Kutafin Law Review

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Vol 8, No 1 (2021)
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The presented issue of the journal opens a new era in its development. This is the first of the so-called thematic issues of the journal. The first issue of KuLawR 2021 is devoted to an important cross-sectoral problem of legal regulation of genomic research and the use of genetic technologies.


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The current science and research trends, as well as the development of personalized medicine, point to the need to use genetic tests in course of the study of pharmaceuticals. Pharmacogenetic testing has become indispensable when developing new pharmaceuticals in order to study both the peculiarities of pharmacodynamic effects or the prospects of personalized treatment, and the characteristics of metabolism or drug-drug interaction. In addition, the introduction of pharmacogenetics in bioequivalence studies allows limiting, at early stages, the criteria for inclusion or non-inclusion of volunteers based on certain gene polymorphisms determining the metabolic rate.

The study of the genetic characteristics of clinical trial participants allows a more detailed analysis of the role of gene polymorphisms in terms of both pharmacokinetics and pharmacodynamics of the studied pharmaceuticals.

A separate important issue is genetic material collection from the clinical trial participants. On the one hand, the use of biological material collections is an essential tool for accomplishing the practical tasks in both the pharmaceutical industry and the state-of-the-art medicine. On the other hand, the legal review and ethics review of genetic material collection and use can become formidable barriers to the development of biobanking. The existing legislative differences between Russia and other countries allow identifying the most challenging regulatory aspects, and can contribute to international law harmonization in the sphere of biobanking in the future.

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The paper studies some aspects and considerations of the legal regulation of genomic research in the context of modern challenges. Approaches to the formulation of some basic concepts in the field of bioinformatics, such as information, information space, are proposed, the importance of these concepts for legal regulation is substantiated. Approaches to the legal regulation of the commercial use of the results of genomic research in the field of bioinformatics are formulated. Approaches to the legal regulation of the activities of biobanks are proposed based on the analysis of the possibility of using blockchain technology to improve the functioning of the biobank, the possibility of attracting investments through crowdfunding financing. The classification of biobanks according to various criteria is given. Approaches to the formulation of such concepts as donation and parenthood are determined within the framework of the legal regulation of genomic research in the field of human reproduction. The influence of modern challenges associated with the development of science and technology on the formulation of these concepts is considered. Approaches to solving the problem of ensuring a balance of private, group and general interests in the field of legal regulation of genomic research are proposed.


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The paper deals with the ethical and legal principles (foundations) of economy that have been important and required to a various extent at different stages in history. Advances in science and technology, emergence of modern biotechnologies, including the genetic ones, as well as shifts to new technological paradigms, on the one hand, make the emerging economy drift towards bioeconomy, and, on the other hand, increase the need for legal and ethical regulators. In view of the above, bioethics and biolaw begin to play an increasingly active role at the new stage of human civilization development. In Russia, the phenomena of bioethics and biolaw are at the initial stage of their institutionalization, they become more and more appealing due to the intensification of public debates, as well as due to an increase in the number of conflicts caused by the attempts to implement and broadly apply the achievements of biology, medicine and other sciences about life in daily practice.

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The aim of the paper is to analyze the bioethical aspects of the institution of human rights in Latin America. The result of the present research is the author's conclusion on the necessity of the practical implementation of legal provisions in this area, and their judicial enforcement in many states of Latin America with the aim of compliance with international standards of human rights. In the face of global uncertainty of COVID-19, it is more necessary than ever to maintain a strong commitment to international law and human rights with responsibility in bioethics, and also to seek to preserve and consolidate what has been advanced in the construction of a world order based on rules and shared values, along with a policy structured on common values and international principles. States must take international responsibility for wrongful acts for the violation of human rights in biolaw. The research methodology was based on general scientific and private scientific methods of cognition (the dialectical method, methods of analysis and synthesis, deduction and induction, comparative legal and historical legal methods). The biolaw basing on the International Law and Human Rights has its special understanding of the issue, which should be supported by further legislative development in Latin America. Latin American courts will not be able to make judgments on bioethical issues for a long time, while it is closely related to biopolitics and other controversial regional political positions. There are structural and historical problems of Latin American legal culture, a high index of criminal impunity and wide discretion of law-enforcement agencies that do not apply specific principles of biolaw and even bypass official bioethical guidelines in their practice. The author's give overview of the practice of Mexico on the matter of the legislative process in biolaw. The paper focuses on different theoretical approaches.

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Various ethics committees in Belgium, Canada, Denmark, Luxembourg, Portugal, and France have made attempts to describe the notion of euthanasia. Opinion No 063 (January 27, 2000) of the National Advisory Committee on Ethics shows that there has been no concensus on the definition of this concept. It is therefore necessary to review historical background of euthanasia from ancient times to modern period to better understand its potential applications in divergent contexts.

Studies devoted to euthanasia usually involve two modalities, namely active and passive. The active modality entails the act of deliberately killing a patient with or against their will in order to relieve persistent suffering, while the passive modality deals with the rational valid refusal of life-sustaining medical interventions necessary for the patient's life and health. The goal of this article is to present different historical approaches to euthanasia from two modalities and engage the bioethics community in a discussion on legal, social, and ethical issues of euthanasia all over the world.

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Significant progress has been made in the development of genetic technologies in recent decades. Currently, high-performance sequencing and, most importantly, genome editing technologies are widely used and available for laboratories in Russia. Existing technologies are not without drawbacks that significantly hinder further development, in addition, all the necessary reagents and materials, as well as equipment, are produced exclusively abroad. The review highlights the international experience of using genome editing technologies for the treatment and prevention of genetic diseases, vector-borne and viral infections, it offers recommendations for the development of this area in the Russian Federation. Attention is drawn to the legal and ethical regulation, mainly at the level of basic principles. The conclusion is formulated on the need for accelerated adaptation of basic ethical and legal principles for genome editing activities in scientific biomedical activities.

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This paper is devoted to the consideration of legal approaches to discrimination based on genetic status, formulated by the judicial practice of a number of foreign countries: Australia, the United States of America and Canada. The author notes that the regulatory framework for combating discriminatory practices based on genetic status has developed at the level of international law with the adoption of key documents in the relevant area. The author makes a conclusion about the ways to apply genetic information, which often acts as a “tool” for the implementation of discriminatory practices. As genetic testing becomes more widespread, the challenge will inevitably arise to determine what role genetic information should play in human and social life.


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ISSN 2713-0525 (Print)
ISSN 2713-0533 (Online)