Comprehensive stimulation of the pharmaceutical industry as a factor in ensuring drug safety in the Russian Federation

Sekushin Aleksei Yur'evich Postgraduate student, Department of Taxes and Tax Administration, Financial University under the Government of the Russian Federation 15 Verkhnyaya Maslovka str., Moscow, 127083, Russia aleksey.sekushin@gmail.com Other publications by this author

Introduction

Analyzing the global pharmaceutical market, the following trends can be identified^[1]: investment and development of new forms and types of medicines, including by increasing investments in R&D, clinical research, orientation to emerging markets and the transfer of production to developing countries. The trends of the Russian pharmaceutical market differ from the global ones based on the reduction of investments and the presence of companies in the pharmaceutical market of the Russian Federation. One of the main trends in the Russian pharmaceutical market is the import substitution of original foreign medicines from "unfriendly" countries. This trend is dictated by the lack of external investments, as well as the withdrawal of foreign pharmaceutical companies and a reduction in the import of medicines.

At the moment, the following trends can be distinguished in the Russian pharmaceutical market:

1. innovative development of the pharmaceutical industry;

2. import substitution of original medicines from "unfriendly" countries;

3. consolidation of pharmaceutical production in the territory of the Russian Federation by stimulating the development of local production in the territory of the Russian Federation, including the "landing" of foreign pharmaceutical companies, by providing significant benefits.

Based on the current political and economic situation, the trends of the Russian pharmaceutical market differ significantly from the trends of the foreign pharmaceutical market. This article will analyze comprehensive incentive measures for the implementation of these trends.

Next, we will analyze the current state of the pharmaceutical market of the Russian Federation. In accordance with the analytical materials^[2] the Russian pharmaceutical market in 2023 in monetary terms showed an increase of 0.31% from 2,570 billion rubles to 2,578 billion rubles. The number of sales in packages in 2023 decreased from 5,211 billion to 5,078 billion packages. According to Rosstat statistics, inflation in the Russian Federation in 2023 amounted to 7.42%. Thus, based on statistics, it can be concluded that the pharmaceutical market of the Russian Federation is stagnating. The growth of the pharmaceutical market in monetary terms is ensured by an increase in prices for medicines, both imported and manufactured in the Russian Federation (partially medicines are produced from imported substances) (Figure 1).

Figure 1. The volume of the pharmaceutical market of the Russian Federation, billion rubles.

Source: compiled by the author based on data from the DSM Report

This trend can be explained by the following factors. The departure of foreign pharmaceutical companies. The share of foreign pharmaceutical companies in the Russian pharmaceutical market has remained unchanged at 64% over the past 3 years. Based on such a significant share, the suspension of the activities of some companies (even a small part) affects the capacity of the pharmaceutical market. Another important factor in reducing the capacity of the Russian pharmaceutical market is the suspension of imports by foreign pharmaceutical companies. Foreign companies with production facilities in the territory of the Russian Federation are reorienting from the import of medicines to their production, as a result of which the number of medicines is decreasing in the Russian pharmaceutical market.

This trend may only intensify in 2024 and 2025, since in accordance with clause 6 of Article 52.1 of Federal Law No. 61-FZ dated 12.04.2010 "On Circulation of Medicines" importers and manufacturers of medicines must notify federal executive authorities (Roszdravndazor, Ministry of Health) of the cessation of production or import of medicines at least a year in advance before the actual cessation of production or import.

The relevance of the research lies in the development of directions for comprehensive stimulation of the pharmaceutical industry through the use of comprehensive support tools on the example of special investment contracts ("SPIC"). Today, the pharmaceutical industry faces four important challenges:

1) import substitution of foreign medicines^[3];

2) an increase in the volume of production of medicines of domestic production^[4];

3) expanded application of innovations for the development of new drugs^[5];

4) greening of pharmaceutical production^[6].

Thus, despite the current measures to stimulate and encourage investments, the pharmaceutical industry of the Russian Federation is stagnating. At the same time, based on the policy of the Government of the Russian Federation, it can be concluded that the Russian pharmaceutical companies are of the greatest interest to the state in terms of the development of the pharmaceutical market (the "third superfluous" rule, the "second superfluous" rule, the "shelf patent" initiative will be considered further in the text of the work).

