Proposal for a Directive of the European Parliament and of the Council on the application of patients' rights in cross-border healthcare {SEC(2008) 2163} {SEC(2008) 2164} {SEC(2008) 2183}
Date: 2008-07-02
Institutions: European Commission
Subjects: cross-border cooperation, free movement of persons, health care, health policy, organisation of health care, patient's rights, provision of services, social security

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 2.7.2008 
COM(2008) 414 final 

2008/0142 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

on the application of patients' rights in cross-border healthcare 

(presented by the Commission) 

{SEC(2008) 2163} 
{SEC(2008) 2164} 
{SEC(2008) 2183} 

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EXPLANATORY MEMORANDUM 

1. 

BACKGROUND AND PREPARATORY WORK 

In 2003 health ministers and other stakeholders invited the Commission to explore how legal 
certainty  in  the  field  of  cross-border  care  could  be  improved  following  the  Court  of  Justice 
jurisprudence  concerning  the  right  of  patients  to  benefit  from  medical  treatment  in  another 
Member State1. The Court’s rulings on the individual cases are clear in themselves, however, 
it  is  necessary  to  improve  clarity  to  ensure  a  more  general  and  effective  application  of 
freedoms to receive and provide health services. The Commission’s proposal for a Directive 
on services in the internal market at the start of 2004 therefore included provisions codifying 
the  rulings  of  the  Court  of  Justice  in  applying  free  movement  principles  to  health  services. 
This  approach,  however,  was  not  accepted  by  the  European  Parliament  and  Council.  It  was 
felt that specificities of health services were not sufficiently taken into account, in particular 
their  technical  complexities,  sensitivity  for  public  opinion  and  major  support  from  public 
funds.  The  Commission  therefore  developed  a  policy  initiative  specifically  targeting 
healthcare services as a separate issue. 

The  Council  adopted  in  June  2006  conclusions  on  Common  values  and  principles  in  EU 
Health Systems in which it stated that it believes there is particular value in any appropriate 
initiative  on  health  services  ensuring  clarity  for  European  citizens  about  their  rights  and 
entitlements when they move from one EU Member State to another and in enshrining values 
and principles in a legal framework in order to ensure legal certainty2. 

The  European  Parliament  contributed  to  the  discussions  concerning  cross-border  healthcare 
with various reports. The Parliament adopted in April 2005 a report on patient mobility and 
healthcare developments in the European Union3, in March 2007 a resolution on Community 
action on the provision of cross-border healthcare4 and in May 2007 a report on the impact and 
consequences of the exclusion of health services from the Directive on services in the internal 
market5. 

Stakeholders have been also extensively involved in Commission activities regarding patient 
mobility  and  health  care  over  many  years,  in  particular  through  the  High  Level  Reflection 
Process, the Open Forum6 and the High Level Group on Health Services and Medical care7. 

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See the Report of the High Level Process of Reflection on patient mobility and healthcare developments 
in  the  European  Union  and  the  Commission  Communication  on  the  follow-up  to  the  high  level 
reflection  process  on  patient  mobility  and  healthcare  developments  in  the  European  Union,  COM 
(2004) 301 final, 20 April 2004. 
10173/06 SAN 168 SOC 302 MI 132 
A6-0129/2005 final 
B6-0098/2007 
A6-0173/2007 final 
The  last  Open  Health  Forum  attracted  around  380  participants  from  a  wide  range  of  health 
organisations. The Forum recommended during its conference in November 2005 that the Commission 
should  address  the  potential  of  targeted  healthcare  legislation,  because  subsidiarity  is  not  a  sufficient 
guarantee  of  meeting  the  promise  of  universal  access  to  high  quality  healthcare.  The  Forum  also 
confirmed  the  need  for  strong  and  fully  implemented  safeguards  of  patient  safety  at  EU  level  whilst 
respecting  for  the  capacity  of  national  rules  guaranteeing  quality  and  safety.  The  Forum  also 
recommended  to  establish  an  internet  portal  for  the  free  exchange  of  data,  evidence  and  practice  to 
foster continuous learning and innovation, Final Report of the Open Health Forum, Health challenges 
and future strategy, European Public Health Alliance (2005).  

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Consultation  on  the  specific  initiative  on  cross-border  healthcare  started  formally  in 
September 2006 with the publication of a Communication8 inviting all relevant stakeholders 
to  contribute  to  a  consultation  process  regarding  Community  action  on  health  services.  The 
objective of the consultation was to clearly identify the problems and to get input concerning 
objectives and policy options. The Communication as well as the full summary report of the 
responses9 was published on the Commission website10. 

The  Commission  received  280  responses  to  this  consultation  from  a  wide  range  of 
stakeholders, including health professional organisations, health care providers, national and 
regional  governments,  insurers,  the  industry  and  individual  citizens.  A  wide  range  of  issues 
related to healthcare, and in particular to cross-border healthcare, in Europe was raised. These 
were taken into account in preparatory work on this Commission proposal. 

This proposal is also based on several external surveys, analyses and studies conducted in the 
past years. In particular, the European Observatory on Health Systems and Policies provided 
an  independent  expert  analysis11,  which  was  used  especially  in  support  of  the  impact 
assessment of this proposal. This analysis was taking stock of developments on health care in 
Europe, focussing on seven aspects of cross-border health care: pre-authorization and access 
to healthcare; quality and safety; patient rights; cross-border collaboration; health care baskets 
and  tariffs;  past  impacts  of  cross-border  healthcare;  and  cross-border  healthcare  data.  This 
exercise  was  based  on  existing  research,  supported  largely  by  the  European  Commission, 
examples and studies with the aim to provide better understanding of cross-border health care 
from  different  national  health  systems  perspectives  on  the  above  mentioned  aspects  and 
describes  how  current  legal  and  non-legal  uncertainties  have  had  an  impact  on  cross-border 
health  care  in  general  and  the  aspects  mentioned  above  in  particular  (now  and  in  the  past), 
who is affected, in what ways, and to what extent. 

2. 

ELEMENTS OF THE COMMUNITY FRAMEWORK FOR CROSS-BORDER HEALTHCARE 

The  Commission  proposes  the  establishment  of  a  Community  framework  for  cross-border 
healthcare,  as  set  out  in  this  proposal  for  a  directive.  As  well  as  setting  out  relevant  legal 
definitions and general provisions, this is structured around three main areas: 

–  common  principles  in  all  EU  health  systems,  as  agreed  in  June  2006  by  the 
Council,  setting  out  which  Member  State  shall  be  responsible  for  ensuring  the 
common principles for healthcare and what those responsibilities include, in order 
to ensure that there is clarity and confidence with regard to which authorities are 
setting and monitoring healthcare standards throughout the EU; 

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All EU Member States are represented in the High Level Group on Health Services and Medical Care, 
observers  from  the  EEA/EFTA  states  as  well  as  representatives  from  civil  society  have  also  been 
involved in the work of this group; Report on the work of the High Level Group on Health Services and 
Medical Care in 2006, European Commission (2006). 
Commission  Communication,  Consultation  regarding  Community  action  on  health  services,  SEC 
(2006) 1195/4, 26 September 2006. 
Commission  document,  Summary  report  of  the  responses  to  the  consultation  regarding  "Community 
action on health services" (2007) 
http://ec.europa.eu/health/ph_overview/co_operation/mobility/results_open_consultation_en.htm 
Wismar M, Palm W, Figueras J, Ernst K and Van Ginneken E, Cross-Border Healthcare: Mapping and 
Analysing Health Systems Diversity, European Observatory on Health Systems and Policies, 2007. 

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–  a specific framework for cross-border healthcare: the directive will make clear 
the entitlements of patients to have healthcare in another Member State, including 
the limits that Member States can place on such healthcare abroad, and the level 
of  financial  coverage  that  is  provided  for  cross-border  healthcare,  based  on  the 
principle that patients are entitled to obtain reimbursement up to the amount that 
would have been paid had they obtained that treatment at home;  

–  European cooperation on healthcare: the directive establishes a framework for 
European cooperation in areas such as cooperation in border regions, recognition 
of  prescriptions  issued  in  other  countries,  European  reference  networks,  health 
technology assessment, data collection and quality and safety, in order to enable 
the potential contribution of such cooperation to be realised effectively and on a 
sustained basis. 

Based on the case-law, this initiative aims at ensuring a clear and transparent framework for 
the  provision  of  cross-border  healthcare  within  the  EU,  for  those  occasions  where  the  care 
patients  seek  is  provided  in  another  Member  State  than  in  their  home  country.  When  this 
happens,  there  should  be  no  unjustified  obstacles.  The  care  should  be  safe  and  of  good 
quality.  The  procedures  for  reimbursement  of  costs  should  be  clear  and  transparent.  While 
respecting  principles  of  universality,  access  to  quality  care,  equity  and  solidarity,  the 
objectives of this framework will therefore be to: 

–  provide sufficient clarity about rights to be reimbursed for healthcare provided in 

other Member States; 

–  and  ensure  that  the  necessary  requirements  for  high-quality,  safe  and  efficient 

healthcare are ensured for cross-border care. 

3. 

a) 

COHERENCE WITH OTHER COMMUNITY POLICIES 

Regulations for coordination of social security schemes 

This  proposal  would  not  modify  the  existing  framework  for  coordination  of  social  security 
schemes and this framework will remain in place with all the general principles on which the 
regulations on coordination of social security schemes are based, including putting the patient 
receiving healthcare in another Member State on the equal footing with the residents of that 
Member State, and the existing European Health Insurance Card. In terms of patients seeking 
planned healthcare in another Member State, this ensures that if the appropriate care for the 
patients'  condition  cannot  be  provided  in  their  own  country  without  undue  delay,  then  they 
will  be  authorised  to  go  abroad,  and  any  additional  costs  of  treatment  will  be  covered  by 
public  funds.  The  mechanism  for  this  is  already  in  place  through  the  regulations  on 
coordination of social security systems12, and this will continue to be the case. 

The  new  directive  on  cross-border  healthcare  would  put  in  place  an  alternative  mechanism 
based on the principles of free movement and building on the principles underlying decisions 
of the Court of Justice. This would allow patients to seek any healthcare in another Member 

12 

Council Regulation (EC) No 1408/71 of 14 June 1971 on the application of social security schemes to 
employed  persons,  to  self-employed  persons  and  to  members  of  their  families  moving  within  the 
Community. OJ L 149, 5.7.1971, p.2. 

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State that they would have been provided at home and be reimbursed up to the amount that 
would have been paid had they obtained that treatment at home, but they bear the financial 
risk of any additional costs arising. 

Provisions  regarding  entitlements  provided  for  by  this  proposal  and  provisions  regarding 
entitlements provided for by the Regulation (EC) No. 1408/71 are alternative mechanisms for 
the assumption of the cost of cross-border healthcare. When the prior authorisation is sought 
and  granted  within  the  framework  provided  for  by  the  Regulation  (EC)  No.  1408/71,  the 
provisions  of  that  Regulation  apply  and  sickness  benefits  are  granted  according  to  the  rules 
established  by  that  Regulation.  This  would  be  the  case  in  particular  for  treatment  provided 
through  European  reference  networks  as  provided  for  in  the  directive.  When  the  costs  of 
healthcare  are  reimbursed  according  to  Chapter  III  of  this  Directive,  the  provisions  of  the 
Directive  apply.  However,  an  insured  person  shall  always  be  granted  the  authorisation 
pursuant to Regulations on coordination of social security referred to in Art. 3.1 f) whenever 
the conditions of Art.22.1 c) and Art.22.2 of Regulation 1408/71 are met. 

b) 

Framework for mutual recognition of professional qualifications 

This  proposal  would  also  apply  without  prejudice  to  the  existing  framework  for  mutual 
recognition  of  professional  qualifications  established  by  the  Directive  2005/36/EC  of  the 
European  Parliament  and  of  the  Council  of  7  September  2005  on  the  recognition  of 
professional qualifications13. The Directive 2005/36/EC establishes rules according to which a 
Member  State  which  makes  access  to  or  pursuit  of  a  regulated  profession,  including  health 
professions, in its territory contingent upon possession of specific professional qualifications 
shall recognise professional qualifications obtained in an other Member State which allow the 
holder of those qualifications to pursue the same profession there. This proposal does not aim 
to amend, modify or otherwise interfere with the existing rules on the mutual recognition of 
professional qualifications. Neither should any measure, taken by Member States in view of 
implementing this proposal by ensuring that healthcare is provided according to clear quality 
and safety standards, constitute new barriers to the free movement of health professionals as 
regulated by Directive 2005/36/EC. 

c) 

Community framework for protection of personal data 

The  EU  framework  provided  by  the  Directive  95/46/EC  of  the  European  Parliament  and  of 
the Council of 24 October 1995 on the protection of individuals with regard to the processing 
of  personal  data  and  on  the  free  movement  of  such  data14  and  Directive  2002/58/EC  of  the 
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  sector15 
guarantees to patients rights related to privacy with respect to the processing of personal data 
and  this  proposal  is  without  prejudice  to  this  existing  framework.  Ensuring  continuity  of 
cross-border  healthcare  depends  on  timely  transfer  of  data  concerning  patient's  health.  The 
framework provided by Directive 95/46/EC on the protection of individuals with regard to the 
processing of personal data and on the free movement of such data, provides for patient's right 
to have access to his personal data concerning his health. This includes also right to access to 
the patient's medical records, such as diagnosis, examination results, assessments by treating 
physicians  and  any  treatment  or  interventions  provided.  This  directive  should  be  therefore 

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OJ L 255, 30.9.2005, p. 22. 
OJ L 281, 23.11.1995, p.31. 
OJ L 201, 31.7.2002, p. 37. 

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without  prejudice  to  this  Community  framework  established  by  those  directives  and  the 
national laws implementing those directives. 

d) 

E-health 

This  proposal  is  also  without  prejudice  to  the  existing  framework  provided  for  by  the 
Directive  2000/31/EC  of  the  European  Parliament  and  of  the  Council  of  8  June  2000  on 
certain legal aspects of information society services, in particular electronic commerce, in the 
Internal  Market  (Directive  on  electronic  commerce)16.  That  directive  contributes  to  the 
functioning  of  the  internal  market  by  ensuring  the  free  movement  of  information  society 
services,  including  e-Health  services,  between  the  Member  States.  That  directive  stipulates 
information requirements on the information society services providers, rules on commercial 
communications,  rules  regarding  contracts  concluded  by  electronic  means  and  liability  of 
intermediary  services  providers.  The  existing  framework  shall  remain  in  place  and  this 
proposal  applies  only  insofar  as  the  measures  are  not  already  covered  by  the  Directive 
2000/31/EC. 

e) 

Racial equality  

This proposal applies in conformity with the Council Directive 2000/43/EC of 29 June 2000 
implementing the principle of equal treatment between persons irrespective of racial or ethnic 
origin.  That  Directive  prevents  people  in  the  European  Union  from  being  discriminated 
against on grounds of race and ethnic origin and is also applicable to all persons, in relation to 
social  protection,  including  social  security  and  healthcare  (see  art.3.1  e).  Therefore,  the 
principle of equal treatment enshrined in Directive 2000/43/EC which means that there shall 
be no direct or indirect discrimination based on racial or ethnic origin shall remain in place 
and is not affected by the provisions of this Directive. 

4. 

a) 

GENERAL LEGAL ASPECTS 

Legal basis 

The proposal for a directive is based on Article 95 of the Treaty. This legal base is justified by 
both the objective and the content of the proposal. Measures adopted under Article 95 of the 
Treaty  should  have  as  their  object  the  establishment  and  functioning  of  the  internal  market. 
The aim of this proposal is to establish a general framework for provision of safe, high quality 
and efficient cross-border healthcare in the European Union and to ensure free movement of 
health  services  and  a  high  level  of  health  protection,  whilst  fully  respecting  the 
responsibilities of the Member States for the organisation and delivery of health services and 
medical care. The objective of this proposal is therefore fully in line with the requirements of 
both Articles 95 and 152 of the Treaty. 

The  Court’s  rulings  on  the  individual  cases  outlined  above  are  clear  in  themselves,  and  no 
pre-condition  may  be  required  for  the  exercise  of  the  rights  of  patients  recognised  by  the 
Court.  However,  it  is  necessary  to  ensure  a  more  general  and  effective  application  of  these 
internal market rights in practice, and to ensure that they can be exercised in a way which is 
compatible  with  overall  health  system  objectives  of  accessibility,  quality  and  financial 
sustainability. The Court has held that the freedom to provide services includes the freedom 

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OJ L 178, 17.7.2000, p. 1. 

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for the recipients of services, including persons in need of medical treatment, to go to another 
Member  Sate  in  order  to  receive  those  services  there17.  As  the  Court  has  also  held,  the  fact 
that the legislation of the Member State of affiliation does not guarantee a patient covered by 
that  legislation  a  level  of  reimbursement  equivalent  to  that  to  which  he  would  have  been 
entitled if he had received healthcare in the Member State of affiliation is a restriction of the 
freedom to provide services within the meaning of Article 49 EC18. It is therefore necessary to 
address issues in the Directive related to the reimbursement of the cost of healthcare provided 
in other Member States in order to facilitate the right to provide and obtain health services.  

