Risk-Based Approach and Pharmaceutical Compliance in the Sphere of State Supervision of Illegal Circulation of Medical Products

Abstract

The article deals with the problems of introducing a risk-based approach to the regulation of federal state supervision in the sphere of circulation of medicines. The main drawbacks of the risk-based approach regulation in the regulatory legal acts of the Russian Government and Roszdravnadzor are highlighted. The discrepancy of certain provisions of the relevant acts to the principles of administrative law and the Code of the Russian Federation on administrative offences in the part relating to the assessment of the legal value of the period during which a person is considered to be subjected to administrative punishment is noted. Measures to improve the risk- based approach to the organization of state supervision in the sphere of circulation of medicines are proposed. In particular, data on the degree of compliance of the objects of control with the requirements of good practices (GxP, including GMP, GPP, GDP, etc.) and data on the presence of the objects of control systems of pharmaceutical compliance are proposed in the assessment of the risk of harm. The authors formulated the definition of the concept of pharmaceutical compliance. It is concluded that the inconsistency of the administrative-legal and criminal-legal policies to combat cartels in the EAEU member States creates significant risks to achieve the goals of creating a single market of medical products in the Eurasian Economic Union.