Domestic Pharmaceutical Companies Research Articles

The Impact of Drug Approval-Patent Linkage System on Patent Applications: Evidence from the KORUS FTA

Purpose - This paper empirically investigates the impact of strengthened intellectual property rights (IPRs) within the KORUS Free Trade Agreement (FTA) on patent applications filed by domestic pharmaceutical companies in Korea.
 Design/methodology - In this study, the distribution of the dependent variable is assumed to follow a Poisson or a negative binomial distribution, given the count nature of the dependent variable. Therefore, it can be estimated through the Panel Count Model. The study utilizes Poisson panel analysis and negative binomial panel analysis.
 Findings - The results of the negative binomial panel analysis and the Poisson panel analysis affirm that the conclusion of the KORUS-FTA had a significantly positive effect on the number of patent applications by domestic pharmaceutical companies. These findings suggest that domestic pharma- ceutical companies actively sought patents following the signing of the KORUS-FTA, driven by the “drug approval-patent linkage system” designed to fortify intellectual property rights for drugs.
 Originality/value - Limited empirical research has been conducted on the drug approval-patent linkage system in the KORUS-FTA. This study empirically confirmed the impact of institutional changes in the pharmaceutical industry on patent applications at the corporate level within the KORUS-FTA context. Such insights are crucial for formulating strategies for pharmaceutical companies and indicating policy directions for the pharmaceutical industry in the future.

Analysis of Incentive Policies and Initiatives on Orphan Drug Development in China: Challenges, Reforms and Implications

ObjectivesRare diseases are a global public health issue with a more pressing situation in China. Unfortunately, the relevant research and development in this country are still in its infancy, leading to limited drug accessibility. In view of this, the Chinese government has taken a series of countermeasures to promote orphan drug R&D in recent years, which has presented encouraging results. This paper aims to review incentive policies and funding initiatives formulated by the Chinese government and examine their implications on orphan drug R&D.MethodsPolicies targeting orphan drug R&D during 2012–2022 were retrieved from the relevant official websites, categorized into different themes and analyzed for the contents. Data on government funding, drug approval, clinical trial approval and orphan drug designation were collected through internet search to analyze the implications of those incentive policies and initiatives on orphan drug R&D in China.ResultsA total of 20 relevant policy documents were identified and five major themes were revealed through content analysis, including national strategy, expedited approval, safety and efficacy requirements, data protection and technical support. The government input in orphan drug R&D has witnessed a steady annual increase. Driven by those incentives, the numbers of orphan drugs approved for marketing and drug candidates entering clinical studies are increasing year by year, and more domestic pharmaceutical companies are actively involved in the R&D of orphan drugs.ConclusionsOrphan drug development in China is growing rapidly under the stimulation of incentive regulatory policies and more investment in researches. China is working toward a more standardized and comprehensive rare disease ecosystem. However, there are still some challenges, such as the lack of sufficient financial support and the call for systematic legislation on rare diseases, to be addressed for future success.

Research of the domestic market of drugs for the treatment of HIV infection

The aim of the research is to study the domestic market of medicines for the treatment of HIV infection to optimize the drug supply of the target group of patients. Materials and methods. Electronic sources of information (State Register of Medicines of Ukraine, Compendium-online, Tabletki.ua) were used to achieve the goal. System-analytical, mathematical-statistical, and comparative methods of analysis were used. Results. The study of the assortment of drugs for the treatment of HIV infection showed the heterogeneity of the specified segment of the pharmaceutical market of Ukraine: there are solid and liquid dosage forms, both original and generic. The analysis of the company structure made it possible to establish that the national market of drugs for the treatment of HIV infection was dominated by foreign manu­facturers (95.93 %), the largest share of which was pharmaceutical companies from India (67.07 %). The competitiveness of pharmaceutical firms supplying drugs for the treatment of HIV infection was studied. It was established that the firm Janssen-Silag S.p.A., Italy, occupied the most stable position in the studied market segment. A qualitative analysis of the mentioned medicines was carried out. The most effective and rational of them were determined. Conclusions. A study of the domestic market of drugs for the treatment of HIV infection was conducted. The assortment and brand structure of this market segment was determined. The level of competitiveness of the above-mentioned pharmaceutical companies were analyzed, and the most successful of them were identified. At the same time, it was established that domestic pharmaceutical companies supply only 4.07 % of drugs of two out of five groups according to the ATS classification to this segment of the market. In connection with this, the development of new drugs of the specified action and the development of their production in Ukraine is important.