Moreover, whenever healthcare is provided, it is vital for patients to ensure: 

–  clear information that enables people to make informed choices about their healthcare; 

–  mechanisms for ensuring the quality and safety of the healthcare that is provided; 

–  continuity of care between different treating professionals and organisations; 

–  and mechanisms to ensure appropriate remedies and compensation for harm arising from 

healthcare. 

However, there are no clear rules at Community level about how these requirements should be 
met for cross-border healthcare, or who is responsible for ensuring that they are. This is the 
case no matter how the care is paid for – whether it is paid for publicly or privately, whether it 
is undertaken through the regulations on coordination of social security systems or whether it 
is in application of the additional free movement rights described above. 

It  is  often  difficult  for  patients  and  professionals  to  identify  what  rights  exist  for 
reimbursement for cross-border healthcare. This was confirmed by a Eurobarometer survey19 
which showed that 30% of the citizens in the European Union are not aware of the possibility 
to receive healthcare outside their country of affiliation. This uncertainty and confusion about 
the  general  application  of  rights  to  reimbursement  for  healthcare  provided  in  other  Member 
States  is  likely  to  make  it  more  difficult  for  patients  to  use  their  rights  in  practice,  as  those 
responsible will be reluctant to implement rules and procedures when they are not clear about 
what  they  are.  And  if  patients  wish  to  contest  the  interpretations  that  are  given  or  the  rules 
being applied, it is difficult for them to do so in the absence of clarity about what their rights 
are and how they should exercise them. 

The objective of this initiative is therefore to ensure that there is a clear framework for cross-
border healthcare within the EU in order to enable the rights of the patients to be exercised 
whilst ensuring a high level of health protection, by: 

–  providing sufficient clarity about rights to be reimbursed for healthcare provided in other 

Member States for those rights to be realised in practice; 

–  and ensuring that the necessary requirements for high-quality, safe and efficient healthcare 

are also ensured for cross-border care;  

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See in particular Case C-158/96 Kohll, paragraphs 35-36. 
See in particular Case C-368/98 Vanbraekel, paragraph 45. 
Flash Eurobarometer Series #210, Cross-border health services in the EU, Analytical report, conducted 
by The Gallup Organization, Hungary upon the request of the European Commission, the Health and 
Consumer Protection Directorate-General (DG SANCO), 2007. 

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whilst ensuring that such cross-border healthcare is compatible with the overall objectives of 
the  Member  States  of  ensuring  accessibility,  quality  and  safety  of  the  healthcare  that  their 
health  systems  provide.  In  particular,  the  proposal  ensures  that  the  impact  of  cross-border 
healthcare under this proposal does not undermine health and social security systems, either 
through its direct financial impact or through its impact on overall planning and management 
of those systems.  

This proposal respects the fact that health systems are primarily the responsibility of Member 
States  and  fully  respects  the  responsibilities  of  the  Member  States  for  the  organisation  and 
delivery  of  health  services  and  medical  care  in  accordance  with  Article  152  TEC.  Article 
95(3)  of  the  Treaty  further  stipulates  that  the  Commission,  in  its  proposals  for  the 
establishment and functioning of the internal market concerning health, shall take as a basis 
high level of protection of health, taking account in particular of any new development based 
on scientific evidence. In preparation of this proposal, the Commission took fully into account 
the most recent research results and the current best medical practice. Several expert studies, 
analyses  and  research  reports  were  used  in  the  preparatory  work.  The  proposal  will  thus 
ensure that the necessary requirements for high-quality, safe and efficient healthcare are also 
ensured for cross-border healthcare. 

b) 

Subsidiarity 

The overall objective of this initiative is to ensure that there is a clear framework for cross-
border  healthcare  within  the  EU,  in  order  to  provide  sufficient  clarity  about  rights  to  be 
reimbursed for healthcare provided in other Member States for those rights to be realised in 
practice;  and  to  ensure  that  the  necessary  requirements  for  high-quality,  safe  and  efficient 
healthcare are also ensured for cross-border care.  

Issues requiring greater clarity and certainty regarding Community law in this area cannot be 
addressed by the Member States alone. Action by Member States alone or lack of Community 
action  would  significantly  undermine  both  the  safe  and  efficient  provision  of  cross-border 
healthcare, and would leave Member States without a clear capacity to manage and steer their 
health systems as a whole, as emphasised by several Member States during the consultation. 
Cross-border  healthcare  has,  as  the  name  already  predicts,  many  Community-wide  trans-
national aspects. Both national government and individual citizens face in this field challenges 
that cannot be satisfactorily solved by Member States alone. 

According to Article 152(5) of the EC Treaty Community action in the field of public health 
is to fully respect the responsibilities of the Member States for the organisation and delivery 
of  health  services  and  medical  care.  As  confirmed  by  the  Court20,  that  provision  does  not, 
however, exclude the possibility that the Member States may be required under other Treaty 
provisions, such as Article 49 EC of the EC Treaty, or Community measures adopted on the 
basis of other Treaty provisions, to make adjustments to their national healthcare and social 
security systems. As the Court held, this does not mean that this undermines their sovereign 
powers in the field.  

In  any  event,  Member  States  are  responsible  for  the  organisation  and  delivery  of  health 
services and medical care. They are in particular responsible for determining which rules will 
apply  to  the  reimbursement  of  patients  and  to  the  provision  of  health  care.  This  proposal 
changes nothing in this respect. It is important to underline that this initiative does not alter 

20 

See Case C-372/04 Watts, paragraph 147. 

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the Member States' choice of the rules which will be applicable to a specific case. Instead, this 
framework is designed to facilitate European cooperation on healthcare, such as for European 
networks  of  centres  of  reference;  sharing  assessments  of  new  health  technologies;  or  using 
information and communication technology to provide more efficient healthcare ("e-health"). 
By  doing  so,  this  will  provide  additional  support  to  the  Member  States  in  achieving  their 
overall  objectives  of  universal  access  to  high-quality  healthcare  on  the  basis  of  equity  and 
solidarity, which will benefit all patients, whether they move countries or not. 

Since  the  objectives  of  this  proposal  cannot  be  sufficiently  achieved  by  the  Member  States 
and can therefore, by reason of the scale of the action, be better achieved at Community level, 
this  proposal  complies  with  the  principle  of  subsidiarity  as  set  out  in  Article  5  of  the  EC 
Treaty. 

c) 

Proportionality 

local  circumstances.  Moreover, 

In accordance with the principle of proportionality, as set out in Article 5 of the Treaty, the 
Community action shall not go beyond what is necessary in order to achieve those objectives. 
This proposal sets out only general principles creating the EU framework, but leaves a wide 
margin  for  implementation  of  these  principles  by  the  Member  States  according  to  their 
national,  regional  or 
this  proposal  fully  respects 
responsibilities  of  the  Member  States  to  organise,  finance  and  deliver  health  services  and 
medical  care.  The  proposal  does  not  change  the  right  of  Member  States  to  define  the 
healthcare benefits that they choose to provide to their citizens. If a Member State does not 
include  a  particular  treatment  as  part  of  the  entitlement  of  their  citizens  at  home,  this 
mechanism  does  not  create  any  new  entitlement  for  patients  to  have  such  treatment  abroad 
and  be  reimbursed.  Moreover,  this  also  does  not  alter  the  right  of  Member  States  to  apply 
conditions  to  their  benefits,  such  as  going  through  a  general  practitioner  for  referral  to 
specialist treatment. This proposal thus complies also with the principle of proportionality as 
set out in Article 5 of the EC Treaty. 

5. 

CHAPTER I 

5.1. 

Aim of the directive 

The overall aim of this proposal is to ensure that there is a clear framework for cross-
border  healthcare  within  the  EU.  This  requires  action  to  address  barriers  to  the 
provision of cross-border healthcare and which present risks for a high level of health 
protection. 

The  uncertainty  about  the  general  application  of  rights  to  reimbursement  for 
healthcare  provided  in  other  Member  States  is  creating  obstacles  to  the  free 
movement  of  patients  and  of  health  services  more  generally  in  practice.  This  is 
shown  both  by  the  research  and  consultation  which  preceded  these  proposals, 
including surveys of citizens which identify wide degrees of uncertainty, and a high 
number of patients who should have been entitled to reimbursement for cross-borders 
healthcare but who did not claim it.  

Whenever healthcare is provided, it is vital for patients to ensure: 

–  clear  information  that  enables  people  to  make  informed  choices  about  their 

healthcare; 

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–  mechanisms for ensuring the quality and safety of the healthcare that is provided; 

–  continuity of care between different treating professionals and organisations; 

–  and  mechanisms  to  ensure  appropriate  remedies  and  compensation  for  harm 

arising from healthcare. 

5.2. 

Scope of the directive 

The  proposed  directive  applies  to  all  healthcare  provision,  regardless  of  how  it  is 
organised, delivered or financed. It is impossible to know in advance whether a given 
healthcare  provider  will  supply  healthcare  to  a  patient  coming  from  other  Member 
States  or  to  patients  from  its  own  Member  State,  it  appears  necessary  that  the 
requirements  to  ensure  that  healthcare  is  provided  according  to  clear  quality  and 
safety standards are applicable to all health services, without discrimination between 
different  types  of  organisation,  delivery  or  financing  of  the  provision  of  that 
healthcare. 

6. 

CHAPTER II - MEMBER STATE AUTHORITIES RESPONSIBLE FOR COMPLIANCE WITH 
COMMON PRINCIPLES FOR HEALTHCARE 

6.1. 

Responsibilities of authorities of the Member State of treatment 

As set out above, ensuring compliance with common healthcare principles for cross-
border  healthcare  is  essential  for  ensuring  free  movement  of  health  services  The 
combination of variety between systems and lack of clarity about the responsibilities 
of different authorities could act as an obstacle to cross-border healthcare, as shown 
by  research  and  evaluation  including  existing  examples  of  cross-border  healthcare 
and uncertainties of citizens reported through surveys21. 

Given that it is impossible to know in advance whether a given healthcare provider 
will supply healthcare to a patient coming from another Member State, it is necessary 
that  the  requirements  to  ensure  that  healthcare  is  provided  according  to  common 
principles  and  clear  quality  and  safety  standards  are  applicable  to  all  healthcare 
services in order to ensure the freedom to provide and obtain cross border healthcare 
which is the aim of the directive. 

This implies two elements. The first is clarity over which is the Member States who 
should  be  responsible  in  any  given  case  of  cross-border  healthcare  for  ensuring 
compliance with common principles for healthcare.. There was clear consensus from 
the consultation that preceded these proposals that greater clarity was needed on this 
point,  and  that  the  most  appropriate  choice  would  be  to  make  clear  that  it  is  the 
authorities  of  the  Member  State  in  which  the  treatment  is  provided  that  should  be 
responsible  for  ensuring  that  common  principles  are  met  also  in  the  case  of  cross-
border healthcare. 

However, this is not sufficient in itself. The second element is therefore a minimum 
degree of certainty about what the authorities of the responsible Member State will 

21 

See the impact assessment, and the results of the Europe 4 Patients research project referred to above. 

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ensure  for  all  healthcare  on  their  territory.  Whilst  respecting  the  wide  variety  of 
different  systems,  structures and mechanisms put in place by the Member States in 
this  area,  this  will  ensure  a  minimum  core  set  of  common  principles  on  which 
patients and professionals from other Member States know they can rely.  

It  remains  up  to  Member  States  to  decide  on  the  standards  for  healthcare  in  their 
country. It does not interfere in the ability of Member States to organise their health 
systems  as  they  wish.  In  order  to  ensure  that  the  degree  of  harmonisation  that  this 
implies  remains  proportionate,  the  principles  in  the  directive  take  as  a  basis  the 
Council conclusions on "Common values and principles in European Union Health 
Systems"  of  June  2006,  and  therefore  should  not  require  major  adaptations  of 
existing  systems.  The  Commission  will  develop  guidelines  to  facilitate  the 
implementation of these principles. 

As  set  out  in  those  common  values  and  principles,  different  Member  States  have 
different  approaches  to  making  a  practical  reality  of  these  values:  they  have,  for 
example, different approaches to questions such as whether individuals should pay a 
personal  contribution  towards  the  cost  of  elements  of  their  health  care,  or  whether 
there  is  a  general  contribution,  and  whether  this  is  paid  for  from  supplementary 
insurance.  Member  States  have  implemented  different  provisions  to  ensure  equity: 
some have chosen to express it in terms of the rights of patients; others in terms of 
the obligations of healthcare providers. Enforcement is also carried out differently — 
in  some  Member  States  it  is  through  the  courts,  in  others  through  boards, 
ombudsmen, or other mechanisms.  

The directive still provides Member States with the freedom to organise their health 
systems  as  they  wish  in  order  to  achieve  these  common  principles,  in  compliance 
with Article 152, paragraph 5 EC. The aim of this framework is simply to make clear 
which is the Member State that is responsible in any given situation, to avoid gaps or 
overlaps,  and  to  clarify  what  those  responsibilities  mean  in  practice.  The  common 
principles set out in the directive are as follows: 

–  the  first  three  common  principles  (the  clear  definition  by  authorities  of  Member 
States  of  standards  for  quality  and  safety  of  care,  transparency  about  applicable 
standards for patients and professionals, mechanisms to ensure the translation of 
those  standards  into  practice,  and  monitoring)  are  intended  to  ensure  that  the 
fundamental  elements  for  ensuring  quality  and  safety  of  healthcare  are  in  place. 
These  elements  establish  the  basic  elements  to  be  able  to  give  patients  and 
professionals  confidence  about  the  quality  and  safety  of  healthcare  provision 
through all patients and health providers operating on the basis of a common core 
of general obligations; 

–  if  patients  cannot  have  access  to  the  key  medical,  financial  and  practical 
information  relevant  to  the  healthcare  that  they  are  seeking,  this  clearly  would 
constitute  an  obstacle  to  their  freedom  to  receive  health  services  in  another 
Member State by making it difficult for patients to make a rational and informed 
choice between different providers including providers in other Member States; 

–  Member States have to set up procedures and systems to be used in case of harm 
caused  when  healthcare  is  provided.  It  is  clear  that  patients  are  aware  that 
healthcare can go wrong; across the EU, 78% of citizens consider medical errors 

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to be an important problem. This concern is not unfounded; research suggests that 
harm arises from healthcare in 10% of cases. Ensuring clear common obligations 
to  deal  with  circumstances  of  responding  to  harm  arising  from  healthcare  is 
therefore essential to avoid lack of confidence in those mechanisms acting as an 
obstacle to taking up cross-border healthcare. 

–  The Member State of treatment also has to ensure that mechanisms for patients to 
seek redress and compensation if they suffer harm as a result of receiving cross-
border healthcare are in place. However, it is for the Member State to determine 
the nature and modalities of such mechanisms, for example through professional 
liability  insurance,  or  a  guarantee  or  similar  arrangement  which  is  equivalent  or 
essentially comparable as regards its purpose. This requirement should ensure at 
least equivalent protection for provision of healthcare to patients residing in other 
Member  States.  Such  arrangements  should  be  appropriate  to  the  nature  and  the 
extent of the risk, in order to avoid this requirement being disproportionate in the 
context  of  the  provision  of  cross-border  healthcare  and  have  due  regard  to 
guarantees that are already in place in healthcare provider's home Member State, 
where these are different.  

–  ensuring continuity of healthcare requires transfer of the relevant health data and 
in particular a patient's medical records, but this is clearly a very sensitive issue. 
The consultation showed widespread uncertainty about how this can be ensured in 
practice  when  transferring  health  data  to  other  countries,  with  concern  over 
ensuring protection of personal data sometimes hindering appropriate transfer of 
data  that  is  essential  for  continuity  of  care.  It  is  therefore  vital  to  ensure 
confidence that privacy and protection of personal data will also be respected for 
health data transferred to another Member State, both to avoid lack of confidence 
acting  as  a  barrier  to  free  movement  of  health  services,  and  to  avoid  lack  of 
transfer of data undermining continuity of care and thus creating additional risks 
to health protection; 

–  and in order to avoid unsustainable impacts of healthcare, it is important to ensure 
that  patients  from  within  and  outside  domestic  systems  are  treated  in  a  non-
discriminatory  manner.  From  an  economic  point  of  view,  this  avoids  either 
perverse incentives to prioritise patients from abroad ahead of domestic patients, 
or  long-term  undermining  of  capital  investment  in  health.  From  a  health 
perspective, treating patients equitably is essential to ensure that the health impact 
of cross-border healthcare on health consequences such as waiting times remains 
reasonable  and  manageable.  Moreover,  according  to  the  general  principles  of 
equity and non discrimination, patients should in no way be discriminated against 
on  the  basis  of  their  sex,  race,  colour,  ethnic  or  social  origin,  genetic  features, 
language,  religion  or  belief,  ,  political  or  any  other  opinion,  membership  of  a 
national  minority,  property,  birth,  disability,  age  or  sexual  orientation.. 
Furthermore,  as  this  Directive  respects  the  fundamental  rights  and  observes  the 
principles  recognised  in  particular  by  the  Charter  of  Fundamental  Rights  of  the 
European  Union,  it  has  to  be  implemented  and  applied  with  due  respect  for  the 
rights  to  equality  before  the  law  and  the  principle  of  non-discrimination,  in 
accordance with the general principles of law as enshrined in Articles 20 and 21 
of the Charter.. 

