Development Agendas in a Changing World
Edited by Ricardo Meléndez-Ortiz and Pedro Roffe
Chapter 15: A Model Law for the Protection of Undisclosed Data
Carlos M. Correa1 INTRODUCTION The free trade agreement signed by the Central American countries and the Dominican Republic with the United States (CAFTA–DR) requires the introduction of a sui generis regime for the protection of test data submitted for the registration of pharmaceutical and agrochemical products. This modality of protection – which is not mandated by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)2 – subjects test data to standards of protection significantly higher than those required in TRIPS.3 The essential difference is that while the latter protects the test data under the framework of unfair competition, CAFTA–DR requires the grant of exclusive rights for a period of at least five years. The ‘TRIPS-Plus’ protection of test data has become a common element in the recent free trade agreements (FTAs) signed by the United States with developed and developing countries,4 as well as in the protocols of accession subscribed by new Members of the World Trade Organization (WTO). However, numerous developing countries keep a standard of protection consistent with the TRIPS Agreement, without providing for an exclusivity period. Establishing an exclusive right over the test data implies that similar products cannot be registered for its commercialization, within the period of exclusivity, by utilizing or relying on the test data produced by the firm from which they were generated. Several studies have pointed out and quantified5 the implications of such exclusivity for public health. Since it delays the market entry of generic products, it can be expected...
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