A rather risky endeavour: analysing the responsiveness of the European Commission's public consultations on health policy

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A Rather Risky Endeavour

Analysing the Responsiveness of the European Commission’s Public

Consultations on Health Policy

Eva Sweep (1516698)

Dr. Caelesta Braun

Master Public Administration: Public Management & Leadership

1 June 2020

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“It seems to me that the underlying problem with the Anthropocene is that we all

want to feel perpetually assured, but the world offers almost nothing that is either

certain or perpetual.”

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Preface

“Er bestaat een groep riskmanagers Ik ben er één van” (Iduna Paalman, 2019, 11) Oh, the irony of writing one’s thesis on European level risk governance within the public health domain, in the middle of a world-wide public health crisis. The current pandemic, and a case of flu, have kept me indoors for days and gave me plenty of time to ponder risks and crises, causing my topic of research to feel so much closer. The important message that we should all reflect on, is that the way humans react to a certain risk can make or break risk governance. There will always be risks, there will always be virus outbreaks because viruses are simply a form of life. Viruses do not wish to do us harm, they just exist. As a wise man, who happens to be my favourite American author of young adult books, once said: “To me, the great mystery of life is why life wants to be. Wishing to be is the mark of life, and the glory of it” (John Green, 2020). We can only work with what life provides us with and do our very best to contain the harmful incidentals.

Anyway, aforementioned philosophy is not the only thinking I have been doing during my self-imposed quarantine. I also thought about all those people I have to thank before I graduate and say goodbye to education forever. Many thanks go to my supervisor Dr. Caelesta Braun, whose involvement and support have been a source of motivation and inspiration. Who was always patient and understanding with my insecurities and whose encouragement gave me the confidence to successfully finish this project.

My gratitude also goes out to Jolanda den Heijer, for sending me silly jokes through email when things seemed most bleak, and for always being available to help me plan and put things into perspective. Would it be possible to bring a study advisor to my future workplace? If so, I pick Jolanda.

My partner Dennis Jansen also deserves ample appreciation, for his philosophical insights into seemingly dry concepts and being able to explain my own research to others when I could not do it myself. Also, thank you for reading the first drafts and your constructive comments. You are the biggest nerd I know, the best quarantine companion, and I love you for it.

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Thank you, my dearest friend Tessa Verlaan, for all the study dates and for listening to me nagging about the master thesis for at least a whole year. Soon we will both be working adults and I cannot wait to see what life holds for us. Furthermore, thank you for proof-scanning my thesis document and helping me with lay-out, tables and the reference list. You are so much better at these things than I could ever be.

The list of gratitude is endless, and also includes my friends Pereni Konatala, Steven van der Plas and Felix Alkema for proofreading my thesis. Perry, thanks for removing the unnecessary commas that my Dutch brain superfluously added in all the weirdest places. Steven and Felix, you boys were the best study buddies when we could still study together on Campus, and I miss the days when we were so very productive… and sometimes less productive.

For now, my reader, I do hope you find my research interesting and informative. Let it be the capstone of my academic education and, hopefully, the bridge to an interesting and fulfilling future of employment.

Eva Sweep, Waddinxveen, 1 June 2020

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Abstract

This thesis concerns risk governance by the European Commission (EC) in the field of European health policy. The general literature on risk governance claims that involving a broad range of actors from all corners of civil society is important when addressing risks that threaten public health and safety. The goal of this research is to complement the literature and find evidence on the influence of public engagement on risk governance, through the concept of responsiveness. The central question that this thesis aspires to answer regards the influence of stakeholder engagement on the responsiveness of risk governance. To that end, several propositions have been drafted based on the existing literature. During the research, different types of stakeholders have been distinguished, and their influence measured according to stakeholder-specific preferences identified in their responses to four different Open Public Consultations in the field of European health policy.

The evidence found during this research implies that including more powerful stakeholders does not decrease responsiveness of the EC while including less powerful stakeholders increases responsiveness of the EC. No significant impact was detected of the integration of lay and expert knowledge on the responsiveness of the EC. The salience of a policy issue did not increase responsiveness when it came to the number of respondents or the degree of media coverage of the topic. Yet, a link was found between expanding methods of consultation and increased responsiveness of the EC. Therefore, the conclusion of this thesis is that the active engagement of less powerful stakeholders and the expansion of consultation methods increase the responsiveness of risk governance.

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List of Tables and Figures

TABLE 1. ROADMAPS ... 29

TABLE 2. DOCUMENTS OF RESPONSES PER CASE ... 30

TABLE 3. POLICY RESULT DOCUMENTS ... 30

TABLE 4. RATING OF RESPONSIVENESS ... 32

TABLE 5. STAKEHOLDER TYPES (EUROPEAN COMMISSION, 2018A) ... 34

TABLE 6. STAKEHOLDER TYPES (EUROPEAN COMMISSION, 2018B) ... 36

TABLE 7. EXPERTISE OF CITIZENS AND ORGANISATIONS (EUROPEAN COMMISSION, 2018B). 37 TABLE 8. STAKEHOLDER TYPES (EUROPEAN COMMISSION 2017D) ... 38

TABLE 9. EXPERTISE OF CITIZENS (EUROPEAN COMMISSION, 2017D) ... 39

TABLE 10. STAKEHOLDER TYPES OPEN PUBLIC CONSULTATION (EUROPEAN COMMISSION, 2018E) ... 40

TABLE 11. EXPERTISE OF CITIZENS (EUROPEAN COMMISSION, 2019B) ... 40

TABLE 12. STAKEHOLDER TYPES STAKEHOLDER EVENT (EUROPEAN COMMISSION, 2017G) ... 41

TABLE 13. COMPARING THE OUTCOMES OF ALL CASES ... 45

TABLE 14. OBJECTIVES EUROPEAN COMMISSION (EUROPEAN COMMISSION, 2017A) AND THEIR RESULTS IN THE STRATEGIC APPROACH (EUROPEAN COMMISSION, 2019A) ... 47

TABLE 15. STAKEHOLDER PREFERENCES TAKEN UP IN THE STRATEGIC APPROACH ... 50

TABLE 16. RESPONSIVENESS “PHARMACEUTICALS IN THE ENVIRONMENT” ... 51

TABLE 17. OBJECTIVES EUROPEAN COMMISSION (EUROPEAN COMMISSION, 2017B) AND THEIR RESULTS IN THE PROPOSAL (EUROPEAN COMMISSION, 2018D) ... 52

