•ir -tr COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 17.11.1997 
C0M(97) 605 final 
97/0315 (CNS) 
PROPOSAL FOR A 
COUNCIL RECOMMENDATION 
on the suitability of blood and plasma donors and 
the screening of donated blood 
in the European Community 
(presented by the Commission) 

Explanatory Memorandum 
1. INTRODUCTION 
1. Continuing concerns about the quality, safety and efficacy of blood and blood products in the 
European Community motivated the European Commission to recommend, in its 
Communication of December 1994 , the development of a Community blood strategy in order to 
improve confidence in the safety of the blood transfusion chain and to promote Community self-
sufficiency, The Council in its Resolution of June 19952 invited the Commission to continue its 
efforts to define such a strategy using as a basis the activities it had proposed. In November 
1996, Council's Resolution3 on a Strategy Towards Blood Safety and Self-sufficiency in the 
European Community further refined the constituent elements of the strategy by calling for a co­
ordinated approach to the safety of blood and blood products, and calling on the Commission to 
submit proposals as a matter of urgency, drawing upon the Conclusions and Recommendations 
of a Colloquium on blood safety and self-sufficiency held in Adare, Ireland. Responding to this 
invitation, the Commission has been pursuing activities to advance the development of this 
strategy and as a first step has concentrated on the need for common requirements regarding the 
suitability of blood and plasma donors and the testing of their donations. Such requirements can 
make a significant contribution to ensuring the quality and safety of needed blood and plasma, 
restoring the confidence of Community citizens in the blood transfusion system, and 
contributing to the continuing efforts to achieve Community self-sufficiency through voluntary 
unpaid donations. 
2. THE BLOOD TRANSFUSION CHAIN 
2. The blood transfusion chain comprises an extensive number of complex and interrelated 
activities extending from the willingness of an individual to provide blood or plasma for 
therapeutic use; through the elaborate precautions taken in the preparation of both labile blood 
components (red blood cells, white blood cells, platelets and plasma) and stable industrially-
prepared derivatives (e.g. albumin, clotting factor concentrates, protease inhibitors and 
immunoglobulins); to the administration of any of these products to a patient and subsequent 
follow-up. Each of these steps requires meticulous attention to safety. 
3. One of the most crucial links in this chain, however, are the requirements for ensuring the 
acceptance of an individual as a blood or plasma donor and those for testing the donated blood 
or plasma for infectious diseases. As the Commission noted in its 1994 Communication, the 
donor selection process differs across the Community and "it would be beneficial if an 
agreement is reached as regards the rules and practices for donor selection, including new and 
repeat donors as well as donors of whole blood, cellular components and plasma, to be applied 
across the Community". It also referred to the differing testing requirements that exist in the 
Communication from the Commission on Blood Safety and Self-sufficiency in the European Community. 
COM(94) 652 final. 21.12.1994. 23p. 
O.J. No C164. 30.6.95. p. 1 
O.J.NoC374. 11.12.96. p.l 
Department of Health, Ireland. Conclusions and Recommendations. Colloquium on Blood Safety and Self-
sufficiency: An Agenda for the European Community. Adare, County Limerick, Ireland. 4-6 September 1996. 
1 
Community hindering the transfer of blood and the free movement of blood products and 
impeding the goal of self-sufficiency in blood and plasma as starting material used for the 
preparation of medicinal products. These existing variations among the Member States of the 
European Community contribute to a lack of confidence not only among patients but among the 
blood establishments themselves. 
4. Donor selection and the screening of donations were among the topics discussed at the Adare 
Colloquium by Member States experts who recommended, inter alia, that existing guidelines on 
donor selection be reviewed "with a view to making proposals for common criteria to be used in 
the European Community" and that "a minimal set of screening tests should apply in all Member 
States for the testing of whole blood and components for transfusion as well as plasma for 
fractionation". Moreover, they stressed the need for criteria at Community level regarding donor 
identification and determining the core elements and risk behaviours that should be identified 
through a donor screening questionnaire. 
5. In order to establish the basis for common criteria, the Commission in early 1997 conducted a 
survey of the current regulations and practices in the Member States regarding the selection of 
donors and the screening of their blood donations. This survey addressed the current legislative 
requirements in the Member States and guidelines of the Council of Europe and the World 
Health Organization; the criteria for the selection of whole blood and plasma donors; elements 
covered in the donor questionnaire and physical examination; the major reasons for donor 
deferral for the safety of recipients; the current screening tests required for individual whole 
blood donations and plasma obtained through apheresis; and the interpretation of a reactive 
result in the initial screening test for infectious agents (e.g. HIV, HBV, HCV, syphilis) in 
relation to the clinical use of the donation. The outcome of the survey, which was discussed at a 
meeting of national experts in June 1997, and the deliberations at the meeting itself clearly 
reflected variations in regulations and practices in the-Member States. The results of the survey 
are being presented in a working paper of the Commission Services entitled "The suitability of 
blood and plasma donors and the screening of their donations: a 1997 survey of the regulations 
and practices in the Member States of the European Community". 
3. EXISTING AND PROPOSED REQUIREMENTS 
6. Directive 89/381 /EEC5 extended the scope of pharmaceutical legislation to encompass the 
quality, safety and efficacy requirements for industrially prepared medicinal products derived 
from blood and plasma but specifically excluded whole blood, plasma and blood cells of human 
origin. In respect of measures covered by the modification as to testing requirements, referred to 
in Article 6 of that Directive, to be taken by the Member States to prevent the transmission of 
infectious diseases by blood and plasma used as a starting material for the manufacture of 
medicinal products, Article 3 refers to the application of the monographs of the European 
Pharmacopoeia and to recommendations by the Council of Europe and the World Health 
Organization as regards in particular the selection and testing of blood and plasma donors. The 
Directive makes no provision for adaptation to requirements recommended or published on 
donor selection that may have arisen after its adoption in 1989 nor to scientific and technical 
progress. Moreover, since Article 1(2) of the Directive specifically excludes whole blood, 
plasma or blood cells of human origin from its scope, difficulties may arise in practice when 
the final destination of the donation is not known. 
