Abstract

SO.06.10

The effect of the new EU quality and safety standards for human tissues and cells on cornea and tissue banking in Germany

Bredehorn T., Duncker G. I. W.
University Eye Clinic, Halle

The EU-Commission has proposed new quality and safety standards for human tissues and cells used in therapy throughout the European Union. The measure aims to ensure comprehensive binding requirements for these human substances from donor to patient. The Directive sets out clear safety and quality standards on donation, testing and procurement for human tissues and cells regardless of final use, including transplantation and related medical applications. Binding ethical rules and to decide which cells and tissues are permitted, are strictly the responsibility of the Member States. The proposal calls on Member States to collaborate in implementing the proposed measures and to establish accreditation and monitoring structures. Technical standards will be updated, following the structure of the Blood Safety Directive and pharmaceutical law. In Germany requirements in accord with the pharmaceutical law already exist for the banking of tissues and cells, under inclusion of procedures for tissue engineering. At present, many people work under temporary arrangements tolerated by the authorities. For cornea banking in Germany equal requirements and the permission for manufacturing were discussed in the frame of a new tissue and cell transplantation law. A current overview on this topic will be the main part of this lecture.

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