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 the Directives 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62/EC setting standards of quality and safety for human blood and blood components
Date: 2016-04-21
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, blood transfusion, health control, health risk, national implementing measure, quality standard, safety standard, summarising

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 21.4.2016  COM(2016) 224 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 the Directives 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62/EC setting standards of quality and safety for human blood and blood components {SWD(2016) 129 final} {SWD(2016) 130 final}  
 
 
1.  Introduction 

Article  26  of  Directive  2002/98/EC  requires  Member  States  to  submit  to  the  European 
Commission,  before  31  December  2003  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  them  with  an  overview  report  on  the  implementation  of  the  requirements  of  the 
Directive, in particular as regards inspections and control.  

In addition, and in accordance with Article 20(2) of the Directive 2002/98/EC, Member States 
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 inform the European Parliament and the Council of any necessary 
further measures in relation to VUD it intends to take at Union level.  

This  overarching  Report  is  a  summary,  drawing  from  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  Report  in  20063  and  the  Commission  Communication  in 
20104, as well as on the two Reports on the application of the principle of VUD for blood and 
blood components issued in 20065 and 20116. All Member States replied to the transposition 
questionnaire. The 2013 implementation survey was answered by all Member States and also 
by  two  EEA  countries,  Liechtenstein  and  Norway.  All  Member  States,  Liechtenstein  and 
Norway also provided answers to the survey on the implementation of the principle of VUD.  

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 Report7. 

Besides  complying  with  the  legal  obligations,  the  current  report  sets  out  how  Directive 
2002/98/EC  and  its  implementing  Directives  2004/33/EC,  2005/61/EC  and  2005/62/EC 
(henceforth commonly referred to as the EU blood legislation) function in practice, against a 
backdrop  of  significant  scientific  and  organisational  developments  (internationalisation, 
commercialisation) that have taken place in the European blood and blood components sector 
over the past decade. 

Where  appropriate,  data  gathered  through  other  channels  and  supporting  the  findings  of  the 
two  surveys  (e.g.  exchanges  with  the  national  blood  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  Blood 

1    Detailed Member State replies (as well as replies from Norway and Liechtenstein) can be accessed at:  
      http://ec.europa.eu/health/blood_tissues_organs/key_documents/ 
2 

In a number of cases clarification requests were sent to Member States for verification. 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://ec.europa.eu/health/blood_tissues_organs/docs/blood_reportdonation_en.pdf 
4   http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52010DC0003 
5       http://ec.europa.eu/health/ph_threats/human_substance/documents/blood_com_0217_en.pdf 
6      http://ec.europa.eu/health/blood_tissues_organs/docs/blood_reportdonation_en.pdf 
7    Links to be added once published 

2 

 
 
 
                                                            
(RAB) platform, a study mapping the economic landscape of the sector and more recently a 
Eurobarometer survey8 as well as outputs of EU-funded projects were also taken into account.  

2.  Transposition of EU Blood legislation  

A verification of the completeness of transposition into national legislation of the EU blood 
legislation, carried out by the Commission, demonstrated that it is fully transposed in all but 
one  Member  State.  In  the  latter  case,  an  infringement  proceeding  pursuant  to  Article  258 
TFEU is ongoing. 

3.  Implementation of the EU blood legislation 

Overall,  the  implementation  of  the  EU  blood  legislation  by  Member  States  is  considered 
adequate  and  the  legislation  has  resulted  in  the  establishment  of  a  network  of  competent 
authorities  that  oversee  the  field  through  authorisation,  inspection,  and  vigilance.  However, 
some  difficulties  in  interpretation,  implementation  and  enforcement  of  the  legislation  were 
identified, in some cases due to technological and scientific advances since its adoption. As 
the  legislation  in  question  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 for potential cross-border movement 
of blood and blood components. 

