Opinion of the European Economic and Social Committee on ‘Health safety: a collective obligation and a new right’
Date: 2004-10-27
Institutions: European Economic and Social Committee
Subjects: ESC opinion, EU office or agency, conference proceedings, disease vector, epidemiology, health control, international cooperation, public awareness campaign, public health, terrorism

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Opinion of the European Economic and Social Committee on ‘Health safety: a collective obligation
and a new right’

(2005/C 120/10)

Procedure

On 28 January 2004, in accordance with Rule 29(2) of the Rules of Procedure, the European Economic
and Social Committee decided to draft an opinion on: ‘Health safety: a collective obligation and a new
right’.

The Section for Employment, Social Affairs and Citizenship, which was responsible for preparing the
Committee's work on the subject, adopted its opinion on 22 September 2004. The rapporteur was
Mr Bedossa.

At its 412th plenary session of 27 and 28 October (meeting of 27 October 2004), the European Economic
and Social Committee adopted this opinion by 164 votes to 3, with 7 abstentions.

1. Introduction

1.1
For the citizens of Europe, medical safety - which is one
of the basic aspects of public health - means that they have an
enhanced right to care from the competent authorities (even on
occasions when bio-terrorism is involved) and that, on this
basis, they exercise their new right to be kept informed in a
transparent way of the decisions taken by these authorities.

1.2
Safety and healthcare systems are two terms that people
normally associate with each other, albeit subconsciously, even
though the concept of public health is still exposed to down-
ward sociological pressures and to medical customs geared to
performing diagnoses and individual therapy.

1.3
At a time when the upheavals experienced in Europe
clearly show that health risks are no longer a purely medical
matter but have erupted into the social and political arena,
defining a safe health strategy has become the responsibility of
all, particularly political leaders: from now on, citizens must be
certain of having such guarantees.

Health safety does not start from nothing,

1.4
it enriches
and complements the traditional areas of public health, particu-
larly epidemiology,
it draws its support from reflection and
systems developed to monitor drugs, and achieves dominance
as the iatrogenic effects of all medical practices are discovered.

1.5
A health safety-based approach is no different from a
medical approach. It proceeds by stages, it is a series of choices
based on probabilities at a given moment, dictated by an assess-
ment of the cost/benefits ratio and the risks involved. The
quality of health safety mirrors the quality of the healthcare
system.

1.6
Health safety is based on a medical approach and on the
urgent need for a health safety methodology and a genuine
commitment to public action. The field of health safety is, of
course, much broader because it goes hand in hand with
constant medical innovation.

The concept of health safety has to evolve, especially
1.7
when acts of bio-terrorism are to be feared, for example;
it
cannot stand still: a balance has to be struck between striving
for absolute safety, which is unobtainable, and negligence or
positive abstention. The growing effectiveness of the health
system prompts the need for health safety, though one should
not forget to draw comparisons with the poorest countries,
whose only current problem is first to acquire the basics of a
public health system.

1.8
In the EU, which is richer and well versed in spreading
risks, the thing to do now is to get health safety taken into
account on an institutional basis. To discuss health decisions
and make them public it is necessary to use all the means avail-
able, so as to offer the EU's citizens other alternatives than
panic or dissimulation; this is how the EU will become a
mature democracy as regards public health.

2. Historical background to the EU's approach

2.1
Before the Maastricht Treaty of 7 February 1992 on the
European Union, references to health policies in Community
texts were only peripheral. The Treaty of 25 March 1957 estab-
lishing the European Atomic Energy Community (Euratom)
contained specific provisions on protecting the health of the
population against the dangers of ionising radiation.

However,

2.2
‘health protection’ appeared only in Article 36, which stated:

in the Treaty of Rome of 25 March 1957,

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2.2.1
‘The provisions of Articles 30 to 34 shall not preclude
prohibitions or restrictions on imports, exports or goods in
transit justified on grounds of public morality, public policy or
public security; the protection of health and life of humans,
animals or plants; the protection of national treasures posses-
sing artistic, historic or archaeological value; or the protection
of industrial and commercial property. Such prohibitions or
restrictions shall not, however, constitute a means of arbitrary
discrimination or a disguised restriction on trade between
Member States.’

