Stand: September 2022
Ansprechpartner: Marius Bartmann

Autorennachweis

The history of transplantation medicine

There are indications in some ancient myths that man may have attempted to perform transplantations in historic times, but the origins of scientifically sound transplantation practice can be traced back to the early twentieth century, when improvements in vascular surgery and operation techniques provided practitioners with the necessary technological basis. The first successful kidney transplantation was performed between identical twins in the USA in 1954. 1963 saw the first successful liver and also the first lung transplantation. In 1965, the pioneers managed to transplant a pancreas successfully. The first heart transplantation, carried out by Christiaan Barnard in South Africa in December 1967, caught the attention of people throughout the world. The first successful multi-organ transplantation took place in 1989. The problems which became evident during the initial stages, such as the difficulties encountered in preserving organs after removal or in dealing with the recipients’ immunological response, could be addressed and at least to some extent solved through the experience gained and the development of immunosuppressive drugs.

The present state of research

Transplantation medicine today is recognized as being part of standard professional practice in many countries. Especially in the case of end-stage failure of organs which is called terminal organ failure, organ transplantation is mostly the only treatment option. There is a long list of different cell and tissue types, organs or indeed entire organ systems for which the medical basis for transplantation is now secured.

Transplantation can only succeed when the transplanted material is not rejected by the receiving organism. Transplantation of foreign organs may trigger an immunological defence reaction, with the result that the transplanted organ cannot fulfil its proper function. One differentiates between acute rejection and chronic rejection. Acute rejection refers to the period immediately following transplantation, and it may occur in varying degrees of severity. The chronic form of rejection is characterised by a long-term process in which the organ gradually fails. The defence mechanisms of the patient's own body must be kept permanently suppressed with the help of immunosuppressive medication, and this requires a high degree of co-operation on the part of the patient. 

In addition to the phenomenon of failure or rejection of the transplanted organ or tissue, transplantations can also lead to a so-called graft-versus-host reaction in which the immune system cells which are transferred with the transplant recognise the recipient's body as being "foreign" and attack it.

With xenotransplantations, as is the case in general, the biggest obstacle to a successful, long-term transplant are immune responses against the donor organ. Modern techniques of genome editing, particularly the gene scissors CRISPR/Cas9, contributed substantially to engineer pig hearts in such a way so as to minimize the risk of the organism's organ rejection.

In early 2022, a significant advance in the field of xenotransplantation was achieved. For the first time, the heart of a genetically modified pig was transplanted into a patient. Genes were deactivated that can cause rejection reactions of the human immune system. Furthermore, human genes were added to increase acceptance of the foreign organ. Finally, genetic modifications were made to prevent the porcine organ from responding to growth hormones and increasing in size beyond what is normal in humans. The patient survived for 2 months. The exact cause of death has not yet been determined, yet the transplant is considered a milestone in xenotransplantation.

Organ shortage

It has been pointed out worldwide that the demand of donor organs is increasing. According to the Spanish Transplant Organization (ONT), roughly 49.000 patients were on the organ transplant waiting list in Europe alone at the end of 2020, compared to roughly 28.000 actual transplantations. 

According to statistics gathered by the German Organ Transplantation Foundation, on whose data all the following transplant numbers are based, a total of 3,508 organs were transplanted in Germany in 2021, 529 of which were living-donor transplants. In the great majority of cases this involves kidney transplants (56.8%), followed by liver transplants (23.8%) and similar rates of lung (8.1%) and heart transplants (9.4%). Less common are transplantations of the pancreas (1.9%) and small intestine (0.1%). 

The following table shows the transplant numbers for 2013-2021:

There is a great disparity between organ demand and organ donations. In 2021, there were 8.730 transplantable patients on the corresponding waiting list. 6.593 patients needed a kidney, 848 a liver, 727 a heart, 291 a lung, and 271 a pancreas.

The DSO assumes that the leak about breaches of directives on organ procurement in 2012 caused a loss of trust in the transplant system as a whole (inspections had identified cases of data manipulation in certain transplant centres by which patients were supposed to receive donor organs more quickly). It also attributes the decline in organ donations to the growing importance of advance decisions, for in cases where a person signed a form against life-sustaining measures and yet declared his or her willingness to donate organs, a contradiction often arises between the patient’s advance decision and the organ donor declaration.

