Data protection and market exclusivities for pharmaceuticals in the EU

Abstract

Non-patent protection for pharmaceuticals in the EU dates back to 1987, when a formal system for the protection of the regulatory data used to secure the authorisation of pharmaceuticals was first established. Although often termed “data exclusivity” in recognition of the exclusive rights that it confers over the use of that data for a fixed period, it is only generally in practice that it confers market exclusivity during that period, as others can in theory replicate the generation of such data. Over time regulatory data protection has grown in importance, and has not only been extended in scope, to protect data used to secure a significant new indication, a paediatric use marketing authorisation, or a change of legal status, but it has been supplemented by a true market exclusivity regime in the form of orphan drug protection. This has thus resulted in the current framework of non-patent exclusivities conferred by the regulatory system for medicinal products in the EU as reviewed in this paper, consisting of the following such regimes: