Impact of the German tissue act on xenotransplantation
Authors: Schmidt H. 
Published: September 2010

In Germany a Tissue Act was introduced 1st of August in 2007. This act is reflected by modifications of the Transplant Act, the Act for pharmaceutical agents and the Transfusion Act. It differentiates organs and tissues. Several terms are defined by this new act. The term Tissue includes cardiac valves, vessels, cornea, skin, bone marrow, tendon, bone, and also cells such as hepatocytes, ovary cells, dendritic cells, chondrocytes, osteocytes, and adipocytes. Any institution, which is involved in resecting tissue, tissue analysis, processing tissue, tissue storage and preservation, its handling and transport including redistribution is called Tissue Institution. A registry for monitoring the Tissue Institutions and their specific tissue handling was implemented. Follow‐up of any tissue is now legally required. Hospitals have the chance to get actively involved in any part of tissue handling. The parallel organ and tissue procurement in brain dead persons has been addressed by this law, but important specifications are missing. Organ donation has mandatory priority. Since Germany has a tradition for organ scarcity, a shortage for tissues derived from non‐transplantable organs such as valves, pericard, hepatocytes, and islets will be a concern also in the future in Germany. Shortage of distinct tissues has to be defined and depending on the needs of the patients rules for allocations are required. This in turn will require waiting lists for patients, who are in need for tissues. Depending on the development in organ and tissue shortage the need for xenogenic agents will receive further attention.

There were no concerns of safety in tissue processing in the past in Germany. However, the European Law required to introduce a German Tissue Act. Many processes in Tissue Banking were not well defined before this act was implemented. Now, all processes need authorized Tissue Institutions, which is both money‐ and person‐demanding. Anyone involved in tissues has now tremendous more administrative work to overcome. Many routine procedures are not allowed anymore by law unless all legal requirements will be fulfilled. Many surgeons e.g. need on a daily base vessel for reconstructing the resected tissues. Once the surgeon has no backup of a Tissue Institution, which has the license of obtaining, preparing and storing vessels, they need to buy a vessel from a Tissue Institution while the surgery has to go on.

The advantage of this act is that standard procedures will be worked out in more details and quality of tissue transplantation will improve. This in turn will result in improved safety for the patients.

This new act will also raise the discussions in the scientific community, how it can be transferred into practise. This debate will also cover the concerns on organ and tissue scarcity. To overcome the predictable limitations in Germany a stronger wish for alternative therapeutic strategies will be articulated in the scientific community, but also in the public. This may enhance the interest to support the development of therapeutic xenogenic agents, especially in combination with e.g. biotechnological implants.

A network of Tissue Institutions will develop, which will be usable also for introducing new xenogenic agents into clinic. Standard operating procedures for handling human derived tissues will be applicable in part for xenogenic tissues and organs. Therefore, besides the problems introduced by the German Tissue Act, there is a chance of raised interest for alternative transplantation strategies including the use of xenogenic therapeutics.