International Journal of Civil Engineering and Technology (IJCIET)
Volume 10, Issue 04, April 2019, pp. 165-173, Article ID: IJCIET_10_04_018
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ISSN Print: 0976-6308 and ISSN Online: 0976-6316
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INTEGRATION PROCESSES IN THE SYSTEM
OF STATE REGULATION OF THE MEDICINE
SPHERE WITHIN THE EAEU
Kundyzay Tobzhanova
Researcher, al-Farabi Kazakh National University, Almaty, Kazakhstan
Gulmira Kassenova
Phd, al-Farabi Kazakh National University, Almaty, Kazakhstan
Zhazira Idrysheva
Phd, al-Farabi Kazakh National University, Almaty, Kazakhstan
Bibinur Sydykova
Researcher, Semey Medical University, Semey, Kazakhstan
ABSTRACT
The object of research – is influencing of integration processes in the system of state
people registration in the field of medicine. As part of the study, we set the task to study
the field of medicine within the framework of the EAEU. To identify the relationship
between the quality of regulation of integration processes x, of occupational
development and the sphere of circulation of medicines was carried out a survey among
20% of the population and based on the received data carried out correlation analysis.
The authors proceeded from the following hypotheses: a) high self-efficacy of state
regulation; b) the influence of the sphere of drug circulation within the EAEU; c) there
is Straight May interconnection between government and medicine within the EAEU.
Analysis results allowed to make conclusion about significant factors influencing the
quality of integration processes which are directed relationship of the two components
and self-efficacy.
Key words: self-efficacy; Professional Development; integration processes in
medicine; EAEU ; management.
Cite this Article: Kundyzay Tobzhanova, Gulmira Kassenova, Zhazira Idrysheva,
Bibinur Sydykova, Integration Processes in the System of State Regulation of the
Medicine Sphere within the EAEU, International Journal of Civil Engineering and
Technology 10(4), 2019, pp. 165-173.
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Kundyzay Tobzhanova, Gulmira Kassenova, Zhazira Idrysheva, Bibinur Sydykova
1. INTRODUCTION
The business program of the Forum "Eurasian week" representatives of the governments of the
Eurasian Economic Union (EAEC), and discuss the business and the strengths and weaknesses
of the integration process in the Union. The plenary session “The real sector of the economy of
the EAEU: capacity building in the context of integration” will be devoted to qualitative
changes in the economy and trade.
Strong economic, labor and cultural ties of the members of the EAEU became the basis for
the creation of the Union, which countries received opportunities, including the formation of a
qualitatively new space for doing business and developing entrepreneurship. Thanks to the
formation of the EAEU, trade and administrative barriers between countries were removed,
B2B-and B2G-interaction was facilitated for participants in economic activities, transport
infrastructure and logistics were developed. Further development and strengthening of
integration requires a lot of work. Their consequence will be a significant increase in the
investment and export potential of the countries of the Union, with particular attention paid to
the development of the medicine sector.
At the present stage of human development, medicines have been transformed from a means
of preserving life into a tool to ensure the quality of life, which is confirmed, in particular, by
the following statistics: expenses of citizens on medicinal facilities in to all the world at 2011
amounted to 956 billion dollars, and according to experts, by 2016 they have grown to 1.2 bln.
Dollars [7] and in 2020 and did increase two-fold.
The UN Human Rights Council (HRC), in its resolution, points out that access to medicines
is one of the most important conditions for the gradual ensuring the full realization of the right
of everyone to the highest attainable standard of physical and mental health. This basic human
rights mechanism of the UN confirmed the commitment of Member States to provide for all its
citizens, non-discriminatory access to essential medicines, as well as their affordability and high
quality [8].
This is extremely relevant in terms of ensuring access to medicines for vulnerable categories
of the population (the disabled, the elderly, children, etc.), as well as in the context of the
statement of the UN High Commissioner for Human Rights that this problem is not adequately
reflected in the national and international action plans [6]. To create effective mechanisms for
ensuring the safety of public health and strengthening the health system at the global and
national levels in the drug safety segment, a comprehensive and integrated international legal
analysis of the activities of states, international intergovernmental organizations and other
participants in the established drug circulation system is required.
