World Health Organization, WHO Regional Office for Europe, Declaration on the Promotion of Patients' Rights in Europe, reprinted in 45 International Digest of Health Legislation 411 (1995).
A WHO European Consultation on the Rights of Patients, meeting in Amsterdam
from 28 to 30 March 1994, endorsed the document Principles of the rights of
patients in Europe as a set of principles for the promotion and implementation
of patients' rights in WHO's European Member States.
The meeting gave detailed consideration to a wide range of possible strategies
based on the principles presented in the document and on the recent and current
experiences of participants. The essence of these strategies is presented below.
Strategies for the Promotion of Patients' Rights
The development of a strategy to promote patients' rights and responsibilities
has to be carefully prepared, in order to ensure that the intention is translated
into practical action which Commands the support of all parties involved. Such
action does not follow automatically, but takes time to become fully effective.
National situations vary in respect of legal frameworks, health care systems,
economic conditions, and social, cultural and ethical values, but there are
certain common approaches which can be appropriately adapted to the circumstances
of each country. We encourage all interested parties in our countries to initiate
or renew multiple strategies of implementation, which will likely need most
or all of the following components:
legislation or regulations, specifying the rights, entitlements and responsibilities of patients, health professionals and health care institutions;
medical and other professional codes, patients' charters and similar instruments, drawn up in the light of agreed common understandings between the representatives of citizens, patients, health professionals and policy-makers, and periodically revised in response to changing circumstances;
networking between and among patient and health care provider groups, recognizing the distinction between citizen and user participation;
government support for the establishment and effective running of nongovernmental organizations (NGOs) in the field of patients' rights;
national colloquia and conferences to bring the parties together to create and promote a shared sense of understanding;
involvement of the media in informing the public, stimulating constructive debate and sustaining awareness of the rights and responsibilities of patients and users and their representative organs;
better training in communication and advocacy skills for health professionals as well as for patient and other user groups, in order to further the development of a proper understanding of the perspective and role of all parties;
promotion of research to evaluate and document the effectiveness of legal
and other provisions and the various initiatives taken in the diverse contexts
of the different countries.
Cooperation between WHO, the Council of Europe and the European Union in support
of patients' rights would be further enhanced by action taken as a result of
this Consultation. Consistency of policy positions, coordinated strategies of
implementation and an understanding of how their respective resources and competences
can best be used are essential components of a sustained European movement to
promote and protect the rights of patients and their professional providers
and advisers. International NGOs also have a critical role to play in promoting
the rights of patients.
The forthcoming WHO Regional Conference on Health Policy (Copenhagen, 5-9
December 1994) will provide an important opportunity for further promoting patients'
rights in Europe. The proposed WHO Regional Conference on Health Care Systems
in Transition in Europe, to be held in Vienna on 23-28 March 1996, will also
explore issues concerning the rights, roles and responsibilities of both patients
and providers. We propose to WHO that the Regional Office should establish an
appropriate mechanism to monitor developments in countries and to present the
findings to the Vienna Conference.
Principles of the Rights of Patients in Europe: A Common Framework
Social, economic, cultural, ethical and political developments have given rise to a movement in Europe towards the fuller elaboration and fulfilment of the rights of patients. New and more positive concepts of patients' rights have been advocated. In part, this has been a reflection of the central place given both to full implementation of the concept of respect for persons and to equity in health as a policy objective in Member States. As a consequence there is now greater emphasis on the encouragement of individual choice and the opportunity to exercise it freely, and the commitment to build mechanisms for ensuring quality of care.
Developments within health care systems such as their increasing complexity,
the fact that medical practice has become more hazardous and in many cases more
impersonal and dehumanized, often involving bureaucracy, and no less the progress
made in medical and health science and technology have all placed new emphasis
on the importance of recognizing the individual's right to self-determination
and often on the need to reformulate guarantees of other rights of patients.
Simultaneously, the human rights movement has gathered importance in the world
since 1945 when, in the Charter of the United Nations, Member States reaffirmed
their faith in fundamental human rights. This was followed, on 10 December 1948,
by the adoption of the Universal Declaration of Human Rights and, on 4 November
1950, by the signature of the European Convention of Human Rights. Governments
are more and more giving their active consideration to such issues. The World
Health Organization's study of patients' rights in Europe shows that increasingly
there are shared principles that are being adopted in a number of countries
and which seem to be independent of the characteristics of a given country's
health system. It seems timely to give this policy trend further momentum.
The present document is an attempt to formulate a set of patients' rights
which reflects the evolving concepts and is relevant to the context in which
health care will be provided in future.
