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The Law of Off-label Uses of Medicines: Regulation and Litigation in the EU, UK and USA
The Law of Off-label Uses of Medicines: Regulation and Litigation in the EU, UK and USA
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Excellent- More about The Law of Off-label Uses of Medicines: Regulation and Litigation in the EU, UK and USA
This book explores the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA, assessing how traditional rules are being adapted to tackle potential risks and scientific uncertainty. It will be an essential resource for researchers, academics, and policy-makers.
Format: Hardback
Length: 198 pages
Publication date: 12 August 2022
Publisher: Taylor & Francis Ltd
This comprehensive book delves into the intricate regulatory framework governing the untested and unapproved uses (off-label uses) of medicines in the European Union (EU), the United Kingdom (UK), and the United States (USA). Before these medications reach patients, extensive testing and approval by regulatory bodies are conducted to minimize the risk of adverse reactions. However, physicians have the authority.
Off-label uses are prevalent in various fields, including pediatrics, oncology, rare diseases, and, more recently, in the treatment of COVID-19. While off-label uses may provide hope, they also introduce risks and uncertainties. Therefore, clarification is necessary to enhance patient rights protection while providing legal certainty for healthcare stakeholders.
To achieve this, this work elucidates the regulatory mechanisms and litigation trends related to off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to address potential risks and scientific uncertainties. The book provides an overview of the applicable regulations, considering the impact of Brexit on off-label policies in the UK and the EU, as well as national off-label policies in the context of combating the COVID-19 pandemic. It also explores the conditions under which physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions.
This book serves as a vital resource for researchers, academics, and policy-makers engaged in the fields of medical law and ethics, public health law, pharmaceutical law, and private comparative law. It offers a comprehensive examination of the regulatory landscape surrounding off-label uses of medicines, shedding light on the challenges and opportunities faced by healthcare professionals and policymakers in this domain.
Weight: 540g
Dimension: 234 x 156 (mm)
ISBN-13: 9781032078984
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