TABLE 18. STAKEHOLDER PREFERENCES TAKEN UP IN THE PROPOSAL ... 54

TABLE 19. RESPONSIVENESS “TRANSPARENCY AND SUSTAINABILITY OF THE EU RISK ASSESSMENT MODEL IN THE FOOD CHAIN” ... 55

TABLE 20. OBJECTIVES EUROPEAN COMMISSION (EUROPEAN COMMISSION, 2016) AND THEIR RESULTS IN THE ACTION PLAN (EUROPEAN COMMISSION, 2017E) ... 56

TABLE 21. STAKEHOLDER PREFERENCES TAKEN UP IN THE ACTION PLAN ... 58

TABLE 22. RESPONSIVENESS “ANTIMICROBIAL RESISTANCE” ... 59

TABLE 23. OBJECTIVES EUROPEAN COMMISSION (EUROPEAN COMMISSION, 2017F) AND THE RESULTS IN THE EVALUATION (EUROPEAN COMMISSION, 2019B) ... 60

TABLE 24. STAKEHOLDER PREFERENCES TAKEN UP IN THE EVALUATION ... 62

TABLE 25. RESPONSIVENESS “EVALUATION OF THE BLOOD, TISSUES AND CELLS LEGISLATION” ... 63

TABLE 26. RESPONSIVENESS ASSESSMENT OF DIFFERENT STAKEHOLDER TYPES ... 66

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TABLE 28. COMPARING THE OUTCOMES OF INTEGRATION PER CASE ... 70 TABLE 29. COMPARING THE OUTCOMES OF SALIENCE PER CASE ... 72 FIGURE 1. MEDIA COVERAGE “PHARMACEUTICALS IN THE ENVIRONMENT” (FACTIVA, 2020) ... 75 FIGURE 2. MEDIA COVERAGE “TRANSPARENCY AND SUSTAINABILITY OF THE EU RISK

ASSESSMENT MODEL IN THE FOOD CHAIN” (FACTIVA, 2020) ... 75 FIGURE 3. MEDIA COVERAGE “ANTIMICROBIAL RESISTANCE” (FACTIVA, 2020) ... 75 FIGURE 4. MEDIA COVERAGE OF THE “BLOOD, TISSUES AND CELLS LEGISLATION” (FACTIVA, 2020) ... 75

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1. Introduction

Risk and uncertainty are characteristic for human life. It is the reason we take out insurances, to protect ourselves physically and financially, in case we are affected by illness or misfortune. Protecting ourselves from and responding to things that may happen in the future plays a significant role on our human-centred planet. Some risks are small and personal, others are big and impactful to a large part of society or even the world. What happens when a risk threatens a larger group of people, when a potential problem is transboundary and may affect many countries? Internationally operating organisations like the European Union (EU) were created to manage problems that cut across borders, and because the EU exists by the grace of the people (and perhaps large companies), European civil society is consulted on the way the EU should approach risk governance situations. The goal of this research is to clarify the way in which different types of stakeholders have an impact on EU risk governance and whether engaging those stakeholders has a positive impact on the responsiveness of risk governance. This research consists of a comparative case study regarding EU risk governance in the public health domain. It is an explorative research, that aims to complement the existing literature on this topic.

1.1 Underlying questions and relevance

This research concerns the question to what extend stakeholder engagement leads to more responsive policy making. Over the past years, risk governance scholars have emphasised the importance of involving and including various types of actors in the regulation and addressing of risk situations in society. With various types of actors, these scholars refer to citizens and organisations with, for example, different levels of expertise and power (e.g. Van Asselt & Renn, 2011; Klinke & Renn, 2011). Nonetheless, Van der Vegt (2018) has found that there is a lack of evidence when it comes to the impact of public engagement on risk governance. Therefore, one could wonder whether the assumptions of risk governance scholars concerning the positive effects of including a wide range of stakeholder types are well-grounded. Specifically, whether public engagement is a driver for more responsive policy making, supposing the concept of responsiveness links with that of public engagement. This research will contribute theoretically to the existing literature, by filling this gap as defined by Van der Vegt (2018). Furthermore, this research explores the concept of responsiveness and

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aims to specify that concept. Authors who have investigated responsiveness (e.g. Coleman, 1999; Linde & Peters, 2018) did not come to a conclusive definition of the concept and this research intends to complement the conceptualisation of previous authors by making responsiveness measurable. Both the problem of definition of responsiveness and the lack of evidence regarding the impact of stakeholder engagement will be addressed by assessing whether the stakeholders’ type, degree of power and expertise matter when it comes to influencing risk governance of the European Commission (EC) in the public health domain. Engaging stakeholders and listening to their wishes and demands, incorporating their preferences into policy, connects to the idea of responsive policy making. The research question that follows from this is: What is the influence of stakeholder engagement on the responsiveness of risk governance?

Researching responsiveness, and therefore the possible improvement of risk governance, is beneficial for citizens, governments and other public and private organisations, assuming it will help find ways in which society can be protected more effectively from certain risks. Furthermore, involving stakeholders in policy making leads to certain groups in society influencing policy. It is interesting and beneficial to explore what happens if one group is more actively involved than the other, and whether or not this leads to responsive government behaviour. What happens when governmental organisations are not responsive towards particular groups of stakeholders? When certain groups are passed over by politicians during the policy making process, this may cause resistance from those groups in the future. What does it mean for the level of democracy of the EU if certain groups are more actively involved than others, and when the EC is more responsive towards particular groups? Moreover, what does it mean for the information on which the EC base their policy after an Open Public Consultation? If we, as members of civil society, know what information EU policy is based on and towards which actors the EC is responsive, we will have more insight in the policy making process and we will know how we may be able to influence this process. It might, for example, be beneficial for citizens to unite themselves in groups or join an organisation in order to influence policy. A better insight in this process of engagement leads to an improvement of the democratic process and therefore to an improved approach towards risks that everyone in society is subject to.

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1.2 Reading guide

The rest of this thesis is planned according to the following structure: The next chapter explores the existing literature on risk governance and responsiveness and thereafter formulates four propositions based on that literature. The third chapter discusses the methods of research used in this study, and operationalises the concepts identified in the theoretical framework. Chapter 4, “Mapping the cases”, explores the four selected cases and describes the empirical data, especially background information and quantitative data, needed to draw conclusions on the propositions. This will be done in chapter 5. The evidence found in different cases will be compared and, if possible, propositions will be accepted or rejected. The final chapter provides a discussion of the results and a conclusion, in which the research question will be answered and recommendations for future research will be given.

