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 Directives 2004/23/EC, 2006/17/EC and 2006/86/EC setting standards of quality and safety for human tissues and cells
Date: 2016-04-21
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, blood transfusion, cytology, health control, health risk, national implementing measure, organ transplantation, quality standard, safety standard, summarising

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 21.4.2016  COM(2016) 223 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 Directives 2004/23/EC, 2006/17/EC and 2006/86/EC setting standards of quality and safety for human tissues and cells {SWD(2016) 127 final} {SWD(2016) 128 final}  
 
 
1.  Introduction 

Article  26  of  Directive  2004/23/EC  requires  Member  States  to  submit  to  the  European 
Commission, before 7 April 2009 and every three years thereafter, a report on the activities 
carried out in relation to the provisions of the Directive, including an account of the measures 
taken  in  relation  to  inspection  and  control.  The  Commission  is  required  to  transmit  these 
national reports to the European Parliament, the Council, the European Economic and Social 
Committee  and  the  Committee  of  the  Regions.  The  Commission is  also  required  to  provide 
the European Parliament and the Council with an overview report on the implementation of 
the requirements of the Directive, in particular as regards inspections and monitoring.  

In  addition,  and  in  accordance  with  Article  12(1)  of  Directive  2004/23/EC,  Member  States 
also have to submit to the Commission reports on the application of the principle of voluntary 
and  unpaid  donation  (VUD)  every  three  years.  On  the  basis  of  these  national  reports,  the 
Commission is required to report to the European Parliament and the Council and to inform 
them of any necessary further measures in relation to VUD it intends to take at Union level.  

This  report  is  based  on  the  replies  to  questionnaires  that  the  Commission  sent  to  Member 
States  in  2012  (verification  of  the  completeness  of  transposition),  2013  (implementation 
survey)1,2  and  2014  (implementation  of  the  VUD  principle)  and  follows  up  on  the 
Commission  communication  published  in  January  20103  as  well  as  the  two  reports  on  the 
application  of  the  principle  of  VUD  for  tissues  and  cells  issued  in  20064  and  20115.  All 
Member  States  replied  to  the  transposition  questionnaire.  The  implementation  survey  was 
answered by all Member States except Greece, and also by two EEA countries, Liechtenstein 
and Norway. All Member States, and also Liechtenstein and Norway provided answers to the 
survey on the implementation of the VUD principle.  

The  full analysis of the Member States’ replies to the 2013 implementation survey and the 
2014 survey on the implementation of the VUD principle is included in the two staff working 
documents accompanying this report. 

Besides  complying  with  the  legal  obligations  pursuant  to  Article  12  (1)  and  Article  26  of 
Directive  2004/23/EC,  the  current  report  sets  out  how  Directive  2004/23/EC6  and  its 
implementing  Directives  2006/17/EC7  and  2006/86/EC8  (hereafter  commonly  referred  to  as 
the  EU  tissue  and  cell  legislation)  function  in  practice,  against  a  backdrop  of  significant 
scientific and organisational developments (internationalisation, commercialisation) that have 
taken place in the tissue and cell sector over the past decade. 

1  Detailed  Member  States’  replies  (as  well  as  replies  from  Norway  and  Liechtenstein)  can  be  accessed  at 

2 

http://ec.europa.eu/health/blood_tissues_organs/key_documents/ 
In a number of cases clarification requests were sent to Member States. It is important to note that the hyperlinks contain 
the original replies of Member States, whilst the report reflects the updated information provided by Member States. This 
can lead to certain discrepancies. In such cases this report contains the updated information.  

3  http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0708:FIN:EN:PDF  
4  http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1422283594361&uri=CELEX:52006DC0593  
5  http://ec.europa.eu/health/blood_tissues_organs/docs/tissues_voluntary_report_en.pdf  
6  Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality 
and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and 
cells (OJ L102, 07.04.2004, p. 48).  

7  Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament 
and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues 
and cells (OJ L38, 9.2.2006, p. 40).  

8  Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament 
and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain 
technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ 
L294, 25.10.2006, p. 32). 

2 

 
 
                                                            
Where  appropriate  data  gathered  through  other  channels  and  supporting  the  findings  of  the 
two  surveys  (e.g.  exchanges  with  the  national  competent  authorities  during  the  bi-annual 
meetings  with  the  Commission,  mandatory  annual  reporting  to  the  Commission  of  serious 
adverse  reactions  and  events  (SARE),  alerts  launched  in  the  Rapid  Alerts  for  Tissues  and 
Cells (RATC) platform, Eurobarometer survey exploring the views of EU citizens on tissue 
and  cell  donation9  and  the  output  of  a number  of  relevant  EU-funded  projects  and  studies) 
were also taken into account. 

2.  Transposition of the EU tissue and cell legislation  

A verification of the completeness of transposition into national legislation has been carried 
out  by  the  Commission  and  demonstrated  that  the  EU  tissues  and  cells  legislation  is  fully 
transposed  into  national  legislation  in  all  but  two  Member  (which  have  failed  to  fully 
transpose  the  requirements  of  the  Directives  for  reproductive  cells).  As  a  consequence, 
pursuant to Article 258 TFEU, the Commission has brought action against one Member State 
to  the Court of  Justice10, and  launched an infringement proceeding against  another Member 
State, which is ongoing.   

3.  Implementation of the EU tissues and cells legislation 

Overall, the implementation  of the EU tissues and cells  legislation by the Member States is 
considered  adequate  and  the  legislation  has  resulted  in  the  establishment  of  a  network  of 
competent authorities that oversee the sector through authorisation, inspection, and vigilance. 
However,  some  difficulties  in  interpretation,  implementation  and  enforcement  of  the 
legislation have been identified, which in some cases could be explained by the scientific and 
technological advances since its adoption. As the EU legislation in the tissue and cell does not 
provide  a  basis  for  full  harmonisation  and  as  Directives  allow  the  Member  States  a  certain 
degree  of  discretion  as  to  how  to  ensure  their  implementation,  there  are  accordingly  many 
differences  between  Member  States  in  the  approaches  they  have  taken  to  implementation. 
These differences facilitate successful integration of the requirements into national legislation 
but in some cases they may limit the mutual acceptance of authorisations with consequences 
on the cross-border movement of tissues and cells.  

3.1.  Designation  of  competent  authority  or  authorities  responsible 

for 

the 

implementation of Directive 2004/23/EC 

All  reporting  Member  States  have  appointed  competent  authorities  for  tissues  and  cells. 
Concerning the number of competent authorities, in some Member States only one authority 
is  responsible  for  the  oversight  of  the  tissue  and  cell  sector,  whereas  in  other  countries  the 
tasks are divided amongst two or three authorities (based either on type of tissues and cells or 
on  duties  e.g.  accreditation/authorisation  v.  inspections/vigilance  or  the  allocation  of  tasks 
between  federal and  regional  levels).  In  some  Member  States  the authorities  for  tissues  and 
cells  are  also  responsible  for  the  oversight  of  other  sectors  (e.g.  organs,  blood  and/or 
medicinal products) (Fig.1 and 2), which can be beneficial from an efficiency point of view. 

http://ec.europa.eu/health/blood_tissues_organs/eurobarometers/eb822_en.htm 

9 
10  Case C-29/14, judgment pronounced on 11 June 2015. In 2015 the MS concerned has adopted new legislation for the 

ART sector and is in process of implementing it. 

3 

 
 
 
 
 
                                                            
s
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)
s
A
C

(

1 National CA
(AT, BE, BG, DE, DK, EE, FI, HR, HU, IE, LI,
LU, LV, MT, SI, SK)

2 National CAs (CZ, ES, RO, UK)

4 

16 

3 National CAs (FR, LT, NL, NO, PL, PT, SE)

7 

Regional CAs (DE, ES, FR, IT, SK)

5 

CAs dedicated to ART (FR, PT, UK)

3 

4

0

2

6

8

10

12

14

16

18

Number of countries 

Fig. 1. Tissues and cells competent authorities in the reporting EU Member States and EEA countries 
(2011 data) 

e
h
t

r
e
d
n
u
s
r
o
t
c
e
s

r
e
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O

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a
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f
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s
A
C

Medical devices (AT, BE, CZ, DK, ES, FR, IE,
LT, LU, LV, NL, SE, SI, and LI, NO)

Medicinal products  (AT, BE, CZ, DE, DK, EE,
ES, FI, FR, HU, IE, LU, LV, MT, NL, SI and LI)

Organ transplantation (DK, EE, ES, FI, FR, HR,
IE, IT, LU, LV, MT, NL, PL, PT, SE, SI, UK
and NO)

Blood and blood components (AT, BE, CZ, DE,
EE, ES, FI, FR, HU, IE, LU, LV, MT, NL, PT,
SE, SI, SK, UK and LI, NO)

15 

17 

18 

21 

0

5

10

15

20

25

Number of countries 

Fig. 2. Other responsibilities of tissues and cells competent authorities in the reporting EU Member 
States and EEA countries (2011 data) 

Wherever  accreditation  and  inspections  are  undertaken  by  different  authorities,  a  good 
communication  and  coordination  between  respective  authorities  needs  to  be  ensured.  More 
generally speaking, it was difficult to assess how divisions of tasks impacts oversight of the 
sector,  especially  as  some  of 
the  national  competent  authorities  did  not  provide 
precise/complete information.  To facilitate good regulatory communication between Member 
States,  as  well  as  to  comply  with  the  annual  reporting  requirements  to  the  Commission,  a 
well-informed  national  coordinating  contact  is  essential,  even  where  responsibilities  of 
national competent authorities are shared among multiple organisations or regions. It has to be 
highlighted that, irrespective of the organisational set up in each country, it is important that 
authorities have appropriate resources at their disposal in order to ensure their independence 
from economic operators, in the sector and from other influences.  

3.2. Obligations of Member State competent authorities  

4 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Supervision  of  human  tissue  and  cell  procurement.  The  high  number  of  procurement 
organisations shows that this activity is well developed across the Union. The survey showed 
that  all  reporting  Member  States  authorise  the  conditions  of  procurement  by  inspecting 
procurement organisations and/or by evaluating the procurement-related documentation made 
available  by  the  tissue  establishment  working  with  procurement  organisations.  Furthermore, 
besides procurement of replacement tissues, haematopoietic stem cells and reproductive cells, 
some  Member  States  also  reported  a  significant  number  of  procurement  organisations 
carrying out procurement of tissue and cells to be used for manufacturing of advanced therapy 
medicinal products (ATMP) (Fig. 3). Concerning testing laboratories, the survey showed that 
in most of the reporting Member States accreditation/designation/authorisation or licensing of 
testing laboratories is the responsibility of authorities other than the tissue and cell competent 
authorities.  

332 
7% 

1065 
22% 

1455 
30% 

POs carrying out  procurement
of replacement tissues

POs carrying out  procurement
of  HSC

POs carrying out  procurement
of reproductive tissues and
cells
POs carrying out  procurement
of  tissues and cells for ATMP
manufacturing

1973 
41% 

Fig. 3. Number of procurement organisations (POs) reported by the EU and EEA countries  
(Total POs = 4825; 2011 data) 

Accreditation,  designation,  authorisation  or  licensing  of  tissue  establishments.  The  survey 
confirmed that this core responsibility of competent authorities is well implemented across the 
Union. At the end of 2011, 2047 tissue establishments were authorised in the EU, showing an 
almost 20% increase compared to the 2008 data (Fig. 4). It is also interesting to highlight the 
split between private and public ownership of tissue establishments. In some Member States 
the sector is fully controlled by public organisations, whilst in others private operators make a 
significant contribution (Fig. 5). Some mixed models have emerged where, for example, the 
private sector may take the role of a third party for processing or storage, with all donation, 
promotion and distribution activities remaining in public hands. 

5 

 
 
 
Musculo-skeletal
Ocular (cornea, sclera, etc.)
Cardio-vascular
HSC (other than cord blood)
Cord blood
Skin
Reproductive
Multitissue
Other

172 

368 

88 
63 
67 
49 

114 

91 

58 
42 

255 

193 

189 

270 

81 
67 

827 

769 

0

100 200 300 400 500 600 700 800 900

Number of tissue establishments  

2011 data

2008 data

Fig. 4. Number of accredited/designated/authorised/licensed tissue establishments per type of 
human tissues and cells (comparative data; data submitted by 27 Member States and two EEA 
countries) 
Legend: HSC = haematopietic stem cells 

900
800
700
600
500
400
300
200
100
0

530 

132 

179 

13 
52 

5 
35 

12 
33 

43 

177 

242 

23 
121 

57 
40 

13 
37 

Private

Public

Fig. 5. Tissue establishments’ status (public vs. private)/type of tissue (2011 data; data submitted by 
25 Member States and one EEA country) 
Legend: ART = assisted reproductive technologies 

The  survey  revealed  a  variety  of  approaches  for  the  implementation  of  the  procurement 
requirements  laid  down  in  Directive  2006/17/EC,  especially  when  granting  authorisation 
(e.g. prior  on-site  inspection  vs.  desk-based  review  of  documentation,  differing  criteria  for 
major  changes  requiring  a  notification  of  the  competent  authorities,  differing  duration  of 
authorisation  and  conditions  of  renewal).  In  addition,  in  several  Member  States,  only  tissue 
establishments  are  authorised  to  procure  tissues  and  cells,  with  some  countries  authorising 
tissue establishments just for procurement activities. 

As underlined by several national competent authorities, a more harmonised procedure for the 
accreditation,  designation,  authorisation  or  licensing  of  tissue  establishments  would  foster 
mutual trust and acceptance between Member States which are essential for ensuring a prompt  

6 

 
 
 
 
 
supply of tissues and cells to the patients in need for the cases in which tissues and cells are 
distributed from another Member State than the one where the patient is treated.  

Authorisation  of  tissue  and  cell  preparation  processes.  Diverse  practices  related  to  the 
implementation  of  the  requirements  of  Article  4  of  Directive  2006/86/EC  were  reported. 
These  are  of  particular  importance  given  the  numerous  technological  developments  in  the 
field  in  recent  years.  New  processing  methodologies,  unthought-of  of  when  the  Directives 
were adopted, are now commonly applied: pre-cutting of corneas with the transplant of only 
the anterior or posterior segment to one patient, decellularisation of skin and heart valves in 
the  tissue  establishment  to  enhance  cellularisation  in  vivo  in  the  recipient,  numerous  new 
pathogen inactivation or sterilisation techniques including the use of radioprotectants to allow 
treatment  with  high  doses  of  gamma  irradiation,  transplantation  of  highly  selected  cell 
populations to be used for the same essential function in the recipient as in the donor, have all 
increased the importance of robust preparation process authorisation. As suggested by some 
Member States, a procedure setting higher (minimum) standards for the authorisation of tissue 
and  cell  preparation  processes  at  the  tissue  establishments  (as  referred  to  in  Article  4  of 
Directive  2006/86/EC)  may  encourage  mutual  trust  and  acceptance  between  Member  States 
and thus strengthen the cross-border movement of tissues and cells across EU. 

Inspections and control measures.  The analysis of the replies concerning inspections of tissue 
establishments  indicates,  overall,  an  adequate  implementation  of  the  EU  requirements.  In 
terms  of  inspection  outcomes,  mostly  minor  shortcomings  were  recorded  with  few 
suspensions  and  revocations  of  authorisations  (Fig.  6).  This  may  suggest  that  tissue 
establishments are striving to comply with the EU quality and safety requirements, but it may 
also  indicate  under-enforcement,  e.g.  in  countries  which  have  never  reported  any 
shortcomings.  Even  though  most  respondents  confirmed  respecting  the  required  2-year 
interval  between  inspections,  some  Member  States  suggested  that  prioritising  inspections 
based on factors like the size of establishment, range of activity, experience of inspectors and 
compliance history may prove valuable especially in a period when financial constraints have 
a considerable influence on the staffing of departments in charge of inspections.  

Authorisation 
suspended 
4 
1% 

Authorisation 
revoked 
1 
0% 

Major 
shortcomings 
150 
27% 

No 
shortcomings 
49 
9% 

Authorisation 
suspended 
3 
1% 

Major 
shortcomings 
131 
29% 

Authorisation 
revoked 
3 
1% 

No 
shortcomings 
63 
14% 

Minor 
shortcomings 
345 
63% 

Minor 
shortcomings 
243 
55% 

a 

b 

Fig. 6. Outcome of tissue establishment inspections performed in 2011 

a.  Non-reproductive tissues and cells. Total inspections = 549; data reported by 22 Member States 

b.  Reproductive cells (ART sector). Total inspections = 443; data reported by 21 Member States 

7 

 
 
 
 
Another  important  issue  highlighted  by  some  Member  States  was  the  need  to  foster 
harmonisation  of  the  inspection  practices  in  the  Member  States.  Even  though  most  of  the 
Member  States  reported  using  the  Operational  Manual  for  Competent  Authorities  on 
inspection  of  tissue  and  cell  procurement  and  tissue  establishments11,  there  is  no  common 
inspections 
agreement  on 
(e.g. classification  of  minor,  major  and  critical  deficiencies).  As  a  consequence,  identical 
shortcomings may result in different outcomes for the inspected establishments depending on 
their geographical location (e.g. penalties vs.  revocation or suspension of license for the same 
deficiency).  

the  classification  of 

identified  during 

shortcomings 

Concerning  joint  inspections  by  authorities  from  more  than  one  Member  State,  a  small 
number have been organised in recent years. Their outcome was in general satisfying and in 
particular  allowed  bringing  expertise  where  this  might  be  missing  within  the  own  Member 
State.  

Traceability. The survey showed that a donor identification system was implemented by most 
Member  States,  with  a  unique  code  for  each  donation  being  assigned,  predominantly  at  the 
level  of  the  tissue  establishment.  It  has  to  be  underlined  that  countries  which  reported 
difficulties  in  implementing  the  donation  identification  system  were  either  developing 
a central  allocation  system  for  identifiers  or  were  waiting  for  the  adoption  of  the 
implementing legislation introducing a Single European Code for tissues and cells. Moreover, 
most  of  the  Member  States  stated  that  the  new  coding  requirements,  now  laid  down  in 
Directive  (EU)  2015/565  amending  Directive  2006/86/EC12,  should  contribute  to  a 
harmonised  implementation  of  the  Single  European  Code  for  tissues  and  cells  and  actively 
supported their development. Regarding data storage for at least 30 years, almost all Member 
States  and  EEA  countries  comply  with  the    requirements  of  Article  9  of  Directive 
2006/86/EC, by requesting both paper and electronic records to be maintained for that period.  

