la aprobación de esta Ley el gobierno español trata de cumplir su obligación de
transponer al Derecho español la
Directiva 2011/83/UE. Como se indica en la Exposición de motivos del citado
Proyecto «(L)a directiva supone un nuevo impulso a la protección de los
consumidores y usuarios europeos y a la consolidación de un mercado interior,
dirigido a reforzar la seguridad jurídica, tanto de los consumidores y usuarios
como de los empresarios, eliminando disparidades existentes en la legislación
europea de los contratos de consumo que crean obstáculos significativos en el
mercado interior». Siempre según la misma fuente, «(C)on esta finalidad, la
directiva amplía la armonización de los ordenamientos internos de los Estados bajo un enfoque de armonización plena,
con excepciones puntuales, e introduce modificaciones sustanciales en la
vigente normativa europea en materia de contratos con los consumidores y
usuarios, recogida en nuestro derecho interno a través del texto refundido de
la Ley General para la Defensa de los Consumidores y Usuarios y otras leyes
habrá para comentar y discutir cuál será el efecto útil de la citada modificación,
como lo hubo para comentar y discutir el de la Directiva 2011/83/UE (véase, al
final, una lista de algunos de los artículos referentes a dicha normativa
objetivo es en esta ocasión evidenciar que el calamitoso sistema de legislar a
tres niveles (comunitario, estatal y autonómico) no tiene sentido:
un lado el legislador comunitario adopta Directivas (aunque sea bajo un enfoque de armonización plena),
el gobierno debe modificar la correspondiente Ley y casi todas las Comunidades
autónomas cuentan con su propia Ley para la Defensa del Consumidor [Ley 2/2012,
de 28 de marzo, gallega de protección general de las personas; Ley de Cantabria
1/2006, de 7 de marzo, de Defensa de los Consumidores y Usuarios; Ley 16/2006,
de 28 de diciembre, de Protección y Defensa de los Consumidores y Usuarios de
Aragón; LEY 1/2011, de 22 de marzo, de la Generalitat, por la que se aprueba el
Estatuto de los Consumidores y Usuarios de la Comunitat Valenciana; Ley
11/1998, de 9 de julio, de Protección de los Consumidores de la Comunidad de
Madrid; Ley 13/2003, de 17 de diciembre, de Defensa y Protección de los
Consumidores y Usuarios de Andalucía… y así sucesivamente (véase la lista
completa en: http://www.consumo-inc.gob.es/guiaCons/derecho/leyesCcaa.htm
puede negar que se trata de una absurda y amarga tarta nupcial (por pisos) que no
produce más que confusión y empeora la indefensión de los consumidores.
nuestra opinión este caos legislativo tiene una sola solución: que en la Unión
Europea se adopten únicamente Reglamentos que armonicen plenamente una materia
tan sensible para sus ciudadanos…
Bibliografía (Directiva 2011/83/UE):
- Salvatore Mazzamuto, “La nuova
direttiva sui diritti del consumatore”. Europa e diritto privato,
nº 4 (2011) 861-909.
- Stepehn Weatherill, “The Consumer
Rights directive: how and why a quest for ‘coherence’ has (largerly) failed”. Common
Market Law Review, Vol. 49 nº 4 (2012) 1279-1318.
- Jules Stuyck [et al.], “La directive
2011/83/UE relative aux droits des consommateurs”.Revue des affaires
européennes, nº 3 (2012) 519-578.
- Peter Rott, “More coherence? A
higher level of consumer protection? - A review of thenew Consumer Rights
Directive 2011/83/EU”. Revue européenne de droit de la consommation, nº 3 (2012) 371-392.
- Gilles Paisant, “La directive du 25
octobre 2011 relative aux droits des consommateurs”. La semaine juridique.
