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Institutions of the European Union

Institutions of the European Union (4th edn)

Dermot Hodson and John Peterson
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p. 23610. European agencies: Managing Europeanizationlocked

p. 23610. European agencies: Managing Europeanizationlocked

  • R. Daniel Kelemen
  •  and Giandomenico Majone


This chapter examines why European Union agencies have been created and what impact they are having on European governance. It begins with a discussion of theories that explain law-makersʼ design choices and the increasing popularity of European agencies, focusing on delegation and policy credibility, the politics of agency design, and legal obstacles to delegation. It then looks at the development and operation of three regulatory agencies: the European Environment Agency, the European Medicines Agency, and the European Food Safety Authority. It also considers issues regarding the EU agenciesʼ independence and accountability before concluding with an analysis of the model in which an EU agency serves as the coordinating hub of a network of national regulatory authorities.


Over the past three decades, the European Union (EU) has instituted more than forty agencies in a wide variety of policy areas, with headquarters spread out across the member states. EU agencies are now well established as an integral part of the EU’s model of governance. This chapter analyses why EU agencies have been created and what impact they are having on European governance. EU leaders have delegated regulatory powers to agencies both in response to functional pressures and because of political motivations relating to inter-institutional politics in the EU. The chapter spotlights the development and operation of three particular European agencies: the European Environment Agency (EEA); the European Medicines Agency (EMA); and the European Food Safety Authority (EFSA).

p. 237Introduction

This chapter examines the rise of EU agencies. EU agencies—sometimes also labelled ‘authorities’ or ‘centres’—can be defined as ‘EU level public authorities with a legal personality and a certain degree of organizational and financial autonomy that are created by acts of secondary legislation in order to perform clearly specified tasks’ (Kelemen 2005: 175). Over the past three decades, the EU has established more than forty agencies in a wide variety of policy areas, with headquarters spread out across the member states. With the establishment of these agencies, along with the creation of other de novo bodies as described by Hodson and Peterson in Chapter 1, the EU has quietly managed to expand its regulatory capacity without directly increasing the size or capacity of the EU’s primary executive organ—the European Commission. EU agencies are now well established as an integral part of the EU’s model of governance. This chapter analyses why they have been created and what impact they are having on European governance.


The first EU agencies—the European Centre for the Development of Vocational Training (Cedefop) and the European Foundation for the Improvement of Living and Working Conditions (Eurofound)—were created in the 1970s, but these were operational, rather than regulatory, bodies. The 1990s produced a second wave of agencies, this time dealing with regulatory issues, including the European Environment Agency (EEA) and the European Medicines Agency (EMA). A third wave of agency creation started at the beginning of the twenty-first century with the creation of the European Food Safety Authority (EFSA), the European Maritime Safety Agency (EMSA), the European Aviation Safety Agency (EASA), and the European Railway Agency (ERA). It has continued with the recent creation of EU authorities in the fields of securities, banking, and pension regulation. Most European regulatory-type agencies of the second and third generation advise the Commission on the technical or scientific aspects of regulatory problems, but have not been given the formal authority to take final and binding regulatory decisions.

In addition to the regulatory agencies on which we focus in this chapter, the EU has also established a handful of executive agencies that perform managerial tasks on behalf of the Commission, such as the Education, Audiovisual and Culture Executive Agency (EACEA), the European Research Council Executive Agency (ERC Executive Agency), and the Executive Agency for Small and Medium-sized Enterprises (EASME). It has also set up a number of agencies focusing on foreign and security policy, such as the European Union Institute for Security Studies (EUISS), the p. 238European Defence Agency (EDA), and others focused on justice and policing, such as the EU Judicial Cooperation Unit (Eurojust), the European Asylum Support Office (EASO), and the European Agency for the Management of Operational Cooperation at the External Borders (Frontex). While this chapter focuses exclusively on EU agencies with some regulatory dimension (see Table 10.1), the creation of these regulatory agencies should be understood as part of a broader trend in the EU toward delegating authority to autonomous bodies outside the structure of the European Commission.

Why EU agencies? Theories of agency creation

When they agree to regulate a field at the EU level, EU law-makers in the Council of Ministers and European Parliament (EP) have a number of options in setting up bodies that can be tasked with making and implementing regulation (Coen and Thatcher 2008; Kelemen and Tarrant 2011). First, they can simply delegate to the European Commission, as member state governments did for most of the EU’s history when they decided to delegate regulatory tasks to the EU level. Second, law-makers can delegate tasks to specially established networks of national regulatory authorities (NRAs), as did securities regulators when they delegated certain regulatory tasks to the Committee of European Securities Regulators (CESR) in 2001. Finally, they can delegate to EU agencies outside the structure of the European Commission, as in the case of the EEA, the EMA, or the more recently created ESMA. What, then, explains law-makers’ design choices and the increasing popularity of EU agencies?

Delegation and policy credibility

First, compelling functional reasons exist for delegating regulatory powers to agencies—namely, to enhance the credibility of long-term policy commitments. Political uncertainty and time inconsistency are the main causes of the credibility problem. Political uncertainty is a direct consequence of the democratic process. One of the defining characteristics of democracy is that it is a form of government pro tempore (Linz 1998). The requirement of elections at regular intervals implies that the policies of the current majority can be subverted by a new majority with different, and perhaps opposing, interests; hence the uncertainty about future policies.

