Pharmaceutical Organizations Research Articles

60 Years “Assistant – Pharmacist” In Varna

A brief historical overview of the development of the pharmacy work, the profession “Assistant pharmacist” and the pharmaceutical organizations in Bulgaria on the occasion of the 60 th anniversary of the profession in Varna. Before the Liberation of Bulgaria, persons with insufficient pharmaceutical training performed the medical care of the population. After the Liberation, the “Temporary rules for the organization of pharmacies in Bulgaria” were created. According to the rules, the managers of the pharmacies were required to be master pharmacists, but until 1895 only 18 people have a legal degree in pharmacy. On August 11, 1883, a “Regulation for the admission of pharmacy students and assistants in pharmacies” has been established, which marks the beginning of the training of pharmacy assistants, whose training takes place in pharmacies.

Augmenting learning processes of absorptive capacity for innovation: Insights for effective leadership within global pharmaceutical companies

AbstractAbsorptive capacity (AC), which comprises exploratory, transformative, and exploitative learning processes, enables organizations to exploit external knowledge for adopting innovation. Despite extensive research into AC, leadership styles have received little attention. This paper discusses the results of a study undertaken in three pharmaceutical organizations that augments AC theory relating to top‐ and middle‐level management behaviour. The findings suggest that the influence of transformational and transactional leadership styles varies between the AC learning processes within and across organizations. We also explored CEOs' knowledge, trust in middle management, and intention towards sharing knowledge, which facilitate the learning processes. The research has implications for the enhancement of opportunities to enable successful innovations based on the recognition of leadership styles and managers' roles. We report several novel contributions that are of value to academics and practitioners.

Social Networks and Problem-solving in the Context of Biopharmaceutical Research and Development

Problem-solving is a vital aspect of scientific innovation. It is especially important in the biopharmaceutical field which, despite its innovative reputation, faces high project failure rates. To cope with research obstacles, these organizations utilize an evolving matrix structure with structured turnover of cross-functional (interdisciplinary) research teams. Problem-solving becomes social and relies on scientists’ ability to activate network contacts. What kind of social network contact facilitates problem-solving? Two different theoretical perspectives set different expectations. The needs perspective suggests specific types of resources are useful at different problem-solving phases. Different types of resources are locked into different types of social network ties. As problem-solving progresses and the required resources change, profiles of network contacts change. Turnover should be greatest between problem-identification, which calls for interpersonal support and familiarity, and problem-understanding, which calls for new knowledge and formal authority. In contrast, what I call the strong core perspective posits a stable core of multi-purpose network contacts. In terms of the types of network contacts, the needs perspective expects problem-solving phases to be independent; the strong core perspective expects path dependence. To explore network contact characteristics associated problem-solving phases and test for path dependence, I surveyed members of the American Association of Pharmaceutical Scientists, the largest pharmaceutical professional organization, about the contacts they utilized while dealing with the most serious research obstacle they encountered in the past year and which contacts were useful for identification and understanding. A multi-level path model copes with the nested data structure and tests for path-dependence. Results support the strong core perspective; strong path dependence indicates that scientists utilize contacts associated with strong tie strength and competence-based trust for both problem-identification and problem-understanding. Scientists form stable sets of social contacts during nascent problem-solving phases.