O.J. No L181, 28.6.89, p.44 
7. Council Decision 94/358/EC6 accepted on behalf of the European Community, the Convention 
on the elaboration of a European Pharmacopoeia which aims to harmonise quality specifications 
for active substances and excipients in order to facilitate the free circulation of medicinal 
products in the countries party to the Pharmacopoeia. This harmonisation simplifies 
pharmaceutical and biological testing requirements for marketing authorisations. The European 
Pharmacopoeia's monograph on 'Human Plasma for Fractionation' makes only a reference to 
Council of Europe recommendations regarding the selection of donors which are therefore not 
mandatory. 
8. Council Directive 95/46/EC addresses the protection of individuals with regard to the 
processing of personal data and the free movement of such data. This Directive requires that 
certain sensitive data in particular that related to the health of an individual be subject to 
reinforced protection. It covers only personal data and not that rendered anonymous so that 
the person is no longer identifiable. Processing of medical data is prohibited unless the data 
subject gives his explicit consent. This prohibition is not applicable, however, if the 
processing of the data is for the purpose of preventive medicine, medical diagnosis, the 
provision of care and treatment or the management of health services, and the- data are 
processed by a health professional subject to the obligations of professional secrecy. 
9. At the level of the Member States, the Commission's survey highlighted the significant 
variations in legislative requirements regarding the selection of donors and the testing of 
donations. These range from extensive and detailed legislation developed in recent years, to 
regulations dating to 1980, to non-binding national guidelines. Legislative revisions in the 
area of blood are currently underway in two Member States. These variations hinder the 
transfer of blood (and plasma) and the free movement of blood and plasma products, thus 
impeding the achievement of Community self-sufficiency. 
lO.Therefore, in keeping with the goal of making a contribution towards ensuring a high level of 
health protection to the citizens of the Community, and providing for the attainment of self-
sufficiency in blood and plasma through voluntary unpaid donations, and in view of the 
variations both in legislation and practice in the Member States, the Commission considers it 
imperative that common requirements be introduced by all Member States based on agreed 
recommendations. These should be based on the outcome of its survey and the latest scientific 
evidence regarding the determination of the suitability of donors and the screening of their 
donations. As stated in a recent report by the Swedish National Working Group on Blood Self-
sufficiency8 "many European citizens do not trust the quality and safety of blood products 
originating from countries other than their own. Only by implementing common standards can 
we increase the trust between Community Member States, enhance the free movement of blood 
and blood products, and reach the goal of Community self-sufficiency". These requirements 
must, pursuant to Article 129 of the EC Treaty, be based on Council recommendations, which 
should aim at promoting sound practices and consistency throughout the Community without 
being disproportionate with regard to the overall objectives being pursued, namely the safety and 
sufficiency in the Community of blood and plasma and the health protection of the donors. To 
that end, the proposed recommendations should address donor suitability and eligibility, 
volumes collected, and the screening of samples of donated blood, and should be congruent with 
the provisions of Directive 89/3 81 /EEC. 
O.J. No L158, 25.6.94, p.70. 
O.J. No L281. 23.11.95. p.31 
Swedish National Working Group on Blood Self-sufficiency. European self-sufficiency in blood and blood 
products: Balancing supply and demand. Background Paper to the statement by the Swedish Minister of Health 
and Social Affairs, Margot Wallstrom, (Health) Council Meeting, Luxembourg, June 5 1997. 6p. 
3/H-
4. DONOR SUITABILITY 
11 .Ascertaining the suitability of an individual who has offered to donate blood or plasma is 
essential in order to ensure that there are no detrimental effects to the prospective donor's health 
and to protect that of future recipients of the blood products emanating from that donation. The 
initial step in this process is the provision of accurate and understandable information to the 
prospective donor about the benefits and hazards, both to their own health and that of future 
recipients, associated with blood and plasma donation. Agreement by the prospective donor of a 
willingness to proceed should be followed by the identification and registration of the donor, the 
recording of this information in an appropriate data file, the verification of certain physical 
parameters, and the compilation of a medical history to identify and screen out those who may 
be at some health risk either to themselves or to recipients of their donation. 
12. Although the true effectiveness of written questionnaires in screening out donors with high risk 
behaviours has not yet been fully demonstrated, and the need for a Community-wide 
comprehensive and common questionnaire not established due especially to cultural differences 
in the Community, it is essential that several core elements and risk behaviours be addressed 
during the pre-donation process. These should be addressed in the written questionnaire, or the 
interview with a trained health care staff member, or both and should cover a number of diseases 
and conditions, as well as certain risk factors, on which there is solid scientific consensus for 
their inclusion. 
13.Acceptance criteria for donors of whole blood and apheresis plasma should be clearly 
established to ensure that there are no detrimental effects to the donor's health and additional 
criteria need to be imposed for the protection of future recipients of the blood products deriving 
from their donation. Donors, who for one of many reasons may be deemed ineligible to donate 
blood either temporarily or permanently should be given appropriate counselling. The 
discretion of the physician is paramount in the final determination of eligibility of a donor. 
5. DONOR INELIGIBILITY 
14.A prospective donor may be considered ineligible to donate blood or plasma, either 
temporarily or permanently, at any time during the donation process. Such individuals are said 
to be "deferred" and the period of time during which they are considered ineligible varies 
according to different factors. It is important that appropriate records of such deferrals are 
maintained in such a way that while the confidentiality of the data is maintained, the 
information is accessible to authorised individuals whether at a donation site or when matters 
of safety are concerned. Such manual or computerised records are often referred to as donor 
deferral registers (DDR). 
15.The survey of the requirements and practices in the Member States revealed general agreement 
regarding permanent deferral for particular situations such as HIV / AIDS, hepatitis C, syphilis, 
etc.. Temporary deferral showed both commonality among Member States for some situations, 
and considerable variation for others. For example, temporary deferral ranged from 6-12 
months for tattoos; 2-5 years after recovery from tuberculosis; 1-2 years after recovery from 
toxoplasmosis; from "each service / doctor has own criteria" to 5 years for hepatitis A. These 
variations appear to reflect an absence of conclusive scientific data about the time frame for 
deferral of donors on which sound decisions can be made. Supplementary survey information 
submitted to the Commission following the meeting of experts also reflected the variations in 
practices. In order to arrive at suggested common criteria, therefore, a mean time frame of the, 
5 
responses received is proposed. The scientific basis upon which these deferral periods are 
made must be kept under review. 
