Strategic factors of development of the enterprises

The complication of economic development of the Russian industry connected with changes in conditions of attraction of credit resources with certain difficulties of access to some foreign technologies and a number of types of goods results in need to consider tasks of import substitution and optimization of costs of production as priority in the combination. In this regard, measures for stimulation of development of industry are carried to number of the key directions of development of domestic economy by the state. Features of the transportation or energy company directly reflect and in an essential part define the main problems of functioning of producers. Insufficient competitiveness of the enterprises of some industry (for example transportation or energy company) of Russia in an essential measure is connected with the low level of finishing results of a scientific research and developments to a stage of the organization of production. In article authors consider the target directions and sources of development of production of the Russian Federation in the conditions of import substitution policy, and also represent results of the conducted research that has allowed to reveal features of factors of strategic development of the enterprise and to formulate the principles of strategic approach to development of the transportation or energy enterprises of industry.


Introduction
Analyzing the current features of the pharmaceutical market, their importance for the state and trends in the development of pharmaceutical production seems logical to refer to the classification of the most important factors which influence on the economic activity of pharmaceutical companies and study the dynamic of changes in this impact. The assessments dynamics of the external factors significance of the domestic pharmaceutical production development by the industry enterprises depends on various factors [1]. For example, the place and importance of state regulation of the investigated sector as an external impact factor is high rated.

Methods
Supporting business processes include the processes that are diverse in a content but similar in functional meaning, they provide the provision and assistance for basic operating processes of integrated group.
The details of main business processes are reflected in the model as well. These details have an influence on the way how to specify the separation of tasks between the working group staff of consulting company and could be considered as a basis for contract relationship between the customers and consulting companies including the identification of consulting company's contract stages.
In accordance of the model the certain items of works could be represented as follows.
The features of diversified company strategic management are reflected in the structure of the subprocesses that are belonged to the management business process of vertically integrated construction company.
In frames of the process we could identify some sub-processes: the sub-process of strategic management (it generates key long-term strategic targets for results of the group's functioning); the sub-process of general horizontal coordination and unification (it generates certain methodological approaches that focus on the standards and uniformity of the group's elements, group's results and group's technology); the sub-process of cascading the strategy for a horizontal level (it includes certain controlling mechanism for each horizontal level); sub-process of process oriented management support (it aimed at collecting the data for business analysis); sub-processes of financial accounting and taxation managing (provides the collecting accounting data, bookkeeping and preparation of the financial, statistical and tax returns).
A specialist of the industry attributed to the number of key aspects legislative's regulation following factors in order of priority the need for change and improvement:  Price restrictions on the drug market, including the necessity in revising the order of price regulation for drugs on the vital list [2];  Insufficiently developed procedure for regulating the acquisition of medicines under government contracts [3,4];  Tax administration order of the pharmaceutical manufacturers activities, including the procedure for applying tax incentives and controlling the determination of prices between interdependent enterprises (transferees);  The procedure for applying the term "local producer" for the purpose of pricing and the production quality standards application;  Complexity, duration of drug registration procedures;  The order of regulating the methods of medicines promotion;  Lack of harmonization in legislation with WTO member countries and the customs union;  Low level of rights protection to intellectual property;  Absence of significant preferences for Russian producers of medicines.
It should be noted that the number of enterprises that identified the key problem of deficiencies in the system of state regulation of pharmaceutical production decreased from 36% in 2015 to 28% in 2017. Significant, by one third, is presented a reduction in the impact of a lack of public funding. Specialists also highlight the influence of factors of corruption and falsification of drugs.
Particular attention is paid to the weak level of patent protection of the rights to medicines in the Russian Federation and the wide possibilities for organizing the production of generic drugs of known drugs. However, it is important and timely to note the appearance in 2017 a new influence of environmental factors on the industrial manufacturer, transportation or energy company, real estate development company. About 10% of enterprises already in August 2017 described as significant factors determined by the complication of international cooperation and the growth of a negative outlook for economic risks related to the impact of economic sanctions, including restrictions on financing, a decrease in consumer trade activity, a rise in the cost of bank loans and a growth in the medicines price.

