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Paid Living Donation and Growth of Deceased Donor Programs

Ghahramani, Nasrollah MD

doi: 10.1097/TP.0000000000001164
In View: Around the World

Limited organ availability in all countries has stimulated discussion about incentives to increase donation. Since 1988, Iran has operated the only government-sponsored paid living donor (LD) kidney transplant program. This article reviews aspects of the Living Unrelated Donor program and development of deceased donation in Iran. Available evidence indicates that in the partially regulated Iranian Model, the direct negotiation between donors and recipients fosters direct monetary relationship with no safeguards against mutual exploitation. Brokers, the black market and transplant tourism exist, and the waiting list has not been eliminated. Through comparison between the large deceased donor program in Shiraz and other centers in Iran, this article explores the association between paid donation and the development of a deceased donor program. Shiraz progressively eliminated paid donor transplants such that by 2011, 85% of kidney transplants in Shiraz compared with 27% across the rest of Iran's other centers were from deceased donors. Among 26 centers, Shiraz undertakes the largest number of deceased donor kidney transplants, most liver transplants, and all pancreas transplants. In conclusion, although many patients with end stage renal disease have received transplants through the paid living donation, the Iranian Model now has serious flaws and is potentially inhibiting substantial growth in deceased donor organ transplants in Iran.

1 Division of Nephrology, Department of Medicine, Pennsylvania State University College of Medicine, Penn State Hershey Medical Center, Hershey, PA.

Received 19 August 2015. Revision 25 January 2016.

Accepted 27 January 2016.

The author declares no funding or conflicts of interest.

N.G. is the sole author of the article. He has reviewed the literature, analyzed, and interpreted the data and drafted the article.

Correspondence: Nasrollah Ghahramani, MD, MS, FACP, Penn State College of Medicine, Mail Code H040, 500 University Drive, Hershey, PA 17033. (nghahramani@hmc.psu.edu).

The increasing gap between the number of patients with end-stage renal disease and the number of available organs for transplant organs has stimulated discussions about financial incentives to increase living donation.1,2 It has been proposed that regulated trials are needed to address the paucity of evidence about financial incentives.

Since 1988, Iran has operated the only government-sponsored paid living unrelated donor (LURD) transplant program.3-7 Although there have been many articles about the proposed benefits, concern has been expressed about the ethical shortcomings, the direct monetary relation between donor and recipient with resultant commercialization and commodification, exploitation of the poor, stigmatization of donors, and suppression of altruistic donation.8-11 These concerns have been acknowledged by pioneers of nephrology in Iran.12,13 The purpose of this article is to use available evidence to examine how the “Iranian Model” works in Iran currently and to examine the areas of proposed advantage and concern.

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The Iranian Model of Paid Living Unrelated Transplants

Details of the Iranian Model have been previously published.5,14 The first renal transplant (RT) in Iran was performed in Shiraz in 1967 and 114 RTs were then performed before the 1979 revolution. During the following decade, access to and costs of dialysis became prohibitive, and in 1988, the Iranian government created and sponsored a paid LURD RT program. All potential recipients and donors are required to register with the Dialysis and Transplant Patient Association, which obtains consent, conducts primary evaluation and introduces the recipient to the potential donor. After negotiation and agreement on payment terms, the matched pair is cleared by Dialysis and Transplant Patient Association and referred for RT. According to the Iranian Model, transplants are to be performed at university hospitals.5,14 After the transplant, the government pays 10 000 000 Iranian Rials (equivalent of US $300) as “gift of altruism” and provides a 1-year health insurance for the donor. This is supplemented with payment by the recipient that is currently usually about 100 000 000 Rials (US $3000),15 or the equivalent of 9 months of an average Iranian teacher's salary.

Because the inception of the Iranian Model through to the end of 2012, more than 30 000 LD kidney transplants have been performed,16 the vast majority from paid LDs. According to the ministry of health (MOH), the number of patients on the waiting list in 2011 was 17 910, whereas 2273 RTs were performed that year.17

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Deceased Donor Transplant in Iran

On May 21, 1989, Dr. Iraj Fazel obtained an unambiguous ruling (fatwa) from Ayatollah Khomeini that recognized brain death and allowed deceased donor (DD) transplants. Based on the fatwa, some centers began performing DD transplants,18-21 which gained momentum after the parliament approved the Brain Death Legislation in 2000.16 There are currently 13 organ procurement units14 and 26 transplant centers in the country. As a strategy to increase DD KT, the government has allocated funds to organ procurement units according to the number of organs procured.14 Although this has led to an increase in DD KT, the rate of growth has been slow. Approximately, 800 DD transplants are performed annually, of which approximately 30% are undertaken in the Shiraz Transplant Unit.

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DD Transplant: A Comparison Between Shiraz and Other Centers in Iran

The Shiraz experience provides opportunity for an evidence-based analysis of potential contributors to growth of the DD program in Shiraz compared with other areas in the country.

