Legal Regulation of Personal Data Processing in the Pharmacovigilance System in Russia

ANNOTATION graduate qualification work Andriesh Ksenia Ilyinichna Subject: Legal regulation of personal data processing in the system of pharmacovigilance in Russia. The graduate qualification work consists of 78 pages with an appendix, 74 sources were used. Key words: pharmacovigilance; pharmacovigilance system; personal data protection; data on health status; data on minor adverse events; big data; recommendations. The object of the study is public relations arising in the sphere of personal data turnover in the system of pharmacovigilance in Russia The subject of the study are international, foreign, regional, Russian regulatory legal acts, by-laws, official documents, guidelines, scientific doctrines, ideas and concepts, materials of pharmacovigilance practice and personal data protection, as well as statistical data and studies. The aim of the study is to examine and analyze the processes of pharmacovigilance and personal data processing in these processes, their legal regulation with a focus on the key process of pharmacovigilance and personal data processing - work with information on minor adverse events (reactions), as well as to identify the specifics of personal data processing for the purposes of pharmacovigilance. The objectives of the study are defined taking into account the set aims. Problem statement (project task): the hypothesis that there is a different, other than consent, basis for processing of personal data for the processing of reports of minor adverse events. Scientific (practical) significance of the research. The investigated topic is one of the most interesting complex topics of pharmacovigilance and personal data protection. The topic, which is related to the right to health, the development of medicine, obtaining complete and accurate information and protection of privacy, ensuring privacy and confidentiality, has practical application on a daily basis. Based on the results of the study, proposals for amendments to the current legislation and directions for the development of legal regulation were formulated. The study consists of an introduction, three chapters and a conclusion. The introduction discusses the relevance of the chosen topic, sets the goals and objectives of the study, project assignment (problem). The first chapter of the study analyzes the pharmacovigilance as a complex activity and system, its principles and objectives in comparison with the concept of personal data regulation, goals and objectives of personal data protection and regulation of personal data circulation; the correlation of public and private interests in the system of pharmacovigilance and personal data circulation, the place of personal data processing in the system of pharmacovigilance; the specificity of the participants of the pharmacovigilance system, their role in the processing of personal data. The second chapter is devoted to a detailed analysis of one of the central institutions of pharmacovigilance - reporting of minor adverse events (reactions). It deals with the composition of the minor adverse event (reaction) report, the role of personal data in it and its importance for the whole system of pharmacovigilance. The third chapter explores the issue of the proper legal basis for processing personal data in reports of minor adverse events as a key problem and challenge in collecting and analyzing such reports for the purposes of pharmacovigilance in Russia, forms a project solution within the current legislation in Russia, offers practical ways to solve the problem, as well as suggestions for improving the legislation. The conclusion contains generalizing conclusions on the results of the study. The total volume of the study is 100 pages.