Edition générale, nº 3 (2012) 103-111. ww
Twentieth anniversary of the
European Union health mandate: taking stock of perceived achievements, failures
and missed opportunities – a qualitative study
Nicole Rosenkötter*, Timo Clemens, Kristine Sørensen and
* Correspondence: email@example.com Department
of International Health, CAPHRI, Faculty of Health, Medicine and Life Sciences,
Maastricht University, Duboisdomein 30, Maastricht 6229 GT, The Netherlands
The Maastricht Treaty from
1992 marked the beginning of the health mandate of the European Union (EU) as enshrined
today in Article 168 of the Lisbon Treaty (TFEU, Treaty on the Functioning of
the European Union) . The original EU health mandate focused primarily on
stimulating cooperation between member states and supporting national actions
(Art. 129 (1), Treaty of the European Union (TEU)) . It embodied the Union
with only limited legislative powers on health matters. Although this initial
mandate was enhanced through subsequent Treaties, today Article 168, still
gives the EU relatively circumscribed power in areas of public health (Art. 168
(4), TFEU). Healthcare continues to remain a national competence and in this
regard, the EU “shall respect the responsibilities of the
member states for the definition of their health policy and for the
organization and delivery of their health services”
168 (7), TFEU). Despite the restricted Treaty-based mandate for health, the EU has
a relevant role to play in national public health and health systems policies
and has expanded its remit in areas beyond the Treaty . Areas affected by EU
provisions are extensively described in the literature [4-11]. To illustrate the
main developments in the area of what can be called “EU health policy” a
timeline is illustrated in Table 1. However, because of its limited legal
mandate, some EU legal initiatives were highly contested [12, 13].
Therefore, one can pose the
question of what has been achieved over the last twenty years. It may be argued
that, despite its narrow legislative scope, the health mandate has triggered
important European actions in certain public health areas like tobacco control
[14,15], infectious disease control [16,17], European guidelines [18-20] and
the development of an EU public health infrastructure . In recent years,
the EC has summarized in annual reports a diverse nature of key public health
achievements such as communications and recommendations, health policies, EC
co-financed actions and established networks (e.g. high level groups,
scientific committees, platforms) [22-24].
However, stakeholders in the
field provide examples indicating that public health relevant EU policies such as
single EU policy assessments on the Common Agriculture Policy (CAP) [25, 26],
pharmaceuticals , or the Health in All Policy (HiAP) approach  do not
always meet the expectations of the public health community. In these papers
the authors express concerns about potentially detrimental health effects [25, 26]
or disappointment about the support of the policies and approaches aimed at
improving health in Europe [27, 28]. Also, EU agencies such as the European
Centre for Disease Prevention and Control (ECDC) are described as agencies with
a limited legal mandate, competences and resources for EU public health but, at
the same time, with promising prospects to develop as a renowned international
player in the field .
In addition, an evaluation
of the EU Health Strategy acknowledges its status as a guiding framework for EC
health policies and joint EC and member state actions on health but also
identifies the missing impact of the Strategy on other EC policies as well as
on member state health policies and actions
Evaluations of the EU public
health programmes, which are one of the EC’s financial instruments to
implement its strategic health goals, criticize missing prioritization of topics,
barriers for participation in projects for some member states and ineffective
dissemination of project results [31, 32].
Hence, the available
evidence of the impact of EU health policies, infrastructure, and actions is
elusive, and the identification of the value of public health relevant EU-level
actions across all policies is lacking.
In this paper, we aim to
explore and provide an overview of influential public health relevant EU-level
policy outputs and a summary of policy outputs or actions perceived as an
achievement, a failure or a missed opportunity by interviewing key experts in
the field. By this, we intend to establish a qualitative indication of which EU
health policies have contributed to the improvement of population health in
The study focused on the
evolvement of the health mandate since 1992, the year the Maastricht Treaty was
signed. The study was carried out in two consecutive phases: (1) qualitative
interviews, suitable to identify expert perceptions, and (2) voting on
influential and public health relevant EU policy outputs and actions based on
nominal group technique. The study adhered to the RATS guidelines on
qualitative research .
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 nongovernmental 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
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
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 .
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
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.
Nominal group technique
A slightly adapted nominal
group technique  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
dependability have been ensured by enlarging the sample until saturation was
reached in terms of the identification of EU policy actions and their
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.
consistently mentioned that, during the twenty-year history of the EU health
mandate, specific initiators induced change in European public health policy.
The most important identified initiators included the Maastricht Treaty with
its later amendments, the health-related rulings of the European Court of
Justice, and the health crises such as Bovine spongiform encephalopathy (BSE)
and Severe Acute Respiratory Syndrome (SARS). In addition, the internal market
provisions with the foreseen free movement of goods, people, services and
capital, initiated change with both negative and positive public health impact.
