Instituto de Estudios Políticos y Derecho Público "Dr. Humberto J. La Roche"
de la Facultad de Ciencias Jurídicas y Políticas de la Universidad del Zulia
Maracaibo, Venezuela
Esta publicación cientíca en formato digital es continuidad de la revista impresa
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Vol.41 N° 76
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2023
Recibido el 14/12/22 Aceptado el 16/01/23
ISSN 0798- 1406 ~ De pó si to le gal pp 198502ZU132
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Vol. 41, Nº 76 (2023), 400-418
IEPDP-Facultad de Ciencias Jurídicas y Políticas - LUZ
Private-law denition of the concept and
legal nature of human genetic information
DOI: https://doi.org/10.46398/cuestpol.4176.23
Hanna Krushelnytska *
Abstract
The article explores the private law regime of human genetic
information. To achieve the objective, an analysis of bibliographic
sources in the eld of genetic and genomic research, legal support
for the circulation of genetic information and its legal protection
was carried out. The document also analyses the provisions of
the legislation and practice of the United States and the Member
States of the European Union. General and specic methods of
scientic knowledge, including dialectical methods, formal logic
and comparative law, were used to solve the problems raised. The
article claries the doctrinal and legal denitions of the concepts
of “genome” and “gene” of an individual. It points out the dual
nature of the human gene as a material object: a DNA molecule, and also
as a unit of hereditary information that is intangible in nature. The article
explores the possibility of attributing genetic information to objects of
civil rights, in particular material objects, intangible movable property
and the results of intellectual activity. The conclusions support the need to
distinguish between the concepts of genetic information and genomics. In
addition, it reviews theoretical approaches to dene the concept and nature
of genetic information.
Keywords: genetic information; genes and genome; privacy; personal
data; private law.
* PhD in Law, Senior Lecturer of the Department of Civil Law Disciplines, National Academy of Internal Aairs,
02000, Kyiv, Ukraine. ORCID ID: https://orcid.org/0000-0001-9934-6973
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CUESTIONES POLÍTICAS
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Denición de derecho privado del concepto y
naturaleza jurídica de la información genética humana
Resumen
El artículo explora el régimen de derecho privado de la información
genética humana. Para lograr el objetivo se realizó un análisis de fuentes
bibliográcas en el campo de la investigación genética y genómica, soporte
legal para la circulación de la información genética y su protección legal. El
documento analiza también las disposiciones de la legislación y la práctica
de los Estados Unidos y los Estados miembros de la Unión Europea.
Para resolver los problemas planteados se utilizaron métodos generales y
especícos del conocimiento cientíco, incluidos métodos dialécticos, de
lógica formal y de derecho comparado. El artículo precisa las deniciones
doctrinales y legales de los conceptos de «genoma» y «gen» de un individuo.
Señala la naturaleza dual del gen humano como objeto material: una
molécula de ADN, y también como una unidad de información hereditaria
que es de naturaleza intangible. El artículo explora la posibilidad de atribuir
información genética a objetos de derechos civiles, en particular objetos
materiales, bienes muebles intangibles y los resultados de la actividad
intelectual. En las conclusiones se fundamenta la necesidad de distinguir
entre los conceptos de información genética y genómica. Además, revisa los
enfoques teóricos para denir el concepto y la naturaleza de la información
genética.
Palabras clave: información genética; genes y genoma; privacidad;
datos personales; derecho privado.
Introduction
A quantum leap in the development of medicine, biology, genetics, and
genomics has allowed scientists to solve one of nature’s greatest mysteries
– to decipher the human genome. Genetic engineering methods of today
make it possible to interfere with human DNA by introducing specic
mutations or replacing or editing some gene fragments. Moreover, in the
context of the COVID-19 pandemic, thanks to continuous scientic research
on human DNA and RNA, scientists have been able to create vaccines
relatively quickly based on articial messenger RNA, which uses human
heritable information to produce proteins and corresponding antigens.
