Vol 25, No 1 (2021): BIOMEDICINE AND LAW

GENETICS AND LAW
Biomedicine and Law: mutual trust and perspectives
Yastrebov O.A.
Abstract

The publication raises issues of interaction of rapidly developing areas of bio-medicine and international legal standards, and national legislation of states. Attention is focused on the need for legal guarantees in the field of editing the genome of living organisms, in vitro fertilization, etc. It is proposed to form a uni-form attitude and establish the boundaries of what is permissible in the field of genetic practice so that the situation does not get out of the control of the human mind.

RUDN Journal of Law. 2021;25(1):9-13
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Human rights and modern biomedicine: problems and perspectives
Romanovskiy G.B., Romanovskaya O.V.
Abstract

The article is devoted to the emerging threats to human rights in the context of the development of biomedical technologies, as well as to the identification of social risks requiring legal resolution in this area. It suggests a human rights model for regulating innovative methods of diagnosis and treatment. The purpose of the article is to analyze legislation in the field of modern biomedicine, genetic engineering, and related innovative technologies. A comparative legal study applied in the work made it possible to substantiate a framework model for regulating modern biomedicine. The main task of such a model is to identify risks affecting fundamental human and civil rights and freedoms. With this approach, the details of regulation are the subject of bylaws or the corresponding prescriptions of professional medical organizations. Methods . The basis of this research was formed by such research methods as analysis of legal regulation, formal legal and comparative legal methods. The main results of the study are to determine the legal links between modern biomedical technologies and the concept of personalized medicine. In fact, the lack of interaction of new advances in biomedicine with the basic provisions of medical care has been revealed. The article proves the need to impose restrictions on the alleged popularization of innovative technologies by persons without medical education, using them for dubious social purposes. The risks of developing updated eugenics have been outlined. The tendency of relativism in consolidating the principles of mutual relations between a person, state, and society has been identified. Conclusions. The development of biomedicine requires an adequate response from the Russian legislation, which does not yet take into account most of its achievements. This creates certain risks for human and civil rights and freedoms. The article substantiates the introduction of bans on the most ethically questionable technologies and experiments. It is proposed to expand the powers of professional medical organizations (including the transfer of some of the regulatory powers to them).

RUDN Journal of Law. 2021;25(1):14-31
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Legal regulation in the field of genetically modified organisms (GMO) turnover in Russia and foreign countries
Novikova R.G.
Abstract

One of the most relevant issues, which today’s society face is the use of advanced technologies in the field of GMO and GM-food. Taking a look at the world map of law we can see diverse legal regulation of GMO turnover, especially in the context of regulation and control of genomic studies and their practical application, risk assessment of uncontrollable GMO spreading and technologies of genetic editing of organisms including at the level of research planning. The comparative legal analysis of foreign regulation (including in dominant jurisdictions), provided in this article allows revealing those distinctions, determining the basic tendencies in GMO legal development and connected products with GMO components, including the matters of control with regard to GMO turnover. The analysis allowed drawing several recommendations on borrowing foreign experience for the sake of revising Russian regulation, i.e., taking regulatory measures to develop the relevant sphere of social relationships - legal acts, governmental decrees, etc. oriented towards the development of biotechnologies, raising confidence of citizens in genetics, stimulation of GMO production efficiency, and innovative development. Russia is a member of the Eurasian Economic Union (EAEU); therefore, the article discusses the national laws of these countries concerning GMO and contains recommendations for harmonizing the legal framework of the supranational level in the field of GMO turnover.

RUDN Journal of Law. 2021;25(1):32-66
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Legal regulation of gene editing procedure: USA and EU experience
Trikoz E.N., Mustafina-Bredikhina D.M., Gulyaeva E.E.
Abstract

The problem of legal regulation of gene editing in recent years has obviously become global in nature due to the lack of unified systematic legislation in the world. The authors set a goal to study the main existing regulatory legal acts and determine whether there is currently an array of legislation that protects and at the same time establishes responsibility for the «editors» of the genome and persons who have given consent to it, before future generations, who will receive the edited gene, but who did not actually ask for it. The authors analyzed the most known general public cases related to patent disputes for the CRISPR-Cas9 genome editing technology and came to the conclusion that the strong desire to obtain the legal status of the author of the CRISPR/Cas9 genome modification technology is explained not by scientific ambitions but by commercial interest in a promising technology.