16.1n those situations where a donor is deferred temporarily, provisions must be made to allow 
him / her to be considered for donation again at the end of the deferral period. 
6. DATA PROTECTION 
17. Although the measures taken by Member States to ensure the protection of data related to a 
blood or plasma donor were not addressed in the Commission survey, relevant requirements 
are laid down in Directive 95/46/EC. Measures to ensure positive donor identification, the 
verification of data, safeguards against unauthorised access to information, data additions, 
deletions or modifications, data irregularities and discrepancies and the security of 
confidential data all need to be taken into account. This is particularly applicable in cases 
where an individual is deferred. 
18.Article 8 of the Directive refers to the processing of special categories of data including that 
concerning health. According to this Article, the processing of such data shall be prohibited in 
the Member States. It establishes, however, certain cases in which this prohibition shall not 
apply such as when the data subject has given his / her explicit consent to the processing of 
those data, when the data processing is required for the purposes of preventive medicine, 
medical diagnosis, the provision of care or treatment or the management of health care 
services, and where those data are processed by a health professional subject under national 
law or rules established by national competent bodies to the obligation of professional secrecy 
or by another person also subject to an equivalent obligation. The Article also establishes that 
Member States may, for reasons of substantial public interest, lay down exemptions to the 
prohibition with such measures notifiable to the Commission. 
7. VOLUMES COLLECTED 
19.The maximum amount of whole blood or plasma collected from a donor at any one sitting and 
over a 12 month period, the time interval between the donations, and the allowable frequency 
over a given time period have been established in order to prevent any adverse effects to the 
health of the donor as a consequence of the donation. For whole blood, the maximum volume 
collected during an individual donation (450 ml ± 10%) and the minimum time interval 
between donations (8 weeks) are practically the same in all the Member States and are in 
keeping with recommendations of the Council of Europe (1997) and the World Health 
Organization (1994). Two Member States as well as the standards of the American 
Association of Blood Banks (AABB), however, permit a higher volume (500- 525 ml). 
20.For apheresis plasma, the maximum volume collected during an individual donation and over 
a 12 month period varies among the Member States - from 550 to 650 ml per donation; 0.5 to 
1 litre per week; and 10 to 25 litres per year. The frequency of donations varies between twice 
per week and twice a month and the maximum number of donations varies between 4 and 50 
per year. This wide variation may be attributed in part to the differences between manual and 
automated plasmapheresis. 
21. As a significant volume of plasma and plasma products, sourced from donors who are paid, is 
imported into the Community from the United States of America, it has to be noted that the 
allowable maximum plasma volume per individual donation, and over a 12 month time frame, 
6 
are higher in the USA than those currently permitted in several Member States. The 
maximum volume of plasma allowed per donation in the USA depends in practice on the 
weight of the donor: 625 ml for donors weighing between 50-67 kg; 750 ml for donors 
weighing between 68-79 kg; and 800 ml for those weighing 80 kg or more. 
22.According to the 1997 report of the Swedish National Working Group on Blood Self-
sufficiency, "the volume of plasma collected is based mainly on theoretical calculations about 
how much fluid can be lost without risk to the donor. In the US where the body size of the 
donor is used to determine the allowable volume, the donor's blood status has been 
systematically monitored without detecting disturbances." 
23.In view of the Community's goal of self-sufficiency and the lack of progress towards it, 
serious consideration has to be given to allowing an increase in the maximum allowable 
volumes of plasma currently prevailing in the Member States. This would contribute to the 
goal of self-sufficiency. The view espoused by some that higher volumes are detrimental to 
the health of the donor does not appear to be substantiated by scientific evidence. On the 
contrary, the United States Department of Health and Human Services stated in 1992 in a 
memo9 to licensed source plasma establishments that "An analysis based on comparison 
between the allowable volume of source plasma derived from whole blood collected during 
manual plasmapheresis and the experience to date with all of the approved equipment 
(automated plasma collection devices) indicates that there is no discernible impact on donor 
safety, or product quality with the use of the current limits in preference to any other". 
24.Until scientific evidence is adduced to show that permitting an increase in the volume of 
blood or plasma collected from a donor or reducing the time interval between donations has a 
detrimental effect on the donor's health, and in view of the benefits for Community self-
sufficiency, it is proposed that increased volumes such as those accepted in the United States 
scheme be recommended for application by the Member States. Programmes using increased 
volumes should be monitored closely to ensure that no detrimental effects accrue to the donor. 
8. SCREENING OF SAMPLES OF DONATED BLOOD 
25.Whether it is a donation of whole blood or components intended for transfusion purposes or 
plasma collected through apheresis and intended for transfusion or further manufacturing into 
medicinal products, sample specimens of the blood taken from the donor at the time of 
collecting the blood and plasma should be tested for markers of infections that can be 
transmitted to recipients. In order that the citizens of the Community have the highest degree of 
confidence in the safety of the blood and blood products administered for therapy, Member 
States should apply the same screening tests to the common source for both whole blood and 
components used for transfusion,and plasma used for fractionation with one exception, namely 
when plasma is collected by plasmapheresis for the sole purpose of fractionation some tests may 
not be required because the virus is not transmitted by plasma-derived products. 
26.The survey showed that whether the donation is of whole blood or plasma, almost all Member 
States require a sample of the donor's blood to be tested for antibodies against the hepatitis C 
virus (anti-HCV), antibodies against the human immunodeficiency virus type 1 and 2 (anti-
Department of Health and Human Services. FDA. Memo to All licensed Source Plasma Establishments. 4 
November 1992. 
7 
HIV 1 and 2), the surface antigen of the hepatitis B virus (HBsAg), and syphilis. With the 
exception of syphilis, this reflects the mandatory requirements of the European 
Pharmacopoeia monograph on 'Human Plasma for Fractionation' for all blood and plasma 
donations used as source material for the preparation of industrially manufactured medicinal 
products. As syphilis is not transmissible by plasma-derived products, the Biotechnology 
Working Party of the Committee for Proprietary Medicinal Products (CPMP) advised in 1995 
that this test is not required for plasma for fractionation . Only one Member State does not 
test for syphilis. 