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7. 

CHAPTER III – USE OF HEALTHCARE IN ANOTHER MEMBER STATE 

7.1. 

Healthcare provided in another Member State  

The  right  to  reimbursement  of  the  costs  of  healthcare  provided  in  another  Member 
State  from  the  statutory  social  security  scheme  of  patients  as  insured  persons  was 
recognised  by  the  Court  of  Justice  in  several  judgements22  The  Court  has  held  that 
the freedom to provide services includes the freedom for the recipients  of services, 
including  persons  in  need  of  medical  treatment,  to  go  to  another  Member  Sate  in 
order to receive those services there23. It has to be remembered that all the case-law 
of the Court of Justice in this matter are based on referrals initiated by single citizens 
trying to exercise individual rights stemming from the EC Treaty itself. 

As  the  Court  has  also  held,  the  fact  that  the  legislation  of  the  Member  State  of 
affiliation  does  not  guarantee  a  patient  covered  by  that  legislation  a  level  of 
reimbursement  equivalent  to  that  to  which  he  would  have  been  entitled  if  he  had 
received healthcare in the Member State of affiliation is a restriction of the freedom 
to  provide  services  within  the  meaning  of  Article  49  EC24.  From  the  research  and 
consultation  preceding  these  proposals,  a  certain  degree  of  uncertainty  exists  about 
the  general  application  in  practice  of  the  rights  deriving  from  these  judgements, 
which acts as a barrier to the free movement of services. It is therefore necessary to 
address issues in the Directive related to the reimbursement of the cost of healthcare 
provided in other Member States in order to facilitate the right to provide and obtain 
health  services.  Provisions  of  Article  6  and  7,  and  partly  also  Articles  8  and  9 
therefore  provide  for  reimbursement  of  costs  in  case  of  healthcare  provided  in 
another Member State, in order to facilitate the provision of healthcare services.  

This  Directive  does  not  provide  neither  for  transfer  of  social  security  entitlements 
between  Member  States  nor  for  coordination  of  social  security  schemes.  The  only 
social security system concerned by the provisions of Chapter III of the directive is 
the social security system of the Member State where the patient is insured, and the 
only entitlements covered by Chapter III are the entitlements provided in accordance 
with  the  social  security  system  of  the  patient's  Member  State  of  affiliation.  The 
provisions regarding access to and reimbursement of healthcare provided in another 
Member State are introduced to enable patients and healthcare providers freedom to 
receive  and  to  provide  healthcare  and  to  remove  unjustified  obstacles  to  that 
fundamental freedom within the patient's Member State of affiliation. 

This proposal does not change the right of Member States to define the benefits that 
they choose to provide. If a Member State does not include a particular treatment as 
part  of  the  entitlement  of  their  citizens  at  home,  this  directive  does  not  create  any 
new  entitlement  for  patients  to  have  such  treatment  abroad  and  be  reimbursed.  In 
addition,  the  proposal  does  not  prevent  the  Member  States  from  extending  their 
benefits-in-kind  schemes  to  healthcare  provided  abroad,  a  possibility  already 

22 

23 
24 

See in particular Case C-158/96 Kohll [1998] ECR I-1931, Case C-120/95 Decker [1998] ECR I-1831, 
Case  C-368/98  Vanbraekel  [2001]  ECR  I-5363;  Case  C-157/99  Smits  and  Peerbooms  [2001]  ECR  I-
5473;  Case  C-56/01  Inizan  [2003]  ECR  I-12403;  Case  C-8/02  Leichtle  [2004]  ECR  I-2641;  Case  C-
385/99 Müller-Fauré and Van Riet [2003] ECR I-4503, and Case C-372/04 Watts[2006] ECR I-4325. 
See in particular Kohll, paragraphs 35-36.  
See in particular Vanbraekel, paragraph 45. 

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implemented  by  several  Member  States.  The  evidence  available  as  set  out  in  the 
impact  assessment  indicates  that  the  application  of  free  movement  principles 
regarding  use  of  healthcare  in  another  Member  State  within  the  limits  of  the  cover 
guaranteed by the sickness insurance scheme of the Member State of affiliation will 
not undermine the health systems of the Member States or financial sustainability of 
their social security systems.  

In the light of the case-law of the Court of Justice, it is not appropriate to establish or 
maintain the requirement of any prior authorisation for reimbursement by the social 
security  system  of  a  Member  State  of  affiliation  for  non-hospital  care  provided  in 
another  Member  State.  In  so  far  as  the  reimbursement  of  such  care  remains  within 
the limits of the cover guaranteed by the sickness insurance scheme of the Member 
State of affiliation, the absence of prior authorisation requirement will not undermine 
the  financial  equilibrium  of  social  security  systems25.  As  regards  hospital  care,  the 
Court of Justice has however recognised that it cannot be excluded that the possible 
risk  of  seriously  undermining  a  social  security  system's  financial  balance  or  the 
objective  of  maintaining  a  balanced  medical  and  hospital  service  open  to  all  may 
constitute overriding reasons in the general interest capable of justifying a barrier to 
the principle of freedom to provide services. The Court of Justice has also recognised 
that the number of hospitals, their geographical distribution, the way in which they 
are organised and the facilities with which they are provided, and even the nature of 
the medical services which they are able to offer, are all matters for which planning 
must be possible.  

Therefore this Directive does not introduce a general prior authorisation requirement 
but  allows  Member  States  to  provide  for  a  system  of  prior  authorisation  for 
assumption  of  costs  for  hospital  care  provided  in  another  Member  State,  provided 
however, that Member States can provide evidence that the following conditions are 
met: 

–  had the treatment been provided on its territory, it would have been assumed by 

its social security system; and  

–  the  consequent  outflow  of  patients  due  to  the  implementation  of  the  directive 
seriously undermines or is likely to seriously undermine the financial balance of 
the social security system and/or this outflow of patients seriously undermines, or 
is likely to seriously undermine the planning and rationalisation carried out in the 
hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital 
care and logistical and financial wastage, the maintenance of a balanced medical 
and  hospital  service  open  to  all,  or  the  maintenance  of  treatment  capacity  or 
medical competence on the territory of the concerned Member.  

In such cases, and according to the relevant jurisprudence, the introduction of a prior 
authorisation  scheme,  which  will  limit  the  exercise  of  rights  conferred  upon  the 
citizens directly by the EC Treaty, must be proportionate and justified by imperative 
reasons as those mentioned in the same case-law. In some instances, Member States 
may not have an existing set of defined reimbursement levels for particular types of 
care (for example, in health systems with integrated public financing and provision). 

25 

See in particular Kohll, paragraph 42. 

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In this instance, Member States should put in place a mechanism for calculation of 
costs  that  are  to  be  assumed  by  the  statutory  social  security  system  for  such  cross-
border  healthcare,  provided  that  this  mechanism  is  based  on  objective,  non-
discriminatory  criteria  known  in  advance  and  the  costs  assumed  according  to  this 
mechanism are not less than what would have been assumed had the same or similar 
healthcare been provided in the territory of the Member State of affiliation. 

7.2. 

Non-hospital care 

On the basis of the assessment of the current and future extent of cross-border non-
hospital  care  as  set  out  above,  there  is  no  evidence  to  suggest  that  such  care  will 
undermine  either  the  financial  sustainability  of  health  and  social  security  systems 
overall or the organisation, planning and delivery of health services26. On that basis, 
the  obstacle  to  free  movement  represented  by  a  prior  authorisation  requirement  for 
such  cross-border  non-hospital  care  is  not  justified,  and  such  prior  authorisation 
should therefore not be required for non-hospital care.  

However,  Member  States  may  have  limitations  on  the  choice  of  provider  or  other 
domestic planning mechanisms which are applied domestically, including conditions, 
criteria  of  eligibility  and  regulatory  and  administrative  formalities.  These  may  also 
be  applied  to  cross-border  non-hospital  healthcare,  provided  they  respect  internal 
market  freedoms  and  any  such  restrictions  on  access  to  non-hospital  healthcare 
abroad are necessary, proportionate and non-discriminatory. 

7.3. 

Hospital care 

As  mentioned  above,  the  Court  of  Justice  in  its  judgements  recognised  the  specific 
nature  of  health  services  provided  by  hospitals,  for  which  planning  is  necessary27. 
However,  there  is  no  consistent  definition  of  what  constitutes  hospital  care 
throughout the different health systems of the EC. This diverse understanding gives 
rise  to  different  interpretations  in  practice  of  the  principles  of  free  movement  of 
health  services  established  by  the  Court  of  Justice  among  the  Member  States.  The 
difference of definition could therefore constitute on the one hand an obstacle to the 
freedom for patients to receive healthcare services because patients would be subject 
to  different  provisions  within  this  directive  depending  on  the  definition  of  hospital 
care.  In  order  to  overcome  that  obstacle,  it  is  necessary  to  provide  a  minimum 
Community definition of hospital care. The introduction of a minimum harmonized 
definition for the purposes of this directive will also ensure that there is no distortion 
of  competition  among  health  systems  because  they  will  all  be  subject  to  consistent 
rules. 

The  closest  commonly-used  definition  to  hospital  care  is  that  of  inpatient  care 
(meaning treatment that requires at least one night of stay in a hospital or clinic). For 
this  reason,  Article  8(1)  introduces  a  minimum  Community  definition  of  hospital 
care on that basis. However, it may be appropriate to also consider as hospital care 
certain other kinds of treatment as hospital treatment, if that treatment requires use of 
highly specialised and cost-intensive medical infrastructure or medical equipment or 
involving  treatments  presenting  a  particular  risk  for  the  patient  or  the  population 

26 
27 

See in particular Müller-Fauré and van Riet, paragraph 93. 
See in particular Smits and Peerbooms, paragraphs 76-80. 

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Article  8(1)  therefore  also  stipulates  that  a  regularly  updated  technical  list  of  such 
treatments may be specifically defined by the Commission. 

As above mentioned and taking into account what the Court of Justice has held with 
regard to the free movement of services applied in the context of patients mobility, a 
system  of  prior  authorisation  for  the  reimbursement  of  hospital  care  provided  in 
another  Member  State  may  be  justified  by  the  need  to  plan  the  number  of  hospital 
infrastructures,  their  geographical  distribution,  the  mode  of  their  organisation,  the 
equipment with which they are provided and even the nature of the healthcare which 
they are able to offer. The aims of such planning is to ensure, within each Member 
State,  access  to  a  balanced  range  of  quality  hospital  care,  to  secure  efficient  cost 
management  and,  so  far  as  is  possible,  to  avoid  wastage  of  financial,  technical  or 
human resources28.  

However, as with non-hospital care, on the basis of the assessment of the current and 
future extent of  cross-border  hospital care as set out above,  there is no evidence to 
suggest that such care will undermine either the financial sustainability of health and 
social  security  systems  overall  or  the  organisation,  planning  and  delivery  of  health 
services.  Nevertheless,  with  regard  to  cross-border  hospital  care,  it  should  be 
possible  for  Member  States  to  introduce  a  system  of  prior  authorisation  to  address 
situations  where  the  financial  balance  of  the  health  and  social  security  system  of  a 
Member State, the maintenance  of  a  balanced medical  and  hospital service open to 
all, or the maintenance of treatment capacity or medical competence on their national 
territory  is  seriously undermined  or  is likely to be  seriously undermined. However, 
such systems of prior authorisation should be limited to cases where there is evidence 
that the outflow of patients due to cross-border hospital care undermines or is likely 
to undermine the financial sustainability of health and social security systems overall 
or  the  organisation,  planning  and  delivery  of  health  services.  and  that  prior 
authorisation  is  necessary  and  proportionate  to  maintain  the  financial  and 
organisational balance of the health and social security system in question. The prior 
authorisation system must be limited to what is necessary and proportionate to avoid 
such impact and shall not constitute a means of arbitrary discrimination. 

In  any  event,  as  for  non-hospital  care,  domestic  limitations  for  planning  reasons 
applied by Member States, including conditions, criteria of eligibility and regulatory 
and  administrative  formalities,  may  also  be  applied  to  cross-border  hospital 
healthcare, provided they respect internal market freedoms and any such restrictions 
on  access  to  hospital  healthcare  abroad  are  necessary,  proportionate  and  non-
discriminatory. 

7.4. 

Procedural guarantees 

According  to  established  case-law,  any  national  administrative  procedures  and 
decisions, that the access to cross-border provision of services is made subject to, are 
obstacles  to  the  free  movement  of  services  unless  they  are  objectively  justified, 
necessary  and  proportionate.  This  is  even  more  evident  in  the  area  of  healthcare 
where administrative practices differ significantly between Member States, and often 
even  between  regions  within  Member  States.  It  is  therefore  appropriate  to  require 

28 

See again in particular Smits and Peerbooms, paragraphs 76-80. 

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that  national  administrative  procedures  regarding  use  of  healthcare  in  another 
Member  State  provide  to  the  patients  comparable  guarantees  of  objectivity,  non-
discrimination and transparency, in such a way as to ensure that decisions by national 
authorities are made in a timely manner and with due care and regard for both these 
overall principles and the individual circumstances of each case. This should be the 
case  regarding  procedures  relating  to  financial  issues  such  as  reimbursement 
(including  reimbursement  of  costs  of  healthcare  incurred  in  another  Member  State 
after  the  patient's  return),  but  also  medical  procedures  such  as  referral  or  seeking 
second opinions. 

7.5. 

Information for patients and national contact points  

Appropriate  information  for  patients  is  a  necessary  precondition  for  improving 
patients' confidence in cross-border healthcare and thus for achieving free movement 
of  health  services  in  the  internal  market  as  well  as  high  level  of  health  protection. 
The current practice in providing information to patients on aspects of cross-border 
healthcare  in  the  Member  States  is  rather  limited.  Many  contributors  to  the 
consultation preceding these proposals felt that currently it is difficult for patients to 
identify their rights with regard to cross-border healthcare. Clear information is often 
felt to be missing. It was widely argued that in many Member States patients are not 
aware of the possibilities and their entitlement to receive treatment abroad and to get 
reimbursed. For example, a study conducted by the Health Consumer Powerhouse in 
France, Poland, United Kingdom, Spain and Germany showed that 25% of citizens 
believe that they do not have the right for treatment abroad and 30% are unsure29. As 
set  out  above,  this  was  confirmed  by  the  recent  Eurobarometer  survey30  which 
showed  that  30%  of  the  citizens  in  the  European  Union  are  not  aware  of  the 
possibility to receive healthcare outside their country of affiliation. 

The  directive  therefore  set  outs  the  requirements  for  information  on  all  essential 
aspects of cross-border healthcare to be provided to patients in order to achieve the 
objectives  of  the  internal  market.  In  order  to  improve  provision  of  information  to 
patients  regarding  cross-border  healthcare,  it  is  appropriate  to  require  that  such 
information is easily accessible and in particular, to establish national contact points 
for  cross-border  healthcare.  The  form  as  well  as  numbers  of  those  national  contact 
points is to be decided by the Member States. The national contact points can be also 
incorporated in or build on activities of existing information centres, provided that it 
is  clearly  indicated  that  they  are  also  national  contact  points  for  cross-border 
healthcare. The national contact points should have appropriate facilities to provide 
information on possibilities for cross-border healthcare and the applicable processes, 
and to provide practical assistance to patients if needed. Such information about the 
process  for  having  access  to  cross-border  care  (e.g.:  procedures  to  be  followed, 
timetable  for  reimbursement)  is  distinct  from  information  about  content  of  the 
healthcare  itself  (e.g.:  cost,  timetable  for  availability,  outcomes),  which  should  be 
provided  by  the  providers  in  question  and  which  is  covered  under  Chapter  II.  The 
existence  of  national  contact  points  does  not  preclude  Member  States  from 

29 
30 

http://ec.europa.eu/health/ph_overview/co_operation/mobility/docs/health_services_co147.pdf 
Flash Eurobarometer Series #210, Cross-border health services in the EU, Analytical report, conducted 
by The Gallup Organization, Hungary upon the request of the European Commission, the Health and 
Consumer Protection Directorate-General (DG SANCO), 2007. 

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establishing  other  linked  contact  points  at  regional  or  local  level,  reflecting  the 
specific organisation of their healthcare system. 

7.6. 

Rules applicable to healthcare services 

When healthcare is received by a patient in a Member state, which is not the country 
where  he  is  insured,  it  is  essential  for  the  patient  to  know  in  advance  which  rules 
shall be applicable. An equivalent level of clarity is needed in case where healthcare 
providers temporarily move to another Member State to provide healthcare there or 
when healthcare is provided cross-border. Given that in accordance with the Treaty 
art.152.5 the organisation and delivery of health services and medical care rests upon 
Member States, the rules applicable to the actual provision of healthcare (as defined 
in Art.4 a) ) of the Directive has to be governed by the rules of the Member State of 
treatment.  This  indication  in  clear  terms  of  this  principle  will  help  the  patient  in 
making an informed choice, and will avoid misapprehension and misunderstanding. 
It  will  also  establish  a  high  level  of  trust  between  the  patient  and  the  healthcare 
professional. 

