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0PHARMACEUTICAL SCIENCES
Самборський О.С.
1вано-Франювський нацюнальний медичний утверситет, кандидат фармацевтичних наук, доцент Слободянюк М.М.
Нацюнальний фармацевтичний унiверситет (м. Харюв), доктор фармацевтичних наук, професор Евтушенко О.М.
Нацюнальний фармацевтичний ymiверситет (м. Харюв), доктор фармацевтичних наук, професор
ПИТАННЯ РИЗИКУ ТА УПРАВЛ1ННЯ ПРОЦЕСАМИ НЕВИЗНАЧЕНОСТ1 У ФАРМАЦЕВТИЧН1Й СФЕР1
THERE IS A QUESTION OF RISK AND MANAGEMENT OF VAGUENESS PROCESSES IN THE
FIELD OF PHARMACEUTICAL
Samborskyi O.S.
Candidate of Pharmacy (Ph. D.), associate professor of the Department of Organization and Economics of Pharmacy and Drug Technology, Ivano-Frankivsk National Medical University, Ivano-Frankivsk
Slobodyanyuk M.M.
Doctor of Pharmacy, Professor, Professor of the Department of Pharmaceutical Marketing and Management, National University of Pharmacy, Kharkiv
Yevtushenko O.M.
Doctor of Pharmacy, Professor, Professor of the Department of Pharmaceutical Marketing and Management, National University of Pharmacy, Kharkiv
АНОТАЦ1Я
Статтю присвячено огляду науково-практичних mдходiв до визначення та класифшацп ризишв.
Особливу увагу придшено формуванню поняття «ризик», а також виявленню стльного i ввдмшного в щдходах вичизняних i зарубгжних авторiв щодо класифжаци ризишв. Наголошуеться на необхщносл вивчення питань управлшня ризиками в фармацевтичнш сферi в зв'язку з високим ступенем реатзацп фiнансових, техшчних та iнших видiв ризик1в. Особлива увага придметься питаниям управлiння ризиками, пов'язаними з шновацшною дiяльнiстю в фармацп, з питаннями якосп лiкарських засобiв.
Висвiтлено деяк1 тдходи до формування системи ризик-менеджменту на рiзних етапах розробки i розвитку iнновацiйного лiкарського препарату.
ABSTRACT
This article is an overview of scientific approaches to the definition and classification of risk.
Particular attention is paid to the formation of the concept of "risk" and identify common and different approaches to domestic and foreign authors on risk classification. The necessity of studying risk management in the pharmaceutical field due to the high degree of implementation of financial, technical and other risks. Particular attention is paid to managing the risks associated with innovation activities in the pharmacy, the issues of quality medicines.
The article deals with some approaches to the formation of risk management at various stages of design and development of innovative drug.
Ключовi слова: ризик, фармащя, класифжац1я, невизначешсть, шновацп, лжарсьш препарати.
Keywords: risk, pharmacy, classification, ambiguity, innovations, medicines.
One of the key priorities of state politics in Ukraine is to ensure health life of our nation, which significantly depends on the level of provision, quality, efficiency and safety of medicines. Herein a significant role is given to native pharmaceutical companies, which help to fulfill the tasks of social politics of our country as to providing the population with vitally important medicines. A guarantee of a successful fulfillment of the tasks of this program is safety functioning of a pharmaceutical company and quality of its goods, which allow having regular profit and efficient working process.
Recently the subject of different trends of investigation of the state of uncertainty and risks as a threat for a permanent existence of a pharmaceutical company is more often discussed in literature. Pharmaceutical business also takes a risk consciously for adequate benefit in the form of profit. Economic environment becomes more and more commercial, adds extra elements of uncertainty to entrepreneurial activity, and extends limits of risk and its level. As the practice shows, any pharmaceutical company is a source of danger from economic, ecological and social point of view. Its activity is influenced by numerous factors, which require regular monitoring and management [4,
5, 17, 18]. Therefore, a risk management system is an integral part of the management system, which ensures efficiency and safety of production economic activity in modern conditions. The pharmaceutical company follows and ensures the risks on a regular basis, which allows it to respond to internal and external changes on time, thus to reduce a probability of financial, material, moral, human and other losses [13].