Currently, gene editing is rapidly emerging worldwide, and scientic
research in genetic engineering is on the verge of spreading the practice
of genetic “improvement” of an individual (Straiton, 2019). On the one
hand, this knowledge is instrumental, making it possible to discover and
402
Hanna Krushelnytska
Private-law denition of the concept and legal nature of human genetic information
develop methods for treating existing and avoiding potential diseases that
previously posed a mortal danger to entire populations.
On the other hand, insuciently protected access to genetic information
about an individual as the keys to its biological nature can lead to
discrimination based on heritable genetic traits and iniction of colossal
damage not only to the carrier of genetic information but also to his relatives
and future descendants.
In many countries of the world, the collection, storage, and use of genetic
information are carried out in the plane of public law, which is associated
with the taking, processing, and storage of samples of biological material
and the extraction of genetic data to search for criminals, identify corpses
or missing persons. In addition, several states carry out mandatory genetic
registration of specic categories of citizens, including military personnel
and persons whose activities are associated with an increased risk of death
or missing.
However, in this article, we are discussing the private-law nature
of genetic information because most of the legal acts adopted by the
international community to regulate the use of genetic information pay
special attention to its condential status and recognise that the interests
of an individual prevail over the interests of society and the benets of
scientic research.
This approach indicates the recognition of genetic information as part
of the private sphere of human life, which allows us to consider genetic
information as a category of private law. Therefore, today it is crucial to
solve the issue of the possibility and practicality of classifying genetic
information as objects of civil rights and the formation of a special civil-law
regime for genetic information, as well as a mechanism for its protection.
That is why the article aims to explore the private-law nature of human
genetic information and the legal regulation of its collection, storage, and
use through the prism of protecting the rights of the individual from whom
the genetic information originates. This study has the following objectives:
• determine the concept, the legal nature of genes and the human
genome, as well as their place in the system of objects of civil rights;
• analyse the legal regime of human genetic information;
• explore the mechanisms of the legal protection of human genetic
information.
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1. Literature review
Even though the regulation of biomedical activities in the eld of genetic
technologies began to take shape relatively recently, among law science
research, one can already nd many works devoted to the legal regime of
human genetic information. This testies to the growing relevance on a
global scale of the chosen problem of the article.
Imekova and Boltanova (2020), in their studies on the place of genetic
information in the system of objects of civil rights, drew attention to the
fact that in order to determine the civil-law regime of genetic information,
it is of fundamental importance to distinguish between genetic information
and genetic data. Scientists noted that genetic information is personalised
information, while genetic data is pseudonymised and characterised by a
formalised form.
A slightly dierent approach was identied in the scientic works of
Novoselova and Kolzdorf (2020), who distinguish between the concept
of genetic data as personalised information about a certain individual,
and genetic information as a sequence of nucleotides responsible for the
manufacture of a product with a specic function or otherwise aecting the
management of biological processes in the body (i.e. non-personalised data
that can be specic to an unlimited number of persons).
Kwiatkowski (2020), in order to identify problems of legal regulation
in the eld of genetic and genomic research, analysed the jurisprudence of
the European Court of Human Rights in determining the legal regime of
objects of genetic and genomic research, in particular genetic information,
biological materials, embryos, as well as practice regarding the search for a
balance of private and public interests in determining the boundaries of the
implementation of genomic and genetic research.
Kosseim et al. (2004) studied the general directions of legal regulation
adopted at the international, regional, and national levels for the protection
of genetic information. Shabani and Borry (2018) analysed the new General
Data Protection Regulation (GDPR), which came into force in 2016 and
repealed Directive 95/46/EC (European Union, 2016), in the context of
improving the eciency and harmonisation of personal data protection in
the EU, taking into account the inclusion of genetic data in the catalogue of
special categories of data (sensitive data).
Clayton et al. (2019), examining the legal landscape of genetic privacy,
note that few legal doctrines or legislation, in general, provide adequate
protection or meaningful control over the disclosure of an individual’s
genetic information.
