Rethinking institutional entrepreneurship: The case of the construction of the orphan drug field in Europe

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.