State risk management is provided according to the Economic Code of Ukraine from 16.01.2003, which states the connection between the risk and business is the following: "Article 42. Entrepreneurship as a kind of entrepreneurial activity. Entrepreneurship is an individual, initiative, systematic, to its own risk economic activity, which is provided by the subject of economic activity (entrepreneurs) in order to achieve economic and social results and to get income». Other legislative documents such as the Law of Ukraine No.6/96 «On insurance» from 07.03.1996 and Decree of the President of Ukraine No. 293/94 «On compulsory insurance of property of state companies and or-ganizations» from 13.06.1994 can prevent risk situations. Legislative acts which regulate pharmaceutical activity are significantly focused on providing the appropriate level of pharmaceutical assistance, sanitary, technological, ethic and other norms and rules of manufacturing, goods promotion and distributions of medicines, which has a proximate influence on a frequency and a degree of risks. The basic legislative act in this branch is the Law of Ukraine 123/96 «On medicines» from 04.04.1996 and a decree of the Cabinet of Ministers of Ukraine No.843 from 10.09.2008 «On confirming a criterion according to which a degree of risk is assessed as a result of activity in the sphere of health protection for safety of life and health of the population, and a frequency of projected measures of state monitoring (control) is determined. Some regulations deal with a system of risk management in the sphere of pharmaceutical supervision - there's a decree of the Ministry of Health of Ukraine from 27.12.2006 No.898 «On confirming the order of supervision the adverse reactions permitted to use». According to these documents manufacturing of medicines, wholesale and retail sale of medicines, use of medicines are subject to a high degree of risk. The above-mentioned facts concentrate our attention on the necessity to study the problem of risk and development of theory and practice of management the processes of uncertainty.
Based on the following, the purpose of our work is to analyze sources of literature which deal with the problems of determination and classification of risks in pharmaceutical companies.
Materials and methods. With the help of a content analysis, the analysis of works dedicated to the problem of risks in our country and abroad has been made.
Results. The investigation delivered shows that a risk is a complex phenomenon, which has lots of numerous, sometimes contradictive real components. The fact is that the basis of risk is a feasible theory of market activity and uncertainty of situation. Planning
of manufacturing, forecasting of sales and amount of cash flow, development of construction projects and business plans are based only on the expected calculations, but not on their actual amount. Therefore, instead of income a company may have losses, the amount of which may even exceed the invested money [17, 19, 20, 30-32].
One should take into account that the risk is typical of all aspects of the company's activity, for pharmaceutical company its distribution is determined prior to the development of a new drug, from marketing investigation of the market, and is completed at the stage of the use of this drug, when there may be a risk of the absence of the necessary therapeutic effect or an adverse reaction may occur.
Subjective and objective nature of risk is determined by the fact that it is caused by the subjective processes as well as processes, which exist despite of the will and consciousness of people. In reality financial economic activity of the company is provided under the terms of uncertainty. The choice of one or another strategy of development may cause increase as well as decrease of invested money. But under the conditions of uncertainty there always exists lots of alternative options of decision making. The probability of a successful distribution (maximum income and minimum expenses) of any of them depends on a great number of internal and external factors which influence the company. These realities greatly determine the essence and concept of risk [19, 20, 22].
The theory of entrepreneurial risk has different views as to the definition of the "risk" concept. Analysis of economic literature shows that among the scientists there isn't a common interpretation of this term. Scientists are more likely to consider it as a classical or neoclassical theory. Then, Algin A.P. [1] determined risk as «...activity or measures to remove uncertainty...», Ustenko O. L. [34] determines risk as «a chance to lose by t he market subject part of income as a result of a certain manufacturing or financial activity, and characteristics of its activity, which is the consequence of uncertainty». G.V. Chernova gives similar definition of a risk: «Economic risk is some opportunity to have losses, which is determined in monetary value» [33].
Though, the consequences of risk are more likely to appear in the form of financial losses or impossibility to get the expected income, however the risk is not only the undesirable results of decisions confirmed. There's a danger not only to achieve the expected goal, but there's a chance to exceed the expected income. This is the essence of entrepreneurial risk, which is characterized by the combination of an opportunity to achieve undesirable as well as especially favorable deviations from the forecasted results. That is why, the more comprehensive, to our mind, are definitions which characterize all sides of risk. Thus, Kynev Y.Y. [15] gives the following: «Risk is a consequence of the action or a lack of action as a result of which there's a real chance to get uncertain results of different character, which have both negative and positive effects on financial and economic activity of the company». Balabanov I.T. [3] in the most general
form gives a definition of a risk as a possible danger of losses, which come out from the peculiarity or other natural phenomena and kinds of human activity. At the same time, he underlines that from the economic point of view a risk is an opportunity to make an event, which may cause three basic economic results: negative (loss), zero (absence of expected income) or positive (income). Similar, but the shortest and the most precise definition of the risk are given by A.O. Starostyna and V.A. Kravchenko: «Risk is a possible throwing of the results, their possible fluctuation around the expected result» [31, 32].