RUDN Journal of Law. 2021;25(1):67-86
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Legal aspects of using genetic evidence on the example of US judicial practice
Ponomareva D.V., Sorokina E.M.
Abstract

Advances in genomic research, biobanking and DNA identification technologies are expanding the use of biological and genetic evidence in litigation. The discovery of DNA and one of its functions to transmit hereditary information made it possible to look differently at the theory of a genetic predisposition to deviant behavior. The relevance of the study is due to the fact that the availability and increase of genetic research allows, along with the traditional use of genetic expertise in litigation (search and identification of a criminal, establishment of paternity), to expand the possibility of using the achievements of genetics by the parties to prove other circumstances in court. In this article, the authors analyze the US jurisprudence regarding the possibility of a party using the protection of genetic evidence in order to present a position in justification of the mitigation of punishment for an accused due to her genetic predisposition to criminal behavior. The authors also paid attention to the consideration of the issue of using the results of genetic testing in civil proceedings in order to prove the fact of the influence of the inherited gene on deviant behavior. In carrying out this study, the authors used a significant number of Russian and foreign sources of scientific literature. General and specific scientific methods of cognition, including the formal legal and comparative legal method, were used as research methods

RUDN Journal of Law. 2021;25(1):87-106
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International Legal Regulation of Genetic Research and Implementation of International Legal Standards in this sphere into Russian Legislation
Kubyshkin A.V., Kosilkin S.V.
Abstract

The article analyzes the topical issues of international legal regulation of genetic research; it provides a comparative analysis of two groups of international acts regulating relations related to genetic research and application of their results on creation, use and circulation of genetically modified organisms (except humans), on the study of human genome and application of their results. The article deals with the issues of objects and methods of genetic research regulation, balance of interests as the basis for legal regulation of public relations in the field of genomic research. It also considers approaches to ensuring a balance of private, group and common (public) interests. Criticism of certain provisions of the Convention on Human Rights and Biomedicine is given, the question of the inadmissibility of legal opposition between the protection of human rights and the interests of science and society as a whole is raised. The authors put forward proposals on the implementation of a number of international norms in Russian legislation and its further improvement, as well as on the use of blockchain technology in genetic research.

RUDN Journal of Law. 2021;25(1):107-125
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Self-Regulation of genetic studies in Russia: search for the optimal model
Alimov E.V., Leshchenkov F.A.
Abstract

The article is devoted to the general analysis of self-regulatory practices of genetic research in Russia (conducted by public research institutions and commercial companies). Selfregulation is a special type of regulation, performed by organizations providing genetic research and their associations as well as by relevant professional and scientific community; it is regulated by local acts, agreements, memoranda, professional standards, codes of ethics, etc. and is aimed at establishing relationships in the field of organization, provision and use of results of genetic studies. Basically, selfregulation is especially critical in various aspects of organization and conducting genetic research in the worldwide perspective. The analysis provided by this article allows concluding that self-regulation practice in Russia is applied in several public research institutions, but rather fragmentarily. Moreover, the development of such form of regulation goes slowly. At the same time non-public genomic institutions are trying to evade any significant self-regulation of their activities; they do not provide for any expanded rules or standards of their practices (or they just confine themselves to references and general provisions which are not in line with the specifics of the mentioned activities). On the other hand, it is important to keep in mind that the current Russian legislation is full of gaps in terms of regulating genetic research process. Analysis of several websites of Russian private companies providing genetic profiling services revealed that those organizations almost never place complex information guides on their information portals; they neither provide the standards for performing genetic research in an intelligible form. The websites do not contain any information on possible risks or threats to health connected with application of medical procedures, while the issue of disclosure the gathered genomic information to third parties (e.g., enforcement agencies) is often ignored. More than that, there are hardly any published standards for conducting genomic research or documents on protecting patients’ rights, etc. Thus, we are forced to acknowledge that the institute of self-regulation in the field of genetic studies is not developed well enough in Russia. The current fragmented nature of legal regulation and selfregulation concerning genetic research may contribute to violation of rights and legitimate interests of patients in terms of confidentiality and safeguarding genetic information, gathered in the process of research. The state therefore should within the established goals of intensive genetic technological development provide all the necessary conditions (including of legal character). However, it is still not clear how the issues of legal regulation of status of genetic research participants, protection of genetic data, incentives for providing genetic research, etc. should be handled. We assume that one of the possible ways of tackling the aforementioned challenges is developing relevant complex legal regulation (including departmental acts) and/or investing the frontline public research institutions with special functions (i.e., within a special council, commission, or association). Such powers will contribute to regulating certain aspects of administering and conducting genetic research and using its results in the framework of legal regulation, which should be mandatory, including for non-public organizations, offering genetic services in the territory of the Russian Federation.

