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4.4.2011 Official
Journal
of
the
European
Union L
88/45
DIRECTIVES
DIRECTIVE 2011/24/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 9 March 2011
on the application of patients’ rights in cross-border healthcare
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
Article 114(3) TFEU explicitly requires that, in achieving
EUROPEAN UNION,
harmonisation, a high level of protection of human
health is to be guaranteed taking account in particular
of any new development based on scientific facts.
Having regard to the Treaty on the Functioning of the European
Union, and in particular Articles 114 and 168 thereof,
(3)
The health systems in the Union are a central component
of the Union’s high levels of social protection, and
Having regard to the proposal from the Commission,
contribute to social cohesion and social justice as well
as to sustainable development. They are also part of the
wider framework of services of general interest.
Having regard to the opinion of the European Economic and
Social Committee ( 1 ),
(4) Notwithstanding
the
possibility
for
patients
to
receive
cross-border healthcare under this Directive, Member
Having regard to the opinion of the Committee of the
States retain responsibility for providing safe, high
Regions ( 2 ),
quality, efficient and quantitatively adequate healthcare
to citizens on their territory. Furthermore, the trans
position of this Directive into national legislation and
its application should not result in patients being
Acting in accordance with the ordinary legislative procedure ( 3 ),
encouraged to receive treatment outside their Member
State of affiliation.
Whereas:
(5) As
recognised
by
the
Council
in
its
Conclusions
of
1-
2 June 2006 on Common values and principles in
(1)
According to Article 168(1) of the Treaty on the Func
European Union Health Systems ( 4 ) (hereinafter the
tioning of the European Union (TFEU), a high level of
‘Council Conclusions’) there is a set of operating prin
human health protection is to be ensured in the defi
ciples that are shared by health systems throughout the
nition and implementation of all Union policies and
Union. Those operating principles are necessary to ensure
activities. This implies that a high level of human
patients’ trust in cross-border healthcare, which is
health protection is to be ensured also when the Union
necessary for achieving patient mobility as well as a
adopts acts under other Treaty provisions.
high level of health protection. In the same statement,
the Council recognised that the practical ways in which
these values and principles become a reality vary
(2)
Article 114 TFEU is the appropriate legal basis since the
significantly between Member States. In particular,
majority of the provisions of this Directive aim to
decisions about the basket of healthcare to which
improve the functioning of the internal market and the
citizens are entitled and the mechanisms used to
free movement of goods, persons and services. Given that
finance and deliver that healthcare, such as the extent
the conditions for recourse to Article 114 TFEU as a
to which it is appropriate to rely on market mechanisms
legal basis are fulfilled, Union legislation has to rely on
and competitive pressures to manage health systems,
this legal basis even when public health protection is a
must be taken in the national context.
decisive factor in the choices made. In this respect,
( 1 ) OJ C 175, 28.7.2009, p. 116.
( 2 ) OJ C 120, 28.5.2009, p. 65.
(6)
As confirmed by the Court of Justice of the European
( 3 ) Position of the European Parliament of 23 April 2009 (OJ C 184 E,
Union (hereinafter the ‘Court of Justice’) on several
8.7.2010, p. 368), position of the Council at first reading of
occasions, while recognising their specific nature, all
13 September 2010 (OJ C 275 E, 12.10.2010, p. 1), position of
types of medical care fall within the scope of the TFEU.
the European Parliament of 19 January 2011 (not yet published in
the Official Journal) and decision of the Council of 28 February
2011.
( 4 ) OJ C 146, 22.6.2006, p. 1.

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L 88/46
EN
Official Journal of the European Union
4.4.2011
(7) This
Directive
respects
and
is
without
prejudice
to
the
a number of occasions that overriding reasons of general
freedom of each Member State to decide what type of
interest are capable of justifying an obstacle to the
healthcare it considers appropriate. No provision of this
freedom to provide services such as planning
Directive should be interpreted in such a way as to
requirements relating to the aim of ensuring sufficient
undermine the fundamental ethical choices of Member
and permanent access to a balanced range of high-
States.
quality treatment in the Member State concerned or to
the wish to control costs and avoid, as far as possible,
any waste of financial, technical and human resources.
The Court of Justice has likewise acknowledged that the
(8) Some
issues
relating
to
cross-border
healthcare,
in
objective of maintaining a balanced medical and hospital
particular reimbursement of healthcare provided in a
service open to all may also fall within one of the dero
Member State other than that in which the recipient of
gations, on grounds of public health, provided for in
the care is resident, have already been addressed by the
Article 52 TFEU, in so far as it contributes to the
Court of Justice. This Directive is intended to achieve a
attainment of a high level of health protection. The
more general, and also effective, application of principles
Court of Justice has also held that such provision of
developed by the Court of Justice on a case-by-case basis.
the TFEU permits Member States to restrict the
freedom to provide medical and hospital services in so
far as the maintenance of treatment capacity or medical
competence on national territory is essential for public
(9)
In the Council Conclusions, the Council recognised the
health.
particular value of an initiative on cross-border healthcare
ensuring clarity for Union citizens about their rights and
entitlements when they move from one Member State to
another, in order to ensure legal certainty.
(13) It is clear that the obligation to reimburse costs of cross-
border healthcare should be limited to healthcare to
which the insured person is entitled according to the
(10) This
Directive
aims to establish rules
for facilitating
legislation of the Member State of affiliation.
access to safe and high-quality cross-border healthcare
in the Union and to ensure patient mobility in
accordance with the principles established by the Court
of Justice and to promote cooperation on healthcare
(14) This
Directive
should
not
apply
to
services
the
primary
between Member States, whilst fully respecting the
purpose of which is to support people in need of
responsibilities of the Member States for the definition
assistance in carrying out routine, everyday tasks. More
of social security benefits relating to health and for the
specifically, this Directive should not apply to those long-
organisation and delivery of healthcare and medical care
term care services deemed necessary in order to enable
and social security benefits, in particular for sickness.
the person in need of care to live as full and self-
determined a life as possible. Thus, this Directive
should not apply, for example, to long-term care
services provided by home care services, in assisted
(11) This
Directive
should
apply
to
individual
patients
who
living facilities and in residential homes or housing
decide to seek healthcare in a Member State other than
(‘nursing homes’).
the Member State of affiliation. As confirmed by the
Court of Justice, neither its special nature nor the way
in which it is organised or financed removes healthcare
from the ambit of the fundamental principle of the
freedom to provide services. However, the Member
(15) Given their specificity, access to and the allocation of
State of affiliation may choose to limit the reim
organs for the purpose of organ transplants should fall
bursement of cross-border healthcare for reasons
outside the scope of this Directive.
relating to the quality and safety of the healthcare
provided, where this can be justified by overriding
reasons of general interest relating to public health. The
Member State of affiliation may also take further
(16) For the purpose of reimbursing the costs of cross-border
measures on other grounds where this can be justified
healthcare, this Directive should cover not only the
by such overriding reasons of general interest. Indeed, the
situation where the patient is provided with healthcare
Court of Justice has laid down that public health
in a Member State other than the Member State of
protection is among the overriding reasons of general
affiliation, but also the prescription, dispensation and
interest that can justify restrictions to the freedom of
provision of medicinal products and medical devices
movement envisaged in the Treaties.
where these are provided in the context of a health
service. The definition of cross-border healthcare should
cover both the situation in which a patient purchases
such medicinal products and medical devices in a
(12) The
concept
of
‘overriding
reasons
of
general
interest’
to
Member State other than the Member State of affiliation
which reference is made in certain provisions of this
and the situation in which the patient purchases such
Directive has been developed by the Court of Justice in
medicinal products and medical devices in another
its case-law in relation to Articles 49 and 56 TFEU and
Member State than that in which the prescription was
may continue to evolve. The Court of Justice has held on
issued.

---

EN
4.4.2011 Official
Journal
of
the
European
Union L
88/47
(17) This
Directive
should
not
affect
Member
States’
rules
The overarching values of universality, access to good
concerning the sale of medicinal products and medical
quality care, equity, and solidarity have been widely
devices over the Internet.
acknowledged in the work of various Union institutions.
Therefore, Member States should also ensure that these
values are respected with regard to patients and citizens
from other Member States, and that all patients are
(18) This
Directive
should
not
give
any
person
an
entitlement
treated equitably on the basis of their healthcare needs
to enter, stay or reside in a Member State in order to
rather than on the basis of their Member State of
receive healthcare in that State. Where the stay of a
affiliation. In doing so, Member States should respect
person on the territory of a Member State is not in
the principles of free movement of persons within the
accordance with the legislation of that Member State
internal market, non-discrimination, inter alia, with
concerning the right to enter or stay on its territory,
regard to nationality and necessity and proportionality
such person should not be regarded as an insured
of any restrictions on free movement. However,
person according to the definition in this Directive.
nothing in this Directive should oblige healthcare
Member States should continue to be able to specify in
providers to accept for planned treatment patients from
their national legislation who is considered as an insured
other Member States or to prioritise them to the
person for the purposes of their public healthcare scheme
detriment of other patients, for instance by increasing
and social security legislation as long as the patients’
the waiting time for treatment of other patients.
rights set out in this Directive are secured.
Inflows of patients may create a demand exceeding the
capacities existing in a Member State for a given
treatment. In such exceptional cases, the Member State
should retain the possibility to remedy the situation on
(19) When
a
patient
receives
cross-border
healthcare,
it
is
the grounds of public health, in accordance with Articles
essential for the patient to know in advance which
52 and 62 TFEU. However, this limitation should be
rules will be applicable. The rules applicable to cross-
without prejudice to Member States’ obligations under
border healthcare should be those set out in the legis
Regulation (EC) No 883/2004 of the European
lation of the Member State of treatment, given that, in
Parliament and of the Council of 29 April 2004 on
accordance with Article 168(7) TFEU, the organisation
the coordination of social security systems ( 1 ).
and delivery of health services and medical care is the
responsibility of the Member States. This should help the
patient in making an informed choice, and should avoid
misapprehension and misunderstanding. It should also
establish a high level of trust between the patient and
(22) Systematic
and
continuous
efforts
should
be
made
to
the healthcare provider.
ensure that quality and safety standards are improved
in line with the Council Conclusions and taking into
account advances in international medical science and
generally recognised good medical practices as well as
(20) In order to help patients to make an informed choice
taking into account new health technologies.
when they seek to receive healthcare in another Member
State, Member States of treatment should ensure that
patients from other Member States receive on request
the relevant information on safety and quality standards
enforced on its territory as well as on which healthcare
providers are subject to these standards. Furthermore,
(23) Ensuring
clear
common
obligations
in
respect
of
the
healthcare providers should provide patients on request
provision of mechanisms for responding to harm
with information on specific aspects of the healthcare
arising from healthcare is essential to prevent lack of
services they offer and on the treatment options. To
confidence in those mechanisms being an obstacle to
the extent that healthcare providers already provide
taking up cross-border healthcare. Systems for addressing
patients resident in the Member State of treatment with
harm in the Member State of treatment should be
relevant information on those specific aspects, this
without prejudice to the possibility for Member States
Directive should not oblige healthcare providers to
to extend the coverage of their domestic systems to
provide more extensive information to patients from
patients from their country seeking healthcare abroad,
other Member States. Nothing should prevent the
where this is more appropriate for the patient.
Member State of treatment from also obliging other
actors than the healthcare providers, such as insurance
providers or public authorities, to provide the
information on specific aspects of the healthcare
services offered, if that would be more appropriate
(24) Member
States
should
ensure
that
mechanisms
for
the
with regard to the organisation of its healthcare system.
protection of patients and for seeking remedies in the
event of harm are in place for healthcare provided on
their territory and that they are appropriate to the nature
and extent of the risk. However, it should be for the
(21) In
its
Conclusions
the
Council
recognised
that
there
is
a
Member State to determine the nature and modalities
set of common values and principles that are shared
of such a mechanism.
across the Union about how health systems respond to
the needs of the population and patients that they serve.
( 1 ) OJ L 166, 30.4.2004, p. 1.

