Opinion of the European Economic and Social Committee on Patients' rights
Date: 2007-09-26
Institutions: European Economic and Social Committee
Subjects: approximation of laws, association, health policy, medical training, patient's rights, professional ethics

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Official Journal of the European Union

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Opinion of the European Economic and Social Committee on ‘Patients' rights’

(2008/C 10/18)

On 14 July 2005 the European Economic and Social Committee, acting in accordance with Rule 29(2) of its
Rules of Procedure, decided to draw up an opinion on: Patients' rights.

The Section for Employment, Social Affairs and Citizenship, which was responsible for preparing the
Committee's work on the subject, adopted its opinion on 17 July 2007. The rapporteur was Mr Bouis.

At its 438th plenary session, held on 26 and 27 September 2007 (meeting of 26 September), the European
Economic and Social Committee adopted the following opinion by 108 votes to none, with two absten-
tions.

1. Justification and recommendation

Commission to take initiatives enabling the implementation of
heath policy which respects patients' rights. This requires:

1.1
For many years now, European countries and the
European Community have addressed the question of the rights
of health service users, establishing charters or a comprehensive
body of legislation enabling the affirmation of such rights (1).
These obviously depend on the quality of the health system and
the way healthcare is organised. However, respect for such rights
is also dependent on the behaviour and cooperation of health
this might be
professionals and patients
expected to be an area where there is potential
for rapid
improvement.

themselves;

thus

1.1.1
In 2002, the Active Citizenship Network proposed a
European Charter of Patients' Rights. These rights, which are
based on the EU Charter of Fundamental Rights (Article 35), are
important in European citizens' dealings with health systems in
their respective countries. Despite this, a study carried out by
citizens' organisations in 14 EU countries shows that the level
of protection of these rights varies greatly from country to
country. This calls into question the European Commission's
commitment to guarantee all European citizens effective access
to health services on the basis of the solidarity principle.

1.1.2 We are witnessing today an evolution in public policy
where, increasingly, the tendency is to advocate citizens' involve-
ment, with the development of participatory methods in various
European countries: consensus conferences in Denmark;
the
setting-up of citizens' juries in several European States; general
assemblies, etc. The Council of Europe and the European Parlia-
ment are promoting such participatory initiatives.

1.1.3
In the light of the European Charter of Fundamental
Rights, the communication from the Commission Consultation
regarding Community action on health services,
the Statement of
common values and principles in EU health systems adopted by the
Health Council on 1 June 2006, the case law of the European
Court of Justice in the field of patient mobility, the European
Parliament report on patient mobility and healthcare develop-
ments in the European Union and the European Parliament
resolution of 15 March 2007, the EESC calls on the European

(1) Charter of Fundamental Rights of the EU, texts adopted by the Council

of Europe, French Law No 2002-303 of 4 March 2002.

— the gathering and analysis of comparative data on the regu-
latory and ethical obligations in force in each EU country,

— the devising, in the most appropriate form, of a Community

course of action applicable to issues in this field,

— the planned evaluation of

the application of

the texts

promulgated and policies decided,

— the dissemination of the results of this work to the relevant
national authorities and representatives of the various socio-
professional and user groups concerned,

— the establishment of a European Patients' Rights Day.

1.1.4
The European Economic and Social Committee is
therefore addressing the issue of patients' rights in order to
draw the attention of the European institutions to the need to
respect these rights, particularly in the light of EU citizens' right
of free movement between the 27 Member States and their
equal opportunities
to enjoy high-quality service in their
country of origin or host country, and above all to encourage
their practical application in all of the Member States. In addi-
tion,
these rights implies the need for
changes in relations between all health professionals and health
care structures and patients on a day-to-day basis.

the reaffirmation of

1.1.5
In addressing these issues there is often a need for
ethical reflection where the responses are based on the political
and social system of the country concerned. However, in spite
of disparities in the way health systems are organised and the
diversity of the debate, developments in health-related issues
reveal a similar pattern in all European countries and a general
and inescapable trend towards the assertion of the rights of
people seeking care.

