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Germany Considering Opt-Out Law for Organ Donation, Again

The following open letter was published on March 9, 2024, by Renate Greinert of the German human rights group Critical Clarification about Organ Transplantation (KAO). I have translated it into English, but the entire open letter (in German) may be found under the “Open Letter” link below.

Summary of the letter:

  • Even though the Bundestag (the German Federal Parliament, which is comparable to the House of Commons of the United Kingdom) rejected a proposed opt-out rule for Germany in 2020 (a rule which would have made organ donation mandatory for all citizens unless they had previously opted out), the Bundesrat (similar to the British House of Lords) is now calling for just such an opt-out rule once again.

  • This would cause a total disenfranchisement of all dying intensive care patients with severe brain damage since organ-preserving techniques must begin before a diagnosis of “brain death” is made. These patients would thus automatically be given resuscitation or surgery to preserve organ viability for the benefit of third parties. For example, to meet the “therapeutic goal of brain death,” people would be given chest compressions in the event of their cardiac arrest to preserve their organs for transplantation.

  • Knowledge gaps in both the German general public and on the part of their legislators make it clear that neither group has a good understanding of what an opt-out policy would entail.

  • Currently, the use of non-heart-beating donors, also known as donation after circulatory death (DCD), is considered murder in Germany and is prohibited.

  • The open letter quotes the American doctors and bioethicists Robert Truog and Franklin Miller, who call for the abolition of the dead donor rule and the “justified killing” of critically ill (but not yet dead) patients to alleviate the worldwide shortage of organs.

  • The open letter calls for comprehensive public education about organ donation and asks politicians to uphold the civil rights of dying people with severe brain damage.

Open Letter – Motion for a resolution by the German Federal Council on the introduction of the opt-out rule as the basis for organ donation.

The German Federal Council [Bundesrat] is calling for the introduction of an opt-out rule for organ and tissue removal without individual consent, although the German Federal Parliament [Bundestag] had previously rejected this in 2020. The amended Transplantation Act, which came into force on March 1, 2022, called for an online register as part of the expanded consent regulation that documents the consent for, or rejection of, organ and tissue donation. To date, this electronic directory has not been fully implemented.

Curtailment of patient autonomy enshrined in the German Civil Code

If the renewed attempt to win a majority in the German Bundestag for the opt-out solution were crowned with success, every German citizen could automatically be made a potential organ donor and subjected to organ removal – unless he or she had previously objected. Such a regulation is not in line with the provisions of medical law on treatment consent enshrined in the German Civil Code, and would be tantamount to a fundamental disenfranchisement of all dying intensive care patients with severe brain damage.

Impact on patients’ rights and palliative care for the dying

The opt-out regulation would override the principles of medical end-of-life care and palliative medicine, and allow invasive measures such as resuscitation or surgery on all potential organ donors in the context of so-called donation-centered, organ protective therapy for the benefit of third parties without the consent of the patients. The current Transplant Act’s extended consent solution, on the other hand, provides for ethically, legally, and medically justified donation-centered treatment only on the basis of the patient’s wishes, especially since the dying process of an organ donor is completely different from that of a person receiving palliative care – and for his or her relatives as well.

A high willingness to donate organs, but a good deal of ignorance about the intensive therapy of organ donors for the benefit of others

The German Federal Council considers the introduction of the opt-out regulation to be legitimate, despite its incompatibility with patient autonomy, based on a supposedly predominantly positive attitude towards organ donation among the population. However, it turns out that the high willingness to donate organs is due to information gaps, as many people do not know exactly the difference between death and brain death. One indication of this is that resuscitation of a dying person is rejected by the majority (study). However, in the case of a declaration of consent for organ donation, resuscitation measures for the purpose of organ removal may well take place. The obvious contradiction is not surprising, because the information documents of the Federal Center for Health Education do not contain a detailed explanation of the life-prolonging, donation-centered intensive therapy to be used for every organ donor.

Knowledge gaps also exist among legislators:  the organ donation process begins BEFORE and not AFTER brain death

The general ignorance about the organ-protective treatment concept, which has long been criticized in the scientific literature, seems to be widespread even in the German parliament. In 2020, the members of the Bundestag passed a transplant law that made donor recruitment unfeasible. It did not allow access to the organ donor register until after the brain death  had been determined. However, the donation-centered intensive therapy must begin before the onset of (brain) death. For this reason, the German Interdisciplinary Association for Intensive Care and Emergency Medicine called on the legislators to quickly make an amendment: inspection of the organ and tissue donor registry must be allowed before brain death.

The legally required separation of intensive care and transplant medicine no longer applies

In 2021, the proposed amendment of the Transplantation Act demanded by the German Interdisciplinary Association for Intensive Care and Emergency Medicine promptly took place: medical staff were allowed to view the registry before brain death was determined – either to initiate palliative care for the dying – or in the case of a declared willingness to donate organs, donation-centered intensive therapy must be started before brain death. In addition, in the event of expected brain death, there is an obligation to provide information to the transplant physicians, i.e. while the patients are still alive. Previously, intensive care physicians were only obliged to provide information to the transplant medical staff after the brain death had been determined.

