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Interacción y Perspectiva Dep. Legal pp 201002Z43506
Revista de Trabajo Social ISSN 2244-808X
Vol. 13 N
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2 192-202 pp. Copyright © 2023
Julio-diciembre
ARTÍCULO DE INVESTIGACIÓN
Socializar la responsabilidad civil de una organización médica por causar
daños a la salud/DOI: 10.5281/zenodo.7812180
Yury Alexandrovich Svirin*, Alla Andreevna Neznamova**, Vitaliy Anatolevich
Malcev***, Vladislav Petrovich Sorokin****, Eduard Eduardovich Artyukhov*****
Resumen
Durante muchos siglos, la responsabilidad civil en el sistema jurídico romano-germánico
se basó en el principio de responsabilidad individual, según el cual debe establecerse
una relación de causa-efecto entre el delincuente y el daño causado, así como en el
principio de culpabilidad del causante del daño. Al mismo tiempo, el desarrollo de la
ciencia y la tecnología, incluida la medicina, determina la aparición de un daño diferido
en el tiempo y el perjuicio causado a los descendientes, lo que implica la culpabilidad
implícita del delincuente. En estas condiciones, es necesario discutir la socialización de
los principios básicos de la responsabilización del autor del daño. El tema se divulga
utilizando métodos científicos generales (análisis sistémico, teórico e histórico) y
métodos científicos especiales (derecho comparado, análisis lógico, técnico y jurídico,
especificación e interpretación). El estudio pretende identificar la naturaleza teórica y
práctica de la exigencia de responsabilidad a las empresas farmacéuticas y a las
organizaciones que utilizan las nuevas tecnologías genéticas por los daños a la salud que
hayan causado. También es necesario explorar la posible socialización de la
responsabilidad civil por daños a la salud. El artículo examina algunos principios de la
responsabilidad civil individual por los daños causados a la salud humana por los
productos farmacéuticos y las tecnologías genéticas. Se concluye que los principios de
exigencia de responsabilidad por daños a la salud deben modificarse, considerando la
socialización de dicha responsabilidad.
Palabras clave: responsabilidad civil individual, socialización de la responsabilidad civil,
causante de daños, daños a la salud, culpabilidad.
Recibido: 08/02/2023 Aceptado:15/03/2023
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* Doctor en Ciencias Jurídicas, Profesor de la Universidad Estatal Rusa de Justicia (RLA del Ministerio de Justicia
de Rusia), Moscú, Rusia. Abogado honorario de Rusia. Miembro de la Academia de Ciencias Naturales, Moscú,
Rusia. ORCID ID: https://orcid.org/0000-0001-7616-2637. E-mail: usvirin@mail.ru
** PhD en Derecho, Profesor Asociado, Academia de Trabajo y Relaciones Sociales, Moscú, Rusia; Profesor
Asociado, Universidad Estatal de Gestión, Moscú, Rusia. ORCID ID: https://orcid.org/0000-0002-7534-6327.
E-mail: aanezn@gmail.com
*** PhD en Derecho, Profesor Asociado, jefe del Departamento "Teoría del Derecho, Derecho Civil y Procesal
Civil" del Instituto de Derecho de la Universidad Rusa de Transporte (MIIT), Moscú, Rusia. ORCID ID:
https://orcid.org/0000-0001-8340-8180. E-mail: maltsev@ui-miit.ru
**** PhD en Derecho, Profesor Asociado del Departamento de Apoyo Jurídico a la Economía de Mercado de la
"Escuela Superior de Derecho" de la Facultad de Administración Estatal y Municipal de la Academia Rusa de
Economía Nacional y Administración Pública bajo la Presidencia de la Federación Rusa, Moscú, Rusia. ORCID
ID: https://orcid.org/0000-0002-0279-9907. E-mail: sor.vladislav2013@yandex.ru
***** Primer adjunto jubilado del Fiscal de San Petersburgo, Rusia. ORCID ID: https://orcid.org/0000-0002-
7977-1515. E-mail: e.artiuhov@yandex.ru
Abstract
Socializing the civil liability of a medical organization for causing harm to
health
For many centuries, civil liability in the Romano-Germanic system of law was based on
the principle of individual liability, according to which a cause-and-effect relationship
between a delinquent and the damage done must be established, as well as on the
principle of guilt of an offender. At the same time, the development of science and
technology, including medicine, determines the onset of harm delayed for a long time
and the harm caused to descendants, implying the implicit guilt of the delinquent. Under
these conditions, it is necessary to discuss the socialization of the basic principles of the
offender responsibility. The topic is disclosed using general scientific methods (systemic,
theoretical, and historical analysis) and special scientific methods (comparative law,
logical, technical, and legal analysis, specification, and interpretation). The study aims
at identifying the theoretical and practical nature of bringing pharmaceutical companies
and organizations using new genetic technologies to responsibility for the harm to health
they caused. It is also necessary to explore the possible socialization of civil liability for
harm to health. The article considers some principles of individual civil liability for the
harm caused to human health by pharmaceuticals and genetic technologies. It is
concluded the principles of bringing responsibility for harm to health should be changed,
considering the socialization of such responsibility.
