Foreign Pharmaceutical Companies Research Articles

The price of mistrust: the impact of a medical ethics scandal on scientific capacity in Sub-Saharan Africa

ABSTRACT This study investigates how negative news alleging ethical misconduct in clinical trials can hinder scientific development in emerging economies. We examine a 2000 exposé surrounding a clinical trial conducted in Northern Nigeria, leading to decades of community mistrust in foreign pharmaceutical companies. By comparing scientific output of researchers in affected and less affected regions, we find a significant decline in publication growth, particularly for medical researchers. An exploration of the mechanisms suggests that eroded community support and participation in research and reduced international collaboration contributed to this slowdown. This study highlights the importance of the science-community relationship in fostering scientific development. Our findings imply that a ’social li- cense to operate’ grounded in community trust is essential for scientific progress, and that future research on the determinants of scientific capacity in developing countries should consider community attitudes and involvement.

Development and validation of a high-performance liquid chromatography with tandem mass spectrometry method for quantification of tofacitinib in human plasma

Introduction. The use of tofacitinib as a pharmacological treatment for rheumatoid arthritis remains relevant in the light of the predicted increase in prevalence of the disease. At the same time, due to the withdrawal of several foreign pharmaceutical companies from the Russian pharmaceutical market, there has been a heightened demand for domestically produced medications, including generic formulations of tofacitinib. Registration of generic drugs necessitates the conduct of bioanalytical studies. Development and validation of a method for quantifying the analyte in biosamples remains to be a crucial part of the bioequivalence studies.Aim. The aim of this research is to develop and validate a method for the quantitative determination of tofacitinib in human plasma using high-performance liquid chromatography as the separation system coupled with a tandem mass spectrometer for detection purposes.Materials and methods. Biosample preparation was based on plasma proteins precipitation using acetonitrile. Baricitinib was selected as an internal standard. The analytical range of the method was 1.00 to 200.00 ng/mL and was further expanded to 0.30 to 200.00 ng/mL during the analytical phase of the study. The mobile phase consisted of water and acetonitrile, both acidified with formic acid (0.1 % v/v). The stationary phase was a Phenomenex Kinetex C18 column [100 × 3.0 mm, with a particle size of 5 µm (Phenomenex, USA)]. Sample separation and detection were carried out using high-performance liquid chromatography coupled with a tandem mass spectrometry (HPLC-MS/MS), operating in positive ion mode. The multiple reaction monitoring (MRM) transitions selected for the analyte and the internal standard were 313.30 to 173.00 m/z and 371.90 to 186.00 m/z, respectively.Results and discussion. The developed assay was validated in accordance with the current requirements of regulatory documentation from the EAEU (Eurasian Economic Union), FDA (US Food and Drug Administration), and EMA (European Medicines Agency) with the following parameters being evaluated: selectivity, specificity, carry-over, matrix effect, recovery, calibration curve, lower limit of quantitation, accuracy, precision, stability. The validated method was applied in the analytical part of a bioequivalence study of domestically produced generic tofacitinib.Conclusion. A method for the quantitative determination of tofacitinib in human blood plasma with an analytical range of 0.30–200.00 ng/mL was developed and validated. Application of the assay during the analytical phase of bioequivalence study of generic tofacitinib confirms the possibility of using the method in similar bioanalytical investigations.

The long 1992 in medicinal (non-)security of Russia. Report II. Market networks and institutes

The year of 1992 is very important milestone in history of Russian pharmaceutical market. It began not in January 1922, but in December 1991, when the President and Government enactments to open free market for medications were promulgated. The advisers of B. N. Yeltsin considered market economy as reliable mean to overcome medicinal deficiencies, corruption and bureaucratic monopoly. However, panacea did not work. Moreover, it caused completely new problems. The human and state security implies protection from threats of dependencies. The unprepared dive into market plunged Russians and the country into severe dependence on import of medications and foreign pharmaceutical companies. The proposed study expands our publications in this journal and in journal "Pharmacy" in 2022. At that time, analysis of medication scarcity was implemented on the basis of published sources and relied on journalistic evidences. The current study is carried out on the basis of archival documents of the Ministry of Health Care of the Russian Federation and authors interviews of representatives of regulator. The second report reconstructs the sequence of the emergence and correlation of the structural elements of the Russian pharmaceutical market.

