Formation of the concept of legal regulation of preimplantation genetic diagnosis in the Russian Federation in the context of ensuring and protecting reproductive freedom of the individual

Author(s):  
V.V. Komarova , N.A. Altinnik , G.N. Suvorov

Objectives. The aim of this study is the formation of a concept of preimplantation genetic diagnosis (PGD) in the Russian Federation in the context of ensuring and protecting reproductive freedom of the individual. Material. The regulatory legal acts, the doctrinal sources of the Russian Federation are examined to identify key problems that impede the formation of the desired concept. Methods used: general philosophical, general scientific, private scientific, special (structural-legal, formal-legal). Results. The basic postulates of the concept of legal regulation of PGD in the Russian Federation are substantiated. As part of the analysis of domestic legislation, key problems are identified that impede the formation of the desired concept that meets the level of development of medical science and the needs of consumers of medical services. The conclusion is justified that it is necessary to fix at the legislative level the place of pre-plantation genetic tests in the assisted reproductive technologies system, thus giving PGD independent significance outside the context of the problems of infertility treatment. It has been argued that, in addition to the norms of the basic law on protecting the health of citizens, a separate sub-legislative normative legal act of the Ministry of Health of the Russian Federation should be developed in the system of legal regulation of PGD in Russia, forming a set of mandatory requirements for the PGD procedure, depending on diagnostic goals, as well as determining which methods are preferable depending on the goal and what results the consumer can count on. Conclusions. It is noted that in the system of norms on genetic research, special attention should be paid to genetic counseling, establishing mandatory requirements for the content of the consultation - in relation to PGD, this should include explanations regarding the algorithm and method of the study, the possibilities and limitations of this type of diagnosis for each a particular case, the features of its application to solve a single genetic problem.

Author(s):  
N.A. Altinnik , V.V. Komarova , M.A. Borodina et all

The article is devoted to the problem of determining the basic principles of the legal regulation of preimplantation genetic diagnosis (PGD) in the Russian Federation, taking into account existing international experience. It is substantiated that the development of national legislation in this area should include the legal definition of PGD as one of the stages of using assisted reproductive technologies, as well as the establishment of generally binding requirements for the procedure, conditions and features of the diagnosis, taking into account the need to minimize the damage caused to the embryo. A comprehensive model for the development of domestic legislation and law enforcement is proposed, the content of which includes state guarantees and restrictions harmoniously complemented by ethical requirements developed by the professional community of specialists in genetics, extending the content of the process of genetic counseling for PGD, interpretation of research results and ensuring compliance with the principle of reproductive freedom in deciding on the results of diagnosis.


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.


Author(s):  
A.A. Mokhov ◽  
A.N. Yavorsky ◽  
A.R. Pozdeev

The urgency of the article is determined by the need to ensure biological and ecological safety of Russia. The article gives examples of failures of auxiliary reproductive technologies in the Russian Federation and abroad which at present do not have adequate algorithms of legal resolution and are unsafe for ecology and man. Investigating the existing Russian legislation it has been revealed that passing only of obligatory medico-genetic consultation and incomplete medico-genetic inspection with approximate assessment of the genetic status of the donor does not exclude development of the fetus with severe genetic diseases, which is considered by the consumer of the service as poor quality and unsafe. It is noted that in cases of use of biomaterials from abroad, a comparative study of the genome becomes unlikely due to paragraph 7 of Art. 55 of the Federal Law of 21.11.2011 № 323-FZ "On the fundamentals of public health protection in the Russian Federation" and the order of the Ministry of Health of Russia from 30.08.2012. (ed. 01.02.2018) № 107n "On the order of using assisted reproductive technologies, contraindications and restrictions on their use". The conclusion was drawn on the need to develop and fix organizational and legal mechanisms and develop appropriate procedures.


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):  
L.Y. Larina

The study of the problems of legislative regulation of criminal responsibility for transport security requirements violation is due to the necessity to ensure it as part of national security. The purpose of the study is to identify the shortcomings of the legislative structure of article 263.1 of the Criminal Code of the Russian Federation, preventing its effective application in practice, and suggest ways to overcome them. In the research on the basis of comparison of the content of article 263.1 of the Criminal Code of the Russian Federation with the norms of the Federal Law “On transport security” and Decrees of the government of the Russian Federation analyzed some blank signs of transport security requirements violation. In the study we identify deficiencies of the legislative construction of article 263.1 of the Criminal Code of the Russian Federation, the necessity of its correction, and formulate proposals for changing the individual characteristics and the sanctions of article 263.1 of the Criminal Code of the Russian Federation. In particular we discuss the proposal to change the sanctions of part 1 of article 263.1 of the Criminal Code of the Russian Federation in connection with the inconsistency with the sanction of part 1 of article 118 of the Criminal Code of the Russian Federation. In addition, it is proposed to expand the range of subjects of crime under part 2 of article 263.1 of the Criminal Code of the Russian Federation.


Author(s):  
Anna Rolandovna Purge

The object of this research is the correlation between public law and private law principles in the context regulation of the use of assisted reproductive technologies in the Russian Federation and the Republic of Tajikistan. The subject of this research is the norms of the Russian and Tajik legislation that regulates the procedure of using assisted reproduction technologies, as well as public law and private law principles of their regulation. The scientific novelty of this work lies in carrying out a comprehensive analysis of the relevant problematic on correlation between public law and private law principles in the context of regulation of the use of assisted reproductive technologies in the Russian Federation and the Republic of Tajikistan (taking into account the contradiction and conflicts of law of these legal relations). The author’s special contribution lies formulation of the original proposals for the progressive solution to the problem of correlation between public law and private law principles in regulation of the use of assisted reproductive technologies in the territory of the Russian Federation and the Republic of Tajikistan.


