Finanziamento UE – NextGenerationEU PRIN 2022 "Clinical trial data between privatization of knowledge and Open Science" PNRR M4C2 investimento 1.1 Avviso 104/2022

Clinical research produces enormous amounts of data. This especially in the pharmaceutical field during pre-clinical and clinical tests. These data represent an invaluable resource from multiple points of views: scientific interests in creating new medicines and pursuing progress and innovation in the health domain, the necessity to verify the studies carried out, the purely commercial approach on protecting the effort to obtain a marketing authorisation, and the public interest in access and disclosure. Access to this information is often severely limited by forms of exclusive rights and other forms of protection and control that persist on various Ministero dell'Università e della Ricerca MUR - BANDO 2022 levels and make it impossible to take (public) advantage of such important resources. On the contrary, Open Science (OS), Open Access (OA), findability, accessibility, interoperability, and reuse (FAIR) principles, transparency and flexibility needs and the creation of public databases push forward the implementation of accessible or open data. The recent pandemic has tragically brought this problem to bear and in this application context there is currently a lack of clarity and knowledge among the different stakeholders in the legal, philosophical and ethical fields. The project aims to investigate the interplay between privatization of knowledge by pharmaceutical developers and OS for clinical trial data from multiple perspectives. The first objective of the research will be the comprehensive legal mapping of the regulatory framework for the protection of data in clinical research in the European Union (EU) legal system and in some selected Member States, including Italy, while briefly considering the international context. It shall be also examined if and how this scenario may be consistent with the instances promoted by OS and OA. The legal analysis uses a comparative methodology that takes into account the complex regulatory framework