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
Publicación cientíca en formato digital
ISSN-Versión Impresa 0798-1406 / ISSN-Versión on line 2542-3185
Depósito legal pp 197402ZU34
ppi 201502ZU4645
Vol.40 N° 74
2022
Recibido el 15/05/2022 Aceptado el 12/08/2022
ISSN 0798- 1406 ~ De pó si to le gal pp 198502ZU132
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de Es tu dios Po lí ti cos y De re cho Pú bli co “Dr. Hum ber to J. La Ro che” (IEPDP) de la Fa-
cul tad de Cien cias Ju rí di cas y Po lí ti cas de la Uni ver si dad del Zu lia.
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avan ces o re sul ta dos de in ves ti ga ción en las áreas de Cien cia Po lí ti ca y De re cho Pú bli-
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Vol. 40, Nº 74 (2022), 207-223
IEPDP-Facultad de Ciencias Jurídicas y Políticas - LUZ
Legal Responsibility for Illicit Trade in
Pharmaceuticals under Conditions of the
Covid-19 Pandemic
DOI: https://doi.org/10.46398/cuestpol.4074.11
Mariia Shcherbina *
Mykhailo Akimov **
Iryna Ozerna ***
Ilgar Huseynov ****
Halyna Rossikhina *****
Abstract
The aim of this study was to examine the optimal types and
The research used methods of systematic approach, descriptive
analysis, synthesis and prognosis, systematic and formal legal
and comparative selection. It has been established that illicit trade in
pharmaceuticals is carried out by organized criminal groups and is related to
compliance with international standards of criminalization and imposition
of sanctions for illegal circulation of counterfeit medicines. All this leads
to the conclusion that the illicit trade in pharmaceuticals manifests itself
be foreseen. Equally promising is the development of a model for law
enforcement activity that includes criminalization of trade in low-quality,
unregistered and counterfeit pharmaceuticals, according to international
measures for legal persons and compensation for their victims.
* Postgraduate student, Criminal, Civil and International Law Department, Zaporizhzhia Polytechnic
** PhD in Legal Sciences, Associate Professor, Criminal Law Department, National Academy of Internal
*** PhD in Law, Assocciate Professor, Department of State and Law Sciences and Public Management,
208
Mariia Shcherbina, Mykhailo Akimov, Iryna Ozerna, Ilgar Huseynov y Halyna Rossikhina
Legal Responsibility for Illicit Trade in Pharmaceuticals under Conditions of the Covid-19
Pandemic
Keywords:
legal liability; organized crime.
Responsabilidad Jurídica por Comercio Ilícito de
Productos Farmacéuticos en Condiciones de la Pandemia
Resumen
El objetivo de este estudio fue examinar los tipos y medidas óptimos
de responsabilidad legal por delitos en el campo del comercio ilícito de
La investigación utilizó métodos de enfoque sistemático, análisis
descriptivo, síntesis y pronóstico, selección sistemática y legales formales
y comparativos. Se ha establecido que el comercio ilícito de productos
farmacéuticos es realizado por grupos delictivos organizados y se relaciona
con la corrupción y el delito cibernético. También el artículo ha revelado
fallas legales típicas, que complican la cooperación internacional en este
campo y conducen al incumplimiento de los estándares internacionales
de criminalización e imposición de sanciones por la circulación ilegal de
que debe preverse la responsabilidad administrativa o penal. Igualmente es
prometedor el desarrollo de un modelo para la actividad de aplicación de la
ley que incluya la criminalización del comercio de productos farmacéuticos
internacionales; castigos proporcionales a las personas físicas y medidas
estos.
Palabras clave:
mercados ilegales; responsabilidad legal; crimen
organizado.
Introduction
similar to other rights recognized by the international community. Patient
safety is the most important component of the provision of medical care
(Shojaei and Salari, 2020)
countries of the world.
CUESTIONES POLÍTICAS
Vol. 40 Nº 74 (2022): 207-223
of counterfeit drugs in treatment protocols alongside legal medications.
mortality rate increases (Haji et al., 2021). However, the illegal circulation
of medicines has an extremely negative impact not only on the health of the
population but also on the economic situation. In particular, the growth of
the markets for counterfeit pharmaceuticals may exceed $ 16.04 trillion in
2030 with the prospect of increasing to $ 24.24 trillion in 2040 (,
et al., 2021).
of the vast majority of countries (Europol, 2020c). However, due to the
illicit trade in pharmaceuticals, the pandemic has become more destructive
to the lives, health, and well-being of the elderly, people with serious
concomitant diseases, and persons with low socio-economic status (United
Nations, 2020).
