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 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
Date: 2010-01-19
Institutions: European Commission
Subjects: application of EU law, blood transfusion, health control, public health, quality standard, report, safety standard

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EUROPEAN COMMISSION 

Brussels, 19.1.2010 
COM(2010)3 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 2002/98/EC setting standards of quality and safety for the 
collection, testing, processing, storage and distribution of human blood and blood 
components and amending Directive 2001/83/EC 

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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 2002/98/EC setting standards of quality and safety for the 
collection, testing, processing, storage and distribution of human blood and blood 
components and amending Directive 2001/83/EC 

1. 

INTRODUCTION 

Article  26  of  Directive  2002/98/EC1  requires  Member  States  to  submit  to  the 
European  Commission,  commencing  on  31  December  2003  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 
requirements of the Directive, in particular as regards inspection and control. 

This  report  is  based  on  the  replies  to  questionnaires  on  transposition  and 
implementation that Member States send to the Commission on a yearly basis upon 
request. All Member States except Estonia have submitted a report on the activities 
undertaken  in  relation  to  the  provisions  of  the  Directive  in  2008.  Iceland, 
Lichtenstein,  Norway,  Switzerland,  Croatia,  the  Former  Yugoslav  Republic  of 
Macedonia and Turkey also submitted a report. 

2. 

RESULTS 

2.1. 

Implementing Directives  

Directive  2002/98/EC  provides  that  specific  technical  requirements  should  be 
decided  in  accordance  with  the  ‘Comitology’  procedure.  In  this  respect,  three 
Commission Directives supplement the provisions of Directive 2002/98/EC: 

● 

Commission  Directive  2004/33/EC  of  22  March  2004  as  regards  certain 
technical requirements for blood and blood components2.  

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2 

Directive  2002/98/EC  of  the  European  Parliament  and  of  the  Council  of  27  January  2003  setting 
standards of quality and safety for the collection, testing, processing, storage and distribution of blood 
and blood components (OJ L 33, 8.2.2003, p. 30). 
Commission  Directive  2004/33/EC  of  22  March  2004  implementing  Directive  2002/98/EC  of  the 
European Parliament and of the Council as regards certain technical requirements for blood and blood 
components (OJ L 91, 30.3.2004, p. 25). 

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● 

● 

Commission  Directive  2005/61/EC  of  30  September  2005  as  regards 
traceability  requirements  and  notification  of  serious  adverse  reactions  and 
events3. 

Commission  Directive  2005/62/EC  of  30  September  2005  as  regards 
Community standards and specifications relating to a quality system for blood 
establishments4. 

Member  States  may  maintain  or  introduce  more  stringent  protective  measures  than 
those of the Directive 2002/98/EC, provided that they comply with the provisions of 
the Treaty. For instance, 26 Member States apply additional testing requirements to 
take  into  account  their  specific  national  epidemiological  situation  (for  more 
information, see section 2.6.2). 

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

2.2. 

Designation of competent authorities (Art. 4 of Directive 2002/98/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. 

2.3. 

Obligations on Member States’ authorities (Art. 5-8 of Directive 2002/98/EC) 

2.3.1.  Designation,  authorisation,  accreditation  or  licensing  of  blood  establishments 

(Art. 5) 

Under  Article  5(1),  Member  States  must  ensure  that  activities  relating  to  the 
collection and testing of human blood and blood components, whatever the intended 
purpose,  and  to  their  preparation,  storage  and  distribution  when  intended  for 
transfusion,  are  undertaken  only  by  the  blood  establishments  which  have  been 
designated/authorised/accredited/licensed  by 
that 
purpose. 

the  competent  authority  for 

2008, 

States 

of  December 

As 
the 
21  Member 
designation/authorisation/accreditation/licensing of all existing blood establishments 
in their respective territories (Belgium, Czech Republic, Denmark, Germany, Ireland, 
Greece,  Spain,  France,  Italy,  Cyprus,  Latvia,  Lithuania,  Luxembourg,  Hungary,  the 
Netherlands, Austria, Poland, Slovakia, Finland, Sweden and the United Kingdom). 
This means that 775 blood establishments (‘BE’) were already authorised in the EU 
at  the  end  of  2008.  Bulgaria  (5  BE),  Malta  (1  BE),  Portugal  (24  BE)  Romania  (42 
the 
BE) 

completed 

finalising 

currently 

Slovenia 

BE) 

had 

and 

are 

(3 

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Commission  Directive  2005/61/EC  of 30 September  2005 implementing  Directive 2002/98/EC of  the 
European Parliament and of the Council as regards traceability requirements and notification of serious 
adverse reactions and events (OJ L 256, 1.10.2005, p. 32). 
Commission  Directive  2005/62/EC  of 30 September  2005 implementing  Directive 2002/98/EC of  the 
European Parliament and of the Council as regards Community standards and specifications relating to 
a quality system for blood establishments (OJ L 256, 1.10.2005, p. 41). 

