International Journal of Surgery 12 (2014) 1363e1368
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Review
Current progress in public health models addressing the critical organ shortage Kumaran Shanmugarajah a, d, *, Vincenzo Villani a, Maria Lucia L. Madariaga a, c, Joseph Shalhoub d, Sebastian G. Michel a, b a
Transplantation Biology Research Center, Massachusetts General Hospital, Building 149, 13th Street, Charlestown, Boston, MA 02114, USA €t München, Munich D-81377 Germany Department of Cardiac Surgery, Ludwig-Maximilians-Universita Department of Surgery, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02129, USA d Department of Surgery & Cancer, Imperial College London, Exhibition Road, London SW7 2AZ, United Kingdom b c
h i g h l i g h t s The impact of presumed consent legislation for organ donation is undetermined. Public campaigns and supported transplant coordinators increase organ donation. Providing incentives to donors increases organ donation. Mandated choice models may offer a possible method of increasing donation.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 27 July 2014 Received in revised form 6 November 2014 Accepted 11 November 2014 Available online 13 November 2014
Since its inauguration in 1954, the field of modern transplantation has made great strides in surgical technique, the prevention of acute and chronic rejection, the minimization of immunosuppressionrelated side-effects and transplant tolerance. As such, organ transplantation is used worldwide as a curative, life-saving treatment for people with end-stage organ failure. However, the successes of organ transplantation have resulted in the number of patients on transplant waiting lists far exceeding the number of organs available, with growing numbers of patients dying while awaiting transplants. In order to address this critical organ shortage, a number of legislative changes have been implemented worldwide to increase the number of individuals registering as organ donors. These have included presumed consent donation, incentivized organ donation, commercial organ transplantation and mandated choice models. This article will address these public health policies in turn. The implementation of these strategies and the evidence for their efficacy will be evaluated. Based on this, we have identified that wellsupported transplant coordinators approaching next-of-kin, incentives and public health campaigns are key factors that increase organ donation. Finally we propose a modified mandated choice model that may be an alternative option to maximize the number of available organs for transplantation. © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Organ shortage Policy Donation Presumed consent Explicit consent Mandated choice
1. Introduction The great success of modern-day organ transplantation has resulted in its biggest conundrum e the number of people waiting for transplants is simply higher than the number of organs
* Corresponding author. Transplantation Biology Research Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02129 USA. E-mail address: [email protected] (K. Shanmugarajah). http://dx.doi.org/10.1016/j.ijsu.2014.11.011 1743-9191/© 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
available. In the United States alone, even with over 30,000 organ transplants performed last year, 18 people die daily on transplant waiting lists [1]. In order to address this challenge, transplant surgeons have adopted Expanded Donor Criteria, including Donation after Cardiac Death with the aim of increasing the number of organs that can be retrieved from potential donors. But perhaps more significantly, various public health policies have been employed to increase the actual number of registered donors. Many of these policies have been associated with increased rates of organ
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donation. However, whether changes in legislation themselves have had a causative effect is controversial. This article will review the literature concerning the implementation of various public health policies and aim to identify factors that increase organ donation. The implementation and efficacy of presumed consent organ donation, incentivized organ donation, commercial organ transplants and mandated choice models will be assessed. 2. Presumed consent organ donation A no-action default in public policy is the condition imposed when an individual fails to make a decision. In an explicit consent or “opt-in” system, people will not become organ donors unless they register. By contrast, in a presumed consent or “opt-out” system, individuals are organ donors unless they register not to be. Opt-out systems have been described as “hard” when the stated wishes of the deceased patient are adhered to without consultation of the family. On the other hand, “soft” opt-out systems incorporate the wishes of family members. A number of studies across Spain, Austria, Belgium and Singapore have observed an increase in organ donation following the implementation of opt-out legislation [2]. Similarly, comparison studies have shown increased donor rates in countries with opt-out systems compared with opt-in systems (Fig. 1) [3e6]. It has been suggested that adoption of an opt-out policy may increase organ donation for three reasons: (i) decision-makers identify the default choice as the recommended choice by the policy maker, (ii) demonstrating a choice requires effort, and many people would rather avoid making an unpleasant decision about organ donation and, (iii) loss aversion, or fear of change [7]. Despite the correlations between high donor rates and opt-out policies, the implementation of opt-out systems for organ donation has been controversial for a number of reasons. Firstly, the ethics of assuming consent from silence has been questioned. These concerns are particularly important to transplant recipients, who need to know that their organ was donated freely and altruistically,
and intensive care practitioners who have expressed fears that optout systems could damage vital end-of-life relationships between physicians, patients and families [8]. The removal of organs from patients who did not wish to donate, but did not explicitly opt-out raises the possibility of negatively impacting the public's perception of transplantation and may thwart efforts to increase organ donation rates. Such drops in organ donation rates have been observed in some countries, such as Chile, following passage of optout legislation [9]. Secondly, while the previously described association studies have shown a relationship between opt-out systems and higher numbers of organ donors, the true efficacy of opt-out legislation remains to be confirmed. The scientific evidence that legislation alone can increase organ donation is unclear as policy changes are not made in isolation and concomitant changes made with opt-out legislation may act as confounding factors. For example, implementation of opt-out systems have been followed by government funding for transplant programs, hospital-level reimbursement for identifying donors, improved infrastructure and coordination of transplant networks, increased public awareness and education on organ donation and positive public attitudes towards transplantation [3,10]. The fact that legislation itself does not change organ donation rates is well illustrated by the Spanish experience. Currently, Spain has the highest rate of organ donors in the world and utilizes an opt-out system which was introduced in 1979. However, the rate of organ donation only increased, from 14.3 to over 30 donors per million population, with the creation of n Nacional de Trasplantes in 1989 [2]. In particular, the Organizacio introduction of well-trained transplant coordinators and public health campaigns helped influence this dramatic increase in transplant donors. Finally, the practical implementation of hard versus soft opt-out systems is unclear. Despite the distinction, questionnaire studies involving transplant professionals have demonstrated that organ donor consent almost always involves consultation with the nextof-kin in both opt-out systems, as well as in opt-in systems [11]. Therefore, certain countries that use opt-out organ donation
Fig. 1. Comparison of the donation rate with the donation system used (presumed versus explicit consent) among the 25 countries with the highest registered rate of deceased organ donation. These 2012 data are based on the Global Observatory on Donation and Transplantation data, produced by the WHO-ONT collaboration.