A precise and logical definition of a risk is given in the suggestions of the working group of the International standards organization (ISO), which deals with the development of terms in the sphere of risk management: «Risk is a combination of feasibility of a certain event and its consequences» [37, 40].
Having realized the necessity to follow and manage the risks, it is appropriate to determine the number and types of risks for a specific company. Classification of risks means systematization of a large number of risks based on some features and criteria, which allow their combination into more general concepts. One of the first classification of risk was given by J.M.Keins, who determined three kinds of risk: entrepreneurial risk; "creditor's risk" - a risk that a credit will not be paid off; a risk of change of a monetary unit (market risk). Keins states that the above-mentioned risks are closely interrelated. Now, basically every book gives one of the definitions of risk classification. In most cases the selected criteria do not allow include numerous risks, although there's a number of key risks, which is widely used in economic literature and in pharmaceutical activity. Thus, the
overwhelming majority of authors point out the following risks: a business risk (business); a market risk; a credit risk; an operational risk. A few more numbers are added to these basic elements, which exist in this or that order: a business risk; a liquidity risk; a legal risk; a regulatory risk.
There isn't any well-developed risk classification. Moreover, there are over 40 different criteria of risks and over 220 kinds of risks, therefore there isn't the only definition of this issue in economic literature [5, 8, 9, 11, 15, 17, 20, 30]. The reason for such uncertainty is a close interrelation of risks and their inter-changeability. Different names of risks, different approaches to their components and sources of origin generate confusion and obscurity of definition. We analyzed data from the literature, which allowed us study the most widely-spread and optimal approaches to classification. The authors usually suggest [3, 4, 5, 8, 34, 35] classification of risks according to the determined features (a chart). In the chart there's an example of classification of risks with the elements, which are more often used in the modern sources of literature and create a logically developed system. Thus, the approaches of the above-mentioned authors are a little bit similar regarding classification of risks, but there are some divergences as to what group or sub-group belong commercial risks, transport risks or force majeure risks.
There are also differences in the content of a more comprehensive classification, when we give a precise interpretation of a list of risks, which belong to the structure of «a higher by the level» kind of risk. For example, Chernova G.V. [33] considers forecasted and partially-forecasted risks to belong to the classification of risks.
Chart
Approaches of different authors as to the risks classification
Features Type of risk
By the type of risk • anthropogenic risks
• natural risks ..
• mixed risks
By the connection with • entrepreneurial [234,247,262J __
entrepreneurship • non-entrepreneurial [247] ^
By the place of function- • internal
ing of an entrepreneur (by the • external
source of origin)
By the level of origin • company (some entrepreneurs)
• branch
• inter-branch ^^
• regional
• state
• global
By the sphere of origin • social political ^^
• administrative legislative
• production
• commercial ^
• financial
• natural-ecological ^^
• demographic
• geopolitical ^^
+ additional:
• innovative
• professional
• transportation
• technical
• investment
• resource
By the reasons of origin • uncertainty of future
• lack of information /
By the degree of risk mo- • motivated
tivation • partially motivated /
• doubtful
Components of the most widely-spread risks
connected with the internal activity of the company
connected with the environment
military actions local conflicts
revolutions, radical changes, escalation of political
situation in the country
changes in political course of the state
changes of geopolitical situation
risk of conflicts with a society
PH3HKH M/mKP(rexHiwHi) manufacturing risks transportation risks
sales risks, including accepted risks (consumer risks) risks of interaction with counterparties and partners risks of unforeseen competition transportation risks force majeure risks
by the placc of origin
by the types of financial transactions
by the subject
by the complex of instruments by the complexity of investigation by the sources of origin by financial consequences by the level of financial losses by the chance to foresee
By the degree of consistency • systematic • non-systematic
According to the acceptable limits • acceptable • critical • catastrophic
By the realization of risks • realized • unrealized
By the extent of influence • individual • multi-personal
By the possibility of forecasting • forecasted • partially forecasted
By the degree of influence on the activity • negative • zero • positive
By the degree of validity • justified • non-justified
By the possibility of insurance • insuring • non-insuring
By the possibility of losses • statici • dynamic
By consequences • pure • speculative
By the character of risk • economic • human being risks • natural factors risks • force majeure risks
By the degree of danger • anthropogenic • natural • mixed
By the character of an object, which is subject to risk • harm to health and life of population • property risks • civil responsibility
Some scientists refer classification «according to the place of functioning of an economic subject» to the sources of risk by dividing them into external and internal. However, despite of some divergences, the above-mentioned approaches allow make a logically motivated classification which does not contradict theoretical principles of risk management.
