Thursday, August 2, 2012

News from Germany: Organ Transplantation and “Research Donations” – Round 2?

On July 21, 2012, the Bundespraesident, the German Chancellor Dr. Angela Merkel and the German Health Minister D. Bahr finally signed the “The Act to Amend the German Transplantation Act” (“Transplantationsgesetz”, “TPG”.  It is published in the Federal Law Gazette Number 1, BGBl. I 35/2012, p. 1601 and became effective on August 1, 2012.  The act has been described here at PredictER News, July 20, 2012.

From day one, the act has had its critics, in large part, because of the organ transplantation scandal uncovered at the University of Goettingen (Germany) in June 2012.  An organ transplantation specialist is believed to have manipulated medical records in exchange for money so that several patients were able to receive organs through Eurotransplant earlier than it otherwise would have happened. Eurotransplant is responsible for the allocation of donor organs in Austria, Belgium, Croatia, Germany, Luxembourg, the Netherlands and Slovenia (information from Eurotransplant). Currently, because of the suspicion of homicide in 23 cases, the German Law Enforcement Agency (“Staatsanwaltschaft Goettingen”) is leading investigations. The Staatsanwaltschaft Goettingen is investigating if the manipulation of the medical records caused the death of other patients. The agency is investigating whether or not patients were not able to obtain organs in time, because the donations had been given to other patients for whom the medical records and (with that) the listings in Eurotransplant had been manipulated.

Because of this severe incident, the German Organ Foundation, among others, is already advocating for amendments to the TPG to better ensure the safety and quality of organ donations. A better control system other than as regulated in the Act to Amend the German Transplantation Act should be established.  For now the German Health Minister does not see the necessity for changes; however, he does not exclude changes in the future.

Consequences for Research with Human Cells and Tissue?

The incident might also influence the use of human cells and tissue in research. At the moment, the confidence in the fairness of organ and tissue donations has decreased. It remains to be seen, to what extent the organ transplantation scandal will influence research donations and if the German Organ Transplantation Act will be amended again. In both cases, the trust of the citizenry has to be regained.

-- Bianca Buechner, Ph.D., LL.M. Candidate
Indiana University Robert H. McKinney School of Law

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