Paper

Pharmacogenetics in Europe: Barriers and Opportunities
D. Gurwitz, E. Zika, M.M. Hopkins, S. Gaisser, D. Ibarreta

European Commission Joint Research Center, Institute for Prospective Technological Studies, Seville, Spain

Address of Corresponding Author

Public Health Genomics 2009;12:134-141 (DOI: 10.1159/000189625)

  Key Words

• Adverse drug reaction
• Cost-effectiveness
• Diagnostics
• Personalized medicine
• Policy

  Abstract

This paper reviews the current situation in the field of pharmacogenetics/pharmacogenomics (PGx) in Europe. High expectations surrounding the clinical application of PGx remain largely unmet, as only a limited number of such applications have actually reached the market and clinical practice. Thus, the potential impact of PGx-based diagnostics on healthcare and its socio-economic implications are still unclear. With the aim of shedding some light on these uncertainties, the Institute for Prospective Technological Studies (IPTS) of the European Commission's Joint Research Centre (JRC) has conducted a review of the 'state of the art' and a further analysis on the use of pharmacogenetics diagnostics for preventing toxic drug reactions and improving drug efficacy in Europe. The paper presents highlights from the JRC-IPTS studies and discusses possibilities for improving translation of PGx research in Europe by comparing some experiences in the USA. We also illustrate the related barriers for the clinical uptake of PGx in Europe with specific case-studies. Most of the barriers identified extend beyond the European context. This reflects the global problems of scarcity of data demonstrating proven clinical validity or utility and favorable cost-effectiveness studies to support the clinical application of PGx diagnostic tests in the clinical setting. Another key barrier is the lack of incentives for the private sector to invest in the development and licensing of PGx diagnostic tests for improving the safety and efficacy of out-of-patent drugs. It therefore seems that one key aspect where policy can affect the clinical uptake of PGx is via sustaining large-scale industry-academia collaborations for developing and proving the utility of PGx diagnostics.

Copyright © 2009 S. Karger AG, Basel

  Author Contacts

Dolores Ibarreta
European Commission Joint Research Center
Institute for Prospective Technological Studies
C/Inca Garcilaso, Seville (Spain)
Tel. +34 954 488 445, Fax +34 954 488 434, E-Mail dolores.ibarreta@ec.europa.eu

  Article Information

Published online: February 10, 2009
Number of Print Pages : 8
Number of Figures : 0, Number of Tables : 1, Number of References : 56