European union – law system
Patient rights international view
European Union
• „transcending nation-states “
FOR THE PURPOSE OF COOPERATION HUMAN
DEVELOPMENT
EU represents „a new legal order of
international law“
(ref: According to its Court of Justice)
EUROPEAN UNION –
„IN A NUTSHELL“
Week 5+6, part Ia
EUROPEAN UNION AND HEALTH
Week 5+6, part Ib
EU and public health
• works to protect and improve the health:
of all Europeans throughout their lives
main objectives of EU health policy:
• prevent disease,
• promote healthier lifestyles,
• promote well-being,
• protect people from serious cross-border threats to health,
• improve access to healthcare,
• promote health information and education,
• improve patient safety,
• support dynamic health systems and new technologies,
• set high quality and safety standards for organs and other
substances of human origin,
• ensure high quality, safety and efficacy for MP, MD
Eu and health organisation
• the organisation and delivery of HC is the
responsibility of individual countries
• HOWEVER: the EU brings „added value“ =
EU - Key challenges in health
• Sustainability:
– Ageing population
• Reducing the incidence of preventable
diseases:
• Health inequalities
• Life expectancy at birth
EU - Key challenges in health
• New and emerging health problems:
• Health security
Health stratégy in EU
2007: the EU adopted its ‘Health strategy’.
• Based on four key principles:
1. Europeans have shared health values;
2. Health is the greatest wealth;
3. Considerations about health must be included in
all policies;
4. „EU’s voice must be heard on all issues affecting
global health“
Health stratégy in EU
• Identified three key objectives:
1. fostering good health in an ageing Europe;
2. protecting citizens from health threats;
3. supporting dynamic health systems and new
technologies
EU financial support - health
• The EU's work will complement and support national
efforts in four key areas:
• disease prevention and health promotion measures;
• protecting citizens from cross-border health threats;
• innovative and sustainable health systems;
• better and safer healthcare for citizens.
• All 28 EU countries plus Iceland and Norway participate
in the programme
What?
• coordination mechanism for communicable
diseases to include all health threats caused by
biological, chemical or environmental factors;
• EU alert systems
• EU Health Security Committee (HSC):
• European Centre for Disease Prevention and
Control (ECDC)
• EU-wide research networks
WHAT?
• Strengthening the quality, safety and efficacy
of medicines
• Tackling the risk factors of chronic disease,
cancer
• Promoting healthy and active ageing
WHAT?
• Research and health expertise
• Sustainable, cost-effective health systems
• Increasing the use of e-health and
telemedicine
EU LAW SYSTEM
European Union law
• system of rules operating within the member
states of the EU
• to „promote peace, values and the well-being
of its peoples“
European Union law
• European Union law is the basis for European
integration
(European unification).
• on the basic historical experience of
continental European law.
• It is an independent legal system that is superior
to the national legal systems.
European Union law
• EU has to operate among a plurality of
national legal systems.
• ….the European Court of Justice
resolve conflicts of laws between different
systems.
European Union
Within the EU itself the Court of Justice's view is
that:
if EU law conflicts with a provision of national
law:
EU LAW HAS PRIMACY.
European law
• is organized in the so-called "Acquis
communautaire“
[aˌki kɔmynoˈtɛːʁ]
• the accumulated legislation, legal acts, and
court decisions
• constitute the body of European Union law
S
European Union law
• Primary law
• Secondary law
• Supplementary law = Case law
Primary law
• mainly of the Treaties of the EU
• Contain formal and substantive provisions,
which frame the implementation of the
policies of the European institutions.
