COMMISSION OF THE EUROPEAN COMVIUNITIES 
C0M(93) 198 final 
Brussels, 25 May 1993 
COMMUNICATION FROM THE COMMISSION 
TQ THE COUNCIL. THE EUROPEAN PARLIAMENT ANP THE ECONOMIC AND SOCIAL COMMITTEE 
on 
BLOOD SELF-SUFFICIENCY 
IN THE EUROPEAN COMMUNITY 
À 
INTRODUCTION 
Increasing concern about the quality, safety and supply of human blood and plasma 
products, particularly as a consequence of the AIDS epidemic, served as background to an 
exchange of views on the free movement of blood products by the Ministers of Health 
meeting within the Council in November 1989. 
In June 1989, in the framework of the development of the single market, the Council of the 
European Communities unanimously adopted Directive 89/381/EEC'1' extending the scope 
of existing pharmaceutical legislation to include medicinal products derived from human 
blood or plasma and prepared by industrial procedures. The Directive, which does not 
apply to whole blood, plasma or blood cells of human origin, has two main aims: 
introduction of stringent quality and safety criteria for medicinal products 
derived from human blood and plasma, particularly in relation to preventing 
the transmission of viral diseases; 
promotion of self-sufficiency of the European Community in human blood 
or human plasma through voluntary and non-remunerated donations. 
With regard to self-sufficiency, the Directive provides that: "Member States shall take the 
necessary measures to promote Community self-sufficiency in human blood or human 
plasma. For this purpose, they shall encourage the voluntary unpaid donation of blood and 
plasma and shall take the necessary measures to develop the production and use of products 
derived from human blood or human plasma coming from voluntary unpaid donations. 
They shall notify the Commission of such measures. " 
At their meetings of 13 November 1989 and 11 November 1991, the Council of Health 
Ministers addressed these issues further and requested the Commission to prepare a report 
on the subject of self-sufficiency and the encouragement of voluntary unpaid donations 
within the Community. 
Given the previous work of the Council of Europe in this field, and its continuing interest 
in this area, it was agreed that an enquiry into blood self-sufficiency should be conducted 
jointly. Ensuing difficulties in obtaining data from the Member States, however, resulted in 
delays in the preparation of the report. 
1. Council Directive of 14 June 1989 extending the scope of Directives 65/65/EEC 
and 75/319/EEC on the approximation of provisions laid down by law, regulation 
or administrative action relating to proprietary medicinal products and laying down 
special provisions for medicinal products derived from human blood or plasma. 
(O.J. L 181 of 28 June 1989, p.44-46). 
A Commission Staff Working Paper(2) presented to the Health Council at its meeting of 15 
May 1992 outlined the major issues dealing with the safety and supply of human b!ood in 
the Community and affoided Council members the opportunity to reiterate the importance 
of the principles outlined in the Directive and their keen interest in receiving the 
Commission's Communication on the subject of self-sufficiency. Interest in litis Issïie was 
again expressed at the Council's meeting of 13 November 1992. 
This Communication, prepared in response to the Council's request, is based on the results 
of the joint enquiry conducted for the Commission and the Council of Europe by Professor 
Van Àken of the Central Laboratory of the Netherlands. Red Cross Blood Transfusion 
Service, and takes into account the comments on his report™ received from representatives 
of the Member States. 
2. RATIONALE FOR SELF-SUFFICIENCY 
2.1 Blood and its Derivatives 
The vital and indispensable nature of blood, which is comprised basically of cells (red and 
white), platelets and plasma, and the fact that for therapeutic purposes humans are its only 
source at present, highlight the importance of ensuring its optimal use. This is achieved by 
separating it into its major constituents and whenever appropriate using these instead of 
whole blood in the treatment of diseases and injuries. These constituents can be divided 
into two main groups: labile (or unstable), which have a shelf life varying from a few days 
to one year depending on the constituent itself as well as the storage conditions; and stable 
medicinal products derived from blood or plasma, with a shelf life of several years. 