The other threat to policy credibility—time inconsistency—occurs when a government’s optimal long-run policy differs from its preferred short-run policy, so that the government in the short run has an incentive to renege on its long-term commitments. In the absence of some binding commitment, the government will use its discretion to pursue what appears now to be a better policy. If the policy-makers have the possibility of revising the original policy to achieve such short-term gains, economic actors will recognize this incentive and change their behaviour accordingly.p. 239p. 240p. 241p. 242

Table 10.1 European regulatory agencies


Start of activities



Official website

European Environment Agency (EEA)


To collect and disseminate information on the state and trends of the environment at European level; to cooperate with relevant scientific bodies and international organizations


Office for Harmonization in the Internal Market (Trade Marks and Designs) (OHIM)


To contribute to harmonization in the domain of intellectual property and, in particular, the domain of trade marks


European Medicines Agency (EMA)


To protect and promote public and animal health through the evaluation and supervision of medical products for human and veterinary use


Community Plant Variety Office (CPVO)


To implement the regime of Community plant variety rights, a specific form of intellectual property rights relating to new plant varieties


European Agency for Safety and Health at Work (EU-OSHA)


To provide the Community bodies, the member states, and stakeholders with all relevant technical, scientific, and economic information; to create a network linking national information networks, and to facilitate the provision of information in the field of health and safety at work


European Union Agency for Fundament Rights (FRA)


To provide EU and member state institutions with assistance and expertise on fundamental rights when implementing Community law, and to support them in formulating and taking measures


European Food Safety Authority (EFSA)


To provide independent scientific advice on all matters with a direct or indirect impact on food safety; to carry out assessments of risks to the food chain; to give scientific advice on genetically modified (GM) non-food products and feed


European Aviation Safety Agency (EASA)


To assist the Community in establishing and maintaining a high level of civil aviation safety and environmental protection in Europe; to promote cost-efficiency in the regulatory and certification processes; to promote worldwide Community views regarding civil aviation safety standards


European Maritime Safety Agency (EMSA)


To provide technical and scientific advice to the Commission in the field of maritime safety and prevention of pollution by ships; to contribute to the process of evaluating the effectiveness of Community legislation


European Network and Information Security Agency (ENISA)


To assist the Community in ensuring particularly high levels of network and information security; to assist the Commission, the member states, and the business community in meeting the requirements of network and information security, including those of present and future Community legislation


European Railway Agency (ERA)


To provide the member states and the Commission with technical assistance in the fields of railway safety and interoperability, in particular by carrying out continuous monitoring of safety performance, and producing a public report every two years


European Centre for Disease Prevention and Control (ECDC)


To work with national health protection bodies to strengthen and develop continent-wide disease surveillance and early warning systems; to develop authoritative scientific opinions on risks posed by new and emerging infectious diseases


European GNSS Agency (GSA)


To manage the public interests and to be the regulatory authority for the European GNSS (Global Navigation Satellite Systems) programmes


European Fisheries Control Agency (EFCA)


To strengthen the uniformity and effectiveness of enforcement by pooling EU and national means of fisheries control, and monitoring resources and coordinating enforcement activities


European Institute for Gender Equality (EIGE)


To support the work of EU institutions in promoting gender equality by collecting and analysing data, facilitating dialogue between stakeholders, and raising public awareness


European Chemicals Agency (ECHA)


To coordinate registration, evaluation, authorization, and restriction processes under REACH; to ensure consistency in chemicals management across the EU; to provide technical and scientific advice and information on chemicals


European Securities and Markets Authority (ESMA)


To safeguard the stability of the EU’s financial system by ensuring the integrity, transparency, efficiency, and orderly functioning of securities markets, as well as enhancing investor protection


European Banking Authority (EBA)


To safeguard the stability of the financial system, the transparency of markets and financial products, and the protection of depositors and investors; to work with national regulators to prevent regulatory arbitrage, strengthen supervisory coordination, and promote supervisory convergence; to provide advice to the EU institutions on banking and financial regulation


European Insurance and Occupational Pensions Authority (EIOPA)


To support the stability of the financial system, and the transparency of markets and financial products, as well as the protection of insurance policyholders, pension scheme members, and beneficiaries


Body of European Regulators for Electronic Communications (BEREC)


To promote consistent implementation of EU regulations on electronic communications, based on best practices


Agency for the Cooperation of Energy Regulators (ACER)


To provide advice to EU institutions on energy-related issues; to take binding individual decisions on terms and conditions for access, and operational security for cross-border infrastructure if the NRA’s national authorities cannot agree


Single Resolution Board (SRB)


To ensure the orderly resolution of failing banks; to establish standard rules and procedures for resolution; to take decisions on resolution within the Banking Union



* Prior to UK withdrawal from the EU


p. 243One way of enhancing the credibility of long-term policy commitments is to delegate the implementation of those objectives to politically independent institutions. The delegation of regulatory powers to some agency distinct from the government itself can serve as a means whereby governments can commit themselves to regulatory strategies that would not be credible in the absence of such delegation (Gatsios and Seabright 1989). In the EU context, member states may agree that it is in their long-term interests to cooperate on harmonizing regulation in a particular area so as to integrate the market, but they will face short-term incentives to defect from their agreements. To make their policy commitments credible, member states may have an incentive to delegate to a politically independent, supranational regulatory authority. Indeed, in a general sense, this is the very raison d’être for the European Commission.

These considerations explain why there may be a functional need for independent regulatory bodies at the European level, but they do not by themselves explain the creation of EU agencies. They do not tell us how agencies will be structured, what powers will be delegated to them, or why new autonomous agencies—rather than the European Commission itself—will be tasked with regulation. While functional considerations play a key motivating role, the process of agency design is ultimately driven by political considerations. The design of EU agencies is the result of political compromises involving EU law-makers in the Council of Ministers, the EP, and the European Commission.