2.3
The insertion of an Article 118A into the Single Euro-
pean Act in 1986 extended the powers of the Community
institutions by enabling the European Commission to make
proposals in the field of health, based on the need for a ‘high
level of protection.’

(a) the fight against the major health scourges, by promoting
research into their causes, their transmission and their preven-
tion, as well as health information and education …’.

2.8
The new structures set up (e.g. the European Agency for
the Evaluation of Medicinal Products) can have an even greater
impact if the European institutions are engaged in a policy of
increased cooperation with non-EU countries and the major
international organisations, particularly the World Health Orga-
nisation, the Council of Europe, the Organisation for Economic
International Atomic
Cooperation and Development,
the
the Office of
Energy Agency for radiation protection,
United Nations for Drug Control and Crime Prevention for
drug addiction. This cooperation must be continued.

the

2.4
Another indirect reference to health protection could be
found in Article 130R of the Treaty of Rome, added by the
Single European Act, which stipulated that action by the Com-
munity relating to the environment should aim, among other
things, to ‘contribute towards protecting human health.’

3.1 The health decision

3. The principles of health safety

2.5
The Treaty on European Union radically changed the
prospects for European integration as regards health, since it
introduced a Title X entitled ‘Public Health’, under which ‘The
Community shall contribute towards ensuring a high level of
human health protection.’ Under Article 129(4) the Council, to
achieve its objectives, may adopt either incentive measures,
provided for in Article 189B, or recommendations.

2.6
Similarly, the concept of health protection appears in
other articles of the Treaty on European Union, since Article
129A, concerning consumer protection, mentions measures to
protect the health and safety of consumers.

2.7
A precise legal framework, which would be improved in
Article 179 of the draft Treaty establishing a Constitution for
Europe, will allow the European institutions to deploy their
activities as regards public health:

‘1. A high level of human health protection shall be ensured in
the definition and implementation of all the Union's policies
and activities.

3.1.1 Medical decisions are taken against a background of
uncertainty: uncertainty about pathology, the effects of treat-
ments and their respective risks; imperfect medical information
for the patient about the options for further examinations and
health equipment; a lack of precision in medical questioning
dominated by emotion or concern; and clinical examinations
that by their nature are only approximate.

3.1.2
A medical act is often the result of a series of decisions
based on probability and taken in a situation of uncertainty:
the more choices and decisions are involved in a diagnosis or
treatment,
the greater the risk, or even the probability, of
making an error, although such an error may not necessarily
be culpable.

3.1.3
In each medical act or decision there is an element of
the imponderable, a hazard that cannot be controlled in the
present state of scientific knowledge, an unavoidable statistical
risk which is part and parcel of medical science.

The lack of health safety has human causes: a mistake
3.1.4
or non-culpable error by the practitioner, and factual causes:
risks that are known but are statistically inevitable, given the
state of scientific knowledge, and unknown risks, which are
always possible.

2. Action by the Union, which shall complement national
policies, shall be directed towards improving public health,
preventing human illness and diseases, and obviating
sources of danger to physical and mental health. Such
action shall cover:

3.1.5
It is impossible to talk about health safety without
mentioning these basic features of medical decisions. When
health or life is at stake, it is often difficult to agree to ask only
for the possible. However, there is no medical activity without
risks, because life is not without risks.

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3.2 Risk/benefit ratio

4.1 Health monitoring

The same observations apply to health safety decisions
3.2.1
as to medical decisions, and inaction is a decision in the same
way that action is; failure to do anything can be reprehensible.

It

is a question of weighing the therapeutic risk
3.2.2
against the risks of spontaneous evolution. The irrational denial
that risk exists in health-related matters is just as irresponsible
as negligence.