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2. Exploring the literature

2.1 Risk governance

According to Van der Vegt (2018), there is a lack of evidence regarding the impact of public engagement on risk governance. The current research covers the influence stakeholder engagement has on risk governance and how this impact can be explained through the concept of responsiveness. Before we can dive into that question, the most important concepts it contains must be defined. Governance, according to Van Asselt and Renn (2011), is a process in which non-state actors play a bigger role alongside public actors. Risk refers to the chance of damage and has three main characteristics: uncertainty, complexity and ambiguousness. Together these two concepts make up the primary topic of the current research; Van Asselt and Renn (2011) define risk governance as

the various ways in which many actors, individuals, and institutions, public and private, deal with risks surrounded by uncertainty, complexity, and/or ambiguity. It includes formal institutions and regimes and informal arrangements. It refers to the totality of actors, rules, conventions, processes, and mechanisms concerned with how relevant risk information is collected, analyzed, and communicated, and how regulatory decisions are taken (Van Asselt & Renn, 2011, 432)

Risk governance scholars (e.g. Van Asselt & Renn, 2011; Klinke & Renn, 2011) emphasise the importance of involving non-state actors and interest groups in decision-making during risk governance. Van Asselt and Renn (2011) propose three principles in their article that make risk governance a more valid endeavour: communication and inclusion, integration, and reflection. In risk governance, good communication between participating actors is of vital importance. Communication links with trust and inclusion, which refers not only to the inclusion of different actors, but also to their important role in framing the risk in question. Inclusion of all actors provides the risk governance project with more information in uncertain, complex and ambiguous situations. Secondly, communication has a democratic function and helps increasing agreement between actors. Lastly, the involvement of more actors in decisions related to risk makes for more socially responsible outcomes (Van Asselt & Renn, 2011).

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knowledge are integrated in one collection accessible to all (Van Asselt & Renn, 2011). Van Asselt and Van Bree (2011), after Van Dijk et al., argue that experts should be open to questions from lay people. Furthermore, after Löfstedt et al., they comment that a change in the role of experts is needed: they should be open to questioning, honest about the uncertainties at hand and receptive to scientific diversity (Van Asselt & Van Bree, 2011). Van der Vegt (2018) argues that lay and expert knowledge in risk governance are often still seen as separate units that should be integrated in order to gain the best outcomes. Klinke and Renn (2011) understand integrative governance as the capability of governmental, as well as societal actors to create and implement policy cooperatively.

According to Van der Vegt’s (2018) review of the literature on the relationship between risk governance and public engagement “there is a lack of evidence when it comes to the impact and incorporation of public engagement in risk governance” (Van der Vegt, 2018, 1143). Public engagement, as defined by Rowe and Frewer (2005), means that the public participates actively with governmental actors in a decision-making process, through negotiation and conversation. In a risk governance model by Klinke and Renn (2011) expert, stakeholder and public involvement are incorporated in the stage of communication and deliberation. They also propose an adaptability through communication, involvement and deliberation with nongovernmental actors such as stakeholder groups that represent society and the public in general. This, among other things, indicates the involvement of experts and the discourse and conversations they may have about the risk in question (Klinke & Renn, 2011).

Furthermore, the reflection principle means that the organisations and other actors and stakeholders involved, reflect upon their actions throughout the process and improve on them where they can (Van Asselt & Renn, 2011; Klinke & Renn, 2011). It means that participants in the decision-making process continue to appreciate the complexity, uncertainty and ambiguity of the issue (Van Asselt & Renn, 2011; Van Asselt & Vos, 2006). These three components of risk governance indicate that more responsive governance involves communication with and inclusion of different interest groups in society, as well as the integration of expert and lay knowledge and the reflection of government actors on their own actions. However, the degree of reflection is difficult to measure and does not fit within the comparative case study this thesis aspires to be. Therefore, this component will not be elaborated on in the theoretical framework. Nonetheless, the degree of reflection is

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important because it indicates whether responsiveness can only be found in the final policy product or that it is taken into account over a longer period of time. Hence, the reflection principle will be covered more extensively in the discussion chapter of this thesis.

Responsiveness & engagement

Remarkably, in the literature on government responsiveness only a small number of authors describe a certain definition of the concept. For example, Linde and Peters (2018) understand government responsiveness as a “buffer” of support, in which the government can make decisions without losing their credibility. The authors argue that doing the responsible thing is not always the same as being responsive. Going after long-term goals may cause a government to put aside the people’s short-term preferences. A government is seen as responsive when it creates a “reservoir of goodwill” that the government can use to implement policy at the expense of the wishes of the public without losing the trust of said public (Linde & Peters, 2018, after Easton, 1965). Still, this is only an understanding of what happens when a government is responsive, not a direct definition of the concept itself. Other scholars who use responsiveness as a measure or as a dependent variable, make clear what they mean when they write about responsiveness, although not in a very conclusive way. From the literature, it is evident that responsiveness has something to do with adhering to the public’s demands and wishes (e.g. Coleman, 1999; Toshkov, Mäder & Rasmussen, 2018). The Cambridge Dictionary defines responsiveness as “the quality of having a reaction to something or someone, especially a quick or positive reaction” (Cambridge Dictionary, n.d.). Responsiveness of government can therefore be understood as the quick and positive reaction of a government to its citizens. A more precise conceptualisation of responsiveness will follow in the next section.

The other side of the public involvement coin is public engagement, which is defined as the involvement of the public in policy and decision-making. Where responsiveness of government can be seen as government action, public engagement can result from either active involvement of citizens and interest groups by the government or active participation through the initiative of the public itself (Rowe & Frewer, 2005). According to Rowe and Frewer (2005), public engagement is the result of three possible mechanisms: public

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directed from the government to the public, public consultation is directed in the opposite way and public participation is the mechanism that flows both ways (Rowe & Frewer, 2005).

2.2 Responsiveness conceptualised

As described before, responsiveness can be defined as the extent to which the government responds quickly and positively to the demands of citizens and interest groups that are being involved or involve themselves in risk governance policy making. However, the word ‘positive’ implies a value judgement. A government that responds quickly and negatively to the wishes and demands of the public and citizens, may also be considered responsive. Of course, citizens, interest groups and other actors in civil society might have contradictory interests. A responsive government may react positively to one group or actor but negatively to the other. Therefore, I propose to define responsiveness as the extent to which the government responds affirmatively to the wishes and demands of citizens, interest groups and other public actors that are involved in the policy making process. This definition encompasses not only the acknowledgement of public wishes and demands but also the translation of that acknowledgment into action. Toshkov, Mäder and Rasmussen (2018) find that policy change is more likely to be implemented when the public supports it. Thus, it is important that the public finds the information, and the way the government actor makes use of it, complete and credible. This can be translated to the concept of responsiveness; policy change is more likely to be implemented when it is responsive to citizens’ demands and wishes (Toshkov et al., 2018). According to the used definition of responsiveness: if the public opinion on the matter is also reflected in the final policy product, the policy maker has been more responsive than when the opinion of stakeholders involved is not reflected. In other words, responsive policy making translates the acknowledgement of wishes of stakeholders into action.

