scholarly journals Principles of Correlation Between Self-Regulation and State Legal Regulation of the Relations Related to Genetic Research: Modern Prospects

2019 ◽  
Vol 8 (2) ◽  
pp. 3850-3855

The principles of correlation between self-regulation and state legal regulation of the relations related to genetic research have been discussed in this article. Today the development of genetics and applied genomic medicine has a direct effect on legal relations on protecting the rights and legal interests of an individual. The main goal of the study is to research regulatory legal acts, judicial practice, and doctrinal sources aimed at determining the optimal correlation of the beginnings of self-regulation and state legal regulation of relations related to genetic research. When writing the article, the methods of collecting and studying singularities, the generalization methods, the scientific abstraction methods, as well as the method of inquiry into regularities have been used. This study is characterized by using the experience of foreign self-regulatory organizations and professional associations involved in genetics. In their study, for the first time, the authors have substantiated the conclusion that the model of the optimal correlation of state regulation and self-regulation of legal relations related to genetic research is based on the following principles: 1) informed consent for genetic research and protection of the confidentiality of the obtained information, 2) participation of self-regulating associations of medical geneticists in developing national standards for the quality of medical services in genetic research, as well as the requirements for medical organizations and medical employees who provide them, and 3) legalization of the legal status of a person providing counseling services in genetic research and in associated areas related to defining a strategy for the treatment of genetically determined diseases and the use of assisted reproductive technologies (genetic counselors). In the article it has also been stated that it is necessary to define the legal mode of protecting the information obtained during the genetic research depending on classifying such research as a certain specific category – diagnostic, pre-symptom or prognostic (carried out to assess the vulnerability of an individual to a specific disease). Third parties can only access the results of diagnostic genetic research.

Lex Russica ◽  
2020 ◽  
pp. 54-61
Author(s):  
K. V. Mashkova ◽  
M. V. Varlen ◽  
A. Yu. Shirokov

A secular trend of the development of medicine in the 20th century was on the ways of strengthening the foundations of public health, formation of systems of affordable medical care. Human genome deciphering opens wide prospects for using the obtained data in medicine. In recent years commercial medical organizations have been developing genetic research and personal genomic testing services. The paper is devoted to the analysis of the importance of legal self-regulation in the field of genomic counseling in the Russian Federation. The authors investigate the prospects of the introduction of personalized medicine and limitations that arise today in one of the areas of the approach under consideration, namely: forecasting predisposition to diseases of mixed nature, which is related to the peculiarities of development of medical and demographic situation in the world. The question is raised about the need for broad population studies to verify the risk values for diseases with low genetic determinacy. The authors conclude that it is impossible to predict what medicine of the future will be, but the results of genome decryption and increasing availability of personal data represent a unique social phenomenon that should be developed within the legal framework. In the coming years, the debate on the role of legal mechanisms in the self-regulation of genetic research and genetic services will become increasingly important. At the international level, this discussion will be focused on the fundamental issue of respect for individual rights in the interpretation of the data received. As genetic advice evolves, the issue of responsibility for the information provided and the availability of national regulatory mechanisms within the framework of state regulation or self-regulated professional associations will become a key concern.


Author(s):  
M.V. Medvedev , G.N. Suvorov , S.S. Zenin

The formation of new trends in the development of molecular genetic diagnosis has allowed to use this knowledge to identify pathologies of the child's development before his birth at the prenatal level. The use of new assisted reproductive technologies(art), aimed at combating infertility, allows to postpone this period even before the implantation of the embryo of the future mother. The use of new techniques should be carried out only for medical reasons, but the mechanism of their legal regulation has not been formed to date, which may be the basis for the use of genetic research carried out within the framework of art in the context of medical expediency. The above allows us to raise the question of the need to develop special legal norms that allow to solve the problem only from the perspective of modern bioethical ideas, but also from the perspective of the formation of law enforcement practice in this area.


