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Books > Law > Laws of other jurisdictions & general law > Private, property, family law > Torts / delicts
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The Law of Off-label Uses of Medicines - Regulation and Litigation in the EU, UK and USA (Hardcover)
Loot Price: R4,564
Discovery Miles 45 640
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The Law of Off-label Uses of Medicines - Regulation and Litigation in the EU, UK and USA (Hardcover)
Expected to ship within 12 - 17 working days
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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.
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