Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
Date: 2010-01-06
Institutions: European Commission
Subjects: application of EU law, cytology, exchange of information, organ transplantation, quality standard, report, safety standard, storage, trading operation

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EUROPEAN COMMISSION 

Brussels, 6.1.2010 
COM(2009)708 final 

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL, THE 
EUROPEAN PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE AND THE COMMITTEE OF THE REGIONS 

on the application of Directive 2004/23/EC on setting standards of quality and safety for 
the donation, procurement, testing, processing, preservation, storage and distribution of 
human tissues and cells 

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COMMUNICATION FROM THE COMMISSION TO THE COUNCIL, THE 
EUROPEAN PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE AND THE COMMITTEE OF THE REGIONS 

on the application of Directive 2004/23/EC on setting standards of quality and safety for 
the donation, procurement, testing, processing, preservation, storage and distribution of 
human tissues and cells 

1. 

INTRODUCTION 

Article  26  of  Directive  2004/23/EC1  requires  Member  States  to  submit  to  the 
European Commission, before 7 April 2009 and every three years thereafter, a report 
on  the activities  undertaken 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  reports  to  the  European  Parliament,  the 
Council,  the  European  Economic  and  Social  Committee  and  the  Committee  of  the 
Regions,  and  to  provide  them  with  a  report  on  the  implementation  of  the 
requirements of the Directive, in particular as regards inspections and monitoring. 

This  report  is  based  on  the  replies  to  questionnaires  on  transposition  and 
implementation that Member States send to the Commission on a yearly basis and is 
particularly focussed on the one referring to the year 2008. All Member States except 
Latvia and Luxembourg submitted a report on the activities undertaken in relation to 
the provisions of the Directive in 2008. Norway, Croatia and Turkey also submitted a 
report. 

This first Commission report provides an overview of the situation in the 27 Member 
States.  

2. 

RESULTS 

2.1. 

Implementing Directives 

Directive  2004/23/EC  provides  that  specific  technical  requirements  should  be 
adopted  in  accordance  with  the  ‘Comitology’  procedure.  In  this  respect,  two 
Commission Directives supplement the provisions of Directive 2004/23/EC: 

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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 L 102, 7.4.2004, p. 48). 

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● 

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Commission  Directive  2006/17/EC  of  8  February  2006  as  regards  certain 
technical  requirements  for  the  donation,  procurement  and  testing  of  human 
tissues and cells2.  

Commission Directive 2006/86/EC of 24 October 2006 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 cells3. 

Member  States  may  maintain  or  introduce  more  stringent  protective  measures  than 
those  of  Directive  2004/23/EC  provided  that  they  comply  with  the  Treaty.  For 
instance,  14  Member  States  apply  additional  testing  requirements  to  take  into 
account  their  specific  national  epidemiological  situation  (for  more  information,  see 
section 2.5.1). 

No  Member  State  indicated  particular  problems  in  intra-community  exchanges  of 
tissues and cells due to more stringent measures in other Member States. 

2.2. 

Designation of competent authorities (Art. 4 of Directive 2004/23/EC) 

Under  Article  4(1),  Member  States  must  designate  the  competent  authority  or 
authorities  responsible  for  implementing  the  requirements  of  the  Directive.  All 
Member  States  have  designated  a  competent  authority  in  accordance  with  this 
provision.  In  21  Member  States,  the  designated  competent  authority  is  responsible 
for  all  types  of  tissues  and  cells.  France,  Greece,  Portugal,  Finland  and  the  United 
Kingdom have a specific competent authority for reproductive tissues and cells. 

2.3. 

Obligations on Member States’ authorities (Art. 5-11 of Directive 2004/23/EC) 

2.3.1. 

