scholarly journals FEATURES OF LEGAL REGULATION OF GENOMIC RESEARCHES: FAILURES, SECURITY CONCERNS AND PROSPECTS

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):  
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.


2020 ◽  
pp. 3-8
Author(s):  
D. V. Piven ◽  
◽  
I. S. Kitsul ◽  
I. V. Ivanov ◽  

The article suggests legislative implementation of certain “medical” amendments to the Constitution of the Russian Federation. The authors propose to add two articles to the Federal law “on the basics of public health protection in the Russian Federation” dated 21.11.2011 N323-FZ. In one article, it is proposed to reveal and specify the content of the newly introduced in the Constitution of the Russian Federation concept “unified legal bases of the health care system”. Another proposed article reveals the forms and content of work on the coordination of health issues, again referred by the Constitution of the Russian Federation to the joint responsibility of the Russian Federation and the subjects of the Russian Federation. According to the authors, the proposed changes in legislation will allow to ensure in practice the proper implementation of “medical” amendments to the Constitution of the Russian Federation, which in turn will ensure the improvement of legal regulation of the organization and activities of health care, and strengthen its material and technical base.


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.


2021 ◽  
Vol 30 (1) ◽  
pp. 59-83
Author(s):  
Andrey Fursov

Currently, public hearings are one of the most widespread forms of deliberative municipal democracy in Russia. This high level of demand, combined with critique of legal regulations and the practices for bringing this system to reality – justified, in the meantime, by its development (for example, by the Agency for Strategic Initiatives and the Public Chambers of the Russian Federation) of proposals for the correction of corresponding elements of the legal code – make both the study of Russian experiences in this sphere and comparative studies of legal regulations and practical usage of public hearings in Russia and abroad extremely relevant. This article is an attempt to make a contribution to this field of scientific study. If the appearance of public hearings in Russia as an institution of Russian municipal law is connected with the passing of the Federal Law of 6 October 2003 No.131-FZ, “On the general organisational principles of local government in the Russian Federation,” then in the United States, this institution has existed since the beginning of the 20th century, with mass adoption beginning in the 1960s. In this time, the United States has accumulated significant practical experience in the use of public hearings and their legal formulation. Both countries are large federal states, with their own regional specifics and diversity, the presence of three levels of public authority and different principles of federalism, which cause differences in the legal regulation of municipal public hearings. For this reason, this article undertakes a comparative legal analysis of Russian and American experiences of legal regulation and practical use of public hearings, on the example of several major municipalities – the cities of Novosibirsk, Nizhny Novgorod, Voronezh and New York, Los Angeles, and Chicago. A comparison of laws influencing the public hearing processes in these cities is advisable, given the colossal growth in the role of city centers in the industrial and post-industrial eras. Cities in particular are the primary centers for economic growth, the spread of innovations, progressive public policy and the living environment for the majority of both Russian and American citizens. The cities under research are one of the largest municipalities in the two countries by population, and on such a scale, the problem of involving residents in solving local issues is especially acute. In this context, improving traditional institutions of public participation is a timely challenge for the legislator, and the experiences of these cities are worth describing. The unique Russian context for legal regulations of public hearings involves the combination of overarching federal law and specific municipal decrees that regulate the hearing process. There are usually two municipal acts regulating public hearings on general issues of the city district (charter, budget, etc.) and separately on urban planning. In the United States, the primary regulation of public hearings is assigned to the state and municipality level, with a whole series of corresponding laws and statutes; meanwhile, methodological recommendations play a specific role in the organisation of hearings, which are issued by the state department of a given state. It is proposed that regulating the corresponding relationships at the federal subject level will permit a combination of the best practices of legal administration with local nuances, thereby reinforcing the guarantee of the realization of civil rights to self-government. There are other features in the process of organizing and conducting public hearings in the United States, which, as shown in the article, can be perceived by Russian lawmakers as well in order to create an updated construct of public discussions at the local level.


