Scientific-practical and legal problems of implementation of the personalized medicine
The article is devoted to the comprehensive analysis of scientific, practical and legal issues of personalized medicine that is a rapidly developing science-driven approach to healthcare. It is concluded that there is lack of general legal framework for the encouragement of scientific researches and...
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Інститут експериментальної патології, онкології і радіобіології ім. Р.Є. Кавецького НАН України
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| Цитувати: | Scientific-practical and legal problems of implementation of the personalized medicine / N.O. Bezdieniezhnykh, V.V. Reznikova, O.V. Rossylna // Experimental Oncology. — 2017 — Т. 39, № 3. — С. 229–233. — Бібліогр.: 23 назв. — англ. |
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Bezdieniezhnykh, N.O. Reznikova, V.V. Rossylna, O.V. 2018-06-19T09:06:53Z 2018-06-19T09:06:53Z 2017 Scientific-practical and legal problems of implementation of the personalized medicine / N.O. Bezdieniezhnykh, V.V. Reznikova, O.V. Rossylna // Experimental Oncology. — 2017 — Т. 39, № 3. — С. 229–233. — Бібліогр.: 23 назв. — англ. 1812-9269 https://nasplib.isofts.kiev.ua/handle/123456789/138535 The article is devoted to the comprehensive analysis of scientific, practical and legal issues of personalized medicine that is a rapidly developing science-driven approach to healthcare. It is concluded that there is lack of general legal framework for the encouragement of scientific researches and practical implementation in this field. The article shows foreign experience and prospects for the introduction of personalized medicine as a key concept of healthcare system, which is based on a selection of diagnostic, therapeutic and preventive measures that would be the most effective for a particular person in view of individual characteristics. The conclusions and proposals to improve the current legislation and development of personalized medicine in Ukraine are suggested. en Інститут експериментальної патології, онкології і радіобіології ім. Р.Є. Кавецького НАН України Experimental Oncology View of the problem Scientific-practical and legal problems of implementation of the personalized medicine Article published earlier |
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Scientific-practical and legal problems of implementation of the personalized medicine |
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Scientific-practical and legal problems of implementation of the personalized medicine Bezdieniezhnykh, N.O. Reznikova, V.V. Rossylna, O.V. View of the problem |
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Scientific-practical and legal problems of implementation of the personalized medicine |
| title_full |
Scientific-practical and legal problems of implementation of the personalized medicine |
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Scientific-practical and legal problems of implementation of the personalized medicine |
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Scientific-practical and legal problems of implementation of the personalized medicine |
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scientific-practical and legal problems of implementation of the personalized medicine |
| author |
Bezdieniezhnykh, N.O. Reznikova, V.V. Rossylna, O.V. |
| author_facet |
Bezdieniezhnykh, N.O. Reznikova, V.V. Rossylna, O.V. |
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View of the problem |
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View of the problem |
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2017 |
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English |
| container_title |
Experimental Oncology |
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Інститут експериментальної патології, онкології і радіобіології ім. Р.Є. Кавецького НАН України |
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Article |
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The article is devoted to the comprehensive analysis of scientific, practical and legal issues of personalized medicine that is a rapidly developing science-driven approach to healthcare. It is concluded that there is lack of general legal framework for the encouragement of scientific researches and practical implementation in this field. The article shows foreign experience and prospects for the introduction of personalized medicine as a key concept of healthcare system, which is based on a selection of diagnostic, therapeutic and preventive measures that would be the most effective for a particular person in view of individual characteristics. The conclusions and proposals to improve the current legislation and development of personalized medicine in Ukraine are suggested.
