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Is Post‐Mortem Organ Donation a Duty Towards Society and Can It Be Justified by Public Interest? Recent Bills to Amend the German Transplantation Law

The issue of organ donation from deceased donors remains unsatisfactorily resolved in Germany. The number of donors has remained very low in recent years. Consequently, the German Bundestag was holding a debate on two MP bills aimed at amending the organ transplantation law. Two main bills were presented by different groups of MPs. The more controversial of them, supported by the Minister of Health, tried to introduce the opt-out model into Germany’s organ transplantation system. The second one aimed to improve the existing opt-in model. During the final voting, the Bundestag decided against the opt-out model and in favour of the improved opt-in one. In some experts’ eyes, an opt-out model imposes an obligation on the citizens to donate an organ after brain death. Can such a duty to the society be justified by public interest or other principles? The goal of this article is to offer an answer to this question by analysing the provisions of the German constitution.

the Health Minister Jens Spahn decided to go further and introduce the opt-out model into the German transplantation system, in the form of "double objection" (German: doppelte Widerspruchslösung) 7 . A similar system is in place in Poland 8 . The minister's plans were supported by the German Chancellor Angela Merkel, but they failed to get the support of a majority in the CDU/CSU/SPD coalition. Therefore two main competitive bills have been introduced by groups of individual MPs, unrelated to their party affiliation. The German parliament, the Bundestag, considered them in June 2019 and October 2019 but failed to reach a solution. The first bill regulated the opt-out model with the double objection procedure in the Transplantation Act 9 ; the second one, which was less radical, gave priority to strengthening the citizens' willingness to donate organs 10 . The final voting took place on 16 January 2020, when the improved opt-in proposal was adopted by 432 votes in favour, 200 against and 37 abstentions 11 . Interestingly, a survey carried out by ZDF television on the same day showed clear public support for the opt-out model with a large 61% advantage over 36% 12 . Both bills provoked a lot of discussion, both in the media and among legal scholars. Let us therefore look at this discussion and analyse the ethical and legal problems with the proposed solutions.

Some facts about organ donation
The organ transplantation process in Germany needs to be reformed. As mentioned above, 9,400 people are currently awaiting transplantation, while only 955 donors per year decide to donate organs post-mortem 13 . However, these statistics do not reflect the entire picture. In a single case of donation, many organs are usually donated. In practice, most organs -kidneys, pancreas, liver, heart and lungs -can be collected for transplantation at the same time. This means that, ideally, one donor can provide organs for several patients on the waiting list 14 . On average, 3.3 organs are removed from a donor every time. This number explains the fact that in 2018, a total of 3,113 organs were removed from 955 donors 15 . From this perspective, the shortfall in the number of donors seems less disastrous.
provisions concerning paperwork were simplified and improved. Another aim of the new law was introducing better care for the families of a deceased donor. Details of the bill available at: Spahn: Die Zahl der Organspenden kann weiter steigen [Eng. Spahn: The number of organ donations can continue to increase], Bundesministerium für Gesundheit, 1.04.2019, https://www.bundesgesundheitsministerium.de/gzso.html, accessed on: 15 August 2019. 7 Known also as the implied assent: in the case of the lack of the declaration of intent from the potential donor it is presumed that he or she agreed to donate his or her organs.

Legislation and practice to date
There are two basic models of consenting to organ donation: an opt-in model (a consent model) and an opt-out model (an objection model). Under the opt-in model, donation is only possible with the consent of the deceased. This model is used in some European countries 16 as well as in the USA 17 . Contrary to the opt-in model, in the opt-out model organs can be removed if there is no information about the donor's objection. This model is applicable in most European countries 18 . The distinction between the consent and objection models frequently leads to misunderstandings. These concepts often raise doubts and fears that in the absence of a clear declaration, such as a donor document, in the opt-in model there may be no consent for a donation, and in the opt-out model the absence of objection will always result in a donation. However, this is usually not the case, neither in practice nor in law.
