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Purpose: the research of the significance, positive and negative socio-economic factors, features of scientific, technological and legal development of biotechnology in Russia and in the world; the identification of the existing problems of the legal regulation of biotechnology in Russia; studying the experience of foreign countries in the legal regulation of biotechnological activities; studying the characteristics of biotechnological objects to correlate them with the sources of increased danger, including the activities related to the development, creation and testing of viruses, as having increased danger to others. Design/Methodology/Approach: Industry 4.0 leads to the mass introduction of cyber-physical systems in production, to the automation of most of the production processes, to the endowment of devices with artificial intelligence and the introduction of many other modern technologies. Biotechnology is an integral part of Industry 4.0, which involves a rapid breakthrough in the research of medicines, diagnostic methods, finding new vaccines, creating the ways to protect human organisms and biosystems, and creating artificially modified biological microorganisms. The demand for biotechnology creates the need to create and improve the legal framework for biotechnological developments. The authors used the methods of systematic analysis and comparative legal analysis to identify and consider the existing problems of the legal regulation of biotechnology in Russia. Findings: biotechnology implies significant changes in various spheres of society’s activity, including a positive modification of the medical sphere, due to the wide spread of new methods of personalized medicine, and an increase in the efficiency of treatment. The issue of recognizing the increased harmfulness of certain objects or activities in relation to such areas of biotechnology as the energy waste management, biofuel production, bioenergy engineering, the prevention and elimination of environmental pollution, bioengineering, breeding technology, production of electrical energy from biomaterials, etc. remains unresolved. The liability for causing harm by activities that create increased danger, due to the inability of a person to fully control it, is one of the gaps in the current civil law regulation. The justification and assessment of recognizing certain specific types of biotechnology as a source of increased danger have yet to be objectively justified by the doctrinal basis, judicial practice and the regulations. Originality/Value: it is concluded that the high prospects of the theoretical biotechnological developments cause the need for their legalization and legislative regulation. Based on the danger, harmfulness and uncontrollability of viruses, any activity related to viruses, from their creation to the work of medical staff to treat an infected person, is recommended to be recognized as a source of increased danger. The definition of the source of increased danger is given, and the criteria for classifying an object as a source of increased danger are called. The identified criteria are compared with the characteristic features of biotechnological objects. It is suggested that the activities associated with the risk of infection with infectious diseases be considered a priori as a source of increased danger. The inability of a person to control the spread of viruses, including infection, harmfulness and increased probability of causing harm, prove the need for a separate indication in the legislation of this source and the adoption of appropriate measures for any activity in which a person is directly exposed to the contact with infection and the threat of infection and spread of the disease. |
