In the last decade scientists conducting observational studies in Italy faced several obstacles, mostly caused by ambiguous terminology and definitions, and by a national legislation that need to be updated. This has been causing not only long and expensive authorization processes (which make Italy less competitive, compared with other European countries), but has been producing also potential limitations for an effective control of the study protocols quality and for the design of innovative research projects. In particular, the Italian legislation currently regulates only observational studies on medicinal products, leaving the conduct of other observational studies without a normative reference.

Recently, the Italian Society of Pharmaceutical Medicine (SIMeF) together with the Istituto Superiore di Sanità (ISS), the University of Milano Bicocca (Centro di Ricerca Interuniversitario Healthcare Research & Pharmacoepidemiology), the Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) and the Società Italiana di Farmacologia (SIF) activated a working group to formulate specific recommendations for the definition of the new forthcoming national legislation on observational studies, in the framework of law 11 January 2018, n. 33 and legislative Decree 14 May 2019, n. 52. The recommendations were later formally approved by several other Italian scientific societies* and the underlying concepts were positively discussed with representatives of the Italian Drug Agency (AIFA), the Health Ministry and the Data Privacy Authority.

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Reference: The increasing need for a new Italian legislation to facilitate execution of observational studies assuring ethics and the highest standards of scientific and methodological quality.  Carlo Petrini, Giovanni Fiori, Gualberto Gussoni, Sara Cazzaniga, Giovannni Corrao, Valeria Lovato, Dario Manfellotto, Francesca Mastromauro and Alessandro Mugelli. Ann Ist Super Sanità 2020 | Vol. 56, No. 3: 257-259. DOI: 10.4415/ANN_20_03_01