STRATEGIES AND SOCIAL SYSTEMS:
THE RE-ORGANISATION OF THE EUROPEAN MEDICINES DEVELOPMENT PROCESS

The European R&D in life sciences is considered fragmented, because institutions, organisations and individuals still operate regionally or nationally. Benefits are difficult to distribute and measure, because the health care systems across Europe differ significantly. What strategy is possible in such a situation and how can it be formulated? At the intersection of political, economic, administrative and social systems, strategic action seems to be a multidimensional process of overlapping, dynamic and changing interests. Given the unpredictability and frailty of this situation, how can strategy be consciously formulated, and through what mechanisms can it be implemented? How do institutions and organisation exercise agency when the initial conditions are difficult to know and effects – hard to predict? How do the European Commission, the Industry, the Academia and the regulatory authorities formulate a joint strategy? How is this strategy possible to implement?

Strategy is formulated and implemented in multiple social systems. It is a complex process, which cannot be controlled by a particular agency. I conceptualise strategy both as a mode of thinking and manipulating the intersections of these systems and as concrete practices.

My empirical objects are the mechanisms through which individuals in a particular setting establish the meaning of interaction and agree on common goals and actions. How do individuals in this specific setting and in the related organisations make clear which system is enacted, where are the borders between different systems? What mechanisms do keep these systems together (or apart)? To collect the data I use an extensive participant observation, review of documents, and interviews with industry executives and experts, commissionaires, safety and pharmaco-vigilance specialists, representatives of patient organisations, clinicians. Main players in this strategy process are the European Commission, EMEA and EFPIA. The boundaries around the empirical object are not only drawn around organisational arrangements, but around the goal to re-organise the process. I collect the empirical data in real time and in a longitudinal perspective since 1997.