27.Requirements for other tests for markers of various diseases transmissible by blood 
transfusion vary among the Member States. A malaria test is generally not required but five 
Member States allow for it "when required" or required "for travellers to endemic areas". 
Testing for antibodies to human T-cell lymphotropic virus (anti-HTLV I and II) is carried out 
in six Member States with one indicating that it is carried out on first time donors and another 
reporting that although not required it is done. Testing for hepatitis B core antibodies (anti-
HBc) is carried out in five Member States for whole blood donations with three requiring it 
only for first time donors. HIV p24 antigen test is not required in any of the Member States 
but is a pilot project in one. Only one Member State requires neopterin testing for whole blood 
donations. 
28.The survey substantiated earlier reports regarding tests that are required in some Member 
States and not in others leading to impediments on the utilisation of excess plasma, the free 
movement of plasma-derived products, and therefore to a lack of progress towards 
Community self-sufficiency. This difficulty arises particularly with reference to alanine 
aminotransferase (ALT) which is not required by the European Pharmacopoeia. Plasma 
collected by some Member States that has not undergone this test is rejected for use by others. 
It is noteworthy that an expert panel at the National Institute of Health of the United States 
recommended that its use be discontinued since, as shown by scientific data, it had outlived its 
usefulness and was of little value now given the availability of the HCV test. This view was 
reiterated by the experts to the Adare Colloquium who considered that ALT screening had 
become redundant because of the specific screening for HBsAG and antibodies to hepatitis C. 
29.lt follows from the above that a set of scientifically-based and broadly-supported 
requirements, as well as a procedure for making decisions, depending on the results of the 
various tests that donated blood undergoes, should be established based on agreed 
recommendations for the Community. 
9. COMMON TERMINOLOGY 
30.A fundamental requirement for arriving at common criteria related to the suitability of donors 
and the testing of donations is the use of common terminology. Confusion and 
misunderstandings often arise as a result of different interpretations of the same terminology. In 
spite of the existence of several glossaries, there is still no consistent use of several terms in this 
sector such as blood products, repeat donors, etc. Therefore common terminology for use 
throughout the Community is proposed. 
10 DGIII/5941/94. "Selection and screening of donors for blood / plasma as starting material for medicinal products. 
Position paper for CPMP on harmonisation of selection and screening of donors/exclusion criteria" in"Inventory 
of Provisions relating to Medicinal Products Derived from Human Blood or Plasma", Brussels, March 1995. 
10. SCIENTIFIC COMMITTEE AND REPORTING 
31.The dynamic and rapidly-evolving environment of transfusion medicine, such as cytapheresis, 
total blood apheresis and cord blood collection as well as the questions posed by the availability 
or introduction of new technologies such as genome amplification technology (GAT) - a highly 
sensitive technique capable of detecting viral genomes even when serological tests are 
negative - as a possible screening test, demands that mechanisms be in place for the 
Community to have ready access to scientific and technical guidance and be able to respond 
quickly to changing technology and scientific information. Consideration will be given by the 
Commission to establishing a Scientific Committee on blood to advise it on these and the 
other matters covered in the proposed recommendation. 
32.Moreover, in order to ensure that all Member States are fully aware of developments that have 
implications at Community level and to keep the Council informed of the measures that have 
been taken towards the implementation of common criteria in the Community, the 
Commission could prepare reports as appropriate. 
PROPOSAL FOR A 
COUNCIL RECOMMENDATION 
on the suitability of blood and plasma donors and 
the screening of donated blood 
in the European Community 
\p 
THE COUNCIL OF THE EUROPEAN UNION 
Having regard to the Treaty establishing the European Community, and in particular Article 129 
thereof; 
Having regard to the proposal from the Commission ; 
Having regard to the opinion of the European Parliament, 
1. Whereas in accordance with point (o) of Article 3 of the Treaty, Community action must 
include a contribution towards the attainment of a high level of health protection; 
2. Whereas the Commission's Communication on Blood Safety and Self-sufficiency in the 
European Community of December 1994 identified the need for a blood strategy in order to 
reinforce confidence in the safety of the blood transfusion chain and promote Community self-
sufficiency; 
3. Whereas Council in its Resolution of 2 June 1995 , in response to the Commission's 
Communication, invited it to submit appropriate proposals in the framework of development of 
a blood strategy; 
4. Whereas Council in its Resolution of 12 November 1996 on a strategy towards blood safety 
and self-sufficiency in the European Community invited the Commission to submit proposals 
as a matter of urgency with the view to encouraging the development of a co-ordinated 
approach to the safety of blood and blood products; 
5. Whereas the European Parliament in its resolutions on blood safety and self-sufficiency through 
voluntary unpaid donations in the European Community has stressed the importance of 
ensuring the highest level of safety in the selection of donors and the testing of donations and 
has reiterated its continued support for the objective of Community self-sufficiency; 
6. Whereas Council Directive 89/381/EEC extended the scope of pharmaceutical legislation to 
guarantee the quality, safety, and efficacy of proprietary industrially prepared medicinal 
products derived from human blood or human plasma; whereas it does not apply to whole 
blood, to plasma, or to blood cells of human origin; 
i 
.2 
3 
4 
5 
6 
7 
8 
9 
10 O.J. 
O.J. 
