those qualities that are necessary for a distinctly human life.� They propose, therefore, permitting the declaration of death by a more lenient higher-brain standard, meaning that some individuals now considered alive would be considered dead and thus potentially deceased donors.

3. The Self-Definition of Death: Some argue that because defining death is such a biologically and morally ambiguous matter, individuals should be permitted to declare, by means of a living will, which reasonable definition of death should apply to them-ranging from the strictest cardiopulmonary standard to the whole brain-death standard to the higher brain-death standard.

4. Criteria for Dying Donors: Some argue that we should disentangle the question of defining death from the question of who is an eligible donor.� This would mean developing clinical and legal criteria for permitting organ removal from the severely debilitated and/or the nearly dead-that is, that class of patients whose medical condition is defined as futile and/or for whom death is imminent.� Rather than debating interminably the best definition of death, they argue that we should establish protocols for using dying donors.

The moral arguments and practical implications of these different possible reforms are explored in great length, as noted, in Working Paper #2.� The first three policy reforms-cardiopulmonary definition, higher brain definition, and the self-definition of death-would require explicit changes in state law, specifically in the version of the Uniform Determination of Death Act adopted state by state.� The final option-developing criteria for dying donors-would seem to necessitate granting legal authority to surrogates to declare dying individuals as eligible donors or legal authority to individuals to declare in their living wills the medical conditions in which they desire to be donors.� It would also seem to require the creation of eligibility standards at the level of clinical practice-that is to say, a determination of how sick, how disabled, or how close to death a patient must be for physicians to licitly remove a person's organs, vital organs included.

One range of policy options involves creating new incentives or offering new rewards for being an organ donor.� While disincentives are the costs that originate with the act of donation, incentives are the rewards offered to those who donate.� These potential incentives vary significantly in type, and include: (1) public honors or medals for organ donors and/or their families; (2) gifts to charity in the name of the donor; (3) preferred status as a potential donor recipient; (4) health insurance coverage for living donors or insurance premium reductions for those who agree to donate their organs after death; (5) life and disability insurance for living donors; (6) payment of a deceased donor's funeral expenses; (7) cash payment for organs, with either fixed prices set and paid by the government or a true organ market with prices set by the laws of supply and demand.� We will consider each of these options briefly in turn.

Public recognition of organ donors might take a variety of forms: a medal or plaque that the federal or state governments present to the living donor or the deceased donor's family; a memorial for organ donors with each donor's name inscribed; an annual day of recognition, with each new donor's name read aloud at a public ceremony.� Honoring donors in this way would elevate them in the eyes of their fellow citizens; it would pay tribute to their generous act of gifting.

Currently, only a few states provide honors to organ donors.� In Kentucky, the Governor conducts an annual ceremony honoring organ donors.� In Maine, the Governor publicly recognizes one donor, recipient, or listed person per year during the Organ Donor Awareness Day celebration, and presents five donors with the "Gift of Life" award.� In New York, a donor is awarded the "New York State Gift of Life Medal of Honor."� And in Ohio, local and statewide programs recognize families of deceased donors.�

The federal government also recognizes donors.� The last few presidents have published proclamations celebrating organ donors and donations.� Currently both chambers of Congress are deliberating over the Gift of Life Congressional Medal Act of 2006, which would provide donors and their families with a commemorative medal.�

Such programs could be expanded without altering existing law or policy, so long as such honors are not interpreted as a form of "valuable consideration."� The strength of such an initiative is that it elevates public awareness of the good of organ donation and rewards those who donate without turning organs into commodities or undermining the principle of "gifting."� It recognizes the virtue of citizens freely choosing to assist one another, and thus helps stave off the individualism that liberal democracies sometimes foster.� The argument against such a policy is that it is an inadequate incentive for increasing the number of organ donors, or (alternatively) that it elevates the good of organ donation too much, transforming a private choice into a civic duty.

Another way to honor organ donors and potentially create new incentives for organ donation is to make a charitable donation in the donor's name.� The donor or donor's family could pick a charity of their choice, and the federal government, state governments, or private philanthropies could make a contribution as a way to honor or remember the donor's altruistic act.� Such a policy might achieve multiple goods at once: spurring more people to donate, providing a way to remember donors who have passed away, and expanding the nation's philanthropy in general.

Yet some might argue that, especially for living donors, the prospect of such a charitable gift might become the reason, or a reason, to donate.� It would introduce cash payment into the mix in a novel way-not to cover the costs of donating, but as a reward for donating.� Moreover, in order to really act as an incentive, such gifts would need to be more than mere token contributions, and if funded by federal or state governments, such a program would be a considerable public expense.� Some might also worry about which charities donor's would choose, and what criteria, if any, should be established for eligible recipients of these charitable gifts.

