The article analyzes key instruments of international legal regulation of preimplantation genetic diagnostics (PGD) procedure. The authors substantiate the conclusion that the requirements and principles formulated in these instruments can be successfully used for the development and improvement of the national legal framework aimed at regulating the PGA. The main directions of such use are defined. First, it is necessary to consider the existence of genetic predisposition to a particular disease or chromosomal disorder (the medical purpose) and provide a qualified consultation of a genetic scientist concerning the mechanism and consequences of diagnostics. Secondly, the legal regulation of genetic information obtained through the PGA requires an independent normative framework: determining the framework the law-maker must be guided by the fact that any intervention in the human genome aimed at modifying it may be carried out only for preventive, diagnostic or therapeutic purposes. In this regard, it is important to prohibit the PGA for social purposes (selection of embryo according to specific characteristics, establishment of compatibility between a donor and a recipient, looking beyond the prohibition to choose the embryo gender that is currently imposed under Russian legislation). Third, a separate regulatory framework is needed to resolve the problem of informing the patient about the results of examination: in addition to the right to be informed of the results of examination, it is also necessary to recognize the individual’s «right not to know,» particularly relevant to predictive genetic research.

In the article the author highlights that new technologies can significantly change both the life of each person and the development of human civilization as a whole. In this regard, it is necessary to draw attention to the fact of increasing importance of genetic information contained in human DNA in various areas of life of a human being and, due to this fact, the need for legal science to effectively protect the rights of an individual in order to prevent harm caused by the misuse of his genetic information.

On the basis of the analysis of the problems arising in connection with the use of genetic information about a person, the author concludes that the legislation in this area needs to be improved also with a view to preventing discrimination against individuals on the basis of genome. By its legal nature, genetic information is an element of personal, family privacy of an individual and is included in the broader concept of privacy of the individual. Therefore it must be protected by law as an intangible benefit (Art. 150 of the Civil Code of the Russian Federation). However, the existing legal regulation is not able to take into account the specifics of genetic information and to provide effective protection against misappropriation and misuse of this information including protection against actions aimed at establishing restrictions on the basis of hereditary diseases and other characteristics in employment, conclusion of contracts of insurance, credit agreements, etc.

The legal regulation of the area of human genomics covering both research in the area of human genome and activities carried out to implement their results in life, is today in the stage of development and is tightly linked to scientific progress in the area under consideration. In this regard, the analysis of judicial practice is an important indicator that allows the author to determine problematic practical issues of formation and development of legal regulation in the area under consideration. The best international jurisprudence and case law in the field of the human genome is sporadic and embodies the diversity of approaches to the legal regulation of these issues in different legal systems. If in the USA and Europe such judicial practice began to develop since the end of the twentieth century, in Russia the first case involving the genome was considered in the middle of the current decade, which generally corresponds to the catch-up dynamics of development of Russian law in the area in question. The paper is aimed at the study of the best jurisprudence in the world concerning genomic studies and implementation of their results, including the legal positions of the ECHR and the US courts, as well as the emerging practice of Russian courts. The paper covers judicial practice both in the field of genetic engineering and in the field of genomic information circulation. The paper analyzes specific cases in the area of human genomics dealt with in the course of judicial proceedings on both sides of the Atlantic. It also covers the issues of reflecting the genomic research in the practice of Russian courts, e.g. in Prosecutor Kemerovo v. IK-22. In addition, an attempt is made, on the basis of performed analysis, to identify differences in approaches to legal regulation in different legal systems.

Genetic technologies are rapidly developing, which is not the case for the normative consolidation of scientific achievements and opportunities. The science aimed at improving the quality of life of people is already able to prevent many hereditary disorders by removing the «wrong» gene from the embryo DNA. Editing the human genome is not the future, but the present.

It is assumed that legalization in the area of the human genome editing for preventive or therapeutic purposes is more than possible. The article analyzes the issues of the right to go to court on the ground of legal relations that arise when the human embryo genome is edited during the procedure of in-vitro fertilization (IVF) and subsequently a «genetically modified» child is born.

Due to the lack of detailed legal regulation of the IVF procedure, scientific research on human embryos and genome editing technology, the author does not exclude situations when successful research can be carried out as well as errors can be committed. In the latter case, it is possible to work upon «healthy» DNA elements instead of or together with «sick» elements, which endangers the life and health of not only the potential person, but also his discendants.

Given that the current legislation does not determine the status of a human embryo and establishes the moment of birth as the moment of capacity, while the civil procedural capacity (that is one of the prerequisites for the right to go to a court) of an individual coincides with civil legal capacity, the future human life is deprived of any legal protection. For the same reason, other persons may not go to court in the interests of the unborn child. The article attempts to find a way out of this situation by analyzing Russian and international legislation, as well as the ECHR case law.

