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Integration through Expansive Unification:
The Birth of the European Health Union
Maurizio Ferrera,�Anna Kyriazi,
†
and Joan Mir
o
‡
�University of Milan, Italy
†
University of Milan, Italy
‡
Pompeu Fabra University, Spain; joan.miro@upf.edu
The coronavirus disease 2019 (COVID-19) pandemic pushed the European Union (EU) to
centralize several public health functions. With the European Health Union (EHU)
initiative, four reforms have been adopted to strengthen the EU’s health security
framework: the extension of the European Medicines Agency and the European Centre
for Disease Prevention and Control’s mandates, the creation of the Health Emergency
Preparedness and Response Authority, and the upgrading of the Decision on serious
cross-border threats to health. This article analyses the reconfiguration of authority
patterns resulting from these reforms. It argues that the EHU exemplifies a distinct mode
of integration (expansive unification) in which national sovereignty is not transferred
to
the center but is jointly exercised
at
the center. This mode of integration is suitable for
capacity building in core state domains when functional needs confront reluctance from
constituent units to surrender control.
The coronavirus disease 2019 (COVID-19) crisis marked a significant advance in
the public health commitment and action of the European Union (EU). In the
wake of a European Commission Communication of November 2020, important
steps have been made towards the establishment of a European Health Union
(EHU), an institutional framework mainly (though not only) aimed at addressing
cross-border threats to health (European Commission 2020). The pre-existing
instruments for managing preparedness, surveillance, risk assessment and common
responses were extended and reinforced, while new bodies with delineated tasks
and new procedures for declaring and managing a “public health emergency at
Union level” were established.
In the EU, despite the strong functional pressures generated by the pandemic,
authority centralization in public health policy could not be taken for granted. This
domain qualifies as a “core state power” (Genschel and Jachtenfuchs 2016), as it is
aimed at protecting the physical security of populations, and is therefore firmly
associated with sovereignty, statehood, and national security. As with other core
Publius: The Journal of Federalism
, 1–26
https://doi.org/10.1093/publius/pjae006
# The Author(s) 2024. Published by Oxford University Press on behalf of CSF Associates: Publius, Inc.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://
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state policy fields, the upward delegation of authority to the EU level, and
particularly to supranational institutions, has been limited and belated. At the
beginning of the 1990s health policy was one of the least integrated sectors in the
EU, with deeply entrenched national public health traditions standing in the way
towards centralization (Lamping 2005). Indeed, in the early phase of the pandemic,
even the simplest forms of coordination seemed elusive, as the Member States
reacted with unilateral measures, blaming each other for the externalities of
national decisions (Brooks et al. 2023: 789–729). This notwithstanding, by the end
of 2023 the key pillars of the EHU plan had been put in place. In addition, such an
authority reconfiguration was achieved quite rapidly, in the middle of the crisis:
building the boat while sailing, as it were.
Our argument is that this relative institutional success is due to the specific
mode of authority reconfiguration that has driven the construction of the EHU.
On closer inspection, it becomes evident that national sovereignty over public
health has not been transferred to the center; the EHU has been designed so that
authority on public health can be jointly exercised at the center. Such a pattern goes
much beyond the traditional intergovernmental method, based on Council
negotiations; the exercise of joint authority within the EHU extends also to the
executive and administrative arenas, that is, the traditional preserves of
supranational bodies. The authoritative center of the EU has become more
important, but also more crowded, formally incorporating representatives of the
Member States in virtually all phases of the policy process. At the same time,
supranational actors have also acquired new competences. We label this mode of
integration “expansive unification,” as its outcome is the creation of a unitary
frame for expanding the overall amount of power of both supranational institutions
and the Member States.
Existing studies analyzing the EHU have so far aimed to uncover the
mechanisms through which the COVID-19 crisis became a catalyst for policy
change, propelling new integration steps in the health policy domain (Brooks et al.
2023; Forman and Mossialos 2021). This literature has discussed the design of the
different elements of the EHU initiative and their suitability to address the
weaknesses revealed by the pandemic (e.g., Anderson, Forman, and Mossialos 2021;
Beaussier and Cabane 2020; Deruelle and Engeli 2021). In this article we take a
different approach, focusing on the following questions: what factors allowed the
EU to rapidly centralize some key aspects of public health policy? And what pattern
of authority has resulted from this centralization? For our analysis, we mobilize the
analytical toolkit of federal theory to capture the distinctive nature of the EHU as
an authority structure (see, e.g., Kelemen 2013; Benson and Jordan 2008, 2011).
Taking a federalism approach to analyzing the EHU provides a two-fold benefit.
The analytical toolkit of federalism allows us to unravel the intricate web of inter-
governmental relations and clearly identify the depth and boundaries of the vertical
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separation of power in multi-level polities and policies. Under the federal lens, the
EHU appears as an emblematic case of vertical codetermination resulting from a
peculiar pattern of authority centralization, in which the powers of the constituent
units and those of the supranational center are virtually “fused” together to
produce binding decisions. Admittedly, the EHU lies at the extreme end of this
authority pattern, which does characterize, however, other policy domains of the
EU. We submit that the EHU case may be of interest also for federalism scholars,
as it shows that, in certain types of compound polities, sharing in rule may blur the
boundaries between self-rule and centralized rule, opening up unprecedented
trajectories of political unification which are neither federal nor confederal.
The next section situates our study in the existing literature on the development
of federal systems and EU public health. Subsequently, we elaborate an analytical
framework for capturing the multidimensional nature of political authority in
compound polities. This is followed by the reconstruction of the process which led
to the launch of the EHU and the detailed characterization of the EHU, using
official documents, complemented by press reports and secondary literature. Next,
we discuss the causes and consequences of the expansive unification pattern,
including empirical insights into the political process that led to it. The conclusion
wraps up and links our findings to other pertinent literatures.
