Living Donor List Exchange: an addition to the Dutch living kidney donor programme?

Advisory report | 26-03-2007

Today, some 41 per cent of all kidney transplantations performed each year in the Netherlands involve an organ from a living donor.
The number of living-donor transplants has been boosted by the Netherlands’ successful crossover kidney donation programme. Through this national programme, patients who – because of blood group mismatches and/or immunological problems – cannot directly receive a kidney from the person willing to act as a living donor for them, are matched with other donor-recipient pairs whose circumstances mirror their own. The two patients then exchange donors. However, even with this programme in operation, not all donor-recipient pairs can benefit. It is particularly difficult to find suitable donors for patients in blood group O. The reason being that, if a living donor has blood group O, he or she can usually donate directly, since group O is compatible with all other groups. Consequently, very few such donors will enter the crossover programme. Furthermore, the programme is not always capable of identifying suitable donors for patients when potential direct donors are ruled out because of immunological problems.
A solution to this problem has now been proposed. This involves an exchange between incompatible donor-recipient pairs from the crossover programme and the list of patients waiting for kidneys by post-mortem donation. The donor’s kidney is given to the first compatible recipient on the waiting list, while the donor’s intended direct recipient is given priority for receiving a good quality kidney from the post-mortem pool.
Living Donor List Exchange (LDLE), as this arrangement is known, means that more kidney patients can benefit from living donation than would otherwise be the case, while the number of kidneys available to people on the post-mortem donation waiting list is not affected. LDLE is advantageous for part of the patients on the waiting list. They receive a kidney sooner than would otherwise have been the case. In addition, those who are lucky enough to receive a living organ are better off than with the post-mortem kidney they were waiting for. However, other people – particularly patients with blood group O – lose out because, on average, they will have to wait longer.
The Dutch Transplant Foundation (NTS) has proposed to run practical trials with LDLE. However, it appears that LDLE is prohibited by the existing Organ Donation Act. The NTS has therefore asked the Minister of Health, Welfare and Sport (VWS) to make legal provision to at least allow a pilot scheme to be organised. Before reaching a decision on this matter, the minister sought the advice of the Health Council.
At present, the only country where LDLE takes place is the USA, where – just as in the Netherlands – living donation is common. However, because structured crossover programmes are as yet only available for patients in some parts of the country, LDLE has developed as an alternative to crossover donation there, rather than as a supplementary scheme. Furthermore, there has been criticism of LDLE within the US transplantation community. Some commentators believe that, since people in blood group O have the longest average wait even without LDLE, it is unacceptable to disadvantage them any further.

Impact

Few sound statistical data are available upon which to base forecasts regarding the likely impact of LDLE. Calculations by the NTS suggest that the additional waiting period for an average O-group recipient could be anything from three days (assuming four LDLE procedures a year) to two or three months (assuming ten to fifteen LDLE procedures a year). Unfortunately, the length of time a patient has to wait is in reality determined by various factors, which are collectively too complex to model reliably. Furthermore, it is difficult to predict the demand for LDLE, since such demand is to some degree dormant. Hence, the only way of determining the effect of LDLE is through practical study. It is precisely for that reason that the NTS has asked to be allowed to organise a pilot.

Ethics

The principal advantage of LDLE is that more kidneys are made available, so that more people can benefit from transplants. Furthermore, the additional kidneys are of a high quality and may be expected to benefit the recipient for a long time in most cases. LDLE has the added benefit of making living donation a less uncertain endeavour for those who put themselves forward. Even where direct donation is not possible, successful transplantation remains a possibility; incompatibility between intended donor and recipient does not spell the end of all hope. The introduction of LDLE would also emphasise the social significance of the living donation programme as a whole. Whether that would lead to more people volunteering themselves as living donors, thus enabling more patients to receive organs, is of course a matter of speculation.
On the other hand, various objections may be made to LDLE. If anyone may in principle act as a donor, and if the social significance of living donation is emphasised by LDLE, care must be taken to ensure that donation does in practice remain a genuinely voluntary act. The most serious objections to LDLE concern the principle of justice, however. In this context, distinction must be made between two dimensions of this principle: material and formal justice.
Justice in a material sense (fairness) looks at the distribution of relevant outcomes (transplants) or chances thereof (the likelihood of transplantation). It does not automatically follow that a system is unfair because certain people are disadvantaged by it. A system is fair if it distributes benefit in a manner that may be justified to everyone affected, including the disadvantaged. Looking at LDLE, this might perhaps be the case if a small disadvantage for waiting recipients with blood group O were offset by major benefits for other groups. However, while the figures are uncertain, this appears an unlikely scenario. The reason being that advantage and disadvantage would increase together: the greater the advantage to some, the greater the disadvantage to others. It is therefore doubtful that LDLE would prove to be fair.
Justice in a formal sense involves the consistent treatment of all according to predefined rules and without respect of persons. This requires that people are dealt with on the basis of universally applicable impartial criteria. Universal applicability means that criteria are not individualised. Impartiality rules out expecting any reciprocal acts other than those that may reasonably be expected of everyone to whom the criterion applies. LDLE does involve such reciprocation and does not therefore appear to qualify as formally just: not everyone has a relative or friend who is willing to give up a kidney for them and it is not appropriate that the relatives and friends of kidney patients should feel under a moral obligation to donate. It follows that giving priority to patients who are able to provide a donor for someone else is unfair.
Living kidney donation does not come under the public distribution of scarce resources. Rather, it entails a private agreement concluded within a relationship or, where crossover donation is concerned, within a closed circle of people brought together for their mutual advantage. LDLE, on the other hand, involves advantage derived from a private transaction being transferred to the public system for distributing organs. It is this transference that introduces the issue of formal justice.

