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: 2022-11-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, application of EU law, coronavirus disease, cross-border cooperation, epidemic, organ transplantation, public health, quality standard, safety standard, substance of human origin

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 30.11.2022  COM(2022) 671 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(2022) 376 final}  
 
 
Disclaimer: The information contained in this report is based on Member States’ individual reports. 

Neither the European Commission nor any person acting on its behalf is responsible for the content of 
that information and of any use made of it. 

1.  Introduction1 

This report provides a summary on the implementation of Directive 2010/53/EU2 on standards of 
quality and safety of human organs intended for transplantation  (hereinafter referred to  as  "the 
Directive") by Member States.  

The Directive provides that every three years Member States must report to the Commission on 
the activities undertaken  and, on the experience, gained in  implementing  the Directive (Article 
22(1)),  and  that  the  Commission  must  publish  a  report  on  the  implementation  of  the  Directive 
(Article 22(2)). A first report covered the period 2010-20143.  

This  report covers the period  2015-2021. The extended reporting period takes into account  the 
impact of the COVID-19 pandemic for the organ donation and transplantation sector. It is based 
on  answers  from  the  competent  authorities  for  Organ  Donation  and  Transplantation  from  24 
Member  States4,  gathered  via  a  structured  questionnaire  in  EUSURVEY  (during  the  period 
February-April 2022). The report focuses on the changes within the Member States’ competent 
authorities  since  2015,  the  established  donor  and  recipient  registries,  biovigilance  procedures, 
and responses to the COVID-19 pandemic. The replies from the United Kingdom in respect of 
Northern Ireland5 are summarised in separate paragraphs6.  

As further detailed in this report, the analysis of the replies from the Member States shows that 
overall,  they  did  not  experience  difficulties  with  the  implementation  of  the  Directive,  and  the 
current  legal  framework  ensures  a  high  level  of  safety  and  quality  in  the  organ  donation  and 
transplantation  field.  However,  the  COVID-19  pandemic  created  new  challenges  and  Member 
States  reacted  quickly  to  ensure  safety  of  transplantations,  by  following  updated  protocols  at 
national level as well as the guidance provided by the European Centre for Disease Prevention 
and Control (ECDC).  

1  For  more  information  about  EU  actions  in  the  field  of  organ  donation  and  transplantation,  please  refer  to  the 
Commission dedicated webpage https://health.ec.europa.eu/blood-tissues-cells-and-organs/organs_en. 
2 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 (OJ L 207, 6.8.2010, p. 14). 
3 https://ec.europa.eu/health/document/download/c851f24e-ea0b-4fbc-b55b-
d4fc58ec61ca_en?filename=com_2016_809_en.pdf  
4 For SK, the replies were provided by the delegated body. LU, MT and RO had not replied to the questionnaire.  
5 In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland 
from  the  European  Union  and  the  European  Atomic  Energy  Community,  and  in  particular  Article  5(4)  of  the 
Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of Directive 
2010/53/EU, references to Member States include the United Kingdom in respect of Northern Ireland. 
6  Joint  reply  from  Human  Tissue  Authority  (HTA)  and  National  Health  Service  Blood  and  Transplant  (NHSBT), 
applicable to Northern Ireland for 2015-2021. 

1 

 
 
 
                                                           
2.  Designation and Obligations of the Competent Authorities 7 

Article 17 of the Directive provides that Member States shall designate one or more competent 
authorities (or delegated bodies) to take a series of measures, including keeping a framework for 
quality  and  safety  up  to  date,  authorising  and  controlling  procurement  organisations  and 
transplantation  centres,  issuing  guidance,  and  supervising  organ  exchange  with  other  Member 
States and with third countries.  

a.   Changes in competent authorities since 2015 

Since  the  last  report  on  the  implementation  of  the  Directive,  three  Member  States  have 
experienced changes to their competent authorities for Organs, with the establishment of a new 
authority  taking  over  that  role  (DK,  EE),  or  a  change  in  the  organisational  structure  of  the 
competent  authority  (BG).  In  addition,  two  Member  States  reported  the  adoption  or  entry  into 
force of a new national law for Organs (EE, SI).   

b.  Participation in organ exchanges  

All  Member  States  reported  exchanges  of  organs  with  other  Member  States  and  20  Member 
States8  reported  participation  in  organ  exchange  via  European  organ  exchange  organisations 
(EOEO), such as Scandiatransplant and Eurotransplant, with specific agreements in place. Organ 
exchanges with third countries were also reported by nine Member States (AT, CY, DK, FR, IE, 
IT,  LT,  PL,  SE).  One  Member  State  (IT)  also  referred  to  participation  in  international  kidney-
paired donation programmes for transplant from living donors. 

