Legal regulation in the field of using genetic technologies in the food and feed industry is a complex and multifaceted process that requires a balance between the possibility of developing and implementing high-tech solutions, while ensuring safety (including food safety) and compliance with ethical standards. Thus, the use of microorganisms and their metabolites for food and feed production requires transparent standards defining the permissible ranges of genetic modifications to mitigate risks to both human and animal health and the environment. In Russia, the current legislation lacks the definition of a “producer strain”, which creates legal uncertainty. In the EU, a comprehensive system for assessing the safety and authorization of microorganisms and their metabolites used as food or technological additives is applied. Given the increasing role of microorganisms modified by genome editing technologies in the food and feed industry, as well as the task of forming a common market within the Eurasian Economic Union (EAEU), a balanced approach to regulating this sphere is needed. Such an approach should support biotechnology development while ensuring protection of human health and the environment, as well as the consistency of national laws of the participating countries. This article aims to analyze and compare the main principles and approaches of legal regulation in the EU and the EAEU regarding the use of producer strains. The regulation of the use of microorganisms obtained by genome editing should incorporate the requirements for risk assessment, authorization, and labeling, and to consider the specifics of regulating the use of microorganism metabolites as food and technological additives. Further analysis of the experience accumulated in the EU and other jurisdictions (e.g., the USA) and the adaptation of best regulatory practices to the EAEU conditions, including the creation of safety assessment systems and harmonization of requirements, will facilitate the development of a common market and increase the competitiveness of products from EAEU member states.

The author discusses the legal, medical, and socioeconomic aspects of considering the immune status of employees in vaccination programs as a key element of personalized medicine in public healthcare systems. The development of modern personalized medicine, based on advances in immunology and genetics, opens up new opportunities for optimizing vaccine prophylaxis. The conducted review of foreign and domestic academic literature established the significant influence of genetic factors on both the effectiveness of vaccines and the development of post-vaccination complications. However, the current Russian legislation on mandatory vaccination of employees ignores the individual characteristics of the immune system, thereby raising legal controversies and potential health risks. In this research, the author aims to identify gaps in the regulatory framework arising from the integration of immune status assessment into the system of public law regulation of vaccine prevention in the Russian Federation and to propose on its basis solutions for updating the legislation. As a result, significant gaps in the legal regulation of personalized vaccination were identified. First, the current legislation is lacking the concept of “immune status” or mechanisms for its use, which is important for determining the necessity, safety, and schedules of immunization. Second, it is necessary to introduce preventive serological testing (screening) as legally significant evidence of a sufficient level of antibodies in order to protect the labor rights of employees from unjustified dismissal for the purpose of ensuring epidemiological welfare. Third, there is the absence of reliable protection of data on the immune and genetic status of employees as a special category of personal data. Particular attention is paid to the risks of post-vaccination complications and the need for a balanced approach to individual and public health. The economic benefits of a personalized approach are considered, including the optimization of vaccination costs and the minimization of side effects. The review of international and domestic publications revealed the need to balance public and private interests in ensuring the epidemiological welfare of the population and the rights of employees. It is concluded that the Russian legislation in this field should be improved in order to introduce a scientifically substantiated mechanism for personalizing vaccination, which will increase the safety of immunization programs, develop public trust, improve the level of epidemiological control, and enhance the efficient use of healthcare resources.