Keywords: individual civil liability, the socialization of civil liability, offender, harm to
health, guilt.
1.- Introduction
The principle of individual civil liability adopted by Romano-Germanic law from the
Roman law is based on the following construction: “a specific delinquent – specific harm
– a specific victim”. This legal structure has been used in holding a subject of law liable
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for more than a millennium. However, the world has entered the postgenomic era in the
21
st
century. Progress in the field of genome editing with the help of new pharmaceuticals
or new genetic technologies has a positive effect in the form of a cure for many
previously incurable diseases but also has a negative impact on human health and
descendants, which causes the discussion about changing methods and forms of
protecting human rights, including the right to health. The principles of bringing to civil
liability developed by legal science several centuries ago cannot ensure a balance of
interests between parties to legal relations or protect the rights of the delinquent and
the injured party in the event of harm to the latter’s health.
The current level of development of science in the field of biotechnologies and genetic
technologies contributes to the emergence of fundamentally new pharmaceuticals for
the treatment of rare diseases. The COVID-19 pandemic also accelerated the testing of
such drugs for the treatment and prevention of a new disease that could inflict harm to
health, including the health of a person’s descendants.
In the Russian doctrine, most research is concerned not with the socialization of the
tortfeasor’s responsibility but with the conditions for exempting a medical organization
from liability for the harm caused to the patient’s health, if these harmful consequences
were an act of force majeure. In Europe and the United States, a different approach has
been developed to bring a pharmaceutical company or medical organization to civil
liability for harm to health.
2.- Methods
Throughout the research, we used general scientific methods, including the principle
of objectivity and consistency and theoretical and historical analysis. We also applied
special scientific methods: comparative law, logical and technical-legal analysis, and
specification. The methodological basis of the study was the theory of cognition.
3.- Results
Indeed, most new pharmaceuticals aim at improving the quality of human life and
curing genomic and other intractable diseases. For example, the recombinant DNA
technology developed by US scientist Paul Berg in 1972 was used to construct the
recombinant DNA containing the INS gene. Without long-term testing, new genetic
technologies and new drugs based on a program (code) can pose a threat to the life and
health of the next generations since they edit the human genome and, ultimately,
change the biological patterns of hereditary transmission.
Genetic diagnostic tools allow one to examine the genome of a particular person,
decode it, find broken genes, and fix them. At first glance, it seems to be simple.
However, the human genome consists of 3.1 billion base pairs, forming 25,000 genes
located on 23 pairs of chromosomes. Modern methods of treatment cut out a defective
section in a broken chain of more than 3 billion nucleotides and replace it with a section
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of nucleotides without a defect. There is a danger of cutting out not a defective but a
healthy section of one’s DNA. As a result, the next generations will inherit genomic
diseases. In such a situation, questions certainly arise about who and to what extent
should be responsible for causing harm to human health and their offspring.
In Russia, the use of genetic technologies does not have sufficient legal regulation,
i.e. the law does not establish liability for their misuse and the risks of use are not
assessed, which creates a wide field for possible abuse by unscrupulous medical workers.
