British Journal ofUrology (1995), 76, Suppl. 2 , 97-101

Ethical issues in renal transplantation in developing countries S.A.A. NAQVI and S.A.H. RIZVI Institute of Urology and Transplantation, Dow Medical College and Civil Hospital. Karachi, Pakistan

Introduction

The Declaration of Helsinki states that physicians must be free to use a new therapeutic method if they consider that this method offers the hope of saving a life, returning the patient to health or relieving the patient’s suffering. The Declaration is particularly relevant to transplan- tation because of the immediate and often dramatic benefits of this technology to the patient. Moreover, no branch of medicine is so dependent on public partici- pation (providing recipients and donors) as is transplan- tation, but whereas the successes of transplantation have caused it to grow rapidly in scope as well as numbers, it has also brought with it many ethical issues that need to be addressed continually by society.

Some ethical issues, such as altruism, are universal in appeal but others may be culture specific, e.g. ‘giving’ so that it is difficult to develop a consensus on them in different cultures. The ethical issues of transplantation need to be examined from two diverging perspectives 111. The deontological view upholds the intrinsic value of all patients so that individuals should be treated as ends in themselves and not as means to other persons’ ends. However, the more powerful concept of ethics is based on utility, aimed at achieving the greatest good for the greatest number of individuals. Sometimes the transplant surgeon is torn between the contradiction of his or her obligation to the individual patient and the public policy of general good to all. In such situations public opinion remains the final arbiter, as acquiescence of the community is essential.

Renal transplantation, the first among solid organs, began in the 1950s and more than 250 000 have been carried out around the world, the majority in the affluent nations [ 2 ] . The developing countries have only seen a modest development of transplantation, predominantly renal. Because four-fifths of the world’s population resides in economically poorer areas, the need for trans- plantation in developing countries is therefore greater. However, lack of awareness about the benefits of trans- plantation, together with constraints of resources and lack of trained professionals, are some of the deterrents towards growth of transplantation. Moreover, whatever few resources are available in these countries, they are being used towards the eradication of communicable

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diseases. The track record so far is poor because public health issues, such as availability of potable water supply and sewage disposal, is not universal in these regions.

Transplantation activity is linked to the economic prosperity of a country. The transplantation rate in developed countries ranges from 20 to 40 per million persons (p.m.p.) compared to 1-5 p.m.p. in the developing countries. Notwithstanding the fact that com- pared to dialysis a successful renal transplant is more cost effective, offers a better quality of life and rehabili- tation to patients, unfortunately poverty and lack of awareness prevent these societies grasping these far- reaching benefits of science and technology.

Donor issues in living-related renal transplantation

Primum non nocere, ‘first do no harm’, is the basis of the Hippocratic oath governing all acts of physicians, and transplantation is no exception to this.

The source of donors in renal transplantation is vari- able worldwide. In Europe and North America, the majority of kidneys are obtained from heart-beating, brain-dead individuals called cadavers. In developing countries, laws permitting the retrieval of organs from brain-dead persons does not exist universally. Even in the presence of a supportive brain-death law, the society has inhibitions against fully accepting this form of donation. In the absence of a cadaver law, living donors account for kidney donations in the poorer and under- privileged regions of the world.

The removal of kidneys from healthy persons is of no benefit to the donor, other than perhaps enhancing their self-esteem [3]. The first important ethical issue, there- fore, is that of informed consent. Donor nephrectomy is not without risk to the patient’s life (< 1% mortality in 8000 kidney transplants [ 2 ] ) and this fact has to be well clarified before a person becomes a donor. Although long-term results have not borne out significant ill-effects of uninephrectomy, i.e. hypertension, it is mandatory to inform the potential donor about the long-term effects of donation. Another contentious issue is to examine if excessive pressure has been applied to the donor, even though the donation is intrafamilial. This is sometimes true in cases of female donors, particularly unmarried

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girls, in a male-dominated society, a not uncommon situation in the developing countries [4]. Therefore, the adequacy of informed consent is sometimes suspect in cases of living-related donor transplantation because donors are being treated as mere objects.

