A public health perspective on the effectiveness of European pharmaceutical regulation

Abstract

After more then four decades, the regulation of pharmaceuticals still is an evolving and much discussed topic within Europe from a political and economic perspective. Even though the benefits of regulatory harmonization remain uncontested, the constant review and evaluation of the sector may raise public concerns regarding regulatory performance. If regulatory 0experts still see the need for improving existing regulatory provisions, there is reason to believe that the current system does not live up to its expectations. An assessment of regulatory effectiveness, depicting the degree of goal attainment, provides a systematic answer to such questions. Drawing on the regulatory framework, the governance and the outcomes of the regulatory process the development of regulatory effectiveness since the beginnings of European regulation in the sector is discussed. While a continuous improvement from the perspective of effectiveness is traceable throughout time, some issues impeding the performance of the regulatory regime remain. Even though the pharmaceutical package may help to mitigate some of the identified problems, additional efforts will be necessary to finally strengthen the effectiveness of European pharmaceutical regulation and public health.