Strategy and Structure: (How) is it possible to change the Medicines Development Process in Europe?

The European R&D environment is considered fragmented, while benefits are difficult to measure and distribute within the current differing health care systems. This thesis is based upon empirical data on an initiative pleading for "new safe medicines faster" at the Section of Medicines Development, European Federation of Biotechnology, which strives to dramatically cut the costs for drug development and to make drugs faster available to patients. The individuals in this initiative claim that this can be accomplished through the joined action of all participating organisations and institutions, and particularly the approval authorities. (How) can this strategy be formulated? Such transformation is complex, because it requires the collaboration between industry, political institutions and medicines agencies, which have different agenda and interests. (How) can such a change be managed?

Using structuration theory, I propose how strategy can be conceptualised through a duality of agency and structure. While I claim that a stronger concept of agency is needed, I do emphasise that agents have to be aware how structural properties of social systems frame communication, decisions and action. Strategic change and transformation do not only have positive effects - within the iron cage of organisational isomorphism (Powell/DiMaggio) and the frustrations of power (Foucault) strategy can produce exactly the opposite effects. Companies and organisations can lose their uniqueness, their competitive advantage, their position. How controllable is transformation? How predictable the effects of change? How can we speak of strategy, when effects can hardly be foreseen even by prescient agents?

I examine historical and confidential strategy documents, interviews with industry executives and experts, commissionaires, safety and pharmaco-vigilance specialists to explain how do agents formulate and implement a strategy. Can a strategy for change have the form of a roadmap, and how? A detailed analysis of the agency's performance at that particular initiative - new safe medicines faster - gives some answers.