The politics of agency design

With the drive to complete the single market project by 1992, the EU’s regulatory agenda expanded rapidly—increasing significantly the scale of regulatory functions (information-gathering, analysis, issuance of rules to implement directives, monitoring of enforcement, and so on) that needed to be performed (or at least coordinated) at the European level. These regulatory burdens might have been dealt with simply by expanding the European Commission—and as Hodson and Peterson point out in Chapter 1, the Commission has grown substantially over the past two decades. The Commission itself and its allies in the EP would likely have preferred to address the EU’s need for added capacity by expanding the Commission even further, but there was widespread opposition among the member states to giving the European Commission control over the level of staff and resources that would have been necessary to that end. Quite simply, many governments did not want to see a large, powerful, and centralized EU bureaucracy in Brussels.

In this political context, Commission President Jacques Delors proposed what would become the first in a wave of new EU agencies: the EEA. For the Commission and EP, the idea of establishing autonomous European agencies was an attractive second-best means through which to expand the EU’s regulatory capacity—given that expansion of the Commission itself was unacceptable to member governments. Delegating routine information-gathering and regulatory tasks to agencies was attractive to the Commission, because it allowed the Commission to focus its limited p. 244resources better on its core tasks, such as policy development and enforcement. Moreover, many of the responsibilities granted to EU agencies would not actually be taken away from the European Commission; instead, agencies would perform tasks that might otherwise have been performed by so-called comitology committees, which advised the Commission. Comitology committees were composed of technical experts who represented member state governments; they served not only to provide expert advice, but also to exert intergovernmental control over the Commission in its policy implementation activities. EU agencies would replicate many of the functions of comitology committees, but they would control far more resources, have additional powers, and operate in a more transparent manner. When they agreed to establish these new agencies, the member states insisted that they be subject to considerable intergovernmental oversight, through the creation of management boards that were to be dominated by appointees of member state governments. In other words, with the creation of EU agencies, the European Commission got the expansion of EU regulatory capacities that it wanted, while the member states maintained substantial intergovernmental control over these new entities.

Over the course of the past two decades, the politics of agency design have shifted as a result of the growing power of the EP. Along with the growth of its legislative power, the Parliament has strengthened its oversight of the Union’s executive organs—including the EU agencies. The EP has scrutinized agency budgets, and has demanded that agencies follow formal and transparent regulatory procedures. In essence, the Parliament is acting to ensure that the European agencies will operate in a far more transparent manner than the obscure comitology committees that for so long operated in the shadows of EU governance.

Finally, in a broader sense, the rise of EU agencies has coincided with, and facilitated, a shift in the role of the European Commission. The Commission used to be viewed as the EU’s independent, regulatory bureaucracy, but just as more and more routine regulatory tasks were being delegated to EU agencies, so too the Commission itself was experiencing a progressive politicization, which culminated in 2014 with the introduction of the so-called Spitzenkandidat (‘lead candidate’) process that explicitly linked the selection of the Commission President to the outcome of the European Parliament elections. As the Commission comes to depend on the political support of the EP, it begins to look less like a politically independent supranational regulatory bureaucracy and more like a nascent parliamentary government.

Legal obstacles to delegation

European agencies do not have the powers granted to American regulatory bodies and even lack the more limited competence enjoyed by the regulatory authorities of many member states. Thus, for instance, the regulation setting up the EEA did not include regulatory functions in the agency’s mandate.1 The task of the EEA is mainly to provide information that may be useful in framing and implementing environmental policy. Even those agencies with more substantial regulatory powers, such as the p. 245EMA, the EASA, or the more recently established ESMA, do not, formally speaking, have discretionary decision-making powers. For example, the EMA does not take decisions concerning the safety and efficacy of new medicinal drugs, but submits opinions concerning the approval of such products to the European Commission, which takes the final legal decision.2 Similarly, EFSA is allowed only to assess risk, not to manage it.3 Only the Commission can make final determinations concerning the safety of the food that Europeans—and others who enjoy EU exports—eat.

Ostensibly, the primary reason why European agencies are not granted broader powers is that the Court of Justice has prohibited it. In a 1958 ruling,4 the Court of Justice established the ‘Meroni doctrine’, holding that Community law prohibits the delegation of discretionary powers to bodies—including European agencies—that are not established in the EU Treaties. Thus member states can establish new bodies with discretionary powers—such as the European Central Bank (ECB) or Europol—in EU Treaties, but they cannot do so through normal secondary legislation. The European Commission (2001b: 23) has interpreted the doctrine as follows: ‘Agencies cannot be granted decision-making power in areas in which they would have to arbitrate between conflicting public interests, exercise political discretion or carry out complex economic assignments.’

However, a 2014 Court of Justice ruling may mean that the legal landscape governing the delegation of authority to agencies is changing.5 The ruling concerned the EU’s Short Selling Regulation,6 which had granted ESMA the power to ban short selling during market emergencies. The United Kingdom (UK)—before its 2016 referendum on EU membership—brought a legal action before the Court of Justice seeking to strike down this provision, claiming that it had delegated discretionary rule-making power to ESMA in violation of the Meroni doctrine. The Court of Justice rejected the UK’s claims. Although the Court of Justice did not explicitly overrule Meroni, it offered a very expansive reinterpretation of how much decision-making authority could be granted to an EU agency without this constituting ‘excessive’ discretionary power. In other words, the Court of Justice’s ruling seems to open up the way for the delegation of greater regulatory powers to EU agencies. Indeed, the impact of the Court of Justice’s new, more expansive, reading of Meroni could be detected almost immediately in the context of negotiations over the establishment of a Single Resolution Mechanism (SRM) for failed banks as part of European banking union. The Court of Justice decision came down just as member states were holding these negotiations and governments agreed to delegate to a new Single Resolution Board (SRB) far-ranging powers to wind down failed credit institutions—powers that would have been unthinkable under the Court’s previous stricter reading of the Meroni doctrine.

