The South Centre is pleased to announce the publication of Policy Brief No. 76 entitled “Evolution of Data Exclusivity for Pharmaceuticals in Free Trade Agreements” by Wael Armouti, former Legal Affairs Director at Jordan Food and Drug Administration, Companies General Controller.
Free trade agreements (FTAs) introduce higher intellectual property (IP) protection than those established in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS-plus provisions) that deprive the parties from benefits of the use of flexibilities found in the TRIPS Agreement to protect public health. One such TRIPS-plus requirement is that of data exclusivity. It establishes that the government should provide an exclusivity period for the test data developed by the originator company, on the grounds of an incentive rationale and considerations of fairness. The negative impact of the data exclusivity approach in developing countries means that the entry of cheap generic products is delayed, even under a compulsory license, which will affect access to affordable medicines. Countries that have already signed the FTAs can mitigate its effects on public health by limiting the scope of and providing exceptions to data exclusivity in national legislation.
To access the policy brief directly, go to this webpage: https://www.southcentre.int/policy-brief-76-april-2020/
or download from here