Die Nutzenbewertung von Arzneimitteln nach dem AMG und dem SGB V : Eine Untersuchung zur Erzeugung administrativer Wissensgrundlagen und ihrer gerichtlichen Kontrolle.

»The Benefit Assessment of Medicinal Products under Regulatory and Statutory Health Insurance Law (AMG and SGB V)«Karsten Engelke investigates the fabrication of scientific medical knowledge and its judicial use, taking medicinal products as an example. He demonstrates the underlying procedures of processing uncertain and dynamic medical knowledge in regulatory and reimbursement decisions in German and EU law. Based on an analysis of the case law of the German Federal Social Court, he proposes applying a procedural test to the methodological standards for appraisals of clinical evidence in legal proceedings.