Agency Autonomy Actually: Managerial Strategies, Legitimacy, and the Early Development of the European Union's Agencies for Drug and Food Safety Regulation

Abstract

In recent decades, a series of regulatory agencies has been created at the European Union (EU) level. The existing literature on EU agencies focuses either on autonomy as a reason for the creation of such agencies or on the autonomy that they are granted by design. As a result, we do not know much about how EU agencies' actual autonomy comes about. This article therefore probes into the early development of two specific agencies. On the basis of document analysis and interviews with agency staff members, national experts, EU officials, external stakeholders, and clients, it explores why, in practice, the European Medicines Agency (EMA) seems to have developed a higher level of autonomy than the European Food Safety Authority (EFSA), even though on paper EMA appears to be as autonomous as, or if anything, less autonomous than EFSA. The article demonstrates the importance of investigating the managerial strategies of EU regulatory agencies to understand the actual practice of their autonomy and points to legitimacy as a key condition affecting the early development of such agencies.

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

“…Despite considerable pressures, the decision-making of all three ERAs appears well protected from both public and private external influence. Whereas other studies have argued that EFSA experiences lower degrees of autonomy than EMA and-more recently-ECHA (Groenleer, 2014), this study observes similarly high degrees of autonomy among all three ERAs. A main explanation for this discrepancy can be found in the more narrow definition of autonomy applied here.…”

“…Whereas I argue that EFSA enjoys substantive autonomy, its opinions might nonetheless be disregarded by regulatory policy makers. While EFSA therefore experiences high degrees of autonomy, its policy influence is reported elsewhere to be limited (Groenleer, 2014;Ossege, forthcoming). Whereas the distinction between policy autonomy and influence introduced here increases the analytical leverage of the analysis, the nature of their relationship asks for systematic scholarly attention.…”

“…Although EMA, EFSA, and ECHA differ in certain regards, their extensive similarities recommend them for a comparative study on agency autonomy. Created for different reasons at different points in time, they nonetheless share important organisational and functional traits (Groenleer, 2014): all three ERAs hold similar mandates, as they serve as gatekeepers for products to enter the respective markets and evaluate products and substances already available-potentially withdrawing the marketing permits (Vos, 2014, p. 20). Given their scientific tasks, the selected ERAs are most likely to capitalise on available expertise to protect their autonomy.…”

“…Whereas all EU agencies are independent legal entities-and thus legally autonomous-, their formal autonomy to take policy decisions is often said to be limited (Groenleer 2009(Groenleer , 2014: in fact, all EU agencies-including the ERAs studied in this article-are deprived of formal policy-making competences. Although their scientific opinions form the basis for risk regulation in the EU, the binding regulatory decisions reside with the Commission and the respective Standing Committees; often jointly referred to as the "risk managers" (Busuioc, 2013).…”

“…In fact, many facets of ERAs' day-to-day operation remain in the dark (Groenleer, 2014). When explaining the autonomy of ERAs, two-so far neglected-factors seem particularly worthwhile to study: an agency's expertise and its rulemaking competences.…”