There are two other situations, spousal altruism and altruism between close friends, that fall into the category of living-donor transplantation. Coercion has to be excluded in such situations but it is generally seen that such transplants are without commercial motives and are generated by a genuine desire to help a needy patient.

Guttman has reported that in China many of the kidneys (up to 90%) come from executed criminals [S]. Condemned prisoners were being subjected to blood tests for the purposes of transplantation without their consent. The victims were being informed of the decision of the punishment only hours before the time of execution. The representatives of the Chinese Government have clarified that transplant operations are performed with the consent of the individual. However, there are sufficient reasons to believe that informed consent of the individual may not be possible in such situations and therefore the practice is against established principles of ethics and justice.

Commerce in human kidneys

There is no ethical issue in transplantation that provokes more controversy than obtaining kidneys from unrelated living persons. The guidelines of the Transplantation Society in 1985 [6] and subsequently the guiding prin- ciples of the World Health Organization (WHO) in 1991 [ 71 regarding unrelated donor renal transplantation have been unequivocal on the subject of commerce. There is no ambiguity that altruism should be the prime motive for transplantation and that payment made towards donation by the recipient or any agency on their behalf is not permissible. Not only were potential donors and recipients prohibited to indulge in such activities but the transplant teams were also made responsible so that they did not become a party to commercialism. Understandably, this was done with the purpose of prohibiting trade in kidneys so that it would not grow into a human ‘flesh-market’. There was also a real danger that eventually partial or segmental organs such as livers, lungs and pancreas could become included in this horrible trade. Moreover, this would allow exploi- tation of the poor by the rich, the highest bidder would stand the best chance in the bargain! It was, however, the negative impact of organ trading on the future development of a cadaver programme, especially in developing countries, that such practices were particu- larly reprehensible. Because unrelated kidney transplan- tation would alleviate the donor-organ shortage in the

short term, the development of a cadaver programme would either be stifled or relegated to a lower priority.

Against the backdrop of a worldwide shortage of donor organs, brought about to a large measure by safer driving, the community of transplantologists started viewing sources other than the cadaver less stringently, on ethical principles. For example, some thought that the Transplant Act in the UK was pushed through hurriedly after the Turkish donor crisis, not permitting sufficient discussion [8 ] .

Another development was the growing trade of living- unrelated transplants in some countries. The growth of paid organ transplants from unrelated donors in India was exponential (from 200 in 1984 to more than 4000 in 1994) [9], drawing patients from many regions of the world, especially the Middle East and South Asia. The Transplantation Society sent members of its ethical committee to study the problem. The committee felt that rampant commerce, driven by profit-seeking entreprene- urs, was clearly unethical [lo]. The committee was less clear about some culture-specific issues, such as gifting. The so-called ‘rewarded gifting’ being practised in insti- tutions where modest payments were made to donors without the middlemen was seen as justified if regulated by professional peers. The Indian Government, however, viewed the unrelated donor transplantation with grow- ing concern. The recently enacted transplantation law was a long-awaited measure to check widespread unethi- cal practices in transplantation so that defaulters could be subjected to legal scrutiny and be punished when found guilty [ l l ] .

Some Western ethicists have chosen to differentiate ethical issues in affluent and non-affluent cultures [ 11. In regions that are economically sound, healthcare pro- grammes, as well as unemployment and sickness insurance, provide sufficient safeguards for an equitable and just system of opportunities for transplantation. Cadaver programmes in these cultures are providing organs to patients with reasonable efficiency. Organ selling is rightly condemned by such societies.

In the non-affluent cultures there is lack of social security and people die of poor nutrition and medical care. Abject poverty blurs established ethical values. The question here is not one of condoning the poor for not upholding the values prevalent in affluent cultures, but that such practices are likely to have a negative impact on the altruism which has been the foundation of transplantation activity. The concept of rewarded gifting was promoted by Reddy [12], whereby exploitation of middlemen is supposed to be replaced by compensation to donors under the supervision of professionals in an in- stitution. However well intentioned, the fact that only a handful of centres has been able to sustain the original concept, against hundreds of transplant centres indulging

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RENAL TRANSPLANTATION IN DEVELOPING COUNTRIES 99

in rampant commercialism, speaks for the fragility of such a system. A non-corruptible panel of societal and professional peers entrusted with the task of approval of cases for unrelated-donor transplants will be subject to all the pressures which bring corruption into developing societies in the first place, i.e. the tribal or feudal structure of society, lack of education and unequal economic opportunities to all members of the society.

