Research note. European Regulatory Agencies in EU Decision-Making: Between Expertise and Influence

Research note by Christoph Ossege

Reflecting a global ‘rise of the unelected’ (Vibert, 2007), European Regulatory Agencies (ERAs) have become increasingly important features of regulatory decision-making in the EU. Whether we eat food, purchase medication in a pharmacy, or use our smartphone, each time – often without knowing – these ERAs affect our daily lives. Complementing more established forms of decision making in the EU, ERAs emphasize a trend of ‘depoliticization’ of the public sphere (Flinders, Buller 2006). As expert bodies, ERAs thus ought to engage in regulatory rulemaking and – most centrally – scientific decision-making autonomously from external pressures (Majone, 2009; Weingart, 1999).

Although expertise and autonomy form the operational cornerstones of ERAs (reflecting two sides of the same coin), their specific contribution to the day-to-day functioning of ERAs remains unclear in many respects. In practice, ERAs could for instance prioritize organizational self-interest over scientific expert judgment, turning into ‘political actors in their own right’ (Moe, 1995). Similarly, ERAs might be ‘captured’ by political or economic interests, undermining their autonomy and scientific authority (Carpenter & Moss, 2013). In addition to these ‘internal’ and ‘external’ pressures on the ‘science-based’ operation expected from ERAs, expertise and autonomy are closely related in practice. Carpenter (2001, p. 17) argues that expertise forms a ‘key prerequisite for bureaucratic autonomy’. In addition to this expertise-autonomy nexus, the role of ERAs in public policy making (their ‘policy influence’) remains in the dark: Providing the Commission with expert advice, ERAs are deprived of formal decision-making competences. Nonetheless, their expert advice is suggested to often ‘pre-determine’ the Commission’s regulatory decisions (Busuioc & Groenleer, 2014).

With an emphasis on the importance of expertise for the autonomy and policy influence of ERAs, I study the more general question of whether and under what conditions ERAs meet the preconditions to provide high-quality expert advice, as well as to assess the influence of this expert advice in public decision-making:

How is it assured that ERAs provide high-quality expert advice?

How scientifically do ERAs operate internally?
How autonomous are ERAs from external influence?
How influential are ERAs in the regulatory decision-making at the EU-level and how can this influence be explained?

Answering these questions, I strive to locate ERAs within the wider system of European governance and speak to the perennial question of how to reconcile the need for expert advice with democratic decision-making (Coen & Roberts, 2012). Whereas the necessity of expert advice remains uncontested in the current scholarly debate, consensus has materialized that it ought to complement – rather than replace – a more democratic public preference formation (Eriksen, 2011).

Rooted in a rational institutional account of the policy process, my study builds on insights from delegation theory, knowledge utilisation, and science and technology studies to develop ‘ideal type’ categories of agency behaviour (see Table 1): Do ERAs act as highly autonomous (‘expertise-driven’) epistemic actors, or are they (‘interest-driven’) advocacy actors with limited degrees of autonomy? To increase the analytical leverage of the study, I go beyond the conceptualisations of ‘policy autonomy’ currently employed in the academic debate, by distinguishing between ‘rulemaking-autonomy’ and ‘scientific autonomy’, while clearly separating the autonomy of ERAs from their ‘policy influence’.

Empirically, the study compares three major ERAs (European Medicines Agency (EMA), European Chemicals Agency (ECHA) and European Food Safety Authority (EFSA)), building on the systematic analysis of 39 original expert interviews with agency decision-makers, interest group representatives as well as national and European experts and political representatives.

Findings improve our understanding on the 1) internal operation of ERAs, their 2) autonomy from external pressures, as well as their 3) impact in EU policy-making.

Internal operation of ERAs

Meeting widely-held expectations, the analysis shows that ERAs pool extensive expertise in their scientific committees, depicting them as expertise-driven epistemic actors: Despite sporadic political considerations and heated debates concerning the uncertainties inherent to regulatory science, the committees operate in a highly problem-oriented and deliberative manner. The self-perception of committee members as ‘professionals’ rather than ‘delegates’ forms one explanation. At the same time, I do not only observe that skewed levels of participation among committee members pose a direct threat to the epistemic quality of their decisions; the book also proposes organizational measures to overcome this challenge. Moreover, the analysis shows that the problem-oriented behaviour of ERAs facilitates learning and potentially increases regulatory quality (Radaelli, 2009). When dealing with salient issues, however, all three agencies embrace a more strategic behaviour, aimed at protecting their scientific decision-making from external pressures.

Policy autonomy of ERAs

With regard to the policy autonomy of ERAs, the conceptual distinction between rulemaking autonomy and scientific autonomy allows for fine-grained insights: Although ERAs are granted extensive formal competences to engage in soft-law rulemaking (e.g. standard-setting for authorization procedures), their rulemaking autonomy is heavily circumscribed in practice. At the same time, the scientific autonomy of all three ERAs appears to be very high.

Concerning rulemaking autonomy, the European Commission as ‘guardian of the treaties’ and political principal of ERAs wields particularly strong influence over the rulemaking of ERAs. The fear of litigation shared among ERAs and the Commission, leading the former to rely on legal interpretations of the latter, provides an additional explanation for the limited discretion of ERAs: Whereas NGOs experience limited influence on agency rulemaking, industry federations capitalize on their informal access to agency decision-makers. At the same time, federations successfully advocate their interests in other fora, focusing their efforts on the European Commission and the Council.

The scientific decision-making of all three ERAs, to the contrary, is well protected from influence by both public and private actors. Emphasizing the ability of ERAs to ‘forge’ their own autonomy, the analysis shows 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 meet 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.

Impact in EU policy-making

Finally, the conceptual approach pursued in this study allows to assess the role of ERAs in public policy-making: All three ERAs experience high degrees of policy influence, depicting them as de facto policy makers. Since most regulatory actions of ERAs are characterized by low levels of political salience, the Commission ‘rubberstamps’ the agency opinions. In areas of high political salience, the influence of ERAs appears more limited. Political considerations are ‘crowding in’ (to) regulatory decision-making, reducing the centrality of scientific arguments. The substantive de facto decision-making powers of ERAs – while de jure only the Commission can be held accountable through legal review – emphasize the current challenge to accompany regulatory decision-making in the EU with adequate mechanisms to ensure accountability. This challenge seriously questions the legitimacy of ERAs.

What can we learn from these insights?

The book provides a nuanced picture on the hitherto rather unknown day-to-day operation of ERAs and their role in the EU. Emphasizing the plausibility of rational choice theories to describe the behaviour of ERAs (as delegated agents), the analysis identifies internal and external threats to the scientific operation of ERAs, introduces explanations for their nonetheless highly epistemic operation (even in areas of high political salience), and provides arguments for the substantive variations of policy influence across the operational areas of ERAs. Findings suggest that the behaviour of ERAs can be institutionally designed to a substantive degree. Seemingly minor changes to the design of the expert committees, for instance, bring about major implications for the autonomy as well as the policy influence of ERAs. Findings provide valuable insights on the promises and pitfalls of particular design features of ERAs, which could serve as potential blueprints not only for the reform of existing agencies, but also for the creation of future ones.

At the same time, findings directly enhance our understanding of the main theoretical concepts in the study of EU agencies, expertise and autonomy: Concerning expertise, the heated debates observed in the internal operation of ERAs, involving diverging national and sector-based regulatory traditions expressed in the scientific committees, directly point to the uncertainties and ethical implications inherent to the scientific debates among regulators, emphasizing the important distinction between ‘abstract science’ and ‘regulatory science’ (Renn, 1995).

Concerning the autonomy of ERAs, this book does not only introduce a more rigorous conceptual understanding, distinguishing between the rulemaking autonomy and scientific autonomy on the one hand and the policy influence of ERAs on the other. It also contributes to the theoretical debate on the determinants of autonomy by introducing expertise and rulemaking competences as novel explanations.

Locating ERAs in the wider system of EU governance, their expertise-driven and autonomous operation suggests that they contribute to an ‘executive centre formation’ in the EU (Trondal & Peters, 2013); they simultaneously promote the ‘scientization’ of public decision-making (Guston, 2001). Since ERAs meet the functional demand for high-quality expert advice, I argue that ERAs form legitimate parts of the European governance.

Yet, the analysis shows that current regulatory structures and processes are unable to transparently balance expert advice with legitimate non-scientific concerns in areas of high political salience. Given the inherent political nature of certain debates, regulatory decision-making is, in effect, re-politicised by stealth. This observed deadlock of regulatory decision-making, exemplified in the area of GMO, illustrates the ambiguous role of ERAs in public decision-making. Enabling regulatory decision-makers to balance high-quality expert advice with legitimate political and ethical concerns in a transparent manner therefore forms the major challenge for future debates about regulatory reforms.


About the Author



Christoph Ossege is Senior Policy Officer at the German Federal Financial Supervisory Authority where he works on the regulation of European financial markets. He holds a PhD from Bremen University, Germany, and held visiting research positions at Exeter University, UK, and at ARENA Centre for European Studies, Oslo, Norway.



Table 1

  Epistemic actor (‘expertise-driven’) Advocacy actor (‘interest-driven’)
High autonomy ERAs behave like epistemic communities. They strive to fulfil their mandate (good regulation) by the adequate use of their expert resources, and they are not ‘captured’ or otherwise influenced by non-scientific interests. ERAs behave like other advocacy actors in pursuing their organisational or political interests. At the same time, they are autonomous from other actors. ERAs act like ‘political actors in their own right’ (Moe, 1995).
Low autonomy ERAs act like an internal department: they strive to fulfil their mandate (good regulation) by proper use of their expertise, but they are ‘captured’ or otherwise influenced by external actors. ERAs are not actors distinct from others: we can derive their behaviour by looking at the utility functions of other actors. These external actors induce their preferences into the agencies.



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