Based on the findings in the literature explored earlier in this chapter, responsive risk governance will be understood as an alignment of the final policy product with the preferences of different types of stakeholders involved in the matter. Responsive policy making means being generally responsive towards all types of stakeholders involved, and not significantly more to one than the other. This conceptualisation assumes that translating the wishes of involved stakeholders into action, increases the responsiveness of risk governance.

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2.3 Responsiveness & risk governance

The existing literature on risk governance reflects a normative argument: a government should involve many different stakeholders and actors, be transparent about policy goals, integrate lay and expert knowledge in a structured manner so that it is accessible for all to consult, and make sure all actors involved reflect upon their actions as they go (e.g. Van Asselt & Renn, 2011; Klinke & Renn, 2011). These are the criteria for a valid risk governance endeavour, but they also fit the responsiveness concept very well. Nonetheless, it needs to be established what it means for risk governance to be responsive. In order to do so, several components of valid risk governance will be elaborated on in the following section and linked to the concept of responsiveness, including a factor that may influence the context of risk governance cases. From this, four propositions will be drafted that form the basis of this research.

Communication & inclusion

As described above, van Asselt & Renn (2011) argue that communication and inclusion play an important role in risk governance. Communication between participating actors and inclusion of all participating actors define the success of a risk governance endeavour. Nevertheless, not all actors have the same chances of being included or being communicated to. A study by Grimes and Esaiasson (2014) find that citizens who hold considerable political resources have more opportunity to influence policy outcomes than citizens who do not have these resources. The authors state that “[r]esponsiveness is integral to representative democracy” (Grimes & Esaiasson, 2014, 758). However, they find that inequality of representation in society may lead to unequal policy outcomes. For example, policy makers may choose to consult certain groups of citizens over others because they know they will be less likely to resist or protest the decision. Furthermore, they can choose to consult those groups they feel are similar to their own social group. Finally, citizens and groups that hold greater political resources will participate more actively in the decision-making process and will be more able to influence decision makers towards their favoured policy outcome (Dür, 2008a; Grimes and Esaiasson, 2014). From this follows the assumption that citizens or groups in society with considerable political resources will have more influence on policy makers than

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powerful interest groups have a strong and independent effect on policy making, although their preferences often deviate from those of the public. From this, follows the assumption that including powerful groups may lead to being generally more responsive to those groups, rather than being responsive towards less powerful groups as well. The first proposition, therefore, reads as follows:

P1A: Active involvement of more powerful stakeholders will decrease government

responsiveness regarding risk management policy.

Klüver and Pickup (2019) explore the relationship between public opinion, interest groups and government responsiveness. They argue that different types of interest groups have different kinds of influence on government responsiveness. This is a result that is also found in a paper by Flöthe (2019). She explores the influence of interest groups on policy making through information transmission. The study finds that information transmission depends on the type of actor and the actor’s relationship with the government. Citizen groups are more likely and able to transmit information on public preferences to policymakers than professional, business or expert groups (Flöthe, 2019). From this may be deduced that citizens facilitate responsiveness of government actors more than other interest groups. Efforts to involve groups with less resources may increase the responsiveness of policy outcomes. Involving voices and opinions that are normally not heard as easily expands the government actor’s range of advisers. This increases the possibility to take the preferences of less powerful groups into account and respond to them affirmatively. The government actor will, in this instance, not only listen to the most obvious and dominant actors, but actively ask advice from individual citizens or less prominent interest groups. Following from this reasoning, the next proposition is:

P1B: Active involvement of less powerful stakeholders will increase government

responsiveness regarding risk management policy.

Integration

In order for less powerful groups to be actively involved in risk governance, they need to have access to all relevant information and be able to provide policy makers with their unique knowledge. Only then can they use their knowledge and exercise influence. This research theorises that the integration of information, that is: the collection of lay and expert information in one place, influences the responsiveness of risk governance. In other words,

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the integration of expert and lay knowledge is believed to improve risk governance because it makes this form of governance more responsive.

Van Asselt and Renn (2011) emphasise the importance of involving different interest groups in the risk governance process. The involvement of citizens, private interest groups, professional, business and expert groups may add up and lead to more responsiveness in risk governance. Only using scientific knowledge is not appropriate, according to Van Asselt and Renn (2011). They recommend that implicit, taken-for-granted knowledge, the knowledge of citizens and lay persons or organisations, should be taken into account when managing risks. From this, leads the recommendation to represent different groups in society while making risk governance policy. Nonetheless, Flöthe and Rasmussen (2019) find that the representation of many different groups does not automatically lead to the better representation of public opinion in policy making. However, the authors emphasise that the results of their study do not mean that the composition of interest group communities plays no role in responsiveness at all. The results of an analysis like theirs depends highly on conceptualisation and the research design (Flöthe & Rasmussen, 2019). The concept of integration used in this research, is one that encompasses management of lay and expert knowledge by policy makers. Not only the involvement of different types of stakeholders is important, but especially the manner in which policy makers weigh lay and expert knowledge determines the degree of integration. Integrating lay and expert knowledge in the same place is expected to increase the lay stakeholders’ feeling that they are being taken as seriously as experts. Integration, therefore, means that the acknowledgement of lay and expert knowledge should be included in the process of risk governance. When both lay and expert knowledge are acknowledged during the process of acquiring information, and are reflected in the final policy product, this will make risk management policy more responsive. The proposition following from this reasoning is:

P2: Integrating lay and expert knowledge will increase government responsiveness

regarding risk management policy.

