European Pharmaceutical Companies Research Articles

Unraveling the internal drivers of pharmaceutical company performance in Europe: A DEMATEL analysis

Research background: Internal business factors are vital to how a company achieves its goals. The present study of internal drivers of pharmaceutical company performance is very insightful, as it has the potential to boost further competitiveness, it may allow health authority personnel to have guidelines to make strategic decisions, as well as inspire investor confidence, ensure regulatory compliance and performance benchmarking, and support talent acquisition and retention. In addition, it can identify the important internal factors that need to receive more priority. Purpose of the article: The European pharmaceutical industry is currently facing multiple challenges. This paper aims to map the relative relationships among the internal factors that influence the business performance of pharmaceutical companies in Europe by using the DEMATEL approach. Method: There are two phases of the present study, an extensive literature review and the use of the decision-making trial and evaluation laboratory (DEMATEL) technique. To identify the key internal drivers and their cause-and-effect relationship with pharmaceutical company performance in Europe, data from experts were obtained using the predesigned DEMATEL questionnaire. Findings & value added: The extensive literature review from the Web of Science and Scopus databases found that seven internal factors are very demanding in the case of European pharmaceutical business performance. The main elements that have the highest impact on pharmaceutical business performance in Europe are human resources competencies, the information system, technological competitiveness, and the patent system. However, financial profitability, research and development competencies, alliances with other companies, and supply chain management are the factors that are affected more by other factors. The study is the first attempt to identify the internal business performance of the pharmaceutical sector in Europe by working with pragmatic and perceptive decisions from pharmaceutical stakeholders in Europe.

Does Financing Policy Impact the Financial Performance of the Pharmaceutical Companies in Europe and the United States of America?

In this paper, the research is focused on the empirical study regarding the impact of financing policy on the companies’ financial performance from the pharmaceutical sector, in Europe and in the United States of America, considering that these two geographic areas were strongly involved in the supply of medicine, in the COVID-19 pandemic crisis. To identify the most representative determinants of the companies’ financial performance, from the financing policy perspective, there were investigated a series of studies from the international literature and there were formulated research hypotheses. The database consists of 466 companies, over a period of 10 years, respectively 2012-2021, cumulating a number of 4660 statistical observations, which are used to estimate multiple regression models, with panel data, unbalanced, linear, with no effects, with fixed effects or with random effects. The dependent variables, according to which the empirical models were estimated, are Return on Assets, Return on Equity and Price Earnings Ratio. The independent variables are represented by long-term indebtedness, short-term indebtedness, net debt, current ratio, effective tax rate, asset tangibility, being also used control variables such as dividend payout ratio and company size, measured by turnover and market capitalization. The results highlight, mainly, the negative influence of indebtedness on Return on Assets and Return on Equity, respectively positive influence on Price Earnings Ratio. Furthermore, the results of the empirical models are interpreted from a statistical and economic point of view, by referring to the hypotheses formulated based on previous studies.

Nine Degrees of Uncertainty in Negotiations

Joint decision‐making processes such as negotiations play a vital role in diverse societal contexts spanning from business and politics to sustainability‐related negotiations. One of the most prominent examples of how negotiations play an important role in overcoming societal challenges was the COVID‐19 vaccine supply negotiations. These negotiations have put the spotlight on an aspect of joint decision‐making that always has been of great interest to both negotiation researchers and practitioners yet remains empirically understudied—the effect of uncertainty. In the present article, we develop a framework of uncertainty in negotiation using the COVID‐19 vaccine supply negotiations between the European Union and pharmaceutical companies as an example. More specifically, we categorize different kinds of uncertainty based both on mathematical considerations (i.e., differentiation between risk, ambiguity, and uncertainty) as well as on more circumstantial factors. To do so, we adapted the nine kinds of uncertainty in environmental governance proposed by Dewulf and Biesbroek to the more general context of negotiations. We first differentiate between three natures of uncertainty (i.e., lack of knowledge, unpredictability, and interpretations) and three objects of uncertainty (i.e., issue‐based, strategy‐based, and context‐based). Second, we illustrate the psychological barriers that negotiators face when handling uncertainty, before concluding with proposals for practitioners on how to manage different kinds of uncertainty. Overall, we aim at stimulating investigations of the effects of uncertainty in mixed‐motive decision‐making while simultaneously helping negotiation teachers and practitioners better cope with the additional demands created by specific kinds of uncertainty.