СОВЕРШЕНСТВОВАНИЕ И ОПТИМИЗАЦИЯ ТОВАРНОЙ ПОЛИТИКИ КАК СПОСОБ ПОВЫШЕНИЯ КОНКУРЕНТОСПОСОБНОСТИ АПТЕК

Gathering information is a key component of market research marketing. The search and analysis of marketing information is carried out through four auxiliary systems, namely, an internal reporting system, a system for collecting external current marketing information, a system of marketing research and analysis of marketing information. Based on the information received, marketing research of the drug market is carried out and the needs of the population for pharmaceutical products are studied. Among the many areas of marketing research on the activities of pharmacies, the study of the range of sold medical and pharmaceutical goods in order to determine ways to optimize it is of paramount importance. A prerequisite for marketing research is the study of drugs as a product, its main pharmacotherapeutic properties, indications for use, release forms and other merchandising characteristics. It is important to analyze the assessments of consumer properties and indicators of use for each name of medicinal products in the assortment of a pharmaceutical organization. This article provides approaches to the definition of the assortment policy of the enterprise, gives the classification of the assortment of the enterprise «Pharmacy of low prices». The groups of drugs are identified depending on their effect on the pharmacy income. Based on consumer preferences, the main positions of the assortment of pharmacies, which are needed by consumers of the city of Penza and the Penza region, have been determined. Along with determining the optimal assortment of the pharmacy and the number of drugs for each pharmaceutical group on sale, it is important to determine the optimal ratio of drugs for each pharmaceutical group. An algorithm for the formation of a new assortment of the Low-Price Pharmacy enterprise has been developed. Recommendations for improving the assortment policy of the «Low Price Pharmacy» enterprise are offered. The features of pharmaceutical marketing of the market of non-prescription and prescription drugs have been studied. Optimization of the product policy of pharmacy organizations, taking into account the distribution of drugs by pharmaceutical trade groups, will ensure the survival of small-scale retailers in a competitive environment.

Next steps in AAV preclinical and translational R&D

<div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/Anna Tretiakova pic sa.png" data-image="1"></div><div class="author-det"> <b>Anna Tretiakova</b>, PhD, is a Senior Vice President of Product Development, leading the company’s research and translational programs to deliver clinical candidate vectors. Anna is an industry veteran with more than 30 years of of research and development experience that spans basic research and non-clinical translational sciences, progressing from a bench scientist in academia to senior leadership roles with biotechnology and pharmaceutical organizations. She has spent over a decade exclusively focused on AAV gene therapy for monogenic and non-monogenic diseases in various therapeutic areas at the University of Pennsylvania Gene Therapy Program, Pfizer Rare Disease Research Unit, SwanBio Therapeutics, and, most recently, at AskBio. She completed her graduate education in molecular biology and biochemistry with a PhD from Thomas Jefferson University in Philadelphia and diploma from Novosibirsk State University in Russia. </div></div></div><div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/Shari Gordon pic sq.png" data-image="1"></div><div class="author-det"> <b>Shari Gordon</b> is the Senior Director of Immunology at Asklepios Biopharmaceutical (Ask Bio). Shari is a viral immunologist with 18 years of experience in infectious diseases. Shari’s passion for science began with her graduate work at Emory University focused on HIV pathogenesis and continued with her post graduate work that evaluated novel vaccine approaches using viral vectors. Shari had an illustrious career at GlaxoSmithKline and then ViiV Healthcare advancing biologics for the treatment of HIV and Cancer before joining Ask Bio. At Ask Bio Shari leads the clinical immunology and immunoassays teams that characterize the immune response to AAV gene therapy and immune modulatory approaches. </div></div></div>