8. 

CHAPTER IV - COOPERATION ON HEALTHCARE  

8.1. 

Duty of cooperation 

Realising  the  potential  of  the  internal  market  for  cross-border  healthcare  requires 
cooperation between providers, purchasers and regulators of different Member States 
at national, regional or local level in order to ensure safe, high quality and efficient 
care across borders. In the patient mobility reflection process31, health ministers and 
other  stakeholders  identified  areas  where  the  economies  of  scale  of  coordinated 
action between all Member States can bring added value to national health systems. 
This may concern joint planning, mutual recognition or adaptation of procedures or 
standards,  interoperability  of  respective  national  information  and  communication 
technology  systems,  practical  mechanisms  to  ensure  continuity  of  care  or  practical 
facilitating  of  cross-border  provision  of  healthcare  by  health  professionals  on  a 
temporary or occasional basis.  

To  achieve  the  objective  of  realising  the  potential  of  the  internal  market,  this 
Directive  requires  the  Member  States  to  render  mutual  assistance  necessary  for 
achieving  implementation  of  this  Directive  and  to  facilitate  in  cross-border 
healthcare  provision  at  regional  and  local  level.  As  the  national,  regional  and  local 
administrative  practices  in  the  healthcare  sector  differ  significantly,  mutual 
cooperation  between  different  health  systems  will  help  to  avoid  unnecessary 
obstacles to the free movement of health services. 

8.2. 

Recognition of prescriptions issued in another Member State 

Provision  of  medicinal  products  will  often  be  part  of  cross-border  healthcare,  and 
may form part of an ongoing treatment protocol for a patient which should continue 

31 

For more information and the text of the report of the High Level Process of Reflection on patient 
mobility and healthcare developments in the European Union, see 
http://europa.eu.int/comm/health/ph_overview/co_operation/mobility/patient_mobility_en.htm.  

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to be applied even if they move country. However, there are significant variations in 
the extent to which prescriptions issued in another country are accepted, which cause 
obstacles  in  practice  to  cross-border  healthcare.  Medicinal  products  licensed  within 
the Community all have to meet harmonised standards of quality, safety and efficacy, 
and thus in principle it should be possible for prescriptions issued by an authorised 
person  for  a  specific  patient  in  one  Member  State  to  be  dispensed  in  another, 
provided  that  the  authenticity  and  content  of  the  prescription  are  clear.  In  order  to 
ensure  a  high  level  of  health  protection  whilst  also  facilitating  free  movement  of 
health services, specific measures should be put in place to verify the authenticity of 
the  prescription  and  the  authorised  person  who  issued  it,  to  ensure  that  the  patient 
understands  the  information  concerning  the  pharmaceutical  product  and  (given 
variations  in  names  and  presentation  between  countries)  to  identify  the  medicinal 
product concerned, and certain categories of medicinal products should be excluded. 

8.3. 

European reference networks and health technology assessment  

This  Directive  further  provides  for  cooperation  in  the  specific  areas  where  the 
economies  of  scale  of  coordinated  action  between  all  Member  States  can  bring 
significant  added  value  to  national  health  systems.  This  is  the  case  for  European 
reference  networks  (Article  15),  which  should  provide  healthcare  to  patients  who 
have  conditions  requiring  a  particular  concentration  of  resources  or  expertise,  in 
order  to  provide  affordable,  high  quality  and  cost-effective  care  and  could  also  be 
focal  points  for  medical  training  and  research,  information  dissemination  and 
evaluation.  Establishing  European  networking  for  such  centres  of  reference  would 
help  to  provide  high-quality  and  cost-effective  care  as  well  as  help  to  realise  the 
potential  of  the  internal  market  in  this  area  by  maximising  the  speed  and  scale  of 
diffusion of innovations in medical science and health technologies, and would thus 
bring benefits of the internal market to both patients and healthcare systems as well 
as helping to promote the highest possible quality of care. The High Level Group on 
health  services  and  medical  care  has  already  developed  general  conditions  and 
criteria that European reference networks should fulfil, and these should be specified 
in  detail  through  implementing  measures  taking  into  account  the  results  of  current 
pilot projects.  

Similarly,  this  Directive  provides  for  establishment  of  the  Community  network  on 
health  technology  assessment  (Article  17),  which  should  support  cooperation 
between  responsible  national  authorities,  support  provision  of  objective,  reliable, 
timely,  transparent  and  transferable  information  on  the  short-  and  long-term 
effectiveness of health technologies, enable an effective exchange of this information 
within  the  network  and  to  provide  support  to  policy  decisions  by  Member  States. 
Currently  there  are  wide  variations  and  frequent  duplication  in  such  assessments 
between  and  within  Member  States  in  terms  of  the  methodologies  used  and  the 
consequent uptake of innovations, which act as a barrier to the free movement of the 
technologies  concerned  and  (through  the  consequent  variations  in  healthcare) 
undermine  confidence  in  standards  of  safety  and  quality  across  the  Union. 
Collaborating  on  providing  common  criteria  with  a  view  to  establish  such  an 
evidence base at Community level will help to spread best practice, avoid duplication 
of resources and develop common core information packages and techniques that can 
then  be  used  by  Member  States,  to  help  them  make  best  use  of  new  technologies, 
therapies and techniques and as with European reference networks, will also help to 

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realise the potential of the internal market in this area by maximising the speed and 
scale of diffusion of innovations in medical science and health technologies. 

8.4. 

E-health 

Provision of cross-border healthcare does not necessary require either the patient or 
the  professional  to  physically  change  countries,  but  may  be  provided  through 
information and communication technologies – this is the mode of supply referred to 
as  'cross-border  provision  of  services',  or  "E-health".  This  is  a  mode  of  supply  of 
growing importance, but one which presents specific challenges for ensuring that the 
different  information  and  communication  technologies  of  the  health  systems  of  the 
Member  States  are  compatible  (or  "interoperable").  Widely  different  and 
incompatible formats and standards for information and communication technologies 
used  in  healthcare  provision  are  used  throughout  the  Community,  creating  both 
obstacles  to  this  mode  of  cross-border  healthcare  provision  and  risks  to  health 
protection. It is therefore necessary to provide for Community harmonisation in this 
area  in  order  to  achieve  the  interoperability  of  Member  States'  information  and 
communication technology. However, the proposal does not oblige any introduction 
of e-health systems or services but aims at ensuring interoperability once the choice 
of introducing such systems is done by Member States. 

8.5. 

Data collection 

Although  the  Commission  (drawing  on  the  extensive  research  and  consultations 
preceding  this  proposal)  has  been  able  to  estimate  the  likely  extent  and  nature  of 
cross-border healthcare, data on cross-border healthcare is not sufficiently available 
or  comparable  to  enable  long-term  assessment  and  management  of  cross-border 
healthcare.  Such  data  is  vital  to  be  able  to  monitor  cross-border  healthcare  and  its 
impact  on  health  systems  overall,  in  order  to  ensure  that  an  appropriate  balance  is 
struck between free provision of health services, a high level of health protection and 
respecting  the  responsibilities  of  the  Member  States  for  ensuring  the  overall 
objectives of their health systems. 

8.6. 

Implementing committee 

Measures  necessary  for  the  implementation  of  this  Directive  should  be  adopted  in 
accordance with Council Decision 1999/468/EC laying down the procedures for the 
exercise of implementing powers conferred on the Commission. In particular, power 
should be conferred on the Commission to define for the purposes of this Directive a 
list of treatments, other than those requiring overnight accommodation, to be subject 
to  the  same  regime  as  hospital  care;  accompanying  measures  to  exclude  specific 
categories of medicinal products or substances from the recognition of prescriptions 
issued  in  another  Member  State  provided  for  in  this  Directive;  a  list  of  specific 
criteria  and  conditions  that  European  reference  networks  must  fulfil;  the  procedure 
for  establishing  European  reference  networks.  Since  those  measures  are  of  general 
scope  and  are  designed  to  amend  non-essential  elements  of  this  Directive,  or  to 
supplement this Directive by the addition of new non-essential elements, they must 
be adopted in accordance with the regulatory procedure with scrutiny provided for in 
Article 5a of Decision 1999/468/EC. 

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2008/0142 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

on the application of patients' rights in cross-border healthcare 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
95 thereof, 

Having regard to the proposal from the Commission32, 

Having regard to the opinion of the European Economic and Social Committee33, 

Having regard to the opinion of the Committee of the Regions34, 

After consulting the European Data Protection Supervisor35, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty36, 

Whereas: 

(1) 

(2) 

(3) 

32 
33 
34 
35 
36 
37 

According  to  Article  152(1)  of  the  Treaty,  a  high  level  of  human  health  protection 
must be ensured in the definition and implementation of all Community policies and 
activities.  This  implies  that  high  level  of  human  health  protection  has  to  be  ensured 
also when the Community legislature acts under other Treaty provisions. 

Given that that the conditions for recourse to Article 95 of the Treaty as a legal basis 
are fulfilled, the Community legislature shall rely on this legal basis even when public 
health protection is a decisive factor in the choices made; in this respect Article 95(3) 
of  the  Treaty  explicitly  requires  that,  in  achieving  harmonisation,  a  high  level  of 
protection  of  human  health  should  be  guaranteed  taking  account  in  particular  of  any 
new development based on scientific facts. 

This Directive respects the fundamental rights and observes the general principles of 
law as recognised in particular by the Charter of Fundamental Rights of the European 
Union The right of access to healthcare and the right to benefit from medical treatment 
under  conditions  established  by  national  law  and  practices  are  recognised  by  Article 
35 of the Charter of Fundamental Rights of the European Union.37. Specifically, this 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C , , p. . 
OJ C […], […], p. […]. 
OJ C 364, 18.12.2000, p. 1. 

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21 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Directive has to be implemented and applied with due respect for the rights to private 
and family life, protection of personal data, equality before the law and the principle of 
non-discrimination  and  the  right  to  an  effective  remedy  and  to  a  fair  trial,  in 
accordance with the general principles of law, as enshrined in Articles 7, 8, 20, 21, 47 
of the Charter. 

The health systems of the Community are a central component of Europe’s high levels 
of social protection, and contribute to social cohesion and social justice as well as to 
sustainable  development.38  They  are  also  part  of  the  wider  framework  of  services  of 
general interest. 

As  confirmed  by  the  Court  of  Justice  on  several  occasions,  while  recognizing  their 
specific nature, all types of medical care fall within the scope of the Treaty.  

Some  issues  related  to  cross-border  healthcare,  in  particular  reimbursement  of 
healthcare  provided  in  a  Member  State  other  than  that  in  which  the  recipient  of  the 
care  is  resident,  have  been  already  addressed  by  the  Court  of  Justice.  As  healthcare 
was  excluded  from  the  scope  of  Directive  2006/123/EC  of  the  European  Parliament 
and  of  the  Council  of  12  December  2006  on  services  in  the  internal  market39  it  is 
important to address these issues in a specific Community legal instrument in order to 
achieve a more general and effective application of principles developed by the Court 
of Justice on a case by case basis.  

In its Conclusions of 1-2 June 200640, the Council of the European Union has adopted 
a  statement  on  "Common  values  and  principles  in  European  Union  health  systems" 
and  recognised  particular  value  of  an  initiative  on  cross-border  healthcare  ensuring 
clarity for European citizens about their rights and entitlements when they move from 
one Member State to another in order to ensure legal certainty. 

This directive aims to establish a general framework for provision of safe, high quality 
and efficient cross-border healthcare in the Community and to ensure patients mobility 
and freedom to provide healthcare and high level of protection of health, whilst fully 
respecting the responsibilities of the Member States for the definition of social security 
benefits related to health and the organisation and delivery of healthcare and medical 
care and social security benefits in particular for sickness.  

This Directive on the application of patients’ rights in cross-border healthcare applies 
to all types of healthcare. As confirmed by the Court of Justice, neither their special 
nature  nor  the  way  in  which  they  are  organised  or  financed  removes  them  from  the 
ambit  of  the  fundamental  principle  of  freedom  of  movement.  As  regards  long-term 
care, the Directive does not apply to assistance and support for families or individuals 
who  are,  over  an  extended  period  of  time,  in  a  particular  state  of  need.  It  does  not 
apply, for example, to residential homes or housing, or assistance provided to elderly 
people  or  children  by  social  workers  or  volunteer  carers  or  professionals  other  than 
health professionals. 

38 

39 
40 

Council Conclusions on Common values and principles in European Union Health Systems, OJ C 146, 
22.6.2006, p.1. 
OJ L 376, 27.12.2006, p.36. 
OJ C 146, 22.6.2006, p.1. 

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22 

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(10)  For the purpose of this Directive, the concept of "cross-border healthcare" covers the 

following modes of supply of healthcare: 

–  Use of healthcare abroad (i.e.: a patient moving to a healthcare provider in another 

Member State for treatment); this is what is referred to as 'patient mobility'; 

–  Cross-border provision of healthcare (i.e.: delivery of service from the territory of 
one  Member  State  into  the  territory  of  another);  such  as  telemedicine  services, 
remote diagnosis and prescription, laboratory services; 

–  Permanent  presence  of  a  healthcare  provider  (i.e.:  establishment  of  a  healthcare 

provider in another Member State); and, 

–  Temporary presence of persons (i.e.: mobility of health professionals, for example 

moving temporarily to the Member State of the patient to provide services). 

(11)  As recognised by the Member States in the Council Conclusions on Common values 
and  principles  in  European  Union  Health  Systems41  there  is  a  set  of  operating 
principles  that  are  shared  by  health  systems  throughout  the  Community.  These 
operating principles include quality, safety, care that is based on evidence and ethics, 
patient  involvement,  redress,  the  fundamental  right  to  privacy  with  respect  to  the 
processing of personal data, and confidentiality. Patients, professionals and authorities 
responsible  for  health  systems  must  be  able  to  rely  on  these  shared  principles  being 
respected and structures provided for their implementation throughout the Community. 
It is therefore appropriate to require that it is the authorities of the Member State on 
whose  territory  the  healthcare  is  provided,  who  are  responsible  for  ensuring 
compliance with those operating principles. This is necessary to ensure the confidence 
of patients in cross-border healthcare, which is itself necessary for achieving patients' 
mobility and free movement of provision of healthcare in the internal market as well 
as a high level of health protection.  

(12)  Given  that  it  is  impossible  to  know  in  advance  whether  a  given  healthcare  provider 
will  supply  healthcare  to  a  patient  coming  from  another  Member  State  or  a  patient 
from  their  own  Member  State,  it  is  necessary  that  the  requirements  to  ensure  that 
healthcare  is  provided  according  to  common  principles  and  clear  quality  and  safety 
standards  are  applicable  to  all  type  of  healthcare  in  order  to  ensure  the  freedom  to 
provide and obtain cross border healthcare which is the aim of the directive. Member 
States' authorities have to respect the shared overarching values of universality, access 
to good quality care, equity and solidarity, which have been already widely recognised 
by  the  Community  institutions  and  by  all  the  Member  States  as  constituting  a  set  of 
values that are shared by health systems across Europe. Members States also have to 
ensure that these values are respected with regard to patients and citizens from other 
Member  States,  and  that  all  patients  are  treated  equitably  on  the  basis  of  their 
healthcare need rather than their Member State of social security affiliation. In doing 
so,  Member  States  must  respect  the  principles  of  freedom  of  movement  within  the 
internal market, non-discrimination inter alia with regard to nationality (or in the case 
of  legal  persons,  with  regard  to  the  Member  State  in  which  they  are  established), 
necessity and proportionality of any restrictions on free movement. However, nothing 
in  this  Directive  requires  healthcare  providers  to  accept  for  planned  treatment  or  to 

41 

OJ C 146, 22.6.2006, p. 1. 

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23 

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prioritise  patients  from  other  Member  States  to  the  detriment  of  other  patients  with 
similar health needs, such as through increasing waiting time for treatment.  

(13)  Moreover,  patients  from  other  Member  States  should  enjoy  equal  treatment  with  the 
nationals of the Member State of treatment and, according to the general principles of 
equity and non discrimination, as recognized in Art.21 of the Charter they should in no 
way  be  discriminated  upon  on  the  basis  of  their  sex,  race,  colour,  ethnic  or  social 
origin,  genetic  features,  language,  religion  or  belief,  political  or  any  other  opinion, 
membership  of  a  national  minority,  property,  birth,  disability,  age  or  sexual 
orientation.  Member  States  may  differentiate  in  the  treatment  accorded  to  different 
groups of patients only where they can demonstrate that this is justified by legitimate 
medical grounds, such as in case of specific measures for women or for certain ages 
groups (e.g. free of charge vaccination for children or elderly people). Furthermore, as 
this Directive respects the fundamental rights and  observes  the  principles  recognised 
in particular by the Charter of Fundamental Rights of the European Union, it has to be 
implemented and applied with due respect for the rights to equality before the law and 
the principle of non-discrimination in accordance with the general principles of law, as 
enshrined  in  Articles  20  and  21  of  the  Charter.  This  Directive  applies  without 
prejudice to Directive 2000/43/EC of the Council of 29 June 2000 implementing the 
principle of equal treatment between persons irrespective of racial or ethnic origin, and 
other Directives giving effect to Article 13 of the EC Treaty. In the light of this, the 
Directive  provides  that  patients  shall  enjoy  equal  treatment  with  the  nationals  of  the 
Member  State  of  treatment,  including  the  benefit  from  the  protection  against 
discrimination  provided  for  according  to  Community  law  as  well  as  from  the 
legislation of the Member State of treatment.  

(14) 

In  any  event,  any  measure  taken  by  Member  States  with  a  view  to  ensure  that 
healthcare  is  provided  according  to  clear  quality  and  safety  standards,  should  not 
constitute new barriers to the free movement of health  professionals as enshrined by 
the  Treaty  and  in  particular  regulated  by  Directive  2005/36/EC  of  the  European 
Parliament and of the Council of 7 September 2005 on the recognition of professional 
qualifications42.  

(15)  Research suggests that harm arises from healthcare in around 10% of cases. Ensuring 
clear  common  obligations  to  deal  with  circumstances  of  responding  to  harm  arising 
from healthcare is therefore essential to avoid lack of confidence in those mechanisms 
acting  as  an  obstacle  to  taking  up  cross-border  healthcare.  Coverage  for  harm  and 
compensation by the systems of the country of treatment should be without prejudice 
to the possibility for Member States to extend the coverage of their domestic systems 
to  patients  from  their  country  seeking  healthcare  abroad,  where  this  is  more 
appropriate  to  the  patient,  in  particular  in  the  case  of  patients  for  whom  use  of 
healthcare in another Member State is necessary.  

(16)  Member States should ensure, that mechanisms for the protection of patients and the 
compensation for 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 is for the Member 
State to determine the nature and/or modalities of such a mechanism.  

42 

OJ  L  255,  30.9.2005,  p.  22.Directive  as  last  amended  by  Council  Directive  2006/100/EC  (OJ  L  363, 
20.12.2006, p.141) 

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24 

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(17)  The  right  to  the  protection  of  personal  data  is  a  fundamental  right  recognised  by 
Article  8  of  the  Charter  of  Fundamental  Rights  of  the  European  Union.43  Ensuring 
continuity of cross-border healthcare depends on transfer of personal data concerning 
patient's health. These personal data should be able to flow freely from one Member 
State to another, but in the same time the fundamental rights of the individuals should 
be safeguarded. Directive 95/46/EC of the European Parliament and of the Council of 
24  October  1995  on  the  protection  of  individuals  with  regard  to  the  processing  of 
personal  data  and  on  the  free  movement  of  such  data44  establishes  the  right  for 
individuals to have access to their personal data concerning their health, for example 
in  the  patient's  medical  records  containing  such  matters  as  diagnosis,  examination 
results,  assessments  by  treating  physicians  and  any  treatment  or  interventions 
provided.  These  provisions  also  apply  in  the  context  of  cross-border  healthcare 
covered by this Directive. 

(18)  The  right  to  reimbursement  of  the  costs  of  healthcare  provided  in  another  Member 
State  from  the  statutory  social  security  scheme  of  patients  as  insured  persons  was 
recognised by the Court of Justice in several judgements. The Court of Justice has held 
that the Treaty provisions on the freedom to provide services includes the freedom for 
the recipients of healthcare, including persons in need of medical treatment, to go to 
another  Member  Sate  in  order  to  receive  it  there.  The  same  applies  to  recipients  of 
healthcare  seeking  to  receive  healthcare  provided  in  another  Member  State  through 
other means, for example through e-health services. Whilst Community law does not 
detract  from  the  power  of  the  Member  States  to  organise  their  healthcare  and  social 
security  systems,  Member  States  must  when  exercising  that  power  comply  with 
Community  law,  in  particular  with  the  Treaty  provisions  on  the  freedom  to  provide 
services.  Those  provisions  prohibit  the  Member  States  from  introducing  or 
maintaining  unjustified  restrictions  on  the  exercise  of  that  freedom  in  the  healthcare 
sector. 

(19) 

In  accordance  with  the  principles  established  by  the  Court  of  Justice,  and  without 
endangering  the  financial  balance  of  Member  States'  healthcare  and  social  security 
systems,  greater  legal  certainty  as  regards  the  reimbursement  of  healthcare  costs 
should be provided for patients and for health professionals, healthcare providers and 
social security institutions. 

(20)  This Directive does not address the assumption of costs of healthcare which become 
necessary on medical grounds during a temporary stay of insured persons in another 
Member  State.  Neither  does  this  Directive  affect  patient's  rights  to  be  granted  an 
authorisation for a treatment in another Member State where the conditions provided 
for by the regulations on coordination of social security schemes, in particular Article 
22 of Regulation (EC) No 1408/71 of the Council of 14 June 1971 on the application 
of social security schemes to employed persons and their families moving within the 
Community45and Article 20 of Council Regulation (EC) No 883/2004 of the European 

43 
44 
45 

OJ C 364, 18.12.2000, p. 1. 
OJ L 281, 23.11.1995, p.31. 
OJ  L  149,  5.7.1971,  p.2.  Regulation  as  last  amended  by  Regulation  (EC)  No  1992/2006,  (OJ  L  392, 
30.12.2006, p. 1). 

EN 

25 

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(21) 

Parliament and of the Council of 29 April 2004 on the coordination of social security 
systems46 are met.  

It is appropriate to require that also patients who go for healthcare to another Member 
State  in  other  circumstances  than  those  envisaged  for  coordination  of  social  security 
schemes  established  by  the  Regulation  (EC)  No.  1408/71  should  be  able  to  benefit 
from the principles of free movement of services in accordance with the Treaty and the 
provisions of this Directive. Patients should be guaranteed assumption of the costs of 
that healthcare at least at the level provided for the same or similar healthcare had they 
been provided in the Member State of affiliation. This fully respects responsibility of 
the  Member  States  to  determine  the  extent  of  the  sickness  cover  available  to  their 
citizens and prevents any significant effect on the financing of the national healthcare 
systems.  Member  States  may  nevertheless  provide  in  their  national  legislation  for 
reimbursement of the costs of the treatment at the tariffs in force in the Member State 
of treatment if this is more beneficial for the patient. This may be the case in particular 
for  any  treatment  provided  through  European  reference  networks  as  mentioned  in 
Article 15 of this Directive. 

(22)  For the patient, therefore, the two systems are coherent; either this directive applies or 
Regulation 1408/71. In any event, any insured person who requests an authorisation to 
receive  a  treatment  appropriate  to  his/her  condition  in  another  Member  State  shall 
always  be  granted  this  authorisation  under  the  conditions  provided  for  in  Regulation 
1408/71  and  883/04  when  the  treatment  in  question  cannot  be  given  within  the  time 
medically justifiable, taking account his current state of health and the probable course 
of  the  disease.  The  patient  should  not  be  deprived  of  the  more  beneficial  rights 
guaranteed by Regulation.1408/71 and 883/04 when the conditions are met. 

(23)  The  patient  may  choose  which  mechanism  they  prefer,  but  in  any  case,  where  the 
application of Regulation 1408/71 is more beneficial for the patient, the patient should 
not be deprived of the rights guaranteed by that Regulation. 

(24)  The patient should, in any event, not derive a financial advantage from the healthcare 
provided  in  another  Member  State  and  the  assumption  of  costs  should  be  therefore 
limited only to actual costs of healthcare received. 

(25)  This Directive does not aim either to create entitlement for reimbursement of treatment 
in another Member State, if such a treatment is not among the benefits provided for by 
the legislation of the patient's Member State of affiliation. Equally this Directive does 
not  prevent  the  Member  States  from  extending  their  benefits  in  kind  scheme  to 
healthcare provided in another Member State according to its provisions.  

(26)  This  Directive  does  not  provide  either  for  transfer  of  social  security  entitlements 
between  Member  States  or  other  coordination  of  social  security  schemes.  The  sole 
objective  of  the  provisions  regarding  prior  authorisation  and  reimbursement  of 
healthcare  provided  in  another  Member  State  is  to  enable  freedom  to  provide 
healthcare  for  both  patients  and  healthcare  providers  and  to  remove  unjustified 
obstacles to that fundamental freedom within the patient's Member State of affiliation.. 
Consequently  the  Directive  fully  respects  the  differences  of  national  health-care 

46 

OJ L 166, 30.4.2004, p. 1. 

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26 

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systems and the Member States' responsibilities for organisation and delivery of health 
services and medical care. 

(27)  This Directive provides also for the right for a patient to receive any medicinal product 
authorised for marketing in the Member State where healthcare is provided, even if the 
medicinal product is not authorised for marketing in the Member State of affiliation, as 
it is an indispensable part of obtaining effective treatment in another Member State. 

(28)  Member States may maintain general conditions, criteria for eligibility and regulatory 
and  administrative  formalities  for  receipt  of  healthcare  and  reimbursement  of 
healthcare  costs,  such  as  the  requirement  to  consult  a  general  practitioner  before 
consulting  a  specialist  or  before  receiving  hospital  care,  also  in  relation  to  patients 
seeking  healthcare  in  another  Member  State  provided  that  such  conditions  are 
necessary, proportionate to the aim and are not discretionary and discriminatory. It is 
thus  appropriate  to  require  that  these  general  conditions  and  formalities  are  being 
applied  in  an  objective,  transparent  and  non-discriminatory  way  and  are  known  in 
advance, that they are based primarily on medical considerations and that they do not 
impose any additional burden on patients seeking healthcare in another Member State 
in comparison with patients being treated in their Member State of affiliation, and that 
decisions are made as quickly as possible. This is without prejudice to the rights of the 
Member States to provide for criteria or conditions of prior authorisation in the case of 
patients seeking healthcare in their Member State of affiliation. 

(29)  Any  healthcare  which is not regarded as hospital care according to the provisions of 
this Directive should be considered as non-hospital care. In the light of the case-law of 
the  Court  of  Justice  on  the  free  movement  of  services,  it  is  appropriate  not  to  set  a 
requirement  of  prior  authorisation  for  reimbursement  by  the  statutory  social  security 
system  of  a  Member  State  of  affiliation  for  non-hospital  care  provided  in  another 
Member State. In so far as the reimbursement of such care remains within the limits of 
the  cover  guaranteed  by  the  sickness  insurance  scheme  of  the  Member  State  of 
affiliation,  the  absence  of  a  prior  authorisation  requirement  will  not  undermine  the 
financial equilibrium of social security systems. 

(30)  There is no definition of what constitutes hospital care throughout the different health 
systems of the Community, and different interpretations could therefore constitute an 
obstacle  to  the  freedom  for  patients  to  receive  healthcare.  In  order  to  overcome  that 
obstacle, it is necessary to provide a Community definition of hospital care. Hospital 
care  generally  means  care  requiring  the  overnight  accommodation  of  the  patient. 
However,  it  may  be  appropriate  to  submit  to  the  same  regime  of  hospital  care  also 
certain other kinds of healthcare, if that healthcare requires use of highly specialised 
and cost-intensive medical infrastructure or medical equipment (e.g. high-technology 
scanners used for diagnosis) or involving treatments presenting a particular risk for the 
patient  or  the  population  (e.g.  treatment  of  serious  infectious  diseases).  A  regularly 
updated  list  of  such  treatments  shall  be  specifically  defined  by  the  Commission 
through the comitology procedure. 

(31)  The  evidence  available  indicates  that  the  application  of  free  movement  principles 
regarding  use  of  healthcare  in  another  Member  State  within  the  limits  of  the  cover 
guaranteed  by  the  statutory  sickness  insurance  scheme  of  the  Member  State  of 
affiliation  will  not  undermine  the  health  systems  of  the  Member  States  or  financial 
sustainability  of  their  social  security  systems.  However,  the  Court  of  Justice  has 

EN 

27 

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recognised that it cannot be excluded that the possible risk of seriously undermining a 
social  security  system's  financial  balance  or  the  objective  of  maintaining  a  balanced 
medical  and  hospital  service  open  to  all  may  constitute  overriding  reasons  in  the 
general  interest capable of  justifying a barrier  to the principle  of freedom to provide 
services. The Court of Justice has also recognised that the number of hospitals, their 
geographical distribution, the way in which they are organised and the facilities with 
which they are provided, and even the nature of the medical services which they are 
able  to  offer,  are  all  matters  for  which  planning  must  be  possible.  This  Directive 
should provide for a system of prior authorisation for assumption of costs for hospital 
care received in another Member State, where the following conditions are met : had 
the treatment been provided on its territory, it would have been assumed by its social 
security system and the consequent outflow of patients due to the implementation of 
the  directive  seriously  undermines  or  is  likely  to  seriously  undermine  the  financial 
balance  of  the  social  security  system  and/or  this  outflow  of  patients  seriously 
undermines, or is likely to seriously undermine the planning and rationalisation carried 
out  in  the  hospital  sector  to  avoid  hospital  overcapacity,  imbalance  in  the  supply  of 
hospital  care  and  logistical  and  financial  wastage,  the  maintenance  of  a  balanced 
medical and hospital service open to all, or the maintenance of treatment capacity or 
medical competence on the territory of the concerned Member. As the assessment of 
the  precise  impact  of  an  expected  outflow  of  patients  requires  complex  assumptions 
and  calculations,  the  Directive  allows  for  a  system  of  prior  authorisation  if  there  is 
sufficient  reason  to  expect  that  the  social  security  system  will  be  seriously 
undermined.  This  should  also  cover  cases  of  already  existing  systems  of  prior 
authorisation which are in conformity with conditions laid down in Article 8.  

In any event, if a Member State decided to establish a system of prior authorisation for 
assumption of costs of hospital or specialised care provided in another Member States 
in accordance with the provision of this Directive, the costs of such care provided in 
another Member State should also be reimbursed by the Member State of affiliation up 
to the level of costs that would have been assumed had the same or similar healthcare 
been provided in the Member State of affiliation, without exceeding the actual costs of 
healthcare  received.  However,  when  the  conditions  set  out  in  Article  22(2)  of 
Regulation (EC) No 1408/71 are fulfilled the authorisation should be granted and the 
benefits  provided  in  accordance  with  that  Regulation.  This  applies  in  particular  in 
instances where the authorisation is granted after an administrative or judicial review 
of  the  request  and  that  the  person  concerned  has  received  the  treatment  in  another 
Member State. In that case Articles 6, 7, 8 and 9 of this Directive shall not apply. This 
is  in  line  with  the  case  law  of  the  Court  of  Justice  which  has  specified  that  patients 
who received a refusal of authorisation subsequently held to be unfounded, are entitled 
to have the cost of the treatment obtained in another Member State reimbursed in full 
according to the provisions of the legislation in the Member State of treatment. 

(32) 

(33)  Procedures regarding cross-border healthcare established by the Member States should 
give patients guarantees of objectivity, non-discrimination and transparency, in such a 
way  as  to  ensure  that  decisions  by  national  authorities  are  made  in  a  timely  manner 
and  with  due  care  and  regard  for  both  those  overall  principles  and  the  individual 
circumstances of each case. This applies also to the actual reimbursement of costs of 
healthcare incurred in another Member State after the patient's return. It is appropriate 
that  patients  should  normally  have  a  decision  regarding  the  cross-border  healthcare 
within fifteen calendar days. However, that period should be shorter where warranted 
by the urgency of the treatment in question. In any event, recognition procedures and 

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28 

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rules  on  the  provision  of  services  as  provided  for  by  Directive  2005/36/EC  of  the 
European  Parliament  and  of  the  Council  of  7  September  2005  on  the  recognition  of 
professional qualifications should not be affected by these general rules. 

(34)  Appropriate  information  on  all  essential  aspects  of  cross-border  healthcare  is 
necessary in order to enable patients to exercise their rights to cross-border healthcare 
in  practice.  For  cross-border  healthcare  the  most  efficient  mechanism  for  providing 
such  information  is  to  establish  central  contact  points  within  each  Member  State  to 
which  patients  can  refer,  and  which  can  provide  information  on  cross-border 
healthcare  taking  into  account  also  the  context  of  the  health  system  in  that  Member 
State. Since questions about aspects of cross-border healthcare will also require liaison 
between  authorities  in  different  Member  States,  these  central  contact  points  should 
also  constitute  a  network  through  which  such  questions  can  be  most  efficiently 
addressed.  These  contact  points  should  cooperate  with  each  other  and  should  enable 
patients  to  make  informed  choices  about  cross-border  healthcare.  They  should  also 
provide  information  about  options  available  in  case  of  problems  with  cross-border 
healthcare, in particular about out-of-court schemes for settling cross-border disputes. 

(35)  When healthcare is received by a patient in a Member state, which is not the country 
where he is insured, it is essential for the patient to know in advance which rules shall 
be  applicable.  An  equivalent  level  of  clarity  is  needed  in  case  where  healthcare 
providers temporarily move to another Member State to provide their medical services 
there or when healthcare is provided cross-border. In those cases, the rules applicable 
to healthcare are those provided by the legislation of the Member State of treatment in 
accordance with the general principles set out in Art.5, given that in accordance with 
Art. 152(5) of the Treaty the organisation and delivery of health services and medical 
care  is  of  responsibility  of  Member  States.  This  will  help  the  patient  in  making  an 
informed  choice,  and  will  avoid  misapprehension  and  misunderstanding.  It  will  also 
establish a high level of trust between the patient and the healthcare provider 

(36)  The Member States should decide on the form of those national contact points as well 
as  the  number  of  them.  The  national  contact  points  may  be  also  incorporated  in  or 
build on activities of existing information centres provided that it is clearly indicated 
that  they  are  also  national  contact  points  for  cross-border  healthcare.  The  national 
contact  points  should  have  appropriate  facilities  to  provide  information  on  the  main 
aspects  of  cross-border  healthcare  and  to  provide  practical  assistance  to  patients  if 
needed.  The  Commission  should  work  together  with  the  Member  States  in  order  to 
facilitate  cooperation  regarding  national  contact  points  for  cross-border  healthcare, 
including making relevant information available at Community level, such as through 
the  European  Health  Portal.  The  existence  of  national  contact  points  should  not 
preclude  Member  States  from  establishing  other  linked  contact  points  at  regional  or 
local level, reflecting the specific organisation of their healthcare system. 

(37)  Realising  the  potential  of  the  internal  market  for  cross-border  healthcare  requires 
cooperation between providers, purchasers and regulators of different Member States 
at  national,  regional  or  local  level  in  order  to  ensure  safe,  high  quality  and  efficient 
care  across  borders.  This  is  particularly  the  case  for  cooperation  in  border  regions, 
where cross-border provision of services may be the most efficient way of organising 
health  services  for  the  local  populations,  but  where  achieving  such  cross-border 
provision  on  a  sustained  basis  requires  cooperation  between  the  health  systems  of 
different  Member  States.  Such  cooperation  may  concern  joint  planning,  mutual 

EN 

29 

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recognition  or  adaptation  of  procedures  or  standards,  interoperability  of  respective 
national information and communication technology systems, practical mechanisms to 
ensure  continuity  of  care  or  practical  facilitating  of  cross-border  provision  of 
healthcare  by  health  professionals  on  a  temporary  or  occasional  basis.  Directive 
2005/36/EC  on  the  recognition  of  professional  qualifications  stipulates  that  free 
provision of services of a temporary or occasional nature, including services provided 
by  health  professionals,  in  another  Member  State  should  not,  subject  to  specific 
provisions  of  Community  law,  be  restricted  for  any  reason  relating  to  professional 
qualifications.  This  Directive  should  be  without  prejudice  to  those  provisions  of 
Directive 2005/36/EC.  

(38)  The  Commission  should  encourage  cooperation  between  the  Member  States  in  the 
areas  set  out  in  Chapter  IV  of  this  Directive  and  may,  in  accordance  with  Article 
152(2)  of  the  Treaty  take,  in  close  contact  with  the  Member  States,  any  useful 
initiative  to  facilitate  and  promote  such  cooperation.  Particular  attention  should  be 
given to the possible use of a European Grouping of Territorial Cooperation (EGTC). 

(39)  Where  medicinal  products  are  authorised  within  the  patient's  Member  State  in 
accordance with Directive 2001/83/EC of the European Parliament and of the Council 
of 6 November 2001 on the Community code relating to medicinal products for human 
use47  and  have  been  prescribed  in  another  Member  State  for  an  individual  named 
patient,  it  should  be  in  principle  possible  for  such  prescriptions  to  be  medically 
recognised and used in the patient's own Member State. The removal of regulatory and 
administrative  barriers  to  such  recognition  is  without  prejudice  to  the  need  for 
appropriate  agreement  of  the  patients'  treating  physician  or  pharmacist  in  every 
individual case, if this is warranted by protection of human health and is necessary and 
proportionate  to  that  objective.  Such  medical  recognition  should  also  be  without 
prejudice to the decision of the Member State of affiliation regarding the inclusion of 
such  medicinal  products  within the benefits covered by the social  security system of 
affiliation. The implementation of the principle of recognition will be facilitated by the 
adoption of measures necessary for safeguarding the safety of a patient, and avoiding 
the misuse or confusion of medicinal products.  

(40)  European  reference  networks  should  provide  healthcare  to  all  patients  who  have 
conditions  requiring  a  particular  concentration  of  resources  or  expertise,  in  order  to 
provide affordable, high quality and cost-effective care and could also be focal points 
for  medical  training  and  research,  information  dissemination  and  evaluation.  The 
mechanism  for  identification  and  development  of  the  European  reference  networks 
should be established with the aim to organise at European level equal access to high 
level  shared  expertise  in  a  given  medical  field  for  all  patients  as  well  as  for  health 
professionals.  

(41)  Technological developments in cross-border provision of healthcare through the use of 
information and communication technologies may result in the exercise of supervisory 
responsibilities  by  Member  States  being  unclear,  and  thus  can  hinder  the  free 
movement of healthcare and give rise to possible additional risks to health protection 
through this mode of supply. Widely different and incompatible formats and standards 

47 

OJ  L  311,  28.11.2001,  p.  67.  Directive  as  last  amended  by  Regulation  (EC)  No  1901/2006  of  the 
European Parliament and of the Council (OJ L 378, 27.12.2006, p. 1). 

EN 

30 

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for  cross-border  provision  of  healthcare  using 

are  used 
information  and 
communication  technologies  throughout  the  Community,  creating  both  obstacles  to 
this mode of cross-border healthcare provision and possible risks to health protection. 
It is therefore necessary to provide for Community harmonisation in these areas, and 
to  do  so  through  empowering  the  Commission  to  adopt  implementing  measures  in 
order  to  allow  sufficiently  rapid  establishment  and  updating  of  responsibilities  and 
standards  in  that  area  to  reflect  constant  progress  in  the  relevant  technologies  and 
techniques.  

(42)  Routine  statistics  as  well  as  complementary  data  on  cross-border  healthcare  are 
required  for  efficient  monitoring,  planning  and  management  of  healthcare  in  general 
and cross-border healthcare in particular, and their production should be integrated so 
far  as  possible  within  existing  data  collection  systems  to  enable  appropriate 
monitoring  and  planning  to  take  account  of  cross-border  care,  including  appropriate 
structures  at  Community  level  such  as  the  Community  statistical  system  and  in 
particular Regulation (EC) No …/…of the European Parliament and of the Council on 
Community statistics on public health and health and safety at work [COM(2007)46], 
the  health  information  system  established  within  the  framework  of  the  health 
programme established by the Decision No 1786/2002/EC of the European Parliament 
and of the Council of 23 September 2002 adopting a programme of Community action 
in  the  field  of  public  health  (2003-2008)48  and  other  monitoring  activities  such  as 
those  carried  out  by  the  European  Centre  for  Disease  Prevention  and  Control 
established  by  Regulation  (EC)  No  851/2004  of  the  European  Parliament  and  of  the 
Council  of  21  April  2004  establishing  a  European  centre  for  disease  prevention  and 
control49. 

(43)  The  constant  progress  of  medical  science  and  health  technologies  presents  both 
opportunities and challenges to the health systems of the Member States. Cooperation 
in  the  evaluation  of  new  health  technologies  can  support  Member  States  through 
economies  of  scale  and  avoiding  duplication  of  effort,  and  provide  a  better  basis  of 
evidence for optimal use of new technologies to ensure safe, high-quality and efficient 
healthcare.  This  will  also  contribute  to  the  internal  market  by  maximising  the  speed 
and scale of diffusion of innovations in medical science and health technologies. Such 
cooperation  requires  sustained  structures  involving  all  the  relevant  authorities  of  all 
the Member States, building on existing pilot projects.  

(44)  Measures  necessary  for  the  implementation  of  this  Directive  should  be  adopted  in 
accordance  with  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures for the exercise of implementing powers conferred on the Commission50. 

(45) 

In  particular,  power  should  be  conferred  on  the  Commission  to  adopt  the  following 
measures: a list of treatments, other than those requiring overnight accommodation, to 
be  subject  to  the  same  regime  as  hospital  care;  accompanying  measures  to  exclude 
specific  categories  of  medicinal  products  or  substances  from  the  recognition  of 
prescriptions issued in another Member State provided for in this Directive; a list of 
specific  criteria  and  conditions  that  European  reference  networks  must  fulfil;  the 
procedure for establishing European reference networks. Since those measures are of 

48 
49 
50 

OJ L L 271, 9.10.2002, p. 1. 
OJ L 142, 30.4. 2004, p.1. 
OJ L 184, 17.7.1999, p.23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p.11). 

EN 

31 

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general scope and are designed to amend non-essential elements of this Directive, or to 
supplement this Directive by the addition of new non-essential elements, they should 
be adopted in accordance with the regulatory procedure with scrutiny provided for in 
Article 5a of Decision 1999/468/EC. 

(46)  Since the objectives of this Directive, namely establishing of a general framework for 
provision  of  safe,  high  quality  and  efficient  cross-border  healthcare  in  the  European 
Union,  cannot  be  sufficiently  achieved  by  the  Member  States  and  can  therefore,  by 
reason  of  the  scale  of  the  action,  be  better  achieved  at  Community  level,  the 
Community  may  adopt  measures,  in  accordance  with  the  principle  of  subsidiarity  as 
set out in Article 5 of the Treaty. In accordance with the principle of proportionality, 
as set out in that Article, this Directive does not go beyond what is necessary in order 
to achieve those objectives. 

HAVE ADOPTED THIS DIRECTIVE: 

CHAPTER I 

GENERAL PROVISIONS 

Article 1 

Aim 

This  Directive  establishes  a  general  framework  for  the  provision  of  safe,  high  quality  and 
efficient cross-border healthcare. 

Article 2 

Scope 

This  Directive  shall  apply  to  provision  of  healthcare  regardless  of  how  it  is  organised, 
delivered and financed or whether it is public or private. 

Article 3 

Relationship with other Community provisions 

1. 

This Directive shall apply without prejudice to: 

(a)  Directive  95/46/EC  on  the  protection  of  individuals  with  regard  to  the 
processing  of  personal  data  and  on  the  free  movement  of  such  data  and 

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32 

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Directive  2002/58/EC  concerning  the  processing  of  personal  data  and  the 
protection of privacy in the electronic communications sector51; 

(b)  Regulation (EC) No 726/2004 of the European Parliament and of the Council 
of  31  March  2004  laying  down  Community  procedures  for  the  authorisation 
and  supervision  of  medicinal  products  for  human  and  veterinary  use  and 
establishing a European Medicines Agency52 and Directive 2001/83/EC on the 
Community code relating to medicinal products for human use; 

(c)  Directive 2001/20/EC of the European Parliament and of the Council of 4 April 
2001  on  the  approximation  of  the  laws,  regulations  and  administrative 
provisions of the Member States relating to the implementation of good clinical 
practice in the conduct of clinical trials on medicinal products for human use53; 

(d)  Directive  96/71/EC  of  the  European  Parliament  and  of  the  Council  of  16 
December  1996  concerning  the  posting  of  workers  in  the  framework  of  the 
provision of services54. 

(e)  Directive  2000/43/EC  of  the  Council  of  29  June  2000  implementing  the 
principle  of  equal  treatment  between  persons  irrespective  of  racial  or  ethnic 
origin. 

(f)  Regulations on coordination of social security schemes, in particular Article 22 
of  Regulation  (EC)  No  1408/71  of  the  Council  of  14  June  1971  on  the 
application of social security schemes to employed persons and their families 
moving within the Community55and Council Regulation (EC) No 883/2004 of 
the  European  Parliament  and  of  the  Council  of  29  April  2004  on  the 
coordination of social security systems56. 

(g)  Regulation  (EC)  1082/2006  of  5  July  2006  on  a  European  Grouping  of 

territorial cooperation (EGTC)57 

When the circumstances under which an authorisation to go to another Member State 
in  order  to  receive  appropriate  treatment  under  Article  22  of  Regulation  (EC)  No 
1408/71 must be granted are met, the provisions of that Regulation shall apply and 
the provisions of Articles 6, 7, 8 and 9 of this Directive shall not apply. Conversely, 
when  an  insured  person  seeks  healthcare  in  another  Member  State  in  other 
circumstances, Articles 6, 7, 8 and 9 of this Directive apply and Article 22 of Council 
Regulation (EC) No 1408/71 shall not apply. However, whenever the conditions for 
granting an authorisation set out in Article 22(2) of Regulation (EC) No 1408/71 are 
fulfilled, the authorisation shall be accorded and the benefits provided in accordance 

OJ L 201, 31.7.2002, p. 37. Directive as last amended by Directive 2006/24/EC (OJ L 105, 13.4.2006, 
p.54). 
OJ  L  136,  30.4.2004,  p.1.  Regulation  as  amended  by  Regulation  (EC)  No  1901/2006  (OJ  L  378, 
27.12.2006, p. 1). 
OJ L 121, 1.5.2001, p.34. 
OJ L 18, 21.1.1997, p. 1. 
OJ  L  149,  5.7.1971,  p.2.  Regulation  as  last  amended  by  Regulation  (EC)  No  1992/2006,  (OJ  L  392, 
30.12.2006, p. 1). 
OJ L 166, 30.4.2004, p. 1. 
OJ L 210, 31.7.2006, p. 19. 

2. 

51 

52 

53 
54 
55 

56 
57 

EN 

33 

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with  that  Regulation.  In  that  case  Articles  6,  7,  8  and  9  of  this  Directive  shall  not 
apply. 

3. 

If the provisions of this Directive conflict with a provision of another Community act 
governing  specific  aspects  of  healthcare,  the  provision  of  the  other  Community  act 
shall prevail and shall apply to those specific situations concerned. These include: 

(a)  Directive 2005/36/EC on the recognition of professional qualifications; 

(b)  Directive 2000/31/EC of the European Parliament and of the Council of 8 June 
2000  on  certain  legal  aspects  of  information  society  services,  in  particular 
electronic commerce, in the Internal Market58. 

4. 

Member  States  shall  apply  the  provisions  of  this  Directive  in  compliance  with  the 
rules of the EC Treaty. 

Article 4 

Definitions 

For the purposes of this Directive, the following definitions shall apply: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

"healthcare" means a health service provided by or under the supervision of a 
health professional in exercise of his profession, and regardless of the ways in 
which it is organised, delivered and financed at national level or whether it is 
public or private; 

"cross-border healthcare" means healthcare provided in a Member State other 
than  that  where  the  patient  is  an  insured  person  or  healthcare  provided  in  a 
Member  State  other  than  that  where  the  healthcare  provider  resides,  is 
registered or is established; 

"use of healthcare in another Member State" means healthcare provided in the 
Member State other than that where the patient is an insured person; 

"health  professional"  means  a  doctor  of  medicine  or  a  nurse  responsible  for 
general  care  or  a  dental  practitioner  or  a  midwife  or  a  pharmacist  within  the 
meaning of Directive 2005/36/EC or another professional exercising activities 
in the healthcare sector which are restricted to a regulated profession as defined 
in Article 3(1)(a) of Directive 2005/36/EC;  

"healthcare  provider"  means  any  natural  or  legal  person  legally  providing 
healthcare on the territory of a Member State; 

"patient"  means  any  natural  person  who  receives  or  wishes  to  receive 
healthcare in a Member State; 

(g) 

"insured person" means: 

58 

OJ L 178, 17.7.2000, p. 1. 

EN 

34 

   EN 

                                                 
(i) 

(ii) 

until  the  date  of  application  of  Regulation  (EC)  No  883/2004:  a  person 
who is insured in accordance with the provisions of Articles 1, 2 and 4 of 
Regulation (EC) No 1408/71,  

as from the date of application of Regulation (EC) No 883/2004: a person 
who  is  an  insured  person  within  the  meaning  of  Article  1(c)  of 
Regulation (EC) No 883/2004; 

(h) 

"Member State of affiliation" means the Member State where the patient is an 
insured person; 

(i) 

(j) 

(k) 

"Member  State  of  treatment"  means  the  Member  State  on  whose  territory 
cross-border healthcare is actually provided; 

"medicinal  product"  means  a  medicinal  product  as  defined  by  Directive 
2001/83/EC; 

"prescription"  means  a  medicinal  prescription  as  defined  by  the  Directive 
2001/83/EC  including  prescriptions  issued  and  transmitted  electronically 
(ePrescriptions); 

(l) 

"harm"  means  adverse  outcomes  or  injuries  stemming  from  the  provision  of 
healthcare. 

CHAPTER II 

MEMBER STATE AUTHORITIES RESPONSIBLE FOR COMPLIANCE WITH COMMON 
PRINCIPLES FOR HEALTHCARE 

Article 5 

Responsibilities of authorities of the Member State of treatment 

1. 