Import/export  of  human  tissues  and  cells  to/from  third  countries.  The  data  provided,  even 
though incomplete and sometimes not precisely defined, confirm that increasing volumes of 
human  tissues  and  cells  are  imported  from  or  exported  to  third  countries  (Fig.  7). 
Nevertheless,  it  has  to  be  noted  that  it  is  difficult  to  draw  firm  conclusions  regarding  the 
volume of imports and exports of human tissues and cells due the lack of mandatory reporting 
of  such  information  at  national  level  and  absence  of  a  harmonised  framework  for  data 
collection  in  the  Member  States.  This  may  also  explain  why  some  Member  States  have  not 
put in place a coherent policy to ensure national sufficiency at least for some type of tissues or 
cells.  

In  addition,  some  countries  do  not  distinguish  between  distribution  within  the  Union  and 
import/export from/to third countries which may be considered an important hurdle, not only 
against  data  collection and  analysis,  but  also against  optimal  circulation  of  tissues  and  cells 
for patient benefit across the EU.  

http://ec.europa.eu/health/blood_tissues_organs/docs/manual_en.pdf  

11 
12  Commission Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the 

coding of human tissues and cells (OJ L 93, 9.4.2015, p. 43). 

8 

 
 
                                                            
 
Other (e.g 
amnion) 
20 
0% 

Musculoskel
etal tissues 
898 
17% 

Ocular 
tissues 
245 
5% 

Cardiovascul
ar tissues 
11 
0% 

Haematopoi
etic stem 
cells 
758 
14% 

Reproductive 
cells 
3445 
64% 

Cardiovascula
r tissues 
3 
0% 

Ocular tissues 
405 
4% 

Musculoskelet
al tissues 
4830 
43% 

Haematopoie 
tic stem cells 
353 
3% 

Reproductive 
cells 
158 
1% 

Skin 
5453 
49% 

a 

b 

Fig. 7.  

a. 

b. 

Volume of tissues and cells (units) imported in 2011 (data reported by 15 Member States)  

Volume of tissues and cells (units) exported in 2011 (data reported by 11 Member States) 

Register  of  tissue  establishments  and  reporting  obligations.  In  line  with  the  requirements  in 
Article 10 of Directive 2004/23/EC, national registers of tissues establishments appear to be 
available in most of the responding Member States. However, the tissue establishment reports 
are not always publicly available, mainly due to different interpretations of this provision by 
the  Member  States  authorities.  The  new  legal  provisions  for  the  application  of  the  Single 
European  Code13  shall  also  satisfy  the  requirement  in  Article  10(3)  of  the  Directive 
2004/23/EC, by establishing the EU Tissue Establishment Compendium including all tissues 
their 
establishments 
accreditation/designation/authorised  or  licence14.  By  updating  the  data  in  this  Compendium, 
the tissues and cells competent authorities demonstrate full transparency and provide support 
to  healthcare  professionals  searching  for  an  authorised  tissue  or  cell  provider  within  the 
Union. Moreover, the inclusion in the  EU Tissue Establishment Compendium will reinforce 
the  credentials  of  the  EU  tissue  establishments  to  their  partners  and  customers  around  the 
world.  

coordinates 

status 

their 

with 

and 

the 

of 

Notification  of  serious  adverse  reactions  and  events  (SARE).    The  analysis  of  the  annual 
SARE reports submitted by the Member States demonstrates notable efforts to comply with 
the requirements in Article 7 of Directive 2006/86/EC. In spite of this, both the Commission 
and national competent authorities for tissues and cells acknowledge that there is still a high 
degree  of  under-reporting  requiring  careful  consideration  when  analysing  the  data.    The 
importance  of  SARE  reporting  is  confirmed  by  the  interest  of  the  Member  States  in 
collaborating with the Commission to improve the current reporting system (e.g. refining the 
SARE  reporting  templates  for  improving  collection  of  data  in  the  sector  of  assisted 
reproduction technology (ART)) and to expand communication with other countries and other 
sectors  (e.g.  fostering  cooperation  with  relevant  third  countries  with  regard  to  SARE 
reporting). It should be noted that, although much has been achieved and reporting improves 
every  year,  challenges  related  to  under-reporting  by  organisations  responsible  for  human 

13  Commission  Directive  (EU)  2015/565  of  8  April  2015  amending  Directive  2006/86/EC  as  regards  certain  technical 

requirements for the coding of human tissues and cells. OJ L 93, 9.4.2015, p. 43–55 

14  EU  Tissue  establishment  compendium  is  part  of  the  EU  Coding  platform  that  was  introduced  by  the  Directive  (EU) 
2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and 
cells. 

9 

 
 
 
 
                                                            
application and the lack of accurate data remain. The overall aim of the annual reporting, to 
identify the most frequent causes of SARE and provide appropriate corrective measures, has 
not yet been fully achieved. In this regard, more training of both healthcare professionals and 
vigilance  officers  in  tissue  establishments  and  competent  authorities  will  be  needed  for  an 
appropriate identification and analysis of the “root causes” of these SARE, which should lead 
to the identification and correction of systematic errors.  

Even  though  the  current  requirements  in  Directive  2006/86/EC  refer  only  to  reporting  of 
serious adverse reactions (SAR) in recipients of tissues and cells, the voluntary reporting of 
SAR  in  donors  has  gradually  improved  in  the  past  years,  suggesting  the  Member  States' 
increasing  interest  in  the  protection  of  living  donors.  Some  national  competent  authorities 
considered that it would be useful to strengthen the consideration of pharmacovigilance data 
regarding  medicinal  products  that  are  used  in  the  context  of  donations  of  tissues  and  cells. 
Additionally,  for  cases  in  which  tissues/cells  from  one  donor  will  be  used  for  both 
transplantation  and  manufacturing  of  ATMP,  consideration  should  be  given  on  how  to  best 
exchange  relevant  data  between  the  pharmacovigilance  and  biovigilance  systems  (e.g. 
donation of cells from a living donor which may be found to develop a tumour after donating 
cells  to  an  ATMP  manufacturer  or  recipient  developing  a  tumour/communicable  disease 
following therapy with donated cells from a donor who may have donated cells transplanted 
in another recipient). 

3.3. Donor selection and evaluation  

Consent, data protection and confidentiality. Overall, the survey showed that regardless of the 
consent  system,  all  responding  countries  have  put  measures  in  place  for  verifying  donor 
consent.  An  alert  issued  in  RATC  accompanied  by  recall  of  products  from  an  EU  tissue 
establishment revealed that the consent form and its verification may be very different from 
one  Member  State  to  another,  depending  also  on  the  legal  framework  under  which  the  EU 
tissue  and  cell  legislation  has  been  transposed.  Even  though  only  trained  personnel  are 
allowed to provide appropriate information to donors, this information has been standardised 
at national level in a small number of countries. Concerning donor anonymity, most countries 
rely on the EU and national data protection legislation, but also on coding. In this context, the 
new  requirements  on  the  application  of  the  Single  European  Code  for  tissues  and  cells  laid 
down  in  Directive  (EU)  2015/565  may  be  considered  an  additional  tool  for  ensuring  that 
donor  data  are  not  disclosed  to  the  recipient14.  No  problems  were  reported  regarding  the 
implementation of the provisions related to data protection.   

Donor  selection  and  evaluation.  The  current  survey  showed  that  in  addition  to  the 
requirements  in  the  Directive  2006/17/EC,  the  more  stringent  selection  criteria  required  by 
Member  States  are  usually  justified  for  local  reasons,  such  as  the  increased  prevalence  of 
a certain disease. Divergent criteria might however also create barriers for exchanging tissues 
and cells between Member States for healthcare professionals requesting tissues or cells from 
another  Member  State.  Such  difficulties  were  also  reported  by  operators  manufacturing 
ATMP from human tissues and cells. Several of the selection criteria, as well as the tasks of 
the responsible persons in Member States with more stringent requirements, have been subject 
to  discussion  during  the  bi-annual  national  competent  authority  meetings.  It  was  underlined 
that Member States introducing more stringent safety and quality requirements should inform 
the  other  Member  States  and  EEA  countries,  as  well  as  the  Commission,  regarding  these 
measures,  in  a  transparent  manner.  It  was  also  suggested  that  the  full  list  of  these  more 
stringent requirements could be made available by the Commission.  

When  verifying  the compliance  of  tissues  establishments  with  the  EU  donor  evaluation  and 
selection  requirements,  inspections  are  the  most  important  verification  method  used  by  the 

10 

 
 
Member State competent authorities. Nevertheless, it has to be underlined that a small number 
of countries rely only on the medical records of the donor and/or the autopsy report without 
interviewing  the  donor’s  family  or  his/her  treating  physician/general  practitioner.  The 
application of selection criteria should be transparent and subject to continuous evaluation in 
order to minimize safety risks.  

Procurement  of  tissues  and  cells.  In  most  of  the  Member  States  compliance  with  the 
requirements  for tissue and cell procurement set  by Directive 2006/17/EC is  verified by the 
competent  authorities  when  performing  inspections,  but  also  by  auditing  procurement 
organisations and centres of human application. Responses to the survey showed that this is 
also  the  case  for  procurement  of  tissues  and  cells  for  ATMP  manufacturers,  in  line  with 
Article  3  of  the  ATMP  Regulation.  Provisions  associated  with  procurement,  but  also  with 
donation and testing, are regulated by the tissue and cell legislation and verified during tissue 
establishment inspection. 

Donor  testing.  The  data  reported  show  that  the  EU  and  EEA  countries  comply  with  the 
minimal testing requirements stipulated in the Directive 2006/17/EC. Several countries have 
introduced  more  stringent  testing  requirements  such  as  nucleic  acid  testing  (NAT)  for 
hepatitis B (HBV), hepatitis C (HCV) and/or human immunodeficiency virus (HIV) for non-
reproductive and/or  reproductive tissue  and cells, whereas in most  Member  States and EEA 
countries the use of this type of testing is not required on the basis of  a cost-benefit analysis 
and/or  the  epidemiological  context.  Additional  tests  required  by  Member  States  are  usually 
justified  for  local  reasons,  like  e.g.  the  increased  prevalence  of  a  certain  infectious  disease. 
Several of the testing requirements (e.g. no requirement for NAT testing, the 24 hours limit 
for  blood  sample  collection  from  a  deceased  donor,  testing of  gamete  donors  at  the  time  of 
donation)  have  been  subject  to  debate  at  the  bi-annual  national  competent  authorities 
meetings15 and the various practices shared by the competent authorities showed the need for 
an  evidence-based  risk  assessment  of  some  practical  situations  which  were  not  clearly 
defined/foreseen in Directive 2006/17/EC. It has to be noted that similar to donor selection, 
more  stringent  testing  requirements  introduced  by  some  Member  States  are  sometimes 
perceived by healthcare professionals  ordering tissues or  cells  from other  Member States as 
barriers hampering development and the cross-border movement of tissues and cells between 
Member  States.  Several  Member  States  suggested  that  a  common  list  of  diagnostic  tests 
(panel) for some genetic diseases may be valuable for increasing safety in the EU ART sector.  

3.4. Voluntary and unpaid donation (VUD) 

This  report  shows  that  Member  States  overall  comply  with  Article  12  of  Directive 
2004/23/EC requiring Member States to take the necessary measures to endeavour to ensure 
VUD of tissues and cells. However, the ways in which Member States have implemented the 
principle of VUD are difficult to assess in a comprehensive manner. It has to be highlighted 
that VUD is a factor which is not only ethical in nature, but which may contribute to higher 
safety standards for tissues and cells and therefore to the protection of human health. If donor 
payment were allowed, some individuals could find the monetary remuneration so important 
that  they  might  hide  relevant  medical  and/or  behavioural  information.  Additional  screening 
and  testing  may  reduce,  but  cannot  completely  eliminate,  the  possibility  of  a  transmission 
from  donor  to  recipient.  Therefore  information  provided  by  the  donor  or  his/her  family 
contributes  to  an  accurate  assessment  of  all  risks  associated  to  the  application  of  donated 
tissues or cells. 

15 

http://ec.europa.eu/health/blood_tissues_organs/docs/tissues_mi_20110623_en.pdf  

11 

 
 
                                                            
The  large  majority  of  the  responding  countries  (28)  reported  that  the  principle  of  VUD  is 
mandatory  at  national  level.  However,  one  Member  State  who  reported  that  the  VUD 
principle is mandatory indicated that payment of gamete donors is allowed at national level. 
Another Member State and one EEA country have not yet defined national provisions on the 
application of the VUD principle.  

Although the principle of VUD is mandatory in the large majority of the Member States, its 
concrete application varies across the Union. Only 17 Member States reported having guiding 
principles  regarding the possibility  to  compensate  tissue  and  cell  donors,  but  in  many  cases 
these  principles  were  just  a  description  of  the  practices  allowed  at  national  level.  This  may 
explain the considerable heterogeneity across the EU in the practices vis-à-vis tissue and cell 
donors, with some practices being regarded as compensation in one country and incentives or 
other practices in others. The differences in purchasing power between Member States might 
also explain why a measure is considered a “compensation” in one country and an “incentive” 
in another.  

An  important  issue  is  how  and  by  whom  the  decision    concerning  the  value  and  form  of 
compensations for tissue and cell donors is taken. Most Member States allow compensation to 
be  offered  to  living  donors  (22  countries  for  living  donors  of  non-reproductive  tissues  and 
cells; 17 countries for donors of reproductive cells). Only in a small number of Member States 
is  the  value  of  the  compensation  provided  to  tissue  and  cell  donors  connected  to  national 
economic  indicators  (e.g.  monthly  income,  purchasing  capacity).  Giving  lump  sums  to 
reproductive cell donors, as practised in some countries, may alleviate administrative burden, 
but  it  also  raises  questions  when  the  value  is  determined  solely  by  tissue  establishments  or 
when  the  value  is  significantly  high  in  relation  to  average  national  monthly  income. 
Reimbursement  of  costs  linked  to  travel  and  medication  based  on  actual  costs/receipts  are 
among  the  most  commonly  used  type  of  compensation  for  living  donors.  Other  practices 
include compensation for the inconveniences related to the donation. Limited information was 
provided  on  the  value  of  most  of  the  practices  related  to  tissue  and  cell  donation,  probably 
because  the  costs  vary  considerably  depending  on  the  donation  circumstances  (e.g.  need  of 
prior  testing/medical  treatment,  duration  of  hospitalisation,  effects  on  the  overall  health  and 
capacity to work) or depend on the clinic where the donation takes place.  

States 

Verification  by  the  competent  authorities  of  the  implementation  of  the  VUD  principle  in 
tissue establishments is focused on inspecting documentation related to donor consent. Only 
15  Member 
like 
examination/inspection/approval  of  advertising  materials,  training  of  professionals  to  spot 
illegal  and  fraudulent  activities,  verification  that  the  VUD  principle  is  also  respected  for 
imported  tissues  and  cells.  Verification  during  inspections  of  standard  operating  procedures 
(SOP)  prepared  by  the  tissue  establishments  and  inspecting  patient  and  donor  information 
provided by licensed fertility clinics were reported only by two Member States. 

additional  measures 

reported 

putting 

place 

in 

Development of follow-up registries as an additional tool for ensuring safety of living donors 
was  also  addressed  in  the  survey.  In  this  regard,  18  Member  States  and  one  EEA  country 
reported to have a follow-up registry or database of haematopoietic stem cell donors, but the 
type  of  the  follow-up  examinations,  their  periodicity  and  the  responsible  healthcare 
facilities/professionals  may  vary  from  country  to  country.  Only  six  Member  States  have 
national registries of oocyte and sperm donors. Five Member States have both central oocyte 
and sperm donor  registries. On the other  hand, ten Member  States indicated that, especially 
for  sperm  donors,  such  registries  are  maintained  by  the  tissue  establishments.  It  should  be 
highlighted  that  several  Member  States  indicated  that  there  is  no  national  legal  requirement 
for organising national follow-up registries for living donors. 

12 

 
 
Regarding practices vis-à-vis deceased donors of tissues and cells, only three Member States 
reported that they provide compensation to donor relatives. These consist mainly in providing 
administrative support for the funeral and ensuring full or partial coverage of the cost of the 
funeral/burial/cremation.  Even  though  this  practice  is  considered  as  compensation  by  the 
competent  authorities,  it  may  be  perceived  as  an  incentive  by  the  family/relatives  of  the 
deceased donors, especially in the absence of an expressed consent of the deceased person or 
when,  due  to  financial  constraints,  the  relatives  have  difficulty  covering  the  costs  of  the 
funeral/burial/cremation.   

It  is  important  to  note  that  a  recent  Eurobarometer  survey  on  blood  and  cell  and  tissue 
donation16  showed  that  only  13%  of  EU  citizens  considered  acceptable  to  receive  cash 
amounts  in  addition  to  the  reimbursement  of  the  costs  related  to  the  donation.  However, 
a significant percentage of the respondents (48%) considered that receiving refreshments, free 
testing, or a free physical check-up seem suitable when donating human tissues and cells. 

In relation to the supply-demand balance, 17 Member States and one EEA country reported 
experiencing  regular  shortages  of  tissues  and  cells  on  a national  level,  mostly  for  bone 
marrow  and  haematopoietic  stem  cells,  corneas  and  bone.  The  main  reasons  for  shortages 
were the lack of donors, followed by insufficient procurement capacity at national level and 
technical reasons (e.g. practical difficulties in finding a compatible match for patients in need 
of  an  HSC  transplantation).  In  addition,  the  survey  showed  that  nineteen  countries  (17 
Member States and two EEA countries) did not put in place national policies for promoting 
national self-sufficiency/sufficiency17 for tissues and cells and do not always collect data on 
cross-border movement of tissues and cells at national level. This may suggest a role for the 
EU in supporting Member States to develop national sufficiency policies although the exact 
impact  of  such  policies  on  cross-border  exchanges  and  the  supply  of  starting  materials  for 
medicinal product manufacture would need to be carefully analysed.  