Policy issue salience

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to Warntjen (2012), a salient issue is more likely to attract influence by involved actors than a non-salient issue. That is, a salient issue tends to lead to policy that aligns with the needs and wishes of involved stakeholders more often than a non-salient issue. Klüver and Pickup (2019) find that a higher level of citizen attention for a policy issue leads to more government spending, after lobbying by interest groups. According to the literature, the salience of an issue is a concept typically used to indicate the importance that is attributed to the issue in question by the involved actors (e.g. Warntjen, 2012; Wlezien, 2005). Beyers (2012) argues that different types of actors attach more importance to different types of policy, which makes the salience of an issue a subjective matter. Involvement and participation in risk governance may be influenced by the salience of the issue as well as the salience of the stakeholder. The degree of risk that is attributed to an issue may increase the salience of said issue, because stakeholders are likely to attribute more attention and importance to the matter in question. The more salient an issue is, the more people and organisations know about it. Salience can be measured in different ways, for example by assessing the degree of media coverage, the number of involved commissions if the matter concerns EU policy, and the number of recitals, that is, the reasons given why an issue is important (Warntjen, 2012). The more salient a policy issue, the more likely it is that it stands out to government actors, who in turn may attribute more importance to the issue, pay more attention to it and consequently are more responsive:

P3: The salience of an issue increases government responsiveness regarding risk

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3. Approaching the research

This chapter explains the research design of this thesis, discusses the advantages and disadvantages of the chosen design and operationalises the variables concerned. In this chapter it will also be made clear how the current research will measure responsiveness and how this will be indicated in later chapters.

3.1 Research design

In order to explain in what way the engagement of different stakeholders influences risk governance policy through the concept of responsiveness, four risk governance cases will be studied and compared. These cases concern a policy issue that is meant to protect the European public from health and safety hazards. It is in the public interest that such risks receive a swift and responsive answer: an affirmative reaction of the responsible government institution. Responsive risk governance is understood as an alignment of the final policy product with the preferences of different stakeholders involved in the matter. This alignment should be balanced and the influence of different stakeholders should be comparable in order for risk governance to be called responsive. Being reactive only to the most powerful stakeholders is not considered responsive in this research, neither is being reactive only to business and industry stakeholders. The stakeholders we are talking about can be any European government organisation, academic or public organisation, NGO, business association, other types of organisations and European citizens. Responsiveness of governance will be measured according to the extent to which the final policy product matches the responses of those stakeholders.

The research that will be conducted is a qualitative, comparative case study with a deductive design. Several propositions derived from the literature on risk governance and responsiveness have already been drafted in the theoretical framework. The dependent variable in this research is the responsiveness of risk governance. That is, the degree to which the final policy product of the EC is aligned with the wishes and demands of involved stakeholders. The explanatory variables are the following: the type and degree of power of stakeholders that exercise influence in risk governance policy making and the degree of integration and intertwining of lay and expert knowledge. Another possible explanation of

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variables explain the differences in responsiveness, this research will adopt a most similar systems design, for which there will be variation of the main explanatory variable across cases, while the other variables are kept as stable as possible (Toshkov, 2016). This design will make it possible to explain what type of actor encourages the most responsive risk governance, and under which circumstances. To make a well-informed comparison, four cases will be selected that have a different balance when it comes to the stakeholders involved. Four public consultations of the EC, each concerning a risk for public health in Europe, will be investigated.

Responsiveness measurement

The type of measurement briefly touched upon in the previous section, is called an influence measurement. For the sake of clarity, what is called an influence measurement by Dür (2008a; 2008b) is regarded here as one and the same as responsiveness measurement. Influence measurement is defined by Verschuren and Arts (2004) as

the amount of influence an actor A has in a process of collective decision-making is defined as the extent that A’s preferences are realized in a final decision (product influence) or are adopted by the other actors in the decision-making process (process influence), weighted by the extent that this realization or adoption can be ascribed to A (Verschuren & Arts, 2004, 496)

The operationalisation of responsiveness in this research is very alike to the concept of influence used by said authors. Responsiveness also refers to the degree of influence an actor has on policy and the alignment of preferences that can be found in the final policy product. After explaining the ins and outs of influence measurement, the concept will therefore be referred to as responsiveness measurement. Dür (2008a; 2008b) emphasises the difficulty of conducting an influence measurement because there is no such thing as a clear standard to measure influence. The author states that, although influence measurement methods have many pitfalls and limitations, the topic of interest group influence is too important to ignore (Dür, 2008b). It is vital to recognise the complexity of the method, before drafting the methodology of the current research. Dür (2008b) reviews three methods of influence measurement, each with their own perks and shortcomings. One of the methods he describes is the assessment of preference attainment: the results of the policy process are compared to the initial preferences of the actors involved. The influence of a certain group is reflected by the distance between the ideal of an actor and the final outcome (Dür, 2008b). This is the type

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of responsiveness measurement that will be conducted in the current research. Measuring preference attainment has several advantages. Primarily, it has the ability to detect stakeholders’ influence in the policy outcomes, even when the exact process is not visible. This method is therefore more likely to detect influence than for instance the process-tracing method. However, preference attainment comes with some problems that need to be addressed. First of all, it is difficult to establish preferences (Dür, 2008b; Verschuren & Arts, 2004). Furthermore, controlling for alternative explanations that influence the outcome can be problematic. Lastly, this method makes it hard to uncover the mechanism through which influence was exercised (Dür, 2008b). It is possible to bypass the shortcomings of this method by combining it with another method, for instance process tracing. This is called methodological triangulation (Dür, 2008b). However, combining these methods is an endeavour that does not fit within the scope of this thesis. Instead, this research will combine a qualitative document analysis with existing quantitative information to make inferences.

That said, the preference attainment method will be used in the full knowledge of the limitations of this method. These limitations will be acknowledged and taken into account when making comparisons and drawing conclusions. Comparing responses of the public to the policy document will show to which stakeholders government actors are most responsive when it comes to risk governance cases.

3.2 Operationalisation

As described previously in the theoretical framework, the expectations in this research are that active involvement of powerful groups will decrease government responsiveness while involving less powerful groups will increase government responsiveness; that integrating lay and expert knowledge will increase government responsiveness regarding risk management policy and that the salience of an issue will increase government responsiveness. In this section, the most important concepts will be operationalised. These concepts correspond to the dependent variables of the propositions and to the independent variable of the general research question: responsiveness of risk management policy.

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Responsiveness of risk management policy

The first step in the process is measuring responsiveness of the EC in each of the cases and per stakeholder type. The question that requires answering is: what is the impact different stakeholders have on the final policy product? Responsiveness of risk management policy will be measured through the alignment of the final policy result with the preferences of the involved stakeholders. This will be done through a responsiveness measurement. An in-depth reading of all responses to the Open Public Consultations has resulted in a list of advice and interests given by all stakeholders involved and categorised per stakeholder type. This list will be compared to the final policy product provided by the EC after the consultation. Stakeholders’ suggestions that literally match the action points as described in the policy result, or equal the intention of the stakeholder, will be marked with a colour allocated to the corresponding stakeholder. The indicator for responsiveness, therefore, is the degree to which the recommendations and wishes of the public as stated in the responses are reflected in the final policy result. The outcome of this measurement should be a positive one, evenly distributed over the different stakeholders, in order to be called ‘most responsive’.