A Principles Framework for Digital Provision of Medical Information for Healthcare Professionals.

European pharmaceutical companies have a legal requirement to provide non-promotional medical information (MI) services to support healthcare professionals (HCPs) using their medicinal products. While we are seeing an increased HCP preference and expectation towards digital channels, the lack of a compliance framework relating to the provision of non-promotional MI services is a key factor complicating and compromising the ability for companies to meet this need. Meanwhile, the internet is dominated by a large volume of unregulated, easy access, and potentially low-quality information from diverse sources. The Medical Information Leaders in Europe (MILE) association is therefore proposing a framework of principles to support pharmaceutical companies with the digital provision of MI services; these relate to digital access to non-promotional, medicinal product information to support clinical decision making and patient care. The three established European national MI associations have already considered the framework and expressed their endorsement. MILE continues to invite stakeholders, including pharmaceutical companies, regulators, national industry associations and healthcare professional bodies to engage and help refine and implement this framework. This publication does not constitute legal advice; decision making and accountability remains with each pharmaceutical company.

When speed matters: a discussion on the benefits of a grace period in patent law to accelerate pharmaceutical innovation in times of pandemic.

The unprecedented coronavirus disease 2019 (COVID-19) pandemic is a solemn reminder of the need to accelerate pharmaceutical innovation. The desire for fast access to vaccines triggered discussion of unrestricted access to research findings with the hope of facilitating the drug discovery process to combat COVID-19. Increasingly, abolition of the patent system is being discussed in connection with the fight against the pandemic. This may accelerate discovery of and increase access to medicines. However, society's desire for immediate disclosure of research findings conflicts with the inventor's legitimate interest to protect his or her invention as well as the need to recover investments made to develop the drug. The call for immediate disclosure of research results contradicts the interest of the inventor, whose primary goal is to secure his intellectual property rights, usually by applying for patent protection. In Europe, where patent law is based on the principle of absolute novelty, disclosure of the results reduces novelty and prevents subsequent patenting. Consequently, patenting remains the top priority for pharmaceutical companies in Europe, while disclosure of the results is secondary. The following article looks critically at the idea of using the grace period in European patent law to reconcile the conflicting interests of society and inventors in times of pandemic. In this paper, we investigate whether the implementation of a grace period in European patent law like that known in the USA, Japan, or Korea benefits the disclosure of results and increases the flow of information, ultimately leading to the promotion of innovation and rapid drug discovery. This article questions whether the use of a grace period provides a sufficient incentive to the inventor for rapid disclosure.

PANDA as a Startup-Orientated Cooperative Innovation Strategy for the Chemical and Pharmaceutical Industry

Generating innovations is one of the key success factors of companies and organizations. To constantly create new innovations, an effective innovation strategy must be implemented by companies. Therefore, a variation of different strategic frameworks has been formulated. One framework which combines the idea of Open Innovation with startup-based interaction is the startup-orientated cooperative innovation (SOCI) strategy. The PANDA initiative of Fresenius University of Applied Science can be characterized as a coupled process of the SOCI framework. This paper presents the results of a survey, analyzing the impact of PANDA on the innovation strategies of the chemical and pharmaceutical industry based on the innovation attributes defined by the Oslo Manual 2018. The survey was used to compare 12 PANDA project evaluations implementing by European chemical and pharmaceutical companies. The main results of this study show that PANDA represents an effective tool to foster early-stage innovation development and indicates general effectiveness of SOCI strategies for chemical and pharmaceutical companies.

