COMMISSION OF THE EUROPEAN COMMUNITIES 
COM (89) 532 final - SYN 146 
Brussels, 13 November 1989 
MODIFIED PROPOSAL FOR A COUNCIL DECISION 
Adopting a specific research and technological development programme 
in the field of health: 
Human Genome Analysis: (1990-19S1) 
(Presented by the Comrussion in accordance with 
Article 149, paragraph 3 of the EEC Treaty) 
* 
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Explanatory Memorandum 
A. The first reading of the "Proposal for a Council Decision adopting a 
specific research programme in the field of health: Predictive Medicine: 
Human Genome Analysis (1989 - 1991)"(*) was carried out by the European 
Parliament during the part-session from 13 - 17 February 1989. 
The essential message of the 38 amendnents adopted by the Parliament is as 
follows: "The technical content of the research programme proposed by the 
Commission is justified, but care must be taken to see that individual 
rights are protected and respected while it is being carried out. 
Furthermore, it is essential to guarantee that throughout the programme 
the ethical, social and legal problems which may arise out of applications 
of ever more precise knowledge of the human genome are examined and 
debated. This debate should also identify the limits beyond which such 
applications would become unacceptable by society". 
B. The expression "Predictive Medicine" is no longer used in the title of the 
programme. It has reverted to "Human Genome Analysis", which corresponds 
to reality since the main aim is to increase our knowledge of human 
genetics. However, it is possible that this type of research, which will 
certainly lead to improvements in the treatment of patients suffering from 
certain diseases of genetic origin, will also lead subsequently to 
applications in predictive medicine. But the social acceptability of such 
applications must first be carefully evaluated. 
The modified proposal is drafted in such a way as to guarantee the respect 
both of rules accepted by or acceptable to our democratic society and of 
the integrity and dignity of the person, not only while the programme is 
running but also in its medium- and long-term consequences. 
The clear affirmation of the respect for the integrity and dignity of the 
person has consequences of which several aspects are defined in the 
modified proposal. The consequences both for the individual and for 
society of the application of the results obtained by research on the 
human genome must be analysed at the same time as the research is being 
(*) COM(88) 424 final, 20 July 1988 
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carried out. Possible abuses must be identified, as must, where 
appropriate, recommended national or Community legislative measures. This 
task will be carried out by the Commission assisted by a high-level 
committee which it will set up for this purpose, representing different 
areas of science, law, philosophy and ethics, together with 
representatives of patients* associations. 
The term "eugenics" which is contained in amendment no. 10 lacks 
precision. For this reason it is not used directly in the proposal. The 
approach described above guarantees the exclusion from the programme of 
any tendency towards a type of eugenics which would involve the 
"selection" of the human species by genetic means. This guarantee is 
further strengthened by the explicit exclusion of all research seeking to 
modify human genetic heritage by the alteration of germ cells, in 
accordance with Parliament's request (amendments nos. 21 and 33). But the 
modified proposal goes further: it excludes all intervention at any stage 
in the development of the embryo which might lead to hereditary changes. 
This technical possibility is indeed conceivable, and it must be rejected. 
Protection is guaranteed of the confidentiality of information gained 
during the research and of the anonymity of those concerned. 
The prenormative nature of the scientific data acquired, to be available 
to legislative authorities in particular, is highlighted. 
Lastly, progress reports on the research and on studies of ethical, social 
and legal problems will be submitted annually to the Council and the 
European Parliament, and measures will be taken to keep the public fully 
informed of the Community action. 
C. As far as the European Parliament*s amendments are concerned: 
- amendnents Nos. 1, 3, 4, 7, 11, 12, 16, 17, 21, 22, 23, 28, 32, 33, 35 
and 36 have been incorporated in the modified proposal. Amendnents 21 
and 33 have been supplemented to clarify the exclusion of all work 
seeking to "select" the human species. 
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the intentions expressed in amendments nos. 5, 6, 8, 9, 10, 13, 20, 25, 
26 and 41 are incorporated in the modified proposal in different terms, 
sometimes regrouped or at places in the text other than those foreseen 
in the amendments. 
amendments nos. 14, 15, 18, 19, 24, 27, 29, 30, 31, 34, 39 and 44 
(budgetary amendment) are not incorporated in the proposal. However, 
the modified proposal expresses the ideas contained in some of these 
amendments, especially nos. 14, 15, 18, 19, 27, 29, 30 and 39. 