According to the Yakov and Partners consulting company, most foreign companies have stopped investing in their Russian projects, marketing and promotion. Thus, today it becomes clear that the development of the pharmaceutical industry is impossible without a significant amount of public investment and the development of its financial support system. Further development of comprehensive support tools will further stimulate investment activity, including in the pharmaceutical industry, which will accelerate the implementation of drug safety in the territory of the Russian Federation. An integrated approach to stimulating the pharmaceutical industry is to provide potential investors with a set of several groups of support tools, which include tax, financial and other types of benefits, since it is a set of benefits aimed at different areas of the company that allows you to get the most favorable effect for the development of the industry, including pharmaceutical.

According to the statements of representatives of various departments of the Russian Federation, the implementation of "drug safety" is the most priority area for the development of the pharmaceutical industry. This goal and the term "drug safety" itself are reflected in the Pharma 2030 development strategy, which was approved by Decree of the Government of the Russian Federation dated 06/07/2023 No. 1495-r "On Approval of the Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the period up to 2030". In accordance with the Decree of the Government of the Russian Federation, the term "drug safety" means maintaining the availability of medicines, achieving financial stability and technological independence of pharmaceutical industries, and fulfilling state guarantees for the provision of medicines to the company. Thus, drug safety is ensured by the sustainable and independent development of the pharmaceutical industry in order to provide modern, innovative and high-quality drugs to the population of the Russian Federation.

The purpose of the study is to develop directions for the development of integrated support tools for the pharmaceutical industry using the example of SPIC for the purpose of increasing the investment attractiveness of the industry and the implementation of drug safety.

Within the framework of this study, the following tasks are highlighted:

1. analysis of legislation on SPIC, practical aspects of the application of SPIC;

2. identification of SPIC issues based on the conducted analysis;

3. Development of directions for the development of comprehensive support tools using the example of SPIC.

The achievement of the set goal and the solution of the designated tasks are possible provided that the following general scientific methods are used in the process of research and evaluation of its results:

- deduction and induction – the use of methods makes it possible to improve the quality of work by relying on general scientific principles of conducting research on the theoretical foundations, principles and methods of state financial support for the pharmaceutical industry and ensuring the logic of research;

- analysis and synthesis – the application of this methodology will ensure the construction of a holistic, scientifically based concept for analyzing factors that reduce the effect of government incentives for pharmaceutical production and evaluating the effectiveness of proposals aimed at attracting investment into the industry, its innovative growth and greening;

- analogy – this method allows you to transfer previously studied tasks from one area of research to another, while obtaining new results, in particular, with its help it will be possible to assess the possibilities of using various conceptual approaches in the field of pharmaceutical support, justify the optimal combination of such support measures and choose the most appropriate option for Russian practice.

The scientific novelty of the research lies in the development of new directions for the development of complex tools to support the pharmaceutical industry on the example of SPIC, including the proposed possible mechanisms for the implementation of identified areas that contribute to the growth of the investment attractiveness of domestic pharmaceuticals and the implementation of drug safety.

A review of the literature on the research topic.

This topic is relevant for the purposes of scientific research in two areas: analysis of the pharmaceutical industry and analysis of SPIC. Let's analyze these two areas within the framework of scientific articles.

With regard to the analysis of the pharmaceutical industry, the authors of scientific articles investigated the following issues. As part of her research^[7], Abramova M.B. studied the state, problems and trends in the development of the pharmaceutical market of the Russian Federation. The author reveals its structural heterogeneity, and also shows the dependence of the pharmaceutical market of the Russian Federation on foreign pharmaceutical companies that import a significant share of medicines. However, within the framework of this study, possible directions for the development of the pharmaceutical market have not been proposed, which will reduce the import dependence of the Russian pharmaceutical market.

Subbotina T.N. and Tryakin D.S. in their study^[8] analyze the problems of the Russian pharmaceutical market in the context of the geopolitical crisis of 2022. The main conclusion is that, thanks to timely measures of state support for the pharmaceutical industry, the sanctions pressure did not directly affect the drug supply of the population. Indeed, in 2022, foreign pharmaceutical companies did not leave the Russian market, did not reduce the supply of medicines based on Russian pharmaceutical legislation, which prohibits doing this less than a year before notifying Roszdravnadzor and the Ministry of Industry and Trade of Russia. At the moment, based on statistics, we see that the number of sales in packages has significantly decreased compared to 2022, which indicates a decrease in production in the territory of the Russian Federation and imports of medicines by foreign pharmaceutical companies^[1]. This decrease, as well as dependence on foreign pharmaceutical companies, can seriously affect the provision of medicines to the population. In order to prevent such a situation, it is necessary to stimulate investment activity in the pharmaceutical industry through the use of comprehensive support tools.