The English-Chinese Translation of Scale from the Perspective of Translator Behavior Criticism

With the development of high-quality assessment tools in the medical field, the awareness of copyright in the pharmaceutical industry, the increasing clinical demand for medical scales, and the gradual introduction of foreign authorized scales in China, domestic pharmaceutical companies have purchased the required genuine medical scales from online platforms such as ePROVIDE, EuroQol and Cardiff University Medical Resources. Translator behavior criticism is an evaluative theoretical tool simply used for postevaluation, a dynamic evaluation model that provides a comprehensive and objective guide to translation criticism to ensure the reliability and validity of the scales. In this paper, 20 medical scales are collected. Combined with “in-translation” and “out-of-translation” scales and guided by translation examples in the framework of “truth-seeking-utility-attaining” evaluation, the model will be discussed in detailed translation problems to solve the reliability and validity of the scales, and to provide strategies for improving the quality of the scales.

Corporate social responsibility of pharmaceutical industry in Korea.

Background: Global pharmaceutical companies in Korea argue that the development of innovative drugs should be recognized as a social contribution, yet it has been countered by various stakeholders. The need to distinguish between philanthropic activities and Corporate Social Responsibility (CSR) of pharmaceutical companies and reaching consensus in the Korean context has been raised. We sought to evaluate the CSR status of Korean pharmaceutical companies and collect the stakeholders’ opinions to define philanthropic activities and CSR related to pharmaceutical companies in Korea. Methods: We conducted a literature review on the definition of CSR of pharmaceutical companies, and the CSR activities of the domestic pharmaceutical companies were compared with those of global pharmaceutical companies operating in Korea. The opinions of stakeholder groups (patient advocate groups, consumer organizations, and domestic/global pharmaceutical companies) were collected using focus group interviews (FGI) and written surveys. Results: Literature review suggested that CSR is categorized as “must do” (economic and legal responsibilities), “ought to do” (ethical responsibilities), and “can do” (philanthropic responsibilities), whereas contributions beyond the economic, legal, or ethical responsibilities can be defined as “can do” (philanthropic responsibilities). Domestic pharmaceutical companies simply adopted systems for ethical and ESG (Environmental, Social, and Governance) management, which are at the “ought to do” level (ethical responsibility), whereas the headquarters of these global pharmaceutical companies established the CSR team and systematically reported on the CSR activity, including ESG management reports, which is at the “ought to do” level and further moving to the “can do” level, but the Korean branch rarely has CSR teams, and the CSR activities in Korea were also insufficient. At the FGI, the global pharmaceutical companies argued that CSR activities, such as innovative drug development, should be recognized as similar to philanthropic activities, yet stakeholders besides them suggested that those activities are “can do” rather than being philanthropic. Discussion: We found that the pharmaceutical companies in Korea are attempting to achieve the “ought to do” level (ethical responsibilities) while complying with the “must do” level (legal and economic responsibilities) yet not philanthropic activities. A social consensus regarding the philanthropic responsibilities of pharmaceutical companies in Korea was not reached.

Analysis of the dynamics of the nomenclature of medicines in the government program «Available medicines»

The availability of medicines the public is a problem with the most acute health care systems. Not only the issue of physical availability of medicines, their availability in pharmacies, but also the economic assistance of the population to purchase drugs is relevant. To overcome these problems, the Government has recognized the introduction of a reimbursement process in the pharmaceutical sector. The content of improving the quality and life expectancy of the population, with increasing physical and economic accessibility of drugs for the treatment of the most socially significant diseases, April 1, 2017 the Government introduced a reimbursement program «Available medicines». In the beginning there were spreads with cardiovascular disease, type II diabetes and bronchial asthma. From October 1, 2021, the program includes drugs for the treatment of diabetes mellitus, mental and behavioral disorders, epilepsy.
 The aim of the work is to study the dynamics of the range of drugs included in the government programs «Available medicines» for 2017–2022.
 The content analysis of 13 issues of Registers of medicines subject to reimbursement shows the updating and growth of the number of international non-proprietary names and in accordance with the trade names of drugs for the treatment of nosologies, which countries have recognized as the best. The nomenclature of medicines has been updated twice with international non-proprietary names and in almost 3 varieties – by trade names compared to the first issue, which is associated with both the expansion of names for the treatment of the disease, which were in programs since 2017 and the emergence of new nosology from 2021. On average, the share of drugs of domestic pharmaceutical companies is only 60%, which opens a significant prospect of import substitution, reduces drug prices under the government program «Available medicines» and, for example, increase the physical and economic availability of drugs.
 The conducted studies allow us to conclude that there is a need to improve the assortment policy of the government program «Available medicines» using the population of Ukraine available drugs in accordance with the needs of the population and the standards for the treatment socially significant diseases.