Labile blood products include whole blood, red blood cell concentrate, white blood cells, 
platelets, and fresh frozen plasma. Red cell replacement is the therapy of choice when 
transfusions for correcting anaemia are required. Red cell concentrates alone, or 
supplemented with fresh or frozen plasma and/or serum albumin, are effective in most 
patients for intra-operative transfusions. Platelets are used for primary haemostasis. White 
blood cells are used occasionally for cases of severe septicemia. 
The principal stable medicinal products derived from blood or plasma are: albumin, which 
is used primarily for restoring or maintaining blood volume; coagulation factors, such as 
Factor VIII, required for treating patients with haemophilia; immunoglobulins for 
preventing infectious and autoimmune diseases; and other plasma proteins. 
While the largest portion of stable medicinal products derived from blood is currently 
extracted from plasma coining from whole blood, a certain quantity can be obtained by 
plasmapheresis - (he process involving the removal of blood, separation of the blood cells 
by centrifugation, and reinjection of the packed cells suspended in a suitable medium. In 
addition, the serum portion of placental blood is also used as starting material for the 
preparation of albumin and immunoglobulins. 
2. 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. 
3. W.G. Van Aken. The Collection and Use of Human Blood and Plasma in Europe. 
Council of Europe. 1993. 31p. (ISBN 92-871-2240-7). 
In spite of the significant progress towards the synthesis of certain blood proteins and the 
existence of various substitutes, human blood is still irreplaceable. Therefore it is necessary 
to ensure: 
An adequate supply of labile blood components which, due to their limited 
shelf life, require expeditious use and frequent replacement; 
An adequate supply of blood or plasma as source material for use in the 
production of medicinal products. 
2.2 Self-sufficiency 
Availability of an ample supply of blood and appropriate blood products to an individual or 
group of individuals at the time of need is of the utmost importance. To ensure this, 
reliance may be placed: on products derived solely from blood or plasma coming from a 
specific population of which the individual or group of individuals is a part; on products 
coming from other populations; or on both. When reliance on products coming from other 
populations has been eliminated then a situation of self-sufficiency for the specific 
population in question is considered to have been realized. In practise, the specific 
populations in question correspond to those of the various countries. In order to minimize 
dependency on other populations, as well as for ethical and safety reasons, however, 
countries need to promote blood donations from within their own populations and strive 
towards satisfying their clinical needs for blood and plasma from them. 
Ideally, the goal of self-sufficiency should be achieved through the promotion of voluntary 
and non-remunerated blood and plasma donations, in which the person gives blood, plasma 
or cellular components of his/her own free will without receiving payment, either in the 
form of cash or in kind which could be considered a substitute for money. This could 
include time off work other than that reasonably needed for the donation and travel. Small 
tokens, refreshments and reimbursement of travel costs are compatible with voluntary, non-
remunerated donations/4) 
2.3 Public Health Aspects 
Because blood is vital to the life of numerous patients, it is considered essential that its 
quality and safety be assured and that the health of the donors themselves is protected. 
Several viral, bacterial and parasitic diseases, including AIDS, hepatitis, and malaria, are 
transmissible by blood. Some are tested for specifically and some are not relevant for 
fractionated blood products. 
In 1987, the Council took the view that the European Commmunity pharmaceutical 
legislation should be extended to cover medicinal products derived from human blood and 
plasma. In 1989, the Council thus adopted Directive 89/381/EEC, which covers stable 
medicinal products derived from human blood or plasma. Consequently, these products are 
now subject to the general requirements regarding manufacturing and marketing 
authorization. The principles of Good Manufacturing Practice, laid down in Commission 
Directive 91/356/EÊC55) and detailed in a guide intended for manufacturers, as well as the 
Definition agreed upon by the Council of Europe Blood Transfusion Expert 
Committee (SP-HM) and the League of Red Cross and Red Crescent Societies. 