In this regard, it is proposed to shift attention from attempts to control
access to genetic information to the question of how this data can be used
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Private-law denition of the concept and legal nature of human genetic information
and under what terms, given the need to nd a compromise between the
individual and society.
Levushkin (2019), justifying the possibility of including genes and
genomes in objects of civil rights, considered the issue of the transferability
of genes, genomes, and genetic constructs and the possibility of concluding
various civil-law contracts with them. In addition, he proposes classifying
genes and genomes as objects of intellectual property rights, providing
them with patent protection and establishing appropriate legal procedures.
In general, the notion of recognising the patentability of genes and
genomes (both natural and synthetic) is quite debatable among scientists. It
should be noted that earlier, the position on the inadmissibility of patenting
genes and genetic information prevailed. In particular, Then and Schweiger
(1999) are convinced that a gene is a part of the wildlife that is a common
heritage. No one invented genes; therefore, they cannot be patented.
Herrlinger (2004) points out that issuing a patent for a human gene
violates public order and morality. Michelotti (2007) notes that genetic
compositions are actually plagiarisms from publicly available sources
(natural genes); therefore, synthetic genes should not be protected as
objects of intellectual activity.
However, recently the position of scientists has changed. Beyleveld
(2011) does not question that genes may be subject to patenting. However,
he considers the practicality of including genes in intellectual property due
to the possible risks of limiting patients’ access to innovative developments
in genetic technologies. Burk (2013), analysing US jurisprudence, also
notes that synthetic genes, even those entirely identical to natural ones, are
subject to legal protection as objects of intellectual property rights. Mokhov
et al. (2020) substantiated that genes, in particular edited or synthesised,
are objects of intellectual rights.
Novoselova and Kolzdorf (2020) detail that patenting a sequence or
part of a gene as a substance is possible if certain conditions are met –
the presence of a technical process and the disclosure of a novel technical
function: A new route to the industrial production of a gene sequence shall
be described, or a new function of the gene obtained (discovered) that
allows the creation of a new medicinal product or assay (Segert, 2018; Wolf
et al., 2019).
Thus, in the scientic literature, one can nd a variety of approaches to
the denition of the concept and legal regime of such objects of civil rights
as a gene, a genome, genetic information and genomic information. On this
basis, conclusions about the legal regime and legal protection of genetic
information are very dierent. In this regard, in this article, the author will
unify and supplement the existing approaches in the science of private law.
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2. Materials and methods
Considering the chosen subject of the research, the preparation of
this scientic article used laws and regulations, court decisions, and legal
literature. The subject and object of the study determined the application
of the methodology of the science of civil law, since genetic information is
included in the objects of civil rights in the form of personal information of
an individual, intangible personal property (right to privacy), and results of
intellectual activity.
The tasks set by the author for the study led to the use of general
scientic and special methods of scientic knowledge, including dialectical,
formal logic, and comparative law methods of analysis and synthesis.
Thus, one of the critical methods of this study was the dialectical
method, which manifested itself in identifying and comparing opposite
phenomena. In particular, when studying the possibility of extending the
regime of objects of intellectual property rights to synthetic genes and
referring anonymous and pseudonymised genetic information to personal
data, competing groups of scientic views on these issues are opposed.
In addition, when applying the dialectical method, an alternative
(antithesis) is put forward as opposed to the preferred point of view on the
identity of the concepts of genomic and genetic information. In this regard,
an idea is formed about the dierent legal natures of these phenomena.
The use of methods of analysis and synthesis manifested itself in the
study of judicial practice in the application of legislation in the eld of
collection, storage, and use of genetic information in dierent countries,
in particular, the dissemination of such information on the legal regime of
personal data or intangible personal property (right to privacy).
The formal logic method was applied to understand the logic of the law
regarding the use of genetic information without unnecessary subjectivity,
which made it possible to conclude that genetic information is of a private-
law nature.
The use of a comparative law method was manifested in the study of
legal approaches of various legal systems that regulate the collection,
storage, and use of human genetic information, which made it possible to
identify a relatively high level of freedom of action for subjects in the eld of
circulation of genetic information at the international level.