Applying a Federalist Perspective to the EU
As noted by Vollaard, Van de Bovenkamp, and Martinsen (2016), the federal
perspective appears particularly promising for understanding the interplay between
functional and territorial politics and thus moves beyond the juxtaposition between
intergovernmentalist and neofunctional interpretations of the EU. Virtually all
contemporary democratic federations rest on variants of the cooperative blueprint,
in which the constituent units share in the determination of federal policy in some
key domains (typically including health policy: Fierlbeck and Palley 2015) and
implement/administer federal laws (Mueller and Fenna 2022). Even in the presence
of extensive co-determination, the maintenance of federalism (as a principle of
political organization) requires, however, that the central government and the
constituent units each preserve governing institutions and administrations of their
own, in line with constitutional prescription on the vertical separation of power.
This is the fundamental meaning of “shared rule”: not necessarily sharing in rule,
but the combination of self-rule (for the constituent units) and centralized rule,
each enjoying some autonomy from the other (Fenna and Schnabel 2023). As we
shall see, this tenet of federal theory will help us to overcome not only the
intergovernmentalism/neofunctionalism dichotomy but also to pin down the
distinctive character of the EHU in respect of the federal blueprint.
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The EU is a hybrid political system, characterized by a mix of federal and
confederal features (Fabbrini 2007, 2017). It is best described as a compound polity
of nation-states (Ferrera, Kriesi, and Schelkle 2024), with the latter being, in turn,
highly developed welfare states. EU building is a dynamic balancing act between
“opening” inter-state boundaries (territorial and functional) to reap the advantages
of economies of scale and preserving the “closure” conditions of nation-based
welfare states, which uphold solidarity dispositions. In the field of health policy, the
existence of large (but also diverse) health care systems at the national level has
historically pre-empted ambitious attempts at centralization. In fact, the reluctance
of the Member States towards competence delegation, as well as the absence of
like-minded policy and societal actors advocating further health policy integration,
have been pointed out as key factors to explain why health policy has remained one
of the least likely cases of European integration (Vollaard and Martinsen 2017).
Looked at from the perspective of comparative health federalism, the EU’s
institutional architecture shows, however, some serious structural flaws, as it
subordinates health policy to the higher order constraints of the internal market
and fiscal governance (Greer 2021). On this account, EU health policy seems to fit
the patterns of the so-called new intergovernmentalism (Bickerton, Hodson, and
Puetter 2015) of the post-Maastricht period, which sees Member States keen to
enhance cooperation in new fields due to the supranational scale of functional
challenges, while at the same time being reluctant to delegate sovereignty in
politically sensitive “core state power” areas (Genschel and Jachtenfuchs 2016)—
including health care.
EU competences in this domain have indeed remained limited over time, and
Article 168 of the Treaty on the Functioning of the EU (TFEU) explicitly mandates
the EU to respect national prerogatives regarding health policy and the
organization and delivery of health care. There is however one domain in
which—since 1992—the EU has “shared competences”: public health, including the
prevention of drugs-related health damage and monitoring, setting standards of
quality and safety of organs and substances of human origin, and management of
serious cross-border threats to health. Relying on these competences, the European
Medicines Agency (EMA) and the European Centre for Disease Prevention and
Control (ECDC) were established as independent EU agencies in 1995 and 2004,
respectively. The former is responsible for medicine authorization, while the latter
is charged with monitoring threats to human health from communicable diseases.
In addition, the completion of the single market—based on the principles of free
movement and non-discrimination—incentivized the emergence of a general
framework for cross-border healthcare. In 1999, the DG SANCO (after 2014
renamed DG SANTE—Directorate General for Health and Food Safety) was
established by augmenting the existing DG on consumer protection. Since then,
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DG SANTE has become the leading policy actor on health policy dossiers as well as
the main interlocutor for pressure groups acting in this field.
COVID-19 was not the first public health crisis affecting the EU. During the
2000s, the epidemics of SARS (2002), Swine Flu (2009), and E-Coli (2011) revealed
a series of coordination failures. Thus in 2013 a Decision on Serious Cross-border
Health Threats (European Union 2013) was adopted, defining the powers of the
EU in transnational emergency situations. The Decision codified the ability of the
Health Security Committee (HSC), the (until then) informal group convening
health ministry representatives, to coordinate the national measures in response to
outbreaks. It also established the Early Warning Response System (EWRS), a
framework enabling the Commission and the competent national authorities to be
in permanent communication for risk alert and assessment. The Decision also
included a specific provision allowing the Member States to engage in joint
procurement of medical countermeasures: the Joint Procurement Agreement (JPA)
constitutes a centralized mechanism in which the Commission acts as a permanent
secretariat and the Member States participate on a voluntary basis.
The outbreak of the COVID-19 pandemic in 2020 exposed the persisting
weaknesses in the institutional architecture. The novel virus propagated interna-
tionally, with the features inherent to a transboundary crisis, but on a scale
unprecedented in living memory. As in other compound polities, the EU found
itself under immense pressure, but with an inadequate endowment of policy
capacities, thus facing a much harder test than in earlier crises. The obvious
transboundary character of the pandemic implied a net functionalist pressure to
push authority towards higher levels of government (Greer, de Ruijter, and Brooks
2021). To pass the test, the EU embarked on a balancing act to reconfigure its
authority structure, with a view to reconciling the need for centralization with the
hard constraints posed by the Treaties and the reluctance of national governments.
Authority Reconfigurations in Compound Polities
A New Mode of Governance: Unification
The scholarly debate has analyzed the way in which the EU responded to the
multidimensional crisis triggered by the COVID-19 pandemic through the general
concept of coordination (Ladi and Wolff 2021: 327). We prefer to use the term
“unification,” which connotes the process whereby the Member States come “ever
closer” to each other by means of creative institutional architectures (often—and
increasingly—called “unions,” precisely) empowering them to achieve common
objectives, which could not be reached relying on national resources alone. Such
architectures entail a wide range of possible unifying forms: not only coordination
but also joint policymaking, common funding, the creation of new supranational
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bodies, monitoring and mutual surveillance, the adoption of binding regulations,
and so on.
Unification can play out in various arenas: legislative, executive, administrative,
and judicial. A key—and poorly visible—instrument for unification has been, for
example, the creation of special purpose committees comprising EU and national
officers, with extensive formal powers in the adoption of implementing or
delegated acts. In EU studies, the structure and functions of such administrative
bodies are known as “comitology” (T€urk 2015).