• Determine the formal rules that allocate the
division of competences between the
European Union and Member States
S
scope of primary law
• the founding Treaties establishing the
European Union
• the major Treaties amending the EU
• the Protocols annexed to those Treaties
• additional Treaties making changes to specific
sections of the founding Treaties
• the Treaties of accession of new Member
States to the EU
The treaties – basis for democratic cooperation
built on law: example
The European Coal and Steel Community
The treaties of Rome:
• The European Economic Community
• The European Atomic Energy Community
(EURATOM)
The European Single Act: the Single
Market
Treaty on European Union - Maastricht
Treaty of Amsterdam
1952
1958
1987
1993
1999
2003 Treaty of Nice
2009 Treaty of Lisbon
The EU's legal foundations
• Treaty on European Union
• Treaty on the Functioning of the European
Union
Sources of secondary law
Secondary law comprises:
• unilateral acts
• agreements
Unilateral acts
Two categories:
• REGULATIONS, DIRECTIVES, DECISIONS, OPINIONS,
RECOMMENDATIONS;
those listed in Article 288 of the Treaty on the Functioning of the EU
• "atypical" acts such as COMMUNICATIONS,
RECOMMENDATIONS, white and green papers
those not listed in Article 288 of the Treaty on the Functioning of the EU, i.e
Convention and Agreements
• international agreements signed by the EU and a
country
• agreements :
EU with non-member countries or
EU with international organizations within their areas of
responsibility.
between Member States
• interinstitutional agreements
Sources of supplementary law
• TO BRIDGE THE GAPS LEFT by primary and/or
secondary law.
Primary vs secondary law
• Treaties are the starting point for EU
• Every action taken by the EU is founded on the
treaties.
Legislative vs non-legislative acts
• Legislative acts are adopted following one of
the legislative procedures set out in the EU
treaties (ordinary or special).
• Non-legislative acts do not follow these
procedures = can be adopted by EU
institutions according to specific rules.
Regulations
• are of general application
• binding in their entirety
• DIRECTLY APPLICABLE!!
S
Regulations
• must be complied with fully by those to whom
they apply
• directly applicable =
in all the Member States as soon as they enter into
force and do not need to be transposed into
national law.
• They are designed to ensure the uniform
application of Union law in all the Member
States.
Directives
• binding as to the result to be achieved
• but leave to the NATIONAL AUTHORITIES THE
CHOICE OF FORM AND METHODS
Directives
National legislators:
• must adopt a transposing act
• bring national law into line with their objectives
• to Member States are given some competences,
in transposing directives - to take account of
specific national circumstances.
• Transposition - within the period laid down in the
directive.
S.
Decisions
• binding on those to whom it is addressed
• directly applicable
Recommendations and opinions
do not confer any rights or obligations on those
to whom they are addressed
May provide guidance as to the interpretation
and content of Union law.
recommendation
allows the institutions to communicate their
views
• AND to suggest a line of action
opinion
• allows the institutions to make a statement in
a non-binding fashion, without imposing any
legal obligation on those to whom it is
addressed.
• It can be issued by the main EU
Consolidated texts
• integration of its successive amendments and
corrigenda
• Note: that these texts have no legal value. For
legal purposes please refer to the full texts.
Institutions and bodies
• European Parliament
• Council
• European Council
• European Commission
• Court of Justice
• Court of Auditors
• European Central Bank
• European Economic and Social Committee
• European Committee of the Regions
European Parliament
The Parliament has 3 main roles:
1. Legislative
2. Supervisory
3. Budgetary
• The European Parliament is the EU's law-making
body.
• The Lisbon Treaty gave Parliament significantly
more legislative powers
S.
European Parliament
• Role: Directly-elected EU body with legislative, supervisory, and
budgetary responsibilities
• Members: 751
• President: Antonio Tajani
• Established in: 1952 as Common Assembly of the European Coal
and Steel Community, 1962 as European Parliament, first direct
elections in 1979
• Location: Strasbourg (France), Brussels (Belgium), Luxembourg
• (Luxembourg - administrative offices, Meetings of the whole
Parliament Strasbourg and in Brussels, Committee meetings -
Brussels.)
• Website: European Parliament
European Parliament
• It is directly elected by EU voters every 5
years.
• The last elections were in May 2019.