Patent information analysis of TCM prescription for the treatment of diabetes based on patent analysis and SWOT model

ObjectiveTo analyze the patent information and medication rules of traditional Chinese medicine (TCM) prescriptions for the treatment of diabetes, so as to provide reference for domestic pharmaceutical enterprises in new drug development and patent layout. MethodsThe retrieval strategy was formulated based on the characteristics of TCM prescription. The patent data were retrieved by incoPat and WTMPD patent database. SPSS Statistic21.0 was used to analyze the internal strengths (S), weaknesses (W), opportunities (O) and threats (T) of TCM for the treatment of diabetes on the basis of patent analysis, and different types of combinations of strategies were worked out. ResultsAt present, the patent application for the prescription of TCM for the treatment of diabetes gradually enters the declining period. Three typical domestic pharmaceutical companies (Hebei Yiling Pharmaceutical, Tianjin Tianshili Pharmaceutical and Lunan Pharmaceutical Group) have their own characteristics in the field of technological innovation and patent layout in the treatment of diabetes, but there is a defect of insufficient power of original technology. The high-frequency core TCM for the treatment of diabetes is Radix Astragali, Angelica sinensis, Salvia miltiorrhiza, Chinese yam, Pueraria lobata and so on. The taste of the medicine is mainly sweet, the medicine is warm and flat, and most of them return to the spleen and liver meridian. The prescription of TCM for the treatment of diabetes should be based on replenishing qi and nourishing yin, clearing heat and promoting fluid. ConclusionThe development of TCM patents related to diabetes in China should take the opportunity of market demand and domestic policy support, draw lessons from the characteristic system of TCM patents of key patentees, pay attention to the layout of the peripheral patents and international kindred patents, and establish patent early warning and navigation analysis system at home and abroad to effectively reduce the risk of patent infringement in the international environment.

The study of modern trends in the development of digital logistics in the pharmaceutical industry

Aim. To analyze the current trends in the field of digitalization of pharmaceutical logistics and supply chain management in the context of the coronavirus pandemic and identify factors that hinder the introduction of digital technologies into the activities of pharmaceutical market entities.
 Materials and methods. To achieve the goal of the study, an analysis of foreign and domestic scientific literature, an expert survey of managers and employees of pharmaceutical companies was conducted. The research methods were abstract-logical, monographic, system and content analysis, expert survey.
 Results. The relevance of digitalization of pharmaceutical logistics and supply chain management in the context of the coronavirus pandemic has been substantiated. A review of the practice of implementing digital technologies in the activities of domestic pharmaceutical companies has been conducted. According to the expert survey, the problems of introducing digital technologies into the activities of pharmaceutical companies from the point of view of managers and the staff have been identified. The reasons that hinder the process of introducing modern digital technologies into the activities of the domestic pharmaceutical sector in the field of healthcare have been determined.
 Conclusions. The use of digital technologies is a necessary element of restructuring the information and logistics support for all participants in pharmaceutical supply chains, improving the reliability and quality of their activities and protecting the chains from counterfeit products. This problem is especially relevant in a pandemic when a well-organized and uninterrupted pharmaceutical logistics becomes in many cases an important condition for preserving not only health, but also human life. Therefore, today it is necessary to implement a comprehensive system of measures aimed at increasing the level of digitalization of the pharmaceutical industry, which will contribute to increasing the efficiency of the functioning of pharmaceutical supply chains, as well as improving the reliability and continuity of drug supply to the population of Ukraine.