At the same time, the real volume of illegal circulation of counterfeit
medicine can be assessed only partially. Analysis by UN experts showed
that some countries did not register the production or distribution of
2021). However, you can use the law enforcement data. Thus, under the
coordination of Interpol, more than 34,000 counterfeit medical products
Director-General
the close connection of this illegal activity with international economic and
Salazar, 2021).
has highlighted many interrelated law enforcement problems, such as
210
Mariia Shcherbina, Mykhailo Akimov, Iryna Ozerna, Ilgar Huseynov y Halyna Rossikhina
Legal Responsibility for Illicit Trade in Pharmaceuticals under Conditions of the Covid-19
Pandemic
an increase in the level of cybercrime. Under quarantine restrictions,
governments have allowed online sales of medicine and medical supplies,
as well as direct delivery to customers, to comply with the transportation
Enterprises that wanted to buy consumables and protective equipment
health care system is a global problem that creates optimal conditions for
Crime, 2021).
in the public health and criminal justice systems. They use uncertainty
among the public and authorities to create demand for scarce medicine
and to
of illicit trade in pharmaceuticals led to the inclusion in this activity of
criminal groups that were engaged in the drug business (United Nations
transnational organized criminal activity was formed. This determines the
mainstreaming of the issues of countering it with measures of legal liability,
et al.,
2021).
proper investigative procedures and subsequent judicial trials of cases.
Since such crimes can be transnational and complex, this requires the
provision of expert opinions and legal assistance from other countries
211
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Today, the only specialized international document on combating crime
medical products and similar crimes involving threats to public health
(Elliott et al., 2020; Medicrim, 2011). It determines the need to criminalize
approved drugs (The Council of Europe, 2021).
But to this day, there is no general understanding of the seriousness
of the problem. In particular, pharmaceutical companies are trying to
independently counter the counterfeiting of medicinal products through
the introduction of potential protection measures (Haji et al., 2021). In
for inadequate penalties, or do not include crimes related to the circulation
of trade in counterfeit medicines on online platforms (Interpol, 2020;
et al., 2020).
of legal responsibility is extremely unfavourable, as in the future, the
world will face new epidemics and pandemics. Therefore, we cannot allow
repetition of the situation when the society again will not be ready for stable
functioning in the conditions of the crisis (Borysov, 2021).
Although at the international and regional levels, authoritative structures
patient safety (Haji et al., 2021), the issue of legal liability for illicit trade
relevance.
and adequate measures of legal liability for their commission. It is also
considered important to identify the prospects for the development of these
purpose of this study is to
pandemic as an illegal behaviour with the development of appropriate
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Mariia Shcherbina, Mykhailo Akimov, Iryna Ozerna, Ilgar Huseynov y Halyna Rossikhina
Legal Responsibility for Illicit Trade in Pharmaceuticals under Conditions of the Covid-19
Pandemic
using legal liability.
1. Methodology and methods
of literature and data of law enforcement practice; analysis of the material,
presented in the selected sources, and evaluation of the results of these
pharmaceuticals; determination of the purpose of the article; formulation
of conclusions and practical recommendations for the formation of the
This study used international legal standards regarding the types of legal
liability for illicit trade in pharmaceuticals, and generalization of regional
and international law enforcement practice in countering it, including in the
legal liability.
the method of the systemic approach was used to consider illicit trade in
pharmaceuticals as a component of the shadow economy, on the one hand,
the method of
descriptive analysis was used to determine the types of legal liability for illicit
methods of synthesis and forecasting were used to determine the prospects
legal liability; the method of systematic selection and comparison method
were used to select and compare law enforcement practices countering
illicit trade in pharmaceuticals; the formal-legal method made it possible
to study the peculiarities of illicit trade in pharmaceuticals as a basis for the
application of various types of legal liability.
213
CUESTIONES POLÍTICAS
Vol. 40 Nº 74 (2022): 207-223
2. Results
The analysis of legal liability for illicit trade in pharmaceuticals under
to such trade as grounds for legal liability; b) types of legal liability for these
that can be included in the concept of “illicit trade in pharmaceuticals”, as
it provides for the understanding of both a criminal act and the object for
which it was committed. Trade per se means a certain stage of the activity
of bringing the medicinal product to the consumer and it is made illegal by
the object – the peculiarities of the medicinal product.
authorized medicinal products that do not meet quality standards and/
or technical conditions; b) unregistered medical products are medical
products that have not undergone evaluation and/or approval by a national
composition or source of which were intentionally distorted (World Health
through legal activities (see Figure 1).
Figure 1: Oenses related to the illicit trade in pharmaceuticals
counterfeiting of medical products and similar crimes involving threats to
public health of 2011 (The Council of Europe, 2011).
214
Mariia Shcherbina, Mykhailo Akimov, Iryna Ozerna, Ilgar Huseynov y Halyna Rossikhina
Legal Responsibility for Illicit Trade in Pharmaceuticals under Conditions of the Covid-19
Pandemic
Illicit trade in pharmaceuticals is often equated with other crimes, as it
is a complex, sometimes long-term action, combined with other types of
2).
Figure 2: The ratio of oenses in the eld of illicit trade in pharmaceuticals and
related oenses (European Union Agency for Criminal Justice Cooperation,
2021: 21; Europol, 2020a: 3; Europol, 2020c: 8; Haji et al., 2021: 8; United
Nations Oce on Drugs and Crime, 2021: 13, 19).
