EU policies in personalized medicine-related technologies

Abstract

Against the background of a number of first drug-diagnostic co-products developed and introduced into the European market, European decision-makers feel impelled to react and position themselves in the field of personalized medicine. Their reactions cover a broad range, from the analysis of knowledge requirements for market approval to the need for translational activities and the possible contribution of pharmacogenetics to public health. This article summarizes the current positions of European institutions, based on literature review and expert consultation for three items associated with personalized medicine: biobanks, genetic diagnostics and drug-diagnostic co-products, and provides an outlook on requirements for an effective future European policy on personalized medicine.

Keywords: European policy; biobanks; clinical utility; clinical validity; drug–diagnostic co-development; effectiveness; framework conditions; genetic diagnostics; translational research.