An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan

BackgroundAfghanistan, a low-income landlocked country, is continuously suffering from domestic war and conflicts; the country struggles to provide quality healthcare services, including affordable medicinal products in the required quantity. Moreover, the quality standards of domestic pharmaceutical companies have not been established yet. One of the internationally recognized guidelines for monitoring manufacturing processes in pharmaceutical companies is Good Manufacturing Practice (GMP), recommended by World Health Organization (WHO). Therefore, this study aimed to assess whether a pharmaceutical company in Kabul, Afghanistan adheres to the GMP standards established by WHO.MethodA descriptive cross-sectional study was conducted to assess the WHO-delineated GMP compliance of 25 pharmaceutical companies in Kabul, Afghanistan. The inspection checklist was developed by Afghanistan's National Medicine and Healthcare Products Regulatory Authority (NMHRA) using the WHO-delineated GMP guidelines. In addition, direct observation, interviews with respective delegates, and documentation reviews were conducted to collect research data.ResultOnly 38.33% (1.14 ± 1.08) of GMP contents were complied. Personnel 66.67% (2 ± 1.15) and materials 58.67% (1.76 ± 1.11) were the most commonly complied components, whereas the product recall 12.98% (0.39 ± 0.85), quality assurance 16.44% (0.49 ± 0.81) and quality control laboratory 28.35% (0.85 ± 1.12) were the least complied ones.ConclusionNone of the GMP components was fully adhered to by the pharmaceutical companies in Kabul, Afghanistan. Quality control and assurance should be implemented immediately, including validation and qualification practices.

Analysis of the use of PR-technologies by domestic pharmaceutical enterprises in the implementation of socially oriented marketing in the conditions of the global COVID-19 pandemic

Today, leading foreign and domestic pharmaceutical companies are aware of the importance of using socially oriented tools of marketing communication to achieve economic stability, strengthen competitive positions and form a positive image at the pharmaceutical market. Aim. To study PR-technologies used by domestic pharmaceutical companies as part of the implementation of the concept of socially oriented marketing in the global COVID-19 pandemic. Materials and methods. The methods of logical and meaningful problem formation, desk marketing research, the content analysis of publications in scientific and practice-oriented medical and pharmaceutical literature were used in the work. Results and discussion. The issues of social responsibility of pharmaceutical industry enterprises as a key factor in the successful development of companies under the conditions of coronavirus infection have been highlighted. The specificityhas been considered, and the features of modern PR-tools of pharmaceutical companies have been determined. The Internet resources play an important role among them. The content analysis of the web-sites of the TOP-5 major manufacturers of drugs at the pharmaceutical market of Ukraine has been conducted; the social responsibility areas and the main PR-technologies have been analyzed. Conclusions. It has been found that the leading domestic pharmaceutical companies take an active public position and constantly implement various social programs aimed at supporting the society welfare, especially in the conditions of the COVID-19 pandemic. The information content of the sites of the enterprises under study fully reflects the activities of companies in the field of public relations on the principles of openness, relevance, reliability and social responsibility. Considerable attention is paid to the quality, safety and availability of pharmaceutical products and the provision ofappropriate assistance to healthcare institutions in the fight against COVID-19.

Medical Representatives' User Acceptance of Remote e-Detailing Technology: A Moderated Mediation Analysis of Technology Acceptance Model.

ObjectivesE-detailing methods have steadily evolved toward more contactless and interactive channels, which have received considerable attention during the coronavirus disease 2019 (COVID-19) crisis. Based on the technology acceptance model, this study attempted to identify medical representatives’ perceptions and attitudes towards individual innovativeness that affected users’ intentions to adopt new e-detailing devices utilizing information and communication technology.MethodsThe subjects of the current study were medical representatives at three major multinational or domestic pharmaceutical companies that operate in South Korea. In total, 300 questionnaires were distributed and 221 were returned. The survey elicited information on respondents’ perceived ease of use (PEOU), perceived usefulness (PU), personal innovativeness (PI), and user acceptance (UA) of remote e-detailing technology, in addition to demographic information and occupational characteristics. Structural equation models were fitted to the data. Separate analyses were conducted for different platform types, PCs and mobile devices.ResultsPEOU showed a statistically significant positive association with PU. PEOU, PU, and PI were associated with UA, and PI was a statistically significant moderator. On average, PEOU explained up to approximately 45% of the total variation in UA of remote e-detailing.ConclusionsThe analysis supports the framework of the technology acceptance model. PEOU was a substantially strong direct predictor of UA, and PI had a statistically significant, positive moderating effect between PU and UA. Medical representatives with pro-innovative attitudes are more likely to play the role of early adopters of remote e-detailing if they find this technology to be more useful.