МАРКЕТИНГОВЫЙ АНАЛИЗ РЫНКА ДЕЗИНФИЦИРУЮЩИХ СРЕДСТВ В РЕСПУБЛИКЕ КАЗАХСТАН

В данной статье представлен анализ рынка дезинфицирующих средств в Республике Казахстан. Определены доли отечественных и зарубежных производителей, количество дезинфицирующих средств, представленных на рынке. Выделены лидирующие страны производители, а также фармацевтические организации в Республике Казахстан. В результате исследований было выявлено, что дезинфицирующие средства отечественного производства составляют 15,52% рынка, иностранные - 84,48%. This article presents the analysis of the market of disinfectants in the Republic of Kazakhstan. The shares of domestic and foreign manufacturers, the number of disinfectants presented in the market are determined. The leading countries manufacturers, as well as pharmaceutical organizations in the Republic of Kazakhstan are highlighted. As a result of the research, it was found that disinfectants of domestic production account for 15.52% of the market, foreign - 84.48%. Relevance. At the beginning of 2020, the world is facing a pandemic of coronavirus. It is a potentially severe acute respiratory infection [1], which is a dangerous disease that can occur both in mild and severe forms [2]. The virus is transmitted via airborne droplets with the virus sprayed into the air when coughing, sneezing or talking, or by contact with surfaces, followed by infection in the eyes, nose or mouth. The most vulnerable places are public places, transport, markets, etc. The main measure against the spread of infection is compliance with the rules of personal and respiratory hygiene [3]. But, in addition to this, the disinfection of rooms and surfaces should be carried out. The rapid spread of infection has increased the demand for disinfectants. The most important problem is the development of optimal production of domestic products, since the products of other countries occupy a signicant part of the market.Objective: to analyze the market of disinfectants in Kazakhstan.Objectives:- To consider the producing countries;- determine the dynamics of registered disinfectants from 2016 to 2020;- to compare the market value of the most demanded disinfectants;- determine the percentage of dosage forms.Research materials. Register of disinfection, disinsection and deratization means with certificate of state registration in the Republic of Kazakhstan; Register of state registration certicates of the Republic of Kazakhstan.

Preparing for the Next Normal: Transformation in the Role of Medical Affairs Following the COVID-19 Pandemic.

The medical affairs function represents one of the scientific interfaces in a pharmaceutical organization. Over the last two decades, medical affairs has evolved from being a support function to a strategic pillar within organizational business units. The COVID-19 pandemic has given rise to unforeseen circumstances resulting in a dramatic change in external stakeholder engagements, catapulting the medical affairs function into leading the way on scientific engagements and patient-centric endeavors. The changes in stakeholder interactions and behavior as a result of the pandemic last year are likely to persist in the foreseeable future for which medical affairs professionals need to enhance existing skill sets and acquire expertise in newer domains. In this paper, the transformation of the medical affairs team to a key strategic partner and the skills required to strengthen this transition, in the next normal of a post-COVID world, is explored.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40290-021-00392-x.

A Validation of Ajzen’s Theory of Planned Behavior: Prescribing Behavior of Otolaryngologists during COVID 19 Pandemic in Pakistan

The objective of this investigation was to uncover the magnitude of unethical promotion practicesemployed by pharmaceutical firms on Otolaryngologists and decide if the acknowledged giftsimpacts their feelings with respect to gifts received. It intends to evaluate the perceptions/attitudeof doctors towards gifts offered by pharmaceutical organizations, and impact of these gifts onprescribing behavior. The purpose is to explore whether attitude toward the behaviorsignificantly affect intention; and whether subjective norm significantly affect intention andwhether perceived behavioral control significantly affect intention. The study explores whetherintention significantly affect prescribing behavior and whether perceived behavioral controldirectly significantly affect prescribing behavior. The “Theory of Planned Behavior” TPB allowssuch appraisal and is utilized for assessing anti-biotic use. After the preliminary analysis,thereview was dispersed amongst doctors in an open private training medical clinic and facilities.196 finished surveys were gotten out of 397 Otolaryngologists, (50.5% adjusted reaction rate). Utilizing multivariate examination, the general expectation toward endorsing antibiotic was not truly unsurprising (model R2 = .134). PBC (relative weight = .354) was the main noteworthy indicators. Our exploration structure can additionally be utilized by policymakers to plan and assess intercessions that may adjust the association between doctors and patients to enhance anti-biotic solutions among COVID 19 patients for various districts and age groups. This methodology gives a structure to create strategy experiences by different partner gatherings. It gives an apparatus to policymakers to research different mediation arrangements.