The article analyzes different points of view concerning reproductive human rights. Every year the number of cases when assisted reproductive technologies are used is increasing in Russia. The author draws attention to the lack of a common understanding of reproductive human rights, their protection and regulation in different countries of the world, to different perceptions of legal responsibility for abuses in the field of artificial reproduction of human beings, and to the existence of different definitions of crime in the field of human reproduction.

The article presents an overview of foreign legislation on criminal law protection of human reproductive functions. The study of criminal and civil cases and examination of scientific developments in this area compels the author to admit the existence of abuses and crimes in the field of artificial reproduction of human beings. The article attempts to determine the list of crimes against reproductive human rights and considers them as an object of forensic research.

Equal opportunities for women to participate in sports, including women originally considered male, are accompanied with a debate on the need for gender verification for fear of participation in women’s competitions of female athletes with genetic characteristics more typical of men, which, in some experts’ opinions, gives them unfounded starting advantages. Thus, it is necessary to consider legal, medical and ethical aspects of gender verification in high performance sports. The article analyzes the main alterations developed by the International Association of Athletics Federations (IAAF) Rules for selection of sportswomen with violations of gender formation for participation in competitions. Given the position of the Special Rapporteur of the UN Human Rights Council, the author considers the issue concerning the compliance of these changes with international principles and norms in the field of human rights protection with due regard to non — discrimination, respect for honor, dignity and integrity of the person. It is concluded that there is considerable uncertainty about admissibility of the use of testosterone level as a universal criterion for gender verification, as well as the availability of direct cause-effect relationship between the corresponding hormonal characteristics and the sports results achieved. The author draws attention to the ethical element of gender verification in sport related to the methods offered by IAAF to assess the sufficient level of femininity and the requirement of its adjustment to artificially determined indicators, even when the principle of confidentiality is declared.

The article is devoted to the examination of the problems of providing support for ecological safety of the Arctic zone of the Russian Federation when genomic technologies are being implemented. Relying on the results of the analysis of core documents of the state strategic planning, normative legal acts, programs and plans defining strategic determinations of socio-economic development of the Arctic zone, as well as normative legal acts regulating genomic technologies, the authors determine the main threats (risks) to ensuring ecological safety of the region, analyze potential economic and environmental possibilities for the application of certain genomic technologies with due regard to the vulnerable ecosystem of the Arctic.

Modern science has achieved very significant results in different areas. For ordinary people, it is gratifying that such achievements help to treat complex diseases, and the technologies themselves now reduce the cost of treatment unlike the most other factors affecting the medicine. One of these areas of scientific knowledge is genetic engineering that can change only separate parts of the human body or influence the transformation of the human body in general. This raises ethical issues that provoke a large number of disputes in the society. To overcome them, there is a need for a clear conceptual understanding of the problems associated with the diagnosis and editing of the human genome, on the basis of which an effective normative legal framework that will satisfy the interests of all participants of these legal relations should be developed.

The technology of 3D printing creates serious challenges to the legal system that in its development is lagging behind scientific and technological progress. The development of 3D printing technology leads to the «digitalization» of objects of the material world when the boundaries between the physical world and the digital space are blurred. If 3D printing digitalizes objects of the material world, bioprinting digitalizes the human body. An individual tends to depend on the digital incarnation of his body or its individual organs in the corresponding electronic 3D models.

Bioprinting is aimed at the formation of a new medical paradigm that will result in overcoming the deficiency of human organs and tissues in the field of transplantology. The discovery of the possibility of reprogramming differentiated cells and obtaining induced pluripotent stem cells eliminates the ethical and legal problem associated with the use of stem cells of the embryo. This should be taken into account in the development of a model of legal regulation of relations connected with the creation of bio-print human organs.

Bioprint organs are synthetic organs, so the relations associated with their creation and implantation need independent legal regulation. Contemporary transplantology legislation and bans and prohibitions contained in it do not take into account the features of the creation of organs through 3D bioprinting. It is acceptable to commercialize relations in the field of bioprinting, to perform non-gratuitous transactions in this area, as well as to permit limited turnover of «bioprinting» organs subjecting them to the regulation applied to any other objects of civil law. Legislation on biomedical cellular products is also not able to regulate relations related to the creation and implantation of bio-printed human organs. Thus, the need arises to adopt a special legislative act aimed at regulating relations at all stages of the use of bioprinting technology.

