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 will not be held liable for immaterial harm that could potentially occur to the patient. Copyright © 2020, Czech Medical Association J.E. Purkyne. All rights reserved.
ABSTRACT
This paper focuses on judicial decision-making during the Covid-19 pandemic, especially in the area of judicial oversight or review of various restrictive measures adopted in order to protect public health. A pertinent question is how well-equipped courts are to protect individual rights from excessive interference by public authorities at a time when a lot of essential information about nature and severity of the threat, and which counteractions would be the most suitable, is unavailable. Is it a valid point that law is prepared for usual, nonexceptional circumstances, but fails in times of a true crisis? For this purpose, the paper analyses selected case law and evaluates how it approaches a problem which most developed countries are currently attempting to resolve. © 2021, Czech Society of International Law. All rights reserved.