COM (94)652 final. Brussels. 21.12.1994 
O.J. No C164, 30.6.95, p.l 
O.J.NoC374, U. 12.96, p.l 
O.J.NoC268, 4.10.93, p.29 
O.J.NoC329, 6.12.93, p.268 
O.J. No C249, 25.9.95, p.231 
O.J.NoC141. 13 5.96. p.131 
O.J. No L181, 28.6.89, p.44 
It 
7. Whereas therapeutic use of blood and medicinal products derived from human blood and 
plasma contributes significantly to saving lives and yields considerable benefits for those 
suffering from long term blood disorders; whereas, however, in spite of their significant 
therapeutic value, blood, blood components, and blood and plasma derivatives have the 
potential to transmit infectious diseases; 
8. Whereas the availability of blood and plasma used for therapeutic purposes and as starting 
material for the manufacture of medicinal products is dependent on the willingness and 
generosity of Community citizens who are prepared to donate; 
9. Whereas donations should be voluntary and unpaid; 
10. Whereas in respect of blood or plasma as a starting material for the manufacture of proprietary 
medicinal products, Article 3 of Council Directive 89/381/EEC refers to measures: covered by 
the modification, as to testing requirements, referred to in Article 6 of that Directive, to be taken 
by Member States to prevent the transmission of infectious diseases, comprising the application 
of the monographs of the European Pharmacopoeia and the recommendations of the Council of 
Europe and the World Health Organization as regards in particular the selection and testing of 
blood and plasma donors; to promote Community self-sufficiency in human blood or human 
plasma; and to encourage voluntary unpaid donations of blood and plasma; 
11. Whereas it is not always possible to know at the time of whole blood or plasma collection 
which donation may be used for further manufacture rather than used in transfusion; 
12. Whereas all blood and plasma used for therapeutic purposes, whether for transfusion or for 
further manufacture into industrially-prepared medicinal products, should be obtained from 
individuals whose health status is such as to ensure that transmission of disease does not take 
place, and that each and every blood donation should be tested in accordance with rules 
which provide assurances that all necessary measures have been taken to safeguard the health 
of Community citizens who are the recipients of blood and blood products; 
13. Whereas given that the blood transfusion systems in the Member States of the European 
Community exist to serve its citizens, it is necessary to secure their confidence in the safety of 
these systems; 
14. Whereas disparities in policies and practices among the Member States regarding the 
selection of donors and the screening of donations within the Community are such as to 
undermine confidence among its citizens as well as blood transfusion services in the safety of 
the blood and blood products and hinder the achievement of self-sufficiency; 
12 
15. Whereas the goal of Community self-sufficiency can only be achieved through co-operation 
among the Member States in order to overcome such disparities and build mutual confidence in 
all aspects of safety of the blood transfusion chain; 
16. Whereas the suitability of an individual to donate blood and plasma is an essential component 
in contributing to the safety of blood and blood products and to the goal of self-sufficiency; 
17. Whereas it is essential that all measures be taken to safeguard the health of those who provide 
their blood and plasma and to minimise the hazard of transmission of infectious diseases by 
blood or blood products; 
18. Whereas uniformity and consistency throughout the Community in the acceptance of donors, 
the screening of donations and the recording of relevant data will help to contribute to the 
achievement of self-sufficiency and to increasing confidence in the safety of blood and plasma 
donations and the transfusion process; whereas in order to bring about such uniformity and 
consistency, and build confidence, measures are required at Community level; 
19. Whereas measures at Community level should take into account existing guidelines, 
recommendations and standards in the area of blood at both national and international levels; 
20. Whereas in accordance with the principle of subsidiarity, any new measure taken in an area 
which does not fall within the exclusive competence of the Community, such as donor 
suitability and testing of donations, may be taken up by the Community only if, by reason of the 
scale or effects of the proposed action, the objectives of the proposed action can be better 
achieved by the Community than by Member States; Whereas commonly agreed requirements 
on donor suitability and testing of donations need, therefore, to be introduced in order to 
contribute to the safety of donated blood and plasma and the health protection of donors and 
to permit confidence in safety of the transfusion chain among citizens, especially as they 
move about in the Community, and to contribute to the attainment of Community self-
sufficiency as provided for in Community legislation; 
21. Whereas in accordance with the principle of proportionality, the means to be deployed at 
Community level for promoting sound practices and consistency throughout the Community in 
the suitability of blood and plasma donors and the screening of donated blood must be in 
proportion to the objective pursued; 
22. Whereas recommendations by the Council, pursuant to Article 129 of the EC Treaty, are the 
appropriate means for doing so at Community level; whereas such recommendations must be 
congruent with the provisions of Directive 89/381/EEC; 
13 
23. Whereas recommendations on donor suitability and testing requirements form part of a strategy 
to enhance safety of thé blood transfusion chain, the other elements of which include the 
inspection and accreditation of blood collection establishments, requirements related to 
quality assurance of the processes involved, the optimal use of blood and blood products, 
haemovigilance, and public awareness; 
24. Whereas it is necessary that the best possible scientific advice is available to the Community in 
relation to the safety of blood and blood products; 
25. Whereas Directive 95/46/ËC11 on the protection of individuals with regard to the processing 
of personal data and the free movement of such data lays down special requirements for the 
processing of data concerning health; 
HEREBY RECOMMENDS" THAT 
1. DEFINITIONS 
For the purpose of this Recommendation, Member States assign to the terms listed in Annex 1 the 
meaning given to them therein; 
2. PROVISION OF INFORMATION TO PROSPECTIVE DONORS 
Member States provide to all prospective donors of blood or plasma: 
2.1 For donor awareness 
a. Accurate but generally understandable educational materials about the essential nature of 
blood, the products derived from it, and the important benefits to patients of blood and 
plasma donations; 
b. The reasons for requiring a medical history, physical examination, and the testing of 
donations; information on the risk of infectious diseases that may be transmitted by blood 
and blood products; the signs and symptoms of AIDS, and the significance of 'informed 
consent', self-deferral, and temporary and permanent deferral; 
c. The reasons why they should not donate which may be detrimental to their own health; 
d. The reasons why they should not donate which put recipients at risk, such as unsafe sexual 
behaviour, HIV /AIDS, hepatitis, drug addiction and the use and abuse of drugs; 
e. The option of changing their mind about donating prior to proceeding further without any 
undue embarrassment or discomfort; 
11 O.J. No L281, 23.11.95, p.31 
14 
f. Information on the possibility of withdrawing or self-deferring at any time during the 
donation process; 
g. The opportunity to ask questions at any time; 
h. The undertaking that if test results shows evidence of any pathology, they will be contacted 
by the blood collection centre; 
i. Specific information on the nature of the procedures involved in the donation process and 
associated risks for those willing to participate in apheresis programmes, whether for 
plasma or cellular components. 
2.2 Confidentiality 
a. The measures taken to ensure the confidentiality of: any health-related information provided 
to the authorised health personnel, the results of the tests on their donations, as well as any 
future traceability of their donation; 
b. The assurance that all interviews with prospective donors are carried out in private; 
c. The option of requesting the medical staff of the blood collection centre not to use his / her 
donation. 