One way to honor or reward living donors would be to give them preferred status as organ recipients were they ever to suffer organ failure themselves.� As discussed at much greater length in Working Paper #3, this is already, to some degree, standard practice: living kidney, liver, and lung donors are given extra priority points as potential kidney recipients; because they donated organs, they in effect move up the waiting list to receive organs.� This policy could be expanded-both by moving living donors even higher up the kidney list and by expanding the policy to include liver, lung, heart or other types of organs that a past donor might need in the future.

Defenders of such a policy see it as a form of reciprocity or even care: that is, those who potentially put their health at risk by giving up one of their organs to help another should be helped first if and when they need an organ themselves.� In particular, those who suffer kidney failure later in life after having given a kidney seem to deserve first priority as kidney recipients.� This is not an incentive to donate so much as a way to care for willing donors.

Yet those who oppose preferred status argue that one's status as a prior donor is not a relevant criteria in determining whose need for an organ, in the present, is most medically urgent.� This is especially the case for those organs-like livers-for which there is no alternative to donation in urgent cases, and thus where medical need alone is the only sensible criteria for allocating a scarce resource.� Furthermore, some argue that being an organ donor does not necessarily give one a special claim on available organs; everyone in need should be treated equally.� They argue that one's previous actions, for good or bad, should not advantage or disadvantage one's claim to medical care, which should be allocated according to medical criteria alone.

Some argue that living donors should be provided extended or lifelong healthcare coverage in return for being donors.� Rather than seeing this as an incentive to donate or a reward for being a donor, it might be defended as the only responsible way to care for donors, who require follow-up visits and whose long-term health may be compromised by their gift.� Just as organ donors do a public good by helping or saving the life of another, ensuring the physical well-being of living donors through healthcare access is a public responsibility.� This is especially the case for lower income donors, who might not get the short-term and long-term follow-up care they need because they lack the resources to pay for it.

Yet some argue that guaranteed healthcare, in a country with so many uninsured persons and with the costs of healthcare continuing to rise, would become for many persons a reason to donate.� This would create a situation in which people put their health at risk in order to ensure access to healthcare-a perverse situation, in the eyes of many, especially in an affluent country.� In order to avoid this moral hazard, one could restrict such healthcare benefits only to those who donate an organ to a family member, to ensure that receiving health insurance is not itself the motivation for gifting.� Some believe, however, that offering health insurance in exchange for organs is a morally legitimate and even morally praiseworthy incentive, especially for the poor.� Those without health insurance might be healthier over the long-term with one less kidney if they have access to the best doctors and hospitals for life.� Such a system might, in fact, benefit the health of both donor and recipient alike.

Such a program would of course add a new public expense.� And it might also create a perverse incentive: at present, healthcare coverage is an incentive to work; with coverage guaranteed for life, that incentive might disappear.

Another incentive plan would offer registered organ donors (i.e., those who agree to give their organs at death) reduced health insurance premiums.� Such a program would reward those who agree to be a benefit to the healthcare system as a whole with a healthcare related benefit for themselves.� Yet, at least in the private market, it is unclear how much of a cash value could be placed on agreeing to be a donor at death, since most individuals do not die in such a way that organ procurement is possible.� Unless subsidized by government in the form of a rebate, such a policy would offer a very small premium reduction and thus a limited incentive-though it may be that even a token reduction is enough to motivate people to declare themselves organ donors.� Moreover, unlike providing health coverage to living donors, which can be defended as a form of care, giving potential donors a premium reduction is simply a cash benefit, raising the moral questions explored more fully below in the context of direct cash for organs.

Some argue that living donors should be given a life and disability insurance benefit to protect their families in those rare cases when living donors die or become permanently disabled as a direct or indirect result of giving an organ or part of an organ.� As with health insurance, this can be defended as a form of care for living donors, not payment for being a living donor.� After all, living donors would prefer not to receive such a benefit, since it comes only at the cost of their own death or disability.� Moreover, such a benefit would be one way of ameliorating some of the risk of being a living donor-i.e., the risk of leaving one's family uncared for in the unlikely event that donation leads to death or disability.� One might even define such a benefit as a way of removing disincentives rather than creating novel incentives for donation.