According to a representative survey conducted by the German Federal Centre for Health Education (BZgA) in 2022, 84% of the people questioned had a positive attitude toward organ and tissue donation. However, only 31% had documented their decision with an organ donor card. Hence, the main political aim is to offer a broad education for citizens about the importance and possibilities of organ donation. A central measure was the introduction of the so-called decision solution in 2012. It provides that all Germans over 16 with a health insurance will be regularly questioned about their willingness to donate organs. Nevertheless, in the aforementioned survey of the BzgA only 54% of the people questioned indicated being adequately informed on this matter. At the end of 2018 a debate began about different regulations for organ donation, which on 16 January 2020 led to a vote in the German Bundestag on the revision of the existing regulations (for more on this see also section II. Legal aspects).

However, even if the willingness to donate organs was considerably higher, the demand for organs could probably still not be satisfied by posthumous donation alone. Hence, it is important to utilise and develop alternative ways of graft procurement. For some organs like kidneys and liver there is the possibility of living-donor transplantation. Among the further alternatives to posthumous organ donation are the development of artificial organs ("alloplastic transplantation"), the use of animal organs ("xenotransplantation"), and the cultivation of organs from stem cells. However, as these possibilities of organ procurement are still being developed and since some of them are ethically controversial, additionally there are repeated attempts to commercialise organ donation. Models of commercialisation have been developed for living-donor transplantation as well as posthumous donation. In Great Britain a suggestion by the Nuffield Council on Bioethics caused furore in 2011: the public health care system should cover the expenses of the donor’s funeral. However, such attempts are meeting with much criticism. For instance, the United Nations (UN) and the World Health Organization (WHO) reject any kind of commercialisation of organ donations in view of human rights even if organ shortage causes illegal organ trafficking.

The procedure for post-mortal organ donation in Germany

The procedure to be adopted in Germany in a case of post-mortal organ donation is defined in the Transplant Act ("Gesetz zur Spende, Entnahme und Übertragung von Organen und Geweben" (TPG). The TPG stipulates that three agencies in particular must be involved in the organisation of a post-mortal organ donation: firstly the organ removal hospitals and the transplantation centres, secondly the coordination unit German Organ Transplantation Foundation (DSO) and thirdly the international allocation agency Eurotransplant.

It is the task of the hospital staff to diagnose brain death in accordance with the guidelines of the German Medical Association (Bundesärztekammer) to communicate with the next of kin and to inform the nearest operative centre of the DSO if approval for an organ donation has been obtained – either in the form of an organ donor card or in that the next of kin have confirmed the will of the person who has died. It then devolves upon the DSO to coordinate the removal of the organ. For the protection of the organ recipient, the first step is to conduct appropriate laboratory investigations. If there are no signs of infections or tumour disease which could endanger the recipient, the DSO transmits all relevant data to Eurotransplant, which performs the selection of the recipient with the help of computer analysis.

As soon as the recipient has been selected, Eurotransplant prepares the organ removal together with the DSO and the regional coordination staff of the donor hospital. At the same time, the (international) transport of the organ from the donor hospital to the respective transplantation clinic for the recipient is set in motion. The DSO reimburses the personnel and material costs which arise in the course of an organ donation. The costs incurred for the actual transplantation of the donated organ are carried by the recipient's health insurance. The name of the donor is never communicated to the recipient, and also the next of kin of the donor are not informed as to the identity of the donor. However, the transplantation centre will disclose whether it was possible to transplant the organ or organs successfully, if the next of kin wish to find out.

The procedure for living-donor organ transplantation in Germany

A living-donor transplantation represents a possible alternative to post-mortal donation. According to German transplantation law a living-donor transplantation involving a kidney, parts of a liver or any other organ which cannot regenerate is only allowed between close relatives and persons with very close personal ties. In order to ensure that a donation of this kind takes place on a voluntary basis and that medical risks for the donor are minimised as far as possible, and also to preclude any possibility of abuse or organ trafficking, every potential case must be thoroughly investigated by an expert commission beforehand.

Apart from comprehensive laboratory tests to determine the respective blood groups and other medical factors such as HLA compatibility, cardiopulmonary exercise tests and organ-specific function tests are to be carried out. Finally, investigations in the form of psychological interviews must be conducted with the aim of shedding light on the relationship between the donor and the recipient, the donor's motivation and the extent to which he or she is aware of the possible consequences of losing the organ in question.

