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Vol 21 No 9 Sept/Oct 2016

Book of the Month

Cover of Goode on Commercial Law

Goode on Commercial Law

Edited by: Ewan McKendrick
Price: £170.00

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Access to Medicine versus Test Data Exclusivity: Safeguarding Flexibilities Under International Law

ISBN13: 9783662496541
Published: August 2016
Publisher: Springer-Verlag
Country of Publication: Germany
Format: Hardback
Price: £86.00

This is a Print On Demand Title.
The publisher will print a copy to fulfill your order. Books can take between 1 to 3 weeks. Looseleaf titles between 1 to 2 weeks.

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.

Intellectual Property Law, Medical Law, International Trade
Test Data Exclusivity: Raison d'etre
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.