K. Shanmugarajah et al. / International Journal of Surgery 12 (2014) 1363e1368
policies have demonstrated very high presumed consent rates to organ donation but much lower actual rates of donation. This demonstrates that the majority stay with the default option and that the important decision about organ donation is often made by the next-of-kin following death [11]. Greater clarity is required to determine the true impact of optout legislation itself. In contrast to the existing before-and-after comparisons, or comparative analyses of different countries, a controlled, prospective trial comparing opt-out versus opt-in offers the best chance of determining the impact of such a policy change alone. Last year's passage of an opt-out system in Wales may represent this opportunity, where effects of the legislative change in Wales can be compared to culturally similar parts of the United Kingdom that are exposed to the confounders that accompany this change in law. 3. Incentivized organ donation Rates of organ donation in Israel have traditionally been amongst the lowest of Western countries. Among the reasons for this has been the refusal by some ultraorthodox religious groups to accept brain-death as death and consequently objecting to organ donation [12]. In order to increase the numbers of organ donors the Israeli Ministry of Health introduced the Organ Transplant Act in 2008. According to this law, persons who consent to organ donation or who have first degree relatives that consent to organ donation are given priority if they subsequently require a transplant. In addition, disincentives for living donation were removed, allowing donors to claim reimbursement for loss of income, recovery and transportation [13]. Implementation of this system was followed by significant increases in living and deceased organ donation rates, with preliminary data in 2011 indicating that there was a decrease in the number of candidates awaiting organ transplants and fewer recipients dying on the waiting lists [12]. Despite this initial success, ethical concerns have also been raised. Firstly, patients with numerous first-degree relatives are at an advantage over those with no siblings [14]. A response to this concern is that individuals with few relatives can sign their own donor cards and ensure themselves priority. Secondly, directed living donors (i.e. persons who have already donated organs to specified patients) were not initially given priority in the present Israeli system. The higher priority of persons demonstrating intent to donate by signing a donor card over those who had already taken the risks of donating organs was controversial and raised questions over the ethical basis of this law [14]. However, the Israeli government subsequently passed an amendment to the law, extending priority for organ allocation to those who had already donated an organ. Thirdly, the benefit to persons as a result of the actions of their first-degree relatives, rather than their own good deeds has been questioned. Finally, the passage of this legislation has resulted in opportunity for strategic behavior where people register as organ donors in order to receive priority, yet instruct their next-of-kin to not consent to organ donation upon death [14]. Data gathered to date represents a preliminary insight into the efficacy of the Organ Transplant Act of Israel. However, longer-term follow-up is necessary to assess the true impact of legislation to incentivize organ donation in this way. 4. Commercial organ transplants The sale of organs for transplantation has largely been considered unethical. According to the National Organ Transplant Act of the United States, “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
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affects interstate commerce.” [15]. Similarly, The Transplantation Society states “No transplant surgeon/team shall be involved directly or indirectly on the buying or selling of organs/tissues or in any transplant activity aimed at commercial gain.” [16]. Currently Iran remains the only nation to offer a legalized, regulated system of payment for kidney transplantation, which now accounts for over half of the transplants performed there. Under this system, an organization called The Dialysis and Transplant Patients Association (DAPTA) performs preliminary matching of donors with recipients, with hospital expenses paid by the government. The transplant donor receives a donation from the government and an additional payment from the recipient, with the amount determined prior to transplantation. It is claimed that waiting lists for a kidney have been cleared in Iran, with over 50% of all patients with end stage renal disease transplanted [17]. Within this model, regulations have been implemented to limit transplant tourism by prohibiting non-Iranians from receiving transplants from Iranian donors or donating to Iranian patients. Closer analysis of Iranian kidney donors in questionnaire studies have shown that 66% of organ vendors in Iran lived below the poverty line and 91% expressed satisfaction with their decision to donate [18]. However, these facts have been disputed by some transplant physicians within Iran who have raised concern that the data has been selected from chosen transplant centers to represent the nation. Compensation for organ transplantation is illegal in other parts of the world, but it has been practiced in countries such as India and Pakistan. In Pakistan, it is estimated that commercial transplants constituted 70% of all transplants in 2007, with more than half of the recipients originating from developed countries [19]. These commercial transplants are performed in private centers and involve an organ broker. The recipient pays a fee which covers the cost of the kidney, the immunosuppressive drugs and the hospital stay. Follow-up studies evaluating the outcomes of transplant tourists returning to developed nations, including the United Kingdom and Canada, have demonstrated an increased rate of infectious complications and poor graft outcomes [19]. This has been attributed to the inadequate facilities and poor patient selection criteria by the commercial transplant centers. In addition, 34% of vendors in Pakistan have been reported to live below the poverty line, on less than US$1 per day, with a 90% rate of illiteracy and 69% working as bonded laborers [20]. The motivation for the majority of these donors was to receive financial support to pay off debts and little long-term economic benefit was observed [20]. In an effort to curb the commercial organ trade in Pakistan, the Transplantation of Human Organs and Tissues Ordinance was enacted in 2010 [21]. While slightly reduced numbers of organs have been illegally transplanted after the law was passed, the trade has remained active, particularly because of the ongoing demand for unlawful commercial transplants from foreigners who are unable to get organs in their home countries. The prospect of introducing a system of regulated payment for organs to developed nations has been mooted on numerous occasions [22e25]. In such systems, only living-unrelated (nondirected) transplants would be rewarded, to maintain current rates of cadaveric and living-related donation. As transplantation is considerably more economical than maintaining patients on dialysis, a system of regulated, government-funded compensation for donors may save healthcare costs in the long-term [27]. Proponents of such a system have also suggested that reducing the number of patients on the transplant waiting lists in the developing world would dramatically lower the demand for organ trafficking and commercialism in countries like Pakistan [26]. Prior to adoption of the compensated system of organ donation in Iran, a long list of patients waiting for organs would seek transplants from alternative
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countries, with travel funded by the government. This list was cleared following establishment of the current system [28]. Those opposing payment for organs have suggested that this system raises the potential for exploitation of the poor. The implication here is that the addition of commercial considerations to the already complex decision-making process that surrounds live organ donation may cloud judgment and cause those in dire financial situations to overlook the potential risks [29]. Another argument against payment system is the ethical concern relating to commodification of organs and human tissues, which would depersonalize and devalue the human body [29]. Other concerns have included the possibility of generating unfavorable public opinion towards the field of transplantation, particularly in the event of harm or death to an organ vendor. Such instances would have the potential for significant erosion in the public's trust of government and healthcare professionals [29]. Ethical concerns would preclude the widespread implementation of systems involving payments for organs in the near future. However, policy makers can draw lessons from the existing experiences involving payments and incentives. In particular, governments must find methods of removing disincentives such as loss of income and reimbursement of expenses for those who commit to organ donation.