Additionally, a set of conditions was identified in the interviews that
described and advanced the role of EU health policy as a reference point for
public health. These conditions under which EU health policy made progress
during the past twenty years were (i) the regulatory power at the EU-level,
(ii) EU-led facilitation of cooperation and comparisons across member states;
along with (iii) increased capacity building on EU issues and on EU-level (e.g.
professionalization, development of interest groups, associations).
Influential EU health
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  (n = 10) and the Directive on advertising and sponsorship of
tobacco products  (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”  (n
= 6). The third rank is shared by three policy outputs: the “Framework
for action in the field of public health”  (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”  (n
= 5), and the current over-arching European strategy “Europe 2020”  (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).
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
EU health policy - an
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 role of the
Directorate General for Health and Consumers
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.
“…the DG V was a big DG and then DG SANCO became
separate from that. Health had its own commissioner, its own opportunity to
protect itself and public health benefits.”
(#15, public health advisor/advocate)
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 .
“And this was an important moment in time
where the sectorial approach to AIDS, cancer and other issues has been reduced
gradually and that more the integral horizontal approach, which was applied at that
time already in all member states –
hence Europe was
running behind in that sense, but ultimately was
and taken as guideline for the framing of all sorts of public health actions. “(#02,
EU/national civil servant)
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.
“I don’t know what exactly the reason is, but
they [DG SANCO] are not strong enough to push for health in [the other] DGs.
The obvious example is the latest EU 2020
strategy, you cannot find reference to health anywhere it’s
really a disaster, because of [the] weak DG SANCO. Health is not among the
headline targets, it’s
not among the flagships.”
(#15, public health advisor/advocate)
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.
“…it is now coordinated under the Innovation
Union [of Europe2020], and so Commissioner Neelie Kroes [DG Connect and
Vice-Commissioner] is as much in the
lead as Commissioner John Dalli [DG SANCO]. And that’s
a good sign, if we can get more of those sorts of partnerships on specific
policies, then I think, we’ll
get a better understanding.”(#04, EU/national politician)
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 role of health
agencies: the example of ECDC
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 . 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.
“I suppose the flu epidemic […].
That should be put on the table not only as a missed opportunity, big failure, having
put ECDC at the center of the development, but
the ECDC is not authorized to risk communicational management as you know. So,
in that sense, it is a failure that member states were not able to coordinate
in this very important public health area and use the EU institution, either
ECDC or WHO to do that.”
(#03, public health
participants reported tensions between member states and EU agencies regarding
the transfer of responsibilities from national to EU-level.
“And the member states are very reluctant
to hand over power regarding public health to the Commission, or to Brussels.
Now if you focus on infectious diseases, that is much better because they
understand that there is a need, but again it is not easy.” (#30,
EU/national civil servant)
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.
Health in All Policies
The HiAP approach was generally
assessed as an achievement regarding its potential to address health
determinants outside the health sector.
“[the article on the health mandate] is
very important, because thereby a mandate is created that the Commissioner for
Health and Consumer Affairs […] approaches his colleagues whenever they
make new legislation to ensure that the health protection dimension is
guaranteed; it gives partly a mandate to break into the policy and law
development in sectors which in principle do not have any links with public health.
[…] this is very difficult. But its
potential is very strong.”
(#2, EU/national civil
However, in regard to its
degree of implementation participants commonly perceived HiAP as a missed
Health Impact Assessment, the
implementing tool to HiAP, was regarded as a “tick box exercise”
#15, both public health advisor/advocate) rather than a thorough
consideration of health in other policies areas.
Explanations given during
the interviews demonstrated that conditions to achieve HiAP seemed not to be
established yet and that there seems to be difficulty in bringing DG SANCO
interests in line with the interests of other DGs without over-emphasizing the
Political assertiveness in
convincing other Commissioners and DGs about the relevance for intersectoral
cooperation was perceived to be lacking, even though an Inter-service group on
Public Health with the participation of more than twenty EC departments was
established for this purpose.
Approach to life style
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.
It was considered that the
achievements recognized in EU tobacco legislation were missed in the regulation
of other health-related life style factors such as nutrition and alcohol.