3. INFORMATION REQUIRED FROM PROSPECTIVE DONORS 
Member States ensure that, upon agreement of a willingness to proceed to donate blood or 
plasma, all prospective donors (whether first time, new, repeat or regular) provide to the blood 
and plasma collection establishment: 
3.1 Identification 
Identification, supported by valid official documentation providing name (first and surname), 
address, and date of birth. 
3.2 Health history 
a. Information on their health and medical history including any relevant social and behavioural 
characteristics that may assist in identifying and screening out persons whose donation could 
present a higher risk of transmitting infections as well as those who could have contracted a 
recent infection that may not yet be detectable in the screening tests; 
b. Answers to questions about their health and medical history by way of a written 
questionnaire and a personal interview with a trained health care staff member which 
should address the elements and risk behaviours listed in Annex 2: 
c. Their signature and that of the health care staff member conducting the interviews on the 
donor questionnaire acknowledging that the educational materials provided have been read 
15 
and understood, the opportunity to ask questions has been presented, and satisfactory 
responses have been received; 
3.3 Informed consent 
a. Their informed consent in writing that they wish to proceed with the donation process; 
b. The prospective donor's agreement that if their blood or plasma donation becomes excess 
to the needs of their own Member State, it may be shared with another Member State of the 
Community that is in need ; 
4. REGISTRATION OF DONOR 
Member States, in order to facilitate future verification of repeat and regular donors, future 
tracing of donations, and future exchanges of information* establish a mutually compatible 
donor identification / registration system to: 
4.1 Donor centre identification 
a. Permit every donation centre in each Member State to be uniquely identified, by 
communicating to all other Member States and to the Commission a list of centres and their 
identification comprising the country code and a suitable combination of letters and numbers 
at their discretion; 
4.2 Donor identification and registry 
a. Require that all relevant information regarding the identification of prospective donors be 
recorded in an automated or manual system for new and first time donors and be verified 
prior to each donation for repeat and regular donors; 
b. Provide for the keeping of records on donors and prospective donors in such a way as to 
ensure unique identification, protect the identity of the donor from unauthorised access to 
confidential information, but facilitate future traceability of any donation; 
c. Allow for the inclusion of information related to adverse donor reaction to the donation, 
reasons for preventing an individual from donating, whether on a temporary or permanent 
basis while ensuring confidentiality. 
5. DONOR SUITABILITY 
Member States, in order to ensure the suitability of individuals to be accepted as donors of blood 
and plasma: 
5.1 Suitability criteria for the acceptance of whole blood and apheresis plasma donors 
a. Ensure that general criteria for the acceptance of blood and plasma donors are clearly spelt 
out in every donation centre and that clear messages are presented to donors as to the 
importance of their willingness to donate but also the importance of the acceptance criteria; 
16 
b. Ensure that the responses given to the issues raised in the written questionnaire and / or the 
personal interview, as presented in Annex 2, provide the necessary confidence that the 
donation will not adversely affect the health of a future recipient of the products derived from 
that donation; 
c. Ensure that the prospective donor meets the physical requirements criteria contained in 
Annex 3 in order that there are no detrimental effects to his / her own health as the result of 
the donation; 
d. Ensure that the prospective donor's suitability is determined at each donation session; 
e. Prohibit or phase out the practice of using'replacement donors'; 
f. Require the responsible physician to give his / her written authorisation as to the final 
determination of the suitability of a prospective donor, when this may be questionable. 
6. DONOR INELIGIBILITY 
Member States, in order to ensure that the prospective donors do not cause harm to their own health 
nor that their donation present a risk of transmission of infectious diseases: 
6.1 Deferral criteria for whole blood and apheresis plasma donors 
a. Ensure those who may show evidence of one of the characteristics listed in Annexes 4 and ' , 
5 should be rendered either permanently or temporarily ineligible to donate blood and 
plasma; 
b. Ensure that appropriate provisions are in place in the donation centre for counselling, as 
appropriate, to prospective donors who are deferred. 
6.2 Deferral registers 
a. Maintain a record of any prospective donor deferral, whether permanent or temporary, 
including the reasons why; 
b. Ensure that such donor deferral registers are set up so as to fully respect data 
confidentiality requirements but be available for consultation by authorised personnel of 
the blood collection establishment or appropriate authorities when matters of safety are 
concerned. 
7. DATA PROTECTION 
Member States, in order to ensure the confidentiality of sensitive medical information about 
prospective donors: 
a. Ensure that measures are in place for prospective donor identification and accurate data 
verification; 
17 
b. Ensure that data security measures are in place as well as safeguards against unauthorised 
data additions, deletions or modifications to donor files or deferral registers, and transfer of 
information; 
c. Ensure that procedures are in place to resolve data discrepancies; 
d. Prevent the unauthorised disclosure of such information, while ensuring the traceability of 
donations; 
e. Pay particular attention to compliance with the requirements of Directive 95/46/EC in 
particular its Article 8, when processing data related to blood and plasma donors. 
8. VOLUMES COLLECTED FOR SAFETY OF DONOR 
To protect the health of the donor, Member States: 
a. Adhere to the maximum volumes of blood and plasma collected at a single donation and 
over a 12 month period presented in Annex 6; 
b. Adhere to the minimum time intervals between donations as presented in Annex 6; 
c. Ensure that medical attention is available to the donor in the event of an adverse event 
related to the donation. 
9. TESTING SAMPLES OF DONATED BLOOD 
Member States, in order to ensure the safety of all blood and plasma donations: 
a. Ensure that a sample of all donations whether intended for transfusion purposes or for 
further manufacturing into industrially prepared medicinal products is tested for diseases 
transmissible by blood using licensed screening tests to eliminate units that are repeat 
reactive; 
b. Ensure that all blood donations be found non-reactive for the transmissible disease markers 
listed in Annex 7; 
c. Require re-testing of the blood samples found to be reactive in an initial screening test in 
accordance with the general algorithm set out in Annex 8; 
10. ADDITIONAL MEASURES 
a. Member States take the necessary steps for the dissemination of this recommendation to all 
parties concerned, and in particular to blood establishments in their territory; 
b. Member States take all necessary measures to encourage the voluntary and unpaid donation 
of blood or plasma; 
INVITES THE COMMISSION 
To report on the application of these recommendations and keep the matters covered therein under 
review in order to take the necessary steps for revision and updating. 
