Rechtsprechung zur Verabreichung von Medikamenten außerhalb der zugelassenen Indikationsgebiete („off-label-use”)

Abstract

In the medical treatment of patients drugs not registered for this specific indication are often prescribed. This so-called "off-label-use" is an increasing point of discussion and in the past years had to be settled in court more than once. The debate covers some questions, i. e. whether the health insurance funds have to pay for the prescribed "off-label-use" drugs, and who is responsible in case of side-effects. In this article the most relevant court decisions of German Supreme Courts are reviewed. The decisions show some changes. According to a recent sentence of the German Supreme Court for Social Law an "off-label" medication to be paid by health insurance funds is only allowed under strong conditions: presence of a life-threatening disease or a disease causing a long term severe impairment of the quality of life, no other medication available, and sufficient data from scientific literature supporting an clinical efficacy of the drug. However, in case of an "off-label" medication the physician is fully responsible for all legal consequences.