Based upon an individual ethical view of society as an ensemble of isolated, autonomous and sovereign individuals competing and cooperating within a societal framework, the first principle expresses the ethical norm that a patient must be able to decide autonomously about his/her body , potential therapies and limits of treatment. In order to call a decision an autonomous decision, Beauchamp and Childress point out that three criteria must be fulfilled. First, the patient has to understand the medical problem and the range of possible solutions, including all potential consequences regarding harms and benefits implied by these particular solutions. Second, based on the complete information provided by the physician, the patient’s choice must be made consciously after a process of deliberation concerning the most suitable treatment. Third, this decision-making process must not be unduly influenced by external instances, e. g. physicians or relatives, in order to guarantee that the decision expresses the free will of the patient and is not influenced by persons whose expectations the patient is trying to meet.

Applied to the special context of xenotransplantation, several ethical issues regarding the feasibility of an autonomous patient’s decision arise. Considering the special situation that the area of knowledge about the potential medical consequences and severe risks⁴ of animal-to-human-transplantations is very limited due to a lack of experience, the process of informing the patient is extremely difficult and therefore the first criterion of providing extensive information can hardly be met.

Considering the interests of third parties and reflecting on the ethical obligations arising with regard to the principle of justice, the ignorance about the implications and consequences of this new technology furthermore poses the problem of justifying that public health and safety , as well as the health and safety of the affiliated and medical personnel, are put in jeopardy by technology that is only useful to a special part of the population. In order to solve the conflict between the obligations arising from the principles of respect for autonomy and justice and thereby minimizing the risk imposed on public safety and enabling an enormous growth in knowledge for research and development, lifelong post-operative monitoring has been demanded by the patient and his close next of kin in the medical as well as the ethical discourse and a prohibition to reproduce is being discussed. This solution, although comprehensible, leads to serious restrictions of the autonomy of the patient, his next of kin and the medical personnel engaged in the post-operative treatment, which need a strong legitimization because they contradict the principle of respect for autonomy . Furthermore, as a legal framework regulating the practice of xenotransplantation is still missing, the problem of ensuring the cooperation of all concerned parties arises, heightening the fear of an uncontrolled spread of possibly dangerous xenogeneic infections.

In order to reconcile reasonable public claims for safety guaranteed by the state and the sensible demand of the patients affected, and thereby solving the conflict between the principles of respect for autonomy and justice, two different recommendations have been developed within ethical literature. First, answering primarily the problem of insufficient legal regulations and therefore answering claims arising from the consideration of the principle of justice, the juridical model of informed contract has been proposed. According to this recommendation, the individuals concerned sign a contract obligating themselves to regular post-operative monitoring and possible quarantine, if necessary, to protect the public by prohibiting a diffusion of xenogeneic pathogens. In the case of violations of the duties arising from this contract, the state should be given the right to restrict individual civil rights by forcing them to take part in monitoring procedures or quarantine measures. Assessing this proposition critically and reflecting on the political and juridical implications, it seems extremely unlikely that this solution will be implemented. Despite being intensively discussed within ethical literature, informed contract actually seems to be more of a theoretically interesting solution than a politically and juridical viable measure that is being undertaken within democratic societies that respect a citizen’s autonomy . This position can be supported by reflecting on the comparable case of HIV, where no contrastable juridical measures were seized, thus rendering an extensive change of the existing legal framework to enable the execution of a cure like xenotransplantation almost impossible.

Second, reacting to the problem of restriction of autonomy , the already well-established model of informed consent has been suggested. As mentioned above, the criteria which must be met in order to call a decision autonomous and a consent informed are hardly to be met through the usual routines of patient-physician consultation, as xenotransplantation is being hallmarked by specific conditions. First, the range of available information concerning the benefits and the risks of this treatment strategy are constitutively limited, forcing the patient to decide under the conditions of risk. Second, the range of obligations, e. g. lifelong monitoring, quarantine and the prohibition of reproduction, exceed the normal scope of informed consent, making a decision extremely difficult. Third, the consequences of consent to a xenotransplantation affect not only the patient, but also his next of kin, possibly including children or other groups of persons not fulfilling the preconditions of informed consent.

