– The purpose of this paper is to enrich empirical studies on institutional entrepreneurship (IE), more specifically those focusing on the role of the IE in building a new field (here the orphan drug [OD] field). This research addresses the main paradoxes of IE theories: a deterministic vs free agent point of view; an individual hero vs a collective action approach; and a change vs reproduction perspective.
– A case study of the role of an IE in the building of the OD field in Europe conducted through interviews with the main actors and in-depth documentary research.
– The case highlights the IE resources as products of a dynamic historical process driven by values; the process of building the field as an interaction between framing issues, mobilizing agents and resources, transforming a policy window into a political opportunity. It relativizes the IE role: an indispensable catalyst of collective action that can also reinforce the hegemonic bloc while changing the rules.
– The paper highlights the necessity of longitudinal analysis to address the agent/structure paradox.