The Pharmaceutical Industry in New EU Member States: A Statistical Comparison with Germany. Lessons for Ukraine

Pharmaceutical production is a strategic sector of the EU economy. The authorities of Central and Eastern Europe (CEE) countries that became EU members in 2004 have been building up domestic pharmaceutical industries for purposes of production and distribution of medical drugs (MDs) and medical products (MPs), on the one hand, and government assistance to business entities and public procurement, on the other. The article’s objective is to assess the change in economic performance of the pharmaceutical industry in Poland, Hungary and Czechia after their accession to EU, to make a comparative statistical analysis with Germany, the leader of pharmaceutical production in EU, and to reveal key problems of this industry development in CEE countries, in order to elaborate recommendations for Ukraine on replication of best practices and avoidance of potential risks.
 Results of research show that pharmaceutical producers (group 54 SITC Rev.4) in CEE countries have been focusing mostly on EU market, with Germany being their main partner. The turnover of high tech pharmaceutical goods in CEE countries has significantly grown after the accession to EU, along with the significantly grown imports of these goods and the increasing negative trade balance. Pharmaceutical companies in CEE countries could increase the salaries and the apparent labor productivity, but the gap between them and Germany in salary and productivity terms still remains too wide. In the studied CEE countries there has been significant increase in pharmaceutical R&D spending, but its estimated share remains quite low compared with average figures for EU (16.1%) and Germany (25.6%).
 It is substantiated that because the future Agreement between the European Community and Ukraine on conformity assessment and acceptance of industrial products (ACAA agreement, or “Industrial visa-free regime”), which is being negotiated right now, will cover the pharmaceutical industry, the Ukrainian pharmaceutics will gain benefits only given the consolidated endogenous capacities of the industry and firmly established advantages of localization providing stimuli for European companies to create production facilities and R&D centers in Ukraine (including ones for contract-based R&D and productions). It is demonstrated that the inflow of investment and technologies from European pharmaceutical companies is capable of accelerating production start-up and exports of MDs and MPs (as time need not be lost for setting up all the links of the chain), thus adding up to the assets of Ukrainian producers (through transfer of knowledge and skills), but all the above cannot compensate for domestic efforts aimed at creating tangible and intangible assets in the industry. Given its Eurointegration context, Ukraine needs to pursue the policy of increasing the industry’s endogenous capacities and rely on the comprehensive approach (instead of focusing on MDs and MPs) that will cover the following key areas: biological and chemical ingredients, medical equipment, pharmaceutical fillers and packages, equipment and apparatus for pharmaceutical production. This is expected to reduce the dependence of Ukrainian pharmaceutics on imports and eliminate the problem of “truncated industrialization” that can cause structural imbalances, worsen the balance of payments and weaken the national currency.

The Critical Need to Build a European Governance Model for Online Access to Medical Information Services: A Position Paper.

European pharmaceutical companies have a legal requirement to provide non-promotional Medical Information (MI) services to support healthcare professionals (HCPs) who are using their medicinal products. While the industry has self-regulating bodies with established Codes of Practice, these mainly focus on promotional messaging and commercial activities. In the absence of similar frameworks for MI, such services struggle to understand how to meet HCP digital expectations, often in fear of breaching the promotional codes. This is limiting access to the wealth of non-promotional patient-focussed information held within the industry. Meanwhile, a large volume of unregulated, low-quality information can be readily found on the internet. To understand the current status, the Medical Information Leaders in Europe (MILE) industry association performed a benchmarking survey which explored the online MI service provision of 13 mid-large pharmaceutical companies across Europe. This highlighted a great diversity in approach in terms of geographical coverage and content. Visibility and access for HCPs is complex, compromising online engagement and website utilisation. This MILE position paper highlights the critical need to establish a clear governance model, which empowers pharmaceutical company MI functions to provide unbranded, non-promotional, medicinal product information sources to support HCP online information needs. It is essential to build confidence, transparency and trust by establishing a practical quality framework with principles and standards for online MI services for HCPs.

