BEAUDRY Charlotte
11123907
Master Thesis
EUGO Programme 2016
Supervisor: Zeitlin Jonathan
European Centre for Disease Prevention
and Control
An Evaluation of its influence on its stakeholders
U n i v e r s i t y o f A m s t e r d a m – M a s t e r T h e s i s
Table of Contents Acknowledgment Abbreviations
1. INTRODUCTION ... 5
2. THEORETICAL FRAMEWORK AND LITERATURE REVIEW ... 7
2.1. CONCEPTS DEFINITION ... 7 2.1.1. EU AGENCIES ... 7 2.1.2. INFLUENCE ... 9 2.2. THEORETICAL PERSPECTIVE ... 10 2.2.1. TECHNOCRATIC GOVERNANCE ... 11 2.3. ANALYTICAL FRAMEWORK ... 13 3. METHODOLOGY ... 17 4. THE ECDC ... 19 4.1. CENTRE STRUCTURE ... 19 4.1.1. GOVERNANCE STRUCTURE ... 19 4.1.2. STAKEHOLDERS ... 20 4.1.3. FORMAL INFLUENCE ... 21 4.2. MECHANISMS OF INFLUENCE ... 24 4.2.1. GOOD GOVERNANCE ... 24 4.2.1.1. Independence ... 24 4.2.1.2. Transparency ... 28
4.2.1.3. Network cooperation and partnerships ... 29
4.2.1.4. Review mechanisms ... 32 4.2.1.5. Conclusion ... 34 4.2.2. TRANSMISSION TOOLS ... 35 4.2.2.1. Formal influence ... 35 4.2.2.2. Risk Communication ... 36 5. INFLUENCE ... 43 5.1. INFLUENCE ON COMMISSION ... 43
5.2. INFLUENCE ON MEMBER STATES (BELGIUM) ... 50
5.3. GROWING INFLUENCE ... 54
Acknowledgement
I would like to express my gratitude to the ones who helped and contributed to the realization of this thesis. First of all I would like to thank my supervisor Jonathan Zeitlin for his constant help and guidance throughout the process. His support and constructive feedbacks helped me to stay positive and pushed me to surpass myself. I would also like to thank my classmates for their feedbacks, advices and mutual support during this research process.
Furthermore, this work wouldn’t have been possible without an inside on of the Belgian Institute of Public Health and the Commission. Therefore I want to thank the people in this institute but also from the Commission who made time available for interviews, and who provided me with indispensable information and food for thought.
Finally I would like to dedicate this thesis as a representation of hard work and commitment, to my family, boyfriend and my godfather, without whom this enriching year wouldn’t have happened.
Abbreviations
AF Advisory Forum of the ECDC
CCB DG RTD DG SANTE ECDC
Coordinating Competent Bodies
Directorate General for Research and Innovation Directorate General for Health and Food Safety European Centre for Disease Prevention and Control
EFSA European Food and Security Agency
EMA European Medicine Agency
EMCDDA European Monitoring Centre for Drugs and Drug Addiction
EU European Union
HSC Health Security Committee
MB Management board of the ECDC
MIS Management Information System
MS Member States
WHO World Health Organization
1. Introduction
The European Union (EU) has come a long way since the Schuman Plan in 1950 (Alter and Steinberg 2007: 1). From just a few countries agreeing on the European Coal and Steel Community (ECSC), to 28 countries now part of the Union, or from only economic competence to three degrees of differing EU competences, one truth is that the European integration has deepened over time.
However, when it comes to the protection of human health, the EU institutions still lack competences. Indeed the role of the EU is reduced to support, supplement and coordinate Member States’ actions. In 2005 these competences were delegated from the Commission to a newly created EU agency: the European Centre for Disease Prevention and Control (ECDC). This agency had, among other competences, the duty of providing scientific and technical assistance to Member States and the EU institutions by collecting and evaluating relevant scientific data related to communicable diseases.
In the past few years, it has been relevant to wonder about the existence of such an agency, which could coordinate and help Member States and the Commission with scientific assessments. But even more essential to inquire whether this system functions efficiently. Indeed infectious diseases both outside the EU and inside the EU’s territory have been at the forefront of media interest. Ranging from Influenza, Ebola and now the Zika-virus, Member States have been required to analyse a great amount of scientific data in order to control but also to prevent such diseases spreading to and within the EU.
Although one can consider the European Commission and the Member States to be the primary stakeholders of the ECDC, the Centre has many other stakeholders with which it cooperates (Health Protection Agency & CRISMART 2010: 38). Based on which some authors have argued that the Centre has had difficulties in proving its legitimacy and added value as it operates in a crowded international landscape (Greer 2009). Nevertheless, despite issues of competence, the ECDC does play a key role within the communicable diseases community. There is indeed a major difference between the formal influence, which is based on the competences given to the EU through the TFEU and TEU further delegated to the ECDC and the informal ways in which an agency can exert influence on its stakeholders.
Furthermore, some have claimed that the Centre was a ‘growing organisation’, still developing itself from a structural point of view but also and simultaneously capable of gaining in significance (Interview n°1, 2; Greer 2009). Which in itself leads to the relevant question of knowing whether the agency is significant at all, and if so whether this significance has increased over time. This point will be analysed through different questions; what strategies does the ECDC pursue in order to enhance its internal influence? How
successful are these strategies? Which are the most successful, and why? And lastly, how do the institutional strategies pursued by the ECDC compare to those of other EU agencies?
This work will firstly look at the question of formal and informal influence, by distinguishing components that permit the agency to enhance its performance and its influence. Secondly, the impact of the ECDC’s scientific assessments, on both the Commission and the Member States will be assessed. Thirdly an analysis of whether this influence has increased over time will be undertaken. Concluded by a slight discussion on other agencies’ ways to enhance their own influence.
2. Theoretical Framework and Literature Review
The aim of this thesis is to gain an understanding of how the ECDC enhances its influence within the EU. For this particular reason, it is important to find the right balance between the empirical analysis and the theoretical background. The former will focus on the European Centre for Disease Prevention and Control as well as a brief comparison with other EU agencies, such as EFSA and EMA. The latter will be divided into three sections, the first in which the theoretical perspectives taken for this analysis will be explained. The second, in which important concepts such as the EU agencies and the concept of influence will be defined, and lastly, it will provide a comprehensible analytical framework. Furthermore, literature reviews will be included throughout.