O.J. NrL 193 of 17.7.91. 
testing requirements laid down in Commission Directive 91/507/EEC^6^ have become 
mandatory in order to demonstrate the quality, safety and efficacy of medicinal products xà 
view of their authorization. In addition to these general requirements, which are applicable 
to all medicinal products, Directive 89/381/EEC contains certain eleme**- which are 
specific for blood products, such as the implementation by manufacturers of validated 
manufacturing and purification processes, in order to ensure as far as possible Ik, vira! 
safety of these products. To this end, the Committee for Proprietary Medicinal Products 
(CPMP), in which the competent authorities of the Member States are represented, adopted 
two specific notes for guidance for manufacturers relating to medicinal products derived 
from human blood or plasma and to validation of virus removal/inactivation procedures. 
The safety of labile blood components, including fresh plasma, is heavily dependent on the 
selection and testing of donors in order to prevent the transmission of disease. In spite of 
all the precautions, however, absolute safety cannot be guaranteed. Risks can be minimised 
by carrying out an adequate medical consultation in combination with a pertinent 
questionnaire, and conducting, where necessary, an appropriate examination. As a result, 
the donor can exclude himself/herself or be excluded from making a blood donation due to 
a specific pathology or a risk-factor identified during this process. If necessary, the donated 
blood or certain components can be rejected as a result of abnormal laboratory screening 
results or because its exclusion has been requested. 
Care as to the amount of blood provided by donors, as well as by those who undergo 
plasmapheresis, must be exercised. As the capacity to replace proteins lost during blood 
donation is not unlimited, excessive repetition particularly of plasmapheresis, which is an 
industrial process carried out by both the non-profit and commercial sectors, can deprive a 
donor of his/her own plasmatic proteins and antibodies, rendering him/her more sensitive 
to infection, and possibly susceptible to risks associated with malnutrition. An equilibrium 
between quantity and frequency is needed since increasing either of these two parameters 
could be detrimental to the donor's health; maintaining them at relatively lower levels 
would necessitate an increase in the number of donors in order to maintain the same 
volume of blood or plasma donated during a fixed period of time. 
Providing material benefits to blood donors in the form of cash or in kind, or other 
services, is contra-indicated: for clinical reasons - to avoid the risk of transmission of 
infection to the recipient and to safeguard the health of the donor; for social reasons - to 
ensure all levels of society, irrespective of economic status, participate in donations; and 
for ethical reasons - so as not to exploit or deprive vulnerable population groups either 
inside or outside the Community. 
It is desirable, therefore, that the fundamental principles of voluntary and unpaid donation 
of human blood, as accepted by the Council of Europe, the International Federation of Red 
Cross and Red Crescent Societies, and the International Society of Blood Transfusion, and 
recommended by the World Health Organization, are reaffirmed. 
3. THE STUDY ON SELF-SUFFICIENCY 
3.1. The Inquiry 
For more than 15 years, the Council of Europe has been a strong advocate of national self-
sufficiency for blood and plasma products based on voluntary unpaid blood and plasma 
donations. In 1988, it conducted an enquiry on self-sufficiency based on voluntary non-
O.J.NrL 270 of 26.9.91. 
remunerated donations in 1986 that resulted in the publication of a report^7) , and the 
adoption of "Recommendation R(90)9 of the Committee of Ministers to Member States on 
Plasma Products and European Self-sufficiency". 
Given the experience and continuing interest of the Council of Europe in this area, and the 
fact that its efforts to promote voluntary unpaid blood and plasma donation, as stated in 
Directive 89/381 /EEC, are entirely supported by the Community, it was decided that a 
joint Council of Europe/Commission enquiry should be conducted to ascertain the situation 
regarding self-sufficiency. 
In 1990, a questionnaire was distributed to the Heads of the Transfusion Services or to the 
responsible services of the Ministries of Health in Europe, including the 12 Member States 
of the European Community, to elicit information about the situation as it was in 1989. 
Responses were submitted to Prof. Van Aken who analysed the results and prepared a 
report. 