The need to attract investments in the pharmaceutical industry is noted not only at the national but also at the international level. At the same time, the growth of investments is explained both by the needs of the industry itself and the need to greenize its functioning. The pharmaceutical industry (per unit mass of product) is one of the most resource-intensive, energy-intensive and polluting industries, while the consumption of pharmaceuticals is steadily increasing^[9]. Most high-tech industries are knowledge-intensive and capital-intensive, but compared to other high-tech industries, the pharmaceutical industry has certain specifics, which are reflected in the following aspects. First, the pharmaceutical industry requires more extensive investments in research and development of pharmaceutical products at the initial stage. Secondly, the pharmaceutical industry, despite high investments in R&D, has a relatively high profit margin and gross profit. After successful research and development, it is possible to obtain high monopoly profits provided a high level of patent protection. Thirdly, the pharmaceutical industry is an industry with low elasticity of product prices. Successful new products are often sold at a higher price, which is also an important reason why the gross profit margin of the pharmaceutical industry is higher than in other industries. But the pharmaceutical industry is a high-risk industry, the probability of inefficiency in research and development is very high, so the need for capital is more urgent at an early stage.

Currently, the existing forms of government support for the pharmaceutical industry in various countries of the world include subsidies and tax incentives. Subsidies make it possible to provide a certain cash flow for participants in the micro-market and increase the profits of enterprises. Budget subsidies are deterministic^[10]. Tax benefits in this aspect are universal and more accessible to pharmaceutical companies. At the same time, tax incentives are post-incentives, and enterprises can receive income from tax savings only after achieving public policy standards^[11], therefore, tax benefits are uncertain to a certain extent^[12]. It is this circumstance that leads to the need to consider comprehensive support tools, including both tax benefits and budget subsidies. In Russia, such instruments include special investment contracts.Next, let's look at scientific research on SPIC. Evstafieva Yu.V. analyzes in the study ^[13] the achievement of the goals set for the SPIC, as well as disadvantages, based on the analysis, directions for improving the SPIC are proposed. The main conclusion of this study is the compliance of the SPIC with the challenges and requirements of the Russian economy. At the same time, the author identifies a number of problems relevant to the SPIC at the time of 2019. However, since the study, the SPIC mechanism has significantly changed both within the framework of SPIC 1.0, analyzed by the author, as well as the emergence of a new SPIC – SPIC 2.0. The needs of the Russian economy in the development of various industries, including pharmaceutical, have increased significantly due to a decrease in investment from a number of countries. Thus, the results of this article are a logical continuation of the analyzed scientific work..

The problems of SPIC were considered separately in the scientific work of the authors Nasonov D.S. and Shadurskaya M.M. in 2018^[14]. The authors in this study identified the following problems.

1. A limited period of application of the preferential income tax rate until 2025. This problem is currently irrelevant.

2. Administrative procedures and the amount of documents required when concluding a SPIC. This problem is urgent. The authors in their study do not propose a possible direction of development within the framework of this problem.

3. Excessive disclosure requirements within the framework of the conclusion of the SPIC. Disclosure requirements are necessary to ensure that the Government is confident that the public expenditure on the provision of SPIC is justified. Within the framework of the submitted documents, information is mostly disclosed to the state only in relation to a potential SPIC. This problem is not relevant.

4. High penalties in case of deviation of targets. Indeed, this problem remains relevant at the moment. The authors in their study do not propose a possible direction of development within the framework of this problem.

5. The impossibility of using SPIC for companies with a "branch structure". This problem is not relevant, since the benefits of the SPIC are provided for the development of a specific production. The legislation does not provide for the extension of SPIC to all types of company activities.

6. The absence of legislation on SPIC in the subjects of the Russian Federation providing for benefits. This problem is irrelevant, since legislation on SPIC is provided for in all regions.

However, since 2018, changes have been made to SPIC 1.0, as well as SPIC 2.0 introduced into legislation. At the same time, according to the author, this scientific work does not address individual problems that arise when concluding a SPIC. However, it is worth noting that the problems highlighted by the authors of the works remain relevant at the moment. With regard to the actual problems investigated in the work of Nasonova D.S. and Shadurskaya M.M., this study will propose new and relevant directions for the development of legislation on SPIC, which will stimulate the development of the pharmaceutical sector and the implementation of drug safety.

Glukhova M.N. and Shokhin A.N. analyze ^[15] the mechanism of SPIC application and feedback from the business community regarding SPIC. The conclusions reached by the authors are similar to the conclusions presented in the work of Nasonova D.S. and Shchadurskaya M.M.

