ISSUE: On August 1, 2007, the Law on the Quality and Safety of Human Tissues and Cells came into force. IMPLICATIONS: As a consequence of the new legislation on human tissue, legislative changes were effected upon the Law Regulating Transplantations, Medicine Law and Transfusion Law and the regulation of pharmacies as well as the operating regulations for wholesale pharmaceutical holdings. RESULTS AND CONCLUSION: The substantial increase in regulation caused by the Tissue Act far exceeds the requirements of the EC directive on tissues. As such, it has resulted in a huge increase in material (financial, human) and bureaucracy, with no significant gains in safety or quality in an area that had functioned well under the previous legislation. Copyright 2009 S. Karger AG, Basel.
ISSUE: On August 1, 2007, the Law on the Quality and Safety of Human Tissues and Cells came into force. IMPLICATIONS: As a consequence of the new legislation on human tissue, legislative changes were effected upon the Law Regulating Transplantations, Medicine Law and Transfusion Law and the regulation of pharmacies as well as the operating regulations for wholesale pharmaceutical holdings. RESULTS AND CONCLUSION: The substantial increase in regulation caused by the Tissue Act far exceeds the requirements of the EC directive on tissues. As such, it has resulted in a huge increase in material (financial, human) and bureaucracy, with no significant gains in safety or quality in an area that had functioned well under the previous legislation. Copyright 2009 S. Karger AG, Basel.