The theoretical and methodological basis of the author’s scientic
research was the works of leading scientists and practitioners in the eld
of medical and intellectual law, dedicated to establishing the legal nature
of the concepts of gene, genome, genetic information, and human genomic
information as objects of civil rights. Considerable attention was paid to the
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Hanna Krushelnytska
Private-law denition of the concept and legal nature of human genetic information
results of studies of the judicial practice of dierent legal systems, which
helped to identify the main approaches to determining the private-law
regime of genetic information.
Reviewing of the primary sources of national and international laws and
regulations on the article’s topic contributed to the author’s conclusions.
In total, the article reviewed thirty-seven sources. The complex methods,
techniques, and means determined by the article’s goals and the study’s
objectives helped reveal the issues outlined in the article to the maximum.
3. Results
An analysis of the sources that formed the scientic and theoretical
basis of this study indicates that there are disagreements in the terms used
both in the laws and regulations on the relevant topic and among scientists.
Therefore, the concepts of human genetic and genomic information are
equated, with which the author of this article does not agree. The Universal
Declaration on the Human Genome and Human Rights (UNESCO, 1997)
states that the human genome underlies the fundamental unity of all
members of the human family, as well as the recognition of their inherent
dignity and diversity.
In a symbolic sense, it is the heritage of humanity. In the scientic
literature, the genome is understood as the totality of an organism’s genes,
while the essence is not in the number of such genes but in the combination
of specic genes as an integral system of a living organism.
In turn, a gene is a unit of heritable information responsible for the
formation of certain qualities in the body, and with the help of which
a certain process is encoded. From a biological point of view, a gene is a
specic section of DNA, a sequence of nucleotides located in a particular
place on a specic chromosome and responsible for the formation of
products with a specic function, such as proteins.
That is, a gene is a collection of heritable material located in a single cell
of an organism and contains the biological information necessary to build
and maintain the organism. Genes are present in every living organism
capable of reproduction. Their purpose is to follow, from generation to
generation, the instructions necessary to create and maintain the life of an
organism.
At the same time, DNA molecules do not independently perform a
physical function in living cells and exist solely to store information in time.
DNA, like a ash drive, is only a material carrier on which the information
and instructions necessary for creating and operating living organisms are
recorded in a digitally coded form. In other words, a gene can be viewed
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as an inseparable combination of two components: Material basis – DNA
molecules as a physical basis, as well as intangible content – the information
contained in genes.
Unlike genes, the material carrier of the genome is a person himself/
herself (living or dead), his/her organism, excluded from civil circulation,
so it seems that the human genome should be identied directly with
genomic information.
Although at the conventional level, the genome is dened as the heritage
of humanity, the mechanism of legal regulation of human genome research
and the application of their results in practice is dominated by the dispositive
method, which gives participants in biomedical activities a set of rights and
obligations, creating the basis for the free development of medical science
for the benet of humanity.
Given this, in the doctrine of private law and in practice, genes and the
human genome are already recognised as objects of civil law. At the same
time, the issue of their belonging to one or another named object of civil law
is debatable. In particular, they can be considered as special substances and
(or) a particular type of information of biological origin.
Recently, the discussion of the possibility of including genes in objects
of intellectual property has become increasingly popular, especially
considering the rst successes in working with synthetic genes generated
using computer software. For example, thanks to the Human Genome
Project for sequencing the human genome, it became possible to print a
new genome and introduce it into a living cell based on the code obtained.
However, this approach is often criticised because synthetic genes are
plagiarising publicly available sources (natural genes). Since plagiarists
should not, as a general rule, have the right to claim authorship, synthetic
genes should not receive legal protection as objects of intellectual activity.
Meanwhile, at the regulatory level in European legislation expressly
states that a biological material may be an invention and be protected
by a patent if it is produced by means of a technical process, even where
the structure of that element is identical to that of a natural element. The
same approach was taken in the US when, in 2013, the US Supreme Court,
in the case Association for Molecular Pathology v. Myriad, concluded
that complementary DNA made in laboratory glassware was patentable.