In order to develop practically useful solutions regarding the operationalization of the principles of respect for autonomy and justice, we want to propose focusing on the arrangement of conditions enabling the consent process, which must be specified for this situation. By recommending a set of conditions required in order to allow a durable, binding, informed consent by the affected persons, we intend to initiate a broader discussion within the ethical discourse.

The first condition to be considered in this context is the establishment of an objective, informational structure, enabling the patient, his next of kin and medical personnel to get access to all the relevant information. Therefore, detailed, comprehensible and specified information sheets must be produced in order to meet the different informational needs that patients, their next of kin and medical personnel have. Furthermore, this information needs to be presented and explained to the patients and their next of kin by a physician who is not involved in the xenotransplantation. He/She must have all available facts about possible benefits and dangers of xenotransplantation and alternative treatment, the expected success rates, and the limits of knowledge concerning the consequences available to them in order to ensure that the affected parties are able to make a medically informed – and therefore autonomous – decision. As the decision is very far-reaching and the patient and his/her next of kin are living with and under the threat and the strain of a terminal illness, it is extremely important to enable a sufficient amount of time for them to consider all relevant arguments. Therefore, second, the process of decision-making should be designed accordingly, providing the conditions for long-lasting reflections, discussions and consultations at intervals of several weeks. A third condition is that constant pre- and post-operative medical, psychological and ethical guidance should be provided. In order to facilitate the decision-making process for every party involved, a stable, professional structure of medical and psychological assistance is required prior to commencing treatment, allowing the patient and his/her relatives to express their concerns, fears and inner conflicts in a setting that is free from external and temporal pressure. Furthermore, from a perspective of justice, intensified attention should be given to the affiliates as they might experience conflicts of ethical liabilities. Feeling strongly bonded and ethically obliged to help and support their diseased partner in every way possible, they have to consider the consequences for them and their children as well, for whom they have to make a wide-ranging, representative decision under the condition of insecurity. Considering the case of an affiliate refusing to consent to the procedure, severe ethical and psychological problems will arise for all affected parties, due to the fact that a disagreement concerning the necessity and legitimacy of xenotransplantation between the patient and his/her next of kin either leads to the separation of the partners or to a complete refusal of the transplantation, leaving the life-threating situation of the patient unchanged.

Focusing on the reflection of the advantages and disadvantages of informed consent respectively informed contract, the existing ethical literature doesn’t provide any practicable solutions for the case of conflict between a partner and his/her next of kin. In order to fill this gap within theory and practice, we want to propose the involvement of a professional ethics consultant, who is able to reflect the ethical aspects of the procedure, to structure the discussion, as well as to provide techniques of solving ethical conflicts by reconciling the different positions. Leaving the parties affected without any support structure to take care of and help solve the ethical problems, it can’t be assured that the consent decisions are made autonomously in the sense Beauchamp and Childress proposed, meaning free of pressure and in consideration of all possible, known medical and social consequences.

In addition, considering arguments that are being proposed by virtue ethics, it is furthermore necessary to ethically support the attending physician to find an appropriate way of handling the conflict resulting from the double bind of obligations. As xenotransplantation – in the beginning⁵ – has to be regarded as a technology that is still under development, the attending physician is on the one hand obliged to act in the patient’s interest, but on the other hand he/she is bound to his/her role as a researcher and therefore obliged to achieve progress in the field of science. This situation makes it likely for the physician to experience serious ethical conflicts, which could be alleviated with the help of a professional ethics consultant. As xenotransplantation must be regarded as developing, experimental medical technology – at least in the beginning – professional ethics consultation proves to be a helpful necessity in order to guarantee the ethical justifiability of the process and therefore, the duration of consent.

