Twentieth anniversary of the European Union health mandate: taking stock of perceived achievements, failures and missed opportunities – a qualitative study

Experts were purposely selected to ensure heterogeneity of opinions. The selection was based on their individual profile and professional affiliation. We selected experts that were renowned in the field due to their current or former affiliation to specific EU-level bodies and institutions, research institutes with EU focus, or EU-level non- governmental organization. Selected experts were actively involved in public health research, policy-making, policy advice or advocacy performed at EU level, internally or externally. In addition, snowball sampling was applied until data saturation was reached. Data saturation was assumed as soon as no new EU public health policy actions and their perceptions were mentioned during the interviews.

The potential participants were contacted between December 2011 and March 2012 by a short information email to identify whether they were interested to participate in the interview study. Of 22 contacted experts, twenty participated in this study, one participant could not confirm participation due to time constraints and another did not respond to the invitation. Of those twenty experts nine belonged to the initial purposively selected sample and eleven were identified during the snowball sampling procedure based on recommendations of already interviewed experts. The majority of experts was affiliated to an institution located in Brussels (n = 10). The composition of the study sample in terms of represented professional affiliations is outlined in Table 2.

Upon agreement by the participant, an appointment for the interview was made and participants received an informative letter with more in-depth information about the goal of the study and an informed consent form in which the voluntary basis of the participation has been clarified and anonymized data handling was assured.

Interviews were conducted either face-to-face (n = 4) or via telephone, or Voice over IP (n = 16) in the period between January and March 2012 and were held in English, Dutch or German by one of the three principal investigators (NR, TC, KS). The interviews lasted from 35 to 90 minutes. All interviews were audio-recorded, transcribed verbatim and anonymized.

The interviews were performed using a specifically designed semi-structured interview guide. The guide was developed on the basis of previous desktop research and an internal brainstorming session of an advisory research group consisting of the three principal investigators, four senior researchers, and one junior researcher of the Department of International Health at Maastricht University to identify items relevant for investigating expert perceptions on European public health policy. During the course of this process, a list of public health relevant EU policy outputs, processes or procedures that were regarded as achievements, failures or missed opportunities were first gathered individually and then, following a group discussion, a common list was compiled. This output was used to construct the interview guide containing six guiding themes from which open-ended questions were formulated. The guiding themes included (1) a description of the individual role of the expert in European public health, (2) the individual definition of European public health, (3) the assessment of public health relevant EU-level actions as being an achievement, missed opportunity or failure, (4) the formulation of five influential European policy outputs, (5) consequences of European health policy, and (6) the policy process at the European level. The semi-structured interview guide was used as a framework for the interviews and allowed the interviewers to address other relevant topics that emerged during the interviews.

After completion of interviews the three principal investigators initially performed an internal analysis of each separate interview and an analysis across interviews to identify the scope of EU-level actions and experts’ perceptions of these actions as achievements, failures or missed opportunities [34]. Afterwards, a directed (or deductive) content analysis approach [35, 36] was applied whereby the initially predefined coding scheme with the main categories of interest (achievement, failure, and missed opportunity) was used to summarize the respective topics and the reasoning that appeared during the interviews. Topics that did not fit into one of these main categories were added as new codes and were organized into new categories. The analysis was jointly performed by the principal investigators using NVivo 9 (QSR International Pty Ltd. Version 9).

Furthermore, the results of the content analysis on achievements, failures and missed opportunities were grouped according to the major common themes in a table to provide an overview of the perceptions of the key informants. Prominent EU-level outputs or actions, which were discussed by almost all respondents, are described in more detail in the results section. Where applicable, we used original quotes to illustrate the views and tendencies of experts’ assessments. The professional profile and study ID of respondents are indicated behind the respective quotes. Quotes which were originally given in Dutch or German were translated into English.