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L 88/48
EN
Official Journal of the European Union
4.4.2011
(25) The
right
to
the
protection
of
personal
data
is
a
funda
by virtue of Regulation (EU) No 1231/2010 of the
mental right recognised by Article 8 of the Charter of
European Parliament and of the Council of
Fundamental Rights of the European Union. Ensuring
24 November 2010 extending Regulation (EC) No
continuity of cross-border healthcare depends on
883/2004 and Regulation (EC) No 987/2009 to
transfer of personal data concerning patients’ health.
nationals of third countries who are not already
These personal data should be able to flow from one
covered by these Regulations solely on the ground of
Member State to another, but at the same time the
their nationality ( 3 ) and Council Regulation (EC) No
fundamental rights of the individuals should be safe
859/2003 of 14 May 2003 extending the provisions of
guarded. Directive 95/46/EC of the European Parliament
Regulation (EEC) No 1408/71 and Regulation (EEC) No
and of the Council of 24 October 1995 on the
574/72 to nationals of third countries who are not
protection of individuals with regard to the processing
already covered by those provisions solely on the
of personal data and on the free movement of such
ground of their nationality ( 4 ).
data ( 1 ) establishes the right for individuals to have
access to their personal data concerning their health,
for example the data in their medical records containing
such information as diagnosis, examination results,
assessments by treating physicians and any treatment
(29) It
is
appropriate
to
require
that
also
patients
who
seek
or interventions provided. Those provisions should also
healthcare in another Member State in other circum
apply in the context of cross-border healthcare covered
stances than those provided for in Regulation (EC)
by this Directive.
No 883/2004 should be able to benefit from the prin

ciples of free movement of patients, services and goods
in accordance with the TFEU and with this Directive.
Patients should enjoy a guarantee of assumption of the
(26) The right to reimbursement of the costs of healthcare
costs of that healthcare at least at the level as would be
provided in another Member State by the statutory
provided for the same healthcare, had it been provided in
social security system of patients as insured persons
the Member State of affiliation. This should fully respect
has been recognised by the Court of Justice in several
the responsibility of the Member States to determine the
judgements. The Court of Justice has held that the Treaty
extent of the sickness cover available to their citizens and
provisions on the freedom to provide services include the
prevent any significant effect on the financing of the
freedom for the recipients of healthcare, including
national healthcare systems.
persons in need of medical treatment, to go to another
Member State in order to receive it there. The same
should apply to recipients of healthcare seeking to
receive healthcare provided in another Member State
(30) For patients, therefore, the two systems should be
through other means, for example through eHealth
coherent; either this Directive applies or the Union regu
services.
lations on the coordination of social security systems
apply.
(27) In
accordance
with
the
principles
established
by
the
Court of Justice, and without endangering the financial
balance of Member States’ healthcare and social security
(31) Patients
should
not
be
deprived
of
the
more
beneficial
systems, greater legal certainty as regards the reim
rights guaranteed by the Union Regulations on the coor
bursement of healthcare costs should be provided for
dination of social security systems when the conditions
patients and for health professionals, healthcare
are met. Therefore, any patient who requests an auth
providers and social security institutions.
orisation to receive treatment appropriate to his
condition in another Member State should always be
granted this authorisation under the conditions
provided for in the Unions regulations when the
(28) This
Directive
should
not
affect
an
insured
person’s
rights
treatment in question is among the benefits provided
in respect of the assumption of costs of healthcare which
for by the legislation in the Member State where the
becomes necessary on medical grounds during a
patient resides and when the patient cannot be given
temporary stay in another Member State according to
such treatment within a time limit that is medically
Regulation (EC) No 883/2004. In addition, this
justifiable, taking account of his current state of health
Directive should not affect an insured person’s right to
and the probable course of the condition. However, if a
be granted an authorisation for treatment in another
patient instead explicitly requests to seek treatment under
Member State where the conditions provided for by
the terms of this Directive, the benefits which apply to
Union regulations on the coordination of social
reimbursement should be limited to those which apply
security systems are met, in particular by Regulation
under this Directive. Where the patient is entitled to
(EC) No 883/2004 or Council Regulation (EEC)
cross-border healthcare under both this Directive and
No 1408/71 of 14 June 1971 on the application of
Regulation (EC) No 883/2004, and the application of
social security schemes to employed persons, to self-
that Regulation is more advantageous to the patient,
employed persons and to members of their families
the patient’s attention should be drawn to this by the
moving within the Community ( 2 ), which are applicable
Member State of affiliation.
( 1 ) OJ L 281, 23.11.1995, p. 31.
( 3 ) OJ L 344, 29.12.2010, p. 1.
( 2 ) OJ L 149, 5.7.1971, p. 2.
( 4 ) OJ L 124, 20.5.2003, p. 1.

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EN
4.4.2011 Official
Journal
of
the
European
Union L
88/49
(32) Patients
should,
in
any
event,
not
derive
a
financial
in the Member State of affiliation, as it is an indis
advantage from the healthcare provided in another
pensable part of obtaining effective treatment in
Member State and the assumption of costs should be
another Member State. Nothing should oblige a
therefore limited only to the actual costs of healthcare
Member State of affiliation to reimburse an insured
received.
person for a medicinal product prescribed in the
Member State of treatment, where that medicinal
product is not among the benefits provided to that
insured person by the statutory social security system
(33) This
Directive
does
not
aim
to
create
an
entitlement
to
or national health system in the Member State of
reimbursement of the costs of healthcare provided in
affiliation.
another Member State, if such healthcare is not among
the benefits provided for by the legislation of the
Member State of affiliation of the insured person.
Equally, this Directive should not prevent the Member
States from extending their benefits-in-kind scheme to
(37) Member
States
may
maintain
general
conditions,
criteria
healthcare provided in another Member State. This
for eligibility and regulatory and administrative
Directive should recognise that Member States are free
formalities for receipt of healthcare and reimbursement
to organise their healthcare and social security systems in
of healthcare costs, such as the requirement to consult a
such a way as to determine entitlement for treatment at a
general practitioner before consulting a specialist or
regional or local level.
before receiving hospital care, also in relation to
patients seeking healthcare in another Member State,
provided that such conditions are necessary, propor
(34) Member
States
of
affiliation
should
give
patients
the
right
tionate to the aim, not discretionary or discriminatory.
to receive at least the same benefits in another Member
This may include an assessment by a health professional
State as those provided for by the legislation of the
or healthcare administrator providing services for the
Member State of affiliation. If the list of benefits does
statutory social security system or national health
not specify precisely the treatment method applied but
system of the Member State of affiliation, such as the
defines types of treatment, the Member State of affiliation
general practitioner or primary care practitioner with
should not refuse prior authorisation or reimbursement
whom the patient is registered, if this is necessary for
on the grounds that the treatment method is not
determining the individual patient’s entitlement to
available in its territory, but should assess if the cross-
healthcare. It is thus appropriate to require that these
border treatment sought or received corresponds to
general conditions, criteria and formalities should be
benefits provided for in its legislation. The fact that the
applied in an objective, transparent and non-discrimi
obligation to reimburse cross-border healthcare under
natory way and should be known in advance, based
this Directive is limited to such healthcare that is
primarily on medical considerations, and that they
among the benefits to which the patient is entitled
should not impose any additional burden on patients
within its Member State of affiliation does not preclude
seeking healthcare in another Member State in
Member States from reimbursing the cost of cross-border
comparison with patients being treated in their Member
healthcare beyond those limits. Member States are free,
State of affiliation, and that decisions should be made as
for example, to reimburse extra costs, such as accom
quickly as possible. This should be without prejudice to
modation and travel costs, or extra costs incurred by
the rights of the Member States to lay down criteria or
persons with disabilities even where those costs are not
conditions for prior authorisation in the case of patients
reimbursed in the case of healthcare provided in their
seeking healthcare in their Member State of affiliation.
territory.
(35) This
Directive
should
not
provide
either
for
the
transfer
(38) In the light of the case-law of the Court of Justice,
of social security entitlements between Member States or
making the assumption by the statutory social security
other coordination of social security systems. The sole
system or national health system of costs of healthcare
objective of the provisions regarding prior authorisation
provided in another Member State subject to prior auth
and reimbursement of healthcare provided in another
orisation is a restriction to the free movement of services.
Member State should be to enable freedom to provide
Therefore, as a general rule, the Member State of
healthcare for patients and to remove unjustified
affiliation should not make the assumption of the costs
obstacles to that fundamental freedom within the
of healthcare provided in another Member State subject
patient’s Member State of affiliation. Consequently this
to prior authorisation, where the costs of that care, if it
Directive should fully respect the differences in national
had been provided in its territory, would have been
healthcare systems and the Member States’ responsi
borne by its statutory social security system or national
bilities for the organisation and delivery of health
health system.
services and medical care.
(36) This Directive should provide for the right for a patient
(39) Patient
flows
between
Member
States
are
limited
and
to receive any medicinal product authorised for
expected to remain so, as the vast majority of patients
marketing in the Member State of treatment, even if
in the Union receive healthcare in their own country and
the medicinal product is not authorised for marketing
prefer to do so. However, in certain circumstances

