Intellectual Property and Public Health
Data confidentiality gives protection to the data generated by companies for the purposes of regulatory approval. Some see it as an important incentive for innovation, while others focus on how it might represent a barrier to the introduction of competition.
A Review of Existing Data Exclusivity Legistlation in Selected Countries | IFPMA | January 2004
Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement | Carlos María Correa, University of Buenos Aires | 2002
Encouragement of New Clinical Drug Development: The Role of Data Exclusivity | IFPMA | 2000
Position Paper: TRIPS Article 39.3 Does not require Data Exclusivity Provisions | European Generic medicines Association (EGA) | July 2000