Unification patterns are shaped by several factors: Treaty rules, the nature of the
pertinent issue and policy domain, problem and political pressures, path
dependencies, the interplay, and negotiation between supranational and national
institutions and so on. Federal theory attributes great importance to institutional
details and invites exploration of the multi-level politics of their emergence as well
as their effects on policy performance. The literature on cooperative federalism has
extensively explored the structuring of intergovernmental relations under shared
rule systems. The US debate has coined the bakery metaphor of “marble cake
federalism” (Grodzins 1966) to describe the intermeshing of local, state, and federal
governments in several policy domains, especially in social welfare and public
works. While the term “cooperative” signals the presence of multiple forms of
interplay and synergies across levels, there is a great variation in terms of dedicated
channels, arenas, and institutions facilitating interaction and consensus building,
both horizontally and vertically. The weakness of the cooperative infrastructure of
the US (despite the marble cake) has been pointed out as one of the causes of the
conflictual and poorly effective management of the pandemic in that country
(Cigler 2021).
As we shall see, the marble cake metaphor is a particularly useful analytical lens
for reconstructing the establishment and internal articulation of the EHU. Here the
process of unification has generated a maze of (new) institutional bodies and
arrangements linking supranational institutions and the Member States: a marble
cake compared to which that of the US almost pales.
Expanding Political Authority: A Positive Sum Process?
Unification is not only about the re-definition of tasks but also—and primarily—
about the re-configuration of political authority. A full understanding of this
second aspect requires a brief exercise of conceptualization: what are the
constitutive components of an authority structure? And what is involved, exactly,
in its reconfiguration?
The literature on political power (and authority, i.e., legitimate and formalized
power) distinguishes between two dimensions: scope and infrastructure (Mann
1984). Scope defines the range of domains subject to authoritative decisions;
infrastructure denotes the range of bodies which support decision-making and
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execute decisions. We add two further dimensions, which have been highlighted by
other scholars and are especially pertinent for our purposes: participation rights
and constriction (Bartolini 2022: chapter 4; Z€urn, Tokhi and Binder 2021). The
former defines the circle of actors who are involved (in full or limited capacity) in
the making of decisions. Constriction refers instead to the binding character, the
prescriptiveness of decisions, for example, soft or hard.
Altering a given authority structure need not affect the four dimensions
simultaneously. And, more importantly, it need not produce a zero-sum game
among actors (Barnes 1988; Read 2012). As famously argued by Talcott Parsons, it
is possible to extend the shares of power of a given unit “without sacrifice of the
power of other units” (Parsons 1963: 258). Parsons conceived of power as the
capacity to get things done (power to), but the later literature has brought into the
picture also the notion of power “with”: the combination of the power resources of
different actors to maximize impact (Caputi 2013). The process of enlarging the
scope of political authority to a new domain creates a greenfield in which existing
or additional political actors can gain the right to participate in collective decision-
making (thus increasing power), possibly supported by novel infrastructures. In
fact, scope enlargement has a two-fold impact: it brings additional domains of
social interaction under the reach of political authority and simultaneously assigns
the “shares” of such authority to one or more designated actors. It must be noted
however that, to remain legitimate, scope enlargements must take place “in the
shadow of hierarchy”, that is, under the rules of the extant authoritative status quo.
When reconfiguring an authority structure, actors relate to each other with
different endowments of power, understood both as power to/with and as power
over (Pansardi and Bindi 2021).
We have mentioned above that the EU can be defined as a compound polity of
national (welfare) states, in which authority reconfigurations inevitably entail
balancing acts between supranational centralization and national autonomy. In the
case of scope enlargements, compromises characterized by positive-sum arrange-
ments are easier to forge, especially during hard times. We argue that the EHU
represents an emblematic example of multidimensional and positive-sum authority
expansion—a feature that we capture through the concept of “expansive
unification.”
The Launch of the EHU
When the first wave of the COVID-19 pandemic hit Europe in early 2020, it
exposed serious weaknesses in the EU’s health security framework, particularly in
two core tasks of crisis management: the detection of potential threats through data
collection and analysis; and risk management through resource mobilization (Boin
and Rhinard 2023). Firstly, in the domain of knowledge production, due to the
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weak capacities for surveillance, risk assessment, and early warning, EU institutions
were unable to swiftly detect, monitor, and alert on the evolution of the pandemic
(Beaussier and Cabane 2020). The ECDC failed to warn Member States about the
scale of the danger posed by the virus and its surveillance system remained
hamstrung during the following months by the lack of comparable data and
technical resources (European Ombudsman 2021). The absence of EU-level
coordination was evident in the reliance by national governments on national
experts as well as in the absence of supranational meta-analytical infrastructure and
of coherent systems for sharing data and procedures.
In the domain of risk management and resource mobilization, several
weaknesses emerged at both the national and the EU levels. Neither the EU nor
individual Member States were able to ensure the supply of crisis-relevant medical
countermeasures, such as drugs, devices, and biological products. They were
incapable of effectively monitoring needs, while the lack of coordination among
them in the supply of medical devices and medicines triggered shortages in many
countries (Scholz 2021). In the Spring of 2020, this lack resulted in slow access,
national hoarding, and competition in markets between Member States, and
eventually in distorted prices (Scholz 2021). This happened despite the Member
States having the possibility to use joint procurement. Although the HSC convened
numerous times to discuss the responses in Member States, its limited competences
and constriction capacities made it unable to coordinate national responses.
Consequently, containment measures, including border closures, were implemented
without EU-level coordination, while export restrictions were adopted by some
Member States on personal protective equipment.
After the initial weeks of division among Member States European coordination
increasingly found its way. Nonetheless, overall, policy responses to the COVID-19
pandemic within the EU were reactive, fragmented, and ad hoc. Consequently,
various EU actors called for reinforcing the European health policy framework,
including sectoral interest group organizations (e.g., European Public Health
Alliance 2020, European Patients Forum 2020, EU4Health 2020), the European
Parliament (European Parliament 2020), the Trio Presidency within the Council of
Ministers, constituted in 2020 by Germany, Portugal, and Slovenia, and groupings
of Member States (Politico 2020). On the front of public attitudes, the reluctance
that had hitherto impeded the robust involvement of the EU in healthcare prior to
the pandemic (Vollaard and Martinsen 2017: 340) gave way to increased levels of
support (Zalc and Maillard 2020).