According to the German Organ Transplantation Foundation, 475 out of 1,992 kidney transplants were living-donor transplants in 2021. The number of living-donor kidney donations has thus increased slightly (2020: 450 living-donor kidney transplants). However, as it is possible to provide for an optimal donor-recipient matching, the prospects of success for transplantation from a living-donor are generally significantly better than is the case with post-mortal organ donations. By amendments of the German transplantation act on the one hand and of the Social Insurance Code (SGB V) on the other hand, pending legal uncertainties regarding treatment and aftercare of the donor have been eliminated: The graft recipient's health insurance has to reimburse all costs incurred to the donor, i.e. expenses for pre- and post-operative care, rehabilitation and continued payment of wages during periods of disability.

In some countries, such as Switzerland, so-called cross-over transplantations are allowed. In such cases suitable couples are mutually donating organs when partners cannot donate directly due to incompatibilities. In one specific case cross-over transplantation has been declared to be permissible in Germany as well. In the view of the Federal Social Court (Bundessozialgericht) this was to be justified on the basis of the close personal relationship between the donor and the recipient.

International and European law

The European Union is contractually obliged to lay down the standards of quality and safety of organ transplantations. This follows from Article 168 IV lit. A) of the Treaty on the Functioning of the European Union (AEUV). On this basis, Directive 2010/45/EU on standards of quality and safety of human organs intended for transplantation was adopted on 7 July 2010. Above all, the transplantation directive aims at assimilating the standards of quality and safety Europe-wide and developing more efficient transplantation systems in order to improve the exchange between the member states. Since the European directives are binding for all member states, the directive was implemented into the national law in Germany on 1 August 2012 through the law amending the transplantation act. Regulations of the organ donation, organ removal or organ distribution are left unaffected by the directive since these are regulated by the individual countries.

In addition to the directive, the European Parliament submitted the Action Plan on Organ Donation and Transplantation (2009-2015). In a ten point plan the introduction of a central transplantation register and the appointment of specially trained transplantation coordinators in hospitals are encouraged.

At the level of international law, the Council of Europe created special norms on organ removal in Article 19 et seq. of its Convention on Human Rights and Biomedicine, as well as in a supplementary protocol on transplantation. Since Germany and other countries haven’t yet ratified both treaties under international law, they are so far not legally effective.

Germany
The German Transplant Act (TPG)

In Germany, transplantation of human organs is governed by the Act on "organ and tissue donation, removal and transplantation" (Gesetz über die "Spende, Entnahme und Übertragung von Organen und Gewebe" or: Transplant Act – TPG). The Act was passed by the German Bundestag on 5 November 1997 and came into force on 1 December 1997; an amended version was published on 4 September 2007 and on 1 August 2012. Depending on whether the organs were donated after the death of the donor or taken from a living one, the act prescribes different regulations. 

In general, in Germany the so-called decision solution is in place, i.e. the organs of a deceased person may only be retrieved if the person in question gave permission for organ donation (§ 3 para. 1 no. 1 TPG), e.g. in the form of an organ donor card, or if the next of kin consent to the donation (§ 4 TPG). After years of debate about the introduction of a dissent solution to address the declining number of organ donors, on 16 January 2020 the federal parliament (the "Bundestag") largely confirmed the current legal situation. The Bundestag voted for a draft bill proposed by a group of MPs led by Annalena Baerbock (The Greens). The corresponding act to encourage the willingness to donate organs ("Gesetz zur Stärkung der Entscheidungsbereitschaft bei der Organspende") went into force on 1 March 2022. The act retains the currently existing decision solution, according to which organ donation must be a voluntary and expressly made decision. To encourage the willingness to donate organs it includes a provision to create an online registry in which citizens can document their decision (similar to the Austrian model). Furthermore, physicians are to encourage their patients to document their decision in this online registry on a regular basis. Another group of MPs led by health secretary Jens Spahn (CDU) and health expert Karl Lauterbach (SPD) had proposed a bill favoring the dissent solution instead. Already in April 2019 the Second Law Amendment to the Transplantation Law was passed.

The legal provisions governing post-mortal organ donation under the TPG
The removal of organs or tissue from a deceased donor is only allowed if the donor’s death has been determined according to the rules that are in accordance with the state of knowledge of medical science (§ 3 para. 1 no. 2 TPG) by two independently acting, qualified physicians, who must not be involved in the process of either organ removal or transplantation (§ 5 TPG). Besides, the operation itself must be carried out by a physician (§ 3 para. 1 no. 3 TPG). Likewise, the removal of organs or tissue from a dead embryo or foetus is only permitted after death has been determined by a qualified person. Moreover, the woman who was pregnant with the embryo or foetus in question, must consent to the donation (§ 4a para. 1 TPG).

