La circolazione dei dati genetici e delle biobanche: limiti e prospettive de iure condendo

Over the last years, in the health sector – like in others – a huge amount of information and data has been collected. Such information, data and big data may be used both by medical science, for patients’ analysis and evaluation, and by other subjects/entities, such as public administrations and insurance companies. Within this perspective, genetic data and biobanks show a growing interest. Currently, no comprehensive legal framework exists in the field of biobanks, either at domestic or at international levels. Nor a shared definition of biobanks can be identified. As a consequence, identifying the applicable law to biobanks is a very difficult task. In its first part, the research investigates on the definition and classification of biobanks, with the aim to clarify their legal nature and, as a result, the applicable law. Afterwards, biobanking activity regulations are analysed, with particular reference to biobanks mobility. The paper ends pointing out as a comprehensive and organic intervention by the legislator is desirable. Such intervention should be based on the principle of proportionality and should take into account the particular characteristics of genetic information and of the significant risks of improper use and re-use for different aims of the same information, other than risks of discrimination of individuals, as well as the limits of anonymisation techniques.