The German law currently uses the so-called decision-making solution, or Entscheidungslösung 19 . This solution is a model of obtaining consent. Its name may be explained by the fact that the donor's decision should exist before the process starts. According to § 2 (1a) of the TPG, health insurance companies have a duty to send citizens a donor card along with their electronic insurance card 20 . On the so-called donor card, each insured person can decide whether or not to donate his or her organs. In principle, according to § 3 (1) (1) of the TPG, an organ can only be extracted if there is clear consent.
In accordance with § 4 of the TPG, in the absence of written consent or written objection, a doctor looking after the potential donor turns to their closest family. In such a case, the question to the relatives is asked in two phases. The first phase asks whether the potential donor during his or her life has made a statement about organ donation. The lack of such declaration does not mean that the donation cannot take place. The doctor then proceeds to the second phase, asking whether the relatives consent to organ extraction -i.e. the relatives decide on the donation. In their decision, the relatives of the deceased donor should respect his or her presumed will. The question about consent is asked in four steps: 1) whether there was a written statement from the brain-death donor; 2) whether there was a statement from the donor made to the relatives; 3) what was the presumed will of the potential donor; 4) what is the final decision of the relatives. Only after these four steps can organs be removed, provided that the relatives have given their consent.
In practice, a potential donor after brain death is kept in a stable state through appropriate stabilizing drugs. This is a kind of an intensive therapy applied in order to protect the organs 21 . During this time the physician talks to the family of the potential donor 22 .
This conversation is an indispensable part of the organ donation procedure. Part of the interview is held in the presence of the coordinator of the DSO. This procedure is internationally recognized as "best practice"; the presence of a well-trained transplant donor coordinator increases the chances of obtaining consent for organ donation 23 . The position of the relatives during such a conversation is extremely difficult. Most decisions about organ donation are made after a sudden, unexpected death 24 . For an ordinary person, the required intensive therapy that protects the organs after brain death does not differ much from the intensive therapy before brain death. Respiratory ventilation creates the impression that the person who has already been diagnosed with brain death is still alive; their vital signs are preserved and their temperature is stable 25 . Doubts often emerge as to whether the doctor was not mistaken in pronouncing brain death. In 2018, in Germany, this kind of decision was made in 1,416 cases, out of which 995 were positive and resulted in organ donation, whereas 421 requests were refused 26 .

The proposal for a "double objection" solution: the opt-out principle
In order to increase the number of transplants carried out, one group of MPs drafted a proposal to introduce an objection (opt-out) model, mentioned above. In this case, it is a double objection model, i.e. the so-called soft opt-out model 27 . According to this model, anyone can, during their lifetime, object to donating an organ either by making a relevant entry in the register of objections or by making a written statement. However, if there is no registered objection or no written form of such an objection, the attending physician is obliged to ask relatives whether they know about the deceased's objection to the removal of his/her organs 28 . So it is only the will of the potential donor that matters; as such, the term "double objection" is misleading. The only factor in the decision--making process should be the potential donor's will, not the will of their relatives. In practice, though, it is easy to imagine cases in which the will of the potential donor is replaced by the will of his or her relatives 29 . In the case of such a regulation, not much would change in practice. However, a theoretical approach to the problem shows that from the ethical perspective, our perception of the body has changed. The burden of proof has been shifted in line with the in dubio pro quaestus principle -in case of doubt to be resolved in favour of organ donation. It is one thing to consent altruistically to the organ donation and another to regard silence as consent to the organ donation. It is worth noting that nowadays our individual rights are strictly protected by law 30 . According to law, these rights should only be waived with our consent. However, as far as our organs are concerned, in the name of public interest, our consent is implied in the event of silence. The institution of implied consent is of marginal importance in law 31 . In this case, I ask whether an opt-out model can be applied in the name of public interest. Does this model not restrict our rights, and if it does, is this restriction justified?
4.1. Limitation of the right to self-determination. Articles 1(1) and 2(1) of the German Constitution In international medical ethics, the right to self-determination is often understood as the autonomy of the patient; in our case, it is the autonomy of the donor. The right to self-determination has become the central idea of medical ethics 32 . It is a mark of humanity, a fundamental and natural right that belongs to every human being. It even applies to mentally ill people, who due to a lack of legal capacity cannot exercise their free will to the same extent as others, as well as to people with damaged brain functions.