Dossetor & Manickavel have proposed a utopian con- cept of indirect altruism, whereby a donor organ could be provided to a potential recipient by another person who is suitably compensated in economic terms by an affluent member of society [13]. The patient gets the kidney, the person donating the kidney is rewarded adequately and the philanthropist does a ‘good turn’ to a very ill member of the society, and all of this is supposed to take place with no middleman. They have proposed that part of the compensation is to be directed towards efforts for the establishment of a cadaver pro- gramme, which they call ’mandated philanthropy’. Again, the success of such a programme rests on the control of responsibility at each level to be enforced by a tribunal of peers and responsible members of society, a very difficult act to perform given the socioeconomic setting in developing countries.

Cadaver organ donation: the way forward

Clearly, living-related donors will be able to provide only a limited number of organs, perhaps no more than two to five transplants p.m.p., while living-unrelated donor transplants will only be able to increase unethical com- merce in organ trade. The Indian experience has shown that the unrelated donor trade grows so rapidly that a vested-interest group is created. Thus, the way forward is to create awareness in the society of brain-death criteria and subsequent benefits of cadaveric organ donation. These heart-beating donors will be able to provide kidneys and other organs so that transplantation can be increased to about 20 p.m.p., a 20-fold rise in comparison to a living-related programme.

Let us examine some of the factors which inhibit the institution of cadaver programmes in developing coun- tries [14]. The foremost is lack of awareness and edu- cation about transplantation, which is perceived as ‘experimental’ and as yet incapable of exhibiting endur- ing medical benefit. This is the result of low adult literacy in the population. The elders of the family who are involved in decision making are not aware or are not exposed to the benefits of scientific development. The cultural taboo of respect for the dead forbids post-mortem examination and removal of organs for transplantation, both of which are considered mutilation of a dead body. The issue is not religious because Islam, Christianity and

Buddhism, the major religions in the developing world, all support transplantation by permitting removal of organs for therapeutic proposes. Saudi Arabia, one of the most conservative societies amongst the Muslim countries, has successfully practised cadaver-organ donation for over a decade.

An indifferent professional attitude about transplan- tation is also seen as a deterrent to cadaver donation. Professional colleagues and healthcare professionals have shown little interest towards identification of poten- tial cadavers. In developing countries this has been made still more difficult by the shortage of intensive care units.

Non-heart-beating donor: a window of opportunity

The ethical dilemma facing the family of brain-dead patients is substantial. Granting permission for donation by the next of kin in the presence of a heart-beating individual, warm to touch, whose chest wall is moving with respiration with the assistance of a ventilator. is quite difficult. Legislation supporting cadaver transplantation will not in itself provide the answer, although this can be helpful in protecting the transplant team legally. Unless the family members, in their hour of grief, are motivated enough to permit removal of organs, no amount of legislation will offer a solution. The issue here is of societal acceptance of brain death, which requires the difficult task of preparing the society.

A non-heart-beating donor appears to offer a way out as a first step towards public acceptance in societies reluctant to permit organ retrieval from cadavers. The results of graft outcome from non-heart-beating donors are encouraging [15]. Because the conventional defi- nition of death is satisfied in a non-heart-beating situ- ation, there is a hope that permission for removal of organs will be forthcoming. Understandably, removal of organs other than kidneys will not be helped, but this first step is likely to bring about sufficient awareness in the society. The benefits of such a sustainable programme will be efficacious towards the removal of organs from heart-beating brain-dead individuals in the future.

Allocation of organs

Transplantation of organs has created additional responsibilities to healthcare professionals for which they were not adequately trained. The moral obligations of providing as many organs as possible to the growing waiting list of recipients have created ethical pressures on transplant workers.