Evaluation of Medication Package Inserts in Ethiopia.

Background Patients require accurate and reliable information to help them use their medications safely and effectively. Inadequate patient knowledge may contribute to medication nonadherence which could negatively affect treatment outcomes. The purpose of this study was to evaluate the presentation and completeness of medication package inserts (MPIs) which are available in the Ethiopian market. Methods A cross-sectional document review was performed in February and March of 2019. All MPIs which were authorized by EFDA to sell in the Ethiopian market and available during the data collection period were considered. Results The mean overall completeness score of 200 MPIs was 18.39 ± 4.30. Of the 200 MPIs, only 20% were from domestic pharmaceutical companies. Antimicrobials represented 24% of the total MPIs. Topical preparations, cardiovascular drugs, gastrointestinal drugs, and nonsteroidal anti-inflammatory drugs, accounted for 12.5%,12.5%, 11%, and 9% of the MPIs, respectively. The majority of the MPIs presented information about the drug's use during pregnancy and lactation, 77.0% and 74.0%, respectively. However, only half of the MPIs, 49.5%, gave information about special warnings and precautions. Only a few of the MPIs provided information about instructions to convert tablets or capsules into liquid forms and the possibility of tablet splitting, 4.8% and 8.7%, respectively. Furthermore, only 1.0% had local language translation. Conclusion The MPIs available in Ethiopia provide inadequate information including about the safety of drug products and local language translation. Regulatory authorities should implement stringent regulations to ensure the provision of vital information which extends beyond checking the mere presence of an MPI. They should also act to the possible standardization of MPIs.

MODERN APPROACHES TO THE MANAGEMENT OF THE SOCIAL RESPONSIBILITY SYSTEM IN PHARMACY

Research is devoted to the development of theoretical, methodological and scientific-practical principles of management of socially responsible activities of domestic pharmaceutical companies as a key condition for improving the quality, efficiency and accessibility of pharmaceutical supply, which is especially relevant in a global pandemic, closing state borders and domestic pharmaceutical companies with foreign partners. In addition, the introduction of approaches and tools of socially responsible management in the activities of domestic pharmaceutical companies will increase their investment attractiveness and improve their business reputation, which will have a positive impact on increasing their competitiveness in both domestic and foreign pharmaceutical markets. In the conditions of development of globalization and integration processes, formation of network economy and knowledge society, rapid expansion and complication of interrelations of national economies and people, growth of their interdependence the problem of socially responsible functioning of business, including based on the introduction of international standards of social responsibility (JI). The coronavirus pandemic (COVID-19) has also significantly changed attitudes toward company priorities around the world. The global pharmaceutical industry was one of the first to feel the effects of the closure of China's economy, which accounts for about 40% of world production of active pharmaceutical ingredients (APIs), and other raw material suppliers. The closure of borders and the long-term quarantine regime have posed significant threats not only to the supply chain for pharmaceutical manufacturers, but have also seriously affected the efficiency of pharmacy as a whole. There was a decrease in sales of prescription drugs (drugs), which complicates the withdrawal of new drugs and stimulates changes in the distribution system. The research activities of pharmaceutical companies (FCs) in non-COVID-19 areas have slowed significantly due to the pandemic. Most clinical trials have had to be suspended due to quarantine restrictions, which are slowing the launch of new drugs. Thus, the pandemic disrupted the normal functioning of all components of domestic pharmacy and exacerbated the problem of access to the population of quality pharmaceutical care. The current situation in domestic and international pharmacy should be a major impetus for a complete rethinking of the philosophy of FC, which in these difficult times must finally realize its own great JI, and begin to build more transparent, open, innovative and socially caring. Only the actions of the FC, as socially responsible organizations, will create hope for the survival not only of individual companies, but also of domestic pharmacy as a whole, and, accordingly, to preserve the health of the population of Ukraine.