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L 88/50
EN
Official Journal of the European Union
4.4.2011
patients may seek some forms of healthcare in another
there is a need to introduce a system of prior authori
Member State. Examples include highly specialised care
sation, and if so, to identify the healthcare requiring prior
or healthcare provided in frontier areas where the nearest
authorisation in the context of their system in
appropriate facility is on the other side of the border.
accordance with the criteria defined by this Directive
Furthermore, some patients wish to be treated abroad in
and in the light of the case-law of the Court of Justice.
order to be close to their family members who are
The information concerning this healthcare should be
residing in another Member State, or in order to have
made publicly available in advance.
access to a different method of treatment than that
provided in the Member State of affiliation or because
they believe that they will receive better quality
healthcare in another Member State.
(43) The
criteria
attached
to
the
grant
of
prior
authorisation
should be justified in the light of the overriding reasons
of general interest capable of justifying obstacles to the
free movement of healthcare, such as planning
(40) According
to
the
constant
case-law
of
the
Court
of
requirements relating to the aim of ensuring sufficient
Justice, Member States may make the assumption of
and permanent access to a balanced range of high-
costs by the national system of hospital care provided
quality treatment in the Member State concerned or to
in another Member State subject to prior authorisation.
the wish to control costs and avoid, as far as possible,
The Court of Justice has judged that this requirement is
any waste of financial, technical and human resources.
both necessary and reasonable, since the number of
The Court of Justice has identified several potential
hospitals, their geographical distribution, the way in
considerations: the risk of seriously undermining the
which they are organised and the facilities with which
financial balance of a social security system, the
they are equipped, and even the nature of the medical
objective of maintaining on grounds of public health a
services which they are able to offer, are all matters for
balanced medical and hospital service open to all and the
which planning, generally designed to satisfy various
objective of maintaining treatment capacity or medical
needs, must be possible. The Court of Justice has found
competence on national territory, essential for the
that such planning seeks to ensure that there is sufficient
public health, and even the survival of the population.
and permanent access to a balanced range of high-quality
It is also important to take into consideration the general
hospital treatment in the Member State concerned. In
principle of ensuring the safety of the patient, in a sector
addition, it assists in meeting a desire to control costs
well known for information asymmetry, when managing
and to prevent, as far as possible, any wastage of
a prior authorisation system. Conversely, the refusal to
financial, technical and human resources. According to
grant prior authorisation may not be based on the
the Court of Justice, such wastage would be all the more
ground that there are waiting lists on national territory
damaging because it is generally recognised that the
intended to enable the supply of hospital care to be
hospital care sector generates considerable costs and
planned and managed on the basis of predetermined
must satisfy increasing needs, while the financial
general clinical priorities, without carrying out an
resources made available for healthcare are not unlimited,
objective medical assessment.
whatever mode of funding is applied.
(44) According
to
the
constant
case-law
of
the
Court
of
(41) The
same
reasoning
applies
to
healthcare
not
provided
in
Justice, the criteria for granting or refusing prior auth
a hospital but subjected to similar planning needs in the
orisation should be limited to what is necessary and
Member State of treatment. This may be healthcare
proportionate in the light of these overriding reasons
which requires planning because it involves use of
in the general interest. It should be noted that the
highly specialised and cost-intensive medical infra
impact on national health systems caused by patient
structure or medical equipment. In light of technological
mobility might vary between Member States or
progress, the development of new methods of treatment
between regions within a Member State, depending on
and the different policies of the Member States regarding
factors such as geographical location, language barriers,
the roles of hospitals in their healthcare systems, the
location of hospitals in border regions or the size of the
question of whether this kind of healthcare is delivered
population and healthcare budget. It should therefore be
within hospital or ambulatory care facilities is not the
for Member States to set such criteria for refusing prior
decisive factor for deciding whether it requires planning
authorisation that are necessary and proportionate in that
or not.
specific context, also taking into account which
healthcare falls within the scope of the prior authori
sation system, since certain treatments of a highly
specialised nature will be more easily affected even by
a limited patient outflow than others. Consequently,
(42) Given
that
the
Member
States
are
responsible
for
laying
Member States should be able to set up different
down rules as regards the management, requirements,
criteria for different regions or other relevant adminis
quality and safety standards and organisation and
trative levels for the organisation of healthcare, or indeed
delivery of healthcare and that the planning necessities
for different treatments, as long as the system is trans
differ from one Member State to another, it should
parent and easily accessible and the criteria are made
therefore be for the Member States to decide whether
public in advance.

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(45) Where
the
patient
is
entitled
to
healthcare
and
that
mechanisms for providing such information is to
healthcare cannot be provided within a time limit
establish national contact points within each Member
which is medically justifiable, the Member State of
State. Information that has to be provided compulsorily
affiliation should in principle be obliged to grant prior
to patients should be specified. However, the national
authorisation. However, in certain circumstances, cross-
contact points may provide more information voluntarily
border healthcare may expose the patient or the general
and also with the support of the Commission.
public to a risk which overrides the interest of the patient
Information should be provided by national contact
to receive the cross-border healthcare sought. In such
points to patients in any of the official languages of
instances, the Member State of affiliation should be
the Member State in which the contact points are
able to refuse the request for prior authorisation, in
situated. Information may be provided in any other
which case the Member State of affiliation should direct
language.
the patient towards alternative solutions.
(46) In any event, if a Member State decides to establish a
(49) The Member States should decide on the form and
system of prior authorisation for assumption of costs of
number of their national contact points. Such national
hospital or specialised care provided in another Member
contact points may also be incorporated in, or build on,
State in accordance with the provision of this Directive,
activities of existing information centres provided that it
the costs of such care provided in another Member State
is clearly indicated that they are also national contact
should also be reimbursed by the Member State of
points for cross-border healthcare. National contact
affiliation up to the level of costs that would have
points should be established in an efficient and trans
been assumed had the same healthcare been provided
parent way and they should be able to consult with
in the Member State of affiliation, without exceeding
patient organisations, healthcare insurers and healthcare
the actual costs of healthcare received. However, when
providers. The national contact points should have
the conditions set out in Regulation (EEC) No 1408/71
appropriate facilities to provide information on the
or Regulation (EC) No 883/2004 are fulfilled, the auth
main aspects of cross-border healthcare. The Commission
orisation should be granted and the benefits provided in
should work together with the Member States in order to
accordance with Regulation (EC) No 883/2004 unless
facilitate cooperation regarding national contact points
otherwise requested by the patient. This should apply
for cross-border healthcare, including making relevant
in particular in instances where the authorisation is
information available at Union level. The existence of
granted after an administrative or judicial review of the
national contact points should not preclude Member
request and the person concerned has received the
States from establishing other linked contact points at
treatment in another Member State. In that event,
regional or local level, reflecting the specific organisation
Articles 7 and 8 of this Directive should not apply.
of their healthcare system.
This is in line with the case-law of the Court of Justice
which has specified that patients who were refused prior
authorisation on grounds that were subsequently held to
be unfounded, are entitled to have the cost of the
treatment obtained in another Member State reimbursed
(50) Member States should facilitate cooperation between
in full according to the provisions of the legislation in
healthcare providers, purchasers and regulators of
the Member State of treatment.
different Member States at national, regional or local
level in order to ensure safe, high-quality and efficient
cross-border healthcare. This could be of particular
importance in border regions, where cross-border
(47) Procedures
regarding
cross-border
healthcare
established
provision of services may be the most efficient way of
by the Member States should give patients guarantees of
organising health services for the local population, but
objectivity, non-discrimination and transparency, in such
where achieving such cross-border provision on a
a way as to ensure that decisions by national authorities
sustained basis requires cooperation between the health
are made in a timely manner and with due care and
systems of different Member States. Such cooperation
regard for both those overall principles and the individual
may concern joint planning, mutual recognition or adap
circumstances of each case. This should also apply to the
tation of procedures or standards, interoperability of
actual reimbursement of costs of healthcare incurred in
respective national information and communication tech
another Member State after the patient has received
nology (hereinafter ‘ICT’) systems, practical mechanisms
treatment. It is appropriate that, under normal circum
to ensure continuity of care or practical facilitating of
stances, patients be entitled to receive decisions regarding
cross-border provision of healthcare by health profes
cross-border healthcare within a reasonable period of
sionals on a temporary or occasional basis. Directive
time. However, that period should be shortened where
2005/36/EC of the European Parliament and of the
warranted by the urgency of the treatment in question.
Council of 7 September 2005 on the recognition of
professional qualifications
( 1 ) stipulates that free
provision of services of a temporary or occasional
nature, including services provided by health profes
(48) Appropriate
information
on
all
essential
aspects
of
cross-
sionals, in another Member State is not, subject to
border healthcare is necessary in order to enable patients
specific provisions of Union law, to be restricted for
to exercise their rights on cross-border healthcare in
practice. For cross-border healthcare, one of the
( 1 ) OJ L 255, 30.9.2005, p. 22.

