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Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement
(2002; 77 pages) [Spanish] View the PDF document
Table of Contents
View the documentTHE SOUTH CENTRE
View the documentFOREWORD
View the documentEXECUTIVE SUMMARY
View the documentINTRODUCTION
View the documentI. DATA REQUIRED FOR THE REGISTRATION OF PHARMACEUTICALS
Open this folder and view contentsII. THE RATIONALE FOR DATA PROTECTION
Open this folder and view contentsIII. CONDITIONS OF PROTECTION UNDER TRIPS
View the documentIV. NON-DISCLOSURE OBLIGATION
Open this folder and view contentsV. PROSCRIBED ACTS OF UNFAIR COMMERCIAL USE
View the documentVI. MEANS OF PROTECTION AGAINST UNFAIR COMMERCIAL USE
View the documentVII. THE EXCLUSIVITY APPROACH
View the documentVIII. THE HISTORY OF THE TRIPS NEGOTIATIONS
View the documentIX. CONCLUSIONS
View the documentANNEX I. EXCLUSIVE USE OF DATA AND COMPENSATION UNDER THE U.S. FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT (FIFRA)
View the documentBIBLIOGRAPHY
View the documentBACK COVER
 

FOREWORD

The South Centre published in October 2000 a study by Carlos Correa entitled Integrating Public Health Concerns into Patent Legislation in Developing Countries. Second edition of the study was issued in September 2001, and the French and Spanish translations were published, also in 2001. The study, which was prepared with the collaboration of the World Health Organization, has been given wide circulation in the developing countries and has been found very useful by them in dealing with public health and patent legislation in the context of TRIPS implementation.

The current study by Carlos Correa entitled Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement is continuation of the same work, focusing in depth on the specific issue of marketing approval protection under the TRIPS Agreement and its interpretation, an issue of major practical importance for the developing countries. The World Health Organization has agreed to co-publish this study.

As the earlier study, the current study was produced with the support of the Rockefeller Foundation. The author benefited from an extensive discussion on data protection issues with Prof. Jerome Reichman, whose valuable inputs the author wishes to acknowledge. The author also wishes to acknowledge the support from WHO, which organized a consultation meeting in New York, on 22 October, 2001 to review the draft of the study, at which participated Alfred Engelberg, Trevor Cook, Jim Keon, James Love, Jerome Reichman, Robert Weissman and German Velasquez. The author is thankful for the comments received during this meeting. He is also grateful for the comments by Octavio Espinosa (WIPO), in his personal capacity, Adrian Otten (WTO) and Jayashree Watal (WTO). The text was edited by Robert Weissman.

The author, Dr. Carlos Correa, is the Director of the Masters Programme on Science and Technology Policy and Management at the University of Buenos Aires, Argentina. He participated in the negotiations of TRIPs during the Uruguay Round and has actively pursued the issue of the global intellectual property regime and its implications for development and for the countries of the South. Several of his studies and working papers have been published by the South Centre.

The author is grateful for the support from the Rockefeller Foundation for the preparation of this document.

Any views expressed are the views of the author and do not necessarily reflect the views of the Rockefeller Foundation or of the World Health Organization. The author is solely responsible for the final text.

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