Objectives: The aim of this study was to review and discuss the great variety of ethical issues related to organ donation, organ procurement, transplant activities, and new ethical problems created as a result of technologic and scientific developments.

Materials and Methods: An extensive literature survey was made, and expert opinions were obtained.

Results: The gap between demand and supply of organs for transplant has yielded to organ trafficking, organ tourism, and commercialism. This problem seems to be the most important issue, and naturally there are ethical dilemmas related to it. A wide number of ideas have been expressed on the subject, and different solutions have been proposed.

Conclusion: The struggle against organ trafficking and commercialism should include legislation, efforts to increase deceased-donor donations, and international cooperation. China’s policy to procure organs from prisoners sentenced to death is unethical, and the international community should exert more pressure on the Chinese government to cease this practice. Each particular ethical dilemma should be taken separately and managed.

Key words : Commercialism, Ethics, Organ donation, Organ trafficking, Organ transplant

Introduction

Organ, tissue, and cell transplant procedures are complex activities. These procedures have medical, surgical, financial, social, religious, and ethical aspects. Some of the topics related to the ethics of transplant are (1) organ trafficking, transplant tourism, and commercialization of human organs; (2) uterus transplants; (3) organ procurement from prisoners sentenced to capital punishment; (4) stem cell transplants; (5) transplanting of organs from transgenic animals into humans; (6) neonatal and pediatric organ donation; and (7) donor health.

In this study, our aim was to review and discuss some of the topics related to organ donation, organ procurement, transplant activities, and new ethical problems created as the result of technologic and scientific developments.

Materials and Methods

An extensive literature survey was made by searching the manuscripts included in PubMed using the key words “organ commercialism,” “organ trafficking,” “organ tourism,” “organ donation,” and “ethics.” Opinions of experts were obtained through verbal communication.

Results

The gap between demand and supply of organs for transplant procedures has yielded to organ trafficking, organ tourism, and commercialism. Many attempts have been made and various solutions have been proposed to solve this global issue. Efforts should be concentrated to increasing deceased donations versus use of living donors as there are health and financial problems with many living donors.

The struggle against organ trafficking and com­mercialism should include legislation, efforts to increase deceased-donor donations, and international cooperation. China’s policy to procure organs from prisoners sentenced to death is unethical, and the international community must exert more pressure on Chinese government to quit this practice. Uterine transplant not only carries hope for female infertility but also presents serious legal and ethical problems that need further evaluation and resolutions. Each particular ethical dilemma should be approached separately.

Discussion

Organ trafficking, transplant tourism, and commercialization of human organs During a summit meeting in Istanbul in May 2008, the Transplantation Society and the International Society of Nephrology agreed, through the Dec­laration of Istanbul, to ban all illegal activities related to organ transplant. The Declaration made clear definitions of transplant tourism, trafficking, and commercialism. It provided ethical guidelines for practice in organ donation and transplant. The Declaration has been very influential, and over 100 countries have endorsed its principles. Some nations have strengthened their laws against commercial organ trade.

The Declaration of Istanbul defined organ trafficking as “the recruitment, transport, transfer, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability, or of the living to, or the receiving by, a third party of payments or benefits to achieve the transfer of control over the potential donor, for the purpose of exploitation by the removal of organs for transplantation.” It defined transplant com­mercialism as “a policy or practice in which an organ is treated as a commodity including by being bought or sold or used for material gain.” The Declaration has also made suggestions to increase deceased organ donations and to ensure the protection and safety of living donors.^1,2

The World Health Organization (WHO) has provided 11 guidelines regarding which cells, tissues, and organs may be removed from deceased and living donors for the purpose of transplant.3 Many medical associations and religious people have expressed their ideas against the sale of human organs. Pope John Paul has also stated that organ trade violates the dignity of the human person.⁴

There has been some criticism of the Istanbul Declaration. Ambagtsheer and Weimer have questioned whether efforts to prohibit organ trade are realistic and effective.⁵ They stated that the Istanbul Declaration does not mention how organ trafficking and commercialism should be approached by policy. They claimed that policies addressing transplant commercialism work differently from policies that tackle organ trafficking.

