The German organ allocation system is out of joint. In July 2012, the medical community as well as the broader public got alarmed by several high-profile transplantation scandals.¹ Several physicians at different university hospitals have been accused of altering data related to their patients to make them appear sicker than they actually were in order to place them in front of other patients that were on the waiting list for liver donations. In the case of Göttingen University Hospital, a senior transplant surgeon is currently facing a criminal trial on account of manslaughter in eleven cases because of allegedly manipulating liver allocations. The prosecution argues that by unduly privileging his own patients, the physician intentionally accepted that other patients on the waiting list might die, however the prosecution—so far—has not been able to provide evidence that a certain patient actually died because of the concrete manipulations in question.² Regardless of the outcome of the trial, the transplant scandals have already resulted in a significant decrease in the number of organ donations in Germany.³ The reported case raises complex questions concerning the doctrine of criminal law in terms of causation, normative imputation and mens rea (intention). It is highly controversial among commentators of the science of criminal law whether the physician can actually be convicted of manslaughter or any other criminal offence.⁴

It is not the criminal law, however, which I am going to focus on in this chapter. What is interesting here is the essential normative dimension of organ allocation. Due to recent scandals, the necessity to make tragic choices in the process of priority setting in transplantation medicine becomes central to public awareness: If doctors arbitrarily redistribute the chances of survival for patients on the waiting list , this is not only a problem of respecting certain formal administrative regulations, but also a fundamental problem of justice in public health. To move certain patients up on organ waiting lists means to move other patients down, who might be in even greater need of transplantation therapy. At the core of these allegations, there is an injustice that could amount to a criminal wrong in terms of manslaughter because it affects the survival chances of patients. This directs attention to the fundamental normative impact of the established German organ allocation system. The problem with the manipulations in question is not that instead of one needy human being, it is just another needy human being that has been provided with a liver. The problem lies in the fact that the passed-over person is the patient who should have rightfully—ipso jure—had priority. But what is the significance of rightfully and ipso jure in the context of the German organ allocation system? To blame physicians, who manipulated organ procurement decisions because they allegedly caused injustice to organ allocation, seems to presuppose that the manipulated allocation system itself meets with the basic demands of justice. This brings us back to the overall question of justice in organ allocation.

From a legal point of view, justice has to be measured primarily by the standard of the rule of law and fundamental rights as defined by the German Basic Law (Grundgesetz) . This implies that the statutory framework of organ allocation, as well as the professional guidelines for priority setting have to be in accordance with the basic constitutional demands for the procedural and substantial justification of state-determined allocation orders affecting the basic rights of the people. The kind of justice this article deals with is therefore restricted to what Thomas Osterkamp pre-eminently designated as legal justice (juristische Gerechtigkeit).⁵ I will argue that the statutory and sub-statutory legal framework for organ allocation provided by the German Transplantation Code (Transplantationsgesetz) and the Guidelines of the German Medical Association (Bundesärztekammer) are not in accordance with the rule of law and are therefore unconstitutional.⁶

In German constitutional and administrative law, the intricate problem of allocating scarce resources is discussed under the topic of the administration of a shortage (Verwaltung eines Mangels).⁷ The leading case of the German Federal Constitutional Court (Bundesverfassungsgericht) was concerned with a far less dramatic case of shortage administration, namely the allocation of places at universities. In the so-called numerus clausus-case, the court emphasizes the significance of the allocation decision for the prospective life chances of university applicants.⁸ Therefore, the court decided that it is the duty of the parliament to take responsibility for basic normative allocation decisions.⁹ To take responsibility for the basic allocation decisions means, as the court substantiates, that parliament itself has to determine “at least the relevant types of eligibility criteria and the hierarchy between them” (BVerfGE 33, 393 (345 f.)).¹⁰ Determination by the legislator means, as follows from the well-established constitutional law doctrine of the parliamentary clause (Parlamentsvorbehalt),¹¹ determination by way of adequately precise statutory legislation. If this is true for parliamentary decisions which affect life chances in terms of the career opportunities of university applicants, it has to be demanded a fortiori for the field of organ allocation, which is literally about life chances in terms of survival . The question is whether the German legislature met the constitutional demands of the parliamentary clause with regard to the allocation of organs for transplantation when enacting the German Transplant Code in 1997.

The relevant statutory clause is Sect. 12, paragraph 3, sentence 1 of the German Transplantation Code .¹² According to the law, organs intended for transplantation have to be procured “by rules, which are consistent with the findings of the medical science, particularly by the criteria of prospect of success and exigency.” As follows from the explanatory note to the German Transplantation Code, the legislator wanted to state that organ procurement has to be conducted by “medically justified rules” (Bundestagsdrucksache 13/4355: 26).

What is primarily problematic about this formulation is that it denies the normative nature of allocation decisions in transplantation medicine. The science of medicine is neither qualified nor legitimized to generate normative rules for the prioritization in organ allocation. It is only able to translate normative allocation criteria predetermined by law into medical practice. The science of medicine can specify under which medical circumstances a patient should be declared highly urgent for transplantation. Likewise, the science of medicine and only the science of medicine is qualified to estimate the prospect of success of a certain transplantation therapy for a certain patient. But, what the science of medicine is neither able nor allowed to do is to decide authoritatively whether the exigency and prospect of transplantation outcome are relevant criteria for prioritization and particularly how the criteria of exigency and outcome are related to each other. As the Swiss legislator put it very clearly and in explicit opposition to the German regulatory model: “The thesis, whereas allocation is processed by medical criteria, is insofar wrong: Procurement is carried out on the basis of ethical criteria” (Schweizer Bundesrat 2001, p. 83). That is why Art. 119a paragraph 2 of the Swiss Constitution demands that the criteria for a just organ allocation have to be provided by federal law.

