The Drug Debate: Data Exclusivity is the New Way to Delay Generics
15 Pages Posted: 26 Jun 2018 Last revised: 27 Sep 2018
Date Written: June 12, 2018
The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication.
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