ABSTRACT
Multinational pharmaceutical companies and generic drug manufacturers have long been at odds over "dataexclusivity" regulations. The latter requires a waiting period of at least five years before they can access valuableclinical trial data necessary to bring less expensive forms of innovative drugs to market. Jordan has implemented Dataexclusivity since joining the World Trade Organization and signing Free Trade Agreement with the United State in2001. Before 2001 Jordan allowed Jordanian Pharmaceutical companies to "copy" molecules of MultinationalPharmaceutical companies and sell them under their own trade names. The arrival of the product patent and dataexclusivity meant that Jordanian pharmaceutical companies could no longer copy. This has created lot of problems forthe Jordanian Pharmaceutical companies as their Research and Development for new molecules is at a very emergingstage. The purpose of this study was to find out what is the effect of the application of data exclusivity on thepharmaceutical sector in Jordan.After analyzing 140 medicines used in treating chronic diseases in Jordan in the period between 2004 and 2010 inJordan. It was found that at least 16 % of these 140 medicines had no competition from a generic equivalent as a resultof data exclusivity. This was perceived negatively by local pharmaceutical companies as the originator companies wererelying mainly on the use of data exclusivity instead of patents to preclude generic competition. Data exclusivity wasone of the main reasons behind the delay of the presence of the equivalent generic drug in Jordan contributed to risingof the pharmaceutical expenditure in Jordan