These principles of the rights of patients in Europe have been drafted in
full awareness of the work of others who have already been engaged in drawing
up instruments specific to patients' rights. For the most part though, such
earlier efforts were directed at particular groups or concerned with specific
activities in health care or approached patients' rights from the perspective
of the duties and responsibilities of health care providers and establishments.
The present text is the result of an attempt to refocus these concerns from
the patient's point of view as the user of and partner in health care in all
its various forms. It has been deliberately couched in general terms, so far
as possible avoiding reference to the circumstances of particular groups or
illustrative examples. It is felt, however, that this exposition of general
considerations embraces the basic principles and concepts to be adopted when
promoting and guaranteeing patients' rights in a particular country or other
situation. particular needs and circumstances. The text does not directly cover
questions of implementation, since these are necessarily specific to a country
or situation; it has nevertheless been drafted in the belief that these guidelines
can be further elaborated within countries to suit their particular needs and
In this text, the concept of health care is derived from the principles of
the World Health Assembly resolution on health for all (HFA) (WHA30.43, 19 May
1977) and the related model of health care set out in the Declaration of Alma-Ata
(12 September 1978). Health care thus embraces a full range of services covering
health promotion and protection, disease prevention, diagnosis, treatment, care
and rehabilitation. Accordingly, the patient encounters a wide variety of health
care providers and fulfils a variety of roles, from sick and dependent person
to client receiving advice to consumer or customer obtaining health products
for self-administration. Furthermore, this variety of patient roles implies
a continuum of health states from high-level wellness to permanent disability
and terminal illness.
In the treatment of patients' rights, a distinction should be made between
social and individual rights. Social rights in health care relate to the societal
obligation undertaken or otherwise enforced by government and other public or
private bodies to make reasonable provision of health care for the whole population.
What is reasonable in terms of the volume and range of services available and
the degree of sophistication of technology and specialization will be dependent
on political, social, cultural and economic factors. Social rights also relate
to equal access to health care for all those living in a country or other geopolitical
area and the elimination of unjustified discriminatory barriers, whether financial,
geographical, cultural or social and psychological.
Social rights are enjoyed collectively and are relative to the level of development
of the particular society; they are also in some measure subject to political
judgment regarding priorities for development in a society.
In contrast, individual rights in patient care are more readily expressed
in absolute terms and when made operational can be made enforceable on behalf
of an individual patient. These rights cover such areas as the integrity of
the person, privacy and religious convictions. Although this text does address
social rights, the main focus is on individual rights. The conceptual foundations
for this treatment of patients' rights are for the most part laid on a number
of intergovernmental declarations relating to human rights and freedoms. The
intention is not to create new rights but to apply them in one coherent, comprehensive
statement to the field of patients and health care. For similar reasons the
text does not address general rights, obligations and liabilities, which are
covered by the statutes and case law of each country.
A further issue arises concerning the place of exceptional limitations to
particular rights of patients. For the most part these have been kept out of
the text, in order to state the proposed rights as clearly and simply as possible.
It is therefore pertinent to clarify here at the outset the nature of the principal
forms of limitation. Exceptions to the rights of patients are usually anticipated
in law. The guiding rule in such exceptions is always that patients can be subjected
only to such limitations as are compatible with human rights instruments and
in accordance with a procedure prescribed by law. In practice, this means limitations
which apply for reasons of public order, public health and other persons' human
In some situations, the reason for restricting the rights of the patient is
an overriding interest of a third party (the so-called conflict of duties doctrine),
i.e. the unfettered application of the patient's right would cause serious harm
to a third party, there is no other means to avoid the harm and there is a reasonable
expectation that the restriction would prevent the harm.
In other situations a similar justification applies when the purpose is to
avoid serious harm to the patient (the so-called therapeutic exception). As
this document addresses general principles, these exceptional limitations to
the rights of patients have mostly not been included.
Purpose of the Document
The principles of the rights of patients in Europe are offered as a contribution
to support the growing interest in many Member States in the issues of patients'
rights. In its scope and focus, this document seeks to reflect and express people's
aspirations not only for improvements in their health care but also for fuller
recognition of their rights as patients. In so doing, it keeps in mind the perspectives
of health care providers as well as of patients. This implies the complementary
nature of rights and responsibilities: patients have responsibilities both to
themselves for their own self-care and to health care providers, and health
care providers enjoy the same protection of their human rights as all other
people. There is a basic assumption in the text that the articulation of patients'
rights will in turn make people more conscious of their responsibilities when
seeking and receiving or providing health care, and that this will ensure that
patient/provider relationships are marked by mutual support and respect.
