Investigating the Effect of Data Exclusivity on the Pharmaceutical Sector in Jordan = دراسة أثر نظام حماية البيانات على قطاع الأدوية في الأردن

Abstract

Multinational pharmaceutical companies and generic drug manufacturers have long been at odds over “data exclusivity” regulations. The latter requires a waiting period of at least five years before they can access valuable clinical trial data necessary to bring less expensive forms of innovative drugs to market. Jordan has implemented Data exclusivity since joining the World Trade Organization and signing Free Trade Agreement with the United State in 2001. Before 2001 Jordan allowed Jordanian Pharmaceutical companies to “copy” molecules of Multinational Pharmaceutical companies and sell them under their own trade names. The arrival of the product patent and data exclusivity meant that Jordanian pharmaceutical companies could no longer copy. This has created lot of problems for the Jordanian Pharmaceutical companies as their Research & Development for new molecules is at a very emerging stage. The purpose of this study was to find out what is the effect of the application of data exclusivity on the pharmaceutical sector in Jordan. After analyzing 140 medicines used in treating chronic diseases in Jordan in the period between 2004 & 2010 in Jordan. It was found that at least 16 % of these 140 medicines had no competition from a generic equivalent as a result of data exclusivity. This was perceived negatively by local pharmaceutical companies as the originator companies were relying mainly on the use of data exclusivity instead of patents to preclude generic competition. Data exclusivity was one of the main reasons behind the delay of the presence of the equivalent generic drug in Jordan contributed to rising of the pharmaceutical expenditure in Jordan.