The article considers the main achievements in the field of genetic engineering and biomedicine in the context of formation of the concept of legal regulation of relations in question. The article considers the issues of applying the human DNA editing technology considered by the Nuffield Council on Bioethics in July 2018. The author substantiates the necessity of determining the legal status of the embryo for its use in clinical trials of gene modifications. The paper considers the risks regarding the use of genetic engineering in relation to the person associated with the possibility of social inequality in the society, application of eugenistic approaches, and the probability of selecting the quality characteristics of embryos by parents resorting to in vitro fertilization. The author concludes that it is necessary to form national and international legislation that will protect the rights and legitimate interests of all subjects and will exclude circumvention of the law and abuse of the right. In addition, it is important to ensure international and public control over the use of the latest advances in genetic engineering and biomedicine prior to conducting clinical trials on humans.
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