The Pharmaceutical Industry on the Continent — A 10-Year Perspective since Morges

Abstract

During the last 10 years, interest in causality assessment has generally increased. New methods have been published and existing ones updated. Twenty-two national drug monitoring centers assess causality, though they mostly use evaluators' knowledge and experience, and not a formal method. The relative merits of spontaneous monitoring vs pharmacoepidemiological studies are better understood. Legal implications of causality assessment by an expert vs assessment using a method are discussed. The selection of a method is based on its internal logic, simplicity, or convenience rather than on its proven validity, which is not easily demonstrated.