COMMISSION STAFF WORKING DOCUMENT on the implementation of Directive 2010/53/EU Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on the implementation of Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation
Date: 2017-01-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, Norway, medicine, national implementing measure, organ transplantation, public health, quality standard, safety standard

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 4.1.2017  SWD(2016) 451 final   COMMISSION STAFF WORKING DOCUMENT on the implementation of Directive 2010/53/EU Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on the implementation of Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation {COM(2016) 809 final}  
 
 
COMMISSION STAFF WORKING DOCUMENT  

on the implementation of Directive 2010/53/EU on standards of quality and 
safety of human organs intended for transplantation 

Table of Contents 

1. Introduction ......................................................................................................................................... 4 

2. Verification of the transposition of Directive 2010/53/EU ................................................................. 5 

3. Implementation of Directive 2010/53/EU ........................................................................................... 5 

3.1. Identification of and tasks of the competent authorities and overall set-up ................................. 6 

3.1.1. Organisational set-up ............................................................................................................. 6 

3.1.2. The national level .................................................................................................................. 7 

3.1.3. Combination of levels: regional, national and supra-national ............................................... 8 

3.1.4. Involvement of regional authorities and nature of their tasks ............................................... 9 

3.1.5. Involvement of European Organ Exchange Organisations and nature of their tasks .......... 10 

3.1.6. Conclusion on the overall set-up of authorities and tasks under Article 17 ........................ 11 

3.2. Organ donation and procurement ............................................................................................... 12 

3.2.1. Authorisation of procurement organisations ....................................................................... 12 

3.2.2. Procurement teams coming from abroad to procure organs ................................................ 15 

3.2.3. Framework for ensuring procurement organisations' compliance with the Directive ......... 16 

3.2.4. Personnel involved in the procurement ............................................................................... 18 

3.2.5. Consent system for organ donation ..................................................................................... 20 

3.2 6. The selection and protection of living donors ..................................................................... 22 

3.2 7. The follow-up of transplanted patients ................................................................................ 24 

3.2.8. Other key principles governing organ donation .................................................................. 25 

3.3. Transport of organs intended for transplantation ....................................................................... 26 

3.4. Authorisation of transplantation centres and qualification of personnel .................................... 27 

3.4.1. Authorisation of transplantation centres .............................................................................. 27 

3.4.2. Framework for ensuring compliance with the Directive in transplantation centres ............ 30 

3.4.3. Personnel involved in transplantation activities .................................................................. 31 

3.5. Framework for quality and safety ............................................................................................... 33 

3.6. General points ............................................................................................................................. 34 

3.6.1. Legal framework for non-compliance with the Directive (penalties) ................................. 34 

3.6.2 Organ trafficking .................................................................................................................. 36 

4. Conclusion ......................................................................................................................................... 36 

2 

 
 
 
Annex 

ANNEX 1: 

List of competent authorities and corresponding tasks under Article 17 

List of figures 

FIGURE 1:   Transplants and donors in 2014 in the European Union and Norway 

FIGURE 2:  Levels of competent authorities declared to implement tasks under Article 17 

FIGURE 3:  National level: number of competent authorities declared 

FIGURE 4:  Combination of levels for authorities in charge of tasks under Article 17 

FIGURE 5:  Membership in a European Organ Exchange Organisation 

FIGURE 6:  Member States granting authorisations for procurement organisations 

FIGURE 7:  Duration of authorisations for procurement organisations 

FIGURE 8:  Procurement teams coming from abroad to retrieve organs 

FIGURE 9:  Measures to ensure compliance with the Directive for procurement 

FIGURE 10:  Methods to ensure professional competence of procurement personnel 

FIGURE 11:  National consent systems for organ donation 

FIGURE 12:  Member States granting authorisations for transplantation centres 

FIGURE 13:  Duration of authorisations for transplantation centres 

FIGURE 14:  Measures to ensure compliance with the Directive in transplantation centres 

FIGURE 15:  Methods for ensuring professional competence of the transplant personnel 

FIGURE 16:  Adoption and implementation of operating procedures 

FIGURE 17:  Penalties laid down for infringements to national provisions 

3 

 
 
 
 
 
 
 
1. Introduction 

Organ transplantation has become a major medical practice at the international level over the 
past decades. It is the most cost-efficient way to cure renal failure, but also the only treatment 
available so far for end-stage failure of liver, heart, lung, pancreas or sometimes small bowel. 
However, the shortage of human organs  - donated by living or deceased donors - remains a 
key  challenge.  Almost  32000  transplants  (see  Figure  1)  took  place  in  the  European  Union 
(EU)  in  2014,  but  also  more  than  4000  patients  died  on  the  transplant  waiting  lists,  while 
other patients also died while not even on the lists. In total in 2014, 4523 living donors1 (LD) 
donated  their  organs  along  with  more  than  10000  deceased  donors  (DD)  (counting  both 
Donation  after  Brain  Death  (DBD)  and  Donation  after  Circulatory  Death  (DCD)).  The 
following figure provides an overview of the type and number of organs transplanted in 2014 
in the EU. 

Liver 

Lung  

Heart  

Pancreas  

Transplants in 2014 in the European Union (28 EU Member States + Norway) 
Kidney  
Transplants 
(total) 
31890 

7390 
(3,3%) 
14,5 
7490 

19670  
(21,7%) 
38,7 
19944 

EU 
(% LD) 
pmp 
EU + 
Norway 
pmp 
Figure 1. Transplants and donors in 2014 in the European Union and Norway   

Small 
Bowell  
44 

62,8 
32362 

3,6 
1855 

4,2 
2180 

1,6 
849 

0,1 
44 

2146 

1822 

14,6 

38,9 

818 

3,6 

1,7 

4,2 

0,1 

63 

Donors 
(DD: 
deceased) 
10033 DD 
(4523 LD) 
19,7 
10147 

19,8 

 (Source: 

Council of Europe Transplant Newsletter 2015)  [pmp: per million population] 

The European Commission supports Member States to increase organ availability, to improve 
donation and transplant systems and to ensure quality and safety of these activities. To tackle 
these challenges, the Commission adopted in 2008 the “Action plan on Organ Donation and 
Transplantation (2009-2015)”2, in order to strengthen cooperation between Member States.  

Furthermore, and with a particular focus on quality and safety, the European Union adopted in 
2010 Directive 2010/53/EU3 on standards of quality and safety of human organs intended for 
transplantation. The Directive is based on Article 168 of the Treaty on the Functioning of the 
European Union4 which allows the EU to introduce safety and quality rules for substances of 
human origin. In 2012, the Commission adopted Implementing Directive 2012/25/EU5 laying 
down  information  procedures  for  the  exchange,  between  Member  States,  of  human  organs 
intended for transplantation.  

1 Data extracted from 2015 Newsletter Transplant, International figures on donation and transplantation for 2014  
https://www.edqm.eu/sites/default/files/newsletter_transplant_2015.pdf  
2  Communication  from  the  Commission  of  8  December  2008  -  Action  plan  on  Organ  Donation  and 
Transplantation (2009-2015): Strengthened Cooperation between Member States , COM(2008) 819 
3 OJ L 207, 6.8.2010  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:207:0014:0029:EN:PDF 
4 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=EN  
5 OJ L 275, 10.10.2012  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:275:0027:0032:EN:PDF 

4 

 
 
 
 
 
                                                            
The  Commission  supports  Member  States  in  the  implementation  of  the  Directives  and  the 
Action Plan through co-financing projects under the EU Health  Programme, and  sometimes 
the  EU  Research  Programme.  The  Commission  also  organises  regular  meetings  of  national 
competent authorities (network established by the Directive) and dedicated working groups to 
address specific topics under the Action Plan. 

Article  22  of  Directive  2010/53/EU  requires  Member  States  to  report  to  the  Commission 
every  three  years  on  their  activities  undertaken  to  implement  the  Directive.  Article  22  also 
obliges  the  Commission  to  transmit  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions  a  report  on  the 
implementation  of  this  Directive.  The  present  report  was  drafted  in  order  to  meet  the 
Commission’s  reporting  requirements  and  thus  presents  for  the  first    state  of  play  on  the 
implementation  of  Directive  2010/53/EU.  In  order  to  prepare  this  report,  the  Commission 
launched  a  survey  in  2014  to  which  all  28  EU  Member  States  and  one  EEA  country 
(Norway)6  responded.  Additional  requests  for  clarification  were  sent  and  answered  by 
the  national  situations  until  December  2014. 
Member  States.  This  report  reflects 

2. Verification of the transposition of Directive 2010/53/EU 

According  to  Article  31  of  the  Directive,  Member  States  had  to  “bring  into  force  the  laws, 
regulations  and  administrative  provisions  necessary  to  comply  with  this  Directive  by  27 
August  2012.”  In  order  to  verify  whether  all  Member  States  have  correctly  and  sufficiently 
transposed  into  their  national  law  the  requirements  of  the  Directive,  the  Commission  is 
currently carrying out a “transposition check”. Where necessary detailed follow-up questions 
have been sent to individual Member States to seek clarification concerning the transposition 
of certain provisions. So far, this exercise has pointed to a significant degree of transposition 
across the EU. Nevertheless, pending the responses received on the requests for clarification, 
further  action  may  be  needed  to  ensure  full  transposition  of  the  Directive  across  all  EU 
Member States. 

3. Implementation of Directive 2010/53/EU  

While  the  “transposition  check”  is  a  legal  exercise  based  on  the  analysis  of  the  national 
legislations, the present report is a reflection of the actual implementation of the Directive and 
focuses on the concrete activities, measures and policies taken and reported by Member States 
to implement the Directive. 

For the first implementation  survey, the Commission decided to  focus on those aspects  that 
are important to understand the oversight mechanisms put in place in the Member States. The 
following Articles in the Directive are particularly noteworthy: 

- 

the identification of the different competent authorities and their tasks (Section 3.1. linked 
to Articles 17 and 21); 

6 See the list of countries and official acronyms:http://publications.europa.eu/code/en/en-5000600.htm 

5 

 
 
 
 
 
                                                            
- 

- 

the  schemes  to  authorise  procurement  organisations  as  well  as  donor  and  recipient 
protection  (Section  3.2.  linked  to  Articles  5,  7,  12,  14  and  15);-  the  transport  of  organs 
(Section  3.3.,  Article  8);the  schemes  to  authorise  transplantation  centres  (Section  3.4., 
Articles 9, 12, 17); 
the framework for quality and safety; in particular the existence of operating procedures 
(Section 3.5., Articles 4, 11, 17); 

-  general  considerations  (Section  3.6.,  e.g.  penalties  for  infringement  of  national  rules, 

Article 23). 

3.1. Identification of and tasks of the competent authorities and overall set-up  

To  understand  oversight  mechanisms  in  place,  it  is  first  necessary  to  map  per  country  all 
competent  authorities  responsible  for  the  tasks  defined  by  Article  17  (Section  3.1.1).  It 
appears that these authorities are national bodies, but sometimes also regional or international 
entities. Beyond this general view of the organisational set-up, the national level (3.1.2.) will 
therefore  be  examined,  while  the  combination  of  levels  (3.1.3.),  the  regional  (3.1.4.)  and 
supra-national  (3.1.5.)  levels  will  be  scrutinised  in  subsequent  sections.  This  analysis  is 
supported by the information set out in Annex 1, listing tasks  described in Article 17 and the 
authorities responsible for their implementation.  

3.1.1. Organisational set-up 

Article  17  is  a  key  provision  in  the  Directive  and  concerns  the  designation  and  tasks  of 
competent  authorities.  It  foresees  that  Member  States  “designate  one  or  more  competent 
authorities” and “may delegate, or may allow a competent authority to delegate, part or all the 
tasks assigned to it […] to another body […] deemed suitable”, i.e. to delegated bodies. These 
authorities and bodies are responsible for the following tasks listed in Article 17: 

(a)  establish and keep updated a framework for quality and safety (as defined in Article 4);  
(b) ensure  that  procurement  organisations  and  transplantation  centres  are  controlled  or 

audited on a regular basis; 

(c)  grant,  suspend  or  withdraw  authorisations 

to  procurement  organisations  and 

transplantation centres; 

(d) put in place a reporting system and management procedure for reporting serious adverse 

events and reactions (SARE), also called biovigilance; 

(e)  issue guidance to healthcare establishments, professionals and other parties involved in all 
stages  of  the  chain  from  donation  to  transplantation  (e.g.  guidance  for  the  collection  of 
relevant post-transplantation information); 

(f)  participate in the network of competent authorities (as defined in Article 19); 
(g) supervise cross-border exchange of organs (as provided for Article 20); 
(h) ensure protection of personal data.  

6 

 
 
 
 
 
The  definitions  of  “competent  authority”7  as  well  as  of  “delegated  body”8  leave  Member 
States  significant  discretion,  which  leads  to  a  variety  of  approaches  for  national 
implementation. Annex 1 provides a full list of competent authorities and delegated bodies as 
declared by the 28 Member States and Norway as well as their corresponding tasks. 

Only  in  few  countries,  all  tasks  of  Article  17  are  implemented  by  a  single  competent 
authority. Usually several competent authorities are involved, from different levels: national, 
infra-national (regional/local) or supra-national.  

Figure 2. Levels of competent authorities declared to implement tasks under Article 17 
(national, EOEO, regional) 

For  all  29  countries  considered,  competent  authorities  (or  delegated  bodies)  have  been 
appointed  at  national 
involve  European  Organ  Exchange 
level.  Twelve  countries 
Organisations, while nine countries also use regional-level authorities (Figure 2). 

3.1.2. The national level 

The 29 countries considered reported a total of 68 competent authorities operating at national 
level, including 21 delegated bodies (an average of 2.3 authorities declared per country).  

Only  five  countries  (BE,  BG,  CY,  ES,  HR)  report  to  have  just  one  body  at  national  level 
(Figure  3).  Fourteen  countries  declared  having  two  authorities,  while  six  countries  report 
having three authority(ies) and four countries reported having four competent authorities. The 

7 Article 3 (b) defines a competent authority as “an authority, body, organisation and/or institution responsible 
for  implementing  the  requirements  of  this  Directive.”  For  the  ease  of  reference,  competent  authorities  will  be 
referred to in this report as “CAs”and apart from this chapter where the two categories are explained, “CAs” will 
commonly include both competent authorities and and delegated bodies (“DBs”). 
8 Article 17 stipulates that “Member States may delegate, or may allow a competent authority to delegate, part or 
all  of  the  tasks  assigned  to  it  under  the  Directive  to  another  body  which  is  deemed  suitable  under  national 
provisions. Such a body may also assist the competent authority in carrying out its functions.” 

