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COVID-19 off-label uses of medicines: the role of civil liability and regulation

Physicians can prescribe medicines for different indications than the tested and authorised ones. Such ‘off-label’ uses expand therapeutic options but also create uncertainties. The COVID-19 pandemic triggered new off-label uses and, despite issues being reported in the literature, these have not re...

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Autor principal: Parziale, Andrea
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Palgrave Macmillan UK 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10196280/
https://www.ncbi.nlm.nih.gov/pubmed/37359236
http://dx.doi.org/10.1057/s41288-023-00302-z
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author Parziale, Andrea
author_facet Parziale, Andrea
author_sort Parziale, Andrea
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description Physicians can prescribe medicines for different indications than the tested and authorised ones. Such ‘off-label’ uses expand therapeutic options but also create uncertainties. The COVID-19 pandemic triggered new off-label uses and, despite issues being reported in the literature, these have not resulted in substantial personal injury litigation in the EU. Against this backdrop, this article argues that civil liability plays, in fact, a limited role in off-label uses. In particular, civil liability may incentivise health actors to follow and react to the development of the evidence basis for off-label uses. However, it is ultimately unable to incentivise the conduct of additional research on off-label uses. This is problematic, as off-label research is key to protecting patients and is recommended by international medical ethics. The article concludes by critically discussing proposed mechanisms to incentivise off-label research. It argues that extending civil liability for unknown risks may have undesired effects on insurability and innovation, and most regulatory proposals seem ineffective. Building on the 2014 Italian reform of off-label uses, the article proposes the establishment of a fund financed by mandatory contributions from the industry, which should be used by pharmaceutical regulators to promote off-label research and develop guidelines for prescribers.
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spelling pubmed-101962802023-05-23 COVID-19 off-label uses of medicines: the role of civil liability and regulation Parziale, Andrea Geneva Pap Risk Insur Issues Pract Article Physicians can prescribe medicines for different indications than the tested and authorised ones. Such ‘off-label’ uses expand therapeutic options but also create uncertainties. The COVID-19 pandemic triggered new off-label uses and, despite issues being reported in the literature, these have not resulted in substantial personal injury litigation in the EU. Against this backdrop, this article argues that civil liability plays, in fact, a limited role in off-label uses. In particular, civil liability may incentivise health actors to follow and react to the development of the evidence basis for off-label uses. However, it is ultimately unable to incentivise the conduct of additional research on off-label uses. This is problematic, as off-label research is key to protecting patients and is recommended by international medical ethics. The article concludes by critically discussing proposed mechanisms to incentivise off-label research. It argues that extending civil liability for unknown risks may have undesired effects on insurability and innovation, and most regulatory proposals seem ineffective. Building on the 2014 Italian reform of off-label uses, the article proposes the establishment of a fund financed by mandatory contributions from the industry, which should be used by pharmaceutical regulators to promote off-label research and develop guidelines for prescribers. Palgrave Macmillan UK 2023-05-19 /pmc/articles/PMC10196280/ /pubmed/37359236 http://dx.doi.org/10.1057/s41288-023-00302-z Text en © The Geneva Association 2023, Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Article
Parziale, Andrea
COVID-19 off-label uses of medicines: the role of civil liability and regulation
title COVID-19 off-label uses of medicines: the role of civil liability and regulation
title_full COVID-19 off-label uses of medicines: the role of civil liability and regulation
title_fullStr COVID-19 off-label uses of medicines: the role of civil liability and regulation
title_full_unstemmed COVID-19 off-label uses of medicines: the role of civil liability and regulation
title_short COVID-19 off-label uses of medicines: the role of civil liability and regulation
title_sort covid-19 off-label uses of medicines: the role of civil liability and regulation
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10196280/
https://www.ncbi.nlm.nih.gov/pubmed/37359236
http://dx.doi.org/10.1057/s41288-023-00302-z
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