COMMISSION OF THE EUROPEAN COMMUNITIES 
COM(94) 652 final 
Brussels, 21.12-1994 
COMMUNICATION FROM THE COMMISSION 
ON 
BLOOD SAFETY AND SELF-SUFFICIENCY 
IN THE EUROPEAN COMMUNITY 

A 
1. INTRODUCTION 
2. BLOOD AND ITS SIGNIFICANCE FOR PUBLIC HEALTH 
2.1 Blood as a therapeutic substance 
2.2 Blood as a transmitter of diseases 
2.3 Blood as a commodity 
2.4 The blood transfusion chain 
2.5 Precautionary measures regarding blood safety 
3. ACTIONS UNDERTAKEN AT COMMUNITY LEVEL REGARDING BLOOD SAFETY 
3.1 Council 
3.2 European Parliament 
3.3 European Commission 
4. COMMUNITY SELF-SUFFICIENCY AND CONDITIONS FOR ITS ATTAINMENT 
4.1 Knowledge, attitudes and behaviour of Community citizens 
4.2 Voluntary non-remunerated donations 
4.2.1 Regulations 
4.2.2 Practices 
4.3 Optimal use 
4.4 Progress towards Community self-sufficiency in 1931 
4.5 Trade in blood and blood products 
5. BLOOD SAFETY AND CONDITIONS FOR ITS ATTAINMENT 
5-1 Collection process 
5.1.1 Selection of donors 
5.1.2 Testing of donations 
5.2 Regulatory controls 
6. THE NECESSITY FOR FUTURE COMMUNITY ACTION 
6.1 Increased awareness 
6.2 Donor selection criteria 
6.3 Testing of donations 
6.4 Optimal use 
6.5 Regulatory system 
6.6 Haemo vigilance 
6.7 Continuing close cooperation with Member States 
7. BLOOD SAFETY AND SELF-SUFilCIENCY: THE NEXT STEPS 

1. INTRODUCTION 
Blood and the products derived from it have become an indispensable facet of modem 
medicine. Their use has brought about dramatic advances in therapy and surgery, saved 
countless lives, and improved significantly the longevity as well as the quality of life for those 
who suffer from long-term blood disorders such as haemophilia. Ensuring the safety and the 
supply of blood and blood products, therefore, is of vital importance - safeguards which are 
directly related to the public health objectives of Articles 3(o) and 129 of the Treaty 
establishing the European Community. These objectives, which focus on health protection and 
disease prevention, are particularly important considerations in the context of HIV/AIDS and 
certain other communicable diseases which can be spread through the provision of unsafe 
blood and blood products. 
An essential requisite for health protection is the prevention of diseases, which entails 
minimizing exposure to risk factors implicated in their causation. It was bearing this in mind 
that the Council adopted Directive 89/381/EEC1 related to medicinal products derived from 
human blood and plasma in order to ensure a high level of protection of public health. In 
addition to introducing strict manufacturing criteria, the Directive required Member States to 
take the necessary measures to prevent the transmission of infectious diseases and to promote 
Community self-sufficiency in human blood and plasma through voluntary unpaid donations. 
A report2 to the Council on the state of Community self-sufficiency resulted in it adopting 
Conclusions3 in which the need to achieve this goal through cooperation between Member 
States was reaffirmed and the continued promotion of the quality and safety of blood 
collection and blood-derivative production was inter alia agreed. 
The Council's continuing concern about the quality, safety, and efficacy of blood and blood 
products resulted in it requesting, at its meeting of 13 December 1993, the Commission to 
prepare a report related to the legal provisions and current practices in the Member States on 
the collection, control, and treatment of blood and the distribution and trade in blood and 
blood products with a view to proposing common safety criteria. Immediately following this 
meeting, the Commission invited Member States to provide their legal regulations and 
administrative provisions in this area. 
This Communication draws upon the responses provided by the Member States in written 
submissions and during meetings of experts on self-sufficiency and blood safety convened by 
the Commission. It addresses issues raised by the Ministers for Health, and provides, as a 
background, a review of progress towards blood self-sufficiency in the Community as well as 
coverage of this area by existing Community rules and regulations. Finally, it specifies the 
need for Community action in this area particularly in the context of the Council's Resolution 
concerning the field of public health4 and the Commission Communication on AIDS and 
certain other communicable diseases . 
OJ. n' L 181 of 28.06.89. p.44 
Communication from the Commission to the Council, tlie European Parliament and die Economic 
and Social Committee on Blood Self-Sufficieney in the European Community. (COM(93) 198 
final. Brussels, 25 May 1993. 13p.] 
OJ. n* C 15 of 18.01.94. p.6 
O.J. n* C 165 of 17.06.94. p.l 
Communication from the Commission concerning a Community action programme on the 
2. BLOOD AND ITS SIGNIFICANCE FOR PUBLIC HEALTH 
As a consequence of significant scientific and technical advances both with regard to medical 
knowledge and surgical techniques, blood has come to be regarded as a major cornerstone of 
modern day medicine contributing significantly not only to saving but to improving the lives 
of many. Blood also has particular significance since in spite of its therapeutic uses, it can also 
be a purveyor of disease. 
2.1 Blood as a therapeutic substance 
Since early in the twentieth century, blood transfusion has increased in importance in the 
practice of medicine saving millions of lives throughout the world. With advances in 
technology and breakthroughs in research and development, however, the use of whole blood 
in transfusion medicine has progressively diminished with its individual components assuming 
major therapeutic importance. As outlined in the Commission's Staff Working Paper and its 
Communication on blood self-sufficiency, blood is comprised of almost equal portions of the 
cellular components - red blood cells, white blood cells and platelets - and the clear yellowish 
fluid portion called plasma. Plasma can be separated from the cellular components through 
centrifugation or obtained by plasmapheresis (the process of removing whole blood, separating 
the red cells from the plasma and returning them to the donor), stored as fresh frozen plasma 
(FFP) and then, after thawing, transfused into a patient. It can also be fractionated into a 
number of stable industrially prepared derivatives - albumin, clotting factor concentrates, 
protease inhibitors and immunoglobulins. 
The extent to which these blood products are used in medicine or surgery (Annex 1) ranges 
from the administration of red blood cell concentrates due to thalassemia; to albumin in cases 
of shock; to the use of immunoglobulins to prevent a variety of infectious diseases such as 
hepatitis, chicken pox, tetanus, and rabies; to regular and life-long treatment of haemophilia 
patients with clotting factor concentrates. Moreover, stem cells are being used increasingly for 
bone marrow transplantation. 
2.2 Blood as a transmitter of diseases 
In spite of notable therapeutic advances, blood continues to be one of several media by which 
diseases may be transmitted, as the tragic consequences surrounding the administration of HIV 
(human immunodeficiency virus) contaminated blood and blood products have made all too 
clear. Although HIV has attracted the attention of clinicians, governmental authorities, 
politicians, patients and the lay public, numerous other agents that are transmissible by blood 
do exist. Of the five main types of infectious agents - viruses, bacteria, spirochetes, parasites 
and fungi - transmission of the first four by blood transfusion has been reported (Annex 2). 
prevention of AIDS and certain other communicable diseases in the context of the framework for 
action in the field of public health. Proposa! for a European Parliament and Council Decision 
adopting a programme of Community action on the prevention of AIDS and certain other 
Communicable diseases witliin the framework for action in the field of public health. [COM (94) 
413 final. Brussels, 09.11.1994. 58p.]. 