The amendment of the TPG which came into force on 1 August 2012 provides that all health insurance members who are 16 years or older will be asked frequently if they are willing to donate their organs after death. Proponents of this regulation expect a raising number of donated organs. National health insurances as well as private health insurances are bond to conduct the questioning. 

Moreover, the already existing control mechanisms in medical centers and hospitals, where organ transplant and removal take place, were expanded and tightened through the application of the amending law. The inspection authority is an independent testing and monitoring commission which is located at the German Medical Association. The clinics are legally obliged to provide the committee with documents on the decisions taken concerning the allocation of organs, and to issue the necessary information. The committee must convey any information about the breaches against the Transplant Act (TPG) to the responsible authorities in the respective federal states.

General provisions of the TPG
Apart from the detailed prerequisites for organ removal from both deceased and living donors (§§ 3 8 TPG) the TPG sets out some general principles and procedural requirements. It defines organ donation as a joint task carried out by many different institutions. The so-called TPG commissioners have a key role in the process: The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), the German Medical Association and the German Hospital Federation (DKG) jointly assigned a Coordination Centre for Organ Removal (§ 11 TPG) as well as an agency for organ allocation (§ 12 TPG). Transplantation of organs that are subject to allocation (“vermittlungspflichtige Organe”), such as hearts, kidneys, liver, pancreas and intestines (§§ 3, 4 TPG) may only be performed in authorised hospitals (so-called transplantation centres) (§§ 9, 10 TPG); the respective organs have to be allocated by the allocation agency (§ 11 TPG). The TPG also provides that the transplantation centres must keep waiting lists for the transplantation of such organs. However, not all patients in need of a new organ can be included in the waiting list: Where the risks related to transplantation and the necessary follow-up treatment are too high and the prospects of success are poor, transplantation is not considered an option. Doctors are bound to observe the guidelines for the administration of waiting lists of the German Medical Association; furthermore, they must document the reasons for waiting list inclusion/exclusion and inform the patient accordingly (§ 16 TPG). Pursuant to § 12 TPG, the donated organs must be allocated at national level in accordance with the guidelines for organ allocation of the German Medical Association.

The TPG further stipulates that underage persons may declare their willingness to donate organs from the age of 16 and their objection to organ donation from the age of 14 without consent of a parent or legal guardian.
The TPG also makes provision for criminal and summary offences. Trading in organs is prohibited, as is the transplantation of traded organs, and may be punished with a prison sentence of up to five years (§ 17 TPG). Moreover, the TPG stipulates that the federal authorities, in particular the Federal Centre for Health Education (Bundeszentrale für gesundheitliche Aufklärung) and the health insurance funds shall inform the population on the possibilities of organ and tissue donation and make organ donor cards available (§ 2 TPG). In the course of the amendment of the TPG in August 2012 new legal requirements for hospitals which harvest tissue and organs were stipulated (§ 9a and 9b TPG). Among other innovations, these stipulate for the first time that there must be at least one transplantation commissary in each hospital where organ removal takes place. The main reason for the appointment of a transplantation commissary is the success of the Spanish Transplantation System which is equally recognized by the European Union and the World Health Organization (WHO). The rights of this commissary have been acknowledged in the context of the Second Law Amendment to the Transplantation Law.

Guidelines and opinions of the German Medical Association

Legal regulations pertaining to xenotransplantation in Germany

The German Transplantation Act does not cover xenotransplantation, as (pursuant to § 1 TPG) it only governs the removal and donation of human organs, parts of organs and tissue. In its 1999 opinion on xenotransplantation the German Medical Association decided that the prerequisites for performing xenotransplantations in a reasonably low-risk way were not yet met. For lack of an individual regulation, the provisions of the Medicinal Products Act (Arzneimittelgesetz – AMG) are relevant when it comes to xenotransplantation. Pursuant to § 2 para. 1 no. 1 AMG medicinal products are substances and preparations made from substance which, by application on or in the human body, are intended to cure, alleviate, prevent or identify diseases, suffering, injuries or medical conditions. The prevailing opinion is that a xenograft represents a medicinal product in accordance with the AMG. Pursuant to § 5 para. 1 medicinal products must not be placed or made available on the market if they are unsafe. According to § 5 para. 2 AMG medicinal products are to be considered unsafe if, according to the current state of scientific knowledge, there is reason to suspect that, when used in accordance with their intended purpose, they have harmful effects which exceed the limits considered tolerable in the light of current medical knowledge. Whether this is the case when animal organs are transplanted to humans is subject to controversy.