2.1. Concepts definition 2.1.1. EU Agencies
It is crucial to first clarify certain concepts before looking at the analytical perspective and framework used for this thesis. The first term that needs clarification is ‘EU agencies’. Since the 1990s a wide range of decision-making, monitoring and coordinating tasks have been delegated to a quickly growing number of agencies (Busuioc et al. 2012: 2-4). These agencies cover a broad range of policy areas, have various legal standings as well as competences, and all differ in the degree of engagement in networking with other International or European organisations (Ibid.). EU agencies are frequently perceived as major institutional innovations within the political system of the European Union (Eberlein and Grande 2005). Furthermore, these European institutional arrangements have also been identified as producing ‘good governance’ (Joerges 1999).
In 2005 the European Commission defined agencies as “any autonomous legal entity set up by the legislative authority, in order to help regulate a particular sector at European level and help implement a Community policy” (EC 2005: 11). This broad definition has however been reshaped in order to take into account the differences between the various EU agencies further established. Kelemen has argued that EU agencies were better defined as “EU level public authorities with a legal personality and a certain degree of organizational autonomy that are created by acts of secondary legislation” so as to perform specified tasks (Ibid.).
EU agencies can be categorized according to their competences, forming two main categories. On one side there are the ‘strong agencies’, which have direct influence on the regulation of certain policy areas, such as the European Medicine Agency or the European Food and Safety Authority (Eberlein and Grande, 2005: 99; Eberstein 2014: 4-5 and Jinhee 2011). On the other side are the ‘less powerful agencies’, in the sense that their main tasks lie
in the gathering and exchange of data as well as the coordination of expert networks aiming to create a de-facto harmonisation of Member states’ practices. Barbieri and Ongaro use another categorization and differentiate between “authorization agencies” and “coordination and information agencies” (2008). From there comes the interesting question of knowing whether this last category of agency is also having a particular influence on decision-makers’ activities.
Another way of categorizing EU agencies is by using the term ‘decentralized agencies’, which implies the fact that the body has been separated from the main governing body in order to reach its citizens (Regmi et al. 2010). Chamon (2010) and Scott (2005) however argue that there is not much about decentralised characteristic in the setting up of agencies. They argue that the delegation, when one traces the origin of the agencies, do not come from the EU level per se but already existed at the national level (Chamon 2010: 286). The ECDC for instance, is a centralisation of Member States’ competences, done so in order to increase cooperation and efficiency in dealing with health risks (Interview n° 4).
It is however a matter of perspective, incidentally the creation of agencies is often seen as a compromise between the Member States and the Commission (Chamon 2010: 286; Chiti 2009: 1398). It is regularly argued that Member states are reluctant to give new power to the Commission and therefore prefer to combine their expertise in a newly created agency. Therefore some argue that the Europeanization is happening through establishment of EU agencies (Chamon 2010; Chiti 2009). However in some of the agencies, Member States remain in charge of many aspects; in the ECDC for instance, they also appoint representatives to the boards, who play a crucial role in the functioning of the agency but also in the appointment of the director (Chamon 2010).
Moreover, just as Member States are cautious of a Commission too powerful, the Commission is also not a fervent supporter of strong and too powerful agencies (Chamon 2010). The Commission has characterized EU agencies as ‘satellites’, because they are separate, yet not wholly independent entities from the main body since making them completely independent would generate bureaucratic competition (European Commission 2007: 1). However, the concept of a EU agency is still confusing and ways of classifying them are numerous. For example, the term ‘Networked agency’ was introduced so as to describe an agency heavily relying on networking (Provan and Kenis 2007). However, Coen and Thatcher have introduced an opposite yet very similar term: the ‘agencified networks’ of national regulators (Busuioc et al. 2012: 196). Here they argued that several networks could indeed become centralised around one agency (Ibid.).
2.1.2. Influence
Another relevant concept in this analysis is that of influence. There is however a lack of common definition of influence within the literatures (Jinhee 2011: 4). Numerous literatures and studies have touched upon the term of influence in relation to power. Lasswell and Kaplan (1950) as well as Dahl (1963: 50) define influence as being a subcategory of power. They then argue that power is a combination of influence together with the threat of sanction (Dahl 1963: 50). Lasswell and Kaplan define power when one is involved in the ‘making of the decision: G has power over H with respect to the values K if G participates in the making of decisions affecting the K-policies of H’ (1950: 75). However, this definition is based on a rational model, which fails to take the social perceptions of such influence, bringing nuance and uncertainty within the explanation of a process, into consideration (Liete 2015: 575; Servent et al. 2013: 4). There is indeed a need to consider a constructivist approach to influence.
Servent et al. argue that the first step for an inclusion of social components within the understanding of influence is to recognise that the study of the structure of the system can be combined with the understanding of the agent’s actions (2013: 5). Bachrach and Baratz (1975) distinguished influence from power and more interestingly ‘identified a second face of power, looking at non-decisions as well as positive outcomes’ (Servent et al 2013). Lukes also takes a sociological perspective within which he examines decision-making and non-decision-making power (2005: 59). These perspectives open a door to explore non-decisions but also inactions (Servent et al 2013: 8). It also allows for an investigation of the outcomes and an analysis of the process of such outcomes. In the same line of argument, such concept of influence highlights the significance of going beyond what is happening at the frontstage of the decision-making, in order to explore what happens backstage (Goffman 1959).
Based on this, influence can be pursued through social interactions but also through inter behaviours. The internal actions of an agency can therefore have an external impact on its stakeholders or on the public opinion. What is important here is to look at the actions of the agency and agents within that agency aiming at gaining a stronger position in a given field (Liete 2015: 564). This highlights the actions it undertakes in order to have a stronger influence on the Commission and Member States.
Other authors have analysed the impact of influence itself, Versluis et al. show that especially in risk-related sectors as for instance within the disease prevention or medicines fields, EU agencies have increased their influence on policy formulation and on decision-making (2011). Jinhee further addresses the blind spot between the formal influences – the de jure influence – and the informal influence that has taken place within the current
policy-making pattern in the EU – the facto influence. She further highlights the importance of the informal influence of European agencies on policy making (2011: 76).
