The german «model» of criminal-legal protection of the circulation of medicines and the circulation of medical products: concepts and structure

Abstract

The article examines the German «model» of criminal law protection of circulation of medicines and circulation of medical products. A number of obligations assumed by Ukraine after the conclusion of the Association Agreement between Ukraine, on the one hand, and the European Union, the European Atomic Energy Community and their member states, on the other hand, are analyzed. In particular, obligations related to the legal protection of medicines and medical products.
 The subject of the authors’ consideration is the European standards of the «model» of criminal law protection of circulation of medicines and circulation of medical products against their counterfeiting (falsification), which Ukraine is obliged to take into account (according to the Medicrime convention).
 The criminal legislation of the Federal Republic of Germany is studied, as it provides the most complete protection of the circulation of medicines and the circulation of medical products. The German Medicines Act (1976) and the German Medical Products Act (2002) were developed by the authors.
 The German approach in defining the concept of medicinal products in the Law on Circulation of Medicinal Products is presented, which, according to the authors, is important because it «contradicts» the approach laid down in the Medicrime Convention.
 The article pays attention to the types of German criminal offenses that encroach on the established order of circulation of medicinal products and the types of criminal offenses that encroach on the established order of circulation of medical products.
 The authors find that the main advantages of the German «model» are the detailed inclusion of the provisions of the regulatory legislation, which ensures the circulation of medicinal products and the circulation of medical products, in the content of the structural elements of a specific type of criminal offense: a) in the content of objective and subjective signs of the corresponding composition of the act (on one «level» of the structure of the criminal offense), as well as b) the illegality of these criminal offenses (on another «level» of the structure).
 The content of “the circulation of medicines” and “the circulation of medical products”, provided for in the relevant provisions of the German Law on the circulation of medicines and the Law on medical products, is analyzed.