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DOI: https://doi.org/10.34069/AI/2023.64.04.37
How to Cite:
Pokataev, P., Bodnarchuk, O., Hryshyna, T., Korolkov, V., & Demianchuk, Y. (2023). Advertising of medicines in Ukraine: An
ethical and legal view. Amazonia Investiga, 12(64), 348-360. https://doi.org/10.34069/AI/2023.64.04.37
Advertising of medicines in Ukraine: An ethical and legal view
Реклама Ліків в Україні: Етико-Правовий Погляд
Received: April 12, 2023 Accepted: May 25, 2023
Written by:
Pavlo Pokataev1
https://orcid.org/0000-0003-3806-2197
Oleh Bodnarchuk2
https://orcid.org/0000-0002-3211-1843
Tetiana Hryshyna3
https://orcid.org/0009-0005-1443-8278
Vladyslav Korolkov4
https://orcid.org/0000-0002-3593-8512
Yurii Demianchuk5
https://orcid.org/0000-0002-7695-6338
Abstract
The modern course of Ukraine towards economic
and political and legal rapprochement with
European states involves the adoption of uniform
rules in the field of healthcare. The objective of
this article is to examine the ethical and legal
aspects of advertising medicines in the context of
Ukraine's alignment with European states and the
adoption of uniform healthcare rules. The article
employs a dialectical method to explore the
correlation between ethical and legal
components in medicine advertising. By
analyzing domestic normative and legislative
acts, there was establish methodological features
of medicine advertising from the perspectives of
ethics and law. The research also considers the
broader context of international and national
regulation of advertising in the pharmaceutical
sector. The analysis of ethical and ethical-legal
criteria enshrined in domestic regulations
clarifies the general direction of modern state and
non-state regulation of medicine advertising in
Ukraine. This finding helps to provide a deeper
understanding of the principles guiding
advertising activities in the pharmaceutical
sector.
Overall, the article contributes to the ongoing
ethical and legal research on advertising
1
Doctor of Law, Doctor of Public Administration, First Vice-Rector, Classic Private University, Zaporіzhzhia, Ukraine.
2
Doctor of Law, Professor, Department of Private Law, State Tax University, Irpin, Ukraine.
3
PhD, Associate Professor Department of Practical Psychology Institute of Journalism and Mass Communication, Classic Private
University, Zaporіzhzhia, Ukraine.
4
Dean of the Faculty of Economics and Management, National University “Zaporizhzhia Polytechnic”, Zaporіzhzhia, Ukraine.
5
Doctor of Law, Associate Professor, Department of Private and Public Law, Kyiv National University of Technologies and Design,
Kyiv, Ukraine.
Pokataev, P., Bodnarchuk, O., Hryshyna, T., Korolkov, V., Demianchuk, Y. / Volume 12 - Issue 64: 348-360 / April, 2023
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regulation in the field of medicine circulation. It
provides a foundation for the development of
international and national regulations governing
medicine advertising, emphasizing the
importance of ethical considerations alongside
legal frameworks.
Keywords: morality, ethics, law, medicine,
distribution, advertisement.
Introduction
Cooperation between Ukraine and the European
Union in recent decades has produced processes
of searching for the most optimal model for the
development of the domestic healthcare sector
and its proper regulation. The main normative
regulators of public relations in the
pharmaceutical market, including in the field of
advertising of medicines, are law and morality
(ethics). The understanding of ethics and law as
social regulators depends primarily on the type of
legal understanding that dominates in the legal
consciousness of a particular researcher. The
positivist tradition of legal understanding, which
today dominates in the national regulatory
framework for advertising of medicines, is not
able to fully reveal the essence of the interaction
between ethics and law, as well as all the patterns
of their interpenetration and mutual influence.
The classical formal-logical approach,
characteristic of the positivist type of legal
understanding, is based on a two-level
understanding of law: at the level of language -
legal terms; at the level of logic - definitions
(meanings) of legal terms. The specificity of the
approach used in the research, based on the
dialectical method, differs from the generally
accepted philosophical and legal tradition of
domestic legal science. The legal concept as a
whole is understood in the unity of the term and
definition, that is, in such a way that the latter are
its components. Clarification at the conceptual
level of the nature of the correlation of ethical
and legal principles in the pharmaceutical field of
healthcare at the present stage of its development
in Ukraine will help accelerate the process of
convergence of the national legal system with the
legal system of the European Union.
The issues of the correlation between law and
morality at the present stage of development of
advertising of medicines remain insufficiently
researched. A legal and ethical analysis of
options for balancing public health with the
dissemination of information, how to condemn
advertising actions without simply shifting the
problem, and how significant changes in the
healthcare system can affect this dynamic should
also be at the center of interdisciplinary research
(Schenker et. al., 2014). It should also be noted
that in modern domestic and foreign scientific
research of the methodological measurement of
ethics and law, the potential of the dialectical
method is almost not used. The conducted
research begins to apply dialectics to solving
ethical and legal problems in the pharmaceutical
field of healthcare.
Materials and methods
In connection with the integration of Ukraine
with the European Union, the transformation of
the Ukrainian state is taking place. Rethinking
values in such an important area for human life
and society as healthcare requires updating the
theoretical and methodological model for
understanding the essential properties of social
phenomena. The versatility and interdisciplinary
status of the scientific problem of the correlation
between the ethical and legal components of
advertising of medicines requires a
comprehensive application of scientific methods.
Since the formal-logical method does not allow
us to explore the conceptual content of such
ethical and legal values as justice, honor, dignity,
duty, conscience, responsibility, etc. the
dialectical method was chosen as the main
method of cognition in this research.
The formal-legal method is used to analyze the
norms of the current legislation of Ukraine that
regulate relations arising in the process of
production, distribution and consumption of
advertising of medicines. With the help of the
comparative legal method, modern approaches
were established, which in international
standards and national criteria determine both the
ethical component in the advertising of
medicines, and the ethical component in the legal
regulation of this activity. The purpose of
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understanding the essence of the interaction of
ethics and law in such a specific area of
information support for the stability of the
pharmaceutical market as advertising of
medicinal products determines the need to refer
to the use of the dialectical method. In the process
of ascent from the abstract to the concrete, a
dialectical relationship was revealed in the
staging of advertising activities. Analysis and
synthesis were used to identify the stages of
production, distribution and consumption of
advertising of medicines. There is a dialectical
interconnection between these two methods, as a
result of which they cannot be considered as
separate concepts, because they only co-exist,
they are the nature of each other, two
components, two moments of a single cognition,
the end result of cognition of which is always
represented by their dialectical unity.
(Strelchenko, 2020).
The transition from legal positivism to a
dialectical approach in the reflection and
cognition of reality is justified by the change in
the paradigm of world perception and worldview,
which is taking place in Ukraine in connection
with European integration processes. At the same
time, an unthinking transfer of norms and rules
from the healthcare system of the European
Union to domestic legislation can lead to
negative consequences in the life of a person and
society. This is due to the inclusion of new
concepts from the sphere of advertising of
medicinal products in national legislative acts, as
well as the use of already known terms but with
a different semantic meaning. The compilation of
social relations by legal norms through their
abstractness has a general character, which does
not allow for the understanding of the specific
ethical and legal content of the corresponding
terms used in the legislative acts of Ukraine. To
overcome the terminological ethical-legal
uncertainty in the national sphere of advertising
of medicinal products, the dialectical method of
scientific cognition is used in the research.
Results and Discussion
General provisions of ethics and law in the field
of advertising
Back in 1821, the outstanding German
philosopher G.W.F. Hegel, who first applied
dialectics as a method to the knowledge of ethical
problems in law, noted: "Law and moral
foundations, the true world of law and morality
can be embraced by thought, through thought this
world acquires a meaningful form" (Hegel,
2000). The regulation of ethical principles
historically originates in the form of self-
regulation as a response to the request of civil
society. Further regulation takes place at the
international level within the framework of treaty
law and subsequently takes the form of state
regulation by enshrining in national legislation.
Philosophers suggest that, in historical
retrospect, moral values were formed
simultaneously with law and in competition with
it. At a certain stage in the development of
society, a kind of "division of labor" took place
between law and morality. The subject of legal
regulation remained mainly actions and relations
that were proved as a result of a dispute, if
necessary, were prevented or punished through
measures of state coercion. The subject of moral
assessments were the qualities of the individual,
expressed in their behavior and actions.
The moral foundations of human existence are
studied by ethics as a component of philosophy.
Currently, morality is understood as a form of
social consciousness and a type of social
relations (moral relations), one of the ways to
regulate human behavior in society through
established prescriptions (Shemshuchenko,
2007). Moral norms are characterized by a
certain uncertainty, the presence of some
differences in the moral beliefs of people,
depending on the level of their culture, age,
material well-being, etc. Based on the fact that
morality means the conformity of people's
behavior with moral norms, it is difficult for
ethics to find the main, general criterion for
assessments that determines the content of moral
principles and norms as the basis of moral
behavior. Pharmaceutical ethics as part of social
ethics is the science of the moral value of human
actions. Professional deontology, within the
framework of professional ethics, studies the
moral and ethical culture of a professional, their
behavior in the field of their activity, explores the
problems of professional duty and the proper
form of manifestation of social necessity specific
to morality. Law is defined as a system of
generally binding norms established or
sanctioned by the state, the observance and
execution of which is ensured both by persuasion
and by the power of state coercion. Legal norms
are specific in content, unambiguous, delineate
rights and obligations, and have certain limits of
validity (Shemshuchenko, 2007). With the help
of morality, law seeks to resolve a social conflict
on the basis of what is due as a moral ideal.
Taking into account morality, the interests of
certain groups of people are comprehended and
reflected - collective, community, society; the
ratio of private and public interest in favor of the
public, taking into account public values, is
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determined. Medical deontology is the doctrine
of the principles and norms of behavior of
medical personnel. General medical deontology
is a set of rules for all medical professionals,
regardless of their specialty. Specific types of
medical deontology contain recommendations
related to the characteristics of a particular
medical specialty. The term "deontology" was
proposed by the English lawyer and sociologist
Jeremy Bentham in the 19th century in his work
"Deontology, or the science of morality" to refer
to the theory of ethics as a science of morality
(Biryukova, Kharina, Nesterova, Malakhovskiy,
2021). Medical and legal deontology are
considered the most developed, since the level of
human being depends on the proper
implementation of the professional activities by
medical and legal workers.
Consideration of the ethics of advertising as an
object of informational legal relations was
founded in 1938 by Francis Finkelhor
(Hrytsyuta, 2012). Ethics in the field of law
(legal ethics) is aimed at solving moral problems
in the professional activities of subjects of legal
relations with the help of ethical and legal norms.
Ethical foundations are implemented in law at
three levels:
1) axiological (legal values);
2) epistemological (legal understanding);
3) praxeological (law enforcement).
If it is impossible to resolve a certain social
conflict with the help of law, the norms of
morality are applied. In conditions of lowering
the level of morality, for example, with the
emergence of new values, ethical norms are fixed
in the norms of law. Thus, the moral and legal
forms of regulation of public life as a whole have
a universal character. The interests of society and
the state are the main principle and purpose of
professional activity, in particular in the field of
advertising. The main functions of social ethics
in the field of advertising are informational and
communicative, because under the intense and
purposeful influence of advertising as a social
phenomenon in society and in the individual,
new values and attitudes are formed.
Ethical norms (norms of moral behavior) as
ordinary acts, together with the fundamental
principles, are enshrined in ethical codes -
codified sets of basic principles and rules. As a
rule, such regulatory documents are of a
recommendatory nature, that is to say, not
endowed with legal force. The provisions of
codes of professional conduct do not provide for
legal sanctions against violators of ethical
standards in the field of advertising. However, in
case of violation of ethical prescriptions,
regulated by law, certain legal consequences may
arise.
The general orientation towards limiting the
manifestations of dishonesty in the advertising of
medicines by legal and moral norms is
determined by the peculiarity of the consumer
product by a person that is advertised. Thus, the
potential danger of medicines to the health, and
sometimes the life of the patient, entails the
necessity and obligation of state monitoring and
control in the field of advertising medicines in
different countries of the world.
Correlation of ethical and legal aspects of
advertising at the conceptual level
The ratio of law and ethics as the main social
regulators in the pharmaceutical field of
healthcare, on the one hand, is determined by
their content (philosophical and legal), and on the
other hand, by their interaction (mutual influence
and interpenetration). The essence of law and
morality is the main, relatively stable, qualitative
basis of these categories, which determines their
true nature and purpose in society (Yevhutych,
2017). In ethics and law, the following terms are
widely used to denote universal human values:
justice, honor, dignity, duty, conscience,
responsibility, etc. However, at the conceptual
level, the meanings of these terms in law and
ethics do not coincide. Dialectics, on the other
hand, makes it possible to trace the movement of
thought from the differences between ethics and
law to their contradictions, from their interaction
to unity. Dialectics is the driving soul of any
scientific development of thought, representing
the only principle that introduces an immanent
connection and necessity into the content of
science... Dialectics is such a transition of one
definition to another, in which it turns out that
these definitions are one-sided and limited, that
is, containing negation themselves (Hegel,
1973).
Morality is a form of social consciousness that
reflects reality through moral norms, principles
and rules of behavior. It reflects certain values
that have developed in society, enshrined in the
norms of human behavior and are contained in
the concepts of good and evil, honor and dignity,
conscience, justice and injustice. Morality
regulates the behavior of people in all areas of
life, while law is only socially significant
behavior. Ethics and law are formal normative
systems of public regulation of public relations.
But unlike legal norms, all moral norms are based
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on the rules of absolute deontic logic, that is, they
are reduced to an order or prohibition addressed
to a single individual. Moral norms are not
identical to legal norms either in content, or in
logical-theoretical (hypothesis, disposition,
sanction), or in deontological structure. So, the
main difference between them is the criteria for
evaluating the actions, behavior of people and
their relationships. Ethical concepts, due to their
abstractness, are limitless and can be applied to
natural phenomena and social life. However,
moral concepts are concretized if they relate to
legal relations between people. Legal relations
between people are legal relationships; and moral
– benevolence and compassion, friendship and
guardianship, solidarity and mutual assistance,
etc. Law is directed at social relations that can be
formally defined for protection and reproduction
(or prevention). The general goal of law and its
implementation is the rule of law. The general
goal of morality is the education of a moral and
virtuous person.
The constant cause of contradictions between
law and morality in any society is the formal
certainty of law, which does not always make it
possible to extend its action to situations that
urgently require legal regulation, but not
provided for by law, or, conversely, allows the
application of law to life relationships and
situations where morality considers such
application unfair. Contradictions appear due to
the fact that certain situations that are identical
from the point of view of morality are not
identical from the position of law. Or, on the
contrary, some life circumstances that are similar
from a legal point of view are considered
different from a moral point of view.
The commonality of law and morality is
manifested at the following levels: historical
(genesis and development), teleological
(ordering social relations with fair instructions),
structural (norms, relationships, culture),
categorical (universal scientific generalizations).
Thus, the correlation between the concepts of
ethics and law can be represented by a dialectical
triad: ethics (thesis) – law (antithesis) – ethical
law (synthesis). The unity of morality and law
comes from the commonality of socio-economic
institutions, culture, upbringing, people's
commitment to the ideals of freedom, equality
and justice. Complementing and correcting each
other, law and morality should in no case
duplicate each other; they cannot be identified,
mixed, or replaced by one another or vice versa
(Yurkovska et al., 2018). Rules of law are based
on the principles of ethics and morality. Their
purpose is to establish and maintain balance,
social stability and order, to achieve a social
compromise associated with the creation of a
standard, a model of behavior. Any activity for
the circulation of medicines is implemented
through a system of legal guidelines (legal
norms) contained in regulatory legal acts of
different legal force and determining the
parameters of the proper behavior of the subjects
of this activity (Strelchenko, 2019).
Traditionally, monological (combination of
norms in one legislative act) and polylogical
(combination of norms in special legislative acts)
regimes of legal regulation of advertising of
medicines are distinguished. At the same time, in
international law, we can identify a trend towards
the unification of national laws in different states,
and therefore unified rules for regulating
advertising are being developed that operate
regardless of borders (Pashkov et al., 2017).
International standards for the regulation of
advertising of medicines
The International Chamber of Commerce (ICC)
has been the main body of regulation in the field
of international advertising since 1937, when the
first ICC Code of Advertising Practices was
published. Since then, the ICC self-regulatory
sphere has expanded multiple times in order to
assist companies in responsible promotion of
their products on the market. In 2006, previously
disparate codes were revised and merged into a
single Consolidated Code of Advertising and
Marketing Communications (ICC Constitution,
2018). Its latest update in 2018 follows the
tradition of promoting high ethical standards for
advertisers, advertising agencies and media
worldwide. First of all, the code was conceived
as an instrument of self-discipline of business
entities. It uses the term "advertising" to mean
any form of marketing communications carried
out by the media, usually in exchange for
payment or other valuable consideration.
Legality, dignity, honesty and reliability, social
and professional responsibility are the basic
principles of all marketing communications,
which must comply with the generally accepted
principles of fair competition in business (Article
1). These ethical standards should be followed by
all who are involved in advertising: advertisers,
advertising producers, advertising agencies and
the media. Article 17 of the Code states that
marketing communications must not,
unreasonably for educational or social reasons,
contain a visual image or description of
potentially dangerous activities or situations that
demonstrate a disregard for safety or health
measures, as defined by local national standards.
In particular, the information provided with the
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product must include comprehensive health and
safety instructions where necessary. Appropriate
warnings should be clearly articulated through
the use of images, sound, text or their
combinations. At the level of the principles
regulating sales promotion, it is enshrined that all
promotions must be fair to users, competitors and
other market participants (Article A1).
The Ethical Criteria for Medicinal Drug
Promotion (World Health Organization, 1988),
approved by Resolution 41.17 of the 41st
Assembly of the World Health Organization,
should help to decide whether medicinal drug
advertising practices are in line with generally
accepted ethical standards. These criteria reflect
the general principles of ethical standards,
primarily the principles of honesty and fairness
in the promotion of medicines on the market and
do not constitute legal obligations. Promotion is
the creation and maintenance of permanent links
between the enterprise and the market in order to
enhance sales of goods and form a positive image
by informing, persuading and reminding of its
activities (Olkhovskaya, 2019). The term
"promotion on the market" is used in relation to
all types of information and promotional
activities carried out by manufacturing firms and
supplying firms to stimulate the prescription,
supply, purchase and/or use of medicines. All
promotional materials containing any claims
about medicines must be reliable, accurate,
truthful, meaningful, balanced, up-to-date,
evidence-based. They should not contain
wording or unverified conclusions that are
misleading. Any information that could lead to
unjustified use of a medicine or unnecessary risk
should also not be omitted. The word "safe"
should only be applied to medicinal products that
have been properly tested. Comparison of
medicines should be based on real facts, be
impartial and reasoned. Information and
advertising material should be presented in a way
that does not distort the essence of the promoted
medicines.
In the European Union, integration and legal
standards for the circulation of medicines are
provided with the help of a single legal
terminology, a unified definition of medicines,
concepts and categories associated with their
circulation (Pasechnyk, 2015). In the Member
States of the European Union, medicinal
products intended for marketing are subject to
secondary EU law, in particular Directive
2001/83/EC (2001) of the European Parliament
and of the Council on a Community Code
relating to medicinal products for human use.