3.1. Designation of competent authority or authorities  

All  Member  States  have  appointed  competent  authorities  for  blood.  In  half  of  the  countries 
one authority is responsible for the entire oversight of the blood sector, whereas in others the 
tasks  are  divided  amongst 
(based  on  duties,  e.g. 
accreditation/authorisation  versus  inspections/vigilance,  or  based  on  the  allocation  of  tasks 
between  federal  and  regional  levels).  Several  Member  States  mentioned  the  limited  role  of 
authorities at federal/national level and pointed to the important tasks attributed to/carried out 
by regional competent authorities. In the vast majority of Member States, the authorities for 
blood are also responsible for the oversight of other sectors (e.g. organs, tissues, cells and/or 
medicinal products), which can be beneficial for achieving greater efficiency and coherence. 

three  authorities 

two  or 

8  http://ec.europa.eu/health/blood_tissues_organs/docs/20150408_cc_report_en.pdf; 

http://ec.europa.eu/health/blood_tissues_organs/docs/20150408_key_findings_cc_en.pdf 
http://ec.europa.eu/health/blood_tissues_organs/eurobarometers/eb822_en.htm 

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CZ, DE, IE, FR, LI, NO, PL, RO

AT, BE, CY, CZ, DE, DK, FR, IE, IT, LI, LV, NL, NO, PL,
SE, SI, SK, UK

CY, CZ, DK, EE, FI, FR, HR, IE, IT, LI, LV, MT, NL, NO,
PL, PT, SE, SK

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AT, BE, CY, CZ, DE, DK, EE, FI, FR, HR, IE, IT, LI, LV,
MT, NL, NO, PL, SE, SI, SK

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s
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AT, BE, BG, CY, CZ, DE, DK, EE, FI, FR, HU, IE, LI, LV,
MT, NL, PL, SE, SI, SK, UK

Fig. 1: Additional fields of competence for national blood competent authorities  

0

5

10

15

20

25

Wherever  different  oversight  activities  (authorisation,  inspection,  haemovigilance)  are 
undertaken by different authorities, good communication and coordination between respective 
authorities  needs  to  be  ensured.  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  point  is  essential,  even  where 
competent  authority  responsibilities  are  shared  among  multiple  organisations  or  regions. 
Irrespective  of  the  organisational  set-up,  it  is  important  that  authorities  have  appropriate 
resources at their disposal to enable them to carry out the required duties, as well as to ensure 
their independence from economic operators in the sector and from other influences.  

3.2 Obligations of blood competent authorities  

Accreditation,  designation,  authorisation  or 
licensing  of  blood  establishments.  The 
implementation  survey  confirmed  that  this  core  responsibility  of  national  competent 
authorities is well developed across the Union. At the end of 2011, 1363 blood establishments 
were authorised in the EU. These authorisations also cover 731 mobile sites, 534 satellite sites 
and 253 plasma collection centres.  

There are differences between Member States in relation to the duration and terms of renewal 
of the individual authorisations. Some Member States called for more common procedures for 
authorisation across the Union.  

Inspections and control measures.  In 2012, 22 countries reported having performed 760 on-
site  inspections.  In  addition,  thematic/focused  inspections,  inspections  following  SARE  and 
desk-based  assessments  are  organised.  In  almost  all  countries,  the  inspections  of  blood 
establishments overlap with inspections in other areas. 

4 

 
 
 
 
 
 
Others:

Hospitals:

5 

Medical devices:

6 

Advanced therapies:

Pharmaceuticals:

Organs:

Tissues and cells:

9 

8 

11 

16 

0

2

4

6

8

10

12

14

16

18

20

Fig. 2:  Overlapping inspection schemes 

19 

Whilst  overall  Member  States  seem  to  correctly  implement  the  provisions  concerning 
inspections, a number of Member States reported difficulties related to staffing, which makes 
compliance with the required 2-year inspection interval challenging. Several Member States 
expressed interest in applying instead a risk-based prioritisation planning for inspections.  

There  is  diversity  between  Member  States  in  organisation  (e.g.  desk-based  versus  on-site), 
and  outcome  (i.e.  classification  and  follow-up  of  deficiencies)  of  inspections.  Also  the 
inspection  approaches  vary  significantly  towards  mobile  and  satellite  sites,  hospital  blood 
banks, plasma collection centres and potential third country players.  

Levels of inspector empowerment and training were regularly commented upon in the replies 
to the implementation survey. The value of international projects, at EU level and organised 
by  the  Council  of  Europe,  are  clearly  appreciated  by  most  of  the  national  competent 
authorities as a means to help maintain an adequate level of training and know-how within the 
group of inspectors and to help ensure a uniform level of compliance verification throughout 
the EU. 