Generally, the possibility of patenting human genes diers in dierent
jurisdictions (Table 1).
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Private-law denition of the concept and legal nature of human genetic information
Table 1. The possibility of patenting human genes in dierent countries’
jurisdictions
Countries Genes as an object of patenting
European
Union
Genes isolated from the human body or produced by means
of a technical process, even where the structure of that
element is identical to that of a natural element
US Complementary DNA, synthetic genes, human-altered DNA
sequences
Australia Synthetic or altered natural genes
South Korea Genes, parts of genes and other biomaterials isolated from
nature, regardless of the source of origin
Mexico,
Argentina, Brazil
Articially isolated natural genes modied by humans
Japan Genes articially isolated from their natural environment,
subject to industrial feasibility
Source: authors.
Despite the debatable issue of attributing genes and the human genome
to a specic type of objects of civil rights, it is necessary to agree with the
need to establish a special civil-law regime for genes, which would clearly
provide for the possibility or impossibility of performing specic actions
(transactions) with genes as an object, as well as related to such actions,
a set of rights and obligations, permissions and prohibitions of dierent
subjects participating in the relations gene engineering.
At the same time, the civil-law regime of genes should be inextricably
linked with the right to life of an individual, providing a citizen with qualied
medical care and patient treatment process, since any fact of interaction
between an individual (patient) and a doctor, geneticist and other medical
sta, gives rise to ensuring the right to healthcare.
Taking into account the established dierence in the concepts of the
genome and the gene as a whole and partial, it can be concluded that genetic
information can be contained in any DNA molecule and store information
about a certain quality, inclination of an individual, or features of the
construction of his/her body.
Genetic information can reveal traits specic to a particular person
and inherent traits in members of his/her family or even wider groups.
In addition, genetic information can indicate both a real-life trait of an
individual and only the correctness of the fact that a trait encoded in a
particular DNA molecule will appear in an individual later.
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In turn, genomic information is contained in a certain set of genes
uniquely combined, revealing the characteristics of a particular individual
as a unique being. At the same time, thanks to the genetic information
of an individual, he/she can be easily identied; that is why, from a legal
point of view, it is more appropriate to use the term “genetic information”,
since it corresponds to the concept of “genetic data”, which is used in most
international and national regulations to refer to information that identies
an individual.
In its most general form, genetic information is data and information
obtained from a specic material source as a result of an individual’s specic
activity. At the same time, thanks to an individual’s genetic information, he/
she can be easily identied since it contains information about the previous,
current physical and mental health of an individual, blood type, and other
identifying information.
The main characteristic of genetic information is the presence of
information about specic fragments of DNA, which is the carrier of
heritable information about the individual and serves as the source of all
genetically determined traits studied during the examination of biological
objects.
A specic material source of human genetic information can be
any biological materials, for example, biological samples (blood, blood
plasma, skin, bone cells) or even a whole human corpse. As for the special
activity during which genetic information is obtained, it can be a medical
examination, testing, screening, medical and scientic research, genetic
and molecular assays, and other types of biomedical activities.
An analysis of the legal literature made it possible to conclude that the
concept of genetic information is used to dene dierent phenomena. In
particular, genetic information is dened as the following:
• genetic data containing information about human health
(personalised to some extent), access to which may be restricted;
• general non-personalised information about the structure of
proteins, encoded by the sequence of nucleotides;
• the general concept of nature embedded in every cell that belongs
to everyone.
At the same time, along with genetic information related directly
or indirectly to a specic individual and allowing him to be identied
(personalised genetic information), it is also possible to extract data that
allows us to obtain information about the relatives of an individual or
about a certain group of persons (non-personalised data, which most often
contained in a certain information system – a database).
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Private-law denition of the concept and legal nature of human genetic information
The International Declaration on Human Genetic Data (UNESCO,
2003) uses the term “human genetic data” to mean information about the
heritable characteristics of individuals obtained by analysis of nucleic acids
or by other scientic analysis. From this denition, we can conclude that
genetic data is one of the types of genetic information.
