Regulation of cell‐based medicine – the German experience

Abstract

In the member states of the European Union, the field of cell‐based medicine and tissue preparations is determined by the law of the European Community (EC). The implementation of the EC directives is mandatory and makes Community law binding in the EU Member States. The Tissues and Cells Act of July 20, 2007 transposed the Directive 2004/23/EC, which is setting standards for human tissues and cells, into German law. This Tissue Act is not a law on its own, but makes significant amendments of the Medicinal Products Act, the Transplantation Act and the Transfusion Act. According to the Amsterdam Treaty (1997) and the Directive 2004/23/EC itself, the national legislators may stipulate stricter provisions, thus exceeding the minimum requirements specified in this EC directive. Accordingly, a real harmonization of the standards for human tissues and cells within the European Union is not intended and not possible. The Directive 2004/23/EC includes minimum standards to ensure high quality and safety margins for human tissues and cell preparations released for clinical application in humans. The standards cover the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells. The German Tissue Act defines tissues and cell preparations as pharmaceutical drugs governed by the German Drug Act. The need for high standards in quality and safety is highlighted, most of the loopholes that might otherwise allow operation outside national drug legislation in the field of local tissue banking and tissue engineering have been closed. As a consequence, donated tissues and stem cell preparations are subjected to strict regulations which mainly aim to prevent the most serious adverse effects of allogeneic tissue transplants, the transmission of infectious pathogens. Whenever possible, a validated inactivation procedure should be included in the manufacturing process. Tissues and stem cell preparations now usually require national approval, a procedure which in principle is comparable, although somewhat simplified, to the well‐established national licensing procedure for blood components seeking post‐marketing approval from the national authorities (Paul Ehrlich Institute). According to the highly positive experiences obtained with the standardization and licensing of blood components combined with a local and national system for surveillance, it can be expected that the national approval and local and national surveillance of stem cell and tissue preparations will contribute to a significantly improved quality and higher safety profile for the patients. However, the bureaucratic efforts which are inevitable consequences of the new regulations are still a matter of some dispute.