Therapeutic innovation in the European Union: analysis of the drugs approved by the EMEA between 1995 and 2003
Domenico Motola [1], Fabrizio De Ponti [1], Pasqualino Rossi [2], Nello Martini [2] & Nicola Montanaro [1]
[1] Department of Pharmacology and Interuniversity Research Centre for Pharmacoepidemiology, University of Bologna,
Bologna, Italy,
[2] Italian Medicines Agency (AIFA), Ministry of Health, Rome, Italy
British journal of Clinical Pharmacology 2005:59(4):475-8
Since January 1995, all European Union applications for marketing approval for medicinal products derived from
biotechnology and other drugs considered potentially innovative follow the EMEA centralized procedure. In order to
assess the overall degree of therapeutic innovation of these drugs, we considered, for each approved agent, its
target, the availability of previous treatments and the extent of its therapeutic effect. The following scores for
therapeutic innovation were assigned through a consensus process: ‘A’ (important), ‘B’ (moderate) and ‘C’ (modest).
The overall degree of important/moderate therapeutic innovation was 47% of all therapeutic agents (32% important;
15% moderate). Most (80%) of the EMEA-approved therapeutic agents were for serious diseases. The remaining ones were
for risk factors (7%) or nonserious diseases (13%).