The National Organ Transplant Act (NOTA) that passed into law in 1984 has provided a legal framework for organ transplantation in the United States for the ensuing quarter century. Section 274e of that act reads as follows:
It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.
The term ‘valuable consideration’ does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ.
National Organ Transplant Act provides for the financial administration of organ transplantation, including the reimbursement of expenses associated with organ donation and transplantation. The prohibition of the exchange of ‘valuable consideration’ has prevented the buying and selling of organs within the United States and has made such activities a criminal offence. The donation of an organ is a noncommercial transaction and the term ‘altruistic’ donation is often used without defining the extent or nature of the altruistic motive.
In 1994 the State of Pennsylvania passed a law that would have permitted a funeral benefit for families of deceased donors and a fund was generated for this purpose. Because of concerns, justified or otherwise, that this State law contravened the provisions of NOTA the law was not put into practice. The so-called ‘Norwood Act’ passed in January 2008 was a noncontroversial amendment to NOTA to permit the exchange of organs in living donor kidney exchange protocols.
In October 2008 the Organ Donor Clarification Act (ODCA) was filed from the Office of Senator Specter (Republican of Pennsylvania) amending section 301 of NOTA in a manner that would permit the enactment of the 1994 Act to allow payment of funeral expenses in Pennsylvania. The ODCA, however, and its subsequent modifications and iterations would have a major impact on the nature of the prohibitions included in the original NOTA far beyond the borders of that state.
What follows is a summary of some of the comments that I have made in correspondence with Senator Specter's staff. It should be noted that although grave concerns are expressed regarding the specific nature of the amendments to NOTA and their impact, the motivations and ethical standards of those who support such amendments are respected and not questioned.
I wish to comment
… on the legislation you have drafted (Organ Donation Clarification Act of 2008 and its subsequent versions) that would amend section 301 of the National Organ Transplant Act (NOTA-42 USC 274e).
I greatly appreciate your concern for the welfare of transplant candidates and organ donors in the United States. I particularly commend you on the clarification of the term ‘valuable consideration’ in NOTA such that it
… does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, lost wages, screening, pretransplantation care, and follow-up care incurred by the donor of a human organ in connection with the donation of the organ.
I would add that the inclusion of health insurance for organ donation-related medical complications would go a long way towards providing for the long-term health of living donors. Such insurance is particularly important in the United States, which is the only developed nation that is faced with the problem of ensuring the provision of healthcare for living donors who are uninsured. These important clarifications are fully consistent with the Declaration of Istanbul [1••] and other international norms and would go a long way to removing substantive disincentives to organ donation. The ODCA is cited in the context of international norms because of the profound effect that practices in the United States have on the international transplant community.
For reasons that are not clear, this progressive language, which was present in the first draft of the bill, has been omitted from subsequent iterations. I stress my strong support for any and all measures that would serve to remove financial and other disincentives to organ donation. I also strongly commend and support the express prohibitions, found in later versions of the bill, relating to organ transplant brokering and trafficking.
I am greatly concerned, however, by the content of paragraph 5 of the original draft of ODCA which proposes government incentives designed to increase the rate of organ donation and which reads as follows:
The term ‘government incentive to increase the supply of donated human organs’ means a benefit, credit, deduction, discount, entitlement, exemption, preference, subsidy, voucher, waiver, commemorative medal or similar award, or other incentive that is made, disbursed, provided, or permitted by the Government of the United States or any State, territory, tribe, or local government of the United States for the purpose of increasing the supply of donated human organs.
In subsequent versions of the bill this language has been modified and there were concerns that the bill would permit frank cash payments to donors, which many of its initial supporters found to be an anathema. The vague terms government ‘rewards’ and ‘benefits’ have been introduced into the text and are specifically supported in the bill. The precise nature of these rewards and benefits are not defined, but they presumably relate to the provision of loans, pensions, scholarships, or tax rebates. For the purpose of the comments that follow I will group these rewards and benefits, essentially cash equivalents, under the term ‘material gain’.