Some authors have stressed the legal framework in which agencies are operating, while others assess their role and potential impact derived from their legal competences as laid down in their founding regulations and formal designs (Vos 2000 and Busuioc et al. 2012). Another set of literature touches upon the crisis management and the importance of such EU bodies for the coordination of Member States responses (Boin et al. 2013; Leite 2015). Leite work argues that because there is a lack of European integration within risk and crisis management, any voluntary cooperation and progress through EU body must be considered as important (Leite 2015).
However there is a gap to be filled in the literature concerning the analysis of EU agencies’ mechanisms to enhance their informal influence based on constant factors. In order to reduce this gap, Jinhee developed her concept to assess influence based on indicators such as resources, environment and motivation (2011: 5-7). Many points of this framework are relevant for this work and its analysis of the ECDC’s increase of informal influence. Indeed Jinhee looks at the political salience of the agency, but also at the amount of information commissioned by the agency in order to assess its resources. Furthermore, the motivation part is relevant here as she touches upon the networking of such agencies (Ibid.).
The focal point of this work is however more concentrated on the actions of the agency rather than on the formal competences such as laid down in the founding regulation. It will look at the agency’s actions, its development and the strategies it deploys in order to gain more influence in the area of protection of human health.
This research will require one to acknowledge that some indicators exist, which de facto increase legitimacy or increase the scientific quality of the agency, resulting in more or less influence. Based on this, it will then be possible to assess whether there was any growth of influence at all.
2.2. Theoretical perspective
Some authors have focused on the relationship between the agencies, as agents, and their principals (Pollack 1997; Thatcher and Stone Sweet 2002). Some of these authors have furthermore argued that agencies do not have only one principal, often the Commission, but several parents. Waterman, Rouse and Wright (1998) have focused on bureaucratic autonomy that assumes multiple sources of influence on agencies. This perspective focuses on the relationship between the agent and the principals, where the agent is dependent of its
principals’ wills (ibid). This perspective mainly puts an emphasis on the actions of the principals towards the agent.
Although the analysis of the relationship between the agency and its principals is very relevant for this topic, more emphasis must be put on the agency itself. The institutionalist perspective focuses more on the agency as a distinct actor and therefore more suited to look at the agency’s strategies to exercise influence on decision-makers (Martens, M. 2012). Indeed the institutionalist perspective’s focus starts from the assumption that institutions matter (Ibid.). Institutionalists put an emphasis on the importance of the introduction of values and see the existence of such institutions as being beyond ‘the technical requirements of the tasks at hand’ (Selznick 1984: 17). However the focus here is not only on how the agency has become or is to become independent and how it can gain necessary formal competences so as to act on its own, but to look at its informal activities and mechanisms developed in order to gain importance and influence.
A more prominent set of literature regards the EU as a system of ‘network governance’ based on achieving and promoting common interests (Curtin and Egeberg 2008: 650; Pollak and Slominski 2009: 906). It is the very aim of network agencies to coordinate already existing national networks and supranational institutions by providing one distinct administrative framework (Hofmann and Turk 2006). The ECDC can be understood as such a network agency as it creates coherence, and coordinates and produces stability among network activities. The ECDC can indeed be perceived as a technocratic and managerial body supposedly linking national and supranational authorities.
2.2.1. Technocratic governance
Meynaud (1969) and Frank Fischer (1990) talk about another interesting perspective on governance: technocratic governance. They define technocratic governance in ‘classical political terms as a system of governance in which technically trained experts rule by virtue of their specialized knowledge and position in dominant political and economic institutions’. A vast literature has discussed the increase of technocracy as a concept (Burris 1993; Williams 1971). Another set of literature discussed the relationship between scientification and politicisation (Lee 2008; Weimer 2015; Weimer and Pisani 2016). Weimer looks at the reasons for the failure of deliberation at EU level regarding GMOs regulation and argues that politicisation of GMO decision-making is not the only factor that has led to problems. She argues that the scientification of the authorisation processes has played an important role in the failure of governance in this field (Weimer 2015). Weimer and Pisani apply the
administrative legitimacy concept based on Fisher’s framework, by looking at the EU regulations focusing on the ‘co-production’ of EU law and scientific expertise (2016).
Robert Fischer (2008) argues that a technocratic mode of governance makes politics more rational as well as efficient because it relies on experts who are objectively able to deal with issues of high complexity and come up with scientific solutions. It is argued that technocratic governance tends to function more efficiently in policy areas where political attachment is low and uncertainty is high (Radaelli 1999). However, both citizens and enterprises have complained that EU technocrats working in ‘isolation tend to produce too much regulation and bad legislation’ (Ibid.).
Authors such as Fischer (1990) or Radaelli (1999) looked at the debate on the difference between technocratic utopias and the contemporary technocrat. Radaelli argued that the main difference was the inclusion of democratic values, which in the latter are present but absent in the former (1999: 4). Technocratic governance is characterized by a change in the nature of power, where due to its complexity and the growth of independent agencies, public policy is often isolated from public scrutiny (Ibid.). It is furthermore characterized by a risk of technocratic mentality, where political conflicts are not considered as a democracy factor but only as the result of ignorance in a particular policy field (Idem, p. 4-5).
The technocratic governance debate is based on the very fact that the decision-makers, often the Commission or Member States, do not understand all issues raised by the experts because of the high level of scientific background and specific technologies one requires to understand disease risk analysis. Therefore the decision-makers will often rely on the experts without a full understanding of the actual issues, being a ‘blind driver taking directions from the passenger in the back seat’ (Vos 2006: 122). As Fischer puts it, politics is more and more required or indeed reduced to the very technically oriented task of ‘keeping the machine running’ (1990). Another pertinent point within technocratic governance is the absence of citizens’ elections for experts. This is because experts are chosen among the most excellent scientists, and not among the most politically presentable (Fischer 2008: 5).
Although technocratic governance has been argued to be rational and more effective, it is also true that the stronger the scientific expertise is relied upon in the democratic decision-making on risks, the more difficult it becomes to legitimate such decision-decision-making (Weimer and Pisani 2016: 4). Furthermore stated in the famous Pfizer ruling, and re-argued by Weimer and Pisani, is that the experts do have scientific legitimacy but lack democratic legitimacy or any political responsibilities. ‘Scientific legitimacy is not a sufficient basis for the exercise of
public authority’ (Idem: 2). Therefore the more scientific opinions are relied upon, in a systemic and automatic way, the more the agency will need to prove its normative legitimacy. However it is also true that the way actors interpret the practices of other actors can have an impact on whether such actors will rely on them for any decision-making (Leite 2015: 575). In other words, legitimisation of actions can have great impact on the influence the agent has on further actions, such as decision-making but also on non-actions (Ibid.).