A slightly adapted nominal group technique [37] was used for triangulation purposes. During the interviews, the participants were asked for five influential policy outputs of European health policy-making. Following the finalization of all interviews, all participant nominations were compiled in one list and reoccurring topics were removed. To ensure comparability of policy outputs and actions, we grouped the nominations into categories under the following headlines: (a) secondary legislation and court decisions; (b) soft laws, strategies, and programmes; (c) agencies, centres, organizations; (d) networks, policy platforms, cooperation; and (e) others. Participants were asked in an online survey to select three outputs per category which were, according to their opinion, most influential. Based on the participants’ nominations, a ranking in terms of a frequency distribution of selected influential policy outputs for each category was determined. The online survey was completed by 18 out of 20 participants who took part in the interviews.

The design and analysis of the study was guided by applying Guba and Lincoln’s test for trustworthiness [38]. Credibility and dependability have been ensured by enlarging the sample until saturation was reached in terms of the identification of EU policy actions and their perceptions. Moreover, three researchers in the primary research group in combination with an internal advisory research group were involved with the aim of reflecting upon the study design and critically questioning the findings. Additionally, the primary research group met regularly during the interview period to exchange initial findings and experiences on the interview process. The members of the internal advisory research group were experienced in EU public health policy research or qualitative research methodologies. The confirmability was strengthened by the use of several investigators both in the data collection process and in the analysis phase, combined with the use of triangulation, where interview participants were also asked to participate in the ranking exercise.

The Medical Ethical Committee of the University Hospital Maastricht and University Maastricht declared that no ethical approval was required for this type of research. All participants were informed about their role and rights as study participant prior to their interview participation. All participants provided written or audio-recorded informed consent to be interviewed.

The ranking of influential policy outputs of EU-level health policy-making is provided in Table 3.

In the category “secondary legislation and court decisions”, the patients’ rights decisions made by the European Court of Justice (n = 12) were chosen by most of the respondents as influential policy output, followed by the Directive on the application of patients’ rights in cross-border healthcare [39] (n = 10) and the Directive on advertising and sponsorship of tobacco products [14] (n = 9). In the category entitled “soft laws, strategies, and programmes”, the first and second EU public health programmes [40, 41] (n = 9) were selected most frequently, followed by the 2008–2013 health strategy “Together for Health” [42] (n = 6). The third rank is shared by three policy outputs: the “Framework for action in the field of public health” [43] (n = 5) which is the Commission’s first proposal setting out EU-level public health after the introduction of the health mandate in the Maastricht Treaty, the Council conclusions “Towards modern, responsive and sustainable health systems” [44] (n = 5), and the current over-arching European strategy “Europe 2020” [45] (n = 5). In the third category on “agencies, centres and organizations”, the European Medicines Agency (EMA, n = 15) ranked top, followed by the ECDC (n = 13) and the European Food Safety Authority (EFSA, n = 9). Among “networks, policy platforms and collaborations”, the European presidencies (n = 13) were selected most often by the respondents, followed by the collaboration of the European Commission (EC), the World Health Organization Regional Office for Europe (WHO-EUR) and the Organization for Economic Co-operation and Development (OECD) (n = 8). Moreover, the three entries on the third rank include the EU Health Policy Forum (n = 6), the network on epidemiological surveillance and control of infectious diseases (n = 6), and the network on Health Technology Assessment (n = 6). The fifth category was not topic specific therefore, work on European level health determinants (n = 10), the exchange of best practices (n = 8), and published scientific reports which influenced EU policy-making (n = 7) were ranked on the first three positions.

At a glance, the label “achievement” was allocated to the public health mandate as it is laid down in the Treaties, the establishment of EU-level agencies dealing with public health topics and successes in smoking prohibition, food safety and infectious disease control. The label “missed opportunity” was allocated to the insufficient degree to which the HiAP approach is implemented and the ways in which health promotional aspects of alcohol and nutrition were handled. The label “failure” was less often assigned with the missing integration or link to social policies appearing in some interviews under this heading as well as the strength of the internal market which annulled national protective alcohol legislations in some member states. In Table 4, we provide the full list of EU-level outputs or actions which, based on the content analysis and the identified thematic categories, were mentioned as achievements, missed opportunities or failures by the key informants. Due to a broad and divergent spectrum of perceptions, topics almost always shared aspects of achievements, missed opportunities or failures. In the following section, we focus on those EU-level outputs or actions which were mentioned by the majority of respondents during the interviews and allowed us to draw a comprehensive picture on the breadth and the diversity of expert perceptions.