Sixteen  Member  States  (BG,  CY,  CZ,  DE,  EE,  EL,  ES,  FR,  HR,  IE,  IT,  LT,  LV,  PL,  SI,  SK) 
indicated  that  they  would  be  interested  in  increasing  exchanges  of  organs  with  other  Member 
States mostly in cases of children (14), less commonly transplanted organs (9) or cases of ABO 
blood  types  incompatibility  (8).  Some  Member  States  expressed  difficulties  regarding  other 
specific cases  such as  hyperimmunised patients  (CY,  IT) as  well as  urgent  cases requiring fast 
response (PL).  For all those specific cases, Member States  consider increased exchanges  as an 
opportunity to increase the donor pool, hence in turn increasing the probability for patients to be 
matched  with  a  donor  and  receive  a  transplant.  This  is  particularly  the  case  for  small  Member 
States, and for difficult-to-transplant patients, or when there is no national organ transplantation 
programme.  In  the  case  of  children,  it  also  relates  to  the  small  number  of  paediatric  deceased 
donors, or the lack of expertise and specific transplant programmes for children for some organs 
(again  related to  the small number of cases,  and  the difficulty to  maintain a programme of the 
highest  quality)  (CZ,  HR,  SI,  SK).  One  Member  State  (DK)  stated  that  a  potential  increase  of 
collaboration would probably and primarily be organised through the relevant EOEO. 

c.  Collaboration  between  competent  authority/delegated  body  for  Organ  Donation  and 

Transplantation and authorities and stakeholders in adjacent areas  

7 Article 17 and Chapter V of the Directive. 
8 All Member States which replied, except Belgium, Cyprus, Finland and Spain. 

2 

 
 
 
                                                           
The majority of Member States (199) reported the existence of collaboration, to various degrees, 
between  their  competent  authority/delegated  body  for  organs  and  authorities/stakeholders  with 
adjacent areas of expertise (see Table 1). 

Blood 
Tissues and Cells 
Medicinal 
Products 
Medical Devices 
Others 

To a great 
extent 
2 
6 

To some 
extent 
5 
4* 

- 

- 
1  

3 

2 
3 

Occasionally 

Never 

4 
3 

8 

6 
3 

2 
- 

3 

6 
5 

Not 
applicable 
6 
7 

5 

5 
6 

*Of note, for Spain, the competent authority for organs is also the competent authority for Tissues and Cells, 
and it has collaborations with the dedicated competent authority on Assisted Human Reproduction. 

Table  1:  Existing  collaborations  between  Member  States  competent  authority/delegate  body  and 
authorities and stakeholders of adjacent areas of expertise. 

The  collaborations  are  more  frequent  with  the  authorities/stakeholders  in  the  tissues  and  cells 
area  than  with  the  ones  in  the  blood  area.  Interactions  with  authorities/stakeholders  from  the 
medicinal  products  or  medical  devices  sectors  are  rather  occasional.  Some  Member  States 
mentioned  other  collaborations  are  happening  with  various  medical  institutes  (DE,  IT,  SI), 
hospitals (LV), medical agencies (EE, SE), health Ministries (DE, IT) and other bodies (BG).  

The most prevalent topics of these collaborations are vigilance (14), traceability (11) and donor 
protection (10), but  also  accreditation of transplantation  centres, development and maintenance 
of  registries  related  to  transplantation  medicine,  or  tissue  donation  and  banking  (PL).  Another 
Member State (SI) highlighted the topic of promotion of donation based on fundamental ethical 
principles,  altruism  and  a  non-profit  approach,  and  underlined  that  cooperation  with  other 
competent authorities was important to ensure transparency.   

Seven Member States (EL, ES, FR, IE, IT, LV, SI) expressed interest for increased collaboration 
with authorities/stakeholders from adjacent areas of expertise, in particular in relation to difficult 
cases for organ transplantation (e.g., children), the harmonisation of practices, donor protection 
and voluntary unpaid donation, and educational programmes and communication initiatives.  

d.  Northern Ireland 

Competent  authorities  for  Northern  Ireland  did  not  report  any  changes  since  2015.  Northern 
Ireland has an agreement with an EOEO and participates in organ exchanges with EU Member 
States as well as with third countries.  Northern Ireland stated that there is potential to increase 
living donation through the UK Living Kidney Sharing Scheme, in which it participates. There is 
also interest for future cooperation with Ireland.  

9 All Member States which replied, except Belgium, Cyprus, Finland, Greece and Lithuania. 

3 

 
 
 
 
 
 
                                                           
Regarding  collaborations  with  other  authorities  and  stakeholders,  Northern  Ireland  reported 
extensive  collaborations  with  authorities  in  tissues  and  cells  and  medicinal  products  sectors, 
whereas collaborations with authorities in the blood and medical devices areas happen to some 
extent. Those collaborations are mainly about vigilance, traceability and donor protection.  

