Legal aspects

II. Legal aspects

1. Germany

The German Transplantation 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: Transplantation Act – TPG)(see module German transplantation law).

 The Act was passed by the German Bundestag on 5th November 1997 and came into force on 1st December 1997; an amended version was published on 4th September 2007.

The legal provisions governing post-mortal organ donation under the TPG

The TPG stipulates the so-called extended consent solution(see module Narrow and extended consent solution), and  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(see modul organ donor card), or if the next of kin consent to the donation (§ 4 TPG). Furthermore, 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 legal provisions governing living donation under the TPG

Living donation is only permissible in Germany if the donor is of full age and capable of consent, has been adequately informed and has consented to the removal (informed consent), and is considered suitable as a donor according to medical judgment; furthermore, it has to be ensured that the person is exposed to no foreseeable risk beyond that of the operation (§ 8 para. 1 TPG). Whereas self-renewing organs or tissue may also be donated to unknown persons, the donation of non-regenerative organs (e.g. kidney, parts of the liver) is only permissible for the purpose of transplanting to relatives of the first or second degree, spouses, registered life partners, fiancé(e)s or other persons with whom the donor obviously has a very close personal relationship (§ 8 para. 1 no. 4 TPG).

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. Accordingly, 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 German Medical Association’s Guidelines for waiting list inclusion(see module Guidelines of the German Medical Association (Bundesärztekammer) for waiting list inclusion); 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 of the Federal Medical Association (Bundesärztekammer)(see module Guidelines of the German Medical Association (Bundesärztekammer) for organ allocation).
The TPG further stipulates that underage persons may declare their willingness to donate organs donation 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). Health insurance funds shall further invite the persons insured with them at regular intervals to make a personal decision regarding organ donation.

Guidelines and opinions of the German Medical Association

The Transplantation Act (TPG) commits the Bundesärztekammer (German Medical Association) to establish Guidelines for specific areas of transplantation medicine, which must account for the current state of medical science (§ 16 TPG). These Guidelines have been elaborated by the “Permanent Committee on Organ Transplantation of the Bundesärztekammer” (Ständige Kommission Organtransplantation der Bundesärztekammer) and have been updated at regular intervals to account for new findings in medical science. The interdisciplinary Committee includes experts from the fields of medicine, law and philosophy, but also patients as well as relatives of organ donors. Pursuant to the provisions of the TPG the Bundesärztekammer has issued the following Guidelines:
• Guidelines for the determination of brain death(see module Guidelines of the German Medical Association (Bundesärztekammer) for the determination of brain death)
• Guidelines for waiting list inclusion(see module Guidelines of the German Medical Association (Bundesärztekammer) for waiting list inclusion)
• Guidelines for organ allocation(see module Guidelines of the German Medical Association (Bundesärztekammer) for organ allocation)
• Guidelines regarding essential measures for the protection of organ recipients(see module Guidelines of the German Medical Association (Bundesärztekammer) regarding essential measures for the protection of organ recipients)
• Guidelines regarding quality assurance measures(see module Guidelines of the German Medical Association (Bundesärztekammer) regarding quality assurance measures)

In addition to these Guidelines, which are legally binding for all actors involved in the transplantation process pursuant as defined by § 16 TPG, the Bundesärztekammer has published recommendations and opinions on the issue of organ transplantation(see module Recommendations and Opinions of the German Medical Association (Bundesärztekammer) with regard to organ transplantation). 

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(see module Opinion of the German Medical Association (Bundesärztekammer) on xenotransplantation) the Bundesärztekammer 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(see module The criterion of brain death) may give rise to lively debate – particularly in Japan(see module Legal regulations 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. Depending on the respective legislation, some countries apply the “dissent solution”(see module Dissent solution), the “narrow” or the “extended consent solution”(see module Narrow and extended consent solution) or the “information solution”(see modul Information solution). 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 Italy, Luxemburg, Austria(see modul Legal regulations in Austria). Portugal, Slovenia, Spain, the Czech Republic, and Hungary. In Belgium, Finland and Norway, the extended dissent solution is applied, i.e. the next of kin can also object to organ donation. Denmark, Greece, Great Britain, the Netherlands, Switzerland, as well as Germany apply the extended consent solution which provides that the deceased person must have consented to organ donation during their lifetime, e.g. in the form of an organ donor card(see module Organ donor card). Where this is not the case, the extended consent solution allows 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. 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. In France and Sweden, the so-called information solution is applied: Organs may be removed unless the deceased person objected to post-mortal organ donation during their lifetime. While the next of kin must always be informed about the intended organ removal, they have no right to object to it.

  Previous: I. Medical aspects Next: III. Ethical aspects