The categories used for this analysis are as follows: business, industry and trade organisations’ preferences; case-specific stakeholders’ preferences; citizen stakeholders’ preferences or other stakeholders’ preferences. Business, industry and trade organisations include among others the pharmaceutical industry, manufacturers and other private businesses. The case-specific stakeholder is the stakeholder whose existence is influenced the most by policy that follows from the consultation in question, or the stakeholder with a certain knowledge-based authority. For example: when a case concerns an environmental and health issue, environmental organisations are case-specific stakeholders. Similarly, when the issue is about safety in the food chain, consumers and consumer organisations are the ones to suffer the consequences of such a problem the most. Therefore, they are case-specific stakeholders in that case. In the case concerning a medical issue, patients and donors are case-specific stakeholders, because such policy would influence their health directly. Citizen stakeholders include all individual European citizens who respond to a consultation. ‘Other stakeholders’ are the stakeholders that are not otherwise classifiable, such as NGOs, academic institutions and public organisations.

The expectation is that a policy product that reflects mainly business preferences is less responsive than a policy product that reflects relatively as many business preferences as

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case-specific stakeholder preferences. A balanced reflection of preferences is the key to a responsive policy product. When a policy product reflects relatively many other preferences than business preferences, it is again not as responsive as would be the case with a more balanced reflection. In order to be able to distinguish actual impact from similarities caused by using the same terms and jargon, a comparison between the initial road maps and the final policy product will be performed. By doing so, we can answer the questions whether the respondents’ preferences were already present in the initial road maps, what is new in the final policy product and what was not used in the final policy product.

Communication and inclusion

The second step of measurement is answering questions about who responded to the consultation and what types of stakeholders were targeted by the EC. What types of actors were responding to the consultation and what is the ratio of these types of stakeholders compared to others? If there is a dominant group of stakeholders, or if less powerful stakeholders were not actively involved, this indicates that communication and inclusion are not ideal. Academic and public institutions are larger and therefore more powerful. Some business organisations will be considered more powerful as well, especially if they have a direct link with the industry in question; for example, the pharmaceutical industry. Consultations that actively seek to get responses from citizens, smaller NGOs, businesses and other organisations are expected to have more responsive policy results. Citizens and smaller organisations can be understood as less powerful actors because they have more difficulty to get their standpoint represented in the media or picked up by politicians than large organisations or academic institutions with an authority based on knowledge about the field. The type of actor a respondent is defined as can be found at the top of every response and will be used as an indicator for communication and inclusion. Engaging business and industry organisations is seen as less inclusive than engaging case-specific stakeholders.

Whether organisations and citizens all get the same opportunity to respond is an indicator for communication and inclusion as well. When organisations and citizens are targeted with different questionnaires or when one of them gets more opportunity to give feedback, communication and inclusion will be affected negatively.

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Integration

The third step in the process is to determine how the EC manages lay and expert knowledge and whether all responding stakeholder types, experts or not, are represented during the consultation. Are the preferences of organisations and citizens, experts and lay people, equally reflected in the final policy product? If the answers to these questions are positive, integration will be considered more ample than if the answers are negative. The integration measurement focuses on the process of the consultation—how does the EC distinguish between lay and expert stakeholders—rather than the outcome, which is used for the responsiveness measurement.

The integration of lay and expert knowledge can be recognised in the cases through different indicators. Is expertise an issue, or is it not acknowledged at all? Does the EC distinguish between organisations and citizens who are experts or non-experts? Is expert knowledge mentioned separately in the factual reports or the policy result document, or is expert and lay knowledge not distinctively separated? Integration is more distinct, when both types of knowledge can be found in the same place and when one type of knowledge is not taken more seriously than the other. Indicators for who is an expert are quite straightforward. In most cases, the EC asked respondents about their knowledge of a topic. The citizens and organisations who consider their knowledge on the topic to be ‘very good’ or ‘good’ will be marked as experts. Citizens and organisations whose knowledge is ‘sufficient’ or less than that will be marked as lay people or organisations. If the EC does not ask after the respondents’ expertise, this indicates that there is no management of expert and lay knowledge at all, which will be considered poor integration.

Policy issue salience

The last step in the analysis includes the measurement of salience of the policy issue, that is, the prominence of the policy issue in the media and politics and its prominence among certain stakeholders or in particular Member States (Wlezien, 2005). It is expected that the more salient an issue is, the more government actors are likely to be responsive while handling the issue. In the case of risk governance and the EU consultations, this means that a consultation is more salient when more attention is given to the issue in question. An indicator for this is the number of responses a consultation receives. The more responses a consultation gets, the more salient an issue is considered. The duration of the consultation is an indicator for salience

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as well: the longer the period of consultation, the more salient an issue will be. Sometimes, the EC consults stakeholders on more than one occasion, for example by organising a stakeholder event or doing a questionnaire as well as a feedback round. More consultation steps indicate a higher level of salience of the issue. If the EC has endeavoured more than one attempt to receive feedback, this positively affects salience.

The last indicator that will be taken into account in this research is the degree of media coverage. The higher the degree of media coverage, the more salient an issue will be considered. Media coverage will be analysed with the help of Factiva1_{, a programme that is} wired to look for certain key words in published media and provides the user with the number of times these key words were mentioned in the media within a chosen time frame. The region of search will be limited to Europe, as this research concerns European policy and the language of search will be English. Of course, media may have published on the topics in question in different European languages. However, searching in all European languages is not possible and by using only English for all four cases, the results are expected to be generally representative. Media coverage, and therefore salience, of the different cases will be compared to each other, which will enable us to see whether the salience of an issue is a factor when it comes to government responsiveness.

3.3 Case selection

Because this thesis intends to fill a gap in the literature and sharpen the existing theory, it will make use of a small-N comparison. Such a comparison is often performed with this exact purpose (Toshkov, 2016). The four risk governance cases that are selected for this research are open consultations that concern public health in the EU. First of all, this research will explore the case of pharmaceuticals in the environment, in which the EC seeks views on the risk that pharmaceuticals pose in the environment as a means to support their Strategic Approach towards this problem (European Commission, 2017a). Secondly, we will look at the transparency and sustainability of the EU risk assessment model in de food chain. The EC, in this case, wants to obtain different perspectives on the transparency and independence, risk communication and the governance of said risk assessment model and the European Food Safety Authority (EFSA) (European Commission, 2017b). Thirdly, the case of antimicrobial

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resistance will be studied. In full, this consultation is called the “Open Public Consultation on possible activities under a ‘Commission Communication on a One Health Action Plan to support Member states in the fights against Antimicrobial Resistance (AMR)’” (European Commission, 2017c). The objective of the consultation is to improve upon the evaluated One Health Action Plan. Finally, we will dive into the case of the evaluation of blood, tissues and cells legislation. This legislation aims to improve the safety of blood, tissues and cells transplantations in the EU (European Commission, 2017f).