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4.4.2011
any reason relating to professional qualifications. This
prescriptions, as long as this does not prevent
Directive should be without prejudice to Directive
prescriptions from other Member States that contain
2005/36/EC.
the common list of elements from being recognised.
The recognition of prescriptions should also apply for
medical devices that are legally placed on the market in
the Member State where the device will be dispensed.
(51) The
Commission
should
encourage
cooperation
between
Member States in the areas set out in Chapter IV of this
Directive and may, in accordance with Article 168(2)
TFEU, take, in close contact with the Member States,
(54) The
Commission
should
support
the
continued
devel
any useful initiative to facilitate and promote such coop
opment of European reference networks between
eration. In that context, the Commission should
healthcare providers and centres of expertise in the
encourage cooperation in cross-border healthcare
Member States. European reference networks can
provision at regional and local level, particularly by iden
improve the access to diagnosis and the provision of
tifying major obstacles to collaboration between
high-quality healthcare to all patients who have
healthcare providers in border regions, and by making
conditions requiring a particular concentration of
recommendations and disseminating information and
resources or expertise, and could also be focal points
best practices on how to overcome such obstacles.
for medical training and research, information dissemi
nation and evaluation, especially for rare diseases. This
Directive should therefore give incentives to Member
States to reinforce the continued development of
(52) The
Member
State
of
affiliation
may
need
to
receive
European reference networks. European reference
confirmation that the cross-border healthcare will be,
networks are based on the voluntary participation of
or has been, delivered by a legally practising health
their members, but the Commission should develop
professional. It is therefore appropriate to ensure that
criteria and conditions that the networks should be
information on the right to practise contained in the
required to fulfil in order to receive support from the
national or local registers of health professionals, if estab
Commission.
lished in the Member State of treatment, are, upon
request, made available to the authorities of the
Member State of affiliation.
(55) Rare
diseases
are
those
that
meet
a
prevalence
threshold
of not more than five affected persons per 10 000, in
line with Regulation (EC) No 141/2000 of the European
Parliament and of the Council of 16 December 1999 on
(53) Where medicinal products are authorised within a
Member State and have been prescribed in that
orphan medicinal products ( 1 ), and they are all serious,
Member State by a member of a regulated health
chronic and often life threatening. Some patients affected
profession within the meaning of Directive 2005/36/EC
by rare diseases face difficulties in their quest for a
for an individual named patient, it should, in principle,
diagnosis and treatment to improve their quality of life
be possible for such prescriptions to be medically
and to increase their life expectancy, difficulties which
recognised and for the medicinal products to be
were also recognised by the Council Recommendation
dispensed in another Member State in which the
of 8 June 2009 on an action in the field of rare
medicinal products are authorised. The removal of regu
diseases ( 2 ).
latory and administrative barriers to such recognition
should be without prejudice to the need for appropriate
agreement of the patient’s treating physician or phar
(56) Technological
developments
in
cross-border
provision
of
macist in every individual case, if this is warranted by
healthcare through the use of ICTs may result in the
protection of human health and is necessary and propor
exercise of supervisory responsibilities by Member
tionate to that objective. The recognition of prescriptions
States being unclear, and can thus hinder the free
from other Member States should not affect any profes
movement of healthcare and give rise to possible addi
sional or ethical duty that would require pharmacists to
tional risks to health protection. Widely different and
refuse to dispense the prescription. Such medical recog
incompatible formats and standards are used for
nition should also be without prejudice to the decision of
provision of healthcare using ICTs throughout the
the Member State of affiliation regarding the inclusion of
Union, creating both obstacles to this mode of cross-
such medicinal products among the benefits covered by
border healthcare provision and possible risks to health
the social security system of affiliation. It should further
protection. It is therefore necessary for Member States to
be noted that the reimbursement of medicinal products is
aim at interoperability of ICT systems. The deployment
not affected by the rules on mutual recognition of
of health ICT systems, however, is entirely a national
prescriptions, but covered by the general rules on reim
competence. This Directive therefore should recognise
bursement of cross-border healthcare in Chapter III of
the importance of the work on interoperability and
this Directive. The implementation of the principle of
respect the division of competences by providing for
recognition should be facilitated by the adoption of
the Commission and Member States to work together
measures necessary for safeguarding the safety of a
on developing measures which are not legally binding
patient, and avoiding the misuse or confusion of
but provide additional tools that are available to
medicinal products. These measures should include the
Member States to facilitate greater interoperability of
adoption of a non-exhaustive list of elements to be
included in prescriptions. Nothing should prevent
( 1 ) OJ L 18, 22.1.2000, p. 1.
Member States from having further elements in their
( 2 ) OJ C 151, 3.7.2009, p. 7.

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Union L
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ICT systems in the healthcare field and to support patient
empowered to adopt delegated acts in respect of the
access to eHealth applications, whenever Member States
criteria and conditions that European reference
decide to introduce them.
networks have to fulfil.
(57) The interoperability of eHealth solutions should be
(61) It
is
of
particular
importance
that,
when
empowered
to
achieved whilst respecting national regulations on the
adopt delegated acts in accordance with Article 290
provision of healthcare services adopted in order to
TFEU, the Commission carry out appropriate consul
protect the patient, including legislation on Internet
tations during its preparatory work, including at expert
pharmacies, in particular national bans on mail order
level.
of prescription-only medicinal products to the extent
that they are compatible with the case-law of the Court
of Justice and Directive 97/7/EC of the European
Parliament and of the Council of 20 May 1997 on the
(62) In
accordance
with
point
34
of
the
Interinstitutional
protection of consumers in respect of distance
Agreement on better law-making ( 4 ), Member States are
contracts ( 1 ) and Directive 2000/31/EC of the European
encouraged to draw up, for themselves and in the
Parliament and of the Council of 8 June 2000 on certain
interests of the Union, their own tables illustrating, as
legal aspects of information society services, in particular
far as possible, the correlation between this Directive
electronic commerce, in the Internal Market ( 2 ).
and the transposition measures, and to make them
public.
(58) The
constant
progress
of
medical
science
and
health
tech
nologies presents both opportunities and challenges to
(63) The European Data Protection Supervisor has
the health systems of the Member States. Cooperation
also delivered his opinion on the proposal for this
in the evaluation of new health technologies can
Directive ( 5 ).
support Member States through economies of scale and
avoid duplication of effort, and provide a better evidence
base for optimal use of new technologies to ensure safe,
high-quality and efficient healthcare. Such cooperation
(64) Since the objective of this Directive, namely providing
requires sustained structures involving all the relevant
rules for facilitating the access to safe and high quality
authorities of the Member States, building on existing
cross-border healthcare in the Union, cannot be
pilot projects and consultation of a wide range of stake
sufficiently achieved by the Member States and can
holders. This Directive should therefore provide a basis
therefore, by reason of its scale and effects, be better
for continued Union support for such cooperation.
achieved at Union level, the Union may adopt
measures, in accordance with the principle of subsidiarity
as set out in Article 5 of the Treaty on European Union.
In accordance with the principle of proportionality, as set
out in that Article, this Directive does not go beyond
(59) According
to
Article
291
TFEU,
rules
and
general
prin
ciples concerning mechanisms for the control by
what is necessary in order to achieve that objective,
Member States of the Commission’s exercise of imple
menting powers are to be laid down in advance by a
regulation adopted in accordance with the ordinary legis
lative procedure. Pending the adoption of that new Regu
HAVE ADOPTED THIS DIRECTIVE:
lation, Council Decision 1999/468/EC of 28 June 1999
laying down the procedures for the exercise of imple
menting powers conferred on the Commission
( 3 )
continues to apply, with the exception of the regulatory
CHAPTER I
procedure with scrutiny, which is not applicable.
GENERAL PROVISIONS
Article 1
Subject matter and scope
(60) The Commission should be empowered to adopt
delegated acts in accordance with Article 290 TFEU in
1. This
Directive
provides
rules
for
facilitating
the
access
to
respect of measures that would exclude specific
safe and high-quality cross-border healthcare and promotes
categories of medicinal products or medical devices
cooperation on healthcare between Member States, in full
from the recognition of prescriptions, as provided for
respect of national competencies in organising and delivering
in this Directive. In order to identify the reference
healthcare. This Directive also aims at clarifying its relationship
networks which should benefit from support by the
with the existing framework on the coordination of social
Commission, the Commission should also be
security systems, Regulation (EC) No 883/2004, with a view
to application of patients’ rights.
( 1 ) OJ L 144, 4.6.1997, p. 19.
( 2 ) OJ L 178, 17.7.2000, p. 1.
( 4 ) OJ C 321, 31.12.2003, p. 1.
( 3 ) OJ L 184, 17.7.1999, p. 23.
( 5 ) OJ C 128, 6.6.2009, p. 20.

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2. This
Directive
shall
apply
to
the
provision
of
healthcare
to (f) Council Directive 2000/43/EC of 29 June 2000 imple
patients, regardless of how it is organised, delivered and
menting the principle of equal treatment between persons
financed.
irrespective of racial or ethnic origin ( 7 );
3. This
Directive
shall
not
apply
to:
(g) Directive 2001/20/EC of the European Parliament and of
(a) services in the field of long-term care the purpose of which
the Council of 4 April 2001 on the approximation of the
is to support people in need of assistance in carrying out
laws, regulations and administrative provisions of the
routine, everyday tasks;
Member States relating to the implementation of good
clinical practice in the conduct of clinical trials on
(b) allocation of and access to organs for the purpose of organ
medicinal products for human use ( 8 );
transplants;
(c) with the exception of Chapter IV, public vaccination
(h) Directive 2001/83/EC of the European Parliament and of
programmes against infectious diseases which are
the Council of 6 November 2001 on the Community code
exclusively aimed at protecting the health of the population
relating to medicinal products for human use ( 9 );
on the territory of a Member State and which are subject to
specific planning and implementation measures.
(i) Directive
2002/98/EC of the European Parliament and of
4. This
Directive
shall
not
affect
laws
and
regulations
in
the Council of 27 January 2003 setting standards of quality
Member States relating to the organisation and financing of
and safety for the collection, testing, processing,
healthcare in situations not related to cross-border healthcare.
storage and distribution of human blood and blood
In particular, nothing in this Directive obliges a Member State
components ( 10 );
to reimburse costs of healthcare provided by healthcare
providers established on its own territory if those providers
are not part of the social security system or public health
system of that Member State.
(j) Regulation
(EC)
No
859/2003;
Article 2
(k) Directive 2004/23/EC of the European Parliament and of
Relationship with other Union provisions
the Council of 31 March 2004 on setting standards of
This Directive shall apply without prejudice to:
quality and safety for the donation, procurement, testing,
processing, preservation, storage and distribution of human
(a) Council Directive 89/105/EEC of 21 December 1988
tissues and cells ( 11 );
relating to the transparency of measures regulating the
prices of medicinal products for human use and their
inclusion in the scope of national health insurance
(l) Regulation
(EC)
No
726/2004
of
the
European
Parliament
systems ( 1 );
and of the Council of 31 March 2004 laying down
Community procedures for the authorisation and super
(b) Council Directive 90/385/EEC of 20 June 1990 on the
vision of medicinal products for human and veterinary
approximation of the laws of the Member States relating
use and establishing a European Medicines Agency ( 12 );
to active implantable medical devices ( 2 ), Council Directive
93/42/EEC of 14 June 1993 concerning medical devices ( 3 )
and Directive 98/79/EC of the European Parliament and of
(m) Regulation (EC) No 883/2004 and Regulation (EC) No
the Council of 27 October 1998 on in vitro diagnostic
987/2009 of the European Parliament and of the Council
medical devices ( 4 );
of 16 September 2009 laying down the procedure for
implementing Regulation (EC) No 883/2004 on the
(c) Directive 95/46/EC and Directive 2002/58/EC of the
coordination of social security systems ( 13 );
European Parliament and of the Council of 12 July 2002
concerning the processing of personal data and the
protection of privacy in the electronic communications
(n) Directive 2005/36/EC;
sector ( 5 );
(d) Directive 96/71/EC of the European Parliament and of the
Council of 16 December 1996 concerning the posting of
(o) Regulation (EC) No 1082/2006 of the European Parliament
workers in the framework of the provision of services (
and of the Council of 5 July 2006 on a European grouping