Supervision of human tissue and cell procurement (Art. 5) 

Under  Article  5,  the  competent  authority  or  authorities  must  ensure  that  tissue  and 
cell  procurement  complies  with  the  stipulated  requirements.  Commission  Directive 
2006/17/EC  established  the  requirements  for  the  procurement  of  tissues  and  cells: 
selection  criteria  for  donors,  testing  requirements,  consent  and  donor  identification, 
procurement procedures, reports, labelling and reception at the tissue establishment. 

procurement 

organisations 

The 
be 
accredited/designated/authorised/licensed  by  the  competent  authority  or  authorities 
but the conditions of procurement need to be verified. These could be checked via an 
inspection  of  the  procurement  organisation  or  via  an  inspection  of  the  tissue 
establishment receiving tissues and cells from a particular procurement organisation. 
In  this  respect,  six  Member  States  (Bulgaria,  Germany,  Denmark,  France,  Ireland 

have 

not 

do 

to 

2 

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Commission  Directive  2006/17/EC  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 L 38, 9.2.2006, p. 40). 
Commission  Directive  2006/86/EC  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 L 294, 25.10.2006, p. 32). 

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and  the  United  Kingdom)  carried  out  53  inspections  of  procurement  organisations 
during 2008. 

2.3.2.  Accreditation/designation/authorisation/licensing of tissue establishments and tissue 

and cell preparation processes (Art. 6) 

Under Article 6(1), Member States must have in place an appropriate mechanism to 
ensure  that  all  tissue  establishments  where  activities  of  testing,  processing, 
preservation, storage and distribution of human tissues and cells intended for human 
applications are undertaken have been accredited, designated, authorised or licensed 
by a competent authority for the purpose of those activities.  

An  accreditation/designation/authorisation/licensing  system  of  tissue  establishments 
is  in  place  in  23  Member  States  (Belgium,  Bulgaria,  Czech  Republic,  Denmark, 
Germany, Estonia, Ireland, Spain, France, Italy, Cyprus, Latvia, Lithuania, Hungary, 
the  Netherlands,  Austria,  Poland,  Portugal,  Romania,  Slovenia,  Slovakia,  Finland, 
and  the  United  Kingdom).  The  system  is  decentralised  in  five  Member  States 
(Germany,  Spain,  France,  Italy  and  Hungary)  where  the  process  is  channelled 
through federal states, regions or autonomous communities. 

Sweden,  Malta  and  Greece  did  not  have  an  accreditation/designation/authorisation/ 
licensing system in place at the end of 2008. Sweden intends to implement its system 
during the course of 2009. 

No information has been received from Luxembourg in this respect. 

Although the accreditation/designation/authorisation/licensing system is for the most 
part established in the Member States, around half of them indicated that they have 
yet 
the  accreditation/designation/  authorisation/licensing  of  each 
individual tissue establishment in their territory. 

to  finalise 

Inspections  play  a  key  role  in  the  accreditation/designation/authorisation/licensing 
system which varies from prior compulsory on-site inspections to desk-based review 
of documentation. 

Under  Article  6(2),  the  competent  authority  or  authorities  must  authorise  the  tissue 
and cell preparation processes which the tissue establishment is entitled to carry out. 
Fourteen  Member  States  have  specific  systems  for  authorising  tissue  and  cell 
preparation processes (Belgium, Bulgaria, Czech Republic, Germany, Ireland, Spain, 
France, Cyprus, Lithuania, the Netherlands, Austria, Poland, Portugal and Slovenia). 
In the other Member States, in the absence of specific authorisation systems, tissue 
and cell preparation processes are normally verified and authorised during a general 
inspection  for  the  purpose  of  accreditation/designation/authorisation/licensing  of  a 
tissue  establishment.  In  some  Member  States,  a  different  institution,  independent 
from  the  competent  authority  or  authorities,  is  responsible  for  validating  and 
authorising  of  the  preparation  process.  This  is  the  case  in  Romania,  where  the 
Medical  College  of  Physicians  is  responsible  for  the  approval  of  the  preparation 
processes. 

Only  three  Member  States  (France,  Germany  and  Ireland)  conducted  inspections 
solely for the purpose of authorising preparation processes in 2008.  

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According to the information received from Member States, as of 31 December 2008 
a total of 1 716 tissue establishments were accredited/designated/authorised/licensed: 
42  skin  establishments,  172  musculo-skeletal  establishments,  63  ophthalmic 
establishments  (cornea,  sclera,  etc.),  49  vascular  establishments  (heart  valves, 
vessels,  etc.),  193  haematopoietic  stem  cell  establishments  (other  than  cord  blood), 
91 cord  blood  banks,  769  reproductive  tissue  and  cells  establishments,  270  multi-
tissue  establishments  and  67  other  types  of  tissue  and  cells  establishments 
(chondrocyte  cells,  genetically  modified  cells,  keratinocyte  cells,  myeloblast  cells, 
etc.). 

