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New Cannibal Markets

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Jean-Daniel Rainhorn
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Samira El Boudamoussi

Part 4. Organs for Sale

An Alternative to Trade: The Iran Experience

Mitra Mahdavi-Mazdeh

Texte intégral

1Globalization as an international integration process based on the movement of capital and people combined with knowledge dissemination has made organ shortage a global challenge. New strategies are required to protect vulnerable individuals and developing countries’ resources in the face of foreign demand at low cost under the name of medical tourism. Sometimes the possibility of bending the rules may become a threat to people who are less well-off. Purchasing an organ from a socially disadvantaged person cannot be viewed in the same way as the purchase of a simple medical service. It is, in fact, a commodification of the human body, reminiscence of an era of slavery.

2Iran has developed a solution aimed at addressing organ shortage using regulated, government-supervised compensated living unrelated donation, where payment to the donor is legally approved. Below is a brief description of the various stages of development of transplantation, brain-death donation (BDD) program implementation, and the use of unrelated donors in Iran.

Development of transplantation in Iran

3Transplantation began in Iran in the era of the 1979 Revolution, along with economic challenges related to frozen overseas assets and sanctions. During that period, dialysis facilities were not available and funding patients who intended to do transplantation abroad was not easily affordable for the Ministry of Health, whose main mission was to fully support soldiers wounded in the Iran-Iraq war. In 1985, two renal transplantation centers were established, and 274 renal transplantations were performed in the two following years. In 1988, a government regulated and compensated living-unrelated-donor (LURD) program was approved by the Council of Guardians. However, the law of Gift of Altruism had not been approved by the Board of Ministers before the rejection of the Brain Death Organ Donation Act in parliament in 1995. When the efforts to make BDD legal failed in the early 1990s, this step was taken to minimize shortage of organs. This decision caused remarkable increase of living donation from 11 per million population (pmp) in 1996 to 17.8 pmp in 1998 and 20.1 pmp in 2000, without considerable change during the following 10 years. In 1999, it was announced that the waiting list had disappeared. In addition to an increased number of donations, the number of renal transplantation centers increased from 2 in 1985 to 13 in 1992 and 23 in 2001 (Mahdavi-Masdeh 2012; Ghods and Savaj 2006).

Brain-death-donation program implementation

  • 1 Mycophenolate and cyclosporine are drugs used for the prevention of organ transplant rejection.

4The next breakthrough in the Iranian transplantation program was the Organ Transplantation and Brain Death Act, which was passed in 2000. Year after year, experts in various decision-making committees had reiterated the necessity of brain-death organ donation, spearheading the legalization of organ donation from brain-dead people. The country needed an action plan. Critical steps in its implementation included: developing expertise in medical and surgical donor and recipient management, provision of laboratory facilities for different tests and banking of potential recipients’ blood samples, managing the expense of recipients’ immunosuppression and the procedure, training teams, and public acceptance and trust. More than 7,000 living kidney transplantations all over the country not only empowered the medical teams, but also motivated the community to participate in providing solutions to the organ shortage for other patients with end-stage liver or heart failure. As a side note, this high level of transplantation activity had turned Iran into a huge market for immunosuppressive drugs. Over time, drug prices became more reasonable and in 2003 some local pharmaceutical companies started to manufacture Mycophenolate Mofetil under license and then in 2004 generic cyclosporine,1 which decreased the price of drugs even more.

5The government’s strategy to promote the BDD program included not increasing the live-donor incentive payment in line with inflation and the foreign currency exchange rate. The savings were then allocated to the BDD program, which required a more sophisticated infrastructure not available easily in many developing countries, including Iran. The last essential steps taken were related to transparency and investment in developing public trust. Accordingly, it was decided that the declaration of brain death should be signed by five Ministry of Health and Medical Education-appointed physicians (an internist, a neurologist, a neurosurgeon, an anesthesiologist, and a forensic medicine specialist). Gradually, the BDD program was implemented based on its strict definition of brain death, publicizing the outcomes, and without forbidding living donation. Based on national data, substantial increase of BDD was achieved. The BDD share in kidney transplantation increased from 2.2% in 2000 to 26% in 2010 (Mahdavi-Mazdeh 2012).

Unrelated live donors

6The last item, which is the main focus of this chapter, is this program’s approach to the challenges of living donation and the local solutions that were tried. Iran has had the unique experience of legal donor payment. As a result, local professionals play a key role in investigating the main short-and long-term medical risks with a constant reminder of primum non nocere (do no harm) and awareness raising about ethical issues related to the financial connection between donor and recipient as well as to the possibility of exploitation of vulnerable kidney donors.