5. Mandated choice models Psychological research has demonstrated that preferences are not yet articulated in the minds of those who have not been asked [7]. The decision about organ donation is frequently made by relatives of the deceased at a time of significant emotional distress. Therefore, in order to allow well considered decisions relating to organ donation to be made by the organ donors themselves, mandated choice models have been put forward [30]. In mandated choice models of organ donation, all adults are asked to make a decision on whether to donate their organs. Under this system, individuals are free to choose to donate, not donate or defer the decision to their relatives. As the name suggests, it is compulsory for all persons to make a decision, with the expressed choice potentially revocable. It has been suggested that the
question of organ donation can be presented to members of society as part of tax returns, driver's license application forms or benefit claims. A survey study in young adults in the United States indicated that a mandated choice model for organ donation is widely supported when compared with other organ donation systems including presumed consent [31]. In addition, mandated choice models have previously received support from the American Medical Association [32]. It has been argued that forcing people to make a decision on organ donation is unacceptable as it undermines an individual's autonomy. On the other hand, supporters of mandated choice models maintain that this model actually promotes autonomy, by ensuring a person's preference for their organs is upheld after death rather than allowing relatives to override the wishes of the deceased [33]. Importantly, decisions about end-of-life questions can be difficult and some people might not feel able to make them. This is illustrated by the experience in US state of Virginia, where a mandated choice model for organ transplantation was attempted and 24% of the population refused to select a preference [34].
6. An alternative solution Our review of the literature has identified that mandated choice models, well-supported transplant coordinators approaching relatives, incentives and public education campaigns are effective methods of increasing organ donation rates. Based on this, one possible way to drive organ donation rates would be to develop a modified mandated choice model which actively and systematically presents all members of society with three simple options (Fig. 2): (i) registration as an organ donor (ii) registration as not an organ donor (iii) deferred registration As in mandated choice models, voter registration or driver's license application may represent suitable portals to ask this question and would allow access to a significant proportion of a country's population. In comparison to existing models, the burden
Fig. 2. Schematic of our modified mandated choice model. This model is different than previous mandated choice models as it offers the option of deferred registration, in which persons are considered organ donors under “soft” presumed consent. In this instance, the next-of-kin is consulted at the time of death.
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of challenging citizens to think about death and decide their organ donation status is likely to raise ethical and legal questions. However, given the number of lives that are lost while waiting for an organ transplant, simply asking a question seems morally acceptable. Indeed, this schema empowers people to make informed, active choices. Asking a universal question of the general population will increase awareness and help close the gap between the number of people that declare to be in favor of organ donation, and the number of individuals that effectively enroll as organ donors. A number of conditions must be satisfied for this proposed system to be successful. First, the responder population must be informed on the importance of organ transplantation. This can be achieved through school, social networks, and mass media. Second, registration of a choice should be observed as “hard” d these choices should not be vetoed by family members and should be respected by the medical team. Furthermore, a person's choice is mutable over time, and there should be ready access to a central registry where a person can update his or her choice. Lastly, this system differs from traditional mandated choice systems owing to the presence of an additional option: the choice not to decide. Forcing doubtful responders to select an option could lead them to opt-out. In this model, people who choose not to decide and defer registration would be considered potential organ donors in a “soft” opt-out system. At the end of life, the families of these individuals should be consulted in a sensitive manner by skilled transplant coordinators. 7. Conclusion Effective political solutions that can be enacted in the near future are urgently needed to address the critical organ shortage. Widespread adoption of a vendor-based system is currently considered a step too far and would threaten to thwart the significant efforts of transplant professionals who have strived to slowly build rates of voluntary donation. However, governments must work to eliminate remaining disincentives, such as healthcare bills and loss of earnings, which currently deter potentially willing donors. It has even been suggested that living-unrelated donors be nationally recognized for their altruism, in a manner similar to military heroes [35]. In addition ongoing efforts to concurrently increase the numbers of cadaveric donors are also required. Given the discrepancy between the number of people that would donate and those who actually do, the gap between intent and action must be closed. For this to happen the question of organ donation must be actively presented to all members of society. Ethical approval None. Funding Nil. Author contribution KS e conception and design, analysis, writing of manuscript and critical review. VV e conception and design, analysis, writing of manuscript and critical review. LM e conception and design, analysis, writing of manuscript and critical review. JS e Analysis, design and critical review of manuscript and critical review.