In this connection, A.Yu. Sokolov and N.V. Bogatyreva (2020) claimed that the state
should play a major role in the system of social control to determine the risks inherent
in the use of genomic technologies. However, each country has its system of control
over new pharmaceuticals, drugs, and genetic technologies. In the US, professional
associations of large corporations involved in the development of new technologies have
more control. Since such control is exercised by private companies, when harm is done,
the court places the responsibility on private companies. In Russia, control is assigned
to the state and it would be logical to hold the state responsible for the harm caused to
human health since it exercises not only control over the release of new drugs but also
regulate the circulation of such drugs. This reveals one aspect of socialized civil liability
for harm caused to human health as a result of exposure to new genetic drugs.
The possibility of compensation for harm to a citizen’s health due to the use of
medicines is enshrined in Article 69 of the Law of April 12, 2010 No. 61-FZ “On the
Circulation of Medicines”, according to which the right to compensation for harm is
postulated only for persons who have suffered harm to their health, but not life. Thus,
only a person whose health was harmed during the use of medicines can be a plaintiff
in civil proceedings. Their offspring are deprived of the right to appeal to the court.
When considering cases in the court, the question will certainly arise about what is
meant by the human health category and how to interpret the construct of causing harm
to health. According to M.N. Maleina (2014), health as an intangible good should be
understood as a certain physical and mental state of a person characterized by the
absence of diseases or pathologies associated with the loss, psychological, physiological,
anatomical disorders, and/or functions of the human body. Therefore, harm to health
should be regarded as a violation of anatomy, integrity, physiological functions, and
psychological and mental disorders and diseases. The consequence of causing harm to
health will be the development of a disease or exacerbation of an existing disease,
pathological process, trauma, tissue necrosis, etc. It seems that harm to health should
be considered not only in relation to a person who took new drugs but also to their
descendants.
Litigation should distinguish between the state of health of a person before the use
of pharmaceuticals and the state of health after the use of drugs. However, we cannot
observe physiological changes in the body (physiological changes) with the naked eye
since these processes are hidden. In all cases of inflicting harm to human health, it is
necessary to conduct a forensic medical examination. Such an examination should be
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carried out by a special board consisting of the most experienced forensic doctors and
clinicians.
It is also necessary to dwell on the epistemological essence of the concept of
pharmaceutical products. According to Law No. 61-FZ “On the Circulation of Medicines”,
a pharmaceutical product is understood as a pharmaceutical substance of a recombinant
nucleic acid, consisting of a cell line and excipients that passed the state registration as
a product for medical use and allowing for the regulation, repair, replacement, addition,
or removal of a genetic sequence. Based on the analysis of the above-mentioned laws,
it should be concluded that a medical device that does not consist of a cell line but
embodies methods and techniques for influencing the human body is a technology rather
than a pharmaceutical product.
In cases of compensation for harm to human health caused by pharmaceutical
products, the main problem is the concentration of evidence. To date, there are
practically no scientific studies on the concentration of evidence in cases of compensation
for harm caused by new pharmaceutical products. Consequently, the issues of searching,
concentrating, and evaluating evidence require special research. In such cases,
evidence-based work differs from evidence-based work in ordinary medical cases.
Based on the analysis of judicial practice in ordinary medical cases, the court should
establish the following circumstances for the correct consideration and resolution of
cases:
a) To determine the harm caused to human health;
b) To identify the subject who injured someone’s health;
c) To establish a cause-and-effect relationship between the harm and the action of
the harm-doer;
d) To prove the guilt of the perpetrator.
In ordinary medical cases, the court uses the principle of individual responsibility
focused on by the Constitutional Court of the Russian Federation in Resolution No. 28-P
of December 13, 2016 (Constitutional Court of the Russian Federation, 2016). However,
this principle is not applicable in cases of compensation for harm to health caused by
pharmaceuticals or genetic technologies, when it is necessary to proceed from the
principle of socialized liability of all drug manufacturers since it is not possible to identify
a specific manufacturer. The principle of individual liability in such cases will make it
impossible to compensate for harm to human health since individual liability is eroded
in a group and the existence of civil liability is called into question. P. Jourdain, Honorary
Professor of the University of Paris 1 Pantheon-Sorbonne, drew attention to the crisis of
individual civil liability and emphasized that the latest changes in civil liability revealed
deep problems within the institution. Laws should adapt to the transformation of society
and the new requirements for compensation for harm, which requires a revision of the
foundation of responsibility and the common role of guilt (Jourdain, 2021).
