Regulatory exclusivities for medicinal products for human use in the EU.

Abstract

The placing on the market of medicinal products for human use in the EU is strictly regulated and harmonized by Regulation (EC) number 726/2004 and Directive 2001/83/ EC . The main objective of this legislation is the protection of public health and therefore the key principle is that no medicinal product may be placed on the market before the quality, safety and efficacy of the product has been assessed and approved by the competent authorities in a marketing authorization procedure. A marketing authorization is granted on the basis of an application dossier containing extensive data, including clinical research data, to document and demonstrate the quality, safety and efficacy of the medicinal product under evaluation. The development and placing on the market of medicinal products, including the compilation of the marketing authorization dossier, requires a significant amount of time, resources and money. The European legislature has recognized that it was necessary to offer proper protection in the form of data and market protection to enable adequate recovery of and return on investment for the costs of these research requirements. Furthermore, additional incentives in the form of special exclusivities or extension of data or market protection periods were introduced to stimulate new research in specific areas, for example, research of new therapeutic uses of known substances which bring a significant benefit to patients or the bringing to the market of medicinal products for patients suffering from rare (orphan) diseases in accordance with Orphan Regulation (EC) number 141/2000. Finally, the Pediatric Regulation (EC) number 1901/2006 introduced, on one hand, an obligation for pharmaceutical companies to research the use of their medicinal products in children and, on the other hand, a special reward for the fulfillment of this obligation. These different protection and exclusivity rights, which are without prejudice to existing intellectual property rights (e.g., patents), are often referred to as ‘regulatory exclusivities’. In this article, we will provide a brief overview of these regulatory exclusivities and their main features.