Analysis of Perception and Status Survey on the Introduction of QbD System by Pharmaceutical Companies in Korea

The purpose of this study was to investigate and analyze the application status and system introduction perceptions of quality-by-design (QbD) in domestic pharmaceutical companies and confirm the necessity of introducing an effective QbD system. Currently, QbD-applied drug development is an international trend, and the introduction of QbD domestically is urgent because domestic pharmaceutical companies need QbD data even when exporting overseas. Therefore, 51 domestic pharmaceutical companies were surveyed to analyze their perceptions and opinions on the current status of QbD application and the introduction of the system. The results showed that most pharmaceutical companies, except 4.7% of total respondents, recognized the need for QbD for the following reasons: to improve the quality of medicines, responding to requests from overseas regulatory authorities when exporting products, problem-solving drug development and production, and proactively responding to the introduction of the QbD system by the Ministry of Food and Drug Safety. Although they are aware of its need, respondents are not implementing QbD due to cost and time issues and state that it is challenging to apply the QbD example in practice due to the method and amount of experimentation. Thus, the results of this study revealed that domestic pharmaceutical companies need QbD experimental and process guidelines and practical QbD examples. These results can be used as the foundation for the introduction and stable settlement of a domestic QbD system in the future.

Аналіз вітчизняного ринку ветеринарних інсектоакарицидних засобів

The main condition for ensuring the economic efficiency of agricultural livestock rearing is the maintenance of wellbeing of farm animals, which is characterized by high productive qualities and the necessary reproductive capacity. At the same time, outbreaks of diseases of various etiologies, including parasitic, are often the cause of reduced productivity of animals. Pest insects control is important in the conditions of intensive animal husbandry, when at big farms and complexes animals are concentrated in large numbers. This increases the risk of reproduction and rapid spread of many insects that parasitize farm animals and are carriers of infectious and invasive diseases and cause economic damage due to reduced animal productivity and quality of raw materials. Protection of animals from ecto- and endoparasites requires the development and creation of highly effective antiparasitic drugs, because providing the necessary range of means to combat diseases of animals, inexpensive in price, in user-friendly forms is a way to further development of animal husbandry. Recent years mark a development of the domestic market of medicines for veterinary use, an increase in the number of registered drugs, the development of enterprises producing medicines, an increase in the number of companies engaged in pharmaceutical activities in both wholesale and retail. All this speaks of the prospects of the market of medicines for veterinary use. Specialists working in the field of production and sale of medicines need immediate, objective and reliable information on the state of the pharmaceutical market. This information has a significant volume and dynamism. Identifying the peculiarities of the formation of the market of veterinary goods at the state level should contribute to the improvement of management methods in this sphere, and the development of veterinary entrepreneurship. Therefore, the reorientation of domestic pharmaceutical companies to the principles of marketing will ensure the search, development and production of effective and competitive drugs, which will meet the pressing needs of customers. The aim of the work was to study the structure of the domestic pharmaceutical market, namely veterinary insectoacaricides. Our research focused on such tasks as studying the nomenclature of veterinary insectoacaricides of foreign and domestic manufacturers by the following indicators: manufacturers, species, forms of release and means of administration. The study of imported products also focused on the country of manufacture according to the State Register of Medicines. The study uses the methods of survey, analysis, comparison, generalization to get the required information. Statistical method was used to process the obtained data. Insectoacaricides are a significant share of the domestic pharmaceutical market. The study group is represented by 186 drugs of domestic and foreign manufacture, which is about 3% of the total number of all registered drugs. Of the 186 registered drugs, 35.5% (66) are imported and 64.5% (120) are domestic. Among insectoacaricides of foreign manufacture, the largest market share is occupied by Merial and KRKA, d.d., Novo mesto – 10.6% each (7 drugs each), KVP Pharma and Veterinar-Product GmbH – 9.1% (6 drugs), and among domestic companies the products of TOV “UKRBIONIT”; VK “KRUG”; TOV “NOVA PLUS” comprises 14.2% (17 drugs), TOV “Vetsintez” and TOV “NOVA PLUS” - 10.8% (13 drugs each), TOV “MEDIPROMTEK”, TOV company “Product”, TOV “NVP “SUZIRIA” – 8.3% (10 drugs each). The implementation of marketing activities which includes the research of the pharmaceutical market, allows companies to better adapt to market economy conditions, determine tactics of competitive behavior, adapt to change, improve strategy, change the production process according to consumer requirements and needs.