2021 ◽  
Vol 23 (2) ◽  
pp. 16-23
Author(s):  
MIKHAIL DEGTYAREV ◽  

In connection with the adoption of the Federal Law of July 31, 2020 No. 258-FZ “On Experimental Legal Regimes in the Field of Digital Innovations in the Russian Federation” and of the Federal Law of July 31, 2020 No. 247-FZ “On Mandatory Requirements in the Russian Federation” (Article 13 “Experimental legal regime”) the topic of experimental legislation was updated. The article is devoted to the application of the experimental approach in legal regulation. The author reveals the essence of the concept of experimental legislation, explains the goals and objectives of using the appropriate technologies. The author notes that although in a broad sense it can be said that the adoption of any new law is in itself an experiment, there are still significant differences within the experimental law. The author sets out the essential features of a legislative experiment. The article examines the reasons for the need and prerequisites for the rationality of the use of experimental legislation. The author shows the nature of legislative experimentation and the merits of this toolkit. The author shows the areas of relevant application of the method of experimental legislation. The species diversity of methods of experimental regulatory regulation is indicated. The article compares the method of practical experimental legislation and the method of thought experiment in norm-writing and law- making activities. The article compares the method of practical experimental legislation and the method of digital duplicate-models of legislative acts. The author substantiates the existence of limits of applicability of the method of experimental legislation and demonstrates selected technologies of experimental legislation. In conclusion, the author turns to the complex and controversial problems of using the method of experimental legislation.


2021 ◽  
Vol 66 (6) ◽  
pp. 111-115
Author(s):  
O. Kochetkov ◽  
V. Klochkov ◽  
A. Samoylov ◽  
N. Shandala

Purpose: Harmonization of the Russian Federation legislation with current international recommendations Results: The concept of the radiation safety system has been significantly modified by recommendations of ICRP (2007) and IAEA (2014). An analysis of existing international regulatory framework for radiation safety allowed to identify the main provisions to be implemented in the Russian legal and regulatory framework. It’s showed that the current Federal Law of 09.01.1996 No. 3-FZ «On Radiation Safety of Population» must be ultimately revised to be harmonized with international documents. General approaches to legal regulation of radiation safety should be essentially modified to create a strong relationship between this law and other regulatory and legal documents in force in the Russian Federation. Conclusion: An article-by-article analysis of the current Federal Law of 09.01.1996 No. 3-FZ «On Radiation Safety of Population « showed the need to modify 22 existing articles and add 12 new articles in order to harmonize it with international documents. Given such a large volume of modification it is advisable to pass a new law with simultaneous abolition of the current federal law. A new name has been proposed: Federal Law of the Russian Federation «On Radiation Safety in the Russian Federation». The enactment of the Federal Law of the Russian Federation «On Radiation Safety in the Russian Federation» with the main by-laws approved by the Russian Federation Government – «Radiation Safety Standards» and «Basic Rules for Ensuring Radiation Safety» – will allow to establish an actual regulatory framework for ensuring radiation safety of personnel and population in Russia.


Author(s):  
O. V. Morozov ◽  
M. A. Vasiliev ◽  
A. G. Biryukov

The Central Bank, the emission center, the reserve system, the federal treasury all these and other names are used to show the element of economy of a concrete state functioning, which controls money, i.e. estimates and administrates the money mass, buying capacity of residents in respect of goods, jobs and services, exerts influence on inflation processes and so on. The article provides results of researching the standing of normative and legal regulation, practice of using authority and responsibility, specific features of the Bank of Russia functioning as a relatively independent body of state governance and on this basis the articles studies the trends of improving management, norms of work development, procedures of working out and submitting to the State Duma of the Federal Assembly of the Russian Federation reports on federal laws bills, whose regulation is included in the competence of the Central Bank. Proposals dealing with amendments to the Federal law ‘About the Central Bank (the Bank of Russia)’ were formulated.


