UK Biobank and the Legal Regulation of Genetic Research

2022 ◽  
pp. 307-331
Author(s):  
Jean V. McHale
Legal Concept ◽  
2021 ◽  
pp. 195-204
Author(s):  
Alexey Anisimov ◽  
◽  
Olga Popova ◽  

Introduction: the paper examines the problems associated with the definition of the legal regime of the technologies and products obtained using GMOs. The experts in the field of genetics have not yet come to an unambiguous conclusion about the degree of harm or benefit of products obtained using genetic modifications. Russia has strict restrictive measures for the production of genetically modified products. Consequently, there is virtually no market for genetically modified seeds produced in Russia. Nevertheless, the world is actively developing industries for the production of genetically modified agricultural products, and the market for the production of seeds is “captured” by a small number of foreign companies. On the other hand, climate change dictates the inevitability of using genetically modified products, the need to accelerate genetic research, and the production of GMO seeds and food. In this context, the authors set a goal to find a compromise (balanced) legal regulation of the legal regime of the technologies and products obtained using GMOs. Methods: the methodological framework for the research is a set of methods of scientific cognition, among which the formal-legal method and the method of comparative legal analysis are the leading positions. Results: the authors propose to consider the bans or support for GMO products in the context of trends in global climate change and ensuring food security. The authors have made a comparative analysis of the provisions of the international norms and the Russian legislation on the research and application of GMO technologies and products, which helped to identify an unbalanced legal regulation of the use of the GMO technologies in Russia, which reduces its competitiveness in this area on the world market. Conclusions: the Russian legislation needs to minimize this legal imbalance, which puts researchers in the field of plant genetics and producers of GMO seeds and food in unequal (worse) conditions. The legal regulation should ensure the coexistence of organic (environmentally friendly) agriculture, traditional agriculture, and the use of the GMO technologies; the introduction of special labeling of GMO products; the broadening of the powers of regional authorities in the use of GMO technologies; as well as the application of the principle of “traceability” to GMO products.


Author(s):  
V. I. Przhilenskiy

The article examines the experience of legal regulation of biobanks in the Nordic countries in the context of the interaction of law and bioethics. The article analyzes the moral possibilities and legal boundaries of access to personal data by the state, society and the research community, provided that the inviolability of private life is strictly observed. On the basis of legislation of individual Nordic countries, as well as the regulatory framework of the European Union, the successes and difficulties in achieving the stated goal are discussed. The issues of opening, functioning and closing of biobanks, as well as the institutional, value and socio-cultural contexts of relevant practices are considered separately.


2021 ◽  
Vol 25 (4) ◽  
pp. 901-916
Author(s):  
Natalya G. Zhavoronkova ◽  
Vyacheslav B. Agafonov

The relevance of this study is determined by the fact that at present legal regulation of genetic research is not comprehensive and does not provide a complete regulation of social relations in the focus. Оne of the factors hindering the development of genetic technologies is the absence of a basic law On genetic technologies. The purpose of the study . The article is devoted to the analysis of modern legal problems and the search for optimal solutions to the organizational and legal problems of the program for the development of genetic technologies implementation. Materials and methods of research . In order to understand modern approaches to relevant problems of improving the organizational and legal mechanism of the program for the development of genetic technologies implementation associated with environmental and biological risks and threats, a comparison of various methods of legal regulation and management, including dialectical, logical, and predictive methods, as well as the method of system analysis, is carried out. Results. Application of these methods allowed to conduct a comprehensive legal analysis of the current legislation and state strategic planning documents, work out a theoretical and legal basis for the development of the basic law On Genetic Technologies and formulate other proposals to improve the current legislation. The core powers of the National (federal) Bioresource Center, the network of federal and regional centers of genetic technologies, as well as the National Center for Biosafety have been identified and grounded by the authors.


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

Objectives. The purpose of this study was to study the legal regime of pre-implantation genetic diagnosis (PGD) procedures in Israel in the context of the formation of the concept of legal regulation of this diagnosis in the Russian Federation. Materials. The legal acts and doctrinal sources of Israel on the problems of PGD and genetic research are examined. Methods used: general philosophical, general scientific, private scientific, special (structural-legal, comparative-legal, formal-legal). Results. The features of the legal regulation of the PGD procedure in Israel are determined, the ways of partial borrowing of such in Russia are proposed. Conclusions. It has been established that the general concept of legal regulation of PGD in Israel can be proposed for borrowing due to the following components: 1) an integrated approach to legal regulation of PGD in which the recommendations for diagnostics are formulated based on the results of the implementation of state programs to support genetic studies and the fight against congenital diseases; 2) a combination of legislative regulation of basic guarantees in the field of PGD with subjective by-law regulation of indications and conditions for each stage of diagnosis; 3) a combination of legislative and by-laws regulation with regulation at the level of professional guidelines; 4) the flexibility of normative legal regulation, which allows authorizing the implementation of PGD in certain non-standard cases; 5) the existence of special requirements for the content of genetic counseling in PGD, which serves as an important guarantee of protecting the rights of consumers of medical services.