Medicinal advertising must include any form of
targeted information, surveys or use of incentives
to promote the prescribing, supply, sale or
consumption of medicinal products. In particular,
it applies to: the population; persons qualified to
prescribe or dispense such medicines; visits by
medical sales representatives to persons qualified
to prescribe medicines; supply of samples; the
use of incentives to encourage the prescription or
dispensing of medicines in the form of a gift,
offer or promise of any benefit or reward in cash
or in kind, unless their real cost is minimal;
financing of promotional activities involving
persons qualified to prescribe or dispense
medicines; financing of scientific conferences
with the participation of persons qualified to
prescribe or dispense medicines, in particular the
payment of their travel and living expenses
associated with such participation. Advertising
of medicines does not apply to: labeling and
accompanying leaflets tabs; correspondence,
which may be accompanied by non-advertising
material necessary to answer a specific question
about a specific medicinal product; factual
information announcements and reference
material regarding, for example, repackaging,
warnings about adverse reactions as part of
general medicine warnings, sales catalogs and
price lists, provided that they do not contain
information about the product; information about
human health or diseases, in the absence of
references, even indirectly, to medicinal products
(Article 86). Advertising of a medicinal product,
firstly, must encourage the rational use of the
medicinal product, presenting it objectively and
without exaggerating its properties, and
secondly, must not be misleading (Article 87).
Member States must prohibit the advertising to
the public of medicinal products which:
a. are available on prescription only;
b. contain substances defined by international
convention, in particular the 1961 and 1971
United Nations Conventions, as
psychotropic or narcotic substances.
They must prohibit direct distribution by the
pharmaceutical industry of medicines to the
public for promotional purposes. Member States
have the right to prohibit in their territory the
advertising to the public of medicinal products
the cost of which may be reimbursed. To public
it is allowed to advertise medicinal products
which, due to their composition and purpose, are
prescribed and developed for use without the
intervention of a doctor for diagnostic purposes
or for the prescription of treatment or
observation, where appropriate, on the advice of
a pharmacist (Article 88). The following special
types of medicine advertising are distinguished:
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1) advertising for an indefinite circle of people
(population);
2) advertising addressed to healthcare
professionals (doctors, junior medical
workers, pharmacists) (Pashkov, Olefir,
2017).
The Code of Practice (Ethos) of the International
Federation of Pharmaceutical Manufacturers &
Associations (IFPMA, 2019) specifies that
materials related to pharmaceutical products and
their uses, whether they are promotional or no,
that is sponsored by a company must clearly state
who sponsored it. Promotion should not be
disguised. According to the Information
Consistency Standard, advertising must not
conflict with approved local product information.
The standard of accuracy and non-misleading
requires that advertising information must be
clear, legible, accurate, balanced, fair and
complete enough to enable the recipient to form
their own opinion about the therapeutic value of
the relevant pharmaceutical product.
Promotional information must be based on an
updated assessment of all evidence and clearly
reflect that evidence. It must not be misleading
by distortion, exaggeration, undue emphasis,
omission, or in any other way. Every effort
should be made to avoid ambiguity. Absolute or
comprehensive requirements should be used with
caution and only with proper qualifications and
justification. In general, descriptions such as
"safe" and "no side effects" should be avoided,
and appropriate qualifications should always be
cited.
With the development of modern science and the
pharmaceutical industry, the range of medicines
is expanding on the world market. Total global
pharmaceutical revenue, which stood at $1.121
trillion in 2022, is expected to continue to grow
at a rate of $1.435 trillion until 2027 (Statista
Health Market Outlook, 2023). Overall, the
pharmaceuticals market is expected to grow by
5.39% on average between 2023 and 2027
(Statista). In turn, a wide range of pharmaceutical
products requires operational awareness of
medical and pharmaceutical workers about
medicines. Pharmaceutical companies conduct
their business depending on the strategy of
promoting medicines among doctors in exchange
for increasing the professional knowledge of the
doctor. Everyone in this trade, besides of
regulatory obligations, must be mindful of ethical
beliefs (Kabir et al., 2021). Failure to comply
with these conditions leads to the existence of
unfair practices for the promotion of medicines
by pharmaceutical companies among healthcare
professionals. A separate link in the chain of
corrupt relations in the pharmaceutical sector is
medicine marketing, which involves the
establishment of unethical relations between
pharmaceutical companies and medical workers
(Bozhenko, 2022). In order to reduce the risks of
violating the law in the field of unfair
competition, paying significant fines and lengthy
litigation, these companies implement
compliance programs aimed at increasing the
ability to act in compliance with both external
(national laws or international treaties) and
internal (codes of ethics and behavior) norms and
rules. There are positive trends in the regulation
of pharmaceutical promotion, such as rules
requiring mandatory disclosure of information
about the financing of medical professionals and
patient groups, but more systemic fundamental
changes are still needed. Most pharmaceutical
companies have their own codes of ethics, which
in some countries provide for the disclosure of
payment information to third parties (Alves et al.,
2019). However, often the information work of
medical (pharmaceutical) or sales representatives
of these companies is accompanied by the
inclination of medical and pharmaceutical
workers to recommend and prescribe products to
patients in order to form a positive impression
about them in the latter. Pharmaceutical
companies can finance medical professionals to
promote their products, which is one of the main
types of corruption offenses in the healthcare
sector (Bozhenko, 2022). However, in many
countries around the world there are legal
restrictions for healthcare professionals to
perform activities related to the advertising of
medicines. For example, in Ukraine, the Law of
Ukraine "Fundamentals of Ukrainian Legislation
on Health Care" (Law No. 2801-XII, 1992)
prohibits medical, pharmaceutical and
rehabilitation specialists from advertising
medicines during their professional activities
(Article 78-1). It is significant that the legislator
has not introduced a complete ban on
communication between company
representatives and medical workers. Naturally,
without professional communication of the
medical and pharmaceutical communities, the
development of medical science and,
accordingly, improving the quality of treatment
in the interests of patients is impossible
(Aleksіeіev & Anishchenko, 2019).