RUDN Journal of Law. 2021;25(1):126-143
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Biomedicine issues in the European Court of Human Rights Case-Law: Boljević v. Serbia
Bukuru J.
Abstract

The article considers the recent case-law of the European Court of Human Rights in cases related to the use of the achievements of biomedicine in the light of the implementation of human rights and freedoms provided for by the European Convention on Human Rights and its additional protocols. In fact, the author pays special attention to the case of Boljević v. Serbia , in which the applicant, a Serbian citizen, alleged that his right to respect for private and family life had been violated as a result of the refusal of the Serbian national courts to reopen paternity proceedings, in which the applicant intended to prove, through DNA testing, that Mr. A was his biological father. It has to be mentioned that in this case in the 1970s the Serbian national courts issued final decision according to which Mr. A was not recognized as the applicant's biological father, and the applicant indicated that at that time it was impossible to carry out DNA test and he did not know about the existence of such decision (during the proceedings, the applicant was represented by a lawyer appointed by local authorities, since he was a minor), and that now there is such a possibility. In this connection, the applicant argued that the denial to satisfy his claims on procedural basis by the domestic courts violated his right to family and private life. The ECtHR ruled that Art. 8 of the Convention has been violated. In that case, the issues of compliance with a balance of private and public interests were dealt with (the interests of the applicant to establish his biological father identity and the interests of the state in maintaining legal certainty).

RUDN Journal of Law. 2021;25(1):144-163
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HUMAN REPRODUCTION AND HUMAN RIGHTS
Human rights and women's reproductive health in the countries of Latin America
Mustafa G.A.
Abstract

The problem of induced termination of pregnancy has been a burning issue for mankind for centuries. An analysis of doctrine and legislation demonstrates that there is no consensus on this issue. The problem of induced termination of pregnancy is defined by ethical, religious, medical, social and legal aspects, which is also associated with the uncertainty of the legal status of the embryo. The aim of the study is to analyze the legislation of Latin American countries regarding the legal regulation of abortion, in order to verify its compliance with the fundamental rights - the right to life, the right to health and the right to inviolability. Special scientific methods were used in the research: comparative law, legal and technical methods. The relevance of the problem stems from the need to solve the controversial issue of legalization of artificial termination of pregnancy. The existence of disagreement lies in the lack of a unified approach in seeking to resolve this situation.

RUDN Journal of Law. 2021;25(1):164-178
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Preimplantation and prenatal genetic diagnostics in Russian Federation: ethical and legal issues
Lapaeva V.V.
Abstract

The topicality of the article is due to the strategy of transition to personalized medicine in Russia, based, among other things, on technologies of preimplantation and prenatal genetic diagnostics. The purpose of the article is to analyze the main directions of ethical and legal support for the development of these technologies. The work is based on the study of relevant international regulations, foreign and Russian legislation using the methods of legal-dogmatic and philosophical-legal analysis. The article substantiates the need for a clearer distinction between legal and moral-religious approaches to regulating relations in applying these technologies. The task is to find legal structures that can take into account the moral aspects of the problem without replacing legal regulation with an appeal to moral and religious values and norms. An example of this approach is the development of a legal regime for manipulations with embryo in vitro, in which the necessary legal protection of the embryo is provided by recognizing its special ontological status as a constitutional value of the common good. From these positions, the author identifies a range of issues that should form the organizational and legal context necessary to ensure adequate guarantees of human rights in the field of application of the considered genetic technologies. The legal regulation of this range of issues should be fixed in a special federal law on genetic testing.