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The cases of harm to health caused by pharmaceuticals or genetic technologies
should be divided into three types:
1) Cases where harm is inflicted on a patient taking a certain drug. For example, as
a result of an incorrect diagnosis or an incorrect dose assigned by an attending physician,
i.e. off-label use or the use of the drug outside the instructions. Most often, such cases
are explained by the doctor’s ignorance. However, there are other cases of off-label use
caused by the incorrect promotion of drugs by pharmaceutical companies (Starchenko,
2021). According to A.V. Kuzmina, it is necessary to distinguish between such constructs
as an error in the use of the drug and incorrect use of the drug. “An error in the use is
the result of unintentional actions, while incorrect use is the intentionally inappropriate
use of the drug” (Kuzmina, 2016: 76). In such cases, it is necessary to establish a cause-
and-effect relationship between harm to health and the actions of the doctor.
2) Cases when harm is caused by medical products with the correct prescription and
use. In such cases, either a pharmacy or a pharmaceutical company can be sued in
conformity with consumer protection law. Under the current practice, it is presumed that
a medical product meets the established requirements and is guaranteed by a special
procedure for introducing this drug into circulation until proven otherwise. In these
cases, only an examination can confirm a low-quality drug and its effect on the patient’s
health, as well as a cause-and-effect relationship between them. However, conducting
an examination and drawing accurate conclusions is challenging since it is difficult to
distinguish between the side effects of a drug and the symptoms of a disease. In
addition, the doctor can prescribe several medications at once during treatment and
harm can be caused by a complex of drugs.
3) Cases when harm to health is inflicted not on the patient, but on their offspring
(the so-called “delayed harm to health”). There are no such cases in Russia but they can
be found in Europe and the US (especially in recent years). For this category of cases, it
is necessary to develop a different standard of proof and rules for assessing evidence
since the general rules cannot be applied because a certain drug is produced not by one
but by several pharmaceutical companies and it is almost impossible to establish a
specific subject of pharmacological activity that was guilty of causing harm to the health
of a citizen. As a result, the standard of proof should differ from the standard of proof in
ordinary civil cases, including in cases of injury not related to pharmaceuticals.
In addition to civil liability for harm to health caused by drugs, harm to human health
can also be caused by the use of certain genetic technologies. The treatment of a patient
with the help of new genetic technologies might not always have a positive effect,
depending on the subject using this or that technology. Any genetic technology has
certain risks for human health, therefore the law “On State Regulation in the Field of
Genetic Engineering Activities” distinguishes four levels of risks to human health. The
Decree of the President of the Russian Federation “On the Development of Genetic
Technology in the Russian Federation” also refers to the risks of uncontrolled distribution
and use of genetic technologies. Based on the foregoing, it can be concluded that genetic
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technologies have several features inherent in a source of increased danger since such
activities are not controlled by human beings.
A.V. Pekshev (2021) claimed that the results of medical care could not be predicted
due to high risks and described relationships between the patient and the medical
organization as aleatory relations. However, not all medical care is unpredictable,
therefore it is not acceptable to consider the relationship between the person taking
drugs and the pharmaceutical company as an aleatory relationship with the transfer of
risks to the patient or their offspring. The consent of a person to the voluntary use of
medical products or the use of genetic technologies should not be the basis for exempting
entities using genetic technologies or manufacturing pharmaceutical products from
liability.
Since there are practically no technical regulations for the use of genetic technologies
that would minimize the risks to human life and health, the court should regard such
harm as harm caused by a source of increased danger with all the ensuing consequences.
It is no coincidence that the relevant literature indicates that medical activity has a risky
nature due to the complexity of the technologies used and the human factor. Thus,
responsibility for the risk should be assigned to the provider of such services based on
the risk itself rather than based on guilt (Svirin et al., 2017).
