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  COM(2016) 809 final   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 {SWD(2016) 451 final}  
 
 
1.  Introduction 

Article  22  of  Directive  2010/53/EU1  requires  Member  States  to  report  to  the  European 
Commission, before 27 August 2013 and every three years thereafter, on the activities carried 
out  in  relation  to  the  provisions  of  the  Directive.  The  Commission  is  required  to  transmit  a 
report  on  the  implementation  of  this  Directive  to  the  European  Parliament,  the  Council,  the 
European Economic and Social Committee and the Committee of the Regions.  

In  2013,  several  Member  States  were  still  in  process  of  implementation;  hence  the 
Commission  sent  questionnaires  to  Member  States  in  2014  (implementation  survey).  This 
Report  draws  from  the  replies  to  this  implementation  survey,  which  was  answered  by  29 
countries, all Member States and Norway. The analysis of these countries' replies to the 2014 
implementation survey is included in the Staff Working Document accompanying this Report. 
Where  appropriate,  data  gathered  through  other  channels  were  also  taken  into  account  (e.g. 
exchanges with the national organ competent authorities during the bi-annual meetings with 
the Commission, Council of Europe annual Transplant Newsletters2, Eurobarometer surveys3 
and outputs of EU-funded projects). 

This  implementation  report  focuses  on  the  institutional  set-up  in  Member  States,  and  in 
particular  on  the  identification  of  the  authorities  in  charge  of  the  different  tasks  listed  in 
Article  17  of  Directive  2010/53/EU.  The  Annex  to  the  Staff  Working  Document 
accompanying this Report sets out all authorities and their tasks.  

This  report  also  makes  some  references  to  the  Action  Plan  on  Organ  Donation  and 
Transplantation4, which complements Directive 2010/53/EU in improving quality and safety, 
and also focused on increasing organ availability and enhancing efficiency and accessibility 
of transplantation systems. 

2.  Transposition of Directive 2010/53/EU  

Pursuant to Article 32 Directive 2010/53/EU, the deadline for its transposition elapsed on 27 
August  2012.  The  verification  of  the  adequate  transposition  of  Directive  2010/53/EU  (also 
referred to as EU organ legislation in this document) into national legislation is ongoing.  

3.  Implementation of Directive 2010/53/EU 

Overall, from what appears in this first survey, the implementation of the EU organ legislation 
by Member States is considered adequate. The legislation has resulted in the establishment of 
competent  authorities  that  oversee  the  activities  from  donation  to  transplantation  in  each 
country.  The  authorities  apply  a  framework  for  quality  and  safety  including  authorisation, 
inspection  and  vigilance.  However,  some  difficulties  in  interpretation,  implementation  and 
enforcement of the legislation were also identified.  

1    Directive in the Official Journal: http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32010L0053  
   Corrigendum to the Directive: http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32010L0053R(01)  
2    https://www.edqm.eu/en/organ-transplantation-reports-73.html  
     http://www.ont.es/publicaciones/Paginas/Publicaciones.aspx  
3  2002-3 Eurobarometer: http://ec.europa.eu/health/ph_threats/human_substance/documents/ebs_183.5_fr.pdf 
2006-7 Eurobarometer: http://ec.europa.eu/health/ph_threats/human_substance/documents/ebs272d_en.pdf  
2009-10 Eurobarometer: http://ec.europa.eu/public_opinion/archives/ebs/ebs_333a_en.pdf  

4   Action Plan on Organ Donation and Transplantation (2009-2015): strengthened cooperation between Member 
States,  COM(2008) 819/3 

2 

 
 
 
 
                                                            
 
It  is  important  to  underline  that  the  legislation  in  question  does  not  provide  a  basis  for  full 
harmonisation and accordingly many differences exist in the national approaches. Whilst this 
is fully legitimate, in some cases it may limit comparability of national transplant systems and 
mutual  acceptance  of  authorisations  and  inspections,  with  consequences  for  potential  cross-
border movement of organs. 