Towards increased cooperation and coordination in the European Community to ensure adequate 
blood availability (Commission Staff Working Paper). [SEC(92)360. 24 February 1992. 8p] 
As viral infections can be transmitted by virus-infected blood cells or by the free virus in 
plasma, the virus-types transmissible by the cellular components and plasma differ. Viral 
infections transmissible by whole blood and blood cell concentrates (notably red cells and 
platelets) include the human immunodeficiency viruses, the hepatitis viruses, parvovirus B19, 
the human T-cell leukaemia viruses, cytomegalovirus and the Epstein Ban* virus. The first 
three can also be transmitted by whole plasma and plasma derivatives. 
Infection with these different viruses may lead to various diseases such as severe 
immunodeficiency from HIV and cirrhosis from the hepatitis viruses. 
Several non-viral organisms transmissible by blood transfusion, such as spirochetes, parasites 
and bacteria can be the cause of infections, and blood from donations can become 
contaminated by bacteria (e.g. staphylococci) at the time of donation. 
2.3 Blood as a Commodity 
There are mixed emotions surrounding the use of blood as a commodity. On the one hand, 
there is strong sentiment that the human body and its parts are inviolable and that no profit 
or commercialization should be derived from them; on the other hand, there is an increasing 
demand for blood products, including high purity plasma derivatives that have been developed 
as a result of continuing research and development and at considerable expense. In spite of 
the altruistic and unpaid nature of many blood and plasma donations, however, the costs of 
the collection, testing, processing, handling, storage and distribution associated with blood 
products are high and have to be met in one way or another. 
Trade in blood and blood products, therefore, has to be considered from the perspective of 
whole blood and its cellular components, on the one hand, and that of medicinal products 
derived from plasma on the other. 
2.4 The blood transfusion chain 
The numerous activities that occur from the moment an individual offers to donate blood or 
plasma until after the blood product has been administered to the patient can be described as 
the blood transfusion chain. The first link in this chain is the donor whose state of health is 
important not only for him/herself but for the recipient at the end of the chain. The second 
major link is the testing of the donation itself for any indication of a disease that could be 
potentially transmitted, removal and destruction of any donation that is infected, and medical 
consultation with those donors who are suspected of having a communicable disease. The third 
major link is viral inactivation of the medicinal products derived from plasma in accordance 
with agreed good manufacturing practices. The fourth crucial link is the appropriate and 
prudent administration of the blood product to the patient by the treating physician. And the 
final link is the follow-up of patients who have received any blood product in case they 
develop an immune reaction or other adverse side-effect. 
By ensuring that the risks associated with each link are minimized, the overall safety of the 
blood transfusion chain thus can be assured. 
2.5 Precautionary measures regarding blood safety 
As blood and plasma are biological substances, there is always the danger that they will be 
contaminated by infectious agents. The risk of a disease occuring as a result of their 
transmission by blood and plasma varies depending on their prevalence in the population; the 
state of health of the donor who may have a natural immunity to certain viruses; the immunity 
of recipients who may have antibodies that neutralize certain infectious agents; and the 
quantity of the infectious agent in the blood or plasma donation. 
To ensure the highest level of blood safety, three key elements need to be addressed - the 
selection of donors, the testing of donations, and the removal or inactivation of infectious 
agents. As donor selection is directed towards guaranteeing not only the safety of the recipient 
but also the health of the donor, questions that may identify factors linked to possible disease 
transmission or hazardous to the donor's own health, such as drug use, presence of diseases, 
recent surgery or child birth, or visits to endemic areas, need to be posed. In addition, 
examination of key physical parameters, such as blood pressure and haemoglobin level, needs 
to be carried out. Based on defined criteria, donors can then be accepted, deferred or not 
accepted for donation. In some such cases, medical treatment may be required. Awareness 
among donors themselves of the dangers of disease transmission by blood may also result in 
voluntary self-exclusion. 
Testing blood donations takes into account blood group determination on the one hand and 
the identification of infectious agents on the other. Screening for viral infections transmissible 
by blood is carried out by the detection of specific antibodies or antigens (infectious markers) 
against the agent concerned. Specialized procedures, however, are required to identify bacteria 
and parasites. Donations found to be positive for infection should be discarded and the donor 
concerned should be invited to be retested, using confirmatory tests, which may result in 
deferment of further donations. 
Efforts to develop safe and effective methods of removing bacteria and viruses from whole 
blood and its cellular components, without changing their integrity, continue. Donor selection 
and the screening of individual donations as well as proper processing and storage of these 
components are key elements in these efforts. 
For manufactured medicinal products derived from plasma, viral inactivation procedures exist 
thus minimizing the risk of viral transmission. Techniques for virally inactivating fresh frozen 
plasma are currently clinically validated. 
The on-going efforts of those concerned with the safety of blood and blood products have 
helped to reassure donors and patients that all possible measures are being taken to protect 
their health. Nevertheless, in order to ensure the delivery of safe blood and blood products 
there is a need to be ever vigilant to the prevalence of infectious markers, which differ from 
area to area, to the appearance of as yet unknown pathogens, as well as to the appearance of 
new variants of existing viruses. 
3. ACTIVITIES UNDERTAKEN AT COMMUNITY LEVEL REGARDING 
BLOOD SAFETY 
Within the European Community, specific measures have been taken and calls for further 
action have been made to ensure the safety of the blood supply as well as to protect the health 
of both the donor and the recipient. 
3.1 Council 
The free movement of industrially manufactured medicines, taking as a base a high level of 
health protection, has been the primary objective of Community pharmaceutical legislation. 
Its provisions include directives, guidelines for quality, safety and efficacy studies, marketing 
authorization procedures and requirements with regard to good manufacturing practice. As 
outlined in the Communication on blood self-sufficiency, recognition that existing provisions 
were inadequate with regard to proprietary medicinal products derived from human blood or 
human plasma led to the adoption of Directive 89/381/EEC, which includes reference to the 
goal of self-sufficiency, as well as requirements for good manufacturing practice 
(91/356/EEC7) and testing (91/507/EEC8). In addition, an early information exchange system 
on defective medicinal products was set up under Directive 75/319/EEC9 in an effort to keep 
all competent authorities informed of problems that could result in the withdrawal of or major 
changes to the marketing authorization of a given product. 
The Council's Conclusions (94/C 15/0310) on self-sufficiency in blood in the European 
Community reaffirmed the need to achieve this goal through cooperation between the Member 
States and agreed inter alia to continue to promote the quality and safety of blood collection 
and of blood-derivative production. 
With regard to the exchange of blood and its components in cases of emergency, the Council 
adopted Decision 86/346/EEC11 accepting, on behalf of the Community, the European 
Agreement on the Exchange of Therapeutic Substances of Human Origin. 