Contract manufacturing came forward

Regulators and the public alike learned a lot about the arcane mechanisms of the pharmaceutical supply chain in 2020 as the world monitored the development of therapies and vaccines that might bring life back to normal. A key discovery: outsourcing does not always mean offshoring. Far from it. Production costs have pushed generic-drug manufacturing to low-cost Asia over the last 20 years, but drugmakers have also increased their reliance on drug-ingredient firms close to home for their more cutting-edge therapies. A group of US and European pharmaceutical chemical companies has evolved since the 1990s into a full-service industry, now global, offering development and manufacture of active pharmaceutical ingredients (APIs), finished-dose drug production, and new technologies like cell and gene therapy. These contract development and manufacturing organizations (CDMOs) have acquired customers’ plants as big pharma gravitates toward exiting large-scale manufacturing. CDMOs also provide essential services to the small biotech ventures at

Preparation of Direct Healthcare Professional Communication: An Exploratory Study on the Experiences and Perceptions of European Pharmaceutical Companies and the EMA.

Despite the regulatory requirement for cooperation between marketing authorization holders (MAHs) and European Medicines Agency (EMA) in the direct healthcare professional communication (DHPC) preparation, no literature has explored DHPCs from an industry-regulator perspective. This constitutes a significant knowledge gap as any possibility of improving current DHPC effectiveness depends on decisions in the cooperative preparation phase. Thus, this EU-centered study explores differences in perceptions and experiences of DHPCs of European MAHs and EMA. European MAHs ([Formula: see text]) and EMA representatives ([Formula: see text]) were interviewed. The verbatim transcripts were coded into themes using NVivo software. Interview analysis was performed following a phenomenological approach of meaning condensation. The DHPC process was perceived as burdensome by the industry. One company stated the process was time-consuming either due to EMA's internal lengthy approval process or the translation activities with local company affiliates and national competent authorities. Three companies stated that DHPCs were not effective. One company stated that DHPCs are sent out due to legal Obligations and not because of their use as a risk minimization measure (RMM). Newly emerged safety concerns were found difficult to phrase. Optimization proposals included improved timelines, scrutinization of healthcare professionals and better communication tools in clinical practice. DHPCs were not perceived as optimal, although the most effective intervention as it targets healthcare professionals directly. Continuous evaluation by EMA of DHPCs and evaluation on how to reach healthcare professionals are necessary. It is believed that industry perceptions from this study can support EMA with improved regulatory decision making to benefit public health.

The European Federation of the Pharmaceutical Industry and Associations' Research and Animal Welfare Group: Assessing and benchmarking 'Culture of Care' in the context of using animals for scientific purpose.

The European Federation of Pharmaceutical Industries and Associations’ Research and Animal Welfare group members reflected on the concept of a Culture of Care in relation to animal care and use and on differences in its understanding and application across European pharmaceutical companies. The term ‘Culture of Care’ is used across different regions and organizations but rarely with any defined indicators to support working practice.The European Federation of Pharmaceutical Industries and Associations’ Research and Animal Welfare group has developed a framework to help organizations identify gaps or potential areas for improvement in support of a positive Culture of Care.The framework is a tool that identifies five areas of focus for a Culture of Care: company values; strategic approach at establishment level; implementation structures; staff support; and animal care and procedures. The framework is intended as an aid for continuous improvement, highlighting where indicators of good practice are present. We expect it to provide points of reflection and ideas for those looking to implement a Culture of Care in a structured way, while facilitating a professional and strategic approach. To prevent it supporting a ‘tick-box’ exercise, the framework must not be used as an auditing tool, but as a starting point for consideration and discussion about how care manifests within the context and constraints of individual establishments.