Done at Brussels g For the Council 
The President 
Blood 
Blood product 
Blood component 
Plasma derivative 
Cell-derivative 
Donor 
First time donor 
Deferred donor 
Lapsed donor 
New donor 
Prospective donor 
Repeat donor 
Regular donor ANNEX 1 
Common Terminology 
Whole blood collected from a single donor and processed either for transfusion or 
further manufacturing 
Any therapeutic product derived from human whole blood or plasma donations. 
Therapeutic components of blood (red cells, white cells, plasma, platelets) that can be 
prepared by centrifugation, filtration, and freezing using conventional blood bank 
methodology. 
Highly purified human plasma protein prepared under licensed pharmaceutical 
manufacturing conditions 
A therapeutic product derived from a blood component (as derived from leukocytes 
- interferon, cytokines - or from outdated erythrocytes - haemoglobin solution) 
Someone who has never donated either blood or plasma. 
Someone who, for protection of their own health or that of potential recipients of blood 
products prepared from his / her donation, is not permitted to give blood or plasma. 
Someone who routinely had donated blood or plasma (regular donor) and has stopped 
presenting himself / herself to donate. 
Someone who has not donated blood or plasma within the last year or is not listed in 
the local donor registry. 
Someone who presents himself / herself at a blood or plasma collection 
establishment and states his / her wish to give blood or plasma. 
Someone who has donated before and within the last year in the same donation 
centre. 
Someone who routinely donates their blood or plasma at the permissible time 
intervals. 
Replacement donor Donors recruited by patients to enable them to undergo elective surgery. 
Medicinal product derived from blood or plasma 
Same meaning as in Directive 89/381/EEC 
Suitability Process by which an acceptance decision of a prospective blood or plasma donor 
can be made. 
Personal data Any information relating to an identified or identifiable natural person who can be 
identified, directly or indirectly, in particular by reference to an identification 
number or to one or more factors to his physical, physiological, mental, economic, 
cultural or social identity. (Directive 95/46/EC) 
Voluntary, unpaid blood donation 
Same meaning as in Directive 89/3 81/EEC 
l9 
ANNEX2 
Common Elements to be Covered in a Donor Questionnaire 
Indication that the questionnaire is to be completed, signed and dated 
General health of the donor 
Whether prospective donor 
has recently consulted a doctor 
is taking any medication 
has haemophilia or related blood clotting disorders 
participates in hazardous sports (e.g. motor racing) 
undertakes employment that might cause problems within 24 hours after blood donation 
is pregnant or has delivered a child now under 1 year (for women) 
has received growth hormone or pituitary extract treatment 
has received a blood transfusion 
has had a corneal or dura mater transplant 
has undergone tattooing, acupuncture, body piercing by someone other than qualified and / or 
licensed professional 
has been in recent contact (<3 weeks) with contagious infections, chicken pox, measles 
has recently received a vaccination(polio, tetanus, holiday vaccinations) 
has recently (<5 days) ingested aspirin (or other pain killers) 
is working as a prostitute 
is HIV positive 
has a spouse who is HIV positive 
has a family history of Creutzfeldt-Jacob disease (CJD) 
self-injects drugs 
Whether prospective donor has / had 
Brucellosis 
Epilepsy 
Hepatitis 
Jaundice 
Major surgery/serious illness 
Malaria 
« Whether prospective donor has travelled 
• Outside Western Europe & North America 
• Men who have sex with other men 
• Sexual activity in Africa 
• Sexual activity in countries other than those in Africa: (to specify country) 
• Self-exclusion option 
The questionnaire has to be given and completed at every visit. 
2o 
ANNEX3 
Common Acceptance Criteria for Blood and Plasma Donors 
Age 
Blood and plasma donors should be 18 - 65 years of age. Acceptance of first time donors age 60 -
65 is at the discretion of the responsible physician. Repeat donors may continue to donate after 
the age of 65 with the permission of the responsible physician given annually. 
For whole blood, donors aged 17, and not legally classified as minors, may be accepted; 
otherwise written consent should be required according to applicable law. 
Body weight 
Donors weighing no less than 50 kg may donate whole blood or plasma. 
Blood pressure 
The systolic blood pressure should not exceed 180 mm of mercury and the diastolic pressure 
should not exceed 100 mm of mercury. 
Pulse 
The pulse should be regular and between 50 - 110 beats per minute. Those prospective donors who 
undergo intensive sport training and have a pulse rate lower than 50 beats per minute may be 
accepted. 
Haemoglobin 
The haemoglobin concentration should be determined prior to donation and shall be no less than 
12.5 g/100 ml for females and 13.5 g/100 ml for males (or equivalent values expressed in mmol / 
1). For apheresis plasma donors, the minimum shall be 12.5 g/100 ml for both males and females. 
Haematocrit 
The packed cell volume (haematocrit) should be determined prior to donation and shall be no less 
than 38% for females and 40% for males. For apheresis plasma donors, the minimum shall be 
38%. 
Donation interval 
For whole blood, the time interval between donations should be greater than 8 weeks. 
For apheresis plasma, this interval should not be less than 72 hours. 
Donation frequency 
For whole blood, the maximum number of times allowable for donations should be 6 / year for 
men, 4 / year for women and 3 / year for pre-menopausal donors. 
For apheresis plasma, the maximum donation frequency should be twice per week, 
Z\ 
ANNEX4 
Common Deferral Criteria for Blood and Plasma Donors 
(For protection of donor) 
1. Permanent deferral 
Prospective donors with any or a history of any of the following should be declared permanently 
ineligible to donate blood or plasma for the protection of their own health: 
• Auto-immune diseases 
• Cardiovascular diseases 
• Central nervous system diseases 
• Malignant diseases 
• Abnormal bleeding tendency 
• Fainting spells (syncope) or convulsions 
Permanent deferral in cases where prospective donors have or have had a severe or chronic 
gastrointestinal, haematological, metabolic, respiratory, or renal disease, not included in the preceding 
categories, should be determined by a qualified physician in the blood collection establishment. 
2. Temporary deferral 
Ineligible for 1 year 
• Abortion 
• Pregnancy (after delivery) 
NOTE: Additional reasons may exist for the temporary deferral of a donor for the protection of their own 
health. A decision as to length of time is at the discretion of a qualified physician in the blood 
collection establishment. 
