Responsabilità civile da usi off-label di farmaci: potenzialità e limiti, tra UE e USA

Off-label prescriptions (i.e., pharmaceutical uses that diverge from the terms of the product regulatory authorization and information) uses are widespread in many areas where there is a lack of licensed therapeutic alternatives, including the treatment of new coronavirus infection. Such prescriptions expand the treatment options for patients; yet, since they are not formally validated, they can also expose them to substantially experimental risks and uncertainties. This article provides an overview of how the civil / tort liability systems in the EU and the USA deal with injuries caused by off-label uses of medicines, considering the position not only of prescribers, but also of manufacturers and regulators. The concluding paragraph outlines the potential and limits of the reconstructed judicial approaches and identifies further research avenues.