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Clinical Trials on Medicinal Products as a Case of No-Fault Liability?

Publication at Faculty of Law |
2020

Abstract

Clinical trials of medicinal products represent a very beneficial activity that is connected to an inherent risk to the health and life of persons in whom the new medicines are tested. Civil liability for immaterial harm in the context of clinical trials is not properly addressed in Czech law.

In this paper, we argue for the suitability of strict liability that would be applicable to all bodily harms except for those that did not arise as a result of the materialisation of inherent risks of clinical trials. The types of strict liability regulated by the valid Civil Code are either inapplicable or applicable in a very limited scope in the context of clinical trials.

We suggest that there are two possible solutions. First, there could be created a special strict liability based on the analogical use of the relevant principles of some of the existing types of strict liability.

Second, a special public insurance system could be introduced from which the harms would be compensated for.