3.2.3
The culture of the risk/benefit ratio is far removed
from the concerns of a European society which has managed
to substantially reduce natural risks.

In order to assess the health safety of an act or
3.2.4
product,
to use a risk scale that makes it
it
possible to determine the minimum risk rather than zero risk.
Five criteria should be applied in this risk/benefit ratio:

is important

— degree;

— reality of the situation;

— frequency;

— duration;

— necessity.

As epidemiologic monitoring is an essential compo-
4.1.1
nent of public health protection,
it is necessary to establish
specific arrangements for health monitoring through a Euro-
pean centre in order to ensure health safety (see point 6.3).

The purpose of health monitoring is

4.1.2
to identify
medical accidents and iatrogenic pathologies, to determine the
unforeseen or undesirable effects of the use of therapeutic
protocols, to carry out checks and analyse the findings and to
evaluate the effectiveness of health intervention procedures; in
short, all the activities necessary for health safety.

At

international

level, efforts have been made to
4.1.3
advance health monitoring
information
exchange and alert procedures under the auspices of the WHO
and the European Union.

establishing

by

4.1.4 Multilateral texts exist on organising cooperation at all
levels, in all areas of specialisation and on all continents. They
enable the rapid implementation of health measures designed
to ensure the maximum level of health safety.

It is therefore up to the public authorities, exposed to
3.2.5
converging or contradictory pressures of public opinion and
producers of health care, to decide,
in conditions of uncer-
tainty, whether to adopt the most pessimistic – and hence the
most conservative – hypothesis in terms of public health or to
opt for the most plausible estimate.

4.2 Choice of therapeutic strategies

4.2.1
The quality and safety of the choice of the therapeutic
strategy depend primarily on the current state of science, and
therefore on practitioners' knowledge of it.

3.2.6 Moreover, health decisions sometimes have to be
taken in a crisis situation. The authorities then have to deal
simultaneously with a spate of problems, the malfunctioning of
certain systems and deeply divergent views on the decisions to
be taken.

— The first factor as regards improving this knowledge is
obviously medical and pharmaceutical research and the
advances in therapeutics or diagnostics which result from
it.

To avoid having to improvise when faced with an
3.2.7
urgent situation,
it must be possible to count on tried and
tested procedures for evaluation, monitoring and intervention.
This requires analysis of previous crises and a health safety
methodology.

3.2.8
Regardless of the scientific and medical safeguards,
ultimately the assessment of the risk/benefit ratio frequently
involves a deep conviction.

4. Medical factors of health safety

Five key factors are involved here.

— Initial medical training is the second key factor for health
training
safety as regards the choice of strategy,
which is adapted to advances in science and in the organi-
sation of the health system.

initial

— The third aspect is continuing medical training: the assimi-
lation of the latest data is, as in all high-tech risk sectors,
one of the determinants of safety.

— The final element contributing to the safety of therapeutic
choices is medical evaluation, which has become the link
between research,
training and the day-to-day work of
members of the health professions.

— Medical evaluation can be defined as the body of quality

control procedures in the health system.

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— The evaluation of diagnostic and therapeutic techniques
and strategies involves ensuring the evaluation of the tools
placed at the disposal of health professionals: medical tech-
nologies, diagnostic methods, medicines and a package of
procedures and services.

— The WHO defines this evaluation of quality, and conse-

quently of the quality of this care, as follows:

‘A process which makes it possible to guarantee each
patient
the range of diagnostic and therapeutic acts
whereby he can achieve the best possible results in terms of
health,
in accordance with the current state of medical
science, at the most cost-effective price for an equivalent
result, with the least iatrogenic risk and with a view to the
greatest satisfaction in terms of procedures, outcome and
human contacts within the health system.’

— Finally, the evaluation must define benchmarks, i.e. draw
less broad
up recommendations based on a more or
consensus within a college of physicians or associations of
experts (‘consensus conferences’) so as to arrive at some
guidelines.