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

Article 17 of Directive 2010/53/EU foresees that Member States shall designate one or more 
competent authorities (or delegated bodies) to take a series of measures:  
(a)  establishing and keeping updated a framework for quality and safety,  
(b) ensuring  the  regular  control  or  audit  of  procurement  organisations  and  transplantation 

centres,  

(c)  grant,  suspend  or  withdraw 

the  authorisations  of  procurement  organisations  or 

transplantation centres, 

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

reactions, 

(e)  issue  appropriate  guidance  to  healthcare  establishments,  professionals  and  other  parties 

involved in all stages of the chain from donation to transplantation or disposal,  

(f)  participate in the network of competent authorities and coordinate at national level input 

to the activities of that network,  

(g) supervise organ exchange with other Member States and with third countries,  
(h) ensure  that  the  fundamental  right  to  protection  of  personal  data  is  fully  and  effectively 

protected in all organ transplantation activities. 

All Member States have appointed competent authorities at national level to ensure oversight. 
Competent authorities can also be appointed at infra-national level (regional or local) or at the 
supra-national  level  (European  Organ  Exchange  Organisations,  EOEOs).  Fourteen  countries 
only have authorities at national level (BG, CY, CZ, EE, EL, IE, LT, LV, MT, PL, PT, RO, 
SK, UK), while others also report to have authorities at regional level and/or supra-national 
level.  The  total  number  of  competent  authorities  at  national  level  is  68  (an  average  of  2.3 
authorities declared per country). This includes 21 delegated bodies.  

Ministries of Health often play a key role in the implementation of Directive 2010/53/EU. In 
five countries, delegated bodies include hospitals. Eurotransplant and Scandiatransplant, two 
EOEOs, were reported by respectively eight and four countries as delegated bodies.  

Key tasks under Article 17 of Directive 2010/53/EU which are typically performed at national 
level include (a) framework for quality and safety, (d) SARE (Serious Adverse Reaction and 
Events)/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. 

Authorities at regional level can be administrative entities which have decentralised powers 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 

3 

 
 
 
 
 
most common tasks are (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).  

Two EOEOs exist at the European level which were intrusted with a task pursuant to Article 
17 of Directive 2010/53/EU. The EOEOs are Eurotransplant (AT, BE, DE, HR, HU, LU, NL 
and  SI),  and  Scandiatransplant  (DK,  FI,  NO,  SE)5.  Also  the  South  Alliance  for 
Transplantation  (SAT)  is  an  EOEO  created  in  2012.  SAT  is  however  not  reported  to  be 
directly involved in the tasks of Article 17. 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 
(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.  It  is  important  to  note  that  some  countries 
concluded  bilateral  agreements  (for  exchanging  organs  or  transplant  patients)  with  other 
countries or partners (healthcare establishments): CY with AT (for lungs), MT with IT. Three 
countries  (CY,  IE  and  LV)  report  exchanging  organs  with  or  sending/receiving  patients 
to/from other countries on a bilateral case-by-case basis outside any agreement.  

To  conclude,  three  types  of  organisational  “models”  can  be  defined:  i)  countries  operating 
with authorities only at national level (14 countries), ii) countries operating with authorities at 
national  and  regional  levels  (3  countries)  and  iii)  countries  operating  with  EOEOs  (12 
countries). In all three settings, multiple authorities and bodies can be involved to implement 
the tasks, in line with size, healthcare organisation and capacities of each country concerned. 

Member States with a unique authority or a limited number of bodies and levels allow 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.  

Wherever different oversight activities (authorisation, inspection, vigilance) are undertaken by 
different authorities, communication and coordination needs to be ensured. A well-informed 
and  strong  national  coordinating  contact  point  is  therefore  essential,  in  particular  where 
competent  authority  responsibilities  are  shared  among  multiple  organisations  and  levels. 
Irrespective  of  the  organisational  set-up,  it  is  important  that  authorities  have  appropriate 
resources  at  their  disposal  to  carry  out  the  required  duties,  as  well  as  to  ensure  their 
independence from economic operators in the sector and from other undue influences. 

3.2.Organ donation and procurement 

To ensure quality and safety in the donation, procurement organisations play a key role.  