But even if the legal obstacles to greater delegation of power to agencies have been reduced, political obstacles remain. Some of the political actors involved in the design of European agencies prefer not to see them take on discretionary regulatory powers. While some member states would be happy to transfer more rule-making power from the Commission to agencies, the design of EU agencies and decisions over which powers they will exercise require the agreement of the Commission and p. 246EP as well. The Commission, for its part, prefers to maintain ultimate decision-making authority; it is enthusiastic to see routine regulatory tasks delegated to EU agencies in large part because it knows (or in the past knew) that, under the Meroni doctrine, it retained the last word. A number of the EU agencies established in recent years—from EASA to the European Chemicals Agency (ECHA), to the SRB and ESMA—have been granted regulatory powers that would seem to push them into the realm of discretionary decision-making. With the relaxation of the Meroni doctrine, this trend is likely to continue. Indeed, in the context of Europe’s recent refugee crisis, member states have already agreed to a far-reaching expansion of Frontex’s operational capacity and duties, and the Commission is considering proposing a dramatic centralization of asylum policy in the hands of the EASO. Nevertheless, political opposition to granting EU agencies extensive regulatory powers will continue to act as a limit on their delegated authority.

The growing role of agencies

The EEA and the other agencies established in the mid-1990s were ad hoc experiments in institutional innovation. But, over the past decade, EU agencies have become an integral aspect of the EU’s regulatory landscape. Today, proposals to expand EU regulation substantially are regularly accompanied by plans for the establishment of an EU agency, which may take on regulatory, informational, or executive tasks (Rittberger and Wonka 2010). As plans for new agencies proliferated, the Commission called for the establishment of a common framework on which to model them. The 2001 White Paper on European Governance (European Commission 2001b) contained a section on ‘Better application of EU rules through regulatory agencies’, and called for the establishment of a common framework for the creation, operation, and supervision of agencies. The following year, the Commission proposed such a framework for the agencies and, in 2005, a draft inter-institutional agreement on EU agencies was published. However, adoption of the agreement was blocked in the Council. In 2008, the Commission finally withdrew the stalled agreement and presented a new communication on European agencies that promised to relaunch the debate about their place in governance. Representatives of the Commission, EP, and Council subsequently met to discuss issues concerning the structure, supervision, and operations of the agencies—but they did not agree on a uniform framework for European agencies.

While the Council, Commission, and Parliament have been unable to agree on a standard template for agencies, they nonetheless have continued to create new ones. In recent years, agencies have been created in sectors such as energy—the European Agency for the Cooperation of Energy Regulators (ACER), financial market regulation (ESMA, the EBA, and the European Insurance and Occupational Pensions Authority, or EIOPA), and banking (the SRB), in which member states had long resisted the establishment of new agencies (see Table 10.1). In these fields, in p. 247which regulatory decisions entail substantial distributional consequences, member states had previously sought to rely on networks of NRAs to provide the necessary coordination without establishing EU bodies that might constrain national regulatory discretion. However, disastrous regulatory failures and a growing acceptance that the network model alone was inadequate led member states to agree to link these networks to powerful EU agencies (Kelemen and Tarrant 2011).

The politics of institutional choice: The birth of the European Environment Agency

In January 1989, Commission President Jacque Delors proposed the establishment of a European Environment Agency, to strengthen the Community’s information-gathering, monitoring, and implementation capacity. Member states, European institutions, and environmentalist groups all voiced support for the proposal, but were deeply divided over specific structural choices—especially those concerning the regulatory powers and effective independence of the new agency. Many in the EP favoured a body with regulatory ‘teeth’. In varying degrees, all member states opposed the idea that the agency could monitor the implementation of European environmental legislation by national regulators, preferring to restrict its task to the collection of environmental information and to networking with national, European, and international research institutions. The position of the Commission was ambivalent. On the one hand, officials in the Directorate-General for the Environment (DG ENV) were concerned about the criticism of industry and some member states that the Commission’s environmental proposals were not grounded in ‘good science’. They were even more concerned by the poor implementation of environmental directives. Hence the idea that the EEA could become a sort of inspectorate of national environmental inspectorates had a number of influential supporters within the Commission. On the other hand, this institution was reluctant to surrender regulatory powers to an agency operating at arm’s length. In a 1989 proposal, the Commission outlined four functions for the new body:

to coordinate the enactment of European Community (EC) and national environmental policies;

to evaluate the results of environmental measures;

to provide modelling and forecasting techniques; and

to harmonize the processing of environmental data.

Because of the expected opposition by the member states, no inspection tasks were contemplated.

