This article examines the legal challenges arising from the rapid development of regenerative medicine. The analysis focuses on gene therapy and cell therapy, which are subject to dual regulation under Federal Law No. 180-FZ of June 23, 2016 “On Biomedical Cell Products” and Federal Law No. 61-FZ of April 12, 2010 “On the Circulation of Medicines”. It also considers the emerging international legal framework governing the circulation of medicines within the Eurasian Economic Union (EAEU). The aim of this study is to identify systemic gaps in the legal regulation of gene and cell therapies resulting from the dual regulatory framework (Federal Laws No. 180-FZ and No. 61-FZ) and conflicts with the EAEU law. The importance of implementing flexible legal mechanisms is emphasized, including “hospital exception” and experimental legal regimes, which can facilitate the adoption of innovative regenerative medicine technologies.
The timely and effective implementation of cell therapy products and regenerative medicine approaches necessitates the development of improved legal approaches to regulating innovative treatments. This article identifies key conflicts of law that hinder the adoption of new therapeutic methods. A systemic analysis of legal acts governing regenerative medicine, with a specific focus on cell and gene therapy, is conducted. Using a specialized legal approach, recommendations are formulated for improving legislation to ensure the accelerated adoption of regenerative medicine products, including through the application of “hospital exception” widely used in international practice (which explains the use of a comparative legal approach). The article demonstrates that gene therapy extends beyond medicinal products to include human genome editing, which is increasingly viewed as a potential experimental treatment for certain genetic diseases. Such modern technologies as CRISPR/Cas9 (“genetic scissors”) fall outside existing regulatory frameworks. The article highlights the specific features of legal regulation governing cell therapy products. The need for a flexible regulatory approach and the introduction of experimental legal regimes for regenerative medicine technologies is substantiated.

The author carries out a review of international and national approaches to the legal regulation of genetically modified organisms (GMOs) and products derived using new breeding technologies (such as genome editing) in the context of food security. Relevant legal acts and law enforcement practices across various jurisdictions are analyzed with the purpose of identifying the most effective risk management models and approaches that promote innovation in the agricultural sector.
A comparative law method was used to compare the regulatory approaches applied in the EU, non-EU countries, countries of the North and South America, Africa, and the Asia-Pacific region. The key international (the Cartagena Protocol on Biosafety) and national legislation documents in the field of risk assessment and classification of genome editing products are analyzed. Special attention is paid to the dichotomy of “process” and “product” regulative approaches.
The study identified the emergence of a highly differentiated regulatory system at the global level. Countries, such as the USA, Canada, Argentina, and Australia, apply flexible, evidence-based risk assessment frameworks that exempt products of precise mutagenesis from strict GMO-specific regulation. In contrast, the EU, New Zealand and several other jurisdictions follow a “process”-based approach, subjecting all gene-edited organisms to national legislation. In developing countries, including Africa and Latin America, regulatory fragmentation is observed, ranging from restrictive bans to promotion of biotechnologies. In conclusion, the lack of harmonized international standards creates barriers to trade and innovation relevant to food security. Predictable and transparent regulation remains essential for the commercialization of modern biotechnological products.

Advances in biotechnology challenge the adequacy of classical legal institutions as applied, e.g., to genetic research involving human biological material. Such studies frequently lead to the creation of protectable intellectual property; however, existing legal frameworks fail to safeguard the interests of individuals who provide their biological material. This problem is particularly relevant in cases where the biological material is unique and its specific properties contributed to the created intellectual property. The author argues the feasibility of granting specific intellectual property rights to providers of biological material. Although such individuals should not be granted authorship status, their contribution warrants legal acknowledgement in situations where their biological material plays a decisive role in the creation of protectable intellectual property. This primarily concerns property rights that assume the possibility to receive compensation or a portion of the income from the use and exercise of exclusive rights to the intellectual property created with and/or using the biological material. The work is structured as a sequential analysis of fundamental questions: the legal nature of biological material, the legal basis for its use, the admissibility of intellectual property rights in respect of objects created using such material, and legal mechanisms for safeguarding the interests of the owner of the biological material. A differentiated approach is proposed for cases where the biological material lacks unique characteristics and is used solely as a means for scientific research, and cases where the biological material possesses characteristics that enable the creation of protectable intellectual property. In the latter situation, particular attention should be paid to ensuring adequate protection of the property rights of the owner of the biological material.

The development of biotechnologies, genetic research, and data-driven health applications has brought the human genome to the center of contemporary legal debates. In Brazil, the protection of the human genome does not derive from a single, comprehensive statute, but rather from a multilevel legal framework that combines constitutional guarantees, biosafety regulation, and personal data protection. This normative dispersion raises relevant questions concerning the coherence, scope, and effectiveness of genomic protection within the Brazilian legal system. This research, which sets out to analyze the legal regime applicable to genomic protection in Brazil, focuses on the interrelation of three foundational legal instruments: the 1988 Federal Constitution, the Biosafety Law (Law No. 11,105/2005), and the General Data Protection Law (Law No. 13,709/2018). The central purpose is to show that these different levels of regulation do not function in isolation, but rather converge in a coordinated manner to collectively establish the human genome as a legal value deserving of special protection and targeted normative attention connected to the imperatives of dignity, privacy and non-discriminatory treatment. The research was guided by the following question: to what extent does the convergence of constitutional principles, biosafety standards, and data protection regulations establish a cohesive legal model capable of safeguarding genomic integrity in Brazil, given the accelerating pace of biotechnology and the broadening reach of genetic data handling? The research sustains the hypothesis that, although fragmented, the Brazilian legal system establishes an integrated regime of genomic protection, in which constitutional principles serve as the normative foundation, the Law No. 11,105 of March 24, 2005 (Biosafety Law) imposes ethical and technical limits on genetic research, and the Law No. 13,709 of August 14, 2018 (General Data Protection) ensures informational selfdetermination and safeguards against misuse of genetic data. However, the absence of a unified statutory framework engenders interpretative challenges that demand systematic and teleological legal analysis.

The genetic potential of Antarctic krill and other marine genetic resources offers significant scope for innovation, with ongoing genome sequencing projects continually revealing new functional genes and potential pathways. However, the legal and ethical implications of patenting these innovations remain largely unexplored. While the recent UN Marine Biodiversity of Areas Beyond National Jurisdiction (BBNJ) Agreement introduces a benefit-sharing provision for genetically unmodified marine organisms, its application to existing patents on oceanic genetic resources is yet to be determined. This paper examines the current intellectual property rights pertaining to krill within the framework of this new international legal instrument governing high seas genetic resources. It argues that while the BBNJ Agreement may permit krill patenting, the common heritage of humanity principle necessitates a degree of self-restraint to mitigate concerns arising from their public domain resource character.