EU Market Access Teams: New Instruments to Tackle Non-tariff Barriers to Trade. College of Europe EU Diplomacy Paper 2009/9, December 2009

In reaction to modern protectionism, the European Union has reshaped its trade policy based on the principles of partnership and prioritisation. With the Market Access Partnership it has formalised a new diplomatic trade tool in third countries: the Market Access Teams. These teams are networks with multiple stakeholders and they are acting in a decentralised manner in the respective host countries. The various Market Access Teams created worldwide since 2007 underline the growing interest from the EU, Member States and businesses in offensive trade policy instruments. These instruments should be directed at opening foreign markets and eliminating obstacles to trade for European exporters. This paper analyses under what conditions Market Access Teams can effectively remove non-tariff barriers to trade (NTBs) for European exports in third countries. It focuses on non-tariff barriers for the European pharmaceutical industry in three Asian countries (Philippines, Indonesia and Japan). Pharmaceutical products are truly global products which are easy to transport and confronted by global competition and they heavily rely on European intellectual property rights knowledge. I argue that Market Access Teams in their composition and function are an adequate translation of the Commission’s strategic ambition to deliver more tangible results for European exporters through offensive trade policy. A Market Access Team is likely to be more successful, the greater the cohesiveness of its members, the more salient a non-tariff barrier to trade for the European Commission and the less salient that NTB in the host country. The study draws on trade literature, news sources, questionnaires and interviews

Proposed best practice for projects that involve modelling and simulation

Modelling and simulation has been used in many ways when developing new treatments. To be useful and credible, it is generally agreed that modelling and simulation should be undertaken according to some kind of best practice. A number of authors have suggested elements required for best practice in modelling and simulation. Elements that have been suggested include the pre-specification of goals, assumptions, methods, and outputs. However, a project that involves modelling and simulation could be simple or complex and could be of relatively low or high importance to the project. It has been argued that the level of detail and the strictness of pre-specification should be allowed to vary, depending on the complexity and importance of the project. This best practice document does not prescribe how to develop a statistical model. Rather, it describes the elements required for the specification of a project and requires that the practitioner justify in the specification the omission of any of the elements and, in addition, justify the level of detail provided about each element. This document is an initiative of the Special Interest Group for modelling and simulation. The Special Interest Group for modelling and simulation is a body open to members of Statisticians in the Pharmaceutical Industry and the European Federation of Statisticians in the Pharmaceutical Industry. Examples of a very detailed specification and a less detailed specification are included as appendices

European Pharmaceutical Price Regulation, Firm Profitability, and R&D Spending

EU countries closely regulate pharmaceutical prices whereas the U.S. does not. This paper shows how price constraints affect the profitability, stock returns, and R&D spending of EU and U.S. firms. Compared to EU firms, U.S. firms are more profitable, earn higher stock returns, and spend more on research and development (R&D). Some differences have increased over time. In 1986, EU pharmaceutical R&D exceeded U.S. R&D by about 24 percent, but by 2004, EU R&D trailed U.S. R&D by about 15 percent. During these 19 years, U.S. R&D spending grew at a real annual compound rate of 8.8 percent, while EU R&D spending grew at a real 5.4 percent rate. Results show that EU consumers enjoyed much lower pharmaceutical price inflation, however, at a cost of 46 fewer new medicines introduced by EU firms and 1680 fewer EU research jobs.

Development and characterization of a new human hepatic cell line

The increasing demand and hampered use of primary human hepatocytes for research purposes have urged scientists to search for alternative cell sources, such as immortalized hepatic cell lines. The aim of this study was to develop a human hepatic cell line using the combined overexpression of TERT and the cell cycle regulators cyclin D1 and mutant isoform CDK4R24C. Following transduction of adult human primary hepatocytes with the selected immortalization genes, cell growth was triggered and a cell line was established. When cultured under appropriate conditions, the cell line expressed several hepatocytic markers and liver-enriched transcription factors at the transcriptional and/or translational level, secreted liver-specific proteins and showed glycogen deposition. These results suggest that the immortalization strategy applied to primary human hepatocytes could generate a novel hepatic cell line that seems to retain some key hepatic characteristics