National moral, ethical and legal criteria for
advertising medicinal products
In Ukraine, at the constitutional level, a person,
their life and health, honor and dignity,
inviolability and security are recognized as the
highest social value. Ensuring the economic and
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information security of Ukraine is the most
important function of the state, the cause of the
entire Ukrainian people.
The preamble of the founding Law of Ukraine
"Fundamentals of Ukrainian Legislation on
Health Care" (Law No. 2801-XII, 1992) states
that every person has a natural, inalienable and
inviolable right to health care. Responsibility to
present and future generations for the level of
health and the preservation of the gene pool of
the people of Ukraine, the introduction of a
healthy lifestyle is assigned to society and the
state. It is the state's responsibility to ensure
compliance with the requirements of the law on
the restriction of advertising of medicines
(Article 19). At the same time, state regulation of
advertising activities through law is directed, first
of all, to the prevention and termination of unfair
advertising. Promotional ethics and advertising
are one of the key legislative and regulatory
vectors that determine the most active
fundamental factors of influence on the legal
basis for the circulation of medicines (Solovyov,
2018). Thus, medical, pharmaceutical and
rehabilitation specialists during their
professional activities do not have the right to
advertise medicines, including prescribing
medicines on forms containing advertising
information, and indicating manufacturers of
medicines (trademarks) (Article 78-1). At the
same time, their professional duty is the
requirement to comply with professional ethics
(Article 78). In general, about the advertising of
goods harmful to human health, Article 32 of the
said Law contains a reference prescription to the
Law of Ukraine "On Advertising" (Law of
Ukraine No. 270/96-VR, 1996).
The Law of Ukraine "On Advertising" (Law of
Ukraine No. 270/96-VR, 1996) defines
advertising as information about a person or
product, distributed in any form and by any
means, and intended to form or maintain
awareness of advertising consumers and their
interest in such a person or product (Article 1).
This Law does not apply to announcements of
individuals not related to entrepreneurial
activities (Article 2). At the same time, such
concepts as "social advertising", "sponsorship"
used in the Law indicate that the purpose of
advertising activities is not necessarily to make a
profit. It is this Law that defines the features of
advertising medicines as a socially significant
category of goods, which directly affects the
health of consumers and requires increased
control by the state. Thus, it is allowed to
advertise medicines that are duly authorized by
the central executive body implementing the
state policy in the field of healthcare for use in
Ukraine and dispensed without a doctor's
prescription and not included by the central
executive body in the field of healthcare to the
list of medicines prohibited from advertising.
Advertising activity is also limited to the
establishment of legal and ethical principles and
norms in order to exercise the right to complete,
reliable information about the medicinal product
and to prevent harm to both public and state
interests and consumer rights. Thus, the basic
principles of advertising are determined by:
legality, accuracy, reliability, the use of forms
and means that do not cause harm to the
consumer of advertising. It is indicated that
advertising should not undermine public
confidence in advertising and must comply with
the principles of fair competition; must not
contain information or images that violate
ethical, humanistic, moral standards, neglecting
the rules of decency (Article 7). It is prohibited
to advertise medicines, the use and dispensing of
which is allowed only by prescription, as well as
medicines included in the list of medicines
prohibited from advertising. It is determined that
the advertisement must contain: objective
information about the medicinal product and be
carried out in such a way that it is clear that the
given message is an advertisement, and the
advertised product is a medicinal product; the
requirement to consult a doctor before using the
medicinal product; recommendation on
mandatory familiarization with the instructions
for the medicinal product; warning text that
contains: "Self-treatment may be harmful to your
health." It is forbidden to post: information that
may give the impression that when using the
medicinal product, consultation with a specialist
is not necessary; that the therapeutic effect of the
use of the medicine is guaranteed; images of
changes in the human body or its parts as a result
of illness, injury; recommendations or references
to the recommendations of medical
professionals, scientists, medical institutions and
organizations on advertised goods or services;
special expressions of gratitude, letters, excerpts
from them with recommendations, stories about
the use and results of the advertised goods or
services from individuals; images and mentions
of the names of popular people, heroes of film,
television and animation films, authoritative
organizations; information that may mislead the
consumer about the composition, origin,
effectiveness, patent protection of the advertised
product, etc. At the same time, it is allowed to
distribute advertising of medicines placed in
specialized publications intended for medical
institutions and doctors, as well as distributed at
seminars, conferences, symposiums on medical
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topics. Participation of doctors and other
professional medical workers, as well as persons
whose appearance imitates the appearance of
doctors, is prohibited in the advertising of
medicines. The Law contains the term "ethics"
and the term combination: "ethical norms",
"ethical and moral and legal aspects", "ethical
and humane considerations", but they are not
directly associated with advertising. The terms
"advertisement" and "advertising" are covered by
the term "media provision" (Article 26). The
terms "promotion of the relevant product on the
market" (Article 1) and "advertising activities"
(Article 22) are also used.