European Parliament
Legislative role
• Passing EU laws, together with the Council of the
EU,
based on European Commission proposals
• Deciding on international agreements
• Deciding on enlargements
• Reviewing the Commission's work
programme and asking it to propose legislation
European Council
• Role: Defines the general political direction and
priorities of the European Union
• Members: Heads of state or government of EU
countries, European Commission President, High
Representative for Foreign Affairs & Security Policy
• President: Donald Tusk
• Established in: 1974 (informal forum), 1992 (formal
status), 2009 (official EU institution)
• Location: Brussels (Belgium)
• Website: European Council
What does the European Council do?
• Decides on the EU's overall direction and
political priorities
The Council of the European Union
• Role: Voice of EU member governments, adopting EU
laws and coordinating EU policies
• Members: Government ministers from each EU
country, according to the policy area to be discussed
• President: Each EU country holds the presidency on a
6-month rotating basis
• Established in: 1958 (as Council of the European
Economic Community)
• Location: Brussels (Belgium)
• Website: Council of the EU
The Council of the European Union
• Together with the European Parliament, the
Council is the main decision-making body of
the EU.
The Council of the European Union
1. Negotiates EU laws
2. Coordinates member states' policies
3. Develops the EU's common foreign and
security policy
4. Concludes international agreements
5. Adopts the EU budget - jointly with the
European Parliament.
Court of Justice of the European Union
(CJEU)
• Role: Ensuring EU law is interpreted and applied the
same in every EU country; ensuring countries and EU
institutions abide by EU law.
• Court of Justice: 1 judge from each EU country, plus 11
advocates general
• Location: Luxembourg
• Website: Court of Justice of the European Union (CJEU)
The Court of Justice of the European
Union (CJEU)
• settles legal disputes between national
governments and EU institutions
• 2 courts
European Commission
• Role: Promotes the general interest of the EU by
proposing and enforcing legislation as well as by
implementing policies and the EU budget
• Members: A team or 'College' of Commissioners,
1 from each EU country
• President: Jean-Claude Juncker
• Year established: 1958
• Location: Brussels (Belgium)
• Website: European Commission
European Commission
• politically independent executive arm
• responsible for drawing up proposals for new
European legislation,
The EU institutions
European Parliament
Court of
Justice
Court of
Auditors
Economic and Social
Committee Committee of the Regions
Council of Ministers
(The Council) European Commission
European Investment Bank European Central BankAgencies
European Council (summit)
How EU laws are made
Citizens, interest groups, experts: discuss, consult
Commission: makes formal proposal
Parliament and Council of Ministers: decide jointly
National or local authorities: implement
Commission and Court of Justice: monitor implementation
European Ombudsman
• Ombudsman: Emily O'Reilly
• Established in: 1995
• Location: Strasbourg (France)
• Website: European Ombudsman
• Role: investigates complaints about poor
administration by EU institutions or other EU
bodies.
… citizens or residents of EU countries or by EUbased
associations or businesses.
What does the Ombudsman do?
S.
How does the Ombudsman work?
• launches investigations
• make recommendations to the institution
Human rights
Patient rights
Week 5+6 part II
Universal Declaration of Human Rights
• UN
• Formalized in 1948
• Recognition:
– THE INHERENT DIGNITY
– EQUAL AND UNALIENABLE RIGHTS OF ALL MEMBERS OF THE
HUMAN FAMILY
is the foundation of freedom, justice and peace in
the world,
Fundamental rights in the EU:
There are three sources:
• the EU’s Charter of Fundamental Rights;
• the European Convention on Human
Rights (ECHR);
• the constitutional traditions of Member States.
EU Charter of Fundamental Rights
The Charter contains rights and freedoms under
six titles:
1. Dignity,
2. Freedoms,
3. Equality,
4. Solidarity,
5. Citizens' Rights,
6. Justice.
Convention for the Protection of Human Rights and Dignity
of the Human Being with regard to the Application of Biology
and Medicine
• was opened for signature on 4 April 1997
in Oviedo
• https://www.coe.int/en/web/conventions/full-
list/-/conventions/treaty/164
• https://www.coe.int/en/web/conventions/full-
list/-
/conventions/treaty/164/signatures?p_auth=
Convention for the Protection of Human Rights and Dignity of the Human
Being with regard to the Application of Biology and Medicine
• Art. 3 – equal access to health care of appropriate
quality
• Art. 4 – professional standards
• Art. 5 – free informed consent
• Art. 6 – Protection of persons not able to consent
• Art. 8 – emergency requiring urgent solutions
• Art. 9 – previously expressed wishes
• Art.10 – privacy and right for information
Patients' rights
• vary in different countries and in different
jurisdictions,
• often depending upon prevailing cultural and
social norms.