Council Decision 91/317/EEC12 adopting the 1991-1993 "Europe Against AIDS programme" 
specifically identified, in the plan of action, the prevention of HIV transmission through the 
fostering of Community self-sufficiency in blood products by encouraging voluntary unpaid 
donors and continuing the efforts made to ensure transfusion safety. Council Resolution 
94/C15/0213 called for the extension of this plan of action until the end of 1994; following the 
Commission's proposals, the European Parliament and the Council are set to adopt a Decision 
under Article 129 prolonging the programme until the end of 1995. 
With regard to the framework for Community action in the field of public health, Council 
Resolution 94/C 165/0114 agreed that priority should be given inter alia to AIDS and other 
7 
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9 
10 
11 
12 
13 
14 OJ. n* L 193 of 17.07.91. p.30 
O.J. n* L 270 of 26.09.91. p.32 
O.J. n* L 147 of 09.06.75 
O.J. n* C 15 of 18.01.94. p.6 
O.J. n* L 207 of 30.07.86. p.l 
O.J. h' L 175 of 04.07.91. p.26 
O.J. n# C 15 of 18.01.94. p.4 
O.J. n* C 165 of 17.06.94. p.l 
(2) 
communicable diseases as well as disease surveillance and the collection of reliable and 
comparable health data. It emphasized that Community action should be aimed at supporting 
and encouraging cooperation between Member States and promoting coordination of their 
policies and programmes for health protection in the priority areas. 
Recognizing the risks of the spread of communicable diseases within the Community due to 
the existence of the single market and the free movement of persons and foodstuffs, Council 
adopted Resolution 92/C326/0115 on the monitoring and surveillance of communicable 
diseases. In its Conclusions 94/C15/0416 on this matter, Council stressed the need for an 
epidemiological network in the Community, covering all diseases but collecting data on 
communicable diseases as a priority with a view to acquiring better knowledge of their causes 
and their epidemiological context. 
3.2 European Parliament 
The concern of the European Parliament about the safety of blood and its derivatives and its 
support for the goal of Community self-sufficiency has been reflected in a report , numerous 
written and oral questions dealing with blood-related issues, as well as in the adoption of two 
Resolutions ,19 which called inter alia, for an action plan to improve safety and promote self-
sufficiency through voluntary unpaid donations, for the strengthening of controls to increase 
blood and blood product safety, and for the drawing up of an instrument which would 
guarantee monitoring of blood safety from donation to use. It also called on the Council to 
promote in-depth discussions on these issues and the setting up of a European blood safety 
authority. 
Parliament has also taken considerable interest in the frequency and incidence of various 
communicable infectious diseases. It has adopted resolutions concerning the fight against 
AIDS which reflect its concern about the spread of the epidemic and the need for Community 
intervention. Parliament also expressed the need for epidemiological surveillance, analysis, and 
training in its resolution on public health policy after Maastricht20, which called on the 
Commission to set up an epidemiological investigation service, to collect, analyse and 
disseminate data on notifiable diseases and to encourage the setting-up and operation of 
exchange schemes for health professionals. 
3.3 European Commission 
The Commission's Communication on self-sufficiency in blood and plasma in the Community 
presented inter alia key issues of concern to Member States and specific actions for 
consideration. Its acceptance led to a request for additional information related to legal and 
trade aspects of the blood transfusion chain with the view to proposing common safety 
criteria. 
18 
19 
20 O.J. n*C 326 of 11.12.92. p.l 
O.J. n* C 15 of 18.01.94. p.6 
Report of the Committee on the Environment, Public Health and Consumer Protection on Self-
sufficiency in and safety of blood and its derivatives in the European Community. A. CECI. 
European Parliament. 25 February 1993. (A3-0075/93). 20p. 
O.J. n* C 268 of 04.10.93. p.29 
O.J. n' C 329 of 06.12.93. p.268 
O.J. n* C 165 of 17.06.94. p.l 
Regarding the safety and reliability of in vitro diagnostic medical devices, the Commission 
is preparing a proposal for a Directive laying down, in the context of blood transfusion, 
essential requirements to enhance health protection and safety of patients, users and third 
persons. It contains provisions covering reagents and equipment specifically intended for in 
vitro examination of blood (e.g. blood groups; HIV and hepatitis tests) which will be the 
subject of strict conformity assessment procedures implying the intervention of third party 
certification bodies. 
Additional safety precautions related to plasma pool testing and batch release for medicinal 
products derived from blood have been introduced by the Committee for Proprietary Medicinal 
Products (CPMP) in which the competent authorities of the Member States are represented. 
Furthermore, tests to be carried out on samples of each production batch by an official 
laboratory prior to being placed on the market, should this be requested by a Member State, 
have been defined. 
The Commission has prepared several Communications which address aspects relevant to the 
promotion of blood safety and self-sufficiency including: the implementation of the 1991-1993 
"Europe Against AIDS" programme21; the framework for action in the field of public health ; 
the action programme related to health promotion, information, education and training ; and 
an action programme on the prevention of AIDS and certain other communicable diseases. It 
has also received the advice of its Group of Advisers on the Ethics of Biotechnology. 
4. COMMUNITY SELF-SUFFICIENCY AND CONDITIONS FOR ITS 
ATTAINMENT 
One of the measures that have been identified as helping to promote the safety of blood and 
its products has been the attainment of self-sufficiency through voluntary non-remunerated 
donations. Promoted by the Council of Europe and supported by the Community, it is based 
on the fundamental principle that the human body and its parts are inviolable and should not 
be used for the purposes of trade. Protecting the health of the donor and avoiding donor 
exploitation; minimizing the risk of infection to recipients; ensuring donor participation from 
all social strata of the population irrespective of economic status; and promoting independence 
from importation and hence stability in the supply and cost of products have been presented 
as complementary tenets to this principle. 
In adopting Directive 89/381/EEC, which covers blood and plasma as the starting material for 
the preparation of medicinal products, Council accepted Community self-sufficiency (as 
distinct from national self-sufficiency) through voluntary unpaid blood and plasma donations 
as a goal. Its attainment, however, is influenced by several factors: the willingness of the citi­
zens of the Member States to donate blood and plasma; the interpretation in the Member 
States of non-remunerated donations as defined by the Council of Europe; optimal use of these 
products by treating physicians taking fully into account the very special nature of their 
21 
22 
23 Programme 1991-1993 "Europe Against AIDS". Report from the Commission on the 
Implementation of the plan of action 1991-1992. [COM (93) 42 final of 10 March 1993]. 
Commission communication on the framework for action in the field of public health. [COM(93) 
559 final. Brussels, 24 November 1993. 55p.] 
Community action programme on health promotion, information, education and training [COM (94) 
202 final]. 
source; and differing regulations and practices in the Community which may restrict the 
exchange of blood and blood products between Member States and hinder the attainment of 
self-sufficiency. Safety aspects of the blood transfusion chain, irrespective of the end use of 
the blood and plasma donation, also need to be considered particularly in relation to whole 
blood, plasma and blood cells of human origin, which were specifically excluded from 
Directive 89/381/EEC and to which its requirements do not apply. 