Whilst regulations in the area of food safety were generally acknowledged as an
achievement by preventing food-borne health threats; a potential mandate to
address the composition of food and thereby, prevent, inter aliaobesity
or non-communicable diseases seemed to be neglected and was labeled as a missed
“…food safety has been majorly put forward
over the last twenty years, in the sense that we know that the food will not be
contaminated. But then it is a missed opportunity in the sense that beyond food
safety there is health promotion and then one wanted the Union to have more
powers to regulate issues on the content of saturated fat for instance or the
percentages of sugar and so on.”
(#03, public health
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.
“I think the diet platform […]
can be seen as a failure and opportunity. […] If we had not created that platform then
arguably the issue wouldn’t have been tackled at all. And in a way
that has been really brought some issues of complexity to the political discussion
around issues around marketing of food, around self-regulation, reformulation,
some of the initiative like salt in diet has come as a commitment from that
platform.”(#05, public health advisor/advocate)
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.
“And it is correct, that the Common
Agriculture Policy has not been taken up health in the beginning, but by now
they are doing this very consciously. […] Thus, I really see an improvement; I
actually do not see a situation anymore in which health was influenced really
negatively [by the Common Agriculture Policy].”
(#26, EU/national civil
Internal market provisions
were perceived as ambivalent by the respondents. The EU is based on internal
market rules that also affect EU health policy.
“The engine of European health policies is
still the market.”(#23, academia)
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:
“[…] the public health aspect, which is
written into Article 95 [now Article 114, TFEU] on the internal market, you can
put limits on the internal market on the grounds of public safety, public
morality and public health, is almost never used. What if DG Internal Market
was turned into our greatest weapon?”
(#32, public health
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:
“If you just go to the DG Internal Market
and grab the first person you see and ask them what public health means, they
will tell you it’s the exception member states use to
defend local weird monopolies on peculiar alcohol, or something like that. It’s
an exception to a rule.”
The recent EU patients’ rights
Directive in cross-border healthcare  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 cross-border Directive will turn out
to be incredibly important. Particularly because it is so symbolic important if
you like because it does represent really the first time that the EU has got
any concrete in relation to healthcare as opposed to public health. The
consequences of this remains to be seen.”
(#29, EU/national civil
“Therefore, I see the patients’ Directive
as a true success from a legislative perspective”
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.
“The cross-border Directive […]
will have consequences of more consumer empowerment, consumer rights, patient
rights, more consumer participation and more literacy,…”(#03,
public health advisor/advocate)
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:
“It is positive in the way people can be
treated where they want, but it is still my point of view that we […] want
to have our own level of quality and we don’t want others to decide what level it
should be. Perhaps, because we have a very high quality […].
But of course we
don’t mind to tell others about it, we don’t
mind others to come in, we don’t mind to help others to get the same
standard - that is cooperation, so I always say I love cooperation but I do
mind the harmonization.”. (#18, EU/national politician)
This study provides an
overview of public health relevant EU-level actions of the past twenty years.
We outlined the diverse nature of expert perceptions on key developments in the
field and provided a ranking of the most influential achievements. The
assessment of outputs or actions being an achievement appeared across and
within interviews along with assessments of outputs or actions being a missed
opportunity and less often a failure. Thereby, it turned out that the EU public
health field has significantly developed its organizational structures (DG
SANCO, supranational agencies dealing with public health) and incorporated
public health topics like infectious disease control and tobacco control,
whereas the HiAP approach still included untapped potential. This finding
Challenge of Implementation”  of the HiAP concept in
the EU [28, 49]. Given the fact that according to Article 9 and Article 168
(1), TFEU ,
a high level of human health
protection should be ensured within all EU policies and actions, it was seen as
a weakness that the uptake of health consideration in the general EU policy-making
process was low . Ollila described the importance of communication and
cooperation strategies for a successful realization of the HiAP approach .
The deficiency of these strategies was raised during the interviews which
indicated that the performance of EU health players is perceived to be particularly
poor in this regard.
interview responses with tasks formulated in the health mandate of the EU
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
high level of human health protection’  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  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
. 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 . 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 .
Characteristics of EU
health policy that influenced experts’ perception
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
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
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 . 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 labelling 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.