ОСОБЕННОСТИ ЛЕКАРСТВЕННОГО ОБЕСПЕЧЕНИЯ СЕЛЬСКОГО НАСЕЛЕНИЯ РЕСПУБЛИКИ АДЫГЕЯ

Improving the availability of medical and medicinal care is the most important task of all levels of government and especially relevant in the context of modernization of the health system. The purpose of the work was to analyze the peculiarities of the functioning of the Drug Provision System of the Rural Population of the Republic of Adygea to identify reserves for its development and substantiate directions for further improvement, taking into account regional conditions. It was established that in the Republic of Adygea out of 160 units of medical organizations, the right of retail trade in drugs, 112 medical and obstetric items that have licenses for pharmaceutical activities are used by drug trading. A feature of the implementation of pharmaceutical activities in rural areas is the absence in most places of modern transport highways, which creates logistics problems and significantly complicates the regular delivery of drugs to the population. Among the positive points, the appearance of an additional way of delivering drugs to the feldsher-obstetric items located in hard-to-reach (mountainous) areas implemented in the federal population to ensure the necessary drugs is noted. The inclusion of pharmacies of partners in the system of ensuring the population did not require additional agreements and expenditures on their services, since this function does not carry additional costs, but at the same time increases their image. It has been established that over the past 2 years, the quality of drugs in the countryside residents decreased significantly. In the region, the number of current pharmaceutical activities has decreased by 21%, the number of operating paramedic-obstetric items has also decreased by 18%, and the number of pharmacies of the program has decreased by 2.8 times. Currently, unresolved problems of the organizational nature came to the fore, among which: the absence of working capital organizations for the acquisition of drugs, in the presence of extrabudgetary funds received from the implementation of paid medical services; insufficient legal training of individual officials of medical organizations in state procurement issues; the absence from the overwhelming number of retail trade licenses for transportation of goods of pharmacy assortment and others. The identified problems are based on the basis of the work plan of health authorities, pharmaceutical activities, medical and pharmaceutical organizations of the Republic of Adygea to improve the forms and working methods for the provision of agricultural drugs.

АНАЛИЗ УДОВЛЕТВОРЕННОСТИ НАСЕЛЕНИЯ КАЧЕСТВОМ ПРЕДОСТАВЛЕНИЯ УСЛУГ ПО ЛЬГОТНОМУ ЛЕКАРСТВЕННОМУ ОБЕСПЕЧЕНИЮ

Drug therapy is one of the main components of medical care for the population, and the provision of drugs is an important indicator of its availability and quality. The purpose of our work was to analyze satisfaction with the quality of the provision of services for preferential drug provision. The works of domestic and foreign scientists in the field of preferential drug provision, as well as regulatory and organizational documentation on pharmaceutical activities were taken as an information base. The survey method served as the main research method. The objects of the study were the visitors of the pharmacy organizations of the Oryol region, who receive drugs under the program of preferential drug provision. The study found that 49.0% of respondents had difficulties in making an appointment with a doctor; cases of refusal to issue a prescription were indicated by 29.0% of the respondents; 45.0% of the respondents had to spend a long time on obtaining a preferential prescription for a drug by the decision of a medical commission. The majority of respondents (54.0%) do not receive medicines on preferential terms on time (postponed for more than 10 days). Almost half of the surveyed respondents (48.0%) are not satisfied with the treatment with prescription drugs prescribed under the program of preferential drug provision, due to the lack of drugs prescribed by a doctor in the pharmacy organization at the time of contact and their preference for drugs from other manufacturers. Most of the respondents (61.0%) consider the range of preferential drugs to be insufficient for the treatment of their underlying disease. Some respondents (20.0%) are not satisfied with the service in a pharmacy organization; 19.0% are dissatisfied with the quality and completeness of information about medicines received from a doctor and a pharmacy worker. The results obtained were communicated to the management of medical and pharmaceutical organizations serving privileged categories of citizens in the Oryol region. The authors of the study developed a Standard Operating Procedure “Procedure for Selling Medicines to Beneficial Categories of Citizens”, which helps to optimize the quality of service in pharmacies for the population receiving medicines under the preferential drug provision program.

A hidden web of policy influence: The pharmaceutical industry's engagement with UK's All-Party Parliamentary Groups.