4.1 Knowledge, Attitudes and Behaviour of Community citizens 
The most important and fundamental consideration in the attainment of Community self-
sufficiency is the willingness of the citizens of the Member States to donate the blood and 
plasma required both for direct transfusion and for the preparation of medicinal products. And 
their perceptions, realistic or not, play a crucial role. 
As set out in its Communication on blood self-sufficiency, the Commission has now carried 
out a survey of the knowledge, attitudes and behaviour of the general public regarding blood 
and blood donations within the framework of the EUROBAROMETER public opinion 
surveys. In April 1994, approx. 13,000 European citizens of the 15+ age group were 
interviewed on a nationally representative basis in all 12 Member States regarding their 
perception and understanding of questions relating to blood. 
The major findings showed that Community citizens are reasonably well-informed about blood 
and are aware of the existence of different blood groups. There is, however, general lack of 
awareness about the frequency with which blood can be donated, what plasma is and the fact 
that it can be donated instead of whole blood. Health problems or negative advice from 
doctors, lack of time, and fear of getting AIDS were the major reasons given for not donating 
blood. And in spite of general awareness that blood donations are tested for diseases, a large 
percentage of Europeans are afraid of having a blood transfusion, primarily because of the fear 
of contracting HIV/AIDS. Moreover, there is a general lack of awareness about the 
Community's goal of self-sufficiency through voluntary non-remunerated donations even 
though this goal is generally supported. 
Based on the number of misconceptions that exist among European citizens regarding blood-
related issues, there is a need to continue to ascertain people's knowledge about this important 
subject, in particular so that they can be provided with factual and reliable information. 
4.2 Voluntary non-remunerated donations 
Non-remunerated blood donation is one of many health care issues that are the subject of 
divergent views today. While regulations concerning donor recruitment have been established 
by some Member States, differences of opinion about the ethical principles and safety issues 
related to "incentives" or "compensations" given to blood and plasma donors persist. 
Furthermore, the definition of voluntary non-remunerated donation as put forward by the 
Council of Europe24 is viewed differently by the Member States particularly as it relates to the 
relevant provision in Directive 89/381/EEC 
4.2.1 Regulations 
A survey carried out by the Commission shows that regulations and practices related to donor 
recruitment and voluntary non-remunerated donations in the Member States vary widely from 
explicit legislation, to general health regulations but with no precise reference to remuneration, 
to no specific stipulations. A few Member States stated that in their legislation non-compliance 
with the principle of voluntary non-remunerated donations could result in legal action. 
In the Member States, donors are generally voluntary and under no pressure to donate. Some 
strictly prohibit directed donations by family or friends or where the donor and recipient know 
each other. In situations where blood shortages exist, however, friends and family members 
of patients in a few Member States may be asked to donate. In those that are not yet self-
sufficient, physicians may make treatment conditional on the availability of blood, which could 
put pressure on the patient as well as on his/her relatives to donate. In some Member States, 
regular donors are contacted by telephone or letter by the transfusion services or by donor 
organizations. 
It is not the practice in the Member States to collect blood in prisons and one specifically 
reported that it is not carried out in refugee centres. Some countries collect from soldiers in 
civil and military centres, others do not. 
4.2.2 Practices 
The incentives provided to both blood and plasma donors within the Member States range 
from absolutely no payment or reimbursement, to days off work, or to "expense allowances". 
Donors normally receive refreshments (a non-alcoholic drink and biscuits or sandwiches) in 
order to replace fluid loss and as a way of ensuring that they rest after the donation to reduce 
the risk of fainting. In all Member States, their generosity is generally recognized through 
medals, certificates, diplomas and small gifts of negligible commercial value, commensurate 
with the number of donations, as well as official award ceremonies and celebration parties for 
high frequency donors. 
One Member State provides free medical care to donors when proposed by the blood services 
and provides its voluntary blood donor groups with meeting and record storage facilities, as 
well as financing for its promotional leaflets and telephone expenses. 
Member States permit time off work for donations ranging from the net time to donate 
blood/plasma to one day off work which in one country is specifically restricted to a 
maximum of four days per year for blood and plasmapheresis donations. A voucher system 
for plasmapheresis (voucher ± 1.25 ECU) is in place in one Member State. 
24 A donation is considered voluntary and non-remunerated if the person gives blood, plasma or 
cellular components on his/her own free will and receives no payment for it, either in the form of 
cash, or in kind which could be considered as substitute for money. This would include time off 
work other than that reasonably needed for the donation and travel. Small tokens, refreshments 
and reimbursements of direct travel costs are compatible with voluntary, non-remunerated 
donations. (Council of Europe) 
10 
Reimbursement of travel expenses ranges from none at all, not even upon presentation of a 
bus or train ticket, to actual travel costs when requested, particularly when the donor has to 
travel a long distance or at night. In one Member State, transportation, if required, is provided 
by blood banks and in a few cases (plasmapheresis combined with long journeys), 
reimbursement is given, when supported by documentation, to the employer for the time off 
work 
Blood and plasma representatives, in one Member State, have adopted a recommendation that 
while no payment should be made for the donation of blood or plasma itself, an "expense 
allowance" of up to a maximum of 25 ECU per donation is justifiable and compatible with 
the guidelines of the WHO and the Council of Europe. These representatives have espoused, 
however, that no "expense allowance" should be paid for the first donation and an upper limit 
must be imposed in the case of frequent plasma donations so that the "expense allowance" 
cannot be assimilated to a payment. In this country, both state and local authority blood-
donation services as well as commercial plasmapheresis centres provide donors with an 
"expense allowance" for direct costs (e.g. for the journey and time taken), which is granted 
as a lump sum in order to avoid administrative costs. Whole-blood collections organised by 
the Red Cross in the same Member State, however, are without any such "expense allowance". 
From the foregoing, it is evident that the interpretation of the concept of non-remuneration is 
not uniform throughout the Community. Incentives to encourage blood and plasma donations 
do take place including time off work beyond that actually required for the donation and flat 
rate "expense allowances". 
4.3 Optimal Use 
Optimal use of blood and blood products without depriving patients of what they need can 
contribute to achieving Community self-sufficiency. Yet it is known that practices differ in 
the Community. A study, known as SANGUIS (Safe ANd Good Use of blood In Surgery)25, 
was carried out between January 1990 and June 1992 within the framework of a European 
Community Research Concerted Action to assess when, why and how much blood, blood 
components, plasma derivatives, and artificial colloids were requested and transfused in 
specified elective surgical procedures carried out in university hospitals in Europe. This study 
showed that in a large number of teaching hospitals in the Community, utilization of specific 
products varied widely between hospitals in the same country and more so between hospitals 
of central-northern Europe and the Mediterranean countries. The use of whole blood in some 
hospitals was found to be quite high and in others where whole blood was not requested, red 
cells and plasma were often used together, effectively reconstituting whole blood and negating 
the widely accepted concept of blood component therapy. In some hospitals, plasma was used 
for volume replacement, thereby removing plasma from fractionation and effectively negating 
efforts elsewhere towards self-sufficiency. 