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MODIFIED PROPOSAL FOR A COUNCIL DECISION 
Adopting a specific research and technological development programme 
in the field of health: 
Human Genome Analysis: (1990-1991) 
(Presented by the Commission in accordance with 
Article 149, paragraph 3 of the EEC Treaty) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES 
Having regard to the Treaty establishing the European Economic Community, and 
in particular to Article 130 Q (2) thereof, 
Having regard to the proposal from the Commission(*), 
In cooperation with the European Parliament(2), 
Having regard to the opinion of the Economic and Social Committee^), 
Whereas Article 130 K of the Treaty stipulates that the framework programme 
shall be implemented through specific programmes developed within each 
activity; 
Whereas by its Decision of 28 September 1987(4) the Council has adopted a 
framework programme of Community research and technological development 
(1987-1991), in which it provided for activities to be undertaken in the 
field of healthj 
h OJ H* 
2) OJ N° 
3) OJ N° C 56/47, 6.3.1989 
4) OJ N° L 302, 24.10.87, p. 1 
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Whereas, for the evaluation of each specific programme and the selection of 
Community actions, the framework programme sets out criteria among which is 
that of contributing to the strengthening of the economic and social 
cohesion of the Community, consistent with the pursuit of scientific and 
technical quality; 
Whereas two successive pluriannual programmes of research and training of the 
European Economic Coniminity in the field of biotechnologies(5), of which the 
second is still in progress, have shown the possibility and usefulness of a 
Cormunity action promoting the utilization of modern biology for scientific 
and industrial purposes; 
Whoreas the framework programme has foreseen in its activity "Quality of 
life" under the "Health" line 1.1, the initiation of new activities relating 
to the development of knowledge of the human genome; 
Whereas a specific programme to study the human genome is therefore necessary 
and, in particular, it is necessary to: 
develop and spread the basic technologies concerning the study of the 
human genome, with the intention of improving knowledge of matters of 
medical importance, 
improve the resolution of the human genetic map and to refine the 
physical map by the creation of ordered clone libraries, as a basis for 
locating genes of medical importance and for a better general 
understanding of gene function, and 
organise networks and coordination, on a European and international 
scale, of researchers from all disciplines working in this field; 
Whereas the carrying out of the above-mentioned goals requires the 
undertaking at Community level of actions aiming at: 
filling some existing gaps in scientific and technological knowledge, and 
encouraging cooperation between European research institutions with a 
view to furthering the development of existing technologies while 
5) OJ N° L 375, 20.12.1981, p. 1; OJ N° L 83, 25.3.1985, p. 1 
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promoting all research sectors capable of generating new lines of 
research; 
Whereas, simultaneously, measures will be taken to promote cooperation 
between the Community programme and similar ones developed in non-Member 
States or by international organizations; 
Whereas the right to a genetic identity forms part of the integrity and the 
dignity of an individual, and this principle is recognized in the 
constitutions and laws of Member States and in the Community legal system as 
forming part of the fundamental rights for which respect is ensured; 
Whereas the results which can be achieved from human genome research require 
the development of an integrated approach taking into account ethical, social 
and legal aspects of their possible applications and the need to avoid any 
improper use of those results; 
Whereas there are good grounds for guaranteeing the right of an individual 
in complete possession of the facts to choose whether or not to be informed 
of his genetic characteristics; 
Whereas, in the absence of clear standards and provisions concerning possible 
developments in the field of genome analysis, there may be a risk on the one 
hand that attempts are made to intervene in the human genome in order to 
make the modifications so obtained hereditary, and on the other hand that 
genetic analyses are carried out for monitoring purposes which may have a 
profound effect on social life; whereas there are, accordingly, good grounds 
for taking the necessary steps to preclude unacceptable developments, 
particularly as regards predictive medicine; 
Vfoereas, furthermore, it is necessary to develop during the course of the 
programme the prenormative aspects arising from human genome analysis by 
establishing a reliable scientific data set which could provide a basis for 
political authorities to establish sound,, clear and responsible regulations; 
Whereas the Scientific and Technical ResearchCommittee (CREST) was consulted 
on the following measures, 
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HAS ADOPTED THIS DECISION: 
Article 1 
A specific research and technological development programme for the European 
Economic Community in the field of Human Genome Analysis, as defined in the 
Annex, is hereby adopted for a period of two years commencing on 1 January 
1990. 
