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EUGLOREH project THE STATUS OF HEALTH IN THE EUROPEAN UNION:
TOWARDS A HEALTHIER EUROPE
FULL REPORT PART IV - PROTECTING AND PROMOTING PUBLIC HEALTH AND TREATING DISEASES: HEALTH SYSTEMS, SERVICES AND POLICIES 12. INSTITUTIONAL AND POLICY DEVELOPMENTS AT EU AND MEMBER STATE LEVEL 12.1. Introduction | «» |
12.1. Introduction
A number of institutional and policy developments have
taken place at EU and Member States level which make it nowadays possible to
cope better with the growing challenges to health. The European integration
process started its life in 1950 as a direct response to shortage in coal and
steel that led Robert Schuman, the French Foreign Minister, to propose that
French and German coal and steel production should be “pooled”. Europe has come
a long way since that initial start in 1950, moving from a coal and steel
initiative through a purely economic Community to become a European Union with
economic, social and political dimension. The 50th Anniversary of the Treaty of
Rome, signed on 25 March 1957, has been recently celebrated with the Berlin
Declaration.
The single market for goods, persons, services and
capitals is one of the European Union’s undoubted successes. Over the past two
decades, the single market for goods has been a major driver of economic growth
and competitiveness frontiers. This has created employment and prosperity,
expanded consumer choice and helped EU manufacturers face up to globalisation.
Despite these achievements, there are still some obstacles and many companies,
especially small and medium-sized enterprises, are not fully benefiting from
the opportunities on offer. Too many companies still face barriers when trying
to sell their goods elsewhere in the European Union. Local rules on the size,
shape and performance of products are often applied in an arbitrary or heavy
handed manner. The practice undermines one of the European Union’s basic
principles: the free movement of goods. Not surprisingly, this can make
companies, especially small and medium-sized firms, reluctant to look for sales
beyond their domestic market. A new proposal tabled by the Commission is
intended to compel public authorities to explain why they will not let a
product lawfully marketed in other Member States into their market. The changes
will ensure greater transparency and give companies a more effective right of
redress.
Health protection is a traditional core function of each
Member State of the European Union and this is still largely the case today.
From the start, the Treaties of the European Community have recognised the
right for Member States to derogate from the principles of single market for
reasons of public order or to protect the health of their citizens. For more
than 40 years, public health was not formally part of mainstream European
policies. During the 70’s, there were exceptions in a few areas, such as health
and safety at work, or the free movement of pharmaceuticals and the recognition
of the qualifications of health professionals. Nevertheless, certain pilot
schemes such as “Europe against cancer” and “Europe against AIDS” demonstrated
the willingness of the single market health Ministers to cooperate and to
become associated with Commission initiatives in the field (Table 12.1). Even
today, public health remains mainly a Member State competence.
Table 12.1. Health – related precursor programmes at European
Community level.
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Health
promotion
The aim was to
improve the general standard of health by improving knowledge about risk
factors, and encouraging people to adopt healthy lifestyles and behaviours.
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Health
monitoring
The aim was to
produce comparable information on health and health-related of the
population, on diseases and health systems based on European-wide common agreed
indicators.
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Communicable
diseases
The objectives
of the programme were to help contain the spread of AIDS and reduce mortality
and morbidity due to communicable diseases.
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Cancer
The Community
action plan against cancer contained 22 measure, covering the fields of data
collection, public information, education, cancer training for health-care
workers, early detection and systematic screening, quality of care, and
research.
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Rare
diseases
The aim of the
programme was to develop work on rare diseases. Specific
attention was given to improving knowledge and to facilitating access to
information about these diseases.
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Injury
prevention
The aim was to
contribute to public health activities which seek to reduce the incidence of
home and leisure injuries
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Pollution-related
diseases
The aim was to
contribute to help to develop policies and strategies in the field of health
and the environment, focusing on the prevention of pollution-related
diseases, including the improvement of knowledge and understanding of health
risks associated with them.
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Drug
prevention
The aim was to
help in combating drug dependence, in particular by encouraging cooperation
between the Members States, supporting their action and promoting coordination
between their policies and programmes.