One of the main conclusions of this study was the profound and totally unexplained variations 
in the use of blood products in six surgical procedures for similar categories of patients and 
showed inter alia the need for improved use of blood resources through agreement on best 
blood transfusion practice. 
25 Safe and good use of blood in surgery (SANGUIS) - Use of blood products and artificial 
colloids in 43 European hospitals. EUR 15398. G. Sirchia et al (eds). European Commission. 
1994. 235p.] 
11 
4.4 Progress towards Community self-sufficiency in 1991 
Periodic updates regarding blood and plasma donations and the availability and use of blood 
products in the Community, as suggested in the Communication on blood self-sufficiency and 
endorsed by the Council on 13 December 1993, can provide an indication as to the progress 
that is being made towards Community self-sufficiency. The survey of the situation in 1991 
showed inter alia that from 1989 to 1991: 
Whole blood donations increased in ten of the twelve Member States. 
Member States were almost entirely self-sufficient for whole blood and blood 
components in 1991, except Greece which requires large quantities of red cell 
concentrates for its thalassaemia patients. 
The volume of plasma obtained from voluntary, non-remunerated whole blood and 
plasmapheresis donations increased by 20%. 
The volume of plasma available for fractionation, derived both from whole blood and 
obtained through apheresis from voluntary, non-remunerated donors, increased by 36%. 
The degree of plasma self-sufficiency improved significantly despite increased use of 
certain plasma products notably factor VIII concentrates. 
Use of fresh frozen plasma and whole blood for transfusion decreased reflecting 
progress towards optimal use of blood and its components. 
Large differences still exist a^ong the Member States regarding use of fresh frozen 
plasma, factor-VIII concentrates, and albumin. 
The plasma shortage for preparing medicinal products persisted necessitating 
importation of both plasma and final products from outside the Community mainly 
from the USA. The amount of plasma imported, primarily by the Federal Republic of 
Germany, Italy and Spain, increased by 5%. The amount of factor-VIII concentrates 
imported, primarily by the Federal Republic of Germany, increased by 16%. 
Information about the situation regarding blood and plasma collection and use in 1993 is 
currently being compiled and a revised questionnaire for use in 1995 has been finalized. 
4.5 Trade in blood and blood products 
Irrespective of the method of collection, considerable expense is incurred in the collection, 
testing, processing, storage, distribution and use of blood and blood products as well as related 
research and development. These activities must be financed either through the health care 
system or through normal market procedures. 
The Collection and Use of Human Blood and Plasma in the European Community in 1991. W.G. 
van Aken. July 1994. European Commission. CEC/LUX/V/F/159/94. 39p. 
12 
As most Member States have achieved self-sufficiency in whole blood and cellular 
components, exchanges between Member States are limited. Exchanges of fresh components 
do occur but usually when shortages exist. Member States that have an excess of red blood 
cells do make them available at cost to third countries and one Member State that experiences 
a shortage of this blood component on a continuing basis currently obtains it from outside the 
Community. 
The situation with regard to source plasma used in the preparation of medicinal products and 
the products themselves is quite different. Currently, there is a deficit throughout the 
Community in the quantity of plasma derived from voluntary non-remunerated donations to 
enable both the public and private sectors of the plasma products industry to produce sufficient 
medicinal products to satisfy existing demand. As a result, much of the source material, i.e. 
plasmapheresis plasma, used for fractionation by the private sector, is obtained from paid 
donors from third countries, in particular the United States where there are no laws prohibiting 
payment; and donors may receive USD10-15 for each donation of about 650 ml and may give 
up to 60 litres per year. 
In addition, final products, such as factor VIII, albumin and immunoglobulins, are also 
imported. Curtailing such imports (both plasma and final products) at this time would have 
adverse consequences especially for hospital patients, those requiring emergency care, as well 
as those suffering from blood disorders such as haemophilia. 
Euroslat data indicate that in the past trade in source plasma and plasma products between the 
Community and third countries has been conducted primarily with the USA and Austria. 
Importations from the United States are significantly higher than exportations to it due in part 
to the licensing and inspection requirements imposed by the US Food and Drug 
Administration. Exports from the Community in the past have been primarily to Austria. 
Within the Community, manufacturing and marketing of medicinal products derived from 
blood and plasma is open to both the public and private sectors of the plasma products 
industry provided all marketing conditions are met. While it is estimated that the market share 
is currently divided between the public (40%) and private (60%) sectors, with the latter 
providing between 60-100% for particular products, the private sector considers that measures 
introduced in the name of national self-sufficiency on the basis of non-remunerated donations 
in some Member States deprives it of the opportunity of marketing its products in those 
Member States. It is also of the view that these regulations which impede the placing on the 
market of medicinal products derived from paid plasma create a monopolistic environment that 
could lead to increased costs for medicinal products and deprive patients and physicians of 
continued access to new technologies and products. This point of view is countered by several 
Member States that have established publicly-run systems which, in their opinion, address 
these concerns. Some Member States require certification that blood products are derived from 
voluntary unpaid blood donors. 
Development of genetically engineered plasma derivatives and alternatives to cellular 
concentrates (i.e. soluble haemoglobin) may have significant consequences in the future on 
blood donations, the usage of products, the pricing of medicinal products derived from blood, 
as well as on the exchange of these products. 
13 
5. BLOOD SAFETY AND CONDITIONS FOR ITS ATTAINMENT 
While significant advances have been made towards making blood and blood products safe, 
it must always be borne in mind that the biological nature of blood and plasma makes them 
susceptible to contamination and since new infectious complications cannot be excluded, the 
task of minimizing the risks associated with blood transfusion is far from complete. New 
technologies that continue to emerge will require close scrutiny for their ability to improve 
on current standards of screening for infectious diseases. 
5.1 Collection process 
Safety of blood and plasma collection involves two main activities - selection and testing 
Selection refers to the clinical processes of enquiry involving some form of interaction 
between a blood transfusion service professional and the donor, based on a structured 
questionnaire and supported by additional detailed guidance documents. Testing is the 
laboratory examination of a sample of the donation to determine specific biological parameters 
and to detect, through so-called infectious markers, the presence of agents that produce 
communicable diseases. 
5.1.1 Selection of donors 
With the number and kind of infectious markers differing from Member State to Member 
State, and from region to region within a Member State, as well as a higher probability of 
these occuring in first time donors, donor selection is of vital importance. The donor selection 
process, however, differs across the Community. Whether the donation is for whole blood or 
plasmapheresis plasma, variations exist: 
in the frequency of the clinical examination, ranging from a medical examination at 
every donation to none routinely required; 
in the person who conducts the donor interview who varies from a physician to a trai­
ned staff member of the collection centre; and 
in the information programmes for both donors and the general public. 
The process, however, generally includes the administration of a questionnaire which again 
differs both within and across Member States. 
The reliability and effectiveness of questionnaires in eliciting information about potential risk 
factors or exposure to diseases, such as HIV, both from first time donors and those donating 
repeatedly has yet to be determined. This is significant when it is realized that the incidence 
of infectious markers is 5-20 times higher in first time donors. It should also be noted that 
many repeating donors may sign a donor declaration without carefully re-reading it. Donor 
selection, therefore, is a crucial link in the safety of the blood transfusion chain. 