Challenges and opportunities for access to Advanced Therapy Medicinal Products in Brazil

Background aimsThe marketing authorization of Advanced Therapy Medicinal Products (ATMPs) in Brazil is recent. The features of these therapies impose specialized regulatory action and are consequently challenging for developers. The goal of this study was to identify the industry's experience in clinical development, marketing authorization and access to ATMPs through the Unified Health System (SUS, acronym in Portuguese), from a regulatory perspective. MethodsA survey containing structured questions was conducted among research participants who work at companies that commercialize ATMPs. A descriptive analysis was performed. ResultsWe invited 15 foreign pharmaceutical companies, of which 10 agreed to participate. Overall, participants assessed that Brazil has a well-established regulatory system, especially the sanitary registration by the National Health Surveillance Agency (Anvisa), which ensures the quality, safety, and efficacy of the products. The Agency's good interaction with the regulated sector, the harmonization of sanitary and ethical assessment systems with other countries, and the analysis time in the biosafety assessment of Genetically Modified Organisms (GMOs) stand out as positive in industry's evaluation. On the other hand, it is important to advance the pricing regulation for these products since Brazilian regulations do not establish specific criteria for ATMP. One of the biggest challenges is the difficulty for the SUS in reimbursing these very high-cost therapies, especially using current Health Technology Assessment (HTA) methods. ConclusionsConsidering the increasing number of approvals of cell and gene therapies in Brazil in the coming years, a close dialogue between the industry and the public sector is recommended to advance regulatory improvements (pricing and HTA). Additionally, the construction of policies to promote the national Health Economic-Industrial Complex, based on a mission-oriented vision that encourages innovative models of financing, especially those that consider risk-sharing and co-financing technologies, will help provide the population with universal, equitable and sustainable access to ATMP in the SUS.

The long 1992 year in medicinal (non-)security of Russia. Report I. Market trial

The year 1992 is an important landmark in the history of Russian pharmaceutical market. It began not in January, but in December 1991, when orders of the President and the Government to open free market of medications were promulgated. The Yeltsin advisers conceived that market economy was infallible means to combat medication shortages, corruption and bureaucratic monopoly. However, panacea did not work. Moreover, it gave rise to completely new problems. The human and state security implies protection from threats of dependence. The unprepared dive into market plunged Russians and the country into deep dependence on imported medications and foreign pharmaceutical companies. The proposed study proceeds our publications in this journal and in journal "Pharmacia" in 2022. At that time, analysis of medication "famine" was implemented on basis of published sources and relied on journalistic evidences. The current study was carried out on the basis of archive documents of the Ministry of Health of the Russian Federation and authors interviews of representatives of the regulator. The first report reveals administrative mechanism that engendered crisis of medication supply in the first post-Soviet year of our country.

Маркетинговые программы современных фармацевтических предприятий

The article is devoted to comparative analysis of the experience of marketing programs development used by pharmaceutical industry organizations operating both in Russia and in foreign countries. The relevance of the chosen topic is explained by the fact that, while trading in specific goods, it is important for the pharmaceutical industry to develop and implement the program containing the main aspects of product promotion, attracting consumers, and increasing the efficiency growth. The research methods are characterized by comparative analysis and information synthesis. The purpose of the study is to summarize the experience of domestic and foreign pharmaceutical companies in marketing programs development, taking into account the specifics of the main products. The results of the study are identification of the main tools used to attract and retain customers. The obtained results can be used by pharmaceutical companies in Russia to improve the quality of interaction with potential customers using the Internet, which determines the general vector of marketing programs for the development of pharmaceutical industry organizations. In the work domestic pharmaceutical industry is characterized as an object of marketing research. Development features of Russian pharmaceutical sector are highlighted, and theoretical analysis of marketing program concept is carried out. The author's interpretation of marketing program concept for pharmaceutical enterprise is proposed, and the stages of marketing program formation are highlighted. Peculiarities and general features of marketing program formation for domestic and foreign manufacturers are determined.

Challenges in Global Access to CAR-T cells: an Asian Perspective.

