Pharmaceutical Industry In Europe Research Articles

Approaching the history of an Egyptian biomedicine

AbstractThis piece explores the history of medicine in Egypt, the roots of an Egyptian practice of biomedicine in particular, through its historiography. In the period after World War II, the term “biomedicine” came to describe a practice of medicine defined by the close relations among clinicians, biological laboratory research, and the pharmaceutical industry in Europe and the United States. The history of medicine in Egypt and other parts of the Middle East and North Africa has long possessed close links to that in regions of Europe. In Egypt too, biomedicine has deep historical roots shaped by the influence of the nineteenth‐century Ottoman‐Egyptian state, the experience of colonialism, and the anti‐colonial objectives of the post‐colonial Egyptian state in the second half of the twentieth century. These influences were particularly important in relation to the treatment of schistosomiasis, one of Egypt's top‐ranking health problems of the twentieth century. The history of schistosomiasis demonstrates the gaps in the historiography of medicine in modern Egypt as well as how we might begin to consider the emergence of biomedical knowledge and theory at sites in Global South.

FutureTox: Building the Road for 21st Century Toxicology and Risk Assessment Practices

This article reports on the outcome of FutureTox, a Society of Toxicology (SOT) Contemporary Concepts in Toxicology (CCT) workshop, whose goal was to address the challenges and opportunities associated with implementing 21st century technologies for toxicity testing, hazard identification, and risk assessment. One goal of the workshop was to facilitate an interactive multisector and discipline dialog. To this end, workshop invitees and participants included stakeholders from governmental and regulatory agencies, research institutes, academia, and the chemical and pharmaceutical industry in Europe and the United States. The workshop agenda was constructed to collectively review and discuss the state-of-the-science in these fields, better define the problems and challenges, outline their collective goals for the future, and identify areas of common agreement key to advancing these technologies into practice.

Pharmaceutical Public-Private Partnerships in the United States and Europe: Moving from the Bench to the Bedside

Both to address unmet medical needs and to improve industry competitiveness, regulators in both the United States and the European Union have taken bold steps to translate academic research from the university lab to the patient. A pharmaceutical public-private partnership (PPPP), which is a legally binding contract between a private pharmaceutical enterprise and a public research university (or a private university doing research funded with public funds), can be a significant tool to ensure a more efficient payoff in the highly regulated world of pharmaceuticals. In particular, a properly framed binding contract, coupled with respect for positive social norms, can move the parties away from an inefficient prisoners’ dilemma Nash Equilibrium to the Pareto Optimal Frontier. When coupled with appropriate attention to the difficult task of coordinating the actions of interdependent actors, a PPPP arrangement can enhance the likelihood of successful commercialization by flipping the parties’ incentives as compared with more traditional contracts. Because PPPPs are less common in Europe than in the United States, a key purpose of this article is to provide an annotated roadmap that universities, private firms, and EU policy makers can use to create efficient PPPPs to enhance for-profit innovation in the pharmaceutical industry in Europe. A secondary purpose is to suggest amendments to the U.S. laws governing the patenting of government-funded technology to prevent undue burdens on the sharing of certain upstream medical discoveries and research tools. Our analysis is not only comparative; it also combines, we believe for the first time, a game theory and law and management approach to for-profit PPPPs.

From Javanese Coca to Java Coca: An Exemplary Product of Dutch Colonial Agro-Industrialism, 1880-1920

In 1875 the Botanical Garden of Buitenzorg introduced two coca plants on the island of Java, which was then part of the Netherlands East Indies. Within a thirty-year period, starting in 1892, Java succeeded in becoming the world's leading exporter of coca leaves, surpassing the traditional coca producers in Peru and Bolivia. How and why did this occur? We argue that the story of the transformation of Javanese coca into "Java coca" as part of a "branding" process is closely linked to the rise of the ethical pharmaceutical industry in Europe and a laboratory revolution in botany, chemistry, and pharmacy. The story is also one of transnational circulation of experts, expertise, and the coca plants and leaves that traveled among South America, Europe, and Southeast Asia. Furthermore, this case study illustrates the nineteenth-century transition from colonial botany and "green imperialism" to what we conceptualize as "colonial agro-industrialism."

Challenges Faced in the Integration of Pharmacogenetics/Genomics into Drug Development

Pharmacogenetics and pharmacogenomics are rapidly developing areas of research, with potentially enormous clinical implications and an increasing number of requests for inclusion of pharmacogenetic discoveries in drug labels. While academic centers have been central to the development of research in this area, the need for collaboration amongst academia, industry and regulators is important in order to proceed with high quality and utmost speed. As a number of issues need to be addressed jointly by the different parties, the Group for the Respect of Ethics and Excellence in Science, a not-for-profit organization that constitutes an interface between regulators, academic scientists and representative of the pharmaceutical industry in Europe, organized a meeting to discuss the use of pharmacogenetics/genomics in drug development. The areas for discussion amongst the participants included design of pharmacogenetic studies, regulatory requirements in the European Union, pharmacokinetic and pharmacodynamic aspects with a proposal on future prospects for recognition of pharmacogenetic biomarkers in Europe. A common principle agreed by the group was that there was a need to discover much earlier areas that would have an impact on the safety or efficacy of a new drug. Future guidelines should offer guidance using different scenarios with the common goal of improving the process of drug development.