In view of the increased mobility of persons within the Community and the potential for the 
introduction of more obstacles to the movement of blood and blood products, 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. 
14 
5.1.2 Testing of donations 
Directive 89/381/EEC and the accompanying provisions were aimed at harmonizing the 
quality, safety, and efficacy requirements for medicinal products derived from blood, thus 
ensuring their free circulation. Article 3.1 of the Directive requires that testing of human blood 
and plasma, when used as the starting material for the manufacture of medicinal products, 
shall comprise those measures recommended by the Council of Europe and the World Health 
Organization (WHO) as well as the application of the monographs of the European 
Pharmacopoeia regarding blood and plasma. The provisions of the latter have been made 
applicable by Directive 91/507/EEC and are supported by guidelines developed by the CPMP. 
As these Directives do not apply to whole blood, to plasma or to blood cells of human origin, 
divergences exist within the Community regarding the testing requirements for blood and 
plasma donations. 
Some Member States do not differentiate at the collection stage between blood for transfusion 
and blood that is destined or may be used for fractionation; others do. As a consequence, 
testing requirements that may be compulsory in one Member State for blood and plasma for 
fractionation may not be in another. This can result in medicinal products derived from plasma 
manufactured in accordance with the regulations of one Member State being prevented from 
appearing on the market of another because a particular test has not been carried out. As an 
example, one Member State requires each donation to be screened for syphilis with the 
consequence that no product is allowed to be placed on its market, even coming from another 
Member State, that does not have a similar requirement. 
Both the public and private sectors share the concern that these differing testing requirements 
in Member States throughout the blood transfusion chain are introducing barriers to trade of 
medicinal products derived from blood. 
The scientific basis for some differences in testing requirements between blood for transfusion 
and for fractionation is clear. For example, HTLV-I and II appear only in the cellular fraction 
and are thus removed in the first manufacturing stage of the medicinal products derived from 
blood or plasma; the syphilis agent is rapidly inactivated by freezing the plasma, a process to 
which all collected plasma is subjected. A particular point of contention among the Member 
States is alanine aminotransferase (ALT) testing which was originally introduced as a 
surrogate test for post-transfusion hepatitis when specific screening for hepatitis C was not yet 
possible. This test is not included in the list of mandatory tests of the European 
Pharmacopoeia monograph on plasma for fractionation. As this monograph is worded so as 
to allow flexibility, however, some Member States require this test while others do not. 
It is evident that the differing testing requirements in the Member States hinder the free 
movement of blood and blood products and are therefore an impediment to the goal of 
Community self-sufficiency. 
5.2 Regulatory Controls 
In each Member State, there are responsible bodies for authorizing the manufacturing of 
pharmaceutical products and the monitoring of procedures in order to ensure that high levels 
of quality and safety are maintained. Inspectors are required to make on-site visits to the 
manufacturer to ensure regulations are being followed and negative reports can result in 
closure until corrective measures are taken. In accordance with Community legislation, each 
Member State is responsible for inspections on its own territory, and information exchanges 
15 
between the competent authorities, such as through the CPMP, help to facilitate the resolution 
of problems between them. 
In at least one Member State, blood is considered a medicinal product and is therefore subject 
to pharmaceutical regulation. This is not the case, however, in others. On the basis of an on­
going survey being carried out by the Commission, there are preliminary indications that the 
regulatory controls regarding licencing and accreditation of blood collection establishments 
differ widely across the Member States. Many have no licencing requirements for the 
collection of blood or plasma; no standard requirements for collection centres across the 
country; no routine and/or unannounced inspections by national authorities nor peer 
inspections, and differing time periods for licence renewals. In one Member State, the 
extraction of blood and blood components for transfusion as well as the extraction of plasma 
for fractionation constitutes the manufacture of medicinal products, for which a licence is 
required. In others, this interpretation does not apply. 
This existence of divergent national regulations concerning the collection and treatment of 
blood contributes to a reluctance, if not a refusal, on the part of certain Member States to 
accept blood and plasma coming from others. Serious consideration, therefore, needs to be 
given to harmonizing the licensing and accreditation of blood collection, processing and 
distribution establishments across the Community that do not fall within the scope of Directive 
89/381/EEC. 
6. THE NECESSITY FOR FUTURE COMMUNITY ACTION 
6.1 Increased awareness 
As a result of the AIDS pandemic as well as several incidents related to the distribution of 
contaminated medicinal products derived from blood and plasma in the Community, public 
confidence in the blood transfusion system has been seriously undermined. Patients and 
persons with haemophilia have been particularly affected. Demands for stricter regulations of 
the blood transfusion system have increased. It is extremely important that the confidence of 
the citizens of the Community is reestablished; this can be done by means of a number of 
measures including appropriate information and education campaigns. 
The results of the Eurobarometer survey show that knowledge about blood-related issues in 
the Community is inadequate and is insufficient in relation to the goal of Community self-
sufficiency. There is the need, therefore, to increase awareness levels among the population 
regarding blood and plasma, its uses, the precautions that are taken to maximize safety, as 
well as the goal of Community self-sufficiency. This could be done through better targetted 
campaigns of a general nature or specifically targetted to blood awareness. There is also the 
need to have more detailed information about the knowledge and attitudes of specific groups, 
such as students, regarding blood and blood donation with the view to enlarging the blood 
donor base. The latter could be done in cooperation with blood donor groups. 
6.2 Donor selection criteria 
The process of donor selection should be properly monitored and documented and its 
effectiveness should be demonstrated properly in particular by reference to an acceptable low 
level of frequency of infectious markers. In spite of the fact that several guidelines, including 
those of the Council of Europe, already exist in this area and certain Member States have 
16 
relevant requirements embodied in regulations, there is significant variation in the donor 
selection processes in the Member States. There is the need for common procedures among 
blood and plasma collection centres within the Community if obstacles to the movement of 
these products are to be overcome. These common procedures would help to provide the 
necessary reassurances of the safety of blood and blood products originating from whatever 
Community source. 
A first step in this process could be taken by the development of a common and well-
structured questionnaire with appropriate criteria for the selection of donors taking into 
account the differing social/cultural environments in the Community and the regulations and 
procedures currently in force. An examination of the efficacy of existing donor selection 
procedures could provide a basis on which to select the criteria for such a questionnaire so 
as to provide optimal guarantees for the safety of the donor and the recipient. 
6.3 Testing of donations 
Despite the existence of testing requirements in the Community, some differences remain in 
the screening of blood and plasma for transfusion and for fractionation in the Member States. 
As the importance of these screening tests cannot be overestimated, the available scientific 
data, both in favour and against specific screening tests, need to be compiled so that a sound 
basis against which to establish their validity can be developed. There is a clear need for 
harmonization in this respect to ensure the free circulation of medicinal products derived from 
blood but also to facilitate the future centralized procedure for authorization of medicinal 
products. Moreover, a comparative survey is needed of the currently used testing kits in the 
blood transfusion field, their proficiency and proper utilization, as well as the licensing of the 
critical diagnostics intrinsic to ensuring the safety of the blood supply and quality control 
measures in the Member States. 