A. B. Sokolov in his research^[16] analyzes SPIC 2.0 and suggests the following directions for the development of this tool:

1. Expanding the pool of experts by creating interdepartmental working groups with the involvement of foreign specialists and researchers of the Russian Academy of Sciences. Indeed, the expansion of the pool of experts can speed up the procedure for concluding a SPIC, but at the same time it is necessary to change the legislation on SPIC 2.0. At the same time, in the current economic and political situation, it is difficult to attract foreign specialists.

2. Achieving openness and transparency of the tender procedure for concluding SPIC 2.0. In accordance with Resolution No. 1048, the procedure for concluding SPIC 2.0 is open, data on the process of concluding SPIC 2.0, the selection of applications are published in open access in the state information system of industry. However, a significant package of documents and the duration are a serious barrier to the conclusion of a SPIC 2.0 by a potential investor.

3. Creation of special and simplified conditions and rules for small and medium-sized businesses. In this paper, an analysis of the lack of relevance of such comprehensive support measures for small and medium-sized businesses will be disclosed.

4. The need to apply SPIC 2.0 to production, not technology. In accordance with the list of modern technologies established by the Government of the Russian Federation, SPIC 2.0 requires the production of any technology on a full cycle, that is, to the stage of the finished product for purposes, for example, obtaining the status of "Made in Russia".

At the same time, the author in this study does not propose certain steps, mechanisms necessary for the implementation of directions for the development of complex support tools using the example of SPIC.

Summarizing the results of the analysis of scientific research, the following conclusions can be drawn.

1. Scientific research is not aimed at analyzing comprehensive support tools specifically for the pharmaceutical industry.

2. The identified problems in the framework of the presented articles are partially irrelevant.

3. The authors of scientific publications do not propose development directions, as well as steps and mechanisms within the framework of the proposed development directions.

Thus, the relevance and scientific novelty of the stated purpose of the work is confirmed by the analysis of scientific research on this topic.

Comprehensive support tools as the most effective method of achieving drug safety in the Russian Federation

It is possible to achieve the growth of investments and production activity in 2 tax areas:

1) to increase the number of tax benefits (of various types) for a number of industries and types of industries that provide solutions to economic problems;

2) apply comprehensive financial support tools for businesses (for example, regional investment projects, special investment contracts).

Earlier it was noted that the establishment of tax benefits requires a mandatory assessment of their effectiveness – this is an extremely difficult task, the correct solution of which has not been found at the moment in theory and practice. To date, tax legislation is overloaded with tax benefits, including those that appeared in 2022-2023. The problem of assessment is complicated by the fact that industries have different susceptibility to tax incentives^[17], as a result of which tax incentives are often ineffective and do not lead to an increase in investment and production activity, unlike budget subsidies^[18]. In this regard, the second direction on the use of integrated support tools is more reasonable in the context of a mobilization economy.

For the purposes of analyzing comprehensive support measures, let's take SPIC 1.0 and SPIC 2.0, since the goals of these support tools are, respectively, import substitution and market launch of innovative technologies, including medicines and medical devices.

The differences in the conclusion of SPIC 1.0 and SPIC 2.0 are presented in Table 1 in accordance with Federal Law No. 488-FZ "On Industrial Policy".

Table 1 – Comparison of differences between SPIC 1.0 and SPIC 2.0

In 2019, SPIC 1.0 ceased to operate after the introduction of SPIC 2.0. This is due to the fact that the Government of the Russian Federation, represented by the Ministry of Industry and Trade, changed the policy of stimulating investments from import substitution to the implementation of promising and innovative projects on the list of relevant technologies. However, due to the events of 2022 and the departure of a significant number of foreign companies, it became necessary to import substitution, since many different technologies also left with the departure of foreign ones. As for the pharmaceutical industry, most foreign companies remained, but at the same time foreign companies stopped investing in the Russian market, which led to the cessation of clinical trials in the territory of the Russian Federation. The termination of clinical trials in the territory of the Russian Federation means the termination of the market launch not only of innovative drugs, but also of various generics that play a significant role in the country's drug safety, since their production is cheaper, supplies from various companies at once generally increase the availability of drugs with a single INN on the market. Thus, in the field of pharmaceuticals, there is also a need for import substitution.

In April 2022, the Russian Federation resumed the provision of this support tool on the same terms specified in the Decree of the Government of the Russian Federation dated 07/16/2015 No. 708 "On Special Investment Contracts for certain industries" (together with the "Rules for concluding special investment contracts").

