An analysis of the fulfilment criteria for a medical experiment with regards to the use of intravenous ketamine in the treatment of drugresistant depression

Abstract

Introduction: Clinical experience, as well as the results of real-world data analysis point to the need for developing a model for the care of patients with drug-resistant depression, which could lead to improved access to effective and safe treatment. Scientific studies carried out to date have unequivocally documented the mode of action of ketamine and identified factors which can influence the efficacy of single infusions of ketamine for depression as well as in cases of affective bipolar disorder. Material and method: Case report including a review of national and international literature and an analysis of the case in the light Polish of EU law. Discussion: The use of ketamine in the treatment of drug-resistant depression raises question regarding its legal qualification, in particular whether such treatment can be characterized as a medical experiment. Conclusions: In the light of international publications, which confirm the validity of the method described above, one might assume that the treatment could be qualified as off-label use of a medicine, but not as a medical experiment as it is understood in the legislation (art. 21 ZawLekU). However, given the nature of this treatment, its qualification as off-label use is not the only one possible and others cannot be immediately ruled out.