6.4 Optimal use 
Attitudes towards blood transfusion and the use of medicinal products derived from plasma 
have changed in the last ten to fifteen years due to the emergence of blood-borne diseases 
(notably HIV), new medical technology, increasing health care costs, and the results of clinical 
trials. Knowledge about the clinical effectiveness of the varying approaches to the prescribing 
and use of blood and blood products across the Community, however, is hampered by a 
continuing lack of access to and provision of relevant information thus inhibiting the 
establishment of policies regarding their optimal use. Both the self-sufficiency surveys and 
the SANGUIS study have demonstrated wide variations in transfusion practices in the Member 
States. Consensus conferences and guidelines on the use of specific blood products do not 
appear to have had a significant impact on changing the behaviour of physicians and there is 
a need, therefore, to carry out studies on the optimal use of blood and blood products 
recognizing that its significance is directed towards: the patient - whose safety and therapy are 
of paramount importance; the donor - who should be guaranteed that his/her donation is used 
in the best possible way; self-sufficiency - ensuring that source materials (blood and plasma) 
are used optimally; good clinical practice - ensuring inter alia that blood and blood products 
are administered only when needed; and finally the financial implications. Moreover, there 
is a need to include in a standardized way in clinical records the reasons for transfusion, its 
actual administration and the outcome. Results of further studies could be used as the basis 
for establishing sound blood transfusion practices throughout the Community. 
17 
6.5 Regulatory system 
With the increasing movement among Member States of blood products and blood units, 
which are being drawn in one country for transfusion in another, differing licensing and 
inspection requirements for both blood and plasma collection establishments across the 
Community stand in the way of the free movement of blood and blood products and thus the 
objective of Community self-sufficiency. Common requirements including quality control and 
quality assurance procedures and good manufacturing practice, which have been established 
for medicinal products derived from blood and plasma, need to be defined and agreed upon 
for blood collection establishments and inspection and certification programmes need to be 
put in place. The objectives of such programmes would be to verify the implementation of 
requirements agreed upon and to provide a tool for the improvement of practices as they relate 
to donors and patients. Such an inspection and certification programme would have to be 
determined in consultation with the responsible authorities of the Member States. 
6.6 Haemovigilance 
The minimization of risks associated with blood transfusion constitute a major priority. 
Because blood transfusion deals with a biological material in which infectious agents may be 
present, it is essential to be ever vigilant so that potential biological changes can be detected 
at any time. Moreover, since there is insufficient information as to the precise extent of 
infection or transfusion errors, there is the need to develop concrete measures for their 
prevention. This applies also to the immune reactions that may follow a transfusion as a result 
of previous immunizations (e.g. pregnancy, previous transfusion). 
As indicated in the Commission's Communication related to AIDS and certain other 
communicable diseases, there is a need to improve, at Community level, the availability, 
quality, relevance and dissemination of data related to diseases transmitted by inter alia blood. 
Establishment of Community-wide surveillance systems on blood transmitted diseases and 
adverse reactions at both national and Community level could help to keep transfusion 
specialists informed, in a timely and orderly fashion, of new infectious agents in particular, 
their potential danger, and appropriate measures to be taken to avoid their transmission. Such 
a system could be based on a network of blood transfusion centres linked with national or 
Community epidemiological agencies which are looking at these issues on a broader scale. 
Existing haemovigilance and pharmacovigilance systems, therefore, would need to be 
examined in order to assess their contribution to such a system. 
6.7 Continuing close cooperation with Member States 
The Communication on blood self-sufficiency in the European Community was based inter 
alia on the results of a joint enquiry conducted for the Commission and the Council of 
Europe 7, took into account the comments received from representatives of the Member States, 
and identified issues and priorities for action. This Communication on blood safety and self-
sufficiency has taken into account information provided by the Member States in these areas 
as well as issues of concern and activities to be undertaken expressed by the Member States 
at meetings held by the Commission. 
27 
Collection and use of human blood and plasma in Europe. W.G. van Aken. Council of Europe 
1993. 31p. (ISBN 92-871-2240-7) 
18 
In view of the complexity of the issues rejated to blood transfusion as well as the importance 
of blood and blood products to the health of the citizens of the Community, the Commission 
will continue to draw upon the expertise of representatives from the Member States. Their 
medical, scientific, manufacturing and managerial expertise in relation to the operation of 
blood transfusion services, will continue to be of assistance to the Commission in addressing 
issues related to blood safety and self-sufficiency in the Community. 
7. BLOOD SAFETY AND SELF-SUFFICIENCY: THE NEXT STEPS 
In conclusion, there is a clear need to formulate a Community blood strategy aiming at 
improving confidence in the safety of the blood transfusion chain and promoting self-
sufficiency in the Community. 
To this end, the main activities to be undertaken could include: 
Development of scientifically sound policies and agreed procedures in the donor 
selection process among blood collection establishments within the Community in 
order to provide the necessary reassurances of the safety of blood products originating 
from whatever Community source. 
Implementation of efficient validated and reliable screening tests in the Community. 
Development of quality assessment criteria and good manufacturing practices 
regarding collection, testing, processing, and transfusion of blood and blood products 
and patient follow-up procedures. 
Development of a haemovigilance system for the collection of epidemiological data 
related to the blood transfusion chain. 
Development of educational programmes directed towards health professionals on the 
optimal use of blood and blood products. 
Support for the dissemination of information on blood and blood products and the 
collection, processing and transfusion procedures through promotional materials, films, 
campaigns. 
The Commission will continue to collaborate with the Member States to develop this blood 
strategy and will report on the progress made in this regard in due course. 
19 
ANNEX 1 
Therapeutic Uses of Blood Products 
Blood Products Therapeutic Use 
CELLULAR COMPONENTS and PLASMA 
Red blood cell concentrates 
Platelet concentrates 
Fresh frozen plasma (FFP) 
PLASMA DERIVATIVES 
Albumin 
Clotting factor concentrates 
Protease inhibitors 
Immunoglobulins RBCs are administered when the oxygen carrying capability of 
blood is diminished so that organs or tissues no longer function 
properly primarily as a consequence of blood loss due to trauma 
(e.g. car accidents), surgery, or delivery, or loss of red cells because 
of hereditary diseases such as thalassemia. 
Patients suffering from platelet deficiencies, particularly those 
undergoing treatment for blood disorders (e.g. leukaemia), and 
cancer patients receiving chemotherapy and irradiation, receive 
platelet concentrates to prevent life-threatening bleeding. 
Plasma which after collection is frozen to a temperature that will 
maintain the activity of labile coagulation factors is called FFP. It 
is used to treat bleeding in patients undergoing liver transplantation 
and for some rare clotting factor deficiencies. It is also used 
postoperatively and inadvertently as a nutritional substitute. 
Albumin is used primarily when loss of blood or severe infection 
(septicemia) causes a drop in blood pressure giving rise to shock. 
Albumin-deficiency, caused by its decreased synthesis (e.g. in 
patients with severe liver disease) or losses (e.g. severe burns) may 
also be an indication for its administration. 
