In the last few years, the fields of Medicinal Chemistry and especially the ones related to the so-called Personalized Medicine, have received a great attention. Significant investment and remarkable researches surround the matter; however, not all those promising advances are reaching patients as quickly as they should. The absence of an adequate regulatory framework could be of no help. The complete and/or massive sequencing of individual genomes faces many ethical-legal challenges. Some of them are access to Personalized Medicine; the treatment of a large volume of sensitive information and the use of tools produced by "big data" systems in clinical care or in predictive models. In addition, the legal protection of personal data related to health, the exercise of autonomy by patients, closely related to the regulation regarding clinical trials, are seriously involved. Our purpose of this work is to review the regulations of the European Union, in an attempt to contribute to a better understanding of the legal framework for the implementation and development of health systems based on Personalized Medicine.
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