Mainstream ethical literature focuses on the debate of the advantages and disadvantages of informed contract or informed consent. By posing the question this way, important aspects concerning the possibility of a third way of solving the problem are lost from sight. Changing the commonplace theoretical perspective and looking at xenotransplantation from an order ethical perspective, as it has been developed e. g. by Karl Homann (Homann and Suchanek 2000) and Ingo Pies (2009), might prove to be helpful in creating an innovative contribution to the discourse and a viable solution which could guide future political debates.⁶ According to this theoretical approach, based on e. g. game theory reflections, a distinction is made between moves in the game, rules of the game and a regulating framework of conditions enabling rules and moves of the game. This distinction provides the theoretical and practical ground for escaping the narrow horizon of individual ethics. Thereby ethical claims towards and accusations of misbehavior or lacking sense of responsibility of individual actors (like e. g. company leaders) can be missed, as they prove to be ineffective, because they focus on individual moves instead of on the framework enabling only specific – and sometimes ethically illegitimate – moves.

Applied to the context of xenotransplantation, it is necessary to consider the fact that besides medical personnel, the state, the patient and his/her next of kin, companies providing transplantable cells and organs are an indispensable partner in the process of putting xenotransplantation into effect. As a legal regime regulating questions of liability in the case of an outbreak of xenogeneic infections is still missing, it proves to be most important to develop ideas for an ethically legitimate framework respecting and reconciling the interests of all parties (state, pharmaceutical companies, medical personnel and patients). Therefore, it is necessary to reflect on the different interests pursued by the different parties in order to recognize conflicts and convergences of interest and thereby develop frameworks that enable ethically legitimate moves.

The state simultaneously wants to achieve the aims of providing the best possible health care to sick citizens on the one hand, and to secure the safety of all its citizens on the other hand. The patient (as well as his affiliates) is most interested in getting the therapy that is the most beneficial and least harmful to him/her as well as to his/her loved ones. The medical personnel aim to provide the best possible and safest treatment for the patient without being exposed to the risk of acquiring a serious illness. The companies have the objective to sell safe products as profitably as possible. The absence of specific legal regulations clarifying the question of accountability in the case of an unexpected spread of xenogeneic diseases limits the available options by making it economically necessary for companies to establish disclaimers of warranties in order to avoid potentially ruining claims, e. g. by transferring the complete liability to the patient or medical personnel as consumers. This transfer of liability practically results in ethically problematic and unjustifiable restrictions of autonomy , like the prohibition of reproduction or the process of life-long monitoring. The ethical principle of respecting the patient’s autonomy in the context of xenotransplantation must therefore lead to the development of a legal framework ensuring companies disclaimers of warranties by state guarantees, meaning that the state will take full accountability in the case of the outbreak of xenogeneic infections. In addition to the guarantees concerning disclaimer warranties, the state has to establish a legal framework of shared responsibilities in order to fulfill its constitutional duty to protect its citizens. According to this, each party (companies, state, medical personnel, patient and his/her next of kin) has a responsibility to avoid every practice known as potentially promoting a xenogeneic infection . Based on this system of shared responsibilities, the state takes responsibility in the case of an outbreak of a xenogeneic infection , while regular cases of liability will be treated according to the existing legal procedures regulating the use of pharmaceutical products by dividing the responsibility among pharmaceutical companies and medical personnel, respectively the medical institutions. If the framework of juridical conditions will be designed accordingly, neither the patients nor medical personnel nor the companies will have to bear the whole risk and restrictions of individual autonomy can be kept to a minimum.

As xenotransplantation does not only affect public, private and corporate interests, which can be illustrated within an order ethical framework, but also the wellbeing of animals needing specific reflection, this chapter concludes with a brief overview of the most important animal ethical positions in order to widen the theoretical perspective of the ethical discussion⁷ on xenotransplantation.