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designation/authorisation/accreditation/licensing process and expect to complete this 
work in the course of 2009.  

The  competent  authority  or  authorities  may 
the 
designation/authorisation/accreditation/licensing  of  a  blood  establishment  if  it  is 
found  to  no  longer  comply  with  the  requirements  of  the  Directives.  During  2008, 
Germany, the Netherlands and Slovakia revoked or suspended initial approvals given 
to  some  blood  establishments  for  various  reasons  such  as  incorrect  donor  testing, 
lack of appropriate donor interview facilities and questionnaires, and general lack of 
compliance with applicable regulations. 

suspend  or 

revoke 

2.3.2.  Hospital blood banks (Art. 6) 

Article  6  stipulates  that  Articles  7,  10,  11(1),  12(1),  14,  15,  22  and  24  apply  to 
hospital blood banks. Sixteen Member States have specific rules governing hospital 
blood  banks  in  addition  to  the  provisions  covered  by  the  above-mentioned  articles 
Ireland,  Greece,  Spain,  France,  Italy,  Latvia, 
(Belgium,  Czech  Republic, 
Luxembourg, Hungary, Austria, Poland, Romania, Slovenia, Finland and the United 
Kingdom). The specific measures relate to authorisation of hospital blood banks and 
to inspection, quality management and reporting systems. Most Member States have 
also created specific schemes for cooperation with blood establishments. 

According to the Member States’ reports, as of 31 December 2008 there were around 
4 133 hospital blood banks in the EU. In most Member States hospital blood banks 
are  part  of  the  hospital  facilities,  while  in  others,  like  Italy,  they  are  considered  as 
blood establishments. 

2.3.3. 

Inspection and control measures (Art. 8) 

Under  Article  8(1),  Member  States  must  ensure  that  the  competent  authority 
organises  inspections  and  appropriate  control  measures  in  blood  establishments  to 
check that the requirements of the Directive are complied with. 

All  Member  States  except  Cyprus  have  inspection  and  control  systems  in  place. 
Twenty-two Member States conducted regular inspections of blood establishments in 
2008. 

In four Member States inspections of blood establishments are performed by regional 
or autonomous communities’ services (Germany, Spain, Italy and Poland). In the rest 
of the Member States, inspections are performed by the central competent authority. 

In  eleven  Member  States,  the  authority  granting  the  designation/authorisation/ 
accreditation/licensing  is  the  same  as  the  one  performing  inspections  (Czech 
Republic,  Denmark,  Germany,  Ireland,  Greece,  Latvia,  Luxembourg,  Hungary, 
Finland, Sweden and the United Kingdom). 

2.3.3.1.  Inspection of hospital blood banks 

Although not specifically required by the Directive, 20 Member States have systems 
in  place  for  inspecting  hospital  blood  banks  (Belgium,  Czech  Republic,  Denmark, 
Germany,  Ireland,  Greece,  Spain,  France,  Italy,  Latvia,  Luxembourg,  Hungary,  the 
Netherlands, Austria, Poland, Portugal, Romania, Slovenia, Sweden and the United 

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Kingdom). In most of them, hospital blood banks are inspected in the same way as 
blood  establishments;  this  is  the  case  of  the  Czech  Republic,  Denmark,  Germany, 
Greece, Ireland, Italy, Latvia, Hungary, Romania, Sweden and the United Kingdom. 

In  six  Member  States,  the  inspection  of  hospital  blood  banks  is  performed  by 
regional services (Bulgaria, Greece, Spain, France, Austria and Poland). 

In  many  cases,  hospital  blood  bank  inspections  are  performed  by  independent 
scientific societies or transfusion centres, or as part of the hospital facilities general 
inspections which are performed by other competent authorities. 

2.4. 

Quality management (Art. 11-13 of Directive 2002/98/EC) 

2.4.1.  Quality system for blood establishments (Art. 11) 

Under Article 11(1), Member States must take all necessary measures to ensure that 
each  blood  establishment  sets  up  and  maintains  a  quality  system  for  blood 
establishments based on principles of good practice.  