In the legal literature, there is a position that the concept of information
includes both information, which is viewed as information related to a
specic subject, object, fact, case, the rights to which belong to the subject
of information, and data – a set of information, combined and ordered
according to a certain attribute, several attributes or criteria, the rights to
which, as a general rule, belong to the author of this information.
From this point of view, information about the heritable characteristics
of specic individuals is more genetic information than genetic data. Such
genetic information is of an individual, personal nature as relating directly
or indirectly to a specic or specic person. In turn, genetic data have a
sign of mass character, are non-personalised data (pseudonymised) and
primarily pursue research goals, for example, to develop measures to
increase life expectancy, develop technologies for screening the human
gene pool, assess genetic risks, create medicinal products, and genome
sequencing.
According to para. 1 of Article 16 of the Additional Protocol to the
Convention on Human Rights and Biomedicine concerning genetic testing
for medical purposes (CETS No. 203), research on a person may only be
undertaken if the persons undergoing research have been informed of their
rights and the safeguards prescribed by law for their protection. It follows
from the above that this Convention considers genetic information in the
context of the personal data of an individual.
Also, in accordance with Regulation (EU) 2016/679 of the European
Parliament and of the Council of 27 April 2016 on the protection of natural
persons with regard to the processing of personal data and on the free
movement of such data, and repealing Directive 95/46/EC (General Data
Protection Regulation) “genetic data” is dened as personal data relating to
the inherited or acquired genetic characteristics of a natural person which
result from the analysis of a biological sample from the natural person
in question, in particular chromosomal, deoxyribonucleic acid (DNA) or
ribonucleic acid (RNA) analysis, or from the analysis of another element
enabling equivalent information to be obtained (European Union, 2016).
At the same time, according to paragraph 26 of the Regulation, the
principles of personal data protection do not apply to any information
concerning an identied or identiable natural person, as a result of which
the processing of genetic information for statistical or research purposes
is excluded from the scope of data protection, which once again conrms
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the dierence between genetic information as personal information of an
identied person and genetic data as non-personalised information of a
certain circle of persons.
Consequently, the protection and dissemination of genetic information
are carried out in accordance with the legal regime of personal data in the
part in which genetic information identies a particular person, aecting
the right to inviolability of his private life. Even if we proceed from the
fact that pseudonymisation is the processing of personal data, genetic
information is subject to protection until it is depersonalised, after which it
loses the status of personal data.
However, international, regional, and national regulations do not
consider that DNA is a carrier of genetic information not only about a
particular person but also about his/her parents, relatives, and descendants.
In addition to its individuality, the DNA molecule is associated with
another main property – heredity and the method of transmitting heritable
information relating to an indenite circle of persons. Thus, it is essential to
provide for the condentiality of genetic information not only as personal
data of a particular individual but also as an identifying feature of a whole
group of people connected by family ties.
It should also be noted that para. 27 of the EU Regulation states that it
does not apply to the personal data of deceased persons. Member States
may provide for rules regarding the processing of personal data of deceased
persons.
Given the above, based on the fact that human genetic information
is personal biometric data obtained from specic fragments of DNA
(sometimes RNA) of a living individual or a corpse, based on which it is
possible to identify an individual, determine the genetic propensities of an
individual, obtained voluntarily, and in cases provided for by law, forcibly
xed in a biological sample and (or) stored in an information record,
database, one can draw an unambiguous conclusion that the concept of
“genetic information” is wider than the concept of “personal data”.
More often, genetic information has the form of data that has been
processed using computer technology. Therefore, ensuring the security
of genomic information will always be associated with the operating DNA
databases that generate such information and ensure its storage.
Such databases are created both to register oenders and for other
purposes of identifying and establishing legal facts (search for missing
persons, establishing paternity, databases for medical purposes). Such
databases of genetic information operate in the USA, the United Kingdom,
the countries of the Middle East and Asia. The Icelandic database generally
contains the genotypes of the country’s entire population.
