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Publications of Belaia Olesia Valer'evna
Law and Politics, 2020-9
Belaia O.V. - Protection of genomic research data as the objects of intellectual property pp. 167-178

DOI:
10.7256/2454-0706.2020.9.33797

Abstract: The object of this research is the determination of legal nature of genomic research data and their role among the objects of civil law. The subject of this research is the data of preclinical and clinical studies of pharmaceutical products, mostly those that contain biomaterial and biomedical cell products. The author underlines the problem of the absence of due legal regulation of genomic research data as the objects of law within Russian legislation, as well as protection of their rightsholders from anticompetitive use. The author reveals the possibility of recognizing genomic research data as the results of intellectual activity that are subject to legal protection as objects of intellectual property, as well as the need to enshrine them in the provisions of the Part 4 of the Civil Code of the Russian Federation. The main conclusion consists in the substantiation of the need for protection of genomic research data as the objects of civil law. Arguments are adduced on the potential reference of genomic research as the results of intellectual activity to the objects of intellectual property. The list of data that may comprise trade secret is subjected to critical analysis. The author proposes the original classification of the results of intellectual activity as the objects of intellectual property from the perspective of the presence of creative beginning as directly invented by human, and indirectly reflecting the result of human activity. The conclusion is formulated on the independent nature of the results of genomic research as the objects of intellectual property in the form of the results of intellectual activity. The author underlines the need for protecting genomic research data as a variety of results of such tests as the know-how, as well as corresponding revision of legal definition of trade secret captured in civil legislation.
Law and Politics, 2020-9
Belaia O.V. - Protection of genomic research data as the objects of intellectual property pp. 167-178

DOI:
10.7256/2454-0706.2020.9.43372

Abstract: The object of this research is the determination of legal nature of genomic research data and their role among the objects of civil law. The subject of this research is the data of preclinical and clinical studies of pharmaceutical products, mostly those that contain biomaterial and biomedical cell products. The author underlines the problem of the absence of due legal regulation of genomic research data as the objects of law within Russian legislation, as well as protection of their rightsholders from anticompetitive use. The author reveals the possibility of recognizing genomic research data as the results of intellectual activity that are subject to legal protection as objects of intellectual property, as well as the need to enshrine them in the provisions of the Part 4 of the Civil Code of the Russian Federation. The main conclusion consists in the substantiation of the need for protection of genomic research data as the objects of civil law. Arguments are adduced on the potential reference of genomic research as the results of intellectual activity to the objects of intellectual property. The list of data that may comprise trade secret is subjected to critical analysis. The author proposes the original classification of the results of intellectual activity as the objects of intellectual property from the perspective of the presence of creative beginning as directly invented by human, and indirectly reflecting the result of human activity. The conclusion is formulated on the independent nature of the results of genomic research as the objects of intellectual property in the form of the results of intellectual activity. The author underlines the need for protecting genomic research data as a variety of results of such tests as the know-how, as well as corresponding revision of legal definition of trade secret captured in civil legislation.
Legal Studies, 2019-6
Belaia O.V. - Legal Principles of Using Human Corpse as Genetic Material pp. 16-25

DOI:
10.25136/2409-7136.2019.6.30137

Abstract: The aim of this research is to discover and analyze legal principles of using human corpse as biological material and source of genomic information. In the course of her research, Belaya has analyzed Russian laws that regulate the process of collecting and using tissues, body organs and corpse of a dead individual and set forth rules for collection, use, storge and destruction of genomic information. The researcher describes wills that express consent or non-consent of using an individual's corpse, tissue and organs after his or her death as well as procedures of obtaining such consent from relatives or legal representatives. The researcher focuses on the problems arising in the process of legal fixation and practical implementation of particular legal principles in the course of using human corpse as genetic material. The methodological base of the research includes a combination of general and special research methods such as analysis, legal modelling and forecasting, dialectical materialistic, structural functional, legal logical, comparative legal and systems approches. The main outcome of the rsearch is analysis of current laws on collection and use of human corpse as genetic material and source of genomic information, collisions and contradictions in associated legislation and recommendations on how to eliminate them. The author also offers her own classification of legal principles of using human corpse as genetic material and source of genomic information. She also defines general and special legal principles of using such objects of civil circulation.
International Law and International Organizations, 2019-2
Belaia O.V. - Practice of the European Court of Human Rights on the use of human genome information and biomaterials pp. 57-70

DOI:
10.7256/2454-0633.2019.2.30166

Abstract: The goal of this research is the analysis of the practice of the European Court of Human Rights on the use of human genome information and biomaterials. In the course of the study, the author describes the three category associated with determination of requirements to collection, utilization, and storage of human biomaterials. The article examines the question of observance the respondent governments of civil rights in the area of obtaining person’s agreement for donation of tissue and organs right after death along with the agreement of his immediate family, agreement for collection and utilization of DNA materials in establishment of natural relation of people, scientific research on the topic, as well as ensuring confidentiality of genome information about a person. The author reviews the question of developing differentiation approach towards the collection and storage of genetic information and samples with regards to persons convicted of crimes depending on their degree, as well as persons whose criminal prosecution ended in acquittal or dismissal of charges. The main conclusions lies in determination of general trends and rules applied by the European Court of Human Rights in hearing of complaints with regards to collection, utilization and storage of human genetic information and biomaterials. It is noted the despite the affiliation of the examined legislation to a particular state, it corresponds with the key regulations of international acts in the area of respecting human and civil rights to personal and private life, justly balancing private and public interests.
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