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Kutafin Law Review

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Vol 9, No 1 (2022)
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RESEARCH ARTICLES

3-38 615
Abstract

The present study aims at providing an idea that the protection of genetic and genomic information of indigenous peoples and local communities should be legally established at universal and regional levels. There is a trend in many countries towards the disappearance of rare nations and peoples representing genetic diversity. In the case of the collection, processing, storage, transmission of data in the application of artificial intelligence take further action to ensure cybersecurity, develop ethical guidelines and confidentiality requirements for collection and processing genomic and genetic information on the health of indigenous peoples and local communities bearing in mind the provisions of the United Nations Declaration on the Rights of Indigenous Peoples (2007) and the International Convention on the Elimination of All Forms of Racial Discrimination (1965). Although human genes are not covered by the Convention on Biodiversity (1992), it should be applied by analogy in the case of the protection of the “genetic” heritage of mankind. The research uses general scientific and special cognitive techniques wherein legal analysis and synthesis, systemic, formal-legal, comparative-legal, historical-legal and dialectical methods are applied. The author calls on the international community to recognize indigenous genetic information from medical research as the common heritage of mankind and to establish special legal responsibility of present generations for the future of mankind at the universal level. The author of the article notes the importance of prevention the development of racial and ethnic weapons against a certain population group and to prevent the commission of the crime of “genomocide” against indigenous peoples and local communities and to comply with biosafety measures in conducting scientific research and obtaining certain genetic information, to preserve the uniqueness of the biocode of the nations and peoples inhabiting our planet.

39-72 536
Abstract

The objective of the present article is to determine the specific characteristics of the established international legal framework for the application of genetic technologies and to identify general guidelines that influence states’ policies in this area.

Genetic technologies evolve rapidly, raising a number of ethical and legal issues and directly affecting human rights. At the universal level, there is still no international treaty containing uniform rules in this field. At the regional level, the experience of the Council of Europe deserves further study. National approaches to the legal regulation of applying genetic technologies differ since States retain a great deal of discretion in regulating these issues.

Though the Council of Europe Member States enjoy a margin of appreciation in regulating the use of genetic technologies, a number of common distinctive features underlying the international legal framework in this area can still be singled out. These are informed consent, prohibition of reproductive human cloning, prohibition of germ line modification with certain exceptions. They arise primarily from the Oviedo Convention, the Protocols thereto and the ECtHR practice. Soft law documents adopted at the UN, UNESCO and the Council of Europe contribute to the process of their formation, too, but to a lesser extent. The efforts undertaken at the European and universal level shape modern international legal regulation in the field and set up the course of action for States to follow.

73-98 431
Abstract

The article deals with the Belarusian legislation and international legal acts in order to answer the question whether the rejection of the medical model of disability is implemented in Belarusian sports law. The author studies the concept of a disabled person, models of disability and legal regulation of adaptive sports from the point of view of sports law and human rights. It is proved that despite the declaration of non-discrimination of persons with disabilities, the problems associated with the medical model of disability remain very relevant in Belarus. The Belarusian legislation uses the concept of formal equality, but it is supplemented by victimization of disability and objectification of persons with disabilities. The emphasis is shifted to the charity nature of medical care, which brings us back to the medical model. The article argues the importance of adopting a Draft Law on Adaptive Physical Culture and Adaptive Sports to eliminate the existing shortcomings of the legal regulation of sports for persons with disabilities. The author also emphasizes that equalization of opportunities in sports should be defined much wider than providing sports facilities, ensuring equal conditions and opportunities for the development of adaptive movement in relation to the conditions and opportunities for the development of non-disabled sports and non-disabled physical culture. Equalization of opportunities should include a freedom of adaptability as a key category and one of the basic principles of the adaptive movement.

ARTICLES

99-118 314
Abstract

The purpose of this article is to describe the need for establishment of the institution entitled “genetic ombudsman” — a new body in the field of human rights protection — in the Russian Federation. The paper addresses the following issues: (1) the role of the ombudsman as an institution acting as a guarantor of democratic freedoms and the value of human life; (2) historical development and the process of becoming the ombudsman; (3) the need to create the institution of the genetic ombudsman during the era of Industry 4.0 (digital society); (4) factors that influence the society’s demand for the establishment of the aforementioned institution; (5) the main goals and objectives of the genetic ombudsman (legal, economic, medical). This research allowed for the possibility not only to highlight the importance of the genetic ombudsman in the context of the political and legal reality but also to identify existing gaps in the normative regulation. In this article, based on the key provisions of the theory of competence, the author attempted to conceptualize the activities of the genetic ombudsman, describe characteristics of this institution, and summarize areas for further research. In the course of this study, logical, comparative legal and formal methods were used.

