["Expert approved international standards of evidence-based medicine": a proposal]

Section 35b of the German Code of Social Law Book V (SGB V) mentions "expert approved international standards of evidence-based medicine" (EbM). An idea which started as a reform movement in and for clinical medicine more than twenty years ago is here, from a socio-legal perspective, being utilised as a normative concept in terms of a standard-creating methodology, which is meant to form the basis for the "methods and criteria" of comparative benefit/risk assessment of medical drugs mentioned in the respective law. The present paper places the standards in a hierarchy between "description and analysis of benefits" at the bottom and, at the top, "fundamental concerns of EbM". Apart from a variety of standards, we propose seven basic principles and four fundamental concerns of EbM (pursuit of empirical truth, patient welfare, pragmatism, procedural justice). Each of the basic principles, standards, methods and criteria can be taken to substantiate the respective superordinate category (basic concerns etc.). The position and role of the standards will be explained using the example "search for and selection of literature".