Driven by Expertise and Insulation? The Autonomy of European Regulatory Agencies

Abstract

Expertise and autonomy are cornerstones to the effective operation and legitimacy of European Regulatory Agencies (ERAs). Yet, we know little about ERAs' actual autonomy, nor about factors shaping it. This article studies ERAs' actual autonomy from public and private actors, emphasising two crucial explanatory factors: expertise and rulemaking competences. The lack of insights on expertise is particularly striking, as expertise-the "raison d'être" and main resource of expert bodies-provides ERAs with a potentially powerful means to increase autonomy. Relying on a rational institutionalist framework within which ERAs enjoy substantive discretion to pursue their goals, the study empirically compares three powerful ERAs-the European Medicines Agency, the European Chemicals Agency, and the European Food Safety Authority. Based on the analysis of 39 semi-structured expert interviews, findings show that expertise is a crucial explanation for ERAs' substantive autonomy from the Commission. Towards research intensive private stakeholders, the role of expertise becomes less pronounced. Instead, ERAs are more successful in protecting their autonomy by engaging in the risk-averse interpretation of the regulatory framework and by adapting rules over time to adapt their needs: they engage in "procedural insulation". Political salience provides a scope condition for ERAs to use expert knowledge and rulemaking competences more strategically-potentially undermining scientific quality.

Structural reform histories and perceptions of organizational autonomy: Do senior managers perceive less strategic policy autonomy when faced with frequent and intense restructuring?

“…By testing the aforementioned propositions, we contribute to the dynamic and relational perspective of the study of organizational autonomy (see Maggetti and Verhoest ), a burgeoning section of the literature attempting to determine to what extent perceived autonomy is a function of an organization's experiences with political principals and other environmental actors during its lifetime (see also Carpenter ; Ossege ; Zito ). Moreover, the study complements existing work on de facto versus formal autonomy by zooming in on the senior manager perceptions.…”

Changing standards for drug approval: A longitudinal analysis of conditional marketing authorisation in the European Union

“…Carpenter (2004a) adds that regulators and bureaucratic leaders also have strategic interests to safeguard their reputation by balancing efficient approval with the prevention of safety scandals. Thus, permanent ambiguity is triggered by the distributional consequences of regulation and is visible in attempts by companies to capture authorities, and by authorities to insulate themselves from interest groups (Ossege, 2015) or co-opt them (Carpenter, 2004b).…”

The Expert-Executive Nexus in the EU: An Introduction

“…Several of the cases discussed in this issue also point to how the presence of agencies at the European level have implications for how science is funneled into decisionmaking and the implications of this not least for agency-Commission interactions. As argued, for instance, in the case of ECHA, EMA and EFSA (Ossege, 2015 (this issue)), the scientific expertise that these agencies draw on is the basis for their ability to maintain an independent advisory role vis-à-vis the Commission.…”

“…Also the role of expertise plays out differently for European agencies when they deal with private stakeholders than with their Commission parent or partner departments. Vis-à-vis the latter, the European Medicine Agency, European Chemicals Agency and the European Food Safety Authority's superior specialized expertise guards their policy autonomy, whereas with strong private stakeholder with considerable technical and scientific capacity of their own, agencies engage in procedural insulation in order to protect their independence (Ossege 2015 (this issue)).…”