In affluent countries of the developed world, where cadaver-organ donation is fully established, the dilemma of allocation of organs is more profound and a continuing

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100 S.A.A. NAQVI and S.A.H. RIZVI

debate has ensued [16]. Should allocation favour the most needy patients or the patients in whom the long- term survival of the graft is likely to be superior, i.e. ‘better match on tissue typing’. Length of time on the waiting list and distance from home to transplant centres are generally regarded as ethically legitimate factors in allocation. The social worth of an individual, e.g. bread- winner, mother with a large number of children to take care of, useful members of society such as judges, doctors, etc., are more difficult in terms of assigning priority. Still more difficult to justify are patients requiring second or third transplants when many patients are waiting for their first organ for replacement.

In developing countries, cadaver-organ donation forms only a small part of the total transplant activity so that the ethical issues of allocation currently faced by the Western countries are yet to be addressed. Allocation of kidneys in a living-related donor programme is dictated by the availability of family donors. The use of unrelated donors obtained by payment is ethically unacceptable unless spousal altruism or unequivocal altruism between friends has been demonstrated clearly.

Can organ trading in developing countries be prevented?

Dialysis facilities are crucial towards a meaningful trans- plant programme [ 11. In economically poorer countries, dialysis is limited because the cost of running a pro- gramme is exorbitant. Moreover, unless more dialysis centres start functioning in public hospitals, awareness about various forms of renal replacement therapy will not be possible. The patients, their relations and society at large can only relate to problems of renal failure when they are confronted by a real-life situation. Therefore, the larger the number of patients being maintained on dialysis, the more will be the need for transplantation.

With the help of philanthropists, a sustainable pro- gramme of dialysis can be started in teaching hospitals and regional public hospitals, targeting the patients whose families are keen for intrafamilial transplants. The dialysis programme at our centre is being run on a community-help basis and we transplant between 70 and 80 patients a year. The patients do not have to pay for any of the services, including transplantation and follow-up medicines, which are financed by public donations and government funds. Such a community- aided programme of renal rehabilitation can become a role model in developing countries.

A living-related donor transplantation can be an important second step to introducing transplantation. Not only will the good result demonstrate the success of the new technology but it will also permit the growth of a relevant infrastructure and training of personnel to

enable future growth. Success is crucial for creating confidence in the community before family donors start coming forward for donation.

Knowledge about kidney diseases and the socioecon- omic problems associated with renal failure are an important step towards societal awareness. Publicity in print and the electronic media is essential so that people discuss the need and benefits of each form of renal replacement therapy. A concerted effort in the form of a campaign about transplantation will help in the passage of supportive legislation but also make the society aware of the benefits of transplants so that a cadaver pro- gramme could become a reality, not only to help patients with end-stage renal disease, but also with end-stage failure of heart, liver, pancreas and lungs.

One important way of checking commercialism in poorer countries should be to initiate transplantation predominantly in public-sector hospitals. The profit motive of private-sector hospitals promotes the majority of centres to indulge in unethical activities because the necessary ethical safeguards will have to compete with commercial interests. In public hospitals, professionals are salaried and are not being paid for each transplant performed. In private centres the ethical standards, irres- pective of professional peers and societal safeguards, are not able to avoid the slippery slope towards commercial- ism. This is precisely the reason why unrelated living- donor transplantations have burgeoned in private hospi- tals in many developing countries. Of the 6000 renal transplants being carried out every year in India, three- quarters are in centres that are unregulated, where rampant commercialism continues unabated for profit. Only a minority of centres perform transplants that could be termed ethical by universal ethical standards. This is a testimony of how a profit-driven trade in developing countries makes an unholy alliance between patients, unrelated donors, private clinics and doctors.

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Authors S.A.H. Rizvi, MBBS, FCPS, FRCS, FRCSEd, FKCP. Professor and

Director, Sindh Institute of Urology and Transplantation (SIUT), Dow Medical College and Civil Hospital. Karachi 74400, Pakistan. .

S.A.A. Naqvi, MBBS, MCPS, MS, Professor of Urology, Sindh Institute of Urology and Transplantation (SKJT), Dow Medical College and Civil Hospital. Karachi 74400. Pakistan.

British Journal o/ Urology (1995), 76, Suppl. 2. 97-101