Some argue that, as with health insurance, life insurance is still a cash benefit that could become a reason, if not the reason, to donate. (As with a health insurance benefit, a life and disability benefit could be limited to interfamily donation only.)� More deeply, some argue that the need for such a benefit points to a deeper problem with living donation itself: the fact that donors put not only themselves, but also their families, at risk by being living donors.� Of course, they often do so in the name of another family member.� The question, also raised in Working Paper #1, is whether some kinds of inter-family donation are more ethically sound than others-for example, husband giving to wife or sister giving to brother, as opposed to daughter giving to father or parent giving to grandparent.

Another way of rewarding or honoring organ donation is to pay for some portion of a donor's funeral expenses.� Such a policy could work in multiple ways: providing a cash benefit or tax credit to the families of deceased donors; providing rebates to funeral homes that offer reduced prices to donors; or putting money every year in a special account for everyone who maintains themselves in a donor registry.� Such policies could also vary in the size of the benefit-from a token payment, as a way to honor the memory of the donor, to full coverage of all funeral expenses, as a way to increase the donor pool by making donation financially appealing to individuals and families.� Such a policy would reward those who do a public good with a public honor, and it would ameliorate the economic burden some families face in providing a proper burial and proper remembrance for their loved one.� Moreover, it would create an additional reason to be a donor without putting a cash value on particular organs or treating the body as alienable property.

Critics of such a proposal believe that paying a death benefit of this sort might deform the care of individuals in their final days, or create divisions at death among family members who disagree about whether to take money in exchange for a loved one's organs, even in the limited form of reimbursement for funeral expenses.� In general, they worry about opening the door to payment for organs, or making compensation a reason or the reason to donate.� On a practical level, some argue that incentives for deceased donors will have only a limited effect on boosting the organ supply, given that for most individuals and families, the willingness or unwillingness to donate at death turns on moral and psychological considerations; the prospect of reimbursement is not likely to turn non-donors into donors, or family members who say no into family members who say yes to donation.� Where incentives can have the largest impact-for better or worse, depending on one's perspective-is in the rate of living donation, by giving healthy individuals a reason to sell their organs to strangers.� There, not funeral expenses, is where the action is.

One of the most discussed proposals for increasing the organ supply is to allow individuals to sell their organs.� The idea of monetary incentives takes a variety of forms, and given its prominence in recent debates, it merits a somewhat more extended discussion.� Such a system of payment could involve living donors who agree to sell their organs in the present, deceased donors whose appointed surrogates are paid at the time of organ procurement, or potential donors who sell the future rights to their organs if and when they become available at death.� Some believe cash payment should only be permitted for deceased donors, where the possibility for harm is more limited.� Others believe that cash payment would have the greatest impact, by far, in increasing the supply of organs from living donors turned vendors, by giving them a monetary reason to supply their organs that would not exist otherwise.

One specific proposal is for the federal government or state governments to pay organ vendors directly.� This could involve either paying a fixed price for each individual organ (most relevant to living donors, who might sell a kidney, part of a liver, or part of a lung) or paying a fixed price for the right to procure all available organs (relevant only to deceased donors).� Defenders of "fixed price, public payer" compensation proposals seek to distinguish them from true organ markets: they argue that the compensation would be public, not private, and thus would represent the appreciation of the entire community rather than a private contract between parties.� Moreover, a public compensation system for increasing organ procurement could be kept separate from the system of organ allocation so as not to endanger the equity of organ allocation, whereas the right to sell one's organs in the open market would likely give special advantages to wealthy prospective buyer-recipients.� Of course, the government could also set prices for organs without being the payer; or it could create hybrid arrangements, such as giving private insurance companies rebates and tax incentives for buying organs on behalf of their clients.

A different proposal would permit and promote the buying and selling of organs in the open market, with prices and practices set by supply and demand, just as with other valuable commodities.� Most likely, such a system would give rise to organ brokers who act as middle-men, matching prospective buyers with potential sellers, and matching both suppliers and recipients with a medical facility that can perform the procurement and transplantation.� It would likely include both "spot markets," where living individuals or relatives of the deceased could sell their organs now; and "futures markets," where living individuals could sell the rights to their organs if and when they die in a manner that makes organ recovery possible.� The highest prices would likely be paid for living organs from healthy donors, who provide not a potential future commodity but an actual present commodity.� The future rights to one's organs would likely command a far lower market price because most people do not die in such a way that organ retrieval is actually possible. There already exists a black market for living organ donors, suggesting that the most likely organ sellers would be the very poor at home and especially abroad, who see their organs as a valuable economic asset, and who judge that selling them is a way to improve their quality of life.

