Ways to improve administrative liability for violations in pharmaceutical activities

Abstract

Pharmaceutical activity, as a component of the healthcare sector, is certainly one of the most important areas of the industry, because its essence is to provide citizens with safe, high-quality, and affordable medicines.

The aim of the work is to develop the basic elements of the concept of improving administrative liability for offences in the pharmaceutical sector.

Materials and methods. The study materials included the provisions of the current Code of Ukraine on Administrative Offenses and the laws of Ukraine governing pharmaceutical activities. The analysis also relied on statistical data from the State Service of Ukraine on Medicines and Drugs Control, as well as analytical reports issued by the World Health Organization and the European Medicines Agency. The methodological basis is a system of general scientific and special legal methods. The dialectical method is used to reveal the reform of administrative tort law as a dynamic process of development of legal norms.

Results. Based on an analysis of scientific sources, the authors put forward a generalized conceptual framework outlining the key trends in the reform of administrative tort legislation in the pharmaceutical sector, drawing on diverse scholarly approaches. The study identifies the following priority areas for updating legislation on administrative liability in the circulation of medicinal products: codification of offenses related to medicinal product circulation; clarification of the objective and subjective elements of administrative torts (including precise definitions of such concepts as “non-compliance with standards”, “violation of the rules governing the circulation of medicinal products”, “dispensing”, and “distribution”); differentiation of sanctions according to the gravity of the violation, its consequences, and the form of guilt; and consideration of special regulatory regimes, including martial law, states of emergency, and humanitarian operations.

Conclusions. The focus of the reform should include the development of special criteria for bringing to justice, taking into account the degree of public danger. It is also advisable to differentiate sanctions depending on the severity of the offence and the parties involved.