A mixed set of theories will help us to grasps several and distinguishable keys of the ECDC’s governance and way of enhancing its influence. Technocratic governance will help us understand the debate on whether pure scientific-based risk assessment is helping the ECDC to influence the Commission and the Member States, or instead harming its legitimacy as it lacks public involvement, and consideration of other values within its risk analysis. The multiple principal model will help us to grasp the relationship between the agency and the Member States as well as the Commission. As we look at the agency as being created to serve the Member states and the Commission, its principals.
2.3. Analytical Framework
This analytical framework will be composed of several factors, some of which have been indicated and analysed within Jinhee’s work (2011). However it will deviate from it in several ways. This analysis does not look at what formally gives the ECDC influence on the decision-making, although we need it as departure, but rather it looks at what exactly the agency can reinforce in order to gain further influence among its EU peers. Further referred as informal influence, it is described by Brie and Stölting as the facto influence exercised by informal processes which arise through flexible social interactions within and outside the formal institutional setting (2012). This framework aims to assess whether the increase of scientific quality or the increase of legitimisation is the main mechanisms to do so.
2.3.1. Scientific quality vs. legitimisation
On one hand the, research should not be about whether one agency has scientific knowledge but rather recognize that all agencies have ‘scientific knowledge’. And from there research should focus on the means used by the agency to handle, strengthen and spread this particular knowledge. In other words, the focus is to see what are the components permitting the enhancement the scientific knowledge of the agency. This line of argument is consistent with the technocratic governance rationality. The main argument here is that by reinforcing certain governance factors the agency will reinforce the quality of its work, therefore enhancing its influence. However there is also an argument that supports the idea that
increasing legitimacy would be a way to enhance the agency’s reputation and therefore enhance its reliability, thus influence. This argument is however in contradiction with the concept of technocratic governance, which does not focus on legitimacy but rather on efficiency. As previously stated, some have argued that technocratic governance can harm an agency’s legitimacy or reputation (Dabrowska 2007). This is mainly because scientific expertise does not involve any other societal or democratic values therefore a strong reliance on science only renders the system un-democratic (Ibid.). However legitimacy can also harm the efficiency of an agency; by the inclusion of public debates and focuses on legitimacy the agency will lose time and will not per se increase the quality of its output (Ossege 2016).
2.3.2. Factors
First of all this thesis will look at the governance of the ECDC primarily through four components. (i) The independence of the ECDC’s staff in the Managing Board and in the Advisory Forum and experts involved in the Centre’s risk assessments. But will also touch upon the (ii) transparency of its activities. Independence and transparency aspects are arguably enhancing the good governance of an agency (Johnston 2002; Weiss and Steiner 2006). These good governance factors are important for the agency to achieve its goal. Indeed issues of transparency and independence are directly linked to the quality of the agency output (Vos 2000). Moreover, having independent judgements and being able to trace the reasons for such judgment are important components for the agency stakeholders’ trust in the agency. Once the agency has implemented measures to promote these two components, they will then be able to rely fully on the outcome of the agency.
Moreover, the reputation of an agency is directly linked to its ability to do its work efficiently. If the agency does not have a good reputation, this will reduce its potential influence. Stakeholder will not trust its work and may call for another scientific body to provide a second opinion. This in turn will result in the agency not fulfilling the tasks it was created for. In order to ensure the legitimacy of the agency it is important for the latter to ensure its independence, transparency and quality of scientific work.1 However increasing independence also plays a crucial role in the quality of its work.
This thesis will then look at (iii) whether the agency has any review mechanisms concerning the agency governance aspects as a whole as well as whether it reviews its strategic objectives and how often. Furthermore whether (iv) the agency has reinforced partnerships with other experts will also be looked at. Many authors have argued that these
1 Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and Control, Preamble (14)
aspects were linked to what can be called ‘good governance’. Indeed, learning from past actions and learning by sharing best practices are ways to improve performance and efficiency of an actor (Sabel and Zeitlin 2008).
Second of all this work looks at the mechanisms for spreading the agency’s knowledge among decision-makers. It argues that the way the agency spreads the information it possesses has a strong importance in the influence the agency will have. Chalmers pointed out that the “medium (of influence) is more important than the message” (2013; 41). For this the risk communication activities will be looked at.
Risk communication shapes how individuals perceive risks. Important factors within such activities are therefore the voluntariness, equity, uncertainty, reversibility and origin or the risk (Sandman 1989). They argue together with Springston and Weaver Lariscy (2005) that there has been a huge emphasis on the need for planning communication and strategies in advance as well as being prepared. Meaning that preparedness has a direct impact on the trustworthiness of an organisation or agency at any level of the public health community (Fisher at al 2011; Barnett et al. 2005).
Designing and delivering strategic plans informed by projections of future trends is considered to be a key component of an establishment’s reputation and relationship management strategy. A plan that is based on knowledge of the expectations of audiences and
Good governance Dimensions Reinforcement strategies
Independence
To what extent is the ECDC politically independent?
How did the agency reinforce the independence of its experts and staff
Transparency To what extent is the ECDC
transparent?
How did the agency reinforce the transparency of its activities and elections
Partnership & networks
To what extent does the ECDC have contact with other experts?
How did the agency reinforce its partnerships and network contacts with other experts?
Review mechanism
To what extent does the ECDC review its own work and governance system?
How did the agency reinforce its reviewing mechanisms?
existing relationships and lines of communication is particularly valuable for crisis communications teams (Mitchell 1986).
The risk communication analysis in this work will be twofold: first it will look at how far the Centre puts its knowledge at the disposal of its stakeholders and to the public. Second it will look at the relationship between the Centre and its stakeholders. Indeed many argue that compliance with advice might emerge only as relationships are built, nurturing trust and loyalty and a shared understanding of risk (Adil 2008; Alaszewski 2005).
Furthermore the transmission of knowledge is very much done through informal contacts between actors playing a role on both sides. This means that the relationship and frequency to which they cooperate is crucial to the intensity to which one could have influence on the other.