4.3 Performance of health care and medical acts

4.3.1
Compliance with obligations is monitored by all the
authorities concerned and there is a large and uniform body of
case law which specifies the obligations of health professionals
and defines the concept of conscientious, attentive health care
that conforms with current scientific knowledge.

Clearly, the performance of medical acts depends on
4.3.2
health safety arrangements, which vary considerably according
to the nature of the acts and the existence of ‘natural’ risks.

4.3.3
Comparing the difficulties inherent in the performance
of acts, i.e. leaving aside statistically avoidable – albeit marginal
– risks, is the only way to establish the health safety conditions
to be observed. This is a kind of a risk/benefit analysis which
makes it possible to set a standard health safety level which is
both accepted and expected.

of the people and provide health services under the best
safety conditions.

4.5 Use of health products

Health products used for prevention, diagnosis and
4.5.1
treatment are subject to strict laws and regulations, known as
‘topical regulations’ and governing:

— medicines;

— medical devices;

— products of human origin;

— laboratory agents;

— legal basis of human body products and elements used for

therapeutic purposes.

4.5.2
provide a genuine safety chain.

The health regulations applicable to these products

5. Proposals – EESC recommendations

5.1 The administrative aspects of health safety

5.1.1
have yet to take account of health safety principles.

The public health institutions of the EU Member States

5.1.2
Health safety is not the result of some equation or
formula; it is based on the spirit of precaution and contradic-
tion.

for

calls

safety

Health

cross-border

5.1.3
awareness
campaigns and initiatives. We must resist the illusion of some
Maginot line that can effortlessly seal off the next epidemic.
Health risks are unpredictable, infinitely varied, and generally
appear unexpectedly. Behaviour towards the illness changes,
viruses mutate, infectious agents renew themselves or hide.

4.4 Organisation and operation of healthcare structures

5.2 Clearly recognised powers

— Health safety is largely determined by the quality of the

organisation and operation of the healthcare system.

— Health safety imposes an obligation of resources on all
public or private establishments,
resources which are
provided for by regulations and subject to special authorisa-
tion. The healthcare system must be able to meet the needs

Given the lack of any specific legal

instruments for
5.2.1
public health protection, some European Union countries have
tended to skirt around the problem, sometimes employing
dubious practices, often involving improper use of social
security regulations, because this enables them to mix up
health and economic issues in the same debate. While it is legit-
imate to appreciate the cost of healthcare and to make the
most rational use of the limited resources available, it is never-
theless dangerous to confuse the two issues.

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It

5.2.2
is one thing to acknowledge the effectiveness,
quality and safety of a product or a therapy; it is quite another
to decide that it is to be made available under national health-
care schemes. The problems involved in public health decision-
making are compounded by the fact that there are several
competing authorities.

5.2.3
Establishing the areas of competence means estab-
lishing responsibilities and, consequently, establishing the
health authority that will take up the moral, administrative
and/or legal burden. This responsibility can only be fully exer-
cised as long as there are no shortcomings or ambiguities in
the relevant texts that might lead to disagreement or action
that could distort the choices that need to be made.

and supplement information upstream of the decision-making
process.

5.4.3
In the most sensitive or technical areas, it would even
seem essential to call on third-country experts of international
repute. By opening up to international experts, a consensus
could be achieved in all the countries concerned, thus avoiding
any time lags that might be universally detrimental
(i.e. to
patients and stakeholders of all kinds).

This could enable the debate to rise above any particu-
5.4.4
larities of national healthcare culture or practitioner training
methods.

5.3 A recognised health administration

5.5 Separate roles for experts, decision-makers and managers

At European level, public health administration is
5.3.1
inadequate and has very weak legal support.
It also lacks
medical legitimacy, owing to the scarcity of resources. All that
must be improved.