These are used principally to treat bleeding episodes in patients with 
shortages in one or more of these proteins (e.g. haemophilia A); and 
regular injections improve both their quality of life (e.g. less joint 
injury) and longevity. 
Protease inhibitors (e.g. antithrombin III) curb excess clotting factor 
activity. Deficiency of these proteins may cause diseases such as 
venous thrombosis and lung emphysema which are prevented 
through treatment with protease inhibitor concentrates. 
These are plasma proteins that play a role in the defense mechanism 
against viral and bacterial infections. They are used mainly in the 
prevention of a variety of infectious diseases such as hepatitis, 
smallpox, chicken pox, tetanus, and rabies and in the treatment and 
prevention of haemolytic disease of the newborn due to Rh 
incompatibility. Increasingly high doses of immunoglobulins are 
being used to treat patients with auto-immune diseases and further 
indications for their use are increasing. 

20 
ANNEX 2 
Major Infectious Agents Transmissible by Blood and Blood Products 
INFECTIOUS AGENT 
Viruses* 
Human immunodeficiency virus type 1 (HIV-1) 
Human immunodeficiency virus type 2 (HIV-2) 
Human T-cell leukaemia virus type I (HTLV-I) 
Human T-cell leukaemia virus type II (HTLV-II) 
Hepatitis A virus (HAV) 
Hepatitis B virus (HBV) "^ 
Hepatitis C virus (HCV) j 
Cytomegalovirus (CMV) 
Epstein-Barr virus 
Parvovirus B19* 
Spirochetes** 
Treponema pallidum 
Borrelia burgdoferi 
Parasites** (rare in the Community) 
Plasmodium species OUTCOME 
} 
} AIDS 
myelopathy 
acute T-eeli leukaemia 
acute hepatitis 
acute/chronic hepatitis 
liver cirrhosis 
liver cancer 
pneumonitis 
glandular fever 
aplastic crisis 
foetal loss 
syphilis 
lyme disease 
(borreliosis) 
malaria 
Bacteria 
Contamination with a variety of bacteria 
can occur at the time of donation. septicaemia 
Are not transmitted by virally inactivated plasma, with the exception of 
parvovirus B19 
Transmitted only by the cellular components 

21 
ANNEX 3 
Eurobarometer Survey 
European citizens are reasonably well-informed about blood: 98% are aware of the 
existence of different blood groups; 90% are aware that donating blood does not 
permanently reduce its volume in the body; and 89% are aware that blood donations 
are tested for diseases. Television is the dominant information source. 
There is a general lack of awareness about the frequency with which blood can be 
donated. 
Knowledge about plasma is lacking with only 34% aware that it can be donated 
instead of whole blood with this most apparent in Greece (14%), Portugal (18%) and 
Denmark (18%)28v 
Donating blood is considered by about half those interviewed as the right thing to do. 
Interviewees would donate to support a relative or friend (33%), in case of a major 
disaster (30%), before an operation (26%), and because of the rarity of the blood group 
(25%). 
There are significant variations in the acceptance of blood donated by anyone: overall 
(46%), Denmark (80%), U.K. (73%), The Netherlands (70%), Italy (33%) and 
Germany (24%). 
The general opinion (78%») is that freely donated blood should be provided free of 
charge to people who need it; a charge to cover collection, testing and distribution 
costs would be acceptable to 13%; a charge over and above these costs to finance 
research, information and donor campaigns is supported by 6%. 
Only 1% approved of selling blood as any other product while 55% considered that 
blood should be given for the sake of giving. 
Over half (55%) believe that blood transfusions are safer today than they were 10 
years ago, 14% believe they are as safe, while 23% doubt their current safety. 
Because of AIDS, 70% are more afraid than before regarding the safety of blood and 
blood products. Giving blood is frightening for 27%, with this response much higher 
in Portugal (51%) and Spain (41%). 
Receiving blood is of concern to a large percentage of Europeans (73%), particularly 
in Italy (87%); having an injection (35%) and having an operation (47%) is more 
frightening now than about 10 years ago. 
28 Note: Denmark has been self-sufficient in plasma derived from whole blood for several years. 

22 
ANNEX 4 
• 29 
Major Survey Findings on Self-sufficiency in 1991 
From 1989 to 1991: 
The number of whole blood donations increased by about 6% from 15.2 million30 to 
16.1 million. 
Use of red blood cell concentrates (RBC) remained unchanged (data from Germany not 
included); the number of whole blood transfusions declined by 7%; use of fresh frozen 
plasma dropped by 20%; and consumption of platelet concentrates increased by 32%. 
More than 4.1 million litres of plasma were collected from whole blood donations and 
plasmapheresis from voluntary, non-remunerated donors - a 20% increase. 
The volume of plasma derived from whole blood available for fractionation increased 
by 47%o from 1.7 to 2.5 million litres; the volume obtained through apheresis from 
voluntary, non-remunerated donors increased by 22%. The total volume of plasma for 
fractionation increased by 36% - from 2.5 to 3.4 million litres. 
Importation of plasma for fractionation from outside the EC, primarily by the Federal 
Republic of Germany, Italy and Spain, increased by 5% from 2.0 to 2.1 million litres. 
Total consumption of factor-VTII preparations was 827.8 million ÏU - an 11% increase 
(As 1989 data for Germany was unavailable, it was not included in calculation). The mean usage 
per patient ranged from 0.4 (Greece) to 4.7 (Luxembourg) with varying treatment 
regimens accounting for the differences. Total consumption of albumin preparations 
amounted to 82,328 kg, an increase of 5%. 
The plasma volume required to satisfy the reported use for factor-VIII concentrates 
varies between 4.6 and 5.5 million litres depending on the final yield. Considering the 
3.4 million litres available for fractionation, the resulting plasma shortage was 1.2 to 
2.1 million litres. 
The quantity of factor-VIII concentrates imported (mainly from the USA), increased 
by 16% to 273 million units (primarily by Germany). 
Use of factor VIII products increased by 11% while the number of haemophilia 
patients treated regularly increased by 3%. 
29 
30 The Collection and Use of Human Blood and Plasma in the European Community in 1991. W.G. 
van Aken. July 1994. European Commission. CEC/LUX/V/F/159/94. 39p. 
Corrected figure based on revised data from the Member States 

?3 
FINANCIAL ASPECTS 
"The financial implications of this Communication have been taken into account in the 
proposal for the budget for 1995 and in the Commission proposal for a European Parliament 
and Council Decision concerning AIDS and certain other Communicable diseases within the 
framework for action in the field of public health. [See attached Financial Statement. Section 
7,2. HIV/AIDS AND OTHER COMMUNICABLE DISEASES - Specific prevention measures 
(vaccination, safety of blood and blood products)]". 
ISSN 0254-1475 
COM (94) 652 final 
DOCUMENTS 
EN 05 
Catalogue number : CB-CO-94-680-EN-C 
ISBN 92-77-84025-0 
Office for Official Pablicatioiis of the European Coinmiiiiities 
L-2985 Luxembourg