The findings of the VUD survey suggest that Member States should collect more information 
on  the  day-to-day  practices  vis-à-vis  donors  in  both  procurement  organisations  and  tissue 
establishments, especially when these operators are responsible  for deciding the type and/or 
value of the compensation provided to donors.  

On the basis of the information collected, the Commission will  follow up  with the Member 
States  in  order  to  promote,  where  desirable,  a  common  understanding  of  Article  12  in  the 
Directive  2004/23/EC.  Issues  to  be    addressed  include    transparency  of  the  decisions 
regarding donor compensation, the type and value of the compensations for donors, especially 
for the situations when such decisions were conveyed to procurement organisations or tissue 
establishments.  Best  practices  to  ensure  tissue  and  cell  sufficiency/self-sufficiency  or 
measures to reduce shortages might be  addressed as well as best practices on verification of 
the  implementation  of  the  VUD  principle  by  the  competent  authorities.    There  is  a  need  to 
find the  most  appropriate solutions to  ensure both  the respect of the Article 12 of Directive 
2004/23/EC  and  an  adequate  supply  of  tissues  and  cells  to  the  patients  in  need  across  the 
Union. 

http://ec.europa.eu/COMMFrontOffice/PublicOpinion/index.cfm/Survey/getSurveyDetail/search/426/surveyKy/2030 

16 
17  For the purpose of the survey, in order to facilitate a consistency in replies, those terms were defined as follows:  

- 

- 

'National  self-sufficiency'  was  defined  as  fulfilling  the  needs  of  human  tissue  and  cell  products  for  medical 
application  (e.g.  transplantation,  ART  procedures)  of  the  resident  population  by  accessing  resources  from  within 
the country’s population.  
'National sufficiency was defined as fulfilling the needs of human tissue and cell products for medical application 
(e.g. transplantation, ART procedures) of the resident population by accessing resources from within the country 
and through regional/international cooperation. 

13 

 
 
                                                            
3.5.  Quality and safety of tissues and cells 

It has to be highlighted that safety and quality is a major concern for EU citizens, with 56% of 
respondents  to  the  Eurobarometer  survey  on  blood  and  cell  and  tissue  donation18  citing  the 
risk  of  contracting  a  disease  as  a  major  concern  when  accepting  donated  substances.  A 
majority also supported European legislation to ensure the safety and quality of blood, tissues 
and cells. 

is  systematically  verified  during 

Quality  management,  responsible  person  and  personnel.  The  present  implementation  survey 
confirmed  that  Member  States  are  trying  to  ensure  an  appropriate  level  of  training  for  their 
tissue  establishment  personnel,  and  the  compliance  with  the  requirements  of  Directive 
2004/23/EC 
inspections  and  also  before  granting 
authorisation/accreditation/licence  to  tissue  establishments.  It  is  noted  that  an  additional 
support on training of tissue establishment personnel was given through EU-funded projects 
such as European Quality System for Tissue Banking (EQSTB)18 and European Good Tissue 
Practices  (EuroGTPs)19.  Good  practices  developed  by  the  EU-funded  initiatives  were  also 
included by the Council of Europe in a dedicated Guide to the Quality and Safety of Tissues 
and Cells20. In this regard, several national competent authorities have called for an EU-level 
endorsement  of  Good  Tissue  Practice  guidelines  (GTP),  similar  to  Good  Manufacturing 
Practice  guidelines  (GMP)  approach  in  the  pharmaceutical  sector  and  for  continuing  to 
provide support for training of inspectors at the EU level. 

Tissue  and  cell  reception,  processing,  storage,  labelling  and  packaging.  The  importance  of 
inspections was highlighted again in the context of compliance with the requirements in the 
Directive  2006/86/EC,  as  the  most  frequent  approach  to  verify  their  implementation. 
Mandatory  SOPs  are  also  required  during  the  authorisation/accreditation/designation  or 
licensing process in most of the responding countries. Developing more detailed requirements 
for these activities as part of GTP was supported by several national competent authorities for 
tissues and cells.  

Distribution of tissues and cells for human application. As demonstrated by the Member State 
replies, there are important cross-border movements of human tissues and cells within  the EU 
and  EEA  countries  (Fig.  8).  Even  though  such  movements  may  be  explained  by  the 
globalisation  of  healthcare  products  and  services,  the  common  quality  and  safety  standards 
laid down in the EU tissues and cells legislation have created the framework for facilitating 
trans-national  movements  within  the  Union.  However,  it  has  to  be  noted  that,  as  for  import 
and  export,  data  collected  by  the  Member  States  probably  serve  different  purposes  and  use 
various methodologies, so it is very difficult to draw a clear conclusion on the importance of 
EU  distribution  compared  to  import/export  from/to  third  countries  and  therefore  to  evaluate 
tissue and cell sufficiency at EU level.  

One concern raised during national tissue and cell competent authorities meetings was direct 
distribution of gametes (i.e. sperm) to individuals for self-application without the involvement 
of  a  health  professional.  Several  authorities  underlined  that  in  such  situations  there  is  a 
significant risk of losing traceability, including inappropriate reporting of pregnancy rate and 
serious  adverse  reactions  following  medical  application  (e.g.  children  born  with  genetic 
diseases not reported back to the distributing tissue establishment). The competent authorities 
allowing  such  practices  were  requested  to  evaluate  if  and/or  how  traceability  and  reporting 
requirements are ensured by the tissue establishments distributing gametes to individuals and 

18 
19 
20 

http://ec.europa.eu/chafea/projects/database.html?prjno=2003209  
http://eurogtps.com/  
https://www.edqm.eu/en/organ-tissues-cells-transplantation-guides-1607.html  

14 

 
 
                                                            
Cardiovasc
ular tissues 
(heart 
valves, 
vessels) 
141 
1% 

HSC (bone 
marrow, 
PBSC, cord 
blood, DLI) 
1033 
8% 

to  take  the  necessary  measures  in  case  such  practices  do  not  fulfil  the  safety  and  quality 
requirements  laid  down  in  the  EU  tissue  and  cell  legislation.  The  Commission  is  closely 
following this case. 

