gms | German Medical Science

10. Jahrestagung der GAA Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

16. bis 17.10.2003, Bonn

Off-label use: current legal issues

Rechtliche Aspekte des Off-Label-Use

Meeting Abstract

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  • corresponding author Christian Dierks - Walter-Benjamin-Platz 6, 10629 Berlin, Tel. +49(0)303277870, Fax. +49(0)3032778777

Gesellschaft für Arzneimittelanwendungsforschung u. Arzneimittelepidemiologie (GAA) e.V.. 10. Jahrestagung der Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie (GAA) e.V.. Bonn, 16.-17.10.2003. Düsseldorf, Köln: German Medical Science; 2003. Doc03gaa09

The electronic version of this article is the complete one and can be found online at:

Published: October 16, 2003

© 2003 Dierks.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Background and Aim

Recent jurisdiction of the Federal Social Court has outlined the exceptional conditions under which the Statutory Health Insurance is obliged to finance the off-label use of a medication. However, several legal questions remain yet unanswered.


According to the verdict of the Federal Social Court (19.03.2003 - B 1 KR 37/00 R) the German Statutory Health Insurance may not finance an off-label use unless the disease is severe, there is no therapeutic alternative and scientific evidence or a consensus of the scientific community gives way for the assumption of therapeutic efficacy. To apply this jurisdiction it is essential to define off-label use in regard to indication, application and dosage. There is little insecurity concerning the severeness of a disease, but one might argue that this parameter is in reverse correspondence to the proof of efficacy, so that less proof is necessary for more severe diseases. More recent jurisdiction points out that therapeutic alternatives must be available for the individual and not just on abstract grounds. If imported drugs without a German marketing authorisation are part of the scope of therapeutic alternatives remains undecided as yet. Finally questions concerning the prescribing physicians' redress will have to be discussed. There is good arguments in favour of culpable negligence as a precondition for redress. Further more redress sums might need to be reduced by cost savings from not prescribing an alternative.


There still is no safe legal ground for off-label-prescribing. Definitions and conditions of such use still need further development to reconcile efficient resource allocation with the patient's entitlement to participating in state of the art pharmaco-therapy.