A degree of risk depends on numerous factors, which are connected with the activity of the company as well as factors, which do not depend on it. Processes or phenomena, which provide the formation of the risk and determine its character are called risk-forming [26, 34].
As showed from the investigations, the number of risk-forming reasons for a pharmaceutical company is big enough and as a result their classification is much harder than the classification of risks.
According to the sources of literature and foreign principles of risk management, all risks-forming factors can be divided into two groups: internal, which appear in the process of the company activity; and external, which appear outside of it [1, 3, 5, 8, 15, 22, 24].
Moreover, risks differ according to the level of their influence of the company on these factors.
In economic literature there are two basic approaches to market investigation. The integral microe-conomic risk-forming factors that influence the activity of an economic subject including pharmaceutical company are the following:
• people's behavior (who have to deal or do not have to deal with the organization);
• technologies and technical factors (both internal and external for the organization);
• level of management (indicators of efficiency, terms and work schedule, reputation, organizational behavior).
The macroeconomic integral risk-forming factors are usually the following:
• economic factors (change of the currency exchange rate; level of inflation; change of the price for raw material, energy carriers; change of taxation rate);
• political circumstances;
• commercial and legal relations;
• change of climatic conditions and the environment [8, 15, 20, 21, 35].
There are sometimes other principles of risk sources based on the concept of "danger" or «tendency to risk». These classifications usually present subgroups of the above-mentioned sources of risk.
The analysis of the trends of theoretical investigations in the sphere of efficient risk management in pharmaceutical market allows us to make a summary that in these investigations much attention is given to risks, which have to deal with the quality of medicines and their efficiency, but some problems connected with the risk-forming factors are underestimated.
A special attention should be given to risks connected with innovative activity of pharmaceutical companies [7, 9, 10, 12, 20, 21]. Nowadays there's a great need to upgrade national economics on the basis of innovations, pharmacy is a national leader in this sphere. In Ukraine «A Concept of state politics in the innovative sphere for the period of 2015-2019» is being formed, the key goal of which is to create social economic, organizational and legal conditions for efficient reproduction, development and use of scientific technical potential of the country, to ensure implementation of up-to-date environmentally friendly, secure technologies, manufacturing and distribution of new kinds of compatible products, including development and production of medicines.
At the moment it is difficult to speak about innovative projects and their management in Ukraine, the dynamic of innovative development is insufficient, Ukraine has got weak positions so far: in the index Doing Business 2016 Ukraine occupies the 80th place; in the global innovative index (GII), made up by the scale INSEAD, Ukraine took the 56th place out of 128. However, tendencies of development has a positive dynamic - by the index of innovations Ukraine increased by 7 points (from the 63rd place in 2014), and great results have been achieved by the state - by the index of innovative efficiency (the proportion of the results of the countries to their initial conditions) Ukraine took the 12th place out of 128 [6, 23, 39, 40]. Due to the above-mentioned, innovative activity and problems connected with it will be actual in the next decade. The problems of risks definition and management in innovative activity of pharmaceutical companies will be especially actual due to the fact that currently and in the future this branch is innovative and open for investments, dynamic, compatible and commercially attractive. At the same time, it is connected with the life and health of our nation. Therefore, risks taken while making medicines should be reduced to the lowest level with the help of the risk-management program in each company. The development of these programs, especially at the industrial pharmaceutical companies, gives a great economic efficiency, ensures increase of the quality of medicines, reduces the risk for the patient and ensures maximum feedback from the innovations used by setting a certain level of control.
The researches pay attention to risks caused by the product itself as well as by means of its development. The process of risks management is a source of requirements. In pharmacy there have been lots of events according to which summary has been made and which turned into the GxP rules. These rules are only the program of reducing well-known risks connected with the production of medicines. Taking into account a long period of time (about 10-15 years) of
searching and development of medicines, high cost of their production (more than 2 billion USD), more and more attention of scientists and experts of the demand is given to the necessity to guarantee reimbursement of investments and to get an expected income, saving of resources, risks forecasting and management of the processes of uncertainty. The authors suggest and use determination of the number of investments required, terms of their contribution, and make a sales forecast in the optimistic, pessimistic and the best variants [10, 12-14, 16, 28, 29]. It allows determine the expected income and profit, financial turnover in time and terms of investments reimbursement. To implement the forecasted plans marketing and loyal programs are developed. Based on the set of scientific researches and at the stages of distribution and use of medicines methodological and scientific practical principles of special risks management have been justified [12].