Article 2 
The amount deemed necessary as the financial contribution from the Community 
for the execution of the programme is 15 million ECU, including costs of a 
staff of two persons. 
Article 3 
Detailed rules for the implementation of the programme are set out ia the*? 
Annex. 
Article 4 
1. The Commission shall send to the Council and to the European Parliament 
an annual report on the progress of the programme. 
2. In the second year of the programme implementation, the Commission shall 
undertake a review of the programme and it shall send the results of this 
review to the Council and to the European Parliament, together, if 
necessary, with any proposals for modification or prolongation of the 
programme. 
3. An evaluation of the results achieved shall be carried out by independent 
experts and published in the form of a communication to the Council and 
to the European Parliament. 
4. The above-mentioned reports shall be established taking account of the 
objectives and evaluation criteria set out in the Annex to this decision 
and in conformity with the provisions of Article 2, paragraph 2 of 
Decision 87/516/Euratom, EEC. 
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Article 5 
The Commission shall be responsible for the implementation of the programs. 
It shall be assisted in its execution by an advisory committee, hereinafter 
called "the committee", composed of representatives of Member States and 
chaired by a representative of the Commission. 
Article 6 
1. The Commission shall submit to the committee a draft of the measures to 
be taken. The conrtittee shall give its opinion within a period set by the 
chairman according to the urgency of the matter, decided by a vote if 
necessary. 
2. The opinion shall be recorded in the report of the meeting; moreover, 
each Member State shall have the right to have its own opinion recorded 
in the report. 
3. The Commission shall take due note of the opinion given by the committee. 
It shall inform the committee of the procedures through which that 
opinion was taken into consideration. 
Article 7 
The procedures laid down in Article 6 shall apply in particular to: 
the contents of the calls for proposals; 
the assessment of the proposed projects and the estimated amount of the 
Community's contribution to themj 
departures from the general rules governing Community participation set 
out in the Annex;, 
the participation in any project by non-Coramunity organizations and 
enterprises referred to in Article 8(2); 
the measures to be undertaken to evaluate the programme; 
arrangements for the dissemination, protection and exploitation of the 
results of research carried out under the programme. 
Article S 
1. The Commission is authorized, in conformity with Article 130 N of the EEC 
Treaty, to negotiate agreements with non-member States and international 
organizations, particularly with non-member States taking part in 
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European cooperation in the field of scientific and technical research 
(COST) and with countries which have concluded scientific and technical 
framework cooperation agreements with the Community, with a view to 
associating them fully or partially with the programme. 
2. VThere framework agreements for scientific and technical co-operation 
between European non-Member States and the European Communities have been 
concluded, organizations and enterprises established in those countries 
may, on the basis of the criterion of mutual benefit, become partners in 
a project undertaken within the programme. 
Article 9 
This Decision is addressed to the Member States. 
Done at , .....1989 
For the Council, 
The President 
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ANNEX 
for a specific research programme in the field of health: 
Human Genome Analysis 
1. OBJECTIVES 
Use and improvement of new biotechnologies in the study of the human genome 
for a better understanding of the mechanisms of genetic function, as well as 
the prevention and treatment of human diseases. In the pursuit of these 
objectives, optimal cooperation will be sought with the programmes of non-
member States and international organizations. 
At the same time measures will be taken to develop an integrated approach to 
the ethical, social and legal aspects of possible applications of results 
obtained through the programme to ensure that they are not misused and also, 
with prenormative aspects in mind, to establish a set of bioethical 
principles to be followed in the developments to come. 
Alteration of germ cells or any stage of embryo development with the aim of 
modifying human genetic characteristics in a hereditary manner is excluded 
from the programme objectives. 
2. TECHNICAL CONTENT 
Precompetitive Ccmnunity research, setting up and reinforcement of networks 
of European laboratories, and training, intended to allow the use of modern 
technologies for the study and setting up of the human genetic map as well as 
possible medical applications of the knowledge gained. 
The research described below will require the use of data-processing 
facilities for the handling of data, and the development of integrated 
databases to serve European networks. 