The Law of Ukraine "On Medicinal Products"
(Law No. 123/96-ВР, 1996) determines that the
features of advertising medicines are determined
by the Law of Ukraine "On Advertising" (Law of
Ukraine No. 270/96-VR, 1996), that is, not the
Law of Ukraine "Fundamentals of Ukrainian
Legislation on Health Care" (Law No. 2801-XII,
1992). The same Law permits the advertising of
medicines dispensed without a doctor's
prescription and not included in the list of
medicines prohibited from advertising. It is
established that the advertising of medicines, the
use and dispensing of which is allowed only by
prescription, as well as those included in the list
of medicines prohibited from advertising, is
prohibited. The current Law of Ukraine "On
Medicinal Products" (Law No. 2469, 2022),
which has not yet entered into force, states that
the requirements for advertising medicines are
established by the Law of Ukraine "On
Advertising" (Law of Ukraine No. 270/96-VR,
1996), taking into account the specifics defined
by this Law (Article 87). This Law, adopted
taking into account the provisions of the
Directive of the European Parliament and
Council 2001/83/EC (2001), enshrines a number
of new terms for national legislation in the field
of medicine circulation: "ethical and scientific
requirements", "ethical principles", "principles of
medical ethics". Section VIII of Directive
2001/83/EC (2001) of the European Parliament
and of the Council uses the terms "advertising of
medicinal products", "advertisement of
medicinal products" (Articles 16g, 92) and the
term "marketing" (Article 98). And in this Law,
the term combinations are used: "advertising and
promotion of medicines", "advertisement and
promotion of medicines", "distribution of
medicines", "promotional events", "promotional
materials", "promotional statements" (Article
87). Thus, promotion of a medicinal product is
defined as information about a medicinal
product, disseminated in any form and by any
means, intended to form or maintain awareness
of medical and pharmaceutical workers,
rehabilitation specialists about such a medicinal
product and aimed at promoting the prescription,
dispensing, sale or use of a medicinal product
(Article 2). It should be noted that the term
"promotion" is not new to Ukrainian legislation.
Thus, due to the fact that, as of 2013,
pharmaceutical companies, in addition to direct
advertising of medicines, actively used the means
and methods of promoting medicines that are not
regulated by national regulations, by Order of the
Ministry of Health of Ukraine dated October 09,
2013 No. 870, it was approved and introduced
guideline "Medicines. Proper Promotion
Practice. Standardization of MHU 42-1.2:2013"
was put into effect. The specified national
standard, taking into account the provisions of
Section VIII of the Directive of the European
Parliament and of the Council 2001/83/EC
(2001), proposed a new system of hierarchy of
concepts in the field of medicine promotion and
introduced some new terms. Advertising and
promotion of medicines were devoted to separate
sections of the guide. The concept of "medicine
promotion" was defined as a set of activities or
any ongoing, supported activity, including
through the media, the Internet, organized or
sponsored by a pharmaceutical company in order
to promote medicines, increase the volume of
recommendations, supply or use of medicines. At
the same time, the promotion of medicinal
products also included such activities as:
advertising of medicinal products, the
advertising of which is permitted in accordance
with the requirements of the current legislation of
Ukraine; providing information about any
medicines; sponsorship. The concept of
"promotional material" was understood as any
informational carrier created for the purpose of
promoting a medicinal product both among
healthcare professionals and among any other
persons. Also, the term "promotion" is used in the
Action Plan aimed at obtaining support for
granting Ukraine the status of a candidate
member of the European Union, approved by the
Decree of the Cabinet of Ministers of Ukraine on
June 17, 2022 No. 480-r. and in the
Communication Strategy for the European
Integration of Ukraine for the period up to 2026,
approved by the Decree of the Cabinet of
Ministers of Ukraine dated December 9, 2022
No. 1155-р. The terms "promotion" and
"marketing" are used as synonyms in the Action
Plan for the implementation of the Human
Development Strategy for 2021-2023, approved
by the Decree of the Cabinet of Ministers of
Ukraine dated December 9, 2021 No. 1617-р.
The term "promotion and advertising of
medicines" is used in the Decision of the
Volume 12 - Issue 64
/ April 2023
357
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National Security and Defense Council of
Ukraine "On the state of the national healthcare
system and urgent measures to provide citizens
of Ukraine with medical care" dated July 30,
2021, put into effect by Decree of the President
of Ukraine dated August 18, 2021 No. 369/2021.
In the IFPMA Code of Practice (Ethos) (2019),
the term "promotion" means any activity
conducted, organized or sponsored by a member
company and directed at healthcare professionals
for the purpose of promoting the prescriptions,
recommendations, supply, use or consumption of
their pharmaceutical products through all
communication methods, including the Internet.