This proposal was quite distant from the EP’s ‘ideal point’. The fact that Beate Weber, rapporteur of the EP’s Environmental Committee, travelled to Washington p. 248DC to gain first-hand knowledge of the United States’ (US) Environmental Protection Agency (EPA) suggests the model of regulatory agency that European parliamentarians had in mind. The EP Environmental Committee maintained that the EEA should be given power to police environmental abuses, to supervise national enforcement of EC environmental regulations, and to carry out environmental impact assessments (EIAs) on certain Community-funded projects. Also, the composition of the management board became a point of contention. According to the EP, environmental groups should be represented on the board, alongside representatives from the member states, the Commission, and the EP itself, and the board should be allowed to take decisions by majority vote.

Comparing the preferences of the main political actors—member states, Commission, EP—with the provisions of the regulation setting up the agency, we see that the member states clearly won the contest over the structure and powers of the agency. The decisive influence of the national governments is revealed by the composition of the management board, which was to be dominated by member state appointees. As mentioned, the main task assigned to the agency is to provide the EU and the member states with environmental information and, in particular, ‘to provide the Commission with the information that it needs to be able to carry out successfully its tasks of identifying, preparing, and evaluating measures and legislation in the field of environment’.7 The wording is sufficiently vague, however, to make it unclear whether the agency would be allowed to directly influence policy formulation, for example by evaluating alternative proposals for regulatory measures. Political compromise produced an institutional design characterized by uncertain competences, unresolved conflicts, and failure to deal with the serious implementation problems of EU environmental policy. The compromise over the creation of the EEA established a model that then provided a rough template for subsequent agency proposals. Each agency was created in distinctive political circumstances, and the details of the powers granted to agencies and the oversight structures put in place varied as a result. However, a number of key elements of the design of the EEA have been replicated in other agencies. For example, agency management boards have continued to be dominated by representatives of member state governments and the agencies have served as hubs of regulatory networks that include (rather than replace) NRAs.

From committees to agency: The development of the European Medicines Agency

Our next example provides valuable insights into how obscure comitology committees have been transformed into a structure in which they become the operational arm of European agencies and link with national authorities to form transnational regulatory networks. The first attempt by the EC to regulate the testing and marketing of pharmaceutical products was a directive introduced in 1965 with the dual p. 249objective of protecting human health and of eliminating obstacles to intra-Community trade. This directive established only the principle that no medical drug should be placed on the market without prior authorization, and defined the essential criteria of safety and efficacy for drug approval.

The second phase of regulatory developments began in 1975, with another directive setting up the ‘multi-state drug application procedure’ and establishing the Committee for Proprietary Medicinal Products (CPMP). This Committee composed of national experts has played, and continues to play, a key role in the EU’s approach to the regulation of pharmaceuticals. Under the multi-state procedure, a firm that had received a marketing authorization from the regulatory agency of a member state could ask for the recognition of that approval by at least five other member states. The agencies of these countries had to approve or raise objections within 120 days. In the event of objections, the CPMP had to be notified and would express its non-binding opinion within sixty days. The procedure did not work well: the national agencies did not appear to be bound either by the decisions of other regulatory bodies or by the opinion of the CPMP. Subsequent simplifications failed to streamline the approval process, as national regulators continued to raise objections against each other almost routinely. Hence firms generally chose to continue to seek authorization from each national agency separately.

A different approval process was introduced in 1987 for biotechnology and other high-tech products. This new ‘concertation procedure’ required that the application for the authorization be filed both with the national authorities and with the CPMP. The country in which the authorization had been filed acted as rapporteur, but, unlike under the old multi-state procedure, no decision on the application was to be made by any member state before the CPMP had expressed its opinion. The final decision remained with the member states, however. The evaluation of the application, led by the rapporteur country, was carried out at the same time in all of the member states—hence the name ‘concertation procedure’. The new process was an advance with respect to the old practice, but was nevertheless problematic for firms because, as with the previous procedure, there was a tendency for delays in the notification of decisions following the CPMP opinion. Waiting for all countries to notify their decisions following the Committee’s opinion could result in serious delays in a firm’s ability to start marketing a new drug.

In 1995, the problematic multi-state and concertation procedures were replaced by three new approaches and a new agency (see Box 10.1). The multi-state procedure was replaced by a decentralized procedure, which continues and reinforces the principle of mutual recognition introduced in 1975; the concertation procedure was replaced by the centralized procedure set out in the same regulation that also established the EMA (see Box 10.2).8

Under the centralized procedure, applications are made directly to the agency, leading to the granting of a European marketing authorization. Use of this procedure is compulsory for products derived from biotechnology and optional for other innovative medicinal products. The EMA is also called on to arbitrate disputes arisingp. 250

Box 10.1 An overview of the European authorization system

Human and animal health

The European system for the authorization of medicines for human and veterinary use has been in place since 1995. It is designed to promote both public health and the free circulation of pharmaceuticals. Access to the European market is facilitated for new and better medicines—benefiting users and European pharmaceutical research.

EMA: A network agency

The European system is based on cooperation between the nationally competent authorities of the member states and the EMA. The EMA acts as the hub of the system, coordinating the scientific resources made available by member state national authorities, including a network of thousands of European experts.

The EMA is designed to coordinate the scientific resources of the member states, acting as an interface between the national competent authorities rather than as a highly centralized organization.

The European procedures

The European system offers two routes for authorization of medical products, as follows.

Centralized procedure

Decentralized procedure

Applications are made directly to the EMA, leading to the granting of a European marketing authorization.

Use of this procedure is compulsory for products derived from biotechnology.

Applicable to the majority of conventional medicinal products.

Applications are made to the member states selected by the applicant and the procedure operates by mutual recognition of national marketing authorizations.

Where mutual recognition is not possible, the EMA is called upon to arbitrate.