Results
From the point of view of classification and detailed research of the legislative regulation directions of pharmaceutical production, we have proposed a scheme that summarizes the key elements of state regulation system of processes for the development, production and sale of pharmaceutical products, including pharmaceuticals and pharmaceutical substances, based on current legislative and regulatory documents. Elements of state regulation are reflected in the relationship with individual stages of providing consumers with pharmaceutical products and are correlated with existing regulatory documents, the full name of which is given in the list of used literature. An important fact is that all stages consistently -from the moment of performing research to the time of sale of the finished goods to the buyer are regulated.
So, before starting the organization of production, the results of scientific research must pass the procedure of state registration, and also can be protected by a patent [5,6,7].
Further, all production operations are subject to implementation in accordance with the quality standards for the production of pharmaceutical products that meet international requirements [5].
Also are the subject to licensing, which includes both the verification of the relevant documentation, and verification of the actual conformity of the manufacturing enterprise with the licensing requirements.
In case of selling pharmaceutical products from the point of view of control over the commercial market, are presented the norms regulate transfer pricing, which is allowing to control prices between interdependent enterprisesproducers, as well as sellers, and the prices of several groups of drugs on the list of essential drugs. In addition, the restrictions on the market of pharmaceutical products are imposed from the point of view of methods for promoting goods.
Considering the state pharmaceutical market, presented by medical-prophylactic institutions and programs of additional medicinal provision, it is possible to say that the normative documents act both in terms of pricing and in terms of organizational procedures for the procurement of medicines and medical equipment.

Discussion
Such organization of state regulation can be characterized as two-functional. The stimulating function is expressed by a set of measures to provide the market with the necessary quantity of the most socially significant preparations of an appropriate level of quality at acceptable prices (organization of purchases, pricing, quality assurance, and protection of production technologies).
The second function of state regulation is a dissimulating or limiting function. Introducing and improving restrictions in the form of licensing requirements, state standards of production quality, limiting the ways of promoting goods, the legislator strengthens the control of the pharmaceutical market and its foundations -producers.
Thus, above are considered some of the most significant external factors at the current time, affecting the development of manufacturing enterprises in the pharmaceutical industry.
Summarizing the meaning and mechanisms of the manifestation of properties in the issue of the impact on the enterprise's activities of a set of external circumstances, in which the pharmaceutical industry operates due to our opinion, it is possible to divide these meaning and mechanisms into the following categories:  Factors affecting the processes of development and admission to the production of new medicines and pharmaceutical substances, including providing enterprises with the required level of services for standardization and quality control of new developments;  Factors affecting the level of financial and economic support for the development of research and production, including the expense of budgetary, non-budgetary sources, systems of subsidizing investment in pharmaceutical production, tax administration and stimulating the development of production;  Factors affecting the processes of ensuring the production and technological development of research and production;  Factors affecting the mechanisms of promotion of the products being developed and manufactured to markets of different levels;  Factors that ensure the information environment of pharmaceutical manufacturers both in terms of protecting their intellectual property, and in terms of information exchange, the formation of the necessary databases and knowledge bases;  Factors that ensure the coordination and regulation of the pharmaceutical research and production development.
In the current conditions, under the influence of external factors, including taking into account the effect of instruments of state regulation, changes both the nomenclature of the target tasks and the main essence of these tasks in enterprise development.
It should be noted that the dynamics of changes in the strategic objectives of the pharmaceutical enterprises development of pharmaceutical enterprises are: the share of enterprises planning organizational changes, including restructuring, increased from 45% in 2015 to 55% in 2017.
It is necessary to highlight the directions of organizational changes: rejection of non-core businesses (8%), mergers (13%), creation of joint ventures (19%), construction of new production facilities (15%). In terms of creating joint ventures, the trend is determined by a number of benefits for localized, that is located on the territory of the Russian Federation pharmaceutical manufacturer and by the barriers (administrative, financial, and from 2014 -political) for the opening by foreign companies production in Russia. With regard to the implementation of new construction projectstheir share decreased from almost 30% in 2013 to 15% in 2016. At the same time, plans to bring new types of drugs to the market are declining (47% of enterprises in 2013 and 34% by 2017) [8].
It is important to note that, according to researchers, among the new drugs on the market comes the vast majority of modifications of known drugs, while the share of new innovative products, which include new pharmaceutical substances -is negligible, due to this fact plans for the renewal of the products are not plans to start the production of innovative new products. Finally, in 2017, the share of producers that do not plan future changes is increasing (from 0% in 2013 to 8% in 2017).
Thus, the identified trends indicate a further expansion of the processes of business consolidation on the background of plans to optimize its structure in order to reduce costs, however, renewal, increase of innovative and competitive properties of pharmaceutical products is not a priority direction of development of industrial enterprises, which does not correspond to program documents and stimulating measures of state development.

Conclusions
Summarizing the results of a study of the domestic pharmaceutical market characteristics, the state of pharmaceutical production and the sources of financing for its development, and also taking into account the program measures of state stimulation of domestic pharmaceutical production development it is necessary to emphasize the importance of scientifically based, purpose-oriented [8,9], corresponding to the directions of the state development strategy choice of each particular enterprise in the industry [10].
The duration of developing, testing, registering and organizing the production of new innovative medicines processes, the necessity of forecasting the development of medical knowledge, technology, the needs of the pharmaceutical market and the public health system that shapes the needs of this market, limited resources, and other factors that determine real economic and political conditions for the development of pharmaceutical production -all these necessitate the use of strategies approaches to the development of Russian pharmaceutical manufacturers.