Looking at the German organ transplant system, the first observation that can be made is that it contains a very fragmented structure of decision-making and a variety of institutions holding competences within the allocation process. Key agents here are the doctor or transplant centre, the German Medical Association (Deutsche Ärztekammer) and the German Organ Transplantation Foundation (Deutsche Stiftung Organtransplantation). The main regulation can be found in the federal Organ Transplantation Act (Transplantationsgesetz (TPG)); details are concretised in guidelines laid down by the German Medical Association. Additionally, and of high significance, there is the Dutch foundation and organ exchange system Eurotransplant. It is here that the allocation decisions of eight collaborating European countries, including Germany, are made.
Legal scholars have been researching into this quite unique structure during the last 20 years and have found constitutional limitations arising from the principle of democracy, the rule of law and the fundamental rights of the patient. Exploratory interviews showed, however, that access to transplantation treatment is not harmonised in German hospitals and given subjective rights of patients are not well-known. This PhD project seeks to elaborate whether and to what extent the eventual recipient of an organ has subjective rights during the allocation process and how concrete legal claims can be formulated in this field.
The core fundamental right that the work builds its line of argumentation on is the right to life and physical integrity, laid down in Art. 2 II 1 of the Basic Law (GG). It is well accepted in literature and the rulings of the Constitutional Court that the right to physical integrity and life does not only require an omission of harm by the state, but also an obligation to protect by way of positive measures. Nevertheless, there are questions of delineation when it comes to the positive obligation of the highest democratic institution, namely the legislator.
Regarding other distribution systems, constitutional literature and the Constitutional Court have developed the theory of fundamental rights to equal access and participation deriving from a fundamental freedom in combination with the right to equal treatment, Art. 3 I GG. Such rights arise in fields which are monopolised by the state and where participation is a necessary condition for the citizen in order to realise a fundamental right. This precondition is fulfilled by the organ transplant system.
Statutory law is therefore already interpreted in coherence with this fundamental right to equal access and participation, which leads to a general acceptance of a subjective right of the patient to be put on the waiting list. More disputed, but coherently accepted as well, a right to be accepted as transplant patient and a right to stay on the waiting list also ensue from the derivative right of participation, given the medical indication. Besides this very basic warranty of access, the literature remains vague with respect to other aspects of the distribution system that indirectly shape and (might even) hinder access to donor organs. The thesis therefore looks at the distribution system for donor organs in detail through the lens of these two constitutional arguments: the duty to protect and the right to equal access and participation. The guiding question is whether the potential organ recipient can claim a positive duty of the legislator with regard to the legal design of recipient selection for donor organs. In other words, the study examines whether the legislature has a positive obligation to reform the Transplantation Act.
In this way, the study develops the right to participate in the donor organ receipt procedure from Art. 2 II 1 in conjunction with Art. 3 I GG. This represents a claim in the broader sense to the design of a recipient selection in compliance with the protection of the fundamental rights. In addition to the widely recognised claims to be added to the organ-specific waiting list and to the application of allocation criteria in conformity with the fundamental rights, it also gives rise to the so-called capacity exhaustion. This requirement of a constitutional allocation system has been developed by the National Constitutional Court in another context of a scarce resource, namely in the leading cases regarding university access. Furthermore, in view of the obstacles to judicial control in transplantation law, the study asks whether effective protection of the fundamental rights requires legal protection of these legal positions. In this context, a special focus rests on the law of damages and measures of control that are seen as of particular importance with regard to the prevention or reduction of violations of rights. Both the law of damages and measures of control require a certain level of transparency in the decision-making process. It is analysed to what extent the right to equal access is not only supported and protected by the law of damages, but specifically demands the existence of applicable statutory law of damages and/or internal or external control measures in order to be considered enforceable to the extent required by constitutional law. It is seen not only as compensation for infractions of the primary subjective rights but also as a controlling procedure with preventive effect. This holds true especially and gains importance with respect to the extreme scarcity of donor organs, due to which the patient’s chance to enforce the primarily guaranteed right to access is limited and legal protection is practically reduced to retrospective control of the allocation.
In the second chapter, the thesis examines whether the details of the existing system of recipient selection sufficiently realise the right to participate in donor organ allocation. Looking at the latest scientific developments in the field of organ procurement, this work in particular answers the question of whether the obligation to capacity exhaustion currently demands legislative reaction to innovative technologies. Whereas a stagnating number of donors may not alleviate scarcity, medical innovations like 3D printing of organs and xenotransplantation could provide relief. However, such innovations can give raise to ethical or legal controversies and create new conflicts of interest, in which the fundamental right to participation must be weighed against other interests.
Regarding the judicial review of organ distribution decisions, the study elaborates on the different layers of decision-making in the distribution system. Finding legal access to the Eurotransplant foundation is seen as the substantial challenge of the patient seeking legal protection as – at first glance – there is no legal relation between the potentially damaged patient and the Dutch foundation. In light of the laid-out relevance of the adherence to the fundamental rights, the work identifies delicate deficits in view of legal protection with regard to the non-publication of the allocation code and used programming data and to the non-information about decisions taken. The receipt of merely anonymised data in an annual publication does not enable patients to enforce their right to the compensation of damages and legal protection.
