COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to Article 294(6) of the Treaty on the Functioning of the European Union   concerning the  position of the Council at first reading on the adoption of a Directive of the European Parliament and of the Council on the application of patients' rights on cross-border healthcare
Date: 2010-09-20
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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EUROPEAN COMMISSION 

Brussels, 20.9.2010 
COM(2010) 503 final 

2008/0142 (COD) 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT 

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union  

concerning the 

position of the Council at first reading on the adoption of a Directive of the European 
Parliament and of the Council on the application of patients' rights on cross-border 
healthcare 

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2008/0142 (COD) 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT 

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union  

concerning the 

position of the Council at first reading on the adoption of a Directive of the European 
Parliament and of the Council on the application of patients' rights on cross-border 
healthcare 

1. 

BACKGROUND 

Date of transmission of the proposal to the EP and the Council 
(document COM(2008)414 final – 2008/0142(COD)): 

2nd July 2008 

Date  of  the  opinion  of  the  European  Economic  and  Social 
Committee: 

4 December 2008 

Date of the opinion of the Committee of the Regions: 

12 February 2009 

Date of the opinion of the European Parliament, first reading: 

23 April 2009 

Date of transmission of the amended proposal: 

Date of political agreement: 

[*…]. 

8 June 2010 

Date of adoption of the Council position: 

13 September 2010 

*  Taking  into  account  the  developments  in  Council  at  the  time  of  the  European 
Parliament first reading, the Commission did not find necessary to prepare a revised 
proposal  but  expressed  its  views  on  the  Parliament  amendments  in  the  document 
SP(2009)3507 sent to the European Parliament on 20 October 2009. 

2. 

PURPOSE OF THE COMMISSION PROPOSAL 

The  overall  aim  of  the  proposed  Directive  is  to  establish  a  clear  and  transparent 
framework  for  the  reimbursement  of  healthcare  within  the  EU  in  cases  where  the 
care is provided in a Member State other than the country of affiliation (cross-border 
healthcare).  This  followed  the  Court  of  Justice  jurisprudence  confirming  that 
independently  of  the  rights  to  scheduled  treatment  in  another  Member  State  as 
granted by Regulations 883/2004 and 987/2009, there exist the rights of patients to 
benefit  from  medical  treatment  in  another  Member  State  under  Article  56  of  the 
Treaty on the Functioning of the European Union (TFEU). 

In order to achieve this objective, the proposal is structured around three main areas: 
(1)  ensuring  that  patients  receive  safe  and  high  quality  healthcare,  (2)  helping 

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patients to exercise their rights to reimbursement of cross-border healthcare, and (3) 
fostering  EU  cooperation  on  healthcare  in  the  area  of  recognition  of  prescriptions, 
European reference networks, health technology assessment, and eHealth.  

3. 

COMMENTS ON THE POSITION OF THE COUNCIL 

3.1. 

General comments 

The European Parliament adopted its position at the first reading on 23 April 2009. 
The Commission accepted in full, in part or in principle 92 out of 120 amendments 
adopted  at  the  first  reading  as  it  considered  that  these  amendments  clarified  or 
improved the Commission proposal and were consistent with the general aim of the 
proposal. 

While  the  position  of  the  Council  at  first  reading  adopted  on  13  September  2010 
contains  elements  departing  from  the  Commission's  proposal  and  creating  risks  of 
legal  uncertainty,  the  Commission  did  not  stand  against  it  in  order  to  allow  the 
legislative  process  to  move  forward.  However,  the  Commission  indicated  to  the 
Council  in  the  attached  declaration  that,  during  the  second  reading,  it  reserves  the 
right  to  support  European  Parliament  amendments  substantially  improving  certain 
provisions of the position of the Council at first reading. Regulation 883/2004 on the 
coordination  of  the  social  security  systems  and  its  implementing  Regulation 
987/2009 already grants a right to planned treatment in another Member State . The 
Regulations, adopted on the basis of Article 48 of the Treaty on the Functioning of 
the  European  Union,  grant  a  person  authorised  by  his/her  competent  institution  a 
right to receive health care in another Member state under the same conditions as the 
persons  insured  in  that  Member  State,  with  a  right  to  claim  the  complementary 
reimbursement  if  the  financial  conditions  in  the  competent  Member  State  are  more 
favourable  than  the  financial  conditions  in  the  Member  state  of  treatment.  The 
authorisation,  which  is  always  required  by  the  Regulation  883/2004,  can  not  be 
refused if the treatment in question is provided for by the legislation of the competent 
Member  state  and  can  not  be  delivered  to  the  person  within  a  medically  justified 
time-limit.  