EU public health policy is
subject to divergent perceptions of how successful or unsuccessful specific
topics have been tackled and how far European integration in public health
policy should go. From the findings, it is unequivocal that the EU has
strengthened its role over the past twenty years in supporting, coordinating,
and supplementing member states’ actions on public health issues
as laid down in Article 168 (2), TFEU. The EU is now a recognized player in
public health in Europe. However, when it comes “to
the promotion of a high level of […] protection of human health […] in
defining and implementing its policies and activities”
9, TFEU), further work is needed to achieve the full potential of the EU health
several EU member states disconnected on national level the Ministry of Health
from Social Affairs. At the time of writing only seven out of 28 EU member
states organized health and social affairs within one ministry (Spain, France,
Sweden, Finland, Estonia, Greece, the Netherlands).
ASPHER: Association of
Schools for Public Health in the European Region;
DG: Directorate General;
DG Connect: Directorate
General for Communications Networks, Content and Technology;
DG SANCO: Directorate
General for Health and Consumers; EC: European Commission;
ECDC: European Centre for
Disease Prevention and Control;
EFSA: European Food Safety
EMA: European Medicines
EMCDDA: European Monitoring
Centre for Drugs and Drug Addiction;
EU: European Union;
GATS: General Agreement on
Trade in Services;
HEIDI: Health in Europe:
Information and Data Interface;
HIA: Health Impact
HiAP: Health in All
HTA: Health Technology Assessment;
OECD: Organization for
Economic Cooperation and Development;
SARS: Severe acute
SDoH: Social Determinants of
TFEU: Treaty on the
Functioning of the European Union;
WHO-EUR: World Health
Organization- Regional Office for Europe.
The authors declare that
they have no competing interests.
All authors were involved in
setting up the study. NR and TC coordinated the study. NR, TC and KS carried
out the interviews, performed the analysis, and interpreted the results. NR
drafted the manuscript. All authors revised the manuscript and approved the
The paper was partly
presented at a symposium held on 5th June 2012 in Brussels, Belgium, the
European Public Health Conference on 10th November 2012 in Malta,
and a conference on the 20th anniversary of the EU health mandate on 22nd
May 2013 in Maastricht, the Netherlands. We would like to express our sincere
thanks to the experts who invested their time and participated in the
interviews. Their views and perceptions on European public health policy were
highly valued. We would like to thank Wilco Tilburgs and Hassan el Fartakh for
their support in transcribing the interviews and Ann Borg for her support and
helpful recommendations during the final editing process. We also appreciate
the support of our colleagues at the Department of International Health at
Maastricht University; in particular Kasia Czabanowska, Matt Commers, Kai
Michelsen, Christoph Aluttis and Beatrice Scholtes gave advice in setting up
and designing the study, questioning the results, or reviewing the manuscript.
1. European Union: Treaty
on the Functioning of the European Union. Lisbon: European Union;
2. European Union: The
Maastricht Treaty. The Treaty on the European Union (TEU). Maastricht:
European Union; 1992.
3. Lamping W, Steffen M: European
union and health policy: the “chaordic” dynamics
of integration. Soc Sci Quart 2009, 90(5):1361–1379.
4. The impact of the EU law on
health care systems. Edited by McKee M, Mossialos E, Baeten R. Brussels:
P.I.E.-Peter Lang; 2002.
5. Mossialos E, McKee M: EU
Law and the Social Character of Health Care. Brussels: P.I.E.-Peter Lang;
6. Greer SL, Hervey TK,
Mackenbach JP, McKee M: Health law and policy in the European
7. Greer SL: The
Politics Of European Union Health Politics. Maidenhead: Open University
8. Health systems governance in
Europe - the role of European union law and policy. Edited by Mossialos E,
Permanand G, Baeten R, Hervey TK. Cambridge: Cambridge University Press; 2010.
9. Hervey TK, McHale JV: Health
Law and the European Union. Cambridge: Cambridge University Press;
10. Steffen M (Ed): Health
Governance in Europe - Issues, challenges and theories. New
York: Routledge; 2005.
11. Greer SL, Kurzer P
Union Public Health Policies - Regional and global trends. Abingson,
UK: Routledge; 2013.
12. Adamini S, Versluis E,
Maarse H: European
policymaking on the tobacco advertising ban: the importance of escape routes. Health
Econ Policy Law 2011, 6(01):65–84.