Under Article 6(4), the competent authority or authorities may revoke or suspend the 
accreditation/designation/authorisation/licensing  of  a  tissue  establishment  if  it  is 
found  to  no  longer  comply  with  the  requirements  of  the  Directives.  Five  Member 
States (Denmark, France, the Netherlands, Poland and Romania) indicated that some 
initial approvals given to tissue establishments were revoked for various reasons such 
us lack of traceability systems, suspicion of illegal or fraudulent activities, problems 
with 
the 
accreditation/designation/authorisation/licensing requirements. 

compliance  with 

sterilisation 

processes, 

lack 

or 

of 

2.3.3. 

Inspections and control measures (Art. 7) 

Under  Article  7(1),  Member  States  must  ensure  that  the  competent  authority  or 
authorities  organise  inspections  and  that  the  tissue  establishments  carry  out 
appropriate control measures. 

Comprehensive  inspection  systems  are  in  place  in  23  Member  States  (Belgium, 
Bulgaria, Czech Republic, Denmark, Germany, Estonia, Ireland, Spain, France, Italy, 
Cyprus,  Latvia,  Lithuania,  Hungary,  the  Netherlands,  Austria,  Poland,  Portugal, 
Romania,  Slovenia,  Slovakia,  Finland  and  the  United  Kingdom).  Only  15  Member 
States conducted initial or regular inspections of tissue establishments in 2008. 

Sweden,  Malta  and  Greece  do  not  yet  have  inspection  systems  in  place.  Sweden 
intends to implement an inspection system in the course of 2009. 

No information has been received from Luxembourg in this respect. 

Article  7(5)  provides  that  ‘Guidelines  concerning  the  conditions  of  the  inspections 
and control measures and on the training and qualification of the officials involved in 
order to reach a consistent level of competence and performance, shall be established 
in accordance with the Comitology procedure’. 

Although Member States already have inspection systems in place, there is a need to 
provide  guidance  to  them  so  as  to  reach  a  consistent  level  of  competence  and 
performance.  The  Commission  is  currently  working  on  the  development  of  such 
inspection measures. The envisaged measures aim at guiding Member States towards 
a consistent and equivalent way of performing inspections in the field of tissues and 
cells.  This  would  foster  mutual  trust  and  recognition  between  Member  States.  The 
measures  on  inspections  should  not  be  seen  as  a  tool  for  the  development  of 
harmonised inspection systems in the Member States, but rather as specific guidance 
for gradually reaching equivalent performance. 

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2.3.4. 

Import/export of human tissues and cells (Art. 9) 

(a) 

Imports 

Under Article 9(1), Member States must take all necessary measures to ensure 
that  all  imports  of  tissues  and  cells  from  third  countries  are  undertaken  by 
tissue establishments accredited/designated/authorised/licensed for the purpose 
of  those  activities  and  that  imported  tissues  and  cells  can  be  traced  from  the 
donor  to  the  recipient  and  vice  versa.  In  this  respect,  only  11  Member  States 
have  clearly  identified  tissue  establishments  explicitly  authorised  to  import 
tissues  and  cells  (Bulgaria,  Czech  Republic,  Denmark,  Germany,  Ireland, 
France,  Italy,  the  Netherlands,  Austria,  Slovenia,  and  the  United  Kingdom). 
Eight Member States (Bulgaria, Denmark, Germany, Greece, France, Hungary, 
Italy, and Romania) have a register of tissue establishments in third countries 
from which imports are performed.  

Sixteen Member States reported that they imported tissues and cells from third 
countries  during  2008  (Belgium,  Bulgaria,  Denmark,  Germany,  Estonia, 
Ireland,  Greece,  Spain,  France,  Italy,  Lithuania,  the  Netherlands,  Portugal, 
Romania, Slovenia, and the United Kingdom).  

Slightly  less  than  50%  of  Member  States  importing  tissues  and  cells  use 
bilateral  agreements  to  verify  the  equivalence  of  standards  for  quality  and 
safety  of  the  tissues  and  cells.  International  standards  like  EATB4,  AATB5, 
JACIE6,  WMDA7  and  NETCORD8  are  also  used,  depending  on  the  tissue 
and/or cell involved. 