- 12 -
2.1 IMPROVEMENT OF THE HUMAN GENETIC MAP 
Establishment of a Europe-based network, extending worldwide, for the 
collection and mapping of the DNA of large families, in order to provide 
research scientists with well-characterized genetic material and sets of 
probes to determine the location of the relative positions of genes on the 
chromosomes. 
2.2 SETTING UP OF ORDERED CLONE LIBRARIES OF HUMAN DNA 
Setting up of a European network of laboratories working on establishing 
overlapping clone libraries, and support for limited sequencing of cDNA. 
2.3 IMPROVEMENT OF THE METHODS AND BASIS FOR THE STUDY OF THE HUMAN GENOME 
New biochemical reagents (restriction enzymes, etc.). Improvement of methods 
for the detection and localization of genetic markers (techniques for 
labelling DNA probes, amplification of genes, etc.). Development of new 
vectors for the cloning of large DNA fragments and of procedures for the 
transfection of chromosomes. Development of model systems for the 
reproducible and stable expression of medically important genes both in vivo 
and in vitro aimed at the well-being of patients. Development of new 
computer software for the storage and manipulation of data from genome 
sequencing and mapping. 
2.4 TRAINING 
Setting up of a training programme to assist with the technology transfer of 
molecular genetics methods, in particular to Member States in which these 
techniques are currently underdeveloped. 
3. BPU34ENTATION 
3.1 The programme shall be implemented through cost-shared or marginal cost 
contracts, support to centralized facilities and networks, training 
contracts, training grants, courses, consultations with national experts, 
organization of study-group meetings, participation in seminars and 
symposia, publications, studies, dissemination of results to all 
interested groups, and organization of public presentations. 
- 13 -
Community participation will be up to a maximum of 50% in the case of 
cost-shared contracts and could reach 100% in other cases. 
Participants may be research institutions, universities, private 
enterprises, or combinations of them, located in Member States or in the 
non-member States referred to in Article 7, or competent organizations in 
a position to make a significant contribution. 
Projects must be carried out by participants from more than one country, 
and include at least one participant from one Member State. 
Fellows coming from non-^nember States will be accepted in the training 
programme, provided that they meet the required conditions and that their 
costs are covered from other sources, such as other Community programmes 
or actions which support fellows coming from developing countries. 
The contracts concluded by the Commission will govern the rights and the 
obligations of each party, in particular the means of distribution, 
protection and exploitation of the results of the research. 
3.2 The drawing up of research contracts can only take place if the 
contracting parties undertake to abstain from all research seeking to 
modify the genetic constitution of human beings by alteration of germ 
cells or of any stage of embryo development which may make these 
alterations hereditary. 
The contracts shall regulate the granting of licences arising out of 
research projects and in particular there shall be no right to exploit on 
an exclusive basis any property rights in respect of human DNA. In 
addition, the Commission shall reserve the right to publish the results 
of the research performed within the scope of the contracts. 
The contracts will guarantee that the members of the families 
participating in the studies referred to in paragraph 2.1 above will be 
fully informed about and have consented to the use and study of their 
DNA. The contracts will also guarantee complete protection of the 
confidentiality and anonymity of the personal data, obtained in the 
programme. 
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3.3 The Commission will ensure that during the execution of the programme 
there will be wide-ranging and in-depth discussions of the ethical, 
social and legal aspects of human genome analysis and that possible 
misuses will be identified regarding applications of the results obtained 
or of future developments of that research. It will ensure that the far-
reaching consequences of the research will be evaluated in a responsible 
manner, and will submit to the Council and to the European Parliament an 
annual report, possibly with legislative recommendations arising as much 
from the research policy angle as frcm the legal one. To this end, the 
Commission will obtain advice from experts in different fields of 
science, law, philosophy and ethics, together with representatives of 
patients1 associations. 
4. EVALUATION CRITERIA 
The Communication from the Commission to the Council relating to the 
evaluation of Community research and development programmes(°) states that 
the objectives and milestones for each research programme have to be set out 
in verifiable and, where possible, quantitative form. These reference marks 
are listed below: 
4.1 The long-term objective of this programme is to contribute to a better 
understanding of the mechanisms of genetic function as well as to the 
fight against human diseases arising from genetic variation (including 
genetic diseases sensu stricto and many common diseases with a genetic 
component, such as heart disease and cancer), through early diagnosis, 
prevention, and improvement of prognosis and therapy. The Commission 
proposes to achieve this objective by: 
- the management of networks of laboratories set up around European 
facilities for (a) the improvement of the human genetic map and (b) the 
setting up of ordered clone libraries of human DNA, either of the 
complete genome or of selected chromosomes, together with cDNA 
sequencing; 
6) OJ N° C 14, 20.1.87, p. 5 
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- the launching of a programme of precompetitive research aiming at 
improvement of the methods and basis for the study of the human genome; 
- the setting up of a programme of training to increase the distribution 
of modern genetic technologies in Europe, and to improve technological 
know-how in European laboratories; 
- the promotion of cooperation with non-member States and international 
organizations. 