A truly free market in organs would affect not only organ procurement but organ allocation: the wealthiest individuals would have readiest access not only to the most organs but to the best organs.� Most likely, a two-tier system would evolve, with the wealthy securing their organs from living donors in the private market and the less affluent joining the public waiting list for organs from the deceased that are donated rather than sold.� Some seek to develop a system that would permit organ selling in the free market while preserving a system of organ allocation that is dictated by moral and medical criteria rather than market criteria.� But others believe that such a division between procurement and allocation is problematic, since it would prohibit the creation of a motivated buyer pool (i.e., those who need organs for themselves or their loved ones) and thus would prevent supply and demand from setting prices.

The argument for financial incentives is rooted primarily in the desire to increase the organ supply and thus ameliorate the current suffering and potential death of those on organ waiting lists.� Advocates argue that organs should be treated like any other commodity, where the free market effectively brings supply and demand into balance, and that we already permit the buying and selling of blood, sperm, and human oocytes. They see concerns about the "commodification of the body" as vague and unconvincing, especially when they stand in the way of the concrete good of saving lives by potentially expanding the organ supply, and especially when there are wealthy people desperate to buy organs and poor people desperate to sell them, an exchange that mutually benefits both parties.

A second, related argument for permitting organ selling is the desire to expand the scope of human freedom.� Advocates argue that free choice should dictate the provision of organs; that those individuals who believe selling a "redundant organ" could improve the quality of their life should be permitted to do so; and that it is condescending to protect the poor (or anyone else) against the rational choices they might make for themselves, including the decision to sell part of their body.� They note, quite correctly, that everyone else involved in the organ transplantation business-the doctors, the health insurance companies, those working for organ procurement organizations, and so on-profits in some way from the practice of organ transplantation, except for those who supply the most valuable asset: the organs themselves.� They further argue that permitting individuals to sell their organs would not prevent anyone from giving their organs; vending and gifting could co-exist, allowing everyone to act on the values they hold dear.

The most common objection to payment for organs is that such monetary incentives would exploit the poor, who would bring harm to themselves motivated only by money. Of course, to defenders of organ markets, the freedom to sell their organs extends opportunity to the poor, who stand to benefit the most from this new freedom and expanded ownership over their own bodies.� They would not be coerced to sell their organs; they would merely be given the option to do what many poor people want to do anyway (and in some cases are doing already); and they would be lifted up from the dangerous underground market, where the health of the donor is a low priority, to a regulated system of compensation, in which all exchanges are legal and provide adequate safeguards for donor health.� Yet critics of organ selling believe that in a wealthy society like our own, we do not really benefit the poor by encouraging them to believe that the only way or best way to make ends meet is to sell their body parts-that is, to sell "assets" that require no work, no skills, and no possibility for long-term self-improvement.� They argue that, in fact, we consign the poor to hopelessness if the only hope we extend them is the one-time sale of a kidney.� And while it is true that everyone else in the business of organ transplantation is paid for their services, they are paid because of their professional skills, not for selling their bodies.

When it comes to deceased donors, critics of cash payment fear that adding money into the mix would only disrupt the already difficult period of mourning.� It could lead to new tensions among surviving family members who disagree about the propriety of taking money for organs; it could tempt surrogates to alter the course of care in order to get paid; it could (in the case of "futures markets") give a third party a commercial claim on the body that trumps the interests of the surviving family, whose wishes and needs as mourners might violate the business arrangement entered into years ago by the deceased.

Yet perhaps the strongest objection to organ selling is that some people believe it would invite us to see the body as a mere thing, like any other commodity or natural resource. The market works efficiently by making things generic and therefore interchangeable; the price system is effective because it can put a price on anything, with little regard for what the thing is.� In many cases, this reduction of things to comparable quantities is desirable, since it allows different commodities to be traded, and thus allows a multitude of different producers and consumers to obtain what they need and dispose of the valuable things they wish to sell.� But in some cases, as with the human body, the market's blindness to what a thing is arguably debases those who trade in it.� The very efficiency that would come from depersonalizing the source of organs-by treating them as mere resources, not as parts of this embodied person-makes the whole enterprise, in the eyes of some, morally compromised.� Even if a market in dead bodies were to increase the organ supply-which many opponents of organ sales readily admit-they believe that the cost of putting so explicit, so impersonal a price on the body is too high for society as a whole.