3.2 The Findings of the Van Aken Report 
Despite the wealth of data provided by the 12 Member States in responding to the 
questionnaire, presenting an accurate profile of the situation with regard to self-sufficiency 
in the Community in 1989 has proved difficult. Some of the responses were not complete 
and data from one Member State to another were not always comparable. Some data were 
not available, some, such as that from non-public sources, were confidential, and some 
appeared to contradict those reported by other sources. Furthermore, one Member State 
provided data related to 1988 rather than to 1989. 
However, based on the results of the enquiry and information obtained through direct 
contact with respondents Prof. Van Aken reported, inter alia, that: 
3.2.1 The unpaid blood donor population in the European Community 
remained relatively stable from 1986 to 1989 at 8 to 9 million. 
3.2.2 The number of whole blood donations increased by about 5% from 
14.7 million in 1986 to 15.4 million in 1989. 
3.2.3 In most Member States, more than 75% of whole blood collections 
were separated into plasma and red cell concentrates before being 
transfused. Use of whole blood remained relatively high, however, in 
Portugal (30%), Greece (46%), and Italy (60%). Compared to 1986, 
the relative use of both red blood cell and platelet concentrates 
increased in all countries. 
3.2.4 An estimated 0.4 million litres of plasma could be saved for 
fractionation if usage of whole blood was more closely monitored. 
3.2.5 There was a marked increase (+151%) in the number of unpaid 
donors who participated in plasmapheresis rising from 47,000 in 
1986 to at least 118,000 in 1989. 
3.2.6 More than 3.4 million litres of plasma were collected in 1989 by 
means of whole blood donations and plasmapheresis. Of this amount, 
an estimated 0.9 million litres were used directly for transfusions and 
7. Plasma Products and European Self-sufficiency: Collection, Preparation and Use. 
Council of Europe, 1992. 66p. 
an estimated 2.5 million litres were used for the production of plasma 
products. The exact amount of plasma collected in the Federal 
Republic of Germany, however, was not known as the number of 
remunerated donations and the quantity of imported source material 
was unknown. 
3.2.7 Importations of plasma for fractionation from outside the European 
Community, primarily by the Federal Republic of Germany, Italy 
and Spain, were estimated at between 1.6 and 1.9 million litres. 
3.2.8 The two plasma products that play a dominant part in determining 
self-sufficiency are Factor VIN and albumin. For Factor VIII 
preparations, total consumption rose from 500 million International 
Units (IU) in 1986 to 614.9 million IU in 1989 - a 23% increase. 
Consumption in Denmark, France and Greece appeared to have 
decreased. The mean usage per patient ranged from 0.4 - 4.5 IU with 
variations in treatment regimen accounting for the differences. 
Clinical use of Factor VIII showed a continuous increase since 1986 
largely because of its prophylactic administration to prevent bleeding 
episodes and chronic joint injury in persons suffering from 
haemophilia. For albumin, although specific questions regarding its 
clinical use were not included in the 1989 enquiry, estimated 
consumption varies between 200-500 kg per million in countries with 
fully-developed health care systems. 
From the responses, it was also determined that for the year 1989 (1988 for France): 
Belgium, Greece, France, and Luxembourg reported that they were self-
sufficient in Factor VIII although the level of use varied in the different 
countries. Denmark, Italy, Netherlands, and the United Kingdom expected 
to achieve it between 1990 and 1994. The situation in the Federal Republic 
of Germany and Ireland was not clear. 
Denmark, the Federal Republic of Germany, France, Ireland, Luxembourg, 
and Netherlands reported self-sufficiency in albumin. Belgium, Italy, and the 
United Kingdom expected to reach it between 1990 and 1994. The situation 
in Greece was unclear. 
Spain and Portugal reported that they were not self-sufficient in plasma 
products and gave no indication when they expected to be. 
Based on these findings, the report concluded that self-sufficiency for plasma products 
derived from blood of unpaid donors is an attainable goal and several recommendations on 
how this could be achieved were presented. These were: 
Encouraging appropriate clinical prescribing of medicinal products derived 
from human blood and plasma in order to guarantee optimal use of plasma 
products. 