The selected cases have in common that they concern a risk for the public health and safety of Europeans. The public health domain is an interesting and useful field to study government responsiveness and stakeholder engagement because it is a domain that concerns Europe’s civil society at large. The outcomes of these consultations directly affect European citizens, companies, consumer and patient organisations and other stakeholders. It is therefore useful to investigate the ways in which these stakeholders are able to influence policy making in this domain. For example, the outcomes of the consultation about pharmaceuticals in the environment concern all Europeans because they affect not only their safety, wellbeing and health but also the quality of the environment they live in. The same applies to the case of antimicrobial resistance. The consultation on transparency and sustainability of the EU risk assessment model in the food chain especially affects consumers and organisations active in the food domain but is of general importance to food safety and therefore public health. The evaluation of the blood, tissues and cells legislation is of particular importance to patients and healthcare professionals who deal with specific medical procedures, but also to European public health in general. Such a legislation counteracts epidemics, for example the HIV/AIDS epidemic as we have known in the last century. The advantage of this selection of consultations is that they all aim to improve public health in general, while also having their own unique point of focus. The pharmaceuticals in the environment consultation concerns, as its name already gives away, the environment as well as public health. The consultation on the transparency and sustainability of the risk assessment model in the food chain, focuses on the safety of food. The antimicrobial resistance consultation focuses on human and animal health, while the evaluation of the blood, tissues and cells legislation focuses on medical procedures and routines. In other words, the cases concern public health while at the same time covering a wide range of subjects within that field. Furthermore, the respondents involved in the consultations include

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many different types of stakeholders such as citizens, businesses and NGOs, but also specific stakeholders engaged in that particular subject. It is therefore expected that these cases are representative for risk governance cases about public health in general, as well as for other cases of risk governance in different fields. The results found in this study may therefore be useful for risk governance cases in fields other than the public health domain.

The four chosen consultations were held within in year from each other and can therefore be assigned to the same time period. The public responses these consultations received were from expert as well as lay stakeholders. These factors account for the similarity of the cases. However, the cases differ in terms of ratio of experts versus lay stakeholder responses, and how the EC treats citizens and organisations according to their expertise. The pharmaceuticals in the environment consultation, for example, has only one response from an EU citizen, while the other three cases consulted many more individual citizens. The antimicrobial resistance consultation has received much more input from academic institutions than the other cases, whereas consultation about the risk assessment model in the food chain received more attention from business associations. That way, this thesis aims to explain how the influence of various stakeholder types differs and how this can account for government responsiveness.

3.4 Data collection

The most important method of analysis for this thesis will be an elaborate document analysis. This document analysis is threefold and includes roadmaps of the EC, responses from organisations and citizens and the final policy product. Empirical evidence will be retrieved from the consultation section of the EC website and from reports on the results of the Open Public Consultations launched by the EC. The first part of the data used in the analysis is the initial EC proposal in the form of roadmaps. These roadmaps, as listed in table 1, contain the EC’s policy plans and are made with the intention of receiving public responses.

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Table 1. Roadmaps

Some proposals or roadmaps have received responses that are public on the website, and these will be collected and used for analysis. Other cases have so many responses that they cannot be analysed separately. For these cases the report on the Open Public Consultation drafted by the EC will be used to identify stakeholders’ preferences. In table 2 is displayed what kind of documents will be used per case.

Furthermore, the final policy results will be collected from the same source, in order to compare them to the public responses. The documents are easily accessible through the public channels of the EU and provide the policy results after consultations. These documents are outlined per case in table 3.

Consultation Document name Document date

Pharmaceuticals in the environment

Roadmap: Strategic approach to pharmaceuticals in the

environment

28/04/2017

Transparency and

sustainability of the EU risk assessment model in the food chain

Roadmap: Transparency and sustainability of the EU risk assessment model in the food chain

20/12/2017

Antimicrobial resistance (AMR)

Action Plan Against the rising threats from Antimicrobial Resistance: Road Map

16/11/2016

Evaluation of the blood, tissues and cells legislation

Evaluation of Union legislation on blood, tissues and cells

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Table 2. Documents of responses per case

Table 3. Policy result documents

Consultation Document name Document type

Pharmaceuticals in the environment

Responses Web content

Transparency and

Responses

Synopsis report European Commission

Web content

Commission staff working document

Antimicrobial resistance (AMR)

European One Health Action Plan against Antimicrobial Resistance (AMR): Factual report of the online public consultation

Factual report

Evaluation of the blood, tissues and cells legislation

Summary of Responses to the Open Public Consultation for the Evaluation of the Blood, Tissues and Cells Legislation Summary of the Blood, Tissues and Cells Stakeholder Event

Factual report

Consultation Document name Document type

Pharmaceuticals in the

environment European Union Strategic Approach to Pharmaceuticals in the Environment

Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee

Transparency and

Proposal for a regulation of European Parliament and the Council on the transparency and sustainability of the EU risk assessment in the food chain

Proposal for legislation

Antimicrobial resistance

(AMR) A European One Health Action Plan against Antimicrobial Resistance (AMR)

Action plan

Evaluation of the blood,

tissues and cells legislation Evaluation of the Union legislation on blood, tissues and cells

Commission staff working document

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3.5 Data analysis

The strategy for data analysis is a qualitative one and comprises a qualitative text analysis of the relevant documents. Document analysis is a method that includes the systematic evaluation of documents. The information that the used documents contain, needs to be interpreted in order to draw meaningful conclusions from them. A document analysis is particularly useful when a study is in need of elaborate descriptions of an event or phenomenon (Bowen, 2009). According to Bryman (2012), who refers to the concept of qualitative text analysis as qualitative content analysis, such a content analysis is used to find underlying themes in the documents used by the researcher. In order to collect the relevant data needed for this current research to carry out a responsiveness measurement, a systematic and in-depth reading of the relevant documents has to be performed. It is important that this text analysis goes into the details of the information the documents contain. Information about the preferences of the different stakeholder types will be extracted from the separate responses on the open consultations and the documents that summarise the results of the questionnaires. These documents also provide information on the type of stakeholder, and sometimes on their size and their expertise. Every type of stakeholder will be allocated a colour, which is used to mark their preferences in the factual reports and the policy result documents. Per case, for each stakeholder all these preferences will be collected in a document which can thereafter be compared to the final policy product. For the empirical part of this research, we are looking for overlap between respondents’ preferences and the policy result. However, in order to measure responsiveness, the suggestions respondents make should be specific for the type of stakeholder they belong to and be reflected (almost) literally in the corresponding policy result documents. In other words, we are looking for stakeholder-specific preferences taken up by the EC in the policy result document. Furthermore, of interest are stakeholder-specific preferences that are directly turned down by the EC in the policy result document. This will result in four responsiveness schemes, one per case, in which the responsiveness of the EC towards the relevant stakeholders is rated according to the method presented in table 4.