RUDN Journal of Law. 2021;25(1):179-197
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BIOETHICS AND LAW
A principled approach to bioethical regulation of genetic counseling: mapping the bioethical problems of genetic counseling and models for their solution
Shevchenko S.Y., Shkomova E.M.
Abstract

Genetic counseling is a field of high-tech medicine, and its development gives rise to many ethical and legal problems associated primarily with the specifics of genetic data. The purpose of this article is to map the problems of bioethical regulation in genetic counseling, as well as approaches to their solution. To structure the problem field, a principlist approach was chosen. Main results: It is shown that bioethical problems of genetic counseling arise not only in connection with adherence to separate bioethical principles, but also in connection with the conflict between the principles of autonomy and beneficence. It is proposed to distinguish two dimensions of this conflict: 1. Individual, associated primarily with the exercise by a person of the right not to know about his/her hereditary risks; 2. Family, associated with the contradiction between the observance of medical secrecy (as part of autonomy) and the potential benefit from informing the patient's relatives about their possible hereditary risks. Conclusions: The models for resolving bioethical collisions highlight new aspects of meaning of autonomy. In the context of genetic counseling, it is possible to understand autonomy not as non-interference, but as an opportunity to control the disposal of genetic data. At the same time, in the context of regulating this disposal, the autonomy of the patient's family members can also be taken into account.

RUDN Journal of Law. 2021;25(1):198-213
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Legal and ethical regulation of genetic research
Przhilenskiy V.I.
Abstract

The paper deals with the problems of genetic research regulation stemming from the peculiarities of this area of knowledge where research is practically inseparable from patient treatment, and cognitive practices are connected with the development and implementation of new devices, methodologies, and technologies to a much greater extent than in other areas of human activity. The issues of genetic research regulation are analyzed in the context of the concept suggested by Helga Nowotny and Giuseppe Testa distinguishing three human technologies of standardization through which control over the development of knowledge about genes is exercised. These three technologies are law, governance and bioethics, and the efficiency of their interaction is declared a necessary and sufficient condition for the successful development of molecular genetic sciences. The paper examines all the three technologies one by one, identifies the specifics and difficulties of their implementation in present-day Russian science, and assesses the genetic research prospects assuming the implementation of the aforementioned technologies. Particular attention is paid to institutionalization of ethics committees as an element of the genetic research regulation system. Substantiation is provided for the thesis that ethical committees should act as an institution combining rulemaking, management, and expert functions rather than as a structure capable of performing advisory and recommendatory functions only. The ability of the Russian society and state to withstand the grand challenges of our time is associated with the success in solving this problem.

RUDN Journal of Law. 2021;25(1):214-231
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Ecosystem approach in legal regulation of biosafety
Krasnova I.O.
Abstract

In Russia, the aim to attain biosafety is declared in the strategic political documents without being adequately addressed in law relating to interaction between human communities and natural systems. To involve the ecological approaches into environmental legislation it seems reasonable to include into the general concept of beneficial quality of the environment the biological health of nature, when the impact of pathogenic, disease generating factors emanated by nature shall be minimized. The legal regulation should be based on the ecosystem and nature-based approach assuming that social development should follow and be in harmony with laws of nature. This approach will allow to upkeep the biological balance and biological health of nature and ensure biological safety of nature for human communities.

RUDN Journal of Law. 2021;25(1):232-247
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LEGAL RESEARCH METHODOLOGY
System-synergetic approach to studying the essence of state power
Zyrianov A.V.
Abstract

This article is devoted to the problem of cognition and understanding of the essence of state power. Actualization is carried out by searching for a new paradigm approach in order to determine the fundamental principles that are correlated with the idea to optimize and increase the efficiency of the corresponding sphere of public relations. Acting as an alternative to the substantial and relativistic approach to the study of state power, the system-synergetic approach analyzes the phenomenon of “power” based on the definition of “system”, within which the functions of communication and regulation of public relations are assigned to power. As a result, power is seen as a property or function of a social, in particular, political system, the need for which is determined by the presence of society itself and the task of maintaining its integrity. The analysis allows stating that in most modern concepts there is a consistent rejection of the traditional interpretation of power as the result of subject-object relations, where the subject of power is an active, energetic principle, and the object undergoes impact. In contrast to the position of traditionalism, there is a tendency to interpret power as a complex polysystem permeating the entire social structure of society. As a structural and synergistic effect of the system, power is not a property of its individual element, since each element must certainly be correlated with other units of the given system. Power is an intrasystem relatedness of all elements. As a structural principle, power is realized on the basis of equivalent exchange, which means not the equivalence of the exchanged elements, but a situation in which one element is unconceivable without the other, i.e. one element exists in relation to the other, and co-develops with it. Thus, power really fulfills the function of streamlining socio-political ties, making their separation and differentiation expedient. Power, therefore, is the beginning, creating structures, increasing heterogeneities in a continuous social environment and connecting them together. Such a view allows interpreting power as a principle of functioning of the state system: if the state system, with the help of some value proposition, manages to reproduce the corresponding content of consciousness, then it functions quite stably.