3.  Donor and recipient follow-up 

For  some  organs  such  as  kidneys  and  livers,  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  economic  consequences. 
Hence,  living  donors  must  be  carefully  screened,  selected  and  followed  up,  as  laid  down  in 
Article  15  of  the  Directive.  On  the  other  hand,  the  follow-up  of  transplanted  patients  is  left  to 
Member  States’  decisions,  but  recital  24  of  the Directive  recognises  that  competent  authorities 
should have a key role to play in this matter10 and Article 17(2)(e)11 also includes this aspect. 

a.  Registries for living donors12 

Registries for living donors exist in most of the Members States (22), but Lithuania and Sweden 
do not keep such registries. Since the last report, Austria and Hungary established a registry for 
living  donors  follow-up,  while  Estonia  now  uses  the  Scandiatransplant  database.  A  national 
transplantation  registry  is being  developed in  Germany  (covering both  dead and living  donors, 
and  in  addition  to  the  registry  on  liver  and  kidney  living  donation  already  in  place  for  quality 
assurance).  

Registries  vary  across  the  Member  States  in  their  characteristics  and  about  the  organisation 
hosting  them.  While  data  is  kept  at  hospital  level,  the  hospitals  also  provide  it  to  the  national 
registries.  In  Spain,  there  can  be  an  intermediate  step  of  uploading  data  to  a  regional  registry, 
before upload to the national one. The national registries are hosted either by hospitals/transplant 
centres  (CY,  IE,  FI,  SI),  national  competent  authorities  (AT,  CZ,  ES,  FR,  HU,  PL),  national 
transplant  organisations  (LV,  NL,  SK),  health  Ministries  (IT,  PL),  national  institutes  (DE)  or 
registries  maintained  by  EOEOs  such  as  Scandiatransplant  (DK,  EE)  and  Eurotransplant  (BE).  
Most  registries  are  managed  by  IT  tools,  with  databases  (CZ,  IE,  HR,  PL,  PT)  and/or  Excel 
sheets (BG, CY, CZ, LV). One Member State reported use of paper format documentation (SI).  

Living donor follow-up  intervals  vary  among Member States.  In  Austria, automated  reminders 
are sent  to  the procurement  centre  with  a request to  carry out  the next  follow-up check on the 

10 “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  information  between  Member  States 
would facilitate further improvement of donation and transplantation across the Union.”. 
11 “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.”. 
12 Article 15(3) and (4). 

4 

 
 
 
                                                           
living  donor  in  question  and  to  enter  the  data.  Denmark  reported  that  there  is  a  delay  in  data 
entry  of  follow-up  information.  Some  Member  States  reported  that  maintaining  a  registry  for 
living  donors  improved  their  long-term  follow-up  (AT,  ES,  FR),  including  establishment  of 
standardised examination times for them (AT) or rules for their psychological and/or psychiatric 
follow-up (PT). 

The  majority  of  Member  States’  registries  (17)  include  data  on  100%  of  the  living  donors, 
whereas Italy reports 94%, the Netherlands 67%, and three other Member States (BE, BG, DE) 
have no available  figure  (see  Figure 113).  Follow-up data for living donors is  fully recorded in 
nine Member States’ registries (see Figure 2). In seven other Member States (DK, ES,  IT, NL, 
PL,  PT,  SK),  the  percentage  of  donors  with  follow-up  data  included  in  the  registry  varies 
between 50 and 98%. Six Member States did not provide that data (AT, BE, BG, DE, FR, HU), 
but one of them highlighted that it is planning to calculate the completeness of follow-up data in 
2022 (AT). 

b. Registries of organ recipients 

Registries of organ recipients are kept by all Member States except three (Austria, Belgium and 
Sweden, while Austria and Belgium have a registry for the follow-up of living donors). Half of 
the Member States had registries of organs recipients in place before the Directive was adopted. 
Five Member States (EE, HU, LV (for liver), PT, SI) established their recipient registries  after 
2015,  while  in  Germany  a  national  transplantations  registry  (covering  both  donors  and  organ 
recipients) is being developed. Most registries of organ recipients are organised in a similar way 
to the registries for living donors. 

Registries  include  data  mainly  on  patients  transplanted  with  kidney  (21),  liver  (18)  and  other 
organs such as heart (12), pancreas (11), lungs (10), intestine (4) and others14 (see Figure 3). Two 
Member States reported the inclusion of all organ recipients in their registry (FI, FR). 