It is also unacceptable in a court session on cases of causing harm to health by
pharmaceuticals or genetic technologies to establish a cause-and-effect relationship
between a delinquent and a person. It means that law should establish a cause-and-
effect relationship between harm and a drug or genetic technology until the opposite is
proven. Such a rule should become the standard of proof in these cases. In France and
Germany, a cause-and-effect relationship is presumed and not proven in pharmaceutical
injury cases. In ordinary medical cases, the establishment of a cause-and-effect
relationship is mandatory to bring a doctor or medical organization to civil liability.
In Russia, there are no prerequisites for conducting forensic examinations in civil
cases related to genetic technologies and causing harm to health by such technologies.
Genetic examinations are used to identify the DNA of the criminal or victim (the so-called
genomic fingerprinting) only in criminal cases. Other countries have a similar situation
with genetic expertise, including the US, even though genetic technologies are most
developed and widespread there.
In legal proceedings, the process of proof aims at establishing facts of different
significance. To designate the entire set of facts to be proven, the doctrine uses such a
term as “limits of proof”. To determine the subject of proof and the limits of proof in a
civil case means to give the entire process of collecting, researching, and evaluating
evidence the right direction.
It seems that the subject of proof should be determined depending on the category
of the dispute. Thus, there are different subjects of proof in cases, for example, about
causing harm to health by surgical intervention and harm caused by pharmaceuticals or
genetic technologies. Since it is almost impossible to establish the actual delinquent in
cases of harm to health by drugs, the subject of proof should only include the harm
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caused by a specific drug rather than by a specific delinquent. In ordinary medical cases,
it is imperative to establish a cause-and-effect relationship between the harm done and
the tortfeasor.
The fact of causing harm by a pharmaceutical company must be presumed by law.
Along with individual (subjective) liability, there might be an objective liability for risk
directly related to the socialized concept of law. In common law, there is a vicarious
liability for risks, when guilt is not proved in a trial and all possible tortfeasors are held
liable. Thus, a collective or indefinite delinquent fundamentally challenged the
requirement of individual causality in tort law. In one of the cases, the victim was harmed
because her mother, being pregnant, took pills containing the DES substance, which
later turned out to be harmful to the embryo. Subsequently, the daughter filed a lawsuit
against several companies out of 300 firms that produced drugs containing the
substance. The victim was unable to prove which drugs her mother had been taking for
many years before her pregnancy. Thus, there was no evidence of the individual
causality of the actions of a particular delinquent which had adverse consequences for a
particular victim and no specific tortfeasor among the defendants. However, the
California Supreme Court ruled in favor of the victim. The court indicated that the
defendants collectively represented a major market share and the harmful drug could
be produced by one of them. If the defendants were unable to refute this assumption,
then each of them could be held liable for the harm caused to the health of the victim in
the amount equal to the share of each respondent in the market for this product. When
making this decision, the US court for the first time departed from the principle of
individual liability and constructed a legal structure of socialized liability of all possible
harm-doers, in which the responsibility was assigned not to a specific harm-doer but to
all possible harm-doers for the very fact of releasing dangerous goods that could harm
the victim. The court did not establish a cause-and-effect relationship between the harm
inflicted and the tortfeasor. This judicial precedent in Anglo-Saxon law called into
question the principle of individual causality and gave rise to a serious scientific
discussion about the legal nature of this civilistic phenomenon.
Organizations using genetic technologies or producing pharmaceuticals should be
aware of the risk of inflicting harm on human health. Therefore, they should be held
liable for the very fact of creating a risk or participating in hazardous activities. In this
regard, D.E. Bogdanova (2012) highlighted that the idea of evidence-based grouping
was closely related to the socialization of civil liability.
In Russia, the civil law doctrine is traditionally based on the postulate that a victim
should prove that a delinquent harmed them by actions. In other words, a cause-and-
effect relationship must be established between harm and a certain delinquent. However,
the socialization of civil law and the strengthening of the principles of justice in the
sphere of responsibility change scientific and judicial approaches regarding
compensation for the harm caused by pharmaceuticals.
According to Yu.A. Svirin, a pharmaceutical company or a medical organization that
opposes evidence-based activities must bear the risk of adverse consequences. If it
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evades the examination and fails to provide the experts with the necessary materials
and documents, the court must recognize the fact that needed clarification in the course
of the examination as established (Svirin, 2023).
