Ethical conflicts around the procedure preimplantation genetic diagnosis and their overcoming by legal remedies based on foreign experience

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

Objectives. The purpose of this study is to study the essence of ethical conflicts arising over the use of preimplantation genetic diagnosis (PGD) and to identify ways to overcome them by legal means, taking into account existing foreign experience. Materials. The legal acts and doctrinal sources of Australia, Great Britain, Canada, China, New Zealand, USA are investigated. The methods used are: general philosophical, general scientific, private scientific, special (structural-legal, comparative-legal, formal-legal). Results. Ways to resolve ethical conflicts around the PGD procedure that are relevant for use in Russian conditions are proposed. Conclusions. It was established that the resolution of ethical conflicts around the procedure should be based on state legal regulation of requirements related to informing patients about the content of the services provided and the consequences of the procedure, methods and procedures for the independent interpretation of the results. In addition to the official fixing of the list of genetic diseases, for the presence of markers which are allowed to conduct research, the legislation on the protection of the health of citizens must establish a procedure for authorizing PGD in exceptional cases, as well as factors and circumstances that must be taken into account and evaluated when an appropriate decision is made (including the features of a family history, an assessment of the degree of impaired function of the organism, the state of individual organs and their systems during development of the corresponding disease, etc.). Regulatory requirements can be supplemented and developed in the content of professional manuals

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

Objectives. The purpose of this study is to study the essence of ethical problems that arise in the field of genetic screening for prenatal diagnosis (PND) and determine possible ways to overcome them by legal means, taking into account the existing foreign experience. Materials and methods. Normative legal acts and doctrinal sources of Great Britain, Germany, Ireland, France and Switzerland are studied. Methods used: General philosophical, General scientific, private scientific, special (structural-legal, comparative-legal, formal-legal). Results. Ways to resolve ethical problems that arise or may arise in the future as a result of genetic screening for PND, which can be applied within the Russian legal system, are proposed. Conclusions. It is stated that most of the identified ethical problems are related to the lack of normative consolidation of the legal status of the fetus. It is presumed that the beginning of ethics should serve as the guide for legislation in this area. At the same time, it is emphasized that the legal regulation of genetic screening in PND should be flexible enough to optimally ensure the interests of all participants in these relationships. In addition, in this direction, it seems appropriate to refer to the experience of a number of foreign countries, whose legislation provides for fairly strict requirements in the field of PND.


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):  
Oleksandr M. Bukhanevych ◽  
Serhii O. Kuznichenko ◽  
Anastasiia M. Mernyk

The study investigates the foreign experience of constitutional and legal regulation of restrictions on human rights in conditions of emergency and martial law in Macedonia, Armenia, Belarus, Moldova, Georgia, Latvia, Lithuania, Albania, Azerbaijan, which is relevantin modern conditions, based on the presence of local military conflicts, emergencies, or the possibility of their existence in many countries of the world. The purpose of this study was to analyse the text and content of the constitutions of foreign countries to clarify and explain the groundsfor restricting human and civil rights and freedoms in conditions of emergency and martial law. To achieve this purpose, the study employed a system of methods of scientific cognition, namely general scientific (analysis, synthesis), particular (comparative, quantitative and qualitative analysis, approximation), as well as special legal (formal legal, comparative legal) methods. The practical value of the study lies in the identification of four prevailing trends in the constitutions of foreign states to the procedure for determining the scope of restrictions on human rights under special regimes: 1) consolidation of an exhaustive list of rights and freedoms in the constitutions, which cannot be restricted during the period of emergency and martial law; 2) consolidation of an exhaustive list of rights and freedoms in the constitution, which can be restricted to protect human rights, the democratic structure of the state, public safety, the well-being of the population and morals; 3) combining the first two options for consolidating restrictions in the text of the constitutions; 4) consolidation of the possibility of limiting the rights and freedoms of the individual in the texts of constitutions by state authorities under special legal regimes in the interests of national security without specifying partiular rights and freedoms that may (or may not) be restricted


2008 ◽  
Vol 17 (3) ◽  
pp. 293-299 ◽  
Author(s):  
RICHARD V. GRAZI ◽  
JOEL B. WOLOWELSKY ◽  
DAVID J. KRIEGER

We report here on recent developments in Israel on the issue of sex selection for nonmedical reasons by preimplantation genetic diagnosis (PGD). Sex selection for medical reasons (such as in cases of sex-linked genetic diseases) is generally viewed as uncontroversial and legal in European and American law. Its use for nonmedical reasons (like “balancing” the gender ratio in a family) is generally illegal in European countries. In the United States, it is not illegal, although in the opinion of the Ethics Committee of the American Society for Reproductive Medicine (ASRM), it is problematic. This position is undergoing reconsideration, albeit in a limited way.