Increasing the number of donors and/or donations in order to guarantee a 
sufficient supply of plasma, and promoting plasmapheresis if this does not 
fully make up the shortage. 
Increasing the yield of fractionation procedures for Factor VIII. 
Promoting quality assurance of blood collection in all Member States, and 
identifying the origin (country and type of donation) of the source plasma 
when products are placed on the market in the Community. 
Ensuring that health authorities are able to supply data regarding the 
collection and use of plasma products so as to facilitate the analysis and 
monitoring of developments towards self-sufficiency, and encouraging the 
setting-up of a European data bank. 
4. ISSUES RAISED BY MEMBER STATES 
To ensure that the report prepared by Professor Van Aken accurately reflected the national 
situations in 1989, consultations were held with scientific consultants and national experts 
from the Member States and comments on both the factual and subjective or policy aspects 
as well as the recommendations, were elicited. While no fundamental objections to the 
overall findings nor to the general thrust of the report were raised, several key issues 
emerged relating to: 
- The principle of self-sufficiency. 
- The timeliness of the study. 
- The character of blood and plasma donations. 
- Blood Donors / Plasmapheresis. 
- Optimal Use of Blood and Blood Derivatives. 
- Quality and Safety of Cellular Blood Products. 
- Information Exchange. 
4.1 The Principle of Self-sufficiency 
The principle of self-sufficiency, particularly in medicinal products derived from blood and 
blood products, is viewed as a goal of health policy and continues to receive the 
endorsement of the Member States. The degree to which this goal has been attained varies. 
Some Member States already have reached self-sufficiency in the supply of blood and 
cellular constituents but still import plasma and plasma products, another has reached self-
sufficiency in whole blood for use in transfusions while pursuing a policy of seeking self-
sufficiency in plasma-based products sourced from its own volunteer donors, and others 
have not yet achieved self-sufficiency. 
While concensus on the principle of self-sufficiency exists, there is some ambiguity with 
regard to its practical implementation. The generally accepted definition, and that cited in 
the report™), links a population and its potential needs in blood and blood products to the 
same population and the satisfaction of those needs. This implies that Community self-
sufficiency will be achieved from within the Community itself. Concern has been raised, 
8. Self-sufficiency - Provision of human blood and blood products from within a 
population to satisfy the clinical needs of that population. (CEC. 111/3602/90. 25 
January 1990. Informal meeting of European experts on medicinal products derived 
from human blood or plasma. Brussels, 9-10 January 1990). 
8 
however, that strict adherence to this definition imposes restrictions on the 
importation/movement of blood and blood products and hence impedes the clinical freedom 
of doctors to choose the most suitable product for individual patiente, thus depriving them 
of access to advances in blood products, many of which originate in commercial 
pharmaceutical companies outside the European Community. Whilst recognizing the 
legitimacy of this concern, it was noted nevertheless that application of this practice 
contradicted the meaning of Community self-sufficiency and more accurately reflected the 
principle of sufficiency in which the related key factors of need, quality and safety, 
availability, and control (Le assurance with respect to quality, safety ana supply) are 
assured and through which the clinical needs of patients, and concomitantly the clinical 
freedom of physicians, are taken into account it has to be noted, moreover, that as the 
provision relating to self-sufficiency in Directive 89/381/EEC applies only to human blood 
or human plasma as a starting material for the manufacture of medicinal products, it is 
narrower in scope than the définition presented above and that cited in the Van Aken 
report. 
The view that Community self-sufficiency should be brought about through national self-
sufficiency was also expressed by some Member States. How it will be achieved, however, 
is up to me Member States themselves. Those that have achieved self-sufficiency could 
offer to or be called upon by the Member Suites mat have not to make available surplus 
supplies with preference given to products coming from voluntary unpaid donations. If 
supplies are not available from within the Community itself, however, then they will need 
to be obtained from elsewhere. 