13 Member States were asked the percentage of living donors included in the registry for the year 2021 (or 2020 if no 
figure yet available for 2021): 11 Member States reported their data for the year 2020, other 11 for the year 2021. 
14 Registries for face (FI), vascularised tissue allografts (PL) (vascularised tissues are strictly speaking not organs, 
but their transplants need to be organised as if they were organs). 

5 

 
 
 
                                                           
The  majority  of  Member  States’  registries  (17)  include  data  for  all  recipients  who  received  an 
organ  during the  last  year  for  which  there  is  complete  data15  (see  Figure  4),  while  Lithuania 
reported coverage of around 22% of recipients, the Netherlands an interval of 87-96% and Italy 
99.5%  of  organ  recipients.  Follow-up  data  for  organ  recipients  is  fully  recorded  in  fourteen 
Member  States’  registries  (see  Figure  5).  In  five  Member  States  (DK,  FR,  IT,  NL,  SK),  the 
coverage is more than 50% (it can vary according to the specific organ considered); two Member 
States (BG, DE) did not provide the data.  

c.  Northern Ireland 

Northern  Ireland  has  registries  for  organ  living  donors  (with  requirement  from  the  competent 
authority to report all living donors in a timely manner) and recipient, both hosted by a delegated 

15 Member States were asked the percentage of organ recipients included in the registry for the last year for which 
they have complete data (2021, otherwise 2020): 12 Member States provided percentages for the year 2021 and 9 for 
2020. 

6 

 
 
  
 
 
                                                           
body  (NHSBT).  Regarding  living  donors,  since  2015,  Northern  Ireland  has  started  to  expand 
paired/pooled and altruistic donor schemes and started collecting additional information around 
these transplants. The registry of organ recipients covers kidney, liver, heart, lung, pancreas and 
intestines.  Both  registries  include  100%  of  living  donors  and  recipients,  and  all  data  on 
immediate follow-up (while data for follow-up after one year was not yet due).   

4.  Biovigilance16 

Article 11 of the Directive provides that Member States  shall have a system in place to report, 
investigate, register and transmit information, in due time, related to serious adverse events and 
reactions. 

a.  Reporting systems for information concerning serious adverse events and reactions (SARE) 

The majority of Member States have specific operating procedures in place for the notification of 
any  SARE  to  the  Competent  Authorities  and  to  the  concerned  procurement  organisations  or 
transplantation centres, as well as for the notification of the management measures with regards 
to SARE to the Competent Authority. Since 2015, three Member States (DK, EE, FR) reported 
changes in their reporting systems, while another Member State (IE) reported to be in the middle 
of the revision of its current biovigilance system to further align it with latest guidance and best 
practice. 

For the notification of SARE, some Member States refer to a national digital platform (FR, PT, 
LV), others mention published forms (BG) or a written procedure (NL). 

Most  systems  operate  at  national  level,  with  reporting  exchanges  between  on  one  hand  the 
hospitals/transplantation centres, which describe the SARE (including classification in terms of 
seriousness/likelihood of recurrence), take and report on immediate measures, and on the other 
hand, the national transplant organisation (DE, PL, SK) or the national competent authority (BG, 
EE, ES,  FI,  FR, HR, SI).  In  addition,  in  Czech  Republic,  Italy  and  Spain,  there is  reporting  at 
regional level. 

SARE  reporting  is  also  managed  via  or  in  close  collaboration  with  EOEO  for  Member  States 
involved in Scandiatransplant (DK, EE, FI, LT) and Eurotransplant (AT, BE, DE, HR, HU, NL, 
SI).  For  organs  exchanged  with  other  Member  States,  the  EOEOs  are  launching  alerts  and 
reporting to centres and competent authorities. All the transplant centres in the Scandiatransplant 
area  are  in  permanent  direct  contact  with  each  other.  One  Member  State  (BE)  stated  that  each 
SARE coming in from Eurotransplant is discussed in a national workgroup. 

While immediate actions are taken by the transplantation centres, the next steps usually involve 
the  competent  authorities  who  analyse  the  case  and  ensure  close  coordination  with  relevant 

16 23 out of 24 Member States provided answers to this section of the survey, while one Member State (SE) did not 
report on biovigilance, which falls under the competences of another authority which could not reply to the survey. 

7 

 
 
 
 
 
                                                           
medical and other actors. A Member State (LT) reported that in a second step, the centre carries 
out an investigation and notifies the competent authority with reasons of SARE and conclusions. 
Another one (FR) mentioned that local biovigilance coordinator (in the centres) need to provide 
an annual report summarising relevant corrective measures implemented in their establishment. 