Transmission of knowledge
Indicators Reinforcement strategies
Formal competences
On request of the decision-makers or own initiative?
Not the activities of the agency per se but need to assess it before acknowledging any mechanisms
Risk
Communication
What is the risk communication situation?
a. Assessing the available knowledge
b. Assessing its relationship with its stakeholders
Has the ECDC increased its available scientific documents? Has the ECDC strengthened its relationship with its stakeholders? How much contact do they have?
3. Methodology
The European Centre for Disease Prevention and Control is the focus of this work for several reasons. First research and articles have been concluded on the importance of EU agencies, however these always seem to refer to the legal competences of such agencies in order to answer the degree of influence they exert on the Commission (Ossege 2016). I have chosen the ECDC so as to focus on the social interaction between actors that is crucial but often put aside. This work is a qualitative research as it aims to look at the actions of the ECDC to exert informal influences and its motives (Kothari 2004: 3-4).
The research questions will be answered by gathering information on the development of independence, transparency, review mechanisms and relationship with partners so as to assess whether these components have improved over time. But also on two further important points which are the level of knowledge that was put at the reach of stakeholders and its increase over time, and the nature of the relationship between the ECDC and its stakeholders (Commission and Member States) and the improvement of these over time.
First of all the ECDC has more than two stakeholders, however Member States and the Commission were taken as main ones because they are the principals of the Agency. The Commission created it and it is essentially composed of Member States representatives. Furthermore the Centre principally works for the Commission and for the Member States.
The analysis will be based on two main sources, either interviews or analysis of documents, in order to ensure the quality of each source. The information received in the interviews will be, as far as possible crossed analysed by documents and vice versa. The interviews will first investigate the components and whether stakeholders believe they were improved over the years and second will investigate the stakeholders’ perceptions of the ECDC’s influence. The interview session involved 6 respondents from both stakeholders, the Commission and Belgium as example for MS. The first interview was a semi-structured interview with a member of the managing board of the ECDC. The second interview was also a semi-structured with a Belgian expert working within the Belgian Institute and being part of a network of experts within the ECDC. The third one was also a semi-structured interview, with a particularly respected person within the Belgian public health community, also being strongly involved within the ECDC managing board. The fourth one was a semi-structured Skype interview with a very respected Belgian doctor who is part of the advisory forum of the ECDC. The fifth was a brief email conversation with an important person within the ECDC and the sixth was a semi-structure phone interview with a member of DG SANTE, within the unit of Public health, country knowledge, and crisis management.
These respondents were picked for different however important reasons. First of all, four respondents are from Belgium, which gave me inside on how the ECDC was perceived within this MS. Second of all, two of them were part of the risk management side, being more politically involved and the two others from the federal institute of public health, therefore more focused on the scientific side. This division gives a balance and objectivity to the analysis of perception of the ECDC’s influence. Furthermore these four respondents were all somehow involved within the Centre, however some strongly while others in a softer way. This also gave the opportunity to assess whether the involvement within the ECDC has a certain impact on their perceptions. And finally one respondent was from the DG SANTE within the Commission, which was crucial to assess the influence of the Centre on the Commission.
The analysis of documents is an important source for the assessment of the indicators of influence. By looking at annual reports from 2005 onwards, the strategic reports but also at other corporate reports evaluating the implementation of goals; steps and initiatives that have led to improvement of these particular components will be distinguished.
The part on influence will rely strongly on the combination of interviews and documents analysis. First of all, the influence of the ECDC on the Commission will be looked at based on a random choice of requested risk assessments from the Commission. Where the following actions of the Commission in relation to those risk assessment’s recommendations will be assessed. Second of all, the influence of the Centre on the MS will be assessed through the risk assessments and reports found on the website of the Belgium Federal Institute of Public Health and through the risk communication as presented on websites of risk managers of the Belgian Federal Public Services.
Belgium is separated in federal and regional governments, meaning that units, which can potentially be responsible for a part of risk assessment or risk management are present in all regions as well as at the federal level. However the choice to focus on the federal bodies to assess influence is based on the fact that first the Federal Institute of Public Health (wiv-isp) is the focal point of the ECDC, meaning the institute with which cooperation will be stronger.
4. The ECDC
The case of the European Centre for Disease Prevention and Control is here assessed through the above-mentioned components and their reinforcing strategies. However more is to be said on Centre itself before one can thoroughly explore the relevant components.
4.1. CENTRE STRUCTURE
Creation of the ECDC is based upon the idea of a strict separation of the two functions of risk assessment and risk management. The agency is designed so as to ensure that the scientific risk assessment is as independent and objective as possible (Busuioc 2012: 116).
4.1.1. Governance structure
The Centre is composed of two main bodies, the Management Board (MB) and the Advisory Forum (AF). According to the article 14 (1)(2) of the founding regulation,2 the management board has to be composed of one Member States representative, three members appointed by and representing the European Commission and two representatives of the Parliament. The representatives are appointed based on a broad range of competences and expertise. They are accountable for the management and leadership of the Agency as well as making sure the Centre acts in line with its founding regulation (Ecdc.europa.eu (1)).
The MB is the main body for review and evaluation. It focuses on approving and monitoring implementation of the Centre’s work programme as well as its budget. It also adopts the annual reports and reviews the external evaluations. The management board is also perceived as a place where not only strategic and technical decisions are made, but also a place where thinking and discussions are the main focus (Interview n°1). Indeed, despite the request of the Commission based on financial reasons, the Centre refused to meet less than three times a year due to the determination of the board’s members to continue open board discussions in which issues are brought up and solutions are found (Interview n°1).
Based on article 18 of the ECDC’s founding regulation, the AF is the body responsible for advising the Director on the quality of the ECDC scientific work. This body is composed of representatives of national public health institutes, performing similar tasks to those of the Centre. National representatives are nominated by Member States based on their scientific expertise. Furthermore, one public health official from the Commission is appointed to contribute to the AF, and three more members also appointed by the Commission to represent EU level interests, such as non-governmental organisations, patients or academia. However,
2 Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and Control
these three do not possess voting rights. By meeting at least four times a year, the forum also serves as a platform to exchange information and to strengthen cooperation between public health institutions.