These worries about commodification are especially significant, some people believe, when we consider buying organs from living (and probably mostly poor) donors.� Living donors necessarily expose themselves to some harm, an exposure that makes greatest moral sense when done to benefit a family member or friend as an act of love.� It makes less moral sense, they argue, as an act of commerce.� True, the motive to sell one's organs might still be love: namely, the desire to benefit one's family with the proceeds of one's sale.� And the poor, merely by being poor, are no doubt already exposed to a variety of risks comparable to or greater than the risks associated with giving up a kidney. But even if this is so, some argue, it does not justify the act of organ removal by physicians, whose willingness to put a healthy donor at risk is rooted in the direct connection between the donor's sacrifice and the donor's desire to see a particular person benefit from the organ he has given.

Most of the policy reforms considered above are animated by the desire to increase the organ supply and thus come to the aid of those now waiting for transplantable organs. Other policy proposals involve ensuring that donors, both living and deceased, are treated with dignity and never exposed to undue risk or insufficient respect.� Another approach-not incompatible with current policy or with the reforms considered above-is to look for ways to decrease the need for organs by preventing organ decline or repairing organ failure without requiring human organs.� All we can do here is highlight three notable strategies, each of them worthy of much greater consideration and analysis: (1) preventative medicine; (2) xenotransplantation; and (3) regenerative medicine.

Preventative medicine means exactly what its name suggests: keeping people healthy so they do not get sick.� Some of the more common preventative measures include eating a healthy diet, exercising, getting enough rest, not smoking, not drinking to excess, and taking preventative medications that halt or slow down bodily decline.� By living more responsibly early in life, one might not need a transplantable organ later in life.�

Nearly everyone would applaud and support such measures.� Yet preventative medicine necessarily has limits.� First, it does not help those who already suffer or are destined to suffer from organ failure.� Second, even if preventive measures delay bodily decline, deterioration is inevitable.� And third, some people enjoy their vices, and perhaps are even willing to pay the cost later in life.� It may be that preventative medicine will change the prevailing causes of death, such that the body shuts down as a whole rather than certain parts needing replacement.� In this sense, it might ameliorate one of the miseries of organ failure: knowing that an extended quality of life is possible if only an organ were available.� And preventative medicine might surely allow individuals to be healthier longer, unburdened by renal failure or heart troubles.� But in the end, we will almost certainly continue to look for alternative ways to treat organ failure, in addition to ways that aim to prevent it.

Xenotransplantation involves transplanting organs from non-human species into human patients.� At present, xenotransplantation is a theory, not a possibility.� Grave obstacles remain-from the uncertain biological compatibility of non-human organs with the human body, to worries about introducing deadly animal diseases into human circulation, to worries about the long-term viability of animal organs.� But there is interesting research, albeit speculative, underway in this area.� If it were possible and safe, xenotransplantation might solve a crucial problem: most people believe it would be morally licit to harvest animals as sources of life-saving organs and to kill animals in order to procure their life-saving organs.� The supply would thus more than meet the demand, and it would do so in a way that might be less morally hazardous than other potential routes of boosting the human organ supply.

Another alternative to human organs would be the possibility of repairing existing organs or building new ones from scratch.� Such a prospect, at present, is wholly speculative. But exciting work in fields like nanotechnology, stem cells, and the creation of artificial organs might, in the future, offer us a solution to our problems.� Some of these methods, of course, introduce their own novel moral problems.� And, as with preventative medicine and xenotransplantation, they offer little help to those now waiting for organs or those who will need them in the years just ahead.

This section has attempted to lay out a range of possible policy reforms for the Council's consideration.� As it deliberates, the Council would do well to keep in mind the human goods at stake in our organ policy-health, freedom, and dignity central among them-as well as the moral and practical arguments for preserving crucial elements of the current system.� In an area as complex as organ transplantation, the pursuit of some goods always risks compromising others, and the preservation of even the most important goods may leave us to endure a heavy weight-including the weight of those who suffer and often die waiting for organs that never come.

ENDNOTES

1. The NCCUSL is a non-profit association of commissioners from each state in the Union, the District of Columbia, Puerto Rico, and the Virgin Islands.� The association was founded in 1892 in response to a growing interdependence between the states.� The NCCUSL was designed to create uniform statute proposals on significant issues that each state might adopt and declare law.� It is important to remember that the NCCUSL does not create law, but rather recommends models that might then become law.� For more information on the NCCUSL, see their website, www.nccusl.org.�

2. www.nccusl.org

3. www.nccusl.org

4. This number is according to the NCCUSL website.� The states that have adopted the 1987 Act are: Alabama, Arizona, Arkansas, California, Connecticut, Hawaii, Idaho, Indiana, Iowa, Minnesota, Montana, Nevada, New Hampshire, New Mexico, North Dakota, Oregon, Pennsylvania, Rhode Island, Tennessee, Utah, Vermont, Virginia, Washington, and Wisconsin.

