Scientific progress and advances in biotechnology continue to raise controversial questions about human nature, rights, and dignity. The rapid development of modern biomedical technologies draws the authors’ attention to relationships between constitutional and bioethical values. Technological advances, such as CRISPR-Cas9 genome editing, the artificial creation of human skin, tissues, and organs, the latest reproductive technologies, the use of artificial intelligence in medicine, etc., – altogether underscore the importance of revisiting the ethical boundaries of permissible intervention in human nature and the need to update theoretical and legal approaches to the protection of human dignity, life, and personal autonomy.

In this work, we aim to identify the key bioethical principles and analyze the nature of human dignity as a unifying category that forms the basis of bioconstitutionalism. The need for new legal approaches to the regulation of biomedical technologies is justified, and the role of legal and cross-cultural aspects in ensuring the balanced development of technologies and the protection of human rights is emphasized. In conclusion, the need to develop new conceptual foundations for the regulation of the biotechnological sphere in the context of technological progress is emphasized.

The authors set out to examine challenges associated with defining conceptual frameworks for regulating genomic medicine. The relevance of the study stems from the rapid development of genomic technologies, which alter the existing understanding of human biology. For the first time in human history, science enables forecasting the results of human intervention in human biology through genetic editing. In addition, there appear models for the use of human DNA for technological purposes, e.g., in computers (thus giving rise to a new field of biocomputing) and as memory storage.

Our aim is to identify key gaps in the regulation of genomic technologies; examine the impact of innovations in this area on conventional legal institutions; and outline prospects for improving Russian legislation in this sphere.

The inclination of states to maximize the possibility of genetic sequencing among their populations is shown. This creates opportunities for the development of personalized medicine, enabling the prognosis of human health and the shaping of their health-preserving trajectory. At the same time, previously unexpected risks are emerging, such as the “geneticization” of the law and the state, the vulnerability of human rights, and the use of medical data for achieving social goals. International legal instruments in the field of genomic medicine were adopted in the late 20th and early 21st centuries, when humanity did not yet have complete data on the human genome. Despite discussions regarding the need to adopt a universal convention in this area, practical steps toward achieving this goal have not yet been taken. It is noted that neither international nor national instruments define the concepts of DNA and the human genome. It is emphasized that uncertainty in legal regulation is a significant feature of genomic technologies. We also analyze the legal gaps arising from the use of the human genome for technological purposes. Biocomputing and the use of DNA as a memory storage device are cited to illustrate these issues.

Innovations, including innovative pharmaceuticals, are key factors in the development of modern economy, contributing to the availability of high-quality and effective medical care. However, legislation is lacking a legal definition of an “innovative medicinal product.” Moreover, the current legal doctrine lacks a unified view on the essence of this concept and the advisability of its enshrining in law. The author reviews the main approaches to defining an innovative medicinal product (remedy) using doctrinal sources and the achievements of professional communities with the purpose of disclosing the content of the legal regime for innovative medicinal products. This includes an examination of the essential elements of such a legal regime, a study of the concepts of “pharmaceutical market” and “pharmaceutical market participants,” and the impact of the legal regime for innovative medicinal products on the pharmaceutical market. The author analyzes various definitions of an innovative medicinal product formulated by representatives of the doctrine and professional communities, e.g., the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union. Existing approaches to the legal regime for innovative medicinal products are analyzed. The study relies on formal-logical, dogmatic, comparative, and axiological methods. Approaches to defining the concept of an innovative drug are analyzed, including its scope and content, as well as its main elements. Relationships between the concepts of an innovative drug, an original drug, and other concepts contained in legislation are examined. The need of enshrining the concept of an innovative drug in legislation is argued, along with the scope and possible areas of its practical application. The content of the legal regime for innovative drugs is considered, including its main elements and constituting components. Approaches to the concept of pharmaceutical market and the composition of its entities, considered both in a broad and narrow sense, are formulated; the influence of the legal regime for innovative drugs on the activities of pharmaceutical market agents is identified. The results obtained underscore the relevance of introducing the concept of “innovative drug” into official documents for ensuring the transparency of funding, creating incentives for scientific research and innovation in pharmaceuticals, and extending the availability of modern drugs. The legal regime for innovative drugs consists of three levels: general, special, and specific. The specific component of the legal regime is aimed at stimulating research, protecting intellectual property rights, ensuring accessibility and competition, influencing the activities of a wide range of pharmaceutical market participants.

The permanently extending scope of human biomaterial application has brought the issue of their legal nature to the forefront. This article analyzes the legal nature of biomaterials intended to restore the health of a citizen (originator or recipient), as well as biomaterials used in the formation of biobanks for conducting, inter alia, scientific and clinical research. The importance of introducing the categories “functional biomaterial” and “donor biomaterial” is underscored; criteria for differentiating their legal regime are developed. It is proposed to classify donor biomaterials into those related to the recipient’s personality and those not related to the recipient's personality. On this basis, the legal regime for each type is distinguished. The possibility of sharing human biomaterial for the purposes of scientific research purposes is considered. The recognition of biomaterial objects as intangible assets excludes the possibility of their joint use; however, under the condition of depersonalization of information and the loss of personalized properties, such objects, representing the results of intellectual activity, can form collections and big data databases. Falling under the legal regime that regulates the results of intellectual activity, the boundaries of the absolute right to use such objects should be defined, assuming free access and openness of information while observing a number of conditions for conducting scientific research.

The rapid development of biomedical technologies and the growing number of biobanks in the Russian Federation underscores the importance of their legal regulation, particularly in relation to potential insolvency (bankruptcy). This study aims to identify the specific features of legal regulation of biobank bankruptcy, taking into account the unique nature of their assets and their social significance. The research was conducted using an integrated approach, including an analysis of bankruptcy legislation and civil law governing the circulation of biological materials, judicial practice, and doctrinal sources. The research methodology involved the principles of analysis and synthesis, comparative and formal legal analysis, as well as the method of systems analysis. The conducted research has revealed gaps and ambiguities in the current legal regulation of biobank bankruptcy, particularly concerning the legal status of biological materials, procedures for their valuation and inclusion in the bankruptcy estate, and the protection of donors’ and patients’ rights. Risks associated with the potential misuse or improper disposal of biological materials during bankruptcy proceedings are identified. In conclusion, recommendations for improving bankruptcy legislation to reflect the specific characteristics of biobank activities are provided. These recommendations aim to ensure the safety of biological materials, safeguard the rights of donors and patients, and enhance the transparency and predictability of biobank bankruptcy procedures. The study emphasizes the need to develop special rules for regulating the bankruptcy of biobanks, taking into account their operational particularities and the unique nature of their assets

Measures to prevent bias in personalized psychiatry research include strict data control, transparency of all procedures (from obtaining signed informed consent from patients with mental disorders to administering information transfer processes between departments within one or more research institutions), adherence to ethical standards, and a multi-level system of checks and audits. The specific nature of personalized psychiatry, based on individual data (genetics, biomarkers, lifestyle data), requires special attention to the integrity and reliability of the information. This article presents a review of international experience and, on this basis, advances proposals for preventing potential bias in the results of medical and biological research on mental functions. Distortions can occur at various stages of research – from poor collection and systematization of material, errors in entering data into tables (due to carelessness or lack of automation of this process) to intentional changes in the results through technical manipulation of microscopy images.