The  competent  authorities  are  involved  in  the  coordination  of  vigilance  organisation,  the 
developments  of  tools,  the  registration,  investigation,  and  follow-up  of  each  SARE,  the 
transmission  of  relevant  information  concerning  SARE  in  a  timely  manner  to  affected  centres, 
including tissue establishments possibly affected (see paragraph b), the preparation of corrective 
measures and/or preventive measures, as well as the publication of annual vigilance reports.  

In some Member States  (ES, PL,  IE,  IT),  an expert  panel is  also  involved  to  review the cases, 
take decisions about corrective measures if needed. It can also propose measures for improving 
the quality of the current vigilance system. During official inspections, the operating procedures 
for the notification are inspected regularly (FI). 

In addition, competent authorities organise training on vigilance for the biovigilance coordinators 
(FR).  Some  competent  authorities  also  reported  the  publication  of  guidelines  to  help  the  local 
biovigilance  coordinators in  their tasks (FR), or  for the  reporting of SARE by donor hospitals, 
laboratories/pathologies, and transplant centres (DE). 

b.  Interconnection  between  the  reporting  system  for  organ  transplantation  and  the  notification 

system established for the transplantation of tissues and cells 

In Member States where the competent authority for organs is also the competent authority for 
tissues and cells (BG, EE, ES, FI, FR, IT, LT, LV, PL, SI) as soon as a case is reported, possible 
affected tissues and cells recipients or tissue establishments are identified and notified as well as 
organ transplantation centres. The same biovigilance tools/systems are used for SARE for organs 
and tissues and cells (EE, FI, FR, SI); another Member State (IT) reported the development of a 
flow chart to ensure proper notification between different involved actors. 

In  another  Member  State  (DE),  a  dedicated  system  has  been  established  to  allow  a  reliable 
linkage  between  the  organ  procurement  organisation  and  the  different  tissue  banks  in  case  a 
donor donated both organs and tissues or cells. One Member State (IE) mentioned the existence 
of an arrangement between both functions, which will be further developed. 

In some Member States, there is no automatic connection between both systems and the relevant 
information  is  communicated  by  email  or  phone  (DK),  exchanged  between  the  competent 
delegated bodies (AT), or communicated directly to the tissue establishments by the competent 
authority (HU) or the delegated body for organs (SK). In other cases, the relevant information is 
passed  between  the  transplantation  centres  and  the  tissue  establishments  directly  (BE).  Six 
Member  States  (CY,  CZ,  EL,  HR,  NL,  PT)  reported  having  no  interconnection  between  the 
reporting  systems  for  organ  transplantation  and  the  notification  system  established  for  the 
transplantation of tissues and cells.  

8 

 
 
 
c.  Procedure of contact between competent authorities in case of SARE that can affect several 

Member States  

Many Member States rely on the communication channels of the EOEOs they are part of, such as 
Eurotransplant (AT, BE, DE, HR, HU, NL, SI) and Scandiatransplant (DK, EE, FI), noting that 
direct contact from the competent authority to others is rarely needed, as the EOEOs have well 
established procedures for such events to alert the transplant centres (DK).  

In other instances (CY, EL, ES, IE, IT, LT, PL, PT, SK) the communication between competent 
authorities  happens  directly  via  phone  or  email.  Of  note,  this  information  can  be  found  in  the 
contact list on a dedicated webpage17.  

Two Member States (BG, LV) reported that in case of other Member States involved, the SARE 
would  be  reported  through  the  Rapid  Alert  system  for  human  Tissues  and  Cells  (RATC)  and 
another one mentioned that a system like RATC might be a useful tool for information sharing 
between competent authorities regarding alerts and vigilance events in the field of organs (FR). 
In  addition,  one  Member  State  (PT)  referred  to  specific  bilateral  organ  exchange  agreements, 
which  define  procedures  for  reporting  SARE  (in  line  with  the  requirements  of  Directive 
2012/25/EU18).  

One  Member  State  explained  that  it  does  not  have  a  specific  procedure  regarding  vigilance 
information  that has to  be shared with  competent authorities  from  other Member States,  as the 
majority of organs are collected and transplanted in its own country (FR), but in necessary case, 
the competent authority would contact directly known counterparts in the country concerned (as 
was the case during the COVID-19 pandemic).  

Member States are contacted in case of a SARE notified in another Member State and that might 
affect them, in a symmetric way. 

d.  Northern Ireland. 