The term "distribution" (wholesale of medicines)
in the Law is defined as the activity of business
entities (except for individuals - entrepreneurs) to
purchase medicines from business entities that
have the appropriate license (manufacturers,
importers or distributors), storage,
transportation, supply, import, export and sale of
medicines from pharmacy warehouses (bases) to
other subjects of wholesale or retail trade in
medicines that have received appropriate licenses
for this, to medicine manufacturers, directly to
medical institutions or legal entities, structural
units of which are medical and preventive
healthcare institutions. It should be noted that the
regulatory and legal definition of the term
"distribution of medicinal products" is given in
the Resolution of the Cabinet of Ministers of
Ukraine dated November 30, 2016 No. 929 "On
Approval of the License Conditions for the
Implementation of Economic Activities in the
Production of Medicines, Wholesale and Retail
Trade in Medicines, Import of Medicines
(excluding active pharmaceutical ingredients)".
Distribution (wholesale distribution) of
medicines is defined as any activity related to the
receipt, storage, supply, transportation and
import/export of medicines, with the exception of
their sales directly to citizens for personal
consumption. This activity is carried out jointly
with manufacturers or their representatives,
importers, other enterprises engaged in
wholesale and/or retail trade in medicinal
products, and medical and preventive healthcare
institutions. We should note that a medicine as a
product of pharmaceutical activity in the process
of circulation, from manufacturer to consumer,
may contain a variety of intellectual property
objects and be protected through the system of
copyright, industrial property rights (Kodinets et
al., 2022).
At the level of self-regulation in Ukraine, there is
the Code of Ethics of Pharmaceutical Workers of
Ukraine (2010), approved by the VII National
Congress of Pharmacists of Ukraine. It defines
the fundamental ethical principles based on
universal human values and the norms of
professional behavior and moral responsibility of
pharmaceutical workers in the process of their
professional activities, based on the foundations
of pharmaceutical ethics and deontology. The
Code is based on international ethical standards,
and its legislative base is determined by the
Constitution of Ukraine, the Civil Code of
Ukraine, the Laws of Ukraine "Fundamentals of
Ukrainian Legislation on Health Care", "On
Medicinal Products", "On Protection of
Consumer Rights" (Law of Ukraine No. 30), "On
Advertising" and other regulatory legal acts of
Ukraine. In particular, it provides for the
obligation of a pharmaceutical worker to comply
with the norms of the legislation of Ukraine on
the advertising of medicines. Therefore, the Code
of Ethics for Pharmaceutical Workers of Ukraine
is a recommendatory act, however, it
demonstrates a combination of ethical and legal
prescriptions and is based on the provisions of
the current legislation of Ukraine and
international standards in the field of public
health and pharmaceuticals (Terzi et al., 2019).
The code uses: the term "self-promotion" and the
term "unethical advertising". The terms
"marketing" and "distribution" of medicinal
products are used as synonyms in relation to the
principles of advertising. The Code also uses the
terms "promotion of medicines", "distribution of
medicines", "marketing of medicines",
"advertisement of medicines". However, their
definitions are not given.
Therefore, the terms and term combinations for
the designation of concepts related to the
advertising of medicines used both in the national
code of ethics and in acts of legislation of
Ukraine can be classified into the following
terminological groups. The first (single-valued)
group: 1) advertisement, advertisement of a
medicinal product; 2) advertising, advertising
activities, advertising of medicines; 3)
promotion, promotion of medicinal products,
promotional events, promotional materials,
promotional statements; 4) marketing, marketing
of medicines; 5) distribution of medicines. The
second (synonymous) group: 1) promotion and
marketing; 2) marketing and distribution. The
third (equivalent) group: 1) advertisement and
promotion of medicinal products, promotion and
advertising of medicines, advertising and
promotion of medicinal products.
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Conclusions
The research shows that the regulation of ethical
foundations of public relations through morality
and law historically originated in non-state, and
subsequently in state forms. Law and morality, as
social normative regulators, are aimed at
establishing and maintaining order in society and
form the standards of people's behavior. Moral
norms are generalized rules of behavior through
ideas and principles that form the social qualities
of the individual, regulate their internal
awareness of their behavior. The norms of law as
specific rules of conduct determine, support and
regulate the external form of the latter.
At the level of international and national
regulations that define ethical and legal standards
and criteria in the field of advertising of
medicines, using the dialectical method,
correlations and mutual transitions of the
definitions of ethical and legal concepts are
revealed, the unity of moral and legal systems is
traced.
The conducted research proves that the
implementation of the provisions of international
legislation, primarily of the European Union in
the field of advertising of medicines, into
Ukrainian legislation has a generally positive
effect, manifested in the elimination of gaps that
exist in domestic legislative acts. The current
state of the problems of bringing Ukraine closer
to the European standards for regulating the
advertising of medicines at the conceptual level
has been researched. It is determined that the
legislation of Ukraine contains a number of
thematic concepts that either coincide or are
close in terms of definitions to the concepts
contained in the relevant EU legislation.
It has been established that a conceptual
inconsistency in the ethical-legal terminology
used in domestic regulatory acts governing
relations advertising of medicinal products at
both state and non-state levels still remains. This
requires the continuation of scientific research on
the regulation of advertising of medicinal
products in Ukraine in order to further unify
domestic terminology with the terminology of
European Union legislation.
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