Moreover, the agency is currently based on seven disease specific programmes including, Antimicrobial Resistance and Healthcare-associated Infections; Emerging and Vector-borne Diseases; food and Waterborne diseases and Zoonoses; Influenza and other Respiratory Viruses; HIV, sexually transmitted infections and viral Hepatitis; Tuberculosis and Vaccine Preventable Diseases (ECDC 2010a). The development of the diseases programmes has become a priority since 2010, with the ‘multiannual strategy on disease-specific programmes 2010-2013’ which entered into force. Those disease programmes have been reinforced thorough the ECDC development.
In addition to these vertical disease programmes, the Centre is also composed of horizontal functional units. These include surveillance; scientific advice; identification of emerging health threats; preparedness and response; training and health communication (ECORYS 2008). These activities are the main functions of the Centre and operate in a horizontal way within each diseases programme.
4.1.2. Stakeholders
The centre has two significant stakeholders, the Member States and the European Commission (HPA&CRISMART 2010). Indeed, the Centre is required to deliver scientific opinions to them when requested, but also is required to peer review and evaluate or support the MSs or the COM at any time. Furthermore, the Centre has many points of contact with the Commission and the Member States. Coordinating Competent Bodies (CCB) have been designated in each MS in order to cooperate with the Centre. These are National Health Institutes who have the same scientific purpose as the Centre. They manage of relational and coordination interactions, strategic and overarching interactions related to a specific disease group as well as technical and operational interactions related to a specific area (Elliott et al. 2012; Ecdc.europa.eu (2)). Regarding the Commission, DG SANTE, among others, is the unit responsible for the managing of risk in the area of communicable diseases. Additionally, the Health Security Committee (HSC) was created in 2001, as an informal advisory group on health security. It is chaired by the Commission and composed of officials from national governments (EC 2009). Its main function is the coordination of Member States in risk management and actions, and risk communication (Interview n°4 and ec.europa.eu (1)). More is to be said about the competences of the ECDC and its formal link with there particular stakeholders.
4.1.3. Formal influence
The European Union as stated in the article 4 and 6 of the Treaty of the European Union (TEU), has shared competence when it comes to ‘Common safety concerns in public health matters’ and only supporting, coordinating and supplementing competence regarding matters of protection and improvement of human health. These competences reveal several crucial points for the analysis of influence. The shared competence only concerns common threats to the safety of European citizens as a whole. This cross-border characteristic is the reason why such competence is given to the EU, however shared competence only means that the EU can regulate as long as the Member States have not yet done so.
Another point concerning the protection of human health in general is that EU institutions do not have the right to legislate in that field. This means that all the European Commission can do is enact recommendations, reports, guidelines, which are not binding. The flip side of this is that all competences remain with the Member States. They are therefore the ones responsible for any legislation in the field of protection of human health. This lack of competence at EU level is due to a common reason to restrain the delegation of competence: the unwillingness of states to give up their sovereignty (Chamon 2010: 288). This division of competences is important for the understanding of the creation of the agency and possible or lack of formal influence on the Commission and Member States.
The principle of conferral means that an institution has to act within the limit of its competences. The Meroni doctrine which was developed in a 1957 court judgement,3 stated that a European Institution cannot delegate more power than this one first had. This is why the explanation of the division of competence is pertinent; broadly speaking the EU agency can only be delegated the power that the EU has.
The agency was created based on the legal basis 152(4) TEC, which is now the article 168(4) TFEU. Based on which the Centre has five main activities, (i) the search, collection, collation, evaluation of relevant scientific data, (ii) to provide scientific opinions and scientific and technical assistance such as trainings, (iii) provide timely information to the Commission, MS, other EU Agencies or International Organisations, (iv) coordinate the European Networking of bodies active in the field of communicable diseases and (v) the exchange of information, expertise and best practices.
3 Cases 9/56 and 10/56, Meroni & Co, Industrie Metallurgiche v. High Authority, (1957-1958) ECR
The Centre works most of the time for the Commission or the Member States however it is permitted to act on its own initiative when there is an outbreak of unknown illness, which risks spread to or within the Community. Then the Centre is required to act based on its own initiative until the source of the outbreak is known. However, the Centre can only act within communicable diseases issues or when in coordination and cooperation with other competent bodies and only upon requests from those particular bodies.
The first important task here is the scientific opinions and assessments that the Centre has to provide to the Commission and the Member States. Indeed, this is where the Centre can exercise a certain influence. In its founding regulation, the centre is required to provide independent opinions but also to maintain scientific excellence by setting up new ad hoc scientific panels if no independent scientific expertise is available. The formal procedure for scientific opinion is also laid down in the founding Regulation – article 7. The centre is required to issue scientific opinion when the Commission requests so, regarding any matter within the Centre mission as well as in areas where EU law allows for the Centre to be consulted. Moreover, the Centre has to deliver scientific opinions at the request of the European Parliament as well as at the request of the Member states.
Once the Commission receives the scientific opinion, upon its request, the Commission is not legally bound by it. Meaning that the Commission may or may not base its further guideline or communication based on the ECDC’s scientific opinion (Interview n°5). The Centre usually sends different guidelines to the Commission. However, the formal rules are that the Commission does not have to wait for the ECDC guideline or advice, and can issue communication based on other scientific opinions (Interview n°5).
Another important task where the ECDC can exert influence is through its scientific and technical assistance and training. The Centre is requested to provide such technical expertise to MS, the Commission and other EU agencies regarding the development, regular review and update of preparedness plans. Providing scientific or technical assistance in any fields, upon request of the Commission, MS, third countries or even International Organisations – such as the WHO. This task includes helping out the Commission or MS to develop guidelines on good practices or on protective measures to be taken in response to human health threats. The ECDC can be requested to provide technical support to strengthen preparedness in MS but also to facilitate MS’s alignment with certain decisions, such as the decision 1082/2013/EU, by promoting good practices and methodological toolkits on preparedness planning or by providing evaluations of responses (ECDC 2016: 3).
However, an evaluation of responses or support to strengthen preparedness is only allowed when requested by the MS or the Commission. Furthermore if the Centre is invited to do so within particular MS, the final evaluation and requirements for improvement has no legal weight and the Member States are not obliged to follow the ECDC’s reviews (Interview n°1). However when the guidelines and toolkits development have the purpose to help MS to get in line with EU decisions, which are in general binding, the importance of such ECDC’s guidelines can increase enormously (Interview n°1).
