Potential threats to the use of genetic technologies and legal ways to resolve them

Karimov Vyacheslav Khamitovich PhD in Law Docent, the department of Criminal Law and Criminology, Altai State University 656049, Russia, Altaiskii Krai krai, g. Barnaul, ul. Lenina, 61 karimovvh@mail.ru Other publications by this author

Kazantsev Dmitrii Aleksandrovich PhD in Law Associate Professor, Department of Criminal Law and Criminology, Altai State University 656049, Russia, Altaiskii Krai krai, g. Barnaul, ul. Sotsialisticheskii, 68, of. 310 kazancevbui@mail.ru

The relevance of research.

Currently, genetics has opened up limitless opportunities in various sectors of social development. In the food sector, genetic technologies have made it possible to significantly increase the number of products produced. Genetic research is of absolute importance in the field of medicine, allowing solving problems in the field of hereditary predisposition to various diseases, reproductive health, increasing the body's resistance to external adverse effects, including the appearance of dangerous pathogens. Genetic technologies are also gaining importance in law enforcement. Thus, thanks to the DNA databases created and the forensic genetic studies conducted, more than 30 thousand crimes were solved in Russia, about 70 thousand persons involved in their commission were identified ^[5]. Other promising areas are also developing. Meanwhile, despite the enormous benefits to social progress, rapidly developing scientific trends in the field of genetics can give rise to a number of possible threats that pose a danger to life, health, human security, society, the state and the environment, Science paradoxically begins to play both the role of savior and existential threat ^[20].

The purpose of the study.

To analyze the use of genetic technologies in order to identify potential threats to humans, society, and the environment. To identify possible directions to eliminate legal gaps regulating the use of genetic technologies.

Materials and methods.

The research methodology includes the following methods. First of all, it is a formal legal method consisting in the study of legislation on genomic technologies regulating the protection of human and civil rights and freedoms, ensuring the safety of society and the state, environmental protection when using them. The comparative legal method is also important, the essence of which, within the framework of our research, is to study and compare the legislation of Russia and foreign countries devoted to this problem. The historical and legal method can be applied in determining the origins of problems and determining the further development of genomic technologies, in order to timely identify possible risks. In the course of work on the article, the authors conducted an investigation of legal information on the use of genetic technologies, summarized the scientific literature on the subject of research.

Results.

It is necessary to understand what possible dangers threaten a person, society, the environment from the unsettled public relations in the field of the use of genetic technologies, which may arise as a result of thoughtless, and possibly intentional criminal behavior of persons using them, to suggest legal ways to resolve them.

First of all, it is necessary to come to an understanding of what is actually meant by genetic technologies. In this case, we join the concept put forward by X. Novoton and D. Test, that the development of genetics is carried out by society with the help of technologies of legal regulation, guidance and bioethics ^[16].  

The issues of legal regulation of genetic technologies are given great attention in the norms of international law. Of particular importance is the Convention on the Protection of Human Rights and Dignity in connection with the Application of the Achievements of Biology and Medicine (Oviedo Convention), which calls for preventing the achievement of medicine against the person himself, prohibiting any form of discrimination against a person on the basis of his genetic heritage. The Convention specifies that genetic testing can only be carried out for medical purposes, for prevention, diagnosis or therapy. It gives special meaning to the principle of priority of the interests and benefits of an individual over the interests of society or science.

Domestic legislation does not contain a legal definition of genetic technologies, but in a semantic context, they are partially disclosed in the Decree of the President of the Russian Federation No. 680 dated 28.11.2018 "On the development of genetic technologies in the Russian Federation". These are understood as technologies of genetic editing, ensuring the development of biological drugs, diagnostic systems. In addition, the concept of genetic technologies is contained in scientific and technical documents, in particular, in the Scientific and Technical Program "Development of innovative genogeographic and genomic technologies for identification of personality and individual characteristics of a person based on the study of the gene pools of the regions of the Union State ("DNA identification")". There, they are understood as a set of methods and tools for analyzing the entire human genome or a large number of DNA markers distributed across the genome, with nominal quality and optimal costs due to the current level of development of science and technology.  

We believe that in the first of the sources under consideration, the concept is not fully disclosed, which, in general, is indicated in the Decree itself (including), and in the second, this definition does not fully reflect the essence of genetic technologies, since it does not indicate objects of the animal and plant world. It is impossible to consider only the human genome in isolation, since the genetic technologies developed by it have a significant impact on changes in the biosphere, which, in turn, affect the person himself in the future.

By genetic technologies we mean an organized system of methods and means of research, impact, modification and use of the human genome, animal and plant world, as well as organizational, technical, methodological support and regulatory regulation of such activities.

It should be noted that, despite the large number of regulations adopted both in Russia and abroad, legal regulation in this area requires further improvement in order to eliminate the existing or possible risk of harm to a person, society and the surrounding world. As noted in a number of studies, the problems of the negative impact of genetic technologies are caused by factors of an organizational, ethical and legal nature ^{[2, 14, 18, 19, 21, 24, 27]}. It should be noted that genetic technologies are developing so rapidly that legal regulation in this area, having a certain static nature due to the peculiarities of the legislative process, does not have time to meet the existing realities.

In our opinion, the objects of public relations that may be affected by genetic technologies may be the constitutional human rights to life, health, safety, environmental protection, privacy, personal and family secrets.

At the same time , they may be exposed to dangerous effects:

1) gentic biomaterial of a person, objects of the animal and plant world, which is in direct causal connection with a possible danger to life and health as carriers themselves, as well as other people, animals, plants. Such material can cause harm to them, including with a projection to subsequent generations;

2) genomic information contained in various information sources, databases. Illegal distribution and use of such information directly affects the constitutional human rights in the field of privacy, protection of personal data, personal and family secrets, etc. 

Let's analyze these directions in more detail.

1. Threats arising from genetic research.

As it was noted earlier, one of the areas of genetic technologies in which the constitutional rights and freedoms of man and citizen can be violated is the dangerous impact on the genome of biological material and the illegal use of genetically modified material.

The legal definition of biological material is specified in Federal Law No. 180-FZ of 23.06.2016 "On Biomedical Cell Products" and Federal Law No. 242-FZ of 03.12.2008 "On State Genomic Registration in the Russian Federation". As such, human, animal, plant cells, blood, organs and tissues, embryos, as well as new products of genetic engineering – artificial biomaterial and cellular products created on the basis of human biomaterial can act.

One of the promising, but at the same time, requiring close attention from the legislator and law enforcement practice, is genetic engineering. In Russia, this area is regulated  Federal Law No. 86-FZ of July 5, 1996 "On State Regulation in the Field of genetic Engineering". According to the specified source, genetic engineering activity is understood as activities carried out using genetic engineering methods in order to create genetically engineered organisms, as well as to work in the field of genetic manipulation for the purposes of genetic diagnostics and gene therapy, testing of genetically modified organisms, waste disposal of such activities, transactions and other activities, related to genetic engineering technologies. From the content of the law under consideration, it can also be understood that only non-inherited modification of the genome is allowed. The above, in general, corresponds to the legal position in most foreign countries ^[3].

In our opinion, the potential risks of genetic research are as follows:

1) In the human genome editing procedure.

Recently, quite successful studies have been conducted on the editing of hereditary human genes that carry dangerous diseases. For example, in 2017, researchers edited the human genome in order to get rid of Hunter syndrome, and in 2018, the embryo of a child was subjected to genomic editing using the CRISPR-Cas9 method to develop resistance to HIV. Of course, this is a serious and necessary step towards the further progress of mankind. Meanwhile, we believe that such technologies have not been fully studied and require further research. Thus, it is noted that there is a high probability of undesirable changes in random points of the genome. Ethical issues are also touched upon in this case, since healthy embryos, in fact, living people, have already become the objects of intervention ^[8].

It seems that without abandoning further scientific research in this direction, it is necessary to limit the possibility of their use exclusively for scientific and medical purposes and specify specific criteria for such activities. Their need can be justified to increase people's resistance to various dangerous pathogens, such as Covid – 19, or to eliminate the possibility of transmission of dangerous hereditary diseases.

We believe that it is impossible to edit the signs of appearance, physical condition, etc. without serious reasons.. There is a danger of the appearance of a "fashion" for certain signs, which may cause further inequality in society, depending on financial capabilities. What has been said can also change the driving force of humanity, which encourages further improvement of its capabilities. There may also be a decrease in biological diversity, affected parties conditioned by morality, ethics, culture, religion, etc.

2) Uncontrolled release of genetically modified products (GMOs) may become another area of dangerous impact. This direction is one of the most promising and economically attractive in agriculture and animal husbandry. In Russia, the procedures for the release of genetically modified products are permissive on the basis of licensing, certification, and registration of genetically modified organisms, as well as control. Currently, there is a ban on the cultivation of genetically modified organisms and plants, except for the implementation of such activities for experimental and research purposes. Similar restrictions exist in the food industry, where there is a ban on the use of embryo transplantation, cloning and methods of genetic engineering, genetically engineered and transgenic organisms in the production of organic products. Thus, in our country there is a conservative and protective policy of legal regulation of GMOs, which is criticized by supporters of more active use of such technologies ^[4].

Let us disagree with them for the following reasons.

On the one hand, of course, in the conditions of an increase in the population of the planet, such products, more resistant to external negative influences, can solve food problems. Moreover, manufacturers, conducting their own research, prove its safety.

On the other hand, at present, there are a number of independent scientific studies indicating the potential danger of the use of GMOs for human health, animals that harm nature. For example, A. Pushtai's experiments demonstrated that prolonged feeding of transgenic potatoes to animals causes serious changes in their internal organs ^[11]. There is also a negative impact on reproductive functions ^[15]. New genes can be integrated into the genome of another organism, and the organism can receive new toxins formed as a result of the activity of transgenes ^{[7, 9]}. Too little time has passed to confirm the harmlessness of GMOs, evidence of the safety of transgenic products should outpace their commercial use ^[17]. The development of neuropharmacological means of controlling behavior poses a threat ^[26]. The release of genetically modified organisms into the environment can cause the replacement of natural flora and fauna with genetically modified species, which damages genetic resources by reducing biological diversity.

Thus, the results of genetic engineering may be associated with poorly researched or fundamentally new risks caused by the inheritance of various pathogenic conditions, the appearance of diseases that were previously rare or not found in various populations of the living and plant world.

We believe that the current control over the release of GMOs is justified and necessary. It should be noted that in the Russian Federation, such public relations, unfortunately, are not put under proper criminal protection. For example, in Germany, the Law "On the Regulation of Genetic Engineering Activities" provides for both material and criminal liability for carrying out genetic engineering activities without a corresponding permit ^[23]. We believe that the gap should be eliminated, including by including in Chapter 26 (Environmental crimes) of Article 248.1 of the Criminal Code of the Russian Federation "Violation of rules in the production of genetically modified products". These threats may arise either in the form of careless acts (thoughtlessness or negligence), or intentionally. Public danger consists in causing harm to human life and health, the environment (qualified, material composition associated with socially dangerous consequences) or the threat of causing such harm (formal composition).

3) With the development of genetic engineering, new means for creating biological weapons have appeared. The striking capabilities of genetic weapons are based on the properties of genetically modified organisms or specially designed nucleic acid molecules. Their harmful effect consists in blocking the regulatory gene or introducing an aggressor gene that poses a danger to the vital activity of the organism ^[6]. Researchers note that under the guise of conducting research in the field of genetics, they can develop bioweapons for its use in future military conflicts ^[10].

Such dangers are difficult to control and pose a threat to all mankind (it does not matter whether they were created maliciously or their uncontrolled spread occurred). The Covid-19 pandemic has shown how individual viruses can be modified at the genetic level, creating global threats to the world. Of particular importance is the genetic predisposition to certain diseases, which can protect or, conversely, threaten human life and health. In medicine, it has been proven that in 40% of cases, hereditary transmission of genetic abnormalities and diseases is manifested ^[13].

As indicated, there is a need to criminalize a number of socially dangerous acts related to the use of genetic technologies, but, at the same time, a bias in criminal policy should be avoided ^[1]. We believe that there are enough norms in the Criminal Code of the Russian Federation regulating the sphere of responsibility for the creation and use of biological weapons, which does not require improvement of criminal law legislation devoted to this problem. At least for the moment. In particular, the Criminal Code of the Russian Federation provides for liability for a terrorist act using biological substances (Part 3. Article 205 of the Criminal Code of the Russian Federation); development, production, accumulation, acquisition or sale of weapons of mass destruction (Article 355 of the Criminal Code of the Russian Federation); crimes under Chapter 16 of the Criminal Code of the Russian Federation.

4) Another area that requires close attention of the legislator and law enforcement practice is the use of genetic material for cloning, the use of human embryonic material, other organisms and the correlation of this activity with the norms of morality and ethics, public health.

Currently, the market for the use of embryonic material is potentially huge, and the area under consideration is largely not controlled by the state, which creates threats that have a pronounced ethical character. Domestic legislation requires further improvement. In particular, the Criminal Code of the Russian Federation does not provide for public relations in the field of illegal creation and use of embryonic material as an object of protection, which makes it difficult to attract perpetrators who violate the rules in this area.

Modern world practice has a lot of examples where this area is regulated in detail. Thus, the French Criminal Code contains a section "On the protection of the human embryo", where the conception of human embryos by extracorporeal method for research, scientific or experimental purposes, as well as the implementation of any experiments on the embryo can be punished for a serious term of imprisonment. The proposal of E.V. Chervonykh to introduce Article 120.1 of the Criminal Code of the Russian Federation "Illegal use of organs and cellular tissue of a human embryo" into the Criminal Code of the Russian Federation seems quite justified in this regard ^[28].

2. Legal protection of genomic information.

To begin with, it is necessary to determine what genomic information is. In our country, such a concept can be found in the Federal Law "On State Genomic Registration in the Russian Federation". In accordance with the aforementioned Law, genomic information is personal data that includes encoded information about certain fragments of deoxyribonucleic acid of an individual or an unidentified corpse that do not characterize their physiological characteristics.

It seems that this definition does not fully reflect the essence of such information, since it considers only data on registered persons and unidentified corpses for the purpose of their registration, search, identification for the needs of law enforcement. Requires an expansive interpretation.

It should be noted that genomic information is, first of all, biometric personal data of citizens. We agree on this issue with Suranova T.G. Suvorov G.N. pointing out that in the domestic legal system at the moment personal data is understood quite narrowly, which radically differs from the approach adopted in many foreign countries. There, such data is understood to include all information about the state of health, about the detected disease or disability, the possible risk of disease, information obtained during registration or the provision of medical services, including genetic data and biological samples ^[25].

Another feature of genomic information is that, unlike other biometric personal data, it contains information not only about the person carrying the DNA, but also about his blood relatives and even about individual national groups.

In addition, such information can be obtained not only through forensic DNA analysis, but also by a combination of other means and methods of genetic testing, including genetic screening, genetic monitoring. These directions make it possible to identify the presence of hereditary diseases, the harmful effects of environmental exposure on the genome of certain groups of the population.

It is worth asking about the need for legal regulation of relevant information resources containing personal information, which, unfortunately, have been ignored by the legislator in the Russian Federation. Moreover, Federal Law No. 152?FZ of 27.07.2006 "On Personal Data" does not say anything about genomic personal data. Article 11 of this source contains only a general formulation about biometric personal data, without listing them and even more so disclosure.

We believe that genetic information about individuals, along with other biometric personal data (fingerprint information, data on the appearance of a person, on the structure of the iris, on the voice), i.e. information that can be accumulated and processed in specialized information resources, should be specified in Article 11 of the Federal Law of the Russian Federation "On Personal data of citizens".

We believe there is a real danger of illegal distribution and use of accumulated information. The above fully applies to genomic data stored in the corresponding electronic databases, which are of a global nature. Taking into account the idea of genetic certification of the population studied by many countries, it should be assumed that the globalization of DNA data banks will continue, and the problems, in the absence of proper legal regulation, will only worsen. At the same time, in case of negligence or criminal intent, as well as in case of unauthorized access through malware, such information can become available to an unlimited number of persons and used for criminal purposes, which creates dangerous consequences not only for the person himself, the owner of personal genetic data, but also for his close relatives. Information that constitutes a personal and family secret, for example, the secret of adoption, can also be distributed.

There is a threat of collecting and using information about the genetic predisposition to diseases of both a single person and individual national groups. Such data has been actively collected recently. For example, within the framework of the international project "1000 Genomes" (The 1000 Genomes Project), 26 groups of the world's population were studied and a systematic catalog of human genetic variations and genotypes was created. Such studies are certainly useful to society. Meanwhile, with full access to information of criminal persons, a threat is created from terrorist organizations and even hostile states, which can become the basis for manipulation in international relations. The danger lies in the fact that when studying the genetic diversity of different ethnic groups, it can be found out which diseases affect them ^[29].

It should be noted that genetic information about individuals in our country can be stored and processed both in state information resources and in private medical laboratories. And if the activities of state bodies of the Russian Federation engaged in forensic DNA analysis and further storage of relevant information are controlled and regulated (Federal Law No. 242-FZ of December 3, 2008 "On State Genomic Registration in the Russian Federation"). Then the activities of private clinics engaged in genetic research and further storage of information remain questionable. The problem lies in the lack of proper control by the state. As a result, these subjects can avoid liability in case of violation of the rules for obtaining, storing and processing genetic information. A system of biobanks has been created in Russia to date, but the requirements for the organization are determined not by Law, but by a statutory regulatory act of the Ministry of Health of the Russian Federation, which pays attention to ensuring the safety of the carrier of genomic information, but not the information itself. Researchers note that the regulatory framework of biobanking and bioinformatics is in its infancy and requires perfection ^[27].

It seems necessary to adopt legislative acts regulating the field of genetic testing and maintaining banks of genetic personal data at the level of federal legislation. Such sources could be the Laws of the Russian Federation "On State biometric registration in the Russian Federation". "About genetic testing in the Russian Federation". The reason for the need to adopt these Laws is that, despite the actual existence of the spheres of activity under consideration, their regulatory regulation is scattered across various legal sources or is absent altogether. 

In addition, responsibility should be provided for the illegal collection, distribution and use of personal data of citizens, including biometric. Unfortunately, despite the urgency of this problem, this area is not regulated by domestic criminal legislation. As a solution, it is possible to introduce a new norm – Article 137.1 of the Criminal Code of the Russian Federation "Violation of the secrecy of personal data of citizens". Part 1 of the proposed article would have a formal composition and would provide for liability for the illegal collection, distribution and use of personal data of citizens, regardless of the occurrence of socially dangerous consequences. As qualifying compositions of the specified article, it would be possible to provide for liability for such activities committed by a group of persons by prior agreement, organized by a group of persons, using information and telecommunications networks, using official position, as well as entailing grave consequences (material composition).

Conclusion.

Summing up the issues discussed, we believe that the areas of research in the field of genetics will increase qualitatively and quantitatively, opening up new opportunities for the development of society. At the same time, the use of genetic technologies is fraught with dangers that infringe on constitutional human rights: life, health, safety, privacy, personal and family secrets, a favorable environment.

Proper legal regulation is necessary to prevent such threats. In particular, we propose the development and adoption of Federal laws "On state biometric registration in the Russian Federation", "On genetic testing in the Russian Federation". Clarification of the provisions of Article 11 of the Federal Law "On Personal Data". Criminal law protection of public relations in the field of the use of genetic technologies by including articles in the Criminal Code of the Russian Federation:  120.1 of the Criminal Code of the Russian Federation "Illegal use of organs and cellular tissue of a human embryo", 137.1 of the Criminal Code of the Russian Federation "Violation of the secrecy of personal data of citizens", 248.1 of the Criminal Code of the Russian Federation "Violation of rules in the production of genetically modified products". 

We believe that legal regulation in the field of genetic technologies requires further improvement, including in the areas we propose.

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