Conclusion 
Hie attainment of self-sufficiency in blood and blood products at Community level 
through voluntary non-remunerated donations is the ultimate goal and there is a 
clear obligation on Member States to promote this for medicinal products derived 
from blood and plasma. 
4.2 Timeliness of the study 
Aware of the act that difficulties in obtaining the relevant data delayed the preparation of 
the report, Member States nevertheless acknowledged that it addressed the situation with 
regard to self-sufficiency in me Community in 1989» Given that it was based on data that is 
now more man three years old, however, it was deemed not to be a precise foundation on 
which to take decisions but could serve as a basis for further examination of the issue. 
In this regard, Member Slates agreed on the need to update the study on a regular basis in 
order that progress wimin the Conmiunity towards the goal of self-sufficiency could be 
measured and to supplement national data with data sought from industry. It was desirable 
that the next update be conducted as soon as possible and that the compiled data, even 
though incomplete, accompanied by brief explanations be disseminated quickly with the 
more extensive narrative to follow at a later date. To fadlhate this effort, particularly in 
the compilation of the data by the Member States, the questionnaire used for the 1989 
study, supplemented with questions of particular relevance to the pbannaceiitical industry, 
was considered as the most appropriate way of obtaining the relevant data. 
Conclusion 
Recognizing the benefits that will accrue from having up-to-date mformation with 
regard to self-sufficiency and building on the experiences from the 1989 study, 
mechanisms should be put in place for the regular updating of the study and the 
timely dissemination of the results. To facilitate this effort, Member States should 
set up appropriate systems to improve their data collection. 
4.3 Character of Blood and Plasma Donations 
In keeping with Directive 89/381/EEC, mere is general consensus that blood donations 
should be neither induced nor rewarded either in kind or monetary terms. This tenet is 
adhered to strictly in some Member States but not in others. Although a significant amount 
of blood and plasma is donated free-of-charge and material benefits in the form of 
payments in cash or in kind, or other services, are not normally provided nor are they 
considered desirable, incentives to encourage blood and plasma donations do prevail. These 
incentives range from the provision of small refreshments, certificates or little grants, to 
compensation for transportation costs, to days off work for public service employees in one 
Member State and for all employees in another. One Member State provides an "expense 
allowance" on a flat rate basts to compensate donors for loss of earnings due to time off 
work to give blood, costs incurred in travelling to and from the donor centre, and 
subsistence expenses, although this "allowance" is not intended to be a financial incentive 
to give blood. In another, a fee is paid to a donor organization for blood donor recruitment 
publicity. While it is acknowledged that some gray areas exist in which compensation 
would be deemed acceptable, such as in the case of a donor with a rare blood type who 
must travel long distances to give me donation, this should be the exception rallier man the 
rule. 
Although the pharmaceutical industry currently provides compensation for blood and 
plasma, Directive 89/381/EEC stipulates mat it is the responsibility of the individual 
Member States to develop the production and use of products derived from human blood or 
human plasma coming from voluntary unpaid donations. 
Conclusion 
The principle of voluntary and unpaid blood donations has been endorsed and is 
being supported by all Member States. In practice, however, mis prinrinle is not 
strictly adhered to in all of mem; those which tolerate lax attitudes in this respect 
should take measures necessary to eliminate practices which undermine tins 
principle. 
4.4 Blood Donors/ Plasmapheresis 
An important actor in the effort to achieve self-sufficiency is the availability of sufficient 
resources. How best to ensure this is still the subject of discussion. Developing and 
expanding plasmapheresis programmes, which is viewed by at least one Member State as 
the only way of achieving self-sufficiency, has been promoted in some countries to cover 
the need for plasma products. In some cases this is being done in cooperation with blood 
donor services and the pharmaceutical industry. The idea that plasmapheresis should be 
stepped up only if supplies of whole blood donations are insufficient to meet requirements, 
however, was disputed on the grounds mat plasma from plasmapheresis is superior to 
plasma from whole-blood donations and better tor further processing. In any event, the 
difference between the recommended limit on the amount of plasma collected from each 
donor per year, as cited in the Van Aken report (15 litres) and the figure quoted in the 
guidelines of the Medical Council of the Federal Republic of Germany (25 litres) needs to 
be clarified. 
