On the issue of mandatory insurance of patients participating in clinical trials

Persons involved in the clinical research of new medicines for medical use bear the risk of causing harm to life or health, which requires the introduction of adequate forms, methods and methods to protect their interests. One of the most effective ways to protect against risks is recognized as insurance in voluntary and mandatory forms. Subjects who have received permission to organize clinical trials are required by the current legislation to insure the life and health of patients participating in such studies. However, in the report of the Insurance Market Department of the Central Bank of Russia, this insurance is classified as so-called imputed (i.e. quasi-mandatory) types. Based on the review of the current legal acts, the author comes to the conclusion that life and health insurance of a patient participating in clinical trials of a medicinal product for medical use can reasonably be attributed to mandatory types of insurance. In the course of the study, statistical data were also analyzed, which allowed us to conclude that the quality of loss settlement is insufficient (the annual share of refusals of insurers on payments is on average 50%) and the low level of loss-making, which requires optimization of the tariff policy in this type of insurance.