Pharmacogenetics and Pharmacogenomics: State-of-the-Art and Potential Socio-Economic Impact in the EU

It is often said that advances in pharmacogenetics (PGx) could positively impact the pharmaceutical and health care sectors facilitating drug development (i.e. better understanding of disease mechanism, improved drug safety and efficacy) and a system of personalized medical care. However, the high expectations surrounding the clinical application of PGx are still largely unmet. Thus its potential impact on health care and its socio-economic implications remain uncertain. To diminish some of these uncertainties, IPTS embarked on a prospective study of the field with a three-fold objective that included mapping the current R&D status (i.e. mapping key actors, trends and outputs of academic and industrial R&D activities in the field), assessing the clinical impact (in socio-economic terms) in four EU member states (Germany, Ireland, the Netherlands and the UK), using two case studies (HER-2 and TPMT testing), and finally a comparison of regulatory and quality assurance frameworks in the US, the EU and the four EU member states mentioned above.