7 

 
 
 
         
 
                                                            
involvement  of  multiple  authorities  and  delegated  bodies  calls  for  a  good  coordination 
between  them.  The  same  applies  for  Member  States  that  work  with  European  Organ 
Exchange Organisations and authorities at regional level. 

Figure 3. National level: number of competent authorities and delegated bodies declared 

National Ministries of Health  

Ministries of Health often play a key role in the implementation of Directive 2010/53/EU, but 
Member States define the national Ministries' powers as regards the tasks under Article 17 in 
different  ways.  For  17  countries,  the  relevant  national  Ministry  has  been  reported  as  a 
competent authority even when it delegates (some of) its tasks to other bodies, whereas for the 
12  other  Member  States  (BG,  CY,  DK,  EE,  ES,  HU,  IE,  LV,  MT,  PT,  SE,  UK)  the 
corresponding  Ministry  is  not  defined  as  a  competent  authority  as  it  does  not  perform  any 
operational task on its own and has delegated all tasks. 

Delegated bodies 

16  Member  States  also  report  having  appointed  delegated  bodies,  usually  just  one  single 
delegated body (in 13 countries). These delegated bodies are often public agencies depending 
on the Ministries of Health. In five countries, delegated bodies include hospitals operating as 
transplantation  centres  at  a  regional  (Sweden)  or  national  levels  (Denmark,  Estonia,  Latvia, 
Norway).  Eurotransplant  and  Scandiatransplant, 
two  European  Organ  Exchange 
Organisations,  were  reported  by  eight  respectively  four  countries  as  delegated  bodies 
contributing to tasks under Article 17.  

3.1.3. Combination of levels: regional, national and supra-national 

In  15  countries,  two  further  levels,  besides  the  national  level,  are  involved  in  the 
implementation  of  the  Directive:  regional  authorities  and  European  Organ  Exchange 
Organisations  (EOEOs).  Figure  4  shows  the  different  levels  involved  and  the  different 
combinations of levels. The figure highlights the complexity of the oversight settings and the 
necessity of good coordination mechanisms in each country and between countries. 

8 

 
 
 
 
 
Figure 4. Combination of levels for authorities in charge of tasks under Article 17 

Tasks implemented at national level, levels of competent authorities involved per task 

Key  tasks  under  Article  17,  which  are  typically  performed  at  national  level,  include  (a) 
framework  for  quality  and  safety,  (d)  SARE/biovigilance,  (e)  issue  guidance,  (f)  attend 
meetings of the network of competent authorities, and (h) personal data protection. Unless the 
countries have regions with important responsibilities (see next section), the tasks (b) control 
and  audit,  and  (c)  authorisation  are  also  mainly  implemented  at  national  level.  Where  the 
country is a member of an EOEO, task (g) supervision of the cross-border organ exchange is 
implemented with the support of an EOEO.  

3.1.4. Involvement of regional authorities and nature of their tasks  

Member  States  have  different  interpretations  of  the  regional  level,  often  depending  on  the 
national legal system and on the organisation of responsibilities in the country. The regional 
level may refer to administrative entities of Member States which have decentralised powers 
(AT,  BE,  DE,  ES,  FI,  FR,  IT)  or  specific  responsibilities  /  task  allocation.  For  instance, 
Sweden reported four hospitals having a coordination role for a whole region, thus de facto 
being delegated bodies at regional level. Among the nine Member States which report a role 
for regional competent authorities, the most common tasks executed at this level are tasks (b) 
control  and  audit  (in  six  countries)  and  (c)  authorisation  (in  seven  countries).  The  total 
number  of  tasks  assigned  to  the  regional  competent  authorities  varies  according  to  the 
countries from a single task (Finland) to six tasks (Denmark and Spain). 

9 

 
 
 
 
 
 
 
 
3.1.5. Involvement of European Organ Exchange Organisations and nature of their tasks 

Article 3 provides for a general definition of an EOEO: “a  non-profit organisation, whether 
public  or  private,  dedicated  to  national  and  cross-border  organ  exchange,  in  which  the 
majority of its member countries are [EU] Member States.” For EOEOs, Article 21 foresees 
that  Member  States  or  competent  authorities  may  conclude  agreements  with  such 
organisations and delegate to them the performance of activities covered by Article 17, inter 
alia tasks (a) framework for quality and safety, and (g) supervision of the cross-border organ 
exchange. Figure 5 shows which Member States use EOEOs and which don’t.  

Figure 5. Membership in an EOEO for tasks under Article 17 

Three  EOEOs  exist  at  the  European  level,  supporting  three  groups  of  Member  States: 
Eurotransplant  (AT,  BE,  DE,  HR,  HU,  LU,  NL,  SI),  Scandiatransplant9  (DK,  FI,  NO,  SE), 
and the South Alliance for Transplantation (SAT), created in October 2012 by France, Italy 
and  Spain  (ES,  FR,  IT,  PT  and  CH,  CZ,  EL).  The  last  one  is  however  not  reported  to  be 
directly involved in the tasks of Article 17. Therefore it does not appear on Figure 5.  

Where  a  country  is  member  of  an  EOEO,  task  (g)  supervision  of  cross-border  exchange  is 
indeed implemented by or with the support of this EOEO. Often the EOEO is also associated 
for task (a) framework for quality and safety. The other most commonly performed tasks by 
EOEOs  include  (d)  reporting  and  management  of  Serious  Adverse  Reactions  and  Events 
(SARE),  (f)  participation  in  network  of  competent  authorities,  and  (h)  personal  data 
protection. It needs however to be noted that even within the same EOEO, members do not 
report exactly the same tasks, thus showing that different approaches or agreements might be 
in place between each country and the EOEO.  

Typically  the  membership  in  an  EOEO  or  the  cooperation  with  an  EOEO  (but  not  as  a 
member) requires some sort of contractual arrangement. Concerning the membership and the 
existence  of  a  formal  agreement  between  the  EOEO  and  the  country,  seven  Member  States 
(DE,  FI,  HR,  HU,  LU,  NL,  SI)  and  Norway  reported  being  members  of  an  EOEO  with  a 

9 Iceland is also member of Scandiatranplant but is not captured in the present report (not EU Member State). 

10 

 
 
 
 
 
 
 
                                                            
formal agreement whilst the remaining three Member States (Austria, Belgium,  Sweden) do 
not have yet a formal agreement in place. Several countries are engaged in the conclusion of 
an agreement with Eurotransplant (e.g. Austria, Belgium). Additionally, Sweden also stressed 
the  level  of 
that 
transplantation centres and not at the national level. 

in  Scandiatransplant  occurs  rather  at 

indicated  membership 

the 

Among the 17 countries that are not members of an EOEO, nine declare that they collaborate 
with  an  EOEO  (BG,  CZ,  EE,  EL,  FR,  IT,  LT,  SK,  UK).  Formal  agreements  have  been 
concluded by five of them (BG, CZ, EL, IT, LT). Countries that collaborate with an EOEO 
reported that the collaboration consists mainly in cross-border organ exchange. Additionally, 
the United Kingdom reported “sharing learning, experiences and benchmarking practices.” 

Finally,  seven  countries  (CY,  IE,  LV,  MT,  PL,  PT,  RO)  reported  that  they  have  no 
relationship with an EOEO. However, for cross-border organ exchange (and their supervision, 
task (g)), three of them have concluded bilateral agreements with other countries or partners 
(healthcare  establishments):  Cyprus  with  Austria  (for  lungs),  Malta  with  Italy,  and  Portugal 
with Spain. Three other countries (Cyprus, Ireland, Latvia) report exchanging organs with or 
sending/receiving patients to/from other countries on a bilateral case-by-case basis outside the 
scope of any agreement. On the issue of cross-border organ exchange, it should be added that 
the EU-funded Joint Action FOEDUS, building upon the previous project COORENOR,  now 
offers an operational common IT platform for rapid cross-border organ exchange suitable for 
all European countries (involved or not in EOEOs and in bilateral agreements).  

3.1.6. Conclusion on the overall set-up of authorities and tasks under Article 17 

All Member States reported having competent authorities (and delegated bodies) in place to 
cover  all  tasks  defined  under  Article  17.  The  overall  set-up  of  competent  authorities  in 
Member  States  and  Norway  and  the  tasks  they  are  implementing  largely  differ  from  one 
country to another.  
As visible in Figure 4 above, three types of organisational “models” can be defined in relation 
with tasks of Article 17:  
i) countries operating with authorities only at national level (14 countries),  
ii)  countries  operating  with  authorities  at  national  and  regional  levels  but  not  at  the  EOEO 
level (3 countries) and  
iii) countries operating with EOEOs (12 countries). 
In  all  three  types  of  settings,  several  competent  authorities  and  delegated  bodies  can  be 
involved to implement the tasks, also because it needs to fit to the size and capacities of the 
country  concerned  and  because  the  organ  donation  and  transplantation  is  completely 
embedded in the overall organisation of the health system in the country.  
While  in  all  Member  States,  the  competent  authorities  should  have  a  key  role  to  play  in 
ensuring  the  quality  and  safety  of  organs  during  the  entire  chain  from  donation  to 
transplantation,  Member  States  with  a  unique  authority  or  a  limited  number  of  bodies  and 

11 

 
 
 
 
 
levels  allow,  as  suggested  in  Recital  2410  of  the  Directive,  for  a  clearer  identification  of 
authorities in charge of the tasks under Article 17, as well as for other tasks outside the scope 
of  this  Directive  such  as  consent  systems,  managements  of  waiting  lists  or  allocation  of 
organs, and for accountability in general. 
The involvement of multiple (levels of) authorities might require enhanced coordination and 
communication to ensure safety and quality.  

3.2. Organ donation and procurement 

Organ donation is the first step in the transplantation process. To ensure quality and safety in 
the donation, procurement organisations play a key role. This section will cover procurement 
activities and organisations (Sections 3.2.1. to 3.2.4.), the consent systems for organ donation 
(3.2.5.),  the  selection  and  protection  of  living  donors  (3.2.6.),  the  follow-up  of  transplanted 
patients (3.2.7.) as well as other key principles for donation (3.2.8).  

3.2.1. Authorisation of procurement organisations 

To  ensure  oversight  of  organ  procurement  activities,  Articles  5,  6  and  17  of  the  Directive 
require that procurement organisations are duly authorised, with adequate personnel, material 
and equipment. 

Definitions and authorisation of procurement organisations 

The Directive provides for a broad definition of procurement organisations in Article 3 (k): “a 
healthcare  establishment,  a  team  or  a  unit  of  a  hospital,  a  person,  or  any  other  body  which 
undertakes  or  coordinates  the  procurement  of  organs  and  is  authorised  to  do  so  by  the 
competent authority under the regulatory framework in the Member State concerned.”  

The definition of an “authorisation” in the Directive also encapsulates different concepts and 
therefore  allows  for  various  interpretations  in  the  national  laws:  “authorisation”  means 
“authorisation, accreditation, designation, licensing or registration, depending on the concepts 
used and the practices in place in each Member State.” 

Consequently, a wide range of entities can fall within the scope of an “authorised procurement 
organisation”  under  these  definitions  and  this  is  also  reflected  in  the  variety  of  replies 
received from Member States. Most Member States use several of the options proposed in the 
definition. (e.g. procurement organisations are both national bodies and hospitals).  

10 Recital 24 of the Directive: “the competent authorities of the Member States should have a key role to play in 
ensuring  the  quality  and  safety  of  organs  during  the  entire  chain  from  donation  to  transplantation  […].  As 
emphasized by  the  Recommendation  Rec(2006)15  of  the Committee  of  Ministers  of  the  Council  of Europe  to 
Member  States  on  the  background,  functions  and  responsibilities  of  a  National  Transplant  Organisation 
[competent  authority],  it  is  preferable  to  have  a  single  non-profit  making  body  which  is  officially  recognised 
with overall responsibility for donation, allocation, traceability an accountability. However, depending especially 
on  the  division  of  competences  within  the  Member  States,  a  combination  of  local,  regional,  national  and/or 
international  bodies  may  work  together  to  coordinate  donation  allocation  and/or  transplantation,  provided  that 
the framework in place ensures accountability, cooperation and efficiency.” 

12 

 
 
                                                            
Authorisations  for  procurement  organisations  are  granted  at  the  level  of  the  healthcare 
establishment  in  the  majority  of  Member  States  and  Norway  (27  of  29  countries). 
Additionally,  they  are  granted  to  the  team  or  unit  of  the  hospital  (9/29);  to  any  authorised 
body  which  coordinates  the  procurement  of  organs  (8/29);  or  to  any authorised  body  which 
undertakes  the  procurement  of  organs  (4/29).  Such  authorisations  are  also  granted  to 
individual healthcare professionals (7/29).   

Linked  to  the  definition  of  procurement  organisations,  the  authorisation  scheme  used  in 
Member States to authorise them is a key issue to ensure oversight of procurement activities. 
Member States  were  firstly asked if they grant  authorisations for procurement  organisations 
i.e.  if  they  have  an  authorisation  scheme  in  place.  All  countries  reported  having  such  an 
authorising  scheme,  and  26  reported  that  all  the  existing  procurement  organisations  in  their 
country had effectively been granted an authorisation (Figure 6).  

Figure 6. Member States granting authorisations for procurement organisations 

State  of  play  in  Member  States  reporting  that  not  all  procurement  organisations  have  been 
authorised  

All  countries,  except  three,  report  that  all  their  procurement  organisations  have  been 
authorised  (Figure  6).  Malta  and  Ireland  are  in  the  process  of  granting  authorisations  or 
developing relevant quality systems within the centres to grant authorisations (Malta does so 
with  the support of the EU-funded project ACCORD, work package of twinning activities). 
Sweden  commented  that  not  all  procurement  organisations  have  yet  been  fully  authorised 
because,  while  included  in  their  register  (registration  process  complying  with  the  above 
definition  of  authorisation),  those  carrying  out  highly  specialised  interventions  require  an 
additional authorisation for these interventions. They explained these processes to be directly 

13 

 
 
 
linked  to  the  transposition  of  the  Directive,  with  some  delay  taken  in  the  adoption  of 
secondary legislation and/or in the implementation of practical arrangements. 

Particular cases: same authorisation for procurement and transplantation activities 

Additionally,  some  Member  States  reported  using  a  unique  scheme  for  authorising 
procurement organisations and transplantation centres, i.e. in these countries all procurement 
organisations  are  transplantation  centres  having  an  authorisation  for  procurement  activities 
(see also section 3.4.). Four Member States explicitly reported granting a single authorisation 
both  for  procurement  organisations  and  transplantation  centres  (Denmark,  Estonia,  Greece, 
Italy). Estonia specified that the authorisation for organ procurement is covered by the licence 
to  handle  organs.  In  Greece,  although  the  national  law  differentiates  procurement  and 
transplant  activities,  all  transplantation  centres  are  also  procurement  organisations  meaning 
that  no  separate  authorisation  has  been  granted  so  far.  Several  other  countries  also  seem  to 
grant a single authorisation even if they did not explicitly indicate doing so (Finland, Latvia, 
Malta). For example Finland specified that there is no separate process to grant authorisations 
for procurement organisations and that only one transplantation centre exists, which also has 
the teams for organ procurement. In some countries, every authorised transplantation centre is 
authorised to perform organ procurement (Belgium, Italy).  