Additive manufacturing, 3D printing and bio-printing are technologies of the Fourth Industrial Revolution. Currently, due to the possibility of hacking the human genome, it is important to define the concept of legal regulation of relations concerning bioprinting and creation of a regulatory framework for their legal regulation, which would determine who should be held responsible for the defect takes place when printing a human organ (a creator of a digital template, a manufacturer of a 3D printer or a person who operates the 3D printer), what obligations arise with regard to the template, who owns the rights to it, what contracts mediate the relationship between the template creator, the printer manufacturer, the material manufacture, the person who manages the printer and the consumer. One more question is what are the limits of the principle of freedom of contract in the field of 3D printing, in particular in the field of bioprinting. When considering the issues of 3D printing of human organs, inevitably arises the question of rights, obligations and responsibility of a medical organization within which the medical organization would carry out medical intervention in order to implant and transplant printed organs. One more issue that needs consideration is the legal framework of printed organs. It is obvious that before they are implanted in the human body, they can be subject to the regulatory framework applicable to things. After implantation, the printed organ should lose the properties of things and it should be subject to the legal regulation that is applied to intangible things. To this end, the author suggests that it is necessary to introduce certain restrictions on the principle of freedom of contract in this area and the possibility of carrying out medical intervention only by certain entities (medical organizations) authorized to perform such operations.

At the present stage of the formation of the rule of law and developed civil society in the Russian Federation, the possibility of using and protecting genes, genomes and genomic technologies, mainly related to the sphere of private life, becomes particularly relevant. The world has already formed a scientific direction — gene editing. The practice of implementation of such developments is aimed at the implementation of genetic «improvement» of a person, his life and health. Society has existed for a long time in the era of genetic engineering. Currently, quite a large number of scientific studies are being conducted and many practical experiments are being implemented, both medical and socio-legal, aimed at involving genes and genetic structures in the framework of the legal field, in civil circulation.

A particularly large number of questions and practical problems arise in determining the possibility of including genes and genomes as objects of legal relations and their definition as objects of civil rights.

Debatable is the question of the turnover of genes, genomes, genetic structures and the possibility of making various civil transactions with them, the entry of subjects (participants) of genomic technologies in the binding and proprietary relationships with genes. The possibility of inclusion of genes and genomes in the objects of intellectual property rights and ensure their patent protection, the establishment of legal protective procedures is proved.

There is an objective need to qualify and determine the legal nature of genes and genomes as objects of civil rights and the establishment of a special civil regime of genes, genomes and genetic structures. This special civil law regime of genes has a civil law nature. The author’s definition of a special civil-law regime of genes as objects of civil rights is proposed, the features and content of this regime are determined. The possibility of regulatory and legal regulation of genomic studies and the implementation of their results in medical practice is proved.

In the last few decades, issues related to the legal regulation of genetic research and the legal regime of genetic information derived from it have become particularly relevant both at the international level and at the level of individual countries. However, Russia has only recently come to realize the need for legislative regulation of the relevant relations. At the same time, a distinctive feature of such regulation is the emphasis on public-legal aspects, and civil-legal aspects have been left without due attention.

The distinction between genetic information and genetic data is essential for the determination of the civil law regime of genetic information. Genetic information is personified genetic (genomic) information (information), because it has an individual, personal character as relating directly or indirectly to a particular or identifiable person. Genetic data is non-personalized (anonymized) genetic data, which are characterized by a formalized species, often contained in the information system and in this regard — systematized. Genetic information is an element of such an intangible good as the secret of private life, genetic data are, as a rule, an element of such a result of intellectual activity as a database. In addition, it is concluded that there is no doctrinal or legislative basis for the recognition of genetic information as an independent object of civil rights. The necessity of additional legislative regulation of activity of the biobanks carrying out storage of biomaterials, respectively, genetic data is proved. Genetic information contained in such biobanks should be subject to the legal regime of privacy.

The paper deals with the problem of finding a balance of interests in the light of the use of gene therapy. The rapid development of new medical technologies determines the need to solve bioethical problems related to ensuring respect for human dignity. Gene therapy refers to specialized, including high-tech, medical care and is a set of genetic engineering (biotechnological) and medical methods aimed at making changes in the genetic apparatus of human somatic cells for the treatment of diseases. At the same time, the main directions of modern gene therapy can be attributed not only to untraceable genome modifications, namely genome editing in situ (in vivo) and genome editing of somatic cells in vitro with subsequent transplantation, but also inherited genome modifications, i.e. editing of the embryo genome.

Editing of the embryo genome gives rise to a serious discussion, due to the legislative ban on interference in the human embryonic line. Despite this ban, the use of CRISPR/Cas9 has contributed to the creation of the world’s first people with artificially altered genes, resulting in the scientific community called for a moratorium on the editing of the human genome in clinical practice. The current situation is due to the need to find a fair balance of private and public interests in the field of gene therapy. According to the author, in the context of the embryo genome editing public interest is manifested in the development of scientific research. This allows the state not only to create the conditions for ensuring the protection of the population health, improve the level of their life, but also to establish control over the person, to obtain certain advantages in international relations with other sovereign states. In view of this, ensuring a fair balance between private and public interests in the application of gene therapy should be based on the principle of priority protection of the rights and interests of the individual.