AT given research we have tried reply on questions as far as today state integration
processes meet high demands for self-efficacy and professional development, how they interact
and as this reflected on quality this process. In previous studies, many problems were examined
and analyzed regarding the study and circulation of drugs (for example, reporting, functions,
procedures, practice and independence conducting).
Questions are regarding the state and features influences self-efficacy and professional
development of state integration processes on the quality of medicine in the country within the
framework of the EAEU.
Hypothesis of the present research can articulate as follows: if the quality of the integration
process depends on the ability, effort, impact on the sector, the directed on change effectiveness
and
Internal interaction of these processes (state and medical sectors) should increase
productivity this direction as a whole. Task submitted at article research has become finding
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Integration Processes in the System of State Regulation of the Medicine Sphere within the EAEU
out influence separate factors on the quality of the state's processes in this area, for what was
held poll respondents.
Analysis of the research results allowed to the authors make a series of recommendations
for improving efficiency state integration processes in this area.
Theoretical aspects and literature review. The theoretical basis of the study are the work of
local specialists, dedicated general theoretical problems of international law, above all, Aldis
(2008), Azfar ( 2005 ) , Bachelet ( 2011 ), Baron ( 2008 ) , Bertoldi ,Barros ( 2011 ) , Boutros Ghali (1992), Branco (2010), Buckley (2001), Cherici, Frazier, Adams and Brantner (2009),
Colin, Kelley ( 2006 ) , Dudel , Franke , Hatt , (1988), Dutfield (2003), Abdrakhmanova, M.,
Mutanov, G. (2018) [22].
In the doctrine of international law and in the science of humanitarian and technical fields,
certain stages of the circulation of medicines and related problems were investigated. Both in
the number of works and in the degree of coverage of the international legal aspects of the topic
of dissertation research, the work of foreign authors differs, among which the work of Professor
Aldis stands out for its complexity . The author analyzes the cooperation of states at the
universal, regional and bilateral levels in the matter of convergence and harmonization of the
legal regulation of the circulation of medicines. [1] The types and methods of harmonizing the
rules for regulating the circulation of medicines in the United States, Japan and within the EU
were fundamentally studied in the work of prof. Harvard University Hatt [18]
Professor Azfar, in his work, addressed the problems, which are associated with access to
safe and effective drugs in the context of the human rights to the highest attainable standard of
health. Important individual aspects of the international legal regulation of the circulation of
medicines were the subject of research in the work of Russian legal scholars. [2]
In the work of Baron contains a comprehensive analysis of the main trends in the
development of international legal regulation of biomedical research in the context of the
international protection of human rights. In the context of analyzing general issues of ensuring
human security in order to identify the main segments of ensuring the safety of medicines
circulation, studies were studied [4].
Over the past decades, the following trends have emerged in addressing the problems of
global health, including the regulation of the circulation of medicines:
1) the inability of states to independently confront growing global threats;
2) reduced efficiency WHO;
3) randomness activities international participants of the health management;
4) trade liberalization and development of intellectual property protection mechanisms
influenced by the processes globalization;
5) increasing inequalities in access to necessary treatment and medical technologies.
Providing the population with safe, effective and high-quality medicines in the necessary
volumes and at reasonable prices is a subject of concern for policy makers at the global and
national level, and institutions implementing health programs [11].
May 29, 2014 the members of the Customs Union, noting the successful implementation of
the objectives of the Customs Union and Common Economic Space signed the Treaty on the
Eurasian Economic Union (EAEU). The agreement was concluded on the basis of international
treaties concluded mainly in 2009–2010 within the framework of the formation of the legal base
of the Customs Union of Russia, Kazakhstan and Belarus
The Union acts, first of all, in the role of an international organization for regional economic
integration of equal independent states. EA EU is open for accession of other countries such
integration involves the sphere of regulation, the economy, science, education, culture,
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Kundyzay Tobzhanova, Gulmira Kassenova, Zhazira Idrysheva, Bibinur Sydykova
environment and trade. A separate section of the Treaty is devoted to the regulation of the
circulation of medicines and medical devices.
The agreement formulates the basic principles for regulating the circulation of medicines,
the most relevant in the context of this study are:
1
harmonization and unification of the legislation of Member States in the field of drug
circulation regulation funds;
2 the formation of uniform requirements for the quality, efficacy and safety of medicines in
circulation on the territory Union ;
3 development and application of common methods of research and control in assessing the
quality, effectiveness and safety of drugs.