Opinions adopted by the EMA scientific committees in either the centralized procedure or following arbitrations lead to binding decisions adopted by the European Commission. Purely national authorizations remain available for medicinal products to be marketed in one member state.

under the decentralized (mutual recognition) procedure. Opinions adopted by the EMA in either the centralized procedure or following arbitration lead to binding decisions formally adopted by the Commission.

The technical work of the agency is carried out by the Committee for Medicinal Products for Human Use (CHMP, the successor of the old CPMP), by the Committee for Veterinary Medicines (CVMP), and by two smaller and newer bodies: the Committee for Orphan Medicinal Products (COMP), established in 2001 and charged with reviewing designation applications from persons or companies who intend top. 251

Box 10.2 The EMA mission statement

The mission of the European Medicines Agency (EMA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health.

Working with the member states and the European Commission as partners in a European medicines regulatory network, the [EMA]:

provides independent, science-based recommendations on the quality, safety and efficacy of medicines, and on more general issues relevant to public and animal health that involve medicines;

applies efficient and transparent evaluation procedures to help bring new medicines to the market by means of a single, EU-wide marketing authorisation granted by the European Commission;

implements measures for continuously supervising the quality, safety and efficacy of authorised medicines to ensure that their benefits outweigh their risks;

provides scientific advice and incentives to stimulate the development and improve the availability of innovative new medicines;

recommends safe limits for residues of veterinary medicines used in food-producing animals, for the establishment of maximum residue limits by the European Commission;

involves representatives of patients, healthcare professionals and other stakeholders in its work, to facilitate dialogue on issues of common interest;

publishes impartial and comprehensible information about medicines and their use;

develops best practice for medicines evaluation and supervision in Europe, and contributes alongside the member states and the European Commission to the harmonisation of regulatory standards at the international level.

Source: European Medicines Agency, Annual Report 2015

develop medicines for rare diseases (‘orphan drugs’); and the Committee on Herbal Medicinal Products (HMPC), established in 2004 to provide scientific opinions on traditional herbal medicines. A network of some 3,500 European experts underpins the scientific work of the EMA, and of its committees and working groups.

The CHMP (with similar rules applying to the CVMP) is composed of two members nominated by each member state for a three-year renewable term. These members, in fact, represent the NRAs. Although Commission representatives are entitled to attend the meetings of the Committee, the Commission is no longer represented, no doubt to emphasize the independence of the CHMP.

In keeping with the political compromise common to the establishment of all EU agencies, the new EMA was put under the control of a management board dominated by member state appointees. When the EMA was restructured in 2004, member states acquiesced to the Parliament’s demand that EP and stakeholder representatives p. 252be added to the Agency’s management board, although member state representatives still held a majority. The Council also agreed to the Parliament’s demand that the nominee for the position of agency executive director appear before the Parliament prior to her or his formal approval by the Council.

In fact, the Committee has become more important, as well as more independent, since the establishment of the EMA. In the new situation, Committee members have greater incentives to establish the agency’s, and their own, international reputation than to defend national positions. Using Alvin Gouldner’s (1957: 58) terminology, we may say that the agency creates a favourable environment for the transformation of national regulators from ‘locals’ (that is, professionals who have primarily a national orientation) to ‘cosmopolitans’, who are likely to adopt an international reference-group orientation. It does so by providing a stable institutional focus at the European level, and a forum in which different risk philosophies are compared and mutually adjusted, and by establishing strong links to national and extra-European regulatory bodies. Overall, the EMA has been highly successful at least insofar as pharmaceutical manufacturers report satisfaction with the agency’s centralized procedure and many companies seek centralized authorizations (Kelemen and Tarrant 2011). In spite of this success, the EMA will have to move from its home in London once the UK leaves the EU in light of its 2016 referendum vote on membership.

The pursuit of regulatory credibility: The European Food Safety Authority

The food sector is an area in which EC regulation dates back to the earliest days of the Community. Traditionally, policy on food safety was developed by the Commission, assisted by a large number of comitology and expert committees. Several regulatory failures—of which the bovine spongiform encephalopathy (BSE), or ‘mad cow disease’, epidemic attracted the greatest public attention—revealed the inadequacy of the traditional approach. The BSE outbreak exposed serious shortcomings in the overall coordination of European policies on agriculture, the internal market, and human health. In 1996, the EP set up a temporary committee of inquiry into BSE. The committee concluded that both the Council and the Commission had neglected their duties, and that the UK government had exerted pressures on the Commission’s veterinary services in order to avoid Community inspections and to prevent the extent of the epidemic being made public. The Commission was criticized for having given priority to the management of the beef market rather than to the risks to human health posed by BSE and for having downplayed the problem despite concerns raised by a number of experts. The Committee of Inquiry also noted that there had been severe problems with the workings of the Commission’s Scientific Advisory Committee.p. 253

Box 10.3 The EFSA mission statement

The Authority shall provide scientific advice and scientific and technical support for the Community’s legislation and policies in all fields which have a direct or indirect impact on food and feed safety. It shall provide independent information on all matters within these fields and communicate on risks.

The Authority shall contribute to a high level of protection of human life and health, and in this respect take account of animal health and welfare, plant health, and the environment, in the context of the operation of the internal market.

The Authority shall collect and analyse data to allow the characterization and monitoring of risks which have a direct or indirect impact on food and feed safety.