An assessment of the general value of EU-level public health actions over the last twenty years resulted in mainly ambivalent judgments. On the one hand, many relevant activities were performed at an EU-level and the existence of a health mandate contributed to an EU social model. On the other hand, its dependence on political will and economic circumstances influenced the development of EU-level public health policy and led to the perception that more should or could have been achieved within and beyond the possibilities of the current health mandate.

The establishment of the Directorate General for Health and Consumers (DG SANCO) in 1999 as an independent, formal structure for EU health policy was generally discussed as an achievement. The formation of DG SANCO, and thus, the political decision to separate the health dossier from DG V, the former DG with the responsibility for health policy as well as a focus on employment and social policies, was controversially perceived. The establishment of DG SANCO led, on the one hand, to a more mature health policy field.

On the other hand, aspects of failure were mentioned regarding the detachment of health and social policy at EU-level. According to the respondents being separated led to a loss of collaboration for more holistic health policies and actions in health systems and healthcare at EU-level.^a

Following the formation of DG SANCO, it was seen as a beneficial way forward for the DG to shift its sectorial policy approach from a focus on specific topics such as cancer, drug dependence, health monitoring, accidents and injuries, or pollution-related diseases, to a horizontal one with the formulation of the first health strategy with three cross-cutting objectives: health information, health threats and health determinants [46].

Since it fostered more visibility of the public health field and closer cooperation by financing projects, joint actions and research across Europe, the Public Health Programme of DG SANCO was commonly discussed as being supportive to the development of European public health and the mobilization of the public health community.

Aspects of missed opportunity became relevant when assessing the representation of health in other EU policies.

While the cooperation with other DGs was recurrently discussed as problematic, the potential for the “Partnership on Active and Healthy Ageing” under the European Innovation Union appeared as a unique theme and was regarded as an achievement for strengthening health policy on the general EU policy agenda.

With regard to assessing the status of DG SANCO cooperation with other international policy actors, respondents had mixed perceptions. Whereas some argued that DG SANCO’s collaboration with international organizations like the WHO-EUR or the OECD is improving and therefore, can be considered as an achievement, others asserted that this collaboration was not sufficiently established and can therefore be categorized as a missed opportunity.

The establishment and the work of EU public health agencies like the EMA, the ECDC, the EFSA, and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) were regarded as an achievement and as an important step forward towards the strengthening of the European dimension in health. The work and the scope of the agency mandates was a recurring topic and subject to diverging perceptions. As an example, in the case of the ECDC, its development was assessed as an achievement whilst its scope was considered a missed opportunity.

The bioterrorism attacks on the United States of America in 2001 and the SARS crisis led to calls for better international coordination of infectious disease surveillance and the establishment of ECDC in 2004 [47]. Hence, the setting up of ECDC was commonly perceived as an achievement, since it gave preceding EU actions in infectious disease control a formal structure and maintained actions in the field. Also, the close collaboration with the respective national public health agencies during outbreaks and in negotiating and developing common guidelines for infectious disease control were regarded as an important task of the ECDC.

However, a number of respondents were critical of the scope of the ECDC mandate and thus, looked at this as a missed opportunity. Questions were raised on whether the ECDC’s responsibility in surveillance, risk assessment and training are sufficient or if additional responsibilities in risk communication and management were needed to assure full stewardship during and in the prevention of health crises.

Moreover, interview participants reported tensions between member states and EU agencies regarding the transfer of responsibilities from national to EU-level.

Since the largest burden of disease in the EU is caused by non-infectious rather than infectious diseases, a call was put forward to further increase the mandate of ECDC to all public health relevant aspects and not focus only on infectious diseases.

The HiAP approach was generally assessed as an achievement regarding its potential to address health determinants outside the health sector.