13. Szyszczak E: Patient’s
rights: a lost cause or missed opportunity? In Health Care and EU Law.
by Van de Gronden J, Szyszczak E, Neergaard U, M K. The Hague: T.M.C. Asser
14. European Parliament and
Council of the European Union: Directive on the approximation of the
laws, regulations and administrative provisions of the Member States relating
to the advertising and sponsorship of tobacco products (2003/33/EC). Off
J Eur Union 2003, L152:16–19.
15. European Parliament and
Council of the European Union: Directive on the approximation of the
laws, regulations and administrative provisions of the Member States concerning
the manufacture, presentation and sale of tobacco products (2001/37/EC). Off
J Eur Union 2001, L194:26–35.
16. European Parliament and
Council of the European Union: Decision setting up a network for the
epidemiological surveillance and control of communicable diseases in the
community (2119/98/EC). Off J Eur Union 1998, L268:1–7.
17. European Commission: Commission
Decision 2000/57/EC on the early warning and response system for the prevention
and control of communicable diseases under Decision No 2119/98/EC. Off
J Eur Union 2000, L21:32–35.
18. European guidelines for
quality assurance in colorectal cancer screening and diagnosis. Edited
by Segnan N, Patnick J, von Karsa L. Luxembourg: Publication Office of the
European Union; 2010.
19. Arbyn M, Anttila A,
Jordan J, Ronco G, Schenck U, Segnan N, Wiener HG, Herbert A, Daniel J, von
Karsa L: European
guidelines for quality assurance in cervical cancer screening. 2nd
editionLuxembourg: Office for Official Publications of the European
20. Perry N, Broeders M, de
Wolf C, Törnberg S, Holland R, Von Karsa L, Puthaar E: European guidelines for
quality assurance in breast cancer screening and diagnosis. 4th
edition Luxembourg: Office for Official Publications of the European
21. Permanand G, Vos E: EU
regulatory agencies and health protection. In Health Systems
Governance in Europe. Edited by Mossialos E, Permanand G, Baeten
R, Hervey T. New York: Cambridge University Press; 2010:134–185.
22. Public Health and Risk
Assessment Directorate: Key Achievements 2009. Luxembourg:
Directorate General for Health and Consumers (DG SANCO); 2010.
23. Public Health and Risk
Assessment Directorate: Key Achievements 2010. Luxembourg:
European Commission; 2011.
24. Directorate General for
Health and Consumers (DG SANCO): Health in the EU. What is in there for
you? Recent achievements. Luxembourg: European Commission; 2012.
25. Birt CA: CAP
on Health? The impact of the EU Common Agricultural Policy on public health. London:
Faculty of Public Health; 2007.
26. Lloyd-Williams F, O’Flaherty
M, Mwatsama M, Birt C, Ireland R, Capewell S: Estimating the
cardiovascular mortality burden attributable to the European common
agricultural policy on dietary saturated fats. Bull World Health Organ
27. Permanand G, Mossialos
E, McKee M: Regulating
medicines in Europe: the European medicines agency, marketing authorisation,
transparency and pharmacovigilance. Clin Med J Royal Coll Physicians 2006, 6(1):87–90.
28. Stahl TP: Is
health recognized in the EU’s policy process? An analysis of the
European commission’s impact assessments. Eur
J Public Health 2010, 20(2):176–181.
29. Greer SL: The
European centre for disease prevention and control: hub or hollow core? J
Health Polit Policy Law 2012, 37(6):1001–1030.
30. Public Health Evaluation
and Impact Assessment Consortium: Mid-Term Evaluation of the EU Health
- Final Report. Bologna: Public Health Evaluation and Impact
Assessment Consortium; 2011.
31. European Court of
Public Health Programme (2003–2007): An effective way to improve health?
Special Report No 2//2009. Luxembourg: European Court of Auditors;
32. Public Health Evaluation
and Impact Assessment Consortium: Mid-Term Evaluation Health Programme (2008–2013)
- Final Report. Bologna: Public Health Evaluation and Impact
Assessment Consortium; 2011.
33. Clark JP: How to
peer review a qualitative manuscript. In Peer Review in Health
edition. Edited by Godlee F, Jefferson T. London: BMJ Books; 2003:219–235.