The  minimum  standards  and  specifications  relating  to  a  quality  system  for  blood 
establishments were adopted by Commission Directive 2005/62/EC. 

Article  2  of  Directive  2005/62/EC  provides  that  good  practice  guidelines  are  to  be 
developed by the Commission in accordance with the ‘Comitology’ procedure for the 
interpretation  of  the  Community  standards  and  specifications  established  in  the 
annex to the Directive. 

The Commission is currently working on the development of such guidelines.  

2.4.2.  Record keeping (Art. 13) 

Under Article 13(1), Member States must ensure that blood establishments maintain 
records of: the preceding year’s activity; testing performed; information provided to 
donors; information obtained from donors; and information regarding the suitability 
of blood and plasma donors and the screening of donated blood. 

As  a  good  practice,  22  Member  States  receive  annual  reports  from  blood 
establishments  on  the  previous  year's  activities  in  accordance  with  Annex  II  to 
Directive  2002/98/EC  (Belgium,  Bulgaria,  Czech  Republic,  Denmark,  Germany, 
Ireland,  Greece,  Spain,  France,  Italy,  Latvia,  Lithuania,  Luxembourg,  Hungary, 
Malta, the Netherlands, Poland, Portugal, Romania, Slovenia, Slovakia and Finland). 
Twelve  Member  States  have  made  the  reports public  through  their  web  pages  on  a 
voluntary  basis  (Denmark,  Germany,  Spain,  France,  Lithuania,  Luxembourg, 
Hungary, Malta, the Netherlands, Slovenia, Slovakia and Finland). 

2.5. 

Haemovigilance (Art. 14-15 of Directive 2002/98/EC) 

Under  Article  14(1),  Member  States  must  ensure  that  blood  establishments 
implement a system for identifying each single blood donation and each single blood 
unit and components thereof, enabling full traceability to the donor as well as to the 
transfusion and the recipient thereof.  

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Under  Article  15,  Member  States  must  ensure  that  any  serious  adverse  events5 
(accidents  and  errors)  related  to  the  collection,  testing,  processing,  storage  and 
distribution  of  blood  and  blood  components  which  may  have  an  influence  on  their 
quality and safety, as well as any serious adverse reactions6 observed during or after 
transfusion which may be attributed to the quality and the safety of blood and blood 
components, are notified to the competent authority, 

All Member States, except Cyprus and Bulgaria, have a system in place for notifying 
serious adverse events and reactions to the competent authority or delegated body.  

In  some  Member  States  haemovigilance  systems  are  linked  to  other  national 
vigilance systems:  

● 

● 

● 

● 

vigilance systems for human tissues, cells or organs in 13 Member States; 

the pharmacovigilance system in 12 Member States;  

the medical devices vigilance system in 15 Member States;  

the communicable diseases vigilance system in 15 Member States. 

Member  States  must  submit  an  annual  report  to  the  Commission  on  the  adverse 
reactions and events notified to the competent authority or authorities in accordance 
with  Article  8  of  Directive  2005/61/EC.  The  annual  report  on  haemovigilance 
covering  the  period  from  1  January  to  31  December  2007  was  submitted  to  the 
Commission  by  23  Member  States  (Belgium,  Bulgaria,  Czech  Republic,  Germany, 
Denmark, Estonia, Greece, Spain, France, Hungary, Ireland, Italy, Lithuania, Latvia, 
Malta,  the  Netherlands,  Poland,  Portugal,  Romania,  Slovenia,  Sweden,  Finland  and 
the United Kingdom). 

The  competent  authority  or  authorities  should  organise  inspections  and  carry  out 
control  measures  as  appropriate  whenever  there  is  a  serious  adverse  reaction  or 
event. Four inspections were conducted in this respect during 2008. 

2.6. 