Amendments made by the European Parliament at the first reading  

Amendments  accepted  by  the  Commission  and  incorporated  in  full,  in  part  or  in 
principle in the position of the Council at first reading:  

With  regard  to  the  scope  of  the  proposed  Directive,  the  position  of  the  Council  at 
first  reading  clarifies  that  this  Directive  does  not  apply  to  services  in  the  field  of 
long-term care whose purpose is to support people in need of assistance in carrying 
out routine, everyday tasks. This covers amendment 38 made by the Parliament and 
is acceptable to the Commission.  

In relation to organs, the position of the Council specifies that only the allocation and 
access  should  be  excluded,  given  their  particular  nature,  which  is  acceptable  to  the 
Commission,  while  Parliament  called  for 
the  general  exclusion  of  organ 
transplantation which is not acceptable for the Commission as organ transplantation 

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as such is a medical service covered by the principle of freedom to provide services 
enshrined in the TFEU. 

Amendment 59 strengthens the Commission proposal on safety and quality standards 
imposing to the Member State of treatment the obligation to define clear safety and 
quality standards for healthcare provided on its territory. The Council confirmed that 
cross-border healthcare shall be provided according to safety and quality standards of 
the Member State of treatment but there is no explicit obligation for Member States 
to define clear safety and quality standards.  

However, the Council proposes some additional provisions which may exercise some 
pressure  on  Member  States  to  adopt  safety  and  quality  standards  in  this  regard, 
including information of patients upon safety and quality standards, possibility for a 
Member  State  to  refuse  to  grant  prior  authorisation  in  case  of  serious  and  concrete 
concerns on quality standards of a healthcare provider in another Member State and 
cooperation between Member States through the exchange of information on safety 
and  quality  standards.  The  Commission  considers  some  of  these  provisions  as  an 
improvement on the status quo and does, therefore, not oppose the Council text.  

The  Parliament  adopted  several  amendments  related  to  national  contact  points  (97, 
98, and 99), clarifying the format of these contact points, including the involvement 
of  stakeholders  and  access  to  information.  These  amendments  are  acceptable  in 
principle to the Commission. 

The  Council  confirmed  the  concept  of  the  national  contact  points  and  the  need  of 
cooperation between them. However, it did not support their competence to provide 
help to patients in the event of harm and deleted any reference to the power of the 
Commission to adopt measures related to the functioning of these contact points.  

Both Parliament and Council attributed the competence of providing information on 
quality and safety of care to the contact point in the Member State of treatment. The 
Commission  considers  that  the  national  contact  points  in  the  Member  State  of 
affiliation should remain responsible for this, as initially proposed, to ensure an easy 
access for patients to all necessary information. Equally, these contact points should 
keep the competence to help patients protecting their rights in the event of harm.  

Amendments  rejected  by  the  Commission  and  incorporated  in  full,  in  part  or  in 
principle in the position of the Council at first reading:  

Parliament  adopted  amendments  60,  94,  and  100  addressing  the  difficulty  for  a 
patient to obtain information on health professionals established in another Member 
State. Three different types of solutions are suggested: information on registration or 
status of the health professional, information on disciplinary or criminal findings, and 
restricted access to competent authorities only.  

In this context, data protection and presumption of innocence are important rules and 
principles  to  be  taken  into  account,  and  that  is  why  these  amendments  are  fully  or 
partly  unacceptable  to  the  Commission.  Patients  could  receive  information  on  the 
status  of  a  particular  health  professional  only  through  the  assistance  of  national 
contacts points and within the limits imposed by the principles of data protection and 
presumption  of  innocence.  This  is  the  approach  taken  by  the  Council  which  is, 
therefore, acceptable to the Commission. However, it should be clarified that patients 

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can  ask  for  the  assistance  of  the  national  contact  point  in  the  Member  State  of 
affiliation  which  requests  this  information  from  the  competent  authorities  in  the 
Member  State  of  treatment.  This  would  represent  a  proportionate  solution  which 
could be implemented in compliance with data protection rules. 

