Title The law of off-label uses of medicines : regulation and litigation in the EU, UK, and USA / Andrea Parziale

Published Abingdon, Oxon [UK] ; New York, NY : Routledge, Taylor & Francis Group, 2023 ©2023

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Description 1 online resource Contents Off-label use of medicines between clinical research and practice -- The regulation of off-label uses in the EU, EU Member States, and UK -- The US regulation of off-label uses of medicines -- Litigation trends in the EU, EU Member States, and UK -- Litigation trends in the USA -- The influence of the precautionary principle in the civil litigation on off-label uses Summary 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 Bibliography Includes bibliographical references and index Notes Andrea Parziale is a Marie Skłodowska-Curie Fellow at the Institute for Transnational Legal Research at the Faculty of Law, Maastricht University Online resource; title from electronic title page (ProQuest ebook central, viewed February 8, 2023) Subject Drugs -- Labeling -- Law and legislation -- European Union countries Drugs -- Labeling -- Law and legislation -- Great Britain Drugs -- Labeling -- Law and legislation -- United States Off-label drug use -- European Union countries Off-label drug use -- Great Britain Off-label drug use -- United States Drugs -- Law and legislation -- European Union countries Drugs -- Law and legislation -- Great Britain Drugs -- Law and legislation -- United States LAW / General LAW / Comparative LAW / Health Drugs -- Labeling -- Law and legislation. Drugs -- Law and legislation. Off-label drug use. Form Electronic book ISBN 9781000634334 1000634337 9781003212010 1003212018 9781000634389 1000634388

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