ART 
Sperm 
1233 
19% 

ART 
oocytes 
745 
11% 

ART 
embryo 
83 
1% 

Other 
(amniotic 
membrane) 
14 
0% 

ART 
embryo 
28 
0% 

Other  
113 
1% 

Musculoske
letal tissues 
1450 
11% 

Ocular 
tissues 
316 
3% 

ART 
oocytes 
760 
6% 

HSC (bone 
marrow, 
PBSC, cord 
blood, DLI) 
405 
6% 

Cardiovasc
ular tissues 
(heart 
valves, 
vessels) 
327 
5% 

Ocular 
tissues 
232 
4% 

a 

Musculosk
eletal 
tissues 
3516 
54% 

ART Sperm 
8827 
70% 

Fig. 8.  

b 

Volume of tissues and cells (units) distributed from one MS to other EU MS and/or EEA 

a. 
countries in 2011 (Data reported by 18 countries)  

Volume of tissues and cells (units) received by MS from other EU MS and/or EEA countries in 

b. 
2011 (Data reported by 15 Member States) 

Relations between tissue establishments and third parties. The fact that third parties may be 
involved  in  all  steps  of  the  chain  from  donation  and  procurement  to  distribution  in  most 
Member  States  highlights  the  importance  that  needs  to  be  given  to  the  written  agreements 
established  by  tissue  establishments  and  their  verification  by  the  national  competent 
authorities.  In  this  respect,  it  should  be  highlighted  that  the  new  Directive  (EU)  2015/56621 
provides for the harmonisation of the minimum requirements in terms of contents of written 
agreements between importing tissue establishments and their third country suppliers. 

Penalties. The penalties foreseen in national legislation, their criteria for implementation and 
their  effective  implementation  can  differ  significantly  between  Member  States.  There  is  no 
harmonisation  in  defining  or  applying  such  penalties,  therefore  it  is  difficult  to  evaluate 
whether similar measures are applied by all the Member States in case of a specific breach of 
the legislation in this area. In any event, the number of penalties imposed is very low. 

4.  Support for the implementation of the EU tissue and Cell Directives  

The European Commission has been supporting the implementation of the legislation by the 
Member States by encouraging the active participation of national Competent Authorities in a 
series of actions, from bi-annual expert group meetings to EU-funded projects. 

The  regular  meetings  of  the  national  competent  authorities  as  part  of  the  Competent 
Authorities on Substances of Human Origin Expert Group (CASoHO E01718) developed into 

21  Commission Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the 

equivalent standards of quality and safety of imported tissues and cells (OJ L 93, 9.4.2015, p. 56).  

15 

 
 
 
 
 
                                                            
a  well-appreciated  platform  for  discussions,  allowing  for  sharing  best  practices  and 
clarification of common difficulties encountered at national and EU level.     

Since 2003, a number of projects have been funded under the  multi-annual programmes for 
Union action in the field of health22 addressing the area of human tissue and cells for clinical 
application.  Projects  such  as  EUSTITE,  EuroGTP,  SOHO  V&S,  and  the  on-going  joint 
actions ARTHIQS and VISTART23 have provided a strong support to Member States in their 
efforts  to  implement  the  requirements  of  the  EU  tissue  and  cell  legislation.  These  actions 
allowed for the development of guidelines and manuals in areas of common interest such as 
inspections and vigilance, included training courses for Member States Competent Authorities 
and  their  inspectors  and  brought  together  professionals  in  the  tissue  banking  sector  for  the 
development of detailed technical guidance in line with the EU legal requirements.  

As regards the risk of transmission of communicable diseases thorough tissues and cells, the 
collaboration with ECDC proved extremely valuable. In addition to providing regular updates 
during  the  bi-annul  meeting  of  the  tissue  and  cell  expert  sub-group  on  the  epidemiological 
situation relevant to the tissue and cell sector, the development of risk assessments (e.g. for 
HTLV, malaria, dengue and chikungunya)  and preparedness plans (e.g. for WNV outbreaks) 
provided a valuable contribution to policy and decision making in this sector at both national 
and EU level.   

Finally the Commission developed - in close cooperation with Member States - a Rapid Alert 
Platform for Tissues and Cells (RATC) which facilitates web-based communications between 
Member States in case of alerts relating to human tissues or cells transferred across borders. 

5.  Conclusions 

In  conclusion, this  Report reveals  an overall adequate  application  of the current  quality  and 
safety  requirements  of  the  EU  tissues  and  cells  legislation  in  most  of  the  responding  EU 
Member  States  and  EEA  countries.  Significant progress  has  been  made  in  many  areas,  also 
through the active support by Commission funded projects and other initiatives. However, the 
report points to  some gaps  and difficulties in  relation to  the application and enforcement of 
the  existing  provisions  (e.g.  definitions,  requirements  on  the  safety  aspects  regarding  living 
donors, inspections framework), some of them owing to the different  approaches taken by the 
Member States when transposing and implementing the current EU legislation and others due 
to  the  scientific  and  technologic  developments  since  the  adoption  of  the  Directives.  The 
Commission  will  follow-up  with  Member  States  to  address  situations  where  the  legislation 
might not have been fully or correctly implemented. 

As  regards  the  implementation  of  the  VUD  principle,  the  Commission  survey  showed  that 
Member  States  overall  comply  with  Article  12  of  Directive  2004/23/EC  requiring  them  to 
take  the  necessary  measures  to  encourage  VUD.  However,  Member  States  interpretation  of 
what is considered compensation and incentive vary.   

The gaps and difficulties identified suggest that a further in-depth evaluation might be useful. 
The  Commission  will  consider  the  need  for  an  evaluation  in  order  to  assess  the  relevance, 
effectiveness, efficiency, coherence and the EU added value of Directive 2004/23/EC and its 
implementing Directives.  

22 
23 

http://ec.europa.eu/chafea/documents/health/leaflet/transplantation-transfusion.pdf 
http://ec.europa.eu/health/blood_tissues_organs/projects/index_en.htm 

16