Decreasing short-and long-term medical risks

7The surgical procedure is the leading factor that could increase a live donor’s short-term risk. From this respect, related and unrelated donors are exposed to similar risk. Although no higher risk of long-term kidney-related disease or lower survival rates have been demonstrated in long-term follow-up, steps are taken to ensure that the ethical rule of “do no harm” is followed (Segev et al. 2010; Ibrahim et al. 2009).

8The steps taken to reduce short-term risks include scheduling the procedure electively and avoiding emergency appointments, in addition to having the procedure to be done by an expert team in well-qualified hospitals. An important aspect of the Iranian model is that all transplantation teams belong to universities licensed by the Ministry of Health and Medical Education in order to guarantee that well-trained teams ensure the medical and surgical management of both donors and recipients (Mahdavi-Mazdeh 2012; Ghods and Savaj 2006; Einollahi and Taheri 2008). Introduction of laparoscopic nephrectomy in Iran has made the procedure safer (Simforoosh et al. 2014). In addition, donors are provided with one year of medical insurance coverage (Mahdavi-Mazdeh 2012). Verifying that pre-transplantation laboratory tests are as comprehensive and accurate as possible is another mandatory item in the Iranian model transplantation protocol (Nafar et al. 2014). After primary medical evaluation, the potential donor and recipient are referred to a nephrologist for final testing and approval, and the donor is checked by the transplant surgeon as well (Ghods and Savaj 2006; Einollahi and Taheri 2008; Haghighi and Ghahramani 2006). However, some argue that there may be no reliable test to check whether there is a family history of kidney disease (Danovitch 2014).

9Although the program suffers from lack of long-term follow-up of the donors, it has been well documented in various international studies that there are no serious long-term complications in donors who have been carefully screened (Ibrahim et al. 2009).

Is monetary compensation for donation ethical?

10Kidney transplantation is a gift of life for end-stage renal disease (ESRD) patients. It also saves government and insurance agencies money and provides a paid job for the medical team. The main concern is the donor share. Physicians and nurses not only have the benefit of seeing their patient recover, they are also paid for their work. Donors, on the other hand, must face the fear of life-long disability and probable lost job opportunities. A compensation should not be looked upon as a taboo subject or be denied for fear of organ trafficking. Furthermore, it is not wishful thinking that donor incentives can serve another altruistic purpose in the person’s own family. In 2005, Heidary Rouchi et al. studied 600 living donors in Iran and found that 365 donors (60.8%) had financial and altruistic motivation, each to some degrees. The financial motivations were mainly related to having money for medical needs of one of their family members or maintaining family reputation (Heidary Rouchi et al. 2006). It is not fair to impose additional burdens on donors by neglecting their right to be compensated to do their own altruistic action.

11Such an incentive can not only increase the donor pool as is shown in the Iranian model but also eliminate the unregulated markets. The downside of the program is the direct financial connection between donor and recipient in addition to the governmental payment. This gift of altruism results from the limited national budget for this purpose. A guarantee of transparency of the payment would reduce any underground transactions, but at the expense of donor and recipient direct contact. If it could be done centrally, as it used to be done in the late nineties, it would be much more ethical [Mahdavi-Mazdeh 2012; Ghods and Savaj 2006).

Is this just another program for the rich?

12Those who argue that incentives do harm to recipients and exploit poor donors to benefit the rich tend to base their arguments on international organ trafficking data (Danovitch 2014; Matas et al. 2012; Delmonico et al. 2012). The main recipients of these markets have been from Western countries with the highest gross domestic product (GDP) per capita and top ranks—United States ($51,749, 6th), Canada ($42,533, 9th), and Israel ($31,869, 25th). The main donors originate from countries with low GDP—India ($3,813, 133rd), Pakistan ($2,741, 140th), the Philippines ($4,339, 130th), and China ($9,083, 93rd) (World Bank 2014; Wikipedia 2014). Moreover, once the recipients return home, they receive reimbursement for immunosuppressive agents from insurance agencies. Consequently, lower-income countries’ ability to provide transplant services for their own population is sabotaged as their recipients cannot compete with wealthy potential Western recipients.