Source: Regulation (EC) No 178/2002 of 28 January 2002

Responding to these and other criticisms, in 1997 the Commission issued a Green Paper on the general principles of food law in the EU. It was followed in 2000 by a White Paper on food safety, proposing the creation of what became the EFSA in the context of a reform of the entire food safety system, ‘from farm to table’. EFSA was to take on responsibilities relating to the risk assessment and risk communication parts of the regulatory system envisaged by the Commission. However, risk management, comprising legislation and control, was not to be transferred to the agency. EFSA was to be guided by the best science, independent of industrial and political interests, open to public scrutiny, scientifically authoritative, and closely linked to national scientific bodies. The reform proposals contained in the White Paper formed the basis of a regulation that laid down the general principles and requirements of food law, established EFSA, and sets out its mission (see Box 10.3).

The organizational design of EFSA is broadly similar to that of the EMA: a management board, an executive director, a scientific committee, and a number of scientific expert panels and their working groups. There are, however, some important differences that are best understood in light of the credibility crisis of EU food safety regulation in the aftermath of BSE and the rising power of the EP. The BSE crisis exposed the potential dangers of interference by national officials in objective risk assessments. Under pressure from the Parliament, the member states agreed to put EFSA under control of a management board that did not guarantee each member government a representative. The board comprises fourteen members appointed by the Council—in consultation with the Parliament, from a list drawn up by the Commission—plus an additional representative of the Commission. Four members must have a background in organizations representing consumer and other interests in the food chain, and no member is an official government representative. The principle of one representative per country has instead been retained in the composition of p. 254the advisory forum, which assists the executive director and advises on scientific matters, priorities, and work programmes.

The tension between the desire to enhance regulatory credibility by appealing to independent scientific expertise and the refusal to delegate regulatory powers to EFSA has been temporarily resolved by the doubtful expedient of an organizational separation of risk assessment (the function assigned to the authority) and risk management, which remains the responsibility of the Commission. However, the separation of risk assessment and risk management is problematic, because while the two functions are conceptually distinct—one dealing with scientific issues; the other, with economic, legal, and political issues—they are closely intertwined in practice. The setting of rational regulatory priorities, for example, entails economic, political, and scientific judgements that cannot be easily separated. Again, the determinations of the risk analysts can effectively pre-empt the decisions of the risk managers. Thus it is often impossible to determine with certainty whether a ‘dose–response function’—measuring the probability of an organism’s response to different levels of toxicity—follows a linear or a non-linear model, yet the scientists’ choice of one or the other model is crucially important to the determination of an acceptable level of risk (Majone 2003). Because risk assessment and risk management are so difficult to separate in practice, the refusal to set up a regulatory agency fully responsible for food safety entails a serious accountability deficit without solving the credibility problem.

Independence and accountability

In any democracy, there is a tension between the desire for regulatory bodies to be simultaneously independent and accountable. As we saw at the beginning of this chapter, the desire for policy credibility provides an important functional motivation for agency independence. However, in a democratic polity, when regulatory powers are entrusted to a non-elected body, there is understandably a desire to balance this independence with a healthy dose of accountability. The basic problem is always how ‘to control and validate the exercise of essentially legislative powers by administrative agencies that do not enjoy the formal legitimacy of one-person, one-vote election’ (Stewart 1975: 1688). Law-makers can try to ensure some measure of accountability by giving the agency very specific instructions in the laws that they ask it to implement, putting in place a variety of oversight and judicial review mechanisms, and imposing rigid administrative procedures that force the agency to act in an open and transparent manner (McCubbins et al. 1987).

From the outset, EU agencies have been subject to a variety of control mechanisms designed to ensure that they cannot deviate too far from the will of their political masters. This oversight has long been evident in the composition of agency management boards, whereby member states ensured that their representatives could keep a watchful eye over agency operations. As the power of the EP has grown over the p. 255past two decades, it too has asserted itself as a political master of the EU agencies. This assertion has been evident both in the EP’s scrutiny of agencies’ budgets and in the Parliament’s demands that the agencies adopt more formal, transparent, and judicially enforceable administrative procedures. The impact of these demands is evident in the regulations founding a number of the recently created EU agencies. For example, the EASA and the ECA, both of which have been given authority to make decisions concerning the safety of products, are required to follow detailed, transparent procedures, to give reasons for their decisions, and to provide applicants access to a board of appeal to contest decisions. Substantial accountability mechanisms have been put in place, and certainly the EU agencies operate in a far more transparent and accountable manner than the comitology committees that preceded them.

The network model

It is clearly impossible to transpose to the EU the American model of federal agencies operating independently from the regulatory authorities of the states. Regardless of what one thinks of the alleged legal obstacles to the adoption of such a model, it is certain that the member states would reject it. However, again and again, member states have proven themselves willing to construct systems in which the national regulators become components of EU-wide networks, coordinated by European agencies.

The model in which an EU agency serves as the coordinating hub of a network of NRAs should not be confused with a model of governance that relies exclusively on a network of NRAs in the absence of a European agency. Some scholars (Eberlein and Grande 2005) and many practitioners have argued that EU-wide networks of NRAs provide an effective alternative to establishing more formal, centralized EU agencies. In some sectors, such as energy and financial market regulation, many national governments long resisted calls for the establishment of EU agencies by insisting that networks of NRAs could achieve the needed cooperation and harmonization. However, the actual experience with such networks—in fields from pharmaceuticals, to telecoms, to energy, to financial market regulation—has been unimpressive. EU networks regularly fail to deliver regulatory harmonization because pursuit of national self-interests regularly trumps the impact of ‘professionalization’ and other normative pressures that network governance theorists claim should facilitate effective cooperation. Indeed, it is for this very reason that some of these loose, ineffectual networks were eventually subsumed into more centralized structures under the leadership of a European agency (as in the fields of medicines, energy, and financial services regulation).

