Title:Personalized Medicine and Medicinal Chemistry: Toward a Legal Framework in the European Union
Volume: 18
Issue: 25
Author(s): Aliuska Duardo-Sánchez*Iñigo De Miguel Beriain
Affiliation:
- Department of Public Law, Chair in Law and Human Genome Research Group, University of the Basque Country UPV/EHU, 48940, Leioa, Biscay,Spain
Keywords:
Personalized medicine, Medicinal chemistry, Legal issues, Genomics, Data protection, Clinical trials.
Abstract: 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.