Length of the authorisation 

Figure 7. Duration of authorisations for procurement organisations 

More  than  half  of  the  countries  (18/29)  grant  to  procurement  organisations  authorisations 
unrestricted in time (Figure 7). Of these, Cyprus specified though that such authorisations are 
in the process of being time-restricted to one year.  
In 11 EU Member States, authorisations of procurement organisations are valid for a specific 
duration.  In  three  of  them,  durations  are  variable  while  in  the  other  eight  countries,  fixed 
validity periods are in place, ranging from two to five years. Five years is the most common 
duration,  applied  in  five  Member  States.  When  authorisations  are  time-limited  to  variable 
durations,  validity  terms  for  authorisation  are  set  by  Member  States  according  to  different 

14 

 
 
 
 
 
criteria. Durations are set at the regional level in Spain, while in Denmark they are based on 
elements such as the length of the post-occupancy of the doctor responsible for procurement 
activities.  In  Member  States  with  fixed  validity  periods,  elements  can  alter  the  fixed-term 
authorisation: in Lithuania and Romania, procurement authorisations are valid on the basis of 
a  five-year  period.  However,  the  validity  is  scaled  down  to  two  years  when  it  is  the  first 
registration (Lithuania) and authorisations are re-evaluated every two years in Romania. 

Renewal and withdrawal of the authorisation 

In  several  Member  States,  the  scheme  for  renewal  of  authorisation  requires  that  the  criteria 
applied to grant the initial authorisation are met again at the time of renewal. A few countries 
report having withdrawn authorisations, usually temporarily, because the initial conditions for 
granting  the  authorisation  were  no  longer  fulfilled,  for  example  due  to  the  departure  of  key 
health professionals 

3.2.2. Procurement teams coming from abroad to procure organs 

It  is  current  practice  in  Europe  that  procurement  teams  come  from  abroad.  Teams  from  
partner countries come over, within established cooperations, to procure organs usually to be 
transplanted in the partner country. This helps avoiding losing organs (from existing donors) 
that would otherwise not be procured. For example, a heart or lung procurement team might 
go  over  to  countries  with  only  renal  or  hepatic  transplant  programmes.  While  these  organs 
would anyway not be transplanted in the country of origin, such collaboration is still a way for 
the country of origin to be associated with such procurement programmes in partner countries 
and eventually to also gain experience with these organs. 

26 Member States reported that procurement teams come from abroad on a regular or an ad 
hoc basis (Figure 8). In 21 of them such activities are performed within the framework of a 
fixed collaboration like an EOEO or a bilateral cooperation. Most frequently they follow the 
Eurotransplant or Scandiatransplant frameworks, as a full member or as a partner country of 
such  EOEO  (for  example  Bulgaria,  Estonia  and  Lithuania  with  Eurotransplant).  Several 
countries  have  (also)  bilateral  collaborations  with  other,  often  neighbouring  countries,  for 
example  Cyprus  with  Italy  or  United  Kingdom,  Finland  with  Estonia,  Luxembourg  with 
France, Malta with Italy, Portugal and Spain, Slovakia and Czech Republic.  

15 

 
 
 
 
 
Figure 8. Procurement teams coming from abroad to retrieve organs 

3.2.3. Framework for ensuring procurement organisations' compliance with the Directive  

To secure a framework for the quality and safety of transplantation activities, Member States 
must  establish  a  system  which  guarantees  procurement  organisations  respect  the  provisions 
laid down by the Directive. Ensuring this compliance can be achieved by several means, often 
combined:  mainly  by  control,  audit  or  inspection  of  the  procurement  centre,  meaning 
conducting on-site inspections, or by desk-based analysis of the mandatory documentation.  

The  most  commonly  used  method  to  ensure  compliance  is  the  establishment  of  on-site 
controls, audits or inspections of procurement centres, being reported by 22 countries (Figure 
9). Desk-based analysis of the mandatory documentation is also a frequent measure, used in 
20 Member States. Alternatively, only three Member States declared to use other means (see 
below). All countries reported making use of at least one of the aforementioned methods and 
16  of  them  use  both  control/audit  of  procurement  organisations  and  desk-based  analysis  of 
mandatory documentation (BE, CZ, DE, DK, EE, ES, FI, FR, HU, IT, LU, LV, MT, PT, RO, 
UK).  These  figures  suggest  that  the  combination  of  different  measures  may  be  the  most 
successful way to ensure that the requirements of the Directive are fully met.  

16 

 
 
 
 
Figure 9. Measures to ensure compliance with the Directive (for procurement) 

Control, audit or inspection of procurement organisations 

Among  the  22  countries  that  control/audit  or  inspect  procurement  organisations,  more  than 
half  have  defined  regular  schemes  at  national  level  (12/22).  Such  schemes  provide  for  a 
control or inspection of procurement organisations on a regular basis ranging from every year 
(Czech Republic,  Luxembourg) to every three (Latvia) or  five years (Slovenia). A two-year 
length of time between controls is however the most common period, occurring in seven of 
the  countries  which  use  such  a  method  (BG,  EE,  FR,  IE,  LT,  MT,  RO).  In  some  other 
Member States, schemes for inspections of procurement organisations are set at regional level 
and  therefore  vary  from  one  region  to  another  (Germany,  Italy,  Spain).  Three  countries 
declared  that  they  have  established  risk-based  inspection  schemes  (Denmark,  Estonia, 
Finland), which is an approach also used in other health sectors, and mentioned in the blood 
and tissues and cells sector. 
Rules for inspection and control have not been fixed so far in two Member States (Belgium, 
Portugal) and Norway.  

Desk-based analysis of mandatory documentation  

records of procurement activities or annual reports on transplantations,  

In  most  of  the  countries  which  have  adopted  this  approach,  the  mandatory  documentation 
includes: 
- 
-  protocols and operating procedures related to the performance of procurement activities, 
-  qualifications of the personnel and 
- 
Two  Member  States  have  mentioned  an  EOEO  as  regards  to  the  analysis  of  mandatory 
documentation:  Belgium  reported  the  use  of  the  quality  form  issued  by  Eurotransplant  and 
Austria  uses  the  mandatory  documentation  as  set  by  this  EOEO  to  ensure  compliance  of 

reports on serious adverse reactions and events (SARE).  

17 

 
 
 
 
procurement  organisations.  Greece  reported  using  the  same  type  of  documentation  both  for 
the compliance of procurement organisations and transplantation centres. Germany and Latvia 
also indicated that a unique legislative act provides for the mandatory documentation for both. 
Three Member States only use this method to ensure compliance with the Directive (Austria, 
Cyprus,  Greece).  Their  mandatory  documentation  mainly  covers  annual  reports  of 
procurement activities.  

While  very  relevant  to  verify  some  formal  conditions  and/or  to  map  some  gaps,  the  desk-
based analysis of the mandatory documentation alone may not be sufficient to fully verify the 
compliance of a procurement organisation. The in-situ control/audit/inspection often includes 
(or is preceded by) an analysis of the mandatory documentation. 

Other methods implemented by Member States   

Three Member States reported using other methods than the two measures mentioned above. 
Poland indicated that “transplant teams responsible for procurement need to hold a five-year 
permit from the Polish Ministry of Health”, and within this authorisation process, there is a 
procedure foreseen for “checking and auditing” the organisations (not further described).  
In  Sweden,  until  2013,  supervision  has  been  limited  to  reports  on  vigilance  and  adverse 
events.  Swedish  authorities  also  mention,  as  part  of  the  mandatory  documentation, 
“traceability  and  documents  regarding  responsibilities  for  transport,  notification  of  SARE” 
and add that “supervision of the transplantation activities are within our regular supervision of 
the health care establishments”, within explicitly and formally mentioning inspection, control 
or audit, not the systematic desk-based analysis of the necessary documentation.  
The  Dutch  authorities  explained  their  “other  method”  by  answering  that  “procurement 
organisations have to comply with the law.” 
In  conclusion,  these  measures  classified  by  some  countries  as  “other”  are  not  well  detailed, 
despite follow-up questions.  

3.2.4. Personnel involved in the procurement 

Articles 4 and 12 of the Directive require Member States to ensure that the personnel involved 
in  procurement  activities  are  “suitably  qualified  or  trained  and  competent  to  perform  their 
tasks and are provided with the relevant training”.  

Different approaches can be adopted to assess the competency of the healthcare personnel:  

- at the moment of recruitment verifying the qualifications, (23 countries) 
- through the completion of regular training programmes (24 countries) or  
- through additional certification (11 countries). 

All Member States declared having in place at least one of these three measures to ensure that 
the procurement personnel are capable of performing  their tasks  (Figure 10).  Most Member 
States  combine  different  methods,  which  may  be  the  most  comprehensive  way  to  meet  this 
requirement. 

18 

 
 
 
 
It  should  also  be  noted  that  different  kinds  of  healthcare  personnel  are  involved  in 
procurement  and  donation  activities  (often,  but  not  only,  so-called  “transplant  donor 
coordinators”  or  “key  donation  personnel”,  nurses/doctors,  different  specialties  etc.).  The 
profiles  also  depend  upon  the  healthcare  and  educational  systems  of  the  Member  States 
considered. 

Figure 10. Methods to ensure professional competence of healthcare personnel (procurement) 

Training can be provided at the international level through international conferences such as 
EDTCO  or  ESOT  congresses11  or  sessions  organised  by  EU-funded  projects  (for  example 
ETPOD12,  the  European  Training  Course  in  Transplant  Donor  Coordination  or  the  pilot 
project on training and social awareness13, see also below), for example mentioned by Malta. 
Programmes  designed  for  continuous  training  are  also  offered  at  the  national  level  (Ireland, 
Italy, the Netherlands, Portugal) or at the regional level (Bulgaria, Latvia) including the local 
scale  (hospitals).  Few  Member  States  offer  training  at  all  levels.  Training  is  provided  by 
specialised bodies including foundations, healthcare establishments, professional associations 
and societies. Some Member States have made such specific continuous training programmes 
mandatory in order to be able to continue carrying out the related professional activity.  

Italy specified that the certifications required from the coordinating transplantations units are 
offered periodically through a national programme whilst in Poland the required certification 
consists  of  a  specialisation  in  clinical  transplantology,  offered  by  medical  universities.  In 
these cases, the certification constitutes more than a simple training programme, because it is 
a formal procedure by which an accredited or authorised person or agency (here: a competent 

11 For example ESOT Congress in September 2015: http://esot2015.esot.org/ 
12 European Training Programme on Organ Donation (ETPDO): http://etpod.il3.ub.edu 
13 Financing Decision: http://ec.europa.eu/health/blood_tissues_organs/docs/organs_c2015_4583_en.pdf 
Call for tender: http://ec.europa.eu/dgs/health_food-safety/funding/contracts_en.htm 

19 

 
 
 
 
 
                                                            
authority,  medical  university  or  professional  organisation)  assesses,  verifies  and  attests  in 
writing by issuing a certificate, the qualification of individuals (healthcare professionals), in 
accordance with established requirements or standards. 

Member  States  that  reported  ensuring  the  suitability  of  personnel  by  other  means  perform 
checks  on  their  profiles  and  qualifications  during  the  authorisation  process  of  the  centres 
(Portugal,  United  Kingdom).  
(Cyprus,  France,  Romania)  or  during 

inspection 

EU-level support 

Additional  support  to  improve  the  qualification  level  of  the  personnel  involved  in  organ 
donation  was  provided  by  the  European  Union.  The  European  Commission  co-financed  the 
European  Training  Programme  on  Organ  Donation  (ETPOD)14  under  the  framework  of  the 
EU  Health  Programme  2003-2008.  Finalised  in  2010,  the  project  developed  four  training 
modules  for  the  different  levels  of  professionals  involved  in  organ  donation  and  provided 
guidance on the methodologies to adopt to achieve best possible results in such courses. The 
outcome  of  the  project  and  the  guidelines  issued  can  be  used  by  Member  States  as  tools  to 
improve and develop relevant training courses. As regards to the training for transplant donor 
coordination, a dedicated course15 was funded by the European Commission in 2011 in order 
to  increase  the  quality  and  quantity  of  donation  and  transplant  coordination  in  the  EU.  In 
addition,  under  the  6th  work  package  of  the  EU-funded  ACCORD  Joint  Action16  ending  in 
2015, the Dutch-Hungarian twinning programme allowed not only the training of Hungarian 
procurement surgeons, but also to improve and make available in English, via the European 
Society  for  Organ  Transplantation,  a  dedicated  e-learning  platform  and  IT-tool  for  organ 
procurement  surgery.  Also  EU-funded,  the  ODEQUS  project17  offers  tools  to  improve 
donation programme at hospital level, while the pilot project on organ donation (training and 
social awareness)18 to start in 2016 will help Member States in their training efforts. Last but 
not  least,  the  Working  Group  on  Deceased  Donation  under  the  EU  Action  Plan  on  Organ 
Donation  and  Transplantation,  composed  by  experts  from  different  EU  Member  States  and 
chaired  by  the  European  Commission,  developed  in  2011  a  Manual,  for  the  competent 
authorities, providing  examples of  good practices  on how to  appoint  and train key donation 
personnel and coordinators. 

3.2.5. Consent system for organ donation 

Article 14 of the Directive requires that procurement activities are “carried out only after all 
requirements  related  to  consent,  authorisation  or  absence  of  any  objection  in  force  in  the 
Member State concerned have been met”. Indeed Member States have in place different types 

14 ETPOD: http://etpod.il3.ub.edu/ 
See also: http://ec.europa.eu/chafea/projects/database.html?prjno=2005205 
15 European Training Course in Transplant Donor Coordination in the European Union 
16 http://www.accord-ja.eu/twinning 
17 European Quality System Indicators and Methodology on Organ Donation (ODEQUS): 
http://ec.europa.eu/chafea/projects/database.html?prjno=20091108 
18 Financing Decision: http://ec.europa.eu/health/blood_tissues_organs/docs/organs_c2015_4583_en.pdf 
Call for tender: http://ec.europa.eu/dgs/health_food-safety/funding/contracts_en.htm 

20 

 
 
 
 
 
                                                            
of national (sometimes even regional) schemes for consent to donate organs after death. Two 
main consent systems exist in Europe:  
- 

an  “opt-in”  system  under  which  donors  are  required  to  explicitly  give  their  consent  for 
organ donation,  
an “opt-out” system, which lays down the principle of presumed consent unless a specific 
request for non-removal of organs is made before death.  

