Date of Award

3-10-2009

Degree Type

Dissertation

Degree Name

Doctor of Law (SJD)

Department

Law

First Advisor

Sompong Sucharitkul

Second Advisor

Christian Okeke

Third Advisor

Sophie Clavier

Abstract

To examine the compatibility between data protection and the right to access medicines in the current data protection regimes, this study examines the concept of data protection in current legal regimes, examine exclusive data protection regime, discusses the impact of the right to medicines on data protection regime, finally provide sound legal reform and recommendations to improve the protection of pharmaceutical data. In its entirety, this research aims at researching the protection regime of pharmaceutical data from top to bottom; therefore, this research conducts a comprehensive analysis within three dimensions of protections: first, the international dimension represented by TRIPS, second; the regional dimension represented by NAFTA, and CAFTA and other regional agreements and; third, the national dimension represented by Israel and India. Another attempt of this research is to explore the entire exceptions of data exclusivity. The research reviews the exceptions provided under Article 39.3 of the TRIPS. In addition, the compulsory license scheme is another possible ground to exclude data exclusivity although it provides under the patent regime; therefore it also examined. The thesis will explore the three major sources of WTO documents, 2001 WTO DohaDeclaration, 2003 Doha Decision and 2005 Amendment to analyze current trends and pattern of exceptions of data exclusivity, within the international as well as the national system. This research also provides an overview of human rights instruments to justify its call for the reconciliation of the protection of pharmaceuticals data with the right to health and medicines. In the last chapter, the case of Taiwan shows how a state like Taiwan is making such reconciliation a reality.

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