As noted earlier, SPIC 2.0 is provided to companies implementing innovative products (competitive products at the global level), according to the list of relevant technologies approved by the Government of the Russian Federation. SPIC 2.0, compared with SPIC 1.0, assumes both the introduction and development and implementation of technologies. At the moment, SPIC 2.0 is the most relevant for the state in the field of pharmaceuticals, since it is within the framework of this benefit that promising medicines can be brought to the market.

The main purpose of the industrial policy of the Russian Federation, within the framework of which companies are supported by providing benefits to SPIC, is:

"1. the formation of a high-tech, competitive industry that ensures the transition of the state's economy from an export-raw material type of development to an innovative type of development;

2. Ensuring the country's defense and state security;

3. ensuring employment of the population and improving the standard of living of citizens of the Russian Federation."

The SPIC (both SPIC 1.0 and SPIC 2.0) provides tax benefits, the status of a "Russian manufacturer" and the opportunity to obtain the status of a sole supplier in public procurement. These benefits are the same for both support tools. Let's reveal these benefits in more detail.

In case of conclusion of a SPIC, the following tax benefits are provided^[19]:

• the rate of 0% on income tax paid to the federal budget, if the other party to the conclusion of the SPIC is the Russian Federation, in accordance with paragraph 1.14 of Article 284 of the Tax Code of the Russian Federation;
• a reduced income tax rate (up to 0%) paid to the budget of a constituent entity of the Russian Federation, in accordance with Article 284.9 of the Tax Code of the Russian Federation, while the amount of the reduced rate in each constituent entity of the Russian Federation is determined independently;
• Benefits are also provided for corporate property tax, as well as transport and land tax;
• The SPIC also provides for a stabilization clause, the essence of which is that the company that concluded the SPIC will not be subject to changes in tax legislation if these conditions worsen the current taxation under the SPIC.

One of the features of the income tax benefit is that it can be applied to the base of activities within the framework of an investment project for which a SPIC is concluded or to the entire base of income tax. If applied to the entire income tax base, it is necessary to fulfill the condition for the minimum share of income from the sale of goods produced within the framework of the project for which the SPIC is concluded.

Tax benefits are an important part of the conclusion of the SPIC, since the tax savings taken into account when compiling the financial model of the proposed investment project, for example, allows you to obtain NPV (Net Present Value, net present value) and IRR (Internal rate of return, internal rate of return) values that allow you to accept this investment project.

However, important benefits within the pharmaceutical market of the Russian Federation in obtaining SPIC are the status of "Russian manufacturer" and the status of the sole supplier in public procurement^[13].

The status of "Russian manufacturer" allows the company to participate in public procurement of medicines with advantages in determining the supplier (the "third superfluous" rule, the "second superfluous" rule). The essence of the "third superfluous" rule is that if two or more applications with goods with the status "made in the EAEU" are offered within the framework of public procurement, applications containing foreign medicines are rejected. The status of a "Russian manufacturer" allows pharmaceutical companies to more likely conclude contracts with the state for the supply of medicines and thereby guarantee themselves revenue from the implementation of an investment project. Products within the framework of the SPIC, for example, are automatically assigned the status "made in the Russian Federation" if the agreement with the Russian Federation provides for a provision on a certain level of localization in accordance with the legislation of the Russian Federation.

The company can receive the status of "sole supplier" only if the total investment in the project is at least 3 billion rubles. Upon obtaining the status of a sole supplier, contracts for the supply of medicines are concluded without a competitive procedure.

Thus, as we can see, the SPIC contains significant benefits, which are most relevant for the pharmaceutical industry. It allows both the company to save on taxes, thereby increasing the number of potential investment projects to be accepted, and it is more likely (the "third extra" rule) or completely (the only supplier) to guarantee revenue when implementing an investment project.

Let's consider the statistics provided by the state information system of industry^[20] in relation to the SPIC.

Table 2. The effect of the SPIC since the introduction of this mechanism, 2024, million rubles.

Based on the presented statistics, we see that the amount of investments is more than 11 trillion rubles, while the lost income tax is less than 1%. These projects have either been implemented or are under implementation. It can be concluded that the SPIC is an effective tool, since, on the one hand, it stimulates investment activity in the territory of the Russian Federation, on the other hand, budget expenditures are minimal in relation to the volume of investments. At the moment, 89 SPICAS have been concluded. At the same time, the pharmaceutical industry is the third largest in terms of the number of SPIC prisoners. Thus, the SPIC is available to the largest industrial enterprises that have the opportunity to implement large investment projects.