5. For further details on the breakdown of the organ donation laws among the states, see the spreadsheet at the end of this essay.

6. The exceptions are Massachusetts, Mississippi, and New York.

7. The exceptions are Maryland, Mississippi, New Hampshire, South Carolina, and West Virginia.

8. There is one main exception.� New Jersey's law states: "the death of an individual shall not be declared upon the basis of neurological criteria pursuant to sections 3 and 4 of this act when the licensed physician authorized to declare death, has reason to believe, on the basis of information in the individual's available medical records, or information provided by a member of the individual's family or any other person knowledgeable about the individual's personal religious beliefs that such a declaration would violate the personal religious beliefs of the individual.� In these cases, death shall be declared, and the time of death fixed, solely upon the basis of cardio-respiratory criteria pursuant to section 2 of this act."

9. The NCCUSL promulgated the Act in 1980 in order to help clarify the "medical determination of biological death."� The Act states: "an individual who has sustained either irreversible cessation of circulatory and respiratory functions, or irreversible cessation of all functions of the entire brain, including the brain stem, is dead.� A determination of death must be made in accordance with accepted medical standards."� It is worth noting that the NCCUSL left the Act sufficiently vague to permit adjustments in determining death in two ways.� First, the Act gives physicians the discretion to determine the meaning of "irreversible."� Second, the Act states that death must be determined by using "accepted medical standards."� This clause allows physicians to use new forms of medical technology to determine death, and thus to be more precise in their determination as technology advances.� For more details on the Act, see the NCCUSL's website, www.nccusl.org.�

10. There is one major exception.� Roughly a third of the states have "hoarding laws," which declare that organs procured within the state must first be offered to a citizen of that state before they are offered to a citizen of another state.� The states are permitted to have these laws because the HHS has not officially regulated organ allocation.� The rules governing allocation are simply UNOS rules, and the states are not legally bound to obey them.

11. The few exceptions reside in: Title 5 (Government Organization and Employees), Title 8 (Aliens and Nationality), Title 10 (Armed Forces), and Title 18 (Crimes and Criminal Procedure).

12. For those who are interested in the laws not described here please see the following.� 8 USC Sec. 1611: Aliens who are not qualified aliens are ineligible to receive organ transplantations using federal public health benefits.� 8 USC Sec. 1621: Aliens who are not qualified aliens are ineligible to receive organ transplantations using state and local public health benefits.� 10 USC Sec. 1109: Establishes an organ and tissue donor registry for the armed forces personnel.� 18 USC Sec. 2721: Prohibits the release of personal information from state motor vehicle records with an exception of organ donation information.� 42 USC Sec. 274b: Lists the general provisions respecting grants and contracts made by the federal government to OPOs.� 42 USC Sec. 274c: The HHS Secretary must designate and maintain an administrative unit that provides technical assistance to the groups involved in the transplant process and that provides information to the public about organ transplantation and about the national and state resources available for transplantation.� 42 USC Sec. 274d: Every two years the HHS Secretary must produce a report on the scientific and clinical status of organ transplantation and submit it to Congress.� 42 USC 274f: The Comptroller General of the United States must report on the efficiency and fairness of organ procurement and allocation by January, 1992.� 42 USC Sec. 274g: Authorizes appropriations for carrying out this part of the law on organ transplantation.� 42 USC Sec. 1320b-8: Establishes the hospital protocols for participating in the program.� 42 USC Sec. 1395rr: Explains the end stage renal disease program of Medicare.��

13. For more information, see the Registry website: www.ustransplant.org.

14. From Supplement III of the 2000 edition (January 19, 2004) of the United States Code.

15. See Section 1138 of the Social Security Act of 1986 and the Federal Register Notice for the OPTN, October 20, 1999.

16. For those who are interested in the regulations not described here please see the following.� 42 CFR Sec. 121.1: Defines the applicability of 42 CFR Sec. 121.� 42 CFR Sec. 121.2: Defines the terms used in this part.� 42 CFR Sec. 121.3: Explains the OPTN structure.� 42 CFR Sec. 121.9: Lists the designated transplant program requirements.� 42 CFR Sec. 121.10: Describes how HHS conducts reviews, evaluations, and enforces rules.� 42 CFR Sec. 405.2100: Gives definitions for the end-stage renal disease (ESRD) program.� 42 CFR Sec. 441.35: Explains federal funding for state projects.� 42 CFR Sec. 441.40: Discusses Medicare and end-stage renal disease.� 42 CFR Sec. 482.45: Explains conditions of participation for hospitals in Medicare and Medicaid.� 42 CFR Sec. 485.643: Explains conditions of participation for critical access hospitals in Medicare and Medicaid.� 42 CFR 486.301: Explains basis and scope of conditions for coverage of OPOs in Medicare and Medicaid.� 42 CFR 486.302: Defines terms used in this subpart.� 42 CFR 486.304: Lists general requirements for designation as member of Medicare and Medicaid.� 42 CFR 486.306: Explains qualifications for designation as an OPO member of Medicare and Medicaid.�� 42 CFR 486.307: Defines OPO service area size designation and documentation requirements.� 42 CFR Sec. 486.308: OPOs that are members of Medicare and Medicaid must also be members of the OPTN.� 42 CFR Sec. 486.309: Explains recertification requirements.� 42 CFR 486.310: OPOs that are members of Medicare and Medicaid must adhere to certain performance standards.�� 42 CFR Sec. 486.316: CMS designates only one OPO per service area.� 42 CFR Sec. 486.318: Lists requirements for changes in ownership or service area of an OPO that is a member of Medicare and Medicaid.� 42 CFR Sec. 486.325: Lists kinds of termination of agreement with CMS.

17. The information provided in the next couple of pages can be found on the UNOS website: www.unos.org.

18. For more information on the allocation standards please see Part 3 of the UNOS policies.

19. See 1.07C of Appendix C to the Bylaws of UNOS.

20. See 1.0 (Member Rights and Obligations) of UNOS policies.

21. For more information on the different requirements for membership, see Appendix B of the UNOS Bylaws.�

22. Region 1-Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont; Region 2-Delaware, District of Columbia, Maryland, New Jersey, Pennsylvania, Northern Virginia, West Virginia; Region 3-Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, Puerto Rico; Region 4-Oklahoma, Texas; Region 5-Arizona, California, Nevada, New Mexico, Utah; Region 6-Alaska, Hawaii, Idaho, Montana, Oregon, Washington; Region 7-Illinois, Minnesota, North Dakota, South Dakota, Wisconsin; Region 8-Colorado, Iowa, Kansas, Missouri, Nebraska, Wyoming; Region 9-New York; Region 10-Indiana, Michigan, Ohio; Region 11-Kentucky, North Carolina, South Carolina, Tennessee, Virginia.

23. The states certainly serve as an important testing ground for policy innovation, and while a comparison of state bills would be extremely useful to have in this part of the essay, the vastness of this project precludes its incorporation here.� If a Council member is interested in the organ transplantation bills of any particular state, the information can be provided.

24. For those who are interested, here is a list of the bills and resolutions that will not be described in this part of the essay.� 109^th Congress, 1^st Session-H. Con. Res. 124: Concurrent resolution "expressing the sense of the Congress regarding the importance of organ, tissue, bone marrow, and blood donation and supporting the goals and ideals of National Donate Life Month"; H.R. 2051: Comprehensive Immunosuppressive Drug Coverage for Transplant Patients Act of 2005; H.R. 3633: Medicare Fairness for Organ Transplant Recipients Act of 2005; S. 173: Comprehensive Immunosuppressive Drug Coverage for Transplant Patients Act of 2005; 109^th Congress, 2^nd Session- H.R. 5209: Safe Tissue Act; S. 2609: Safe Tissue Act.

25. ACOT Charter.

26. Please see www.organdonor.gov for a description of the other recommendations.

27. The exception will be Recommendation 36, which will include the complete recommendation from the ACOT report.

28. To review the other proposals, see the UNOS website, www.unos.org.

29. See A. Bagheri's "Organ Transplantation Laws in Asian Countries: A Comparative Study" in Transplantation Proceedings, 2005, 37:4159-4162; Jose Osmar Medina-Pestana and Valter Duro-Garcia's "Strategies for Establishing Organ Transplant Programs in Developing Countries: The Latin America and Caribbean Experience" in Artificial Organs, 2006, 30(7):498-500; Miriam Meijer's "World Attitudes Toward Organ Donation" in worldtravelcenter.com's Travel Health Newsletter, 2000, Vol. 2, Issue 1; and pages 32-34 of the IOM's 2006 report Organ Donation: Opportunities for Action.�

30. These considerations will be cursory.� A detailed account of the organ policy of each of these countries is beyond the scope of this essay.

31. See Luskin's and Delmonico's "Assessing Organ Donation from the Dead Should Not Be Done by Reporting a Census of the Living" in American Journal of Transplantation, 2003, 3:1185-1187; and pages 33-34 of the IOM's 2006 report Organ Donation: Opportunities for Action.