As already mentioned, the illicit trade in pharmaceuticals is part of the
shadow activities carried out by organized criminal groups. This is due
to the complexity of processes in the pharmaceutical industry. However,
pandemic. Quarantine hurt the organization of activities of pharmaceutical
companies, which had to respond promptly to a sharp increase in demand
for certain types of goods. In addition, quarantine restrictions adversely
et al., 2020).
215
CUESTIONES POLÍTICAS
Vol. 40 Nº 74 (2022): 207-223
et al
of supply chains from manufacturers to distributors allowed criminals to
et al., 2021). Accordingly, various
types of economic chains were formed depending on the capabilities of
organized criminal groups (see Figure 3).
Figure 3: Economic chains involving organized criminal groups in the eld of
illicit trade in pharmaceuticals (Europol, 2020c: 9)
the establishment of administrative liability in the case of illicit trade in
legal medications. However, in other cases, criminal liability should be
established.
Complex organized criminal groups often use corporate structures
Therefore, it is necessary to introduce the responsibility of legal entities
(direct actors) and legal entities shall be subject to criminal liability. A
general approach to legal liability measures can be seen in Figure 4.
business for criminals. When setting sanctions and imposing punishment,
received by the criminal, and the potential harm to public health should be
216
Mariia Shcherbina, Mykhailo Akimov, Iryna Ozerna, Ilgar Huseynov y Halyna Rossikhina
Legal Responsibility for Illicit Trade in Pharmaceuticals under Conditions of the Covid-19
Pandemic
Figure 4: Legal responsibility for falsied medical product-related crimes
(United Nations Oce on Drugs and Crime, 2019: 42)
In addition, victims of crimes should be compensated for the damage
caused by the illicit trade in pharmaceuticals.
expediency of developing a model of legal liability for illicit trade in
transnational nature of this activity, it is reasonable to focus on a general
Good Legislative Practices on
Combating Falsied Medical Product-Related Crime (United Nations
pharmaceuticals-related oenses; establishment of legal responsibility
products; establishment of proportional punishments for natural persons
217
CUESTIONES POLÍTICAS
Vol. 40 Nº 74 (2022): 207-223
crimes.
3. Discussion
A conceptual vision of the grounds and measures of legal liability for illicit
component of a complex problem, consisting of security, economic, social,
management, and law enforcement issues. This determines the diversity of
et al., 2022). In this regard, we could see the growing
importance of the pharmaceutical sector of the economy – the production
of drugs and vaccines (Borysov, 2021), the acceleration of trade, and the
(United Nations, 2020). Since the start of the pandemic, this economic
direction has become the leader in the growth of business activity (Centre
for crime prevention (Borysov, 2021).
medicinal products as the most dangerous phenomenon, as the appearance
change the concept of organized criminal activity as a component of the
shadow economy, which is characterized by the development according
to general economic laws, as the main factor was the demand for scarce
medicine and public pressure on health care systems. In the conditions
of logistical complications, this became an impetus for the production
on Drugs and Crime, 2021).
et al., 2020), it was found that the development of Internet
218
Mariia Shcherbina, Mykhailo Akimov, Iryna Ozerna, Ilgar Huseynov y Halyna Rossikhina
Legal Responsibility for Illicit Trade in Pharmaceuticals under Conditions of the Covid-19
Pandemic
In this context, it must be emphasized that there is an inconsistency
of normative prescriptions regarding falsied medical product-related
crimes
became evident precisely during the conditions of the pandemic.
therefore administrative responsibility is established for their commission
There are proposals not to consider the use of medicines that have not
the other hand, it is proposed to establish legal liability for the impact of
At the same time, the experts point to the comprehensiveness of the
issues, related to the illicit trade in pharmaceuticals, that need to be resolved.
These include a) cybercrimes, the detection of which is complicated by the
corporate policy (Button, 2020) and technological features (Fiorella et al.,
was also rightly noted (, 2021).
Thus, one can say that the crimes of organized criminal structures have
the adaptation of the law enforcement system and maintenance of public
support (Ross, 2017). The main role in this aspect is played by society’s
et al.,
a system of regulatory and institutional tools for combating illicit trade in
Conclusions
The conducted research allows us to draw many conclusions regarding
their commission.
It has been established that the illicit trade in pharmaceuticals is a type
severity, which are committed by organized criminal groups. The latter can
use legal mechanisms and legal entities. However, without establishing
CUESTIONES POLÍTICAS
Vol. 40 Nº 74 (2022): 207-223
It was proposed to develop such a model of law enforcement activities,
which is focused on criminalizing the trade in substandard (low-quality),
standards; establishing of proportional punishments for individuals and
agencies at the regional and international levels.
This study opens prospects for the development of safety standards in
A separate promising direction is the development of legal support for
international cooperation to counter transnational organized crime to
security.
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Pandemic
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Available
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www.serbi.luz.edu.ve
www.produccioncienticaluz.org
Esta revista fue editada en formato digital y publicada
en octubre de 2022, por el Fondo Editorial Serbiluz,
Universidad del Zulia. Maracaibo-Venezuela
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