Regulations in other countries

In many countries, the basic principles governing organ donation and transplantation are quite similar. Now and then, the brain death criterion may give rise to lively debate – particularly in Japan – but in general, the irreversible and total loss of the cerebral functions is legally accepted as being the point in time from which post-mortal organ donation may take place. Organ trade is a punishable offence in most countries, transplantation may only be performed by qualified physicians, and the allocation of donor organs is incumbent on specific institutions. 

As to the question of whether – and in which form – the potential donor must consent to post-mortal organ donation, regulations vary from one country to another. As the only European country, Germany has the decision solution. Denmark Ireland, Iceland, Lithuania, the Netherlands, Rumania, Switzerland and the United Kingdom apply the consent solution, according to which the deceased person must have consented to organ donation during their lifetime, e.g. in the form of an organ donor card. Where this is not the case, the next of kin to decide whether organ donation should take place; this decision must be based on the wish expressed by the deceased prior to death or on their presumed wish. The dissent solution, according to which organs may be removed if the donor has not explicitly objected to post-mortal organ donation during his or her lifetime, is applied, for example, in Austria. 

In Japan, a specific form of the consent solution is applied: Post-mortal organ donation may only take place if the next of kin of the potential donor have declared their consent. Since the respective regulations of organ donation do not only apply to citizens but also to persons staying or visiting temporarily, the Federal Centre for Health Education (BZgA) recommends that people carry along a filled out organ donor card so that they do not unwillingly become organ donors.

Ethical questions arising in connection with post-mortally donated organs

The main issue to be addressed in cases of post-mortal donation is concerned with the point in time at which it becomes ethically justifiable to remove organs from human bodies.

Reliable determination of death

Where organs are to be donated post-mortally, the central debate revolves around the question as to when exactly the donor may be considered to be dead. More specifically, the concept of death needs to be addressed from a philosophical rather than medical point of view. In addition to an irreversible cardiac arrest (cardiac death) a certain sign of death is to be seen in the irreversible and complete functional failure of the entire brain (brain death). This criterion applies in Germany and in most other countries. The term brain death may be applied where the brain has ceased to 'operate', so that its ability to function has permanently disappeared, even though it may be possible to maintain the cardiac and circulatory functions in the rest of the body by means of intensive medical care. The guidelines of the German Medical Association contain precise descriptions of the procedures and processes involved in the diagnosis of brain death. The debate on the definition of brain death reached a climax in connection with several drafts of the Transplantation Law and with its being passed in June 1997, but still today it remains the subject of heated discussion. The argument put forward in favour of using brain death as a sure sign of death maintains that when the brain functions have failed permanently the physical-mental unity which makes up the human being is irretrievably destroyed. As soon as brain death has occurred, the human being is no longer able to think, recognize, decide, plan, feel or perceive. He or she can no longer experience consciousness, nor self-awareness, so that other persons can, at the most, have a relationship to him/her, but it is no longer possible to establish a relationship with him/her.

Those who oppose the use of brain death as a general criterion for death consider brain death as merely a stage encountered on the path leading to death, a phase which must still be associated with the life which is in the process of being extinguished. As many patients for whom brain death has been diagnosed still display physiological reactions – from bodily warmth and skin hue through spontaneous embraces up to erections and ejaculations and even the continuation of a pregnancy for a certain time in a brain dead person – they maintain that those affected cannot be regarded as completely dead. A report published in 2008 by the US President’s Council on Bioethics provides support for the opponents of the brain death criterion. The President’s Council concludes that the equation of death and brain death can no longer be scientifically justified. Current research would show that the integration of the organism is an accomplishment brought about by the organism as a whole and not, as previously assumed, by the brain alone. Since the President's Council wants to hold on to the equation of death and brain death, it proposes an alternative justification – a natural-philosophical one instead of a scientific one. According to this new conception, what is decisive is not when a person is biologically dead, but what constitutes her or his life. The President's Council focuses on active human abilities, such as the ability to receive stimuli from the environment and to interact with it. This ability manifests itself, among other things, in spontaneous breathing. Critics, however, consider such a natural-philosophical justification of the brain death criterion problematic because it was unfalsifiable.