Preparation of Direct Healthcare Professional Communication: An Exploratory Study on the Experiences and Perceptions of European Pharmaceutical Companies and the EMA.

Despite the regulatory requirement for cooperation between marketing authorization holders (MAHs) and European Medicines Agency (EMA) in the direct healthcare professional communication (DHPC) preparation, no literature has explored DHPCs from an industry-regulator perspective. This constitutes a significant knowledge gap as any possibility of improving current DHPC effectiveness depends on decisions in the cooperative preparation phase. Thus, this EU-centered study explores differences in perceptions and experiences of DHPCs of European MAHs and EMA. European MAHs (n = 6) and EMA representatives (n = 2) were interviewed. The verbatim transcripts were coded into themes using NVivo software. Interview analysis was performed following a phenomenological approach of meaning condensation. The DHPC process was perceived as burdensome by the industry. One company stated the process was time-consuming either due to EMA's internal lengthy approval process or the translation activities with local company affiliates and national competent authorities. Three companies stated that DHPCs were not effective. One company stated that DHPCs are sent out due to legal obligations and not because of their use as a risk minimization measure (RMM). Newly emerged safety concerns were found difficult to phrase. Optimization proposals included improved timelines, scrutinization of healthcare professionals and better communication tools in clinical practice. DHPCs were not perceived as optimal, although the most effective intervention as it targets healthcare professionals directly. Continuous evaluation by EMA of DHPCs and evaluation on how to reach healthcare professionals are necessary. It is believed that industry perceptions from this study can support EMA with improved regulatory decision making to benefit public health.

Considerations regarding the qualification of clinical trial sites and investigators in clinical trials with ATMPs

Background & Aim ATMPs are medicinal products based on gene therapy, somatic cell therapy or tissue engineering. Regulation (EU) 1394/2007 has been designed to ensure the free movement of ATMPs within the EU to facilitate their access to the EU market and to foster the competitiveness of European pharmaceutical companies while guaranteeing the highest level of health protection for patients. As ATMPs pose specific challenges to developers, manufacturers, regulators and clinicians in terms of complexity and risk profile, distinct rules have been developed for the manufacture and clinical testing of ATMPs. Article 4 of Regulation 1394/2007 has required the European Commission to establish GCP guidelines specific to ATMPs. The stakeholder consultation performed for this purpose, however, has not addressed the qualification of clinical trial sites and investigators. It remains to be elucidated how clinical trial sites and investigators using ATMPs can give documented evidence of their specific qualification, and how Ethics Committees can draw on expertise needed to assess this special group of innovative medicines. Methods, Results & Conclusion Chimeric antigen receptor (CAR)-transduced cells highlight the challenges in qualification of trial sites and investigators. With patients in desperate need, clinicians have put growing pressure on regulators and politicians to render these promising therapies more rapidly available, irrespective of existing gaps in infrastructure, clinical expertise and concepts for the coverage of costs. From the standpoint of an Ethics Committee, documented evidence of the qualification of trial sites and investigators using CAR-T cells and similar ATMPs should include - a risk-benefit analysis that addresses the characteristics of the respective ATMP specifically and appropriately, - the capacity to monitor, grade, manage and document the acute toxicity inherent in this approach, - the infrastructure needed to handle these toxicities, - a data registry and repository for adverse events related to the use of ATMPs in humans, - a recognizable network of collaborating centers who exchange knowledge, share training and help each other in this challenging and important field. Ethics committees will depend on independent experts in ATMPs, especially high-risk (and high-demand) products, to provide guidance in assessing clinical centers and investigators as qualified for these special medicines. Consensus statements by professional societies would be highly welcome. ATMPs are medicinal products based on gene therapy, somatic cell therapy or tissue engineering. Regulation (EU) 1394/2007 has been designed to ensure the free movement of ATMPs within the EU to facilitate their access to the EU market and to foster the competitiveness of European pharmaceutical companies while guaranteeing the highest level of health protection for patients. As ATMPs pose specific challenges to developers, manufacturers, regulators and clinicians in terms of complexity and risk profile, distinct rules have been developed for the manufacture and clinical testing of ATMPs. Article 4 of Regulation 1394/2007 has required the European Commission to establish GCP guidelines specific to ATMPs. The stakeholder consultation performed for this purpose, however, has not addressed the qualification of clinical trial sites and investigators. It remains to be elucidated how clinical trial sites and investigators using ATMPs can give documented evidence of their specific qualification, and how Ethics Committees can draw on expertise needed to assess this special group of innovative medicines. Chimeric antigen receptor (CAR)-transduced cells highlight the challenges in qualification of trial sites and investigators. With patients in desperate need, clinicians have put growing pressure on regulators and politicians to render these promising therapies more rapidly available, irrespective of existing gaps in infrastructure, clinical expertise and concepts for the coverage of costs.

