Open Journal of Political Science
2012. Vol.2, No.3, 32-44
Published Online October 2012 in SciRes (http://www.SciRP.org/journal/ojps) http://dx.doi.org/10.4236/ojps.2012.23005
32
Advocacy and Policy Change in the Multilevel System of the
European Union: A Case Study within Health Policy
Nadia Carboni
National Research Counc il of Italy, Bologna , Italy
Received June 20th, 2012; revised July 10th, 2012; accep te d S ep tember 26th, 2012
Health policy is basically Member States’ competence. However, the European Union has recently raised
a number of key questions facing both (pharmaceutical) industries and public health interests. By apply-
ing the Advocacy Coalition Framework, the paper sheds light on policy change within the European multileve l
system. The analysis is based on a case-study strategy. Two processes in the pharmaceutical policy are
taken into account: the “Pharma Forum” and the “Pharma Package”. They both concern “information to
patient”—a controversial policy issue at the crossroad of competing pressures.
Keywords: Advocacy Coalition Framework; European Union; Policy Change; Lobbying; Pharmaceutical
Policy
Introduction
The main goal of this study is to give evidence of the policy
change process within EU multilevel system1 by empirical ac-
counts of lobbying in health care related issues. By applying the
Advocacy Coalition Framework (ACF) as a theoretical basis for
understanding both EU policy-making process and intergo-
vernmental relations2 within health policy field, this paper ana-
lyzes the policy subsystem-wide dynamics with multiple actors
who structure their relationship into advocacy coalitions moved
by policy beliefs, and try to influence policy by multiple re-
sources and venues. The ACF is often used to explain stake-
holders’ behaviour and policy outcomes in conflicting political
contexts, with two or more coalitions pursuing different policy
objectives (Sabatier and Weible, 2005). This is the case of EU
health policy making, where divergent interests stand in oppo-
sition, public health and health-care on the one hand, and in-
dustrial policy on the other.
The paper is structured as follows: first, we outline the con-
ceptual framework (ACF) and methodology for the analysis;
second, we define the boundary of the policy field (EU health
policy), within which the case-study is carried out; third, we
apply the ACF by sketching out the main actors and their re-
spective roles, the resources involved, the venues of influences,
the patterns of interaction in EU health policy making process;
finally, we draw some conclusions about the theoretical and
empirical contributions of this study.
Theoretical Framework
The ACF (Jenkins-Smith and Sabatier, 1993, 1999; Sabatier,
1998) views the policy process as a competition between
coalitions of actors who advocate beliefs about policy problems
and solutions. This competition takes place within policy sub-
systems, defined as the set of actors who are actively concerned
with an issue and regularly seek to influence public policy re-
lated to it. Actors in a policy subsystem include local and state
government officials, advocacy groups, non-governmental or-
ganizations, community groups, researchers and academics, me-
dia, etc.
Following works in cognitive and social psychology, the
ACF argues that actors perceive the world and process informa-
tion according to a variety of cognitive biases which provide
heuristic guidance in complex situations. In the case of public
policies, such guidance is provided by belief systems about
how a given public problem is structured, and how it should be
dealt with. The belief system is what makes coalitions hold
together and builds the basis for their coo rdination and internal
organization. Jenkins-Smith and Sabatier (1993) distinguish
three levels of beliefs in the belief system of a coalition:
 Deep Core: normative and ontological axioms that define a
vision of the individual, society and the world;
 Policy Core: causal perceptions and policy positions for
achieving deep core beliefs in a given policy subsystem;
 Secondary Aspects: empirical beliefs on how to implement
the policy core.
Coalitions, the ACF argues, form around beliefs, and par-
ticularly around policy core beliefs. In order to realize the goals
generated by their beliefs, advocacy coalitions try to make gov-
ernmental institutions behave in accordance with their policy
cores. In this, they are assumed to be instrumentally rational,
for instance using venues provided by the constitutional struc-
ture through which they can exert influence in an efficient way.
Based on these premises, the ACF perceives policy change as a
transformation of a hegemonic belief system within a policy
subsystem3, whereas policy learning as a process which is most
likely to concern only secondary aspects of a belief system,
leaving the policy core of a coalition intact, and bringing to
minor policy changes (Sabatier, 1998). Minor policy changes4
1The focus of the analysis is on EU level policy-making, activities at the
Member States level are not included.
2Studies involving both the horizontal and vertical relations between sub-
national, national and/or supranational governments may all be categorized
under the field of IGR. Some of these studies might well be conceptualized
as (and this i s the case) European Multi-Level Governance.

N. CARBONI
are the result of two processes: learning within and learning
across coalitions. The second case is where policy brokers may
intervene. When two or more coalitions are in conflict and it is
difficult to have a dialogue between them, policy brokers me-
diate the conflicting belief systems looking for some reasonable
compromise which will reduce conflict intensity. For that, po-
licy brokers have to be able to relativisized the beliefs and pre-
ferences of the competing coalitions to facilitate policy solution.
In addition, they must be linked to decision makers or have ac-
cess to decision-making points.
Within the ACF, we refer to the components of the approach
more useful for our analysis:
a) the role of information and knowledge;
b) the role of policy broker;
c) the factors of success necessary to produce policy change.
Finally, we aim to look for more insights about the role of
policy broker and the definition of policy change at the EU
level. Studies applying the ACF outside the United States con-
firm it has wide applicability. While most of these studies focus
on the descriptive validity of the ACF, more work is needed to
both critically examine its assumptions about policy change in
various institutional contexts. The ACF seems not to explain
several important aspects of policy change, neither does the
model provide a precise framework to examine in detail how
policy brokers accomplish their tasks (Smith, 2000).
Methodology. The ACF approach is tested by using a qua-
litative research strategy-namely a case study design. Two pro-
cesses, the “Pharma Forum” and the “Pharma Package”, have
been selected since they both involve diverging interests (public
health and social protection vs. industrial interests). A certain
level of conflict is necessary in order to study the interplay be-
tween multiple actors in the policy-making process. Moreover,
they both concern information to patient, a controversial policy
issue at the crossroad of competing pressures.
The fieldwork has relied mostly on documents analysis,
semi-structured interviews, and personal observation. The main
sources were governmental documents: Commission commu-
nications, speeches, minutes of the plenary meetings of the
European Parliament and minutes of Council working groups
meeting, positions papers by interest groups, national govern-
ments publications and press releases, etc. The information
collected by documents was combined with semi-structured
interviews, which were carried out during April-June 2009. The
sample of interviewees was made of the key actors we iden-
tified by both relevant documents and the snowball technique.
Starting with suggestions from preliminary interviews, a snow-
ball-sampling technique5 generated a list of stakeholders (n =
30). This method suits the case of health policy, since it allows
us to catch one specific network of interconnected people. By
snowball method we managed to cover all the different types of
actors involved in the process: consumers and patients groups,
umbrella organizations, individual companies, pharmaceutical
industries and civil society groups, policy officers from the
European Commission, members of the European Parliament,
Health attachés from the Permanent Representations in Brussels
(Table 1).
Finally, visiting the European Social Observatory (OSE asbl)
in Brussels for three months has allowed us to take part to
events and conferences about the research topic.
The EU Health Policy within the
Pharmaceutical Sector
Health policy is generally not considered as a policy area of
the Community, because there is no legal Union competence
for that (Lamping, 2005: p. 19). This is basically due to the
successful resistance of national governments to transfer sub-
stantial health policy competencies to the supranational level.
In detail, the European Union did not have policy mandate in
the field of public health until 1999, when the public health
article was amended and renumbered by the Treaty of Amster-
dam as the current Article 152 (Mossialos et al., 2009). Treaty
Article 152 defines the role of the EU as complementing na-
tional policies, sets out procedures by which the EU institutions
may act in the health field, and delineates the types of measures
that may be enacted, but explicitly bars the use of harmoniza-
tion: “Community action in the field of public health shall fully
respect the responsibilities of the Member States for the or-
ganization and delivery of health services and medical care”
(Art. 152, No. 5). Thus, the EU is limited to establishing public
health programmes and incentives in the health policy field.
Moreover, after the health sector’s exclusion from the EU Ser-
vices Directive6, which aims to break down barriers to cross-
border trade in services between EU Member States, health and
long-term care were formally added to the Open Method of
Coordination (OMC)7 procedures conducted by the Social Pro-
tection Committee (SPC) in 2005.
One of the most controversial aspects related to health gover-
nance in Europe is properly the clash between the suprana-
tional free movement rules and national healthcare policy
competencies. This is especially relevant to pharmaceutical
sector. Although pharmaceuticals represent a policy domain
where outcomes are mainly related to market and industrial
policy goals, they must also achieve healthcare interests-such as
eeping healthcare costs down and ensuring the safety, efficacy k
5Snowball sampling may simply be defined as “a technique for finding
research subjects. One subject gives the researcher the name of another
subject, who in turn provides the name of a third, and so on” (Vogt, 1999 ) .
6A wide vari et y o f heal t h related lobbyi ng groups oppos ed th e application o
f
the Serv ices Di rective b y clai ming t hat heal th car e serv ices ar e ‘un ique’ and
should not be treated as any other commercial service; and that Member
States would have difficulty managing their health systems with the addi-
tional EU oversight.
7The EU’s relatively new “open method of coordination” is characterized by
an intergovernmental form of policy-making. Under this open method,
Member States co-operate with each other on legislating reforms by estab-
lishing common timetables, indicators and policies, with greater emphasis
on consensus and mutual learning among Member States. Under the tradi-
tional, so-called “community method” of EU governance, more power was
held by bodies such as the European Commission and the European Court
of Justice than by the Member States.
3The ACF takes into account also the influence of exogenousvariables on
the policy subsystem. Two sets of external factors frame and constrain the
activities of advocacy groups, the one quite stable, the other more dynamic.
Stable parameters include the basic constitutional structure, socio-cultural
values, and natural resources of a political system; dynamic influences in-
clude external changes or events in global socioeconomic conditions (Sa-
batier, 199 8 ).
4The ACF defines minor policy change as a modification of specific beliefs
about causal connections and stakes of the world that have bearing in the
p
olicy issu e area (chang es in second ary aspects of the pol icy subsyst em); in
contrast, the ACF defines major policy change as an alteration of the policy
core beliefs. Policy learning rarely results in major policy change, as it is
secondary aspects which tend to be modified by endogenous learning
whereas it is wholesale shifts in dominant policy core belief which are
associated w ith major policy change (Sm ith, 2000).

N. CARBONI
34
Table 1.
Sample of interviewed organizations (N. interviews = 30).
Consumer s/patients organizations The European Consumers’ Organisation (BEUC); The Euro pean Patients’
Forum (EPF )
Health prof essiona l a nd provider organiza t ions
The European Federation of Nurses Associations (EFN); The Standing
Committee of European Doctors (CPME);
The Pharmaceutical Group of the European Union (PGEU); The European
Hospital and Healthcare Federation (HOPE)
Pharmaceutical industry associations
The Europ ean Generic Med icines Ass ociation (EGA); The Eur opean Feder ation
of Pharmaceutical Industries and Associations (EFPIA); The European medical
technology industry association (EUCOMED); The European Self-Medication In-
dustry (AESGP); The European Association of pharmaceutical full-line wholes al-
ers (GIRP); The representation offices in Brussels of “Merck Sharp & Dohme” and
of “Novartis” companies
Health and social protection organizations European Public Health Alliance (EPHA); Asso ciation I nternational de la
mutualitè (AIM); European Social Insurance Platform (ESIP); European Regional
and Local Health Authorities (EUREGHA)
Institutions
European Parliament: Committee on Industry, Research and Energy; Committee
on the Environment, Public Health and Food Sa fety.
European Commission: The Directorate General for Health & Consumers (DG
Sanco); The Directorate General for Enterprise (DG Enterprise); The Internal
Market and Services Directorate General; (DG MARKT)
Council: Permanent representations of Italy and of Czech Republic to Europe,
Czech Republic EU Presidency
Note: Source : author’s elaboration.
However, only limited attention has been focused on the
and quality of medicines, and the Commission has only com-
petence over the former (Mossialos and Permanand, 2005b).
While the Commission can, for instance, promote the cross-
border movement of medicines by pushing harmonization, ac-
cording to the Single European Market; the Member States
have the power to decide their own healthcare policy priorities,
under the principle of subsidiarity. It means that the Commis-
sion must balance industrial and public health concerns, and
reconcile wider social and political interests within the context
of market harmonization. As a consequence, EU pharmaceuti-
cal policy has reached something of a deadlock “stemming
primarily from a dissonance between the principle of subsidia-
rity and the free movement goals of the Single Market—under
which medicines are treated as an industrial good” (Mossialos
and Permanand, 2005b: p. 49). Nevertheless, the Commission
has been able, for instance, by employing soft law mechanisms
such as the OMC-to establish a wide-ranging Community re-
gulatory framework8, even if a single medicines market remains
a faraway goal.
process of health policy making at the EU level, missing the
dynamics and the interactions among different governmental
and private actors (Mossialos and Permanand, 2005a).
In the following paragraphs we will focus on two different
processes both part of the pharmaceutical policy. The first ex-
amines the High Level Pharmaceutical Forum, a three years
process of stakeholders’ consultation about health care related
issues. The second concentrates on a series of measures re-
cently proposed by the European Commission impacting the
pharmaceutical industry (“the Pharma Package”). Although it
dates back to several Commission attempts to review pharma-
ceutical legislation in order to increase competitiveness of the
EU pharmaceutical industries vis-à-vis US industry, it has not
yet been concluded. Reaching agreement on this issue is diffi-
cult, because it involves conflicting interests among public
health and social protection groups on the one side and Indus-
tries on the other side. In other terms, it refers to the clash between
Member States social protection and public health policy objec-
tives and the Commission industry policy goals.
Finally, although any harmonisation of the laws and regula-
tions on health policy in the Member States is excluded, the
impact of the EU upon health matters is increasing (Leibfried
and Pierson, 2000): The High Level Pharmaceutical Forum
The official aim of the Pharmaceutical Forum was to im-
prove the competitiveness of the pharmaceutical industry and
its contribution to social and public health objectives. By ex-
changing best practices and examining efficiency gains within a
European high level platform, it intended to contribute to en-
suring patients’ access to medicines within a sustainable health-
“Health policy is a challenging example of how to make a
formal non topic one of the Union’s major future policy fields-
despite the treaty” (Lamping, 2005: p. 21).
8For a chronological overview of the development of EU pharmaceutical
policy see: Mossialos a n d Permanand, 2005b: pp. 50-53.

N. CARBONI
care budget, and to discuss the competitiveness of the European
pharmaceutical industry and related public health considera-
tions.
The Forum was set up as a follow-up to the “G10 Medi-
cines”9 which discussed the balance of health objectives and
industry competitiveness in Europe. Compared to the G10, the
High Level Pharmaceutical involved a higher number of stake-
holders. It was composed by at least 40 members, more than
half of which were Member State representatives ( Table 2). Out
of the 10 non-governmental participants, five represent phar-
maceutical and biotech businesses, and five represent non-
business interests. However, these other organisations include
the European Patients Forum, whose legitimacy has been ques-
tioned because of its close ties with industry and its lack of
transparency.
The Pharma Forum was based on three main issues: 1) rela-
tive effectiveness: increasing the quality and quantity of avail-
able data and analysing current assessment processes; 2) pric-
ing and reimbursement: developing solutions for access, and
trade-problems, to ensure timely and equitable access to phar-
maceuticals for patients, to enable control of pharmaceuticals
expenditure by Member States and to reward valuable innova-
tion that also encourages research & development; 3) informa-
tion to patients: improving the quality of information to patients
about diseases and treatment options.
Three working groups focusing on the above topics formed
in 2006, and the first full Forum met and adopted a progress
report in September 2006. In spring 2007, the Commission
organised a public consultation on the work of the Pharma Forum’s
Information to Patient Working Group. A second meeting of
the Forum took place in June 2007 and another progress report
was adopted. The third and final meeting was held in October
2008, when a set of conclusions and recommendations were
adopted.
The consultation lasted three years and it was depicted as not
an easy process by our interviewees:
“During the first year we established common perspectives
and shared best practices; the second year was very critical:
dealing with different interests on the same board was very
painful. At the end we tried to identify common interests and a
balanced approach. But you know, we have the shortcoming
that we could not legislate about those topics. Given that, the
results were ‘wea k’. However weak is better than nothing”
(Policy officer, DG Enterprise).
“It was a very difficult process. The idea was to have a con-
sensus based process. However, you work with different stake-
holders, but first with individuals having conflicting interests. It
is sometimes not clear to identify who is behind the interest
group” (Policy officer, DG Sanco).
“Consensus and support on certain issues by both industries
and patients groups were very hard. We all start from a com-
mon perspective on the problem, but then everybody shows
different positions. The role of the Commission was very im-
portant in finding a compromise among different positions”
(Lobbyist, Pharmaceutical company).
There has also been strong criticism of the composition of
some of the individual working groups, especially the working
group on information to patients. During a public consultation
in spring 2007, several organisations such as the European
consumer organisation (BEUC) and Health Action International
(HAI) strongly criticized the methods and outcomes of the In-
formation to Patients Working Group (Table 3 resumes suc-
cess and failure factors of the Pharma Forum according to the
samp le of interviewees). BEUC said there were major flaws in
the structure of the group, that it was the wrong type of forum
for such a project, and that the methods were “not appropri-
ate, do not bring added value and are not the way to develop
information for patients... It was appointed in a selective
manner without transparency or clear criteria, and with a
Table 2.
Composition of the Pharma Forum.
Governmental participants -Two Comm iss ioners: Enterpri s e & Industry, Health & Consumer Protection;
-Ministers from each of the 27 Member States were invited ;
-Three Members of Europe an Parliament (ALDE, EPP, PSE).
Non-governmental participan ts
-Five representing business: EFPIA (European Federation of Pharmaceutical
Industries & Associations), AESGP (E uropean Self-Medication I ndustry), EGA
(European Generic medicines Association), EuropaBio (European A s sociation for
Bio-industries), GIRP (E uropean Association of Full-Line Wholesalers)
-Five patients and health groups: European Patients Forum (NGO funded by industry),
PGEU (Pharmaceutical Group of the European Union representin g community
pharmacists) CPME (Standing Committee of European Doctors representing all
medical doctors in the EU), AIM (Association Internationale de la Mutualité), ESIP
(European Social Insurance Platform)
Note: Source : author’s elaboration.
9The High Level Group on Innovation and Provision of Medicines—The G10 Medicines Group—was set up following a symposium on Pharmaceutical Industry Competi-
tiveness held in December 2000. The objective of the Group was to review the extent to which current pharmaceutical, health and enterprise policies could achieve the
twin goals of both encourag ing innovation and competitivenes s and ensurin g satisfactory deliv ery of public heal th and social imperati ves. The membership of the Group
consisted of representation at the highest level from different administrations and organisations: from the Member States, the Swedish Minister of Industry, together wi th
the French, German, British and Portuguese Ministers of Health; from the industries, EFPIA, EGA, AESGP; from health organizations, AIM and a patient representative
from the Picker Institute. It was evident the overrepresentation of the pharmaceutical industry. The G10 recommended the need for a workable distinction between adver-
tising and information. Furthermore a collaborative public-private partnership involving a range of interested parties should have been established.
(http://ec.europ a.eu/health/ph_o verview/Docu ments/key08_en .pdf)

N. CARBONI
Table 3.
Pharma Forum: success and failure factors.
+ –
-“all stakeho lders together for the first time” (Lobbyst, Heal th
professional organization)
-“understanding other points of view” (Lobbyst, Patient Organi-
zation)
-“all the interests were represented and had the chance to raise
their own voice” (Lobbyst, Pharmaceutical Company)
-“spreading knowledge” (Policy officer, DG Sanco)
-“exchange of best practices” (Policy Officer, DG Enterprise)
-“Member States a nd stakeholders working together” (Lobbyst,
Pharmaceutical Company)
-“the Pharma Forum was very well orga nized. Moreover, the role
of the Commission was really hel pf u l in favouring the exchange
of practices”. (Lo bb yst, Pharmaceutical Industry Ass o ciation)
-painful proce ss : the more pe op le you have around the table the more
difficult is to achieve consensus (Policy officer, DG Sanco)
-outcome not transparent:
“the process was not at all transparent. Com mission synthesized the
results of the meetings without making clear who contributed to what”
(Lobbyist, Health org anization )
-“it was ve ry time consum ing proce s s” (Lobbyst, Pharmaceutical
Industry Asso ciation)
-criteria for selecting participants were not cl ear:
“We did not understand why some key stakeholders were not invited to
the forum” (L obbyist, Health profession al organizatio n)
-the process was driven by the Commission:
“Commissi on did not m ake circulate our point of view among the other
stakeholders. It decided what or what not to include i n t h e results ”
(Lobbyist, S o cial Protection organization)
-“It was the mountain which has given birth to the mickey mouse”
(Health attaché, Italian Permanent Representation)
-“The Pharma Forum was a way for industries to lobby the
Commission” (Health attaché, Czech Republ ic Permanent
Representation)
Note: Source : author’s elaboration.
composition that was bound to politicize the issues under
discussion”.
A policy officer from DG Sanco replied to our question
about the criteria for inviting advocacy groups to join the
Pharma Forum, as follows:
“We usually invite stakeholders who have expertise in the
topic we discuss. As far as the Pharma Forum we invited 10
stakeholders—half from the private sector, half from the civil
society—whom we think they have expertise in that topic.
BEUC, for example, was not very active on that issue at that
time. Expertise in lobbying is a moving process. Stakeholders
are invited to join policy making process according to the topic
and the expertise they have” (Policy Officer, DG Sanco).
A policy officer from DG Enterprise added:
“We tried to cover all the different interests, but it was clear
for us that in inviting stakeholders we did not want people shut-
ting at the table” (Policy Officer, DG Enterpise).
In June 2007, the Association Internationale de la Mutualité
(AIM) and the European Social Insurance Platform (ESIP)
issued a position statement expressing their dissatisfaction with
the Pharma Forum way of working and substance. They ob-
jected to the use of the word “partnership” to describe the pro-
cedures followed so far in the working group. It read: “ESIP
and AIM still have concerns about the lack of transparency of
the processes, procedure and methodologies in the Forum, in
particular the Working Group on information to patients.” The
statement also indicated that suggestions put forward by ESIP
and AIM were not being taken into consideration in the infor-
mation process and debated: “ESIP and AIM strongly regret
that their constructive proposals made during this process, in
par- ticular the request for a survey for existing patient infor-
mation practices and the use of an EU quality label to identify
high quality information, have not been taken up for further
discus- sion”10.
A major contentious issue in the Information to Patients
Working Group was a proposal to weaken the ban on direct-
to-consumer advertising of prescription drugs11. BEUC, HAI,
AIM and ESIP objected that their concerns over the conflicts
of interest for pharmaceutical companies providing information
for patients between independent information and product
marketing were not taken seriously. They argued that public
health interests should not be mixed or even over-ridden by
commercial interests—i.e. information to patients should not
come directly from those who produce medicines because the
main goal of pharmaceutical companies is to maximise sales.
Similarly, the Pharmaceutical Group of the European Union
(PGEU) stated that health professionals, including pharmacists
and doctors, should remain the primary source of easily acces-
sible and reliable information about medicines, and that the
pharmaceutical industry should not be given more scope to
“push” information to patients.
In the final conclusions, the Pharmaceutical Forum recom-
mended retaining the ban on advertising prescription medicines
to the general public, but at the same time also recommended
that “all the relevant players, including national competent
authorities, the Commission, public health stakeholders and
10 ESIP&AIM Joint Statement:
http://ec.europa.eu/enterprise/phabiocom/docs/pf_20070626_esip_aim_joint
_
statement.pdf;
all contributions to the consultation:
http://ec.europa.eu/health/ph_overview/other_policies/pharmaceutical/result
s_consultation_en.htm;
an overview of comments regarding information to patients can be found
here:
http://www.haiweb.org/28102007/ManyConcerns.pdf.
11In the EU advertising of drugs is regulated by Directive 92/28/EEC ban-
ning advertising of prescription-only drugs to the general public. In 2001 the
Commission proposed a partial lifting of the ban giving manufactures the
chance to inform patients on their medical products for HIV/AIDS, diabetes
and asthma .
12Commission synthesized the results of three years consultation process in
an 11 pages report. A footnote explains that AIM expressed some reserves
concerning the involvement of industry in providing informatio n to patients:
http://ec.europa.eu/pharmaforum/docs/final_conclusions_en.pdf.
36

N. CARBONI
industry, should ensure high quality information”12.
To recap, the reactions from the non-industry stakeholders in
the Pharma Forum show that, although the overall composition
of the Forum was not significantly biased in favour of industry,
crucial areas such as information to patients were dominated by
industry interests. While the final recommendations keep the
current ban in place, they also propose allowing the industry to
act as a source of information for patients. This creates a loop-
hole which finds its way into the Commission’s draft “Pharma-
ceutical Package”, allowing industry to publish written infor-
mation about prescription medicines in newspapers and maga-
zines and on the internet, weakening the advertising ban. It was
only because of strong resistance from public health campaign-
ers (and Member States) that some degree of protection against
advertising of prescription medicines was inserted into the
pharmaceutic al p ack age.
The Pharmaceutical Package
The “Pharma Package”, is the popular name for a series of
measures proposed by the European Commission impacting the
pharmaceutical industry. It contains three important initiatives
plus a Commission communication: a proposal for a directive
on how to modernize pharmacovigilance in order to improve
safety of medicines; a proposal to improve patient safety by
reducing the infiltration of counterfeit medicines into the supply
chain (fighting counterfeits); and a directive on the future direc-
tion of the supply of health information to patients (the in-
formed patient). Among the three legislative proposals, our
analysis will especially focus on the information to patients.
This proposal was a very controversial issue as it emerged in
the Pharma Forum, and which dates back to the Commission’s
attempts to review the EU pharmaceutical legislation (Table 4
for a chronological overview).
In 200113 the Commission’s Directorate Ge neral Enterprise14
proposed a five-year trial relating to article 88 of Directive
2001/83/EC during which the pharmaceutical industry could
direct to a limited extent information to the general public about
medicinal products used for the treatment of aids, asthma and
diabetes (“Review of the EU Pharmaceutical Legislation”). The
European Parliament and Council rejected the proposal. In its
report of 9 October 2002 the Parliament objected to direct-
to-consumer advertising and considered that the Commission’s
proposal would lead to that. Member States were against the
proposal as well. Loosening the ban would influence national
healthcare systems, since demand is stimulated for those medi-
cines that are most advertised.
The Parliament was also worried about the circumstance that
patients would obtain information about medicinal products but
not about other treatments. Therefore, through the same Direc-
tive, the Commission was called upon by the EP to analyze the
different processes in European countries and to draft proposals,
in order to define useful strategies to get good quality, reliable
and non promotional information. In the end, the pilot study
was rejected and replaced by the request for a report.
Parallel to the preparation stage of the review process, the
Commission was pursuing also alternative routes for discussion
to ensure that the topic remained on the agenda. As we outlined
in the previous paragraph, in 2001 the Commission set up the
G10 High Level Group on innovation and the provision of
medicines, which recommended a public-private partnership on
patients information; in 2005 then it established the Pharma-
ceutical Forum which again covered the information to patients’
issue. Furthermore, the Commission increased pressure through
various public consultations plus impact assessment.
Two general web-based public consultations were carried out
respectively in 2007 and 2008. The first formal public consulta-
tion was about a Draft report on practices with regard to the
provision of information to patients on medicinal products,
summarising the current state of play without presenting yet
any political orientations or proposals; the second public con-
sultation specifically addressed the key ideas of the forth-com-
ing legal proposal on information to patients. The first part of
the consultation received 73 responses, the second one 185
Table 4.
Chronological overview o f the Commission’s po lic y proposal on Information to Patients.
Date Policy development
2001 Commission’s proposal for loosening ban on d irect-to-consum er advertising of prescr iption drugs
2001-2002 Commission set up the G10 High Level Group on innovation and the provi sion of m edicines
2002 EP and Council re jected the Commission’s proposal
2005-2008 Commission established the High Level Pharmaceutical Forum
2007-2008 Public consu ltations + Impact assessment
2008 Commission legislative proposal on information to patients inclu ded in the Pharma Pa ckage
Note: Source : author’s elaboration.
13 The pressure from pharmac eutical industry to promote direct informa ti on to patients actually d ated from t h e mid 1990s.
14DG Enterprise is responsible for drafting pharmaceutical legisla tion.

N. CARBONI
Table 5.
Overview of the public consultation responses regarding pharmaceutical industry as an information provider about prescription-only medicines.
Yes No Mixed No comment
Healthcare professi onals and organisations 7 70 15 8
Patient organisations 25 50 10 15
Consumer organization 0 56 44 0
Pharmaceutical industry
organisations and companies 96 0 0 4
Regulators 11 46 29 14
Media and patient infor mation organizat i ons 72 14 0 14
Social insurance organisations 0 100 0 0
Research and others 20 30 0 50
Total 26 48 14 12
Note：“Yes” refers to opinions that highlighted the role of a pharmaceutical company as an information provider, because, for example, nobody knows the product better
than its producer; “No” refers to opinions that declined the role of a pharmaceutical company as an information provider, because, for example, the information that comes
from the producer can not be n eutral; “Mixed” refers to res ponses that accused that there is a l a ck o f a coh e rent d ist in ct ion between advertising and info rmation ; “No com-
ment ” refers to responses that did not take out this issue; Source: Summary of the respons es to public cons ultation on th e key elements of a l egal propos al on information
to patients was l aunched by the Commission on 5 February, 2008.
Source: http://ec.europa.eu/enterprise/pharmaceuticals/patients/docs/summary_publ_ cons_220508.pdf
contributions from the range of relevant stakeholder groups
(Table 5).
DG Enterprise did pressure until it finally managed to move
from High Level discussions requiring consensus to a draft
legal proposal on patient information, which was released in
December 2008, within the “Pharmaceutical Package”. Through-
out all the process DG Enterprise had a clear agenda: allowing
the pharmaceutical industry to communicate information to
patients.
“The Commission doesn’t set out an information strategy but
it just provides the pharmaceutical industries greater flexibility
to provide information directly to the public on prescription
medicines” (Lobbyist, Consumer organization).
“We are very much concerned by the Commission legal pro-
posal. It gives priority to industrial commercial interests rather
than to public health concerns and consumer protection in-
terests” (Lobbyist, Health Organization).
Before the Pharma Package was released, twenty organiza-
tions in the field of health representing patients, consumers,
health professionals and social health insurers sent a joint-let-
ter15 to both the Health Commissioner Vassiliou and the Presi-
dent of the EU Commission Barroso, to express their fears
about the draft proposal relating the pharmaceutical package, in
particular the role it would have given to the pharmaceutical
industry concerning information to patients on prescription-
only medicines.
“The proposed changes to the existing legislation will have a
substantial impact on European patients, consumers and na-
tional health care systems. Any attempts to alter the current
legislative framework should be guided by and based on an in-
depth assessment of patients’ and consumers’ needs… The sig-
natories of this letter ask you to continue to lead in defending
patients and consumer in the pharmaceutical package and to
ensure that public health considerations supersede industrial
interests” (Joint Letter to EC President Manuel Barroso, No-
vember 2008)16.
Member States did not totally welcome the Commission’s
proposal as well. Many ministers expressed their concerns over
the regulation and directive on the provision of information on
medicines by marketing authorisation holders. On 9 June, dur-
ing a Health Council meeting in Luxembourg, it became clear
that over 20 Member States do not see the proposal as a solid
base for negotiations:
“While agreeing that there is a need to improve the infor-
mation to the general public on prescription-only medicinal
products, many delegations fear that the suggested system
could be overly burdensome for competent authorities without
leading to significant improvements in the quality of the infor-
mation provided to patients. In addition, many delegations hold
that the distinction between ‘information’ and ‘advertising’ was
not sufficiently clear. So they fear that the proposals will not
15Joint open letter to Commissioner Vassiliou on the pharmaceutical package:
http://www.epha.org/IMG/pdf/Open_joint_letter_Commissioner_Vassiliou_
9_November_2008.pdf
Letter to EC President Barroso on Pharmaceutical Package November 2008:
http:/ /www.age-pl atform.or g/EN/IMG/pd f_phar maceutical_ package.p df
16In the joint letter sent to EC President Barroso, there was also a claim for
shifting competence on medicines from DG Enterprise to DG Sanco: “Fi-
nally, in order to better ensure that public health considerations are put
before i ndustrial i nterests , we call for competence on medicin es to be t rans-
ferred from DG ENTERPRISE to DG SANCO, and to become a responsi-
bility of the EU Health Commissioner”. Letter to President Barroso on
Pharmaceutical Pa ckage November 2008.
38

N. CARBONI
provide adequate guarantees, and that the prohibition of ad-
vertising of prescription-only medicinal products to the gen-
eral public will be circumvented” (Council Meeting, June
2009)17.
This is a controversial issue, as the EP’s information to pa-
tients rapporteur says, because: “Many Member States believe
that they have the perfect system and they think that more in-
formation will drive up health care costs… the Member States
are afraid of the costs of the enforcement of the legislation [cfr.
the ex-ante checking of the medicine information by health
authorities]” (Europolitics, 2009)18.
The Committee of the Regions (CoR) was on the same criti-
cal wave, blaming that the information to patients proposal was
“biased in favour of pharmaceutical companies and would put
consumers at risk” (Europolitics, 2009)19. According to CoR
rapporteur Susanna Haby (EPP-ED, Sweden), the fact that the
package was drafted by Directorate-General Enterprise and
Industry and not by DG Health “tells you all you need to know
about who is likely to benefit from them” (ibidem). Moreover,
she emphasised that the Commission neglected the role of in-
dependent local health care professionals when it comes to
information to patients on prescribed medicines; in its proposal,
the Commission allows pharmaceutical companies to take the
lead on patient’s information, but the CoR suggests that this
should be done by independent local health care professionals.
Coming back to the advocacy groups’ actions, the most of
them hardly criticized the not transparent process by which
Commission was preparing the legislative proposal about in-
formation to patients. It seemed that the Commission had used
“soft instruments” (Greer and Vanhercke, 2009), such as con-
sultation platforms, to divert public interest advocacy groups’
attention away from the legal proposal drafting process:
“It was very bad. Commission was preparing the package
while we were engaged in the Pharma Forum. Therefore, it was
not very clear who contributed to it. Only one result of the
Pharma Forum—the quality criteria—was partially included in
the package” (Lobbyst, Health organization).
There was actually no link between the topics discussed in
the Pharma Forum (relative effectiveness; pricing and reimbur-
sement; information to patients) and the legislative policy is-
sues proposed in the Pharma Package (pharma-covigilance,
fake medicines, information to patients). Only the info to pa-
tient issue was partially recalled in the Commission legislative
proposals.
When we asked the Commission policy officers involved in
the process the reasons why the Pharma Forum and the Pharma
Package were not linked to each others, and especially why the
Pharma Forum was not used to discuss the upcoming Commis-
sion legislative proposals, the common answer was that “The
Pharma Forum and the Pharma Package were moved by dif-
ferent political mandates. Commission is a very fragmented
policy house: each DG has its own political mandate and com-
munication is not very easy among different Units”. That is to
say that the two DGs involved in the policy making process—
DG Enterprise and DG Sanco-had respectively their own policy
agenda. Moreover, within each DG there are different units and
each unit has its own mandate as well.
Finally, most of interviewees claimed that “The Pharma Pac-
kage was clearly the result of a very strong lobbying, espe-
cially from industries. The Commission made the draft proposal
circulating before it became official, therefore lobbying started
very early in the process.”
As a member of the DG Enterprise Cabinet commented,
Commission is like “a house of glass. Proposals go out too
easily”. The closer you are to the DG responsible for drafting
policy proposal, the more chance you have to influence EU
policy making process.