119-138 446
Abstract

Disclosure of patients’ genetic information to their families is a central bioethical topic in genomic medicine. The issue of disclosure to family is often associated with a balance between patients’ autonomy and confidentiality and beneficence of their relatives. Communicating patients’ genetic risk profiles back to their family members gives them an opportunity to benefit from additional testing, screening and prevention of potential disorder, so that bioethicists have offered a several models of communication with families. There is no unified definition of the term “family” in bioethics or health law, although the concept of “family” has an important position in the history of private law. There are many ambiguities about such issues as “What does ‘family’ mean?”, “How can communication about genetic risks be placed in a framework of family responsibilities?”. The analysis of several cases in genomic medicine carried out in the article allows us to delve into ethical, administrative, and legal details of these issues in genomic medicine. Notions of “disclosure to family,” “intrafamilial disclosure,” “family dynamics” and “the best interests of the child” are discussed in the article in this regard. Various models of disclosure are grounded in different concepts of family and family relations. If we consider the health professional’s duty to warn of risks to be the duty to help family members with exercising their autonomy, the health professional is responsible to family and is not responsible for consequences of disclosure. The notion of relational autonomy (based on recognition of mutual obligations of family members) begins to be discussed in law and bioethics, however, it still lacks the ethical underpinning. The further research could be aimed at developing the ethical concept of dependency in family relations.

139-155 402
Abstract

The paper is the result of a multidimensional comparative study of the ratio of hard to soft Lex Bioetica application on the modern legal map of the world. In terms of methodology, the study was based on both general and special methods of cognition. The formulation of the doctrinal approaches to the issue of Lex Bioеtica would be impossible without a comparative analysis carried out within the framework of interdisciplinary (comparison of the legal doctrine with the related spheres of knowledge, such as philosophy and sociology), cross-branch (comparative analysis of the approaches used in comparative law, philosophy and theory of law as well as in branch legal disciplines), cross-border (comparison of different national legal systems with each other and with international law provisions), as well as chronological (historical comparative analysis) approaches. Application of the sociological method and the legal modeling method allowed identifying the social foundations of Lex Bioеtica evolution existing in the global legal practice, and outlining the potential ways for the reform of the Russian system in this regard. The study also relied on synergistic research. The synergistic method allowed modelling the evolutionary picture of Lex Bioetica on the legal map of the world. The general conclusion with regard to the evolution of Lex Bioetica in Russia is presented in the form of a scientifically substantiated thesis stating that, in addition to developing Lex Bioetica at the integration level of cooperation (primarily in the Eurasian space), the Russian Federation needs to bring the bioethics-related discourse to the level of hard Lex Bioetica.

156-174 385
Abstract

As a result of rhetoric studies development in a specific medicine and healthcare field of interaction, scholars determined the grounds based on which rhetoric of law and medicine is singled out as a subfield of rhetoric. While medicine rhetoric is more focused on the rhetoric of science, the rhetoric analysis of substantive areas of medical law and healthcare prove that application of medicine rhetoric methodology to the areas of medical law results in dehumanization of the subjects of medical law; state healthcare policy implementation is perceived by affected communities as marketization of a national healthcare system; changes in medical law doctrines result in ethical shifts. The authors conclude that development of technologies in general and medical technologies in particular, public access to medical investigations’ results and inception of bioethics have resulted in the situation when the subjects of medical law are required to develop new approaches to communication with the audiences (or affected communities) based on rhetorical concepts.

175-190 620
Abstract

The development of modern medicine is associated with the dynamic translation (transfer) of basic medicine data to clinical research and further on to clinical practice. It is pointed out that research and development in the sphere of genetics and biotechnology, which are of particular significance during the COVID-19 pandemic, are of paramount importance in this regard. The concept of “translational distance” is analyzed as a measure of uncertainty, namely, the number and the size of logical leaps in course of transition from animal model trials to the first stages of human subject research. Translational research ethics has become a revolutionary, diverse, and distinct field of biomedical ethics. When studying the issue, special consideration is given to the critical blocks in translation as well as the characteristic features, types, and phases of translational research. It is emphasized that addressing the issue of minimizing irreducible uncertainty so that research participants could participate in research is a key component of ethical research. In view of the fact that the most important condition for the successful implementation of translational medicine is the adherence to the principles of bioethics when overcoming translational distances is analyzed taking into account the benefit-risk balance. As the development of translational medicine is significantly influenced by the legislation and the practice of its application, the national peculiarities of the attitude of different countries to the issues of ethics and the resolution thereof are studied, including the differences between the continental and the Anglo-Saxon legal families. Along with the formation of a general approach to the choice of a regulatory model in the sphere under consideration, the acceleration of circulation of the information related to science, research and technology, as well as the rapid obsolescence of innovations, should not be overlooked. At the same time, one should pay attention to the existing biological and other risks.



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