The network model has been crucial to the proliferation of EU agencies. By relying on networks of NRAs, EU agencies render themselves less threatening to those who oppose centralization of power. Nevertheless, by creating and coordinating networks of NRAs, the EU agencies can encourage the spread of common regulatory norms p. 256and practices across the member states. Ultimately, the agencies manage to harness the capacities of existing NRAs to serve European ends.


As shown by most chapters in this volume, the rate of institutional innovation in the EU, after six decades of integration, is still remarkable. This is certainly true in the case of European regulatory agencies. The quantitative growth of EU agencies since the 1990s and, with it, expansion of the range of policy areas in which agencies play a role in governance is striking. More recently, we have also seen an increase in the substantive powers of at least some EU agencies, with doctrinal change at the Court of Justice opening the way for a greater delegation of regulatory powers to these agencies.

Inter-institutional politics continues to play a crucial role in the design of EU agencies. In most areas of regulation, design of new regulatory agencies today requires the agreement of the Council, the EP, and the Commission, each of which can simply refuse to propose reforms that would undermine its own authority. The precise terms of the compromise between these institutions varies in the case of each agency and they have failed thus far to agree on a standard template. Nevertheless, the basic outlines of a model of EU agencies has emerged and is now a vital feature of the Union’s regulatory landscape. EU agencies rely heavily on NRAs, but the agencies provide central leadership and harness these authorities into pan-European networks. The two most dramatic crises faced by the EU in recent years—the euro crisis and the refugee crisis—have each revealed the need for greater centralization of regulatory authority in their respective fields, and these crises have prompted the establishment of new agencies (such as ESMA, the EBA, EIOPA, the SRB) or the dramatic scaling up of existing ones (Frontex and EASO). It seems highly likely that the number and authority of EU agencies will continue to grow in the decade to come.

Further reading

Recent examples of the burgeoning literature on regulatory agencies in Europe are the volumes edited by Zwart and Verhey (2003) and Gerardin et al. (2005). Freedman (1978) considers only US institutions, but still provides the most extensive discussion of the legitimacy problems of regulatory agencies. Recent developments in risk regulation, with special emphasis on food safety, are discussed in Majone (2003). The Community method and its implications for institutional reform are analysed by Majone (2005). Shapiro (1997) and Kelemen (2002) provide early accounts of the politics of EU agency design. Kelemen and Tarrant (2011) and Rittberger and Wonka (2010) provide more recent analyses, while Groenleer (2009) provides a detailed book-length analysis of the development of EU agencies.

Freedman, O. (1978) Crisis and Legitimacy (Cambridge: Cambridge University Press).Find it in your libraryGoogle PreviewWorldCat

Gerardin, D., Munoz, R., and Petit, N. (eds) (2005) Regulation through Agencies: A New Paradigm of European Governance (Cheltenham: Edward Elgar).Find it in your libraryGoogle PreviewWorldCat

Groenleer, M. (2009) The Autonomy of European Union Agencies: A Comparative Study of Institutional Development (Delft: Eburon).Find it in your libraryGoogle PreviewWorldCat

Kelemen, R.D. (2002) ‘The politics of “Eurocratic” structure and the new European agencies’, West European Politics, 25/4: 93–118.Find it in your libraryGoogle PreviewWorldCat

Kelemen, R.D., and Tarrant, A. (2011) ‘The political foundations of the Eurocracy’, West European Politics, 34/5: 922–47.Find it in your libraryGoogle PreviewWorldCat

Majone, G. (ed.) (2003) Risk Regulation in the European Union: Between Enlargement and Internationalization (Florence: European University Institute).Find it in your libraryGoogle PreviewWorldCat

Majone, G. (2005) Dilemmas of European Integration: The Ambiguities and Pitfalls of Integration by Stealth (Oxford: Oxford University Press).Find it in your libraryGoogle PreviewWorldCat

Rittberger, B., and Wonka, A. (2010) ‘Credibility, complexity and uncertainty: Explaining the institutional independence of 29 EU agencies’, West European Politics, 33/3: 730–52.Find it in your libraryGoogle PreviewWorldCat

Shapiro, M. (1997) ‘The problems of independent agencies in the US and the EU’, Journal of European Public Policy, 4/2: 279–91.Find it in your libraryGoogle PreviewWorldCat

Zwart, T., and Verhey, L. (eds) (2003) Agencies in European and Comparative Law (Antwerp: Intersentia).Find it in your libraryGoogle PreviewWorldCat

Web Links

The official EU website is the place to start any search for basic information on its institutions and bodies, and this page links directly to the various different European agencies. (See also Table 10.1 for more specific links.)


  • 1. Council Regulation 1210/90 of 7 May 1990 on the establishment of the European Environment Agency and the European Environment Information and Observation Network, OJ L 120/1.

  • 2. Council Regulation 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, OJ L 214/1.

  • 3. Regulation 178/2002 of the European Parliament and the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, OJ L 31/1.

  • 4. Case 9/56 Meroni v High Authority ECLI:EU:C:1958:7.

  • 5. Case 270/12 United Kingdom v Parliament and Council ECLI:EU:C:2014:18.

  • 6. p. 257 Regulation 236/2012 of 14 March 2012 on short selling and certain aspects of credit default swaps, OJ L 86/1.

  • 7. Art. 2 of Regulation 1210/90.

  • 8. See Regulation 2309/93.

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