Therefore one can conclude that the ECDC’s formal influence is quite restricted as its stakeholders are only officially taking into consideration the risk assessments or any of the Centre’s activities when they wish to do so. However as argued previously, influence goes beyond what is legally and officially said or done, this is why we can now go deeper into what we will call the informal influence of the Centre.
4.2. MECHANISMS OF INFLUENCE
Medical and scientific-based agencies, such as the ECDC, EMA or EFSA are important for the executive bodies such as the Commission or the Member States, to take proper and well-informed decisions on public health. The ECDC monitors the prevention and control of infectious diseases. But as stated previously, the EU has only supporting, supplementing and coordinating power when it comes to the safety and protection of public health, which naturally decreases its formal influence.
It was argued that the ECDC was created, like many other EU agencies, so as to please MS and make sure the Commission would not acquire too much power (Chamon 2010). Indeed as seen in the previous sections, Member States representatives are the members of the Centre’s management board, as well as of the scientific bench, the Advisory Forum.
The ECDC has a rather weak position within the human health protection community, as its activities are in no way binding on European decision-makers. Furthermore the legislation concerning broad protection of human health issues are not to be handled at the EU level.
In this section the focus will be on the internal indicators that could be reinforced in order to enhance the ECDC influence within the European Union. This will be divided in two sub-sections further distinguished into several points.
The first mechanism used by the ECDC is strengthening its basic design such as reinforcing transparency and independence and its good governance, which can be done through two main motivations either to promote its reputation through legitimisation, or to improve the quality of its outputs. The second mechanism is to reinforce the way it transmits its work to bodies on which the agency can have influence. Indeed some suggest that the ECDC has two ways to exert influence and this is mainly because of its two main bodies the Management Board focusing on governance issues and via the Advisory forum, which focuses on scientific quality of the Centre output (Interview n°4).
4.2.1. Good governance 4.2.1.1. Independence
Barbieri & Ongaro differentiate between three aspects of autonomy: financial, managerial and strategic autonomy. This includes the autonomy of the agency to have its own budget; a certain autonomy in managing the agency itself and the extent to which it is autonomous to set its own annual strategy (2008: 402). However our focus stays on the general concept of autonomy, meaning the political and industrial independence of the staff and experts and the financial independence of the agency as a whole. Thus, looking at the extent to which the
ECDC is dependent of its principals regarding its budget or if other sources exist and whether the members of the Centre are detached from any political links coming from the principals, the Commission but also other interests such as industrial interests. Independence of an agency is important for two reasons, (i) its efficiency, and (ii) its reputation.
Firstly, independence has been viewed by the Commission in its White Paper on Administrative Reform of 2000 as one of the key principles of a European Public administration. And was further defined in the Code of Good Administrative Behaviour (2000) adopted by the Commission. In this code the Commission links the concept of EU agencies to the independence and go further in explaining that the very existence of EU agencies was a solution to a lack of independence in previous systems. The Commission adds in one of its communication that;
“It is particularly important that they should have genuine autonomy in their internal organization and functioning if their contribution is to be effective and credible. The independence of their technical and/or scientific assessments is, in fact, their real raison d’être. The main advantage of using agencies is that their decisions are based on purely technical evaluations of very high quality and are not influenced by political or contingent considerations” (EC 2002).
Consequently, being independent is the main factor that ensures the ECDC fulfils its true raison d’être to be efficient.
Secondly, the concept of independence was first mentioned as an issue in the founding regulation of the ECDC, where the link between confidence of the EU institutions, general public and stakeholders, and the independence of the agency is explicitly made.4 The regulation even states that when independent scientific panel or expertise is not available in existing networks, the Centre is allowed to set up new independent ad hoc scientific panels in order to function as efficiently as required.5 Certainly, the degree of independence and the reputation that an agency holds are very intertwined (Eberstein 2014).
a. Conflicts of interest and financial independence
First of all, conflicts of interest are one of the issues that need to be looked at when tackling political dependency. Situations of conflicts of interest are quite common in the scientific world, however for the agency to be in line with scientific independence, those have
4 Preamble (14) of Regulation (EC) No. 851/2004 of the European Parliament and of the Council of 21
April 2004, establishing a European Centre for Disease Prevention and Control
5 Article 6 of Regulation (EC) No. 851/2004 of the European Parliament and of the Council of 21 April 2004, establishing a European Centre for Disease Prevention and Control
to be handled accordingly (Busuioc 2012: 729). The agency requires its experts to be selected from among the most experienced in their field. To again experiences however, the experts must spend a couple of years working for certain scientific industries or laboratories. Furthermore the job as experts within the ECDC is only a second statute, most of the experts networking within the Centre are remunerated by their first job, often national health institutes but also industries, health companies, or their own government in health ministries (Interview n° 2). This double job can be a burden for some experts, whose national work comes into correlation with their work within the ECDC. As was the case for one of the head expert who was also the mediator in the ENIVD network6: this had a detrimental effect on the work of the ECDC (Interview n°2). But it can also result in some experts having stronger interests in particular issues or introducing biased views that are detrimental to the scientific objectivity of the Centre.
The founding regulation contains a provision to ensure that conflicts of interests are handled appropriately, although the implementation of this provision took some years. The independence issues within the ECDC was mentioned in the first external evaluation, where the panel focused on the management board members and on whether conflict of interests where touched upon. The survey undertaken by the external panel had respondent from inside but also outside of the Centre. It found that the ECDC staff had estimated that the influence of non-scientific factors on the ECDC’s activities was considerable. Furthermore, already at this point the need for the establishment of a regulation to manage conflicts of interest was mentioned (ECORYS 2008).
Only in 2011 the ECDC introduced its managing procedures concerning declarations of interest for all ECDC staff members. By December 2011, permanent members of both the MB and the AF and their alternates, experts and observers had to fill in their declarations of interest forms. This form was then made a requirement for 100% of the ECDC staff by 2012. Furthermore all newly appointed members of the MB and AF are required to fill in a declaration of confidentiality and of commitment (ECDC 2011a).
Indeed when one accesses the ECDC website pages on its staff, their declarations forms are duly published next to each members and alternates. In practice, it has already happened that a few members, who found themselves in a situation of a conflict of interest with a discussed issue, were put aside from these particular meetings (Interview n°1). It has taken some time, precisely six years for the agency to implement such strong procedure in order to ensure independence of members. Indeed some argue that the Centre has developed strongly
in that regard (Interviews 1, 2 and 4) to reach an exemplary point (Interview 1). The independence of the experts in the Centre was seen as important and very appreciated by the respondent from the Commission (Interview n°6).