1999 ◽  
Vol 5 (6) ◽  
pp. 1134-1139
Author(s):  
M. A. El Hazmi

Prenatal diagnosis of molecular mutations can be of immense value, since diagnosis followed by genetic counselling provides the most appropriate approach to genetic diseases control and prevention. However, ethical, psychosocial and religious considerations hamper adoption of prenatal diagnosis in communities where termination of a pregnancy may not be acceptable. Recently, preimplantation genetic diagnosis has attracted considerable interest. This involves in vitro fertilization, followed by genetic disorder diagnosis using polar bodies or cells extracted from a blastomere stage. The normal blastomere is implanted in the womb and pregnancy proceeds naturally. If an abnormality is diagnosed, the blastomere is not implanted, thus preventing pregnancy with the affected fetus. This paper outlines the potential usefulness of preimplantation genetic diagnosis in the control and prevention of genetic disease in our part of the world


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

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.


2021 ◽  
Vol 74 (10) ◽  
pp. 2651-2658
Author(s):  
Oleksandr Ya. Rogach ◽  
Anatoliy M. Potapchuk ◽  
Tereziia P. Popovych ◽  
Oksana V. Maslyuk

The aim: To highlight and analyze the international aspect of the legal regulation of human organs and tissues transplantation, as well as foreign experience of regulation in this area within the relevant national legal systems (for example, US, Germany, Israel, Switzerland, Spain, Argentina, China and India). Materials and methods: Methodologically, this work is based on the system of methods, scientific approaches, techniques and principles with the help of which the realization of the research aim is carried out. There have been applied universal, general scientific and special legal methods. Conclusions: Thus, the efforts of the international community and the countries under study in the field of transplantation are focused on a wide range of important issues that need to be regulated. The international legal regulation of transplantation covers the results of the activities of such international organizations as the World Health Organization, the Council of Europe, and the World Medical Assembly. The acts adopted by them are mainly of a recommendatory nature (with the exception of some Council of Europe acts on trafficking in human organs) and are addressed primarily to States, offering guidelines and standards for the legal regulation of transplantation within national legal orders. Therefore, the issues of donation and transplantation of human organs and tissues in the respective states are determined by special legislative acts, which comprehensively regulate the procedure for their transplantation.


Author(s):  
M.A. Borodina , N.A. Altinnik , S.S. Zenin et all

Objectives. The aim of this study is to find the most optimal model for providing access to preimplantation genetic diagnosis (PGD) based on generalization and study for existing foreign experience using countries that widely practice this type of diagnosis and have significant clinical experience and have passed the time-tested regulatory framework. Material. The legal acts and doctrinal sources of Austria, Belgium, Great Britain, Germany, Israel, Canada, France, Switzerland, and Japan are studied. Methods used: general philosophical, general scientific, private scientific, special (structural-legal, comparative-legal, formal-legal). Results. The advantages and disadvantages of each of the models of legal regulation of PGD (the medical model, the high-risk model and the model of non-interference) are evaluated, the conclusion is substantiated that it is advisable to build on the combination of these to determine the legal grounds for conducting PGD in the Russian Federation. Conclusions. It has been established that it is advisable to introduce elements of the medical model through the legal definition of lists of monogenic diseases and chromosomal abnormalities that are the basis for PGD, which will eliminate legal uncertainties in understanding and regulating this procedure and provide access to this type of diagnosis within the framework of IVF programs financed from funds Compulsory medical insurance. The implementation of elements of a high-risk model is proposed in conjunction with mechanisms for authorizing PGD for special cases, including the assessment of additional risks in the presence of a major serious genetic disease or indications for determining the risks of aneuploidy. It has been argued that a variable assessment of the conditions for conducting PGD should be provided normatively and include the possibility of proactively authorizing this type of diagnosis at the expense of patients for gene mutations with a relatively low risk of transmission, diseases with incomplete penetrance, and treatable genetic diseases (including, for example, cancer breast and ovarian cancer, some cardiogenetic disorders), etc.


2015 ◽  
Vol 13 (1) ◽  
pp. 110-113 ◽  
Author(s):  
Maria Cristina Santoro Biazotti ◽  
Walter Pinto Junior ◽  
Maria Cecília Romano Maciel de Albuquerque ◽  
Litsuko Shimabukuro Fujihara ◽  
Cláudia Haru Suganuma ◽  
...  

Cystic fibrosis is an autosomal recessive disorder caused by mutations in the cystic fibrosis transmembrane conductance regulator gene. This disorder produces a variable phenotype including lung disease, pancreatic insufficiency, and meconium ileus plus bilateral agenesis of the vas deferens causing obstructive azoospermia and male infertility. Preimplantation genetic diagnosis is an alternative that allows identification of embryos affected by this or other genetic diseases. We report a case of couple with cystic fibrosis; the woman had the I148 T mutation and the man had the Delta F508 gene mutation. The couple underwent in vitro fertilization, associated with preimplantation genetic diagnosis, and with subsequent selection of healthy embryos for uterine transfer. The result was an uneventful pregnancy and delivery of a healthy male baby.


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