Generally, the work regarding tobacco was regarded as an achievement of how European health policy-making effectively addressed a life style risk factor for health.

“The progress around tobacco [Directive on tobacco advertising, Directive on tobacco products, transparency register], the fact that we have a piece of international law on tobacco [WHO Framework Convention on Tobacco Control] is massive and that was European led.” (#05, public health advisor/advocate).

This quote echoed the perception of the majority of respondents who emphasized the leading role of the EU regarding the support and commitment to the WHO Framework Convention on Tobacco Control. Moreover, it was argued that the achievements regarding the regulation of tobacco advertising and smoking prohibition in public places would not have been achieved by single member states independently and thus this was a common achievement initiated and supported by European cooperation. Nevertheless, aspects of a missed opportunity or even failure were mentioned in this regard since some would have appreciated stronger legislative measures to achieve a more harmonized realization of smoke-free legislation across the EU.

With regard to governmental activity on these issues, the EU Platform for Action on Diet, Physical Activity and Health was named as an example of an achievement as well as a failure.

The failure aspect of the EU Platform for Action on Diet, Physical Activity and Health was related to the perception that a platform is a rather weak policy instrument and that more political will to tackle these issues with stronger EU policy or legal instruments would have had more impact.

Additionally, the lack of timely cooperation of public health professionals with other sectors such as agriculture was raised as missed opportunity. It was illustrated that agriculture policy has public health relevant links regarding affordability, accessibility, and the availability of food. However, it was also argued that this cooperation has been developed further over the recent years.

Internal market provisions were perceived as ambivalent by the respondents. The EU is based on internal market rules that also affect EU health policy.

However, the influence of EU market regulations, for example on alcohol policies, was perceived as a failure when member states had more protective and stricter national legislation as was the case in the Nordic countries. Respondents claimed that EU internal market regulations that are more attentive to health issues would be appreciated in this case. Moreover, the potential given by Articles 36 and 114 of the TFEU, which put limitations on the Single Market, was mentioned and it was perceived as a missed opportunity that this potential had not been fully taken up by public health experts:

This was positively exemplified by the case of tobacco control which applied internal market rules for public health purposes to assure harmonized labeling, packaging, nicotine content, etc. across the EU. However, the application of the health argument to put limitations on the internal market rules was also perceived as being negatively connoted by non-public health experts:

The recent EU patients’ rights Directive in cross-border healthcare [39] was mainly regarded as an important achievement. This assessment was not necessarily driven by satisfaction with the scope of the Directive but, instead, because it is the first EU secondary legislation ever enacted specifically on healthcare.

The achievement aspect was supported by perceptions that the Directive will lead to more cross-border cooperation and will have an impact on quality of care as well as on priority setting in healthcare and the packaging of healthcare services. Thereby, it was expected that the Directive will not only influence people who seek healthcare services in other countries but also those who seek services in their home country. In this regard, some expected that the Directive would also ultimately empower patients as consumers of healthcare services.

However, there were also critical voices that interpreted the Directive, as targeting a limited segment of the European population and hence, potentially increasing health inequalities. These respondents also questioned the willingness of the general population to seek healthcare treatment outside their home country. Furthermore, respondents were critical of the extent to which more EU involvement in healthcare of member states would lead to quality assurance in general:

