The Law of Off-label Uses of Medicines: Regulation and Litigation in the EU, UK and USA

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Synopsis
This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit’s impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law.
Copyright:
2023

Book Details

Book Quality:
Publisher Quality
Book Size:
198 Pages
ISBN-13:
9781000634389
Related ISBNs:
9781032078984, 9781032079004, 9781003212010
Publisher:
Taylor and Francis
Date of Addition:
Copyrighted By:
Andrea Parziale, The right of Andrea Parziale to be identified as author of this work has been asserted in accordance with sections
Adult content:
No
Language:
English
Has Image Descriptions:
No
Categories:
Nonfiction, Health, Mind and Body, Law, Legal Issues and Ethics, Medicine
Submitted By:
Bookshare Staff
Usage Restrictions:
This is a copyrighted book.

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