Patients' rights
Growing international consensus:
ALL PATIENTS HAVE A FUNDAMENTAL RIGHT TO:
• privacy,
• confidentiality of their medical information,
• consent to or to refuse treatment,
• be informed about relevant risk to them of
medical procedures.
Patient‘s rights have no borders
CHARTER OF FUNDAMENTAL RIGHTS
AND FREEDOMS (1993) CZE
Constitution
• Everyone has the right to live.
• No one shall be deprived of life.
• Everyone has the right to maintain his human dignity ……
• Everyone has the right to be protected from unauthorized
collection, disclosure or other misuse of his personal data.
• Note:…..General Data Protection Regulation
Act No. 372/2011 Coll., on Health Services
THE POSITION:
OF THE PATIENT AND OTHER PERSONS
IN CONNECTION WITH THE PROVISION OF HS
Act No. 372/2011 Coll
Definition:
• What is HCS
• Who is a patient
• Types and forms of HCS
Health services:
• § 2
• the provision of HC by HP
• The consultation services to assess the
individual treatment process
• medical rescue service
• (transporting patients, anti-toxikomanic seizure
service, services within the scope of the
operation of blood transfusion services ,…. etc)
Health care
• set of activities and measures implemented for natural
persons for the purpose:
– prevention, detection and eradication of illness, defect or health
statute
– maintenance, restoration or improvement of the health statute
– maintaining and prolonging life and alleviating suffering,
– assistance in reproduction and childbirth,
– health assessment,
• preventive, diagnostic, medical, medical, rehabilitation,
nursing or other healthcare provided by healthcare
professionals for the above listed purposes
• medical examination
Patient
• means a natural person to whom is provided
with a health service.
Types of health care according to the timeing of its
provision
• urgent care to prevent or reduce the occurrence of
sudden conditions that directly endanger life or could
lead to sudden death or serious health hazards
• acute care
• the necessary medical care required by the medical
condition of the patient who is a foreign insured
person,
• planned care
types of healthcare provided by the
purpose of its provision
• preventive care
• Diagnostic care
types of healthcare provided by the
purpose of its provision
• dispensary care,
the active and long-term monitoring of the state of
health of a patient at risk of or suffering from a disease
• medical treatment intended to have a favorable effect
on the state of health through the implementation of
an individual treatment procedure in order to cure or
mitigate the consequences of the illness and to prevent
or reduce the degree of disability or disability
types of healthcare provided by the
purpose of its provision
• assessment care
• rehabilitative care
• nursing care
• palliative care
• pharmacy care (pharmaceutical care) 
S.