ВПЛИВ ЯКОСТІ ПРОДУКЦІЇ НА МІЖНАРОДНУ КОНКУРЕНТОСПРОМОЖНІСТЬ ВІТЧИЗНЯНИХ КОМПАНІЙ ФАРМАЦЕВТИЧНОЇ ГАЛУЗІ

The article considers the issues of the impact of product quality on international competitiveness on the example of the pharmaceutical industry of Ukraine. In order to increase the level of competitiveness, companies must form competitive strategies and develop competitive behavior in international markets. Domestic companies in the pharmaceutical industry are involved in global production and sales chains, which help increase the level of international competitiveness of Ukraini-an pharmaceutical companies. Ukraine imports most of its pharmaceutical products from abroad, and the country can pro-vide about a third of its population with its own pharmaceutical products. Increasing the level of international competitive-ness will contribute to the growth of exports, which is achieved through product quality management. The article analyzes the certification of some countries in the pharmaceutical sector. The author calculated the index of Ukraine's participation in the international cooperation of the pharmaceutical sector on the basis of export-import of domestic pharmaceutical products and GDP of Ukraine and the world. The author also constructed a multifactor regression model, which allowed to analyze the international competitiveness of pharmaceutical companies using one of the main factors -the volume of exports of do-mestic pharmaceutical products. Our hypothesis is that the increase in the international competitiveness of pharmaceutical companies, which in turn indicates the growth of exports of their products, is influenced by factors such as: the volume of sold pharmaceutical products, drugs and materials, the number of certificates of pharmaceutical companies and participation index of Ukraine in the international cooperation of the pharmaceutical sector. Thus, we proved the impact of product quality on the international competitiveness of domestic pharmaceutical companies.

Scientific and practical approachеs of formation of logistic innovative systems in pharmaceutical companies

The aim of the work is to analyze and generalize the existing scientific approaches and substantiate the mechanisms of formation of the logistics innovation system of the pharmaceutical company, which is the most important condition for creating modern effective domestic drugs under optimal use of resources and time.Materials and methods. Studies were conducted using databases on the Internet: the State Expert Center, the Ukrainian Patent Office, scientific and metric databases. It has used retrospective, logical, graphic research methods, content analysis.Results. The relevance of the implementation of the logistics concept of innovation management in domestic pharmaceutical companies is substantiated. A key aspect of this concept is the integration of individual parts of the innovation process through the maximum use of information exchange between participants in this process, active innovation, use of existing and creation of new knowledge, which become the main asset of innovation-oriented pharmaceutical company. The essence of the logistics innovation system of a pharmaceutical company is determined, the model of interrelations within the open logistics innovation system of a pharmaceutical company is substantiated. It is proved that with the help of a logistics innovation system it is possible to carry out planning, management, actualization of creation and implementation of innovative medicines at the optimal level of used resources and time for the implementation of relevant innovation projects. It is determined that the logistics innovation system of a pharmaceutical company is related to the management of incoming information and innovation flow (results of basic and applied research, data on clinical and preclinical study of medicines, pharmaceutical development), internal information and innovation flow (information exchange in the internal environment - resource, scientific and informational, organizational, personnel component), the initial information and innovation flow (information for government agencies, consumers, suppliers, the public, organizations interested in using the research results). These flows are integrated and relate to various aspects of the company's innovation.Conclusions. Thus, in order to intensify and activize innovation in domestic pharmacy, it is promising to expand the scope of logistics methods for the development and implementation of innovative medicines. The purpose of the logistics innovation system is to provide the pharmaceutical company with the information necessary for completeness, relevance, reliability, timeliness at a rational cost of their provision, for effective management of material resources

Theoretical aspects of using logistics outsourcing in the organization of medical supply of the Ukrainian Armed Forces

