Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV): Wieviel Arzneimittelrecht braucht die Transfusionsmedizin noch?

Abstract

The preparation of blood components in Germany is regulatedby the German Law on Pharmaceuticals (Arzneimittelgesetz;AMG) and thus by the German Ordinancefor the Production of Medicinal Products and Active Substances(AMWHV). The preparation and quality assuranceof blood components does, however, differ substantiallyfrom that of synthetic drugs. It especially includesmedical decisions. The assignment of blood componentsto the AMG implicates numerous clausesconfined to blood components or modifications of therules for conventional drugs. The most recent version ofthe AMWHV reflects this status of blood components byintroducing a new paragraph (§ 31) limited to blood components.The AMG is highly complicated due to the largenumber of clauses for blood components. It contradictsthe political claim to keep the legal complexity in reasonablelimits. Moreover, it is to be expected that future developmentsof the legal framework for pharmaceuticalswill further increase the fundamental discrepancies inthe requirements for synthetic drugs versus blood components.These considerations question the future benefitsof the German and Austrian strategy to legally assignblood components to pharmaceuticals. The Council ofEurope has clearly separated the legal framework forblood components from that for pharmaceuticals. TheGerman Law on Transfusion does also offer an adequatetool to implement the European recommendations onthe preparation, use and quality assurance of bloodcomponents.