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Table 4. Rating of responsiveness Indicator Meaning ++ + +- -

Very responsive; five or more stakeholder-specific preferences granted

Quite responsive; one or more stakeholder-specific preferences granted

Not responsive, not unresponsive; one general preference granted (e.g. improve legislation); OR one preference granted, one preference contradicted.

Not responsive; no stakeholder specific preferences granted

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4. Mapping the cases

This chapter provides an overview of the four cases studied in the current research. A short, empirical description of each case will be supplemented and clarified by data regarding the types of stakeholders that responded to the respective consultations. This information will be used later on in order to make a comparison between the cases and to be able to draw conclusions from the gathered evidence.

4.1 Strategic approach to pharmaceuticals in the environment

Human and veterinary pharmaceuticals polluting the environment is an upcoming problem in the EU and elsewhere in the world. In 2017, the EC drafted a roadmap to inform relevant stakeholders of a Strategic Approach to pharmaceuticals in the environment. The specific problems this roadmap aims to address concern the production, usage and disposal of active pharmaceutical ingredients (APIs). These APIs affect the (aquatic) environment and animal populations in ways that are still unknown. The uncertainty regarding the presence of APIs in the environment calls for more research. Furthermore, the roadmap includes the approach for the risk assessment of APIs in, for example, drinking water and the effect it has on human health. Consequently, the goal of the initiative is to identify gaps and uncertainties in existing knowledge and solutions to their problems; to investigate how the environment and human health can be protected from pharmaceuticals in the environment whilst ensuring people’s and animals’ access to the right pharmaceutical treatment and maintaining the possibility of innovation. The consultation period lasted from 22 November 2017 until 21 February 2018; no impact assessment was planned for this consultation (European Commission, 2017a).

Open Public Consultation

The roadmap attracted 26 separate responses from 24 organisations and one European citizen. The specifics of stakeholder types that responded to the roadmap can be found in table 5. The large organisations mostly account for the responses from universities and public authorities (European Commission, 2018a).

Remarkably, the great majority of the responses came from organisations in western European countries: Germany, the Netherlands, Belgium, the United Kingdom, France and the Scandinavian countries are well represented. The same cannot be said for eastern and

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southern European countries. The only outlier is a response from a Hungarian NGO that is not very rich in content (European Commission, 2018a).

Table 5. Stakeholder types (European Commission, 2018a)

4.2 Transparency and sustainability of the EU risk assessment model in the food chain The European Food Safety Authority (EFSA) was established in 2002 as the EU’s official body for the risk assessment of food safety. A European Citizens’ Initiative (ECI) from 2017 expressed the concern of citizens regarding toxic pesticides and the procedure of pesticide approval, which they found not transparent and independent enough. The ECI expressed several grievances. First of all, the risk assessment procedure was criticised for its obscurity that led to non-transparent decision-making. Furthermore, this process was not considered independent enough, since the research was done and paid for by the organisation that applied for the risk evaluation in the first place. Generally, the risk communication of EFSA was found insufficient; especially the communication of science-based decisions. EFSA is a highly scientific agency, that experiences difficulties with finding new experts and most of the

Consultation Stakeholder type Number of responses Organisations’

responses Pharmaceuticals in the environment EU citizens Organisations Academic institution Business association Environmental organisation NGO Public authority 26 1 (4%) 25 (96%) 5 (19%) 8 (31%) 3 (11,5%) 6 (23%) 3 (11,5%) 25 5 (20%) 8 (32%) 3 (12%) 6 (24%) 3 (12%)

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initiative, the EC aims to tackle the above-mentioned problems regarding the EU risk assessment model in the food chain (European Commission, 2017b).

Feedback period

The feedback period on the roadmap was held between 20 December 2017 and 17 January 2018 (European Commission, 2017b). Many respondents complained about the timing of the consultation and the short consultation period (e.g. AEGSP, 2018; BLL, 2018; Cefic, 2018; FoodDrinkEurope, 2018; FSE, 2018). Many of these respondents expressed their surprise that an impact assessment was not planned for this consultation (BLL, 2018; FoodDrinkEurope, 2018; Cefic, 2018; FSE, 2018). Others were of the opinion that such an impact assessment is vital and therefore must be carried out (DAFC, 2018; ECPA, 2018). Nonetheless, an impact assessment was not carried out (European Commission, 2018b).

Only 18 organisations found the time to respond to the roadmap. Almost all of these organisations were established in Brussels, Belgium. Two organisations were German, one Danish and one Italian (European Commission, 2018c).

Open Public Consultation

After the feedback period on the roadmap, an Open Public Consultation was held by means of a questionnaire. This questionnaire was aimed at EU citizens as well as organisations. In total, 318 citizens and 153 organisation stakeholders responded to the questionnaire. 18 of the responding organisations had also responded to the roadmap, so we can assume that table 6 contains all stakeholders that responded to the roadmap and the Open Public Consultation (European Commission, 2018b).

The questionnaire asked citizens and organisations to judge their own expertise on the topic. See table 7 for the exact ratio of expert and lay citizens and organisations.

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Table 6. Stakeholder types (European Commission, 2018b)

Consultation Stakeholder type Number of responses Organisations’

responses

Transparency and sustainability of the EU risk

assessment model in the food chain

EU citizens Organisations Trade and business associations Companies and groups NGOs Professional associations National/regional authorities and public bodies Government agencies Research institutes Other 471 318 (68%) 153 (32%) 60 (13%) 22 (4,5%) 20 (4%) 13 (3%) 16 (3,5%) 8 (1,5%) 6 (1%) 8 (1,5%) 153 60 (39%) 22 (14%) 20(13%) 13 (9%) 16(10%) 8 (5%) 6 (4%) 8 (5%)

A rather risky endeavour: analysing the responsiveness of the European Commission's public consultations on health policy