Personalized medicine and genetic data legislation in Italy and in the German-speaking countries

The term “personalized medicine” has been generated to indicate strategies for targetting medical treatments in each individual patient based on his/her own phenotype, genotype, lifestyle, and clinical records. Initially, these strategies were largely based on classical pharmacogenetic and pharmacogenomic methodologies. Later on this concept became progressively wider and included further predictive genomics approaches enabling patient stratifications based upon genetic risk to develop specific diseases. Indeed, improved understanding of human genome brought personalized medicine into the novel dimension of “predictive medicine” which enables quantitation of disease risk in addition to disease presence. The legal, bioethical and socio-economic implications of this advancement have only recently started to attract interest on how to compromise the need of scientific progress and the protection of the fundamental rights both at the individual and at the community levels. This is clearly a very sensitive as well as an extremely complex area as it handles genomic information potentially related to the individual fate. In fact, in several countries, including Italy, there still is no specific discipline which addresses the important issues of genetic/genomic data protection and use. At variance, other Countries are more advanced. Germany, for instance, has a complex regulatory body, termed Gendiagnostikgesetz (GenDG), in force since 2010, providing detailed recommendations to protect individuals from discrimination based on their genetic characteristics, and also establishing special rules in the insurance field. Similar German law, Swiss and Austrian laws were prompted by the notion of “Genetic Exceptionalism”. Indeed, both Switzerland and Austria have legislation on genetic data with interesting profiles on insurance practice.