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1812-9269 |
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https://nasplib.isofts.kiev.ua/handle/123456789/138535 |
| citation_txt |
Scientific-practical and legal problems of implementation of the personalized medicine / N.O. Bezdieniezhnykh, V.V. Reznikova, O.V. Rossylna // Experimental Oncology. — 2017 — Т. 39, № 3. — С. 229–233. — Бібліогр.: 23 назв. — англ. |
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2025-11-27T02:25:57Z |
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Experimental Oncology 39, 229–233, 2017 (September) 229
SCIENTIFIC-PRACTICAL AND LEGAL PROBLEMS
OF IMPLEMENTATION OF THE PERSONALIZED MEDICINE
N.O. Bezdieniezhnykh1, *, V.V. Reznikova2, O.V. Rossylna2
1R.E. Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology, NAS of Ukraine,
Kyiv 03022, Ukraine
2Taras Shevchenko National University of Kyiv, Kyiv 01033, Ukraine
The article is devoted to the comprehensive analysis of scientific, practical and legal issues of personalized medicine that is a rapidly
developing science-driven approach to healthcare. It is concluded that there is lack of general legal framework for the encourage-
ment of scientific researches and practical implementation in this field. The article shows foreign experience and prospects for the
introduction of personalized medicine as a key concept of healthcare system, which is based on a selection of diagnostic, thera-
peutic and preventive measures that would be the most effective for a particular person in view of individual characteristics. The
conclusions and proposals to improve the current legislation and development of personalized medicine in Ukraine are suggested.
Key Words: personalized medicine, medical low, cancer treatment, cancer stem cells.
The beginning of the XXI century is marked by the
completion of a number of global projects that give
hope for substantial progress in the field of in the field
of medical issues, including oncology. Thus, in particu
lar, decoding of the genome, identification of genetic,
epigenetic and transcriptional changes in normal
and tumor cells brings scientists and doctors closer
to new opportunities in early diagnosis and targeted
treatment of cancer patients. Recently, a special hope
is focused on the identification of normal and tumor
stem cells that can be a modern platform in persona
lized approach for optimizing technology of diagnosis
and treatment of patients. However, the successful de
velopment of the new vector of the medicine requires
not only deep fundamental research and introduction
of high technologies, but also parallel development
and creation of the regulatory framework for their
implementation.
The rapid pace of development the modern tech
nologies requires the harmonization of scientific
practical aspects and existing problems of medical law,
which will bring timely access to the real possibilities
of personalized medicine. This means that activity
(including economic) in the field of medical practice
requires careful legislative regulation in order to pro
vide the population with highquality and affordable
personalized medical assistance. Personalized medi
cine is such a model of health care based on a selection
of diagnostic, therapeutic and preventive measures
that would be best for a particular person in view of ge
netic, physiological, biochemical or other individual
characteristics. Personalized medicine is a direction
of modern medicine that uses individually oriented
targeted diagnostic and therapeutic approaches. The
essence of personalized medicine is reduced to the
fact that a person, and not a disease, is placed at the
center of the process of treatment and medical skill.
Especially this mechanism is inherent in the treatment
of patients with oncological diseases. This is due
to various reasons and background of the disease,
which is also accompanied by changes in different
genes that are completely individual in each case.
The right of citizens to health care, unlike other
human rights, has recently become legally enshrined
in legal acts, including in the constitutions of the coun
tries of the world community. Oddly enough, until the
middle of the last century, in the constitutions of states
all over the world the right of citizens to health was
not mentioned, although many other human rights
had already been proclaimed. Due to the prominent
law reform in the health sector in many countries the
subject of the role of medical practice is beginning
to change in collaboration with other members of the
medical and organizational processes. The imple
mentation of legislative innovations implies structural
and organizational changes in the health care system,
the introduction of new organizational and financial
mechanisms, ensuring economic independence, and
increasing the diversity of organizational and legal
forms of medical organizations.
In the policy of the Health 2020 program, the overall
goals are a significant improvement in health and an in
crease in the welfare of the population, reduction of in
equalities in health care, strengthening of public health
and providing the availability of sustainable health sys
tems tailored to individual needs of people. Such sys
tems should be characterized by high quality of care
and the principles of total coverage of medical care,
social justice and sustainability. However, two main
strategic objectives of the policy are to improve health
for all people and to reduce inequalities with regard
to health. Reducing inequities in health is achieved
through the impact on the social and environmental
determinants of health [1]. Albeit, despite the declared
state’s importance of implementing systemic and
integrated health care reform, the Ministry of Health
of Ukraine (the central executive body, which ensures
the formation and implementation of state policy in the
Submitted: August 4, 2017.
*Correspondence: E-mail: beznaliano@gmail.com
Abbreviation used: CSC — cancer stem cells.
Exp Oncol 2017
39, 3, 229–233
VIEW OF THE PROBLEM
230 Experimental Oncology 39, 229–233, 2017 (September)
field of health care) works in this direction in extremely
unsystematic way. For the successful implementation
of the principles and mechanisms of the new European
Health Policy 2020 in Ukraine, justification and deve
lopment of a national strategy and program is neces
sary. It is advisable to direct the new national health
policy in Ukraine to the implementation of strategic
priorities in the field of preservation and strengthen
ing of health, prevention of chronic noninfectious
(especially oncological) diseases, minimization of the
influence of risk factors of disease development on the
basis of a crosssectoral approach, creation of a favor
able for health Environment, formation of responsible
attitude of citizens to personal health and motivation
of the population to a healthy lifestyle.
In such conditions, special attention should be fo
cused on the issue of optimizing the organization and
financing of the medical sector with the creation
of an effective system of public health protection,
through the priority development of primary health
care, family medicine, personalized medicine, which
are able to provide medical needs of the population
at the level of current standards, taking into account
the fundamentals of personalized medicine. After
signing in 2014 of the Association Agreement with
the European Union [2], electing Ukraine’s European
integration vector must ensure gradual forthcom
ing to European standards in the health care system
through a reform aimed at creating a system focused
on the patient, able to provide medical care for all
Ukrainian citizens at the level of developed European
states. The guideline for the reform was the European
Union’s “European Health Strategy 2020” program [3].
According to calculations of specialists, by 2020 the
number of new cancer patients in Ukraine will exceed
200 thousand [4].
Our aim is to conduct a comprehensive analysis
of theoretical, scientific and legal problems of imple
mentation of personalized medicine in Ukraine.
According to Genomics and Personalized Medicine
Act of 2010 the term “personalized medicine” means
any clinical practice model that emphasizes the sys
tematic use of preventive, diagnostic, and therapeutic
interventions that use genome and family history in
formation to improve health outcomes [5].
Although in recent years, there has been significant
progress in clinical oncology: with the development
of new antitumor drugs with targeted molecular ac
tion, the contingent of patients who receive effective
specific therapy has improved their quality of life, but
despite their success, cancer mortality remains high.
At the same time, the empirical choice of the treatment
regimen, the lack of selectivity and limited effective
ness of many antitumor drugs, a large number of side
effects, as well as the high cost of therapy imply seri
ous responsibility of the doctor. That is why the need
for individualization of treatment becomes a topical
issue in contemporary Ukraine, since knowledge of the
molecular and genetic characteristics of the tumor
and the patient will allow the personalization of thera
peutic regimens and reduce the risk of manifestations
of toxi city of chemotherapeutic agents: an individual
approach involves administering to a specific patient
the required preparation in an adequate dose for certain
indications in an effective period of time. Even with the
rapid development of a new generation of anticancer
drugs with targeted selective action — targeted drugs
are designed to inhibit the growth, proliferation and vi
ability of tumor cells through specific interactions with
one or more target proteins. In this case, under the
conditions of formally known molecular targets for each
target drug, the response of the patient to treatment
remains more individual and unpredictable. Therefore,
the main task in oncology remains the choice of the
most effective personalized treatment, which until now
remains the mostly experimental.
“Personalized medicine is the dream of every on
cologist and the legitimate expectation of every can
cer patient”, says Professor Martine Piccart, ESMO
President. “However, currently we are not yet in the
era of personalized oncology but in the era of stratified
oncology, which means we are able to classify cancers
according to critical targets against which we hope
to develop effective drugs. Modern technologies such
as deep DNA sequencing will be powerful tools in the
future allowing us to identify drugable mutations” [6].
There is no official definition of personalized
medicine in the European Union. But for the purpose
of the European Commission report (31 October 2013)
personalized medicine refers to a medical model
using molecular profiling for tailoring the right thera-
peutic strategy for the right person at the right time,
and/or to determine the predisposition to disease and/
or to deliver timely and targeted prevention [7].
America’s legislation is more developed in this
area. On May 27, 2010, in the House of Representa
tives, an A Bill with the aim to secure was adopted the
promise of personalized medicine for all Americans
by expanding and accelerating genomics research
and initiatives to improve the accuracy of disease
diagnosis, increase the safety of drugs, and identify
novel treatments, and for other purposes.
Signed into law by the President on December 13th,
2016, the Act passed the House of Representatives
(39226) and Senate (945) with overwhelming bipar
tisan support. The Act secures $4.8 billion in funding
for the necessary infrastructure to advance precision
medicine. This includes funding to the National Insti
tutes of Health to support the President’s Precision
Medicine Initiative ($1.5 billion) and to Vice President
Biden’s “Cancer Moonshot” initiative ($1.8 billion).
Spending under the Act will advance precision medi
cine more specifically by developing [8].
Can we find an analog of normativelegal regulation
in the domestic legislation? Unlikely. Moreover, even
none of the Concepts of the Ministry of Health does
not foresee the movement of the health care system
in Ukraine towards personalized medicine. Personal
ized medicine is a rapidly developing sciencedriven
Experimental Oncology 39, 229–233, 2017 (September) 231
approach to health care. So does it need a specific
legislation to regulate such social relationships?
Success in the treatment of cancer patients can
be achieved in many respects only due to the success
ful combination of modern scienceintensive technolo
gies, regulated by legislation. However, unfortunately,
deep knowledge of the nature of the malignant process
is not always used in a timely manner in clinical practice
because of the lack of necessary legal norms.
In what area should Ukrainian legislation be de
veloped: medical or scientific and technical? Obvi
ously, it will be impossible to restrict one normative
legal act that would regulate the whole set of social
relations in the field of personalized medicine, but
there should be a key program document that will
define the main concepts, principles, directions, and
stages of the implementation of personalized medicine
in Ukraine. In the future, the regulatory system should
be formulated in a complex way, improving the current
or developing a completely new legislation, whose fun
damental task should be adequate protection: scien
tific development, medical secret, personal data, etc.
The necessity of special regulatory regulation is also
that in its absence it is impossible to realize scientific
achievements in this sphere and to implement them
in real medical practice, what is the urgent problem
of the present.
Claiming to introduce the basics of personalized
medicine, it is necessary to conduct indepth analysis
and refinement of the algorithm using a huge arsenal
of basic and clinical knowledge. For the full implemen
tation of the foundations of personalized medicine
in Ukraine there is also a need for the proper regula
tion of corresponding social relations. Legislation
should comprise and cover the following elements
(components):
• An adequate level of protection of intellectual
property rights for scientific developments, which
are the driving force for the formation of personal
ized medicine. Medical diagnostics and genomic
medicine are the key tools for many personalized
therapies. In this regard, there are issues of intel
lectual property rights that need to be addressed.
So, the world practice goes in such a way that the
application for a patent for the diagnostic method
should undergo even more careful analysis and
verification. For example, in Mayo, the Supreme
Court (the decision Mayo Collaborative Services
v. Prometheus Labs., Inc.) determined that certain
diagnostic analysis — such as a diagnostic test that
correlates to a patient’s health or disease — is not
patentable when only the correlation between the
diagnostic reading and the health status of the
patient is the subject of the patent. The Supreme
Court unanimously held that broadly claimed di
agnostic methods are not patenteligible because
they attempt to patent a law of nature. As a result,
patent applications claiming diagnostic methods
are now more critically examined for patenteligi
bility as well as novelty and nonobviousness [9].
In addition, the question arises about the ownership
of genetic information.
• IT implementation, which will guarantee the security
of personal data, the preservation of medical se
crets, and the provision of high security standards
for electronic health data. There is should be a bal
ance between facilitating the exchange of medical
records among health care providers and public
health officials and the need to ensure the privacy
of personal medical information.
• The foundation for protecting medical and genetic
information, including a guarantee of nondiscrimi
nation based on the results of laboratory and other
research, treatment, etc., including clinical and
genetic research. For example, the Genetic Infor
mation Nondiscrimination Act of 2005 (GINA) [10]
prohibits:
— medical insurance companies from discrimi
nating against applicants on the basis of their
genetic information;
— medical insurance companies from request
ing that applicants for health coverage plans
be genetically tested;
— employers from using genetic information
to refuse employment and from collecting
such data.
• A reliable mechanism for protecting the pa
tient’s rights to effective treatment with the corre
sponding responsibilities of the doctor to conduct
appropriate diagnosis and therapy.
• Reform of state regulation of the health care system
and elements of health insurance with maximum
consideration of the above information, in particu
lar the direction of the entire system for disease
prevention and its diagnosis, which will significantly
reduce the cost of treatment in the future, as well
as stimulate and develop publicprivate partner
ships.
According to expert estimates, about 250 variants
of the tumor disease are differentiated based on only
etiological, pathogenetic, organo and tissuespecific
features, symptomatic and prognostic course of the
pathological process. In this case, the patient’s re
sponse to the use of standard regimens and modes
of administration of drugs, depending on the genetic
constitution of the body, is accompanied by significant
fluctuations in the effectiveness and safety of the
therapy. For example, the frequency of development
of unwanted drug reactions or even death in some
countries goes to the 4–5th place among all its causes.
In addition, numerous pharmacoepidemiological
studies indicate a complete lack of efficacy of drug
therapy in 40% of patients. The individual variability
of the body’s reactions to medication can fluctuate
within 20–95%, the lack of response to pharmaco
therapy — 10–40%, the rate of excretion of drugs
in different patients differs 4–40 times, the metabolism
of drugs — 10–100 times [11].
The factors that determine the response to the
drug and affect the changes in the body’s reaction are
232 Experimental Oncology 39, 229–233, 2017 (September)
complex and function in combinations, some of which
include the basic aspects of human biology, since
a certain response to a drug directly affects the nature
and life expectancy. Genetic variability is recognized
as an important determinant of the individual variability
of the drug response from clinical observations of the
late 1950s (Kalow et al., 1957; Evans et al., 1960).
Observing that the individual variability of the re
sponse to antitumor agents is often greater among the
members of the population, compared to one person
at different times, further emphasizes heredity as the
main determinant of the response to the drug (Vesell,
1989; Kalow et al., 1998). These clinical and population
data contributed to the formation of pharmacogenetics
in the direction of assessing the genetic contribution
to the individual variability in drug therapy [12].
Individual testing of tumor response in cancer
treatment includes ex vivo tests that are important for
predicting individual responses to the therapy. Such
tests are developed on the basis of the response of the
tumor cells to specific anticancer agents in vitro, which
characterizes the sensitivity or resistance to a certain
exogenous factor [13]. Previous studies have shown
positive or negative aspects, peculiarities of applica
tion and limitation, and other properties and problems
of such ex vivo analyzes. Indeed, there are a number
of conceptual problems that do not depend on the
chosen model for identifying an experimental model:
an adequate choice of drug concentration relevant
to the clinical situation; primary tumor or metastasis,
heterogeneity of the tumor; the ability to maximally
simulate the tumor microenvironment ex vivo. It is obvi
ous that between the response of the patient to treat
ment and inhibition of tumor growth in vitro is a rather
complex relationship [14], but despite this, numerous
studies have achieved positive results for patients:
more quick response to therapy, increasing longevity,
reducing the number of chemotherapeutic treatment
lines and side effects and reducing the cost of treat
ment [13]. Finally, some authors demonstrated 78.4%
sensitivity and 90.1% specificity of individual tumor
response testing [13, 15].
