Pharmacogenetic testing: legal considerations for consent, privacy and disclosure.

This review provides an overview of the European legal framework relating to the protection of sensitive data obtained from pharmacogenetic tests. The primary objective of pharmacogenetic testing is neither diagnosis nor prediction of disease, but determining likely responses to medicines based on specific genetic factors. Nevertheless, pharmacogenetic testing can lead to the disclosure of sensitive information and, as a consequence, it is argued that consent is a prerequisite. It is further argued that appropriate protection for privacy and confidentiality is crucial, but that disclosure may be justified in certain exceptional circumstances. This article describes the various European legislative instruments that provide useful guidance on the types of circumstances when disclosure may be justified.