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Access to Medicine Versus Test Data Exclusivity - Safeguarding Flexibilities Under International Law (Hardcover, 1st ed. 2016)
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Access to Medicine Versus Test Data Exclusivity - Safeguarding Flexibilities Under International Law (Hardcover, 1st ed. 2016)
Series: Munich Studies on Innovation and Competition, 4
Expected to ship within 12 - 19 working days
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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.
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