Interestingly, the study indicated that the Treaty-based tasks such as support of cooperation between member states, development of guidelines and indicators, best practice exchange, and periodic monitoring and evaluation on EU-level public health to ensure ‘a high level of human health protection’ [1] were only partially perceived as fulfilled or acknowledged by the interviewed experts. Thematic discussions on actions or policies related to the development of guidelines and indicators appeared with regard to infectious disease surveillance and management of rare diseases but were not a major theme across interviews. The EU-level task to promote best practice exchange among member states was regarded as influential, which is represented by a top position in one of the rankings presented in this paper. With regard to the task of establishing monitoring and evaluation structures, some respondents perceived the status of the EU health information system rather as a failure. This corresponds to observations in the literature indicating that although ground work such as the development of a common EU health indicator set is acknowledged [50, 51] further efforts are needed to implement and maintain health indicators [51] and to develop a permanent and sustainable EU public health monitoring and reporting infrastructure that supports decision making in public health on EU level [50, 51]. Respondents agreed that cooperation in the area of public health between member state representatives and experts as well as with other stakeholder groups has increased and has been facilitated by the EU through various projects, networks, forums, and platforms. This trend was mainly positively perceived since it supported EU-level public health policy by accumulating and exchanging knowledge, generating public support and a legitimacy to act on certain fields [3]. This finding is corroborated by the literature on the potential of new governance instruments for health- and social policy-making at EU-level [11, 52‐54]. However, these new governance instruments can also be regarded as a rather strategic investment of the EC to keep topics on the agenda until a political window of opportunity opens but as an ineffective policy tool to enforce and implement action in due course [6]. The collaboration of a diverse set of stakeholders as it is the case for example in the EU Platform for Action on Diet, Physical Activity and Health can lead to actions that constitute rather a compromise of various interests. Consequently, the results might be disappointing from the viewpoint of public health experts [6, 55]. A final judgment on the impact of facilitating collaboration is to be awaited and may only be made in the long term future. It will require different ways of measuring ‘impact’ compared to the analysis of domestic adaptations when implementing EU hard law [56].

The assessments of EC tasks for public health policy making have been influenced by characteristics like the subsidiarity principle throughout several interviews. On the one hand some participants were in favor of more EU influence on health policies and their implementation. In their view integration and harmonization of health policy did not reach far enough and hence their perception of actions was dominated by the category ‘missed opportunity’. On the other hand some experts were in favor of keeping certain health issues like health care as national responsibility which led to a perception of too much EU involvement and a negative perception of the evolvement of the health mandate.

Public health has a cross-cutting nature and cooperation across DG’s often poses difficulties. Therefore, convincing evidence is required to demonstrate the health impact of policies outside the health domain and strong partnerships are needed to counter strong industrial lobbying groups [6, 57, 58]. The ease of cooperation and the potential to achieve policy coherence between DG SANCO and DGs with stronger regulatory competences like the internal market (e.g. regarding tobacco, pharmaceuticals) or agriculture policy (regarding food safety, subsidies of unhealthy versus healthy food products) represented another characteristic that influenced the individual perception of EU public health policies. Experts who assessed the value of EU health policy actions under the reality of a rather weak health mandate were more likely to perceive EU actions as achievements. This was in contrast to others who strove for more appreciation of social and health matters in EU policies and who perceived a lot of missed opportunities or failures in this regard as the power of the EU was too weak to realize change and to fulfill the objective of the health mandate to ensure human health protection for citizens in the EU.

In summary, underlying themes such as cooperation among European public health professionals, increasing institutionalization, and characteristics such as the issue of subsidiarity or the possibilities to cooperate across EU policy domains influenced experts’ perceptions throughout the topics presented in this paper. These conditions and characteristics are part of what Lamping called the “chaordic dynamics” of European integration in the field of health policies [3]. As our study demonstrated EU health policy does not demonstrate a clear-cut success since the logic of action in the field can involve diverging interests. Nevertheless, the EU public health has quite systematically developed in terms of scope and impact beyond the original mandate.

The ranking of influential policy outputs provided indications on important developments in EU public health policy. However, even though we categorized the outputs, they sometimes differed in character and power which might have led to imbalanced judgments.

Additionally, we received different reasons for labeling EU-level actions or policies as achievements, missed opportunities or failure for public health. Some were identified because they increased the strength or value of EU-level public health policy, whereas, others were identified because they impacted the health of the European population.

The findings of the study may not be empirically generalizable since they were closely linked to qualitative individual perceptions and the settings that participants belonged to. However, we are confident that the broad range of profiles of the experts has ensured the diversity of perceptions on the topics varying from achievement to missed opportunity and failure. Moreover, given that participants were generally active in health policy at EU-level and mainly positive about the EU, this could also have influenced the obtained results to some extent.