RUDN Journal of Law. 2021;25(1):248-262
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Anthropological approach to the concept of legal values: classic, non-classical and post-non-classical
Ivanskiy V.P.
Abstract

The article is devoted to the study of the concept of legal values, their classification. Analysis of legal literature led to the conclusion that legal values are considered only in line with legal positivism, which have a “façade” in relation to the subject of law. According to the author, anthropological approaches - classical, non-classical and post-non-classical - can become a milestone in a conceptually different understanding of the values of law. In this regard, the purpose of the paper is to conduct a study of the values of law in line with anthropological research programs. To achieve the goal, the following tasks were set: 1) to describe the classical (neoclassical), non-classical and post-non-classical anthropological programs; 2) to formulate the concept of legal values and truth within the framework of three paradigms of legal thinking; 3) to classify and rank the values of law. As a result of the study, the following conclusions were made: The legal value in the classical (neoclassical) anthropological paradigm lies in the safe-guarding and protection of inviolability of the biopsychophysiological integrity of the organism, which identifies an individual as a physical person. Therefore, the law has an objectified and alienated from the individual subject character. The value of law in non-classical anthropological discourse is imperative-attributive experiences (legal psyche) or intentional acts of consciousness that constitute legal reality, with which a person is identified - a legal personality. The post-non-classical model of cognition is focused on the discovery of the true essence of a person through identification with a legal being (or pure consciousness), which is an absolute value and creator of transpersonal and extra-social legal reality.

RUDN Journal of Law. 2021;25(1):263-280
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Legal regime: the concept and features
Belyaeva G.S.
Abstract

The purpose of the study is to conduct a general theoretical analysis of scientific approaches to the definition of the concept and essence of the legal regime in order to overcome its narrow industrial understanding and identify the role and significance in the process of legal regulation. General scientific and private scientific methods of knowledge including formal legal and comparative legal methods have been chosen as research methods of this paper. Logical techniques allowing to reveal the essence of legal regimes and formulate the author's definition of them have also been applied. The analysis of scientific works expressing various opinions indicates that at present an instrumental approach to the definition of the concept and essence of the legal regime prevails directly (or indirectly through the procedure of legal regulation) as a set of legal means (instruments). The following are mentioned as signs of the legal regime: mandatory normative legal consolidation (formal legal nature), specific target, special regulatory order based on a combination of legal means and methods of legal regulation, in relation to subjects of law, i.e., in a subjective sense, creating of favorable (or unfavorable) conditions to achieve certain interests, systemic and integrated character of a regime and its special structure. As a result, the author's definition of the legal regime is presented as a special procedure for the legal regulation of public relations, based on a certain combination of legal means and methods of legal regulation (permits, prohibitions, and positive obligations) aimed at achieving the relevant legal goals and planned optimal socially significant result.

RUDN Journal of Law. 2021;25(1):281-293
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CIVIL LAW
Animals as objects of civil rights: current issues
Sinelnikova V.N., Khatuntsev O.A.
Abstract