Traceability. Almost all countries report that a donor identification system was implemented 
in their country, in the majority of countries at national level. All Member States reported that 
the  same  rules  on  traceability  apply  to  blood  establishments  and  hospital  blood  banks, 
allowing tracing of blood and blood components from donor to recipient and vice versa. 

Notification  of  serious  adverse  reactions  and  events  (SARE).    All  Member  States  except 
Hungary reported having a SARE notification system in place, in the majority of them based 
on  the  practical  guidance  developed  in  co-operation  with  the  Member  States  for  the 
compilation  of  the  online  annual  SARE  report.  Twenty  one  Member  States  have  dedicated 
vigilance  officer(s)  in  place.  However  blood  competent  authorities  in  one  third  of  the 
countries do not believe that all blood establishments are reporting SARE. 

5 

 
 
 
50-69%  
SE 
1 

70-99%  
AT,CZ, DE, EL, 
HU, IT, PT, SK; 
8 

100%  
BE, BG, CY, DK, 
EE, ES, FI, FR, 
HR, IE, LI, LT, 
LU, LV, MT, NL, 
NO, PL, RO, SI, 
UK … 

Fig. 3:  Percentage of reporting blood establishments/country 

While all countries report having recall procedures in place, only 14 reported recalls (1867 in 
total).  A  common  reason  for  these  recalls  is  information  received  from  the  donor  regarding 
his/her  health  situation  and  made  available  after  the  donation  event.    While  not  mandatory, 
two-thirds  of  countries  have  put  in  place  donor  self-exclusion  systems.  Most  countries 
organise  root  cause  analyses  to  understand  the  reasons  behind  SARE,  however  there  is 
a generally reported interest in  developing  this approach further, in  particular to  address  the 
challenge of involving local professionals and hospitals in these analyses. There appears to be 
a good interconnectivity with other health-related vigilance systems, in particular on medical 
devices and communicable diseases. These two areas are often cause for general alerts in the 
blood  sector,  as  demonstrated  since  the  launch  of  the  Commission  managed  Rapid  Alert 
System  for  Blood  (RAB),  where  a  number  of  alerts  relating  to  emerging  disease  risks  with 
relevance  to  blood  donor  selection  or  testing  and  to  medical  device  defects  that  were 
important in blood collection or processing were shared among the national blood competent 
authorities. The authorities interact effectively with the RAB system, although many mention 
a  need  to  improve  communication  of  the  information  from  RAB  to  the  local  blood 
establishments,  which  needs  to  be  accomplished  at  national  level.  Clarification  of  the 
operational rules on reporting SARE at EU level would be perceived as helpful by Member 
State haemovigilance experts. 

Although the definition of serious adverse reaction (SAR) in Directive 2002/98/EC, Article 3, 
gives equal importance to SAR in donors and in recipients, the current requirements refer only 
to reporting of SAR in recipients. Nonetheless, the voluntary reporting of SAR in donors has 
increased, suggesting the Member States' increasing interest in the protection of living donors. 

Import and export.  Whole blood and blood components such as platelets and red blood cells 
have a limited shelf-life and are rarely exchanged between Member States, with the exception 
of  rare  emergency  or  humanitarian  situations.  Plasma  and  plasma  derivatives  can  have  a 
longer shelf-life and as fractionation plants exist only in twelve Member States, both plasma 
(the  starting  material)  and  plasma  derivatives  (the  end  product)  are  frequently  exchanged 
across borders, within the EU and with third (non-EU) countries.  

In contrast to blood components for transfusion, the demand for plasma derivatives is steadily 
increasing (around 6% per year) which also generates import flows from third countries into 
the EU. 

The majority of Member States have rules to authorise and control import of blood and blood 
components  for  transfusion,  while  only  about  half  have  such  rules  for  plasma  for 
fractionation.  These  include  standards  for  verifying  equivalent  safety  and  quality  standards, 
which in half of the Member States go beyond the requirements of the EU blood legislation, 

6 

 
 
 
e.g.  adding  requirements  for  the  use  of  the  more  sensitive  nucleic  acid    testing  (NAT)  now 
available as a routine test for hepatitis and HIV screening. 