2020 ◽  
Vol 14 (4) ◽  
pp. 479-485
Author(s):  
O.A. Belov ◽  
◽  
Yu.N. Spiridonova ◽  
A.I. Odintsov ◽  
◽  
...  

The article analyzes modern scientific achievements in the field of genetic research, considers methods of genetic engineering as an integral part of modern biomedicine, and the issues of human cloning. We examine the differences between reproductive cloning and therapeutic cloning, emphasizing the importance of the latter for improving human life, fighting various diseases, and so on. However, along with ethical problems, there are also problems in the world of legal regulation of genetic research and manipulation of human genes. We touch upon the problems of legal regulation of genome research and human cloning in foreign countries and in the Russian Federation, and, above all, the problems of criminal law regulation of genetic engineering. Based on a comparative analysis of international legal acts, national legislation of a number of countries and regulatory legal acts of the Russian Federation, we conclude that there is insufficient legal regulation of issues related to genetic research in Russia, and, supporting the opinion of a number of scientists, we propose to introduce a number of norms in the Criminal Code of the Russian Federation on criminal liability for socially dangerous behavior in the field of modern methods of biotechnology, genetic engineering, and human cloning.


2020 ◽  
Vol 16 (2) ◽  
pp. 123-133
Author(s):  
Рита Хусаинова ◽  
Евгения Ахтямова ◽  
Илдар Минниахметов ◽  
Регина Султанова

Currently, the methods of molecular diagnostic technologies are being developed, improved and implemented in clinical practice, ensuring the progress of medicine. The strategy of the new direction - personalized medicine is diseases prevention and treatment based on the results of molecular genetic researches at the earliest stages of disease, however, the use of genetic testing raises a number of ethical, legal and social issues that require legislative regulation. Information obtained as a result of a genetic test allows us to predict future health status and assess the risks of pathological conditions, but can also be used by third parties to discriminate and infringe on human rights, as well as contain unexpected findings, affecting the family and descendants of the examined person. Aim: analysis and synthesis of theoretical knowledge and practical experience of legal regulation of the issues of preimplantation and prenatal genetic diagnostics; the use of genomic technologies for DNA typing of hereditary diseases and current trends in the improvement of regulatory legal acts in this field of research. Methods: empirical methods of comparison, description, interpretation; theoretical methods of formal and dialectical logic. Private scientific methods are used: legal-dogmatic and the method of interpretation of legal norms. Results: the experience of legal regulation of the genetic research regime both in the countries of the world and in national legislation is studied. It is concluded that the national regulatory framework needs to improve the legal regime of DNA testing. Some ways to resolve regulatory issues of DNA testing are identified.


2019 ◽  
Vol 64 (5) ◽  
pp. 73-75
Author(s):  
А. Самойлов ◽  
A. Samoylov ◽  
Е. Голобородько ◽  
E. Goloborodko ◽  
Т. Астрелина ◽  
...  

Introduction Legal aspects of the application of medical technologies related to the use of ionizing radiation sources. Constitutional aspects of genetic research. Problems of legal regulation of genetic risks. Conclusion


Lex Russica ◽  
2020 ◽  
pp. 69-75
Author(s):  
T. G. Suranova ◽  
S. S. Zenin ◽  
G. N. Suvorov

The paper deals with the features of the legal regulation of genetic research in the Commonwealth of Australia with due regard to the state structure, national, ethical and other factors. The primary source of law in Australia is the common law articulated in judicial precedents (case law) that has recently been supplemented by acts of statutory regulation. The paper thoroughly investigates the processes of storage, access and protection of full-genome sequencing data. The authors analyze the peculiarities of functioning of the judicial system of Australia; the experience of normative consolidation of informed consent for genetic research, confidentiality of obtained information, strategic priorities in integration of the results of genetic research into Australia’s health system. The paper provides the analysis of the list of documents containing indications of cases in which medical organizations should not collect confidential information about a person. As a result of the study, the authors identify certain gaps in the normative legal regulation of genetic research and inconsistencies and contradictions of certain normative legal acts. The paper focuses on specifics of genetic research with the participation of the Aboriginal population of Australia, which, in turn, will help in the formation of the relevant legal framework in the Russian Federation.As a conclusion, the authors note that in the field of legal regulation of the processes of storage, access and protection of genetic information in Australia there is a tendency to use normative regulators. Particular attention is drawn to the normative consolidation of the priority of public interests over private interests and its reflection not only in numerous reservations and exceptions, but also in the framework of generally relevant strategic priorities. Presuming the development of the similar legal framework in the Russian Federation and taking into account the multiethnicity of the population, it should be highlighted that Australia’s experience in implementing the genetic research involving the Aboriginal population should be implemented.


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