The relevance of the research is based on the heated discussion that has unfolded in recent years in connection with changes of the current legislation on legal regime of animals as objects of civil rights as well as awkward suggestions aimed at essentially reshaping the civilistic concept of animals and establishing their special legal status by recognizing them, albeit with some restrictions, as subjects of legal rights. The purpose is to analyze the genesis of animals’ legislation, including but not limited to international legislation, and to reveal the social significance of norms governing the conditions and procedure for acquisition of animals and the limits and principles of their treatment. The article also aims at voicing the authors’ position on participation in the civil circulation of animals. Research methods applied in the work are as follows: formal-legal, dialectical unity, system analysis, interpretation, modeling, and forecasting. The results of the study (conclusions) are realized in proposing to supplement Art. 128 of the Civil Code of the Russian Federation with a new term property as basic in relation to terms things, other property, and property rights. It is also recommended to expand the range of objects of civil rights by identifying animals as an independent object, clarify the revision of Art. 137 of the Civil Code, presenting in it the definition of an animal as an object of civil rights and reflecting the main criterion for classifying animals (turnover). In addition, a judgment was made on changes in Russian legislation introduced in 2020, including the Law On the Animal World, allowing amateur and sports hunting of animals in semi-free conditions and artificially created habitat. This law clearly contradicts international agreements that allow hunting (capture) of animals only for the maintenance of human livelihood.

RUDN Journal of Law. 2021;25(1):294-308
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INTERNATIONAL LAW
The measures against the International Criminal Court (USA v. ICC): the perspective of International Law
Fahmy W.
Abstract

Since its creation, the International Criminal Court has faced the refusal of the United States to cooperate, which, in addition to staying outside the Rome Statute, has undertaken a real strategy of weakening the Criminal Code. The argument put forward by the US Government against the Rome Statute is that an international treaty cannot create obligations for a non-party state and therefore the United States denies any jurisdiction of that jurisdiction over its nationals. As early as 2000, that country had unsuccessfully introduced a proposal before the Preparatory Commission to prevent bringing American military personnel to the Court. The American Service Members’ Protection Act (ASPA), bilateral immunity agreements and Security Council resolutions constitute the arsenal used by States at that time to neutralize the ICC. Recently, the United States signed an order authorizing the United States to prevent and penalize employees of the International Criminal Court from entering the country. The US administration, which has been critical of the ICC for months, is opposed to launching investigation into war crimes in Afghanistan. Is not that a sign of difficulty with the US Legal Justifications? In other words, does this weakness open up the possibility of prosecution in the event of a violation of international law by US?

RUDN Journal of Law. 2021;25(1):309-332
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REVIEWS. DISCUSSION FORUMS
To the anniversary of RUDN Professor Vadim Makhov: Post-release of the International scientific and practical conference
Vasilenko A.S.
Abstract

On November 19, 2020, the annual International Research and Practice Conference Ignatov Readings took place. It was dedicated to the 85th anniversary of the outstanding scientist - Vadim Nikolayevich Makhov - an Honored Lawyer of the Russian Federation, Doctor of Legal Sciencies, Full Professor, whose life and scientific work have been inextricably intertwined with the RUDN University for more than a quarter of a century. The article is dedicated to Vadim Nikolaevich Makhov - a practitioner with the richest experience, an outstanding scientist, and a talented teacher!

RUDN Journal of Law. 2021;25(1):333-339
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Improving measures for the development of financial and legal back up of state support for development programs of higher education institutions in Russia
Vlasenko N.A., Zinkovskiy S.B., Gronic I.A.
Abstract

The RUDN Law Institute research team headed by the Doctor of Sciences, professor of the Department of Theory of Law and State Nikolay Vlasenko performed an expert and analytical work for the formation of a package of proposals on measures and law-making initiatives in order to implement the amendments to the Constitution of the Russian Federation adopted in 2020. The aim was to assess the need to determine the additional source of income of a constituent of the Russian Federation for state support for the development programs of higher educational organizations by changing the system of distribution of tax revenues between federal and regional levels of the budget. The research team included Sergei Zinkovskiy, Ph.D., associate professor of the Department of Theory of Law and State, Mikhail Katsarsky, Ph.D., associate professor of the Department of Theory of Law and State, Irina Gronik, Ph.D., assistant professor of the Department of Civil Law and Civil Procedure Law and Private International Law, Denis Dobryakov, Irina Chernykh and other specialists of RUDN Law Institute. The results of the research can be used by the Government of the Russian Federation, the Ministry of Higher Education and Science of the Russian Federation to form theoretically based proposals related to the dynamics of financial and legal support for state efforts for programs of higher education organizations development in Russia on the territories of subjects of the Russian Federation in connection with the implementation of the amendments to the Constitution of the Russian Federation.

RUDN Journal of Law. 2021;25(1):340-349
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