Publication at Faculty of Law |
2020
Abstract
During the epidemic of COVID-19, there often arises an urgent need for the so-called off-label use of medicinal products, i.e. use of a medicinal product that is not in accordance with its Summary of Product Characteristics (SPC). Most often, a medicinal product registered for a different indication is used.
The goal of this paper is to provide the reader with an analysis of legal conditions under which the off-label use of medicinal products in COVID-19 patients is legally safe. If the provider of health services fulfils these conditions, they would not be held liable for immaterial harm that could potentially occur to the patient.