The tendency with regard to health needs and people's
1.2
expectations, and beyond the health sector in the political
domain, is to seek to give the individual an increasing say in
health-related matters.

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1.3
Advances in medical science and the introduction of
social protection systems have led to a general epidemiological
transition, which is reflected in fewer short-term care cases and,
above all, in the rising incidence of chronic illnesses, a phenom-
enon accentuated by an ageing population. The provision of
care for the chronically sick implies long-term care, as a result
of which sick people accumulate knowledge through their
experience of accessing the health care system and their experi-
ence of their illness.

The arrival of new information technologies, and in par-
1.4
ticular the development of
the Internet, has reinforced this
increase in patients' knowledge and improved their capacity to
exchange views and to question professionals. In some cases,
people sometimes have a thorough knowledge of their illness
which must be taken into account. It is worth being taken into
consideration by healthcare professionals.

1.5
Generally, patients' expectations vis-à-vis professionals
are not limited solely to technical aspects of care but are also
concerned with relational and human aspects.

Finally, living with a long-term illness or disability creates
1.6
new needs and expectations on the part of
the persons
concerned. The challenge for treatment has changed: it is no
longer a matter of seeking a cure at all cost, but more one of
learning to ‘live with’ an illness in an ongoing effort to combat
pain.

Such considerations induce people to play an increasingly active
role with regard to the treatment they receive, with new needs
and expectations.

People's evolving needs and expectations regarding their
1.7
treatment are part of a more profound change in society which
aims to promote a model based on respect
for individual
autonomy and the assertion of individual rights.

1.8
All of these factors lead to the conclusion that the pater-
nalistic model of interaction between doctor and patient has run
its course and consequently that there is a need to rethink the
place of the patient in his interaction with the system, implying
the recognition and introduction of new rights and obligations.

This opinion is

1.9
focused on the rights of patients,
i.e. people using healthcare systems, be they healthy or sick as
defined by the World Health Organisation.

2. Background

2.1
Developments in medicine and in people's health needs
and expectations give reason to consider a person in the context
of his life, which implies not only taking an interest in the indi-
vidual himself but also in his family, even his friends and the
people he works with. Living with an illness or disability implies
taking into account quality-of-life aspects, requiring the involve-
ment of a range of professionals in addition to medical staff.

2.2 While the doctor retains a dominant role in the care of
persons, the notion of a bond between the doctor and the

patient must be built into the functioning of the system, i.e. as
an integral part of the entire body of healthcare, medical and
welfare professionals.

2.2.1
The patient places his trust in the hands of health
professionals and hence the doctor and nursing staff must keep
a close watch on the patient, enabling them to adapt their
views, treatment and assessment accordingly. This interactive
process comprises listening, verbal exchanges and care provi-
sion. It enables a solid relationship to be built, which is essential
for fighting the illness.

2.2.2
Thus, from the outset the medical response to these
problems must be to design a real social procedure and, beyond
the necessary and rigorous performance of technical acts, to
meet people's demands for comprehensive care adapted to the
needs of the individual.

2.2.2.1 Medical and welfare staff must act as an adviser to
their patient, without, however, relinquishing their responsibility.
Their task is therefore to provide care, information and support
to the patient. They devise a therapeutic strategy based on
hypotheses suggested by the patient's symptoms and the rela-
tionship with the patient. Thus the patient has a legitimate right
to request health professionals for a personalised assessment of
his condition, which must make it possible to propose a treat-
ment that is the most suitable in technical and psychological
terms.

2.2.3
Finding the best treatment and the outcome of the
fight against the illness depend to a large extent on the links
forged between the patient and the health professionals treating
him. The outcome is as important for the healthcare staff as it is
for the patient. This implies the need for mediation arrange-
ments, so as to take account of social constraints (working life,
financial factors, recognition of rights, etc.) and the challenges
of emotional and family life. Family members and patient asso-
ciations have a crucial role to play in this context.

2.3
Thus one can consider the advantages to be gained by a
meeting between a patient organisation and an organisation of
health professionals.