In  Northern  Ireland, operating procedures for the notification of SARE  and of its management 
are  in  place:  SARE  are  reported  to  a  delegated  body,  which  then  reports  to  the  competent 
authority. Regular meetings are organised between both to ensure quality and governance of the 
process. There is an interconnection between the reporting system for organ transplantation and 
the notification system for the transplantation  of  tissues and cells (some staff also  work  across 
the teams in charge of vigilance for organs and tissues and cell, being able to link relevant cases). 
In the case of SARE affecting Member States, the delegated body ensures the transmission of the 
relevant  information  to  other  Member  States  in  accordance  with  Article  4  of  Directive 
2012/25/EU. 

17 http://txcontactlist.eu/  
18 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 (OJ L 275, 10.10.2012, p. 27). 

9 

 
 
 
                                                           
5.  Impact of the COVID-19 pandemic in the organ transplantation sector 

In  a statement  from  June  2020,  EU  national  competent  authorities  on  Organ  Donation  and 
Transplantation  highlighted a range of needs at  national  and EU levels to foster recovery  from 
the detrimental effects of COVID-19, and prepare the sector for possible future outbreaks. 

a.  Actions taken and challenges 
Almost  all  Member  States  (except  FR  and  SE)  adapted  their  national  procedures  for  organ 
donation  and  transplantation  in  response  to  the  pandemic  (see  Figure  6).  The  most  prevalent 
action  concerned  harmonised  safety  and  quality  protocols  based  on  guidance  such  as  the  one 
from  the  ECDC19.  Actions  to  facilitate  logistics,  including  those  required  for  cross-border 
exchange  of  organs  and  travel,  and  to  strengthen  capacities  and  skills  of  critical  care 
professionals,  donor  coordinators,  transplant  professionals,  organ  procurement  organisations 
and/or  inter/national  transplant  organisations  were  also  taken  by  many  Member  States  as  a 
response to the pandemic. In addition, some also took measures to support the implementation of 
organ  preservation  technologies20  as  well  as  to  strengthen  research  on  the  effects  of 
communicable diseases on transplantation. Six Member States implemented digital solutions for 
EU-wide  data  collection  and  monitoring  of  post-transplant  outcomes  and  vigilance.  Two 
Member States (ES, IT) set up specific data collection platforms for monitoring of the COVID-
19 effects in the area of transplantation. 

19 https://www.ecdc.europa.eu/sites/default/files/documents/covid-19-supply-substances-human-origin-second-
update.pdf  
20 that allow longer ex-vivo time windows to facilitate transplants when logistics are more complex, e.g. in the case 
of local outbreaks. 

10 

 
 
 
 
 
 
                                                           
One  Member  State  (FI)  noted  that  protocols  are  based  on  the  first  pandemic  wave  when  no 
COVID-19  positive  donors  were  used  for  organ  donation,  and  positive  recipients  were  not 
operated unless for vital indications. On the other hand, Spain and Italy reported regular updates 
of  safety  protocols  and  recommendations  on  the  basis  of  the  pandemic  evolution,  as  well  as 
protocols for the vaccination of transplanted patients. Italy also issued a national protocol for the 
use  of  COVID-19  positive  donors.  In  France,  an  expert  group  provided  recommendations  on 
donor  testing  in  order  to  avoid  transmission  of  COVID-19  to  the  recipients,  which  took  into 
account the nature of the organs (vital versus non vital organs).  

In Italy, webinars for patients/transplant recipients were also organised. One Member State (PL) 
reported  having  adapted  legal  procedures  related  to  accreditation  of  transplantation  centres  to 
online forms.  

One  Member  State  (DK)  noted  that  countries  in  the  Scandiatransplant  area  were  able  to  test 
thoroughly  for  COVID-19  very  early  in  the  pandemic,  took  the  associated  issues  into  account. 
For that Member State, most of the transplant activities continued as usual without any sustained 
drop-in 
the 
transplantations throughout the pandemic, with a record number of transplantations conducted in 
2021. 

transplant  activities.  Another  one  (SE)  reported  no  negative 

impact  on 

Still, the pandemic created other new challenges for the competent authorities, such as problems 
with the organisation of the healthcare systems (intensive care unit (ICU) capacities, availability 
of  operation  theatres,  exhausted  staff)  (reported  by  CY,  DE,  ES,  HR,  IE,  IT,  SK),  or  the  non-
homogenous spread of the pandemic  (in different regions of a same country) which influenced 
transplant  programs  (IT).  Rapidly  changing  measures  and  situations  was  also  a  challenge  for 
several Member States (AT, BE, DE, FR, IE, NL, PT, SI) that required information, coordination 
(to establish updated procedures) and constant adaptation to new protocols.  One Member State 
(SI) reported that many meetings between Eurotransplant members were needed, and a dedicated 
standing  working  group  had  to  be  established  to  monitor  the  most  recent  developments  and  to 
adapt  policies  and  procedures  where  necessary.  Another  Member  State  (AT)  stressed  also 
challenges  in  relation  to  collaboration  and  information  exchange  with  the  national  crisis 
management systems. Member States reported the lack of scientific information at the beginning 
of the pandemic (ES, FI), and the fear of transmitting the disease to transplant patients (ES). It 
was also challenging to test the prospective donors and obtain laboratory results in due time (CZ, 
FR,  HU),  and  screenings  of  donors  and  recipients  was  time  consuming  (EL,  LV.)  Other 
challenges  relate  to  the  setting-up  of  COVID-19  free  pathways  inside  hospitals  (FR,  IT,  LV), 
shortages  of  donors  (BG,  CY,  FR),  as  well  as  difficulties  for  international  exchange  of  organs 
(SI), including regarding international transport logistics (EE).  