The inclusion of ‘material gain’ in the motivation for organ donation, both from the living and the deceased, is fraught with hazard: for donors, recipients, and for the organ transplant endeavor in this country. These objections are not based solely on ethical concerns which have been addressed frequently in the professional and lay press, but on practical consequences, which have received less attention. These objections are summarized as follows:
Experience from both developed and developing countries, of Western and non-Western cultural orientation, indicate that when the motivation for living kidney donation is based on ‘material gain’ it comes at the expense of, and not in addition to, traditional noncommercial related and unrelated donation . There is no country that permits donation for material gain, openly or tacitly, that has parallel robust practices of unpaid living donation, or even deceased donation.
In this regard the recent developments in the international organ transplant scene are instructive. For many years Israel did not prevent its citizens from traveling abroad to purchase kidneys, which they did. Both living and deceased donation in Israel itself steadily dropped to the point that the whole transplant endeavor in that country was threatened. In 2008 the Knesset passed legislation that facilitated the reimbursement of legitimate donor expenses while criminalizing other payments and brokering . An increase in living donation was following after similar legislation was passed in Pakistan (Anwar Naqvi, personal communication). Iran, whose ‘model’ of ‘regulated’ paid donation has been widely discussed, has minimal family-related donation, no noncommercial unrelated donation at all, and limited deceased donation. Of note the Iranian model does not prohibit the provision by recipients or their families of additional benefits and rewards in the form of cash or cash equivalents, and such benefits are commonly given to the donors .
- Broad international experience has shown repeatedly that when living donation is motivated by material gain the donors come from vulnerable segments of society and the material gain becomes coercive (material gain is designed to be coercive since it persuades those who would not otherwise donate, to donate) [5••,6]. It was concern for this phenomenon, which is not surprising, that led to the Declaration of Istanbul [1••]. We are, unfortunately, not devoid of vulnerable populations in the United States. It is unclear to me how legislation could be designed to ensure that those who donate in this country would not be vulnerable to coercion, even if direct cash payments were proscribed. I should add that in Iran almost all donors are poor and uneducated and there have been repeated reports of the poor psychosocial outcomes of their donors [7,8•].
- With respect to deceased donation, studies of families that have declined to consent to donation have shown that financial incentives would have had limited, if any, influence on their decision: some studies have shown a ‘backlash’ effect . The personal experience of the chaplaincy staff at OneLegacy – the Southern California organ recovery organization – who have interviewed bereaved families who have declined to consent suggest that the motives for their decision would not have been impacted by financial incentives (J. Fleming, personal communication). Rather than the solace and compassion that deceased organ donation can bring, the introduction of financial incentives for deceased donation has the potential to introduce family discord and guilt at a time of sudden catastrophic bereavement.
- The introduction of material gain into the motivation for organ donation has the capacity to undermine a core component of the effectiveness and safety of our current organ supply – that component is trust . Much critical information, both from living donors and from the families of deceased donors, cannot be verified by laboratory testing alone (some examples include: a history of hypertension or diabetes; a family history of kidney disease; a distant malignancy; high-risk sex and drug abuse). The pressure on donors to withhold such information for fear of losing their material gain likely accounts for the high risk of complications associated with commercialization of organ donation. It is worth recalling that in November 2007 a shudder of fear went through the transplant community in the United States when an HIV and hepatitis C positive donor in Chicago, whose social history was inadequately appreciated, infected an unwitting group of transplant recipients (New York Times. Four transplant recipients contract HIV. November 13, 2007).
That ‘regulation’ of commercial organ donation in the sophisticated medical environment in this country could obviate this risk has been suggested , and indeed some of the infectious risk could likely be reduced by regulation. However, once trust can no longer be taken for granted, and material gain is permitted to become a normative motive for donation, a whole new regulatory environment would need to be established. To give some examples, medical personnel in transplant programs are not trained to evaluate, neither should they be required to evaluate, for legal residency; for identity theft; for the provenance of body fluid samples; for the authenticity of documents; or for confabulation.
The introduction of a system of governmental rewards and benefits, in cash or cash equivalents, would make it extremely difficult, on both moral and practical grounds, to argue that these rewards and benefits could not be supplemented, overtly or covertly, by the organ transplant recipients or their representatives: regulation of such behavior and its consequences would be extremely difficult. As noted above such ‘supplementation’ has become a normative part of the Iranian model of paid donation .