32. See Rafael Matesanz's "Factors Influencing the Adaption of the Spanish Model of Organ Donation" in Transplant International, 2003, 16:736-741; B. Miranda's, J. Vilardell's, and J.M. Grinyo's "Optimizing Cadaveric Organ Procurement: the Catalan and Spanish Experience" in the American Journal of Transplantation, 2003, 3: 1189-1196; and Richard Luskin's and Francis Delmonico's "Assessing Organ Donation from the Dead Should Not Be Done by Reporting a Census of the Living" in American Journal of Transplantation, 2003, 3: 1185-1187.

33. See Moussa Awuonda's reports in The Lancet: "Swedish Organ-Donor Campaign Offends," May 4, 1996, Vol. 347, Issue 9010, pg. 1256; "Swedish Organ-Donation Drive Set for Success," May 18, 1996, Vol. 347, Issue 9012, pg. 1401; and "Swedish Organ-Donation Law Takes Effect," July 6, 1996, Vol. 348, Issue 9019, pg. 54.

34. See "Swedes Willing to Donate Organs," in Swedish Press, March 2006, Vol. 77, Issue 3, pg. 10; and pgs. 33-34 of the IOM's 2006 report Organ Donation: Opportunities for Action.

35. See Marwan A. Masri et al. "Middle East Society for Organ Transplantation (MESOT) Transplant Registry" in Experimental and Clinical Transplantation, 2004, Vol. 2, No. 2, pgs. 217-220.

36. See Alireza Bagheri's piece in A Cross-Cultural Introduction to Bioethics, 2005, pg. 165; Abraham McLaughlin et al. "What Is a Kidney Worth?" on The Christian Science Monitor website: www.csmonitor.com, June 9, 2004.

37. See Ghulam-Haider Aasi's "Islamic Legal and Ethical Views on Organ Transplantation and Donation" in Zygon, 2003, Vol. 38, No. 3, pgs. 725-734; Sahin Aksoy's "A Critical Approach to the Current Understanding of Islamic Scholars on Using Cadaver Organs Without Prior Permission" in Bioethics, 2001, Vol. 15, No. 5/6, pgs. 461-472; S.M. Akrami et al. "Brain Death: Recent Ethical and Religious Considerations in Iran," Transplantation Proceedings, 2004, 36, pgs. 2883-2887; and Julie Corwin's "World: The Risks, Benefits of a Free Market in Organs" on Radio Free Europe/Radio Liberty's website: www.rferl.org, May 16, 2006.

38. See "China Bans Human Organ Sales" in United International Press, July 2, 2006.

39. See Carl Becker's "Money Talks, Money Kills-The Economics of Transplantation in Japan and China" in Bioethics, 1999, Vol. 13, No. 3/4, 236-243.

40. See "Human Rights in China" in Congressional Quarterly, April 19, 2006, and "A Harvest of Horrors" in Western Standard, May 22, 2006.

41. See the Executive Summary of the Minutes of the OPTN/UNOS Board of Directors Meeting, March 22-23, 2006.

42. There is one major exception to this rule.� Section 4 of the 1987 Uniform Anatomical Gift Act declares that specific medical personnel may permit the removal of organs from decedents without consent from the deceased or from the family of the deceased.� It states: "(a) The [coroner] [medical examiner] may release and permit the removal of a part from a body within that official's custody, for transplantation or therapy, if: (1) the official has received a request for the part from a hospital, physician, surgeon, or procurement organization; (2) the official has made a reasonable effort, taking into account the useful life of the part, to locate and examine the decedent's medical records and inform persons listed in Section 3(a) of their option to make, or object to making, an anatomical gift; (3) the official does not know of a refusal or contrary indication by the decedent or objection by a person having priority to act as listed in Section 3(a); (4) the removal will be by a physician, surgeon, or technician; but in the case of eyes, by one of them or by an enucleator; (5) the removal will not interfere with any autopsy or investigation; (6) the removal will be in accordance with accepted medical standards; and� (7) cosmetic restoration will be done, if appropriate.� (b) If the body is not within the custody of the [coroner] [medical examiner], the [local public health officer] may release and permit the removal of any part from a body in the [local public health officer's] custody for transplantation or therapy if the requirements of subsection (a) are met.� (c) An official releasing and permitting the removal of a part shall maintain a permanent record of the name of the decedent, the person making the request, the date and purpose of the request, the part requested, and the person to whom it was released."� Nearly half of the states have codified this Act.

43. A non-essential organ here means an organ or a piece of an organ that the donor can live without.

44. Please see footnote 42 for further details.