Multinational Pharmaceutical Companies Research Articles

Geneva–Seattle collaboration in support of developing country vaccine manufacturing

ABSTRACTVaccines were once produced almost exclusively by state-supported entities. While they remain essential tools for public health protection, the majority of the world’s governments have allowed industry to assume responsibility for this function. This is significant because while the international harmonisation of quality assurance standards have effectively increased vaccine safety, they have also reduced the number of developing country vaccine producers, and Northern multinational pharmaceutical companies have shown little interest in offering the range of low-priced products needed in low and middle-income-country contexts. This article examines how public–private collaboration is relevant to contemporary efforts aimed at strengthening developing country manufacturers’ capacity to produce high-quality, low-priced vaccines. Specifically, it casts light on the important and largely complimentary roles of the World Health Organization, The Bill and Melinda Gates Foundation, and the Seattle-based non-profit PATH, in this process. The take away message is that external support remains critical to ensuring that developing country vaccine manufacturers have the tools needed to produce for both domestic and global markets, and the United Nations supply chain, and collaboration at the public–private interface is driving organisational innovation focused on meeting these goals.

Recent Developments in Compulsory Licensing of Pharmaceutical Patents in India

On March 9, 2012, under Section 84(1) of the Indian Patents Act, Controller General of Patents granted country’s first and only compulsory licence to Natco Pharma to sell Bayer AG’s patented oncology drug Nexavar (Sorafenib Tosylate). Since then, India has not issued any other compulsory licence even though two more such applications have been received. India has also implemented a special compulsory licence regime under Section 92A(1), for the manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity to address public health needs. In view of the recent developments, and given the economic consequences of compulsory licensing, it has become important for multinational pharmaceutical companies procuring patents and doing business in India to understand the country’s compulsory licensing laws and reevaluate their business strategies, while domestic companies pursue alternate options to access patented lifesaving medicines within the legal system.

‘Hey You? Get Off My Cloud’: Evaluation of Cloud Service Models for Business Value within Pharma X

Recent reports note that managers need to operate at the intersection of business and current innovative technology. Most notably, ‘Strategy is not just informed by technology but powered by it’. The opportunity to evaluate aspects of ‘cloud service models’, as critical new systems, is therefore invaluable. Our research offers a pragmatic view of the characteristics of these technologies and a useful approach for identifying which may be most suitable in relation to the generation of business value. An example is provided of cloud service requirements within a multi-national pharmaceutical company (Pharma X) which is considered as a complex organizational context of significant interest. A highly qualitative methodological approach was adopted from personal interviews with a number of senior managers involved in new technology adoption. The extent of ‘benefits’, ‘risks’, ‘when to use’ and ‘when not to use’ were determined for a variety of common cloud service models to provide a schematic of important issues for evaluation and development. The research is insightful for large private sector multinational organisations which extends an analysis beyond the usual public sector studies. We conclude with lessons learned which demonstrate the most appropriate cloud enabled business models that support senior managers engaged in cloud service processes. Recent reports note that managers need to operate at the intersection of business and current innovative technology. Most notably, ‘Strategy is not just informed by technology but powered by it’. The opportunity to evaluate aspects of ‘cloud service models’, as critical new systems, is therefore invaluable. Our research offers a pragmatic view of the characteristics of these technologies and a useful approach for identifying which may be most suitable in relation to the generation of business value. An example is provided of cloud service requirements within a multi-national pharmaceutical company (Pharma X) which is considered as a complex organizational context of significant interest. A highly qualitative methodological approach was adopted from personal interviews with a number of senior managers involved in new technology adoption. The extent of ‘benefits’, ‘risks’, ‘when to use’ and ‘when not to use’ were determined for a variety of common cloud service models to provide a schematic of important issues for evaluation and development. The research is insightful for large private sector multinational organisations which extends an analysis beyond the usual public sector studies. We conclude with lessons learned which demonstrate the most appropriate cloud enabled business models that support senior managers engaged in cloud service processes. Recent reports note that managers need to operate at the intersection of business and current innovative technology. Most notably, ‘Strategy is not just informed by technology but powered by it’. The opportunity to evaluate aspects of ‘cloud service models’, as critical new systems, is therefore invaluable. Our research offers a pragmatic view of the characteristics of these technologies and a useful approach for identifying which may be most suitable in relation to the generation of business value. An example is provided of cloud service requirements within a multi-national pharmaceutical company (Pharma X) which is considered as a complex organizational context of significant interest. A highly qualitative methodological approach was adopted from personal interviews with a number of senior managers involved in new technology adoption. The extent of ‘benefits’, ‘risks’, ‘when to use’ and ‘when not to use’ were determined for a variety of common cloud service models to provide a schematic of important issues for evaluation and development. The research is insightful for large private sector multinational organisations which extends an analysis beyond the usual public sector studies. We conclude with lessons learned which demonstrate the most appropriate cloud enabled business models that support senior managers engaged in cloud service processes.

Selecting Regional Postponement Centre Using PESTLE-AHP-TOPSIS Methodology: A Case Study in a Pharmaceutical Company

Supply network planning can be considered as one of the key elements to an effective supply chain management. Decision on where and in which form a company should hold its inventory can give not only cost competitiveness but also responsiveness to customer requirement. This research is based on a case study of a multinational pharmaceutical company with international suppliers and a presence in several countries. The company has a few regional supply factories (affiliates or third parties), including one in Indonesia, serving its Asia-Pacific market. Pharmaceutical products involve many stock keeping units (SKUs) in different packaging formats even though they share the same ingredients. To enhance its supply network, the company is evaluating the option of a regional postponement centre which would serve as a consolidation and repacking facility to direct the demand of similar products from several markets to its supply nodes. This research project evaluates in which country the regional postponement facility should be best located. The research uses a combination of PESTLE-AHP-TOPSIS methodology. The criteria and sub-criteria are derived using PESTLE methodology, while the ranking and analysis is done using AHP-TOPSIS. The final result shows that Singapore is the most suitable location for the company’s regional postponement centre.

Evaluation of Pharmacovigilance Practice in Pharmaceutical Companies in Nigeria

Nigeria provides strong commercial opportunities for both domestic and multinational pharmaceutical companies. Both local and international regulations require marketing authorization holders to monitor the safety of their pharmaceutical products; however, the extent to which these regulations are being followed is not clear. The objective of this study was to evaluate pharmacovigilance practices in pharmaceutical companies in Nigeria. In this descriptive study, a pretested questionnaire was distributed to 67 pharmaceutical companies based in Lagos, Nigeria. The questionnaire focused on nine basic pharmacovigilance requirements to assess pharmacovigilance practices at each company. A total of 31 companies (46 %) returned the study questionnaire; the majority were domestic companies marketing imported pharmaceutical products. Eight companies (26 %) had a pharmacovigilance unit as an integral part of either the regulatory or the medical unit. There were no standalone pharmacovigilance units. Fewer than ten companies had standard operating procedures for processing individual case safety reports, periodic safety update reports, conducting clinical trials, and training of staff on pharmacovigilance and risk-management plans. We found very little implementation of quality pharmacovigilance systems in the pharmaceutical companies surveyed. Improvements are needed to ensure effective safety monitoring by pharmaceutical companies in Nigeria. Regular inspections, audits, and enforcement of pharmacovigilance guidelines by health authorities would improve and strengthen pharmacovigilance systems in Nigeria.

Scientific output of the emerging Cuban biopharmaceutical industry: a scientometric approach

Cuba has developed a biopharmaceutical sector that involves some of the country's most relevant scientific institutions. Despite the severe constraints on resources resulting from the U.S. embargo, the results achieved by this sector have contributed to put the country's health indicators at the same level of high-income nations. Recently, the creation of BioCubaFarma as a cluster of high-technology enterprises organized around a closed cycle model becomes one of the most relevant efforts of the Island in order to make biopharmaceuticals one of the country's leading export earners. The main aim of the current paper was to characterize BioCubaFarma through a battery of Scopus-based bibliometric indicators. A comparison with the most productive multinational pharmaceutical companies was made. Regression analysis of annual productivity, number of citations, scientific talent pool, innovative knowledge and other citation-based indicators was performed. Differences and similarities between BioCubaFarma and multinational companies in four Scopus subject categories related to this sector were identified. The most productive and visible institutions from BioCubaFarma were also characterized. Qualified human resources, innovative knowledge, leadership, high specialization in the field of vaccines development and non-dependence of international collaboration are strengths of the organization. However, it is still necessary to increase the number of articles published in highly visible journals with the aim to achieve a better citation-based performance. Moreover, to increase the contributions from less-productive institutions, more clinical research published in medical journals and more collaboration with universities and health institutions could also have positive benefits for BioCubaFarma's pipelines and portfolios.

Factors influencing the difference between forecasted and actual drug sales volumes under the price–volume agreement in South Korea

This study analyzed factors contributing to increases in the actual sales volumes relative to forecasted volumes of drugs under price–volume agreement (PVA) policy in South Korea.Sales volumes of newly listed drugs on the national formulary are monitored under PVA policy. When actual sales volume exceeds the pre-agreed forecasted volume by 30% or more, the drug is subject to price-reduction. Logistic regression assessed the factors related to whether drugs were the PVA price-reduction drugs. A generalized linear model with gamma distribution and log-link assessed the factors influencing the increase in actual volumes compared to forecasted volume in the PVA price-reduction drugs.Of 186 PVA monitored drugs, 34.9% were price-reduction drugs. Drugs marketed by pharmaceutical companies with previous-occupation in the therapeutic markets were more likely to be PVA price-reduction drugs than drugs marketed by firms with no previous-occupation. Drugs of multinational pharmaceutical companies were more likely to be PVA price-reduction drugs than those of domestic companies. Having more alternative existing drugs was significantly associated with higher odds of being PVA price-reduction drugs. Among the PVA price-reduction drugs, the increasing rate of actual volume compared to forecasted volume was significantly higher in drugs with clinical usefulness.By focusing the negotiation efforts on those target drugs, PVA policy can be administered more efficiently with the improved predictability of the drug sales volumes.

Homeoprophylaxis in Cuba: The End of an Era?

From 2004 to 2015 some of the largest homeoprophylactic interventions were executed in Cuba. However, significant changes occurred in early 2015 at the Finlay Institute where the interventions were planned and delivered. In addition, Cuba's borders are now open to multinational pharmaceutical companies. This raises concerns regarding the effects this will have on natural medicine.

Work transformation following the implementation of an ERP system

Purpose The purpose of this study is to introduce the Human Resources (HR) module of the SAP suite in the Italian branch of a leading multinational pharmaceutical company. This study can be re-conducted within the interpretive tradition of information technology studies focusing on the attempt to understand and describe how software users in the HR department interpreted the enterprise resource planning (ERP) technology, how they changed their work practices and the changes that occurred in organizational discourses and meanings alongside the process. Design/methodology/approach The case study/intervention took start with the impulse of the Italian HR department manager, who was struck by the way that the ERP system technology implementation was affecting work life of the employees in the department. This research/intervention used interviews, focus groups and internal documents as sources of data. The authors conducted and analyzed 20 narrative interviews and 3 focus groups with middle managers, and they analyzed about 120 pages of internal memos. Findings The implementation of ERP systems is almost invariably accompanied by great expectations of increased process rationalization, efficiency and cost-effectiveness, and upper managers’ discourses make large use of what Engeström et al., 2010 have called process efficiency rhetoric. But the ERP technology, most likely, will neither revolutionize management nor will it become a “complete calculation machine” that runs an entire work organization (Quattrone and Hopper, 2005, p. 731). Originality/value The implementation of the ERP system has caused conflicts and disturbances, aggravating contradictions that already existed between activity systems and introducing new types of contradictions. Pre-existent contradictions become clearer; there is a stronger interconnection between activity systems. The individual agents could experiment an expansion in their activities if only they will initiate a movement of expansive learning and if they are not prevented from doing so by coercive control. The natural expansion of the subjects’ scope of activity and horizons of possibilities could be sustained by the ERP technology if it is not used as a tool for domination and if the upper management does not try and separate what cannot in actuality be separated: The actors’ capabilities of improvised learning, which makes the institution of a new mode of the activity possible, and their capacity to assume collective control of the meaning and direction of the transformation of the activity. ERPs are technologies that can naturally bring transformations in the activity system and networks where they are introduced, but in some cases, they can easily and in a non reflective manner be intended as tools for oppression by the upper management.

Drugs for cardiovascular disease in India: perspectives of pharmaceutical executives and government officials on access and development-a qualitative analysis.

BackgroundIndia shoulders the greatest global burden of cardiovascular diseases (CVDs), which are the leading cause of mortality worldwide. Drugs are the bedrock of treatment and prevention of CVD. India’s pharmaceutical industry is the third largest, by volume, globally, but access to CVD drugs in India is poor. There is a lack of qualitative data from government and pharmaceutical sectors regarding CVD drug development and access in India.MethodsBy purposive sampling, we recruited either Indian government officials, or pharmaceutical company executives. We conducted a stakeholder analysis via semi-structured, face-to-face interviews in India. Topic guides allow for the exploration of key issues across multiple interviews, along with affording the interviewer the flexibility to examine matters arising from the discussions themselves. After transcription, interviews underwent inductive thematic analysis.ResultsTen participants were interviewed (Government Officials: n = 5, and Pharmaceutical Executives: n = 5). Two themes emerged: i) ‘Policy-derived Factors’; ii) ‘Patient- derived Factors’ with three findings. First, both government and pharmaceutical participants felt that the focus of Indian pharma is shifting to more complex, high-quality generics and to new drug development, but production of generic drugs rather than new molecular entities will remain a major activity. Second, current trial regulations in India may restrict India’s potential role in the future development of CVD drugs. Third, it is likely that the Indian government will tighten its intellectual property regime in future, with potentially far-reaching implications on CVD drug development and access.ConclusionsOur stakeholder analysis provides some support for present patent regulations, whilst suggesting areas for further research in order to inform future policy decisions regarding CVD drug development and availability. Whilst interviewees suggested government policy plays an important role in shaping the industry, a significant force for change was ascribed to patient-derived factors. This suggests a potential role for Indian initiatives that market the unique advantages of its patient population for drug research in influencing national and multinational pharmaceutical companies to undertake CVD drug development in India, rather than simply IP policy-directed factors.Electronic supplementary materialThe online version of this article (doi:10.1186/s40545-016-0065-7) contains supplementary material, which is available to authorized users.

Implications of Novartis v Union of India on Pharmaceutical Trade

Novartis spent nearly 15 years seeking a patent in India for Glivec. That quest reached its dead end, at last, on April 1st. India’s Supreme Court rejected the Swiss drugmaker’s patent. It represents critical issues related to intellectual property protection and access to medicines, which will impact how multinational pharmaceutical companies conduct pharmaceutical trade in India in the future, as well as India’s role as the “Pharmacy of the Developing World”. India’s verdict is likely to serve as a model for other developing countries in terms of how they choose to interpret their obligations pursuant to the TRIPS Agreement.

Current Scenario of Global and Indian Pharmaceutical Marketing and Management

The world pharmaceutical industry has been changing profoundly in the last decade. Intensive globalization, increased competitiveness and the fight for global market shares create new challenges for pharmaceutical companies. Fast globalization definitively reinforces the consolidation of the world Pharmaceutical industry. The current shift in the marketing strategy is work by multinational Pharmaceutical Companies. It is now High-end development that is being carried out by leading companies. And, increasingly, other companies are finding themselves competing against, or working with, new innovation-based companies. My study focuses on objectives, importance, levels, theories, functions and types of pharmaceutical management and also pharmaceutical marketing, difference between general marketing and pharmaceutical marketing. Also study the overlook on Global Pharma Industry and Indian Pharma Industry. In this study the top 50 companies in 2009 and 2014 year are listed out. Also OTC segments and Pharmaceutical Policy are included in this article.

Orphan drug development in China - Turning challenges into opportunities.

Of over 7,000 known rare diseases, only 5% currently have an available treatment option worldwide. Moreover, the vast majority of rare disease patients in China have no access to treatment due to limited availability and the lack of appropriate infrastructure in China's healthcare system. Despite increased interest in orphan drug development, drug companies in China with active programs on drugs to treat rare diseases are still limited. Hence, there is a huge unmet need in China, with over 10 million patients suffering from rare diseases. Nonetheless, this has created unprecedented opportunities for the Chinese drug development market. Life science innovation in China has recently received a healthy boost from the 13th National Five-Year Plan and from on-going reform of the China Food and Drug Administration (CFDA). Rare diseases are now recognized as a national priority with increasing governmental support, creating tremendous opportunities for both domestic and multinational drug companies. China is anticipated to play an increasingly important role in the global fight against rare diseases. To ensure future success, Chinese drug companies should leverage the valuable knowledge assembled over the past three decades by Western countries in the area of orphan drug development.

Transplanting International Courts: The Law and Politics of the Andean Tribunal of Justice

The Andean Tribunal of Justice (ATJ) is the third most active international court and the oldest and most successful of eleven transplanted copies of the European Court of Justice (ECJ). Drawing on over a decade of interviews, archival research, and case coding, Transplanting International Courts examines the ATJ’s creation, doctrinal development, and contributions to the law and politics of the Andean Community. Alter and Helfer evaluate the ATJ in a wider perspective, seeking to understand how transplanted supranational institutions operate in practice and the strategies that international judges deploy to navigate turbulent political environments, especially in developing country contexts.Transplanting International Courts begins by analyzing how the European judicial model shaped the ATJ’s original design and foundational legal doctrines. But the ATJ has since charted its own path, most strikingly in the area of intellectual property (IP). The ATJ has built deep and mutually supportive relationships with domestic IP administrative agencies that have allowed it to confront governments pressured by the U.S. and by multinational drug companies to abandon limits on IP that promote public health and protect consumers. Outside of this IP island, the ATJ is less legally and politically influential. The tepid support of national judges and the lack of jurist advocacy movements prevent the tribunal from graining greater legal and political traction.This pattern has continued even as Andean Community has faltered. Riven by ideological divisions among the member states, in some respects the regional integration project has moved backward over the last decade. Even in this fraught political climate, the IP island is flourishing and the Andean legal system continues to confront state noncompliance. As they explore multiple aspects of the Andean legal system, Alter and Helfer’s interdisciplinary analysis elucidates the many factors that contribute to and limit the effectiveness of all international courts.This working paper includes the table of contents and introductory chapter of the book.

Medicines development and regulation in Africa

Africa is one of the world’s fastest-growing economic regions, with a rise in its pharmaceutical industry value from $4.7 billion in 2003 to $20.8 billion in 2013. Multinational pharmaceutical companies are becoming more active in drug production and clinical trials across Africa, and there is an increase in the number of local companies engaged in medicines development and marketing. Such expansion of the local pharmaceutical industry requires trained pharmaceutical specialists to support it. The current situation and future requirements for local medicines development, regulation, education and training needs are discussed.

Processamento linguístico-computacional de pacotes lexicais: um estudo de corpus na área de Regulamentação Farmacêutica