13More is needed to put an end to such an approach than just passing laws in vulnerable countries. Such laws create a resurgence of underground organ markets, and the decreased rate of foreign recipients in one country corresponds to a parallel increase in other similar countries. Furthermore, it has been proved that banning cannot be enforced. Passing appropriate national laws and tougher restrictions on insurance compensation are both needed to discourage wealthy recipients from traveling abroad to get the organs (Lavee et al. 2013). The other side of the coin is that recipients may also be exploited in such international black markets due to unsuitable donor selection and possible transmission of infections (Matas et al. 2012; Inston et al. 2005). It seems that it is mandatory to support national solutions that aim at addressing the global organ shortage based on each country’s infrastructure and facilities. It can be anticipated that with open-ended growth in the number of potential recipients, these markets and brokers will grow even faster than before unless regulatory organizations take some more creative practical local steps to respond to the global dilemma.

14From a national point of view that could apply in any country, including Iran, authorities should not only pay attention to strategies for equal access of all inhabitants to kidneys as the best renal replacement therapy, but also assure provision of immunosuppressant medications. Provision of postoperative immunosuppressive agents is as important as equal opportunity access to organs to make transplantation a successful program for lower-income patients.

15In Iran, recipient and donor must be Iranian. If wealthy candidates from high-income countries had been allowed on the scene, there is little doubt they would have flowed in and won the competition hands down (Mahdavi-Mazdeh 2012; Ghods and Savaj 2006; Einollahi and Taheri 2008).

16Another governmental strategy to prevent inequalities and health disparities regarding transplantation has been importation, subsidization, and even funding for domestic production of essential immunosuppressive medications by pharmaceutical companies and then coverage of the remaining cost by public insurance agencies, as many low-income recipients were not able to afford them by themselves (Ghods and Savaj 2006; Tavallaii et al. 2009). These two strategies aimed at giving everyone an equal opportunity to successful transplantation. Consequently, transplantation would not be just for rich.

17This program shows the advantages of local solutions over a standard global approach.

Better organs for the rich and exploitation of the poor?

18Another concern is that if this approach could guarantee the low socioeconomic class access to organs equally, then the rich would pay more to get “better” organs or to undergo transplantation sooner (Delmonico et al. 2012). Studies looking into this issue in particular were not found. However, based on different studies of recipients, it seems that most of them do not belong to the wealthy percentile of the population, and if it were true there would be no necessity for Iranian health authorities to allocate some of the finite budget of health (6% of GDP) to make transplantation medications affordable (Table 1). Another nail in the coffin of the assumption of better organs for the rich is the fact that all Iranian unrelated donors who undergo extended laboratory tests based on national protocols are young (18 ≤ age < 35). Accordingly, none of them can get better score than the other (Mahdavi-Mazdeh 2012; Einollahi and Taheri 2008; Tavallaii et al. 2009).

19Other important issues are the donor’s motivation for donation and his or her socioeconomic situation. Although poverty and standard of living varies considerably among countries, there is a clear consensus that Iranian paid donors are worse off and their main motivation for donation is financial incentive. Based on national data, unemployment rates were reported as 12.1% in 2005, 10.6% in 2007, and 12.2%–15.5% in 2012 (World Bank 2014). The rates among donors were reported to be 20% (118/600), 29% (139/478), and 15% (15/100) in different studies (Mahdavi-Mazdeh 2012). Meanwhile, in most studies their educational level was 6–12 years or university training in more than 80% and 6% respectively. In an interesting study on 424 donors in 2008, they rated stressful events of life higher than the general population. For example they gave the score of 17.4 ± 4.2 to child birth and 18 ± 3.9 to hospitalization of a family member in comparison with 6.6 ± 6.9 and 16 ± 4.6 by general population scoring respectively (Mahdavi-Mazdeh 2012; Nejatisafa et al. 2008). This could suggest that donors are more sensitive to their surroundings, which may persuade them to make such a decision to try to make a difference to their families.

Table 1. Economic situation of recipients in the Iranian model.

Recipients

Ghods et al. 2001

Fathi-Ashtiani et al. 2007

Tavallaii et al. 2009

Sample size
Gender (M/F))
Age (mean ± sd) years
Time from
TX (months)

500
315/185

125
87/38
39.6 ± 13.8
43 ± 15

242
165/77
36.0 ± 14.0
35.0 ± 13.0

Economic status

Poor: 252 (50.4%)
Middle class:
181 (36.2%)
Wealthy: 67 (13.4%)Middle class: Those who could afford only average housing, food, and college training of their children.

