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'Personalised medicine' refers to a medical approach that uses molecular insights into health and disease to guide decisions with regard to the prediction, prevention, diagnosis and treatment of illnesses. Genetic factors play a role in most human diseases, with gene variations contributing to their incidence or course. New tools harnessed by personalised medicine include '-omics' technologies, which seek to define and explain the molecular mechanisms of the human body, and biomarkers, allowing us to subdivide patients into groups according to their likely response to a specific treatment, and so decide on the best-suited medication. Integrating advances in molecular technology into clinical practice comes with challenges, namely the translational gap, data protection, regulatory clarity and cost. Moreover, it is considered essential to educate patients (to acquire health literacy) as well as healthcare professionals (both in terms of providing them with undergraduate education and with continuous opportunities to advance their skills). EU initiatives in the field of personalised medicine include the Innovative Medicines Initiative (IMI), financial support to major research projects, and participation in international consortia. The Luxembourg Council Presidency has made personalised medicine one of its health priorities.