Review of the European Pharmaceutical Legislation

Abstract

EU pharmaceutical legislation has been revised (Directive 2001/83/EC and Regulation 2309/93). Will this mean that the registration of generic medicines becomes easier? What will be the effect on a new enlarged EU and its member states?

Following a protracted European co-decision procedure, which required a lot of to-ing and fro-ing between the European Commission, European Parliament and Council, an agreed position was voted by the European Parliament in December 2003 and formally agreed by the Council in March 2004. It was imperative that the revision of the law be finalised (and at least certain parts put in place) before the 1st May, 2004 accession to the EU of ten new member states. During this process, numerous amendments were introduced and the positions of a number of concerned parties heavily lobbied.

The final outcome has been roundly criticised in terms of reaching a fair compromise between the various interests — in that no one group seems specifically pleased. The revised law does, however, contain a number of important new aspects for generic medicines. These are outlined here in tabular format for convenience of reference.