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Ethical and legal framework and regulation for off-label use: European perspective

Authors Lenk C, Duttge G

Received 18 March 2014

Accepted for publication 4 May 2014

Published 12 July 2014 Volume 2014:10 Pages 537—546


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Christian Lenk,1 Gunnar Duttge2

1Institute for History, Theory and Ethics of Medicine, Ulm University, Ulm, Germany; 2Center for Medical Law, Göttingen University, Göttingen, Germany

Abstract: For more than 20 years the off-label use of drugs has been an essential part of the ethical and legal considerations regarding the international regulation of drug licensing. Despite a number of regulatory initiatives in the European Union, there seems to remain a largely unsatisfactory situation following a number of critical descriptions and statements from actors in the field. The present article gives an overview of the ethical and legal framework and developments in European countries and identifies existing problems and possible pathways for solutions in this important regulatory area. In addition to the presentation of the ethical and legal foundations, some attention is given to criticisms from medical practitioners to the current handling of off-label drug use. The review also focuses on the situation confronted by patients and physicians when off-label prescriptions are necessary. Through legal descriptions from a number of countries, possible solutions for future discussion of European health care policy are selected and explained.

Keywords: ethics, law, Europe, health care policy

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