The Policy Subsystem: Actors, Beliefs,
Resources
Advocacy Coalitions and Policy Core Beliefs
The ACF assumes that stakeholders are primarily motivated
to convert their beliefs into policy and then seek allies to form
advocacy coalitions to pursue the identified policy objectives.
Advocacy coalitions include actors of similar core beliefs who
engage in a nontrivial degree of coordination (Jenkins-Smith
and Sabatier, 1999: p. 120). Looking at the advocacy groups’
policy positions on the press releases and on the organisations’
website, we can broadly identify20 two main coalitions in our
case study. For instance, Table 5, which gathers the results of
the public consultation about info to patients carried out by the
Commission in 2008, shows at least two coalitions. Coalition A
consists of affiliations with pro-industry beliefs (pharmaceutical
industry as an information provider), including pharmaceutical
industry associations and companies, media and patient infor-
mation organisations. Opposing the pro-industry coalition is
Coalition B, clearly supporting public health/social protection
interests21, that includes healthcare professionals and organisa-
tions, patients and consumers groups, regulators, social insu-
rance organizations. Among anti-industry affiliations, the strong-
est alliance is between health professional and social insurance
organizations and consumers groups. Research and patient or-
ganizations do not show so clear-cut percentages opposing the
role of industry as info provider. As patient groups are funded
somehow by pharmaceutical industries, they cannot be totally
in opposition with it.
Advocac y Coalitions and Usable Resources
The pro-industry coalition controls a sizable amount of re-
sources. First, coalition A affiliations could count on the finan-
cial resources provided mainly by pharmaceutical Industries.
Among coalition A members, there are considerable multina-
tional pharmaceutical companies able to do effective lobbying
on their own. The pro-industry coalition’s beliefs system is also
supported by the Directorate Enterprise and Industry of the
Commission, which clearly aims to increase European pharma-
ceutical industry competitiveness vis-à-vis US industry and
harmonize pharmaceutical market in Europe22. In having access
to legal authority, Coalition A can offer two relevant resources:
20We decide to polarize advocacy groups in their preferences in order to
simplif y the analysis. Howev er, we are aware that more than two coalitions
could be identified according to the different degree of convergence/diver-
gence between actors’ policy preferences.
21Its policy core belief is “that public health considerations supersede indus-
trial interests”, as it was stated in the joint letter about the “Pharma Pack-
age” to bo th th e Euro p ean Co mmiss ion er f or Heal th and the Pr esid ent of th e
EU Commission Barroso.
17http://www.consilium.europa.eu/uedocs/NewsWord/en/lsa/108380.doc
18http://europolitics.abccom.cyberscope.fr/social/council-should-start-discus
sing-full-pharma-package-artb252293-26.html
19http://www.europolitics.info/social/cor-considers-executive-s-proposals-bi
ased-art2421 80 - 26.htm l

N. CARBONI
skilful leadership and information. Within Coalition A there are
advocacy groups driven by charismatic lobbyists, which have
been able to build longstanding collaborative and trust-based
relationship with the Commission. Commission needs technical
information and pharmaceutical industry associations/compa-
nies have the resources to provide EU institutions with data,
reports, policy analyses and especially evidence-based argu-
ments.
Compared to Coalition A, Coalition B controls fewer re-
sources. At the individual level, coalition B members engage in
lobbying activities with varying degrees of financial support.
They globally have fewer financial resources than their coun-
terparts, but many of them usually get grants and funds from
Commission and EU projects.
Coalition B has also access to mobilizable members from the
health community and Member States. As we have seen in the
Pharma Package case study, twenty health organizations sent a
joint letter to Commissioner Androulla Vassiliou; the letter was
intended to encourage the Commissioner to stand firm with her
position towards the Information to Patients part of the Pharma-
ceutical Package. Following this, EPHA, working with several
EPHA members and other partner organisations, co-signed and
sent another letter related to the launch of the Pharmaceutical
Package to the President of the European Commission Barroso
and the press. The letter warned the College of Commissioners
that various parts of the Pharmaceutical Package (Counterfeit
Medicines, Pharmacovigilance and Information to Patients)
should be reconsidered. It called for the different parts of the
Pharmaceutical Package to be unbundled, as the separate parts
should be considered individually given that they deal with
different issues.
More than financial and informational resources, coalition B
affiliations base their strength on public and health community
support to apply political leverage to the process.
Advocacy Coali t i ons and Accessibl e Ven ues
Coalition A and Coalition B have been active in several
routes. Members of both coalitions were pursuing all the avail-
able venues-Commission, EP, Council, but each one seems to
have its own preferred channel according to policy preferences,
resources, relationship pattern, etc. Whereas industry and some
patient groups had good access to DG Enterprise, public health
and consumer organizations were considered stakeholders of
DG Sanco. Thus, Coalition A and Coalition B have been re-
spectively oriented to Directorate of Enterprise and Industry
(DG Enterprise) and Directorate for Health & Consumers (DG
Sanco). Bearing in mind that the proposals were developed by
DG Enterprise, Coalition A had a privileged access to the pro-
cess. DG Sanco was not completely able to counterbalance the
industry-oriented proposals of DG Enterprise. It was only cre-
ated in 1999 with a very limited mandate and without a strong
culture compared to the experienced DG Enterprise.
Then, pro-industry advocacy coalition was lobbying the
Commission more than the EP; conversely anti-industry coal-
ition members were pressing MEPs more than Commission’s
policy officers.
Council is still an undiscovered land for both coalitions,
since advocacy groups are still in the stage of learning how to
approach this institution (Carboni, 2009).
In sum, Coalition A has a comparative advantage in terms of
organisational capacity, financial resources and expertise. The
position of industries is strengthened by their ability to lobby at
all levels of the EU institutional system and by their close rela-
tionship to the Commission, who plays a central and strategic
role in the policy making process as we see in the next section.
Policy Broker and Policy Change
The pharmaceutical policy subsystem is polarized between a
pro-industry advocacy coalition and an anti-industry advocacy
coalition. These coalitions are mainly divided in their policy
preferences: Coalition A aims to increase and protect pharma-
ceutical industry interests, while Coalition B cares that public
health considerations supersede industrial interests. The conflict
is mainly driven by normative beliefs, making policy change
extremely difficult. As far as now, neither advocacy coalition is
totally getting what it really wants. It is just too early in the
process to assess whether stakeholders have exhausted all the
available venues and resources23. The best option for both coa-
litions is a consensus-based approach.
In the case examined here, policy learning is observed, as it
is predicted by the ACF. Policy learning within and between
coalitions is an important aspect of policy change. In this policy
subsystem, policy learning globally consists of the widespread
of knowledge, scientific and technical information, relationship
building, willingness and capacity to compromise.
Learning process is most likely to concern only secondary
aspects of a belief system, leaving the policy core of a coalition
intact, and bringing to minor policy changes (Sabatier, 1998).
Minor policy changes are the result of two processes: learning
within and learning across coalitions. The second is more interest-
ing in this case as it is where policy broker may intervene. Pol-
icy brokers play a crucial role within consensual decision-mak-
ing systems: they mediate between conflicting interests during
political negotiations, control information, and translate diver-
gent opinions into co mpromise s. This was mai nly the role play ed
by the Commission in this case study:
“Commission has played an important role in achieving
consensus among different interests. Commission is aware it
needs to involve more and more stakeholders in the process.