Este trabalho tem por objetivo demonstrar um aplicativo computacional desenvolvido para a extracao de pacotes lexicais de tres palavras e apresentar por meio deste as unidades lexicais recorrentes entre documentos de especialidade. O metodo quantitativo aplicado, em principio, explora um tipo de texto produzido pelas industrias do setor farmaceutico, o qual esta diretamente relacionado a assuntos regulatorios no âmbito das agencias internacionais de vigilância sanitaria. No entanto, os procedimentos de analise podem ser adotados para investigar outros aspectos linguisticos dentre a variedade de generos e tipos textuais, como tambem possibilita a identificacao de termos. O estudo tem como principal enfoque a frequencia de ocorrencia dos padroes lexicais em corpus autentico da lingua em uso por meio de ferramentas linguistico-computacionais, em particular nas pesquisas voltadas ao estudo da linguagem em contextos empresariais, e busca multiplicar os trabalhos de Douglas Biber com base na combinacao de palavras recorrentes em corpora especificos. O referencial teorico- -metodologico baseia-se na Linguistica de Corpus, que e capaz de dialogar, especificamente, com a Linguistica Computacional e oferecer meios para o desenvolvimento do aplicativo e ao processamento dos pacotes lexicais. O corpus coletado reune quinze exemplares do documento escrito na lingua inglesa, totalizando cerca de 110 mil palavras, cuja delimitacao contempla diferentes localidades do mundo, envolvendo varios autores. Os resultados desvelam a possibilidade de investigacao nas divisoes internas dos textos mediante o cruzamento entre documentos de uma mesma especialidade.Palavras-chave: pacotes lexicais, corpus de especialidade, ferramenta linguistico-computacional.

Yusuf Hamied: leader in the Indian generic drug industry

Yusuf Hamied: leader in the Indian generic drug industry

A Longitudinal Investigation of Person–Organization Fit, Person–Job Fit, and Contextual Performance: The Mediating Role of Psychological Ownership

In this study we present new insights into the relationships surrounding employees’ feelings of psychological ownership (PO) at work and the resulting effects on contextual performance. Characterized by a feeling of possession, PO has been theorized to have positive influences on the attitudes and behaviors of employees. To explore PO’s effects, we conducted a three-stage questionnaire survey of employees and their supervisors at a multinational pharmaceutical company in Taiwan. To help attenuate the errors associated with common method variance that trouble most studies using simultaneous data, a longitudinal approach was taken to investigate the relationships between person–organization fit, person–job fit, and PO. During the first stage of data collection, 330 questionnaires were sent to employees, and 168 (51%) valid questionnaires were returned. During the second stage, questionnaires were sent to the 168 employees who had responded to the first-stage survey. There were 134 (80%) valid questionnaires returned. Finally, during the third stage, questionnaires were sent to the supervisors of all 134 employees who had responded to the second-stage survey. There were 88 (66%) valid questionnaires returned. Findings reveal that person–job fit was significantly related to PO, and PO was significantly related to contextual performance. However, contrary to predictions, person–organization fit was positively, but not significantly, related to PO. We conclude by discussing the implications of these findings for both academics and practitioners and make suggestions for future research.

REFORMATION OF THE STRUCTURE INTERNATIONAL HEALTH LAW IN ORDER TO IMPROVE THE TRANSBOUNDARY INFECTIOUS DISEASES MANAGEMENT

The structure of international health law is currently composed under the philosofical basis of segregate and dichotomous international community. This structure affects the handling and management of TID, which is currently much harm the interests of developing countries as the emerging of multinational pharmaceutical companies. This study aimed to understand and analyse the existing system and structure of international health law (lex lata) to be used as a basis in an effort to design an ideal structure of international health law system.Keywords:international health, reform, structure of law.Key words: International health, reformation, legal structure.

Partial Publics

This essay examines how the publics of public health and those of public domain are reshaping one another in efforts to commercialize and manage modern traditional medicine in Tanzanian universities, government laboratories, nongovernmental clinics, and ministry offices. I argue that struggles over the practices that constitute the public to which contemporary traditional medicine will appeal are also struggles over who is obliged to respond to pain and debility, to mediate the consequences of misfortune, and to take responsibility for the inequalities that shape health and well-being. Postindependence and socialist dreams had cast traditional medicine as the basis of an indigenous pharmaceutical industry and promised freedom from multinational pharmaceutical companies and global capitalism more broadly. By generating new publics, current scientific efforts to exploit the therapeutic and commercial value of therapeutic plants are experimenting with political and social philosophies, with biological efficacy, and with new forms of wealth and property. The uneven, contradictory, and partial projections of the public at play in these efforts are raising thorny questions about the forms of sovereignty that are possible within the neoliberal restructuring.