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Public health is a relatively new-comer on the European
scene arriving only in 1992 when the Maastricht Treaty included an article on
“encouraging cooperation between Member states" and “if necessary, lending
support to their actions” in public health. This legal competence was
strengthened in 1997 with the Amsterdam Treaty when the EU was mandated to
ensure “a high level of human protection” in the “definition and implementation
of all union policies and activities” and to work with Member States to improve
public health, prevent illness and “obviate sources of danger to human health”
(Article 152(1)) (Table 12.2). Whilst the Amsterdam amendment extended the
scope of public health related policy, it maintained the “subsidiarity
principle” for health which provides that harmonisation of Member States
“Public Health legislation is prohibited and that the Union shall continue to
respect fully the Member States” responsibilities for the organisation and
delivery of their own health services and medical care (Article 152 (4.5).
Even when a “public health competence “was first
established in the Maastricht Treaty, protecting health was listed as one of
many “activities” in Articles 3, where the E.U., is to make “a contribution to
the attainment of a high level of health protection” (art.3p) in pursuing E.U.
priority objectives and policies. Therefore, the large and persisting
fragmentation of health issues in several sections on the Treaty other than
Article 152 that specifically concerns health is not surprising (Table 12.2).
Table 12.2. EU Treaty Articles concerning health
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Art. 43-48: right of establishment, which includes among others, physicians
and other health professionals;
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Art. 49 and
50 (services, including medical and sanitary
services)
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Art. 95
(3), (6) and (8) concerning health in relation to
the internal market
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Art. 133(6) concerning common commercial policy, stating that health services
“…shall fall
within the shared competence of the Community and its Member States…”.
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Art. 137
(1) (a) “The community shall support and
complement the activities of the Member States in the following fields: a)
improvement in particular of the working environment to protect workers’
health and
safety”
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Art. 149 (Vocational and teacher training, including health field
exchanges)
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Art. 152
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1. 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 diseases, 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.
2. The
Community shall encourage cooperation 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, coordinate 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 coordination.
3. The
Community and the Member States shall foster cooperation with third countries
and the competent international organisations in the sphere of public health.
4. The
Council, acting in accordance with the procedure referred to in Article 251
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 37, measures in the veterinary and phytosanitary
fields which have as their direct objective the protection of public health;
(c) incentive
measures designed to protect and improve human health, excluding any
harmonisation 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.
5. Community
action in the field of public health shall fully respect the responsibilities
of the Member States for the organisation 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.
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Art. 153 “The Community shall contribute to protecting the health, safety
and economic interests of consumers”.
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Art.
158-161 (Economic and social cohesion: for
example, structural and cohesion funds that, among others, also support
health projects);
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Art. 163 concerning the objective to promote all the research activities
deemed necessary by virtue of other chapters of this Treaty
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Art. 174
(1) “Community policy on the environment shall
contribute to pursuit of the following objectives: (…) – protecting human
health”.
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Art. 177 on development cooperation includes a requirement to ‘contribute
to the general objective of…respecting human right and fundamental freedoms’.
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Art.
300-302 (Closing of agreements with Third
Countries and with International Organizations, also on heath and
health-related issues).
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The value of health has become more prominent in many
policies of the European Union, now enlarged to 27 countries and half a billion
citizens (Table 12.3). Prevention has the potential to reduce costs that would
otherwise have gone on treatment and burdened the economy. Nevertheless,
preventive strategies have to be adjusted to different situations and
conditions prevailing in each of its Member States. In addition, in each
country there is a balance to be struck between individual choices and
voluntary behaviour changes on the one hand and regulatory measures on the
other hand (for example, nutrition and obesity). Moreover, what is
cost-effective in one country of the EU is not necessarily cost-effective in
another one, depending on the prevalence of different diseases, medical
culture, demography and public expectations.
Table 12.3. Some examples highlighting the broad impact of
other EU policies on health, health service and health systems.