- 

However, it should be stressed that, regardless of the consent system applied in the country, it 
is  standard  practice  to  approach  and  consult  family  members  of  the  deceased  prior  to  any 
decision to procure an organ. 
Figure 11 provides a picture of national choices made regarding consent systems and reported 
by  Member  States  (despite  the  fact  that  consent  systems  are  outside  of  the  direct  scope  of 
Directive 2010/53/EU). More than half of the EU Member States (17/28) and Norway have 
adopted an opt-out system at national level for organ donation. Seven Member States have an 
opt-in system in place while four countries have a mixed system.  

Opt-out systems 

Most  European  countries  work  on  a  “presumed-consent”  basis,  and  this  system  is  often 
supported  by  registers:  citizens  can  choose  to  document  officially  their  refusal  (in  France), 
their explicit willingness to donate, or sometimes both types of registers are available in the 
country (for example in Belgium and in Slovenia). While families are always consulted, their 
consultation  might  be  organised  differently  in  practice:  In  Greece  for  example,  where  the 
principle is “presumed consent”, after death of a citizen who had not expressed any opposition 
to donation during his/her life, a family's written consent is required. Norway also indicated 
that consent from relatives of the donor was always required after death of the donor. 

Figure 11. National consent systems for organ donation 

Opt-in systems  

21 

 
 
 
 
 
 
     
 
Opt-in systems in theory require the explicit consent of the donor. Seven countries reported 
having set up opt-in systems. However the functioning of such systems can vary from an opt-
in  system  in  the  strict  sense:  for  instance,  in  some  countries,  the  system  requires  express 
consent from the donor but allows the donation with the consent of the next of kin when no 
express  consent  from  the  deceased  donor  has  been  given  during  their  life  time  (Denmark, 
Germany, Ireland).  

Mixed systems 

Countries with regional differences or countries combining elements of both opt-in and opt-
out systems that cannot be classified in one of these categories only are classified as countries 
with  mixed  systems.  For  instance  in  Italy,  donors  have  the  possibility  to  explicitly  declare 
their consent for organ donation (via donor cards, registration in national system through local 
health units, id-paper, signed statement…) and if the consent is not known, relatives are asked 
for  non-opposition  to  retrieval.  In  the  United  Kingdom,  the  mixed  system  is  the  result  of 
regional differences: an opt-in system was in place throughout the UK but Wales now has an 
opt-out system.  

3.2 6. The selection and protection of living donors  

For some organs such as kidneys and livers (and very experimentally lungs), living donation 
is possible, which complements deceased donation to face organ shortages. However, taking 
an organ from a healthy person to treat another person is an invasive measure and can have 
medical, but also psychological, social and economic consequences for the donor. Therefore 
living  donors  must  be  carefully  screened,  selected  and  followed  up  before,  during and  after 
donation. 

Article  15  lays  down  that  Member  States  shall  take  all  necessary  measures  to  ensure  the 
highest possible protection of living donors and shall ensure that they are selected on the basis 
of their health and medical history, by competent professionals (this selection should happen 
through  assessments  that  may  provide  for  the  exclusion  of  persons  whose  donation  could 
present unacceptable health risks). In addition, Member States shall ensure that a register or 
record  of  living  donors  is  in  place  and  shall  carry  out  their  follow-up  Moreover,  they  shall 
have a system in place in order to identify, report and manage any event potentially relating to 
the quality and safety of the donated organ (and hence of the recipient) as well as any serious 
adverse reaction in the living donor that may result from the donation.  

Over the last years, several EU-funded projects such as EULID, ELIPSY, EULOD, ACCORD 
have created tools and methodologies to support Member States in these efforts. 

Overall,  most  countries  have  introduced  registers  or  records  for  living  donors.  Most  of  the 
countries (17/29)  reported  having  initiated  a register  before  the  adoption  of  the  Directive in 
July 2010 (BG, CZ, DE, DK, EE, EL, FI, FR, HU, IE, IT, LV, NL, NO, PL, SK, UK), while 
others have launched such records in 2014 or 2015. 23 countries report keeping a register or a 
record  to  follow  up  living  donors.  The  remaining  six  countries  (AT,  HR,  LU,  MT,  PT,  SI) 
reported that they have no such register in place at present, but some of them plan to establish 

22 

 
 
 
ones in the near future (Croatia, Portugal, Slovenia). In Luxembourg, the implementation of 
this register will be subject to an update of the related national scheme. Austria, Hungary and 
Portugal reported that they do not keep records at national level, though some are kept in each 
transplantation centre. Malta also indicated that no national record was kept but that data was 
available.  

Type of record/register: establishment, level of record keeping and content 

In most Member States maintaining records of living donors, record keeping is set at national 
level (16/23). Four Member States reported that a record is kept at the international level, their 
national  data  on  living  donors  being  included  in  the  relevant  record  hosted  by  their  EOEO 
(Belgium with Eurotransplant; Denmark, Sweden and Norway with Scandiatransplant). Some 
Member States specified that a record is locally kept by each transplantation centre (Finland, 
Romania).  
Significant  discrepancies  are  noted  between  Member  States  in  the  content  and  type  of  data 
captured  in  the  register,  often  depending  on  the  type  of  transplantation  performed.  Some 
countries did not mention any limitation of the record to donors of a specific kind of organs, 
while  in  other  Member  States  records  are  only  kept  for  kidneys  (in  Finland,  Greece  and 
Spain)  or  liver  (Germany).  The  notions  of  "record"  or  "register"  are  not  interpreted  in  the 
same way in Member States, leading to differences in the content of such reporting documents 
(light/comprehensive  information).  A  few  countries  mentioned  the  unreliability  of  their 
records,  which  can  lack  some  information  or  be  unclear  since  data  on  living  donors  is 
included in more general medical records which do not focus on living donors (Estonia).  

Being aware of such differences in the way Member States keep track of and follow up their 
living  donors  (differences  that  affect  the  collection  of  accurate  and  valuable  data  on  the 
availability of organs from donors, thus reducing transplantation possibilities), the European 
Commission  co-financed the Joint Action ACCORD19. One priority area for ACCORD was 
living donor registries: national  registries and international data sharing. The guidelines and 
standards produced for the set-up and implementation of such registers has been recognised as 
a benchmark, and the development of this model for a (European) Register of (national/local) 
Registries, aimed at collecting living donor follow-up data in an international database, was 
also  studied  and  tested.  After  results  of  this  project  received  positive  feedback  from 
competent  authorities  who  also  asked  for  continued  support  on  this  topic,  the  European 
Commission  was  able  to  propose  its  inclusion  within  the  scope  of  a  new,  so-called  “pilot 
project” initiated by the European Parliament. This project focusing on kidney diseases20 will 
start in 2016 and will further support Member States willing to improve their living donation 
systems.  The  recently  adopted  Council  of  Europe  Resolution  on  the  same  topic,  explicitly 

19 "Achieving Comprehensive Coordination in ORgan Donation throughout the European Union" 
http://ec.europa.eu/chafea/projects/database.html?prjno=20112102  
http://www.accord-ja.eu/living-donor-registries 
20  2015  funded  pilot  project  (to  start  in  2016)  providing  funding  to  support  Member  States  in  this  field:  "The 
Effect of Differing Kidney Disease Treatment Modalities and Organ Donation and Transplantation Practices on 
Health Expenditure and Patient Outcomes"). The project focuses on kidney diseases, since the majority of living 
donors 
as  well): 
http://ec.europa.eu/health/blood_tissues_organs/key_documents/index_en.htm#anchor3_more  

donors  will 

included 

donors 

kidney 

living 

liver 

(but 

are 

be 

23 

 
 
 
                                                            
mentions ACCORD deliverables as reference documents21 and thus confirms and expands the 
recognition of their value also to non-EU Member States.  

Type of follow-up of living donors  

The  majority  of  countries  provide  a  follow-up  to  living  donors  after  donation  (27  of  29 
countries). However, living donors are not currently provided with medical follow-up in two 
Member States (Bulgaria, Greece). In a few Member States, the need for a medical follow-up 
and its frequency are assessed on a case-by-case basis for each donor. Estonia also specified 
that follow-up is only conducted upon a patient's request, in case of a post-operatory problem. 
As  regards  to  the  frequency,  some  countries  have  set  fixed  periods  for  conducting  medical 
follow-ups, which occur on a regular basis varying from a week after donation and every two 
weeks after, to monthly or yearly medical evaluations. Roughly half of the countries (16/29) 
provide a lifelong medical attention to donors, while seven have defined fixed terms for their 
follow-up, ranging from a year to five, ten or thirty years. While four countries do not seem to 
have a scheme at all for donor follow-up (Bulgaria, Greece, Lithuania and Luxembourg), two 
other (Austria and Estonia) have not defined schemes for the regularity of follow-ups.   
In all 27 countries where a medical follow-up is provided to donors, such follow-up includes a 
review  of  the  general  health  status  of  the  donor,  evaluation  of  any  complication  and 
functioning  of  the  remaining  organ.  In  addition,  the  medical  treatment  provided  is  assessed 
and blood pressure or blood status are considered in 26 countries. Psychological aspects are 
not considered in six of them. Results of past EU-funded projects such as EULID, ELIPSY 
and  the  ACCORD  Joint  Action  provide  tools  to  set  up  a  solid  follow-upsystem.  The  future 
EU-funded pilot project on kidney diseases22, to start in 2016 for three years, will include a 
dedicated work package on the follow-up of living donors for kidney and liver living donors, 
to help Member States further improve their corresponding schemes.  

3.2 7. The follow-up of transplanted patients  

While the follow-up of living donors is a core requirement of Directive 2010/53/EU (Article 
15), the follow-up of transplanted patients is left to Member States’ decisions. Recital 24 of 
the Directive recognises that “the competent authorities of the Member States should have a 
key  role  to  play  in  ensuring  the  quality  and  safety  of  organs  during  the  entire  chain  from 
donation to transplantation and in evaluating quality and safety throughout patients’ recovery 
and during the subsequent follow-up.  
Therefore,  besides  the  system  for  reporting  serious  adverse  events  and  reactions,  the 
collection of post-transplantation data is needed for a more comprehensive evaluation of the 

data 

sharing and 

international 

its  Explanatory  Memorandum 

21  Resolution  CM/Res(2015)11  on  establishing  harmonised  national  living  donor  registries  with  a  view  to 
facilitating 
at: 
https://www.edqm.eu/sites/default/files/resolution_on_establishing_harmonised_national_living_donor_registrie
s_with_a_view_to_facilitating_international_data_sharing_2015_11.pdf 
https://www.edqm.eu/en/organ-transplantation-recommendations-resolutions-74.html  
22 Pilot project "The Effect of Differing Kidney Disease Treatment Modalities and Organ Donation and 
Transplantation Practices on Health Expenditure and Patient Outcomes" (C(2015) 4582 final, 10.07.2015) 
See Financing decision and corresponding annex published on 10 July 2015: 
http://ec.europa.eu/health/blood_tissues_organs/docs/organs_c2015_4582_en.pdf 
http://ec.europa.eu/health/blood_tissues_organs/docs/organs_c2015_4582_annex_en.pdf 

-  See  more 

24 

 
 
 
 
 
                                                            
quality  and  safety  of  organs  intended  for  transplantation.  Sharing  such  information  between 
Member  States  would  facilitate  further  improvement  of  donation  and  transplantation  across 
the  Union.”  Task  (e)  foreseen  for  competent  authorities  under  Article  17  also  includes  this 
aspect:  “issue  appropriate  guidance  to  healthcare  establishments,  professionals  and  other 
parties involved in all stages of the chain from donation to transplantation or disposal, which 
may  include  guidance  for  the  collection  of  relevant  post-transplantation  information  to 
evaluate the quality and safety of the organs transplanted.”  
The European Commission, to support Member States and international sharing on this topic, 
co-funded via the EU Health Programme the collaborative project EFRETOS23. The general 
objective  of  this  project  was  to  provide  a  common  definition  of  terms  and  methodology  to 
evaluate the results of transplantation, and to promote a model for registry of registries with 
follow-up data. The project was finalised in 2011 and since then results produced have been 
available to all Member States. It also provided a blue-print for a European registry enabling 
the monitoring of patients and the evaluation of transplant results beyond national borders. In 
addition,  registers  developed  and  held  by  transplant  professionals  and  societies  -  such  as 
ERA-EDTA24 for kidneys or ELTR25 for livers - also play a key role in these topics, several 
competent authorities collaborate with them and the European Commission encourages such 
cooperations by inviting them to meetings with all authorities in Brussels. Finally, the future 
EU-funded  pilot  project  on  kidney  diseases  to  start  in  2016,  already  mentioned  above,  will 
also  include  a  Work  package  on  the  follow-up  of  transplanted  patients,  building  upon 
EFRETOS consensus results. 

3.2.8. Other key principles governing organ donation 

In  addition  to  consent  requirements  (see  Section  3.2.5.)  and  the  selection  and  protection  of 
living donors (see Section 3.2.6.), other key principles govern organ donation. Article 13 of 
the  Directive  lays  down  that  donations  of  organs  from  deceased  and  living  donors  are 
voluntary  and  unpaid,  but  that  the  principle  of  non-payment  shall  not  prevent  living  donors 
from receiving compensation, provided it is strictly limited to making good the expenses and 
loss of income related to donation. The Directive asks Member States to define the conditions 
under  which  such  compensation  may  be  granted,  while  avoiding  there  being  any  financial 
incentives or benefit for a potential donor.  
Six Member States reported that they have not defined the conditions for such compensation. 
Of these Malta and Romania indicated that no compensation was given, as happens in Latvia 
in  case  of  living  donation.  Ireland  is  in  process  of  defining  a  national  scheme  for 
compensation.  
Also related to this topic, cross-border living organ donation is a specific issue that requires 
coordination  between  Member  States,  in  particular  regarding  the  donor  follow-up.  A 
Recommendation26  concerning  financial  aspects  of  cross-border  living  organ  donations  was 

23 European Framework for the Evaluation of Organ Transplants: http://www.efretos.org/ 
24 Register of the European Renal Association - European Dialysis and Transplant Association: 
http://www.era-edta.org/ 
25 European Liver Transplant Registry: http://www.eltr.org/ 
26  Recommendation  No  S1.  of  15  March  2012.  concerning  financial  aspects  of  cross-border  living  organ 
donations: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32012H0810(01) 

25 

 
 
 
                                                            
also  issued  at  EU  level  in  2012  by  the  administrative  Commission  for  the  coordination  of 
social security systems.  

3.3. Transport of organs intended for transplantation 

Because organs must be transplanted quickly after the procurement, the transportation of the 
organs intended for transplantation is a key stage in the chain from the donor to the recipient, 
in particular when organs are exchanged across borders. The quality and safety aspects of the 
transport are covered by Article 8 (and Article 9.3.b.). 

Organisation of organ transportation 

Transportation  of  organs  is  managed  differently  across  the  EU.  Transport  coordination  is 
organised  either  by  the  procurement  team  (e.g.  Cyprus),  by  transplantation  centres  (e.g. 
Belgium, France, Slovakia), by an authority at regional level (Denmark) or, more frequently, 
by an authority at national level or by a body which has been delegated the task (e.g. ES, HR, 
LV,  NO,  PT).  Transport  can  involve  private  transportation  companies  (external  contracts), 
internal  transportation  services  from  transplantation  centres  or  competent  authorities,  or 
specialised state transport systems. 

Ensuring the respect of transportation rules  

Countries  usually  ensure  that  the  organisations/companies  involved  in  the  transportation  of 
organs have appropriate procedures in  place  through the establishment of specific  operating 
procedures  or  rules  on  transportation.  Bodies  responsible  for  coordinating  transport  set  up 
protocols to be followed by transportation services and issue guidelines and instructions. As 
foreseen  under  Article  9.3.b.,  at  the  arrival  of  organs,  transplantation  centres  check  if 
dedicated procedures have been regarded and if the conditions of preservation and transport of 
shipped organs have been maintained. Most of the time, a competent authority is responsible 
for  auditing  or  conducting  inspections  to  ensure  the  respect  of  these  procedures.  In  a  few 
countries,  the  transportation  can  occur  only  in  the  presence  of  a  medical  doctor  (e.g. 
Bulgaria). 

Labelling of shipping containers, documents on organ and donor characterisation 

As  required  under  article  8,  in  all  countries  with  the  exception  of  Lithuania,  labelling 
information  on  transport  containers  includes  identification  of  the  transplantation  centre  of 
destination; a statement that the package contains an organ and details on the type of organ; 
recommended  transport  conditions.  In  the  majority  of  countries  (27/29),  organs  are  always 
transported accompanied by a report on organ and donor characterisation (except for Greece 
and Luxembourg).  
The  information  on  organ  and  donor  characterisation  is  not  labelled  in  English27  in  15 
Member  States,  but  most  of  the  time  labelled  in  the  national  /  local  language.  Commission 

27 Excluding states where the information is labelled both in English and in another language.  

26 

 
 
 
 
 
 
                                                            
Implementing  Directive  2012/25/EU28  on  cross-border  exchange  of  organs  foresees  (Article 
4) that Member States shall ensure that, in case of cross-border exchange, such information is 
written  in  a  language  mutually  understood  by  the  sender  and  the  addressee,  or  in  absence 
thereof, in a mutually agreed language, or failing that, in English.   
Last but not least, on the preservation of organs, it can be noted that an EU-funded Research 
project such as COPE29 (Consortium for Organ Preservation in Europe) contributes, thanks to 
clinical  trials,  to  investigating  new  techniques  for  organ  preservation  and  comparing  the 
different techniques available. 

3.4. Authorisation of transplantation centres and qualification of personnel 

This  section  is  devoted  to  the  authorisation  schemes  for  transplantation  centres  (3.4.1.),  the 
framework  set  by  Member  States  to  ensure  that  transplantation  centres  comply  with  the 
Directive (3.4.2.) and to ensure the qualification of personnel involved in transplant activities 
(3.4.3.).  

3.4.1. Authorisation of transplantation centres 

In the same way as for procurement organisations (see Section 3.2.1.), the Directive (Articles 
9 and 17) foresees an authorisation scheme for transplantation centres, in order to ensure the 
oversight of transplant activities. 

Definitions and authorisation of transplantation centres 

Again, the Directive provides for a broad definition of transplantation centres in Article 3 (r): 
“a healthcare establishment, a team or a unit of a hospital or any other body which undertakes 
the transplantation of organs and is authorised to do so by the competent authority under the 
regulatory framework in the Member State concerned.” Consequently, different levels can fall 
within  the  scope  of  a  “transplantation  centre”.  Like  for  procurement  organisations,  the 
definition  of  an  “authorisation”30  in  the  Directive  also  encapsulates  different  concepts  and 
therefore  allow  for  various  interpretations  in  the  national  laws.  Most  Member  States  use 
several of the options proposed in these broad definitions. Authorisations for transplantation 
centres  are  granted  at  the  level  of  the  healthcare  establishment  in  the  majority  of  Member 
States and Norway (26 of 29 countries). Additionally, they are granted to the team or unit of 
the hospital (11/29) or to any authorised body which undertakes the transplantation of organs 
(2/29).  

The authorisation scheme used in Member States to authorise transplantation centres is a key 
issue  to  ensure  their  oversight.  All  Member  States  mentioned  to  have  such  authorisation 

28 Commission Implementing Directive 2012/25/EU of 9 October 2012 laying down information procedures for 
the exchange, between Member States, of human organs intended for transplantation.  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:275:0027:0032:EN:PDF  
29 http://cope-eu.com/ 
30  ‘authorisation’  means  authorisation,  accreditation,  designation,  licensing  or  registration,  depending  on  the 
concepts used and the practices in place in each Member State. 

27 

 
 
 
 
 
 
                                                            
scheme  (but  it  is  to  be  noted  that  for  six  Member  States  (AT,  BE,  DE,  ES,  FR,  IT)  the 
regional level in charge of authorising, see Annex 1 and in particular the column for task (c)).  

State of play in Member States where not all transplantation centres have been authorised  

25 countries answered that all transplant centres had effectively been authorised, while four 
countries (Ireland, Luxembourg, Latvia, Malta) explained that they were still in the process of 
granting (new or renewed) authorisations to (some of) their centres. They explained that this 
process  is  directly  linked  to  the  transposition  of  the  Directive,  with  some  delays  in  the 
adoption of secondary legislation and/or in the implementation of practical arrangements. 

Figure 12. Member States granting authorisations for transplantation centres  

In Ireland, initial inspections have been performed in all transplantation centres and a quality 
system  based  on  these  is  currently  being  developed.  The  authorisation  scheme  is  also  in 
progress in Latvia while Malta reported being in the process of authorising the transplantation 
unit of the State hospital, which has already  been authorised for procurement activities.  For 
Luxembourg, it should be noted that no transplantation activities are performed currently and 
that no transplantation centres exist, thus none have been authorised. 

Specific cases  

In  Estonia  and  Sweden,  all  transplantation  centres  have  been  authorised.  However,  they  are 
not granted any specific authorisation since either holding a valid licence for specialised care 
or being registered as a healthcare provider with a transplantation orientation is considered as 
equivalent  to  an  authorisation  within  the  national  legislation,  also  in  line  with  the  broad 
definition of “authorisation” in Directive 2010/53/EU. 

Length of the authorisation 

15  countries  reported  to  grant  authorisations  to  transplantation  centres  which  are  not  time-

28 

 
 
      
 
 
limited (to be compared to the authorisations of procurement organisations, not time-limited 
in  18  Member  States:  the  same  15  countries  plus  Cyprus,  Luxembourg  and  Sweden,  see 
Section 3.2.1.). In this line, the length of validity of authorisations granted to transplantation 
centres  is  relatively  similar  to  the  validity  of  authorisations  granted  to  procurement 
organisations. 
As  for  the  14  Member  States  which  grant  time-limited  authorisations  to  transplantation 
centres, situations vary between authorisations for a fixed period (one, two, three, four or five 
years) and authorisations for variable periods (Figure 13).  

Authorisations with variable time-limited validities  

In  four  Member  States  authorisations  are  granted  for  variable  durations:  Sweden  and  three 
countries  that  also  have  a  similar  variable  validity  for  authorisations  of  procurement 
organisations:  Denmark,  Italy  and  Spain.  Different  criteria  are  taken  into  consideration  to 
decide about this length. In Denmark, in the same way as for procurement organisations, the 
validity  period  of  the  authorisation  corresponds  to  the  length  of  the  post-occupancy  of  the 
doctor responsible for transplantation activities or to the duration of the hospital's function of 
transplantation  centre.  In  Italy,  different  time  frames  are  set  according  to  the  type  of  organ 
donor: in the case of living donors, the validity of the authorisation is three years, while for all 
other  cases  it  is  two  years.  In  Sweden,  the  type  of  organ  determines  the  time  limit:  for 
instance,  the  duration  of  the  authorisation  extends  to  five  years  for  heart  and  lung 
transplantations. In some countries, the validity of the authorisation differs from one region to 
another as it is decided at regional level (Spain). 

Figure 13. Duration of authorisations for transplantation centres 

29 

 
 
 
 
Fixed time-limited authorisations 

In countries where authorisations are granted for a fixed period, the most common duration is 
five  years  (5  of  9  Member  States)  and  the  authorisation  is  renewed  after  an  evaluation  has 
been conducted to ensure that the initial requirements for granting the authorisation are still 
met. These five countries (France, Lithuania, Poland, Romania, Slovenia) are equally granting 
authorisations for five years to procurement organisations. These countries assess the results 
of  transplant  activity  or  the  capability  of  the  transplantation  centre  to  carry  out 
transplantations (e.g. Greece). In Lithuania, licences must be registered and are valid for two 
years after the first registration and for five years after the first renewal of authorisation.  

Cyprus  grants  authorisations  to  transplantation  centres  for  one  year  (not  limited  in  time  for 
procurement organisations), while Malta, Greece and Croatia grant them for exactly the same 
validity as for procurement organisations, respectively two, three and four years. 

3.4.2. Framework for ensuring compliance with the Directive in transplantation centres 

As reflected in Figure 14, in most EU Member States and Norway (27/29), compliance with 
the  requirements  of  the  Directive  is  verified  through  conducting  on-site  controls,  audits  or 
inspections  of  the  transplantation  centres  (measure  a).  Only  Austria  and  Greece  do  not  use 
inspections. More than half of the Member States (19/28) perform desk-based analysis of the 
mandatory  documentation  (measure  b).  Slightly  more  than  half  of  the  countries  use  both 
methods (17/29).  

Figure 14. Measures to ensure compliance with the Directive in transplantation centres 

30 

 
 
 
 
 
 
Member  States'  procedures  to  ensure  compliance  of  transplantation  centres  are  similar  than 
those to ensure compliance of procurement organisations. Measure a) control/audit/inspection 
is  respectively  used  in  22  Member  States  for  procurement  organisations  and  in  27  Member 
States  for  transplantation  centres,  while  measure  b)  desk-based  analysis  is  conducted  in  20 
countries for procurement organisations and in 19 for transplantation centres.  

Mechanisms for controls/audits/inspections of transplantation centres 

Countries that perform controls, audits or inspections have different systems in place. Some of 
them  have  adopted  a  risk-based  approach  for  implementing  controls  (Denmark,  Estonia), 
while others have set fixed periods of time: every year (Cyprus), every two years (BG, IE, LT, 
MT, RO), every three years (Czech Republic, Latvia), or every five years (France, Slovenia).  
The  operational  procedure  for  conducting  controls  is  defined  at  different  levels:  either  at 
national  level  (Slovakia)  or  regional  level  (Spain)  and  in  some  countries  both  levels  are 
involved (Germany).  

Desk-based analyses of the mandatory documentation 

In  some  Member  States,  the  required  documentation  is  specified  by  the  national  legislation 
(BG, DE, EE, FR, HU, IT, LV, RO). Italy reported the involvement of the regional level in 
the  analysis  of  the  mandatory  documentation.  One  country  reported  following  the  relevant 
provisions established by an EOEO (Austria and Eurotransplant). 
In most of the countries which specified the nature and content of mandatory documentation, 
such documentation includes: 
-  qualifications of personnel involved in transplantation activities,  
-  protocols and operating procedures related to organ transplantation,  
- 

annual reports on transplantation activity.  

Portugal reported additional documents such as written proof of the donor's informed consent. 
Sweden mentioned investigating mandatory SARE reports.  

Combining  inspections  and  analysis  of  the  documentation  is  the  approach  adopted  in  15 
countries  for  procurement  organisations  and  in  17  for  transplantation  centres,  and  seems  an 
appropriate approach as both methods enable to check complementary aspects.   

3.4.3. Personnel involved in transplantation activities  

Articles 4 and 12 require that the transplantation personnel are suitably qualified and trained 
to  perform  their  tasks.  As  for  the  procurement  personnel,  that  purpose  can  be  achieved  by 
using several methods, as reflected in Figure 15. 

Twenthy-tree  countries  ensure  that  the  healthcare  personnel  involved  in  the  transplant 
activities  are  suitably  qualified  or  trained  and  competent  at  the  time  of  recruitment, 
considering  the  corresponding  qualifications  of  the  applicants  (measure  a,  used  in  23/29 
countries). Some Member States request registration to the relevant regulatory body (Malta, 
the Netherlands); require previous experience (Germany, Italy) or relevant training in addition 
to qualifications (BE, DE, IE, LT, PT, RO). 

31 

 
 
 
 
Regular  training  programmes  are  foreseen  in  24/29  countries.  These  can  be  organised  at 
different  levels:  at  national  level  in  Germany,  Ireland  and  Lithuania,  at  both  national  and 
international  levels  are  involved  in  Malta,  Poland  and  Sweden,  at  hospital  level  in  DE,  IE, 
LV,  NL,  PL  and  UK.    Five  countries  (DE,  IE,  LV,  MT  and  SE)  also  declare  to  rely  on 
trainings  organised  by  professional  societies  or  organisations  -  for  Europe  in  particular,  the 
Section  of  Surgery  and  the  European  Board  of  Surgery  of  the  European  Union  of  Medical 
Specialists  (UEMS)31  operating  in  close  collaboration  with  the  European  Society  of  Organ 
Transplantation  (ESOT).  A  twinning  training  programme  was  also  mentioned  (by  Malta)  as 
well  as  annual  training  courses  organised  by  professional  societies  at  the  international  level 
between Scandinavian countries. 

Sixteen countries require additional certification, which can be obtained by following specific 
courses  offered by professional organisations  (Germany) and  might require a  registration of 
the specialisation needed (Latvia). The Netherlands reported a mandatory programme offered 
at  national  level  by  the  Health  Ministry;  Slovenia  and  Romania  also  mentioned  national 
training  modules.  International  training  programmes  (such  as  UEMS  scheme  mentioned 
international  certification 
above) 
complementary  to  (or  replacing)  national  certifications  (when  recognised  by  national 
competent authorities authorising transplantation centres and teams). 

to  a  certification  can  also  constitute  an 

linked 

Eleven  countries  combine  use  of  all  three  measures  (a,  b,  c).  Five  Member  States  reported 
other  measures,  including  assessment  of  personnel  during  the  authorisation  process  of  the 
transplantation  centre  (Cyprus,  France);  requirement  of  a  mandatory  length  of  previous 
experience  for  physicians  and  assistants  to  carry  out  transplantation  activities  (Austria); 
mandatory  attendance to congresses and symposiums respectively for physicians and nurses 
(Germany). 