Our objective was to examine conflicts of interest between the UK's health-focused All-Party Parliamentary Groups (APPGs) and the pharmaceutical industry between 2012 and 2018. APPGs are informal cross-party groups revolving around a particular topic run by and for Members of the UK's Houses of Commons and Lords. They facilitate engagement between parliamentarians and external organisations, disseminate knowledge, and generate debate through meetings, publications, and events. We identified APPGs focusing on physical or mental health, wellbeing, health care, or treatment and extracted details of their payments from external donors disclosed on the Register for All-Party Parliamentary Groups. We identified all donors which were pharmaceutical companies and pharmaceutical industry-funded patient organisations. We established that sixteen of 146 (11%) health-related APPGs had conflicts of interest indicated by reporting payments from thirty-five pharmaceutical companies worth £1,211,345.81 (16.6% of the £7,283,414.90 received by all health-related APPGs). Two APPGs (Health and Cancer) received more than half of the total value provided by drug companies. Fifty APPGs also had received payments from patient organisations with conflicts of interest, indicated by reporting 304 payments worth £986,054.94 from 57 (of 84) patient organisations which had received £27,883,556.3 from pharmaceutical companies across the same period. In total, drug companies and drug industry-funded patient organisations provided a combined total of £2,197,400.75 (30.2% of all funding received by health-related APPGs) and 468 (of 1,177-39.7%) payments to 58 (of 146-39.7%) health-related APPGs, with the APPG for Cancer receiving the most funding. In conclusion, we found evidence of conflicts of interests through APPGs receiving substantial income from pharmaceutical companies. Policy influence exerted by the pharmaceutical industry needs to be examined holistically, with an emphasis on relationships between actors potentially playing part in its lobbying campaigns. We also suggest ways of improving transparency of payment reporting by APPGs and pharmaceutical companies.

PHARMACEUTICAL SERVICES: STATUS AND DEVELOPMENT TRENDS

The aimof the review is to provide an analysis and generalization of the main directions of research in the sphere of pharmaceutical services, and their characteristics associated with the determination of their main development trends.Materials and methods. For the analysis, the information store on the basis of scientific publications by Russian and foreign scientists, devoted to research in the field of pharmaceutical services (PSs), has been used. The search for publications was carried out in the open and accessible sources of the latest twenty years (the retrospective period of 2001-2021), located in scientific and technical libraries of institutions, as well as in electronic databases: Elibrary, Medline / PubMed, Cochrane Library, Scopus, Cyberleninka, Google-academy, J-stage. When forming the information array, the search for publications was carried out according to the following requests: pharmaceutical services (pharmaceutical care services), the provision of pharmaceutical services, the quality of pharmaceutical services. For the conceptualization of the study, 87 scientific publications obtained as a result of information retrieval, have been used.Results.In the course of the study, a logical and structural analysis of the main directions in which research in the field of providing PSs in our country is developing, has been carried out. The main trends in the study of the providing services’ activity in the sphere of drug circulation, are characterized. A comprehensive analysis of the category of "pharmaceutical service" has been carried out. The terminological content of this concept, the groups of features characterizing the economic and social essence of educational institutions have been generalized, and the most characteristic features that make up the structure and content of educational institutions, have been identified. The existing approaches to the development of the nomenclature and types of PSs have been analyzed and the systematization of pharmaceutical works and services using the process approach, have been proposed by the authors.Conclusion.The conducted study indicates the presence of several directions in the development of research in the field of providing PSs, aimed at improving the quality of services for the population in pharmaceutical organizations. However, the most important role in the research is assigned to the study and assessment of the quality of educational institutions, the development of approaches to its optimization. As evidenced by the results of the analysis and generalization, the most successful activity in the provision of services in the field of drug circulation requires the implementation of a process approach and the implementation of Quality Management Systems (QMSs).