The Eurasian Economic Commission has prepared a draft agreement on common principles
and rules for the circulation of medicines within the framework of the Eurasian Economic
Union. The agreement is aimed at increasing the availability of safe, effective and high-quality
medicines, as well as enhancing the competitiveness of pharmaceutical manufacturers and
eliminating unreasonable restrictions in mutual trade. Increased competition is achieved
through the provision of national treatment suppliers States members EA EU.
The agreement approves the procedure for the interaction of states in identifying counterfeit
drugs. Introduces a centralized procedure for collecting data on the detection of counterfeit
products for prompt with drawl from the market. A unified register of registered medicines is
introduced, as well as an information database on the identification of side effects and cases of
drug inefficiencies.
It is worth noting that the ongoing integration processes are not accompanied by the creation
of specialized bodies with supranational character. The implementation of uniform
requirements and standards in the field of regulating the circulation of medicines is assigned to
state regulatory bodies.
To form a unified drug circulation system, Member States should develop draft rules of
good manufacturing practice (CMP), good clinical practice (GCP), good laboratory practice
(CLP), good pharmacovigilance practice (GPP), drug-based labeling requirements on the best
international practice.
Certainly, harmonization processes have a positive impact on the development of the
regulatory framework in the field of drug circulation regulation. However, doubts remain about
the effectiveness of these processes to counter the threats and challenges in the circulation of
medicines in this region. The introduction of an effective system for regulating the circulation
of medicines should be accompanied by the formation of an adequate material and technical
base among manufacturers, which will allow them to truly maintain high levels of quality of
medicines means.
At present, in the documents of the Commission there is no provision for the development
of research activities in the framework of a single pharmaceutical market EAEU. The volume
of investment in research and development and the number of clinical trials of new drugs
remains extremely low relative to developed pharmaceutical markets. It requires the
development of a unified strategy for introducing changes in the regulatory acts of member
states in order to create favorable conditions for attracting investment and stimulating the
development of research activities.
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Integration Processes in the System of State Regulation of the Medicine Sphere within the EAEU
2. SELF-EFFICACY
Work integration process is to ensure that none of the work in the interaction with the people,
carrying out certain tasks in certain case are manifested. Self-efficacy is important motivational
by design.
It is effects on individual the choice goals character and the way under proposition effort
overcome difficulties but also on manifestation infusion. Boost self-efficacy processes can
carry to specific tasks through a variety of cognitive, motivational and affective processes
adoption solutions. For example, oestriasis research demonstrated what level effi-cacy can
show an attitude to work, professionally preparation satisfaction work, level education and
susceptibility to new knowledge [21].
3. RESEARCH METHODS
It conducted a qualitative analysis of the data obtained in the course of ISS research to identify
factors. The data were obtained as a result of questioning and interviewing.
Questionnaire sheet composed of two parts. AT the first parts contained Bazo Wai personal
information - floor, age, experience and a place work respondents.
In second parts - questions regarding self-efficacy, state and sector interaction.
Everything answers questionnaire measured using a 5-point Likert-type scale (1 = certainly
not, completely not I agree; 2 = possibly not, more not I agree, than I agree; 3= answer neutral,
neither Yeas neither nor; 4= possibly Yes, more I agree, than not I agree; five = surely Yes,
completely I agree).
Some of the questions were developed in accordance with the scales of self-efficacy ,
proposed R. Schwarzer and M.Erusalem [20].
After test some wording of questions at questionnaires were phased to clarify.
Last Review Points carefully studied to avoid repeated questions. For checks authenticity
and reliability of questionnaire used factor alpha Kronbach (table 1), which the whole showed
reliability questionnaire (α Kron bach = 0.96).
Table 1 Information about the reliability and its questionnaire
Variable
Professional
development
Self- efficacy
Quality
The name of
thefactors
CoefficientCronba
The totalcoefficient
ch α ofeach factor αCronbach of each variable
Process selfefficacy
Learning
opportunity
Interaction
Oh try
Confidence and
effort
Trend and
Productivity
Control
Professional quality
Purpose and
mission
Value of the object
The
totalcoefficient α
Kronbach
0.830
0.954
0.864
0.958
0.856
0.880
0.914
0.960
0.710
0.775
0.730
0.872
0.844
0.622
Sources: Compiled by the authors
AT this research we analyzed the following commonly known the hypotheses:
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Kundyzay Tobzhanova, Gulmira Kassenova, Zhazira Idrysheva, Bibinur Sydykova
a) high self-efficacy is positive affects on quality process ;
b) organizational culture as main factor affects on professional influence development ;
c) there is straight interconnection between public sector and health care dependency ;
d) professional development directly affects the quality process .