The  Member  States  of  treatment  shall  be  responsible  for  the  organisation  and  the 
delivery  of  healthcare.  In  such  a  context  and  taking  into  account  principles  of 
universality, access to good quality care, equity and solidarity, they shall define clear 
quality  and  safety  standards  for  healthcare  provided  on  their  territory,  and  ensure 
that: 

(a)  mechanisms are in place for ensuring that healthcare providers are able to meet 
such standards, taking into account international medical science and generally 
recognised good medical practices; 

(b) 

the  application  of  such  standards  by  healthcare  providers  in  practice  is 
regularly monitored and corrective action is taken when appropriate standards 
are  not  met,  taking  into  account  progress  in  medical  science  and  health 
technology; 

EN 

35 

   EN 

(c) 

healthcare providers provide all relevant information to enable patients to make 
an  informed  choice,  in  particular  on  availability,  prices  and  outcomes  of  the 
healthcare  provided  and  details  of  their  insurance  cover  or  other  means  of 
personal or collective protection with regard to professional liability; 

(d)  patients have a means of making complaints and are guaranteed remedies and 

compensation when they suffer harm arising from the healthcare they receive; 

(e) 

(f) 

systems  of  professional 
insurance  or  a  guarantee  or  similar 
arrangement,  which  are  equivalent  or  essentially  comparable  as  regards  their 
purpose and which are appropriate to the nature and the extent of the risk are in 
place for treatment provided on their territory; 

liability 

the fundamental right to privacy with respect to the processing of personal data 
is  protected  in  conformity  with  national  measures  implementing  Community 
provisions on the protection of personal data, in particular Directives 95/46/EC 
and 2002/58/EC; 

(g)  patients  from  other  Member  States  shall  enjoy  equal  treatment  with  the 
nationals  of  the  Member  State  of  treatment,  including  the  protection  against 
discrimination  provided  for  according  to  Community  law  and  national 
legislation in force in the Member State of treatment.  

Any  measures  taken  by  Member  States,  when  implementing  this  Article,  shall 
respect  the  provisions  of  Directive  2005/36/EC  on  the  recognition  of  professional 
qualifications  and  Directive  2000/31/EC  on  certain  legal  aspects  of  information 
society services, in particular electronic commerce. 

In so far as it is necessary to facilitate the provision of cross-border healthcare and 
taking as a basis a high level of protection of health, the Commission, in cooperation 
with the Member States, shall develop guidelines to facilitate the implementation of 
paragraph 1. 

CHAPTER III 

USE OF HEALTHCARE IN ANOTHER MEMBER STATE 

Article 6 

Healthcare provided in another Member State 

Subject  to  the  provisions  of  this  Directive,  in  particular  Articles  7,  8  and  9,  the 
Member  State  of  affiliation  shall  ensure  that  insured  persons  travelling  to  another 
Member  State  with  the  purpose  of  receiving  healthcare  there  or  seeking  to  receive 
healthcare provided in another Member State, will not be prevented from receiving 
healthcare  provided  in  another  Member  State  where  the  treatment  in  question  is 
among the benefits provided for by the legislation of the Member State of affiliation 
to  which  the  insured  person  is  entitled.  The  Member  State  of  affiliation  shall 

2. 

3. 

1. 

EN 

36 

   EN 

2. 

3. 

4. 

5. 

reimburse  the  costs  to  the  insured  person,  which  would  have  been  paid  for  by  its 
statutory social security system had the same or similar healthcare been provided in 
its  territory.  In  any  event,  it  is  for  the  Member  State  of  affiliation  to  determine  the 
healthcare that is paid for regardless of where it is provided. 

The costs of healthcare provided in another Member State shall be reimbursed by the 
Member State of affiliation in accordance with the provisions of this Directive up to 
the level of costs that would have been assumed had the same or similar healthcare 
been provided in the Member State of affiliation, without exceeding the actual costs 
of healthcare received. 

The Member State of affiliation may impose on a patient seeking healthcare provided 
in  another  Member  State,  the  same  conditions,  criteria  of  eligibility  and  regulatory 
and  administrative  formalities  for  receiving  healthcare  and  reimbursement  of 
healthcare costs as it would impose if the same or similar healthcare was provided in 
its territory, in so far as they are neither discriminatory nor an obstacle to freedom of 
movement of persons.  

Member  States  shall  have  a  mechanism  for  calculation  of  costs  that  are  to  be 
reimbursed  to  the  insured  person  by  the  statutory  social  security  system  for 
healthcare  provided  in  another  Member  State.  This  mechanism  shall  be  based  on 
objective,  non-discriminatory  criteria  known  in  advance  and  the  costs  reimbursed 
according to this mechanism shall be not less than what would have been assumed 
had the same or similar healthcare been provided in the territory of the Member State 
of affiliation. 

Patients travelling to another Member State with the purpose of receiving healthcare 
there  or  seeking  to  receive  healthcare  provided  in  another  Member  State  shall  be 
guaranteed  access  to  their  medical  records,  in  conformity  with  national  measures 
implementing Community provisions on the protection of personal data, in particular 
Directives 95/46/EC and 2002/58/EC. 

Article 7 

Non-hospital care 

The Member State of affiliation shall not make the reimbursement of the costs of non-hospital 
care provided in another Member State subject to prior authorisation, where the cost of that 
care,  if it had been  provided in its territory, would have been paid for by its social security 
system. 

Article 8 

Hospital and specialised care 

1. 

For the purposes of reimbursement of healthcare provided in another Member State 
in accordance with this Directive, hospital care shall mean: 

EN 

37 

   EN 

(a) healthcare which requires overnight accommodation of the patient in question for 
at least one night. 

(b)  healthcare,  included  in  a  specific  list,  that  does  not  require  overnight 
accommodation of the patient for at least one night. This list shall be limited to:  

- 

- 

healthcare  that  requires  use  of  highly  specialised  and  cost-intensive  medical 
infrastructure or medical equipment; or  

healthcare  involving  treatments  presenting  a  particular  risk  for  the  patient  or 
the population.  

This  list  shall  be  set  up  and  may  be  regularly  updated  by  the  Commission.  Those 
measures,  designed 
this  Directive  by 
to  amend  non-essential  elements  of 
supplementing it, shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 19(3). 

The Member State of affiliation may provide for a system of prior authorisation for 
reimbursement by its social security system of the cost of hospital care provided in 
another Member State where the following conditions are met: 

(a) 

(b) 

had the healthcare been provided in its territory, it would have been assumed 
by the Member State's social security system; and  

the purpose of the system is to address the consequent outflow of patients due 
to  the  implementation  of  the  present  Article  and  to  prevent  it  from  seriously 
undermining, or being likely to seriously undermine: 

(i) 

the financial balance of the Member State's social security system; and/or  

(ii) 

the planning and rationalisation carried out in the hospital sector to avoid 
hospital  overcapacity,  imbalance  in  the  supply  of  hospital  care  and 
logistical  and  financial  wastage,  the  maintenance  of  a  balanced  medical 
and hospital service open to all, or the maintenance of treatment capacity 
or medical competence on the territory of the concerned Member State.  

The  prior  authorisation  system  shall  be  limited  to  what  is  necessary  and 
proportionate  to  avoid  such  impact,  and  shall  not  constitute  a  means  of  arbitrary 
discrimination. 

The Member State shall make publicly available all relevant information on the prior 
authorisation systems introduced pursuant to the provisions of paragraph 3.  

Article 9  

Procedural guarantees regarding the use of healthcare in another Member State 

The Member State of affiliation shall ensure that administrative procedures regarding 
the  use  of  healthcare  in  another  Member  State  related  to  any  prior  authorisation 
referred to in Article 8(3), reimbursement of costs of healthcare incurred in another 
Member  State  and  other  conditions  and  formalities  referred  to  in  Article  6(3),  are 

2. 

3. 

4. 

5. 

1. 

EN 

38 

   EN 

 
 
based on objective, non-discriminatory criteria which are published in advance, and 
which are necessary and proportionate to the objective to be achieved. In any event, 
an insured person shall always be granted the authorisation pursuant to Regulations 
on coordination of social security referred to in Art. 3.1 f) whenever the conditions of 
Art.22.1 c) and Art. 22.2 of Regulation 1408/71 are met. 

Any such procedural systems shall be easily accessible and capable of ensuring that 
requests  are  dealt  with  objectively  and  impartially  within  time  limits  set  out  and 
made public in advance by the Member States.  

Member  States  shall  specify  in  advance  and  in  a  transparent  way  the  criteria  for 
refusal of the prior authorisation referred to in Article 8(3). 

Member States shall, when setting out the time limits within which requests for the 
use of healthcare in another Member State must be dealt with, take into account: 

(a) 

the specific medical condition,  

(b) 

the patient's degree of pain,  

(c) 

the nature of the patient's disability, and  

(d) 

the patient's ability to carry out a professional activity. 

Member  States  shall  ensure  that  any  administrative  decisions  regarding  the  use  of 
healthcare  in  another  Member  State  are  subject  to  administrative  review  and  also 
capable  of  being  challenged  in  judicial  proceedings,  which  include  provision  for 
interim measures. 

Article 10 

Information for patients concerning the use of healthcare in another Member State 

The Member States of affiliation shall ensure that there are mechanisms in place to 
provide  patients  on  request  with  information  on  receiving  healthcare  in  another 
Member  State,  and  the  terms  and  conditions  that  would  apply,  inter  alia,  whenever 
harm is caused as a result of healthcare received in another Member State. 

The information referred to in paragraph 1 shall be made easily accessible, including 
by  electronic  means,  and  shall  include  information  on  patients'  entitlements,  on 
procedures for accessing those entitlements and on systems of appeal and redress if 
the patient is deprived of such entitlements. 

The Commission may, in accordance with the procedure referred to in Article 19(2), 
develop  a  standard  Community  format  for  the  prior  information  referred  to  in 
paragraph 1. 

2. 

3. 

4. 

5. 

1. 

2. 

3. 

EN 

39 

   EN 

1. 

2. 

1. 

2. 

Article 11  

Applicable rules to healthcare provided in another Member State 

When healthcare is provided in a Member State other than that where the patient is 
an insured person, or in a Member State other than that where the healthcare provider 
resides, is registered or established, such healthcare service is provided according to 
the legislation of the Member State of treatment in accordance with Art.5. 

This article does not apply as far as the recognition of the professional qualifications 
is concerned. 

Article 12 

National contact points for cross-border healthcare 

Member States shall designate national contact points for cross-border healthcare and 
communicate their names and contact details to the Commission. 

The  national  contact  point  in  the  Member  State  of  affiliation  shall,  in  close 
cooperation  with  other  competent  national  authorities,  and  with  national  contact 
points  in  other  Member  States,  in  particular  in  the  Member  State  of  treatment,  and 
with the Commission: 

(a) 

provide  and  disseminate  information  to  patients  in  particular  on  their  rights 
related  to  cross-border  healthcare  and  the  guarantees  of  quality  and  safety, 
protection  of  personal  data,  procedures  for  complaints  and  means  of  redress 
available  for  healthcare  provided  in  another  Member  State,  and  on  the  terms 
and conditions applicable; 

(b)  help patients to protect their rights and seek appropriate redress in the event of 
harm  caused  by  the  use  of  healthcare  in  another  Member  State;  the  national 
contact  point shall in particular inform patients about the options available to 
settle  any  dispute,  help  to  identify  the  appropriate  out-of-court  settlement 
scheme  for  the  specific  case  and  help  patients  to  monitor  their  dispute  where 
necessary; 

(c) 

(d) 

gather  detailed 
settlement of disputes and facilitate co-operation with those bodies; 

information  on  national  bodies  operating  out-of-court 

facilitate  the  development  of  international  out-of-court  settlement  scheme  for 
disputes arising from cross-border healthcare; 

3. 

The Commission shall, in accordance with the procedure referred to in Article 19(2), 
adopt: 

(a)  measures  necessary  for  the  management  of  the  network  of  national  contact 

points provided for in this Article; 

(b) 

the nature and type of data to be collected and exchanged within the network; 

EN 

40 

   EN 

(c) 

guidelines  on  information  to  patients  provided  for  in  paragraph  2(a)  of  this 
Article. 

CHAPTER IV 

COOPERATION ON HEALTHCARE 

Article 13 

Duty of cooperation 

1. 

2. 

1. 

Member  States  shall  render  such  mutual  assistance  as  is  necessary  for  the 
implementation of this Directive. 

Member  States  shall  facilitate  cooperation  in  cross-border  healthcare  provision  at 
regional  and  local  level  as  well  as  through  information  and  communication 
technologies,  cross-border  healthcare  provided  on  a  temporary  or  ad  hoc  basis  and 
other forms of cross-border cooperation. 

Article 14 

Recognition of prescriptions issued in another Member State 

If a medicinal product is authorised to be marketed on their territory in accordance 
with  Article  6(1)  of  Directive  2001/83/EC,  Member  States  shall  ensure  that 
prescriptions  issued  by  an  authorised  person  in  another  Member  State  for  a  named 
patient  can  be  used  in  their  territory  and  that  any  restrictions  on  recognition  of 
individual prescriptions are prohibited unless they:  

(a) 

(b) 

are  limited  to  what  is  necessary  and  proportionate  to  safeguard  human  health 
and are non-discriminatory or  

are based on legitimate and justified doubts about the authenticity or content of 
an individual prescription. 

2. 

For facilitating the implementation of paragraph 1, the Commission shall adopt: 

(a)  measures  enabling  a  pharmacist  or  other  health  professional  to  verify  the 
authenticity  of  the  prescription  and  whether  the  prescription  was  issued  in 
another  Member  State  by  an  authorised  person  through  developing  a 
Community  prescription 
interoperability  of 
ePrescriptions; 

template,  and  supporting 

(b)  measures  to  ensure  that  medicinal  products  prescribed  in  one  Member  State 
and  dispensed  in  another  are  correctly  identified  and  that  the  information  to 
patients concerning the product is comprehensible; 

EN 

41 

   EN 

3. 

4. 

1. 

(c)  measures  to  exclude  specific  categories  of  medicinal  products  from  the 
recognition of prescriptions provided for under this article where necessary in 
order to safeguard public health. 

The  measures  referred  to  in  points  (a)  and  (b)  of  paragraph  2  shall  be  adopted  in 
accordance with the regulatory procedure referred to in Article 19(2). The measures 
referred to in point (c) of paragraph 2, designed to amend non-essential elements of 
this  Directive,  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 19(3).  

Paragraph  1  shall  not  apply  to  medicinal  products  subject  to  special  medical 
prescription as provided for in Article 71(2) of Directive 2001/83/EC. 

Article 15 

European reference networks 

Member States shall facilitate the development of the European reference networks 
of healthcare providers. Those networks shall at all times be open for new healthcare 
providers  which  might  wish  to  join  them,  provided  that  such  healthcare  providers 
fulfil all the required conditions and criteria  

2. 

The objective of European reference networks shall be: 

(a) 

(b) 

to  help  to  realise  the  potential  of  European  cooperation  regarding  highly 
specialised healthcare for patients and for healthcare systems from innovations 
in medical science and health technologies 

to  help  to  promote  access  to  high  quality  and  cost-effective  healthcare  for  all 
patients  with  a  medical  condition  requiring  a  particular  concentration  of 
resources or expertise. 

(c) 

to  maximise  cost-effective  use  of  resources  by  concentrating  them  where 
appropriate;  

(d) 

to help to share knowledge and provide training for health professionals;  

(e) 

(f) 

to provide quality and safety benchmarks and to help develop and spread best 
practice within and outside the network;  

to help Member States with an insufficient number of patients with a particular 
medical condition or lacking technology or expertise to provide a full range of 
highly specialised services of the highest quality. 

3. 

The Commission shall adopt: 

(a) 

a  list  of  specific  criteria  and  conditions  that  the  European  reference  networks 
must  fulfil,  including  the  conditions  and  criteria  required  from  healthcare 
providers wishing to join the European reference networks, in order to ensure, 
in particular, that the European reference networks: 

EN 

42 

   EN 

(i) 

have  appropriate  capacities  to  diagnose,  to  follow-up  and  manage 
patients with evidence of good outcomes so far as applicable; 

(ii)  have  sufficient  capacity  and  activity  to  provide  relevant  services  and 

maintain quality of the services provided; 

(iii)  have  capacity  to  provide  expert  advice,  diagnosis  or  confirmation  of 
diagnosis,  to  produce  and  adhere  to  good  practice  guidelines  and  to 
implement outcome measures and quality control; 

(iv)  can demonstrate a multi-disciplinary approach; 

(v)  provide  high  level  of  expertise  and  experience  documented  through 
publications,  grants  or  honorific  positions,  teaching  and  training 
activities; 

(vi)  provide strong contribution to research; 

(vii)  are involved in epidemiological surveillance, such as registries; 

(viii)  have close links and collaboration with other expert centres and networks 

at national and international level and capacity to network; 

(ix)  have close links and collaboration with patients associations where such 

associations exist. 

(b) 

the procedure for establishing European reference networks. 

4. 

The measures referred to in paragraph 3, designed to amend non-essential elements 
of  this  Directive  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 19(3). 

Article 16 

E-health 

the 

The  Commission  shall,  in  accordance  with  the  procedure  referred  to  in  Article  19(2),  adopt 
information  and 
specific  measures  necessary  for  achieving 
communication  technology  systems  in  the  healthcare  field,  applicable  whenever  Member 
States  decide  to  introduce  them.  Those  measures  shall  reflect  developments  in  health 
technologies  and  medical  science  and  respect  the  fundamental  right  to  the  protection  of 
personal  data  in  accordance  with  the  applicable  law.  They  shall  specify  in  particular  the 
necessary  standards  and  terminologies  for  inter-operability  of  relevant  information  and 
communication  technology  systems  to  ensure  safe,  high-quality  and  efficient  provision  of 
cross-border health services. 

interoperability  of 

EN 

43 

   EN 

1. 

2. 

3. 

4. 

1. 

2. 

3. 

Article 17 

Cooperation on management of new health technologies 

Member States shall facilitate development and functioning of a network connecting 
the national authorities or bodies responsible for health technology assessment.  

The objective of the health technology assessment network shall be: 

(a) 

to support cooperation between national authorities or bodies; 

(b) 

to support provision of objective, reliable, timely, transparent and transferable 
information  on  the  short-  and  long-term  effectiveness  of  health  technologies 
and  enable  an  effective  exchange  of  this  information  between  national 
authorities or bodies.  

Member States shall designate the authorities or bodies participating in the network 
as referred to in paragraph 1 and communicate to the Commission names and contact 
details of those authorities or bodies. 

The Commission shall, in accordance with the procedure referred to in Article 19(2), 
adopt  the  necessary  measures  for  the  establishment  and  the  management  of  this 
network and specifying the nature and type of the information to be exchanged. 

Article 18 

Data collection for statistical and monitoring purposes 

Member  States  shall  collect  statistical  and  other  additional  data  needed  for 
monitoring purposes on the provision of cross-border healthcare, the care provided, 
its providers and patients, the cost and the outcomes. They shall collect such data as 
part  of  their  general  systems  for  collecting  healthcare  data,  in  accordance  with 
national and Community law for the production of statistics and on the protection of 
personal data. 

Member States shall transmit the data referred to in paragraph 1 to the Commission 
at  least  annually,  except  for  data  that  are  already  collected  pursuant  to  Directive 
2005/36/EC. 

Without prejudice to the measures adopted for the implementation of the Community 
Statistical  Programme  as  well  as  to  those  adopted  for  the  implementation  of 
Regulation  (EC)  No  …/…of  the  European  Parliament  and  of  the  Council  on 
Community  statistics  on  public  health  and  health  and  safety  at  work 
[COM(2007)46], the Commission shall, in accordance with the procedure referred to 
in Article 19(2), adopt measures for the implementation of this Article. 

EN 

44 

   EN 

CHAPTER V 

IMPLEMENTING AND FINAL PROVISIONS  

Article 19 

Committee 

1. 

2. 

3. 

The Commission shall be assisted by a Committee, consisting of representatives of 
the Member States and chaired by the Commission representative. 

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  of  that 
Decision. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set 
at 3 months. 

Where  reference  is  made  to  this  paragraph,  Article  5a  (1)  to  (4),  and  Article  7  of 
Decision  1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof. 

Article 20 

Reports 

The Commission shall within five years after the date referred to in Article 22(1) draw up a 
report on the operation of this Directive and submit it to the European Parliament and to the 
Council. 

To that end and without prejudice to Article 22, the Member States shall communicate to the 
Commission  any  measure  they  have  introduced,  modified  or  maintained  with  a  view  to 
implement the procedures laid down in Articles 8 and 9. 

Article 21 

References to other legislation 

As  from  the  date  of  applicability  of  Regulation  (EC)  No.  883/2004  of  the  European 
Parliament  and  of  the  Council  of  29  April  2004  on  the  coordination  of  social  security 
schemes59 : 

–  references to Council Regulation 1408/71/EC in this Directive shall be construed 

as references to Regulation 883/2004; 

59 

OJ L 166, 30.4.2004, p.1. 

EN 

45 

   EN 

                                                 
–  references to Article 22 of Council Regulation 1408/71/EC in this Directive shall 

be construed as references to Article 20 of Regulation 883/2004. 

Article 22 

Transposition 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative  provisions 
necessary to comply with this Directive by … [one year after its entry into force].  

They  shall  forthwith  communicate  to  the  Commission  the  text  of  those  provisions  and  a 
correlation table between those provisions and this Directive.  

When Member States adopt those provisions, they shall contain a reference to this Directive 
or be accompanied by such a reference on the occasion of their official publication. Member 
States shall determine how such reference is to be made. 

Article 23 

Entry into force 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 24 

Addressees 

This Directive is addressed to the Member States. 

Done at Brussels, […] 

For the European Parliament 
The President 
[…] 

For the Council 
The President 
[…] 

EN 

46 

   EN 

 
LEGISLATIVE FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL: 

Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  for  the 
application of cross-border healthcare patient rights 

2. 

ABM / ABB FRAMEWORK 

Public health 

3. 

BUDGET LINES 

3.1. 

Budget  lines  (operational  lines  and  related  technical  and  administrative 
assistance lines (ex- B.A lines)) including headings: 

XX0101: for the payment of the officials 

XX010211: for the payment of the committee costs 

3.2. 

Duration of the action and of the financial impact: 

From 2009, duration not defined  

This  budget  intends  to  cover  the  costs  of  the  future  Committee  on  cross-border 
healthcare that will be set up as announced in the Directive after the adoption of that 
Directive by the Parliament and the Council: 

2 FTE administrator valued at € 117,000 each  (according to the specific Guidelines), 
to support the comitology process. 

Costs  of  the  plenary  session,  with  one  participant  from  the  27  Member  States.  10 
meetings scheduled per year, valued at € 20,000 each. Actual costs of the meetings 
and frequency of those meetings might need revision, depending on the final shape 
of  the  directive,  after  adoption  by  council  and  parliament,  and  the  necessary 
comitology structures. 

3.3. 

Budgetary characteristics:  

Budget line 

Type of expenditure 

New 

EFTA 
contributi
on 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

XX 0101 

Comp 

Non-diff60 

XX 010211 

Non com  Non-diff61 

NO 

NO 

NO 

NO 

NO 

NO 

5 

5 

60 
61 

Non-differentiated appropriations hereafter referred to as NDA 
Non-differentiated appropriations hereafter referred to as NDA 

EN 

47 

   EN 

                                                 
4. 

SUMMARY OF RESOURCES 

4.1. 

Financial Resources 

4.1.1. 

Summary of commitment appropriations (CA) and payment appropriations (PA) 

Expenditure type 

Section 
no. 

2009 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total 

EUR million (to 3 decimal places) 

Operational expenditure62 

Commitment Appropriations 
(CA) 

8.1. 

Payment 
(PA) 

Appropriations 

a 

b 

Administrative expenditure within reference amount63 

Technical  &  administrative 
assistance (NDA) 

8.2.4. 

c 

TOTAL REFERENCE AMOUNT 

Commitment 
Appropriations 

Payment Appropriations 

a+c 

b+c 

Administrative expenditure not included in reference amount64 

Human 
associated 
(NDA) 

resources 

and 
expenditure 

8.2.5. 

d 

Administrative  costs,  other 
than  human  resources  and 
not 
associated 
reference 
in 
included 
amount (NDA) 

costs, 

8.2.6. 

e 

0.234  0.234 

0.234 

0.234 

0.234 

0.234 

1.404 

0.200  0.200 

0.200 

0.200 

0.200 

0.200 

1.200 

Total indicative financial cost of intervention 

TOTAL CA including cost 
of Human Resources 

TOTAL  PA  including  cost 
of Human Resources 

a+c
+d+
e 

b+c
+d+
e 

0.234  0.234 

0.234 

0.234 

0.234 

0.234 

1.404 

0.200  0.200 

0.200 

0.200 

0.200 

0.200 

1.200 

62 
63 
64 

Expenditure that does not fall under Chapter xx 01 of the Title xx concerned. 
Expenditure within article xx 01 04 of Title xx. 
Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05. 

EN 

48 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Co-financing details: not applicable 

If  the  proposal  involves  co-financing  by  Member  States,  or  other  bodies  (please 
specify  which),  an  estimate  of  the  level  of  this  co-financing  should  be  indicated  in 
the table below (additional lines may be added if different bodies are foreseen for the 
provision of the co-financing): 

EUR million (to 3 decimal places) 

n + 1 

n + 2 

n + 3 

n + 4 

Year 
n 

n  +  5 
and 
later 

Total 

Co-financing body 

…………………… 

TOTAL  CA  including  co-
financing 

f 

a+c
+d+
e+f 

4.1.2.  Compatibility with Financial Programming 

(cid:58) 

(cid:133) 

(cid:133) 

Proposal is compatible with existing financial programming. 

Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the  financial 
perspective. 

Proposal  may  require  application  of  the  provisions  of  the  Interinstitutional 
Agreement65 (i.e. flexibility instrument or revision of the financial perspective). 

4.1.3.  Financial impact on Revenue 

(cid:58) 

(cid:133) 

Proposal has no financial implications on revenue 

Proposal has financial impact – the effect on revenue is as follows: 

Budget line 

Revenue 

EUR million (to one decimal place) 

Prior to
action 
[Year n-
1] 

[Year 
n] 

Situation following action 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

[n+5]66

a) Revenue in absolute terms 

b) Change in revenue 

 ∆ 

65 
66 

See points 19 and 24 of the Interinstitutional agreement. 
Additional columns should be added if necessary i.e. if the duration of the action exceeds 6 years 

EN 

49 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
4.2. 

Human Resources FTE (including officials, temporary and external staff) – see 
detail under point 8.2.1. 

Annual requirements 

Year n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total  number  of  human 
resources 

2 

2 

2 

2 

2 

2 

5. 

CHARACTERISTICS AND OBJECTIVES 

5.1. 

Need to be met in the short or long term 

Not applicable. 

5.2. 

Value-added  of  Community  involvement  and  coherence  of  the  proposal  with 
other financial instruments and possible synergy 

Not applicable. 

5.3. 

Objectives, expected results and related indicators of the proposal in the context 
of the ABM framework 

Not applicable. 

5.4.  Method of Implementation (indicative) 

(cid:133)  Centralised Management 

(cid:58) 

(cid:133) 

directly by the Commission 

indirectly by delegation to: 

(cid:133) 

executive Agencies 

(cid:133) 

bodies set up by the Communities as referred to in art. 185 of the 
Financial Regulation 

(cid:133) 

national public-sector bodies/bodies with public-service mission 

(cid:133) 

Shared or decentralised management 

(cid:133)  with Member states 

(cid:133)  with Third countries 

(cid:133) 

Joint management with international organisations (please specify) 

Relevant comments: 

EN 

50 

   EN 

 
 
 
 
 
 
6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

Regular  reporting  of  the  working  groups  will  be  ensured  and  disseminated  to  the 
member States and Commission services. 

6.2. 

Evaluation 

6.2.1.  Ex-ante evaluation 

Not applicable. 

6.2.2.  Measures taken  following  an intermediate/ex-post evaluation (lessons learned from 

similar experiences in the past) 

Not applicable. 

6.2.3.  Terms and frequency of future evaluation 

An evaluation of the running of the working group will be done after 5 years. 

7. 

ANTI-FRAUD MEASURES  

Not applicable. 

EN 

51 

   EN 

8. 

DETAILS OF RESOURCES 

8.1. 

Objectives of the proposal in terms of their financial cost 

Commitment appropriations in EUR million (to 3 decimal places) 

Type of output 

Av. 
cost 

Year n 

Year n+1 

Year n+2 

Year n+3 

Year n+4 

Year n+5 and 
later 

TOTAL 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

of 

(Headings 
Objectives, 
and 
actions 
outputs should be 
provided) 

OPERATIONAL 
OBJECTIVE  No.1 
67……… 

1: 
on 

Action 
Committee 
cross-border 
healthcare 

- - Output 

N° meetings 

10 

0.200 

10 

0.200 

10 

0.200 

10 

0.200 

10 

0.200 

10 

0.200 

60 

1.200 

- Output 2 

Action 
2………………. 

- Output 1 

Sub-total 
Objective 1 

OPERATIONAL 
OBJECTIVE  No.2 
1……… 

67 

As described under Section 5.3 

EN 

52 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Action 
1………………. 

- Output 1 

Sub-total 
Objective 2 

OPERATIONAL 
OBJECTIVE  No.n 
1 

Sub-total 
Objective n 

TOTAL COST 

EN 

53 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.2. 

Administrative Expenditure 

8.2.1.  Number and type of human resources 

Types of post 

Staff to be assigned to management of the action using existing and/or 
additional resources (number of posts/FTEs) 

Year n 

Year n+1  Year n+2  Year n+3  Year n+4  Year n+5 

A*/AD 

2 

2 

2 

2 

2 

2 

Officials or 
temporary 
staff68 (XX 01 
01) 

B*, 
C*/AST 
Staff  financed69  by  art. 
XX 01 02 
Other  staff70  financed by 
art. XX 01 04/05 

TOTAL 

8.2.2.  Description of tasks deriving from the action 

Running  of  the  new  comitology  Committee  ("Committee  on  safe,  high-quality  and 
efficient  cross-border  healthcare") established in accordance  with  Article  19  of  this 
Directive  and  its  working  groups  that  will  work  on  the  implementation  of  the 
Directive 

Costs  of  the  plenary  session,  with  one  participant  from  the  27  Member  States.  10 
meetings scheduled per year, valued at € 20,000 each. Actual costs of the meetings 
and frequency of those meetings might need revision, depending on the final shape 
of the directive, after adoption by the Council and the Parliament. 

The  needs  for  human  and  administrative  resources  shall  be  covered  within  the 
allocation  granted  to  the  managing  DG  in  the  framework  of  the  annual  allocation 
procedure. 

8.2.3. 

Sources of human resources (statutory) 

(cid:58) 

(cid:133) 

(cid:133) 

(cid:133) 

(cid:133) 

Posts currently allocated to the management of the programme to be replaced 
or extended 

Posts pre-allocated within the APS/PDB exercise for year n 

Posts to be requested in the next APS/PDB procedure 

Posts  to  be  redeployed  using  existing  resources  within  the  managing  service 
(internal redeployment) 

Posts required for year n although not foreseen in the APS/PDB exercise of the 
year in question 

68 
69 
70 

Cost of which is NOT covered by the reference amount 
Cost of which is NOT covered by the reference amount 
Cost of which is included within the reference amount 

EN 

54 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.4.  Other  Administrative  expenditure  included  in  reference  amount  (XX  01  04/05  – 

Expenditure on administrative management) 

EUR million (to 3 decimal places) 

Budget line 
(number and heading) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year n+5  
and later 

TOT
AL 

Technical 

1 
and 
assistance (including related staff costs) 

administrative 

Executive agencies71 

Other 

technical 

and 

administrative 

assistance 

- intra muros  

- extra muros 

Total  Technical  and  administrative 
assistance 

8.2.5.  Financial cost of human resources and associated costs not included in the reference 

amount 

EUR million (to 3 decimal places) 

Type of human resources 

Year n 

Year n+1  Year n+2  Year n+3  Year n+4 

Year n+5
and later 

0.234 

0.234 

0.234 

0.234 

0.234 

0.234 

Officials  and  temporary  staff 
(XX 01 01) 

Staff  financed  by  Art  XX  01 
02  (auxiliary,  END,  contract 
staff, etc.) 

(specify budget line) 

cost 

Total 
of  Human 
Resources  and  associated 
costs 
in  reference 
amount) 

(NOT 

Calculation– Officials and Temporary agents 

Rate of €117,000/ staff used to quantify the  costs, as suggested in BUDG guidelines 

71 

Reference should be made to the specific legislative financial statement for the Executive Agency(ies) 
concerned. 

EN 

55 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Calculation– Staff financed under art. XX 01 02 

[…] 

8.2.6. Other administrative expenditure not included in reference amount 

EUR million (to 3 decimal places)

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 

and 
later 

TOTAL 

XX 01 02 11 01 – Missions 

XX 01 02 11 02 – Meetings & Conferences 

XX 01 02 11 03 – Committees72  

0.200 

0.200  0.200  0.200  0.200  0.200  1.200 

XX 01 02 11 04 – Studies & consultations 

XX 01 02 11 05 - Information systems 

2 

Total 

Other  Management 

0.200 

0.200  0.200  0.200  0.200  0.200  1.200 

Expenditure (XX 01 02 11) 

3  Other 

expenditure 

administrative 
including reference to budget line) 

nature 

of 

an 
(specify 

expenditure, 
than  human  resources  and 
in 

Total  Administrative 
other 
associated  costs  (NOT 
reference amount) 

included 

0.200 

0.200  0.200  0.200  0.200  0.200  1.200 

Calculation - Other administrative expenditure not included in reference amount 

[…] 

The  needs  for  human  and  administrative  resources  shall  be  covered  within  the  allocation 
granted to the managing DG in the framework of the annual allocation procedure. 

72 

Specify the type of committee and the group to which it belongs. 

EN 

56 

   EN