The wide gap between demand and supply has unfortunately stimulated commercial traffic in human organs, especially from living donors, and this has resulted in black markets. This need-driven problem has caused some to believe that prohibition alone is not effective in combatting organ com­mercialism and trafficking. Consequently, a regulated system of kidney selling has been proposed and defended.⁶ Proponents of this idea claim that organ sales can reduce black market abuse. Jecker⁷ stated that the best approach is not to ban sales, and kidney sales should be tolerated, within limits. Semrau8 suggested that the medical community should take market proposals seriously.

In a proposed market design, Erin and Harris⁹ suggested that the market should be monopsonistic with a single government agency as the only buyer. Other requirements should include a fixed price, kidney allocation based on medical need rather than ability to pay, and qualified donors in excellent health providing valid consent and receiving necessary medical care.

In 1988, Iran started and continues the only government-sponsored paid living-donor kidney transplant program to prevent organ commercialism and increase kidney donations.¹⁰

It is estimated that since 1980, over 2000 kidneys have been sold in certain geographic regions. India and Pakistan have passed laws to stop organ tourism and organ sales. In Germany, buying an organ is regarded as a crime and the recipient is prosecuted. Articles 91 and 93 of the Turkish Penal Code regulate crimes of organ and tissue commercialism. All parts involved in trade of organ and tissue are subject to punishment.¹¹

Shimazono and associates¹² conducted extensive research and found that the rate of recipients who underwent commercial organ transplants was around 5% of all recipients in 2005.

Ambagtsheer and associates¹³ also conducted a literature search about the practice of organ purchase. The survey found 86 papers published between 2000 and 2015. The cumulative data showed that, over a 42-year period, 6002 patients have been reported to travel for transplant purposes. Of these, only 1238 were reported to have paid for their transplants.

The main unethical aspects of organ selling include the poor postoperative care of donors, motivation of lower socioeconomically individuals to donate their organs, and the ease of wealthy individuals to access to organs. The donors experience physical, social, and financial hardships post­operatively. Another problem is that the systems of paid donations may compromise altruistic donations.

We have to find ways to distinguish between illicit and altruistic donations and build a voluntary and unpaid system. Because prohibition works reci­procally, the transplant community and legislative bodies should seek alternative solutions for prevention of organ sales.

Uterus transplant
The important events in the history of uterus transplant began in Germany in 1931.The patient died from organ rejection 3 months postoperatively. In Saudi Arabia in 2000, a uterine transplant was performed from a 46-year-old hysterectomy patient into a 26-year-old recipient. The transplanted uterus functioned for 99 days but was removed because of blood clotting.¹⁴ In Turkey, the world’s first uterus transplant from a deceased donor was performed in 2011. The recipient’s pregnancy was terminated in its 8th week. In Sweden in 2012, the first mother-to-daughter womb transplant was performed at Gothenburg University.¹⁵

The first baby born to a uterine transplant was also in Gothenburg University, Sweden in 2014. The recipient was 36 years old while the donor was 61 years old. A male baby was born at 32 weeks by cesarean section. Body weight was 1.8 kg, compatible with birth age.¹⁶ Although uterus transplant procedures offer a new mode of therapy for female infertility, it bears serious surgical, legal, and ethical issues. Donations from living unrelated sources are more problematic, and the need to monitor donors’ genuine altruism and motivation has been emphasized.¹⁷ Clinical concerns and related ethical consultations tend to focus on transplant recipients and their intended neonates.18 The donor should be tested for medical and psychological suitability, be free from coercion, and be fully informed of the risks, benefits, and alternatives to both donor and recipient. Medical workup must include factors that may decrease the effectiveness of the transplanted uterus. The recipient likewise should be screened for medical and psychological status.¹⁹

Organ procurement from prisoners sentenced to capital punishment
China is the only country in the world that conducts this practice. Between 2003 and 2009, there were only 130 freely donated organs in China, although 10 000 transplants had been performed each year.²⁰ The great discrepancy between the number of deceased organ donations, excluding the executed prisoners, and the number of transplanted organs is an obvious substance to this fact. In December 2014, China announced that only voluntarily donated organs from citizens would be used for transplant after January 1, 2015.²¹ There has been an international opposition against the practice of using organs procured from prisoners sentenced to capital punishment, with pressure to halt it. It is still not clear whether China is ready to stop this unethical and unacceptable system.

Stem cell transplant
The problem of tourism is also valid for stem cells. There is the danger of receiving unproven stem cell interventions. The need for donors and the necessity of clinical testing and use are the main issues.