The report published by the US President’s Council rekindled the ethical debate about the brain death criterion in Germany as well because not equating death with brain death would have serious ethical and legal consequences. In Germany, as in other countries, the removal of organs for organ donation is allowed only if the donor is dead (with the exception of living donor transplantation) – this is the so-called "Dead Donor Rule", which is enshrined in the German Transplantation Act (§ 3 TPG).

Organ removal from brain-dead people would therefore have to be regarded as a form of killing if death and brain death are not considered the same. However, if one still wants to adhere to transplantation medicine without organ removal becoming a form of killing, then according to the President's Council there would only be the following two alternatives:

1. Abandoning the "Dead Donor Rule".
2. Organ removal after cardiac death (organ removal from "non heart-beating donors" only).

However, both alternatives are ethically and legally problematic. Abandoning the "dead donor rule" would mean abandoning the unconditional validity of the ban on killing as well. Restricting organ removal exclusively to "non heart-beating donors" would have the consequence that far fewer organs were transplanted. This dilemma is also the motive and the reason why the President's Council chose a new justification of the equation of death and brain death as a way out. 

In February 2015, the German Ethics Council published an opinion on the debate about brain death. The German Ethics Council unanimously considers it acceptable to conform to a person’s consent to organ donation after a correct diagnosis of brain death, thus confirming the basic idea of the prevailing German Transplant Act. The majority of the Council’s members regard brain death as a sufficient criterion for ascertaining the death of a human being. A minority, however, objects to equating the irreversible failure of all brain functions with human death. Similarly to the US President’s Council, this minority considers the Dead Donor Rule superfluous. The removal of organs represents an acceptable form of letting a human being die in an autonomous way rather than a wrongful killing. Since the German Ethics Council failed to reach a consensus on the equation of brain death and death, its opinion consequently demands a transparent exposition of the conflicting views on the criterion of brain death for the public debate.

Consent to post-mortal organ donation

The question arises as to whether a physician is authorised to remove tissue or organs from a dead body for the purpose of healing another person without either the approval of the next of kin or evidence of approval having been given by the dead person during their lifetime. If the person who has died gave such approval either in writing or verbally, the doctors are required to investigate the medical feasibility of carrying out the organ donation and, if possible, to implement it. Opinion remains divided as to how to deal with cases in which the dead person has left neither a statement of consent nor of objection. This gives rise to a condition of uncertainty between public interest in obtaining a sufficient number of organs for transplantation and the interests of the dead person and their next of kin in respect of maintaining the dead body's integrity. Proponents of the dissent solution recommend a compromise: There should be no obligation to remove organs, but the potential donor should carry the burden of decision.

To increase the number of organ donations in Germany, many experts regard an amendment of the Transplantation act (TPG) as necessary. Already in 2011, the health committee of the federal parliament (the "Bundestag") addressed in a public hearing the question of whether the consent solution on organ donations, according to which an organ may only be removed from a person, when she had documented her approval to the donation in an organ donor card before her death, is still up to date. The decision solution in Germany goes a little further than the consent solution because every citizen is to be asked about her willingness to donate and to document her decision on a regular basis. Also the above mentioned dissent solution has been mentioned. The dissent solution, however, is still very controversial.

On 16 January 2020, the Bundestag voted for the draft bill introduced by Annalena Baerbock (The Greens) and other MPs, which confirmed the decision solution but intends to better inform the public. Efforts to educate the public about organ donation will be increased and an online registry will be created, in which decisions regarding organ donation can be documented.

Questions of fair allocation of organs when the supply is limited

A further ethical problem in current transplantation medicine can be seen in the equitable distribution of post-mortally donated organs. The shortage of organs available for transplantation calls for a fair system of organ allocation. The question becomes acute in cases where two or more patients meet the medical criteria for one and the same donor organ. The allocation of organs is then based on the fundamental ethical principles of equal treatment and the achievement of the greatest possible (medical) benefit. However, these two principles can easily collide. Thus a relatively young and otherwise healthy person may be expected to receive the greatest benefit from a transplantation, but this could be at the expense of somebody else for whom the organ in question represents the last chance for survival. It is not possible, from an ethical point of view, to lay down hard and fast rules for applying these two principles – their relationship to each other must be tested again and again in an ongoing and transparent process of social discussion.