2.3.1
Some deplore the loss of trust that comes with the end
of the doctor-patient bond as understood in its traditional sense.
However, this development is to be seen more as a transition
from a relationship based on blind trust to trust built up in a
process of
interaction and exchange between a person, his
family and friends and health practitioners.

3. Inalienable rights

3.1
The affirmation of patients' rights is a human right and
its objective is to promote their eventual autonomy. These rights
are therefore often interconnected. The European Charter of
Patients' Rights, drawn up in 2002 by the Active Citizenship
Network, proclaims 14 rights, which the EESC welcomes and
acknowledges. The EESC considers that three rights are linked
horizontally or are preconditions for other rights.

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3.2 Right to information

The information in question primarily concerns the
3.2.1
patient undergoing treatment.
It must provide details of the
person's illness, how it may evolve over time, the courses of
treatment possible, including the associated benefits and risks,
the health establishments or professionals providing this treat-
ment, and the effects of the illness and the treatment on the
person's day-to-day life. The provision of such information is
particularly important in the case of chronic illness, dependence,
disability or long-term treatment leading to changes in the daily
lives of the person and his family and friends.

of

the

Prevention is a key factor in improving the health
3.2.1.1
Information/awareness-raising
state
campaigns should therefore be developed alongside the setting-
up of structures with the capacity to provide appropriate exami-
nations and care structures.

population.

3.2.2
Information is not an end in itself but a means of
allowing a person to make free and informed choices. For that
reason, the ways in which information is provided are as impor-
tant as the information itself. They are a part of a process which
including the
makes use of different
Internet and telephone helpline services operated by associa-
tions, and where the patient can interact with a wide range of
professionals, each of whom has his own role to play. The oral
transmission of information is crucial. At regular intervals, the
doctor must find out whether the patient understands the facts
relating to his case and ascertain his level of satisfaction.

information sources,

In addition, and irrespective of the person concerned,
3.2.3
the patient's circle of family and friends must also be taken into
account
the
patient is a child or a dependent elderly person. Obviously, the
level of information provided will depend on the patient's state
of health and capacity to decide for himself.

in the information process, all the more so if

3.2.3.1
Every patient must be provided with information in
his own language and his particular incapacities must be taken
into account.

Only informed consent and informed acceptance of the
3.2.4
risks involved can be valid. Information is the outcome of the
doctor-patient bond where only
and
well-being of the patient are taken into consideration.

the best

interests

3.2.5
This access to personalised information is a vital step
towards reducing inequalities related to health disorders, illness
and care provision and improving access to the health system
for all citizens.

It is desirable that the information on a person's state of health,
the diagnostic and therapeutic steps taken and the ensuing
results be recorded in a ‘medical file’. The possibility of the
patient to access this file directly or through a doctor of his
choice, according to his wishes, is also part of patient informa-
tion and autonomy. In any moves to secure further information

and transparency, an appropriate legal
framework should,
however, ensure that when the data is being recorded, it is not
used for any purpose for which it is not intended. Efforts should
be made to make sure that extreme vigilance is exercised as
regards the use of such data, especially where it is electronically
stored and sometimes also when it is transmitted across borders.

It is essential to develop information about the system
3.2.6
so as to make it clearer and more transparent. Patients faced
they have greater
with a proliferation of players may feel
autonomy as individuals or, on the other hand,
they may
become totally dependent on their doctor, depending on the
level of their knowledge and understanding of the system. There
is then a danger here that this could give rise to misplaced
claims on the part of users.

3.3 Right to free and informed consent

The right of patients

to participate in decisions
3.3.1
affecting them must be affirmed. This does not mean the
transfer of responsibility from doctor to patient but rather the
prospect of
them interacting in a therapeutic alliance, each
maintaining his own position, with his own rights and area of
responsibility.

3.3.1.1
The patient's consent does not apply automatically to
all medical acts, now or in the future. Consent is not given once
and for all, but rather it has to be renewed before each impor-
tant medical or surgical act.

The consent of a patient who has been informed in this way
must be explicit, that is expressed objectively. After having been
given the requisite information, the patient may either accept or
reject the course of action which has been proposed to him.