The paper is an attempt of scientific understanding of the legal nature of the embryo in vitro, undertaken on the basis of the regulations governing their legal regime, as well as the practice of their application and doctrinal research. Embryos in vitro, being human embryos conceived and developing outside the mother’s body, because of their autonomous existence have raised questions about their legal nature. Without such determination, it is impossible to decide the fate of embryos in the event of the divorce of the persons who expressed the will to create them, in the event of the death of one or both of them (the so-called «orphan» embryos), in the event of the refusal of one or both of them to continue the reproductive assistance program. The paper examines the main points of view on the nature of the embryo in vitro, established in the doctrine, namely whether it is a subject of law, the object of law or is a special legal phenomenon, sui generis. The author comes to the conclusion that the embryo can not be attributed to the category of things, as well as to a broader category of property due to the lack of value equivalent and the inadmissibility of attempts to determine it, as otherwise contrary to the principles of morality. The embryo does not have legal capacity under the provisions of the current civil law, and granting it such a capacity may entail certain problems and conflicts of interest outlined in the paper. The most optimal is the consideration of the embryo as a special legal phenomenon (sui generis) with the definition of its place in the system of elements of legal relationship or an independent object of civil rights with a special legal regime, as the basis of which the author proposes to lay the principle of respect for human life at any stage of its development and the principle of preservation of human life.

The paper deals with the problems of development of professional and ethical requirements in the field of information sharing about the progress and results of genetic research. The author substantiates the conclusion about the need to adopt such requirements at the level of self-regulatory organizations of geneticists These requirements should include the provisions on additional information, providing information about secondary and random test results in specific cases where the potential benefit for the patient is significant, but the additional load on the specialist is not too noticeable. The requirements should contain a list of specific genetic abnormalities and diseases related to random and secondary results of the study and reported regardless of the patient’s will, as well as the procedure and role of all involved parties (specialists and patients) in the process of disclosure of the results of the study.

Genomic research are currently of key importance in the development of medicine. In order to carry out such activities, it is necessary not only to generate new genetic objects, but also to accumulate samples in the form of various biomaterials. Such collections in recent years are the pride of large biobanks, which spend the maximum amount of effort to save samples for subsequent research or application in practice. However, the functioning of biobanks has another side of the coin: the accumulation of certain information entails an increased level of responsibility for the collected data. In modern Russian conditions, the issues of information leakage from such institutions taking place in foreign countries are still irrelevant. In many ways, the reason for this is only the beginning of the normative legal regulation of the relevant social relations, which are only beginning to appear on the territory of our state. Therefore, there is every reason to believe that such problems will arise and it is important to solve them. Some proposals for such activities are set out in this paper.

The paper discusses the author’s draft of Chapter 15 of the Criminal code of the Russian Federation with a brief comment prepared by Professor G.V. Nazarenko and published in the journal in the framework of the correspondence round table «New Criminal Code of Russia: Conceptual Framework and Theoretical Model». The new title of Chapter 15 proposed in the draft is being discussed, which, like its current title, does not indicate that the measures in question are psychiatric in content. The authors themselves distinguish two types of such measures: «mandatory» in the strict sense of the word, applied to subjects with severe mental disorders, excluding sanity or making impossible the appointment or execution of punishment, and «obligatory», applied to convicts with mental disorders within the limits of sanity. In this regard, it is proposed to name Chapter 15 «Mandatory and obligatory psychiatric measures». The paper discusses the rationale and purpose of the application of mandatory psychiatric measures. According to the authors, the criminal law should disclose the content of the «danger criterion» and define it as a real possibility (a high degree of probability) of committing new acts by this person, provided for in the articles of the Special part of the Criminal Code of the Russian Federation. Analyzing the proposed by G.V. Nazarenko definition of the purposes for the use of mandatory psychiatric measures, the authors believe that it is hardly appropriate to declare such a «change» of the mental state of a person with a mental disorder «which eliminates its social danger» as their purpose. Mandatory psychiatric measures should be aimed solely at improving the mental state of the patient, while the elimination of the danger may in some cases be the result not of an improvement, but of the deterioration of his / her condition or the influence of other unfavourable medical factors. It is concluded that, despite the divergence of scientific positions on a number of issues, the author’s draft of Chapter 15 of the Criminal Code of the Russian Federation, prepared by G.V. Nazarenko, is a significant contribution to the theoretical understanding of the current criminal law governing mandatory medical measures, and outlines generally right directions for its improvement.

Resolution on the results of the meeting of the expert platform "Genome and law: civil aspects" within the International Symposium "Law and modern technologies in medicine».