In Germany, the organs subject to allocation (heart, lungs, liver, kidney, pancreas and intestines) are distributed by the allocation Eurotransplant and according to the guidelines of the German Medical Association. In view of the difficulties inherent in allocating organs, suggestions have been put forward to limit the distribution of donor organs to people who themselves have agreed to allow their organs to be used in the event of their death. Critics of this model point out that its practical implementation could lead to undesired discrimination. There is a broad degree of agreement that social criteria such as a person's standing in society should not play a role in the distribution of organs.

Ethical questions concerning organ donation by living donors

The progress being made in transplantation medicine, together with the present shortage of organs, adds fuel the discussion concerning the legitimacy of donation by living donors. Where an organ donor is still living, the ethical issues revolve around the donor and the recipient, as well as the physician in his or her role as mediator between them.

Free-will decision on the part of a living donor

The donation of an organ by a living donor presupposes his or her informed consent. According to the stipulations of the German Transplantation Act it is permissible only between first and second degree relatives or between people who have a "close personal relationship". The aim of this ruling is to prevent the possibility of trade in organs, to ensure that the donation is, indeed, voluntary, and also to protect donors against making over-hasty decisions which they may regret later if complications arise. In view of the fact that in such cases a healthy person undergoes an operation which does not directly benefit himself or herself and which involves a health risk which could even result in the donor's death, most countries require that the number of such donations be limited to what is absolutely necessary in order to supply the demand for transplants. In Germany, this requirement is implemented by means of the "principle of subsidiarity of post-mortal donation against donation by living persons". This means that a donation from a living donor is only permissible when no suitable organ from a dead person is available at the time of organ extraction. A surgeon may only remove organs from living donors when these criteria of urgency and lack of alternatives are fulfilled. Further, physiological tests must be performed to confirm that the operation will not endanger the potential donor more than is normally to be expected. Finally, psychological tests must be carried out in order to establish whether the donor's decision is truly made of his or her own free will and that he or she is adequately informed. As far as the responsible medical practitioners are concerned, the ethical discussion focuses on the extent to which an operation which does not benefit the person being operated on can be reconciled with the classical principle of medical ethics known as 'nihil nocere' – 'do no harm'.

Extension of the group of potential donors

It is a matter of debate as to whether those people who donate organs or parts of organs while they are still living should receive a remuneration in order to increase the number of people willing to donate. There is a body of opinion which regards such 'acknowledgement payments' as being appropriate in view of the considerable risks and disadvantages which the donor takes upon himself or herself. As they are prepared to make a positive contribution towards reducing the shortage of organs for donation, this deserves recompense. Further, it may be a psychological aid for the recipient if they know that the donor at least receives some sort of financial compensation. Feelings of guilt are common, and could in this way be somewhat relieved. However, many experts from the fields of medicine, law and ethics reject any form of organ sale out of hand. In their view, donation of organs against payment of money is not compatible with human dignity and the constitutionally defined code of ethics, and therefore unacceptable There is grave concern that such a practice would lead to the exploitation of poorer members of society, because such people would be more likely to agree to organ removal while they are still living.

In addition to the idea of providing financial incentives to encourage more people to become living donors there are several other possibilities which have been put forward with the aim of increasing the donor pool. For instance, discussion of cross-over donation has increased in recent years. This could prove to be a life-saving solution for patients who cannot benefit from a donation from close relatives on account of blood group and HLA incompatibility. Another way of increasing the number of donors would be to introduce a so-called pooling system of anonymous living donors. These donors provide organs for persons whom they have not themselves designated and who remain unknown to them.

According to the model presently under discussion the organs donated in this way are to be 'pooled' so as to ensure that mutual anonymity is maintained and the possibility of organ trade is excluded. The pooled organs are then to be allocated according to criteria similar to those which are applied to post-mortal donation.

Ethical implications of xenotransplantation for animals

The ethical implications of xenotransplantation strongly depend on the underlying ethical theory. The most important theories are: anthropocentrism, according to which only human beings possess an inherent moral value, pathocentrism, which defines sentient beings as morally relevant, biocentrism, which assigns moral value to all living beings, and finally holism, a theory that claims that moral significance is not something an individual has but rather the whole system of nature. Within these theories there are further internal differentiations such as the difference between a strong and a weak anthropocentrism. According to the strong anthropocentrism no non-human entity has an intrinsic moral value, while in a weak anthropocentrism non-human beings do have a moral status which is derived from humans, yet they do not possess an internal value of their own.