As regards organ donations when the donor is alive, increased
vigilance must be shown over information about the risks.

3.3.1.2 Where a new treatment is being tried out, the princi-
ples are the same as those implied when seeking the patient's
consent
freedom must be
respected and these principles are geared to the same end:
shared responsibility and trust.

to medical care. The patient's

As regards clinical trials,

3.3.1.3
including those involving
persons who are not sick, a particular pedagogical approach is
required. This approach, which must comply with well-estab-
lished criteria, can only be contemplated if there is a stated
desire to cooperate and it is accompanied by evidence of abso-
lute consent.

3.3.1.4
In an emergency, some exceptions to this rule must
be considered; the consent of the patient must be presumed and
confirmed when he has regained his power of judgement.

3.3.1.5
The patient must have the possibility of choosing a
person to represent him if he is subsequently unable to make
his preferences known.

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3.3.1.6
The consent of a child or a sick minor must be
obtained for minor medical treatment once he has gained a
certain degree of personal independence and is able to make a
proper judgement. Involving children in health education from
the earliest possible age helps to de-dramatise certain situations
and improve cooperation with young patients.

3.4.1.7
The requirement to treat a person with respect does
not cease to apply after death. This implies ensuring that, when-
ever a hospitalised patient dies, his family and friends and the
healthcare professionals who tended him at the end of his life
receive appropriate psychological support and that the wishes
and beliefs of the deceased are strictly respected.

3.4 Right to dignity

Under this heading must be included the right

3.4.1
to
privacy, the right to pain relief, the right to die in dignity,
protection of
for
private life and the principle of non-discrimination.

the human body, respect

the integrity of

Everyone has the right to confidentiality of informa-
3.4.1.1
tion about his health,
the diagnosis made and treatment
provided, as well as to respect for privacy during examinations,
consultations and medical or surgical treatment. This funda-
mental right requires that
the patient be treated with due
respect and that he not be subjected to contemptuous remarks
and attitudes on the part of healthcare workers.

3.4.1.2
People are weakened by sickness, disability and
dependence. The more they feel belittled, the less they feel able
to demand that they be accorded the minimum of respect. It is
therefore up to professionals to be more attentive to the need to
show respect to people who are particularly vulnerable because
of their sickness or disability.

3.4.1.3
Recognition of the importance of time devoted to
consultation, listening to people, explaining the diagnosis and
treatment, both in hospital and elsewhere, is one facet of respect
for people. This investment in time helps to strengthen the ther-
apeutic alliance and save time elsewhere. Healthcare provision is
about devoting time to people.

3.4.1.4
This applies especially to people who already suffer
from lack of social recognition: elderly people in a precarious
social position, people suffering from a physical, psychological
or mental handicap, etc.

3.4.1.5
In terminal cases or where the patient is undergoing
particularly difficult treatment, staff need to be even more vigi-
lant. Respect for a person and his right to die in a dignified
manner is achieved by providing universal access to palliative
care designed to reduce pain and maintain a certain quality of
life by guaranteeing the right of a patient to have his choices
respected until the end of his life. Among other things, this
means putting in place a procedure such as the designation of a
proxy to ensure that the patient's wishes are made known.

Pain management through the provision of effective
3.4.1.6
information and
means and access to specialised facilities:
and information for
training for healthcare professionals
patients and their family and friends need to be developed as
this is about respecting the right of everyone to receive care to
relieve pain.

Some other individual rights need to be enforced as part
3.5
of a public health initiative; this requires that the system, as
currently organised, comes up with an appropriate response.

3.5.1
Right to access to care for all: i.e. not just access to rights
and social protection but to the full range of healthcare services
and professionals without discrimination on the grounds of a
person's social or economic position. This is not part of a move
to open up the health sector but rather of a proactive public
health policy, on the understanding that the practical implemen-
tation of this right differs greatly across countries, depending on
the responsibilities that are taken on and the forms of funding
existing in each country.