When resolving disputes about compensation for the harm to health done by
pharmaceutical companies or medical organizations, the plaintiff refers to the
defendant’s guilt but is not obliged to prove it, as follows from the general rule of proof.
The private rule should change the general rule on the distribution of proving duties,
namely: the tortfeasor is obliged to prove that the harm was caused through no their
fault. The tortfeasor’s guilt is presumed by the rule of law. Moreover, the presumption
of guilt should apply to all the circumstances arising from the fact of causing harm to
health.
On the one hand, the issue of presumption is directly resolved by the legislator in
favor of the victim who does not need to prove the guilt of the medical organization that
caused harm to health in the course of providing medical services. In addition, Article
1064 of the Civil Code of the Russian Federation establishes a presumption of guilt of
the tortfeasor. Under the interpretation of this norm, the defendant (not the plaintiff)
shall prove their innocence. However, Federal Law of November 21, 2011 No. 323-FZ
“On the Basics of Health Protection of Citizens in the Russian Federation” did not enshrine
the right to compensate for the harm caused to a person during the provision of medical
care or the harm caused by pharmaceuticals. This information is not covered in Federal
Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines”. According to Clause
3 of Article 68 of this law, the harm caused to the health of citizens as a result of the
use of drugs or the commission of illegal actions by pharmaceutical companies is
compensated in accordance with the legislation of the Russian Federation. In this
connection, relevant questions are raised in the scientific literature: speaking about the
lawful actions of medical workers, what are legal norms to compensate for harm to
health? Is compensation for harm to health acceptable in this case at all?
In one of the cases about the dangers of the chicken plague vaccine in Germany, the
plaintiff believed that the vaccine supplied by the defendant’s company turned out to be
defective. After vaccination, the plaintiff’s chickens died. The emergence of the virus
remained unclear and the court placed the risk of not proving another cause of harm on
the defendant based on the fact that the main reason under investigation is related to
the production process. According to the court, the defendant as a manufacturer can
explain the relevant factual circumstances better than the plaintiff. The former controls
the production and supply of finished products and determines and organizes the
relevant technical processes (Markesinis & Unberath, 2002). Unfortunately, Russian
courts for the most part refuse to satisfy similar claims, accepting documents on the
quality control measures applied in production as evidence of the defendant’s innocence.
The analysis of judicial practice demonstrates that disputes on compensation for
harm to health when using genetic technologies are more often resolved in favor of
pharmaceutical companies or organizations using genetic technologies. In addition,
there is no uniform assessment of the evidence in this category of disputes. In one of
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the cases, the defendant referred to the fact that all manufactured products were tested
in an independent laboratory and periodically controlled in other laboratories. The
evidence presented by the defendant was sufficient for the court to dismiss the claim,
even though such control did not exclude the presence of foreign substances in the
goods, including after passing the control, until the sale of the goods to the end
consumer.
In our opinion, the socialization of civil liability should not lead to retributive justice.
A tort in the field of causing harm to health should become a sphere of private, social,
or even public interests, therefore the state should enshrine specific tools for protecting
the violated rights in conditions where the generally accepted principles of prosecution
do not work and do not provide adequate protection for the injured party.
4.- Conclusion
Based on the foregoing, we have drawn the following conclusions:
1. At the present stage civil liability should not be regarded as a monofunctional legal
phenomenon correlated with corrective justice. The socialization of law implies the
socialization of responsibility aimed not only at compensation for damage but also at a
fair distribution of adverse consequences among harm-doers when it is impossible to
prove the guilt of a particular delinquent.
2. The civilistic doctrine presumes a general rule, according to which the absence of
guilt of a particular tortfeasor in causing harm exempts them from liability. However, if
harm to health was caused by pharmaceuticals or genetic technologies, it is not required
to prove the guilt of a certain delinquent since the principle of socialized liability of
pharmaceutical companies should apply in case of harm to health.
3. Organizations using genetic technologies should be considered a source of
increased danger with all the ensuing consequences.
4. In cases of harm to human health caused by pharmaceuticals or genetic
technologies, the standard of proof must be changed. A pharmaceutical company or an
organization using genetic technologies shall prove that the harm was not their fault
since their fault must be presumed.
5. In cases of infliction of harm to human health by pharmaceutical preparations, a
cause-and-effect relationship between the tortfeasor and the ensuing consequences
should not be proved.
Bibliographic references
• Bogdanova, D. E. (2012). “Vliyanie printsipa spravedlivosti na evolyutsiyu
ucheniya o prichinnosti v deliktnoi otvetstvennosti [The influence of the principle
of justice on the doctrine of causality in tort liability]”. Advokat, 7, 5-15.
Interacción y Perspectiva. Revista de Trabajo Social Vol. 13 N
o
2 / julio-diciembre, 2023
202
• Constitutional Court of the Russian Federation (2016). Postanovlenie
Konstitutsionnogo Suda RF ot 13 dekabrya 2016 g. N 28-P “Po delu o
proverke konstitutsionnosti podpunkta 1 stati 1301, podpunkta 1 stati
1311 i podpunkta 1 punkta 4 stati 1515 Grazhdanskogo kodeksa
Rossiiskoi Federatsii v svyazi s zaprosami Arbitrazhnogo suda Altaiskogo
kraya” [Decree of the Constitutional Court of the Russian Federation of
December 13, 2016 No. 28-P “On the case of checking the constitutionality of
Clause 1 of Article 1301, Clause 1 of Article 1311 and Subclause 1 of Clause 4 of
Article 1515 of the Civil Code of the Russian Federation in connection with
requests from the Arbitration Court of the Altai Territory”]. Available:
http://publication.pravo.gov.ru/Document/View/0001201612150010
• Jourdain, P. (2021). “Printsipy grazhdansko-pravovoi otvetstvennosti [Principles
of civil liability]”. Vestnik grazhdanskogo prava, 4, 212-241.
https://doi.org/10.24031/1992-2043-2021-21-4-212-241
• Kuzmina, A. V. (2016). “Meditsinskie oshibki pri primenenii lekarstvennykh
preparatov v zdravookhranenii [Medical errors upon using drugs in healthcare]”.
Prakticheskaya pulmonologiya, 3, 76-83.
• Maleina, M. N. (2014). “Yuridicheskaya kharakteristika zdorovya kak
nematerialnogo blaga [The legal characterization of health as an intangible
good]”. Meditsinskoe pravo, 4, 12-16.
• Markesinis, B. S., & Unberath, H. (2002). The German law of torts a
comparative treatise. Oxford; Portland: Hart Publishing, pp. 562.
• Pekshev, A. V. (2021). “Problemy pravovoi otsenki vreda zhizni i zdorovyu,
voznikshego vsledstvie neotlozhnoi meditsinskoi pomoshchi [The legal
assessment of harm to life and health resulting from emergency medical care]”.
Meditsinskoe pravo, 4, 47-50.
• Sokolov, A. Yu., & Bogatyreva, N. V. (2020). “Napravleniya sovershenstvovaniya
kontrolya za primeneniem genomnykh i postgenomnykh tekhnologii v oblasti
rastenevodstva [Directions for improving control over the use of genomic and
post-genomic technologies in the field of crop production]”. Administrativnoe
pravo i protsess, 3, 7-9.
• Starchenko, A. A. (2021). “Risk-orientirovannaya model v sisteme OMS:
problema primeneniya lekarstvennykh sredstv “vne instruktsii” [The risk-based
model in the compulsory health insurance system: the use of medicines “out of
instructions”]”. Meditsinskoe pravo, 5, 30-45.
• Svirin, Yu. A. (2023). Grazhdanskii protsess [Civil proceedings]. Moscow:
Prometei, pp. 326.
• Svirin, Y. A., Mokhov, A. A., Gureev, V. A., Androsova, I. G., & Shilovskaya, A. L.
(2017). “Proof and evidence in cases involving compensation for damage caused
Svirin, Neznamova et al / Socializar la responsabilidad civil de una organización médica por causar daños a
la salud
203
to health or life of a citizen as a result of the use of drugs for medical use”.
Journal of Advanced Research in Law and Economics, 8(1), 250-260.