In many cases data concerning volumes of imports are not available; Member 
States  indicated  that  1 122  units  of  haematopoietic  stem  cells  (HSC),  2 281 
units  of  musculo-skeletal  tissue,  4  units  of  skin  and  7  units  of  reproductive 
tissues and cells were imported during 2008. The competent authorities should 
be  able  to  collect  more  comprehensive  data  on  imports  through  the  tissue 
establishments'  compulsory  annual  reports  in  accordance  with  Article  10(1).

(b)  Exports 

Under  Article  9(2),  Member  States  must  also  take  all  necessary  measures  to 
ensure that all exports of tissues and cells to third countries are undertaken by 
tissue  establishments  accredited,  designated,  authorised  or  licensed  for  that 
purpose.  

Only nine Member States (Bulgaria, Denmark, Ireland, France, Italy, Hungary, 
Slovenia,  Slovakia  and  the  United  Kingdom)  have  a  register  of  tissue 
establishments authorised to export tissues and cells to third countries. 

4 
5 
6 
7 
8 

European Association of Tissue Banks. 
American Association of Tissue Banks. 
Joint Accreditation Committee-ISCT & EBMT. 
World Marrow Donor Association. 
Foundation dedicated to cord blood banking and transplantation. 

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Fourteen  Member  States  exported  tissues  and  cells  during  2008  (Belgium, 
Bulgaria,  Czech  Republic,  Denmark,  Germany,  Ireland,  Spain,  France,  Italy, 
Cyprus,  the  Netherlands,  Portugal,  Romania  and  the  United  Kingdom).  In 
many cases data concerning volumes of exports are not available, but Member 
States  indicated  that  269 units  of  HSC,  489  units  of  ophthalmic  tissue,  6 225 
units  of  musculo-skeletal  tissue  and  10  units  of  amniotic  membrane  were 
exported.  The  competent  authorities  should  be  able 
to  collect  more 
comprehensive  data  on  exports  through  the  tissue  establishment's  compulsory 
annual reports in accordance with Article 10(1). 

The competent authority or authorities may authorise the import or export of tissues 
and cells in case of emergency. Bulgaria, Denmark and Cyprus performed this type 
of  direct  distribution  to  the  recipient  of  specific  tissues  and  cells  during  2008,  in 
particular for 29 units of HSC and 18 units of ophthalmic tissue. 

2.3.5.  Register of tissue establishments and reporting obligations (Art. 10) 

Under Article 10(1), tissue establishments must keep a record of their activities and 
submit  an  annual  report  to  the  competent  authority  or  authorities,  which  should  be 
publicly available.  

Nineteen  Member  States  have  created  an  annual  report  model  on  the  activities  of 
tissue  establishments  that  makes  the  reporting  of  the  yearly  activities  by  tissue 
establishment  easier  (Belgium,  Bulgaria,  Czech  Republic,  Denmark,  Germany, 
Ireland, Spain, France, Italy, Cyprus, Lithuania, Austria, Poland, Portugal, Romania, 
Slovakia, Finland, Sweden and the United Kingdom).  

Sixteen  Member  States  received  annual  reports  from  their  tissue  establishments 
corresponding  to  2008  activities  (Belgium,  Bulgaria,  Czech  Republic,  Denmark, 
Germany,  Ireland,  Spain,  France,  Italy,  Lithuania,  Poland,  Romania,  Slovenia, 
Slovakia, Finland and the United Kingdom). 

It  should  be  borne  in  mind  that  the  reports  obtained  from  the  tissue  establishments 
are crucial in providing an adequate indication of the activities carried out in the field 
as  well  as  reference  data  for  assessing  needs  and  risks  in  the  tissue  and  cell 
transplantation field. 

Only  12  Member  States  had  made  the  tissue  establishments'  reports  publicly 
available  during  2008  (Bulgaria,  Czech  Republic,  Spain,  France,  Italy,  Cyprus, 
Austria, Poland, Portugal, Slovenia, Romania and Sweden).  