Many Member States agree that all the actions taken during the pandemic (as shown in Figure 6) 
are still needed and relevant for their countries (DE, EE, EL, ES, IE, IT, LT, SI), while others 
highlighted  specific  ones  only,  in  particular  the  necessity  for  harmonised  safety  and  quality 
protocols based on guidance such as the one from the ECDC (BE, CY, EL, HR, PL), capacities 
and  skills  of  the  involved  professionals  (BG,  CY,  CZ,  PT,  SK),  and  implementation  of  organ 
preservation  technologies  (BG,  CY,  EL,  HU,  SK).  Also,  cross-border  exchange  of  organs, 

11 

 
 
exchange of best practices and harmonisation of criteria and procedures were reported by  some 
Member States (AT, NL, LV). Two Member States reported to welcome more frequent updates 
of the recommendations for testing and deferral of donors from the ECDC (EE, SE). 

Two Member States (DK, FR) noted that no specific further actions are needed. 

b.  Priorities  to  mitigate  the  detrimental  effects  of  COVID-19  in  the  organ  sector,  and  to 
strengthen the sector in the long term 

Member States reported two main areas that should be prioritised: (i) strengthening the capacity 
of  intensive  care  services,  and  professionals  involved  in  organ  management,  procurement  and 
transplantation  (BG,  ES,  IE,  IT,  NL,  PT,  SI,  SK;  (ii)  development  of  guidance  at  EU  level 
(including  regarding  COVID-19  positive  donors  and  recipients),  allowing  for  more 
harmonisation among Member States and cross-border exchanges (BE, BG, CY, EE, EL, FI, IE, 
LT, LV. In addition, safety protocols and emergency plans would ensure that transplant activity 
would  not  decrease  in  case  of  a  new  pandemic  wave  (HR,  IT).  The  cooperation  of  scientific 
experts, including for comprehensive data collection, was also mentioned as a help to speed up 
developing evidence-based approaches (DE, FI, PT). One Member State (ES) suggested having a 
space  to  share  rapid  recommendations  with  the  NCAs21  and  allow  them  to  put  national 
recommendations in common for comments or suggestions. Implementation of digital solutions 
for data collection and monitoring of post-transplant outcomes and vigilance was also mentioned 
(BG, EL). Some Member States also referred to other needs, in relation to: (i) the development 
and  maintenance  of  an  information  network  with  cross-border  partners  (AT),  (ii)  the 
implementation of telemedicine tools to ensure remote follow-up of patients (IT), (iii) research 
(for example  to exclude or prove organ specific  SARS-CoV-2 transmission to  maximise organ 
transplantation while maintaining quality and safety) (HU). Finally, the need to raise awareness 
of decision-makers (AT), the support for ring fencing of donation and transplantation services in 
Member States (IE), the close cooperation with regional transplant centres (CZ) and addressing 
issues of logistics for transport across Member States (BG) were also mentioned. 

According  to  Member  States,  actions  at  EU  level  are  best  placed  to  address  some  of  these 
priorities, in particular the development of recommendations and guidelines. EU coordination is 
also  seen  as  beneficial  for  the  exchange  of  national  experiences  and  best  practices,  including 
harmonisation  of  donor  testing  measures,  for  the  facilitation  of  logistics  within  the  EU,  for 
increasing organ exchanges (with same conditions for cross-border exchange) and increasing the 
donor pool, for research and exchange of scientific knowledge, which can be improved via big 
data platforms.  

One  Member  State  (DE)  noted  the  necessity  to  become  more  self-sufficient  at  the  EU  level  to 
ensure  the  availability  of  necessary  resources  (perfusion  fluids,  medical  devices  (testing))  and 
avoid  shortages.  It  also  suggested  European  strategies  to  address  the  challenges  related  to  the 
extreme burden for the health care personal, while another refer to the need of financial support 
for education (SI). 

