Access to Medicine Versus Test Data Exclusivity

Safeguarding Flexibilities Under International Law

Owais H. Shaikh (Autor)

Buch | Softcover

XVI, 256 Seiten

2018 | 1. Softcover reprint of the original 1st ed. 2016
Springer Berlin (Verlag)
978-3-662-57021-0 (ISBN)

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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.

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.

Erscheinungsdatum	20.07.2018
Reihe/Serie	Munich Studies on Innovation and Competition
Zusatzinfo	XVI, 256 p. 78 illus., 56 illus. in color.
Verlagsort	Berlin
Sprache	englisch
Maße	155 x 235 mm
Gewicht	4161 g
Themenwelt	Recht / Steuern ► Allgemeines / Lexika
	Recht / Steuern ► EU / Internationales Recht
	Recht / Steuern ► Öffentliches Recht
	Recht / Steuern ► Privatrecht / Bürgerliches Recht ► Medienrecht
	Recht / Steuern ► Wirtschaftsrecht
Schlagworte	Access to medicine • Data exclusivity • Free Trade Agreements • Intellectual Property • TRIPS Agreement
ISBN-10	3-662-57021-1 / 3662570211
ISBN-13	978-3-662-57021-0 / 9783662570210
Zustand	Neuware