"Lost in Legislation": il diritto multilivello delle biobanche di ricerca nel sistema delle fonti del diritto (convenzioni internazionali, leggi europee, nazionali e regionali, softlaw)

The DNA's double helix contains the key access to the understanding of diseases that were considered incurable so far. From the scientifical and subsequent economic point of view its components are, in fact, an unique source of relevant information. However, the hopes of science and personalized medicine are not only stored in the so-called code of life. In recent years the progress of biomedical research is attributable both to the development of molecular biology, which led to the massive analysis of genetic data, and to the possibility of having a critical mass of biological samples, collected, annotated and stored according to high quality standards. Hence, there is a need to create working tools and facilities such as biobanks, able to collect in a systematic, organized and professional way human biological materials. The term biobank knows different variations within the scientific scene, since it’s possible to distinguish them depending on the type of collected material and the purpose for which they were established. Mirroring this variegated scenario, the legal framework of research biobanks is equally in search of a systematic order. There is still no agreed definition of the term biobank, while the regulatory gap is naturally driving to the development of nonbinding guidelines. Therefore, the role of the interpreter in such a situation is to reassemble the pieces of this colorful mosaic, applying the legal rules contained in unspecific legislative provisions in order to give the mutch needed regulatory responses which the stakeholders of the biobanking world are waiting at the European level. At the European level one can detect a strong need to create shared taxonomies, and provide a consistent framework capable of responding to the most pressing legal and ethical challenges raised by biobanks. At the national, Italian level, it is also necessary to pay attention to the scenarios proposed by the recent “regionalization” of biobank law. Absent a common frame of reference, the zeal of some regional legislators could get the unintended effect of fragmenting the discipline, creating standards and procedures which risk to hinder the interaction between the different actors of biobanking. Such a complex subject, in fact, can only be considered in a multidisciplinary perspective, taking into account all the actors involved. Thus, if the medical science side has established the important role of biobanks, on the legislative side an appropriate legislative framework is needed. The latter, composed both by international and national legislation, should protect the interests of the patient - providing clear and balanced rules governing the different stages of human biological material treatment “from the operating room to the laboratory of researcher” - of the health professionals and researchers, ensuring that the same discipline is equipped with the necessary flexibility to not harness the development of science and technology favoured by biobanks.