Analysis of the problems arising at the conclusion of the SPIC

This investment promotion tool has disadvantages. Let's look at them in more detail. In accordance with Federal Law No. 488-FZ dated December 31, 2014 "On Industrial Policy in the Russian Federation", in the case of SPIC 1.0, an investor enters into an agreement with the Russian Federation, a subject of the Russian Federation, as a general rule (within the framework of SPIC 1.0, subjects can also be both the Russian Federation and only a subject of the Russian Federation and a municipality). However, in order to receive tax benefits, it is necessary to conclude a SPIC simultaneously with the Russian Federation and a subject of the Russian Federation. In the case of SPIC 2.0, the investor must conclude an agreement with the Russian Federation, a constituent entity of the Russian Federation and a municipality. From this, the following urgent problem arises. Coordination of the SPIC project, for example, with the Ministry of Industry and Trade of Russia (this agency is a federal executive authority within the SPIC) is not a guarantee of concluding a SPIC, since the investment project option must also be formally agreed with the subject of the Russian Federation and the municipality within the framework of an interdepartmental commission. At the same time, there are no direct rules establishing any requirements of the subjects of the Russian Federation and municipalities for the SPIC. Thus, at the moment there is no transparency of requirements and relationships between a potential investor and a constituent entity of the Russian Federation, a municipality. This problem negatively affects the transparency of the conditions for concluding a SPIC, since the lack of requirements and conditions put forward by the subjects negatively affects the planning of an investment project, forecasting its conclusion by an investor.

The problems in concluding a SPIC for the pharmaceutical industry include the price regulation of medicines from the list of Vital and essential medicines ("VED") of the VED. Medicines from the list of VED are the most important for the state, price regulation is carried out in relation to these medicines, and most government purchases are carried out specifically in relation to medicines on the list of VED. Since such medicines have a marginal selling price from "production", potential investors quite often cannot show the necessary level of profitability, profit, NPV and IRR necessary (attractive) for the adoption of a state project based on the limitation of the selling price from "production" by the state. At the same time, these medicines are among the most important for ensuring drug safety, the localization of which is a priority for the state within the framework of the implementation of the Pharma 2030 strategy.

The following is a scheme for limiting the profitability of an investment project within the framework of regulating the sale price of a medicinal product (Figure 2).

Figure 2. Limitation of profitability

Source: compiled by the author

Thus, one of the serious disadvantages of SPIC for the pharmaceutical industry is the limitation of profitability.

The disadvantages of the SPIC include the sufficient complexity of concluding an agreement with the Russian Federation^[14]. This process can take a significant period of time (up to six months), requires several levels of coordination and adoption at the state level, and also requires the preparation of a significant number of documents, including a financial model, a business plan about the investment project itself, about the activities of the company that wants to implement the investment project. The process of preparing documents and approving the project with government agencies can take a long time and requires a significant amount of resources. Thus, these administrative procedures do not allow small and medium-sized businesses to enter into a SPIC (provided that, for example, there is no minimum investment requirement under SPIC 2.0). At the same time, based on the procedure for concluding a SPIC, requirements for an investor, it can be concluded that these benefits are primarily aimed at large companies that can expand production, introduce modern technologies with their development, build new production facilities, and also have sufficient administrative staff capable of accompanying the process of concluding a SPIC. However, given the focus on large businesses, the process of concluding a SPIC is quite difficult to conclude for large companies, including. Based on this, one of the main problems of the SPIC is serious administrative barriers that require significant resources from potential investors for the purpose of concluding a SPIC.

It is worth noting that this disadvantage implies one of the most important advantages of such investment support tools – administrative barriers allow government agencies to most accurately assess the possibility of implementing a project, its advantages for the state, and the feasibility of implementing a project for the state, since the state should approve such a significant support tool for each company that has expressed a desire to conclude a SPIC, impractical.

As noted earlier, during the passage of all procedures for concluding a SPIC, an agreement is concluded between the Russian Federation (a subject of the Russian Federation, a municipality under certain circumstances) and the company. This agreement regulates the rights and obligations between the company and the state, establishes sanctions for violation of the terms of the SPIC (for example, the company deviates from the targets set in the financial model by more than 20% in a certain year). Thus, the company has obligations to the state for the implementation of the SPIC, its implementation with targets for revenue, production of goods, and the company's working staff. These obligations allow the state to be most confident that additional budget expenditures will be effectively spent, as well as monitor the implementation of the investment project by the company, fine and promptly deprive the company of support in case of serious violations.