31 http://uemssurg.org/divisions/transplantation 

32 

 
 
                                                            
Figure 15. Methods for ensuring professional competence of the transplant personnel 

3.5. Framework for quality and safety 

While  the  authorisation  of  procurement  organisations  and  tranplantation  centres  is  an 
important element in the oversight of donation and transplantation activities, other measures 
also contribute to their quality and safety. 

The  Directive  requires  Member  States  to  establish  a  framework  for  quality  and  safety 
covering all stages of the chain from donation to transplantation or disposal, also requiring the 
issuance of operating procedures for different actions. This section provides a state of play, as 
reported by Member States,  on adoption and the level of implementation of these  operating 
procedures.  

All  29  countries  reported  having  set  and  implemented  operating  procedures  for  the 
verification of the completion of the organ and donor characterisation (c) in accordance with 
Article  7  of  the  Directive.  However,  three  Member  States  do  not  have  any  operating 
procedures  in  place  at  present  for  any  of  the  other  areas  (Portugal,  Romania,  Slovenia). 
Likewise,  Austria  does  not  have  any  procedure  for  ensuring  traceability,  guaranteeing 
compliance  with  provisions  on  the  protection  of  personal  data  and  confidentiality  (f), 
reporting (g) and management (h) of SARE. In addition to the aforementioned actions, there 
is no operating procedure in Romania for the verification of the donor identity (a), neither for 
the verification of the details of the donor's or donor's family consent (b).  

33 

 
 
 
 
 
Variations in the levels of adoption and implementation of operating procedures 

Countries are at different stages in the adoption and implementation of operating procedures. 
Some of them have completed the process and a framework for quality and safety is fully in 
place complying with the Directive, while others have partially adopted a framework and the 
adoption  process  and/or  implementation  for  the  remaining  operating  procedures  is  ongoing. 
Some Member States are updating their national framework relevant to the provisions of the 
Directive (e.g. Romania).  

Differences in the content of operating procedures 

Some  Member  States  declared  that  they  have  operating  procedures  in  place  but  also 
mentioned that they might be different from one hospital or  region to another,  while only  a 
few Member States seem to have national operating procedures in place, at least for the whole 
chain  from  donation  to  transplantation.  Some  Member  States  have  sent  examples  of  their 
operating  procedures  in  attachment  to  their  answers  to  the  implementation  survey.  A  rapid 
analysis of their content revealed significant differences between operating procedures related 
to the same action. 

Projects  co-funded  by  the  European  Commission  have  supported  the  development  of 
operating  procedures  complying  with  the  Directive's  requirements,  for  example,  within  the 
ACCORD Joint Action, the twinning activities between France and Bulgaria32.   
The  European  Commission  encourages  Member  States  to  share  best  practices,  including 
relevant  documents  and  made  sure  to  put  at  the  disposal  of  all  competent  authorities  the 
operating  procedures  shared  by  some  Member  States,  so  that  other  Member  States  can  take 
benefit  to  develop  their  own  versions  and/or  compare  with  their  national  documents,  thus 
contributing  to  an  harmonisation  of  (good)  practices  and  to  a  further  improvement  of  their 
quality and safety frameworks.   

3.6. General points 

3.6.1. Legal framework for non-compliance with the Directive (penalties) 

As  provided  by  Article  23  of  the  Directive,  “Member  States  shall  lay  down  the  rules  on 
penalties  applicable  to  infringements  of  the  national  provisions  adopted  pursuant  to  this 
Directive and shall take all necessary measures to ensure that the penalties are implemented.” 
Member States were asked which types of penalties they have put in place to comply with the 
Directive:  financial  penalties,  imprisonment,  withdrawal  of  authorisation  (for  procurement 
organisations and transplantation centres), other or no penalties in place (Figure 17).  

32 http://www.accord-ja.eu/twinning 

34 

 
 
 
 
 
 
 
                                                            
Figure 17. Penalties laid down for infringements to national provisions 

Only  one  Member  State  (Hungary)  reported  that  no  penalties  have  been  laid  down  for 
infringements  of  national  provisions  adopted  pursuant  to  the  Directive,  but  that  should, 
however, change in the near future when all operating procedures are available.  
Most countries (27/29) have set up financial penalties. Withdrawals of authorisation or prison 
sentences  are  penalties  also  commonly  used  for  breaches  of  national  provisions,  in  place 
respectively in 20 and 19 Member States.  

One  country  established  penalties  which  do  not  fall  within  any  of  the  aforementioned 
categories  (Latvia):  the  mandatory  performance  of  community  service  and  the  suspension 
from medical practice. 

Combined use of options  

In 24 countries (all Member States without Austria, Croatia, Hungary, Portugal and Norway), 
more than one  type of penalty is  being used.  Both financial penalties and imprisonment are 
reported  in  19  countries  while  financial  penalties  and  withdrawals  of  authorisations  are 
common sentences in 19 other countries. 14 Member States declare combining all three types 
of penalties (CZ, ES, FR, IE, IT, LU, LV, MT, PL, RO, SE, SI, SK, UK).  

Types of financial penalties and imprisonment sentences 

In  14  of  the  countries  that  provided  information  on  the  amounts  applicable  in  case  of  a 
financial penalty, such penalties exceed €1,000.  
As regards to the duration of imprisonment, the term does not exceed one year in Belgium and 
the Netherlands whereas in the remaining countries sentences can be longer. The maximum 
length of imprisonment reported is ten years (Poland). 

35 

 
 
 
 
 
 
 
Schemes for ensuring the enforcement of penalties 

All countries with the exception of Hungary reported that all necessary measures are taken to 
ensure  the  implementation  of  penalties.  Most  Member  States  indicated  that  penalties  are 
enforced by national law; a few countries mentioned cooperation between the different levels 
(national  and  local)  to  control  the  enforcement  of  penalties  (e.g.  Czech  Republic).  Slovakia 
specified  the  existence  of  a  reporting  procedure  for  injured  donors  to  a  national  competent 
authority, in addition to the obligation for procurement organisations to report the incident.    

3.6.2 Organ trafficking 

More than half of the countries (19/29) reported that legislation on organ trafficking is set at 
national level. A few Member States referred to the dedicated Council of Europe Convention 
against Trafficking in Human Organs33, adopted in July 2014 but that needs to be ratified in 
each individual Member State. In March 2015, ten EU Member States (AT, BE, CZ, EL, ES, 
IT,  LU,  PL,  PT,  UK)  and  Norway  had  officially  declared  their  intention  to  ratify  this 
Convention.  
As long as organ shortages persist (and it is likely to be the case with an ageing population of 
patients… and of donors), there is a need to continue using and developing the most effective 
ways of increasing the number of organs available for transplantation, within official donation 
and  transplant  systems  that  ensure  quality  and  safety  both  for  recipients  and  donors.  The 
contribution  of  EU-funded  projects  and  international  cooperation  is  key  to  address  these 
challenges (e.g. Joint Actions ACCORD and FOEDUS) or even to directly investigate organ 
trafficking  (project  HOTT34  Combatting  trafficking  in  persons  for  the  purpose  of  organ 
removal). 

4. Conclusion 

All 28 EU Member States and Norway have answered the survey launched by the European 
Commission in 2014 and reported on the activities undertaken in the relation to the provisions 
of Directive 2010/53/EU and on the experience gained in implementing it. These answers 
enable to map all authorities (listed in Annex 1) in place at national, regional and supra-
national levels, in charge of implementing requirements laid down in the Directive. The 
present report and the list enable to understand oversight mechanisms in place to ensure 
standards of quality and safety for human organs intended for transplantation. They also 
reveal a diversity in the type of settings in place in the different Member States but overall 
authorities and mechanism in place to ensure the implementation of standards of quality and 
safety for the whole chain from donation to transplantation. 

33 http://conventions.coe.int/Treaty/EN/Treaties/Html/216.htm  
34 http://hottproject.com/  

36 

 
 
 
 
 
                                                            
ANNEX 1: List of competent authorities and delegated bodies declared by the 28 Member States and Norway and their corresponding 
tasks under Article 17 

37 

 
 
 
 
 
38 

List per country (A-Z) of competent authorities and delegated bodies in charge of implementing tasks described under Article 17 of Directive 2010/53/EU (Directive 2010/53/EU of the European Parliament and of the Council of 7July 2010 on standards of quality and safety of human organs intended for transplantation)This list was established by the European Commission thanks to the 29 official national answers (28 EU Member States + Norway) to the first survey on the implementation of Directive 2010/53/EU: the "implementation survey".The list compiles answers on the authorities appointed at national and regional levels to implement tasks detailed under Article 17 of the Directive, and on the involvement for these same tasks of "European Organ Exchange Organisations". The "implementation survey" was launched by the European Commission in August 2014, national answers reached the Commission until 24 December 2014. First results were presented to competent authorities in March 2015.The original answers were corrected after clarification questions to and discussions with competent authorities (from April to December 2015). This list is attached to the report of the European Commission on the implementation of Directive 2010/53/EU and made publicly available, as well as the 29 original national answers to the "implementation survey".Legend:Scandiatransplant(SAT reported here only for 1 country because the organisation is not involved in tasks under Article 17 of Directive 2010/53/EU)AT (Aus-tria)Level (national (number at national level), regional, EOEO) to implement NameWebsiteIs this institution a competent authority or a delegated body?If this is a delegated body, from which competent authority is/are the task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherATNational (1)Bundesministerium für Gesundheit (Federal Ministry of Health)http://www.bmg.gv.atCompetent Authoritypublic body / public authorityDetails about the Federal Ministry of Health can be found on theInternet under the above mentioned homepage (http://www.bmg.gv.at/).xxxxATNational (2)Austrian Health Agency (Gesundheit Österreich GmbH; in short: GÖG) / ÖBIG Transplanthttp://www.goeg.at/de/OeBIG-TransplantDelegated BodyFederal Ministry of Healthprivate body (limited company fully owned by the MoH)see homepage (http://www.goeg.at/de/OeBIG-Transplant)xxxxxATEOEO levelEurotransplant Internationalhttp://www.eurotransplant.orgDelegated BodyMinistry of Healthprivate body (non-profit foundation under Dutch law)see point 3.5 above (http://www.eurotransplant.org)xxxxxx (others): Running a 24 / 7 duty desk as required by Directive 2012/25/EU.ATregional levelThe 9 Federal Austrian States, called "Bundesländer", singular "Bundesland" ("mittelbare Bundesverwaltung" = they are eventually bound to the ordres of the Federal Minister of Health)xxBE             (Bel-gium)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherBEnational (1)Federal public service Health, Food Chain and Environment, Health care Facilities Organisation Christiaan Decoster, director general DG 1 http://www.health.belgium.beCompetent Authoritypublic authorityxxxxxTasks mentioned in Article 17 of Directive 2010/53/EUSout Alliance for Transplant (SAT) Authority counted as 1 for national levelDelegated body (for the national level) 
 
 
 
39 

BEregional level Inspectie van welzijns- en gezondheidsvoorzieningen: Stef Van Eekert, Lieve Segbroeckhttp://www.zorginspectie.beCompetent Authoritypublic body/ federated entityxxxxBEregional level Service public de Wallonie, Direction générale opérationnelle des Pouvoirs locaux, de l'Actionsociale et la Santé, Christine BierméSante@spw.wallonie.beCompetent Authoritypublic body/federated entityxxBEregional level COCOM Commission Communautaire commune (Bruxelles); Sophie Verhaegenwww.ccc.irisnet.beCompetent Authoritypublic body/federated entityxxBEregional level Ministère de la communauté germanophonewww.dglive.beCompetent Authoritypublic body/federated entityxxBEregional level Communauté française Serge CARABIN - Directeur généralhttp://www.sante.cfwb.be/Competent Authoritypublic body/federated entityxxxxBEEOEO level Eurotransplant International Fundation www.eurotransplant.orgDelegated Bodynon-profit organisationxxBG         (Bul-garia)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherBGnational (1)Bulgarian Agency on Transplantationhttp://iat.bgtransplant.bg     ;              www.bgtransplant.bg        Competent AuthorityPublic body.CA is at a national level. We gave 2 Divisions; second rank budget operator; 2 Directors of the Divisions + 10 experts from whom 5 medical doctors; 2 inspectors; 4 persons working on EU affairs and legal matters.xxxxxxxxCY          (Cy-prus)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherCYnational (1)Transplant Councilwww.moh.gov.cyDelegated bodyMinistry of Healthxxxxxxxx5 regional authorities but their competences are different (example : concerning the French part of the country, university hospitals fall under the competence of “French Community” but the other hospitals falls under the competence of the “Walloon Region”). 
 