Lex Russica ◽  
2020 ◽  
pp. 47-53
Author(s):  
N. V. Kruchinina

Genetic technologies offer wide prospects for socio-economic progress. At the same time, their application in practice could put at stake the interests of society, human rights and freedoms. Therefore, the development of genetic technologies requires its analysis from the standpoint of jurisprudence, thoughtful legislative regulation and protection from uncontrolled spread and criminal use. The paper analyzes different points of view on the use of genetic technologies. The author substantiates the necessity of proper legal regulation and security of the process of development of genetic technologies. The paper contains the results of the scientific research. The paper elucidates the problems related to the use of genetic technologies in the process of artificial human reproduction: imperfection of the legal framework (In particular, lack of the definition of the legal status of human embryo, lack of justification for the legality of its use for research and therapeutic purposes), the threat of the use of genetic technologies for criminal purposes. The author concludes that the use of genetic technologies for criminal purposes is especially dangerous because organized criminal groups focus their attention on genetic technologies. This gives rise to a special criminal situation that requires new approaches for effective counteraction. To this end, the priority is given to identification of crimes committed with the use of genetic technologies and analysis of the emerging practice of investigating this category of crimes. Failure to comply with standards, deviation from regulations and procedures imposed on medical care may result in harm to health or death also when the assisted reproductive technologies are used. The author has made some proposals to solve these problems with due regard to domestic and foreign experience in the use of genetic technologies in the field of human artificial reproduction (in particular, it is proposed to establish effective international cooperation in this area).


Lex Russica ◽  
2020 ◽  
pp. 21-31
Author(s):  
D. A. Belova

The paper is devoted to the study of problems related to the establishment of the origin of children born as a result of artificial fertilization in the comparative legal aspect. It is noted that the principles laid down as the basis of the rules governing the order of the child’s origin vary significantly depending on whether it is a matter of natural or artificial reproduction. In the case of assisted reproductive technologies (ART), the value of blood (genetic, biological) kinship is leveled, and its substituted by the will of the person to acquire parental rights and obligations with regard to the child. A person’s will to become a child’s parent is expressed before the child is born in a written permission to use the ART. It is noted that the absence of normative rules regulating the order of expression of consent and conditions of its validity is an obvious gap in the legal regulation of the ART application. It is proposed to treat consent as informed consent if the person applying for the use of ART is provided not only medical but also legal information concerning the legal status of the person participating in the ART program and the legal implications of such participation. The author investigates requirements applied to mutual consent and voluntary consent, its substantive and revocable nature, as well as inadmissibility of representation when expressing the will to use the ART. The author argues that the will to acquire the status of a parent should be expressed in a separate document describing the content of the will and verified by the notary. In order to ensure the best interests of the child in parental care, it is proposed to impose statutory restrictions on the free will to apply the ART.


Lex Russica ◽  
2019 ◽  
pp. 9-17
Author(s):  
N. A. Altynnik ◽  
V. V. Komarova ◽  
M. A. Borodina ◽  
E. I. Suvorova ◽  
S. S. Zenin ◽  
...  

The article analyzes key instruments of international legal regulation of preimplantation genetic diagnostics (PGD) procedure. The authors substantiate the conclusion that the requirements and principles formulated in these instruments can be successfully used for the development and improvement of the national legal framework aimed at regulating the PGA. The main directions of such use are defined. First, it is necessary to consider the existence of genetic predisposition to a particular disease or chromosomal disorder (the medical purpose) and provide a qualified consultation of a genetic scientist concerning the mechanism and consequences of diagnostics. Secondly, the legal regulation of genetic information obtained through the PGA requires an independent normative framework: determining the framework the law-maker must be guided by the fact that any intervention in the human genome aimed at modifying it may be carried out only for preventive, diagnostic or therapeutic purposes. In this regard, it is important to prohibit the PGA for social purposes (selection of embryo according to specific characteristics, establishment of compatibility between a donor and a recipient, looking beyond the prohibition to choose the embryo gender that is currently imposed under Russian legislation). Third, a separate regulatory framework is needed to resolve the problem of informing the patient about the results of examination: in addition to the right to be informed of the results of examination, it is also necessary to recognize the individual’s «right not to know,» particularly relevant to predictive genetic research.


2019 ◽  
Vol 60 (1) ◽  
pp. 37-44 ◽  
Author(s):  
Svetlana M Sylkina ◽  
Nurlaiym K Mynbatyrova ◽  
Zhuldyz B Umbetbayeva ◽  
Gulmira K Shulanbekova ◽  
Dana U Baitukayeva

In contemporary societies, the use of assisted reproductive technologies has become increasingly widespread, justifying the need for proper legal regulation of the relevant relationships. The purposes of the article are to analyse the nature the content of the phenomenon of surrogacy, to assess the current legislation of Ukraine in this area and to produce a comparative analysis with the legislation of other states. The aim is to formulate recommendations and outline prospects for further development of national legal regulation of surrogacy relationships. Within the framework of this research, the regulatory matrix and individual regulation of surrogacy were subjected to a comparative analysis within the context of ensuring the rights and freedoms of those citizens implementing surrogacy. This assisted in revealing medical and social dimensions of the legal relations of surrogacy, determining their purpose, considering the specifics of concluding a surrogacy agreement and reviewing the legal status of subjects.


