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  • © 2016

Access to Medicine Versus Test Data Exclusivity

Safeguarding Flexibilities Under International Law

Authors:

  • Unique Index of Data Exclusivity and Access
  • In depth analysis of Article 39(3) of the WTO TRIPS Agreement
  • Useful policy recommendations for negotiating data exclusivity in the FTAs and implementation in the national laws

Part of the book series: Munich Studies on Innovation and Competition (MSIC, volume 4)

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Table of contents (8 chapters)

  1. Front Matter

    Pages i-xvi
  2. Introduction

    • Owais H. Shaikh
    Pages 1-19
  3. Test Data Exclusivity and Art 39(3) TRIPS

    • Owais H. Shaikh
    Pages 35-92
  4. Test Data Exclusivity in the US and the EU

    • Owais H. Shaikh
    Pages 93-128
  5. Conclusions and Recommendations

    • Owais H. Shaikh
    Pages 221-232
  6. Back Matter

    Pages 233-256

About this book

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.


Authors and Affiliations

  • MPI for Competition and Innovation, Munich, Germany

    Owais H. Shaikh

Bibliographic Information

Buy it now

Buying options

eBook USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book USD 109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Other ways to access