A rodent model of HIV protease inhibitor indinavir induced peripheral neuropathy

The research leading to these results is part of the EUROPAIN Collaboration, which has received support from the Innovative Medicines Initiative Joint Undertaking, under grant agreement no 115007, resources of which are composed of financial contribution from the European Union's Seventh Framework Program (FP7/2007‐2013) and EFPIA companies’ in kind contribution. We thank Pfizer for providing indinavir and gabapentin. MC received Conicyt grant (Folio 82130016),to complete this work.Peer reviewedPostprin

Development and characterization of a new human hepatic cell line

The increasing demand and hampered use of primary human hepatocytes for research purposes have urged scientists to search for alternative cell sources, such as immortalized hepatic cell lines. The aim of this study was to develop a human hepatic cell line using the combined overexpression of TERT and the cell cycle regulators cyclin D1 and mutant isoform CDK4R24C. Following transduction of adult human primary hepatocytes with the selected immortalization genes, cell growth was triggered and a cell line was established. When cultured under appropriate conditions, the cell line expressed several hepatocytic markers and liver-enriched transcription factors at the transcriptional and/or translational level, secreted liver-specific proteins and showed glycogen deposition. These results suggest that the immortalization strategy applied to primary human hepatocytes could generate a novel hepatic cell line that seems to retain some key hepatic characteristics

Globalisation and Its Impact on Competitiveness: the Case of the British and German Pharmaceutical Industry

This paper assesses the degree of financial and economic globalisation of British and German pharmaceutical companies during 1990 and 2001 and explores the changing balance between globalisation and national embeddedness. It tries to explain both the much lower degree of globalisation of German as compared to British companies in 1990, as well as their catching up at the beginning of the 21st century. The paper suggests that the lesser degree of globalisation of German firms during most of the 1990s partly explains their slide in competitiveness during this period. The conclusion examines prospects for the future of firms in both economies. The paper draws on detailed industry data, as well as case studies of the major firms in the two national industries.globalisation, pharmaceutical industry, performance, British-German comparison

Diagnostic and prognostic factors in patients with prostate cancer : a systematic review

Funding PIONEER is funded through the IMI2 Joint Undertaking and is listed under Grant Agreement No. 777492 and is part of the Big Data for Better Outcomes Programme (BD4BO). IMI2 receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The views communicated within are those of PIONEER. Neither the IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein.Peer reviewedPublisher PD

Clinical Characterization of Patients Diagnosed with Prostate Cancer and Undergoing Conservative Management : a PIONEER Analysis Based on Big Data

Funding statement PIONEER is funded through the IMI2 Joint Undertaking and is listed under grant agreement No. 777492. This joint undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations EFPIA. The European Health Data & Evidence Network has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement no. 806968. The Joint Undertaking is supported by the European Union’s Horizon 2020 research and innovation programme and EFPIA, a large association which represents the biopharmaceutical industry in Europe. The views communicated within are those of PIONEER. Neither the IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained hereinPeer reviewe

A cross-sectional analysis of pharmaceutical industry-funded events for health professionals in Australia

Objectives: To analyse patterns and characteristics of pharmaceutical industry sponsorship of events for Australian health professionals and to understand the implications of recent changes in transparency provisions that no longer require reporting of payments for food and beverages. Design: Cross-sectional analysis. Participants and setting: 301 publicly available company transparency reports downloaded from the website of Medicines Australia, the pharmaceutical industry trade association, covering the period from October 2011 to September 2015. Results: Forty-two companies sponsored 116 845 events for health professionals, on average 608 per week with 30 attendees per event. Events typically included a broad range of health professionals: 82.0% included medical doctors, including specialists and primary care doctors, and 38.3% trainees. Oncology, surgery and endocrinology were the most frequent clinical areas of focus. Most events (64.2%) were held in a clinical setting. The median cost per event was $A263 (IQR$A153–1195) and over 90% included food and beverages. Conclusions: Over this 4-year period, industry-sponsored events were widespread and pharmaceutical companies maintained a high frequency of contact with health professionals. Most events were held in clinical settings, suggesting a pervasive commercial presence in everyday clinical practice. Food and beverages, known to be associated with changes to prescribing practice, were almost always provided. New Australian transparency provisions explicitly exclude meals from the reporting requirements; thus, a large proportion of potentially influential payments from pharmaceutical companies to health professionals will disappear from public view