As a response, in November 2020 the Commission presented its
Communication on “Building a European Health Union: Reinforcing the EU’s
resilience for cross-border health threats” (European Commission 2020). The
document proposed four key initiatives aimed at strengthening the mandate of the
ECDC, extending the role of the EMA, establishing a new Health Emergency
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Preparedness and Response Authority (HERA), and upgrading Decision 1082/2013/
EU on serious cross-border threats to health (SCBTH Regulation for short)
(table 1). Other initiatives, such as the Pharmaceutical Strategy, Europe’s Beating
Cancer Plan, European Health Data Space, and the EU4Health Programme, were
also part of the EHU package.
The Insititutional Design of the EHU
The institutional design of the EHU is complex. There are three key institutions:
EMA, ECDC and HERA. The first two are independent agencies, the third one is a
service of the European Commission. The complexity derives from two factors: on
the one hand, a partial inter-institutional overlap among the various participating
institutions; on the other hand, the different modes of functioning which apply in
ordinary versus emergency situations. In this section, we first introduce the
difference between the ordinary and emergency modes of functioning, we then
illustrate the authority profile of each institution along the four aspects of our
analytical grid: scope, infrastructure, participation rights, and constriction.
Public Health Emergencies in the EU
The public health emergency regime of the EU was codified by the 2013 Decision,
which enhanced the power of the inter-ministerial Health Security Committee and
Table 1 Legislative initiatives on the European Health Union
Proposal
EMA Regulation (EU) 2022/123 of the European Parliament and of the
Council of 25 January 2022 reinforcing the role for the European
Medicines Agency in crisis preparedness and management for
medicinal products and medical devices
ECDC Regulation (EU) 2022/2370 of the European Parliament and of the
Council of 23 November 2022 amending Regulation (EC) No
851/2004 establishing a European Centre for disease prevention
and control
HERA Commission Decision of 16.9.2021 establishing the Health
Emergency Preparedness and Response Authority, C(2021)6772
General Secretariat of the Council—Council Regulation on the
emergency framework regarding medical countermeasures in the
event of a public health emergency at Union level, 15132/21
SCBTH Regulation Regulation (EU) 2022/2371 of the European Parliament and of the
Council on serious cross-border threats to health and repealing
Decision No 1082/2013/EU
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entrusted the Commission with the task of declaring “public health emergencies at
Union level,” following WHO recommendations. The revision of this Decision and
its upgrade to a Regulation as part of the EHU package has confirmed the
competence of the Commission to declare public health emergencies “at Union
level.” This capacity stands at the core of state sovereignty since it enables the
suspension of fundamental rights and the imposition of extraordinary obligations
on citizens. In the new proposed framework however, the declaration of emergency
needs to be based on the advice of an Advisory Committee, comprising
independent experts selected by the Commission, and subsequently, needs to be
approved by the “Committee on cross-border threats to health,” comprising
representatives of all Member States. Nevertheless, on duly justified grounds of
urgency, the Commission may recognize a public health emergency at the Union
level through an immediately applicable implementing act (Article 23(4) of the
SCBTH Regulation). Furthermore, the Regulation expands the legal effects of
emergency declarations, mainly by enabling the activation of the crisis modes of the
ECDC, EMA, and HERA explained in the next sub-sections. The EHU authority
pattern as regards a crucial element of public health policy—emergency
declarations—is thus polyarchic, as the Commission must pass the “comitology”
filter.
Reforming EMA and ECDC
The main objective of the new Regulation concerning the EMA’s mandate was to
create a framework to address the issue of shortages of medicinal products and
medical devices in the event of public health emergencies. In practice, the
Regulation codifies the ad hoc procedures and instruments deployed in the early
phase of COVID-19. EMA expanded its core activities by setting up, in March
2020, the COVID-19 EMA Pandemic Task Force (composed of senior EMA staff)
and instituting other emergency procedures, such as arrangements between the
agency, the Commission, manufacturers and marketing authorization holders, on
the one side, and the Member States, on the other, to make available medical
products to treat COVID-19.
As regards the ECDC, the new Regulation expands the agency’s scope of
competences, transforming its mandate from a restricted risk assessment function
to direct involvement in the coordination of risk management (Deruelle and Engeli
2021). Until 2020, the ECDC had been mainly a hub for information exchange,
tasked with data collection, assessment, and dissemination, as well as the provision
of scientific and technical assistance to both the Commission and Member States.
During the COVID-19 crisis, therefore, the ECDC’s main task was to periodically
release “risk assessments” and provide scientific advice on potential policy
responses, with no authority in relation to prescribing appropriate actions. The
amending Regulation substantially expands the mandate of the ECDC with
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additional responsibilities: operational support to epidemic responses in Member
States; monitoring the capacity of national health systems to respond to
communicable disease threats; providing, upon request of the Commission or the
HSC, public communication on health threats; providing, upon request of the
Commission or the HSC, or on its own initiative, non-binding recommendations
to the HSC for management of communicable diseases; and supporting the
Member States and third countries in developing prevention and response against
future epidemics.
The Regulation empowering EMA created new structures that are activated
following the declaration of a “public health emergency” by the Commission. These
include two steering groups for monitoring shortages, one on medicines and one
on medical devices. Both are composed of a representative of EMA, a
representative of the Commission and one representative appointed by each
Member State. On their initiative or at the request of the Commission or a
Member State, the steering groups may provide recommendations on measures to
ensure preparedness with binding effect on the Commission, which shall take all
necessary actions to mitigate product shortages. Additionally, the Member States
are required to gather information on the availability of such products and submit
this to the steering groups. The Emergency Task Force (ETF), modelled on the
EMA Pandemic Task Force described above, is another new EMA body, to be
convened in preparation for and during public health emergencies, responsible for
accelerating the development and authorization of medicinal products with the
potential to address public health emergencies.