Under  Article  10(2),  the  competent  authorities  are  responsible  for  maintaining  a 
publicly  accessible  register  of  tissue  establishments  specifying  the  activities  for 
which  they  have  been  accredited/designated/authorised/licensed.  Twenty  Member 
States indicated that they have a public register available (Belgium, Bulgaria, Czech 
Republic,  Denmark,  Germany,  Estonia,  Ireland,  Spain,  France,  Italy,  Cyprus, 
Lithuania,  the  Netherlands,  Austria,  Poland,  Portugal,  Slovenia,  Romania,  Finland 
and the United Kingdom).  

In most cases the annual reports and the register are accessible through the competent 
authorities' web pages. 

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Under Article 10(3), Member States and the Commission should establish a network 
linking the  national  tissue establishment registers. Currently this network linking is 
achieved  by  EUROCET  (European  Registry  for  Organs,  Tissues  and  Cells, 
http://www.eurocet.org/),  which  is  a  registry  of  national  tissue  establishments  and 
activity reports managed by the Italian Competent Authority.  

2.3.6.  Notification of serious adverse events and reactions (Art. 11) 

Under  Article  11(1),  Member  States  must  ensure  that  there  is  a  system  in  place  to 
report,  investigate,  register  and  transmit  information  about  serious  adverse  events9 
and  reactions10  which  may  influence  the  quality  and  safety  of  tissues  and  cells  and 
which  may  be  attributed  to  the  procurement,  testing,  processing,  storage  and 
distribution of tissues and cells, as well as serious adverse reactions observed during 
or after clinical application which may be linked to the quality and safety of tissues 
and  cells.  The  procedures  for  notifying  serious  adverse  events  and  reactions  were 
adopted by Commission Directive 2006/86/EC. 

All Member States except for Greece and Latvia have a vigilance system in place to 
report,  investigate,  register  and  transmit  information  about  serious  adverse  events 
and reactions which may influence the quality and safety of tissues and cells. 

No information has been received from Luxembourg in this respect. 

Criteria for the reporting of adverse events to the competent authority have been laid 
down by 22 Member States. 

Criteria for the reporting of adverse reactions to the competent authority have been 
laid down by 21 Member States. 

In  accordance  with  Article  7(1)  of  Directive  2006/86/EC,  Member  States  must 
submit  to  the  Commission  an  annual  report  on  the  serious  adverse  reactions  and 
events  notified  to  the  competent  authority.  The  first  annual  report  on  this  subject, 
covering  the  period  from  1  September  to  31  December  2007  was  submitted  to  the 
Commission  by  only  13  Member  States  (Belgium,  Denmark,  Spain,  Ireland, 
Lithuania, the Netherlands,  Poland, Portugal,  Romania, Slovenia, Slovakia,  Finland 
and  the  United  Kingdom).  The  second  annual  report  covering  the  year  2008  was 
submitted by Member States in the course of August 2009. 

Under  Article  7(6)  of  Directive  2004/23/EC,  the  competent  authority  or  authorities 
must  organise  inspections  and  carry  out  control  measures  as  appropriate  whenever 
there  is  a  serious  adverse  reaction  or  event.  Twelve  inspections  were  conducted  in 
this respect during 2008. 

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According  to  Article  3(m)  of  Directive  2004/23/EC,  ‘Serious  adverse  event’  means  any  untoward 
occurrence associated with the procurement, testing, processing, storage and distribution of tissues and 
cells  that  might  lead  to  the  transmission  of  a  communicable  disease,  to  death  or  life-threatening, 
disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation 
or morbidity. 
According  to  Article  3(n)  of  Directive  2004/23/EC,  ‘Serious  adverse  reaction’  means  an  unintended 
response,  including  a  communicable  disease,  in  the  donor  or  in  the  recipient  associated  with  the 
procurement  or  human  application  of  tissues  and  cells  that  is  fatal,  life-threatening,  disabling, 
incapacitating or which results in, or prolongs, hospitalisation or morbidity. 

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2.4. 

Donor selection and evaluation (Art. 12-15 of Directive 2004/23/EC) 

2.4.1.  Principles governing tissue and cell donation (Art. 12) 

Under  Article  12(1),  Member  States  must  endeavour  to  ensure  voluntary  unpaid 
donations of  tissues and cells. Donors may receive compensation strictly limited to 
making  good  the  related  inconveniences.  In  such  cases  Member  States  must  define 
the  conditions  under  which  compensation  may  be  granted.  Member  States  must 
regularly submit reports on these measures to the Commission. On the basis of these 
reports the Commission will inform the European Parliament and the Council of any 
necessary measures it intends to take.  