Provisions for quality and safety of blood and blood components (Art. 16-23 of 
Directive 2002/98/EC) 

2.6.1.  Voluntary and unpaid blood donation (Art. 20) 

Under  Article  20,  Member  States  must  take  the  necessary  measures  to  encourage 
voluntary  and  unpaid  donations  with  a  view  to  ensuring  that  blood  and  blood 
components are in so far as possible provided from such donations. Member States 
must regularly submit reports on these measures to the Commission. On the basis of 

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According  to  Article  3(g)  of  Directive  2002/98/EC,  ‘Serious  adverse  event’  means  any  untoward 
occurrence  associated  with  the  collection,  testing,  processing,  storage  and  distribution  of  blood  and 
blood components that might lead to death or life-threatening, disabling or incapacitating conditions for 
patients, or which results in, or prolongs, hospitalisation or morbidity. 
According  to  Article  3  (h)  of  Directive  2002/98/EC,  ‘Serious  adverse  reaction’  means  an  unintended 
response  in  donor  or  in  patient  associated  with  the  collection  or  transfusion  of  blood  or  blood 
components  that  is  fatal,  life-threatening,  disabling,  incapacitating,  or  which  results  in,  or  prolongs, 
hospitalisation or morbidity. 

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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 website7. 

2.6.2.  Testing of donations (Art. 21) 

Under  Article  21,  blood  establishments  must  ensure  that  each  donation  is  tested  in 
conformity with the requirements of the Directive. In this respect, all Member States 
comply with the minimum testing requirements as laid down in the Directive.  

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

● 

● 

● 

● 

● 

● 

● 

Anti-HBc  testing8:  Nine  Member  States  (Germany,  France,  Lithuania, 
Luxembourg, Hungary, Malta, Portugal, Slovakia and Sweden).  

NAT HBV testing9: Thirteen Member States (Denmark, Greece, Spain, France, 
Italy,  Latvia,  Lithuania,  Luxembourg,  the  Netherlands,  Poland,  Portugal 
Slovenia and Finland).  

NAT  HCV  testing10:  Eighteen  Member  States  (Belgium,  Denmark,  Germany, 
Ireland,  Greece,  Spain,  France,  Italy,  Latvia,  Lithuania,  Luxembourg,  the 
Netherlands,  Austria,  Poland,  Portugal,  Slovenia,  Finland  and  the  United 
Kingdom).  

Ag  HIV  testing11:  Ten  Member  States  (Bulgaria,  Czech  Republic,  Greece, 
Italy, Cyprus, Luxembourg, Portugal, Slovenia, Slovakia and Finland).  

NAT HIV1 testing12: Seventeen Member States (Belgium, Denmark, Germany, 
Ireland,  Greece,  Spain,  France,  Italy,  Latvia,  Lithuania,  Luxembourg,  the 
Netherlands, Austria, Poland, Portugal, Slovenia and Finland).  

Treponema  Pallidum13 
testing:  Twenty-two  Member  States  (Belgium, 
Bulgaria,  Czech  Republic,  Germany,  Spain,  France,  Italy,  Cyprus,  Latvia, 
Lithuania,  Luxembourg,  Hungary,  Malta,  the  Netherlands,  Austria,  Poland, 
Portugal, Romania, Slovenia, Slovakia, Sweden and the United Kingdom).  

HTLV testing14: Nine Member States (Denmark, Greece, France, Luxembourg, 
the Netherlands, Romania, Portugal, Sweden and the United Kingdom).  

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http://ec.europa.eu/health/ph_threats/human_substance/documents/blood_com_0217_en.pdf. 
Testing for presence of Hepatitis B antibodies. 
Nucleic acid amplification technique for testing Hepatitis B. 
Nucleic acid amplification technique for testing Hepatitis C. 
Testing for presence of HIV antigens. 
Nucleic acid amplification technique for testing HIV1. 
Bacteria generally acquired by close sexual contact giving rise to congenital syphilis. 
Human T-lymphotropic virus. 

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2.7. 

Import/export (Art. 14 of Directive 2002/98/EC, Art. 7 of Directive 2005/61/EC, 
Art. 2(3) of Directive 2005/62/EC) 

Under Article 14(1) of Directive 2002/98/EC, Member States must ensure that, with 
regard  to  blood  and  blood  components  imported  from  third  countries,  the  donor 
identification  system  to  be  implemented  by  blood  establishments  permits  an 
equivalent level of traceability. 

Under  Article  7  of  Directive  2005/61/EC,  Member  States  must  ensure  that  third 
countries’  blood  establishments  have  in  place  a  system  for  notification  of  serious 
adverse events and reactions equivalent to that of the EU Member States. 

Under  Article  2(3)  of  Directive  2005/62/EC,  Member  States  must  ensure  that  for 
blood and blood components imported from third countries and intended for use or 
distribution in the Community, there is a quality system for blood establishments in 
the  stages  preceding  importation  equivalent  to  that  provided  for  in  Commission 
Directives 2005/61/EC and 2005/62/EC. 