National  rules  for  export  often  limit  or  place  conditions  on  export  of  blood  and  blood 
components, e.g. only in situations of emergency, which is seen by many countries as part of 
their  national  policy  to  ensure  self-sufficiency  (see  below).  Rules  for  export  of  plasma  for 
fractionation are usually less restrictive, although practice was reported of plasma export for 
contract fractionation of derivatives which are subsequently to be used for patients only in the 
country  of  collection.  While  many  countries  report  having  data  on  imported  volumes,  it  is 
difficult to draw conclusions in the absence of a harmonised data collection system on import 
and  export  volumes.  Additionally,  the  distinction  between  import/export  from/to  third 
countries and distribution from/to other EU Member States is not consistently applied.  

Data protection and confidentiality. No problems were reported regarding the implementation 
of the provisions related to data protection. 

4.  Shortages, surpluses and self-sufficiency.  

The  VUD  survey  addressed  questions  on  the  balance  between  supply  and  demand,  and  the 
measures  taken  to  achieve  sufficiency.  This  topic  is  intrinsically  linked  with  the  promotion 
and  success  of  the  principle  of  VUD,  as  highlighted  in  recital  23  of  Directive  2002/98/EC. 
Eight  countries  reported  regular  shortages  of  one  or  more  blood  components  in  the  survey. 
These  shortages  often  occur  in  summer/holiday  seasons  when  the  number  of  donors  is 
reduced and the risk of epidemiological outbreaks, such as West Nile Virus, can temporarily 
reduce  the  number  of  eligible  donors.  The  ageing  EU  population  could  exacerbate  supply 
challenges, leading both to increased demand and reduced numbers of eligible donors. Other 
challenges to the principle of (self-) sufficiency are outlined below.    

7

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3

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HU

BG, CY, EL, HU, PT, SE

BG, CY, EL, HU, SE

LV

Whole blood

Red blood cells

Platelets

Plasma fractions

Fig. 4:  Countries reporting regular shortages 

A limited  number of countries report surpluses for some blood  components which indicates 
the potential for cross-border agreements. One national competent authority has taken the lead 
on developing such an initiative within the network of national competent authorities.  

Seven  countries  do  not  recover  all  plasma  from  whole  blood  donations  for  plasma 
fractionation  into  derivatives.  The  UK  and  Ireland  apply  this  policy  as  part  of  their  risk 
mitigation  strategy  for  transmission  of  variant  Creutzfeldt  Jacob  disease.  Other  Member 

7 

 
 
 
 
 
States  reported  to  be  negotiating  agreements  for  fractionation,  while  one  reported  having 
difficulties finding a partner to carry out fractionation.  

In  order  to  address  shortages,  countries  can  put  in  place  policies  to  increase  supply  and  to 
optimise  usage.  In  almost  every  country,  donation  promotion  activities  are the  main  actions 
taken to increase supply. Most common are awareness building campaigns for specific donor 
groups, such as students, or events such as the World Blood Donor Day (WHO, 14 June) or 
Thalassemia  day  (8  May  in  Greece  and  Cyprus).  Many  countries  reported  financially 
supporting  blood  establishments  and  local  players  in  the  organisation  of  such  promotion 
activities (although the financial support in many of these countries also relates to collection, 
processing,  storage  and  distribution  activities).  The  debate  on  possible  compensation  and 
incentives for donors plays an important role in supply management (see below).  

In order to manage demand and supply of blood and blood components, almost all countries 
have policies in place that combine annual forecasting with weekly monitoring. These policies 
involve  players  at  multiple  levels,  national  competent authorities  as  well  as  local clinicians. 
To engage these local stakeholders, countries mention the use of audits and programmes such 
as  the  implementation  of  patient  blood  management  (PBM)  (for  which  there  is  currently 
a tendered study on-going under the Union's Third Health Programme). The service contract 
aims to develop best practices, which could allow for a significant reduction of blood demand 
for many treatments. 

A  majority  of  countries  report  having  policies  to  also  optimise  the  clinical  use  of  plasma 
derivatives,  with  a  small  number  of  countries  having  national  prioritisation  strategies  to 
ensure  supply  to  those  patient  groups  who  are  highly  dependent  on  treatment  with  these 
products. Some Member States would welcome an exchange of best practices in this respect.  

National

Regional

Local

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15 

21 

Operator/blood establishment

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16 

Specific bodies

No policy

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0

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Blood and blood components

Plasma derivatives

Fig. 5: Policy setting to ensure effective use of blood, blood components and plasma derivatives 

The  global  growth  of  utilisation  of  plasma  derivatives,  particularly 
intravenous 
immunoglobulin (IVIG), requires a growing number of donations. Many countries are largely 
supplied with plasma derivatives by just one supplier, either public or private. Public, national 
suppliers  are  predominant  in  a  minority  of  EU  countries.  There  are  a  small  number  of 
international companies that supply the majority of countries. 

Cross-border movement of donors. Five countries reported having donations by donors from 
abroad, while six countries reported having citizens that travel to donate abroad. While two of 
these  latter  six  countries  also  report  regular  shortages  in  national  supply,  the  information 
provided was not sufficient to establish a causal link between these shortages and the cross-

8 

 
 
 
border  movement  of  donors.  The  reported  picture  seems  not  to  be  complete,  with  some 
inconsistencies between the information provided by countries whose citizens travel to donate 
and those who have donors coming from another Member State to donate. While most cross-
border donations seem to be individual initiatives, Hungary and Slovakia reported organised 
transport for their citizens to travel to Austria for plasma donation. 

Views  vary  on  whether  such  cross-border  donations  are  desirable.  Ten  countries  reported 
facilitating  donations  by  donors  from  abroad  by  providing  donor  questionnaires  in  different 
languages. Sixteen reported discouraging such donations by requiring a local ID document or 
a proof or local residence.  

Replacement donors, i.e. donors that are encouraged to make donations to replace those being 
used for a relative or friend, are reported as important for maintaining supply in five countries.  
Policies  towards  them  vary,  from  prohibition  to  seeing  replacement  donations  as  an 
opportunity to contribute to national self-sufficiency by converting them into regular donors. 
From an EU perspective, the relevant question is whether blood collected from these donors 
might have a different safety and quality profile (see below).  

5.  Voluntary and unpaid donation (VUD) 

The ways in which EU Member States have implemented the principle of VUD are difficult to 
assess in  a comprehensive manner. VUD is  a factor which is not  only ethical in nature, but 
which  might  also  contribute  to  higher  safety  standards  and,  therefore,  be  important  for  the 
protection of human health. In a system allowing donor payment, some individuals may find 
the monetary remuneration so important that they might not disclose 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  contributes  to  an  accurate  assessment  of  all  risks  associated  to  the 
transfusion of blood and blood components and the clinical application of plasma derivatives. 

Although  the  large  majority  of  the  responding  countries  (26)  reported  that  the  principle  of 
VUD is mandatory at national level, their legislations often refer to an "encouragement" or to 
a "strong recommendation".  

The practical  application of  the VUD principle varies across the Union. Seventeen  Member 
States  reported  having  penalties  in  place,  addressing  different  situations  such  as  making 
financial gain or collection of donations without consent. According to reports from Member 
States, no such penalties have so far been imposed. Most countries have additional supportive 
measures  in  place,  primarily  focused  on  promoting  VUD  or  defining  compensation  and 
incentives  (see  below).  The  EU  is  significantly  reliant  on  importation  of  plasma  for  the 
manufacture  of  plasma  derived  medicinal  products,  mainly  from  the  United  States.  In  this 
context,  it  is  challenging  for  MS  to  apply  a  requirement  for  the  exclusive  importation  of 
plasma sourced from voluntary and unpaid donors. 

It is common practice to provide refreshments to donors (27 countries) and to give them small 
tokens such as pin badges, pens, towels, t-shirts and mugs (24 countries). In around half of the 
Member States, donors have their travel costs reimbursed and get time off work in the public 
and private sector. In some Member States, donors receive a fixed payment that is not directly 
related to actual costs incurred. 

There  is  considerable  heterogeneity  across  the  EU,  with  certain  practices  perceived  as 
compensation  in  one  country  and  as  incentives  in  another.  For  the  purpose  of  the  survey, 
"compensation" was defined as "reparation strictly limited to making good the expenses and 

9 

 
 
 
inconveniences  related  to  the  donation"  and  "incentive"  was  defined  as  "inducement  or 
stimulus  for  donation  with  a  view  to  seeking  financial  gain  or  comparable  advantage",  but 
even  with  these  (non-binding)  definitions  Member  States  reached  divergent  classifications. 
The  difference  in  purchasing  power  between  Member  States  might  be  one  factor  which 
explains the diverging views on what is or is not an incentive to donate.  

The  maximum  reported  values  of  compensation  and  incentives  are  around  EUR  25-30  per 
donation while the reported values of refreshments and small tokens are between EUR 1 and 
EUR  10  per  donation.  Reimbursement  of  travel  costs  can  cover  the  actual  costs  or  be  a 
standard lump sum. Time off work varies from less than half a day to up to two days. Some 
countries foresee compensation for loss of earnings in some circumstances, e.g. one Member 
State foresees this for plasma apheresis donations.  

Less than half of the countries reported having national guiding principles to define what form 
of  compensation  or  other  practice  is  allowed  and  under  which  circumstances.  In  half  of  the 
countries, the blood establishments either determine, or are involved in determining, the value 
of  the  compensations  and  incentives,  while  in  one-third  of  the  countries  the  national  blood 
competent authorities are involved.  
In  the  Eurobarometer  survey  on  Blood  and  Cell  and  Tissue  Donation9,  only  12%  of  EU 
citizens  reported  that  they  thought  compensation  additional  to  the  costs  related  to  donation 
was  acceptable,  when  donating  blood  or  plasma.  In  contrast,  47-48%  considered  that 
receiving refreshments, free blood testing or a free physical check-up were acceptable. 

6.  Quality and safety of blood and blood components 

Safety  and  quality  of  the  blood  supply  is  an  important  issue  for  EU  citizens,  with  56%  of 
respondents to  the  Eurobarometer survey on Blood and Cell  and Tissue Donation citing the 
risk of contracting a disease as a major concern when accepting donated substances.  

Safety and quality of blood depends on the implementation of a combination of three pillars: 
donor screening for deferral criteria, donor testing and, where possible, pathogen inactivation 
techniques. Combining the implementation of all three pillars, where possible, is probably the 
most effective way to minimise risks. 

Donor  screening  for  eligibility.  The  main  causes  leading  to  deferrals  of  candidate  donors 
reported  by  Member  States  were  low  haemoglobin  levels  (putting  at  risk  the  health  of  the 
donor) as well as risk of transmission of infectious diseases, (sexual) risk behaviours, travel, 
medication and other medical reasons (putting the health of the recipient at risk).  

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

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CZ, DK, NO, PT, SE, UK

BG, FI, EL, FR, IT, LT, NL, PT, RO, SI, UK

BE, BG, CZ, EL, FI, HR, LT, LU, MT, NL, NO, PL, RO, UK

BG, EL, FR, LT, NL, RO, SI, UK

BE, CZ, LT, PT, RO, SE, UK

AT, BE, BG, CY, EL, FI, HR, HU, IE, IT, LT, LV, MT, NL, PL, PT, RO, SI, UK

0

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Fig. 6:  Main causes leading to deferrals/country 

Many countries reported in 2013 on the feasibility/appropriateness of deferring donors on the 
grounds of sexual risk behaviour and about two-thirds of the countries have national guidance 
in  place.  Men  having  sex  with  men  (MSM)  is  the  most  commonly  reported  sexual  risk 
exclusion  criterion  due  to  the  higher  incidence  of  infections  such  as  HIV  within  this 
population. Since the survey was conducted, changes in national policies have been reported 
by  some  countries  during  the  bi-annual  meetings  of  Competent  Authorities;  the  trend  is  to 
move from permanent to temporary (usually 12 months) deferral for MSM.  

Countries identify an increase of the maximum donor age as the most promising initiative to 
improve  the  supply  of  blood  and  blood  components.  Other  eligibility  criteria  that  several 
countries would wish to reflect on relate to the history of malignancy, donor risk behaviour 
and  haemoglobin  levels.  Overall,  Member  States  expressed  interest  in  an  increased  level  of 
donor  protection  and  in  an  overview  of  additional  national  eligibility  criteria  in  order  to 
increase transparency and mutual trust in exchanges. 

laboratories.  Member  States  can  add 

Testing and inactivation technologies. EU legislation defines the minimum serological testing 
for human immunodeficiency virus (HIV) 1/2, hepatitis B and hepatitis C to be carried out for 
every whole blood and apheresis donation. In all Member States these tests are performed by 
authorised 
tests  for  specific  components  or 
epidemiological  situations.  They  reported  conducting  additional  tests  for  syphilis,  malaria, 
hepatitis  A, hepatitis  E and  Parvovirus  B19.  About  two  thirds  of  the  countries  mention  that 
blood  establishments  also  apply  more  sensitive  nucleic  acid  testing  (NAT),  along  with 
serological testing, although several countries also raised questions regarding the cost-benefit 
ratio of this relatively costly testing technique. No additional testing was reported for plasma 
collection, compared with collection of whole blood donations. 