With this amendment, the legislators abandoned a central principle:  the strict separation between

·         the treatment carried out exclusively for the benefit of the individual patients by the intensive care staff in the respective clinic

·         and the transplantation medical organ extraction by doctors coming from outside, guided by external interests.

Opt-out policy and the “therapeutic goal of brain death”:  patient rights would be nullified

Under an opt-out policy, the changed obligation to provide information would have far-reaching consequences. The patient rights of brain-damaged, critically ill intensive care patients would be nullified since the organ donation process does not – as is always claimed – begin “after death.” By law, brain death as a prerequisite for organ removal would have to be waited for in people who have suffered, for example, a stroke, a cerebral hemorrhage, a traffic or sports accident. However, while waiting for the brain death diagnosis, the life-prolonging, donation-centered intensive therapy with the “therapeutic goal of brain death” would have to be applied. “Already, after the determination of brain death, the […] [idea of] chest compressions in the event of a cessation of the heartbeat for the purpose of organ preservation is a daunting idea for many. Should this even be mandatory for potential donors, i.e. dying people […]?” askes internist and chief physician Prof. Dr. Stephan Sahm  in the Frankfurter Allgemeine Zeitung.

The donor category of Non-Heart Beating Donors:  discarded as killing in Germany

The German Federal Council justifies the requested new regulation primarily with the fact that the opt-out solution forms the legal basis in all European countries “with a high volume of organ donations.” This derivation of higher donor numbers ignores a crucial fact: especially in countries that are considered exemplary, such as Spain, Belgium, or the Netherlands, a significant proportion of organ harvests are not based on the brain death criteria established in Germany by the German Medical Association. In addition to ‘organ donation after brain death,’ another donor category has been introduced in these countries: the so-called non-heart beating donors (NHBD; current term donation after circulatory death: DCD).

These are patients whose lives are no longer lost solely due to severe brain damage. Because the brain death criterion has been abandoned in NHBDs, organ resources can be significantly increased by this group of donors alone. In a large proportion of DCD multi-organ donors (Maastricht category III), a ‘controlled cardiac arrest’ is produced as part of a treatment discontinuation. In Germany, the Central Ethics Commission has ethically rejected this method as killing. The German Federal Ministry of Health also declared the NHBD donation to be a procedure to be rejected. Likewise, the majority of the German Ethics Council disapproved of the extension of organ extraction to Non Heart Beating Donors.

“Justified Killing” to reduce the global shortage of organs

In the course of the international debate about the ethical problems of this donor category, however, the renowned American bioethicists Robert D. Truog and Franklin G. Miller pleaded for the abolition of the ‘dead donor rule,’ which makes the death of patients a prerequisite for organ removal. They speak bluntly of “justified killing” (p. 42) in order to alleviate the worldwide “shortage of organs.”

 In Spain, but also in the Eurotransplant network countries of Belgium, Austria, and the Netherlands, NHBD organ harvesting is practiced. It has been contributing to the increase in the number of donors for years. In Belgium and the Netherlands, the donor rate could be further increased by combining donation after circulatory death with active euthanasia, which is legalized by law there. For example, in 2022, the proportion of DCD donors in the Netherlands (57.89%) exceeded the percentage of organ harvesting from so-called heart-beating donors (‘organ donors with beating hearts after brain death’) [Source: Eurotransplant Annual Report, S. 3].

Is an opt-out regulation being considered in order to exploit the DCD donor potential for Germany as well?

If the German legislators intend to maximize the number of organ donors at all costs, possibly they are introducing the opt-out regulation as way to tap into the DCD donor potential that could be ‘exploited’ in Germany. This would be accompanied by an undermining of our palliative medical culture and the patient autonomy guaranteed in the German Civil Code. Dying patients with severe brain damage would potentially be legally deprived of the right to make their own decisions on the basis of the opt-out rule, and intensive care physicians, in spite of their ethical vows under the Geneva Doctors’ Code, would be legally obligated to put aside the well-being of the dying patients without the patient’s consent.

The German Federal Council’s attempt to win a new majority against the Transplant Act’s extended consent solution, which came into force on March 1, 2022, is unacceptable. We appeal to all responsible politicians to uphold the rights of a dying person with severe brain damage who is being treated in intensive care and also the rights of their relatives and the treating intensive care staff. The legislature should oppose the instrumentalization of the State as a quasi-organ procurer.

We would like to invite the media to report on the recent reforms of the transplantation legislation (2021). The public must be comprehensively informed about the legal tension between a living will and the donation-centered intensive therapy associated with an organ donation declaration, which begins before brain death, in order to be able to make an informed decision for or against organ donation.

Renate Greinert

Editorial Office

Critical Clarification about Organ Transplantation


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