 
 
 
 
40 

CZ     (Czech Repu-blic)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherCZnational (1)Ministry of Healthwww.mzcr.czCompetent Authoritypublic authorityxxxxxCZnational (2)KSTwww.kst.cz Delegated bodyxxxxxDE         (Ger-many)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherDEnational (1)Federal Ministry of Healthwww.bundesgesundheitsministerium.deCompetent AuthorityFederal MinistrySelf-administration is a primary regulation principle in the German health care system. In accordance with this principle the Transplantation Act foresees that the Central Federal Association of the Health Insurance Funds, the German Medical Association and the German Hospital Federation jointly appoint a qualified organisation to co-ordinate the procurement of organs (Section 11 of the Transplantation Act)xDEnational (2)Deutsche Stiftung Organtransplantationwww.dso.deDelegated bodyThe German Transplantation Act provides the legal framework for the installation of a national agency responsible for the coordination of post-mortem organ donation. In accordance with Section 11 subsection 1 of the Transplantation Act the removal of an organ, including the preparations for the removal, allocation and transplanting, is the joint responsibility of the transplantation centres and the other hospitals on the basis of regional co-operation. The Central Federal Association of the Health Insurance Funds, the German Medical Association and the German Hospital Federation set up, a suitable facility (co-ordinating agency) for the purpose of organising this task. This task was assigned to the German Organ Transplantation Foundation (Deutsche Stiftung Organtransplantation, DSO) in June 2000.(cid:13)(cid:13)The DSO is a private, non-profit organisation in form of an incorporated foundation under private law.In order to comply with the requirements under Section 11 of the Transplantation Act, DSO has formed seven geographical organ donor regions. Each region serves the donor hospitals and transplant centres in one or several federal states of Germany. Within these regions, organ donations are organised by a regional coordinating centre and, in some regions, additional smaller service centres. All seven regions are headed by an executive physician of the DSO.The administrative headquarter of DSO is located in Frankfurt (Main). The organisation includes four major divisions (Organisation of organ donation and Quality Management, Controlling and IT, Communications, HR/Finance/Contracts) and four supportive departments (Legal Affairs, Statistics, Data Protection, European Projects). The DSO employs approx. 200 in regular occupation (employment as principal professional activity). About 80 people are working in the headquarters. In addition explant surgeons and support personnel (in total about 1000 employees) have a part time contract (secondary employment).The budget covers approx. 35 Mio € and is negotiated annually with the contracting authorities (the Central Federal Association of the Health Insurance Funds, the German Medical Association and the German Hospital Federation) under Section 11 of the Transplantation Act. It covers organisational fees, reimbursement of expenses for donor hospitals, transportation costsand lump sum compensation for transplant commissioners based on the assumption of 3400 transplanted organs.xxxxx 
 
 
 
 
 
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DEnational (3)German Medical Associationhttp://www.bundesaerztekammer.de/Competent AuthorityBÄK is the association of the German medical chambers. It is a private, non-profit organisation.Details can be found under the homepagexDEnational (4 and 5)Prüfungskommission, Überwachungskommissionhttp://www.bundesaerztekammer.de/Delegated bodiesAccording to Section 11 Subsection 3 and Section 12 Subsection 5 of the Transplantation Act the Central Federal Association of the Health Insurance Funds, theGerman Medical Association and the German Hospital Federation jointly appiont both committees.Both committees are private, non-profit bodies.commissions comprise of at least one respresentative of the the Central Federal Association of the Health Insurance Funds, theGerman Medical Association and the German Hospital Federation  and two respresentatives of the Länder. In addition the commission can consult experts as may be necessary in particularin the case of inspections  in the transplantation centres.(x) supporting regional levelDEregional level16 BundesländerSpecial case in Nordrhein-Westfalen The authorisation of the procurement organisations has been delegated to the district government level (Bezirksregierungen: Arnsberg, Detmold, Düsseldorf, Köln, Münster). The Ministry for Health, Emancipation, Care and Age in Nordrhein-Westfalen is the supervisory authority. The requirements are laid down on the federal level in the Transplantation Act and are the same for all regional authorities in the Länder, irrespective of the formal decision at which level the competence is located.RRRDEEOEO levelEurotransplant International Foundation.xxxxxDK         (Den-mark)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherDKnational (1)Danish Health and Medicines Agencywww.sst.dkCompetent AuthorityPublic body - Agency under the Ministry of HealthThe Danish Health and Medicines Authority is the supreme health and pharmaceutical authority in Denmark. In its present form, the Danish Health and Medicines Authority is a young administration formed on 1 March 2012 through the merger of the Danish Medicines Agency and the National Board of Health. The Danish Health and Medicines Authority has around 700 employees,representing a wide range of professional groups – about 20 in all. We perform a great variety of tasks and work across functions and organisations with other authorities, organisations and professional experts – both in Denmark and abroad. We attach great importance to offering the individual employees an opportunity to develop their skills and pursue professional goals. Goals that also contribute to the development of the Danish Health and Medicines Authority. Main activities: We collaborate with decision-makers and help achieve good health for all citizens in Denmark as well as treatment in a high-quality healthcare sector: We license and monitor medicines (including pharmacies, medicine prices,side effects etc.) We issue and withdraw authorisations (18 different professions – fromchiropodists to physiotherapists) We offer advice and provide information (to the citizens, healthcare professionals and authorities) We plan and approve (placing of specialist functions, care pathways, healthcare agreements etc.) Geographic location Head office at Islands Brygge in Copenhagen. The National Institute of Radiation Protection is part of the DanishHealth and Medicines Authority and is based in the Greater Copenhagen area. The Public Health Medical Officers North and South under the Danish Health and Medicines Authority are based in Randers and Kolding, respectively. Health and Medicines Authority and is based in the Greater Copenhagen area. The National Institute of Radiation Protection is part of the Danish Health and Medicines Authority and is based in the Greater Copenhagen area.xxxxxxxxx (others) 
 
 
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DKnational (2)Transplantation Center, Copenhagen University Hospital.www.rh.dkDelegated BodyPublic bodyxxxDKnational (3)Transplantation Center Odense, Odense University Hospital.www.ouh.dkDelegated BodyPublic bodyxxxDKnational (4)Transplantation Center, Århus University Hospital.WWW.auh.dkDelegated BodyPublic bodyxxxDKregional levelxxxxxxDKEOEO levelScandiatransplant(x)EE         (Esto-nia)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherEEnational (1)State Agency of Medicineshttp://www.ravimiamet.ee/Competent AuthorityMinistry of Social Affairs Governmental body under the Ministry of Social Affairs xxxxxxxEEnational (2)Health Boardhttp://www.terviseamet.ee/en/information.html Competent AuthorityMinistry of Social Affairs Governmental body under the Ministry of Social Affairs The Health Board is a governmental body under the Ministry of Social Affairs as is State Agency of Medicines and is independent of the State Agency of Medicines. It performs surveillance and enforcement functions to assure compliance with legal requirements mainly in the fields of healthcare, communicable diseases and control, environmental health, chemical safety and medical devices. It issues activity licences for the transplantation of organs to transplantation centres. xxxEEnational (3)Transplantation  Centre of Tartu University Hospital Delegated Body Ministry of Social Affairs public body xxxxxThey are obliged to follow the legal acts presented by Ministry of Health and they receive their authorisation from Danish Health and Medicines AuthorityIn Denmark the Regions are responsible for the administration of thelocal hospitals and transplantation centers (the centers are a part ofthe hospital) in the region. In Denmark we have 5 regions. The 3transplantation centers are placed in 3 of the 5 regions.. The DanishHealth and Medicines Agency authorises the centers and supervices thecenters and the authorised health care personnel. The Regions areresponsible for the day to day administration of the hospitals. 
 
 
 
 
43 

EL         (Gree-ce)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherELnational (1)Ministry of Healthwww.yyka.gov.gr  Competent AuthorityxxELnational (2)Hellenic Transplant Organization (HTO or EOM in Greek)www.eom.grCompetent Authorityprivate body of public secturexxxxxxxES (Spain)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherESnational (1)Organización Nacional de Trasplantes (ONT)www.ont.esCompetent AuthorityPublic body, agency dependent upon the Ministry of xxxxxxxESregional level19 Autonomous CommunitiesxxxxxxxESEOEO LEVELSouth Alliance for TransplantationFI       (Fin-land)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherFInational (1)Finnish Ministry of Social Affairs and HealthCompetent Authority                                                     xFInational (2)Finnish Medicines Agency (FIMEA)www.fimea.fiDelegated body Public body (central administrative agency operating under the Ministry of Social Affair and Health)xxxxxxxxFInational (3)National Supervisory Authority for Welfare and Health ("Valvira")www.valvira.fiDelegated body Valvira is a nationwide authority which guides municipalities andRegional State Administrative Agencies on legislation associated withValvira’s jurisdiction.xFIregional levelRegional State Administrative Agencies (6)https://www.avi.fi/en/web/avi-en/#.VZ0eM9CU IU xFIEOEO levelScandiatransplantxSouth Alliance for Transplantation is not involved in the tasks described under Directive 2010/53/EU (Articles 21 and 17) 
 
 
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FR       (Fran-ce)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherFRnational (1)Ministry of Health Direction Générale de la SantéMinistère de la Santé, des Affaires sociales et des Droits des femmesCompetent Authority(x)(x)(x - delegated to ARS, see regional (x)(x)(x)(x)(x)FRnational (2)Agence de la biomédecinehttp://www.agence-biomedecine.fr/Delegated AuthorityMinistere de la santé des affaires sociales et des droits des femmes:health ministery  legislates and delegated bodies implement legislation, each within its missionsPublic bodyx(x - opinions)xxxxFRnational (3)Agence nationale de sécurité des médicaments et des produits de santé (ANSM)ansm.sante.frDelegated AuthorityMinistere de la santé des affaires sociales et des droits des femmes:health ministery  legislates and delegated bodies implement legislation, each within its missionsPublic bodyxxxFRregional level22 ARS (Agences régionales de santé) in all 22 regions.Public bodies: implement french legislation in each administrative regionRHR       (Croa-tia)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherHRnational (1)Ministry of Health, Institute for transplantation and biomedicinexCompetent AuthorityxxxxxxxxHREOEO levelEurotransplant International Foundationxxxx 
 
 
 
 
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HU       (Hun-gary)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherHUnational (1)Hungarian National Blood Transfusion Service (HNBTS or OVSZ)www.ovsz.hu/szervdonacioCompetent Authoritypublic body, national instituteThe Hungarian National Blood Transfusion Service (HNBTS or OVSz) is responsible for the provision of the Hungarian health care service providers with blood components. The HNBTS was established in 2000 along the reorganization process of individual hospital centres, based on the principle of centralization and independence. The pharmaceutical GMP-regulatory network was introduced and implemented in 2001. The HNBTS consists of 5 regional and 18 local institutions. The headquarter has confirmation, quality control, HLA typing and blood group reference laboratories, and management of national transplant waiting lists. The Organ Coordination Office is part of the central body with responsibilities of coordination, support and improvement of organ donation, collection, analysis and evaluation of data associated with the different steps of the donation and transplantation process.  Annual budget is approx. 43 Million EUR Overall staffing level: 1273 Number of personnel involved in inspection: 3 Number of personnel involved in EU affairs: 10 Number of personnel involved in legal matters: 4 Number of vigilance officers: 3 The Organ Coordination Office began its activities on January 1, 2007 as a new department of the Hungarian National Blood Transfusion Service . The office centrally coordinates all Hungarian organ procurements process in cooperation with Eurotransplant and forward organ offers from Eurotransplant to Hungarian transplant centers, therefore establishing and operating three levels of donor-transplant coordination.  xxxxHUnational (2)Országos Tisztifőorvosi Hivatal National Public Health and Medical Officer Service Office of theChief Medical Officer (OTH ANTSZ)www.antsz.huCompetent AuthorityPublic bodyCompetent authority tasks belong to the Department of HealthAdministration of the Office of the Chief Medical Officer. Five officersperform these tasks, but other tasks as well.xxxxHUnational (3)National Centre for Patients’ Rights and Documentation (NCPD)www.obdk.huCompetent AuthorityPublic bodyThe National Centre for Patients’ Rights and Documentation (NCPD) was established in November 2012. It served as central office to represent the rights of patients, children and residents in social care; it provided support in solving their problems arising during treatment. From 1st March, 2015, NCPD tasks were extended with the field of quality of health care. In 2016 NCPD will also be responsible for  the actuation of the national accreditation system.  PATIENTS‘ RIGHTS:The NCPD patient rights representatives protect the rights of patients and help them learn and apply those rights. The NCPD may also act officially in the field  of healthcare in case the rights of patients are seriously harmed affecting larger groups of patients. DOCUMENTATION:In addition to legal protection activities, the NCPD manages the medical records of the Hungarian healthcare institutions ceased without legal successor. In relation to this maintains a register, provides the right of access to medical records and preserves and archives documents.CROSS-BORDER HEALTHCARE IN THE EU:The NCPD is the Hungarian National Contact Point (NCP) for cross-border healthcare in the European Union It provides information to patients and healthcare  professionals on the possibilities of planned care  in the EU, the rights related to the care, procedures of complaints and appeals.QUALITY OF HEALTH CARE:In this field NCPD takes part in guideline-development  as a coordinating and evaluating body. Beside NCPD coordinates data collections and analyses, makes conclusions and proposals for decision-makers. NCPD manage the system of quality specialist  of health specialties and also carry out clinical audits.  The national system of health care accreditation has  just created, the NCPD is going to manage it in the field of outpatient care units, hospitals and pharmacies.xxxHUEOEO LEVELEurotransplant Internationalxx  
 
 
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IE       (Ire-land)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) IEnational (1)Health Products Regulatory Authority (HPRA)www.hpra.ieCompetent AuthorityPublic BodyThe role of Health Products Regulatory Authority (HPRA) is to protect and enhance public and animal health, by performing regulatory functions including; authorisation, registration and licensing, safety and compliance monitoring and legislative and regulatory development in theareas of human and veterinary medicines and medical devices, cosmetics, blood, tissues and cells and organs. There are four (4) departments directly involved in carrying out theHPRA’s regulatory functions; 1. Compliance; 2. Human Products Monitoring; 3. Human Products Authorisation and Registration; 4. Veterinary Sciences. And three departments providingorganisational support; 1. Finance and Corporate Affairs;  2. Human Resources; 3. IT and Change Management. The HPRA is largely self -funded by a system of fees which are approvedannually by the Minister for Health following an annual publicconsultation process. The HPRA receives some additional funding from theIrish Department of Health. The HPRA employs over 300 staff. In total there are 13 Inspectors and 4 Managers across the differentspecialities of GMP, GDP, GCP and Blood, Tissue.s and Organs (BTO). The BTO section within the Compliance department currently comprises of:1 x BTO Manager (Inspector); 1 x BTO Inspector and 1 x BTO ScientificOfficer. The BTO team is responsible for the inspection andauthorisation of procurement organisations and transplantation centresunder the requirements of the Organs Directive. They also attendEuropean Commission Competent Authority meetings, participate in workinggroups and assist in developing best practice guidance in the field asrequired. 1 x BTO vigilance officer is also based within the HumanProducts Monitoring Department.xxxxxxIEnational (2)Organ Donation and Transplant Ireland (ODTI) - Health Services Executive (HSE)www.odti.ieCompetent Authority                                                              (the office of the ODTI is set within the HSE, the national body for service planning and delivery of health services in Ireland. The HSE is named as the Competent Authority and the ODTI has been assigned the competent authority functions.)Public BodyOrgan Donation and Transplant Ireland (ODTI) was established to provide governance, integration and leadership for Organ Donation and Transplantation in Ireland. The Office is dedicated to saving andimproving lives by improving organ donation rates in Ireland. The ODTI office is responsible for: The development, coordination and management of a strategic framework for Organ Donation and Transplantation Informing the continual development of services and ensuring best use of resources. Facilitating an integrated team approach to Organ Donation and Transplantation services within Irelandxxxxxx 
 
 
 
 
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IT       (Italy)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherITnational (1)Italian National Ministry of Healthwww.salute.gov.itCompetent Authoritypublic bodyThe Italian Ministry of Health (Ministero della Salute) is the central body of the National Health Services having as its tasks the orientation and planning in matters of health, as well as the definition of objectives for the improvement of the health conditions of the population. The Ministry also establishes the level of care assured for all citizens overall the Italian territory. The MoH, through triennial national health plans, establishes the fundamental objectives of human care preservation, including: preventive care; therapy and rehabilitation; veterinary health; workplace health prevention; and, food hygiene and safety. Furthermore, the MoH plans and supports biomedical research. Ultimately, the MoH aims to ensure that healthcare is guaranteed to all citizens and issues guidelines for the organisation, delivery and funding of healthcare services.xxxxITnational (2)Italian National Transplant Centre (CNT)www.trapianti.salute.gov.itCompetent Authoritypublic bodyThe Italian National Transplant Centre (CNT) is a technical body of theMinistry of Health. It was set up under Law 91 of 1999 and it is locatedat the Italian National Institute of Health. The National Institute ofHealth (ISS) is a public technical and scientific body of the ItalianNational Health Service, under the Ministry of Health. The ISS managesand coordinates research and acts as consultant for the Ministry ofHealth, for the Government and the Regions. CNT coordinates allactivities concerning donation, allocation and transplantation oforgans. It supports the Regions in the regulation of donation, bankingand transplantation of tissues and cells by collating activity data,developing and disseminating practice guidelines, inspecting andcertifying centres and managing a national vigilance programme. It alsomanages the Transplant Information System which collects data regardingdonation, allocation and transplantation of organs, includingtransplanted organ quality, defines protocols about safety and securityof organ donation and criteria for operational protocols for organ andtissue allocation, allocation of organs for urgencies and nationalprograms. It fixes parameters for transplant quality assessment,promotes information campaigns for the general public, in collaborationwith the Italian Health Ministry and patient Associations.x(x)(x)xxxxxITregional levelx (with technical assistance from CNT = CA 2)x (with technical assistance from CNT = CA 2)xThere are 19 regions and 2 autonomous provinces. They authorizehospitals, and all authorized hospitals where there is an ICU, areentitle to perform organ and tissue procurement. Tissue procurement canalso take place in hospitals without ICU. Regions also authorizetransplant centres (after technical advice from CNT). 
 