4. ANALYSIS RESULTS
The 553 questionnaires common among active respondents, received back 232, which
corresponds to 41.95%.
AT basis classification of objects research at this work lies the classification by as follows
parameters (Table 2):
floor [women us (41.4%) men (58.6%)];
age [less thirty years old (18.1%), 31–40 years old (31.9%),
41–50 years old (25.4%), 51-60 years old (22.0%),
60 years old and above (2.6%)];
experience work [more 15 years old (37.1%),
5–10 years old (20.7%),
10–15 years old (16.4%),
Less five years old (25.9%)];
Place work [territorial organ (85.8%), central apparatus (14.2%)].
Table 2 Overall information by to respondents N = 232
Name
% Share
Floor
Female
Male
Total
41.4
58,6
100.0
Age
30 years and younger
31–40 years old
41–50 years old
51–60 years old
more than 60 years
Total
18.1
31.9
25.4
22.0
2.6
100.0
Work experience
Less than 5 years
10–15 years old
5–10 years old
more than 15 years
Total
25.9
16.4
20.7
37.1
100.0
Place of work
Territorial authority
Central apparatus
Total
Sources: Compiled by the authors
85,8
14.2
100.0
Current state of professional development ratings The results of average values for all
sections of the chapter “Professional development” showed that the section “Motivation for
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Integration Processes in the System of State Regulation of the Medicine Sphere within the EAEU
learning” in general was highest score (4.34), most low (3.79) - section "The possibility of
learning."
AT section "Organizational culture” most tall score gained approval "State Institution (place
of work) creates of effective pad for exchange knowledge and experience (3.91), but most low
score (3.65) - “The state institution focuses on personal achievements.”
4.1. Analysis of the impact of each factor on the quality
To analyze the influence of each factor on the quality of the process, we conducted a multiple
regression analysis and determined the coefficients β for each variable. One of the advantages
of the β coefficients is that they allow you to compare the relative contributions of each
independent variable to the prediction of the dependent variable. Coefficients β follows
interpret with points of view relative the influence Nia each predictor on dependent variable.
As a result, built the following model:
y = 0.495 + 0.254x 1 - 0.038x 2 + 0.095x 3 + 0.338x 4 + 0.009x 5 + 0.209x 5
The equation expresses addiction integration process ( y ) from demand for medical care
(x1), opportunities learning (x2), organizational cultures (x 3) experience (x 4), force (x 5) and
the trend and the productivity of our (x6).
Coefficients the equations show quantitative impact of each factor on the RESULT activity
rate unchanged at Nosta others.
Modern economic science cannot yet determine the full impact of the integration processes
at the global level. Th is is not due to the complexity of calculating the results of the integration
and plurality eff ects in time and space. [23]
5. CONCLUSION
The sphere of circulation of medicines is a rather complex system, the structural components
of which are in constant interaction with various spheres of human activity. In the
pharmaceutical industry, there are objectively a number of systemic problems that indicate a
serious threat to ensuring safety in the field of drug circulation at the international, regional and
national levels.
At present, regulation of the circulation of medicines at the international level is very
fragmented. The existing international legal mechanisms, in most cases, are based on the
documents of the so-called “soft law” and cover only certain stages of the circulation of
medicines, which does not allow for adequate control of the safety, quality and effectiveness of
products sold in different regions of the world.
Defining the health sector as a fundamental element of international and national security
and recognizing drug support as an important component of ensuring human security and the
full realization of the right to health, as well as discussing drug issues on the agenda of most
UN organizations, Regional and non-governmental organizations predetermine the formation
international legal regime to ensure the safe circulation of medicines.
For a comprehensive study of this sphere, as well as an assessment of the prospects for the
formation of an international legal regime for ensuring the safety of medicines circulation, the
basic principles and mechanisms for regulating the circulation of medicines at the international,
regional, national levels, as well as the most promising areas for improving the regulation of
this sphere were analyzed .
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