Organ Transplantation

Last update: April 2013
Contact: Lisa Tambornino

Authors

I. Medical aspects

The medical use of the word transplantation refers to the replacement of organs, body parts, tissue and cells for therapeutic purposes. Two basic categories of transplantation can be defined: autologous and allogeneic. In the case of an autologous transplantation tissue or cell material is simply moved from one part of the patient's body to another – in other words, the donor and the recipient of the transplant are one and the same person. When organs, tissue or cells are transferred from one member of a given species (who may or may not still be alive) to another member of the same species, the transplantation is referred to as being allogeneic. Further qualifying terms include syngeneic transplantation(see module Syngeneic transplantation), i.e. transplantation between identical twins, xenotransplantation(see module Xenotransplantation), which refers, for instance, to transplantation between animals and humans, as well as alloplastic transplantation(see module Alloplastic Transplantation), in which human organs are replaced by artificially manufactured ones.

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(see module 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(see module Transplantation immunology and immunosuppression), could be addressed and at least to some extent solved through the experience gained and the development of immunosuppressive drugs(see module Immunosuppressive medication).

The present state of research

About two decades ago, transplantation medicine emerged from its phase as a field of experimental research and today its techniques are recognized as being part of standard professional practice in all developed countries. 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. According to the German Foundation for Organ Transplantation (Deutsche Stiftung Organtransplantation – DSO)(see module DSO), an average of eleven organs are transplanted every day in Germany alone. In the great majority of cases this involves kidney transplants(see module Kidney transplantation and renal replacement techniques), followed by liver transplants(see module Liver transplantation, living-donor liver donation and split liver transplantation) and heart transplants(see module Heart Transplantation). Less common are transplantations of the pancreas(see module Transplantation of the pancreas) and lungs(see module Lung transplantation).
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(see module Transplantation immunology and immunosuppression), 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(see module 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(see module 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.

Organ shortage

At present there is a large discrepancy between the number of patients who require a transplantation on the one hand and the number of available organs on the other. According to statistics gathered by the German Foundation for Organ Transplantation (Deutsche Stiftung Organtransplantation – DSO)(see module DSO), in 2012 about 12,000 people were waiting for an organ to become available – over 8,000 of them for a kidney. Each year about 1,100 people die who could probably have been saved if a suitable organ had been available in time.
As a means of dealing with the ongoing organ shortage, new techniques have been developed such as split liver transplantation and living donor liver transplantation(see module Liver transplantation, living-donor liver donation and split liver transplantation). Also, research continues into alternatives such as xenotransplantation(see module Xenotransplantation)and alloplastic transplantation(see module Alloplastic transplantation).
With the aim of increasing the number of donated organs, the so called Opt-In Solution was introduced in Germany in 2012. It provides that in the future all Germans who are 16 years old or older, are to be regularly questioned about whether they want to donate organs after death. Since there are many people who support the organ donation but until now didn’t express their support, the legislator hopes to increase the number of donated organs through the reform. Although according to information provided by the DSO, the number of organ donors in 2012, in comparison to the last year declined by 12.8%. In 2013 a further decline of these numbers is reported and hence reached its lowest point since 2002. In accordance with the assessment of DSO, the manipulation scandals that became known in 2012 lead to this decline in the organ donations–several transplantation clinics were accused of manipulating data for helping patients to get a donor organ faster.
Recently a suggestions made by the Nuffield Council on Bioethics caused stir in Great Britain: In order to raise the willingness for post mortal organ donation, the British state should bear the funeral costs of those people who declare oneself ready to spent their organs after death. The current debate focusses on benefits and risks arising by such a regulation.

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 law on organ and tissue donation, removal and transplantation (“Gesetz zur Spende, Entnahme und Übertragung von Organen und Geweben” (TPG)(see module TPG). The TPG stipulates that three agencies in particular must be involved in the organisation of a post-mortal organ donation: firstly the hospitals, secondly the German Foundation for Organ Transplantation (DSO)(see module DSO) and thirdly the international allocation agency Eurotransplant(see module Eurotransplant). It is the task of the hospital staff to diagnose brain death in accordance with the Guidelines of the German Medical Association (Bundesärztekammer)(see module Guidelines of the German Medical Association (Bundesärztekammer) for organ allocation), 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(see module 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 transplant represents a possible alternative to post-mortal donation. According to German transplantation law(see module 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 minimized as far as possible, and also to preclude any possibility of abuse or trading in organs, every potential case must be thoroughly investigated by an expert commission beforehand. As well as comprehensive laboratory tests to determine the respective blood groups and other medical factors such as HLA compatibility(see module Transplantation immunology and immunosuppression), 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 Foundation for Organ Transplantation DSO, 795 kidney transplantations using organs from living donors were performed in 2011, and 71 liver segments from living donors were transplanted. Living donor transplantations are increasing in number in the last years. 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. Since the amendment of the transplantation act entered into force and the Social Insurance Code (SGB V) being changed, the legal uncertainty regarding treatment and aftercare of the donor is eliminated: The health insurance of the organ recipient has to pay any costs which incurred for the donor.
In some countries, such as Switzerland(see module Legal regulations in Switzerland), so-called cross-over transplantations are allowed. In such cases suitable pairs are brought together which display matching, i.e. corresponding blood group incompatibility. In one specific case(see module Admission of a cross-over living donation) 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.

Next: II. Legal aspects