"Regulating Healthcare Technologies and Medical Supplies: A Comparative Overview"

A complex relationship exists among EU regulations, current national practices and rules, institutional capacities to implement regulatory adjustments and the legacy of past health and regulatory policy and traditions. However, there is little empirical information on medical devices policy, the medical devices industry, and the assurance of medical device safety and usage. Drawing on a review of the secondary literature and on-going field work, the evidence suggests that the current mix of statecentric and self-regulatory traditions will be as important in determining the implementation and final outcomes of EU-rules as the new rules themselves. EU directives redesign rules, but they do not necessarily lead to institutional change, create institutional capacities, or alter old practices in the short term. Neither EU directives nor national regulatory adjustments determine the "man-machine/skill-experience" interface which is shaped and influenced by local medical traditions and the acceptance of these traditions by local publics

After Heparin: Protecting Consumers From the Risks of Substandard and Counterfeit Drugs

Based on case studies, examines globalization and quality management trends in pharmaceutical manufacturing, barriers to Federal Drug Administration oversight, and the security of pharmaceutical distribution. Makes policy recommendations to ensure safety

The Role of the Health Care Sector in Expanding Economic Opportunity

This report provides an overview and critical assessment of the ways in which multinational pharmaceutical companies currently participate in expanding economic opportunities in developing countries. As pharmaceutical companies become more involved in both business and philanthropic activities in developing countries, it will be important for each company to identify the best strategies available to it to create new economic opportunities and to leverage the benefits of activities already underway. While the primary focus of the industry is, and will most likely continue to be, on increasing access to health care, the potential for expanding economic opportunities through its activities should not be overlooked as a significant outcome. The analysis and case studies contained in the report highlight companies' contributions to economic opportunity expansion through job creation, training and capacity building, and shaping public policy. The report also offers recommendations for future work to increase economic opportunities. This paper is part of the Economic Opportunity Series published by the CSR Initiative at Harvard University Kennedy School

Supply Chain Management in a Highly Regulated Environment – a Case Study of Supplier GMP-Compliance Management in the Pharmaceutical Industry

The purpose if thus study is to explore the impacts of high authority regulation and enforcement to supply chain management practices. As one of the most regulated industries, the pharmaceutical industry was chosen as the research context. More specifically, this study concentrates on the pro-cess of managing supplier’s compliance to guidelines imposed by the European Commission, com-monly called as the Good Manufacturing Practice (GMP). The research context provides a prominent ground for researching the main effects of rigorous authority supervision that may have significant impacts to both business and society. Theoretical part of this study concentrates on the relevant literature on supply chain management, supplier management, supply chain risk management and supply chain sustainability management. This literature review serves as a theoretical framework to understand what are prevalent, or normal, processes and assumptions in these different practices. This understanding is important for identify-ing the anomalies brought by high authority regulation and enforcement. The research was conducted by interviewing informants from six different pharmaceutical compa-nies on their personal perceptions and company’s processes. All the informants had a major role in their company’s supplier GMP-compliance process, thus having significant internal knowledge. A general framework on the supplier GMP-compliance management process is proposed based on the findings. I conclude that rigorous authority regulation and enforcement has several major impacts on how companies manage their suppliers, including disintegration of sub-processes, creation of depart-mental silos and shifting focus towards compliance itself rather than efficiency or rationality of the process. Furthermore, regulations limit risk management options that companies can exercise, which can lead to severe supply chain disruptions. Finally, through authority enforcement and certi-fication programs, there is an unintentional shift of responsibility from industry towards the authorities. Contributions of this study reach beyond expanding theory – the balance between industrial inter-nal self-control and need of regulatory interference and supervision is in headlines now perhaps more than ever before, not least because of the rise of sustainability initiatives. While adding regula-tion may at first seem as straight-forward approach, it has implications that are critical to recognize before imposing new requirements

The Dark Side of Transfer Pricing: Its Role in Tax Avoidance and Wealth Retentiveness

In conventional accounting literature, ?transfer pricing? is portrayed as a technique for optimal allocation of costs and revenues amongst divisions, subsidiaries and joint ventures within a group of related entities. Such representations of transfer pricing simultaneously acknowledge and occlude how it is deeply implicated in processes of wealth retentiveness that enable companies to avoid taxes and facilitate the flight of capital. A purely technical conception of transfer pricing calculations abstracts them from the politico-economic contexts of their development and use. The context is the modern corporation in an era of globalized trade and its relationship to state tax authorities, shareholders and other possible stakeholders. Transfer pricing practices are responsive to opportunities for determining values in ways that are consequential for enhancing private gains, and thereby contributing to relative social impoverishment, by avoiding the payment of public taxes. Evidence is provided by examining some of the transfer prices practices used by corporations to avoid taxes in developing and developed economies

Geo-cultural influences and critical factors in inter-firm collaboration

Inter-firm collaboration and other forms of inter-organisational activity are increasingly the means by which technological innovation occurs. This paper draws on evidence from two studies of the same set of firms to examine the conduct of collaborations over time across different contexts. The purpose is to examine the critical factors associated with successful collaboration and explore the importance of the geo-cultural context in understanding the conduct of inter-firm collaboration. The conceptual framework draws on two main sources: - Storper’s concept of ‘conventions’ of identity and participation and Lorenz’s classification of different types of knowledge. These are used to indicate the kinds and sources of adjustments required for successful collaboration

Emergence of the Biosimilar Sector and Opportunities of Developing Country Suppliers

As biologic products begin to come off-patent, a market is emerging for biosimilars (also known as biogenerics or follow-on biologics). Firms from emerging countries such as India and China have dominated the production of active ingredients in pharmaceutical industries all over the world and are now developing capabilities in biosimilar production. This emergence of a new market dynamic is disruptive to current key players as it has potential challenge their current dominant hold over the market, while for firms from developing countries it creates a sea of opportunities. This rise of biosimilars and capabilities for cheap production in developing country firms has potential to transform patient care in developing countries as well as advanced countries. This paper reviews study data collected at Innogen and the most recent literature to understand how the sector for biosimilars is evolving and the opportunities and challenges faced by emerging suppliers. The aim of the paper is to identify the gaps in the current literature and opportunities for further study in this area

Role of Quality Management in Pharmaceutical Development: Evidence from Islamabad and Lahore

The aim of this paper is to investigate the employee’s perceptions of the impact, of Total Quality Management (TQM), on their roles within the organization and how they perceived the effectiveness of the quality processes in Pakistan Pharmaceutical industry. The universe of this study was the employees of Pharmaceutical industry in Islamabad and Lahore. For this purpose survey method was used by using questionnaire as a tool for data collection. The results have shown that Employee Training and Development, Employee Performance, Quality Process and Team Work are significant factors with the Total Quality Management and correlated with each others. The result shows the application of TQM principles addresses some of the key challenges facing the organization. The study was faced by certain limitations and included time constraints and resources constraints which limited this research to only Islamabad and Lahore offices, of the Pharmaceutical companies. The present study found support that pharmaceutical companies faced the same difficulties with TQM implementations as experienced in other industries. These include achieving a culture of continuous improvement, overcoming a lack of trust and understanding the TQM process itself, and what they were, as a company, trying to achieve. These problems are not new and many companies have difficulties in implementing TQM. Pharmaceutical companies also followed the path of achieving a quality certification; namely, ISO 9000 accreditation, in the pursuit of excellence.Quality Management; pharmaceutical Development; Pakistan; Employee’s Perceptions