Amendments accepted by the Commission as such or subject to rewording, but not 
incorporated in the position of the Council at first reading:  

A number of amendments mainly concerning recitals were accepted in principle by 
the Commission. These referred to equal treatment of men and women in the access 
to and supply of goods and services, the relation of the proposed Directive to other 
legislation, and subsidiarity. They were not fully incorporated in the position of the 
Council as it considered them to be redundant. 

The Parliament proposed in amendment 91 a voluntary system of "prior notification" 
whereby patients receive a written confirmation of the maximum amount that will be 
paid directly to the hospital by the Member State of affiliation. The Commission can 
accept  the  principle  of  this  amendment  but  this  would  need  some  clarification  in 
order  to  differentiate  the  system  of  prior  notification  from  the  prior  authorisation 
systems, either under this Directive or under the Regulation (EC) No 883/2004.  

The  Parliament  calls  in  amendment  92  for  a  legislative  proposal  to  establish  a 
European  Patients  Ombudsman  who  should  mediate  on  patient  complaints  with 
regard  to  prior  authorisation,  reimbursement  of  costs  or  harm.  The  Commission 
understands  the  concerns  of  the  Parliament,  but,  given  the  limits  of  the  Union 
competence in the field of health protection, it would favour the establishment of a 
network between national ombudsmen.  

Amendments  68,  93  and  99  stipulating  that  particular  attention  should  be  paid  to 
persons with disabilities have been accepted in principle by the Commission.  

Amendments rejected by the Commission and the Council and not incorporated in 
the position of the Council at first reading:  

The  Parliament  adopted  several  amendments  (66,  83,  102,  and  106)  which  aim  at 
helping  patients  affected  by  rare  diseases.  The  Commission  cannot  accept  these 
amendments  as  adopted  by  Parliament,  but  is  willing  to  promote  alternative 
solutions, for instance under the Regulation (EC) No 883/2004. 

In the context of cooperation on management of health technologies, the Parliament 
calls in amendment 135 for broad and full participation of all relevant stakeholders. 
For  the  Commission,  stakeholders  should  be  actively  involved  in  the  work  of  the 
network, but the final decisions on a health technology assessment should remain the 
sole competence of the national authorities.  

Amendment  138  makes  reference  to  Directive  2000/78/EC  on  equal  treatment  in 
employment and occupation which lies outside the scope of the Directive on cross-
border  healthcare  and  is  thus  not  acceptable.  Amendment  139  referring  to  the 
Commission proposal (2008)0426 on equal treatment between persons irrespective of 
religion, belief, disability, age or sexual orientation cannot be included as it has not 
yet been adopted. 

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3.2. 

New provisions introduced by the Council 

Double  legal  basis:  The  position  of  the  Council  introduces  Article  168  TFEU 
("public  health")  as  an  additional  legal  basis  for  the  text.  This  is  acceptable  to  the 
Commission.  

Definition of "Member State of affiliation": The Commission proposal defines the 
Member  State  of  affiliation  as  the  Member  State  where  the  patient  will  ask  for  the 
prior authorisation for the planned treatment abroad according to Regulation (EC) No 
883/2004. Thus, the definition of the Directive is aligned with that of the Regulation 
883/2004. The position of the Council at first reading clarifies that, in particular, for 
pensioners and their family members who reside in another Member State but seek 
treatment under the Directive in their home countries, if the home country is listed on 
Annex IV to the Regulation (EC) No 883/2004, it pays for the costs.  

For all other insured persons, the solution found in the position of the Council is that 
for  healthcare  which  is  not  subject  to  prior  authorisation  and  is  provided  under  the 
Directive  in  the  Member  State  that  bears  the  costs  of  the  healthcare  of  that  person 
according  to  the  Regulation  (EC)  No  883/2004,  costs  shall  be  assumed  by  this 
Member  State,  in  accordance  with  the  terms,  conditions,  criteria  of  eligibility  and 
regulatory and administrative formalities that apply. 

The Commission can accept the changes, as they only apply to healthcare provided 
under  the  Directive  and  neither  modify  the  provisions  of  Regulation  (EC)  No 
883/2004,  nor  affect  the  system  of  sharing  the  financial  burden  for  health  as 
established by the Regulations 883/2004 and 987/2009. 

