Mandating data exclusivity for pharmaceuticals through international agreements : a fair idea?

Abstract

Data exclusivity is temporary exclusive user right on the clinical data that need to be submitted to the regulatory authorities to prove that a new drug is safe and effective. For the pharmaceutical industry, data exclusivity is an important addition to the patent system, as data exclusivity will de facto delay the market entry of generic drugs until after the exclusive user rights on the clinical data have expired. In order to assess the normative legitimacy of the industry’s demand to include minimum standards for data exclusivity in international agreements, this contribution evaluates the three justifications that have frequently been advanced, depicting data exclusivity as (1) an essential policy tool to promote innovation; (2) a mechanism to prevent the generic industry from ‘free-riding’; and (3) a legal instrument to protect the industry’s property rights in clinical data