- The concern of the organ transplant community, and of legislators, in the United States must clearly be directed to the welfare of the residents of this country. In our globalized environment, however, the impact of our actions on the international scene cannot, and must not, be ignored. Important progressive legislative and regulatory advances have been made in recent months in the organ transplant laws of Israel, the Philippines, China, and Pakistan . These advances both serve to protect donors and advance the interest of recipients. The introduction of legislation in this country that would permit material gain for donors would have a chilling effect on the international transplant scene that could well ‘blowback’ into this country as donors seek out the rewards and benefits most suited to them.
- We have, by no means, exhausted the opportunities to advance organ donation from both the deceased and the living in this country. The achievements of the Organ Donor Collaborative and the nascent development of a national living donor exchange program are but two examples. In this respect I am particularly concerned by the wording of the legislation would seem to permit individual states to come up with their own proposals for donor rewards and benefits. As a result a national ‘patchwork’ of material gain availability would ensue that could lead to donors and recipients seeking their ‘best deal’. Such a situation would have a chaotic impact on living donation in the country and would make the highly promising and much-awaited national living donor exchange program unworkable.
Across the United States intensive efforts towards educating its multiethnic communities and providing support, solace, and reverence to bereaved families have been rewarded by a steady and gratifying improvement in consent rates, which have increased to as high as 80% in some parts of the country . This has been achieved in the absence of material gain for surviving relatives. There is convincing evidence to suggest that living kidney donation can also be advanced by innovative educational programs and similar initiatives [14•].
There are also wide geographic and programmatic variations in living donation in this country, both in respect to related donation and the various forms of unrelated donation. The causes of these variations are not fully understood . They do not only relate to the availability of living donors, other factors, including education; program size, and staffing; and resources; play a role to an extent that has not been systematically evaluated. Such an evaluation is critical before radical changes are made in the legal underpinnings of living donation.
Dear Senator Specter, as we struggle together with this difficult issue and consider the controversy that surrounds your well intentioned efforts I suggest that we take a step back from our rhetoric and ask ourselves the following basic questions.
Is it our purpose to facilitate donation by making the lives of donors and potential donors easier?
It certainly is, and there is much we can do now without necessarily changing NOTA, modifying its intent, or generating controversy. For example, I want to bring to your attention the program sponsored by the American Society of Transplant surgeons and advertised on the UNOS website (www.unos.org) called National Living Donor Assistance Center (NLDAC). This program provides for travel and lodging expenses (for donors and companions) and a series of other expense reimbursements for donors in need. Many transplant programs are not aware of this option, and they should be. This, and similar programs, should be made widely available across the country; there are no legal prohibitions to doing so. We should also develop legislation to provide for health insurance and life insurance for donation-related events and follow-up. These, and similar recommendations, are detailed in the Declaration of Istanbul and elsewhere [1••,16].
Is it our purpose to facilitate donation by persuading those who have not chosen to donate to do so?
If it is, who precisely are we targeting by a reward or benefit? No wealthy or middle class American will donate for rewards or benefits that are not financially significant: only the poor and desperate, as experience from other countries has shown [5••,6,7,8•]. There are better ways to get citizens to donate. The steady improvement in deceased donor consent rates in many parts of the country have been achieved through the promotion of trust and education in an ethnically sensitive manner and not through financial rewards. Are we so devoid of imagination that the only way we can think of to increase donation is to offer monetary equivalents with all the risks that that entails? Have we truly exhausted every other avenue?
I am gravely concerned that the proposed amendments to NOTA would undermine the considerable achievements that it has permitted. It would unquestionably cause a destructive schism in the transplant community whose efforts would be better spent in promoting endeavors on which there is a broad consensus. I trust that you and your staff will work to craft alternative legislation that would permit NOTA to be strengthened in a manner that would be acceptable to the entire transplant community, nationally and internationally, for the benefit of all in need of organ transplantation.