The use of cell therapy for clinical applications has seen a dramatic increase in recent years, primarily in oncology, especially with the use of chimeric antigen receptor (CAR) T-cell therapies. However, there are some barriers to the widespread adoption of CAR-T cell therapies globally, primarily because of the high cost of manufacturing these cells and clinical infrastructure considerations. We reviewed the different strategies adopted across Asia to implement CAR-T cell therapy and found that these included patient assistance programs, close engagement with funders, cost-effectiveness studies, on-site manufacturing of CAR-T cells, and joint ventures between local partners and foreign pharmaceutical companies. Although on-site manufacturing can reduce the cost of genetic engineering and expansion, it does not address many other hidden costs and quality considerations. Future growth in large-scale regional manufacturing, facilitated by cutting-edge science and innovation, could reduce costs through economies of scale and facilitate the eagerly needed global access.

The Dilemma Of Pharmaceutical Companies In Pakistan: Navigating Price Regulations During A Time Of High Inflation.

Dear Madam, An ever-worsening economic crisis, has hit Pakistan, and the political crisis and recent floods have added to the worsening situation [1]. The inflation rate in Pakistan has hit a record high of 35.4%, leading to the manufacturers’ increase in the cost of essentials and amenities [2]. However, pharmaceuticals have still not been allowed to increase their products’ prices, making it difficult for them to thrive, which has led to their decrease in number over the last few years [3]. Since 2018, the number of foreign pharmaceutical companies in Pakistan has been reduced from 48 to 22. [4]. The local sector is in no better position. Pakistan's pharmaceutical industry has warned that local businesses will have to cease due to extortionate production costs and the devaluation of the rupee, difficulties with imports, and rising inflation [5]. As many as 770 drug manufacturers in Pakistan have been impacted by the medicine shortage crisis consequent to a lack of essential raw products and materials imports [6]. More companies are expected to stop producing medicines owing to high costs in the upcoming days, which may lead to the number of scarce drugs in the country increasing from 500 to 2,500 [7]. Pakistan is the only country with a regulatory authority that controls the prices of all medicines. [8]. This entire situation has created an immense burden for consumers, who are compelled to face the consequence of medicine shortage, forcing them to buy medicines at a much higher cost. The deficit has also led to the production of counterfeit drugs, hurting not only the existing industries but also putting patients’ lives at very high risk. The industry's greatest worry is the complete freezing of pharmaceutical product prices. The government-set pricing structure prevents the pharmaceutical industry from raising the price of any drugs, even those whose costs have increased by more than 100%. With significantly increasing input, associated costs like fuel, electricity, labour, and raw materials have made it difficult for the industry to survive [8]. The government should pay immediate attention to this problem. The Drug Regulatory Authority of Pakistan (DRAP) needs to implement new policies allowing pharmaceutical to increase their products’ prices, ensuring not to overburden consumers with it. DRAP should be strengthened by upgrading to maintain global standards. ---Continue

Analysis of the assortment structure of antidepressants on the domestic pharmaceutical market

а feature of the course of diseases, the correction of which requires the use of antidepressants, is the small number of requests for specialized help in the early stages of the development of mental disorders. This creates certain limitations for fast and effective therapy. However, given that depression is the most common mental disorder in the world, there is a certain scientific interest in researching this pathology. The purpose of the work is a comprehensive assortment analysis of the group N06A "Antidepressants" on the pharmaceutical market of Ukraine. The study of the assortment of antidepressants registered on the pharmaceutical market was carried out in accordance with the Anatomical-Therapeutic-Chemical classification and the data of the State Register of Drugs of Ukraine. The objects of research were information on drugs registered in Ukraine, which belong to category N06A "Antidepressants". According to the data of the State Register of Drugs of Ukraine, as of January 2022, taking into account drugs produced in different dosages, 149 trade names of drugs belonging to category N06A "Antidepressants" and represented by 20 international non-proprietary names were registered. Of all the antidepressants registered on the pharmaceutical market of Ukraine, 52 drugs with a limited validity period of the registration certificate should be noted. The pharmaceutical market of Ukraine for the treatment of depression is clearly dominated by foreign pharmaceutical companies, and the share of domestic companies is represented only by 18.1%, which indicates the need to expand this group of drugs, because 9 out of 20 international non-proprietary names do not have a single domestic drug. Antidepressants are imported to the Ukrainian pharmaceutical market from 19 countries. The main importing countries are: India – 18.9%, Slovenia – 12.3%, Germany – 9.0%, Poland and Turkey – 7.4% each, Hungary – 5.7%. Other countries collectively occupy 39.3% of the pharmaceutical market of imported drugs from category N06A "Antidepressants". But it is important that according to the Anatomical-Therapeutic-Chemical classification, in Ukraine this group of drugs is classified only into 3 subgroups. It should be noted that in Ukraine there are harmonized protocols, where, according to the recommendations for the treatment of depression, drugs are offered that, unfortunately, are not registered on the domestic market, which is reflected in the absence of two subgroups: N06AF and N06AG, which creates certain problems of patient access to high-quality and effective therapy recommended by the 2020 "Protocols for the diagnosis and treatment of patients with mental disorders (Finnish version)".

