[Influence of European regulations on quality, safety and availability of cell and tissue allografts in Germany].

The transplantation of allogenic tissue (bone, cartilage, tendon, skin, amnion and special preparations such as demineralised bone matrix and acellular dermis) is an important component of the treatment of bone and soft tissue defects, particularly in traumatology and orthopaedic, reconstructive and plastic surgery. In Germany, the requirement for such tissue transplants is met by supply from local tissue banks (in particular bone banks) and a small number of regional and national tissue banks. These banks operate on the basis of the "Guidelines for Bone Banks" laid down by the German Chamber of Physicians, and of the German Drug Law (AMG). The 2004/23/EG guidelines issued by the European Parliament and ratified on 31/3/2004 define the quality and safety standards for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. These guidelines will have a major impact on all aspects of tissue banking and transplantation. In particular, the new guidelines will remove the possibility for local tissue banks to operate outside of national drug laws ( section sign 4 a [4]). The currently in draft law on "Quality and Safety of Human Tissues and Cells" ("Tissue Law") of the Federal Health Ministry seems to be heading in this direction, but it also includes possibilities for the continuation of local banks. An additional European guideline draft "Proposal for the regulation of advanced therapeutic medical products" is currently under discussion. This paper assesses the impact of these new pieces of legislation on the quality, safety and availability of human cell and tissue transplants in terms of the current situation and future prospects in Germany.