Given this advantage, one of the serious problems is the opaque requirements for the SPIC. The legislation does not establish requirements for projected financial indicators, production indicators, personnel and other indicators required for disclosure within the framework of SPIC documents. Based on this, a potential investor cannot determine the attractiveness of a potential investment project for the state due to the opacity of the required indicators. This fact creates uncertainty in terms of administrative barriers, which reduces the attractiveness of this investment activity support tool for companies, since if the formal requirements established by law are met, the SPIC may be rejected by the state due to non-compliance with informal requirements, which may change quite often depending on the economic situation, the demand for complex tools for the state, the relevance of the industry. At the same time, the potential investor is not informed about these changes. Thus, one of the problems highlighted in this study is the non-establishment (opacity) of the actual requirements for the purpose of successfully concluding a SPIC.

At the same time, it is worth noting that, based on practice, the penalties applied can be quite high, which can affect investment activity within the framework of the SPIC in the following way: reduce the relevance of the SPIC for investors, which is expressed in a decrease in investment projects being implemented in the territory of the Russian Federation. The relevance of the SPIC is decreasing because companies are not ready to bear the high costs of paying penalties due to violations of the financial model indicators. These penalties are also not regulated by the legislation on SPIC. Thus, in addition to their likely high values, the mechanism for calculating the amount of penalties is opaque, which is also a negative aspect of the conclusion of the SPIC, since the potential investor does not have a full understanding of the possible mechanisms for calculating fines in case of deviations from the targets and, consequently, the possible amounts of fines. Thus, based on this analysis, we will highlight the problem of not establishing a mechanism for calculating penalties, as well as their actual high value, which has a negative impact on the relevance of this comprehensive support tool for potential investors.

It is also worth noting some problems with regard to SPIC 1.0 and SPIC 2.0. If we consider the problems of SPIC 1.0, it is worth noting that at the moment Government Decree No. 719 regulating the process of concluding SPIC 1.0 provides for a restriction on concluding SPIC 1.0 for companies whose capital includes companies from offshore zones. It is worth noting that the latest edition of the list of offshore zones contains the countries of the European Union and other developed countries. This requirement significantly reduces the number of potential investors.

When considering SPIC 2.0, we note the following. For the purposes of concluding SPIC 2.0, it is necessary to add the technology to the list of modern technologies, if the necessary technology is not included in the current list. This process is not transparent, because according to Government Decree No. 319 regulating this process, some stages do not have deadlines, as well as the mechanism for reviewing and deciding on updating the list of modern technologies. According to the author, the current procedure is the most optimal for the state, since the state should analyze relevant and necessary technologies for the state when reviewing the list of modern technologies. However, this significantly reduces the investment potential of the SPIC for business.

Conclusions and suggestions

According to the author, comprehensive support tools containing an obligation to the state are the most interesting and effective, since the obligation stimulates the company to carry out an investment project, while the state controls it, and also provides a significant set of various incentives for the company in order to successfully implement the investment project. Thus, everyone remains in an advantageous position. The state improves socio-economic conditions through the implementation of an investment project, the company receives additional revenue and profit. On the other hand, the "classic benefits" presented, for example, in the Tax Code, which do not contain obligations, cannot be effective at the same level, because the company can use the benefit, so it can stop using the benefits. At the same time, the company either does not have any consequences, or the consequences are only the payment of tax on penalties. This leads to the fact that government spending on benefits does not fulfill its goals, does not stimulate the economy, but is only part of the tax planning of organizations. At the same time, it is worth noting that these conclusions are applicable only to large organizations that have the resources to implement investment projects in which the state may be interested. Small and medium-sized businesses cannot participate in such comprehensive support tools. For such companies, tax incentives without serious requirements and obligations are the most relevant. It is worth noting that the pharmaceutical industry is a highly regulated industry, for the purposes of production in which it is necessary to have very significant capital, thus, significant investments are needed for the implementation of an investment project in the pharmaceutical industry. These comprehensive support tools are the most relevant for the pharmaceutical industry.

According to the author, in order to further develop comprehensive support tools, including SPIC, it is necessary to solve the problems indicated in the analysis. The author suggests the following possible directions for the development of SPIC, distributed according to their relevance and importance for the pharmaceutical industry.