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SM e conception and design, analysis, writing of manuscript and critical review. Conflict of interest None. References [1] U.S. Department of Health & Human Services, http://organdonor.gov/about/ data.html (accessed 31.05.14.). [2] R. Matesanz, B. Dominguez-Gil, E. Coll, G. de la Rosa, R. Marazuela, Spanish experience as a leading country: what kind of measures were taken? Transpl. Int. 24 (2011) 333e343. [3] A. Rithalia, C. McDaid, S. Suekarran, L. Myers, A. Sowden, Impact of presumed consent for organ donation on donation rates: a systematic review, BMJ 338 (2009) 3162e3170. [4] B.J. Boyarsky, E.C. Hall, N.A. Deshpande, et al., Potential limitations of presumed consent legislation, Transplantation 93 (2012) 136e140. [5] R. Coppen, R.D. Friele, S.K. Gevers, G.A. Blok, J. van der Zee, The impact of donor policies in Europe: a steady increase, but not everywhere, BMC Health Serv. Res. 8 (2008) 235, 6963-8-235. [6] J. Fabre, P. Murphy, R. Matesanz, Presumed consent: a distraction in the quest for increasing rates of organ donation, BMJ 341 (2010) c4973. [7] E.J. Johnson, D.G. Goldstein, Defaults and donation decisions, Transplantation 78 (2004) 1713e1716. [8] UK Organ Donation Taskforce, Organs for Transplants: a Report from the Organ Donation Taskforce, 2008. http://www.dh.gov.uk/en/ Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_ 08212 (accessed 31.05.14.). [9] J. Dominguez, J.L. Rojas, Presumed consent legislation failed to improve organ donation in Chile, Transpl. Proc. 45 (2013) 1316e1317. [10] C.J. Rudge, E. Buggins, How to increase organ donation: does opting out have a role? Transplantation 93 (2012) 141e144. [11] A.M. Rosenblum, L.D. Horvat, L.A. Siminoff, V. Prakash, J. Beitel, A.X. Garg, The authority of next-of-kin in explicit and presumed consent systems for deceased organ donation: an analysis of 54 nations, Nephrol. Dial. Transpl. 27 (2012) 2533e2546. [12] J. Lavee, T. Ashkenazi, A. Stoler, J. Cohen, R. Beyar, Preliminary marked increase in the national organ donation rate in Israel following implementation of a new organ transplantation law, Am. J. Transpl. 13 (2013) 780e785. [13] J. Lavee, T. Ashkenazi, G. Gurman, D. Steinberg, A new law for allocation of donor organs in Israel, Lancet 375 (2010) 1131e1133. [14] M. Quigley, L. Wright, V. Ravitsky, Organ donation and priority points in Israel: an ethical analysis, Transplantation 93 (2012) 970e973. [15] The National Organ Transplant Act, 42 U.S.C., 274e (2002). [16] Commercialisation in transplantation: the problems and some guidelines for practice. The Council of the Transplantation Society, Lancet 2 (1985) 715e716. [17] A.J. Ghods, S. Savaj, Iranian model of paid and regulated living-unrelated kidney donation, Clin. J. Am. Soc. Nephrol. 1 (2006) 1136e1145. [18] T. Malakoutian, M.S. Hakemi, A.A. Nassiri, et al., Socioeconomic status of Iranian living unrelated kidney donors: a multicenter study, Transpl. Proc. 39 (2007) 824e825. [19] A.H. Rizvi, A.S. Naqvi, N.M. Zafar, E. Ahmed, Regulated compensated donation in Pakistan and Iran, Curr. Opin. Organ Transpl. 14 (2009) 124e128. [20] S.A. Naqvi, B. Ali, F. Mazhar, M.N. Zafar, S.A. Rizvi, A socioeconomic survey of kidney vendors in Pakistan, Transpl. Int. 20 (2007) 934e939. [21] A. Efrat, The politics of combating the organ trade: lessons from the Israeli and Pakistani experience, Am. J. Transpl. (2013) 1650e1654. [22] J. Radcliffe-Richards, A.S. Daar, R.D. Guttmann, et al., The case for allowing kidney sales. International Forum for Transplant Ethics, Lancet 351 (1998) 1950e1952. [23] D.J. Rothman, E. Rose, T. Awaya, et al., The Bellagio task force report on transplantation, bodily integrity, and the International Traffic in Organs, Transpl. Proc. 29 (1997) 2739e2745. [24] M.M. Friedlaender, The right to sell or buy a kidney: are we failing our patients? Lancet 359 (2002) 971e973. [25] J. Harris, C. Erin, An ethically defensible market in organs, BMJ 325 (2002) 114e115. [26] B. Hippen, A. Matas, Incentives for organ donation in the United States: feasible alternative or forthcoming apocalypse? Curr. Opin. Organ Transpl. 14 (2009) 140e146. [27] A.J. Matas, M. Schnitzler, Payment for living donor (vendor) kidneys: a costeffectiveness analysis, Am. J. Transpl. 4 (2004) 216e221. [28] A.J. Ghods, D. Nasrollahzadeh, Transplant tourism and the Iranian model of renal transplantation program: ethical considerations, Exp. Clin. Transpl. 3 (2005) 351e354. [29] A.J. Matas, The case for living kidney sales: rationale, objections and concerns, Am. J. Transpl. 4 (2004) 2007e2017. [30] A. Spital, Mandated choice. The preferred solution to the organ shortage? Arch. Intern Med. 152 (1992) 2421e2424. [31] A. Spital, Mandated choice. A plan to increase public commitment to organ donation, JAMA 273 (1995) 504e506.
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[32] Council on ethical and judicial affairs, American Medical Association. Strategies for cadaveric organ procurement. Mandated choice and presumed consent, JAMA 272 (1994) 809e812. [33] P. Chouhan, H. Draper, Modified mandated choice for organ procurement, J. Med. Ethics 29 (2003) 157e162.