Роль интеллектуальной собственности в инновационной деятельности российских фармацевтических предприятий

The authors of the study analyze the role played by the intellectual property of domestic and foreign applicants in the Russian segment of the international pharmaceutical market, based on data on patent activity. Modern realities of the Russian pharmaceutical industry are formed under the influence of two multidirectional processes – protectionist policy and technology development in the format of open innovations, which influence the choice of tools for solving the problems of innovation management. Domestic patent holders began to take an increasingly tough stance against competitors from foreign countries, but they still lose to foreign pharmaceutical companies in the quantitative volume of protected technical solutions. The paper presents an analysis of patent applications filed with Rospatent and the Eurasian Patent Office related to the pharmaceutical industry. The authors assessed the share of patent applications in the field of medicine and pharmaceuticals in the total number of technical solutions submitted for registration. Con-clusions and recommendations for optimizing the management systems of Russian pharmaceutical companies and the development of domestic pharmaceuticals are made in relation to existing economic cycles. The changes that have taken place in the region over the past 11 years are identified, and directions for the development of the pharmaceutical industry are formulated.

Determinants of Market Value of Pharmaceutical Industry: An Empirical Testing in India

The paper aims at ascertaining the determinants of market value of pharmaceutical industry firm in India. We use the financial data of one hundred and forty-one Indian Pharmaceutical Industry companies. The results of the study show that the value of the coefficients is very low and therefore, the predictability of determinants of the variable for the value of firm is very weak for pharmaceutical industry in India. Implication of the study may be used by researchers to compare with other foreign pharmaceutical companies to understand the determinants of value of firm of the pharmaceutical industry.

СОВЕРШЕНСТВОВАНИЕ СИСТЕМЫ УПРАВЛЕНИЯ КАЧЕСТВОМ НА ФАРМАЦЕВТИЧЕСКОМ ПРЕДПРИЯТИИ ЗА СЧЕТ ВНЕДРЕНИЯ ЭФФЕКТИВНОГО РИСК-МЕНЕДЖМЕНТА

Abstract. The article presents the results of the analysis of the production and economic activities of Russian and foreign pharmaceutical companies in order to study modern approaches to risk management within the quality management system. Pharmaceutical enterprises are now actively implementing a quality management system, as this allows you to ensure and control quality at the required level throughout the entire life cycle of a medicinal product. Risk management in the pharmaceutical industry is an important component of the pharmaceutical quality system. Analysis of the position of risk management in the pharmaceutical industry in order to form the basis for the development of guidelines for effective risk management is an important area of research. The purpose of this article was to develop competent organizational solutions for the effective operation of a pharmaceutical enterprise related to the improvement of the quality management system through the implementation of effective risk management. The annual reports of pharmaceutical manufacturers of medicines for medical and veterinary use, pharmaceutical substances and substances used in pharmaceutical production were selected as research materials. The methods of information analysis, induction and synthesis were used as research methods. As a result of the work, a diverse approach of pharmaceutical enterprises to the categorization of risks, an uneven distribution of attention to different categories of risks, their underestimation and the need to develop a risk management manual were established, and measures were proposed to introduce this manual into the activities of pharmaceutical enterprises, including conferences and training courses to improve the competence of organizations in the processes of risk management and the involvement of government agencies in the implementation of risk management.