Quality and safety: The Council text stipulates that the system of prior authorisation 
will apply to hospital and specialised care, as per the Commission's original proposal 
and,  in  addition,  to  healthcare  which  could  raise  serious  and  concrete  concerns 
related to the quality or safety of the care with the exception of healthcare which is 
subject  to  Union  legislation  ensuring  a  minimum  level  of  safety  and  quality 
throughout  the  Union.  For  the  same  reason,  Member  States  may  refuse  prior 
authorisation in individual cases.  

For the Commission, an exclusion of certain providers, whether public or private, on 
the grounds of objective concrete and legitimate concerns over the quality and safety 
is  compatible  with  EU  law,  but  only  in  so  far  as  it  does  not  affect  the  professional 
qualification's Directive. Moreover, the meaning and modalities of implementation of 
this provision should be more clearly defined to ensure legal certainty. 

Health technology assessment: The Council deleted provisions which would allow 
the  Commission  to  adopt  measures  for  the  establishment  and  management  of  a 
network on health technology assessment. By contrast, a new paragraph was inserted 
stating  that  the  network  may  receive  EU  aid  which  should  be  allocated  through 
measures  adopted  by  the  Commission.  The  Commission  does  not  object  to  this 
amendment, but is in favour of also maintaining elements of the original proposal, as 
supported by the Parliament. 

Powers of the Commission to  adopt measures:  The  comitology  provisions in the 
Commission proposal have been revised in the light of the coming into force of the 

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Lisbon  Treaty  to  take  into  account  Articles  290  and  291  of  the  Treaty  on  the 
Functioning of the European Union. The Commission agrees with the framework, as 
defined  by  the  Council,  within  which  it  can  exercise  the  delegated  or  implemented 
powers  (duration  of  the  delegation,  revocation,  right  of  objection)  but  cannot  fully 
agree  with  the  choice  made  by  the  Council  of  the  measures  to  be  adopted  through 
delegated  acts  or  implementing  acts.  In  particular,  measures  on  e-prescription,  e-
Health, health technology assessment and on European reference networks should be 
adopted through delegated acts and not through implementing acts.  

3.3.  Major problems when adopting the position of the Council at first reading 

The  position  adopted  by  the  Council  at  first  reading  contains  elements  departing 
from  the  Commission's  proposal  and  creating  risks  of  legal  uncertainty.  They 
concern  in  particular,  the  prior  authorisation  for  the  reimbursement  of  cross-border 
healthcare and eHealth. 

Scope of prior authorisation:  

The  Commission  proposal  foresees  that  the  Member  State  of  affiliation  may  not 
impose a system of prior authorisation for non-hospital care. However, as regards on 
one hand hospital care and on the other specialised care included in list established at 
Union level through a regulatory procedure,  the proposal foresees that the Member 
State  of  affiliation  may  provide  for  a  system  of  prior  authorisation  "to  address  the 
consequent  outflow  of  patients  due  to  the  implementation"  of  the  Directive  and  to 
prevent the financial balance of the Member State's social security system and/or the 
planning  and  rationalisation  carried  out  in  the  hospital  sector  from  being  seriously 
undermined or being likely to be seriously undermined. 

The position of the Council at first reading introduces the possibility for the Member 
State  of  affiliation  to  make  the  reimbursement  of  costs  of  certain  types  of  cross-
border healthcare (hospital, specialised care and healthcare which could raise serious 
and  concrete  concerns  related  to  the  quality  or  safety  of  the  care)  subject  to  prior 
authorisation  without  any  explicit  request  to  demonstrate  an  outflow  of  patients 
resulting  from  the  freedom  of  mobility  or  any  risk  to  the  system.  The  text  simply 
foresees that the system of prior authorisation shall be limited to what is necessary 
and proportionate and shall not constitute a means of arbitrary discrimination. 

The  introduction  of  a  system  of  prior  authorisation  as  proposed  by  the  Presidency 
text is based on a very restrictive interpretation of the jurisprudence. 

Furthermore, the position of the Council at first reading refuses the adoption of a list 
at EU level of specialised healthcare subject to prior authorisation. It only provides 
that the Member State of affiliation shall make publicly available which healthcare is 
actually subject to prior authorisation. The Parliament took the same approach. The 
Commission  considers  that  a  list  at  EU  level  would  have  provided  better 
transparency and more legal certainty.  

Conditions  for  refusal  of  a  prior  authorisation:  The  Council  introduces  a  non-
exhaustive  list  of  criteria  for  refusing  individual  prior  authorisation,  which  may,  in 
the Commission's view, create legal uncertainty for the patients.  