To prevent cross pollution, numerous technological pollution, staff requirements, hygiene, a reliable strategy of quality control and a system of control -these are only a few trends of risk management. It is impossible to avoid risks in innovations because it is very difficult to foresee a success of the innovation at the market or whether there will be a demand on it [10, 20, 28, 29].
General conclusion of scientific literature allow making a summary that in this sphere there's an inconsistency of specialists' opinions as to the classification of innovative risks in pharmacy. More often medicines development risks are divided into regulated and unregulated or into «... those which action cannot be limited and those which can be managed ...». At the existing classifications innovative risk is not often regarded as an individual category, and it is treated as a sub-type of an investment risk or internal risks in the sphere of interaction with technology [20]. As a result, the analysis and selection of methods of innovative risks management is taken place according to the commonly used methods of risk assessment, which doesn't suit in case of assessment of pharmacy projects.
The following classification is often used and it has its internal filling:
1. risks of the conditions of innovative activity which influence goal achievement;
2. risks of the process of innovative activity;
3. risks of the product of innovative activity.
Some authors within the frame of other approach
[9, 11, 21, 24] point out:
1. risks of the stage of research investigations;
2. risks of the stage of R&D;
3. risks of the stage of implementation the results of R&D;
4. risks of promoting a new product made up on the basis of scientific research work to the mark.
Otherwise, risk may be characterized as a chance for the events to appear and the following types of innovative risks are singled out:
1. technical risks of an innovative project;
2. commercial risks of an innovative project.
Other authors single out similar types of risks, which can be subdivided into technical and commercial risks:
1. risks of the wrong selection of an innovative project;
2. risks of insufficient financing of an innovative project;
3. risks of failure of economic agreements;
4. risks of non-compliance with technical settings;
5. marketing risks, connected with providing goods and services for the population;
6. risks ensuring the right for ownership (a license, a copyright) [20, 21, 23, 35].
In foreign literature authors [36, 37, 40] have their own view on this challenge. The non-standard approach is to choose the following risk categories within scientific research and experimental constructive works in pharmaceutical projects (Figure 1).
Thus, studying basic approaches to definition and classification of risks may serve a basis for further research, which is supposed to analyze risks of an innovative activity and factors of their appearance capable to ensure production of management measures in
order to eliminate and compensate the risks, to form "a show-lock" network at the very beginning of the project, thus reducing most financial and other expenses.
Summary:
Having analyzed risks theories, new approaches to risks classification, sources of their origin and the interrelation of risks with the environment have been reviewed.
It is typical for pharmaceutical branch that risk-management should not only protect the cost, reliability and durability of the company as a whole, but to ensure quality of medicines, a high level of medical and pharmaceutical service, social standards of the country to protect the patient.
The above-mentioned information allows focus on the necessity to further research and grouping of risks typical of a certain company under certain conditions in a certain period of time, to develop and implement instruments of risk management at the most dangerous work areas, in particular, at all stages of searching, development, research, planning of production and turnover of medicines especially in the investment activity of the company.
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Унгурян Л.М.
Доктор фармацевтичних наук, доцент, завгдувач кафедри органгзацИ' та економжи фармацИ' Оде-
ського нацюнального медичного утверситету
Беляева О.1.
Кандидат фармацевтичних наук, старший викладач кафедри органгзацИ' та економжи фармацИ'
Одеського нацюнального медичного унгверситету
Прилипко Н.А.
Кандидат фармацевтичних наук, доцент кафедри органгзацИ' та економжи фармацИ Одеського нацюнального медичного Вишницька 1.В.
Кандидат фармацевтичних наук, асистент кафедри органгзацИ' та економгки фармацИ Одеського
нацюнального медичного
ВПРОВАДЖЕННЯ СТАНДАРТ1В НАЛЕЖНОÏ AnTE4HOÏ ПРАКТИКИ (GPP) В СВ1Т1
INTRODUCTION OF STANDARDS OF GOOD PHARMACY PRACTICE (GPP) IN THE WORLD
Unhurian L.M.
Sc.D., Associate Professor, the Head of the Department of organization and economics ofpharmacy, Odessa National Medical University Bielyaieva O.I.
PhD in pharmacy, senior teacher of the Department of organization and economics ofpharmacy, Odessa
National Medical University Prylypko N.A.
PhD in pharmacy, Associate Professor of the Department of organization and economics ofpharmacy,
Odessa National Medical University Vyshnytska I. V.
PhD in pharmacy, Professor Assistant of the department of organization and economics ofpharmacy,
Odessa National Medical University