While it is true that everybody has its own interest and it is not
neutral (Commission included), the more inclusive the EU
process becomes, the more objective it will get” (Lobbyist,
Pharmaceutical Industry).
23The legal basis of the info to patients proposal is Article 85 (internal mar-
ket) of the Treaty and the procedure is co-decision. Therefore, it requires
qualified majority in Council and all the drafts are now at first-reading. The
votes on the EP reports are expected in April 2010. While we are writing
down all th e i s sues raised here, a si g nificant change occu rs: the new Barros o
Commission is planning to move competence for Pharmaceutical policy
from the En terp ris e and I ndus try Direct or ate in to t he Healt h an d Con sumers
directorate-general. DG Sanco will take charge of drafting pharmaceutical
legislation and of decision-making on questions such as product autho-
risation. It will also take on responsibility for the European Medicines
Agency, as well as for some aspects of biotechnology and pesticides that are
to be transferred from the environment department. This institutional change
will probably transform “t he rules of the game”.
22“This Communication outlines the Commission’s vision to ensure that
European citizens will benefit from a competitive industry that generates
safe, innovative and accessible medicines… The pharmaceutical industry
contributes to the well-being of citizens through the availability of medi-
cines, economic growth and employment. Europe has been losing ground in
p
harmaceutical innovation. It is important to slow down or even reverse this
trend” (Commission Communication on the Pharmaceutical Sector, 2008).
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/pharmpack_12_2
008/communication/citizens_summary_communication.pdf
40

N. CARBONI
The position of broker in policy negotiations depends on the
features of the political system and on specific context factors:
the higher the degree of consensus required, the more norms of
compromise create incentives for broker’s action across coali-
tions. In the EU context, the policy making process combines
aspects of intergovernmental negotiations and supranational
centralisation. The Commission draws up the proposal and a
decision has to be taken by Member States in the Council, and
in the case of co-decision with the EP. The Commission has to
search for consensus, trying to avoid decisions that violate
Member States interests. Policy proposals without consensus
can be blocked by intergovernmental haggling (Scharpf, 2000).
Commission has to strategically pursue all the venues and re-
sources available in order to avoid deadlock. By favouring the
exchange of information and opinions among stakeholders,
building supportive networks, promoting public consultations,
it can indirectly influence the policy direction of Member States.
In addition, by attending all the meetings in the Council and in
the EP, Commission knows the bottom lines of the actors in-
volved in the process: the formal and informal institutional
avenues leave room for strategic behaviour. Commission as
policy broker, therefore, takes an important position, where it
can channel information among advocacy groups and influence
the final output, behaving as a strategic actor. The role of the
policy broker can rest on a continuum ranging from brokerage
to advocacy and actors performing this function may inter-
mittently switch towards more advocacy oriented-behaviour
(Jenkins-Smith and Sabatier, 1993: p. 27).
Furthermore, the Commission not only has played the role of
broker in the process, but it has also confirmed to be able of
being both a policy entrepreneur (Cram, 1997; Laffan, 1997)
and a purposeful opportunist (Cram, 1993).
The role of the Commission as a policy entrepreneur should
not be ignored. In the case of information to patients, the
Commission has been able to frame and keep the policy issue
on the EU agenda for almost 10 years. Although the Commis-
sion’s proposal was initially unsuccessful, the Commission has
managed to find a way out of the political impasse (the EP and
Council rejection to Commission proposal) by using alternative
routes (i.e. the G10 and the Pharma Forum) as a platform to
keep issues that were not agreed upon in the review on the po-
litical agenda.
Despite lack of substantial competences, health has been
emerging as a European policy field through many creative
avenues (Greer, 2006). This case study shows how EU integra-
tion can result from the ability of institutions-especially the
European Commission—to use the “material constitution”24 to
influence the structure of politics. Even though the Member
States provided the EU with limited health competences, ex-
cluding harmonization of their laws and establishing the sub-
sidiarity principle for health services and medical care, it does
have numerous responsibilities relevant to health. Commission
as a purposeful opportunist sometimes succeeds in legislating
on issues that do not necessarily fall within its mandate. This
case-study is clearly the example of how the Commission is
able to shape advocacy groups’ strategies and to exploit stake-
holders’ resources and critical junctures among institutions.
To sum up, plans for reform pharmaceutical legislation had
started to take shape inside the Commission already in 2002,
following the reject by the EP and the Council. The Commis-
sion Directorate General—DG Enterprise initiated and fostered
EU high level debates between experts, professionals and
Member State governments on patient information. The not
transparent approach in inviting stakeholders resulted in an
overrepresentation of industrial interests. Furthermore, various
and simultaneous routes pursued by the Commission and over-
lapping consultations created confusion. It was clear that DG
Enterprise had its own agenda-giving patients’ information by
industry and successfully lobbied for that. By creating and fos-
tering high level debates, the Commission not only favored
policy learning, such as sharing experiences, exchange of
knowledge, but also managed to create commitment for its goal
as building of supporting coalitions. In many policy areas the
Commission generally tries to build trust through the creation
of supportive and consultative networks with advocacy groups
or through increasing (sometimes apparently) the level of
transparency and legitimacy by public consultation procedures
(Cram, 1997; Héritier, 2007).
In conclusion, the key to understand the EU policy change
dynamics in health care seems to be the relevant role played by
the European Commission throughout all the policy process.
Commission as policy broker has favoured policy learning and
as part of the advocacy coalition has exerted pressure for policy
change as well.
Beside the role of policy broker in influencing policy change,
the ACF allows us to get some interesting insights about the
factors that increase the chances to get policy change within the
multilevel system of the EU. Bearing in mind that EU policy
making is a consensus-based process, which first of all requires
agreement between the institutional players (Commission, EP,
Council and Member States), the policy analysis suggests that
policy change at the EU level is especially fostered by the fol-
lowing factors25 (Figure 1).
1) Accessible venues
The institutional setting26 with the Commission, the EP and
the Council, each playing a specific role in the legislative proc-
ess, offers advocacy groups access points differentiated ac-
cording to organizational and informational cost of lobbying
(Carboni, 2009). By facilitating or conversely hindering some
courses of actions, institutions define opportunities and con-
straints for actors’ involvement, influencing the success or fail-
ure of the political game. This study shows the central role
played by Commission as both policy broker and policy entre-
preneur in the policy-making process. Access to policy broker
is a strategic venue especially when it takes authority position.
However, Commission results in a very fragmented body. Each
DG represents a world with its own language and network. It
means each DG comes with different treaty bases, different
cultures, different stakeholders and consequently different in-
terests to push on the policy agenda. In our case, the fact that
DG Enterprise controlled pharmaceutical policy instead of DG
Sanco resulted in an industry oriented agenda and an easy ac-
cess to policy making for pro-industry coalition.
2) Available resources
25We take into account the influence of endogenous variables, controlling
for external factors.
26Despite of the increasing role of the ECJ in EU health policy development,
we have not included it in the analysis since it has not played a relevant role
in the selected case-studies.
24The constitution in the material sense must be distinguished from the
constitution in the formal sense, namely a document called “constitution”,
which, as written constitution, may contain not only norms regulating the
creation of general norms, but also norms concerning other politically im-
portant subjects.

N. CARBONI
Coalition A Coalition B
Polic y Broker
Institutions
Policy
Change
Policy bel iefs,
resources, venues
of influ ence
Figure 1.