Act No. 372/2011 Coll
Part 4:
• The position of the patient and other persons
in connection with the provision of HS
• Rights and duties of patient
Rights of the patient
• Provission of HS on adequate professional
level
• the least restrictive environment
• Respect
• Informed consent
Rights of the patient
• patient has right to choose —providers of health services to
meet the health needs
• There are some exceptions
• „Guardian“
Rights of the patient
• Right to ask for consultation service (second opinion)
Rights of the patient
• Information secrecy HCP
• obligation for providers to disclose health
information in medical records, which are
necessary to provide consulting services
• (The General Data Protection
Regulation (GDPR) (Regulation (EU)
2016/679))
Rights of the patient
be informed in advance about the price provided by HS
the manner of their payment
Rights of the patient
To know the name of :
• —Health care professionals
• —other professionals involved in the provision
of HS and
Rights of the patient
Deny presence of
• —persons who are not directly involved in the
provision of HS
Rights of the patient
Right for presence of
• —Legal guardian or a person designated by him - for minors,
patients deprivation of legal capacity
• close relatives or a person designated by the patient
Under certain conditions
Rights of the patient
• To receive visitors in a hospital inpatient and day care
• To receive pastoral care visitors in a hospital inpatient and day
care
Information to patient
• Information about the patient's condition and the
proposed
HS Act No. 372/2011 Sb. - § 31 - 33
• —Information about health condition/state and about the
proposed individual treatment including any changes → TO
the patient or guardian
• In understandable way and sufficient extent
• Given by HCP who delivers the care
• —recorded in the medical records
Information to patient
• To enable to give additional questions
related to health status
To the patient or To person chosen by him
Q must be clearly answered
Information to patient
The content of information - in particular:
• —the cause and origin of disease, stage and expected
development
• —purpose, nature, anticipated consequences and risks of
the proposed HC
• —provide/explain other options of the HS, suitability,
benefits and risks
• other necessary treatment
• —restrictions and recommendations in the way of life
with respect to health state
Patient option
• —to give up to communicate information about
health
…. disable reporting
(extemption)
Patient option
Exception:
• infectious disease or any other disease - risk to life or health other
persons
• the information can be given without the patient's consent under
the law
Information
The Provider is entitled to tell the person who
will personally take care of the patient, the
necessary information:
• —To secure the care to the patient
• To protect their health
Underage patient and the patient deprived of legal
capacity
Right to information and the right to ask questions:
• —legal representative and
• —Also underaged patient - in a way that takes into account:
– —His intellectual maturity
– His ability to understand current information
Note
→ Information on unfavorable diagnosis or
prognosis
• —may be retained:….under special condition
Only for limited period
Note:
Can not be applied:
• —If it is the only way to —take preventive
measures or —undergo early treatment
• —There is a risk to the patient's surroundings
• —
• When patient explicitly asks
Information
Information about the patient - patient can:
• —identify persons who may be informed (and how)
• access to Medical Records (MR)
• make notes or copies of extracts from MR
Patient‘s duties
• The patient is obliged to (§ 41):
• to comply with an individual treatment procedure
if agreed with him;
• Consequences: deliberate / systematic failure →
termination of patient care
Patient‘s duties
• Follow the internal rules of HCF
• —to pay the price of the HS to the provider when not covered
or partially covered by public health insurance
Patient‘s duties
Truely inform about:
• current state of health,
—
• HS provided by other providers,
—
• Use of medicines and Addictive Substances
• —other facts essential for provission of HS
Patient‘s duties
• Duty to identify with ID card
• —
Informed consent
(§ 34 a 35)
• HS can be provided only with patient‘s free and
informed consent
• IC —Can be anytime cancelled
• —Written form needed
—
• → Consent is a part of the medical record
• Signature of patient, ev. Witness and HCP
Informed consent
When patient is not able to write, speak ?
• unmistakable expression of will
Informed consent
• Underage patient and the patient deprived of
legal capacity
(§ 35)
—find out his opinion + recorded in the
documentation
Legal representative
Reverse
= Refusal to consent to HS (§ 34/ 4)
• —were given patient health information
• —patient refuses to consent with HS
• —information must be given repeatedly,
• in the manner from which it is clear that the absence
of HS can seriously damage his health or life-
threatening
• —BUT Patient still disagrees
• → the patient's written declaration (reverse) – to be
attached in his medical record
Previously expressed wishes
• (§ 36)
• —Written form
(informed about consequences and context of
the „wish“)
• —certified signature of the patient and…
• —Validity 5 years
• → provider will take into account
S.
Previously expressed wishes
can not respect:
e.g. active cause of death, threats to others
Progression in HCS
• not applicable (patients minors and
deprivation of legal capacity)
Providing health care services without consent and restraints
Hospitalisation without consent
Possible – reasons (§ 38)
• —without the consent of the patient can only provide
emergency medical care
• Protective treatment - court judgment,
• Quarantine, isolation…
•
• Restrictions on the free movement of the patient - can be
used restraint
• —§ 39
• —conditions of use
• Duties and rigth‘s of HP