An important breakthrough in the sense of ini
tiation and progression of cancer was the discovery
of a cell subpopulation with features of stem cells,
commonly referred to as cancer stem cells (CSC),
a critical factor for a tumor. Most of the authors con
sider them responsible for the phenomenon of resis
tance to antitumor agents and disease progression
[16, 17]. Because of the presence of resistant CSC
clones, each time in the treatment of the patient there
is a variant of subsequent relapse of the tumor, which
will be different, most likely, more resistant to therapy
[18]. Undoubtedly, the choice of effective therapy
is extremely important not only at the beginning of the
treatment process, but also in the context of the
progression of the disease, that is why the research
on the most informative prognostic biomarkers, in
cluding markers, associated with the CSC phenotype,
is extremely important. The targeting of antiCSC
therapy is a new paradigm in the treatment of cancer,
which is one of the key tasks and areas of personal
ized medicine. Recently there was developed a new
test that involves analyzing tumors for the CSC and
parallel study of sensitivity to anticancer drugs —
ChemoID® [19–21]. Studies conducted using this
test showed that patients with the same stage and
other characteristics of the tumor process differ
significantly in the clinical response to treatment,
which also indicates the need for “personalization”
in the diagnosis and treatment of cancer patients
with a special approach to the identification and detail
of tumor cells with CSC phenotype.
Thus, the concept of personalized medicine in
cludes the use of clinical, genomic, transcriptional,
proteomic and other information sources for the
construction of an optimal algorithm for a person
in terms of risk assessment, prevention and treatment:
personalized medicine causes the rejection of the
“protocol/standard” model of medicine characterized
by empirical and “averaged” data [22]. In addition,
understanding the “molecular portrait” of a person
that causes specific properties in susceptibility to the
disease, its progression and response to treatment will
lead to the adaptation of medical care to the require
ments of each individual patient [23].
By the time of the personalized medicine, the
diagnosis of the tumor process, the prognosis of the
course of the disease and the subsequent treatment
were based on histological parameters, including the
tissue origin and stage of differentiation. Experience
has shown that morphological classification is often
of little information and “scarce” in many aspects,
since patients with the same histological diagnosis
may have different responses to therapy and different
course of the disease. Now we see the accumulation
of vast amounts of data on molecular, genetic, epi
genetic and other biomarkers of tumor development
obtained by highly specific modern methods that are
supported by new developments in computer systems
analysis. Personalized medicine is a revolutionary
concept that challenges the traditional fundamen
tal and clinical oncology. Although the transition
to personalized medicine requires a sufficiently large
initial investment, in the long run such a direction will
increase the profitability of future medical practice.
The choice of cancer therapy today is usually based
on prognostic factors, as well as on the experience and
intuition of the doctor, but is associated with the risk
of error in the treatment of a particular patient, which
reduces the effectiveness of treatment, increases its
cost and may even lead to tragic consequences. At the
same time, the extremely significant disadvantage
of modern antitumor therapy is the high cost of drugs,
which also indicates the promise of a personified ap
proach in the management of cancer patients, in terms
of determining the sensitivity of the tumor of the patient
to specific antitumor agents, thereby reducing the
cost of treatment by a reasonable and adequate use
of highcost drugs.
Experimental Oncology 39, 229–233, 2017 (September) 233
Personalized medicine has potentially significant
benefits for patients, clinicians and health care sys
tems alike. Some potential advantages offered by this
new approach include:
• ability to make more informed medical decisions;
• higher probability of desired outcomes thanks
to bettertargeted therapies;
• reduced probability of adverse reactions to medi
cines;
• focus on prevention and prediction of disease
rather than reaction to it;
• earlier disease intervention than has been possible
in the past;
• improved health care cost containment [7].
Thus, today there is no definitive solution to the
issues and problems for all types of cancer, but it be
comes clear that personalized medicine is very impor
tant for patients and hospitals, and such “personaliza
tion” requires the humanization of medicine and begins
with an individual doctor/patient relationship [6].
The perspective of the introduction of personalized
medicine depends on the multidisciplinary approach:
a team of doctors, experts, lawyers, legislators who,
in teamwork and caring for the patient, will make real
istic personalized medicine that will potentially improve
the effectiveness of therapeutic strategies for cancer
patients and increase their life expectancy to improve
its quality. Although this poses a lot of problems in the
organization of medical care, it is a necessary way
to effectively treat each individual patient.
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