Patients should be aware of the practical contributions they can make to the
optimal functioning of the health system. Their active participation in the
diagnosis and treatment process is often desirable and sometimes indispensable.
It is always important that they provide the relevant health professionals with
all the information required for the purposes of diagnosis and treatment, The
patient has an essential role, the reciprocal of the providers, in ensuring
that the dialogue between them is carried out in good faith.
Indeed, the role patients play in the appropriate delivery of health care
should be underlined, especially in today's complex health systems which are
largely supported by collective financial mechanisms and where the economic
and equitable use of resources allocated to health care is an objective which
can be shared by health professionals and patients alike. Equally, while patients'
participation in clinical teaching must be subject to their informed consent,
they should also be aware that the competence of future professionals in par
depends on patients agreeing to be involved in their training.
It is a matter for decision by countries how they might make use of a document
such as this when reviewing their present policies on, practices in and legislative
support to, patients' rights.
Although for the purposes of clarity of presentation some proposals are made
in a clear-cut way, the text is a set of guidelines which could be used in policy
discussions within countries and in the formulation or reformulation, as the
case may be, of national policies, laws or official statements on any or all
of the issues covered. However, it is hoped that this document will be of direct
value to all parties, including patient and consumer bodies involved in health
care, professional associations of physicians and of other health care providers,
and associations of hospitals and other health care establishments.
Against this background, the Principles of the rights of patients in Europe
can be seen, in terms of content, as a document which seeks:
to reaffirm fundamental human rights in health care, and in particular to protect the dignity and integrity of the person and to promote respect of the patient as a person;
to offer for the consideration of Member States a set of common basic principles underlying the rights of patients, which might be used when framing or reviewing patient care policies;
to help patients obtain the fullest benefit from their use of the services of the health care system, and mitigate the effects of any problems which they may experience with that system;
to promote and sustain beneficial relationships between patients and health care providers, and in particular to encourage a more active form of patient participation;
to strengthen existing and afford new opportunities for dialogue between patients' organizations, health care providers, health administrations and wider societal interests;
to focus national, regional and international attention on evolving needs in patients' rights and to foster closer international cooperation in this field;
to ensure the protection of fundamental human rights and to promote the humanization
of assistance to all patients, including the most vulnerable such as children,
psychiatric patients, the elderly or the severely ill.
3. CONCEPTUAL FOUNDATIONS
In drafting these Principles of the rights of patients in Europe, the following
intergovernmental instruments, which together offer a framework and a set of
basic concepts which can be applied to the rights of patients, have been taken
the Universal Declaration of Human Rights (1948)
the International Covenant on Civil and Political Rights (1966)
the International Covenant on Economic, Social and Cultural Rights(1966)
the European Convention for the Protection of Human Rights and Fundamental Freedoms (1950)
the European Social Charter (1961).
The Rights of Patients
1. HUMAN RIGHTS AND VALUES IN HEALTH CARE.
The instruments cited in the introduction should be understood as applying
also specifically in the health care setting, and it should therefore be noted
that the human values expressed in these instruments shall be reflected in the
health care system. It should also be noted that where exceptional limitations
are imposed on the rights of patients, these must be in accordance with human
rights instruments and have a legal base in the law of the country. It may be
further observed that the rights specified below carry a matching responsibility
to act with due concern for the health of others and for their same rights.
1.1 Everyone has the right to respect of his or her person as a human being.
1.2 Everyone has the right to self-determination.
1.3 Everyone has the right to physical and mental integrity and to the security of his or her person.
1.4 Everyone has the right to respect for his or her privacy.
1.5 Everyone has the right to have his or her moral and cultural values and religious and philosophical convictions respected
1.6 Everyone has the right to such protection of health as is afforded by
appropriate measures for disease prevention and health care, and to the opportunity
to pursue his or her own highest attainable level of health.
2.1 Information about health services and how best to use them is to be made available to the public in order to benefit all those concerned.
2.2 Patients have the right to be fully informed about their health status, including the medical facts about their condition; about the proposed medical procedures, together with the potential risks and benefits of each procedure; about alternatives to the proposed procedures, including the effect of non-treatment; and about the diagnosis, prognosis and progress of treatment.
2.3 Information may only be withheld from patients exceptionally when there is good reason to believe that this information would without any expectation of obvious positive effects cause them serious harm.
2.4 Information must be communicated to the patient in a way appropriate to the latter's capacity for understanding, minimizing the use of unfamiliar technical terminology. If the patient does not speak the common language, some form of interpreting should be available.