Efforts are underway in one Member State to increase the amount of plasma recovered 
from whole blood, which can be a cheaper method of obtaining material for fractionation. 
Nevertheless, support was given in the Member States to continuing efforts in recruiting 
and retaining donors, both at regional and national levels, and encouraging cooperation 
between the bodies involved in recruiting donors i.e. blood banks and the Red Cross. 
Conclusion 
Consideration should be given to developing, at an appropriate stage, a basic set of 
principles at Community level to be used in public awareness campaigns about the 
need for blood donations and to motivate people to become voluntary unpaid 
donors, with the methodology to be the object of further deliberations. 
4.5 Optimal Use of Blood and Blood Derivatives 
In striving towards the goal of Community self-sufficiency, it is important to minimize the 
discrepancies between the actual needs for blood and blood products and the available 
resources. Promoting the optimal use of blood and its derivatives is seen as an important 
way of achieving this. The provision of information to hospitals and clinics, the 
introduction of reporting procedures to record the use of whole blood and plasma, and 
inter-institutional comparison of the medical indications on whose basis given blood 
products are administered, were suggested. The introduction of medical audit to the 
National Health Service in the United Kingdom, to promote the optimal use of blood 
derivatives, and the establishment of a Blood Product Committee under the National Health 
Committee in Denmark, to facilitate discussions between users and producers as well as 
administrators from national health services and hospitals, are two initiatives already 
underway. 
In addition, the importance of informing clinicians about the optimal use of blood and 
blood products and the role of transfusion physicians in this regard was highlighted. 
Expanding the knowledge of physicians in this area through the development of an 
appropriate training programme was sought by the Member States. 
Rationalization of treatment of patients within the European Community, which will come 
about as a result of the marketing authorizations for medicinal products derived from 
blood, will help to ensure the optimal use of blood and plasma. The adoption by the CPMP 
of harmonized summaries of product characteristics, with therapeutic indications and 
posologies, for the 20 main plasma derivatives, is also a valuable contribution towards 
optimal use. 
Conclusion 
To encourage the optimal use of blood and blood products throughout the Member 
States, mechanisms should be introduced to extend the knowledge of clinicians and 
pertinent laboratory personnel related to transfusion medicine. 
11 
4.6 Quality and Safety of Blood Products 
Ensuring the quality and safety of blood and blood products is of major concern to the 
Member States. With the implementation of Directive 89/381/EEC, however, medicinal 
products derived from blood and plasma will be granted a marketing authorization only if 
their quality, safety and efficacy is acceptable. One Member State emphasized that it 
considers blood as a medicinal product within the meaning of the law governing medicines, 
and therefore subject to statutory quality and safety requirements. 
Considering that the risks to blood supplies may not be the same in all countries, some 
Member States considered that requirements for identical tests to be carried out throughout 
the Community were not appropriate. While certain threats are common to all blood 
supplies, such as HIV, others are not, and the view was expressed that flexibility should be 
maintained in keeping with Council of Europe guidelines which allow for national 
variations in such matters as the tests to be applied to blood donations. 
To ensure, however, that differences in the detailed screening tests carried out in the 
Member States did not become an obstacle to the free circulation of medicinal products, the 
CPMP adopted the note for guidance on Medicinal Products Derived from Human Blood or 
Plasma^*), which lays down harmonized tests on source material. Moreover, the European 
Pharmacopoeia (Council of Europe) recently adopted a monograph which lays down 
screening tests for plasma used as a starting material for the manufacture of blood 
products^10). 
Regulations governing blood donations, which provide the necessary public health 
safeguards concerning donors' individual health, such as screening to detect diseases 
transmissible by blood or plasma, such as hepatitis B, hepatitis C, and AIDS, have already 
entered into force in the Member States. 