Development of strategic alliances between Russia and Hungary in the field of pharmaceuticals

The development of strategic alliances between Russian and foreign pharmaceutical companies allows not only to introduce biotechnologies in the domestic market, but also to strengthen the policy of import substitution and increase export volumes. That is why it is important to support the creation and functioning of strategic alliances at the state level. The purpose of this article is to study the creation and development of strategic alliances between Russia and Hungary, paying attention to the formation of alliances in the field of pharmaceuticals. In order to achieve this goal, the indicators of export-import operations between Russia and Hungary in the field of “pharmaceutical products”, as well as the main strategic alliances operating between the two countries were considered. It is assumed that the development of Russian-Hungarian strategic alliances in the field of pharmaceuticals with localization of production will help to achieve the goals of the import substitution policy in the field of drug production, as well as to intensify export operations. To test this hypothesis, documents published in the public domain were analyzed, including statistical data on export-import operations in the pharmaceutical market between Russia and Hungary. In general, it was proved that at the present stage of development of the pharmaceutical market of the Russian Federation, it is important to support the creation and functioning of strategic alliances, which will strengthen Russian positions not only in the domestic market, but also in the international market. Thus, the Russian Federation should actively develop and support the development of localized strategic alliances using various methods, which will increase the share of domestic biotechnologies and ensure their export.

Hardware and program system for determination of authenticity of medicines by nuclear quadrupole resonance method

THE PURPOSE. Study the possibility of using a laboratory nuclear magnetic resonance console as a device for detecting counterfeit medicines. The problem of detecting counterfeit and counterfeit medicines is now very acute. Consider the potential of applying the nuclear quadrupole resonance radiospectroscopy method to determine the authenticity and quality of medicines by non-destructive means.ACTUALITY. The nuclear magnetic resonance method is included in the list of physico-chemical methods used in pharmacopia. The spectroscopy of nuclear quadrupole resonance, being similar in physical principles, has its advantages and advantages, which in general will strengthen the control of the authenticity and quality of medicines.METHODS. The theory of nuclear quadrupole resonance and features that allow to investigate medicinal preparations is resulted. The structural design of this hardware and software complex based on the Apollo Redstone nuclear quadrupole resonance spectrometer is described, its nodes are described, characteristics and parameters are given, a special attention is paid to the development of the sensor for the hardwarethe software complex and its coordination system with the spectrometer. Detailed description of its radio technical characteristics.RESULTS. The article shows the results of using the hardware software complex - measurements of spectra of nuclear quadrupole resonance for the drug paracetamol developed by various manufacturers, both Russia and foreign pharmaceutical companies. The possibility of measuring spectral characteristics directly in the package is shown. The necessary multi-pulse series of pulses, used in the measurement of spectral characteristics, are given. The possibility of receiving signals of spin echo with a good signal/noise ratio is shown, as well as the possibility of distinguishing different manufacturers' spectra of paracetamol according to the form of the release.CONCLUSION. The article shows a principal possibility of creation on the basis of this method of compact and portable devices for non-destructive identification of medicinal preparations.

Business models of big pharma in Russia: A pharmaceutical value chain perspective

Large pharmaceutical companies (commonly referred to as Big Pharma) determine transformation trends in the global and national pharmaceutical market, make the largest investments in RD to create new original medicines, act as leaders in the processes of creating cross-border pharmaceutical value chains. In recent years, more and more Big Pharma companies penetrated the Russian pharmaceutical market. The purpose of this work is to identify the business models of Big Pharma companies in Russia from the point of view of their participation in a particular link of the pharmaceutical value chain, as well as to assess future trends. Based on the analysis of the collected information, we identify the following business models for Big Pharma companies: export model of supplying market; model of transferring RD links; production localization model at owned enterprises; model of contract manufacturing; model of participation in the links of wholesale distribution and retail. Foreign companies in Russian pharmaceutical market can use several models, and the more models are used, the deeper the company is integrated into the pharmaceutical chain. Such companies as Sanofi, Abbott, AstraZeneca, and Takeda are engaged in their own localized production and contract manufacturing, and they also exporting produced medicine abroad. So, they are the ones that are mostly involved in the pharmaceutical value chain in the Russian market. The transformation of business models of foreign pharmaceutical companies will be influenced by two interrelated factors: foreign strategy and geographic priorities of Big Pharma and the role of Russia in this strategy, which in turn is determined by the specifics of the Russian pharmaceutical market (compared to other countries).