6 );
of territorial cooperation (EGTC) ( 14 );
(e) Directive 2000/31/EC;
( 7 ) OJ L 180, 19.7.2000, p. 22.
( 8 ) OJ L 121, 1.5.2001, p. 34.
( 1 ) OJ L 40, 11.2.1989, p. 8.
( 9 ) OJ L 311, 28.11.2001, p. 67.
( 2 ) OJ L 189, 20.7.1990, p. 17.
( 10 ) OJ L 33, 8.2.2003, p. 30.
( 3 ) OJ L 169, 12.7.1993, p. 1.
( 11 ) OJ L 102, 7.4.2004, p. 48.
( 4 ) OJ L 331, 7.12.1998, p. 1.
( 12 ) OJ L 136, 30.4.2004, p. 1.
( 5 ) OJ L 201, 31.7.2002, p. 37.
( 13 ) OJ L 284, 30.10.2009, p. 1.
( 6 ) OJ L 18, 21.1.1997, p. 1.
( 14 ) OJ L 210, 31.7.2006, p. 19.

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(p) Regulation (EC) No 1338/2008 of the European Parliament
(ii) for persons referred to in point (b)(ii), the Member State
and of the Council of 16 December 2008 on Community
that is competent to grant to the insured person a prior
statistics on public health and health and safety at work ( 1 );
authorisation to receive appropriate treatment in
another Member State according to Regulation (EC)
No 859/2003 or Regulation (EU) No 1231/2010. If
(q) Regulation (EC) No 593/2008 of the European Parliament
no Member State is competent according to those
and of the Council of 17 June 2008 on the law applicable
Regulations, the Member State of affiliation shall be
to contractual obligations (Rome I) ( 2 ), Regulation (EC)
the Member State where the person is insured or has
No 864/2007 of the European Parliament and of the
the rights to sickness benefits according to the legis
Council of 11 July 2007 on the law applicable to non-
lation of that Member State;
contractual obligations (Rome II) ( 3 ) and other Union rules
on private international law, in particular rules related to
court jurisdiction and the applicable law;
(d) ‘Member State of treatment’ means the Member State on
whose territory healthcare is actually provided to the
(r) Directive 2010/53/EU of the European Parliament and of
patient. In the case of telemedicine, healthcare is considered
the Council of 7 July 2010 on standards of quality and
to be provided in the Member State where the healthcare
safety of human organs intended for transplantation ( 4 );
provider is established;
(s) Regulation (EU) No 1231/2010.
(e) ‘cross-border healthcare’ means healthcare provided or
prescribed in a Member State other than the Member
Article 3
State of affiliation;
Definitions
For the purposes of this Directive, the following definitions shall
apply:
(f) ‘health professional’ means a doctor of medicine, a nurse
responsible for general care, a dental practitioner, a midwife
or a pharmacist within the meaning of Directive
(a) ‘healthcare’ means health services provided by health
2005/36/EC, or another professional exercising activities
professionals to patients to assess, maintain or restore
in the healthcare sector which are restricted to a
their state of health, including the prescription, dispen
regulated profession as defined in Article 3(1)(a) of
sation and provision of medicinal products and medical
Directive 2005/36/EC, or a person considered to be a
devices;
health professional according to the legislation of the
Member State of treatment;
(b) ‘insured person’ means:
(g) ‘healthcare provider’ means any natural or legal person or
(i) persons, including members of their families and their
any other entity legally providing healthcare on the
survivors, who are covered by Article 2 of Regulation
territory of a Member State;
(EC) No 883/2004 and who are insured persons within
the meaning of Article 1(c) of that Regulation; and
(h) ‘patient’ means any natural person who seeks to receive or
(ii) nationals of a third country who are covered by Regu
receives healthcare in a Member State;
lation (EC) No 859/2003 or Regulation (EU) No
1231/2010, or who satisfy the conditions of the legis
lation of the Member State of affiliation for entitlement
to benefits;
(i) ‘medicinal product’ means a medicinal product as defined
by Directive 2001/83/EC;
(c) ‘Member State of affiliation’ means:
(j) ‘medical device’ means a medical device as defined by
(i) for persons referred to in point (b)(i), the Member State
Directive 90/385/EEC, Directive 93/42/EEC or Directive
that is competent to grant to the insured person a prior
98/79/EC;
authorisation to receive appropriate treatment outside
the Member State of residence according to Regulations
(EC) No 883/2004 and (EC) No 987/2009;
(k) ‘prescription’ means a prescription for a medicinal product
or for a medical device issued by a member of a regulated
( 1 ) OJ L 354, 31.12.2008, p. 70.
health profession within the meaning of Article 3(1)(a) of
( 2 ) OJ L 177, 4.7.2008, p. 6.
( 3 ) OJ L 199, 31.7.2007, p. 40.
Directive 2005/36/EC who is legally entitled to do so in
( 4 ) OJ L 207, 6.8.2010, p. 14.
the Member State in which the prescription is issued;

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(l) ‘health
technology’ means a
medicinal
product,
a medical
(c)
there are transparent complaints procedures and
device or medical and surgical procedures as well as
mechanisms in place for patients, in order for them to
measures for disease prevention, diagnosis or treatment
seek remedies in accordance with the legislation of the
used in healthcare;
Member State of treatment if they suffer harm arising
from the healthcare they receive;
(m) ‘medical records’ means all the documents containing data,
assessments and information of any kind on a patient’s
situation and clinical development throughout the care
(d) systems of professional liability insurance, or a guarantee or
process.
similar arrangement that is equivalent or essentially
comparable as regards its purpose and which is appropriate
to the nature and the extent of the risk, are in place for
treatment provided on its territory;
CHAPTER II
RESPONSIBILITIES OF MEMBER STATES WITH REGARD TO
CROSS-BORDER HEALTH CARE
Article 4
(e) the fundamental right to privacy with respect to the
processing of personal data is protected in conformity
Responsibilities of the Member State of treatment
with national measures implementing Union provisions on
1. Taking
into
account
the
principles
of
universality,
access
the protection of personal data, in particular Directives
to good quality care, equity and solidarity, cross-border
95/46/EC and 2002/58/EC;
healthcare shall be provided in accordance with:
(a) the legislation of the Member State of treatment;
(f) in order to ensure continuity of care, patients who have
received treatment are entitled to a written or electronic
medical record of such treatment, and access to at least a
copy of this record in conformity with and subject to
(b) standards and guidelines on quality and safety laid down by
national measures implementing Union provisions on the
the Member State of treatment; and
protection of personal data, in particular Directives
95/46/EC and 2002/58/EC.
(c) Union legislation on safety standards.
3. The
principle
of
non-discrimination
with
regard
to
2. The
Member
State
of
treatment
shall
ensure
that:
nationality shall be applied to patients from other Member
States.
(a) patients receive from the national contact point referred to
in Article 6, upon request, relevant information on the
standards and guidelines referred to in paragraph 1(b) of
This shall be without prejudice to the possibility for the
this Article, including provisions on supervision and
Member State of treatment, where it is justified by overriding
assessment of healthcare providers, information on which
reasons of general interest, such as planning requirements
healthcare providers are subject to these standards and
relating to the aim of ensuring sufficient and permanent
guidelines and information on the accessibility of hospitals
access to a balanced range of high-quality treatment in the
for persons with disabilities;
Member State concerned or to the wish to control costs and
avoid, as far as possible, any waste of financial, technical and
human resources, to adopt measures regarding access to
treatment aimed at fulfilling its fundamental responsibility to
(b) healthcare providers provide relevant information to help
ensure sufficient and permanent access to healthcare within its
individual patients to make an informed choice, including
territory. Such measures shall be limited to what is necessary
on treatment options, on the availability, quality and safety
and proportionate and may not constitute a means of arbitrary
of the healthcare they provide in the Member State of
discrimination and shall be made publicly available in advance.
treatment and that they also provide clear invoices and
clear information on prices, as well as on their authorisation
or registration status, their insurance cover or other means
of personal or collective protection with regard to profes
sional liability. To the extent that healthcare providers
4. Member States shall ensure that the healthcare providers
already provide patients resident in the Member State of
on their territory apply the same scale of fees for healthcare for
treatment with relevant information on these subjects, this
patients from other Member States, as for domestic patients in a
Directive does not oblige healthcare providers to provide
comparable medical situation, or that they charge a price
more extensive information to patients from other
calculated according to objective, non-discriminatory criteria if
Member States;
there is no comparable price for domestic patients.

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This paragraph shall be without prejudice to national legislation
2. National
contact
points
shall
facilitate
the
exchange
of
which allows healthcare providers to set their own prices,
information referred to in paragraph 3 and shall cooperate
provided that they do not discriminate against patients from
closely with each other and with the Commission. National
other Member States.
contact points shall provide patients on request with contact
details of national contact points in other Member States.
5. This
Directive
shall
not
affect
laws
and
regulations
in
Member States on the use of languages. Member States may
choose to deliver information in other languages than those
3. In order to enable patients to make use of their rights in
which are official languages in the Member State concerned.
relation to cross-border healthcare, national contact points in
the Member State of treatment shall provide them with
information concerning healthcare providers, including, on
request, information on a specific provider’s right to provide
Article 5
services or any restrictions on its practice, information
referred to in Article 4(2)(a), as well as information on
Responsibilities of the Member State of affiliation
patients’ rights, complaints procedures and mechanisms for
The Member State of affiliation shall ensure that:
seeking remedies, according to the legislation of that Member
State, as well as the legal and administrative options available to
settle disputes, including in the event of harm arising from
cross-border healthcare.
(a) the cost of cross-border healthcare is reimbursed in
accordance with Chapter III;
4. National
contact
points
in
the
Member
State
of
affiliation
(b) there are mechanisms in place to provide patients on
shall provide patients and health professionals with the
request with information on their rights and entitlements
information referred to in Article 5(b).
in that Member State relating to receiving cross-border
healthcare, in particular as regards the terms and conditions
for reimbursement of costs in accordance with Article 7(6)
and procedures for accessing and determining those
5. The
information
referred
to
in
this
Article
shall
be
easily
entitlements and for appeal and redress if patients
accessible and shall be made available by electronic means and
consider that their rights have not been respected, in
in formats accessible to people with disabilities, as appropriate.
accordance with Article 9. In information about cross-
border healthcare, a clear distinction shall be made
between the rights which patients have by virtue of this
Directive and rights arising from Regulation (EC)
CHAPTER III
No 883/2004;
REIMBURSEMENT OF COSTS OF CROSS-BORDER
HEALTHCARE
(c) where a patient has received cross-border healthcare and
Article 7
where medical follow-up proves necessary, the same
General principles for reimbursement of costs
medical follow-up is available as would have been if that
healthcare had been provided on its territory;
1. Without
prejudice
to
Regulation
(EC)
No
883/2004
and
subject to the provisions of Articles 8 and 9, the Member State
of affiliation shall ensure the costs incurred by an insured
person who receives cross-border healthcare are reimbursed, if
(d) patients who seek to receive or do receive cross-border
the healthcare in question is among the benefits to which the
healthcare have remote access to or have at least a copy
insured person is entitled in the Member State of affiliation.
of their medical records, in conformity with, and subject to,
national measures implementing Union provisions on the
protection of personal data, in particular Directives
95/46/EC and 2002/58/EC.
2. By
way
of
derogation
from
paragraph
1:
Article 6
National contact points for cross-border healthcare
(a) if a Member State is listed in Annex IV to Regulation (EC)
No 883/2004 and in compliance with that Regulation has
1. Each
Member
State
shall
designate
one
or
more
national
recognised the rights to sickness benefits for pensioners and
contact points for cross-border healthcare and communicate
the members of their families, being resident in a different
their names and contact details to the Commission. The
Member State, it shall provide them healthcare under this
Commission and the Member States shall make this information
Directive at its own expense when they stay on its territory,
publicly available. Member States shall ensure that the national
in accordance with its legislation, as though the persons
contact points consult with patient organisations, healthcare
concerned were residents in the Member State listed in
providers and healthcare insurers.
that Annex;

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L 88/58
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Official Journal of the European Union
4.4.2011
(b) if the healthcare provided in accordance with this Directive
the Member State of affiliation. This mechanism shall be based
is not subject to prior authorisation, is not provided in
on objective, non-discriminatory criteria known in advance and
accordance with Chapter 1 of Title III of the Regulation
applied at the relevant (local, regional or national) adminis
(EC) No 883/2004, and is provided in the territory of the
trative level.
Member State that according to that Regulation and Regu
lation (EC) No 987/2009 is, in the end, responsible for
reimbursement of the costs, the costs shall be assumed by
that Member State. That Member State may assume the
costs of the healthcare in accordance with the terms,
7. The
Member
State
of
affiliation
may
impose
on
an
insured
conditions, criteria for eligibility and regulatory and admin
person seeking reimbursement of the costs of cross-border
istrative formalities that it has established, provided that
healthcare, including healthcare received through means of tele
these are compatible with the TFEU.
medicine, the same conditions, criteria of eligibility and regu
latory and administrative formalities, whether set at a local,
regional or national level, as it would impose if this healthcare
were provided in its territory. This may include an assessment
by a health professional or healthcare administrator providing
services for the statutory social security system or national
3. It is for the Member State of affiliation to determine,
health system of the Member State of affiliation, such as the
whether at a local, regional or national level, the healthcare
general practitioner or primary care practitioner with whom the
for which an insured person is entitled to assumption of
patient is registered, if this is necessary for determining the
costs and the level of assumption of those costs, regardless of
individual patient’s entitlement to healthcare. However, no
where the healthcare is provided.
conditions, criteria of eligibility and regulatory and adminis
trative formalities imposed according to this paragraph may
be discriminatory or constitute an obstacle to the free
movement of patients, services or goods, unless it is objectively
justified by planning requirements relating to the object of
4. The
costs
of
cross-border
healthcare
shall
be
reimbursed ensuring sufficient and permanent access to a balanced range
or paid directly by the Member State of affiliation up to the
of high-quality treatment in the Member State concerned or to
level of costs that would have been assumed by the Member
the wish to control costs and avoid, as far as possible, any waste
State of affiliation, had this healthcare been provided in its
of financial, technical and human resources.
territory without exceeding the actual costs of healthcare
received.
8. The
Member
State
of
affiliation
shall
not
make
the
reim
bursement of costs of cross-border healthcare subject to prior
Where the full cost of cross-border healthcare exceeds the level
authorisation except in the cases set out in Article 8.
of costs that would have been assumed had the healthcare been
provided in its territory the Member State of affiliation may
nevertheless decide to reimburse the full cost.
9. The
Member
State
of
affiliation
may
limit
the
application
of the rules on reimbursement for cross-border healthcare based
on overriding reasons of general interest, such as planning
requirements relating to the aim of ensuring sufficient and
The Member State of affiliation may decide to reimburse other
permanent access to a balanced range of high-quality
related costs, such as accommodation and travel costs, or extra
treatment in the Member State concerned or to the wish to
costs which persons with disabilities might incur due to one or
control costs and avoid, as far as possible, any waste of
more disabilities when receiving cross-border healthcare, in
financial, technical and human resources.
accordance with national legislation and on the condition that
there be sufficient documentation setting out these costs.
10. Notwithstanding
paragraph
9,
Member
States
shall
ensure that the cross-border healthcare for which a prior auth
5. Member
States
may
adopt
provisions
in
accordance
with orisation has been granted is reimbursed in accordance with the
the TFEU aimed at ensuring that patients enjoy the same rights
authorisation.
when receiving cross-border healthcare as they would have
enjoyed if they had received healthcare in a comparable
situation in the Member State of affiliation.
11. The
decision
to
limit
the
application
of
this
Article
pursuant to paragraph 9 shall be restricted to what is
necessary and proportionate, and may not constitute a means
of arbitrary discrimination or an unjustified obstacle to the free
6. For
the
purposes
of
paragraph
4,
Member
States
shall
have movement of goods, persons or services. Member States shall
a transparent mechanism for calculation of costs of cross-border
notify the Commission of any decisions to limit reimbursement
healthcare that are to be reimbursed to the insured person by
on the grounds stated in paragraph 9.

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EN
4.4.2011 Official
Journal
of
the
European
Union L
88/59
Article 8
4.
When a patient affected, or suspected of being affected, by
a rare disease applies for prior authorisation, a clinical
Healthcare that may be subject to prior authorisation
evaluation may be carried out by experts in that field. If no
1. The
Member
State
of
affiliation
may
provide
for
a
system experts can be found within the Member State of affiliation or if
of prior authorisation for reimbursement of costs of cross-
the expert’s opinion is inconclusive, the Member State of
border healthcare, in accordance with this Article and
affiliation may request scientific advice.
Article 9. The system of prior authorisation, including the
criteria and the application of those criteria, and individual
decisions of refusal to grant prior authorisation, shall be
restricted to what is necessary and proportionate to the
5. Without prejudice to points (a) to (c) of paragraph 6, the
objective to be achieved, and may not constitute a means of
Member State of affiliation may not refuse to grant prior auth
arbitrary discrimination or an unjustified obstacle to the free
orisation when the patient is entitled to the healthcare in
movement of patients.
question in accordance with Article 7, and when this healthcare
cannot be provided on its territory within a time limit which is
medically justifiable, based on an objective medical assessment
of the patient’s medical condition, the history and probable
2. Healthcare
that
may
be
subject
to
prior
authorisation
shall course of the patient’s illness, the degree of the patient’s pain
be limited to healthcare which:
and/or the nature of the patient’s disability at the time when the
request for authorisation was made or renewed.
(a) is made subject to planning requirements relating to the
object of ensuring sufficient and permanent access to a
balanced range of high-quality treatment in the Member
6. The
Member
State
of
affiliation
may
refuse
to
grant
prior
State concerned or to the wish to control costs and avoid,
authorisation for the following reasons:
as far as possible, any waste of financial, technical and
human resources and:
(a) the patient will, according to a clinical evaluation, be
(i) involves overnight hospital accommodation of the
exposed with reasonable certainty to a patient-safety risk
patient in question for at least one night; or
that cannot be regarded as acceptable, taking into account
the potential benefit for the patient of the sought cross-
border healthcare;
(ii) requires use of highly specialised and cost-intensive
medical infrastructure or medical equipment;
(b) the general public will be exposed with reasonable certainty
to a substantial safety hazard as a result of the cross-border
healthcare in question;
(b) involves treatments presenting a particular risk for the
patient or the population; or
(c) this healthcare is to be provided by a healthcare provider
(c) is provided by a healthcare provider that, on a case-by-case
that raises serious and specific concerns relating to the
basis, could give rise to serious and specific concerns
respect of standards and guidelines on quality of care and
relating to the quality or safety of the care, with the
patient safety, including provisions on supervision, whether
exception of healthcare which is subject to Union legislation
these standards and guidelines are laid down by laws and
ensuring a minimum level of safety and quality throughout
regulations or through accreditation systems established by
the Union.
the Member State of treatment;
Member States shall notify the categories of healthcare referred
(d) this healthcare can be provided on its territory within a time
to in point (a) to the Commission.
limit which is medically justifiable, taking into account the
current state of health and the probable course of the illness
of each patient concerned.
3. With
regard
to
requests
for
prior
authorisation
made
by
an insured person with a view to receiving cross-border
healthcare, the Member State of affiliation shall ascertain
whether the conditions laid down in Regulation (EC)
7. The
Member
State
of
affiliation
shall
make
publicly
No 883/2004 have been met. Where those conditions are
available which healthcare is subject to prior authorisation for
met, the prior authorisation shall be granted pursuant to that
the purposes of this Directive, as well as all relevant information
Regulation unless the patient requests otherwise.
on the system of prior authorisation.

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L 88/60
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Official Journal of the European Union
4.4.2011
Article 9
cooperation on standards and guidelines on quality and safety
and the exchange of information, especially between their
Administrative procedures regarding cross-border
national contact points in accordance with Article 6,
healthcare
including on provisions on supervision and mutual assistance
1. The
Member
State
of
affiliation
shall
ensure
that
adminis
to clarify the content of invoices.
trative procedures regarding the use of cross-border healthcare
and reimbursement of costs of healthcare incurred in another
Member State are based on objective, non-discriminatory criteria
which are necessary and proportionate to the objective to be
2. Member
States
shall
facilitate
cooperation
in
cross-border
achieved.
healthcare provision at regional and local level as well as
through ICT and other forms of cross-border cooperation.
2. Any
administrative
procedure
of
the
kind
referred
to
in
paragraph 1 shall be easily accessible and information relating
to such a procedure shall be made publicly available at the
3. The Commission shall encourage Member States,
appropriate level. Such a procedure shall be capable of
particularly neighbouring countries, to conclude agreements
ensuring that requests are dealt with objectively and impartially.
among themselves. The Commission shall also encourage the
Member States to cooperate in cross-border healthcare provision
in border regions.
3. Member
States
shall
set
out
reasonable
periods
of
time
within which requests for cross-border healthcare must be
dealt with and make them public in advance. When considering
a request for cross-border healthcare, Member States shall take
into account:
4. Member
States
of
treatment
shall
ensure
that
information
on the right to practise of health professionals listed in national
or local registers established on their territory is, upon request,
(a) the specific medical condition;
made available to the authorities of other Member States, for
the purpose of cross-border healthcare, in accordance with
Chapters II and III and with national measures implementing
Union provisions on the protection of personal data, in
(b) the urgency and individual circumstances.
particular Directives 95/46/EC and 2002/58/EC, and the
principle of presumption of innocence. The exchange of
information shall take place via the Internal Market Information
4. Member
States
shall
ensure
that
individual
decisions system established pursuant to Commission Decision
regarding the use of cross-border healthcare and reimbursement
2008/49/EC of 12 December 2007 concerning the implemen
of costs of healthcare incurred in another Member State are
tation of the Internal Market Information System (IMI) as
properly reasoned and subject, on a case-by-case basis, to
regards the protection of personal data ( 1 ).
review and are capable of being challenged in judicial
proceedings, which include provision for interim measures.
5. This
Directive
is
without
prejudice
to
Member
States’
right
Article 11
to offer patients a voluntary system of prior notification
Recognition of prescriptions issued in another Member
whereby, in return for such notification, the patient receives a
State
written confirmation of the amount to be reimbursed on the
basis of an estimate. This estimate shall take into account the
1. If a medicinal product is authorised to be marketed on
patient’s clinical case, specifying the medical procedures likely to
their territory, in accordance with Directive 2001/83/EC or
apply.
Regulation (EC) No 726/2004, Member States shall ensure
that prescriptions issued for such a product in another
Member State for a named patient can be dispensed on their
Member States may choose to apply the mechanisms of
territory in compliance with their national legislation in force,
financial compensation between the competent institutions as
and that any restrictions on recognition of individual
provided for by Regulation (EC) No 883/2004. Where a
prescriptions are prohibited unless such restrictions are:
Member State of affiliation does not apply such mechanisms,
it shall ensure that patients receive reimbursement without
undue delay.
(a) limited to what is necessary and proportionate to safeguard
human health, and non-discriminatory; or
CHAPTER IV
COOPERATION IN HEALTHCARE
Article 10
(b) based on legitimate and justified doubts about the auth
enticity, content or comprehensibility of an individual
Mutual assistance and cooperation
prescription.
1. Member
States
shall
render
such
mutual
assistance
as
is
necessary for the implementation of this Directive, including
( 1 ) OJ L 13, 16.1.2008, p. 18.

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4.4.2011 Official
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European
Union L
88/61
The recognition of such prescriptions shall not affect national
(d) measures to facilitate the comprehensibility of the
rules governing prescribing and dispensing, if those rules are
information to patients concerning the prescription and
compatible with Union law, including generic or other substi
the instructions included on the use of the product,
tution. The recognition of prescriptions shall not affect the rules
including an indication of active substance and dosage.
on reimbursement of medicinal products. Reimbursement of
costs of medicinal products is covered by Chapter III of this
Directive.
Measures referred in point (a) shall be adopted by the
Commission no later than 25 December 2012 and measures
in points (c) and (d) shall be adopted by the Commission no
In particular, the recognition of prescriptions shall not affect a
later than 25 October 2012.
pharmacist’s right, by virtue of national rules, to refuse, for
ethical reasons, to dispense a product that was prescribed in
another Member State, where the pharmacist would have the
3. The measures and guidelines referred to in points (a) to (d)
right to refuse to dispense, had the prescription been issued in
of paragraph 2 shall be adopted in accordance with the regu
the Member State of affiliation.
latory procedure referred to in Article 16(2).
The Member State of affiliation shall take all necessary
4. In
adopting
measures
or
guidelines
under
paragraph
2,
the
measures, in addition to the recognition of the prescription,
Commission shall have regard to the proportionality of any
in order to ensure continuity of treatment in cases where a
costs of compliance with, as well as the likely benefits of, the
prescription is issued in the Member State of treatment for
measures or guidelines.
medicinal products or medical devices available in the
Member State of affiliation and where dispensing is sought in
the Member State of affiliation.
5. For the purpose of paragraph 1, the Commission shall
also adopt, by means of delegated acts in accordance with
Article 17 and subject to the conditions of Articles 18 and
19 and no later than 25 October 2012 measures to exclude
This paragraph shall also apply to medical devices that are
specific categories of medicinal products or medical devices
legally placed on the market in the respective Member State.
from the recognition of prescriptions provided for under this
Article, where necessary in order to safeguard public health.
2. In
order
to
facilitate
implementation
of
paragraph
1,
the
Commission shall adopt:
6. Paragraph
1
shall
not
apply
to
medicinal
products
subject
to special medical prescription provided for in Article 71(2) of
Directive 2001/83/EC.
(a) measures enabling a health professional to verify the auth
enticity of the prescription and whether the prescription was
issued in another Member State by a member of a regulated
Article 12
health profession who is legally entitled to do so through
European reference networks
developing a non-exhaustive list of elements to be included
in the prescriptions and which must be clearly identifiable
1. The
Commission
shall
support
Member
States
in
the
in all prescription formats, including elements to facilitate, if
development of European reference networks between
needed, contact between the prescribing party and the
healthcare providers and centres of expertise in the Member
dispensing party in order to contribute to a complete under
States, in particular in the area of rare diseases. The networks
standing of the treatment, in due respect of data protection;
shall be based on voluntary participation by its members, which
shall participate and contribute to the networks’ activities in
accordance with the legislation of the Member State where
the members are established and shall at all times be open to
(b) guidelines supporting the Member States in developing the
new healthcare providers which might wish to join them,
interoperability of ePrescriptions;
provided that such healthcare providers fulfil all the required
conditions and criteria referred to in paragraph 4.
(c) measures to facilitate the correct identification of medicinal
2. European
reference
networks
shall
have
at
least
three
of
products or medical devices prescribed in one Member State
the following objectives:
and dispensed in another, including measures to address
patient safety concerns in relation to their substitution in
cross border healthcare where the legislation of the
dispensing Member State permits such substitution. The
(a) to help realise the potential of European cooperation
Commission shall consider, inter alia, using the International
regarding highly specialised healthcare for patients and for
Non-proprietary Name and the dosage of medicinal
healthcare systems by exploiting innovations in medical
products;
science and health technologies;

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L 88/62
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Official Journal of the European Union
4.4.2011
(b) to contribute to the pooling of knowledge regarding
(ii) follow a multi-disciplinary approach;
sickness prevention;
(iii) offer a high level of expertise and have the capacity to
(c) to facilitate improvements in diagnosis and the delivery of
produce good practice guidelines and to implement
high-quality, accessible and cost-effective healthcare for all
outcome measures and quality control;
patients with a medical condition requiring a particular
concentration of expertise in medical domains where
expertise is rare;
(iv) make a contribution to research;
(d) to maximise the cost-effective use of resources by concen
trating them where appropriate;
(v) organise teaching and training activities; and
(e) to reinforce research, epidemiological surveillance like
(vi) collaborate closely with other centres of expertise and
registries and provide training for health professionals;
networks at national and international level;
(f) to facilitate mobility of expertise, virtually or physically, and
to develop, share and spread information, knowledge and
(b) develop and publish criteria for establishing and evaluating
best practice and to foster developments of the diagnosis
European reference networks;
and treatment of rare diseases, within and outside the
networks;
(c) facilitate the exchange of information and expertise in
relation to the establishment of European reference
(g) to encourage the development of quality and safety
networks and their evaluation.
benchmarks and to help develop and spread best practice
within and outside the network;
5. The
Commission
shall
adopt
the
measures
referred
to
in
(h) to help Member States with an insufficient number of
paragraph 4(a) by means of delegated acts in accordance with
patients with a particular medical condition or lacking tech
Article 17 and subject to the conditions of Articles 18 and 19.
nology or expertise to provide highly specialised services of
The measures referred to in points (b) and (c) of paragraph 4
high quality.
shall be adopted in accordance with the regulatory procedure
referred to in Article 16(2).
3. Member
States
are
encouraged
to
facilitate
the
devel
opment of the European reference networks:
6. Measures
adopted
pursuant
to
this
Article
shall
not
harmonise any laws or regulations of the Member States and
shall fully respect the responsibilities of the Member States for
(a) by connecting appropriate healthcare providers and centres
the organisation and delivery of health services and medical
of expertise throughout their national territory and ensuring
care.
the dissemination of information towards appropriate
healthcare providers and centres of expertise throughout
their national territory;
Article 13
Rare diseases
(b) by fostering the participation of healthcare providers and
The Commission shall support Member States in cooperating in
centres of expertise in the European reference networks.
the development of diagnosis and treatment capacity in
particular by aiming to:
4. For the purposes of paragraph 1, the Commission shall:
(a) make health professionals aware of the tools available to
(a) adopt a list of specific criteria and conditions that the
them at Union level to assist them in the correct
European reference networks must fulfil and the conditions
diagnosis of rare diseases, in particular the Orphanet
and criteria required from healthcare providers wishing to
database, and the European reference networks;
join the European reference network. These criteria and
conditions shall ensure, inter alia, that European reference
networks:
(b) make patients, health professionals and those bodies
responsible for the funding of healthcare aware of the possi
bilities offered by Regulation (EC) No 883/2004 for referral
(i) have knowledge and expertise to diagnose, follow-up
of patients with rare diseases to other Member States even
and manage patients with evidence of good outcomes,
for diagnosis and treatments which are not available in the
as far as applicable;
Member State of affiliation.

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EN
4.4.2011 Official
Journal
of
the
European
Union L
88/63
Article 14
principle of good governance including transparency, objec
tivity, independence of expertise, fairness of procedure and
eHealth
appropriate stakeholder consultations.
1.
The Union shall support and facilitate cooperation and the
exchange of information among Member States working within
a voluntary network connecting national authorities responsible
2. The
objectives
of
the
health
technology
assessment
for eHealth designated by the Member States.
network shall be to:
(a) support cooperation between national authorities or bodies;
2. The
objectives
of
the
eHealth
network
shall
be
to:
(b) support Member States in the provision of objective,
(a) work towards delivering sustainable economic and social
reliable, timely, transparent, comparable and transferable
benefits of European eHealth systems and services and inter
information on the relative efficacy as well as on the
operable applications, with a view to achieving a high level
short- and long-term effectiveness, when applicable, of
of trust and security, enhancing continuity of care and
health technologies and to enable an effective exchange of
ensuring access to safe and high-quality healthcare;
this information between the national authorities or bodies;
(c) support the analysis of the nature and type of information
(b) draw up guidelines on:
that can be exchanged;
(i) a non-exhaustive list of data that are to be included in
(d) avoid duplication of assessments.
patients’ summaries and that can be shared between
health professionals to enable continuity of care and
patient safety across borders; and
3. In
order
to
fulfil
the
objectives
set
out
in
paragraph
2,
the
network on health technology assessment may receive Union
aid. Aid may be granted in order to:
(ii) effective methods for enabling the use of medical
information for public health and research;
(a) contribute to the financing of administrative and technical
support;
(c) support Member States in developing common identifi
cation and authentication measures to facilitate transfer
(b) support collaboration between Member States in developing
ability of data in cross-border healthcare.
and sharing methodologies for health technology
assessment including relative effectiveness assessment;
The objectives referred to in points (b) and (c) shall be pursued
(c) contribute to the financing of the provision of transferable
in due observance of the principles of data protection as set out,
scientific information for use in national reporting and case
in particular, in Directives 95/46/EC and 2002/58/EC.
studies commissioned by the network;
3. The
Commission
shall,
in
accordance
with
the
regulatory (d) facilitate cooperation between the network and other
procedure referred to in Article 16(2), adopt the necessary
relevant institutions and bodies of the Union;
measures for the establishment, management and transparent
functioning of this network.
(e) facilitate the consultation of stakeholders on the work of the
network.
Article 15
Cooperation on health technology assessment
4. The
Commission
shall,
in
accordance
with
the
regulatory
procedure referred to in Article 16(2), adopt the necessary
1.
The Union shall support and facilitate cooperation and the
measures for the establishment, management and transparent
exchange of scientific information among Member States within
functioning of this network.
a voluntary network connecting national authorities or bodies
responsible for health technology assessment designated by the
Member States. The Member States shall communicate their
5. Arrangements for granting the aid, the conditions to
names and contact details to the Commission. The members
which it may be subject and the amount of the aid, shall be
of such a health technology assessment network shall
adopted in accordance with the regulatory procedure referred to
participate in, and contribute to, the network’s activities in
in Article 16(2). Only those authorities and bodies in the
accordance with the legislation of the Member State where
network designated as beneficiaries by the participating
they are established. That network shall be based on the
Member States shall be eligible for Union aid.

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4.4.2011
6. The appropriations required for measures provided for in
power shall endeavour to inform the other institution and the
this Article shall be decided each year as part of the budgetary
Commission within a reasonable time before the final decision
procedure.
is taken, indicating the delegated powers which could be subject
to revocation and possible reasons for a revocation.
7. Measures
adopted
pursuant
to
this
Article
shall
not
interfere with Member States’ competences in deciding on the
implementation of health technology assessment conclusions
3. The
decision
of
revocation
shall
put
an
end
to
the
dele
and shall not harmonise any laws or regulations of the
gation of the powers specified in that decision. It shall take
Member States and shall fully respect the responsibilities of
effect immediately or at a later date specified therein. It shall
the Member States for the organisation and delivery of health
not affect the validity of the delegated acts already in force. It
services and medical care.
shall be published in the Official Journal of the European Union.

CHAPTER V
Article 19
IMPLEMENTING AND FINAL PROVISIONS
Objections to delegated acts
Article 16
1. The
European
Parliament
or
the
Council
may
object
to
the
delegated act within a period of 2 months from the date of
Committee
notification.
1. The
Commission
shall
be
assisted
by
a
Committee,
consisting of representatives of the Member States and chaired
by the Commission representative.
At the initiative of the European Parliament or the Council this
period shall be extended by 2 months.
2. Where
reference
is
made
to
this
paragraph,
Articles
5
and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.
2. If,
on
expiry
of
the
period
referred
to
in
paragraph
1,
neither the European Parliament nor the Council has objected
to the delegated act, it shall be published in the Official Journal of
The period laid down in Article 5(6) of Decision 1999/468/EC
the European Union and shall enter into force on the date stated
shall be set at 3 months.
therein.
Article 17
The delegated act may be published in the Official Journal of the
Exercise of the delegation
European Union and enter into force before the expiry of that
period if the European Parliament and the Council have both
1. The powers to adopt delegated acts referred to in Articles
informed the Commission of their intention not to raise
11(5) and 12(5) shall be conferred on the Commission for a
objections.
period of 5 years from 24 April 2011. The Commission shall
make a report in respect of the delegated powers not later than
6 months before the end of the five-year period. The delegation
of powers shall be automatically extended for periods of an
3. If the European Parliament or the Council objects to a
identical duration, unless the European Parliament or the
delegated act within the period referred to in paragraph 1, it
Council revokes it in accordance with Article 18.
shall not enter into force. The institution which objects shall
state the reasons for objecting to the delegated act.
2. As
soon
as
it
adopts
a
delegated
act,
the
Commission
shall
notify it simultaneously to the European Parliament and to the
Article 20
Council.
Reports
3. The
powers
to
adopt
delegated
acts
are
conferred
on
the 1. The
Commission
shall
by
25
October
2015
and
Commission subject to the conditions laid down in Articles 18
subsequently every 3 years thereafter, draw up a report on
and 19.
the operation of this Directive and submit it to the European
Parliament and to the Council.
Article 18
2. The report shall in particular include information on
Revocation of the delegation
patient flows, financial dimensions of patient mobility, the
1. The
delegation
of
power
referred
to
in
Articles
11(5)
and implementation of Article 7(9) and Article 8, and on the func
12(5) may be revoked at any time by the European Parliament
tioning of the European reference networks and national
or by the Council.
contact points. To this end, the Commission shall conduct an
assessment of the systems and practices put in place in the
Member States, in the light of the requirements of this
2. The
institution
which
has
commenced
an
internal Directive and the other Union legislation relating to patient
procedure for deciding whether to revoke the delegation of
mobility.

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EN
4.4.2011 Official
Journal
of
the
European
Union L
88/65
The Member States shall provide the Commission with
reference on the occasion of their official publication. The
assistance and all available information for carrying out the
methods of making such reference shall be laid down by the
assessment and preparing the reports.
Member States.
3. Member
States
and
the
Commission
shall
have
recourse
to
2. Member
States
shall
communicate
to
the
Commission
the
the Administrative Commission established pursuant to
text of the main provisions of national law which they adopt in
Article 71 of Regulation (EC) No 883/2004, in order to
the field covered by this Directive.
address the financial consequences of the application of this
Directive on the Member States which have opted for reim
bursement on the basis of fixed amounts, in cases covered by
Article 22
Articles 20(4) and 27(5) of that Regulation.
Entry into force
The Commission shall monitor and regularly report on the
This Directive shall enter into force on the 20th day following
effect of Article 3(c)(i) and Article 8 of this Directive. A first
its publication in the Official Journal of the European Union.
report shall be presented by 25 October 2013. On the basis of
these reports, the Commission shall, where appropriate, make
proposals to alleviate any disproportionalities.
Article 23
Addressees
Article 21
This Directive is addressed to the Member States.
Transposition
1. Member
States
shall
bring
into
force
the
laws,
regulations Done at Strasbourg, 9 March 2011.
and administrative provisions necessary to comply with this
Directive by 25 October 2013. They shall forthwith inform
the Commission thereof.
For the European Parliament
For the Council
When Member States adopt those provisions, they shall contain
The President
The President
a reference to this Directive or be accompanied by such a
J. BUZEK
GYRI E.

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