Right

3.5.2
taking into
to high-quality care: every person,
account the state of his health, has the right to receive the most
appropriate treatment and access to the best therapies and medi-
cines offering the best cost-effectiveness ratio (promotion of
generic drugs). The right to high-quality care also implies the
right to screening and therapeutic education, which calls for
investment in resources and funding, and adequate availability
of properly trained professionals.

3.5.3
Right to prevention and safety of care: citizens want the
health system to be built around and for people. They want to
know more about the therapeutic strategies proposed to them,
take part
in personal and collective prevention efforts, and
ensure that social choices, behaviour and consumption do not
harm health.

4. Recommendations for implementing patients' rights

The affirmation and application of

4.1
these rights is a
source of concern for many professionals, patients, health
policy-makers and user associations. There is an urgent need to
move away from confrontation between the rights of some
parties and the obligations of others. Respect for patients' rights
also means a new distribution and balance for the obligations
and responsibilities of professionals.

As the medical profession is no longer alone in taking
4.1.1
decisions involving people's futures, it can no longer be alone in
assuming full responsibility for them.

In the interests of the common good, it is the collective
4.2
responsibility to help professionals respond to these expecta-
tions:

— by including ethical aspects and respect for the individual
and his rights in their training, so that they understand the
dynamics involved and the resulting implications, and so do
not see patients' rights as a further constraint,

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— by establishing forums and meeting places between profes-

sionals and between professionals and users,

prepare for discussions with professionals with the
support of user associations

— by creating new ways of delivering information to the sick

involving all stakeholders in the health system,

— by developing new pedagogical procedures for dealing with

consent, leading to a therapeutic alliance,

— by creating and bringing into general use new organisational
and pedagogical
solutions designed to minimise stress
suffered by children when undergoing treatment, especially
when they are in hospital,

— by setting up clinical ethics committees in health establish-
for professionals and

thereby facilitating support

ments,
respect for the rights of the sick,

— by including protection and promotion of patients' rights in

ethical codes and codes of conduct for professionals,

— by making the system easier to understand for users whilst
enhancing the position and role of health professionals as a
whole,

— by devising new forms of collective practice involving

doctors and other health professionals:

— group practices, medical health centres

— links between medical, welfare and social professionals,

— by rethinking the role of patient, user, consumer, family and

citizen associations:

— including users' representatives in representative bodies

— recognising the role of certain associations in therapeutic
education, prevention, provision of information to the
sick, etc.

— building links between the structures of associations and

those of professional bodies, etc.

— equipping associations with the means to carry out their
activities and put across their views (training, representa-
tion leave, etc.)

— creating neutral and convivial spaces in hospital estab-
lishments where patients can voice their concerns and

Brussels, 26 September 2007.

— involving associations on the same footing as profes-
sionals in the analysis of complaints and in defining
ways of improving the quality of care.

5. Conclusion: towards an affirmation of collective rights

How effective individual rights turn out to be in practice
5.1
will depend to a large extent on the collective responses which
are made to support this initiative. That is why it is necessary to
work for the adoption of health democracy, implying the collec-
tive involvement of users and their representation in different
parts of the system.

5.2
Patients' rights are one expression among others of
human rights, but by no means a separate category. They are
the manifestation of the desire that no patient wants to be
considered as a being apart and, above all, as someone on the
margins of society.

There is a need to acknowledge that users of

5.2.1
the
healthcare system are becoming more vocal in making known
their feelings about healthcare conditions on the basis of their
own experiences and also because they are receiving increasingly
more information.

5.3
Consequently, it is appropriate to ask about the position
of the patient in the process of making decisions which concern
him, in the interests of transparency of procedures and respect
for individuals.

5.4
The issue at hand is not about adopting a legalistic
consumerist approach but rather about recognising that the
patient is sufficiently mature to take part in decisions affecting
him on the basis of respect for his rights.

5.5
Giving a voice to users and their representatives is all the
more necessary as health issues extend into other areas:
methods of production, lifestyle, working conditions, environ-
mental protection, etc. This implies social, economic and ethical
choices which go beyond the sole responsibility of health profes-
sionals.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS