Report from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions - First Report on the application of the Blood Directive
Date: 2006-06-19
Institutions: European Commission
Subjects: EC Directive, application of EU law, blood transfusion, health control, public health, quality standard, report, safety standard

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 19.6.2006 
COM(2006) 313 final 

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

First report on the application of the Blood Directive 

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1. 

INTRODUCTION 

Article  26  of  Directive  2002/98/EC1  requires  Member  States  to  submit  to  the  European 
Commission, beginning on 31 December 2003 and every three years thereafter, reports on the 
activities  that  they  have  carried  out  in  relation  to  the  implementation  of  its  provisions.  The 
Commission  is  required  not  only  to  forward  these  reports  to  the  European  Parliament,  the 
Council,  the  Economic  and  Social  Committee  and  the  Committee  of  the  Regions  but, 
commencing  on  1  July  2004  and  every  three  years  thereafter,  also  to  provide  them  with  a 
report  on  the  implementation  of  the  Directive’s  requirements,  in  particular  those  relating  to 
inspection and control. 

This first Commission report provides an overview of the situation in the 15 Member States 
that belonged to the European Union as of 31 December 2003.2 

2. 

IMPLEMENTATION (ART. 4) 

Member  States  may  maintain  or  introduce  more  stringent  protective  measures  than  those  of 
the  Directive  while  ensuring  compliance  with  the  Treaty’s  provisions.  Ten  Member  States 
avail  of  this  option  with  measures  that  ranged  from  designating  blood  preparations  as 
medicinal  products,  requiring  additional  testing  for  viruses  such  as  human  T-cell 
lymphotropic virus, introducing nucleic amplification technology for detecting the hepatitis C 
virus and HIV, to imposing more stringent measures for donor selection, biological control of 
donations  and  haemovigilance.  Nine  of  them  planned  to  maintain  existing  requirements  for 
nine months after 8 February 2005 (Art. 7), in order to give blood establishments additional 
time to comply with the Directive. 

3. 

OBLIGATIONS ON MEMBER STATES AUTHORITIES  

3.1. 

Blood establishments (Art. 5) 

Member States must ensure that an appropriate mechanism is in place so that the activities of 
blood  establishments  comply  with  the  Directive’s  requirements.  As  of  December  2003, 
14 Member  States  had  designated  a  competent  authority  in  accordance  with  this  provision. 
Four, however, have more than one – Germany, due to its federal system, has 29; Spain, with 
its autonomous communities, has 18; and Denmark and Sweden each have two. 

The competent authority in 11 of the Member States had designated, authorised, accredited or 
licensed  blood  establishments  to  carry  out  collection,  testing,  preparation,  storage  and 
distribution  activities.  Blood  establishments  in  7  of  them  had  provided  the  competent 
authority with information about themselves, the hospital blood banks they supply, as well as 

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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 human 
blood and blood components and amending Directive 2001/83/EC (O.J. L 33, 8.2.2003, p 30). 
An overview of the latest state of affairs on certain aspects in relation to Directive 2002/98/EC has been 
published on the website:   
http://europa.eu.int/comm/health/ph_threats/human_substance/documents/blood_sum_en.pdf. 

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details  about  the  responsible  person  and  the  quality  system  in  place.  Four  Member  States 
reported that documentation on the quality system is not always submitted completely. 

Six Member States had put in place all provisions for the competent authority to verify blood 
establishments’  compliance  with  the  Directive’s  requirements  and  to  advise  them  on  which 
activities could be undertaken and under what conditions.  

Blood  establishments  in  10  Member  States  were  aware  that  the  competent  authority’s  prior 
approval  was  needed  before  any  substantial  change  could  be  made  to  their  activities.  In 
9 countries,  they  were  also  aware  that  this  authority  could  suspend  or  revoke  their 
designation, authorisation, accreditation or licence if inspection and control measures showed 
non-compliance with the Directive. 

3.2. 

Hospital blood banks (Art. 6) 

Hospital blood banks in 7 Member States had been informed of the requirements applicable to 
them.  

3.3. 

Inspection and control measures (Art. 8) 

The competent authority in 7 Member States had organised inspections and control measures 
in blood establishments in order to ensure compliance with the Directive’s requirements. The 
timeliness  of  inspections  and  control  measures,  however,  varied  from  every  six  months  to 
every three years. Emergency inspections were carried out when necessary. 

Six  Member  States  have  empowered  officials  representing  the  competent  authority  to  carry 
out inspections and control measures in blood establishments and facilities of third parties in 
their  State  that  have  been  entrusted  by  the  authorised  blood  establishment  to  carry  out 
evaluation  and  testing  procedures.  Eleven  confirmed  that  these  officials  are  empowered  to 
examine  any  documents  related  to  the  inspection,  subject  to  the  provisions  in  force  in  the 
Member State at the time of the entry into force of the Directive which place restrictions on 
these  powers.  Three  Member  States  had  not  yet  empowered  officials  to  take  samples  for 
examination and analysis.  

In the event of any serious adverse event or reaction or suspicion thereof that could be linked 
to  the  quality  and  safety  of  blood  and  blood  components,  the  competent  authority  must  be 
notified  and  it  must  organise  inspections  and  other  control  measures  as  appropriate.  Two 
states  had  organised  such  inspections  and  controls  and  4  had  not.  Five  indicated  that  such 
notification was part of their haemovigilance procedures. 

Six Member States indicated that their blood establishments were aware that serious adverse 
events  and  reactions  had  to  be  notified  to  the  competent  authority  in  accordance  with  the 
procedure and notification format. Eight Member States already have procedures in place to 
enable blood or blood components associated with serious adverse events and reactions to be 
accurately, efficiently and verifiably withdrawn from distribution. 

4. 

PROVISIONS FOR BLOOD ESTABLISHMENTS (ART. 9 - 10) 

Blood  establishments  must  designate  a  responsible  person  with  at  least  the  minimum 
qualifications specified in Article 9.2. Ten Member States comply with the formal academic 
requirements, however, practical experience was not always required. 

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The designated person in 5 Member States is responsible for ensuring that every unit of blood 
or  blood  components  has  been  collected,  tested,  processed,  stored,  and  distributed  in 
compliance  with  the  laws  in  force  as  well  as  for  providing  information  to  the  competent 
authority in the designation, authorisation, accreditation or licensing procedures. 

Eight  Member  States  already  allow  for  the  delegation  of  tasks  specified  for  the  responsible 
person  to  other  persons  qualified  by  training  and  experience,  although  in  one  the  actual 
responsibility  is  not  assigned.  Blood  establishments  in  6  States  have  notified  the  competent 
authority of the names of the responsible person and others as well as their specific tasks; 

Five  Member  States  had  informed  their  blood  establishments  that,  where  the  responsible 
person or such other persons are permanently or temporarily replaced, they must immediately 
provide the name of the new responsible person and his or her date of commencement to the 
competent authority. 

Nine  Member  States  confirmed  that  personnel  directly  involved  in  the  collection,  testing, 
processing,  storage,  and  distribution  of  human  blood  and  blood  components  is  qualified  for 
their tasks and has been provided with timely, relevant and regularly updated training. 

5. 

QUALITY MANAGEMENT (ART. 11 - 13) 

Eleven Member States have ensured that each blood establishment institutes and maintains a 
quality  system  based  on  the  principles  of  good  practice.  Shortcomings,  however,  were 
acknowledged in some Member States. 

Nine  Member  States  reported 
to  maintain 
documentation  on  operational  procedures,  guidelines,  training  and  reference  manuals,  and 
reporting forms and provide access to these documents for officials entrusted with inspection 
and control. Access to documents was a legislative requirement in 3 Member States and was 
in compliance with national measures in 4 others. 

that  blood  establishments  are  required 

Most  Member  States  have  procedures  in  place to  ensure  that  blood  establishments  maintain 
records of their annual activities, basic testing requirements, and the information provided to 
and obtained from donors as well as donor suitability requirements. However, the time frame 
for maintaining these records differs from the 15-year minimum the Directive requires. Three 
States require records to be kept for 10 years, one stipulates a retention time of 50 years. One 
Member State indicated that its blood donation centres were not aware that records had to be 
kept for this length of time. 

Eight  Member  States  were  aware  that  the  competent  authority  had  to  keep  records  of  data 
received from blood establishments related to their authorisation, provisions for those already 
existing, inspection and control, the responsible person and adverse events and reactions. 

6. 

HAEMOVIGILANCE (ART. 14 - 15) 

All Member States had taken measures to ensure that blood and blood components collected, 
tested, processed, stored, released and/or distributed on its territory were traceable from donor 
to  recipient  and  vice  versa.  Eleven  Member  States  indicated  that  blood  establishments  had 
implemented  an  identification  system  for  each  blood  donation  and  each  blood  unit  and  its 
components. 

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The  Directive  requires  that  traceability  systems  must  ensure  that  each  unique  donation  and 
type  of  blood  component  can  be  identified  and  been  established  in  accordance  with  the 
requirements set out by the Commission.  

For blood and blood components imported from third countries, Member States must ensure 
that  the  blood  establishment’s  donor  identification  system  permits  an  equivalent  level  of 
traceability.  Four  Member  States  have  identification  systems  to  ensure  traceability.  There 
were indications that blood components and blood-derived medicinal products were imported 
from the rare-blood bank in Amsterdam,  Nordic countries,  Switzerland,  and third countries. 
Two States do not import blood or blood components from third countries. 

Nine Member States had taken measures to ensure that the labelling system for the blood and 
blood  components  collected,  tested,  processed,  stored,  released  and/or  distributed  on  its 
territory complied with the requirements in Annex III.  

Ten Member States were aware that data needed for full traceability had to be kept for at least 
30 years, although their current national requirements ranged from 10 to 50 years. 

7. 

PROVISIONS  FOR  QUALITY  AND  SAFETY  OF  BLOOD  AND  BLOOD 
COMPONENTS 

7.1. 

Donors (Art. 16 - 19) 

All  prospective  donors  of  blood  or  blood  components  in  the  Community  must  be  provided 
with information about donation and upon their agreement to donate give information related 
to  their  identity  and  their  health  to  the  blood  establishments.3  Although  these  requirements 
were  only  adopted  through  the  Comitology  procedure  (Article  29(b)  and  (c))  after  the 
reporting  date4,  eleven  Member  States  already  provided  information  to  donors  as  normal 
practice, and 13 required information to be supplied by donors. 

Nine Member States reported that evaluation procedures and donation deferral criteria were in 
place in blood establishments for all donors of blood and blood components. 

Blood  establishments  are  required  to  document  the  results  of  their  donor  evaluation  and 
testing procedures and report any relevant abnormal findings to the donor. Implementation of 
these requirements was reported by 11 Member States. 

Fourteen Member States indicated that provisions are in place for assessing the suitability of 
individuals  to  donate  blood,  including  an  examination  of  and  an  interview  with  the  donor 
prior to any donation.  

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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 (O.J. L 91, 30.3.2004, p 25). 
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 (O.J. L 91, 30.3.2004, p 25). 

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7.2. 

Voluntary and unpaid blood donation (Art. 20) 

Eleven  Member  States  had  taken  measures  to  encourage  voluntary  and  unpaid  blood 
donations with a view to ensuring that blood and blood components are in so far as possible 
derived from them.5 

7.3. 

Testing of donations (Art. 21) 

Fourteen Member States reported that their blood establishments test each donation of blood 
and blood components in conformity with requirements listed in Annex IV. 

Eight  Member  States  had  procedures  in  place  to  ensure  that  blood  and  blood  components 
imported into the Community were tested in conformity with these requirements. 

7.4. 

Storage, transport and distribution conditions (Art. 22) 

Although requirements for storage, transport and distribution conditions for blood and blood 
components  were  only  adopted  through  the  Comitology  procedure  (Article  29(e))  after  the 
reporting date6, 12 Member States already had relevant requirements in place. 

7.5. 

Quality and safety requirements for blood and blood components (Art. 23) 

Although  the  requirements  for  the  quality  and  safety  for  blood  and  blood  components  were 
adopted through the Comitology procedure (article 29(f)) after the reporting date7,7 Member 
States  reported  that  their  blood  establishments  have  to  ensure  that  the  quality  and  safety 
requirements for blood and blood components meet high standards.  

8. 

DATA PROTECTION (ART. 24) 

Twelve  Member  States  had  taken  measures  to  ensure  that  all  data,  including  genetic 
information,  collated  within  the  scope  of  the  Directive  to  which  third  parties  have  access, 
have  been  rendered  anonymous  so  that  the  donor  is  no  longer  identifiable.  Nine  have  data 
security measures in place as well as safeguards against unauthorised data additions, deletions 
or modifications and transfer of information. 

Procedures to resolve data discrepancies are in place in 6 Member States with improvements 
required in a few others. Eight have measures in place to ensure no unauthorised disclosure of 
such information. 

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It is the intention of the Commission to issue a report on the promotion by Member States of voluntary 
unpaid blood donations in 2006.  
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 (O.J. L 91, 30.3.2004, p 25). 
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 (O.J. L 91, 30.3.2004, p 25). 

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9. 

INFORMATION EXCHANGE, PENALTIES AND TRANSPOSITION  

9.1. 

Information exchange (Art. 25) 

The  Commission  has  convened  a  meeting  with  the  competent  authorities  designated  by  the 
Member States, delegations of experts from blood establishments and other relevant parties on 
25  September  2005  to  exchange  information  on  the  experience  acquired  with  regard  to  the 
implementation of this Directive.  

9.2. 

Penalties (Art. 27) 

Member  States  must  lay  down  rules  on  the  penalties  for  infringements  of  the  national 
provisions,  take  all  measures  necessary  to  ensure  that  they  are  implemented,  and  notify  the 
Commission  of  the  provisions  by  8  February  2005  at  the  latest  and  without  delay  for  any 
subsequent  amendments  affecting  them.  Four  Member  States  indicated  that  penalties  and 
fines already existed. 

9.3. 

Transposition (Art. 32) 

At  the  beginning  of  2006,  13  Member  States  subject  to  the  report  adopted  transposition 
measures.  Two  Member  States  have  informed  the  Commission  that  procedures  for 
transposition are underway, but that they have not yet informed the European Commission of 
the 
the  Directive.  The 
Commission will evaluate the measures of transposition of the Directive in all Member States. 

laws,  regulations  and  administrative  provisions 

transposing 

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