2.5 Patients have the right not to be informed, at their explicit request.
2.6 Patients have the right to choose who, if any one, should be informed on their behalf.
2.7 Patients should have the possibility of obtaining a second opinion.
2.8 When admitted to a health care establishment, patients should be informed of the identity and professional status of the health care providers taking care of them and of any rules and routines which would bear on their stay and care.
2.9 Patients should be able to request and be given a written summary of their
diagnosis, treatment and care on discharge from a health care establishment.
3.1 The informed consent of the patient is a prerequisite for any medical intervention.
3.2 A patient has the right to refuse or to halt a medical intervention. The implications of refusing or halting such an intervention must be carefully explained to the patient.
3.3 When a patient is unable to express his or her will and a medical intervention is urgently needed, the consent of the patient may be presumed, unless it is obvious from a previous declared expression of will that consent would be refused in the situation.
3.4 When the consent of a legal representative is required and the proposed intervention is urgently needed, that intervention may be made if it is not possible to obtain, in time, the representative's consent.
3.5 When the consent of a legal representative is required, patients (whether minor or adult) must nevertheless be involved in the decision-making process to the fullest extent which their capacity allows.
3.6 If a legal representative refuses to give consent and the physician or other provider is of the opinion that the intervention is in the interest of the patient, then the decision must be referred to a court or some form of arbitration.
3.7 In all other situations where the patient is unable to give informed consent and where there is no legal representative or representative designated by the patient for this purpose, appropriate measures should be taken to provide for a substitute decision making process, taking into account what is known and, to the greatest extent possible, what may be presumed about the wishes of the patient.
3.8 The consent of the patient is required for the preservation and use of all substances of the human body. Consent may be presumed when the substances are to be used in the current course of diagnosis, treatment and care of that patient.
3.9 The informed consent of the patient is needed for participation in clinical teaching.
3.10 The informed consent of the patient is a prerequisite for participation
in scientific research. All protocols must be submitted to proper ethical review
procedures. Such research should not be carried out on those who are unable
to express their will, unless the consent of a legal representative has been
obtained and the research would likely be in the interest of the patient.
As an exception to the requirement of involvement being in the interest of
the patient, an incapacitated person may be involved in observational research
which is not of direct benefit to his or her health provided that that person
offers no objection, that the risk and/or burden is minimal, that the research
is of significant value and that no alternative methods and other research subjects
4. CONFIDENTIALITY AND PRIVACY
4.1 All information about a patient's health status, medical condition, diagnosis, prognosis and treatment and all other information of a personal kind must be kept confidential, even after death.
4.2 Confidential information can only be disclosed if the patient gives explicit consent or if the law expressly provides for this. Consent may be presumed where disclosure is to other health care providers involved in that patient's treatment.
4.3 All identifiable patient data must be protected. The protection of the data must be appropriate to the manner of their storage. Human substances from which identifiable data can be derived must be likewise protected.
4.4 Patients have the right of access to their medical files and technical records and to any other files and records pertaining to their diagnosis, treatment and care and to receive a copy of their own files and records or parts thereof. Such access excludes data concerning third parties.
4.5 Patients have the right to require the correction, completion, deletion, clarification and/or updating of personal and medical data concerning them which are inaccurate, incomplete, ambiguous or outdated, or which are not relevant to the purposes of diagnosis, treatment and care
4.6 There can be no intrusion into a patient's private and family life unless and only if, in addition to the patient consenting to it, it can be justified as necessary to the patient's diagnosis, treatment and care.
4.7 Medical interventions may only be carried out when there is proper respect shown for the privacy of the individual. This means that a given intervention may be carried out only in the presence of those persons who are necessary for the intervention unless the patient consents or requests otherwise.
4.8 Patients admitted to health care establishments have the right to expect
physical facilities which ensure privacy, particularly when health care providers
are offering them personal care or carrying out examinations and treatment.
5.CARE AND TREATMENT
5.1 Everyone has the right to receive such health care as is appropriate to his or her health needs, including preventive care and activities aimed at health promotion. Services should be continuously available and accessible to all equitably, without discrimination and according to the financial, human and material resources which can be made available in a given society.
5.2 Patients have a collective right to some form of representation at each level of the health care system in matters pertaining to the planning and evaluation of services, including the range, quality and functioning of the care provided.
5.3 Patients have the right to a quality of care which is marked both by high technical standards and by a humane relationship between the patient and health care providers.
5.4 Patients have the right to continuity of care, including cooperation between all health care providers and/or establishments which may be involved in their diagnosis, treatment and care.
5.5 In circumstances where a choice must be made by providers between potential patients for a particular treatment which is in limited supply, all such patients are entitled to a fair selection procedure for that treatment. That choice must be based on medical criteria and made without discrimination.