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At the same time, genetic information is closely related to the categories
of “private life”, “family life”, “right to respect for private and family life”.
Even the consideration of cases by the European Court of Human Rights
(ECtHR) related to genetic and genomic research takes place within the
framework of the right to respect for private and family life, enshrined in
Art. 8 of the 1950 Convention for the Protection of Human Rights.
In such cases, the ECtHR indicates that genetic information is personal
information, the protection of which is essential for ensuring the right to
respect for private life (ECtHR Decision of 4 June 2013 in the case Peruzzo
and Martens v. Germany). Genetic information contains data that allows not
only to identify a person but also to establish a genetic relationship between
people, as well as ethnic origin, and any uncontrolled or unreasonable use of
genetic information is an interference with respect for private life (ECtHR
Decision of 4 December 2008 in the case S and Marper v United Kingdom).
There has also been a legal debate in the United States about whether
genetic information should be considered in the context of property rights
or the right to privacy. In the end, the prevailing conclusion is that genetic
information should be seen as a right to privacy rather than a vested interest,
since it is privacy that has a more holistic view of the individual. Even in
the practice of US courts in cases related to the human genome, a special
place is given to disputes related to the misuse of genetic information and
discrimination.
Thus, given the value that genetic information is for an individual
as a “carrier” of genetic information and members of his/her family
(including future descendants), as well as the high probability of using such
information by third parties in order to restrict the rights of these persons
and discriminate against them, it is quite justiably extending the legal
regime of privacy to genetic information.
It is to determine the guarantees of the right to condentiality of
genomic and genetic information that the UN International Declaration on
Human Genetic Data was adopted, which is designed to ensure respect for
human dignity, human rights and fundamental freedoms in the collection,
processing, use, and storage of human genetic and proteomic data and
biological samples, from which they are derived, respectively to the
requirements of equality and fairness.
This Declaration sets out the criteria by which genetic data diers from
personal information and requires a special legal regime guaranteed by the
state (Art. 4).
In particular, genetic data can be predictive of genetic predispositions
concerning individuals; they may have a signicant impact on the family,
including ospring, extending over generations, and in some instances, on
the whole group to which the person concerned belongs; they may contain
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information the signicance of which is not necessarily known at the time of
the collection of the biological samples; they may have cultural signicance
for persons or groups.
Such provisions of the Declaration indicate that two types of objects are
used in genetic and genomic research and directly relate to privacy issues –
these are genetic and genomic data, as well as their source – the biomaterial
itself taken from a particular person.
After all, cells, tissues, or any substance of the human body, whether a
sample of skin, bone, hair, or a drop of blood, contain a relatively complete
picture of who we are.
Everything from gender, eye and hair colour to predisposition to certain
behaviours or risk of developing certain diseases can be in a tiny biological
sample that can remain identiable even for hundreds of years. Therefore,
the legal regime of privacy should extend not only to genetic information but
also to biological materials that are material carriers of genetic information.
At the same time, it should be noted that the condentiality of personal
data is a relative concept. For some, the fact that they carry a little-known
gene that is not essential to the average citizen may not be as important as
information about an individual’s credit history or marital status. On the
one hand, DNA is conceptualised as a unique identier and a record of an
individual’s life in the dimensions of the past, present, and future, which
gives an idea of the individual in many aspects.
This naturally leads many people to desire to control and determine
who has access to genetic information about them, provide solid privacy
protections, or even possess personal genetic data. On the other hand,
genetic data is not limited to one person, and information about one person
reveals information about his/her close and distant biological relatives.
Only by studying the vast array of genetic information of many people can
one understand the signicance and uniqueness of individual variants.
The public nature and value of genomic and genetic information make it
challenging to decide what level of control individuals should have to ensure
that privacy is adequately protected. It seems that a particular individual
– a carrier of genetic information is obliged to determine the limits of
interference in his/her personal life and give permission to introduce his/
her genetic information, which is the key to the genome of a particular
person. At the same time, for the development of biology and medicine,
irreversibly pseudonymised genetic information should not be subject to
the legal regime of privacy.
