Access to Medicine Versus Test Data Exclusivity: Safeguarding Flexibilities Under International Law (Munich Studies on Innovation and Competition Book 4)

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. 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. Owais H. Shaikh. Includes Bibliographical References. Front Matter....Pages i-xvi Introduction....Pages 1-19 Test Data Exclusivity: Raison d’être ....Pages 21-33 Test Data Exclusivity and Art 39(3) TRIPS....Pages 35-92 Test Data Exclusivity in the US and the EU....Pages 93-128 Index of Data Exclusivity and Access (IDEAS): Free Trade Agreements....Pages 129-192 Index of Data Exclusivity and Access (IDEAS): National Laws....Pages 193-208 Test Data Exclusivity in FTAs and Access to Originator Pharmaceuticals....Pages 209-219 Conclusions and Recommendations....Pages 221-232 Back Matter....Pages 233-256