Framework for policy change. Source: Adaptat ion from S a b atier (199 8 ) .
Advocacy coalitions’ resources are important elements in
shaping and developing EU health policy. The financial re-
sources, information, public support, leadership skills, which
interest groups have at their disposal, they all influence to some
extent the strategies and the chance of success in achieving
policy change (Carboni, 2009; Weible, 2007). Above all, inter-
est groups’ expertise and capacity to generate knowledge play
an important role at the EU level. The analysis has clearly
shown the favouring of certain types of knowledge over others:
while it is difficult to determine the exact impact of knowledge
on the policy change process, the case-study demonstrates that
different types and uses of knowledge are essential to achieve
policy change outcomes. It is evident that the key to successful
lobbying is strongly based on reputation of providing reliable
information and knowledge-based arguments according to in-
stitutions demands, more than emotional issues.
3) Belief System
This analysis shows that industrial interests prevailed over
the interests of others. This case makes clear how much Euro-
pean Commission controls legislation. The European agenda
for pharmaceuticals is a DG Enterprise agenda. The policy core
beliefs of DG Enterprise and of the pharmaceutical industry
both had a strong focus on creating a competitive European
pharmaceutical industry vis-à-vis US industry. Since individu-
als’ identities are closely tied to their beliefs, they tend to filter
or ignore dissenting information or events that challenge their
belief and readily accept information that bolsters their beliefs.
The DG with the competence to draft legislation selectively
offered access to advocacy groups whose policy preferences
were in line with those of the DG. In both the two analysed
processes, DG Enterprise gave access and listened to pharma-
ceutical companies and associations, more than to public health
and consumer groups. The Commission pursued its own agenda
without taking into account all the interests. It invested in net-
work building and creating alliances with like-minded advo-
cacy groups.
In other terms, the case study illustrates that the political ide-
ology of the institutions influence the receptivity towards the
knowledge and evidence brought in the process by advocacy
coalitions (Bryant, 2002). In the end, Commission was willing
mainly to knowledge and evidence supporting its ideological
perspective. Such findings have serious implications for all
policy fields. Advocacy groups/coalitions should be aware of
the current dominant policy paradigm and the barriers to
change that it may present. As our analysis shows, it may be
difficult to persuade decision makers of the value of public
health interests in developing policy, when the dominant para-
digm in health care policy is industries competitiveness. The
dominant advocacy coalition in the health policy community,
such as pharmaceutical industries, benefit from Commission’s
legal proposal to review pharmaceutical legislation and have
the ears of government. Similarly pro-industry governments
will not be totally receptive to knowledge concerning the social
determinants of health policy, whatever the empirical evidence
could be.
Conclusion
This study has attempted to contribute to both theoretical and
empirical dimensions concerning EU policy change process, by
the application of the advocacy coalition framework developed
by Jenkins-Smith and Sabatier to interest representation in
health care.
On the one hand, the research shows that a public policy ap-
proach is useful to analyze in a more dynamic and process-
oriented way EU integration. The ACF confirms to be a policy
analysis tool, guiding the analyst toward a systematic evalua-
tion of the different categorizations of stakeholders’ policy core
beliefs, coalition membership, usable resources and accessible
avenues. The advocacy coalition approach is conducive to gain
insights into the way resource distribution creates dependencies
between actors and shapes power relations; it enables the re-
searcher to understand how coalitions take shape throughout the
process and how resources and venues contribute to coalition
activities and policy change. Moreover, it takes us beyond the
usual EU-neoliberal approach (Anderson, 2009). ACF allows
identifying the nature, extent, and impact of a structural liberal
bias in EU health policy-making in a way that neither institu-
tions nor multiple streams can, because they tend to hide dif-
ferent power resources.
Within the ACF, we then add insights about some of the un-
derdeveloped components of this theoretical approach, such as
policy broker’s role and policy change definition. First, the
policy analysis demonstrates that in a consensus-based policy
making process—such as the EU joint-decision making system-,
where different policy objectives are in competition and a mul-
titude of stakeholders interact, a small number of specific actors
who facilitate communication and evaluate the different opin-
ions in the network are necessary and important. These actors
are the policy brokers. Whereas policy brokers take a relevant
position controlling over the information and the critical junc-
tures of the political subsystem, they do not only mediate
among different actors, but they could also behave as strategic
actors who pursue their own policy objective. It means that
policy brokers not only can favor policy learning, but they can
also promote policy change. Second, within the broad definition
42

N. CARBONI
of policy change, we identify different types of policy change at
the EU level:
a) policy change as poli cy learning;
b) policy change as change of the state of the policy issue;
c) policy change as change of the structure of politics.
The latter is especially relevant to the theoretical develop-
ment of EU integration studies. It is evident from the policy
analysis how the “material constitution” gives the chance to EU
actors, especially Commission, to change the structure of poli-
tics in the long run. In this case, the Commission has been able
to bypa ss formal leg islative veto poi nts by using informal aven ues
or practises (stakeholders’ consultation processes, public de-
bates, informational platforms, etc.). This is a manner to further
EU integration process, expanding the EU’s role in fields of
Member States’ authority by “ways of doing” rather than “hard
law” (Vanhercke, 2009; Greer and Vanhercke, 2009).
On the other hand, the study presents a rich picture of the in-
tergovernmental praxis in EU health policy landscape. While
the findings of the study cannot simply be generalized to all the
policy areas, this research presents a detailed account of the
nature and way policy-making takes shape at the EU level in a
significant policy field. Above all, the empirical analysis illus-
trates how relevant is advocacy in producing policy change at
the EU level. Lobbying in the multilevel system of the EU is a
strategic activity concerning not only the traditional advocacy
groups, but even institutions. It is evident from this study that
lobbying is a two-way street relationship, a relationship of give
and take, a relationship which can be a mutually-beneficial for
both sides. Advocacy groups seek to influence outcome in the
policy making process by persuading decision makers to sup-
port or even champion their cause that would not have done so
otherwise. But governmental actors want something from lob-
byists too. In order to be successful, you need to lobby institu-
tions giving them what they need. They need expertise and
technical information for policy development; they press advo-
cacy groups to do campaign contributions for them. They ask
lobbyists for assistance in attracting support from other institu-
tions, from the public or others. These are all cases that emerge
from our study. The Commission especially relies on stake-
holders’ resources and strategies to exert pressure on national
governments and expand its competences in policy fields, such
as health, traditionally under Member States subsidiary princi-
ple (Mossialos and Permanand, 2005a). Moreover, in this case
the Commission has been able to act as “successful lobbyist” in
promoting its own policy interest. It has effectively lobbied not
only public health and business interest groups, but also the
European Parliament and the Council (and Member States) to
different degrees. Since almost 10 years from its failed attempt
to review EU pharmaceutical legislation, the Commission has
managed to bring its policy proposal back in the EU legislative
agenda.
To conclude, lobbying results in a “successful” way to get
policy change in the multilevel system of the EU, where the
European Commission plays a pivot role in making a national
policy issue th e cen tral core of a European ba ttle.
Acknowledgements
I would like to thank Scott Greer, Rita Baeten, Liborio Mat-
tina and Giliberto Capano who kindly read the preliminary draft
of this paper and gave to me precious suggestions and com-
ments, and the European Social Observatory (OSE asbl) in
Brussels for its support to this research.
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