Author(s):  
Irina Damm ◽  
Aleksey Tarbagaev ◽  
Evgenii Akunchenko

A prohibition for persons holding government (municipal) positions, for government (municipal) employees, and some other employees of the public sphere who are public officials to receive remuneration (gifts) is aimed at preventing bribery (Art. 290, 291, 291.2 of the Criminal Code of the Russian Federation), and could be viewed as a measure of anti-corruption criminological security. However, the existing collisions of civil, administrative and criminal law norms that regulate this prohibition lead to an ongoing discussion in research publications and complexities in practice. The goal of this research is to study the conditions and identify the problems of the legal regulation of receiving remuneration (gifts) in connection with the performance of official duties that prevent the implementation of anti-corruption criminological security. The authors use the legal theory of security measures to analyze the provisions of Clause 3, Part 1, Art. 575 of the Civil Code of the Russian Federation and Clause 6, Part 1, Art. 17 of the Federal Law «About the Public Civil Service in the Russian Federation», examine the doctrinal approaches to defining the priority of enforcing the above-mentioned norms, study the significant features of the category «ordinary gift» and conduct its evaluation from the standpoint of differentiating between gifts and bribes, also in connection with the criteria of the insignificance of the corruption deed. The empirical basis of the study is the decisions of courts of general jurisdiction. The authors also used their experience of working in Commissions on the observance of professional behavior and the resolution of conflicts of interests at different levels. The conducted research allowed the authors to come to the following fundamental conclusions: 1) the special security rule under Clause 6, Part 1, Art. 17 of the Federal Law «About the Public Civil Service in the Russian Federation», which sets a full prohibition for government employees to receive remuneration (gifts) in connection with the performance of official duties, contradicts Clause 3, Part 1, Art. 575 of the Civil Code of the Russian Federation (the existing legal-linguistic vagueness of categories in Art. 575 of the CC of the RF leads to problems in law enforcement and makes a negative impact on the anti-corruption mentality of people); 2) as the concepts «gift» and «bribe» do not logically intersect, the development of additional normative legal criteria for their delineation seems to be unpromising and will lead to a new wave of scholastic and practical disagreements; 3) the introduction of a uniform and blanket ban on receiving remuneration (gifts) in the public sphere by eliminating Clause 3, Part 1, Art. 575 of the CC of the RF seems to be an effective measure of preventing bribery, and its application is justified until Russian society develops sustainable anti-corruption mentality.


2018 ◽  
Vol 99 (3) ◽  
pp. 527-530
Author(s):  
G M Khamitova ◽  
D V Khamitova

Aim. To propose the development of a new form of informed voluntary consent, taking into account the legal regulation of medical secrecy. Methods. When performing the study, analytical method was used. The analysis of the mechanism of obtaining information about the patient was performed, including the study of a number of laws governing the transfer of information to the third parties without the patient's consent. Results. It was found that the patient's relatives can not be provided with information about the course of the disease and its treatment, unless the patient has previously signed a voluntary consent to transfer the information. The basis for such refusal is Article 13 of Federal Law No. 323-FZ issued on November 21, 2011 (as amended on July 29, 2017) «On the Fundamentals of Health protection of Citizens in the Russian Federation», which establishes the conditions under which information about patient's health can be transferred. This article examines the problem of violation in the field of disclosure of medical secrets, as well as the rights of patient's close relatives to obtain information about his or her state of health. The need to refine the mechanisms of obtaining information, which is a medical secret, is revealed and justified. Conclusion. Based on the review of laws regulating the procedure of information transfer, the authors propose the development of a new form of consent for disclosure of the patient's information about his state of health, which must necessarily be provided to the patient when contacting a medical organization, which in the future will significantly simplify the legal doctor-patient relationships.


2020 ◽  
Vol 66 (5) ◽  
pp. 10-10
Author(s):  
L.I. Dezhurny ◽  
◽  
A.Yu. Zakurdaeva ◽  

The article examines organizational and legal problems related to state registration, production, procurement and use of medical devices for first aid. The study significance is accounted for by the need to find solutions to problems related to equipping first aid activities with medical devices, which is becoming extremely important for the modern Russian society. Moreover, a comprehensive study of these issues has not been undertaken so far. The purpose of the study is to develop a set of proposals of an organizational and legal nature to improve quality of medical devices for first aid and equipping all potential participants of first aid delivery with such devices. To eliminate the problem of low equipment of potential participants of first aid delivery with the means of delivery, the composition of first-aid kits, packs, sets, and packages for all categories of participants have to be approval by the Ministry of Health of the Russian Federation. The authors also propose organizational and legal measures to improve interdepartmental and intradepartmental cooperation in this direction with the Russian Ministry of Health playing the coordinating role. The authors have also identified the need for improving the procedure for state registration of the production of first aid devices either though amending the Federal Law "On the Basics of Public Health Protection in the Russian Federation" regarding the provision that first-aid kits, packs, sets, and packages equipped with medical devices registered in the prescribed manner are not subject to state registration. As an alternative, the authors propose amendments and additions to the Rules of the state registration of medical devices, providing for a simplified state registration of first-aid kits, packs, sets, and packages. In addition, the authors name arguments in favor of improving the clinical trial procedure for first aid medical devices and propose changes to Article 38 of the Federal Law “On the Basics of Public Health Protection in the Russian Federation” in terms of eliminating the problems of legal techniques in the definition of the term “medical device” regarding first aid. Keywords: First aid; first aid kits; first aid equipment; medical devices.


Sign in / Sign up

Export Citation Format

Share Document