105 (84%) <300 $

90% <400 $

Education

Illiterate: 90 (18%)
Elementary: 100 (20%)
High school:
254 (50.8%)
University: 56 (11.2%)

High school/higher: 54 (43.2%)

Outcome

Poor post-renal transplant marital quality can be predicted by monthly family income (OR, 2.20; P =. 028).

Not only the negative impact of low income on HRQL was seen in recipients, but also the anxiety level was higher in this population.

TX transplantation; HRQL health-related quality of life.

Do donors make autonomous decisions to overcome economic constraints?

20Respect of autonomy, the individual’s right to make personal decisions regarding his or her own health and body, represents one of the major general ethical principles of medicine that has made informed consent the sacrosanct prerequisite of any procedure. However, the debate on the subject continues as many argue that poor donors are generally under-informed and so their consent cannot be reliable.

21The prerequisite of informed consent is having competency to understand the provided information and make the decision.

22Some have to show that in unrelated donation, informed consent results from some sort of decision-making calculus. However, if the process of decision-making for organ donation is explored thoroughly, some similarities between living related and unrelated donors surface. It is well known that the key factor for decision in living related donors is affection and regard for the related potential recipient because of love or undue sense of responsibility. Based on different studies, Iranian paid donors chose this option to solve a family problem such as the need for hospitalization of a family member (Mahdavi-Mazdeh 2012; Spital and Taylor 2007). The altruistic consideration in living related donation is direct and easily understandable (a parent to a child), but it is indirect in living unrelated donation, as with domino transplantation—donation to an unrelated person to receive a kidney for the family member from someone else. Although informing the donor as much as possible before donation is mandatory, it is important to look for the impact of disclosure of relevant information on the decisions. In a survey of Iranian nephrologists, 48% believed that more than half of donors were unwilling to know about the complications (Ossareh et al. 2007).

23In addition to a minimum age of donation, there are two main principles in the procedure of informed consent in the Iranian model. First, the form must not only be signed by the potential donor but also by his or her next of kin. This approach is an effort to prevent immediate decision-making and bringing the subject to the family to scrutinize the decision-making process carefully. The second is that the medical team is not part of the process of getting the informed consent (Mahdavi-Mazdeh 2012; Einollahi and Taheri 2008).

Is there any long-term follow-up health-care for Iranian donors?

24It is necessary to ensure optimal follow-up for donors as well as recipients to minimize the possible future risks to them. It should be admitted that there is not any evidence-based follow-up study on Iranian donors, and the model has not implemented a program for long-term follow-up. Azar et al. studied 86 living kidney donors (80 donors were unrelated) after 17.24 ± 5.04 months and found hypertension and micro-albuminuria in 37.5% and 10.4% respectively (Azar et al. 2007). Recently, Fallahzadeh et al. assessed in a cross-sectional study the health status and quality of life of 52 paid unrelated versus 92 related living kidney donors and found similar levels of systolic and diastolic blood pressure between the two groups, but the rate of micro-albuminuria was 35% in unrelated and zero in related donors. However, it was measured just once instead of three times (Fallahzadeh et al. 2013). It is important to pay attention to the fact that many donors do not want to be known as donors. In the Fallahzadeh et al. study, out of 681 and 513 paid and related donors, only 52 and 92 donors participated in the study. International constant approach to Iranian donors as vendors should not be overlooked in this regard.

Conclusion

25To make a long story short, there is strong belief that a global regulated market is not an appropriate solution for organ shortage. Establishing boundaries (same citizenship) protection of both donor and recipient would be one possible solution, which could make it feasible to prevent desperate dialysis patients from wealthy Western countries from looking for vulnerable organ donors in other countries. Providing enough medical facilities may protect both recipient and donor from possible disease transmission or unsuitable perioperative management. Receiving fair compensation based on standards of the country of residence could enable donors to carry through with a decision previously based on altruism. Long-term donor follow-up should be one of the items of any paid unrelated donation program from the very beginning. However, globalizing processes have an undeniable effect on interdependence of economic and cultural activities. Health services, as one of the most important human demands, cannot remain sheltered from them. It is key that experts solve the ethical conflicts regarding such an important issue.

Bibliographie

References

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Notes

1 Mycophenolate and cyclosporine are drugs used for the prevention of organ transplant rejection.

Auteur

Professor in the division of nephrology at Tehran University of Medical Sciences. She has been director of the Iranian Tissue Bank Research Center since 2007. Her major research interests lie in the field of tissue engineering and epidemiologic features of renal replacement therapy, especially renal transplantation in developing countries.

© Éditions de la Maison des sciences de l’homme, 2015

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