Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation: Evaluation Report

Abstract

The most recent comprehensive revision of the EU general pharmaceuticals legislation took place in 2004. In the intervening decades, the global pharmaceutical sector, technological approaches and societal focus have changed. The new Pharmaceutical Strategy for Europe provides a framework for new developments as part of the Commission’s vision to build a stronger European Health Union. This strategy calls for an evaluation of the performance of the current regulatory system and targeted revision of the general pharmaceutical legislation. The report summarises data and analyses to support the evaluation of the legislation, notably Directive 2001/83/EC on the Community code relating to medicinal products for human use and Regulation (EC) 726/2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency. The study followed the Better Regulation guidelines, to develop an intervention logic and a baseline; assess the effectiveness, efficiency, relevance, coherence and EU added value of the legislation; consider lessons learnt from the COVID-19 pandemic in relation to the functioning of the pharmaceutical system; and draw conclusions on the evidence gathered to support future policy decisions.