International Journal for Quality in Health Care 2000; Volume 12, Number 3: pp. 217–225
European Union health policy and its
implications for national convergence
STRASIMIR CUCIC
Dutch Institute for Healthcare Improvement, Utrecht, The Netherlands
Abstract
This paper explores the relevance for health care of European Union (EU) legislation, regulation and policies. Reports,
communications and other materials of the European Commission and other relevant European bodies are screened for
their implications for health care, primarily on the national health system level. The paper provides a brief overview of EU
history and its main institutions, followed by an analysis of health (care)-related provisions in the EU’s main legal
documents – its treaties. The impact of the EU actions on health protection is considered with regard to both actions in
the field of public health and health protection requirements in its policies. In the public health area, information systems
that are now being developed are discussed, followed by an outline of health protection requirements in EU policies that
can have an impact on health systems. These policies are then analysed using the political factions model. Finally an attempt
is made to predict future developments, stressing the need for a far-reaching synchronization of national systems.
Keywords: delivery of health care, European Union, health policy, legislation
This paper explores the relevance of legislation, regulation
and policies of the European Union (EU) for health care in
the Member States. First, a brief history of the EU and its
main institutions is presented, followed by an analysis of
legislation and regulation pertinent to health care. Policies
and actions in the field of public health are discussed, as well
as health protection requirements in ‘other’ EU policies.
These policies are then analysed using models for policy and
political evaluation, and an attempt is made to predict future
developments.
Methods
Main sources of information for this paper were reports,
communications and other materials from the Commission
of the European Union, the European Parliament, the Council
of the EU and the Court of Justice of the EU. A wealth of
information is also available on the World Wide Web, through
the official EU site http://www.europa.eu.int. The materials
were screened with regard to their relevance to health care,
especially at the level of the national health system. Full
analysis of all implications of EU policies for the health
protection of its citizens falls beyond the scope of this article.
The European Union
On 7 February 1992, in Maastricht (The Netherlands), the
European Communities (EC) signed a Treaty creating the
EU. The newly formed EU gained more authority than the
EC, but also the obligation to respect the subsidiarity principle
meaning that everything that is or can be properly regulated
on the national level would not be subjected to European
regulation. Member States have maintained exclusive competence in delivering health care to their populations. The
EU has acquired some prerogatives in health protection,
primarily in the field of public health that has been for the
first time defined as its explicit task in Article 129 of the
Treaty of the EU. The very essence of the Treaty is the
protection of free movement of people, goods, services and
capital within the EU, a task whose fulfilment is being
safeguarded by increasing executive powers at the Union
level and with implication for many sectors of governance
including health care [1].
The first foundations were laid in 1951, with the establishment of the European Coal and Steel Community
followed by the Rome Treaty (1957) establishing the European
Economic Community (EEC). In a broader sense, Member
States have been striving for convergence of their national
legislation and regulation [1] as new EEC regulation has been
developed.
In the 1970s and 1980s, many of the Member States initiated
reforms of health systems and this context is discussed by
Klazinga in this issue [2]. One common denominator of all
these reforms was a greater influence of market forces in
health care. Few noticed that as market forces were making
their entry in the health sector, the sector itself would be
increasingly subjected to EU regulation. Regulation that is
Address reprint requests to S. Cucic, CBO – Dutch Institute for Healthcare Improvement, PO Box 20064, 3502 LB Utrecht,
The Netherlands. E-mail: [email protected]
 2000 International Society for Quality in Health Care and Oxford University Press
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S. Cucic
being developed to provide unobstructed movement of
people, services and capital could now be related to patients
and health professionals, health services and money in the
insurance or national health systems.
In 1997 the Treaty of Amsterdam was intended to replace
the Maastricht Treaty. Although the Amsterdam Treaty has
not yet been enforced (it has to be ratified by all national
parliaments of the Member States by the end of 1999) this
paper will focus on health care implications of this treaty,
related legislation, regulation and action plans.
Institutions of the Union
The classical tri-partite governance model of the Member
States, with the legislative, executive and judicial branches, was
expanded by the introduction of a fourth party representing
governments of the Member States. The political square of
the EU consists of [3]:
• the European Parliament, a directly elected body representing citizens of the EU, charged with passing of
legislation as well as scrutiny and control of the executive power;
• the European Commission, responsible for initiating
proposals for legislation, guarding of the Treaty of the
EU, management and execution of the EU policies;
• the Court of Justice of the EU, providing judicial
safeguard in implementation of the Treaty of the EU
and other legislation;
• the Council of the EU, or Council of Ministers consisting of ministers of the Member States to set political
objectives, legislate, co-ordinate national policies and
resolve differences. This unique body functions both
as supra-national and inter-governmental body deciding
on all key issues by consensus (although in certain
cases qualified majority voting is applied). European
Council (Health), for instance, gathers all Member
States ministers of health, and is supported by EU
High Level Committee on Health with representation
of top-level civil service officials.
Since its founding, the EU business is conducted based
on proposals from the European Commission, advice of the
European Parliament, decisions of the Council of the EU
and interpretation of the Court of the EU [3]. In the last 20
years there has been a clear tendency to strengthen the role
of the EU bodies in respect to national ones. Both Treaties
of the EU, Maastricht and Amsterdam, point in that direction,
as well as emergence of a number of institutions at the EU
level giving it some resemblance of the supra-national state.
Legislation and regulation by the EU, relevant to
health care
The founding Treaties (Rome, Maastricht, Amsterdam) together with the protocols and addenda added to them over
time (including the 1986 Single European Act) are the highest
legal acts of the EU, with the function comparable to
constitution in Member States [1].
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Another important basis for legal instruments within the
EU are European policies promoted by various European
bodies. A distinction can be made between regulation, directives and decrees [1]. Regulations are legally binding in all
Member States; in health care this pertains especially to
insurance schemes. Directives are European guidelines that
have no legal powers, but oblige legislative bodies in Member
States to adapt local legislation consonant with the EU
directive. In health care, directives are often related to professional conduct, pharmaceuticals, medical technology and
patient rights. Finally, decrees formalize a decision related to
a single party (that can be a private person or a state) and
become legally binding only after confirmation by appropriate
national bodies. The EU can also make recommendations
and advisories, but both actions have no direct legal powers.
In addition, the jurisprudence of the Court of Justice of the
EU is constantly refining and clarifying European legislation.
Relations between this complex system of European legislation and regulation and national legislation are not always
harmonious in the health care field. As stated earlier, based on
the subsidiarity principle, health care provision is exclusively
within the competence of Member States, but the health care
sector does fall under European regulation. It seems that the
struggle for an integrated market within the EU agreement
among Member States could be more easily resolved by the
economic principles of free trade and fair competition than
by social aspects of solidarity and equal access [1]. The latter
is often hampered by lack of political will in Member States
which has resulted in slow progress of the ‘People’s Europe’
programmes including issues of access to health insurance/
health care, social protection and support to disadvantaged
groups in the society.
Member States have the right, though, to implement
temporary (limited) measures blocking implementation of the
EU legislation if they estimate that this legislation would have
negative consequences for health.
Treaty of Amsterdam 1997
The role of the EU in health protection is described in Article
152 of the Amsterdam Treaty [4] (Table 1).
Treaty of Rome 1957
The EEC Treaty (Rome) contains some health considerations,
albeit indirect. For instance, the treaty aims to raise the
standard of living or protect free movement of workers (i.e.
patients and health professionals), right of establishment
(health professions, services), and free movement of services
(health services). Health and safety at work as well as health
protection provisions related to foodstuffs and pharmaceuticals are mentioned. Other provisions are used as a
basis for health-related actions [5]. A treaty defining a European Atomic Energy Community (Euroatom-1957) deals,
among others, with protection of health workers and the
general public from the dangers of ionizing radiation [5].
Single European Act 1986
The Single European Act strengthens the EEC role in relation
to health protection, especially in the areas of health and
European Union health policy
Table 1 Article 152; Treaty of Amsterdam
1.
2.
3.
4.
5.
A high level of human health protection shall be ensured in the definition and implementation of all Community
policies and activities.
Community action, which shall complement national policies, shall be directed towards improving public health,
preventing human illness and disease, and obviating sources of danger to human health. Such action shall cover the
fight against the major health scourges, by promoting research into their causes, their transmission and their
prevention, as well as health information and education.
The Community shall complement the Member States’ action in reducing drugs-related health damage, including
information and prevention.
The Community shall encourage co-operation between the Member States in the areas referred to in this Article
and, if necessary, lend support to their action.
Member States shall, in liaison with the Commission, co-ordinate among themselves their policies and programmes
in the areas referred to in paragraph 1. The Commission may, in close contact with the Member States, take any
useful initiative to promote such co-ordination.
The Community and the Member States shall foster co-operation with third countries and the competent
international organizations in the sphere of public health.
The Council, acting in accordance with the procedure referred to in Article 189b and after consulting the
Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the
objectives referred to in this Article through adopting:
(a) measures setting high standards of quality and safety of organs and substances of human origin, blood and
blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more
stringent protective measures;
(b) by way of derogation from Article 43, measures in the veterinary and phyto-sanitary fields which have as their
direct objective the protection of public health;
(c) incentive measures designed to protect and improve human health, excluding any harmonization of the laws
and regulations of the Member States.
The Council, acting by a qualified majority on a proposal from the Commission, may also adopt
recommendations for the purposes set out in this Article.
Community action in the field of public health shall fully respect the responsibilities of the Member States for the
organization and delivery of health services and medical care. In particular, measures referred to in paragraph 4(a)
shall not affect national provisions on the donation or medical use of organs and blood.
safety at work, and EEC actions on the environment and
consumer protection. This has also resulted in a number of
directives on product safety, occupational safety and health.
Articles dealing with approximation of legislation in Member
States stipulate that all proposals directed towards establishment of the internal market have to be based on a
‘high level of health protection’ [5].
Treaty of Maastricht 1992
The EU Treaty (1992) provides a specific definition of the
Union’s powers related to public health in Article 3 and
especially Article 129. The EU was charged with ‘making a
contribution to the attainment of a high level of health
protection’ and it has been decided that ‘health protection
requirements shall form a constituent part of the Community’s
other policies’ [6]. Also, provisions have been introduced or
strengthened in a number of areas relevant to health, such
as consumer protection, education and vocational training,
transport safety and co-operation in the areas of judiciary
and internal affairs.
The Maastricht Treaty brought three important changes in
the EU’s attitude towards health care [5] in that it:
• clearly spelled out the EU’s authority in health protection, especially in the area of public health through
a dedicated article;
• provided a framework for actions by focusing on
public health and prevention of diseases;
• obliged the EU to check all its policies, including
implementing measures and instruments, regarding
possible adverse effects on health or undermining
promotion of health.
EU actions on health protection
Based on its Treaties, various bodies of the Union developed
actions relevant to health protection. All of these actions can
be divided into two groups:
(i) EU activities in the field of public health.
(ii) Health protection requirements in EU policies.
A word of caution might be in order here, as it is commonly
assumed that EU health care activities are limited to public
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S. Cucic
health only. Actually, other EU policies with implications for
health protection have potentially much greater influence
on the health services in Member States. Provision and
organization of health care systems is directly influenced
by activities related to research, training of professionals,
pharmaceuticals, medical technology, telematics and social
security. These activities are founded in EU competence in
the areas of internal market, competition policy, research,
education, energy and agriculture policies.
Actions in the field of public health
In 1993 the European Commission developed a framework
for actions in public health [7], a strategy to implement
provisions of the Treaty of the EU. Eight action programmes
have been developed, of which five are operational: AIDS
and other communicable diseases, drug dependence, cancer,
health promotion and health monitoring. Programmes on
pollution-related diseases, rare diseases and injury prevention
are currently being considered.
Today, although principles and underlying philosophy of
the 1993 Framework for Action remain valid, priorities,
structures and methods are in need of fundamental review
and reformulation [6]. A recent European Commission communication [6] proposes development of public health policy
in the EU. Once the Amsterdam Treaty is formally ratified,
the European Commission is expected to prepare concrete
proposals for the new policy.
In the above mentioned communication, three strands of
action have been envisaged:
• improving information for the development of public
health;
• reacting rapidly to threats to health;
• tackling health determinants through health promotion
and disease prevention.
It should be noted here that the EU Public Health Policy
is being developed based on provisions of the Amsterdam
Treaty, in circumstances that differ considerably from the
situation in 1993 when the Framework was developed. The
European Commission has committed itself to give health
policy a higher priority, as a response to requests from both
the Council of the EU and the European Parliament, as well
as from major actors in the health field [6]. The legal basis
for EU actions is also in the process of change. Whilst in
the Maastrich Treaty (article 129) ‘a contribution’ to health
protection is mentioned, the Amsterdam Treaty Amsterdam
stipulates that ‘A high level of human health protection
shall be ensured in the definition and implementation of all
Community policies and activities’. The focus of EU actions
on health protection, originally limited to prevention of
diseases, in particular major health ‘scourges’, has been
broadened to include actions directed towards ‘improving
public health, preventing human illness and obviating sources
of danger to human health’. The EU has also gained additional
powers regarding the setting of standards for use of organs
and substances of human origin, blood and blood derivatives
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Table 2 Categories of communicable diseases
• Disease preventable by vaccination
• Sexually transmitted diseases
• Viral hepatitis
• Food-borne diseases
• Water-born diseases and diseases of environmental
origin
• Nosocomial infections
• Other diseases transmissible by non-conventional agents
(including Creutzfeld–Jakob’s disease)
• Diseases covered by the international health regulations
(yellow fever, cholera and plague)
• Other diseases (rabies, typhus, viral haemorrhagic fevers,
malaria and any other as yet unclassified serious
epidemic disease)
Annex of EC Decision (1998) 2119
as well as authority to undertake measures directed towards
protection of human health in the veterinary and phytosanitary field. These new powers are limited to the extent
that they ‘shall not affect national provisions for the donation
or medical use of organs and blood’. Member States are also
free to maintain or adopt stricter protective measures than
required by the EU.
However, both Treaties clearly state that incentive measures
undertaken by the EU exclude ‘any harmonization of the
laws and regulations of the Member States’ [6].
The Court of Justice has, in the case United Kingdom vs.
European Commission [8], confirmed that the objective ‘to
contribute to attaining a high level of human health protection’
(Article 3, Treaty of the EU) applies to all areas of EU
policies which have impact on health [6].
Improving information for the development of
public health – IDA/EUPHIN
Based on the EU telematic programme ‘Interchange of data
between administrations (IDA)’, the European Union Public
Health Information Network (EUPHIN) is being developed.
It comprises two systems for monitoring: (i) a common set of
health-related indicators and (ii) surveillance of communicable
diseases. The European Parliament and the Council of the
EU have formally inaugurated the latter system [9]. Categories
of communicable diseases that would be the subject of
surveillance have also been defined [9] (Table 2).
Still, a number of issues have to be resolved before the
system can be fully operational. For instance, technical means
and procedures by which the data will be disseminated and
analysed at the EU level have to be developed. At present,
two options are being considered, creation of European
institutions for the purpose (comparable to the National
Institutes of Health and Centre for Disease Control in the
European Union health policy
USA) or charging different national centres with specific
tasks within the programme and linking them by telematic
means. It seems that the latter option will prevail [10]. Another
interesting development is inclusion of nosocomial infections
in the list of diseases that would be surveyed, bringing
EUPHIN very close to the daily practice of acute care. In
that respect some provisions of the decision establishing the
network, like the obligation of each Member State to inform
and consult the European Commission and other Member
States on the nature and scope of intended preventive measures, could have direct consequences for daily practice in
health care institutions.
Building on the experiences of this programme (IDA/
EUPHIN), a structured and comprehensive EU system for
collecting, analysing and disseminating information will be
developed [6]. Other functions of the system will include
evaluation and appraisal, comparisons and development of
future actions. It has been proposed that the system should
focus on two complementary areas:
(i) Trends in health status and health determinants
(demography, mortality, morbidity, major health determinants, inequalities in health, interactions between health status and socio-economic factors).