الجامعة المستنصرية / كلية الادارة والاقتصاد

The new trends in Iraq’s economic policy by adopting the market mechanism in the economy after 2003, which necessitated the integration between the role of the state represented by the public sector and the role of the private sector in the process of economic and social development that depends on mobilizing the community’s potential for various economic sectors and civil society institutions in institutional organizations that undertake, establishing and operating projects after the separate economic sectors faced challenges and difficulties in achieving development goals at the targeted levels. Therefore, many developed and developing countries sought to create institutions that adopt participatory organizations in which the public and private sectors contribute to directing, managing and operating projects, developing and developing them in order to serve Its objectives are based on a participatory basis, good governance, transparent accountability and mutual benefit, as the relationship between the partnership parties is characterized by an integrative and substitutionary nature at the same time, with a dynamic nature that depends on the size, nature and importance of the role that each sector plays in the development process, according to the prevailing economic system, and its stages of development up to faster rates of economic and social development, and the pharmaceutical industry is one of the Industries that require increased spending on research and development programs to produce patents within the pharmaceutical preparation processes for a new product, as well as flexibility in dealing with these expenses and their impact on the level of pricing and marketing of the pharmaceutical product. Most economic studies go to the fact that spending on research may reach more than 10 % of the value of pharmaceutical sales to obtain a therapeutic product using advanced technology. In this regard, we find that there is a difference in the use of technology in the pharmaceutical industry in both developed and developing countries, as pharmaceutical technology in developed countries depends on training and innovation, while pharmaceutical technology depends in developing countries, including Iraq, on improving manufacturing methods and quality control only. The research has been strengthened by highlighting the pharmaceutical partnership approved by the State Company for the Pharmaceutical Industry / Samarra as a reformist factor in economic activity, as well as supporting and encouraging the private sector and activating its role by emphasizing on building partnerships between the public and private sectors in the pharmaceutical manufacturing sector, and giving way to foreign pharmaceutical companies , the pharmaceutical industry market needs foreign investment to obtain financing sources as well as modern technology according to the formulas of cooperation or concession or contribution to the establishment of new pharmaceutical factories. The research concluded that the research hypothesis is achieved to a large extent when activating the mechanisms of partnership between the public and private sectors on the ground.

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.

THE STATE OF THE PHARMACEUTICAL INDUSTRY IN THE KINGDOM OF MOROCCO

Abstract. IThe purpose of the article was to study the main characteristics of the pharmaceutical industry in Morocco. As materials were studied the official websites of pharmaceutical manufacturers in Morocco, policy documents of industrial pharmaceutical associations, specialized pharmaceutical press of Morocco, educational resources of Morocco and France. As a result, it was found that the pharmaceutical industries of Morocco and Russia are already interacting with each other: BIOCAD supplies high-tech drugs and production technologies to Morocco, Morocco has placed an order with R-Pharm for the purchase of a vaccine against COVID-19, produced under the license of AstraZeneca, and also ordered a million doses of Sputnik V vaccine. Morocco is one of the fastest growing countries in the Middle East and Africa with an economy of $119 billion, a population of 37 million,andtotalhealthspendingof5.5%ofGDP.Expendituresforhealthcarearequitehigh-53.6%oftotalfamilyexpenditures. 31.7% of total health care expenditure is spent on drug purchases. The pharmaceutical industry in Morocco began to develop in 1960 after the end of the French protector and the introduction of the obligation to localize drugs sold in Morocco by foreign pharmaceutical companies. The pharmaceutical industry in Morocco is represented by 51 factories, which cover 2/3 of the country’s drug needs. Mostly generics are produced, 10% of production is exported. The volume of the issue is $1.68 billion (2nd place in Africa). The products are of high quality and certified according to European standards. Morocco is endeavoring to transform its pharmaceutical industry into a strategic asset for influencing African countries through the creation of an «African House of Medicines» based in Morocco, which is the manufacturing and logistics center for medicines in Africa. The main documents regulating the pharmaceutical industry are: Law No. 17-04 of 2006. “Code of Medicines and Pharmacy” and Order of the Minister of Health No. 902-08 5654 of 2008. “Requirements for the premises of pharmaceutical organizations.” Thus, we conclude that the Kingdom is a regional leader with ambitious plans and a large backlog that needs new technologies, markets for pharmaceutical products, a large number of qualified personnel, high-tech drugs at affordable prices. The intensification of cooperation between Russia and Morocco will help both countries to gain a foothold in the rapidly growing pharmaceutical market in Africa.

