This article explores the notion and origin of personalized medicine, as well as its origin, and organizational and legal status in the Russian Federation. Analysis of the legislation in the field of personalized medicine shows that although the right to personalized treatment conforms to the constitutional right to health care, the legal regulation of personalized medicine in the Russian Federation remains fragmented. It is governed only by regulatory acts of secondary legislation, strategic planning acts, and individual clinical guidelines and standards. The author shows here that the legal foundations of personalized medicine in the Russian Federation need to be improved. Firstly, the status of personalized medicine needs to be established; changes need to be made to the current regulatory legal acts regarding the procedure for providing medical care. This would allow doctors to apply the achievements of personalized medicine in clinical practice. Secondly, the author considers that the existing three-level system of healthcare in the Russian Federation, based on the idea of standardization, does not correlate with the ideas of personalized medicine. Another crucial factor is the readjustment of the healthcare system. This would require the development of scientifically grounded proposals on the implementation of precision medicine and to promote public education on genetic counseling. The article highlights advances on the application of the achievements of personalized medicine in the establishment of world-class research centers. The author concludes that the organization of personalized medicine in the Russian Federation requires the adoption of specific measures aimed at the implementation of scientific foundations of personalized medicine into the training of future medical workers, aimed at treating and preventing diseases. These measures also include consoliding the legal status of personalized medicine, the use of achievement of personalized medicine and its methods in clinical practice, as well as the establishment of specialized scientific organizations and the improvement of educational programs.

The European Union has achieved a significant milestone through the widespread implementation of genomic and postgenomic technologies in diverse fields including personalized and regenerative medicine, immunology, nutrition practices, sports medicine, and the wellness industry. This article revolves around the practical application of genomics and EU bioethics, with a specific emphasis on investigating the cutting-edge legal methodologies referred to as Lex Genetica and Legal Biotech. The European Union market for genomic research is presently experiencing significant and swift expansion, coupled with ongoing progress and effective integration of genetic technologies. Consequently, there exists a pressing necessity to strengthen legal protections and guarantees, specifically concerning the privacy of human genomic information, within the domain of EU criminal legislation. Within the framework of Horizon Europe, a funding program dedicated to research and innovation, the European Union (EU) prioritizes three pillars, with one specifically focused on tackling global challenges and augmenting the competitiveness of European industries. The “health” cluster within this pillar underscores the significance of advancing healthcare technologies, reducing health hazards, protecting communities, and fostering the welfare of individuals. Genomic research harbors immense possibilities in achieving these aims and has emerged as one of the most pioneering and groundbreaking fields in recent years. This paper aims to complement prior publications by offering an updated analysis of selected topics since 2018. The urgency of legal regulations for all the accompanying processes becomes evident within the global roll-out of postgenomic technologies and the pan-European tendency to move from fundamental exploratory research to the practical application of omics technologies in the EU (the study of genome, proteome, and metabolome). Numerous jurisdictions in the EU provide for gene-related offenses, including cloning, modifying the human germ line, and dispersing GMOs without appropriate authorizations. However, the specific offenses vary in the EU countries to a large degree. 

This paper represents an attempt by the author to formulate the need for comprehensive regulation of genomic research. The essence of genomic research can be considered through categories such as metascience, synergy, and convergence. Further the article analyzes the various forms of scientific cooperation in this area, in the aims of illustrating the social relations in the field of genomic research, and to highlight their interdisciplinarity and complexity. With reference to the aforesaid social relations, the author proposes the possibility of using a special integrated regulator to govern genomic research, including not only legal, but also ethical and moral norms. The author analyzes a broad range of ethical issues which may arise in the course of genomic research. Conclusions are then drawn with regard to the mechanisms of regulating genomic research by means of the symbiotic method. The article further discusses the relationship of this method with other methods of regulating social relations, suggesting the use of blockchain technology as one of the elements of regulation in the field of genomic research.

This article analyzes the legal regulations concerning the patenting of the results of genomic research at the international, regional and national levels. The authors identify specific areas of copyright protection of the results of genomic research at universal and regional levels (for example, within the framework of integration organizations), as well as topical legal problems which recur in national legislation. The authors pay special attention to the analysis of judicial practice which illustrates patients’ rights (access to the information, the ability to use the results of genomic research, etc.) and the rights of participants carrying out genomic research. The article may be of interest to legal scientists, practitioners and specialists in human genome research (biomedicine, bioinformatics, medicine, human reproduction, etc.).

This article explores the evolution of values and meanings of basic concepts of humanism in the second half of the 20th century and the beginning of the 21st century. The author analyses such fundamental philosophical notions as the nature and existence of man, human rights, freedom, will, and justice. Comparative analysis of the two most important documents in this field, namely the Universal Declaration of Human Rights and the Universal Declaration on Bioethics and Human Rights, shows a conceptual shift in the aforementioned topic. One of the main reasons for such a shift is the introduction in the Universal Declaration on Bioethics and Human Rights of the notion of ‘existence’ as being necessary for the description of human abilities. Also worthy of attention is the approach to justice described by means of awareness. Such notions are absent in the Preamble of the Universal Declaration of Human Rights, suggesting that a new understanding of the phenomenon of man has emerged in the past half-century, thus distinguishing one document from another. The article also analyzes the controversy between J.-P. Sartre and M. Heidegger which played a key role in rethinking humanism as a philosophical concept and value system. Sartre reasonably rejects the identification of existentialism as a pessimistic worldview, arguing that the doctrine of human subjectivity is humanistic in nature. In turn Heidegger highlights the ontological nature of all historical types of humanism, showing their dependence on the metaphysical context. The article discusses the notion of maintaining the universalist perspective, in order to better understand the idea of human rights in a new interpretation through the prism of the philosophy of existence. The conclusion drawn outlines the relevance of an in-depth philosophical interpretation of the basic concepts of bioethics and law.

Since being established as a separate branch of scientific knowledge, behavioural genetics has raised many ethical, legal and social questions. The identification of the genetic origins of behaviour is expanding beyond the scientific field into socially relevant areas such as justice, education and health care. The development of new techniques and analytical approaches, including genome sequencing, non-invasive prenatal testing and optogenetics, has clearly changed the direction of further development of behavioural genetics. This has also transformed the legal and social contexts of biomedical research analysed in this article. The author discusses the expanded scope of behavioural genetics which has become prominent in many countries. The author further focuses on the ethical, legal, social and political issues raised by the potential application of behavioural genetics used for evidentiary purposes in legal proceedings. The author draws the conclusion that behavioural genetics and behavioural genetic evidence are of significant value in determining circumstances relevant to a given case, thus assisting the court in coming to a legitimate and well-reasoned decision. By examining specific categories of cases (civil torts and guardianship cases), the author shows how the application of behavioural genetics can ensure that the rights of certain vulnerable groups (juveniles and persons with mental health problems) are adequately protected.