Foreign Experience of Illegal Import/Export of Medicinal Drugs: Administrative Legal and Criminal Legal Aspects
Author(s): Vadym Nehodchenko*, Roman Barannik, Maksym Pochtovyi, Vadym Polovnikov, Anna Shapovalova
Abstract
Aim: The article examines foreign experience in combating the illiciting of medicines in the context of administrative, legal and criminal regulation.
Methods: The methodological basis is made up of general scientific and special legal methods, in particular comparative legal, systemic and structural, formal legal and legal modeling methods. In the process of the study, regulatory and legal acts (in particular, Directive 2011/62/EU, the MEDICRIME Convention, the US DSCSA) were analyzed, as well as institutional mechanisms of the activities of authorized bodies (EMA, FDA, MHRA).
Results: It is substantiated that the effectiveness of countering the illiciting of medicines is ensured by a combination of preventive administrative measures (licensing, serialization, digital tracking, pharmacovigilance) with strict criminal sanctions (fines, imprisonment, confiscation of assets). It is established that the digitalization of supply chains, interagency coordination and international cooperation play a key role.
Conclusion: The scientific novelty lies in the systematization of modern approaches to legal support for combating illiciting of medicines and determining the optimal model of their adaptation to the national legal system of Ukraine. The practical significance of the results lies in the possibility of using the formulated recommendations in regulatory activities, as well as in the activities of customs and law enforcement agencies. Directions for improving Ukrainian legislation are proposed, in particular, the implementation of a full-fledged track and trace system, harmonization with EU law, strengthening criminal liability and the development of international cooperation in the field of combating pharmaceutical illiciting.