The assessment of xenotransplantation depends on which of these theories is considered correct. The strong anthropocentrism sees no ethically questionable aspect in transplanting an animal organ into a human, as long as there is a benefit for human beings to be found. Since only human beings are given a moral value, animals can be used for the good of mankind in any conceivable way, including xenotransplantation. For a weak anthropocentrism there is a limit to the way animals should be treated, as they do have a moral significance derived from the moral value of a human being. In Kant’s theory, animal abuse harms the abuser, as it reduces her ability to empathize. The abuser is brutalized by her action and therefore the action is not permitted. Accordingly, xenotransplantation are morally justified as long as the animal doesn’t have to suffer unnecessarily.

According to pathocentrism, the preference of “not wanting to suffer” is a necessary ability for an entity to be understood as having a moral value. Some pathocentrists argue that the gradation of moral value does not depend on a particular species membership – theories of that sort are referred to as “speciesistic” – but rather on the degree to which an entity has distinctive preferences. What follows from this thought is a symmetry thesis, according to which beings with equally distinctive preferences should be treated equally. A baboon for instance might have equally distinctive preferences as an anencephalic infant. Anencephalia is a disease that prevents the child’s brain to fully develop and causes the death of the child within a few days. If the preferences of a baboon and an anencephalic infant are indeed equally distinct and will never develop beyond this level, then we are either morally justified in taking organs from both or we are not justified to take organs from either of them.

Critics object that this approach neglects that “harm” is always experienced by an individual and this fact is overseen by advocates of utilitaristic theories such as pathocentrism. Therefore there is no justification for a xenotransplantation as long as a sentient being is harmed, for every living being that can experience the sensation of being harmed has an absolute moral value. Here, harm refers to more than just physical pain. Rather it describes a more encompassing concept to which wellbeing is the opposite.

Finally biocentrism ascribes a moral value to all living beings. Nevertheless, a gradation of the moral value of different beings is possible within this theory. A human being might be more valuable than a plant. In opposition to pathocentrism though, it is not the ability to have preferences, for instance the preference to avoid harm, but rather the fact that an entity is alive, that makes the living being morally valuable. What follows from biocentrism therefore is the call for treating animals and plants more carefully, not necessarily the claim that all living beings are absolutely equal when it comes to moral value.

The majority of professionals in Germany adopt an integrative stance which acknowledges anthroprocentric and biocentric elements. In practice, this means that animals are accorded certain rights, but they are not necessarily to be regarded as equal to humans. Consequently, supporters of this view are in favour of xenotransplantation where it may enable the preservation, saving, promotion and protection of human life.

In Germany, an integrative concept between anthroprocentrism and biocentrism is the most commonly argued for. Advocates of this position assume, that animals do have certain rights, but do not have the same intrinsic (moral) value humans have. Thus, they condone xenotransplantation in cases where the procedure could save, improve, or preserve human life.

However, the animals well being during the procedure also needs to be taken into account. The German animal welfare act requires to minimise the animals pain to an “indispensable” amount (sect. 7 para. 1 TierSchG). Experiments involving animals are only to be conducted if the pain that will be inflicted upon the animal is “ethicallly justifiable” (sect. 7 para. 2 TierSchG).

Ethical implications of xenotransplantation concerning human beings

Another aspect of xenotransplantation which provokes discussion concerns the assessment of its risks and benefits. The allocation of available organs raises the question, whether an economically and logistically extensive research can be justified in the face of the fact that it will only help a relatively small group of people, namely people who need an organ. The question is whether the effort could be spent in a way that helps more people in the outcome. In addition, xenotransplantation is still a highly experimental procedure that requires extensive research including experiments on human beings in order to achieve any progress at all. 

Its advocates stress its value, for instance in helping a seriously ill patient. The critics point out that the risks involved in using transplants of animal origin remain obscure. In the main, these risks concern the rejection reactions, which so far remain beyond satisfactory medical control, and the possibility of transferring infectious pathogens to the transplant recipient and other persons. Risks of a possible infection and a repulsion of animal organs due to the genetic differences between animals and human beings are even higher. The problem does not only involve the possibility of transmission of already known human pathogenic infections but also the risk of infections that formerly weren’t human pathogenic evolving into human pathogenic infections. There is a disagreement though concerning the likelihood of this case. Moreover, in order to meet the ethical requirements of informing the patient of possible risks, there is a claim for public notification of the risk of infections that could evolve into human pathogenic infections. Furthermore there is a discussion concerning the effects of the availability of animal organs on the willingness for organ donation resulting in a possible shortage of “higher quality” human organs.