Sixteen  countries  report  having  pathogen  inactivation  technologies  in  place.  Inactivation 
techniques are mainly used for plasma although pathogen inactivation of platelets is likely to 
be more common going forward. 

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In their responses to the implementation survey, several countries suggested making syphilis 
testing mandatory at EU level, while some suggest making NAT testing for HIV and hepatitis 
mandatory,  despite  the  reservations  mentioned  by  other  countries.  Member  States  also 
highlight the need for good validation of testing technologies, and also pathogen inactivation 
technologies, in  order  to achieve  an effective level of safety  and quality. Countries  also  see 
value in further centralisation of laboratory test results at EU level to facilitate benchmarking 
against average EU rates of positivity. 

Every  change  in  deferral,  testing  or  pathogen  inactivation  policy  has  a  possible  impact  not 
only  on  safety  and  quality,  but  also  on  the  economics  and  on  the  volume  of  donations  and 
supply. The role of common assessments by ECDC and the Commission  was  recognised in 
this context, e.g. when developing a preparedness plan to help blood establishments address 
the seasonal outbreaks of West Nile Virus in some southern EU countries.  

7.   Support for the Implementation of the Blood 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 meetings to EU-funded projects. 

The regular meetings of the expert sub-group on blood and blood components (which is part 
of  the  Competent  Authorities  on  Substances  of  Human  Origin  Expert  Group  -  CASoHO 
E01718) allow 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  health  addressing  the  area  of  blood  and  blood  components. 
Projects such as EUBIS, CATIE, DOMAINE, Optimal Blood Use, EU-Q-Blood-SOP and the 
on-going  joint  action  VISTART  provide  strong support  to  Member  States  in  their efforts  to 
implement the requirements of the blood directives. These actions brought improvements in 
areas of common interest such as quality management and inspection and donor selection and 
included training courses for Member States Competent Authorities and their inspectors.  

As  regards  the  risk  of  transmission  of  communicable  diseases  thorough  blood  and  blood 
components,  the  collaboration  with  ECDC  proved  extremely  valuable.  In  addition  to 
providing regular updates during the bi-annual meeting of the blood expert sub-group on the 
epidemiological  situation  relevant  to  the  blood  sector,  the  development  of  risk  assessments 
(e.g.  for  HTLV,  malaria,  dengue  and  chikungunya)  and  preparedness  plans  (e.g.  for  WNV 
outbreaks) provide 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  the  Member  States,  a  Rapid 
Alert  Platform  for  Blood  (RAB)  which  facilitates  web-based  communications  between 
Member States in case of alerts with relevance in two or more Member States. 

8.  Conclusions 

In  conclusion,  this  Report  reveals  an  overall  adequate  level  of  application  of  the  current 
quality  and  safety  requirements  of  the  EU  blood  legislation.  Significant  progress  has  been 
made  in  many  areas,  often  through  the  active  support  of  Commission  funded  projects  and 
other initiatives.  

12 

 
 
 
 
However,  the  Report  also  points  to  some  gaps  and  difficulties  in  relation  to  the  application 
and  enforcement  of  the  existing  provisions  (e.g.  definitions,  provisions  for  donor  safety, 
inspections framework), some due to different  approaches taken by the Member States and 
others  due  to  technological  advances  and  changing  risks  observed  since  the  legislation  was 
adopted. The Commission will follow-up with Member States to address situations where the 
legislation might not have been fully or correctly implemented. 

The  VUD  survey  shows  that  Member  States  overall  comply  with  Article  20  of  Directive 
2002/98/EC  requiring  them  to  take  the  necessary  measures  to  encourage  VUD.  However, 
Member States' perceptions of what is considered compensation and incentive vary. 

The  gaps  and  difficulties  identified may  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 
2002/98/EC and its implementing Directives.  

13