5.5.1
Health policing powers, which are, in fact, the prero-
gative of decision-makers (whether to authorise, whether to
ban) can only be legitimately exercised if all the information
relating to the public health problem in question is taken on
board.

5.3.2
The public sector can only be effective if it has real
legitimacy, and a health administration can only fully exercise
its health safety role if it is endowed with this dual legitimacy,
i.e. it must be recognised by the official authorities of every EU
country, and of course by the general public, i.e. consumers.

5.5.2
This always involves an appraisal of the benefit/risk
ratio. This cannot be solely scientific, and it must not be
imposed by the manager or by a stakeholder who has some
material or intellectual interest in its being disseminated.

For the sake of scientific, medical and technical cred-
5.3.3
ibility, more resources and first-rate technical staff are needed,
as is cooperation between all the European and national institu-
tions.

5.3.4
Five basic tasks have been identified. These involve
recommending, supervising, checking, appraising and evalu-
ating.

The

5.3.5
establishment of a European public health
network is evidence of the willingness of all European authori-
ties to pool public health players and make existing national
health vigilance instruments more consistent and effective.

5.4 The need for expertise from outside the administration

5.4.1
Regardless of the technical and scientific excellence of
health safety services, the traditional and respected principle of
the contradictory must, of necessity, be applied to health safety
efforts.

Clarification of the roles of expert and decision-maker
5.5.3
ensures transparent links between experts and managers. A
strict code of conduct must be declared and respected. This is
not always taken as read, particularly when the problem is very
technical;
in such cases there are very few experts and they
have often established links with the relevant institutions or
companies.

Transparency, which must be the hallmark of health
5.5.4
safety decision-making, requires each expert to declare to the
health authorities any links he might have with agencies,
companies or individuals affected by his professional opinions.

5.5.5
The European Community has started to outline these
procedures: rolling out transparency procedures, as called for
by the experts themselves, ensures that the experts' opinions
are as objective as possible.

5.6 Transparent decisional procedures

5.6.1
to upset accepted ideas and habits.

As with innovation in general, new health risks tend

5.4.2
Involving independent experts fulfils the objective of
making the most eminent specialists available to the European
authorities, thus making it possible, through dialogue, to refine

5.6.2
listen to the silence’.

The intellectual approach must be the same,

i.e.

‘to

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5.6.3
lished, the risk of collective blindness cannot be ignored.

Regardless of the quality of the vigilance system estab-

5.8 Routine communication

5.6.4
Public debate is crucial. Patients and doctors from
beyond the panel of experts should be able to make their
voices heard, ask the questions that worry them, and sound the
alarm.

5.6.5
give unnecessary cause for alarm.

The debate must be organised properly, so as not to

5.6.6
This ‘health pluralism’, which is crucial to improving
our chances of avoiding new tragedies, will require more trans-
parent decision-making procedures. Without prejudice
to
medical or industrial confidentiality, the experts' findings and
reasons for health decisions must be made public.

5.7 A code of conduct for health safety communication

5.7.1
Despite being made available to a wide audience, there
are some basic aspects of public health communication that are
even more evident in the field of health safety.

Communicating about

5.7.2
issues often means
illness or death. Transparency and
communicating about
restraint must be the key words when organising this delicate
task of the health system.

these

5.7.3
Transparency is essential to ensure confidence and to
avoid the distress that would be caused by revealing informa-
tion that might seem sensational because it appeared to be
surrounded in secrecy.

Health authorities and institutions must comply with
5.7.4
this, just as a doctor has to inform his patient. Given the risks
involved for everyone's health, the ‘duty of truth ’ is essential.

5.7.5
However, this moral obligation is accompanied by a
duty of restraint. Since it is often released in a hurry, informa-
tion must be comprehensible and scientific, and must take care
requires
not
common working rules for the media, health professionals,
patients' associations and the public authorities. Causing panic
or cover-ups are not alternatives.

sensational or alarmist.

to be conflicting,

It

5.8.1
mation particularly closely.