Financialized Corporations in a National Innovation System: The U.S. Pharmaceutical Industry

There are widespread claims that a productivity crisis afflicts the U.S. pharmaceutical industry despite the fact that the U.S. institutional environment provides unique advantages for drug R&D. We argue that the explanation for this productivity paradox is the “financialization” of the U.S. pharmaceutical industry. Driven by shareholder-value ideology, the U.S. pharmaceutical industry has adopted a highly financialized business model. Its key performance metrics are stock-price yield and dividend yield, supported by distributions to shareholders through large-scale stock buybacks and cash dividends. With this financial behavior incentivized by stock-based executive pay, value extraction from corporations for the sake of distributions to shareholders comes at the expense of drug innovation. Simultaneously, however, a number of less-financialized European companies are making use of the U.S. innovation system to outcompete the U.S. companies at home. Arguing that all business enterprises face a tension between innovation and financialization, this article employs the theory of innovative enterprise as a framework for analyzing the evolution of this tension for pharmaceutical companies operating in the United States. We provide evidence of the highly financialized character of the major U.S. pharmaceutical companies in the S&P 500 Index, focusing on distributions to shareholders and the stock-based pay of pharmaceutical executives. After documenting the evolution of the U.S. innovation system for drug R&D since the 1980s and summarizing the U.S. product strategies of seven major European pharmaceutical companies, we pose the hypothesis that under a system of corporate governance supporting innovation, the U.S. innovation system could result in a more innovative pharmaceutical industry.

“It's such a great story it sells itself”? Narratives of vicarious experience in a European pharmaceutical company

This paper analyses how narratives contribute to the multiple and sometimes conflicting corporate identities in a pharmaceutical company. Stories are important for companies; they enable members to legitimize internal decision-making, and to represent themselves towards new employees and clients, as well as within the company (Linde, 2001). In corporate settings, these narratives are often stories of vicarious experience, i.e. “stories about other people engaged in actions that the tellers did not witness” (Norrick, 2013a: 385), as a result of the collective nature of corporate identity.Drawing on a linguistic ethnographic data, we demonstrate how two dominant narratives of vicarious experience, the founder's narrative and the so-called Bad Pharma narrative, serve as shared resources that are strategically mobilized by different tellers (Georgakopoulou, 2007). We examine how these contradictory stories constitute the company's identity discourse. To account for this co-existence, we examine what tellers include in (re)tellings of and reflections on the narrative; how they account for and mitigate certain narrated events; how they establish epistemic authority; and how they position themselves in relation to the narrative by mobilizing personal and collective identities in different ways, including or excluding themselves as protagonists and/or as original tellers of the different identity narratives.

Abnormal market valuation and new product announcements: the role of advancement stage and innovativeness

In this paper, I investigate the role of innovativeness and innovation advancement stage with a view to advancing the development of signalling theory within literature on new product announcements. I examine the effects of innovativeness across the eight stages of innovation advancement, applying the event study methodology to a sample of 407 new product announcements, released during the period of January 2011–December 2016 by European biotechnology and pharmaceutical companies. I found that a high level of innovativeness resulted in larger increases of stock market return when the level of advancement was low (during testing phases), and smaller when the production of the new product had commenced. Subsequently, I present practical insights into the role that the advancement stage plays in new product announcements, which may be used to increase market valuation of the firm.