As for epidemiological surveillance, the declaration of a public health emergency
activates support from the ECDC, enabling it to deploy outbreak assistance teams.
These teams are managed by the “EU Health Task Force”—another newly created
body which increases the operational capacity of the ECDC. The Health Task Force
will be integrated by ECDC staff and experts from the Member States, and its task
will be to support countries with preparedness plans and swiftly intervene in health
crises.
Otherwise, the two Regulations left EMA’s and the ECDC’s pre-existing
authority structures intact. Both agencies are directed by executive structures that
operate under the close strategic guidance of Management Boards while also acting
as coordination hubs of networks of national experts. The Management Boards are
composed of one member designated by each Member State, and other members
designated by the EP and the Commission (in the ECDC case also four
representatives from professional associations). The ECDC and EMA’s management
boards adopt their decisions by simple majority. Member States’ participation in
ECDC and EMA occurs not only at the executive level, but also at the
administrative level, through the networks of expert committees and working
groups that provide information and expertise to the agencies and contribute
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to their regulatory activity. In EMA’s case, this system of bottom-up national input
is known as the “European medicines regulatory network.” EMA has four
committees, which are composed of one member representing each Member State
and which rely on working parties and scientific advisory groups, which also
comprise “national experts” nominated by the Member States. The regulatory
network also includes the European Commission, whose principal role in the
European system is to take binding decisions based on the scientific
recommendations delivered by EMA. The organizational structure of the ECDC
is similar: the Centre coordinates the operations of dedicated surveillance networks
of national authorities, and of national reference laboratories, that assist in
responses to health threats, such as field investigations in the event of disease
outbreaks. What emerges from the analysis of the reforms is, again, the
intertwining of national and EU actors and institutions in the governance of EMA
and the ECDC.
EMA has exclusive competence in marketing authorization of medicines and
medical devices, that is, constituent units cannot approve products that the agency
has not approved. Additionally, EMA can monitor and advise the Member States
and companies, however, it is the national authorities that carry out inspections.
The new EHU rules enhance the EMA’s monitoring capacity in emergencies, by
establishing a system of tracking shortages of medicinal products that should
prevent the lack of communication and data-sharing procedures that undermined
the EU’s initial response to COVID-19. In the field of epidemiological surveillance,
the new regulation strengthens the constriction capacities of the ECDC, for
example, by conferring to the agency the ability to provide (non-binding)
recommendations.
HERA: Ensuring the Supply of Medical Countermeasures
The EHU initiative established a third entity, the HERA, tasked with coordinating
the provision of medical countermeasures. HERA constitutes an internal
Commission service located within the Directorate-General for Health and Food
Safety (DG SANTE), and therefore it is not an independent EU agency as was
originally proposed by the Commission (see below).
HERA’s activities follow two logics, corresponding to a preparedness and crisis
phase. In the preparedness phase, HERA’s scope is focused on knowledge
production and assessment activities, such as supporting research on emerging
pathogens, developing relevant countermeasures and technologies, and supporting
large-scale production facilities.
In crisis phase, HERA assumes crisis management tasks. The council activates
HERA’s emergency framework following the recognition of a “public health
emergency at the Union level” by the Commission. In this operational mode, the
new framework introduces the possibility of centralized, EU-level procurement,
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purchase and manufacturing of crisis-relevant medical countermeasures and raw
materials. As noted, the possibility of using JPAs already existed prior to the
pandemic (European Union 2013). However, the JPA had been designed as a
preparedness rather than as a crisis-response instrument: its lengthy procedures did
not allow for negotiating and purchasing supplies with the flexibility and speed
required in extreme urgencies. Moreover, the EU’s emergency support rules did not
allow the Commission to purchase medical countermeasures. In April 2020, these
rules were amended to allow the Commission to negotiate contracts on behalf of
the Member States for the first time (Council of the EU 2020a). On this basis, the
Commission was able to develop the COVID-19 vaccine strategy. This framework
implied an agreement signed by the Commission and the Member States that made
the Commission responsible for the procurement process and the conclusion of
contracts.
In the case of the COVID-19 vaccines, the agreement set up a monitoring
system centered upon two bodies: a Steering Board overseeing negotiations and
validating contracts before signatures, composed of one representative per Member
State and co-chaired by the Commission and a Member State representative; and a
“joint negotiation team” in charge of negotiating contracts, made up of
Commission officials and representatives from seven Member States (France,
Italy, Germany, the Netherlands, Poland and Sweden) out of the twenty-seven
participating countries.
The HERA regulation institutionalized the experience of COVID-19 manage-
ment in joint EU procurement. Article 7 enables the Commission to act as a
“central purchasing body” for crisis-relevant countermeasures on behalf of Member
States that wish to participate in joint procurement. Although the Commission
carries out and concludes the negotiations with economic operators on behalf of
the participating Member States, Member States participating in the Health Crisis
Board can nominate representatives “to take part in ... the negotiations.”
Furthermore, the deployment and use of crisis-relevant medical countermeasures
remain the responsibility of the participating Member States.
HERA’s management changes depending on the preparedness and crisis modes.
In the preparedness mode, HERA’s organizational structure resembles the EMA
and the ECDC. It is governed by the Head of HERA, appointed by the
Commission. The Head of HERA is “assisted” by the HERA Board, which is
composed of one representative from each Member State, in the formulation of
strategic decisions. When HERA’s emergency framework is activated, another ad
hoc crisis entity, the Health Crisis Board, assumes the tasks of the HERA Board. It
is composed of one Commission representative and one representative from each
Member State but is chaired by the Commission and has a Secretariat composed of
Commission officials.
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Cross-Border Threats to Health: From Knowledge Production to Crisis
Management
The fourth initiative included in the EHU agenda is the new Regulation on Serious
Cross-Border Threats to Health amending the 2013 Decision on the same issue.
This initiative has a transversal character because it redesigns the EU’s public health
security framework, and therefore, the links between all the bodies and instruments
examined so far. Its main purpose is to shift some crisis management functions to
the EU level.