1. One of the main drawbacks in this work is administrative barriers, as well as their opacity, and the lack of established targets. According to the author, these administrative barriers are a significant advantage for the state, and also allow providing investors with more significant benefits. Thus, canceling or reducing the number of requirements is not advisable. However, it is necessary to set targets in Government Regulations governing the SPIC that potential investors should achieve when concluding a SPIC. For example, targets for profitability, production volumes, profit levels, financial indicators, the number of employees employed and other indicators required to be disclosed as part of the SPIC conclusion process. Quantitative criteria should be established depending on the volume of investments and (or) the size of the enterprise (legal entity) itself. Setting specific targets will allow potential investors to assess the feasibility of applying for a SPIC. The feasibility assessment will, on the one hand, increase the number of applications submitted for the conclusion of a SPIC, since investors can most accurately predict the possibility of concluding a SPIC, on the other hand, with a decrease in demand for a comprehensive support tool after setting targets, the state will be able to adjust targets if necessary to increase the number of companies using SPIC.

2. One of the ways to solve the problem of price regulation of the pharmaceutical market, which was highlighted by the author, is also the establishment of targeted administrative barriers. According to the author, it is necessary to set targets adjusted for different industries, since they have different production profitability. Returning to the pharmaceutical industry, it is necessary to establish such requirements for medicines from the list of VED that allow the state to consider and accept an investment project for the production of medicines from the list of VED. Obviously, due to the price restriction on medicines from the list of VED, it is necessary to set lower requirements for the financial performance of the investment project, taking into account the profitability of the sale of a medicinal product from the list of VED. The implementation of this development direction will increase the number of SPIC with companies from the pharmaceutical industry, which will have a positive impact on the implementation of drug safety in the Russian Federation. A possible implementation is shown in the diagram (Figure 3).

Figure 3. Adjustment of targets for companies planning to manufacture medicines from the list of VED.

Source: compiled by the author

Increasing the transparency of administrative barriers and setting targets, including for the pharmaceutical industry, are the most important proposals, since the implementation of these proposals will have the greatest positive impact on stimulating the pharmaceutical industry of the Russian Federation.

3. With regard to the parties involved in the conclusion of the SPIC, the author believes that it is necessary to develop rules governing the interaction of the subject of the Russian Federation, the municipality with the investor, in order to create predictable conditions for the interaction of the investor with the subject of the Russian Federation and the municipality. These rules should be similar to the rules established in Government Regulations governing the SPIC. Creating additional requirements will complicate the process of concluding a SPIC. The implementation of this rule should take place at the level of the Government of the Russian Federation in order to prevent a situation in which not all subjects of the Russian Federation, municipalities establish requirements. The implementation of this development direction will create more predictable conditions for interaction between the state and the investor when using a comprehensive support tool for SPIC, which in the future, subject to the improvement of comprehensive support tools, will accelerate the implementation of drug safety in the territory of the Russian Federation.

4. With regard to penalties, Government Regulations governing the SPIC should establish mechanisms for determining penalties in order to increase the attractiveness and transparency of the SPIC, since potential investors will have an understanding of penalties for violations of the terms of the SPIC. In the Resolutions regulating the SPIC, or in local acts of ministries (for example, the procedure for verifying compliance with the conditions of the SPIC established by the Order of the Ministry of Industry and Trade of Russia"), establish a mechanism, the level of penalties depending on the violations of the investor – failure to achieve targets, the schedule for the implementation of an investment project, the investment schedule. Fines should be set depending on the degree of violation (for example, failure to achieve targets in the amount of 10%, 20%, 30% and beyond). The implementation of this development direction will increase the attractiveness of the SPIC, since the establishment of the proposed penalty mechanism will improve transparency and reduce potential fines, which is a positive factor.

5. As a solution to the problem of limiting the range of investors within the framework of SPIC 1.0, it is proposed to reduce the requirement that legal entities from offshore zones be absent from the capital of the company concluding the SPIC to a limit of 25%. This change will expand the range of potential investors and increase investments in the Russian economy. Increasing the potential range of investors will increase the possible number of applications, which may become an additional growth driver for the pharmaceutical industry of the Russian Federation.

Thus, the comprehensive support tools considered on the example of the SPIC are the most relevant direction for the development of incentives for the pharmaceutical industry both for import substitution and for the implementation of innovative technologies based on the inclusion of obligations in the instrument and, consequently, the opportunity to offer more serious and multidirectional benefits. The implementation of the proposed development directions will increase the attractiveness of comprehensive support tools, as well as ensure the implementation of drug safety in the territory of the Russian Federation.