[34] A.C. Klassen, D.K. Klassen, Who are the donors in organ donation? The family's perspective in mandated choice, Ann. Intern Med. 125 (1996) 70e73. [35] P.A. Terasaki, Congressional gold medal for transplant donors and families, Am. J. Transpl. 5 (2005) 1167.
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Review
Current progress in public health models addressing the critical organ shortage Kumaran Shanmugarajah a, d, *, Vincenzo Villani a, Maria Lucia L. Madariaga a, c, Joseph Shalhoub d, Sebastian G. Michel a, b a
Transplantation Biology Research Center, Massachusetts General Hospital, Building 149, 13th Street, Charlestown, Boston, MA 02114, USA €t München, Munich D-81377 Germany Department of Cardiac Surgery, Ludwig-Maximilians-Universita Department of Surgery, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02129, USA d Department of Surgery & Cancer, Imperial College London, Exhibition Road, London SW7 2AZ, United Kingdom b c
h i g h l i g h t s The impact of presumed consent legislation for organ donation is undetermined. Public campaigns and supported transplant coordinators increase organ donation. Providing incentives to donors increases organ donation. Mandated choice models may offer a possible method of increasing donation.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 27 July 2014 Received in revised form 6 November 2014 Accepted 11 November 2014 Available online 13 November 2014
Since its inauguration in 1954, the field of modern transplantation has made great strides in surgical technique, the prevention of acute and chronic rejection, the minimization of immunosuppressionrelated side-effects and transplant tolerance. As such, organ transplantation is used worldwide as a curative, life-saving treatment for people with end-stage organ failure. However, the successes of organ transplantation have resulted in the number of patients on transplant waiting lists far exceeding the number of organs available, with growing numbers of patients dying while awaiting transplants. In order to address this critical organ shortage, a number of legislative changes have been implemented worldwide to increase the number of individuals registering as organ donors. These have included presumed consent donation, incentivized organ donation, commercial organ transplantation and mandated choice models. This article will address these public health policies in turn. The implementation of these strategies and the evidence for their efficacy will be evaluated. Based on this, we have identified that wellsupported transplant coordinators approaching next-of-kin, incentives and public health campaigns are key factors that increase organ donation. Finally we propose a modified mandated choice model that may be an alternative option to maximize the number of available organs for transplantation. © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Organ shortage Policy Donation Presumed consent Explicit consent Mandated choice
1. Introduction The great success of modern-day organ transplantation has resulted in its biggest conundrum e the number of people waiting for transplants is simply higher than the number of organs
* Corresponding author. Transplantation Biology Research Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02129 USA. E-mail address: [email protected] (K. Shanmugarajah). http://dx.doi.org/10.1016/j.ijsu.2014.11.011 1743-9191/© 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
available. In the United States alone, even with over 30,000 organ transplants performed last year, 18 people die daily on transplant waiting lists [1]. In order to address this challenge, transplant surgeons have adopted Expanded Donor Criteria, including Donation after Cardiac Death with the aim of increasing the number of organs that can be retrieved from potential donors. But perhaps more significantly, various public health policies have been employed to increase the actual number of registered donors. Many of these policies have been associated with increased rates of organ
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donation. However, whether changes in legislation themselves have had a causative effect is controversial. This article will review the literature concerning the implementation of various public health policies and aim to identify factors that increase organ donation. The implementation and efficacy of presumed consent organ donation, incentivized organ donation, commercial organ transplants and mandated choice models will be assessed. 2. Presumed consent organ donation A no-action default in public policy is the condition imposed when an individual fails to make a decision. In an explicit consent or “opt-in” system, people will not become organ donors unless they register. By contrast, in a presumed consent or “opt-out” system, individuals are organ donors unless they register not to be. Opt-out systems have been described as “hard” when the stated wishes of the deceased patient are adhered to without consultation of the family. On the other hand, “soft” opt-out systems incorporate the wishes of family members. A number of studies across Spain, Austria, Belgium and Singapore have observed an increase in organ donation following the implementation of opt-out legislation [2]. Similarly, comparison studies have shown increased donor rates in countries with opt-out systems compared with opt-in systems (Fig. 1) [3e6]. It has been suggested that adoption of an opt-out policy may increase organ donation for three reasons: (i) decision-makers identify the default choice as the recommended choice by the policy maker, (ii) demonstrating a choice requires effort, and many people would rather avoid making an unpleasant decision about organ donation and, (iii) loss aversion, or fear of change [7]. Despite the correlations between high donor rates and opt-out policies, the implementation of opt-out systems for organ donation has been controversial for a number of reasons. Firstly, the ethics of assuming consent from silence has been questioned. These concerns are particularly important to transplant recipients, who need to know that their organ was donated freely and altruistically,
and intensive care practitioners who have expressed fears that optout systems could damage vital end-of-life relationships between physicians, patients and families [8]. The removal of organs from patients who did not wish to donate, but did not explicitly opt-out raises the possibility of negatively impacting the public's perception of transplantation and may thwart efforts to increase organ donation rates. Such drops in organ donation rates have been observed in some countries, such as Chile, following passage of optout legislation [9]. Secondly, while the previously described association studies have shown a relationship between opt-out systems and higher numbers of organ donors, the true efficacy of opt-out legislation remains to be confirmed. The scientific evidence that legislation alone can increase organ donation is unclear as policy changes are not made in isolation and concomitant changes made with opt-out legislation may act as confounding factors. For example, implementation of opt-out systems have been followed by government funding for transplant programs, hospital-level reimbursement for identifying donors, improved infrastructure and coordination of transplant networks, increased public awareness and education on organ donation and positive public attitudes towards transplantation [3,10]. The fact that legislation itself does not change organ donation rates is well illustrated by the Spanish experience. Currently, Spain has the highest rate of organ donors in the world and utilizes an opt-out system which was introduced in 1979. However, the rate of organ donation only increased, from 14.3 to over 30 donors per million population, with the creation of n Nacional de Trasplantes in 1989 [2]. In particular, the Organizacio introduction of well-trained transplant coordinators and public health campaigns helped influence this dramatic increase in transplant donors. Finally, the practical implementation of hard versus soft opt-out systems is unclear. Despite the distinction, questionnaire studies involving transplant professionals have demonstrated that organ donor consent almost always involves consultation with the nextof-kin in both opt-out systems, as well as in opt-in systems [11]. Therefore, certain countries that use opt-out organ donation
Fig. 1. Comparison of the donation rate with the donation system used (presumed versus explicit consent) among the 25 countries with the highest registered rate of deceased organ donation. These 2012 data are based on the Global Observatory on Donation and Transplantation data, produced by the WHO-ONT collaboration.
K. Shanmugarajah et al. / International Journal of Surgery 12 (2014) 1363e1368
policies have demonstrated very high presumed consent rates to organ donation but much lower actual rates of donation. This demonstrates that the majority stay with the default option and that the important decision about organ donation is often made by the next-of-kin following death [11]. Greater clarity is required to determine the true impact of optout legislation itself. In contrast to the existing before-and-after comparisons, or comparative analyses of different countries, a controlled, prospective trial comparing opt-out versus opt-in offers the best chance of determining the impact of such a policy change alone. Last year's passage of an opt-out system in Wales may represent this opportunity, where effects of the legislative change in Wales can be compared to culturally similar parts of the United Kingdom that are exposed to the confounders that accompany this change in law. 3. Incentivized organ donation Rates of organ donation in Israel have traditionally been amongst the lowest of Western countries. Among the reasons for this has been the refusal by some ultraorthodox religious groups to accept brain-death as death and consequently objecting to organ donation [12]. In order to increase the numbers of organ donors the Israeli Ministry of Health introduced the Organ Transplant Act in 2008. According to this law, persons who consent to organ donation or who have first degree relatives that consent to organ donation are given priority if they subsequently require a transplant. In addition, disincentives for living donation were removed, allowing donors to claim reimbursement for loss of income, recovery and transportation [13]. Implementation of this system was followed by significant increases in living and deceased organ donation rates, with preliminary data in 2011 indicating that there was a decrease in the number of candidates awaiting organ transplants and fewer recipients dying on the waiting lists [12]. Despite this initial success, ethical concerns have also been raised. Firstly, patients with numerous first-degree relatives are at an advantage over those with no siblings [14]. A response to this concern is that individuals with few relatives can sign their own donor cards and ensure themselves priority. Secondly, directed living donors (i.e. persons who have already donated organs to specified patients) were not initially given priority in the present Israeli system. The higher priority of persons demonstrating intent to donate by signing a donor card over those who had already taken the risks of donating organs was controversial and raised questions over the ethical basis of this law [14]. However, the Israeli government subsequently passed an amendment to the law, extending priority for organ allocation to those who had already donated an organ. Thirdly, the benefit to persons as a result of the actions of their first-degree relatives, rather than their own good deeds has been questioned. Finally, the passage of this legislation has resulted in opportunity for strategic behavior where people register as organ donors in order to receive priority, yet instruct their next-of-kin to not consent to organ donation upon death [14]. Data gathered to date represents a preliminary insight into the efficacy of the Organ Transplant Act of Israel. However, longer-term follow-up is necessary to assess the true impact of legislation to incentivize organ donation in this way. 4. Commercial organ transplants The sale of organs for transplantation has largely been considered unethical. According to the National Organ Transplant Act of the United States, “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
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affects interstate commerce.” [15]. Similarly, The Transplantation Society states “No transplant surgeon/team shall be involved directly or indirectly on the buying or selling of organs/tissues or in any transplant activity aimed at commercial gain.” [16]. Currently Iran remains the only nation to offer a legalized, regulated system of payment for kidney transplantation, which now accounts for over half of the transplants performed there. Under this system, an organization called The Dialysis and Transplant Patients Association (DAPTA) performs preliminary matching of donors with recipients, with hospital expenses paid by the government. The transplant donor receives a donation from the government and an additional payment from the recipient, with the amount determined prior to transplantation. It is claimed that waiting lists for a kidney have been cleared in Iran, with over 50% of all patients with end stage renal disease transplanted [17]. Within this model, regulations have been implemented to limit transplant tourism by prohibiting non-Iranians from receiving transplants from Iranian donors or donating to Iranian patients. Closer analysis of Iranian kidney donors in questionnaire studies have shown that 66% of organ vendors in Iran lived below the poverty line and 91% expressed satisfaction with their decision to donate [18]. However, these facts have been disputed by some transplant physicians within Iran who have raised concern that the data has been selected from chosen transplant centers to represent the nation. Compensation for organ transplantation is illegal in other parts of the world, but it has been practiced in countries such as India and Pakistan. In Pakistan, it is estimated that commercial transplants constituted 70% of all transplants in 2007, with more than half of the recipients originating from developed countries [19]. These commercial transplants are performed in private centers and involve an organ broker. The recipient pays a fee which covers the cost of the kidney, the immunosuppressive drugs and the hospital stay. Follow-up studies evaluating the outcomes of transplant tourists returning to developed nations, including the United Kingdom and Canada, have demonstrated an increased rate of infectious complications and poor graft outcomes [19]. This has been attributed to the inadequate facilities and poor patient selection criteria by the commercial transplant centers. In addition, 34% of vendors in Pakistan have been reported to live below the poverty line, on less than US$1 per day, with a 90% rate of illiteracy and 69% working as bonded laborers [20]. The motivation for the majority of these donors was to receive financial support to pay off debts and little long-term economic benefit was observed [20]. In an effort to curb the commercial organ trade in Pakistan, the Transplantation of Human Organs and Tissues Ordinance was enacted in 2010 [21]. While slightly reduced numbers of organs have been illegally transplanted after the law was passed, the trade has remained active, particularly because of the ongoing demand for unlawful commercial transplants from foreigners who are unable to get organs in their home countries. The prospect of introducing a system of regulated payment for organs to developed nations has been mooted on numerous occasions [22e25]. In such systems, only living-unrelated (nondirected) transplants would be rewarded, to maintain current rates of cadaveric and living-related donation. As transplantation is considerably more economical than maintaining patients on dialysis, a system of regulated, government-funded compensation for donors may save healthcare costs in the long-term [27]. Proponents of such a system have also suggested that reducing the number of patients on the transplant waiting lists in the developing world would dramatically lower the demand for organ trafficking and commercialism in countries like Pakistan [26]. Prior to adoption of the compensated system of organ donation in Iran, a long list of patients waiting for organs would seek transplants from alternative