Regarding knowledge production and circulation, the legal framework for
epidemiological surveillance and response to cross-border threats is broadened to
include additional reporting requirements and analysis on health systems
indicators, and cooperation by Member States with the ECDC. The Regulation
redefines the so-called “epidemiological surveillance network,” reinforcing the role
of the ECDC within it. The aim of this network is to ensure permanent
communication between the Commission, the ECDC, and the competent
authorities at the national level. A novelty introduced by the reform is the joint
definition, by the Commission and the Member States, of common European
surveillance standards, adherence to which is monitored by the ECDC, reporting to
the HSC its assessments. The ECDC’s interactions with the EU Member States
happen (also) through the newly established EU reference laboratory network.
Therefore, the EU-level infrastructural power is expanded, but participation rights
are guaranteed for national actors, that is, representatives of national public health
institutes that undertake tasks like those of the ECDC at the national level.
The Regulation also expands the scope of the Health Security Committee
(HSC). Chaired by a representative of the European Commission and comprising
representatives of the Member States, the HSC can adopt its recommendations by a
two-thirds majority of the members. The HSC is endowed with the task of
coordinating, in liaison with the Commission, the preparedness and crisis response
planning of Member States for cross-border health emergencies. In fact, a “Union
health crisis and pandemic preparedness plan” needs to be established by the
Commission and approved by the HSC. But the HSC acquires new tasks not only
in relation to prevention but also in relation to crisis management. Following an
alert notification from the Commission or a Member State, crisis management
moves to the HSC, where the Commission and the Member States coordinate
national responses, issue joint crisis communications, and adopt guidance on
specific crisis responses of the Member States. Should the coordination of national
public health measures prove insufficient to ensure an adequate Union response,
the Commission provides further support to the Member States via the adoption of
recommendations on temporary public health measures. The constrictive capacity
of the responsible bodies remains low, but the introduction of soft law instruments
provides them, nonetheless, with minimal tools for eliciting compliance.
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Joint Authority at the Centre
The EHU’s Distinctiveness
As our empirical reconstruction demonstrates, the key scope extension of the EHU
package (that is, a new domain of legitimate EU intervention) has been the shift
from risk assessment to crisis management (table 2). Central to this is the
Commission’s ability to declare a public health emergency “at Union level,” and
the expansion of the legal effects that this declaration entails. At the same time,
preexisting capacities have also been strengthened, especially as regards surveillance
of Member States, which has been made stronger and wider (though with
important caveats, as we explain below). Nonetheless, scope extensions were
combined with a complex system of participation rights reserved for the Member
States in newly created and preexisting bodies, ensuring shared decision-making
“all the way up.”
The three main EHU bodies (EMA, ECDC, and HERA) make up the core of the
EHU, while a plethora of other infrastructures populate the institutional space.
These bodies are the ones inserting the “expansive unification” logic in the EU
public health architecture. There is the Health Security Committee, comprising
representatives of the Member States and the Commission: a hybrid body acting in
the executive arena. The “Committee on cross-border threats to health” is active in
the administrative sphere: it includes representatives of the Member States who
must give the green light to the implementing acts of the Commission in an
emergency. The managing Boards of all bodies have a mixed composition,
including representatives of the Member States, the Commission, and, in the case
of the Health Security Committee, a representative appointed by the European
Parliament as an observer. The EP can request the ECDC’s scientific opinion on
matters falling within its mission, while the EMA shall present a report on crisis
preparedness (foreseen in 2026) to the European Parliament (and the Council).
Note that the direct inclusion of MEPs in federal-level executive and administrative
decisions is a peculiar feature of the EHU. In case of emergency, the HERA Health
Crisis Board takes charge, activating the emergency bodies of the ECDC and EMA:
the EU Health Task Force, the Emergency Task Force, the steering groups of the
European Medicine Regulatory Framework and the Coordination Committee.
Decentralized institutions (focal points, reference labs) which liaise the ECDC with
the Member States complete the institutional setup.
The EHU is also equilibrated in terms of the degree of constriction, that is, the
extent to which decisions are binding. While the EU’s power to enforce a
coordinated response has been incrementally expanded, nonetheless Member States
have retained their prerogatives in important ways. This has happened not only
through their representation in new and old bodies and committees (sharing in
rule), but also because of the low prescriptiveness of any decisions taken. For
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instance, with regards to the joint procurement procedure, while the Commission
negotiates, Member States retain a final say; likewise, while Member States assume
the obligation to prepare national pandemic preparedness plans, the ECDC’s ability
to scrutinize these plans is limited, and it can only issue recommendations—and so
forth.
Overall, then, the distinctive feature of the EHU lies precisely in the high degree
of “fusion” between the central level and the Member State levels. The
supranational body par excellence, that is, the Commission, exercises its executive
Table 2 Expansive unification: authority reconfiguration through the EHU
Authority dimensions EHU innovations
Expansions
in scope
ECDC increases its role in crisis management in addition to risk
management:
•advise Member States and the Commission about preparedness
plans
•new right to activate EU Health Task Force
•right to issue non-binding recommendations for risk management
•new right to define a framework for reporting and auditing
EMA co-monitors potential shortages of medical countermeasures
Member States can mandate Commission for joint procurement in
emergency situations
New infrastructures Increased power to enforce a coordinated response through the HSC
Strengthened, integrated surveillance systems
EMA’s emergency task force
EMA’s medicines and medical devices steering groups
EU health task force
Health task force has the duty to prepare an EU health crisis and
pandemic preparedness plan
Institutionalization of HERA’s health crisis board to manage HERA in
emergency situations
Advisory Committee on public health emergencies
New rights of
participation
Member States involved in the decision-making of pre-existing and
new bodies
Member States obtain co-chairmanship of the HSC
The European Parliament can participate in the HSC as observer
New tasks backed
by constriction
Declaring public health emergencies at Union level
Stronger Member State surveillance on the side of the Commission
New reporting obligations for the Member States as well as private
companies
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and administrative powers under close control and often in conjunction with the
Member States uti singuli, that is, without the filter of the Council and its system of
weighted votes (whereby the number of votes varies according to population size).
