Organ transplantation is an important field of medicine, which contributes to saving the lives of seriously ill individuals. It is hence all the more important that the population have trust in this area of medical provision and care giving. Every individual must have the possibility of making his or her own decision about organ donation on the basis of adequate information. This applies as well to the question of when the person is dead.
In order to strengthen confidence in transplantation medicine in Germany, transparency and an open social discussion are necessary. The German Ethics Council would like to advance this with its current opinion, which deals exclusively with organ donation following brain death. To that effect the Council emphasizes, on the one hand, the broad consensus on many elements concerning the understanding of death and on an appropriate handling of brain-dead individuals. On the other, however, it also highlights the existing controversies. These controversies relate to the question of whether the criterion of brain death is a convincing one for the death of the individual. They relate, too, to the question of whether brain death suffices as a prerequisite for the ethical and constitutional legitimacy of organ removal even in cases when it is not equated with the person's death. These questions cannot be answered solely through the competence of scientific or medical experts, but instead require ethical reflection.
The German Ethics Council unanimously holds that brain death should be adhered to as a precondition for postmortem organ removal. The majority of the Ethics Council is concomitantly of the opinion that brain death is a sure indication of death and that the donation of vitally important organs should only be permissible if the death of the possible organ donor is certified (Dead-Donor Rule). A minority of the German Ethics Council, in contrast, does not consider brain death equivalent to the person's death and assigns brain death merely the role of one necessary criterion for removal of vital organs.
In the interest of a reliable diagnostics of brain death, the German Ethics Council sees the medical profession as duty-bound to continuously adapt its methods to advances in science, as well as to implement these safely in practice. Through relevant professional training, advanced training and continuing education, the demanding professional expertise of examining physicians can be ensured. Physicians with relevant expertise should be available in a comprehensive and timely manner.
Additionally, the German Ethics Council finds it necessary to improve the information and communication surrounding organ donation. Its recommendations cover discussions with donors' next of kin; education of the population; and the appointment of authorized transplantation representatives.
Discussions with and counseling of those persons, who are required in lieu of the possible donor to make a decision regarding an organ donation, should already be permitted to start prior to the determination of brain death. This ought to be clarified in Section 7 of the Transplantationsgesetz (Transplantation Act). Appropriate frameworks for these discussions should encourage communication that is non-directive and open in outcome, and should also respect specific cultural and linguistic needs.
In view of the central function of transplantation representatives for the entire process of organ donation, the German Ethics Council finds it indispensable to create the legal requirements in all German federal states without delay and pursuant to federal law so that transplantation representatives can be assigned in hospitals conducting organ removals and can fulfill their duties adequately.
Materials for education of the population about the "entire scope of the decision" (Section 2 (1) Transplantation Act) concerning organ donation should be supplemented. This should include, among other things, information about a possible collision between a patient's advanced directive and organ-donation declaration, as well about the kind, extent and point in time of organ-protective measures, which for the possible organ donor may already be required under certain circumstances prior to diagnosis of brain death in order to preserve organs to be removed. Furthermore, materials should contain information that in other countries different rules regarding organ removal may apply to German citizens who are traveling there.
In respect to measures for organ protection, the majority of the German Ethics Council also perceives the need for legal action. For cases where the organ donor's assent to organ-protective measures cannot be determined, there should be legal regulation concerning which persons are permitted to make the decision regarding initiation of such measures prior to determining brain death. The legitimacy of conducting organ-protective measures pending final determination of brain death should be tied legally to additional requirements.
In a dissenting opinion, three members of the German Ethics Council reject the suggested legal regulation of organ-protective measures prior to determining brain death; they explain that a physician's contract of care concentrates fundamentally on the welfare of the patient and not on a theoretical possibility for organ donation. They hence find the differentiation of intensive-care activities into patient-oriented versus organ-protective measures clinically irrelevant and misleading.
The complete text of the opinion can be accessed online here (in German). An English version will be available in due course.