Access to Medicine Versus Test Data Exclusivity

Safeguarding Flexibilities Under International Law

  • Owais H. Shaikh

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

Table of contents

  1. Front Matter
    Pages i-xvi
  2. Owais H. Shaikh
    Pages 1-19
  3. Owais H. Shaikh
    Pages 21-33
  4. Owais H. Shaikh
    Pages 35-92
  5. Owais H. Shaikh
    Pages 93-128
  6. Owais H. Shaikh
    Pages 221-232
  7. 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.


Data exclusivity Access to medicine Intellectual property Free trade agreements TRIPS agreement

Authors and affiliations

  • Owais H. Shaikh
    • 1
  1. 1.MPI for Competition and InnovationMunichGermany

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