In this sense, the EHU is a marble cake “all the way up”: national governments sit
in the powerful Council as well as in the executive and the administrative arenas,
casting the shadow of potential vetoes on the overall decision-making process. It
would be misleading, however, to downplay the power of the Commission, as the
latter wields an autonomous source of authority: its Treaty-based monopoly of
legislative proposal, which casts the shadow of a counter-hierarchy vis-a-vis the
comitology system. This prerogative enhances the Commission’s autonomy, as it
can in principle shift a controversial issue from the administrative to the legislative
arenas, where different voting rules apply. It is true that, empirically, neither vetoes
nor strategic shifts have taken place (at least so far). But the mere existence of such
possibilities structures the incentives and opportunities of power interactions,
through the mechanism of anticipated reactions.
How Did we Get Here: Expansive Unification through Constructive Conflict
What kind of political dynamics enabled EHU-building and what can this tell us
more broadly about the process of expansive unification? Owing in part to the
emergency and in part to the Commission’s design of the proposals to codify
already practised ad hoc measures rather than introduce radical changes, the
crisscrossing territorial and partisan conflicts that usually characterize EU social
politics (Ferrera 2017) were largely absent on this occasion. The main line of
disagreement arose between the Council of the EU and the EP, each of them
following a distinct institutional logic.
On the one hand, Member State ministers, while acknowledging the need for
more public health centralization, pursued a deliberate strategy for maintaining or
asserting (joint) control over the newly established or reinforced bodies,
guaranteeing their involvement in any key decisions (Cox and Kurzer 2024). As
can be gleaned through the mandates and other Council documents (e.g., Council
of the EU 2020b; Council of the EU 2021a, 2021b; see also: Politico 2021), during
their deliberations and the interinstitutional negotiations that followed the
Commission’s proposals, the Council of ministers demanded co-chairmanship in
the newly created structures, where this was not already granted. They also
consistently inserted clarifications and caveats into the Commission’s original
proposals, changing the language of the texts to insist on their nonbinding
character. They sought to limit the extensive surveillance regime initially proposed
by the Commission, by for example, demanding longer review cycles; and generally
argued for more Member State autonomy. Overall, while acknowledging the
functional need to coordinate at the center, the Member States were reluctant to
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relinquish control, thus they mobilized to preserve their role as ultimate decision
makers.
On the other hand, the EP not only supported the expansion of central powers
as proposed by the Commission, but also on occasion advocated for expanding
them even more. For example, the EP sought to increase accountability of the
Member States where they had resisted it, for example, by proposing that both the
Commission and the Member States should be required to provide “substantiated
justification” if recommendations made by an EMA steering group are not
considered. Similarly, regarding the ECDC’s mandate, inter alia, to assess the
Member States’ preparedness and response planning or the obligation for Member
States to notify reporting delays, the EP preferred a supervisory rather than simply
a supporting role. The EP called for the new powers (in both their scope and
infrastructural dimensions) to apply also beyond crisis-situations (in the case of
EMA) and to cover non-communicable diseases (in the case of the ECDC). These
proposals did not make it into the final texts, marking the limits of authority
transfer to the center in the expansive unification pattern.
In the case of HERA, the policymaking process took a different route. It was
somewhat more conflictual, and it involved horizontal inter-state tensions. The
Commission presented five possible ways to implement HERA (European
Commission 2021: 3–4) starting from the least ambitious (status quo or marginally
strengthened cooperation) to the most ambitious option (full end-to-end
authority). Member States were divided on the new responsibilities attributed to
HERA: some governments (such as Spain, Belgium, the Netherlands) agreed with
the Commission’s diagnosis and converged towards a rather expansive version
(EPRS 2021: 5), while others (Romania, the Czech Republic, or Denmark) stressed
the importance of respecting the division of competences between EU institutions
and Member States. Governments were also cool to the prospect of the
Commission auditing their health systems to determine their pandemic prepared-
ness (EPRS 2021: 6). Given this disagreement and working under time pressure,
HERA was eventually set up as an internal department within the Commission
(a “Commission service”) via a Decision on 16 September 2021. Because of the
chosen legal basis (Article 122), while an accompanying Council regulation was
necessary to approve it, the EP was excluded from the policymaking process,
though MEPs were still granted an observer role on HERA’s board and a vote on
the budget.
Overall, the dynamics behind the establishment of the EHU can be largely
accounted for based on a combination of neofunctionalist and new inter-
governmentalist logics: while the increasing costs of cross-border spillovers made
room for empowering both the Commission and interest groups to push for
EU-wide solutions, the authority did not shift to the Commission directly, but
mostly to semi-independent agencies and bodies whose institutional design is more
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hospitable to the influence of Member States. However, mainstream integration
theories perform better in illuminating the drivers of integration rather than the
workings of the EU. And this is also the case for the EHU, whose functioning
cannot be captured by the supranational–intergovernmental dichotomy. Thus,
while new intergovernmentalist theory holds that these semi-independent bodies
become increasingly important in the post-Maastricht period at the expense of
supranational institutions (Bickerton, Hodson, and Puetter 2015), the literature on
EU agencies sustains the opposite: “even if national delegates may dominate
numerically on the management boards of EU agencies ... they may in practice be
loosely coupled to ministers,”, these bodies “tending to lean more towards the
Commission than any other potential masters” (Egeberg and Trondal 2017: 679).
Our concept of expansive unification accounts for this apparent paradox: rather
than institutional rivalries and inter-institutional zero-sum games, what the design
of the EHU shows are horizontal dynamics featuring multiple checks and balances
and a polyarchic exercise of joint authority at the center between the Commission,
Member States representatives, and health agencies. Positive-sum authority
expansion facilitated the building of the EHU, by containing both vertical tensions
(between the center and the constituent units) and horizontal tensions (between
the legislative triangle at the top; between constituent units at the bottom).
Mobilizing Consensus in the Pandemic: Downstream Implications of
the EHU
The literature broadly agrees that the EU management of the COVID-19 pandemic,
at least in health policy terms, was rather satisfactory (Dimitrakopoulos and Lalis
2022; Rhodes 2021; Brooks et al. 2023). This positive judgment can be reinforced if
one considers that during the crisis the Union engaged with a double and
demanding task: that of immediately responding to the pandemic emergency
through regulatory and partly spending policies while at the same time launching a
constituent process, that is, designing and legislating the institutional architecture
of a novel permanent structure such as the EHU. This represented a rare and
successful example of “building the ship while sailing”: in fact, the EHU package
has mostly codified and systematized the ad hoc measures taken during the various
phases of the pandemic.
