Administrative and legal support of state control over testing of pharmacological drugs

Abstract

The purpose of the work is to analyze the problems of administrative and legal support of state control over the testing of pharmacological drugs.

Based on the goal, the objectives of the study include identifying theoretical and practical problems in the administrative and legal regulation of testing pharmacological drugs, as well as making proposals for improving the mechanism of state control in this area. Currently, there is an increasing importance of administrative and preventive measures in the field of protecting public health in general and monitoring the testing of pharmacological drugs in particular. This is also due to information about a whole series of unfair tests by a number of foreign pharmaceutical campaigns of drugs in Russia and in new territories that became part of the Russian Federation.

The fundamental conclusion of the article is that the existing system of regulatory regulation of state control over the conduct of medical experiments and experiments involving humans is clearly imperfect. The current system of legal regulation applies only to clinical trials of pharmacological drugs, but does not apply to other forms of therapy. Clinical trials of a drug on a patient involve not only identifying its pharmacological properties, but also treatment, that is, therapy for the patient. The author proves that only the voluntary informed consent of the patient is not enough to protect his constitutional right to protection during medical experiments, provided for in Part 2 of Article 21 of the Constitution of the Russian Federation, due to the experimental nature of therapy or diagnosis.