Application of the Environmental Safety terms and definitions in pharmaceutical organizations

The article describes the applying of pharmaceutical terminology in the Environmental Safety area and the reasons for the emergence of multiple concepts. The study was based on the definitions approved in the scientific industry and in the regulatory documents of the Russian Federation, the EAEU and the EU. It has been found that it is still not possible to unify the existing variations of the terms. Nevertheless, it is necessary to develop a manual, which will provide guidelines on the use of certain terms.

Professional status and role of a pharmaceutical specialist: expert opinion

Self-assessment of the status and role of a pharmaceutical specialist is an important element of professionalization. To evaluate the opinion of the professional pharmaceutical community on the status and role of pharmaceutical specialist in the society, an expert interview of the heads of pharmaceutical organizations (N=32) was conducted. Experts revealed that the prestige of the profession of a pharmaceutical specialist has decreased and that the social significance of the profession was underestimated, affecting the professional status. The role of pharmacists is expandingin addition to drug dispensing and manufacturing; thus, it becomes important to form a high level of satisfaction of the population as pharmaceutical care consumers and to participate in public health and health process together with the doctor. Actual conditions of the pharmaceutical specialist activity affect the status held in the society, and the proper performance of the functions of providing pharmaceutical assistance determines the further development of the profession.

Block Chain in Fake Product Identification System Using QR Code

Every popular brand has fake manufacturers selling a counterfeited item at cheaper rates. Mostly counterfeiting medicine are selling to customer. For these factors combined with block chain technology can lead to an efficient comprehensive approach to reduce counterfeiting. Pharmaceutical organizations face many challenges regarding counterfeit medicines. Detecting fault medicines so that it will save public life. To discover the consciousness of the fake medication issue which requires an expanding security level for the appropriation of lawful pharmaceutical items. Manufacturing to user can be recorded, and the user is assured that the scans weren’t faked. The fake products can be identified by using QR code and it handles the product data

Analysis of consumer behaviour in a retail drugstore chain in Russia based on the type of consumer loyalty

Purpose: To identify the consumer loyalty types in a retail segment of the Russian pharmaceutical market.&#x0D; Methods: A sociological study was conducted in pharmaceutical organisations of various forms of ownership, located in different administrative districts of Moscow (Russian Federation). This was done using a questionnaire developed in advance, and based on literature review. The survey involved 480 respondents selected in a simple random sampling.&#x0D; Results: All questionnaire filled out by the respondents were considered valid. Analysis of the loyalty parameters obtained during the study are as follows: (1) behavioural (repeated purchases), (2) emotional (subjective opinions and experience, sympathy, respect for the brand, etc) and (3) rational (utility assessment) components (4) consumer satisfaction, (5) the desire to buy again, (6) the ability to switch to competitors. They were allocated to four consumer segments. In the course of the study, one consumer segment identified a type of loyalty that had not been previously reviewed by other authors; therefore, a modified classification of the loyalty types was created. Under this classification, constancy, constancy imaginary, inconstancy, and migratory loyalties can be some types of loyalty. The identified socio-demographic characteristics of the respondents influenced the categorization of the loyalty type.&#x0D; Conclusion: A modified classification of loyalty types was created which serves as a parameter for segmentation of the respondents into four groups, with well-readable characteristics and the primary trends in making purchases.

MODERNIZATION OF HIGHER PHARMACEUTICAL EDUCATION IN THE CONDITIONS OF REFORMING CONTROL AND SUPERVISION ACTIVITIES

The training of skilled workers for efficient liaison with regulatory authorities who are capable of training pharmaceutical companies for inspections is one of the most pressing problems in the field of circulation of medicines. The research has identified significant gaps and lack of fundamental knowledge by the senior executives, quality representatives, key personnel and pharmaceutical sales representatives on issues of liaison with regulatory authorities in the context of drastic reformation of administrative procedures. The research presents proprietary experience of teaching a new optional elective course "control and supervision of pharmaceutical activities" at the chair of pharmacy of North-Ossetian State Medical Academy, and characteristic of the training package of the new optional discipline for fifth year students and specialists of pharmaceutical organizations. The research analyses several approaches to solving the tasks of improving basic skills required to prepare for tests for students and specialists in the context of contemporary demands of the pharmaceutical labor market.