5.6 Patients have the right to choose and change their own physician or other health care provider and health care establishment, provided that it is compatible with the functioning of the health care system.
5.7 Patients for whom there are no longer medical grounds for continued stay in a health care establishment are entitled to a full explanation before they can be transferred to another establishment or sent home. Transfer can only take place after another health care establishment has agreed to accept the patient. Where the patient is discharged to home and when his or her condition so requires, community and domiciliary services should be available.
5.8 Patients have the right to be treated with dignity in relation to their diagnosis, treatment and care, which should be rendered with respect for their culture and values.
5.9 Patients have the right to enjoy support from family, relatives and friends during the course of care and treatment and to receive spiritual support and guidance at all times.
5.10 Patients have the right to relief of their suffering according to the current state of knowledge.
5.11 Patients have the right to humane terminal care and to die in dignity.
6.1 The exercise of the rights set forth in this document implies that appropriate means are established for this purpose.
6.2 The enjoyment of these rights shall be secured without discrimination.
6.3 In the exercise of these rights, patients shall be subjected only to such limitations as are compatible with human rights instruments and in accordance with a procedure prescribed by law.
6.4 If patients cannot avail themselves of the rights set forth in this document, these rights should be exercised by their legal representative or by a person designated by the patient for that purpose; where neither a legal representative nor a personal Surrogate has been appointed, other measures for representation of those patients should be taken.
6.5 Patients must have access to such information and advice as will enable
them to exercise the rights set forth in this document. Where patients feel
that their rights have not been respected they should be enabled to lodge a
complaint. In addition to recourse to the courts, there should be independent
mechanisms at institutional and other levels to facilitate the processes of
lodging, mediating and adjudicating complaints. These mechanisms would, inter
alia, ensure that information relating to complaints procedures was available
to patients and that an independent person was available and accessible to them
for consultation regarding the most appropriate course of action to take. These
mechanisms should further ensure that, where necessary, assistance and advocacy
on behalf of the patient would be made available. Patients have the right to
have their complaints examined and dealt with in a thorough, just, effective
and prompt way and to be informed about their outcome.
In these principles of the rights of patients in Europe, the following terms
have been used with the meanings given :
PATIENT(S) User(s) of health care services, whether healthy or sick.
DISCRIMINATION Distinction between persons in similar cases on the basis of
race, sex, religion, political opinions, national or social origin, associations
with a national minority or personal antipathy.
HEALTH CARE Medical, nursing or allied services dispensed by health care providers
and health care establishments.
HEALTH CARE PROVIDERS Physicians, nurses, dentists or other health professionals.
MEDICAL INTERVENTION Any examination, treatment or other act having preventive,
diagnostic, therapeutic or rehabilitative aims and which is carried out by a
physician or other health care provider.
HEALTH CARE ESTABLISHMENT Any health care facility such as a hospital, nursing
home or establishment for disabled persons.
TERMINAL CARE Care given to a patient when it is no longer possible to improve
the fatal prognosis of his or her illness/condition with available treatment
methods; as well as care at the approach of death.
comments by Mrs. G. Pinet, Chief of the department 'Health Legislation' -
Social, cultural and ethical developments, particularly the concepts of dignity
and respect for persons and self-determination on which patients' rights are
based, have given rise to a movement in Europe towards the fuller elaboration
and fulfilment of the rights of patients.
The increasing complexity of health care systems, heavy bureaucracy, and the
progress made in medical science and technology have all placed new emphasis
on the individual's right to self-determination.
The growing awareness of the health needs and the efforts made by health care
providers and health authorities to ensure better information of the population
have created an atmosphere that is conducive to a wider sharing of knowledge.
A better understanding, promotion and protection of patients' rights has always
been a major concern of the WHO : in this context, the Declaration on the Promotion
of Patients' Rights in Europe, adopted in 1994, was the final outcome of a long
preparatory process covering two comparative studies and three international
committees bringing together all the interested parties.
The WHO Declaration provides a common framework for action, which should be
interpreted as a valorisation of citizens' and patients' rights for the purpose
of improving their relationship with health care providers and health service
Under its four major headings - information, consent, confidentiality and
privacy, care and treatment - the Declaration presents a number of principles
and basic concepts that are indispensable for promoting and safeguarding patients'
rights in every country and in every situation.
The very scope and content of the Declaration aim at reflecting and expressing
the individual's aspirations for improving health care. In so doing, it takes
due account of the interests of health care providers and patients alike. It
is based on the fundamental assumption that the articulation of patients' rights
will make people more conscious of their responsibilities when seeking and receiving
or providing health care, which will ensure that patient/provider relationships
are marked by mutual support and respect.