The autonomy of such people will be based on the fact that they have the right not to be merely an object in the decision-making process. They have the right to be treated as having a right to a decision that cannot be articulated. Therefore, the legitimate interests of such a person will be represented 33 . In medicine, the right to self-determination includes the patient's competence to make decisions about the treatment to be performed, as well as the right to donate organs 34 . According to the ethical concept of self-determination, people have a strong need to control their inner integrity. This statement is also in compliance with the Catholic Church doctrine. As a limitation of one's self determination, the Catholic catechism mentions disability and death: "It is morally unacceptable to directly cause permanent disability or death to one human being, even if this would prolong the lives of others" 35 . In the present case, however, we are talking about a donation after death. The opt-out solution is not entirely a restriction on the right to self-determination, as a potential donor has the opportunity to make a decision during his or her lifetime. In most cases, however, this possibility will again be merely theoretical. What citizen, especially young people (whose organs are the most sought after), thinks about death and enters objections in the register? This is a small number of people, because the majority of us try not to deliberate on death and for young people it is a very distant event. The opt-out model therefore takes advantage of this situation, a situation of some ignorance or indifference, and limits the right to self-determination by making a decision for the potential donor. Peter Dabrok, previous chairman of the 31  German Ethics Council (German: Deutscher Ethikrat) has called the opt-out model "the obligation to donate the organ with the possibility of opt-out" 36 .
The German Constitution 37 (German: Grundgesetz, GG), in Article 2(1) in conjunction with Article 1(1), protects fundamental rights by giving their holders the right to make decisions on their own behalf. In a negative sense, it also includes the principle of freedom not to have to deal with certain questions and decisions in order to preserve the right to self-determination 38 . These decisions include, in particular, decisions on medical treatment and, where appropriate, decisions on post-mortem procedures. The opt-out model therefore restricts the right to self-determination by taking a decision for the potential donor unless the donor objects. In theory there is a clear difference between a duty to make an informed decision and a duty to donate. The restriction of the fundamental right to self-determination by imposing an obligation to make a decision is definitely less severe than it would be in the case of the duty to donate. In view of the dramatic fate of patients on the waiting list and limited possibilities of alternative therapies, an obligation to make a decision is considered a comparatively less severe burden. In reality, though, the difference between both forms of obligations might be less clear: lack of action will in many cases result in an actual duty to donate and in removal of organs. Thus what law frames as a duty to decide might in reality be a duty to donate -and should be treated accordingly. Whether the restriction of the right to self-determination may therefore be justified by public interest and by the interest of the organ recipients needs further analysis (see: section 4.4).

The right to life and physical integrity. Article 2(2) GG
The Grundgesetz in the first sentence of Article 2(2) establishes the right to life and physical integrity. A person protected by this principle may decide autonomously about his or her integrity. This right derives from the right to self-determination enshrined in Article 2(1) GG 39 . The right to bodily integrity protects against physical health violations within the meaning of "biological and physiological" 40 . It protects mental health as well, if the violation leads to pain or a comparable effect 41 . The fundamental question is whether a person after brain death is protected by Article 2(2) GG. Constitutional protection ends with death 42 . Currently, in medicine, the moment of cardiac arrest and 36  circulatory arrest has been rejected as the moment of death in favour of the so-called brain death. Brain death implies an irreversible lack of brain functions including the ability to feel, think, and make decisions, while still maintaining vital bodily functions 43 .
Opponents of the brain death definition see it only as a criterion established for the purpose of organ donation 44 . This raises the question of possible abuses during what is referred to as the process of dying (German: Sterbeprozess) and the problem of trust in the healthcare system. Some experts argue the number of donations is likely to increase if confidence in the healthcare system is restored 45 . In view of the crucial importance of the fundamental right to life, and in view of the fact that it is only with this right that we can exercise other fundamental rights, we should be guided by the in dubio pro vita principle. This principle would extend the right to life also to a person diagnosed with brain death 46 . In such a scenario -even in the case of having secured consent of the person with brain death -every removal of organs would imply murder 47 . Nevertheless, we must remember that a person diagnosed with brain death is still dependent on a ventilator to breathe. When the equipment is switched off, the vital signs should stop due to brain inactivity. The brain death criteria are based on the signs of imminent death 48 . The legal interpretation is that there is no time between life and death and therefore the dying person is treated as a living person 49 . However, a person diagnosed with brain death is recognized by law as a dead person because all their vital functions are received by means of technological apparatus and there is no longer any hope of improvement. Therefore, such a person will not be protected by the first sentence of Article 2(2) GG 50 .

Does silence mean consent?
The remaining question is whether it is compatible with the right to self-determination to consider silence as consent in the absence of objections? In this case, there are two seemingly contradictory theories. The first rule, deriving from canon law, says: Qui tacet, consentire videtur. The second rule, which usually applies in civil law, treats silence as lack of declaration if there are no special circumstances that could be treated as an implied declaration 51 .
Qui tacet, consentire videtur, was adopted as a legal rule in Liber Sextus to be supplemented by ubi loqui potuit ac debuit. Here silence means consent if an objection could and should have been made 52 . The opt-out model it based on this reasoning. It means that the potential donor agrees to donate by keeping silent, because the matter is important enough that he or she should have expressed his/her will.
According to the second principle, silence is to be interpreted as an objection if there is an explicit expectation of a statement 53 . If we apply this principle to the opt-out model, it is obvious that, in the absence of an objection, consent to organ donation is not implied in case of silence. If we look at the second alternative, we can see that when it is applied here, the objection statement would be superfluous, because the very fact of silence expresses opposition 54 .
In my opinion, the principle of presumed consent contained in the-opt out model does not allow us to ensure that the posthumous organ donation actually corresponds to the will of the deceased and therefore we cannot be sure that their right to self--determination has not been violated 55 .

Potential justifications for making organ donation compulsory
Can an opt-out model that introduces a form of compulsory donation in some way be legally justified as an obligation to the society based on the principle of public interest or another principle? In order to answer this question, it is necessary to look at the relevant criteria that support this justification.
Firstly "if obligations for the constitutional existence of the community are indispensable and essential" 57 , and if they can be considered particularly close to public affairs and the functioning of the society 58 . The provision of a healthcare system is one of the basic duties of a state. The state has a duty to protect the life and health of the patients on the waiting list. However, the obligation to provide a sufficient number of organs cannot be derived from this state responsibility, nor does the functioning of the society depend on the number of organs provided. It is possible to obtain organs in other ways without imposing an obligation to donate them on the citizens. Secondly, a relevant reference in the text of the German Constitution is considered to be a necessary condition for imposing an obligation 59 . At the moment there is no explicit obligation to donate organs in the German Constitution. However, there is a possibility that such an obligation can be derived from other constitutional provisions. If we follow the principle that the state, by virtue of its sovereignty, can impose obligations, it is imaginable that such an obligation to donate organs could be postulated. In this case, we need to look at the limits of the state's ability to impose obligations onto its citizens. Those limits derive both from the constitution and from the form of the state. Through Grundgesetz, a liberal state was created that respects the freedom of the individual. This does not mean that the citizens do not have any obligations, but it is evident from the constitutional principles that imposing them is only possible to a limited extent 60 . The opt-out model implies a far-reaching obligation to donate organs after death. It is doubtful if this would not cross the constitutional boundaries.
Thirdly, at first glance, there is an obligation of solidarity between the individual and the society in which he or she lives and to which he or she is attached, as well as public interest in sufficient supply of organs for transplants. The existence of a shortage of organs in relation to those on the waiting list and the consequences of that shortage may in principle justify applying the principle of solidarity and public interest 61 . However, only a moral and ethical appeal can be inferred from this duty, and not a legal obligation 62 . Moreover, it should be remembered that the model of welfare state primarily obliges the state to act, not its citizens. Justifying such an obligations on the basis of a general clause of public interest goes too far. Although the citizen must pay social security contributions and taxes, the sacrifice of body parts, and thus the sacrifice of bodily integrity, cannot be expected for the sake of public interest. The case looks different in military service: here, the obligation to sacrifice life, the highest good one possesses, can be justified by protection of the country's sovereignty and the existence of the society which will be covered by the definition of public interest 63 .
Fourthly, both the principle of reciprocity under Article 2(1) GG and the principle of equality under Article 3(1) GG are supported by the simple probability that everyone may find themselves in a situation where they will need an organ. If any of us can be a potential recipient, we can deduct from this that everyone should also be a potential donor. However, such a solution must be based on the right to individual freedom.
Obligations are primarily grounded in the inaction principle 64 . It is difficult to derive from this a duty to take action, which is required in the opt-out model. Organ donation should be an act of goodwill, not an obligation.
Fifthly, the obligation to donate could also be based on obligations arising from human dignity contained in Article 1(1) GG. Supporters of the theory of mutual human obligations assume that the duty of the state is to ensure the inviolability of human dignity under the second sentence of Article 1(1) GG. The obligations of the state under this principle involve the protection of human dignity. They also include the duty of citizens to respect each other's dignity. They are obliged to refrain not only from acting in breach of human dignity, but also from behaving in a certain way and from tolerating certain behaviours 65 . A potential organ donor would violate his or her obligations towards other citizens if he or she violated the dignity of the recipient. The breach of values emphasizes the "duty of the individual (…) to respect the life of another human being" 66 . According to Luchterhandt, the moral duty to help other human beings becomes a legal obligation. However, he also sets limits to that, by restricting this duty to the one "who is closest to the helpless and who is capable of rendering assistance and who also fulfils it in a reasonable manner" 67 . Due to the anonymity of post-mortem donations, there usually is no relationship between the donor and the recipient. The human responsibilities that could result from close relationships are very different. The potential recipient would also be obliged to respect the will of the potential donor, e.g. his or her religious beliefs. Therefore, an obligation to donate cannot be based on this principle.
Sixthly, in German legal scholarship, the introduction of an opt-out-model represents a restriction of the right to self-determination (see section 4.1 above). To be constitutionally justified, a restriction of the right to self-determination in the form of an obligation to express one's opposition needs a legitimate purpose and has to respect the principle of proportionality. The protection of life or health of suffering patients on the waiting lists by increasing the number of organ donations clearly is a legitimate purpose. The conflict between the fundamental right to self-determination and the pursuit of a legitimate purpose therefore has to be solved by applying the principle of proportionality. The principle of proportionality refers to the principle of law that a certain level of proportionality must be applied in the case of interference with an individual right that is considered to be permissible in the public interest 68 . This principle is part of the fundamental modern concept of constitutional state 69 . The opt-out model thus would have to be: 1) appropriate in order to achieve the intended objective; 2) necessary, i.e. there should be no less severe means of achieving the objective, and 3) -according to German legal scholarship -adequate or reasonable (German: angemessen).
1) In the legal discussion on the proposed opt-out-model, objections concerning the appropriateness of the model have been raised. According to critics, it is far from clear whether the proposed model will in fact increase the number of organ donations. A limiting factor will in any case be the small number of brain dead persons -which cannot be increased by the opt-out solution 70 .
2) The decision if the opt-out model is necessary requires an analysis whether alternative, less invasive but comparably effective, solutions exist. Proponents of the opt-out model have tried to show that all previous or current solutions in Germany have so far failed to significantly increase the number of donated organs. However, it remains unclear whether this failure was the result of previous or current legal solutions or rather of structural deficits inside the medical transplantation system. The legal proposal moreover failed to evaluate the most recent legal reform of the transplantation system in 2019 (see: section 1 fn. 5). Naturally, advocates for the improved opt-in model argued that the combined effects of the 2019 reform together with their improvements would constitute a less invasive, equally effective solution. 3) Adequacy requires the measure to be proportionate to the weight and importance of the fundamental right involved 71 . There has to be a balance between the protected fundamental right and the conflicting public interest which requires its restriction. Intense restrictions require a particularly thorough examination. Applying this criterion, the restriction of the right to self-determination of potential organ donors in this case must be balanced with the interest of organ recipients to have a sufficient number of transplants. The proponents of the opt--out principle declare that the only burden to the citizens is to make a statement -a small duty which is easy to fulfil 72 . This argumentation does not go far enough, though. First of all, it should be noted that the citizen bears the risk of his or her opposition being disregarded due to an unfortunate set of circumstances. Furthermore, the opt-out solution does not only cover those who internally agree to a post-mortem donation, but have not expressly stated their will. The omission could have occurred due to completely different circumstances: either because the persons concerned were never confronted with the question, or because they were disinterested or because they didn't manage to take a decision yet. Another possibility is that a person refuses an organ removal, but does not wish to disclose it 73 . Nevertheless, in all these cases a non-action would have the consequence that in the event of brain death the persons concerned would automatically become potential donors and organ removal could be possible. Those grave consequences of not taking a decision -for different reasons -are not adequate to the public interest of increasing the number of transplants.
For good reasons, German law does not treat the absence of an objection as equivalent to a consent 74 . As already mentioned (see: section 4.3) silence usually means neither approval nor rejection but no declaration of will at all. There is no obligation to provide one's own body to third parties in the form of organ donation, as reflected by the very term organ "donation" 75 . The opt-out-solution creates a fiction and implies that a non-opposing person has declared something -which in reality he or she never did. Such purely implied, i.e. fictitious, consent in the core area of self-determination with regard to bodily integrity is inadmissible -especially with such serious consequences as organ removal. Therefore the proposal is not reasonable or adequate -and consequently not proportionate. Constitutionally, the restriction cannot be justified.

A bill to strengthen the willingness to donate organs: the opt-in principle
The second MPs bill promoted the opt-in model, which has been in place in Germany so far. Its aim was to introduce some improvements to the allocation system and to the structures of transplantation, seeing this as a method for increasing the citizens' readiness to donate.
It should be easier for citizens to provide evidence of their decision and to change it. The German Institute for Medical Documentation and Information (German: Deutsches Institut für Medizinische Dokumentation und Information) is working to create an online register for this purpose. It will be also possible to submit a declaration of organ donation when applying for an identity card 76 . Furthermore, the bill foresees a more intensive information campaign. It imposes an information obligation on general physicians, who should hold an information interview with their patients every two years, for which they can charge an additional fee refunded by the healthcare system 77 . Expenditure on transplant coordinators and hospitals carrying out transplantations is also assumed to increase. The solutions in this bill are based on the experience of Spain and Sweden, where priority was given to restoring citizens' confidence in the healthcare system, which in turn increased the number of people who consciously chose to donate an organ 78 .
The second draft followed the existing opt-in principle and argued that imposing the obligation to donate is incompatible with the German constitution and leads to violations of citizens' fundamental rights 79 . According to the supporters of this bill, there is no significant difference in the number of organ transplants between opt-out and opt-in countries and, in that case, why introduce another obligation for citizens that could potentially infringe their rights? 80 .

Final conclusions
The opt-out solution suggests the conclusion that in the event of an unresolved objection, everyone is obliged to accept a post-mortem removal of organs. In the case of an obligation to accept a post-mortem removal of organs, the individual rights of the party under such an obligation are already limited during their lifetime. Such a fundamental or solidarity obligation cannot be derived from the constitution and cannot be justified by public interest. In particular, human dignity itself cannot be used as a basis of its legitimacy. Nor can the duty of the state to protect the right to life and bodily integrity of the recipients of organs provide a justification. The restriction of the right to self--determination by imposing an obligation to express your opposition, has a legitimate purpose but does not respect the principle of proportionality.
The opt-in model seems to be more responsive to the society's needs. It does not impose an obligation on the citizens and, if other countries' experiences do not prove a statistically significant increase in the number of donors, why impose another obligation. The same outcome can be achieved through other methods that interfere with individual rights to a lesser extent.