Abstract
Expectations in the integration of pharmacogenomics into clinical practice remain high in a number of therapeutic areas. This review focuses on the key legal and ethical issues concerning personalized medicine that have given rise to debate, law-making and/or Court decisions in Europe, especially involving: trial subject stratification during clinical trials; the protection of innovation in pharmacogenomics through intellectual property rights; the regulation of access to genetic testing; the regulatory framework for genetic testing devices; gene-based discrimination; legal duties and liabilities resulting from 'tailored' medicine; and confidentiality issues with respect to family members. This article explains these issues and identifies some of the difficulties encountered in seeking to build a harmonized legal framework within Europe.
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