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Dietary Supplements As an Object of Civil Legal Relations in Russia

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Dietary Supplements As an Object of Civil Legal Relations in Russia 1752 Medico-legal Update, October-December 2020, Vol. 20, No. 4 DOI Number: 10.37506/mlu.v20i4.2095 Dietary Supplements as an Object of Civil Legal Relations in Russia Yury Alexandrovich Svirin1, Alexandr Anatolievich Mokhov2, Vladimir Viktorovich Kulakov3, Vladimir Aleksandrovich Gureev4, Svetlana Viktorovna Shimanskaya5 1Doctor of Legal Sciences, Professor, All-Russian State University of Justice, Russia, 2Doctor of Legal Sciences, Professor, Kutafin Moscow State Law University, Russia, 3Doctor of Legal Sciences, Professor, The Russian State University of Justice, Russia, 4Doctor of Legal Sciences, Professor, All-Russian State University of Justice, Russia, 5Senior Lecturer, Academy of Law Management of the Federal Penitentiary Service of Russia, Russia Abstract This paper reviews the legal regulation of the dietary supplement turnover in Russia. Since dietary supplements are an independent object of civil commerce, they must have certain qualities that distinguish them, most importantly, from medicines. According to the authors, the dichotomy in the definition of dietary supplements in the Russian legislation does not allow fully preventing dietary supplements from being confused with other food products, medicines, international non-proprietary names of medicines. The authors also examine the relationship of dietary supplements with such concepts as comestibles and food products. Method: The authors used the method of comparative and systemic analysis, synthesis, and scientific research of the object as an element of civil legal relations. The purpose of the study was to look at dietary supplements as a subject of civil legal relations, to identify problems of protecting dietary supplements as objects of intellectual property law. Results: Although since the mid-1990s, active distribution of dietary supplements has begun in Russia, to date, the legal doctrine has not developed the scientific concept of dietary supplements, and the definitions contained in regulatory acts are contradictory. The analysis of the regulatory framework and judicial practice gives reason to conclude that dietary supplements are recognized as objects of civil legal relations in Russia. They are sold in free circulation, they are movable property, and legislators have established mandatory registration for putting these objects into commodity circulation. Keywords: Object of civil legal relations; dietary supplements; medicines; food products; product life cycle. Introduction the country began an active distribution of nutritional supplements, with Herbalife as the largest supplier. In The history of the development of the legal regulation 1991, the Russian legislators adopted law No. 1034-1 of dietary supplements (further referred to as DS) in “On the sanitary and epidemiological well-being of the Russia has developed in line with the legal regulation population,” of the Russian Soviet Federative Socialist of the entire pharmaceutical market. In the mid-1990s, Republic (RSFSR) which was the foundation for the legal regulation of DS production and circulation. However, this was the first step, not entirely successful, to create a legal framework for the DS production and Corresponding Author: civil commerce. Yury Alexandrovich Svirin 2/1 Asovskaya Street, Moscow, 117638, Russia Currently, Russia is completing the implementation e-mail: [email protected] of the Strategy for the Development of the Pharmaceutical Medico-legal Update, October-December 2020, Vol. 20, No. 4 1753 Market of the Russian Federation until 2020. The goal of Method the strategy was the transition to an innovative model In the research process, we used the following for the development of the pharmaceutical industry of method: comparative and system analysis; scientific the Russian Federation. This is expected to be achieved research of an object as an element of civil legal through consistent technical and technological re- relations; synthesis; structural-functional and statistical equipment of enterprises and the release of innovative analysis, as well as the empirical cognition method. products, including DS, demanded by the population. As a result, by 2020, the export potential of Russian Results pharmaceutical products should exceed the figure of 2008 by 8 times. However, not all goals have been Russia is a member of the Codex Alimentarius achieved, which forces us to carefully study the ongoing Commission. Codex Alimentarius is a code of accepted processes and draw the right conclusions. international standards and related texts concerning food products presented in a unified format. First of all, these Today, the Federal DS Register of the Federal are accepted