PERHAPS A GIFT VOUCHER FOR MUM?: MOTHER'S DAY

Close Notification

Your cart does not contain any items

The Law of Off-label Uses of Medicines: Regulation and Litigation in the EU, UK and USA by Andrea Parziale (EURAC, Italy) at Abbey's Bookshop,
The Law of Off-label Uses of Medicines: Regulation and Litigation in the EU, UK and USA
— —
Andrea Parziale (EURAC, Italy)

The Law of Off-label Uses of Medicines

Regulation and Litigation in the EU, UK and USA

Andrea Parziale (EURAC, Italy)

$77.99

Paperback

Not in-store but you can order this
How long will it take?
English
Routledge
27 May 2024
Constitutional & administrative law
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.
By:  
Imprint:   Routledge
Country of Publication:   United Kingdom
Dimensions:   Height: 234mm,  Width: 156mm, 
Weight:   380g
ISBN:   9781032079004
ISBN 10:   1032079002
Pages:   198
Publication Date:  
Audience:   College/higher education ,  Primary
Format:   Paperback
Publisher's Status:   Active

Andrea Parziale is a Marie Skłodowska-Curie Fellow at the Institute for Transnational Legal Research at the Faculty of Law, Maastricht University

See Also

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

Undermining the Idea of India

Gautam Patel

Hardback

$15.95 

Not in-store but you can order this

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

The Business of Judging

Selected Essays and Speeches: 1985-1999...

Tom Bingham (The late, Senior Law...

Paperback

$89.95 

Not in-store but you can order this

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

Is Administrative Law Unlawful?...

Philip Hamburger

Paperback

$57.95 

Not in-store but you can order this

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

Law, Liberty and State

Oakeshott, Hayek and Schmitt on...

David Dyzenhaus (University of Toronto)...

Paperback

$49.95 

Not in-store but you can order this

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

Nine Black Robes

Inside the Supreme Court's Drive...

Joan Biskupic

Hardback

$64.95 

In Stock 😊

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

No Property in Man

Slavery and Antislavery at the Nation’s...

Sean Wilentz

Paperback

$38.95 

Not in-store but you can order this

ADD +