Veterinary clinical trials and human clinical studies

Abstract

Medicines are the basis of modern medicine and veterinary medicine. Mechanisms of their impact on human and animal bodies are similar. Therefore, clinical trials are carried out in a similar way, regardless of whether people or animals are involved. However, the differences between the legal status of humans and animals, as well as the need to protect people’s personal rights require different standardization of tests of medicinal products intended for use in medicine and veterinary medi- cine. The article compares the legal regimes of these experiments on the basis of the current legal status and its changes, which will occur in the near future. The following issues are discussed: the sources of clinical trial law and the relationship between national and EU normative acts; legal definitions of researcher and sponsor; the mode of selection of the research team leader; the entity having the status of a clinical trial partici- pant; administrative decisions required to legally start an experiment; and the principles of liability for damage related to clinical trials. The author concludes that both the Polish and the EU legislator recognize the need to differentiate between the two regimes, but they implement it in an imperfect manner. A critique of relevant legal provisions is followed by some amendment proposals.