Reasons for conducting preimplantation genetic diagnosis: choosing the optimal model of legal regulation

Mapping Intimacies ◽

10.21516/2413-1458-2020-19-2-177-185 ◽

2020 ◽

Author(s):

M.A. Borodina , N.A. Altinnik , S.S. Zenin et all

Keyword(s):

High Risk ◽

Preimplantation Genetic Diagnosis ◽

Risk Model ◽

Genetic Diagnosis ◽

Medical Model ◽

Legal Regulation ◽

Incomplete Penetrance ◽

Optimal Model ◽

Advantages And Disadvantages ◽

Special Cases

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.

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High-risk consumersʼ perceptions of preimplantation genetic diagnosis for hereditary cancers: A systematic review and meta-analysis

Genetics in Medicine ◽

10.1097/gim.0b013e31822ddc7e ◽

2011 ◽

pp. 1

Author(s):

Gwendolyn P. Quinn ◽

Tuya Pal ◽

Devin Murphy ◽

Susan T. Vadaparampil ◽

Ambuj Kumar

Keyword(s):

Systematic Review ◽

High Risk ◽

Preimplantation Genetic Diagnosis ◽

Meta Analysis ◽

Genetic Diagnosis ◽

Hereditary Cancers

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The current state and legal framework of preimplantation genetic diagnosis (PGD) in Japan

Journal of International Biotechnology Law ◽

10.1515/jibl.2004.1.3.105 ◽

2004 ◽

Vol 1 (3) ◽

Author(s):

Mariko Nishizawa

Keyword(s):

High Risk ◽

Preimplantation Genetic Diagnosis ◽

Reproductive Medicine ◽

Genetic Disorders ◽

Genetic Diagnosis ◽

Legal Framework ◽

Reproductive Technology ◽

Current State ◽

Reproductive Technique ◽

Policy Discussion

AbstractBecause of the rapid advances currently taking place in reproductive technology, Japan is being pressed to adjust its conventional approach to reproductive medicine. One example of the innovations in the technology is the reproductive technique known as preimplantation genetic diagnosis, or PGD (PGD is seen by some as a reproductive technique that can help couples who are at high risk of passing on serious genetic disorders to their offspring. However, it is a contested technology. Concerns are increasingly being raised about the lack of sufficient public debate and policy discussion concerning the test's ethical and social implications. The need for policy discussions and a comprehensive legal system to control all areas of reproductive medicine, including PGD, should be more widely addressed.

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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

10.21516/2413-1458-2020-19-3-255-263 ◽

2020 ◽

Author(s):

V.V. Komarova , N.A. Altinnik , G.N. Suvorov

Keyword(s):

Preimplantation Genetic Diagnosis ◽

Russian Federation ◽

Assisted Reproductive Technologies ◽

Medical Science ◽

Genetic Diagnosis ◽

Reproductive Technologies ◽

Legal Regulation ◽

Reproductive Freedom ◽

The Russian Federation ◽

The Individual

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.

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

10.21516/2413-1458-2020-19-2-170-176 ◽

2020 ◽

Author(s):

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

Keyword(s):

Great Britain ◽

Preimplantation Genetic Diagnosis ◽

Genetic Diseases ◽

Genetic Diagnosis ◽

Legal Regulation ◽

Regulatory Requirements ◽

Foreign Experience ◽

Legal Remedies ◽

Ethical Conflicts ◽

General Scientific

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

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