Legal Regulation оf Insurance оf Clinical Trials оf Medicinal Products іn Ukraine

Abstract

The article examines the current state and prospects of development of insurance for clinical trials of medicinal products in Ukraine, and also substantiates the need to introduce certain types of insurance in this area. As a result of a systematic analysis of current legislation, scientific literature and international acts, the author classifies persons participating in clinical trials of medicinal products into: 1) clinical trial subjects and 2) participants of such a scientific and medical experiment. In addition, the author outlines the main risks that arise for individual trial participants throughout the entire dynamics of clinical trials of medicines and proposes to minimize them by: changing the regulatory approach to making insurance mandatory by clarifying the subject matter of the insurance contract (insurance of liability of the investigator and sponsor of clinical trials); introduction of property insurance and liability insurance of manufacturers of medicinal products with state support; introduction of professional liability insurance of the investigator/co-investigator of clinical trials of medicinal products; introduction of insurance of investment and financial risks in the field of clinical trials of medicinal products with state support. It is also established that the peculiarities of the legal status of clinical trial participants, the specifics of their interests, and the need to participate in the trial influence the formation of the theory of multiple risks arising in the course of a clinical trial of a medicinal product and can be manifested as cases with negative consequences. The theory of multiple risks makes it possible to group them into different areas depending on the criterion of personalization (status of a person participating in a medical experiment: subject/ participant): 1) personal risks; 2) property risks; 3) liability risks.