Law

The Organ Donation Act stipulates that the allocation of organs made available by post-mortem donation must be based firstly upon medical criteria and secondly upon the length of time that a recipient has been waiting. No other considerations may be taken into account. Clearly, LDLE involves the allocation of organs on grounds other than medical condition and waiting time. It would therefore appear that the Act excludes the possibility of LDLE. The NTS is therefore calling for a change in the law to at least allow a pilot study to take place. However, as indicated in a recent report on the evaluation of the Organ Donation Act, changing the law would not be a straightforward matter. LDLE is presently precluded not only by certain passages of the Organ Donation Act, but also by the wider judicial context, which reflects the hitherto express wish of the legislature that fairness should be the guiding principle, not utility. This leads us back to the question of material justice, as outlined above.
From the legal viewpoint, it is also pertinent that LDLE is not consistent with the principle of formal justice referred to earlier. Equal treatment on the basis of prescribed rules and without respect of persons is one of the fundamental principles of Dutch law, with its basis in the constitution. Therefore, even if it could be demonstrated that LDLE was likely to be fair in a material sense, its formal injustice would remain a serious obstacle to its introduction.

Alternatives

In view of the objections to introducing LDLE, it is appropriate to consider whether more acceptable means to the same end may be found within the living donation programme.
First, protocols are being developed, which promise to enable transplantation even where immunological incompatibility exists. Some of these protocols appear to be reasonably effective, but the associated costs are very high, the long-term impact remains unclear and the side effects are considerable. Consequently, such protocols cannot presently be regarded as an alternative to LDLE.
Another possibility is to add to the crossover pool by using kidneys of ‘Good Samaritan donors’ (people willing to act as a living donor for persons with whom they have no familial or emotional bond). However, there are both ethical and legal problems with such a policy. Further study is required to ascertain whether these problems are applicable in all cases. At best, however, Good Samaritan donation can do no more than slightly ease the problem that LDLE is intended to address.
The same is probably true of another possibility: inviting people to forego direct donation. In theory, the shortage of blood group O kidneys in the crossover programme could be largely removed if all living donors donated to the crossover pool, rather than to their intended direct recipients. Naturally, people could not be compelled to donate in this way, but they could be invited to do so. There is no a priori reason to believe that compatible donor-recipient pairs would be unwilling to consider such a move out of a sense of solidarity with less fortunate pairs. However, also in view of the limitations of this option and the objections that can be raised against it, it is improbable that the majority of living donors would positively respond.

Conclusion

The committee concludes that from an ethical perspective, opinion differs as to the acceptability of LDLE. Legally, however, there is no ambiguity: LDLE is contrary to current law. Indeed, there is presently no legal scope even for the pilot scheme that the NTS would like to see. That is not to say that such scope could not be created. However, it would first be necessary for political decision-makers to determine the course to be followed. That in turn implies the legislature considering whether the necessary legal changes are consistent with existing principles of equality, as set out in the constitution and various instruments based upon it. Clearly, any move to allow LDLE would require a fundamental change of the Organ Donation Act.

The committee would like to see further research into alternative means of alleviating the problem that LDLE is intended to solve. Finally, the committee would emphasise that the current interest in LDLE is born out of the serious shortage of transplantable organs, which the current approach and legislation have not sufficiently been able to redress. The demand for LDLE that has emerged should be interpreted as a serious alarm signal.