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Directorate
General
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Policy area
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Initiative
or
legislation
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Potential
impact
on health
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Employment and social
affairs
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Social
security
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Regulation 1408/71 Providing
for the payment
(creating forms E111, E112 etc, co-ordinating of health
services received E112 etc) Co-ordinating in another Member State,
social security for with or
without prior
workers & tourists authorisation,
depending
moving across on the nature of
the
internal
borders
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Providing for the payment health service received in another Member State, with or without prior
authorisation, depending on the nature of the health service
obtained
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Employment and social
affairs
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Labour law and
work organisation
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Directive
2003/88/EC
on the organisation of
Working Time
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Requiring changes in organisation
of hospital staff time schedules
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Internal Market
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Free movement
workers
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Directive
2001/19/EC
on the general
system
for
recognition of
profession al
qualifications
(note there
are separate
directives -for doctors,
nurses, midwives, dentists
and pharmacists)
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Setting
minimum standards for education & training. Promoting cross border
employment, creating the potential competition
between
'employers of choice'
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Internal Market
and Services
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Freedom to
provide and
consume
services
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Directive on Services
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common internal
market rules
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Agriculture
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Food safety
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Many Directives
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Hygienic rules
and a standards for traditional food products
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Enterprise and
Industry
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Pharmaceuticals
and Medical
Devices
Food industry
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Several Directives
Several Directives
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Promoting Good
Clinical Practice. Setting Standards for clinical trials, marketing, &
advertising and the protection of orphan medicinal products
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Information
Society
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Audio visual
policy
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Television
Without
Frontiers
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Controlling tobacco
advertising.
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Information
Society
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E-Health
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Europe Action
plan
on e-health
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Setting common
standards, moving towards the European
electronic health record.
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Research &
Technological
Development
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Bio-medical
and
Social
research
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Frame work
Program me 6
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Providing
EU co-funding for large projects in biomedical
science, information technology and
policy related research.
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Environment
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Environmental
policy
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European Environment
and Health Action Plan 2004-2010
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Reduce the adverse health impacts of certain environmental factors.
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Freedom,
Security Justice Data
P rotecti on
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Protection of
Data
and Privacy
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Directive 95/ 46/EC on data
protection
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Setting common standards for the protection of data privacy
in order to facilitate data sharing –
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Important aspects of health protection have been
incorporated in Community law on the basis of, or in combination with, other
provisions of the Treaty (see Table 12.3), related to the movement of
industrial goods (health products, tobacco) or to the Common Agricultural
Policy (food safety, animal and plant health). In some cases, legislative
measures and capacity building reinforced this co-operation, in particular
through the creation of European agencies. This mix of legislation and
cooperation may vary according to the subject, as illustrated in pandemics or tobacco
control. A more complete legislative framework, consisting of a wide range of
integrated regulatory decisions about good clinical practice and good
manufacturing practices, market authorization, pricing, and reimbursement, was established for
pharmaceuticals and other health products, with many difficult ethical aspects
in the case of therapeutic substances of human origin. While at EU level there has been a
harmonization of market authorization via the European Medicines Agency (EMEA),
pricing and reimbursement policies vary across EU Member States.
Co-operation between the European Commission and National
Health Ministries has greatly improved. The results are discussed during the
two yearly meetings of the EPSCO Council and during the two additional informal
meetings of Health Ministers. This allows the next Presidencies and the
Commission to discuss and better synchronise new health initiatives at European
and national level.
The public health “acquis” – albeit limited – is growing.
The European Convention considered strengthening the public health powers in
the Treaty. These orientations were endorsed in Article III-278 of the
Constitutional Treaty. However, the negative outcomes of the popular referenda
in France and the Netherlands put on hold any discussion on extended health
competences in a foreseeable future. In June 2007, EU leaders agreed on the
mandate for the 2007 Inter-governmental conference (IGC), to draft the reform
Treaty after the “Constitutional Treaty” of 2004 was rejected. On 19 October
2007, the 27 Member states reached agreement on the text of the Reform Treaty,
formally adopted on 13 December 2007 in Lisbon, Portugal, and currently waiting
for ratification. Only minor amendments have been introduced in art. 152.
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