The  latest  Commission  report  to  the  European  Parliament  and  the  Council  is 
available on the Commission website11. 

In most Member States, the principle of voluntary and unpaid donation is ensured by 
law. Some Member States place the responsibility for respecting this principle on the 
tissue  establishments.  Additionally  some  Member  States  organise  campaigns  to 
promote  donation  while  others  do  not  see  this  as  necessary  because  they  have  a 
presumed consent system.  

2.4.2.  Data protection and confidentiality (Art. 14) 

Under  Article  14(2),  Member  States  must  ensure  that  data  and  confidentiality  are 
protected  and  that  no  unauthorised  disclosure  of  information  occurs,  whilst 
guaranteeing the traceability of donations. Article 14(3) provides that Member States 
will take all necessary measures to ensure that the identity of the recipient(s) is not 
disclosed to the donor or his family and vice versa without prejudice to legislation in 
force  in  Member  States  on  the  conditions  for  disclosure,  notably  in  the  case  of 
gametes donation. In 13 Member States, the conditions for disclosure of the identity 
of  a  recipient  and/or  a  donor  are  specified  in  law  (Belgium,  Bulgaria,  Czech 
Republic,  Spain,  France,  Italy,  Cyprus,  Hungary,  Malta,  Poland,  Portugal,  Sweden 
and the United Kingdom). 

2.5. 

Provisions on the quality and safety of tissues and cells (Art. 16-24 of Directive 
2004/23/EC) 

2.5.1.  Tissue and cell reception (Art. 19) 

Under  Article  19(1),  tissue  establishments  must  ensure that  all  donations  of  human 
tissues  and  cells  are  subject  to  the  required  tests  and  that  selection  and  acceptance 
requirements  are  met.  Commission  Directive  2006/17/EC  established  the  testing, 
selection  and  acceptance  requirements  in  respect  of  tissues  and  cells,  as  well  as 
associated documentation and packaging requirements prior to reception at the tissue 
establishment.  

11 

http://eur-lex.europa.eu/LexUriServ/site/en/com/2006/com2006_0593en01.pdf 

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All the reporting Member States comply with the minimum testing requirements of 
Directive 2006/17/EC. However, Italy, Lithuania, Malta and the United Kingdom do 
not perform NAT Chlamydia testing for sperm donors (other than partners)12.  

No information has been received from Luxembourg in this respect. 

Some Member States apply other tests in addition to those established as minimum 
requirements in the Directive, in particular: 

● 

● 

● 

● 

● 

Ag  HIV  testing13:  Four  Member  States  (Czech  Republic,  France,  Malta, 
Romania) 

NAT  HIV1  testing14:  Six  Member  States  (Denmark,  Estonia,  Italy,  Hungary, 
Portugal, Slovakia) 

NAT  HBV  testing15:  Five  Member  States  (Denmark,  Spain,  Italy,  Hungary, 
Portugal) 

NAT  HCV  testing16:  Six  Member  States  (Denmark,  Germany,  Spain,  Italy, 
Hungary, Portugal) 

HTLV-1  testing17:  Eight  Member  States  (Bulgaria,  Germany,  Greece,  Spain, 
France, Italy, Hungary, Romania) 

2.5.2.  Relations between tissue establishments and third parties (Art. 24) 

Under  Article 24(1),  tissue establishments have to have a written agreement with a 
third party each time an external activity takes place which may influence the quality 
and  safety  of  tissues  and  cells.  Twenty-two  Member  States  indicated  that  tissue 
establishments in their territory had notified third-party agreements. 

2.6. 

Exchange  of  information,  penalties,  transposition  (Art.  25-31  of  Directive 
2004/23/EC) 

2.6.1.  Coding of information (Art. 25) 

Article 25 of Directive 2004/23/EC requires the Member States to establish a system 
for the identification of human tissues and cells, in order to ensure the traceability of 
all human tissues and cells. The minimum requirements of a European coding system 
were adopted by Commission Directive 2006/86/EC. 

