PharmaLaw, Cogswell, Tytherton Lucas, Chippenham, Wiltshire SN15 3RL, UK, Tel: +44 (0)1249 740589, Fax: +44 (0)1249 740517, Email: paulranson@pharma-law.com

Revised 30 July 2003.

Abstract

In relation to the development of medicinal products within Europe, the European Commission seeks to strike a balance between the encouragement of innovation and the avoidance of unnecessary research. This balance is supposedly represented by the rules that afford research-based companies a degree of protection against the use by the authorities assessing subsequent applications, of data submitted in support of the application made by the innovator. This paper reviews these rules as they presently stand, how the European Court of Justice (ECJ) and the national courts have interpreted the many 'grey areas' in such rules and the proposals for change for the current regime within the overall review of pharmaceutical regulatory rules to be implemented in time for the enlargement of the Community in early 2004.