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countries, with travel funded by the government. This list was cleared following establishment of the current system [28]. Those opposing payment for organs have suggested that this system raises the potential for exploitation of the poor. The implication here is that the addition of commercial considerations to the already complex decision-making process that surrounds live organ donation may cloud judgment and cause those in dire financial situations to overlook the potential risks [29]. Another argument against payment system is the ethical concern relating to commodification of organs and human tissues, which would depersonalize and devalue the human body [29]. Other concerns have included the possibility of generating unfavorable public opinion towards the field of transplantation, particularly in the event of harm or death to an organ vendor. Such instances would have the potential for significant erosion in the public's trust of government and healthcare professionals [29]. Ethical concerns would preclude the widespread implementation of systems involving payments for organs in the near future. However, policy makers can draw lessons from the existing experiences involving payments and incentives. In particular, governments must find methods of removing disincentives such as loss of income and reimbursement of expenses for those who commit to organ donation.
5. Mandated choice models Psychological research has demonstrated that preferences are not yet articulated in the minds of those who have not been asked [7]. The decision about organ donation is frequently made by relatives of the deceased at a time of significant emotional distress. Therefore, in order to allow well considered decisions relating to organ donation to be made by the organ donors themselves, mandated choice models have been put forward [30]. In mandated choice models of organ donation, all adults are asked to make a decision on whether to donate their organs. Under this system, individuals are free to choose to donate, not donate or defer the decision to their relatives. As the name suggests, it is compulsory for all persons to make a decision, with the expressed choice potentially revocable. It has been suggested that the
question of organ donation can be presented to members of society as part of tax returns, driver's license application forms or benefit claims. A survey study in young adults in the United States indicated that a mandated choice model for organ donation is widely supported when compared with other organ donation systems including presumed consent [31]. In addition, mandated choice models have previously received support from the American Medical Association [32]. It has been argued that forcing people to make a decision on organ donation is unacceptable as it undermines an individual's autonomy. On the other hand, supporters of mandated choice models maintain that this model actually promotes autonomy, by ensuring a person's preference for their organs is upheld after death rather than allowing relatives to override the wishes of the deceased [33]. Importantly, decisions about end-of-life questions can be difficult and some people might not feel able to make them. This is illustrated by the experience in US state of Virginia, where a mandated choice model for organ transplantation was attempted and 24% of the population refused to select a preference [34].
6. An alternative solution Our review of the literature has identified that mandated choice models, well-supported transplant coordinators approaching relatives, incentives and public education campaigns are effective methods of increasing organ donation rates. Based on this, one possible way to drive organ donation rates would be to develop a modified mandated choice model which actively and systematically presents all members of society with three simple options (Fig. 2): (i) registration as an organ donor (ii) registration as not an organ donor (iii) deferred registration As in mandated choice models, voter registration or driver's license application may represent suitable portals to ask this question and would allow access to a significant proportion of a country's population. In comparison to existing models, the burden
Fig. 2. Schematic of our modified mandated choice model. This model is different than previous mandated choice models as it offers the option of deferred registration, in which persons are considered organ donors under “soft” presumed consent. In this instance, the next-of-kin is consulted at the time of death.
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of challenging citizens to think about death and decide their organ donation status is likely to raise ethical and legal questions. However, given the number of lives that are lost while waiting for an organ transplant, simply asking a question seems morally acceptable. Indeed, this schema empowers people to make informed, active choices. Asking a universal question of the general population will increase awareness and help close the gap between the number of people that declare to be in favor of organ donation, and the number of individuals that effectively enroll as organ donors. A number of conditions must be satisfied for this proposed system to be successful. First, the responder population must be informed on the importance of organ transplantation. This can be achieved through school, social networks, and mass media. Second, registration of a choice should be observed as “hard” d these choices should not be vetoed by family members and should be respected by the medical team. Furthermore, a person's choice is mutable over time, and there should be ready access to a central registry where a person can update his or her choice. Lastly, this system differs from traditional mandated choice systems owing to the presence of an additional option: the choice not to decide. Forcing doubtful responders to select an option could lead them to opt-out. In this model, people who choose not to decide and defer registration would be considered potential organ donors in a “soft” opt-out system. At the end of life, the families of these individuals should be consulted in a sensitive manner by skilled transplant coordinators. 7. Conclusion Effective political solutions that can be enacted in the near future are urgently needed to address the critical organ shortage. Widespread adoption of a vendor-based system is currently considered a step too far and would threaten to thwart the significant efforts of transplant professionals who have strived to slowly build rates of voluntary donation. However, governments must work to eliminate remaining disincentives, such as healthcare bills and loss of earnings, which currently deter potentially willing donors. It has even been suggested that living-unrelated donors be nationally recognized for their altruism, in a manner similar to military heroes [35]. In addition ongoing efforts to concurrently increase the numbers of cadaveric donors are also required. Given the discrepancy between the number of people that would donate and those who actually do, the gap between intent and action must be closed. For this to happen the question of organ donation must be actively presented to all members of society. Ethical approval None. Funding Nil. Author contribution KS e conception and design, analysis, writing of manuscript and critical review. VV e conception and design, analysis, writing of manuscript and critical review. LM e conception and design, analysis, writing of manuscript and critical review. JS e Analysis, design and critical review of manuscript and critical review.