Objective To examine the evolution of the legal regulation of basic and preclinical human genome editing research in the People’s Republic of China from 1990 to 2025. Human genome editing is one of the most legally and ethically controversial areas of modern biomedicine. The experience of legal regulation in the field of CRISPR/ Cas9 technologies in the People's Republic of China (PRC) is analyzed. Here, the evolution of these technologies has been accompanied by the formation of a national regulatory framework aimed at ensuring a balance between scientific progress and bioethical restrictions.
Methodology General and specific scientific methods were used, including legal analysis and synthesis, along with the methods of systems, logical-structural and historical-legal analysis.
Results The activities of China’s state bodies (National Health Commission (NHC), Ministry of Science and Technology (MoST), National Ethics Committee for Science and Technology (NECST) in the field of public health policy were analyzed. These bodies ensure the development and application of genome editing technologies, the ethical management of scientific and technological research in this area, including human genome editing. The evolution of China’s national legislation in the field of application of human genome editing technologies was analyzed, including laws, regulations, ethical standards, procedural protocols governing research on genetic modifications using human gametes, embryos and germ cells. The trend toward tightening the legal regime for genome editing in the period from 2018 to the present was noted, which was caused by both the rapid development of technologies (CRISPR-Cas9, base editing) and the He Jiankui case. The new version of the “Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings” (2023), “Trial Measures for Scientific and Technological Ethics Review” (2023), “Ethical Guidelines for Human Genome Editing” (2024) were analyzed. These documents reflect strengthening requirements for the content of ethical review based on respect for human rights. Legislative innovations that provide for criminal liability for illegal implantation of genetic engineering, embryo cloning, illegal collection and smuggling of human genetic resources were outlined.
Conclusions Research in the field of human gene editing should be based on understanding the ethical and legal aspects of clinical practice and the development of adequate mechanisms for regulatory control. The rapid development of genetic engineering technologies determines the need for scientific understanding of the legal regulation of relations arising in connection with the use of CRISPR-Cas9 technologies, primarily from the standpoint of respect for human rights, the limits of intervention in the genome, and determining the legal status of genomic and genetic information. In accordance with the principle of using scientific progress for the benefit of society, a balanced assessment of the interaction of innovations and risks in human genome editing is extremely important.

As a country with a long history of agricultural civilization, China possesses ample genetic germplasm resources. For historical reasons, the conservation of genetic germplasm resources in China has received insufficient attention. Following the foundation of New China, especially since the reform and opening-up period and with the development of the social rule of law, China has gradually established a legal protection system for genetic germplasm resources. This system takes the Seed Law as the core, and the Regulations on the Protection of New Varieties of Plants, the Regulations on the Protection of Wild Plants, the Animal Husbandry Law, and the Patent Law as the supporting laws and regulations. Taken together, these regulations constitute the legal system for the protection of genetic resources. However, a number of issues remain unresolved, including the lack of consistency and completeness of the protection system. The legislation on genetic germplasm resources should be considered as a single and consistent mechanism. Multi-dimensional protection should be elevated to the level of national sovereignty. The awareness among all citizens regarding the importance of protecting genetic germplasm resources should be enhanced.

In China, the sphere of agricultural product trade is facing challenges associated with protection of intellectual property rights. Among the key issues are geographical indication infringement, disputes over rights on new plant varieties, and patent violations related to agricultural technology. Geographical indication infringement is becoming more varied and harder to detect, with e-commerce platforms increasingly being responsible for spreading fake products. New plant variety rights are frequently undermined by counterfeit goods and illegal reproduction. Meanwhile, infringement of agricultural technology patents is concentrated in such areas as smart devices and bio-pesticides. The above issues are addressed using new technologies. Thus, blockchain is instrumental in verifying the authenticity of geographical indication of products by creating an unchangeable record of their production history. DNA fingerprinting helps resolve disputes over plant variety rights by providing solid scientific evidence. Big data and artificial intelligence (AI) have made it easier to monitor and identify infringements, as demonstrated by the anti-counterfeiting model successfully applied in the West Lake Longjing. Satellite remote sensing and the Internet of Things enable comprehensive monitoring of the production process. However, the practical implementation of these technologies faces a number of difficulties. Smalland medium-sized businesses often find them unaffordable, and farmers are not always willing to adopt them. Data is stored by different departments, being fragmentary. The technologies are not always consistent with international standards. These issues can be solved by provision of governmental subsidies to optimize costs, creation of a national data platform, and promotion of international standards for technologies. In the future, in order to create a reliable, smart system for protecting agricultural intellectual property, new technologies (5G and AI) should be combined with conventional methods. This will support China’s agriculture and promote its positions in the global market.

The article reviews the current foreign legislation in the field of public procurement of medicinal products on national markets. The research aim was to analyze the best world practices in this sphere and, on this basis, to formulate recommendations to the Russian legislator on improving the relevant legal acts. India, China, Brazil, the USA, Spain, and Germany were selected as the most representative countries for the research. Over the past 20 years, these countries have developed an integrated system of legal regulation in the field of price setting when conducting public procurement of medicines. These countries apply differentiated approaches to ensure a preferential regime for the procurement of national medicinal products. In conclusion, the author notes that, in order to improve the relevant legal framework, the Russian legislator should intensify the use of such instruments as risk sharing agreements, an improved system of medical technology assessment, and differentiation of medicinal drug localization levels in order to provide support for the procurement of national medicines.