Excellence in education and training advances competitiveness of the pharmaceutical industry in Europe

This commentatory should be read in connection with the subsequent article about current trends in the evolvement of the pharmaceutical industries. It points to importance for the industries to have access to pharmaceutical sciences researchers educated and trained at the highest level through the newly established public–private system of courses in Europe supported by EU.

Patents and the UK pharmaceutical industry between 1945 and the 1970s

The years following the end of World War II saw a rapid increase in the rate of the introduction of new products by the pharmaceutical industry in Europe and North America. Patenting played an increasingly significant role in the industry and the companies, which were investing heavily in research, needed to develop strategies of appropriation to ensure that they recouped the rewards of innovation. This paper explores the use of patents by UK companies during the therapeutic revolution and beyond. It suggests that within a framework of competition, the use of patents and the practice of licensing, combined with the growing complexity of products led to the creation of networks of cross‐licensing, often linked to a variety of collaborative arrangements. In this process, the companies created corporate capabilities which contributed to their growth and international development within the period covered by the paper. By the 1960s, however, the nature of licensing had changed but some collaborative arrangements and the capabilities they created continued to play a significant role in the further international development of the industry. From the late 1970s, as new drugs became more elusive and expensive, as well taking much longer to get into the market, patents for the much sought after ‘blockbuster’ drugs were eagerly pursued. Patents, licensing and various forms of collaboration assumed a new significance in the approaches made by the pharmaceutical corporations to the innovative discoveries of the biotechnology industry in the last two decades of the century.

Location Choices of the Pharmaceutical Industry in Europe after 1992

Differences in regulations, technical standards and national medical cultures across EU member states created a highly segmented pharmaceutical market in Europe prior to the implementation of the Single Market Programme. The subsequent reduction in non-tariff barriers to trade would be expected to have an impact on where pharmaceutical multinationals locate production within the EU. Using discrete choice models, we study separately the determinants of multinational location choices in terms of expanded production at existing facilities and location of start-up firms. Our results support the findings of models which predict reduced rather than increased agglomeration in the face of trade-cost reductions.

Optimising the design of preliminary toxicity studies for pharmaceutical safety testing in the dog

A working party, comprising two animal welfare organisations and some 12 pharmaceutical companies in Europe, was established to minimise the use of the dog in safety testing. As first step, the participants defined the major objectives of preliminary dose-range finding/MTD toxicity studies in non-rodents, defined the principles and requirements for this study type and agreed on a proposal for an optimised study design, based on collective experience of conducting such studies in industry, involving an evaluation of 100 individual study data sets. The suggested study design is explained and described, and reflects current best practice in the pharmaceutical industry in Europe. The implementation of such an optimised design is believed to result in a reduction in the overall numbers of animals used for this purpose, without jeopardising the scientific rationale and usefulness of the studies for informing the conduct of later regulatory studies.

Pharmacoeconomics for the Pharmaceutical Industry in Europe

The role of pharmacoeconomics has evolved as a consequence of cost-containment pressures from the pharmaceutical industries’ ‘external environment’. This paper reviews the published literature on the role of pharmacoeconomics in the pharmaceutical industry and gives a historical background and state-of-the-art picture on the function and importance of pharmacoeconomics for the different stakeholders and decision makers in the healthcare area, with a special focus on the pharmaceutical industry in Europe. Pharmacoeconomics is analysed as a part of decision processes at several stages of drug development and drug marketing. The review focuses on the practices of the application of pharmacoeconomics in various countries in Europe, and the drivers for the development of pharmacoeconomics within pharmaceutical companies are described. Investments made by companies with respect to the pharmacoeconomic function in terms of personnel and budget are derived. It is expected that within Europe, the pharmacoeconomic function will continue to grow in importance in the pharmaceutical industry in the coming years and will have at least a moderate commercial impact on pharmaceutical manufacturers through the pricing and reimbursement mechanism.

Pharmacoeconomics for the Pharmaceutical Industry in Europe

The role of pharmacoeconomics has evolved as a consequence of cost-containment pressures from the pharmaceutical industries’ ‘external environment’. This paper reviews the published literature on the role of pharmacoeconomics in the pharmaceutical industry and gives a historical background and state-of-the-art picture on the function and importance of pharmacoeconomics for the different stakeholders and decision makers in the healthcare area, with a special focus on the pharmaceutical industry in Europe.

The Need for a Control Animal Pathology Database: An International Survey

1. The sensitivity of long-term toxicity tests is impaired due to the 'background noise' of spontaneous lesions which are unrelated to treatment. 2. The need for a comprehensive source of computerized information concerning the occurrence and incidence of spontaneous lesions in control animals has been highlighted by initiatives in Europe and the USA. It is, however, essential to identify the potential users, and the type of information required for such a database to be of value. 3. This information has been acquired following an international survey of the pharmaceutical industry in Europe, Japan and the USA, including responses from 48 toxicologists and toxicopathologists representing 38 company groups. 4. Thirty-eight respondents indicated that they would use a historical control database that was regularly updated with the majority of respondents suggesting that they currently use external sources (Breeder's data, the literature, other companies) occasionally to acquire information on control animal pathology data. 5. The majority (94%) of the respondents indicated that a control animal database should contain information on both neoplastic and non-neoplastic lesions for use in evaluating long-term studies, in particular carcinogenicity studies. 6. The survey confirms the need for a historical control animal pathology database wider then those currently available.