Author(s):  
A. Levchenko

The research aims to determine the role of self-regulatory bodies in monitoring advertising activities and in protecting the child from their adverse influence, to assess the current state of self-regulation in this area in Ukraine and to determine necessary components for its systematic implementation into domestic legal system. In order to achieve aforesaid aims the following methods of legal research have been applied: analysis, systemic analysis, generalization, legal modeling. Specifically, the method of analysis has been used to extract the features of the successful activities that are conducted by selfregulatory organization in other countries. To derive patterns and clarify the reasons for the effective activities of self-regulatory organizations, methods of generalization and systemic analysis have been used. In addition, the method of legal modeling has been elaborated in order to determine the possible ways of self-regulatory system implementation in Ukraine. The author analyzes the concept of self-regulation. The advantages of self-regulation in comparison with the state regulation are evaluated. Namely, it is done through the prism of the relevant legal experience taken from Great Britain, France, the United States of America. The conditions necessary for the implementation of a self-regulatory system are revealed. The current state of self-regulation in Ukraine is scrutinized. This makes it possible to find out the reasons for its underdevelopment in national legal context. In general, the analysis of Ukrainian legislation on advertising is carried out and the issues of the self-regulatory system in the context of protecting children from the negative impact of advertising information are studies thoroughly. Approaches and relevant empirical material analyzed within the article allow the author to arrive at following conclusions. The author identifies the value of self-regulation, particularly, its advantages in comparison with the state regulation. Additionally, the author emphasizes the lack of special legislation in Ukraine that regulates the legal status of self-regulatory organizations in the field of advertising; insufficiency of the scope of public organizations powers stipulated in the legislation; the inconsistency of the activities of a significant number of public associations in this area as well as the absence of a certain sustainable reform in outlined domain. In this vein, the connection between the lack of systemic reforms in this area, desuetude, conflict of laws, as well as incomplete legislation and the decrease in the authority of the law for the actors in the advertising industry is established. The author suggests the ways of implementation of significant institutional changes in the legal regulation for self-regulatory organizations' activities in Ukraine, primarily in terms of consolidating their legal status, functioning certain rules and principles of state control over their activities.


Author(s):  
N.A. Altinnik , S.S. Zenin , V.V. Komarova et all

The article discusses the factors that determine the content of the legal limitations of pre-implantation genetic diagnosis in the framework of the in vitro fertilization procedure, taking into account international experience and modern domestic regulatory legal regulation of the field of assisted reproductive technologies. The authors substantiates the conclusion that it is necessary to legislate a list of medical indications for preimplantation genetic diagnosis, as well as the categories of hereditary or other genetic diseases diagnosed in the framework of this procedure.


Author(s):  
Nikolai A. Ognerubov

In connection with the active development and use of assisted reproductive technologies, protection of the human embryo and its legal status issue is currently being actualized. We make an attempt to reveal and explain some of the international aspects of the criminal law protection of the life and rights of the embryo. We consider the concept of “embryo” not only from the point of view of various scientific approaches (medicine, biology, embryology, jurisprudence), but also from the legislative side. We present and analyze the first mention of the embryo in Roman private law in connection with modern domestic law. We carry out an analysis of international legal acts that provide protection of embryos both “in vitro” and “in vivo”, followed by consideration of specific criminal law norms of foreign countries, namely Brazil and Colombia. We pay attention to some of the most famous cases from the jurisprudence of the European Court of Human Rights in order to understand the applied international legal acts “de facto”. The study also takes into account modern domestic legislation and considers point “g” of part 2 of Article 105 of the Criminal Code of the Russian Federation.


10.12737/7246 ◽  
2014 ◽  
Vol 3 (1) ◽  
pp. 0-0
Author(s):  
Евгений Губин ◽  
YEvgyeniy Gubin

The article deals with the issues of cooperation between state and business, necessity to form a unified policy in the sphere of entrepreneurship and state influence on the business, inter-branch nature of legal regulation of relations between state and business, legal means and forms of state regulation of economy, legislative basis of legal regulation of business activities, correlation of state regulation and self-regulation, concrete means of state influence upon economy. The government’s role in the process of regulation of economic relationships cannot be reduced to the function of an external regulator and controller. Developing a comprehensive and long-term concept of legal support to the current economic reforms can be considered as the strategic target and tool of legal regulation of economic relationships.


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