An efficient coding system is a crucial, but not exclusive, element in the traceability 
chain and ultimately in any vigilance system for human tissues and cells. The human 
tissue and cell chain is dependent on a robust codification system, which will secure 

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Sperm  donors  other  than  partners  must  be  negative  for  Chlamydia  on  a  urine  sample  tested  by  the 
nucleic acid amplification technique (NAT).  
Testing for presence of HIV antigens. 
Nucleic acid amplification technique for testing HIV1. 
Nucleic acid amplification technique for testing Hepatitis B. 
Nucleic acid amplification technique for testing Hepatitis C. 
Human T-lymphotropic virus. 

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the information flow from donation to transplantation and vice versa. The European 
coding system should ensure that the pre-existing traceability/coding systems can be 
maintained and further developed by the Member States, whilst ensuring a minimum 
level of compatibility between them. 

The Commission, in cooperation with the Member States, is working on the design 
of  a  single  European  coding  system  to  provide  information  on  the  main 
characteristics and properties of tissues and cells. 

2.6.2.  Exchange of information 

The  Commission  has  convened  three  meetings  with  the  competent  authorities 
designated  by  the  Member  States  to  exchange  information  on  the  experience 
acquired  with  regard  to  the  implementation  of  Directives  2004/23/EC,  2006/17/EC 
and  2006/86/EC.  The  last  meeting  took  place  on  27-28  May  2009.  Some  of  the 
difficulties identified by Member States were linked to the implementation of testing 
requirements,  in  particular  in  the  Medically  Assisted  Reproductive  Technologies 
(MART)  sector.  The  interpretation  of  the  air  quality  standards  that  tissue 
establishments  need  to  apply  while  tissues  and  cells  are  being  processed  is  also  a 
matter  of  concern  among  Member  States.  More  guidance  on  coding  systems, 
inspections,  import/export  and  vigilance  requirements  was  also  sought  by  Member 
States.  

The  Commission  is  endeavouring  to  provide  Member  States  and  competent 
authorities with appropriate support in these areas.  

2.6.3.  Penalties (Art. 27) 

Member States must lay down rules on penalties applicable to infringements of the 
national  provisions,  and  take  all  measures  necessary  to  ensure  that  they  are 
implemented  and  notified  to  the  Commission.  France,  Poland  and  the  United 
Kingdom reported that they had imposed penalties on some tissue establishments in 
this respect. 

2.6.4.  Transposition (Art. 31) 

By  July  2009,  26  Member  States  had  notified  to  the  Commission  their  national 
transposition  measures  in  relation  to  Directive  2004/23/EC.  National  transposition 
measures  in  relation  to  Directives  2006/17/EC  and  2006/86/EC  have  been 
communicated to the Commission by 25 Member States. In July 2009 there were five 
infringement  procedures  open  for  failure  to  achieve  full  transposition  of  the 
Directives in two Member States.  

3. 

CONCLUSIONS 

Overall, the implementation of the Directives by the Member States is satisfactory.  

This  concerns  in  particular  the  requirement  to  designate  a  competent  authority  or 
authorities and to establish accreditation/designation/authorisation/licensing systems 
of  tissue  establishments;  inspections  systems;  registries  of  tissue  establishments; 

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systems to report, investigate, register and transmit information about serious adverse 
events and reactions; and testing requirements. 

The  degree  of  implementation  of  some  other  measures  suggests  that  further  efforts 
and actions by Member States are needed. This concerns the development of specific 
systems  for  authorising  the  tissue  and  cell  preparation  process;  finalisation  of  the 
accreditation/designation/authorisation/licensing  process 
respect  of  each 
individual  establishment;  the  carrying  out  of  inspections  in  all  Member  States; 
monitoring  of  imports/exports;  fulfilment  of  the  reporting  requirements  (tissue 
establishments' 
of 
accredited/designated/authorised/licensed  tissue  establishments  at  the  level  of  the 
Member  States  and  at  EU  level  -EUROCET-);  preparation  of  annual  reports  on 
adverse events and reactions for the Commission. 

activities, 

register 

reports 

annual 

on 

in 

The  Commission  is  working  with  the  Member  States  to  help  them  develop 
operational solutions in response to the remaining challenges. 

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