Concerning financial independence, the ECDC is completely dependent on the DG SANTE budget (Interview n°4). It has no external financial subsidies and is in fact not allowed to seek or to obtain any other financial resources. This of course goes back to the issues of independence of scientific opinions and the obvious detachment that the Centre must have from any industries, especially regarding any financial attachments (Interview n°4). Therefore the Centre, which was created in order to provide independent advice on technical issues, is required not to gain financial autonomy from its principal, in order to stay in line with its scientific objectivity requirement (Ibid.).
Therefore one can conclude that there is strong evidence that the ECDC is separated from the political interests of the Commission. Moreover the Centre has been doing its best so as to be separated from any other values such as those of industry. However the ECDC is completely financially dependent on the Commission. This conflicts with the concept of autonomy, however it reinforces the idea that the Centre will not be attached to other industries values or interests. Therefore it can be argued that because the Centre needs funding in order to function, the dependence on the DG SANTE budget is less problematic than if the ECDC was linked financially with industrial or other private sources.
It is indeed perceived that the ECDC acts in line with its founding regulation basing its advice on science, insofar as risk assessment and risk management are separated in different bodies (Interview °6). Indeed the ECDC’s main task is the risk assessment of infectious diseases, where political issues and values should not appear (Interview n°6). Where the Commission, especially the DG SANTE and the Health Security Committee are in charge of assessing the political and societal aspects of such risks and must include them within their managerial decisions (Interviews n°3, 4 and 6).
Furthermore, and based on the external evaluation of 2014, there is a broad consensus among stakeholders on the ECDC independence of judgments concerning scientific advice. Moreover, there have not so far been cases of open dissatisfaction (E. Associati srl 2014; Interview n°3). It was even argued that the ECDC management board has strong political aspects in the sense that it has to manage relations and discussions with the political institutions, but that they remain quite separated from any scientific decisions therefore ensuring the technical purity of such advices (Interview n°1).
The issue of independence can hardly be touched upon without the transparency requirement. This is because without transparency, it is rarely possible to check whether the agency is independent or not.
4.2.1.2. Transparency
An increase of transparency of actions enhances the legitimacy of the Agency, thus, its possible influence on further actions. Transparency can be discussed in the light of two main issues: the elections of the ECDC staff and selection of scientific networks, and the transparency of the annual budget spending (Interview 2).
The issue of transparency was mentioned in the first external evaluation concerning scientific advice (ECORYS 2008). Where the external panel found that certain respondent believed that there was a need for more transparency in using different pools of scientific experts. Too much effort would be spent on finding the right external expert to answer particular scientific question or conduct a scientific advice (Idem: 57). Some argue that this task could be left to national institutes, which do have the expertise to decide what network should be used (interview, n°4). Moreover, transparency is also touched upon when addressing the Advisory Forum and scientific panel members; certain respondents from National Health Ministries felt that there was not enough transparency in the appointment of such members (Idem: 77). However the extent to which the units of the Centre contributed to the transparency of the ECDC was qualified as adequate.
Within the 2009 Annual Report of the director, transparency is being tackled via the launch of the new Management Information System (MIS), which helps all users to better plan and monitor the implementation of their activities. It also facilitates the transparent sharing of information across projects and units, and fosters efficient collaboration. It permits project managers to monitor all aspects of their activities and gives an overview of the implementation of the Annual Work Programme (ECDC 2009: 36).
Furthermore the report talked about the need for more transparency within the reports themselves, this comprises the inclusion of more information and more details on the processes (Idem: 64). In the annual report of the director of 2010, argues to have tackled the issue of transparency of reports, which has then resulted in the creation of a second annex to the annual director report. In which the Centre reports on each other actions set out in the ECDC’s annual Work Programme (ECDC 2010b).
Furthermore in the external evaluation of 2014, the panel points out the fact that some aspects of the decision-making within the agency remain somehow obscure to some stakeholders (E. Associati srl. 2014: 6). This includes a need for better ‘transparency in the
selection of priorities proposed to the AF for scoring and the overall readability of the budget’ (Ibid.).
In the annual report of the director of 2011, the transparency concerning finance is touched upon, where it is stated that the Management board issued in June 2011, a positive opinion on the annual account of the Centre. Moreover the report points out that the Centre launched its new internal procedure to further strengthen transparency on recruitment and selection. This joins the improvement for independency; the declaration of confidentiality and declaration of commitment becomes mandatory for everyone. Supplemented by an annual declaration of interest form, which must be filled in by all members, and then published on the ECDC’s website (ECDC 2011a: 33).
Moreover the second external evaluation concluded that there was only weak evidence to claim an issue of transparency and that if there was any at all, the priority to tackle them was rather low (E. Associati srl 2014: 57). The Management board had nevertheless tackled this issue in the strategic multi-annual programme 2014-2020 (ECDC 2014). This was then further reviewed in light of the second external evaluation’s recommendations. In the annual report of the director of 2015, it is stated that transparency goals had been implemented. This was mainly through an increase of video streaming presentations being open to the public and the publication of meeting minutes and reports (ECDC 2015a: 55).
Based on these evidences, and the proof that transparency issues have been tackled and solved in many instances, it is not implausible to characterize the Centre as having improved over time.
4.2.1.3.Network cooperation and partnerships
Network cooperation as well as partnerships with other agencies and international organisations is crucial in the enhancement of quality and reputation. This is for the very simple reason that one entity does not detain the absolute knowledge, but it is in uniting knowledge, capacities and skills that the best output will be delivered.
The ECDC has signed Memoranda of understanding, laying out the nature of the collaboration with three different agencies. The first one was signed in 2007 with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) to work together in areas such as monitoring, communicating and preventing the spread of drug-related infectious diseases within Europe (ECDC&EMCDDA 2007). The second was signed in 2008, with the European Food Safety Authority (EFSA) where their main goal was to foster cooperation and the exchange of scientific information on topics of common interests (ECDC&EFSA 2008). This Memorandum has been renewed in 2014 (Ibid.). In 2010, the ECDC signed one with the