IX 
ANNEX 5 
Common Deferral Criteria for Blood and Plasma Donors 
(For protection of recipient) 
1. Permanent deferral 
Prospective donors with any, or a history of any, of the following should be declared permanently 
ineligible to donate blood or plasma for the protection of potential recipients. 
• Auto-immune diseases 
• Infectious diseases- persons suffering or having suffered from 
Babesiosis 
Brucellosis 
Creutzfeldt Jacob disease (CJD) (persons in whose family this has occurred) 
Hepatitis B (HBsAg confirmed positive) 
Hepatitis C 
Hepatitis, infectious (of unexplained aetiology) 
HIV/AIDS 
HTLVI/II 
Leprosy 
Kala Azar (leishmaniasis) 
Q fever 
Syphilis 
Trypanosoma cruzi (Chagas' disease) 
• Malignant diseases 
Alcoholic, chronic 
Cornea / dura mater transplantation recipient 
Intravenous (IV) drug use 
Males who have sex with other males 
Pituitary hormone of human origin (e.g. growth hormone) recipient 
Prostitutes (male and female) 
2. Temporary deferral 
Prospective donors with any of the following conditions should be declared ineligible to donate blood or 
plasma temporarily. The time interval for deferral varies according to the condition. 
2.1 Ineligible for 3 years 
• Tuberculosis (after recovery) 
2.2 Ineligible for 1 year 
Accidental exposure to blood or blood contaminated instruments 
Acupuncture (if not performed by a qualified physician) 
Blood transfusion recipient 
Body piercing 
Drug allergy (after last exposure) 
Tattoo 
Toxoplasmosis (after recovery) 
Individuals who have had sexual relations with someone infected or at increased risk of 
infection with HBV, HCV, HIV 
23 
2.3 Ineligible for 6 months 
• Mononucleosis infectiosa (after recovery) 
• Surgery, major 
2.4 Ineligible for 4 weeks 
• Following administration of live attenuated viral vaccines 
2.5 Ineligible for 48 hours 
• Following administration of killed / inactivated viral / bacterial and rickettsial vaccines 
• Following administration of vaccines (desensitising) 
• Rabies vaccine (prophylactic administration) 
2.6 Ineligible (time frame variable) 
• Hepatitis A 
• Malaria (does not apply to plasmapheresis donors) 
• Prescribed medicines 
• Tropical diseases (other) 
NOTE: Additional reasons may exist for the temporary deferral of a donor for the protection of the 
recipient. A decision as to length of time is at the discretion of a qualified physician in the blood 
collection establishment. 
H 
ANNEX 6 
Common Volumes to be collected 
and time intervals 
for whole blood and plasma donations 
Whole Blood 
Maximum Volume per donation 
per consecutive 12 month period 
Minimum time interval between donations 
Maximum number of donations per 12 month period 
Automated plasmapheresis 
Maximum Volume per donation Donor Weight 
50-67 kg 
68-79 kg 
80 kg or more 
Minimum time interval between donations 
Maximum number of donations per 7 day period 500 ml 
3 litres 
8 weeks 
6 (males) 
4 (females) 
(3 for pre-menopausal women) 
Volume Collected 
(excluding anticoagulant) 
625 ml 
750 ml 
800 ml 
72 hours 
2 
2s 
ANNEX 7 
Common Testing Requirements for all Blood Samples 
whether a whole blood or plasma donation 
For all blood and plasma donations 
Antibodies to the Hepatitis C virus Anti-HCV 
Antibodies to the human immunodeficiency virus 1 Anti-HIV 1 
Antibodies to the human immunodeficiency virus 2 Anti-HIV 2 
Surface antigen of Hepatitis B HBsAg 
In addition 
For all, excluding plasmapheresis intended only for fractionation. 
ABO group 
Rhtype 
Malaria for travellers to endemic areas 
Treponema pallidum (syphilis) 
2& 
ANNEX 8 
Common Algorithm for 
Interpretation of reactive results in screening tests in relation to 
clinical use of donation and 
Reactive results in supplementary / confirmation tests 
in relation to donor deferral 
blood sample 
1 x screening 
test 
screening test 
reactive/doubtful 
± ^ negative 
donor and donation cleared 
2 repeats of the same test kit 
± 
screening 
test 
\J/ 
unit/ 
donor 
cleared 
vr 
all tests negative 
donor cleared 
± ± 
screening 
test 
+ + M/ 
screening 
test 
+ ? 
± ± 
screening 
test 
+ /? 
± ± 
eliminate unit 
v 
2 repeats of the screening test from another manufacturer 
± ± one of tests doubtful or positive 
in case of positive/doubtful or 
lacking result, plasma processing 
establishment 
to be informed about previous 
donations within 7 days ^ 
2nd blood sample 
X different screening tests 
| all tests negative" ± test positive 
donor cleared ± ± doubtful 
exclude/inform donor ± exclude/inform donor 
± 
look back \k 
further clarification 
x\ 
FINANCIAL STATEMENT 
PROPOSAL FOR A COUNCIL RECOMMENDATION 
ON THE SUITABILITY OF BLOOD AND PLASMA 
DONORS AND THE SCREENING OF DONATED 
BLOOD IN THE EUROPEAN COMMUNITY 
The proposal for a draft Recommendation on the suitability of blood and plasma donors and the 
screening of donated blood in the European Community has no financial impact either on the 
operational budget or on any human or administrative expenses. 
2& 
IMPACT ASSESSMENT FORM ON 
COMPETITIVENESS AND EMPLOYMENT 
PROPOSAL FOR A COUNCIL RECOMMENDATION 
ON THE SUITABILITY OF BLOOD AND PLASMA 
DONORS AND THE SCREENING OF DONATED 
BLOOD IN THE EUROPEAN COMMUNITY 
The proposal for a draft Recommendation on the suitability of blood and plasma donors and the 
screening of donated blood in the European Community has no impact on competitiveness and 
employment. 
l°l 

ISSN 0254-1475 
COM(97) 605 final 
DOCUMENTS 
EN 05 15 
Catalogue number : CB-CO-97-617-EN-C 
ISBN 92-78-27583-2 
Office for Official Publications of the European Communities 
L-2985 Luxembourg 
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