Transplanting organs from transgenic animals into humans
The transfer of animal tissue to humans dates back to 1682 when animal blood was introduced into human veins.²² In 1963, kidneys from chimpanzees were transplanted into 13 patients. In 1984, a baboon heart was transplanted into a baby with heart failure. In 1992, a baboon liver was transplanted into a human.²³ All of these attempts resulted in fatality.²⁴ Transplanting organs from transgenic animals into humans is ethically problematic from both the human and animal side.

Neonatal and pediatric organ donation
The clinical diagnosis of brain death and its confirmation by appropriate tests are followed by the declaration of the condition to family members. A second step is the request of organ donation from medically suitable potential candidates. This is a sensitive process and requires a careful management by experienced professionals. This process is intensified when the dying patient is a child or a neonate. The “dead donor rule” includes both the circulatory criteria25 and the brain death criteria.²⁶

The four basic principles of biomedical ethics, namely autonomy, nonmaleficence, beneficence, and justice must all be considered. Autonomy is the right of self-determination. Nonmaleficence is synonymous with the old Latin proverb “primum non nocere.” Beneficence is the principle that people should do good.²⁷

Donor health
Organ donation is an altruistic act.²⁸ The health of the donor in the early postoperative period and in the long term is extremely important. The medical information and suggestions given to a potential donor about removing a solid organ from his/her body should be detailed. Every possible com­plication and health problems related to transplant must be explained. The morbidity and mortality rates as reported in the current literature should be mentioned before asking for informed consent.

The risk of surgical complications in living donor surgery is 5% to 10%, and the risk of death is 0.5% to 1%.²⁹ Living kidney donation is associated with an increased risk of end-stage renal disease calculated as < 0.5 % increase in incidence at 15 years.30 Goyal and associates³¹ reported rates of 86% decline in health status, 50% persistent pain at nephrectomy site, and 33% long-term back pain among 305 Indian kidney vendors. Similarly Zargooshi³² reported rates of 58% negative impact, 60% of some form of chronic postoperative pain, and 89% negative effect on physical activities among 300 Iranian kidney donors. Naqvi and colleagues³³ reported results of a socioeconomic and health survey among 239 kidney donors in the Penjab region of Pakistan. When preoperative and postnephrectomy health status was compared, only 3 donors (1.2%) stated that their health was as good as before. Furthermore, 148 donors (62%) stated that they felt physically weak and were unable to work as many hours as they did before, and 88 (36.8%) stated that their health was poor and felt ill.

A meta-analysis revealed that kidney donors may have a 5-mm Hg increase in blood pressure within 5 to 10 years after donation versus anticipated increases with normal aging.³⁴ Mjøen and associates³⁵ studied 1901 kidney donors during 1963 to 2007 with a median follow-up of 15.1 years. A control group of 32 621 potentially eligible kidney donors was selected. Donors had a significant corresponding increase in cardiovascular death, with risk of end-stage renal disease greatly and significantly increased. The overall incidence of end-stage renal disease among donors is 302 cases per 1 million.

Segev and colleagues36 studied perioperative mortality in living kidney donors and found 3.1 deaths per 10 000 donors within 90 days of donation. Long-term risk of death was no higher for living donors than for age-and comorbidity-matched participants for all patients and also as stratified by age, sex, and race.

The data about potential risks of organ donation generally come from Western countries. Similar surveys, rare in underdeveloped and developing countries, are needed to reach a more comprehensive understanding about the risks to which lower socioeconomic individuals are exposed.³⁷

In a survey among potential living liver donors, 53 potential donors (37.7%) withdrew from the predonation process, 34 before completing the full evaluation process and 19 subsequent to being cleared for donation.³⁸

Another problem for living donors is the financial aspect. Donation related medical expenses generally are covered by governments or other institutions. However , travel expenses, incidentals, lost wages, and future problems also need consideration.³⁹ Whereas Gordon and associates⁴⁰ discussed whether financial compensation for living-kidney donation would change willingness to donate, Delmonico and associates⁴¹ strictly believed that living and deceased organ donation should be financially neutral acts.

Conclusions

The ethical issues related to organ donation and to organ transplant show a wide spectrum, with each problem requiring separate approaches and methods of management. A legislative framework is im­portant in many situations, but realistic ways of materializing motivations, prohibitions, and sanctions are equally vital. International consensus and cooperation are always mandatory.

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