Innovation in the Pharmaceutical Sector

Abstract

Pharmaceutical innovation, as measured by the number of marketing authorisations applied for and granted, has fallen in the last several years. For example, both the EU and US regulatory authorities have recorded significant reductions in approvals from 1999 to 2003; from 27 to 17 in the EU (centralised procedure: new active substances, or NAS) and 35 to 21 in the US (based on new molecular entities, or NMEs). Further, the European Agency for the Evaluation of Medicinal Products (EMEA) and the US Food and Drug Administration (FDA) have noticed a reduction in the number of applications for marketing authorisations for new active substances, with the number of applications to the EMEA falling from close to 40 in each of the two years 2000 and 2001 to 25 in 2002 and 34 in 2003. Against this background, the Enterprise DG of the European Commission commissioned Charles River Associates to undertake a study investigating whether there is a worldwide crisis in innovation in the pharmaceutical sector (Phase I), the reasons behind this crisis (Phase II), and the tools available to kick-start innovation (Phase III)