The pitfalls of using cash, rewards, and benefits as an incentive to donation are that such donation will come at the expense of, not in addition to, other forms of donation; financial incentives tend to target the poor and the vulnerable and invite coercion; financial incentives undermine the critical ‘trust’ relationship between doctor and donor; financial incentives in the United States will have a ‘blowback’ effect internationally; financial incentives undermine and distract from other measures needed to address the organ donor shortage.
References and recommended reading
Papers of particular interest, published within the annual period of review, have been highlighted as:
• of special interest
•• of outstanding interest
Additional references related to this topic can also be found in the Current World Literature section in this issue (p. 213).
1•• Participants in the International Summit on Transplant Tourism and Organ Trafficking Convened by the Transplantation Society and International Society of Nephrology in Istanbul, Turkey, April 30–May 2, 2008. The Declaration of Istanbul on organ trafficking and transplant tourism. Transplantation 2008; 86:1013–1018. The Declaration of Istanbul addresses the core issues that need to be considered in order to promote an effective, robust, and ethically acceptable organ transplantation
and, in doing so, protect the welfare of donors and recipients.
2 Danovitch G, Delmonico F. The prohibition of kidney sales and organ markets should remain. Curr Opin Organ Transplant 2008; 4:386–394.
3 Israel Transplant Law 2008 addendum 68A. 2008.
4 Ghods A, Savaj S. Iranian model of paid and regulated living-unrelated kidney donation. Clin J Am Soc Nephrol 2006; 6:1136–1145.
5•• Naqvi S, Rizvi S, Zafar M, et al
. Health status and renal function evaluation of kidney venders: a report from Pakistan. Am J Transplant 2008; 8:1444–1450. A unique study on the comparative health of paid and unpaid living kidney donors in Pakistan that confirms the negative impact of paid donation and the risk of infection to recipients of vended organs.
6 Budiani-Saberi D, Delmonico F. Organ trafficking and transplant tourism: a commentary on the realities. Am J Transplant 2008; 8:925–929.
7 Zargooshi J. Iran's commercial renal transplantation program: results and complications. In: Weimar W, Bos MA, Busschbach J, editors. Organ transplantation
: ethical, legal and psychosocial aspects. Lengerich: Pabst Science Publishers; 2008. pp. 80–94.
8• Nejatisafa A, Mortaz-Hedjri S, Malakoutian T, et al
. Quality of life and life events of living unrelated kidney donors in Iran: a multicenter study. Transplantation 2008; 86:937–940. An updated study on the health and psychosocial outcomes of donors from the ‘Iranian model’ that confirms concerns that their outcome is often poor.
9 Rodrigue J, Cornell D, Howard R. Attitudes toward financial incentives
, donor authorization, and presumed consent among next-of-kin who consented vs. refused organ donation. Transplantation 2006; 81:1249–1256.
10 Danovitch GM. Who cares? Impact of the commercialization of kidney transplantation on the doctor/patient relationship. In: Weimar W, Bos M, Busschbach J, editors. Organ transplantation
: ethical, legal, and psychologic aspects. European Commission. Lengerich: Pabst Science Publishers; 2008. pp. 49–55.
11 Matas AJ. Design of a regulated system of compensation for living kidney donors. Clin Transplant 2008; 22:378–384.
12 Danovitch GM. Who cares? A lesson from Pakistan on the health of living donors. Am J Transplant 2008; 8:1361–1362.
13 Sung R, Galloway J, Tuttle-Newhall J, et al
. Organ Donation and Utilization in the United States, 1997–2006. Am J Transplant 2008; 8:922–934.
14• Rodrigue JR, Cornell DL, Lin JK, Kaplan B, Howard RJ. Increasing live donor kidney transplantation: a randomized controlled trial of a home-based educational intervention. Am J Transplant 2007; 7:394–398. Results of a trial of an innovative educational program that led to a meaningful increase in living donation, particularly in minority populations.
15 Kasiske B, Snyder J, Skeans M, et al
. The geography of kidney transplantation in the United States. Am J Transplant 2008; 8:647–657.
16 Schulz-Baldes A, Delmonico FL. Improving institutional fairness to live kidney donors: donor needs must be addressed by safeguarding donation risks and compensating donation costs. Transpl Int 2007; 20:940–946.