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Lex Genetica

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Vol 3, No 1 (2024)
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Lex Genetica: Private-Law Dimension

7-32 567
Abstract

The recent development of biomedical research and greater attention to the use of human bio-material has led to an increase in the number of studies devoted to biobanks. In considering the question of whether a biobank can be subject to insolvency, the present article discusses multiple points of view related to the legal status of biobanks according to which they are perceived either as an object or subject of law. From an analysis of the various organizational forms of biobank activity, the author argues that biobanks should be considered as subjects of law. Here considerations include accessing financial support from government, municipal, and other sources, the possibility of carrying out income-generating activities, mechanisms for the protection of obtained bio-material, the monitoring requirement related to entities carrying out such activities, and the possibility of recognizing such entities as insolvent. Based on the results of this research (including an analysis of the experience of foreign countries), the permissible organizational-legal forms that biobanks are instantiated, namely, public corporations, public-law companies, institutions, and public benefit funds. Because of the sensitivities involved, it is argued that such organizations should be of a non-profit character. In the light of the research question, special attention is paid to the form of a consortium. Due to the impossibility of liquidating the assets of biobank organizations in order to meet the claims of creditors, it is argued that such organizations cannot be declared insolvent.

33-43 417
Abstract

The use of genomic information in banking – in particular, when issuing consumer loans and identifying clients – determines areas for the development of legal regulation of the application of genomic information. The establishment of the legal regime for genomic information is important due to the need to designate responsible persons for ensuring the safety of such information. In order to avoid disputable situations, as well as to protect the interests of banking customers, the present work advocates the introduction of certain amendments to the Federal Law ‘On Personal Data’ of the Russian Federation (2006). According to the proposed amendments, genomic (genetic) information should be classified as personal data. It therefore becomes necessary to increase the responsibility of the recipient of such information, as well as to establish rules for the restoration of a violated right. A suitable package of measures aimed at the banking sector will create an effective mechanism for protecting the genomic information of customers provided to a credit institution for the purposes of receiving banking or other services

Lex Genetica: Public -Law Dimension

44-56 512
Abstract

The article analyses the experience of a number of foreign countries (France, South Korea, China, Germany and Italy) in terms of developing special legislation in the field of ethical examination and creating specialised bodies to exercise relevant powers. Based on the analysis, the necessity of creating a National Council on Bioethics under the President of the Russian Federation in Russia in order to conduct an independent ethical assessment of new technologies in the field of healthcare is advocated. The author identifies the goal of strengthening the legal personality of medical workers in terms of an initial assessment of technological solutions built into practice. The work highlights the need to develop a procedural basis for conducting technological assessment by the medical community based on clearly established principles of legal and ethical expertise. It is emphasised that all technological solutions presented within the framework of strategic development should be aimed at health-saving ends. At the same time, it is advisable to consolidate the normatively established concept of health-saving technologies in order to carry out an examination of the quality of the implemented technological solutions.

Lex Genetica: Comparative Legal Analysis

57-67 516
Abstract

While China and Russia are both major agricultural producers, their influence on the global agricultural industry still lags significantly behind EU countries. Considering the recent China-EU Agreement on Geographical Indications (CEAGI) and the rapid current growth of China-Russia trade, it becomes crucial for China and Russia to discuss the mutual recognition of geographical indications (GIs) for agricultural products. The potential for cooperation in this area consists in promoting import and export trade of agricultural products between China and Russia, thus enhancing the competitiveness of these products in the international market. However, challenges in the mutual recognition of GIs arise due to imbalances in the trade of agricultural products, as well as differences in trading systems and current legislation on geographical indications. A feasible package arrangement could involve mutual recognition of some GIs for agricultural products based on existing Chinese and Russia multilateral trading systems.

68-81 1110
Abstract

Background. The present work focuses on the need to protect prenatal life, which is intricately entwined with delineating the precise biological and legal juncture marking an embryo’s transition into personhood. Drawing upon bioethical insights from domestic frameworks and international jurisprudence, we compare diverse perspectives on the moral and legal standing of the embryo, including its right to life, and invoking legal principles in the context of cellular and regenerative medicine.
Aim. The goal of this article is to investigate the various biosafety policy approaches governing embryonic stem cell research, ranging from outright prohibition to authorization solely for therapeutic or scientific ends. Through our analysis, we focus on the unique national context of Brazil to scrutinize the underlying rationale behind a specific legal challenge questioning the constitutionality of the Biosafety
Law. This law, which permits the utilization of human embryonic cells for research and therapeutic purposes, raises concerns about potential infringement upon the inviolability of the right to life.
Methodology. The research is based on deductive reasoning alongside formal-legal methodologies, including textual interpretation and comparative-legal analysis. The research process involved documentary, bibliographic, and virtual analytical inquiries utilizing a variety of resources such as legislative texts, monographs, academic articles, databases, and online libraries. Results. Through our examination in a distinct national context, we delineate the theoretical-philosophical and normative-ethical foundations underpinning the stances of Brazilian Supreme Court justices concerning the utilization of embryonic stem cells. Their arguments predominantly invoked significant constitutional liberties such as freedom of family planning, scientific research, and academic pursuits, intertwined with considerations of human dignity and the sanctity of life. Additionally, some justices cautioned against the potential hazards inherent in genetic manipulation.
Implications. The legal and ethical ramifications of Brazil’s approach to biosafety legislation concerning embryo rights invoke the necessity for conducting neutral, unfettered scientific inquiry and regenerative therapies according to specific operational parameters. These include safeguarding the integrity of genetic inheritance, preemptive evaluation of potential risks and benefits (adherence to the precautionary principle), and ensuring informed consent for treatments. A significant hurdle consists in the need to establish robust mechanisms for overseeing research involving human embryos within the domains of biomedicine and regenerative cell therapy

Lex Genetica: Аcademic Digest



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ISSN 3034-1639 (Print)
ISSN 3034-1647 (Online)