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Firstly, the mere fact that the position of the Council at first reading provides for a 
non-exhaustive list of criteria creates legal uncertainty.  

Secondly, without a clearer delineation of their scope and modalities of application, 
the  criteria  introduced  by  the  Council  do  not  provide  enough  legal  certainty.  In 
particular, this list includes a criterion whereby prior authorisation may be refused if 
healthcare can be provided on the territory of the Member State of affiliation within a 
time-limit  which  is  medically  justifiable.  This  criterion  makes  the  distinction 
between  the  Regulation  (EC)  N°  883/2004  on  the  coordination  of  social  security 
systems  and  the  Directive  very  difficult  and  risks  undermining  the  rights  granted 
under Regulation (EC) N° 883/2004. Also, this provision should refer to the notion 
of "same or equally effective treatment". 

This list also includes a criterion based on patient safety risk: it would be extremely 
useful to clarify that this criterion cannot be interpreted as allowing such ground for 
refusal, if the same assessment is not carried out for care received domestically. 

eHealth: In its initial proposal the Commission had included an article on "eHealth" 
whose  aim  was  to  establish  the  framework  for  the  adoption,  through  a  comitology 
procedure, of measures to achieve the interoperability (standards and terminologies) 
of information and communication technology systems in the field of healthcare.  

After  some  discussions,  Member  States  have  eventually  agreed  to  initiate  a  formal 
cooperation on eHealth at EU level and have identified three concrete priority areas 
for  patient  safety  and  the  continuity  of  cross-border  healthcare:  identification  and 
authentication  of  health  professionals;  list  of  essential  data  to  include  in  patient 
summaries; and use of medical information for public health and medical research.  

The  Commission  believes  that  the  Council  text  is  more  precise  than  the 
Commission's initial proposal, but lacks working methods, such as provisions giving 
the Commission the power to adopt measures to implement the work at EU level. 

4. 

CONCLUSION 

The  Commission  takes  the  view  that  the  position  of  the  Council  at  first  reading 
contains elements departing from the Commission's proposal which may create risks 
of  legal  uncertainty.  In  order  to  allow  the  legislative  process  to  move  forward,  the 
Commission did not stand against the position adopted by the Council by qualified 
majority in order to allow the legislative process to move forward. 

The Commission indicated to the Council in the attached declaration that it reserves 
the  right  to  support  European  Parliament  amendments  during  second  reading  on 
eHealth, the scope of the prior authorisation, increasing legal certainty for patients, , 
and assuring that the proposed Directive does not undermine the rights granted under 
Regulation 883/2004. 

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ANNEX 

Declaration by the Commission 

In a spirit of compromise, the Commission will not stand against a qualified majority 
vote  in  favour  of  the  Presidency  text  although  it  could  have  benefited  from  some 
more clarity.  

In  particular,  the  Commission  considers  that  the  scope  of  the  prior  authorisation 
scheme should be well defined and justified. 

The Commission is convinced of the need to ensure that patients seeking healthcare 
in  another  Member  State  can  exercise  their  rights  as  confirmed  by  the  Court  in  its 
settled  case-law  and  without  undermining  the  rights  granted  under  Regulation 
883/2004. The Commission proposed the measures necessary to ensure that patients 
benefit  from  legal  certainty  in  exercising  those  rights  while  respecting  Member 
States' power to organise and deliver healthcare.  

The  Commission  recalls  that  the  conditions  for  access  and  exercise  of  health 
professions have been harmonised by the professional qualifications directive.  

As  regards  eHealth,  the  Commission  considers  it  necessary  to  contribute  at  Union 
level  to  creating  the  conditions  for  ensuring  continuity  of  care,  patient  safety  by 
enabling use of medical information across borders, with the highest level of security 
and protection of personal data. 

As  the  position  of  the  European  Parliament  on  prior  authorisation  and  eHealth  is 
more  favourable  to  the  patients,  closer  to  the  Commission's  proposal  and  to  its 
reading  of  the  existing  case-law,  the  Commission  reserves  the  right  to  support  the 
European  Parliament's  amendments  on  these  issues  during  the  second  reading  and 
will  continue  to  collaborate  closely  with  both  institutions  with  the  aim  of  further 
improving the text.  

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