Grounds for legal liability in the pharmaceutical sector of the healthcare sector

Abstract

The aim. To find out the content and essence of the legal liability grounds, to determine the main features of each element. Materials and methods. Synthesis, analysis and comparative law methods were used in the course of the study. Results. The grounds for legal liability in the pharmaceutical field are: 1) the fact of committing an act, defined as an offence by the relevant legislation, i.e. the factual basis; 2) the existence of a legal rule that prohibits such behavior and establishes appropriate sanctions, i.e. the regulatory basis; 3) lack of grounds for release from liability; 4) the existence of a law enforcement act, a written decision of the competent authority in which the person is found guilty and assigned the type and measure of punishment, i.e. the procedural basis. The analysis of the relevant regulatory framework shows some inconsistencies in the legislation governing the pharmaceutical sector in the context of legal liability. Thus, the cited articles of Fundamentals and the Law of Ukraine “On Medicinal Products” presume different types of legal liability for violations of the sectoral legislation. The fact is that Article 80 of the Fundamentals does not presume disciplinary liability, which, in our opinion, may have quite unpleasant precedents. In order to increase the effectiveness of the legal liability mechanism, we consider it appropriate to amend Article 80 of the Fundamentals. Conclusions. The grounds for legal responsibility in the pharmaceutical sphere correspond to the generally accepted approaches to their classification, and also have branch-specific features. In order to bring a violator of pharmaceutical legislation to justice, it is necessary to have several elements and only their combination determines the legal responsibility in the pharmaceutical field as possible and appropriate.