  • During the first 11 years after the DD legislation, there were 3480 DD RTs,17 of that, 963 (28%) had been performed in Shiraz. During this period, 51% of RTs in Shiraz (Malek-Hosseini, S.A., Shiraz, Iran, personal communication, July 8, 2014) and only 12% of RTs at other centers were from DDs (Table 1).17 In 2011, 85% (n = 216) of RTs in Shiraz and 28% (n = 555) of transplants in the rest of the country were from DDs (Table 1 and Figure 1).17
  • Although paid LURD RT remains the predominant form (>60%) of RT across Iran,17 there has been progressive elimination and then, from 2008, cessation of paid LURD RT in Shiraz (Figure 2).
  • Shiraz has, during this period, developed a comprehensive liver transplant program (Figure 3), and all pancreas transplants in Iran have been performed in Shiraz.16
TABLE 1

TABLE 1

FIGURE 1

FIGURE 1

FIGURE 2

FIGURE 2

FIGURE 3

FIGURE 3

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Potential Contributors to the Growth of DD Transplant in Shiraz

The features of the Shiraz Program designed to enhance deceased organ donation include:

  • □ Avoidance of paid LURD RT as the primary form of RT. After the religious decree in 1989, Shiraz imposed a mandatory 6-month waiting period from recipients and if no living related donor or DD became available during that period, the patient could proceed to LURD transplant in Shiraz.
  • □ The Shiraz team partnered with community leaders to promote deceased donation at public venues and through interviews with the media.
  • □ Shiraz Medical School adhered to the tradition of full-time faculty appointment, with no outside practice. This arrangement facilitated dedication of faculty time and effort towards establishment of the local infrastructure for deceased donation and transplantation.
  • □ Shiraz was dedicated to the establishment of a multiorgan transplant center and not simply a renal transplant program, requiring diversification of the origin of donor organs.
  • □ The national reputation of the Shiraz transplant program and the high likelihood of receiving a deceased-donor transplant within 6 months versus the costs of payment to the donor and travel to another center would appear to have deterred most patients from seeking a LURD RT at another center.
  • □ In the year 2011, the national kidney transplant rate was 30 per million population (pmp).17 In the same year, 255 kidney transplants were performed in Shiraz (Table 1), yielding a rate of 37 pmp from the Shiraz catchment population.
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DISCUSSION

Transplant pioneers in Iran, led by Dr. Iraj Fazel, designed and implemented a unique model during the period of the Iranian revolution, subsequent war, and economic sanctions, which allowed thousands of patients to receive RTs throughout 3 decades. The Iranian Model was designed to assist patients with no living related donor, but in practice 81% of LURD recipients have a potential living related donor.22 The medical community subsequently guided religious approval and Brain Death Legislation in 2000 to provide an additional transplant opportunity beyond renal transplantation and for patients unable to access any form of LD.

Evidence indicates that in its current form, the Iranian Model is only partly regulated. The nonanonymous directed donation fosters a direct monetary relationship between donor and recipient with no safeguards against mutual exploitation. Although it was designed to be an organ broker-free process with no transplant tourism, in 2014, individual brokers and 12 organ broker teams have arranged transplantation of foreigners.23,24 The number of unauthorized transplants of foreigners is difficult to estimate,25,26 but citizens from neighboring countries have undergone broker-facilitated LURD transplants in Iran without oversight.12 In 2014, the Iranian MOH prevented an Iraqi with forged documents from undergoing LURD transplant from an Iranian in a private hospital in Tehran,27 but 2 Saudi citizens, using forged documents, were transplanted.28 Brokers in Azerbaijan have arranged for Azeri patients to receive kidneys from paid Azeri donors in Iran.29 Thus, the legal opportunity for LURD RTs for nonnationals facilitated a process in that patients from countries where LURD transplant is illegal, could receive commercial RT, mainly in private hospitals.12 Because of the concern about organ brokerage teams and foreigners receiving RTs from paid Iranian donors, in 2014, the MOH limited RTs to Iranian citizens.12

Advocates of the Iranian Model have identified academic standards and scrutiny as protective components of the regulated system; however, the websites of several private hospitals in Tehran30-33 indicate RT among services offered, and it is known that other private hospitals have been performing RTs (Broumand, B. nephrologist, Tehran, Iran, personal communication, November 4, 2015). Although recent regulations have been implemented to prohibit transplantation of foreigners and transplants in private hospitals, they have not prevented exploitation. Foreigners seeking transplant have been hospitalized with forged documents under pretenses, such as cholecystectomy; and according to officials of the MOH transplants have occurred in hospitals that lacked credentials.24

Due to inflation, the relative value of governmental reward has decreased to a small portion of total payment, and the recipient assumes the major burden.14 The Iranian Model was introduced during a period marked by altruism and monumental sacrifices in the early years after the revolution and during the Iran-Iraq war.34 War time altruism has been replaced by an economy marked by inflation rates ranging from 15% to 35% where the main motive for organ donation and transplantation has been financial gain,35 not only for the donor but also for brokers and others involved. There is no restriction on donors seeking a recipient who will pay more, and thus equitable access to LURD RT is distorted by recipient wealth. This is confirmed by Ghods and Savaj,5 identifying that 84% of the donors, but only 50.4% of the recipients, were from lower socioeconomic groups.

Donor follow-up and outcome studies of the Iranian Model have been limited to single centers, with small sample size, that are either cross-sectional or with very short follow-up.36-38 In 1 study, 500 donors were invited to participate and only 6 responded.14 In the largest available study of donors, the maximum follow-up was 4 years. Thus, long-term safety of donation in this donor population with a mean age of 30 remains a valid concern.39 Donor education is insufficient, as evidenced by a study showing that 80% of donors and donor candidates were unaware of complications of nephrectomy, and only 26% of the approved donor candidates were aware of the need for follow-up.40

Shiraz conducts the largest number of DD RTs in Iran and paid LURD RT has been eliminated. The question remains as to the role of the LURD program in inhibiting development of DD programs across the rest of the country that cannot be explained by cultural resistance to donation because of the cultural similarities between Shiraz and the rest of Iran.

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ACKNOWLEDGMENTS

The author is grateful to Dr. Behrooz Broumand, Dr. Ahad Ghods, Dr. Ali Nobakht Haghighi and Dr. S. Ali Malek-Hosseini for providing insightful mentorship, as well as updated data and information about transplant activities in Iran.

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