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SM e conception and design, analysis, writing of manuscript and critical review. Conflict of interest None. References [1] U.S. Department of Health & Human Services, http://organdonor.gov/about/ data.html (accessed 31.05.14.). [2] R. Matesanz, B. Dominguez-Gil, E. Coll, G. de la Rosa, R. Marazuela, Spanish experience as a leading country: what kind of measures were taken? Transpl. Int. 24 (2011) 333e343. [3] A. Rithalia, C. McDaid, S. Suekarran, L. Myers, A. Sowden, Impact of presumed consent for organ donation on donation rates: a systematic review, BMJ 338 (2009) 3162e3170. [4] B.J. Boyarsky, E.C. Hall, N.A. Deshpande, et al., Potential limitations of presumed consent legislation, Transplantation 93 (2012) 136e140. [5] R. Coppen, R.D. Friele, S.K. Gevers, G.A. Blok, J. van der Zee, The impact of donor policies in Europe: a steady increase, but not everywhere, BMC Health Serv. Res. 8 (2008) 235, 6963-8-235. [6] J. Fabre, P. Murphy, R. Matesanz, Presumed consent: a distraction in the quest for increasing rates of organ donation, BMJ 341 (2010) c4973. [7] E.J. Johnson, D.G. Goldstein, Defaults and donation decisions, Transplantation 78 (2004) 1713e1716. [8] UK Organ Donation Taskforce, Organs for Transplants: a Report from the Organ Donation Taskforce, 2008. http://www.dh.gov.uk/en/ Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_ 08212 (accessed 31.05.14.). [9] J. Dominguez, J.L. Rojas, Presumed consent legislation failed to improve organ donation in Chile, Transpl. Proc. 45 (2013) 1316e1317. [10] C.J. Rudge, E. Buggins, How to increase organ donation: does opting out have a role? Transplantation 93 (2012) 141e144. [11] A.M. Rosenblum, L.D. Horvat, L.A. Siminoff, V. Prakash, J. Beitel, A.X. Garg, The authority of next-of-kin in explicit and presumed consent systems for deceased organ donation: an analysis of 54 nations, Nephrol. Dial. Transpl. 27 (2012) 2533e2546. [12] J. Lavee, T. Ashkenazi, A. Stoler, J. Cohen, R. Beyar, Preliminary marked increase in the national organ donation rate in Israel following implementation of a new organ transplantation law, Am. J. Transpl. 13 (2013) 780e785. [13] J. Lavee, T. Ashkenazi, G. Gurman, D. Steinberg, A new law for allocation of donor organs in Israel, Lancet 375 (2010) 1131e1133. [14] M. Quigley, L. Wright, V. Ravitsky, Organ donation and priority points in Israel: an ethical analysis, Transplantation 93 (2012) 970e973. [15] The National Organ Transplant Act, 42 U.S.C., 274e (2002). [16] Commercialisation in transplantation: the problems and some guidelines for practice. The Council of the Transplantation Society, Lancet 2 (1985) 715e716. [17] A.J. Ghods, S. Savaj, Iranian model of paid and regulated living-unrelated kidney donation, Clin. J. Am. Soc. Nephrol. 1 (2006) 1136e1145. [18] T. Malakoutian, M.S. Hakemi, A.A. Nassiri, et al., Socioeconomic status of Iranian living unrelated kidney donors: a multicenter study, Transpl. Proc. 39 (2007) 824e825. [19] A.H. Rizvi, A.S. Naqvi, N.M. Zafar, E. Ahmed, Regulated compensated donation in Pakistan and Iran, Curr. Opin. Organ Transpl. 14 (2009) 124e128. [20] S.A. Naqvi, B. Ali, F. Mazhar, M.N. Zafar, S.A. Rizvi, A socioeconomic survey of kidney vendors in Pakistan, Transpl. Int. 20 (2007) 934e939. [21] A. Efrat, The politics of combating the organ trade: lessons from the Israeli and Pakistani experience, Am. J. Transpl. (2013) 1650e1654. [22] J. Radcliffe-Richards, A.S. Daar, R.D. Guttmann, et al., The case for allowing kidney sales. International Forum for Transplant Ethics, Lancet 351 (1998) 1950e1952. [23] D.J. Rothman, E. Rose, T. Awaya, et al., The Bellagio task force report on transplantation, bodily integrity, and the International Traffic in Organs, Transpl. Proc. 29 (1997) 2739e2745. [24] M.M. Friedlaender, The right to sell or buy a kidney: are we failing our patients? Lancet 359 (2002) 971e973. [25] J. Harris, C. Erin, An ethically defensible market in organs, BMJ 325 (2002) 114e115. [26] B. Hippen, A. Matas, Incentives for organ donation in the United States: feasible alternative or forthcoming apocalypse? Curr. Opin. Organ Transpl. 14 (2009) 140e146. [27] A.J. Matas, M. Schnitzler, Payment for living donor (vendor) kidneys: a costeffectiveness analysis, Am. J. Transpl. 4 (2004) 216e221. [28] A.J. Ghods, D. Nasrollahzadeh, Transplant tourism and the Iranian model of renal transplantation program: ethical considerations, Exp. Clin. Transpl. 3 (2005) 351e354. [29] A.J. Matas, The case for living kidney sales: rationale, objections and concerns, Am. J. Transpl. 4 (2004) 2007e2017. [30] A. Spital, Mandated choice. The preferred solution to the organ shortage? Arch. Intern Med. 152 (1992) 2421e2424. [31] A. Spital, Mandated choice. A plan to increase public commitment to organ donation, JAMA 273 (1995) 504e506.
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