3.2.1. Authorisation of procurement organisations 

Articles 5, 6 and 17 of Directive 2010/53/EU require that procurement organisations are duly 
authorised and have at their disposal adequate personnel, material and equipment.In view of 
the wide concepts of "procurement organisation" and "authorisation" provided for in Article 3 

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

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of Directive 2010/53/EU, a wide range of entities can fulfil the requirements. Authorisations 
for procurement organisations are granted at the level of the healthcare establishment in the 
majority of countries (27/29). 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).   

All countries reported having an authorising scheme in place for procurement organisations, 
and 26 reported that all the existing procurement organisations had effectively been granted 
an  authorisation.  Three  Member  States  are  still  in  the  process  of  granting  authorisations. 
Additionally, some Member States combine authorisations for procurement organisations and 
transplantation centres. 

In 11 EU Member States (DK, EL, ES, FR, HR, IT, LT, MT, PL, RO, SI), authorisations of 
procurement  organisations  are  limited  in  time:  for  fixed  periods,  ranging  from  two  to  five 
years, in eight countries or for variable periods in three other (for details see Figure 7 in the 
Staff Working Document). Where durations of authorisations are variable, validity terms are 
set according to different criteria. Often, the scheme for renewal of authorisation requires that 
the  criteria  applied  to  grant  the  initial  authorisation  are  met  again.  A  few  countries  report 
having  withdrawn  authorisations,  usually  temporarily,  because  the  initial  conditions  for 
granting  the  authorisation  were  no  longer  fulfilled  (e.g.  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  from  partner  countries  come  over, 
within  established  cooperations,  to  procure  organs  usually  to  be  transplanted  in  this  partner 
country.  This  avoids  loss  of  organs  (from  existing  donors)  that  would  otherwise  not  be 
procured.  For  example,  a  heart  or  lung  procurement  team  might  go  over  to  a  country  with 
only renal or hepatic transplant programmes where hearts or lungs would not be transplanted.  

26 Member States reported that procurement teams come from abroad on a regular or on an 
ad- hoc basis. In  21 of them, such  activities are performed  within the framework of a fixed 
collaboration,  most  frequently  with  or  within  Eurotransplant  or  Scandiatransplant.  Five 
Member  States  also  report  to  receive  procurement  teams  outside  fixed collaborations,  while 
several countries have (also6) bilateral collaborations with other, often neighbouring countries 
(e.g. FI and EE, LU and FR, MT and IT, PT and ES, SK and CZ, CY and IT or UK).  

3.2.3. Ensuring procurement organisations' compliance with the Directive  
To  secure  a  framework  for  the  quality  and  safety  of  procurement  activities,  Member  States 
must  establish  oversight,  using  several  means,  often  combined:  mainly  by  control,  audit  or 
inspection of procurement centres (conducting on-site inspections) or by desk-based analysis 
of the mandatory documentation.  

22  countries  reported  on-site  controls,  audits  or  inspections  of  procurement  centres.  Desk-
based analysis of the mandatory documentation is also a frequently used in 20 Member States. 
16  countries  report  to  use  both  control/audit  of  procurement  organisations  and  desk-based 
analysis.  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.  

6 One country can be involved in different types of collaborations. 

5 

 
 
 
                                                            
Among  the  22  countries  implementing  inspections,  12  have  defined  inspection  schemes  at 
national level. The frequency ranges from every year to every three or five years, with a two-
year  interval  being  most  common  (occurring  in  seven  countries).  In  some  Member  States, 
schemes  for inspections of procurement organisations are set at regional level and therefore 
vary between regions (Germany, Italy, Spain). Three countries reported risk-based inspection 
schemes (Denmark, Estonia, Finland), which is also used in other sectors,  such as the blood 
and  tissues  and  cells  sector.  Rules  for  inspection  and  control  have  not  been  fixed  so  far  in 
three countries (Belgium, Portugal, Norway).  

3.2.4. Personnel involved in the procurement 
Different approaches are used to assess the competency of healthcare personnel: verifying the 
qualifications  at  the  moment  of  recruitment  (23  countries),  completion  of  regular  training 
programmes  (24  countries)  or  additional  certification  (11  countries).  All  Member  States 
reported at least one of these three measures. Most Member States combine different methods, 
which may be a comprehensive way to meet this requirement. 

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 concerned.  

Training  can  be  provided  at  the  international  level  through  congresses  organised  by 
professional societies or sessions organised by EU-funded projects (for example ETPOD, the 
European  Training  Program  on  Organ  Donation  or  the  pilot  project  on  training  and  social 
awareness, see also section 3.5.). Continuous training programmes are also offered at national, 
regional  and  even  local  (hospital)  level.  Few  Member  States  offer  training  at  all  levels. 
Training is provided by specialised bodies including  foundations,  healthcare establishments, 
professional associations and societies.  

3.2.5. Consent system for organ donation 

Three Eurobarometers7 carried out at EU level since 2002 reveal that EU citizens are largely 
supportive of organ donation, independently of the consent system in their country. 

Two  main  consent  systems  exist  in  Europe:  an  “opt-in”  system  under  which  donors  are 
required to explicitly  give  their consent for organ donation,  and  an “opt-out” system, where 
consent is presumed unless a declaration to the contrary is made before death. Regardless of 
the consent system applied in the country, it is standard practice to approach family members 
of the deceased prior to any procurement decision.  

Figure  3  presents  national  consent  systems  as  reported  (note  that  consent  systems  are  not 
subject to Directive 2010/53/EU). Sixteen Member States 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 (e.g., where different regions have different 
systems).  

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. This allows for a complementary source of organs. However, removing an organ 
from a healthy person is an invasive measure and can have medical, psychological, social and 

7 See footnote 5 page 1, last Eurobarometer: http://ec.europa.eu/public_opinion/archives/ebs/ebs_333a_en.pdf 

6 

 
 
 
                                                            
economic  consequences.  Hence,  living  donors  must  be  carefully  screened,  selected  and 
followed up, as laid down in Article 15 of the Directive.  

Most  countries  have  introduced  registers  or  records  for  living  donors  (23/29).  17  countries 
reported having already initiated a register before the adoption of the Directive, while others 
have launched such records in 2014 or 2015. In most of these Member States, 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).  A  few  Member  States  specified  that  a  record  is  locally  kept  by  each 
transplantation centre. Significant differences are noted between Member States in the content 
and type of data captured in the register. Six countries reported not to have a register in place, 
but three of them plan to establish one soon (Croatia, Portugal, Slovenia). 

Over the last years, the European Commission co-financed several projects (see section 3.5.) 
to support Member States in these efforts. The ACCORD guidelines and standards for the set-
up  and  implementation  of  such  registers  are  considered  to  be  a  benchmark,  and  the 
development  of  a  model  for  a  (European)  Register  of  (national/local)  Registries,  aimed  at 
collecting  living  donor  follow-up  data  in  an  international  database,  was  tested.  A  recent 
Council of Europe Resolution explicitly mentions ACCORD deliverables as a key reference8, 
confirming and expanding the recognition of their value also to non-EU countries.  

The majority of countries (27/29) provide a follow-up to living donors after donation. Some 
countries have set fixed periods for conducting medical follow-ups, which occur on a regular 
basis varying from a week after donation and two weeks after donation, to monthly or yearly 
medical  evaluations.  16  countries  provide  lifelong  medical  attention,  while  seven  have 
defined  fixed  terms  for  their  follow-up,  ranging  from  one  year  to  thirty  years.  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. The medical treatment provided is assessed and blood pressure or blood 
status are considered in 26 countries. Psychological aspects are considered in 21 countries.  

Overall,  the  follow-up  of  living  donors  and  the  development  of  registers  to  document  this 
follow-up are important aspects in the implementation of the organ legislation and still areas 
where Member States need to make progress. The Commission intends to continue to support 
Member States. 

3.2.7. The follow-up of transplanted patients  
While the follow-up of living donors is a requirement of Directive 2010/53/EU, the follow-up 
of transplanted patients is left to Member States’ decisions9 10. To support Member States, the 

data 

sharing and 

international 

its  Explanatory  Memorandum 

8  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  
9 Recital 24 of the Directive recognises that the competent authorities should have a key role to play also in this 
matter:  “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  and  in  evaluating  their  quality  and  safety 
throughout  patients’  recovery  and  during  the  subsequent  follow-up.  For  that  purpose,  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  quality  and  safety  of  organs  intended  for  transplantation.  Sharing  such 

-  See  more 

7 

 
 
 
                                                            
European Commission co-funded the EFRETOS project which aimed at establishing common 
definitions for the evaluation of the results of transplantation, and at promoting a model for a 
registry  of  registries  with  follow-up  data.  In  addition,  registers  developed  and  held  by 
transplant professionals and societies - such as ERA-EDTA11 for kidneys or ELTR12 for livers 
- play a key role. Several competent authorities do already collaborate with these professional 
associations and the European Commission encourages such cooperation by inviting them to 
meetings with authorities.  

3.3. Authorisation of transplantation centres and personnel 

The results of the survey regarding transplantation activities are very similar to the results on 
organ donation and procurement (section 3.2.). Also here, the Directive 2010/53/EU provides 
for a broad definition of transplantation centres (different levels possible) and the definition of 
“authorisation” encapsulates different concepts. Authorisations for transplantation centres are 
granted  at  the  level  of  the  healthcare  establishment  in  the  majority  of  Member  States  and 
Norway (26/29). 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).  

All  Member  States  mentioned  to  have  authorisation  schemes  in  place  for  transplantation 
centres  (in  six  Member  States  the  regional  level  in  charge  of  authorising),  and  25  countries 
confirmed that all transplant centres had effectively been authorised, while four countries are 
still  granting  (or  renewing)  authorisations  to  (some  of)  their  centres  (delays  relate  to  late 
transposition  of  the  Directive  2010/53/EU,  to  adoption  of  secondary  legislation  and/or  to 
practical implementation issues). 

14 Member States and Norway reported non time-limited authorisations. The other countries 
authorise for fixed (one, two, three, four or five years) or variable periods.  

In most countries (27/29), compliance with the Directive 2010/53/EU is verified through on-
site controls, audits or inspections of the transplantation centres. Many Member States (19/28) 
perform desk-based analysis of mandatory documentation. More than half use both methods 
(17/29).  

23 countries ensure qualification of staff by verifying this at the time of recruitment. Regular 
training  programmes  are  foreseen  in  24  countries.  Several  countries  also  report  to  rely  on 
trainings organised by professional societies or organisations for example via the Section of 
Surgery  and  the  European  Board  of  Surgery  of  the  European  Union  of  Medical  Specialists 
operating in close collaboration with the European Society of Organ Transplantation.  

3.4. Framework for quality and safety 

information between Member States would facilitate further improvement of donation and transplantation across 
the Union.” 
10  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.” 
11 Register of the European Renal Association - European Dialysis and Transplant Association: 
http://www.era-edta.org/ 
12 European Liver Transplant Registry: http://www.eltr.org/ 

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While  the  authorisation  and  inspection  of  procurement  organisations  and  transplantation 
centres are important oversight elements, other measures also contribute to quality and safety 
of donation and transplantation activities. For example the adoption of operating procedures 
for different actions (listed in the Directive) contributes to a framework for quality and safety 
from donation to transplantation or disposal. 

All 29 countries reported having implemented operating procedures to verify the completion 
of the organ and donor characterisation Article 4 2. (c) (in accordance with Article 7 of the 
Directive  2010/53/EU).  However,  three  countries  reported  not  to  have  any  operating 
procedures in place at present for the other areas in Article 4 (2), such as the verification of 
donor identify, verification of consent or ensuring traceability.  

Countries  seem  to  be  at  different  stages  in  the  adoption  and  implementation  of  operating 
procedures. Some have completed the process and a framework for quality and safety is fully 
in  place,  while  others  have  partially  adopted  a  framework  and  the  adoption  process  and/or 
implementation for the remaining operating procedures is ongoing. Some countries declared 
having  operating  procedures  in  place  but  also  mentioned  that  these  might  vary  between 
hospitals  or  regions.  Only  a  few  countries  seem  to  have  national  operating  procedures  in 
place.  Also  in  this  area,  the  European  Commission  supports  Member  States  via  EU-funded 
projects and by sharing documents made available. 