 
 
 
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LT       (Lithu-ania)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherLTnational (1)Ministry of Health of the Republic of Lithuaniawww.sam.ltCompetent AuthorityPublic bodyIn Ministry of Health of the Republic of Lithuania work over 200peoples. EU Affairs and International Relations Division work on EUaffairs and legal matters.xxxxLTnational (2)National transplantation bureauwww.transplantacija.ltCompetent AuthorityPublic bodyDivisions of National Transplant Bureau are Transplant Coordination, Law and Supervisory, Communication. In total 26 people work in Bureau. Number of inspectors - 3. Law and Supervisory division work on  EU affairs and legal matters.xxxxxLTnational (3)State Health Care Accreditation Agency under the Ministry of Healthwww.vaspvt.gov.lt Competent AuthorityPublic bodyIn State Health Care Accreditation Agency work over 60peoples.Divisions of State Health Care Accreditation Agency areSpecialist licensing, Health care institutions supervision, Medicaltechnologies, Medical devices market surveillance, Health care qualitysurveillance, Legal and common affairs, Information technologies andFinancial.xLTnational (4)National Health Insurance Fund under the Ministry of Healthwww.vlk.ltCompetent AuthorityPublic bodyIn National Health Insurance Fund work over 130 peoples. Departments ofNational Health Insurance Fund are Internal Audit, Public Relations,Insurance Development, Economics, Legal, Orthopaedic Aids Reimbursement,Information Technology, Healthcare Services and Contracting.x x (Prepare and implement draft budget for the Compulsory LU       (Lu-xem-bourg)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherLUnational (1)Ministère de la Santéhttp://www.ms.public.lu/fr/Competent AuthorityxxxxxxxxLUnational (2)Luxembourg TransplantDelegated body xLUEOEO LEVELEurotransplantxxxx 
 
 
 
 
 
 
 
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LV       (Latvia)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherLVnational (1)The State Agency of Medicineswww.zva.gov.lvCompetent AuthorityPublic bodyThe State Agency of Medicines is the state institution under supervision of the Ministry of Health of the Republic of Latvia, that carries out(cid:13)  evaluation, marketing authorisation, monitoring, control and regulation of distribution of medicines and medical devices in Latvia. It is a(cid:13) state agency not financed from the state budget (agency's budget is formed from service fees). There are 13 departments and 144(cid:13) employees (www.zva.gov.lv). 2 senior inspectors for blood, tissues, cells, and organs, including vigilance in the Agency. Legal(cid:13) department consists of 4 employees. EU matters - no dedicated staff.xxxxxxxxLVnational (2)Data State Inspectoratewww.dvi.gov.lvCompetent AuthorityPublic bodyData State Inspectorate is the state institution under supervision of the Ministry of Justice of the Republic of Latvia, that supervises the compliance of personal data protection, accredits and supervises the trusted certification service providers, supervises the compliance with the provisions of unsolicited commercial messagesin Latvia. It is a direct administration institution. There are 4departments and 19 employees.xLVnational (3)Paul Stradin's University hospital Latvian Transplantation centerwww.stradini.lvDelegated BodyCabinet of Ministers Regulation of 29 January 2013 No 70 (minutes No 6, par. 15) regarding the use of human organs in medicine and the use of human organs and the body of a deceased person for medical studies, para 80, 80 1, 82, 82 1, 82 2 , 82 3, 82 4, 82 5.State owned limited liability company Multiprofile hospital department for organ procurement and transplantationMultiprofile hospital department for organ procurement andtransplantationxxMT       (Malta)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherMTnational (1)Superintendence of Public Health https://ehealth.gov.mt/HealthPortal/public_health/healthcare_serv_standards/tissues_cells_organs.aspxCompetent Authoritypar. 15) regarding the use of human organs in medicine and the use ofPublic bodyThe National Competent Authority is the Superintendent of Public Health. The Superintendence has three directorates under its remit- (cid:13)1.The Health Care Standards Directorate which is accountable to the Superintendent of Public Health in managing issues related to the regulation of substances of Human Origin. There is one person responsible for this area, the Director is responsible for regulatory matters related to SOHO, inspections, authorisations, related EU and legal matters and SOHO vigilance. There are two inspectors trained in Substances of Human origin and a separate multidisciplinary inspectorate responsible for the inspection of health care settings including hospital(cid:13)(cid:13)2. The Health Promotion/Disease Prevention Directorate(cid:13)(cid:13)3. The Environmental Health Directorate.(cid:13)(cid:13)The Medicines Authority also falls under the Superintendence from the technical point of view (cid:13)(cid:13)xxxxxxxMTnational (2)Transplant Coordination Unit, Mater Dei Hospitalhttps://ehealth.gov.mt/HealthPortal/health_institutions/hospital_services/mater_dei_hospitDelegated BodyDelegated by the Competent Authority (the Superintendent of PublicPublic BodyMater Dei Hospital is the National Transplant centre and is the only hospital where transplants are allowed.xx (others) 
 
 
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NL       (The Nether-lands)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherNLnational (1)Ministry of Health, Welfare and Sporthttp://www.rijksoverheid.nl/ministeries/vwsCompetent AuthorityThe ministry of health, welfare and sport is a department of the government.The ministry of health, welfare and sport (VWS) is one of the departments of the government. Pharmaceuticals and Medical Technology Department (GMT) is the division in which the team, that is dealing with organ donation and transplantations, operates. (cid:13)(cid:13)(cid:13)(cid:13)(cid:13)(cid:13)xxxNLnational (2)Dutch Transplantation Foundation (NTS)http://www.transplantatiestichting.nl/Delegated BodyMinistry of Health, Welfare and SportThe Dutch Transplantation Foundation is independent governing body underprivate law. The ministry of health, welfare and sport authorised NTS asorgan center.The NTS contains three departements, namely 1) Policy and Organ center,2) Donor- communication, 3) Operational management. NTS is financed partlyby health insurance companies and partly by subsidies from the ministryof health, welfare and sport. At this moment NTS has 60 employees. Thedepartment Policy and Organ center and the policymaker legal affairs aredealing with Europe-related issues. NTS does not have any vigilanceofficers since this responsibilty relies on the Health Care Inspectorate(IGZ).xxxxxxNLnational (3)The Health Care Inspectorate (IGZ)http://www.igz.nl/Competent AuthorityPublic bodyIndependent departements: Cure, care, pharmaceutical products (includingorgans, tissues, cells, and blood);Budget: total € 60 million;Staffing: total 500, 300 dedicated; SoHO: international/Europeaninspection and vigilance: 2 senior, 1 junior, 1 support, 1 legal.xNLEOEO LEVELEurotransplantxxxxNO       (Nor-way)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherNOnational (1)The Norwegian Directorate for Healthwww.helsedirektoratet.noCompetent AuthorityxxxxxNO national (2)Ministry of Health and Care Serviceswww.hod.noCompetent AuthorityxxNOnational (3)Norwegian Board of Health Supervisionwww.helsetilsynet.noCompetent AuthorityxxNOnational (4)Oslo University Hospital Rikshospitaletwww.ous.noDelegated bodyxx 
 
 
 
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NOEOEO LevelScandiatransplantwww.scandiatransplant.orgxPL       (Po-land)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherPLnational (1)Polish Transplant Coordinating Center Poltransplantwww.poltransplant.org.plCompetent AuthorityGovernment AgencyxxxxxxxPLnational (2)Ministry of Health, Department of Health Policywww.mz.gov.plCompetent Authoritypublic bodyxxxxx (legislation and country regula-tions)PT      (Por-tugal)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherPTnational (1)Instituto Português do Sangue e da Transplantação (IPST)www.ipst.ptCompetent AuthorityxxxxxxPTnational (2)Direção-Geral da Saúde (DGS)www.dgs.ptCompetent AuthorityxxxxxRO     (Ro-mania)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherROnational (1)National Transplant Agencywww.transplant.roCompetent AuthorityNOPublic BodyNTA has four regional offices, three administrative departments and the executive board is composed of one executive director, one deputy director and one chief accountant.(cid:13)We have 6 inspectors and 1 person working on EU affairs and legal matters. The budget is about 551.000 RON per year.  xxxx xxxROnational (2)Ministry of Health - The State Sanitary Inspectionwww.ms.roCompetent AuthorityNOPublic bodyInspection and control.xxx 
 
 
 
 
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SE      (Swe-den)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherSEnational (1)Socialstyrelsenwww.socialstyrelsen.seCompetent AuthorityxxxxSEnational (2)Inspektionen för vård och omsorg (Health and Social Care www.ivo.seCompetent AuthorityxxxxSEregional levelTransplantationscentrum, Sahlgrenska universitetssjukhusetwww.transplantationscentrum.se/sv/SU/Omraden/5/Verksamheter/TransplantationscentruDelegated BodyPublic BodyxxxxSEregional levelTransplantationsenheten, Skånes Universitetssjukhus,www.skane.se/sv/Webbplatser/Sodra-regionvardsnaDelegated BodyPublic BodyxxxxSEregional levelTransplantationskirurgiska kliniken , Karolinska Universitetssjukhusetwww.karolinska.se/Verksamheternas/Kliniker--enheter/Transplantationskirurgiska-kliniken/Delegated BodyPublic BodyxxxxSEregional levelTransplantationskirurgi, Akademiska sjukhusetwww.akademiska.se/sv/Verksamheter/Kirurgi/Om-verksamheten1/Sektionen-for-transplantDelegated BodyPublic BodyxxxxSEEOEO  LEVELScandiatransplant(x)  For the sake of consistency with the other Scandiatransplant 'countries', Sweden can be considered as a member of Scandiatransplant (however Swedish CAs would like to stress that it's the four swedish transplant centres that are members, not Sweden as a country).They are obliged to follow the legal acts presented by Socialstyrelsenand they receive their authorisation from Inspektionen för vård ochomsorg by registration. 
 
 
 
 
 
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SI      (Slo-venia)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherSInational (1)Slovenija-transplantwww.slovenija-transplant.siCompetent Authoritypublic bodySlovenija-transplant consists of the following departments: organ, tissue and cells department, informatics and data collection, finance and human resources department, general office. Currently there are 7 full employees and many subcontracts with specialists in the filed of organ and tissue procurement and transplantation.xxxxxxx (others: "keep out in and out regis-ters, coordinate interdisciplinary issues, QAP programme for brain death detection and promotion").SInational (2)Ministry of Healthhttp://www.mz.gov.si/en/Competent AuthorityxxSIEOEO levelEurotransplant International FoundationxxxxxSK     (Slo-vakia)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherSKnational (1)Ministry of Health Slovak Republicwww.health.gov.skCompetent Authoritypublic bodyxxxxxThe tasks which are not marked are shared with NTOSKnational (2)National Transplant Organisationwww.nto.skDelegated BodyMinistry of Health Slovak Republicpublic body, non-profit organisationxxxxThe tasks which are not marked are shared with Ministry of Health 
 
 
 
 
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UK     (Uni-ted King-dom)Level (national, regional, EOEO) to implement tasks listed in Article 17NameWebsiteIs this institution a competent authority or a delegated body?If delegated body, from which competent authority is/are task(s) delegated? Legal statusShort description of this competent authority Task a (framework for quality and safety)Task b (control and audit) Task c (authorisations) Task d (serious adverse events and reactions)Task e (issue guidance) Task f (network of competent authorities) Task g (organ exchange with other countries)Task h (personal data protection) otherUKnational (1)Human Tissue Authority (HTA)www.hta.gov.ukCompetent Authorityn/aGovernment The HTA regulates;(cid:13) the use of tissues, bodies and body parts under the Human tissue Act 2004 across the post mortem, research, anatomy and public display sectors. (cid:13)Tissues and cells for human application under the EUTCD 2007(cid:13)Organ donation and transplantation under the EUODD 2010xxxxxxx (others: The HTA approve all living donor transplants)UKnational (2)National Health Service Blood and Transplant (NHSBT)www.NHSBT.nhs.ukDelegated BodyThere is a service level agreement with the HTA, which details thedelegation of managing: a reporting system for serious adverse eventsand serious adverse reactions; managing a living donation framework;transfer or organs across member states; ensuring traceability recordsand reporting to the HTA.GovernmentNHS Blood and Transplant (NHSBT) was established as a Special HealthAuthority in England and Wales in October 2005 with responsibilitiesacross the United Kingdom in relation to organ transplantation. Itsremit is to provide a reliable, efficient supply of blood, organs andassociated services to the NHS. Since NHSBT was established, the organisation has maintained or improvedthe quality of the services delivered to patients, stabilised the risingcost of blood, and centralised a number of corporate services. AmongNHSBTs responsibilities are:• encouraging people to donate organs, blood and tissues;• optimising the safety and supply of blood, organs and tissues;• helping to raise the quality, effectiveness and clinical outcomes ofblood and transplant services;• providing expert advice to other NHS organisations, the Department ofHealth, Ministers and devolved administrations;• providing appropriate advice and support to health services in othercountries;• commissioning and conducting research and development;• actively engaging in implementing relevant EU statutory frameworks andguidance;•being involved in broader international developmentsxxxx