Title
Off-label prescription of medicationOff-label prescription of medication
Author
Faculty/Department
Faculty of Law
Research group
Personal Rights and Property Rights
Publication type
article
Publication
Dordrecht,
Subject
Law
Source (journal)
European journal of health law. - Dordrecht, 1994, currens
Volume/pages
22(2015):2, p. 165-186
ISSN
0929-0273
1571-8093
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
Affiliation
University of Antwerp
Abstract
Off-label use of medication refers to prescribing a registered medicine outside its approved marketing authorization, purpose, target group, or indication. Off-label prescription is a widely accepted practice. However, no or little regulation can be found. In this article, the legal status of off-label prescription will be examined. Does off-label prescription fall under the therapeutical freedom and is it free from regulation? Or should we equalize off-label prescription with a therapeutical experimentation and should it follow the rules of experimentation? I will also examine whether the patient can give an informed consent. Whether or not this is possible leads to intense discussions. Finally, the potential liability of the prescribing physician is of great importance.
E-info
https://repository.uantwerpen.be/docman/iruaauth/69309f/e52a5706b4f.pdf
Handle