After a period of internal discord during the first weeks of the pandemic in
Europe, the EU proceeded to make the most of its limited competences (Rhodes
2021), its functional performance visibly increasing over time. Already in early
March 2020, the Commission activated the Health Security Committee and created
a new panel of epidemiologists and virologists to advise it; it also activated and
subsequently expanded the “rescEU” stockpile of supplies also increasing its
budget. The Commission was endowed with the task of joint medical supply
procurement, which, between 2020 and 2021, aside from the vaccination campaign,
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produced four joint procurements of personal protective equipment. The
authorization and supply of vaccines faced some setbacks early on but were
overall successful (Martinsen and Goetz 2022, 3). Other EU actions included
coordination of the redistribution of health professionals and patients across
Member States, helping to overcome medical supply problems, and successfully
coordinating the lifting of mobility restrictions during 2020 (Brooks et al. 2023).
Research on the United States and Switzerland—the most emblematic cases of
“coming together federations” (Stepan 1999) and thus most comparable to the
EU—has pointed out, instead, several handicaps in the management of the
pandemic resulting from the compound nature of their political systems, resting on
a double (horizontal and vertical) division of power. In the US, public health
responses have been negatively affected by lack of established infrastructures of
coordination and cooperation across levels of government, as well as by multi-level
partisan rivalries and the dominance of political interests (Alexander Shaw,
Ganderson, and Schelkle 2022). In Switzerland, the federal center initially took
over—possibly overstepping its constitutional limits—stripping the cantons of their
co-decision prerogatives and relegating them to the role of mere implementers.
This produced a subsequent backlash which blurred both accountability and
effectiveness (Uhlmann and Ammann 2021).
In contrast, despite its weak constriction capacities, the EU mobilized a
surprising degree of consensus in its crisis management. Of course, part of the
explanation lies in the relatively limited competences of the EU, implying fewer
incentives for public attention and politicization. At the same time, it can be
argued that the “expansive unification” mode of integration significantly facilitates
conflict resolution and inter-institutional cooperation at both the vertical and the
horizontal levels. As argued by the literature on federalism, strong vertical
coordination fosters trust enables the convergence of interests and enhances the
reliability of inter-governmental interactions (Schnabel and Hegele 2021). The
authority patterns which we have dubbed “marble cake all the way up” can be seen
as an extreme case of vertical coordination in which the constituent units jointly
exercise federal powers at the center. The absence of multi-level partisan rivalries
has neutralized the conflict dynamics which plagued the US experience. The
balance of power between the Member States (acting at the center) and the
Commission in the executive and administrative arenas has in its turn contained
the political strains inherent in the double separation of powers (vertical and
horizontal) which characterizes compound polities (Fabbrini 2007).
Conclusion
The EHU exemplifies a mode of integration that we have called expansive
unification. In the field of public health, this mode of integration has opened the
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functional boundaries of the Member States, but it has not weakened their political
role. The EHU has not inaugurated a top-down infiltration on the side of a
supranational center of a previously autonomous policy space of domestic polities.
Quite to the contrary, it has promoted upward enablement of national
governments in steering new common policies at the center.
The EHU rests on governance structures that are neither intergovernmental nor
supranational since decision-making powers are exercised together by supranational
institutions and the Member States. Both the national executives and the
Commission retain (and have gained, in fact) important prerogatives in all EU-
level ambits of authority and decision-making arenas. Even the European
Parliament has acquired the unprecedented right of a “jump seat” in the
management of the Health and Security Committee. Thus, expansive unification
displays features that cut across the intergovernmental–supranational divide.
Our account offers further evidence that a “weak center”—essentially based on
the “sharing in rule” principle—constitutes a distinctive feature of the EU as a
compound polity of nation-states (Alexander Shaw, Ganderson, and Schelkle 2022).
The center is not an autonomous and separate layer of binding authority. EHU-
building has instead created a composite and polyarchic center: less an autonomous
source of top-down ultimate authority than a site for the joint exercises of
authority. In a way, the center is itself a marble cake, in which the supranational
and the national levels/authorities intermesh with each other in both functional
and institutional terms. If the essential feature of federalism is less the presence of
policy co-determination than the independence of both the central authority and
the authorities of the constituent units, then the EHU (and more generally
expansive unification) does not bring the EU closer to the federal template.
However, the deep formalized enmeshment of domestic and supranational
institutions in the making of constrictive decisions sets the EHU apart from the
confederal template, as typically exemplified by the World Health Organization.
To what extent does the logic of expansive unification inform also other recent
advances in the integration of other core state powers in the EU? There are signs
that such logic has indeed driven developments in other domains, such as
electricity regulation (Rangoni 2023), the functioning of the European Asylum
Support Office in asylum policy, or the design of the Single Supervisory
Mechanism for Banking Union. Also, in these cases, to strike a balance between
joint EU action, national diversity and technical expertise, new governance
architectures have been established, and managed at the EU level through the
interaction between the Commission, national officers and independent experts
(Rangoni 2023). These types of unification also depart from the EU’s classical
“regulatory polity” (Majone 1994) approach because they entail an expansion of
supranational capacity building (e.g. staff and funds).
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The expansive unification logic may indeed become increasingly present in other
sectors of EU integration subject to both functional pressures for centralization and
sovereignty concerns among the Member States. Indeed, our analysis of the public
health domain supports the view that the Member States can accept building new
authority structures at the center as long as they retain channels of participation
within them, including at the administrative stage. These mechanisms of joint
authority are important in the EU compound polity to the extent that they foster
shared understanding, give rise to stabilizing polity norms (Pettit 2023), and
mitigate conflict across jurisdictional frontiers.
Notes
Our research was supported by the European Research Council under the Synergy
Grant number ERC_SYG_2018 grant number 810356, for the project Policy Crisis
and Crisis Politics. Sovereignty, Solidarity and Identity in the EU post 2008—
SOLID.
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