international standards, guidelines, norms, Service for Surveillance on Consumer Rights Protection and rules. The Codex standards are based on reliable and Human Wellbeing (Rospotrebnadzor) lists about scientific data provided by independent international 1 9,500 DS . For example, in 2018 alone, Rospotrebnadzor risk assessment bodies or through special consultations issued 2,302 certificates of state registration for DS. For organized by the World Health Organization (WHO). many years now, the Evalar company has remained the market leader. The second place is occupied by Pharma- Although the concept of DS is an integral part of Med. According to data for 9 months of 2018, there the regulatory framework in the field of sanitary and were more than 52 thousand facilities in the Russian hygienic regulation, the legal doctrine does not contain a Federation engaged in the production and commerce of scientifically based concept of DS. Legislators define DS DS, including 180 enterprises engaged in DS production as follows: DS are compositions of natural or identical to and 52,029 enterprises engaged in DS circulation natural biologically active substances intended for direct (including 735 warehouses, 5,569 retail network intake with food or incorporation into food products to enterprises, 45,725 pharmacy chain facilities). At the enrich the diet with individual nutritional supplements same time, according to the results for 9 months of 2018, from plant-based, animal or mineral raw materials, as the territorial agencies of the Rospotrebnadzor of the well as chemical or biologically active substances and Russian Federation had revealed 1997 violations. These their complexes. It seems to us that this definition lacks figures convincingly demonstrate that the market for the the most important thing, namely, the purpose of their production and distribution of DS in Russia is vast, but application. Should there always be a positive effect there are no clear legal mechanisms for regulating this on the body when taking DS? The history of Russian market. pharmaceuticals is full of cases where certain medicines did not have any medical effect, and the health of patients Violations of the mandatory requirements of the improved only due to the placebo effect. law were identified in 77% of facilities producing DS. During inspections of organizations involved in the DS registration takes place at the federal level and implementation of DS (trading enterprises, storage the state controls all stages of the DS circulation. A depots, pharmacy chains), violations of the established study of the dynamics of the development of legislation requirements were found in 47% of the facilities. 2,412 shows that it follows a chaotic gradual tightening of the decisions were issued on imposing an administrative order of the DS circulation, and there are no uniform penalty in the form of an administrative fine for 17,114.61 rules for the civil circulation of DS in Russia. As a result, thousand rubles. 1,404 DS batches were withdrawn from selling DS makes one balance between legal and illegal commerce. The volume of rejected products amounted activities. The similarity of DS to medicines in many to 1,133.16 kg. respects has predetermined the complex nature of legal relations regulation in the circulation of DS. These figures convincingly demonstrate the need to study DS as the object of legal regulation, and to search The subjects of civil legal relations enter into for a mechanism for the effective regulation of the DS relations to satisfy their needs. The objects of civil civil circulation in the Russian Federation. legal relations are various tangible (including material) 1754 Medico-legal Update, October-December 2020, Vol. 20, No. 4 benefits and intangible (ideal) benefits or the process of According to the law “On trading activities”, their creation, which are part of the activities performed comestibles are products in natural or processed form, by subjects of civil law2. DS can have a great impact which are commercially available and used by humans on human health, not always with positive results. for food (including baby food, diet food), bottled Therefore, the problem of DS turnover is relevant in drinking water, alcoholic beverages, beer and beverages Russia, as the population’s health leaves much to be made based on it, soft drinks, chewing gum, nutritional desired. supplements and DS5. Based on this normative act, one can conclude that DS is a kind of comestible. Legislators define DS as an object of the material world. This follows from Article 1 of Federal law No. According to the law “On food quality”, food 29-FZ “On food quality and safety” dated 02.01.2000 products are products in a natural or processed form used which defines DS as natural (or identical to natural) by humans for food (including baby food, diet food), biologically
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