(ii) Developments concerning health systems (impact
of trends in health status/determinants on health
services, interventions and health expenditure; development/reforms of the health systems, distribution of resources and cost containment measures
and their impact on health status; trends in health
systems’ costs and financing, role of the state and
private insurance; health sector as a productive sector
and a major employer including impact of market
mechanisms, measurement of needs for services, cost
and expenditure calculation and control, public/
private mix and trends in managed care; priorities in
health, priority setting mechanisms, public attitude,
effectiveness of the system).
The system will emphasize identification of best practice,
i.e. regarding safety, efficacy, effectiveness and cost effectiveness in different approaches to health promotion and
prevention, but also in diagnosis and treatment. Activities in
Member States in the fields of evidence-based medicine,
quality assurance and improvement, appropriateness of interventions and health technology assessment would be promoted. Co-ordination will be formalized in order to pool
expertise, gather and exchange information, disseminate findings and stimulate international endeavours [6,11].
Probably even more important is the notion that information and findings from the network should directly
impact EU policy and actions. This could include social
protection of people moving within the EU, utilization of
research findings, application of technology but also use of
structural funds, implementation of the single market and
currency. The system can also be used to monitor consequences of implemented EU legislation in areas like health
and safety, pharmaceuticals and medical devices, free movement of health professionals and competition.
Proceedings of the recent Conference of the European
Council (health) [11,12] indicated a number of areas in the
proposed policy that are in need of future clarifications,
especially in relation to the subsidiarity principle and the
exclusive competence of Member State in providing health
services.
Health protection requirements in EU policies
To be able to operationalize its task in health protection the
European Commission has made a number of arrangements
including reinforcement of inter-service co-operation (consultations and inter-service health group), and production of
an annual report on health implications of EU policies [8].
The latter activity resulted in three reports to the Council,
the European Parliament and the Economic and Social
Committee on the integration of health protection requirements in EU policies [5,13,14]. These annual reports
fulfil a number of important functions: on the one hand their
preparation requires structured and periodic review of EU
policies and their implications for health protection; on the
other it enables key EU structures, Member States and the
general public to gain an overview of these implications.
Finally, the reports have been used as instruments to identify
EU policies that should be complemented with public health
measures.
A number of EU policies, although not primarily directed
towards health protection, nevertheless have impact on health.
Roughly, a distinction can be made between two sets of
actions: on the one hand policies that potentially directly
influence citizens’ health (environment, agriculture), and on
the other hand policies that could have impact on the health
systems (statistics, internal market, competition etc.). In this
paper we will focus on the latter group, and an overview of
main health implications of a number of EU policies is given
(Tables 3 and 4).
Community competition policy does not play a major role
in the health field yet. Health services in Member States are
considered to be a matter of public welfare, covered by the
regulatory framework and as such exempted from anti-trust
measures [5]. However, given the tendency to introduce more
market principles in health care it is not unthinkable that
some aspects of anti-trust regulations could apply. At present,
these are limited to the pharmaceutical products sector,
including financing of research and development. Up to now,
in a number of cases pharmaceutical companies have managed
to persuade the European Commission to exempt them from
the competition regulation on the grounds of expected benefit
to public health. In addition, there are provisions enabling
derogation from the competition policy regarding State aid
for research and development [5]. The European Commission
is also considering taking action on medicinal products’ price
differentials among Member States.
Research
Considerable changes have also been envisaged in the area
of Research and Technological Development policy that
is being carried out by means of successive Framework
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Table 3 Statistics and data protection
Sector
Actions undertaken
Health care implications
Relation to health policy/actions
.............................................................................................................................................................................................................................
Statistics
Creation of Eurostat, EU statistical Collection, analysis and
Framework for EU health
office; framework for priority
dissemination of
statistics, including health
actions within sectoral
statistics on health and safety
status, health determinants and
programmes including social,
including data on demography, health services and resources;
policy health and safety
health resources, education,
co-operation with WHO and
government expenditures on
OECD; Framework for Public
services, social and working
Health Action, EUPHIN
conditions etc.
Internal market/
data protection/
trans-European
networks
Directive on data protection, taking
into account specific implications
for medical research and social
services.
Networks established:
IDA – Telematic Interchange of
Data between Administrations in
the EU
Exceptions to the prohibition on
the processing of data related to
racial/ethnic origin, religion, and
data concerning health and sex
life; also, derogation storage,
processing and access.
Programmes, covering different research sectors. The Fifth
Framework started in January 1999 and has a number of
programmes, research areas, topics and actions with either
direct or indirect relation to health care. Under the theme
‘Quality of life and management of living resources’ with a
budget of 2413 million ECU, a distinction has been made
between ‘key activities’ (i.e. including topics: control of infectious diseases, environment and health, the ageing population and disabilities) and ‘generic research and technology
development’. The latter includes, among others, public health
and health-services research, biomedical ethics and bioethics
in the context of respect for fundamental human values and
socio-economic aspects of life sciences and technologies.
Education and training
Education/vocational training policy facilitates European inter-university co-operation, and has supported a number of
programmes related to public health and health care. Also,
trans-national links between universities and businesses are
being stimulated.
Structural funding
In the area of economic and social cohesion, two instruments
are being used to support so called ‘Objective 1 regions’
(GDP less than 75% of the Community average), namely the
European Regional Development Fund and the European
Social Fund. These structural funds provide support to national efforts to modernize health systems by allocating
substantial funds for improvement of infrastructure and
equipment (ERDF) or development of human potential of
the health care staff (ESF).
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EUPHIN
Actions in public health:
– improving information for the
development of public health
(covering both health status and
health systems, at the
Community and Member State
level)
– rapid reaction to health threats
– health, promotion/disease
prevention
A people’s Europe
It is interesting to note that the Public Health activities of
the EU, described earlier, are being executed within the
broader policy called ‘A people’s Europe’. Other issues in
this policy line include taxation, solidarity, human rights and
fundamental freedoms and information and culture.
Politics of EU policies
Governance in Europe could best be described using the
political factions model in that politicians strive to serve
interests of different groups, bureaucratic agencies and political parties [15]. From the aspect of economy, this is often
manifested by use of (aggregated) policies in order to achieve
redistribution of wealth, rewarding specific constituent groups
[16]. Ideally, various interest groups will compete freely for
political attention. The model stipulates that reforms can
occur only when their consequences will be beneficial for
specific constituent groups of government leaders, or would
not occur if these benefits were not sufficient. The labyrinth
of European politics comprising numerous interest groups
from the entire Member States to different industrial sectors
and political parties, seems prone to factions governance.
Indeed, the delegation procedure for nomination of the
European Commission, the majority of the Commission’s
decisions, and the role of the Council of the EU as ultimate
protector of interest of the most influential constituency
group, namely the Member States, all point in the direction
of this model. Issues relevant for health care are therefore
dependent on the real influence and importance of factions
European Union health policy
Table 4 Internal market/ free movement
Sector
Actions undertaken
Health care implications
Relation to health policy/actions
.............................................................................................................................................................................................................................
Internal market/
EU pharmaceutical legislation
Insure early and simultaneous
National and European systems
free movement of and harmonization of national
access to medicinal products,
for pharmacovigilance (side
goods/
legislation;
with market access being allowed effects, health problems related
pharmaceutical
Creation of European Medicines based on quality, safety and
to use of pharmaceuticals);
products
Evaluation Agency
efficacy; provide identical
Strategy on blood safety and
(authorization, inspection);
marketing conditions and
self-sufficiency based on quality,
Industrial policy for the sector balance between competitiveness safety and efficacy of blood
developed, also for blood and
of the industry and costproducts
rational use of medicines with
containment in health care;
regulation for all medicinal
Regulation of wholesale,
products being prepared
classification, patient information
and advertising
Internal market/
free movement of
goods/
medical devices
Directives covering wide range
of products and technologies,
including many medical devices,
active implantable devices and in
vitro diagnostic devices
Safety requirements in the
process of design, manufacture
and marketing;
Standards in Member States, on
safety and useful operation, will
be replaced with a European
harmonized process of approval
Internal market/
free movement/
mutual recognition
of health
professions’
diplomas
Based on provisions in the
Treaties, Directives to facilitate
free movement of professionals
trained in the Community in
accordance with comparable
training standards (co-ordinated
minimum standards);
Advisory Committees on the
training of health professionals
(per profession) established
Mutual recognition of diplomas
of doctors, nurses, midwives,
pharmacists, dentists and
veterinarians;
A.C.s focus on national training,
reviewing standards (curricula)
and making recommendations;
Comparison tables have been
developed for i.e. medical
specialists training in Member
States, including (minimal)
norms
representing this sector. Apparently, health care interests and
their promoters are being dwarfed in Brussels, to the benefit
of other sectors where European actions are much further
advanced.
Four options for further developments
The EU, its new European Commission, and states that are
queuing to join the Union are all faced with the need to
define how to go further in the health care sector. It is not
very encouraging that four scenarios proposed in the 1991
study on health care coverage and delivery in Member States
[17] are still very real.
Status quo
The first pathway might be called the status quo, or doing
nothing [17]. Full use will be made of exclusive competence,
each country further developing its own health care system.
Any possible conflicts with European regulation will be tested
through legal procedures. This practice will mean isolation of the
health services from the Common Market, and the advantages of
international competition of health care providers, financiers
and effects of the division of labour will be missed. Relatively
slow decision making processes used within the EU, often
requiring consensus of all Member States, can be seen as an
obstacle for a more proactive role in (health) legislation and
policy development. New initiatives of the European Commission that include a proposal for extending its executive
powers are intended to change this situation. European Council
(Health) and the EU High Level Committee on Health can
initiate more European actions in the health field, at the
same time facilitating efficient decision making. Legislation and
regulation in the EU provides sufficient room for development
of European health policy and actions, but these possibilities
are currently not being fully utilized. Finally, recent judgements
[18] of the Court of Justice of the EU will promote changes
in national legislation relevant to health care.
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Harmonization of national systems
Another option will be the harmonization of Europe’s health
care and health insurance systems [17]. In the long run, this
way might lead to a uniform European health care system
financed by a European Sick-Fund or European Community
Health Service. It is hard to believe at present that substantial
differences between health and health financing systems in
the Member States can be standardized enough to merge
into a single system and that 15 Member States will give up
their exclusive right to organize health services at the national
level. However, experiences with mutual recognition of health
professionals’ diplomas indicate that in some aspects health
systems could be harmonized. Development of European
(minimal) quality standards or (standard) practice guidelines
can be envisaged, as well as convergence of insurance packages.
Deregulation
Deregulation is another possible scenario. This leads to a
variety of health care packages, offered by different insurers
with the complete freedom of choice for consumers, both
with respect to insurance as providers of services [17].
International experiences (USA) demonstrate that this approach leads to rising health care costs and skewed distribution
with entire social groups being excluded or insufficiently
protected by the health system, but also that it could be
beneficial for parts of the health-related industry [17]. The
Court of Justice of the EU [18] has already sanctioned the
current situation with national regulation of health insurance
and deregulation at the European level.
Synchronization of national systems
The fourth option could be synchronization of Europe’s
health care and health insurance systems [17]. This scenario
includes respect for both the subsidiarity principle and exclusive responsibility, taking into account European actions
in areas other than health care. It differs from the ‘doing
nothing’ approach as it stipulates full integration of health
services in the European social and market policies. However,
it does not mean harmonization of the health systems because
it respects exclusive competence of Member States and
proposes a stepwise approach protecting access and local
provision of services. The model proposes a European Health
Care System which is more than the sum of its parts,
containing a framework of rules directed to enforcing the
process of economic and social convergence [17], but not
full integration of the systems. This concept, however, requires
extended authorities for the EU bodies and a more efficient
decision-making process, as well as development, implementation and evaluation capacity building within EU
institutions. In practice that might mean some norms on the
European basic package of health services that can be offered
by social sick-funds, national health systems or private insurance schemes; also, there might be guidelines on minimum
standards of coverage, services and quality. Common information systems that are now being developed, as well as
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some aspects of the common public health policy and EU
responsibilities in health protection, would all have positive
effect in this scenario. Co-operation with the World Health
Organization and other countries at present only marginally
influencing developments in the EU sector can also be
facilitated. Above all, political and economic reality in Europe
today makes synchronization the only acceptable option.
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Accepted for publication 18 February 2000
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