GENETIC TECHNOLOGIES AND LAW IN BIOECONOMY
MONOGRAPH
Executive editors
Mokhov A.A., Doctor of Sciences (Law), Professor; Sushkova O.V., Candidate of Sciences [PhD] (Law), Associate Professor
The publication examines a range of legal and related problems associated with the development of genetic technologies acting as a driver of bioeconomy as an economy of a new technological order. The new challenges and threats render increasingly important the role of law in the regulation of both existing and emerging public relations.
The book attempts to formulate and resolve some of the general theoretical and individual applied problems associated with the emergence of genetic technologies, as well as with the implementation thereof in certain sectors and spheres of the economy. However, the work does not contain a complete and systematic representation of the existing views on the problems of the development of genetic technologies due to their absolute novelty for the legal doctrine.
The monograph is intended for a wide range of readers, as it is of an interdisciplinary and cross-sectoral nature. It can be recommended for teachers, researchers, practitioners, and everyone interested in the problems of the technological development in Russia.
The article discusses, from a general theoretical standpoint, the aspects related to the measure of freedom of a subject of law when using genetic information. A particular focus is placed on the fact that the “consumer” of genetic information has a certain degree of individual measure of freedom depending on the meaning in which genetic information is used; the issues of the individual measure of freedom of geneticists and scientists in the field of related (cross-sectoral) knowledge (laboratories and other legal entities) that are holders of unique information, are discussed.
The relevance of recognizing the systemic complexity and different aspects of understanding genetic information is emphasized. Analysis is given to such aspects of genetic information as personal data, medical privacy, intellectual property, a special type of information.
The authors have carried out a comprehensive research of some items of innovative pharmaceuticals in the Russian market. The research identifies the key barriers facing the developers of original pharmaceuticals in course of registration thereof in the Russian Federation. The share of pharmaceuticals with a new active ingredient in the total number of pharmaceuticals registered in Russia over 10 years is determined; the role of Russian specialists in creation thereof is indicated.
The article demonstrates that transnational pharmaceutical corporations deserve much of the credit for bringing original pharmaceuticals into the Russian market.
The authors provide brief recommendations for improving the regulatory framework in the sphere of development and registration of innovative pharmaceuticals in the Russian Federation.
ON THE RUSSIAN PRESIDENTIAL COUNCIL ON ETHICS
The article deals with the main problems associated with the development of ethics-related regulation in various spheres of professional activities. In the author’s opinion, the problem of ethics-related regulation is especially pressing in the sphere of science and innovation, which necessitates the development of such a direction as the ethics of high technologies. The development of ethics requires working out common approaches to ethics-related regulation, responsibility, and expert assessment; revising and systematizing the legislation on ethics; preparing scientifically substantiated recommendations on ethics; responding in a timely manner to the ethical issues arising from the potential emergence and implementation of cutting-edge technologies.
Taking into account the scale of the tasks to be resolved, in the author’s opinion, it is necessary to start developing and implementing the Concept of Ethics of the Russian Federation. This work can be carried out by the Russian Presidential Council on Ethics created by the corresponding Decree of the President of the Russian Federation.
The article deals with the general theoretical, organizational and legal issues associated with the formation and development of the ethics of high technologies in Russia. The authors propose organizational and legal means and mechanisms for resolving the key issues in the sphere under consideration.
Based on the research findings, suggestions on amendments to the existing Russian legislation are made.
The article discusses the notion of an ethical category of trust, including bioethics as an element of biopolitics. The trust is also analysed in the context of the legal consequences of its loss, enshrined in the existing law and existing in the bills under consideration by the legislator. As a category of bioethics, trust is analyzed to take into account the effects of the pandemic SARS-Cov2. The author formulates proposals to improve legislative activity aimed at maintaining trust between the government and society.
Based on a comprehensive analysis of the provisions of the current legislation and the scientific doctrine regulating the issues of the information flow in the healthcare sector, the problems of state regulation in the sphere under consideration are identified and recommendations for improving the current legislation of the Russian Federation are given.
Purpose of the research. Identifying the peculiarities of information about the human genome, and modelling the foundations for potential legal frameworks for genetic (genomic) information.
Research material and methodology. Analysis of the doctrine and the national legislation on information, including genetic information, is performed. Methods used: systemic, logical, modeling.
Findings. It is demonstrated that the Russian legal doctrine and legislation are at the initial stage of research aimed at further formalization of legal frameworks for genetic information about the human genome (as a biological species, an ethnic group member, a specific individual).
Conclusion. Based on the research findings, grounds for identifying legal frameworks for the information about the human genome, as well as potential measures aimed at improving legislation based on the peculiarities of genetic information about a person, a specific individual, and ensuring proper protection of genetic information, are proposed.