1970 ◽  
Vol 21 ◽  
pp. 311-315
Author(s):  
Yu. V. Gontar ◽  
O. Yu. Verlynskyi ◽  
A. Kyrpyi ◽  
I. E. Ylyn ◽  
A. M. Fedota

Aim. Optimization of the algorithm of complex 24 chromosomes screening in programs of assisted reproductive technologies. Methods. Research of non-disjunction chromosomes in preimplantation embryos based on the results of trophectoderm nucleus diagnostics using FISH and NGS-based CCS. During the preimplantation genetic diagnosis (PGD) on the nucleus by FISH were used probes for chromosomes 13, 16, 18, 21, 22, X, Y. Results. Among the demonstrated cases of embryo diagnosis there was only one embryo that showed a coincidence in the results obtained by different investigation methods. In the other sample, where was diagnosed non-mosaic 18 and 22 monosomy by FISH, the NGS-based CCS showed only monosomy 18. The other embryo had ploidy mosaicism indicated by FISH, but according to NGS results it was evaluated as euploid. Conclusions. Embryos obtained in ART programs must be screened for chromosomal aneuploidy in the preimplantation period to increase the effectiveness in the programs of assisted reproductive technologies, using combination of FISH and NGS methods. Keywords: preimplantation genetic diagnosis, assisted reproductive technologies, aneuploid embryos, NGS, FISH.


Author(s):  
Николай Кичигин ◽  
Nikolay Kichigin

The article compares the legal regulation and the law enforcement practice relating to the conduct of environmental assessment in the Russian Federation, procedures for environmental assessment, which is applicable abroad (USA, EU, China). Through the use of historical, comparative legal methods of research concludes that the national system of environmental assessment in the Russian Federation, including the assessment of impact of perspective economic and other activities on environment and ecological examination, is not an effective one and does not meet international standards of environmental assessment. The article analyzes the reasons for the ineffectiveness of environmental assessment in the Russian Federation, identifies the main differences of the Russian model of environmental assessment from their foreign counterparts. The main differences between Russian and foreign models are as follows: stages of the environmental assessment process (no stages of screening and scoping), conduct environmental assessment at the earliest stage of economic activity and at the stage of preparation of project documentation, the lack of methodology for the environmental assessment process, the lack of differentiation of environmental assessment on the individual direction of research, etc. These differences lead to the imperfection and ineffectiveness of environmental assessment in the Russian Federation and need to be addressed. The results can be used in legislative activities in the preparation of draft normative legal acts in the educational activity.


2014 ◽  
Vol 27 (6) ◽  
pp. 710 ◽  
Author(s):  
Kátia Valdrez ◽  
Elisabete Alves ◽  
Teresa Coelho ◽  
Susana Silva

<strong>Introduction:</strong> The Familial Amyloid Polyneuropathy, with the world’s largest focus in Portugal, is recognized by the National Board of Assisted Reproductive Technologies as a serious disease eligible for Preimplantation Genetic Diagnosis. This study aims to determine the prevalence of the use of Preimplantation Genetic Diagnosis in FAP carriers followed in Unidade Clínica de Paramiloidose, Centro Hospitalar do Porto, and to identify the associated factors.<br /><strong>Material and Methods:</strong> Between January and May 2013, a representative sample of Portuguese Familial Amyloid Polyneuropathy carriers, aged between 18 and 55 years, was systematically recruited. The analysis is based on 111 carriers with previous familial diagnosis, who reported having ever tried to get pregnant after 2001. Data on sociodemographic characteristics and use of Preimplantation Genetic Diagnosis were collected through a self-administered questionnaire. Proportions were compared using the chi-square test. Crude and adjusted odds ratios (OR) and the respective confidence intervals of 95% (95% CI) were estimated using multivariate<br />logistic regression.<br /><strong>Results:</strong> The prevalence of use of Preimplantation Genetic Diagnosis was 20.7% (95% CI: 13.6-29.5). After adjustment, a household income above 1000 €/month (OR = 11.87; 95% CI 2.87-49.15) was directly associated with the use of Preimplantation Genetic Diagnosis, while carriers with an individual diagnosis (OR = 0.15; 95% CI 0.04-0.57) and children born after 2001 (OR = 0.07; 95% CI 0.02-0.32) revealed a prevalence of use significantly lower than those with a individual diagnosis and children born before 2001.<br /><strong>Discussion:</strong> The low prevalence of use of Preimplantation Genetic Diagnosis, as well as the less frequent use of the technique by those with a lower household income, shows the importance of improving access to Preimplantation Genetic Diagnosis in the case of Familial Amyloid Polyneuropathy.<br /><strong>Conclusion:</strong> This work contributes to increase the sensitivity of health professionals around the use and accessibility to Preimplantation Genetic Diagnosis among Familial Amyloid Polyneuropathy carriers.<br /><strong>Keywords:</strong> Preimplantation Diagnosis; Amyloid Neuropathies, Familial; Genetic Testing; Assisted Reproductive Technologies.


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