A Competitive Analysis Of Top Ten Pharmaceutical Companies In India

Contemplating the activities and conduct of close contenders is fundamental. Competitive analysis is a significant piece of the vital arranging process, and the wellsprings of such Web data are enhanced, and the data are refreshed much of the time. This expansive intrigue has brought about different definitions and conceptualizations of recognizable contender proof just as different ways to deal with considering it, which disables the reconciliation of existing information planned for responding to fundamental inquiries regarding its revenue, procedures, and suggestions. To compete with the opposition organizations are against, it is essential to survey things that are genuinely working in the business. Inquire about rely upon measurable studying, which is limited most definitely and limit. There can be more recommendations, which can show profitability to the association. In this task, the top ten pharmaceutical organizations of India are firmly watched. The absolute positioning gives according to general income, i.e., overall revenue.

Impact of big data analytics on sales performance in pharmaceutical organizations: The role of customer relationship management capabilities.

In this era of technology development, every business wants to equip its salesforce with a sustainable salesforce automation system to improve sales performance and customer relationship management (CRM) capabilities. This study investigates the impact of big data analytics (BDA) on CRM capabilities and the sales performance of pharmaceutical organizations. A research model was tested based on 416 valid responses collected from pharmaceutical companies through a structured questionnaire. Structural equation modeling (SEM) was employed using Smart-PLS3 to confirm the contribution of BDA to improving CRM capabilities and sales performance. The study finds that individual characteristics such as self-efficacy, playfulness, and social norms, along with organizational characteristics such as voluntariness, user involvement, user participation, and management support, are positive predictors of salesforce perception of BDA. This positive perception of BDA increased the person-technology fit in the salesforce, which ultimately increased the CRM capabilities and sales performance.

The legal status of participants who create medicines in the national innovation system

Formulation of the problem. Carrying out scientific research in the field of creating innovative medicines is the key to the competitiveness of pharmaceutical enterprises in the internal Ukrainian and world markets. Proper legal regulation of the legal status of business entities and scientific institutions that create medicines should become a guarantee of state support for scientific research in this area. Recent research on the topic. The scientific works of V.M. Pashkova, I.S. Voronina, M.V. Bunyak and other researchers are devoted to certain problems of innovative activity in the sphere of medicine circulation. At the same time, the problems of the legal status of participants in the national innovation system who create new medicines have not found their coverage in the scientific literature. The purpose of this research is to determine the legal status of participants in the national innovation system, who create medicines. Article’s main body. The scientific research is devoted to the determination of the legal status of the participants of the national innovation system who create medicines. Legislative and by-laws, statistical information posted on the official websites of authorities, publications of researchers who studied innovative activities in the field of medicine circulation were studied. It is stated that the development of innovative medicines can be carried out by research institutes, institutions of higher education and pharmaceutical manufacturing enterprises. Medicines productions are created in the organizational and legal form of private and state enterprises, business entities. Research institutes and institutions of higher education have legal form of organization. These institutions are subordinate to either the Ministry of Education and Science, or the Ministry of Health Protection, or the National Academy of Medical Sciences, or the State Service for Medicines and Drug Control of Ukraine. Among the conditions for obtaining a license for the medication production there is no requirement for a laboratory to create new medicines at the enterprise. Requirements for such a laboratory are not provided for in legislative and bylaws. Conclusions and prospects for the development. The author proposes definitions of “medicine developer” and “innovative pharmaceutical organization”. The features of the pharmaceutical enterprise innovativeness, in our opinion, are the presence of a scientific department in the structure of the enterprise and the registration of an innovative project by this enterprise in the prescribed manner. The consolidation of these definitions in the legislation of Ukraine may be important for obtaining state support for scientific research on the new medicines creation.