Access to Medicine Versus Test Data Exclusivity

Safeguarding Flexibilities Under International Law
Softcover Nachdruck of the original 1. Auflage 2016
ISBN: 978-3-662-57021-0
Verlag: Springer

Buch, Englisch, Band 4, 256 Seiten, Previously published in hardcover, Format (B × H): 155 mm x 235 mm, Gewicht: 4161 g

Reihe: Munich Studies on Innovation and Competition

This book explores the concept of test data exclusivity protection for pharmaceuticals. Focusing on Art 39(3) of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and relevant provisions in selected free trade agreements (FTA) and national laws, it combines normative, historical, comparative and economic analysis of test data exclusivity protection.At the heart of this book is the novel and original Index of Data Exclusivity and Access (IDEAS), which analyzes the effectiveness of test data exclusivity provisions in FTAs and national laws both on the strength of exclusivity as well as on access to medicine. IDEAS provides a framework for the assessment of current test data exclusivity protection standards on the basis of their proximity to Article 39(3) of the TRIPS Agreement, the scope of exclusivity and the flexibilities in FTAs, and subsequently in national laws. This book aims to broaden national and international policy makers’ grasp of the various nuances of test data exclusivity protection. Furthermore, it provides practical recommendations with regard to designing an appropriate legal system with a strong focus on promoting access to medicine for all.

Zielgruppe

Research

Autoren/Hrsg.

Shaikh, Owais H.

Fachgebiete

• Rechtswissenschaften Internationales Recht und Europarecht Internationales Recht Internationaler Gewerblicher Rechtsschutz, Medien-, IT- und Urheberrecht
• Rechtswissenschaften Internationales Recht und Europarecht Internationales Recht Internationales Handels-, Wirtschafts- und Gesellschaftsrecht

Inhaltsverzeichnis

Introduction.- Test Data Exclusivity: Raison d'être.- Test Data Exclusivity and Art 39(3) TRIPS.- Test Data Exclusivity in the US and the EU.- Index of Data Exclusivity and Access (IDEAS) - Free Trade Agreements.- Index of Data Exclusivity and Access (IDEAS) - National Laws.- Test Data Exclusivity in FTAs and Access to Originator Pharmaceuticals.- Conclusions and Recommendations.