Patients are always inclined to scrutinise health infor-

5.8.2
There is a distinction to be drawn between the type of
information intended for doctors and that intended for the
general public.

5.8.3
The former benefits from the scientific background of
its target group, which has its own channels: courses, confer-
ences, symposia, and professional and industry associations.

On the other hand, communication intended for the
5.8.4
general public cannot assume –without risking being misunder-
stood or causing panic – that the public has the medical knowl-
edge needed to grasp the scope of the information provided. It
has to find a balance between, on the one hand, the need for
information about new or traditional therapies, and on the
other, the risks connected with misinterpreting the informa-
tion.

5.8.5
The information thus released could lead to unneces-
sary or exaggerated public panic or, conversely, unfounded
hopes of new therapies. It is part and parcel of public health
education, which contributes directly to the effectiveness of
health policies, risk prevention, and a pro-active healthcare
system.

5.9 The communication crisis

5.9.1
health, communication has to deal with three requirements:

In a health emergency or serious danger to public

— First of all, the amount of information released must be

proportionate to the health risk.

— Secondly, it should be remembered that information is not
just
intended to increase public awareness, but also to
secure behavioural change. Information therefore needs to
achieve its goal, i.e. prevent or contain the accident without
giving undue cause for alarm and ensure that the public
know what is going on and that the press avoid printing
alarmist and sensationalist stories.

— And thirdly, crucial

information must be given with the
different target audiences in mind, and the order in which
they need to be informed.

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5.9.2 Whatever the scenario, the press plays a decisive role
in the success of crisis communication. The media must some-
times accept the fact that they cannot release information to
the general public until health professionals have been fully
informed. So, there is also a need to provide training for specia-
list
is
journalists who are capable of understanding what
happening and communicating correctly on health safety
matters.

5.9.3
This is difficult since, for example, calculating undesir-
able effects, their origin, the impact of the media on the notifi-
cation rate and overall
involves difficult,
complex analyses, whereas the public expects to be informed
immediately in simple, emotional language.

risk assessment

6. Conclusion

6.1
Through becoming aware of the successive public health
crises which have shaken the world over the past two decades
(AIDS, contaminated blood, SARS,
legionnaires' disease, bio-
terrorism through the threat of anthrax), the EESC proposes to
hold regular high level European congresses on public health.

The aim of these conferences will be to discuss what
6.2
collective measures should be taken, provide precise informa-
tion on these crises, produce coordinated responses, assess the
threats of risks from outside, help speed up diagnoses and
provide adequate responses.

6.3
The EESC recommends that the future European health
monitoring centre in Stockholm be given as of now an exten-
sive and reinforced mandate to draw up targeted and regular
reports on public health and have the necessary measures taken

Brussels, 27 October 2004.

by the EU countries, in accordance with the subsidiarity prin-
ciple.

The EESC considers that it is the ideal place for alerting

6.4
and raising the awareness of European civil society.

6.5
The EESC asks that all the parties concerned adopt an
active attitude towards public health: an overall view of the
crises in public health should enable all experiences to be
shared at a time when such crises are global issues.

6.6
The EESC considers that a grand information policy
must be promoted at European level, involving specific training
for all the actors and organs of the press that have a particular
stake in the matter.

6.7
The EESC would point out that its recommendations are
interlinked and require a strong commitment by the EU coun-
tries to implement them; they include:

— boosting

administrative

cross-border
linkage and administration recognised and allowed every-
where;

capacities, with

— legal powers and the instruments to support them;

— transparent decision-making procedures and stricter ethics,
shared by all, regarding communications on health safety;

— more cooperation and worldwide networking between all
surveillance and monitoring bodies (the European Union,
the World Health Organisation,
the Organisation for
Economic Cooperation and Development, the Council of
Europe, and large national organisations such as the USA's
Centres for Disease Control and Prevention in Atlanta.

The President

of the European Economic and Social Committee

Anne-Marie SIGMUND