Market research of medicinal products which are used in cardiological diseases treatment

Aim of the study is to carry out market research of medicinal products which are used in cardiological diseases treatment.Materials and methods. The products range analysis was performed according to the Ukraine State Register of medicines and classification system of ATC. We have studied the pharmaceutical market of cardiotonic action drugs (С01 – cardiological medicines, namely C01ЕВ – other cardiological drugs and С01ЕХ – various combined cardiological drugs). It has been determined that the market of cardiological action preparations is characterized by favorable environment for implementation of the new offered product from the point of view of drugs’ economic affordability to consumers. Manufacture leaders of this group of preparations of foreign and domestic production have been denoted. Results of the study. The ratio of medicines trade names of foreign and domestic production is 35 % to 65 %, full dominance of domestic medicines is observed. In the period from 2012 to 2016 the supply of domestic products had increased by 37.6 %, and foreign by 18.6 %. Analysis of registered trade names of medicines by manufacturing companies has shown that the main share of the assortment is formed by drugs of European pharmaceutical companies. Conclusions. Тhe development of domestic production of cardiac funds is a positive factor for the development of drugs in this market segment and it indicates the widespread use of this category of drugs among the population of the country. The analysis of dosage forms was conducted, according to which tablets and liquid dosage forms of a combination composition – tinctures and drops – are the most popular among consumers.

If you come, will they build it? The impact of the design and use of a performance management system on researcher motivation

This study constructs a framework describing the impact of the design and use of a performance management system (PMS) on researcher motivation. The analysis is based on an in-depth case study of a large European pharmaceutical company. The results reveal that in order to account for antecedents to researcher motivation, a PMS should distinguish between its design and use, as well as account for idiosyncrasies of research work. The study contributes to literature by (a) emphasizing the need to consider both in PMS studies and practice and (b) identifying PMS-specific antecedents to researcher motivation.

The expert patient

The European Patients’ Academy (EUPATI) is a pan-European Innovative Medicines Initiative project of 33 organisations, led by the European Patients’ Forum with partners from patient organisations (the European Genetic Alliance,...

Drug quality analysis through high performance liquid chromatography of isometamidium chloride hydrochloride and diminazene diaceturate purchased from official and unofficial sources in Northern Togo

Trypanocidal drugs remain the most accessible and thus commonly used means of controlling tsetse transmitted animal African trypanosomosis. In Togo, trypanocides are sold on official as well as unofficial markets, but the quality of these trypanocides is undocumented so a drug quality assessment study was conducted from May 2013 to June 2014. Trypanocides supplied by European, Indian and Chinese pharmaceutical companies and sold on official and unofficial markets in Togo were purchased. In total fifty-two trypanocides were obtained, 24 of these samples from official markets and 28 from unofficial markets made up of a total of 36 diminazene diaceturate and 16 isometamidium chloride hydrochloride samples. The samples were analysed in the reference laboratory of the OIE (World Organisation for Animal Health), Laboratory for the Control of Veterinary Medicines (LACOMEV) in Dakar which uses galenic testing and high performance liquid chromatography (HPLC) testing as standard reference analysis methods. The results revealed a high proportion of trypanocides of sub-standard quality on the Togolese market: 40% were non-compliant to these quality reference standards. All of the HPLC non-compliant samples contained lower amounts of active ingredient compared to the concentration specified on the packaging. Non-compliance was higher in samples from the unofficial (53.57%) than from the official markets (25%; p=0.04).The main drug manufacturers, mostly of French origin in the study area, supply quality drugs through the official legal distribution circuit. Products of other origins mostly found on illegal markets present a significantly lower quality.