Circulation of Falsified Medicinal Products and Medical Devices under the Medicrime Convention: Problems of Defining the Concept and Scope of Application

Abstract

The article examines the circulation of falsified medical products and medical devices under the Medicrime Convention with an emphasis on the scope of this Convention. The Medicrime Convention is a basic international legal act that defines the European standards of the model of criminal law protection of circulation of medical products and medical devices against their counterfeiting (falsification). The author notes that given the importance of these provisions of the Medicrime Convention for the criminal protection of pharmaceutical activity and individual and public health, the specific content of its provisions requires independent analysis. The article proposes to analyse the scope of application of the Medicrime Convention in view of the specific content of “subjects” to legal protection in accordance with the provisions of the Medicrime Convention. The author emphasizes the importance of scrutinizing the terms such as «medical products,» «medical device,» «medicines,» «active substance,» «accessory,» «parts,» «materials,» and «document» outlined in Article 4 of the Medicrime Convention. This scrutiny is deemed necessary to understand the legal standards governing the criminal protection of pharmaceutical activity. To achieve this, the author proposes a comparative analysis of these terms with the pertinent elements of pharmaceutical activity. The goals of this comparative analysis are twofold: a) to elucidate the role of these terms in the framework of criminal protection for pharmaceutical activity; b) to delineate the interrelationships among these concepts, thereby elucidating their significance in characterizing pharmaceutical activity as a subject of criminal law protection. In the opinion of the author, the “national model” of criminal protection of pharmaceutical activity should be focused on ensuring the protection of primarily the rights, freedoms and interests of subjects of pharmaceutical activity, the connections between them, which ensure the circulation of medicinal products, and “stay” outside circulation of medicinal products, as well as connections between subjects of pharmaceutical activity related to their exercise of powers (professional powers) in the field of pharmaceutical activity. In addition, as the author notes, along with pharmaceutical (medical) products, “accompanying” items that ensure “handling” with pharmaceutical products or, in other words, ensure the implementation of pharmaceutical activities with pharmaceutical products, are subject to criminal protection: “accessories intended for use with medical devices”. The author proves that at the level of the Medicrime Convention, medical products and medicines as a separate type of medicinal products are mandatory components of the circulation of medicinal products, and in view of the above ratio of the concepts “medicines” and “medical products” is equivalent to the circulation of medicinal products only in if we take into account the two named types of medicinal products.