(a) 

Import 

Twenty-five Member States have clear rules in place for the authorisation and 
control  of  the  import  of  blood  and  blood  components  for  transfusion  and 
fractionation from EU Member States and third countries (Belgium, Bulgaria, 
Czech  Republic,  Denmark,  Germany,  Ireland,  Greece,  Spain,  France,  Italy, 
Cyprus,  Lithuania,  Luxembourg,  Hungary,  Malta,  the  Netherlands,  Austria, 
Poland,  Portugal,  Romania,  Slovenia,  Slovakia,  Finland,  Sweden  and  the 
United Kingdom).  

The rules are either part of the implementing legal measures or are established 
in separate protocols. In the majority of Member States imports are approved 
by the competent authorities. In the other Member States, blood establishments 
are  responsible  for  authorising  and  verifying  the  equivalence  of  standards  for 
quality  and  safety  of  blood  and  blood  components  as  well  as  of  traceability 
requirements.  Ten  Member  States  use  bilateral  agreements  for  assuring 
equivalent  standards  of  quality  and  safety.  Only  one  Member  State  performs 
inspections  in  third  countries  before  authorising  the  importation  of  blood  or 
blood components. 

(b)  Export 

Seventeen Member States have rules in place for the authorisation and control 
of the export of blood and blood components for transfusion or fractionation to 
EU  Member  States  or  third  countries  (Bulgaria,  Czech  Republic,  Denmark, 
Germany,  Spain,  France,  Italy,  Lithuania,  Hungary,  the  Netherlands,  Poland, 
Portugal, Romania, Slovenia, Slovakia, Sweden and the United Kingdom). In 
most  Member  States,  the  competent  authorities  are  responsible  for  ensuring 
that  exports  comply  with  the  same  quality  and  safety  standards  as  those 
established by the Directives. 

Although  many  competent  authorities  collect  the  annual  report  from  the  blood 
establishments  on  the  previous  year’s  activities,  only  a  very  limited  number  of 

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Member States have data on the imported and exported volumes of blood and blood 
components. 

2.8. 

Exchange  of  information,  reports  and  penalties,  transposition  (Art.  25-32  of 
Directive 2002/98/EC) 

2.8.1. 

Information exchange (Art. 25) 

The  Commission  has  convened  four  meetings  with  the  competent  authorities 
designated  by  the  Member  States  to  exchange  information  on  the  experience 
acquired with regard to the implementation of Directives 2002/98/EC, 2004/33/EC, 
2005/61/EC and 2005/62/EC. The last meeting took place on 27-28 January 2009.  

2.8.2.  Penalties (Art. 27) 

Under  Article  27,  Member  States  must  lay  down  rules  on  penalties  applicable  to 
infringements of the national provisions. 

Only  France  reported  that  it  had  imposed  penalties  on  blood  establishments  in  this 
respect. 

2.8.3.  Transposition (Art. 32) 

All  Member  States  have  notified  to  the  Commission  their  national  transposition 
measures  in  relation  to  Directives  2002/98/EC,  2004/33/EC,  2005/61/EC  and 
2005/62/EC.  

On  6  March  2009  the  Commission  sent  a  template  for  a  concordance  table  for 
Directives  2002/98/EC,  2004/33/EC,  2005/61/EC  and  2005/62/EC  to  the  Member 
States for completion. Twenty-two Member States have sent back completed tables 
to the Commission (Belgium, Bulgaria, Czech Republic, Germany, Estonia, Ireland, 
Greece, Spain, France, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Malta, Poland, 
Portugal, Romania, Slovenia, Slovakia, Finland and the United Kingdom). Based on 
the  tables,  the  Commission  will  assess  the  level  of  transposition  of  the  blood 
Directives. 

3. 

CONCLUSIONS 

Overall, the implementation of the Directives is satisfactory.  

This  concerns  in  particular  the  requirement  to  designate  a  competent  authority  or 
authorities  and  the  establishment  of  inspection  systems  and  control  measures; 
haemovigilance  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  finalisation  of  the 
accreditation/designation/authorisation/licensing  process 
respect  of  each 
individual blood establishment, the carrying out of inspections in all Member States, 
and  the  annual  report  on  adverse  events  and  reactions  for  the  Commission. 
Furthermore,  the  collection  of  reports  on  blood  establishments’  activity  in  the 

in 

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preceding year is a good practice that should be encouraged as it is a valuable source 
of information for both regulators and citizens.  

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

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