34. Miles MB, Huberman AM: Qualitative
Data Analysis: An Expanded Sourcebook. 2nd edition. Thousand Oaks:
SAGE Publications, Inc.; 1994.
36. Hsieh HF, Shannon SE: Three
approaches to qualitative content analysis. Qual Health Res 2005, 15(9):1277–1288.
37. Jones J, Hunter D: Consensus
methods for medical and health servicesresearch.
38. Lincoln YS, Guba EG: Naturalistic
Bury Park, California, United States: SAGE Publisher Inc.; 1985.
39. European Parliament,
Council of the European Union: Directive on the application of patients’ rights
in cross-border healthcare (2011/24/EU). Off J Eur Union 2011, L88:45–65.
40. European Parliament,
Council of the European Union: Decision on adopting a programme of
community action in the field of public health (2003–2008) (1786/2002/EC). Off
J Eur Union 2002, L271:1–11.
41. European Parliament,
Council of the European Union: Decision on establishing a second
programme of community action in the field of health (2008–13)
(1350/2007/EC). Off J Eur Union 2007, L301:3–13.
42. European Commission: White
paper. Together for Health: A strategic Approach for the EU 2008–2013
(COM(2007) 630 final). Brussels: Commission of the European
43. European Commission: Commission
communication on the framework for action in the field of public health
(COM(93) 559 final). Brussels: Commission of the European Communities;
44. Council of the European
conclusions: towards modern, responsive and sustainable health systems (2011/C
J Eur Union 2011, 54(C202):10–12.
45. European Commission: Communication
on Europe 2020. A strategy for smart, sustainable and
inclusive growth (COM(2010) 2020 final). Brussels: European Commission;
46. European Union: Communication
from the Commission to the Council, the European Parliament, the Economic and
Social Committee and the Committee of the Regions on the health strategy of the
European Community (COM(2000) 285 final). Brussels: Commission of the
European Communities; 2000.
47. European Union: Regulation
of the European parliament and of the council. Establishing a European centre
for disease prevention and control. Off J Eur Union 2004, L142:1–11.
48. Koivusalo M: The
state of health in all policies (HiAP) in the European union: potential and
Epidemiol Community Health 2010, 64(6):500–503.
49. Ollila E: Health
in all policies: from rhetoric to action. Scand J Public Health 2011, 39(6
50. Elliott H: European
Union health information infrastructure and policy. In European Union Public
Health Policy Regional and global trends. Edited by Greer SL, Kurzer
P. Abingdon, UK: Routledge; 2013. 51. Verschuuren M, Gissler M, Kilpelainen K,
Tuomi-Nikula A, Sihvonen AP, Thelen J, Gaidelyte R, Ghirini S, Kirsch N,
Prochorskas R: Public
health indicators for the EU: the joint action for ECHIM (European Community
Health Indicators & Monitoring). Archives of public health = Archives
belges de sante publique 2013, 71(1):12.
52. Greer SL: The
weakness of strong policies and the strength of weak policies: law,
experimentalist governance, and supporting coalitions in European union health
care policy. Regul
Governance 2011, 5(2):187–203.
53. Greer SL, Vanhercke B: The
hard politics of soft law: the case of health. In Health Systems
Governance in Europe. Edited by Mossialos E, Permanand G, Baeten
R, Hervey TK. Cambridge: Cambridge University Press; 2010:186–230.
54. The open method of
co-ordination in action: the European employment and social inclusion
by Zeitlin J, Pouchet P. Brussels: P.I.E. - Peter Lang; 2005.
55. Jarman H: Collaboration
and consultation: functional representation in EU stakeholder dialogues. J Eur
Integration 2011, 33(4):385–399.
56. Radaelli C, Pasquier R: Conceptual
issues. In Europeanization:
New Research Agendas. Edited by Vink MP, Graziano P.
Basingstoke: Palgrave/Macmillan; 2007:35–45. 57. Buchner B: Nutrition,
obesity and EU health policy. Eur J Health Law 2011, 18(1):1–8.
58. McKee M: A
European alcohol strategy. BMJ 2006, 333(7574):871–872. doi:10.1186/1471-2458-13-1074
[La primera version de este
artículo se public en BMC Public Health 2013 13:1074]