(University of Oregon School of Law, 2016-08-01) Armouti, Wael; Nsour, Mohammad F.A.
Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement) requires that all members of the World Trade Organization (WTO) take measures to protect the confidential test data submitted by originator pharmaceutical companies as a part of their bid to attain regulatory approval for New Chemical Entities (NCEs). Specifically, members must protect this data against “disclosure” and “unfair commercial use.” Essentially, this broad prescription in Article 39.3 gives WTO members the freedom to set their own rules by allowing them to interpret the Article’s principal terminology and, further, by permitting WTO members to choose the proper approach with which to implement this article.