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4. Discussion
Studies have shown that there is a tendency to classify a gene, a genome,
genetic information and genomic information as objects of civil law and
extend the legal regime of objects of civil rights to them (Mokhov et al.,
2020).
At the same time, there are discussions about the private law nature
of genes – whether to recognise them as material objects, since they are
part of the material world in the form of a DNA molecule (Novoselova and
Kolzdorf, 2020; Althabhawi and Zainol, 2022), whether this is intangible
personal property included in the personal data of a subject of civil law
Imekova and Boltanova (2020), since the DNA molecule itself is of no
particular value – what matters is the code encoded in the gene, that is, the
genetic information.
Does this fact mean that a single human gene is not subject to legal
protection as part of the right to privacy? To perform any manipulations
with the gene, it must be separated from the human body.
That is, genes are contained in any human biological material, including
saliva, urine, and hair, which in most cases, naturally separate from the
body without the informed consent of a person. This means that people
daily leave billions of its genes everywhere, of no value, unless a particular
individual is allowed to be identied (Pormeister, 2018; Ram, 2017).
The legal nature of the human genome is also ambiguous since it does
not have a specic material substance and is contained in the aggregate
of cells of the entire human body; that is, the genome is the intangible
essence of the individual, along with life and health. The genome is devoid
of economic content, and therefore, cannot be attributed to the property.
Since the literature did not distinguish between gene and genome
concepts clearly, the doctrine did not investigate the dierence in the legal
regime of these legal phenomena (Krajewska, 2012; Lewis et al., 2021).
The issue of understanding the legal nature of genomic and genetic
information is also debatable. In particular, there has yet to be a consensus
among scientists on whether genetic information is a separate object of civil
rights or is included in other named objects. Thus, some scientists believe
that genetic information is covered by such intangible personal property
as the right to privacy (Borodin and Ruzanova, 2021; Blinov et al., 2020),
while others point out that genetic data is an element of such an object of
civil rights as a database Imekova and Boltanova (2020).
In addition, in connection with the development of gene editing
technologies, and the creation of synthetic genes using the latest computer
software, at the doctrinal level, discussions are underway about the
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patentability of synthetic genes and genetic data, that is, the possibility of
classifying them as objects of intellectual activity (Marchant et al., 2020;
Wan et al., 2022).
Also promising are studies of the circle of subjects covered by the legal
regime of condentiality of genetic data, given that DNA data can be used to
identify not only the person from whose biomaterial the genetic information
is taken, but also his relatives and future descendants, since in the reviewed
articles the specied concept was not given due attention.
Conclusions
The importance of genetic data is constantly growing due to the
expansion of the possibilities of its practical use. Genetic testing, medical
and biological experiments, as well as mandatory genomic registration
lead to the collection, processing, and storage of large amounts of genetic
information about individuals. This fact indicates the need to determine
the legal nature, develop a specic legal regime, and provide adequate
guarantees to eectively protect genetic information from misuse.
To achieve this, the international community develops the boundaries
of regulation of these issues, which are detailed in the national legislations.
However, what is shared, both at the regulatory and practical level, is
that genetic information is classied as personal data subject to special
protection as the most condential data.
At the same time, it is vital to maintain a balance of private and public
interests, given that genetic information is of particular value for the
development of biomedical technologies in order to explore the causes of
certain diseases and nd ways to overcome them.
International standards for the use of genetic information suggest that
the interests of an individual prevail over the interests of society, which
indicates the need for developing a regulatory framework for the circulation
of genetic information in the plane of private law.
In addition, particular interest and prospects are seen in developing
national legislation to ensure the patentability of synthetic human genes
and genetic information as a result of intellectual activity. At the same
time, it is necessary to approach with particular caution the possibility of
including natural human genes in objects of intellectual property rights.
Thus, given the need for legislative transformations at the national
and international levels, further research will be carried out to conduct a
comparative-law analysis of the relevant innovations.
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