In conclusion, operating procedures seem to be in place and implemented for most donation 
and transplantation activities in Member States, however there is still room for improvement 
and for learning from each other’s experiences in this area. 

3.5.  EU  support  for  the  implementation  of  the  EU  Organs  Directive  and  of  the  “EU 
Action Plan on Organ Donation and Transplantation (2009-2015)” 

The European Commission has been supporting the national implementation of the legislation 
by  a  variety  of  means  ranging  from  regular  expert  meetings  to  EU-funded  projects.  The 
meetings of the expert sub-group on organ donation and transplantation (which is part of the 
Competent  Authorities  on  Substances  of  Human  Origin  Expert  Group  -  CASoHO  E01718) 
allow for sharing of best practices and discussing common problems. 

Since 2008, a number of projects have been funded under the multi-annual programmes  for 
Union action in the field of health, providing support to Member States when implementing 
requirements of Directive 2010/53/EU and of the EU Action Plan, with a particular focus on:  

 

training  of  transplant  donor  coordinators  with  the  European  Training  Programme  on 
Organ Donation (ETPOD)13 or with the “train the trainers” dedicated course14;  
improving quality systems with ODEQUS15;  

 
  developing living donation with EULID, ELIPSY, EULOD, ACCORD16 or the Toolbox17 

prepared within the Living donation Working group;  

  supporting the follow-up of transplanted patients with EFRETOS18;  

13 ETPOD: http://etpod.il3.ub.edu/    See also: http://ec.europa.eu/chafea/projects/database.html?prjno=2005205 
14 European Training Course in Transplant Donor Coordination in the European Union 
15 European Quality System Indicators and Methodology on Organ Donation (ODEQUS): 
http://ec.europa.eu/chafea/projects/database.html?prjno=20091108 
16 http://www.accord-ja.eu/ 
17 http://ec.europa.eu/health/blood_tissues_organs/docs/eutoolbox_living_kidney_donation_en.pdf 
18 European Framework for the Evaluation of Organ Transplants: http://www.efretos.org/ 

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 
 

 

facilitating cross-border organ exchange with COORENOR, MODE and FOEDUS; 
improving  awareness-raising  with  EDD,  FOEDUS  and  the  Commission’s  Journalist 
Workshops19;  
investigating  organ  trafficking  with  HOTT20  (Combatting  trafficking  in  persons  for  the 
purpose of organ removal);  

  supporting non EU countries with dedicated workshops and a direct grant to the Council 

of Europe; 
increasing deceased donation rates thanks to dedicated strategies; 

 
  addressing specific national issues with twinning activities within ACCORD,  
  as well as mapping efforts under the EU Action Plan via the ACTOR21 (mid-term review) 

and FACTOR studies (final review).  

Two projects22 will also start by the end of 2016 to further support Member States in the field. 

4. Conclusion 

Overall, national authorities and oversight mechanisms seem to be established in all Member 
States and Norway to ensure safety and quality standards of human organs. However, in line 
with  the  quite  general  legal  requirements  in  EU  legislation,  the  set-up  of  the  national 
organisations can be fragmented and vary significantly between countries, which increases the 
importance of a good coordination within and between countries.  

Some work might still be needed to  improve MS follow-up, both of recipients and of living 
donors,  and  on  some  aspects  of  the  framework  for  quality  and  safety,  for  example  for 
operating  procedures  or  for  authorisations.  Some  of  this  work  is  already  being  developed 
through Commission funded work. Future implementation surveys and reports will be able to 
demonstrate Member States' progress. 

19 http://ec.europa.eu/health/blood_tissues_organs/events/journalist_workshops_organ_en.htm 
20 http://hottproject.com/ 
21 http://ec.europa.eu/health/blood_tissues_organs/docs/organs_actor_study_2013_en.pdf 
22 See two Financing decisions and annexes adopted on 10 July 2015 : 
http://ec.europa.eu/health/blood_tissues_organs/key_documents/index_en.htm#anchor3 

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