21 This has been organised via the Commission collaborative platform CIRCABC. 

12 

 
 
                                                           
c. Northern Ireland 

Authorities for Northern Ireland reported having taken actions (all shown in Figure 6) during the 
pandemic  and  continue  to  perform  clinical  revision  of  policies  as  knowledge  and  experience 
evolve. The authorities noted that a consistent screening programme across Member States, and 
the sharing of information regarding the type of test performed, is needed to ensure safe cross-
border  exchange  of  organs.  They  reported  as  challenge  the  capacity  of  critical  care  units, 
transplant units and access to ICU beds for recipients. Sharing of policies, procedures, changed 
practices, and data with other Member States is seen as a priority in the long term to mitigate the 
effects of the pandemic. 

6.  Other comments 
a.  Difficulties to implement or interpret the Directive 

Only  2  Member  States  (AT,  IE)  reported  difficulties  regarding  the  implementation  of  the 
Directive,  linked  to  a  complex  coordination  involving  different  stakeholders,  or  collaboration 
and  consolidation  of  different  sectors  and  a  learning  phase  while  introducing  the  quality 
framework.  

One Member State (AT) noted challenges in the interpretation of the Directive, pointing out the 
necessity  for  clear  definitions  and  supervision.  One  Member  State  (HU)  reported  having  more 
stringent rules than in the Directive, with an annual evaluation of its national organ donation and 
transplantation  programme  (publicly  available).  In  addition,  there  is  a  hospital-level  quality 
assurance programme for organ donation, inclusion of all discarded organs in the national organ 
donation registry, and quality reports of the organs at procurement and transplantation phase.  

b.  Relevance  of the  proposed  revision of the legislation on blood,  tissues and cells  (BTC)  for 

the organ sector22 

Member States (DK, EE, ES, FI, FR, HR, IE, LV, NL, SI commented on the close links between 
organs  and  tissue  and  cells  legislative  frameworks  (as  deceased  organ  donors  are  occasionally 
also tissue donors), and to a lesser extent with the blood legislative framework, as they all have 
the same principles regarding  altruistic  donation. Principles  and standards regarding safety and 
quality  (including  harmonisation  of  preventive  measures  in  relation  to  the  transmission  of 
pathogens), living donor protection, non-commercialisation of the human body, traceability and 
biovigilance,  and  increased  role  of  scientific  expert  bodies  to  draft  guidelines  and  share 
knowledge were mentioned as relevant for both the organ and BTC sectors.  

A  clearer  link  between  the  tissues  and  cells  and  organ  legislation  e.g.,  with  respect  to  SARE 
would be welcomed (DK). For another Member State (SI), transparency, traceability, quality and 
safety  of  organs,  tissues  and  cells  require  the  same  principles  and  should  be  covered  by  one 

22 During the survey period (February-April), the proposed revision of the BTC legislation was under preparation : 
https://ec.europa.eu/health/blood-tissues-cells-and-organs/overview/revision-eu-legislation-blood-tissues-and-
cells_en  

13 

 
 
 
                                                           
legislation.  Also,  other  Member  States  expressed  the  necessity  for  building  communication 
channels for information flows between the sectors. Finally, for another Member State (IE), the 
revision  of  the  BTC  legislation  could  also  lead  to  resources  being  available  for  training 
programmes provided to key personnel and teams.  

7. Conclusions  

Overall,  Member  States  did  not  experience  difficulties  with  the  implementation  and 
interpretation of the Organ Directive, in the period 2015-2021 and the current legal framework 
ensures safety and quality in the organ donation and transplantation field. However, the COVID-
19 pandemic created new and additional challenges to Member States, which reacted in a timely 
manner to ensure safety of transplantations, by following updated protocols at national level as 
well as the guidance provided by the ECDC. EU coordination and in particular updated guidance 
from  the ECDC were seen as essential  elements  during the  crisis.  Measures  are still needed to 
face the pandemic, and its long-term effects, and ensure preparedness in case of another crisis.  

Overall, the harmonisation of procedures in the EU is highly valued, as it can also facilitate the 
cross-border  exchange  of  organs.  Member  States  see  the  benefit  of  cross-border  exchanges  for 
increasing the donor pools and overcoming organ deficit at national level and challenges such as 
difficult-to-transplant patients. 

Vigilance, traceability, and donor protection are the most prevalent topics for collaboration with 
authorities  and  stakeholders  with  adjacent  areas  of  expertise,  with  interactions  with  the  tissues 
and cells sector being the most relevant.  

Member States have made progress in establishing their own living donor and recipient registries 
or  rely  on  EOEOs  for  this  function.  There  is  an  added  value  of  the  communication  channels 
provided by the EOEOs in case of SARE involving other Member States. 

14