Aim. To study the essence of the concept of logistics outsourcing in the military sphere, conduct a comparative analysis of the main characteristics of military pharmaceutical logistics and civil pharmaceutical logistics in Ukraine.Materials and methods. To achieve the goal of the study, the analysis of foreign and domestic scientific sources and the current legal documents was conducted. The methods of information retrieval, systematization, content analysis, comparison and generalization were used. Results and discussion. Outsourcing is actively implemented in the Ukrainian Armed Forces during the defense reform in our country. Outsourcing refers to measures aimed at the effective organization and implementation of logistics tasks in accordance with the order of the Ministry of Defense of Ukraine dated 11.10.2016, No. 522 “On approval of the Basic Provisions for Logistic Support of the Ukrainian Armed Forces”. Therefore, the use of logistics outsourcing to organize the supply of medical equipment and supplies to military units and medical units in the Ukrainian Armed Forces is now an urgent direction for optimizing the medical support of troops (forces) and requires careful research. In Ukraine, the term “outsourcing” was started actually to be used only in the 90s of the last century in the civilian sectors of the economy, as well as in the pharmaceutical sector. Today, the introduction and application of a logistics approach to resource management allows pharmaceutical companies to increase their social, environmental and economic efficiency. In the Ukrainian Armed Forces today, outsourcing is used in the food supply of the military personnel.Outsourcing is not currently used in the Medical Service of the Ukrainian Armed Forces. It has been found that the use of outsourcing in the Ukrainian Armed Forces can be accompanied by a number of risks. The analysis of the main characteristics of military pharmaceutical logistics and pharmaceutical logistics in Ukraine has been conducted.Conclusions. Today, outsourcing should be considered as one of the main logistics strategies used by domestic pharmaceutical companies in many areas of their logistics activities. The study of foreign and domestic research indicates the ambiguity in determining the nature of military logistics outsourcing and the volume of services transferred to outsourcers. However, in recent years there has been an active introduction of outsourcing in the military sphere in many countries. The analysis of the main characteristics of military pharmaceutical logistics and civil pharmaceutical logistics in Ukraine has shown the need to develop a legal regulatory framework that standardizes the interaction between the Ministry of Defense of Ukraine (customer) and the outsourcer (private enterprise), as well as to develop the standards for the providing logistics outsourcing services for the organization of medical supplies in the Ukrainian Armed Forces.

공정성 지각과 영업역량이 관계신뢰 및 성과에 미치는 영향 : 제약회사를 중심으로

The pharmaceutical industry is deeply related to the health and life of patients. However, there are negative perceptions towards the bad practices like ‘rebate’ and the government has been trying to regulate it, it hasn’t been working out as expected yet. Therefore, this research addresses to analyze the impact of (the sales rep’s) procedural justice on the performance. It will find the correlation between fairness, competence and relationship trust as well. To test the hypotheses empirically, we conducted a survey of multinational and domestic pharmaceutical companies’ sales representatives. And I have done an actual analysis total of 207 questionnaires using a SEM. Consequently, it shows that the justice(procedural justice, distributive justice) of the sales reps has influenced positively on the relationship trust and performance. In addition, it turned out that competence of the sales rep plays a positive role on the performance as well. Thus, the results could suggest implications as follows. It requires management strategy that creates an environment where employees can do fair activities themselves through morals and ethics training. Also companies need to invest, develop, and conduct training competency programs in order to build the capabilities of sales representatives since it has the biggest impact on performance. This provides a logical and strong support for promoting ethical management of pharmaceutical companies.

Сравнительная характеристика бизнес-моделей лидеров фармацевтического производства: аспекты инвестиционной деятельности

In addition to a detail analysis of various domestic pharmaceutical company’s business models there were investigated companies investment programs, as well as their capital structure and specificity of manufacturing processes that affect the companies investment activity.Objective: Analysis of the investment activity of the domestic pharmaceutical manufacturing companies working in the frame of different business models, as well as determination of their investment activity risks triggers.Research methodology: The analysis was conducted for four business models (biotechnology companies, generic companies, specialized pharmaceutical companies, manufacturers of active pharmaceutical ingredients) on the base of at least three companies in each business model. The database included the information on company’s investment activity for the period from2013 till 2018.Results: Biotech companies focus their long-term investment programs both on R&D projects and market entry to developed countries with a strong regulation system. Long- or medium-term investment programs of generic companies focus on creating huge production capacities, while short-term investment budgets allocate for marketing. Specialized companies, including in the framework of their collaboration with foreign manufacturers, realize their investment programs aimed at developing their own portfolio. Manufacturers of active pharmaceutical ingredients invest in renovations or building manufacturing facilities having a goal to meet GMP standards. Domestic pharmaceutical companies are characterized by an intricate multi-stage owner capital structure, which can negatively affect on attracting external investors.