Conclusion 
The measures that have been implemented within the Community to ensure the 
quality, safety and efficacy of blood and plasma derivatives and the guidelines that 
have been developed by the Council of Europe for the screening of blood supplies 
should help to reassure patients and doctors alike with regard to the quality 
assurance of blood and blood products. 
4.7 Information Exchange 
With the opening of the internal market, the sharing of experience and the regular exchange 
of information is considered to be an important and welcome process and of significant 
value in clarifying misunderstandings, in finding common ground, and in identifying 
differences. A European data bank to compile this information could facilitate the 
monitoring of progress towards self-sufficiency and the changing policies and practices in 
the use of blood, blood components, and medicinal products. 
9. Rules Governing Medicinal Products in the European Community. Guidelines on 
the Quality, Safety and Efficacy of Medicinal Products for Human Use. Volume 
III. Addendum 2. CEC. May 1992. p. 101. 
10. Human Plasma for Fractionation. Council of Europe. 4p. 1993. Unpublished. 
12 
Although such a data bank would not solve the problem of European self-sufficiency, it 
would facilitate better analysis and monitoring of developments towards it. Rather than 
create a new central data bank, however, it was thought to be more effective to utilize an 
already existing facility and to explore ways of expanding its role. To ensure that the 
collection of data did not create difficulties and cause undue expense, consideration should 
be given as to how best to ensure that only useful data would be collected and to explore 
further what type of information should be stored and updated m order to respond to the 
needs of the Member States. 
A comparative study commissioned by Germany on procedures in Sweden; the 
Netherlands, the United Kingdom, and Germany could serve as a basis for identifying the 
type of information to be collected. The results of this study will be available upon its 
conmletion in 1993. 
Conclusion 
Consideration should be given to the development and implementation of 
mechanisms to facilitate the sharing of experience and the exchange of information 
to respond to the needs of Member States. 
5. ACTIONS FOR CONSIDERATION 
In view of the continuing concern among the Member States about the quality, safety and 
supply of human blood and blood products, and taking into account the recommendations 
from die Van Aken report, the comments from the Member States, and the conclusions 
reached regarding the issues raised, die Community could consider undertaking the 
following actions in its efforts to promote self-sufficiency in human blood or human plasma 
through voluntary unpaid donations. 
Reinforcing the importance of the goal of self-sufficiency in blood and blood 
products at Community level while taking mto acccmit me progress achieved 
in the availability of substitute medicinal products. 
Assessing the knowledge, attitudes and behaviour of the general public and 
specific target groups in the Member States regarding voluntary unpaid 
blood donations, developing a bask set of principles at Community level to 
create public awareness about die need for Mood donations, and fostering 
programmes to motivate people to become donors. 
Gathering information on the various tyr^ of remuner^on or rewards gw 
to blood donors. 
Encouraging the optimal use of medicinal products derived from human 
blood and plasma and extending the knowledge of physicians involved in 
transfusion medicine through the development of information programmes. 
Promoting quality assurance of blood collection in all Member States 
through adherence to the guidelines developed by the Council of Europe. 
\ 
V 
>l Updating the report on self-sufficiency in the Community, using a revised 
questionnaire to include data from industry, and putting in place mechanisms 
tor this to be done biannualIy. 
Facilitating the exchange among the Member States of experiences acquired 
in the Member States or elsewhere on blood donation campaigns and 
programmes and promoting discussions between the producers and the users 
of blood products. 
Assisting Member States to improve their data collection systems so as to 
facilitate the analysis and monitoring of developments towards self-
sufficiency, and facilitating the sharing of this data through cooperative 
arrangements. 
ISSN 0254-1475 
COM (93) 198 final 
DOCUMENTS 
EN os 
Catalogue number : CB-CO-93-224-EN-C 
ISBN 92-77-55673-0 
Office for Official Publications of the European Communities 
L-2985 Luxembourg