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

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 fo...

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Detalles Bibliográficos
Autores principales: Lenk, Christian, Duttge, Gunnar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4103928/
https://www.ncbi.nlm.nih.gov/pubmed/25050064
http://dx.doi.org/10.2147/TCRM.S40232
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author Lenk, Christian
Duttge, Gunnar
author_facet Lenk, Christian
Duttge, Gunnar
author_sort Lenk, Christian
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description 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.
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spelling pubmed-41039282014-07-21 Ethical and legal framework and regulation for off-label use: European perspective Lenk, Christian Duttge, Gunnar Ther Clin Risk Manag Review 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. Dove Medical Press 2014-07-12 /pmc/articles/PMC4103928/ /pubmed/25050064 http://dx.doi.org/10.2147/TCRM.S40232 Text en © 2014 Lenk and Duttge. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Review
Lenk, Christian
Duttge, Gunnar
Ethical and legal framework and regulation for off-label use: European perspective
title Ethical and legal framework and regulation for off-label use: European perspective
title_full Ethical and legal framework and regulation for off-label use: European perspective
title_fullStr Ethical and legal framework and regulation for off-label use: European perspective
title_full_unstemmed Ethical and legal framework and regulation for off-label use: European perspective
title_short Ethical and legal framework and regulation for off-label use: European perspective
title_sort ethical and legal framework and regulation for off-label use: european perspective
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4103928/
https://www.ncbi.nlm.nih.gov/pubmed/25050064
http://dx.doi.org/10.2147/TCRM.S40232
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