Katharina Blankat (CINCH/University of Duisburg-Essen)

Understanding different stakeholders’ roles in processes of regulatory decision-making is of great relevance from the perspectives of business, regulators and society. In this paper, we seek to explain why, when, and which stakeholders are salient in regulatory decision-making. To do so, we build a conceptual framework that expands Mitchell, Agle, and Wood’s theory of stakeholder salience to include a dimension of case specific context urgency by using concepts grounded in resource dependence and social movement theory. In a mixed-methods approach, we use this framework and qualitative analysis of expert interviews to develop hypotheses on different stakeholders’ salience in regulatory decision-making, and on moderating effects of context urgency on these stakeholders’ salience. Subsequently, we empirically test our hypotheses using structural equation modeling. Results of analyzing outcomes of health technology assessments of pharmaceuticals in Germany between 2011 and 2015, show that the theory of stakeholder salience can be used to explain different stakeholders’ salience in regulatory decision-making. While the inclusion of case-specific measures of context urgency further contributes to the understanding of regulatory decision-making, we did not find moderating effects on stakeholder-regulatory agency relationships, which raises the question of what makes any context urgent enough for a regulatory agency to react to it.