REGULATORY MECHANISMS OF UKRAINIAN PHARMACEUTICAL MARKET COMPETITIVENESS IN THE CONTEXT OF EUROPEAN INTEGRATION

The purpose of the paper is to summarize and present the differences in the competitive environment of the European Union (EU) and Ukrainian pharmaceutical markets. The method of longitudinal study allowed to detect the patterns of changes and correlations for pharmaceutical products exports and imports volumes over twenty years (2001-2020). Methodology. The research is based on the definition of the pharmaceutical market as a complex socio-economic institution that fulfills the function of pricing medical products and utilizes them to ensure health care functioning. It indicates the population’s wellbeing and requires ongoing maintenance based on needs agreement of households, economic entities, and the state. The quantitative research is based on export-to-import coverage ratio calculations with the identification of pharmaceutical products fraction in the total volume of foreign trade, including the one with the EU. The results of the paper consist in the evaluation of the competitive environment of the European Union’s pharmaceutical market and statistical assessment of Ukrainian foreign trade of pharmaceutical products. They also include the definition of the European integration influence over the Ukrainian pharmaceutical market and well-reasoned recommendations about the application of the state and trade regulation mechanisms. In the paper, we defined the distinctive features of the European countries’ pharmaceutical markets and outlined their main characteristics that have connections to the transnational corporation’s activities, common market, and high concentration. Statistical data collected over 20 years indicated the dynamic development of the Ukrainian pharmaceutical market, despite its small-scale contribution to the foreign trade turnover. The dependence of Ukraine on the foreign supplies of drugs and medications is illustrated by the multiple excesses of imports over exports, especially in the trade relationships with the EU. The EU countries are the leading importers of pharmaceutical products to the Ukrainian market. However, the share of medical supplies exports from Ukraine to the EU countries is negligible. Their key exporters are post-Soviet and developing countries. The growth in Ukraine’s export potential is inextricably linked to the expansion of the competitiveness of domestic medical supplies. Practical implications consist in the development of recommendations concerning the GMP and GDP demands realization, domestic manufacturers cooperation with the leading foreign pharmaceutical companies, the penetration of transnational companies into the Ukrainian domestic pharmaceutical market based on imports of innovative technologies, the improvement of the marketing management of the pharmaceutical products exporting. The priority factor in the growth of the competitiveness of the Ukrainian pharmaceutical market is a successful combination of state and trade regulation mechanisms. The objects of these factors are the pricing policy for material resources and finished products, the introduction of innovations, tax exemptions, and export-import quotas implementation. They also include the establishment of traffic rates that depend on the market saturation with socially significant medical supplies, budget support of the prioritized subsectors of the pharmaceutical industry, and patent protection. The expected results concern the decrease in the dependence of the Ukrainian pharmaceutical market on the foreign distribution of the raw materials and finished products and strengthening the positions of the Ukrainian manufacturers in foreign markets. Value/originality. We evaluated the competitiveness of the national pharmaceutical market based on the criteria of foreign trade performance and detected the priorities of its growth, taking into consideration the synthesis of the state and trade regulation mechanisms.

An Analysis of the Transformation of Mega-Pharma’s Business Model toward the Emerging Market

The Trade-Related Aspects of Intellectual Property Rights（TRIPS) requires all member countries of the World Trade Organization (WTO) to introduce a TRIPS-compatible patent law into their countries. Due to the enforcement of TRIPS in 1995, India in 2005 revised its patent law and enacted the Patents (Amendment) Act, 2005. The 2005 ACT included product patent in pharmaceutical field. Due to the new patent law with product patent protection, large foreign capital pharmaceutical companies one after another re-entered the Indian market and started engaging in both R&D and production targeting the Indian market. However recent data shows the number of patent applications has been declining over the past several years and the number of patented drugs launched in India did not increase so rapidly. This study analyzes transitions of business models of foreign pharmaceutical companies in India based on the patent application data, and the trend of patented drugs in the market. A data analysis and a series of interviews with stakeholders were conducted. As a result of both a quantitative and a qualitative analysis, it was found that foreign pharmaceutical companies changed their strategies in the Indian pharmaceutical market. Since India was required to introduce product patents in the pharmaceutical area, there have been many arguments that once India introduces a product patent, the Indian pharmaceutical industry may decline due to the rapid introduction of foreign pharmaceutical products in the country; many academic papers were published in this context during that time. However, since 2005, when product patents were actually introduced in India, few academic papers were published. This study is unique as it discusses the effects of the introduction of product patents on the Indian pharmaceutical market.