At this point of argumentation a second problem of the cited formulation of the German Transplantation Code in Sect. 12, paragraph 3, sentence 3 has to be addressed. The German Transplantation Code—after all—refers to two criteria, even if this is not supposed to be an exhaustive list, but remains open for further criteria. The two relevant criteria are, as has been mentioned before, prospect of success and exigency. The rather obvious problem with these two criteria is that they are regularly in conflict with each other any time a concrete prioritization decision has to be made; one might even speak of structural contradictory principles, even if there are exceptions.¹³ This is particularly true for the case of liver transplantation . Usually this will occur among relatively young patients, who did not wait too long and who are not yet suffering from high co-morbidity, and who are supposed to have the best prospect outcome through transplantation. At the same time, these patients are often times not ill enough to be very urgent cases.¹⁴ Vice versa, liver patients with a high probability to die within the next 3 months without transplantation—this is the perspective of the MELD–Score —are usually very ill. They are often old and suffer from high co-morbidity and other risk factors, so that the prospected success of transplantation—measured in prospected graft survival time—is usually rather low. Of course, there are exceptional cases in which urgency and prospective outcome might run along the same line, like in the case of acute liver failure in a 17 year old patient who ate toxic mushrooms, but this is not a group of patients transplantation centers have to deal with on a daily basis.

The example shows that by establishing the criteria of prospect of success and exigency the German Transplantation Code points out the central conflict of objectives in organ allocation, but fails to even hint at a possible solution. In conclusion, the normative question of how to determine organ procurement decisions is left wide open. The German Transplant Code gives its blessings to a range of possible allocation schemes, even if these schemes are based on normative principles that are basically inconsistent with one another. So, who is it, who de facto decides about the normative basis of the process of priority setting in organ allocation and who determines the tangible rules for organ allocation in terms of generally binding law? At any rate, as this should have become clear by now, it is not the statutory legislation of the German parliament. This intermediary result alone is enough to conclude that the central statutory norm, which is supposed to determine organ allocation principles is unconstitutional under German basic law, because it does not meet the requirements for creating a democratically legitimized legal framework for the allocation of scarce resources.¹⁵ The constructional flaw of the German Transplantation Code affects the entire German organ allocation system, as can be demonstrated by the example of the guidelines for organ allocation by the German Medical Association, which effectively determine the allocation of organs in Germany today.

As we have seen, the fundamental conflict of objectives in organ allocation is not solved adequately by the German Transplant Code. The legislature, ignoring constitutional requirements, refused to take responsibility for the inevitable normative allocation decisions. As a consequence, balancing the conflicting criteria of prospect of success and exigency, which means a decision about life and death for certain collectives of patients, is conducted effectively by the permanent organ transplants commission of the German Medical Association. The German Transplantation Code, in sentence 16, authorizes the German Medical Association—the exact wording is of special importance here—to determine the state of medical science for the rules on organ allocation. The formulation of the statute presupposes that legal rules on organ allocation already exist, which should be operationalized in a way that is consistent with the state of medical science. As this is not the case however,—there simply are no effective legal rules on organ allocation—the German Medical Association decided to take responsibility not only for the scientific task to determine the state of medical science, but also for the fundamental normative task to legislate rules, which determine prioritization in organ allocation in Germany. Notwithstanding the fact that the professional medical association merely closed a fundamental gap of the German Transplant Code, it was neither qualified nor legitimized to do so. The German Medical Association delegated the task of making guidelines for organ allocation to a special body , the permanent commission on organ transplantation, which is not even mentioned by the German Transplant Code.

Against this background, the majority view within German legal science rightly states that the guidelines of the German Medical Association on organ allocation lack democratic legitimacy insofar as they imply normative rules and do not formulate a state of medical science.¹⁶ Moreover, the guideline -making process lacks transparency and is largely uncontrollable. Due to the impossibility to follow the line of normative argumentation of the organ commission, which even denies the normative nature of allocation decisions, the outcome of the guideline -making process appears to be more or less arbitrary.

The arbitrary nature of the current practice can be demonstrated by using the example of the guidelines on liver allocation. Until 2007, these guidelines favored a system primarily orientated at the utilitarian principle of best prospect outcome: two thirds of the livers to be procured were reserved for patients with a low exigency status. In 2007, the guidelines on liver allocation were changed over to the MELD-Score-System , an allocation scheme which clearly gives priority to urgency as the leading determining criteria in liver allocation.¹⁷ In effect, the normative prerequisites of the guidelines on liver allocation—again an issue of life and death—have been reversed to the opposite.

To be sure, there are very good, in my opinion even compelling normative reasons for giving priority to exigency and urgency in liver organ allocation and therefore it was the right thing to introduce the MELD-Score into the German allocation system.¹⁸ It is not the content of the reorganization of the liver organ allocation system in 2007 that is disturbing from an ethical and legal point of view. What is disturbing and basically a declaration of bankruptcy with regard to the effectiveness of the rule of law, is that the normative paradigm change in liver allocation has been heralded by the German Medical Association in the style of an ancient oracle. It does not appear to the public and even to the professional community that there had been any kind of democratically legitimized deliberation of normative reasons that resulted in the new allocation scheme. The normative justification of the MELD-Score system remains fundamentally opaque. This might, incidentally, also be one of the reasons why many transplant physicians do not accept the MELD-Score system as being normatively adequate, as the current transplantation scandals show. Moreover, the recently sparked discussion about a possible reintroduction of outcome-oriented principles in liver allocation reveals that a reversal of the paradigm change might take place in the same autocratic coup de main –style that characterizes the history of guideline -making by the German Medical Association.