4.2 The primary short-term objective is that the programme should succeed in 
establishing the above-mentioned European networks of laboratories in the 
fields of: 
- the human genetic map 
- ordered clone libraries of human DNA and cDNA sequencing 
- improvement of the methods and basis for the study of the human genome, 
all using data-processing facilities for data-handling and developing 
integrated data bases. 
These objectives should be verifiable in 1991. 
4.3 Particular objectives to be attained within two years of the programme 
implementation are as follows: 
4.3.1 Concerning the human genetic map: 
- the present total of 40 well-studied large families which form the 
basis for the genetic map should be increased to 60 families; 
- genetic material frem these families, and DNA probes, should be made 
available to the European laboratories concerned while respecting the 
individual rights of those families; 
- a central facility should be identified to pool the results and 
establish an improved genetic map at the 1 to 5" centimorgan level, 
and an integrated databank should be set up. 
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4.3.2 The strategies for setting up ordered clone libraries of human DNA 
should be compared and a better approach defined; facilities for 
maintaining the stocks of cloned DNA fragments should be established, 
and the available clones dispatched to interested European 
labofa" tories. 
4.3.3 Substantial improvements should be obtained in the following research 
fields to improve the methods and the basis for the study of the human 
genome: 
- New reagents, such as restriction enzymes, 
- Methodology for cloning large DNA fragments and for the transfection of 
chromosomes, 
- Gene vectors adapted to human somatic cells in vitro, 
- Ifethodology for the detection of a particular gene in a cell, 
- Localization, cloning and sequencing of new genps, especially those 
which are disease-related, 
- New computer software for the storage, collation and analysis of DNA 
sequence data. 
4.4 In addition, the programme should ensure that the following general 
criteria are met: 
4.4.1 That throughout the execution of the programme, the ethical, social and 
legal aspects of human genome analysis should be the subject of wide-
ranging and in-depth discussions, and possible abuses of the results or 
later developments of the work should be identified; principles for 
their utilization and control should be proposed. 
4.4.2 That the drawing up of research contracts shall presuppose that the 
contracting parties undertake to abstain from all research seeking to 
nodify the genetic constitution of human beings by alteration of germ 
cells or of any stage of embryo development which may make these 
alterations hereditary. 
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4.4.3 The members of the families taking part in the studies mentioned in 
paragraph 2.1 must have been informed and given their consent, and the 
confidentiality and anonymity of personal data must be ensured. 
4.4.4 That the development and the application of somatic gene therapy are 
not provided for within the framework of the present programme. 
4.4.5 That actual or potential medical applications should be facilitated. 
4.4.6 That potential opportunities for commercial developments should be 
obtained. 
4.4.7 That the overall technological standard of the participating European 
laboratories must have been improved. 
4.4.8 That taking account of the results of Community, national or commercial 
research activities in human genetics, the evaluation panel should 
consider whether the human genome analysis has contributed to the 
development of the results of the said activities in regions of the 
Community other than those in which the research was conducted. The 
evaluation panel should also ascertain whether cooperation with non-
member States and international organizations has indeed been achieved 
and whether this cooperation has had positive results. 
• -AS-
FICHE FINANCIERE 
PROGRAMME ANALYSE PU CENOME HUMAIN 
Les points 1 à 4 de la fiche financière originale de la proposition 
COH<88)424 restent inchangés. 
5. INCIDENCE FINANCIERE PE L'ACTION SUR LES CREP1TS D'INTERVENTION 
(Y conprls les dépenses de personnel (l agent de catégorie A, 1 
agent de catégorie C) et les dépenses de fonctionnement 
administratif et technique). 
5.1. Çoftt tOtll MmUlU tPUtt 11 dUTéi «lYllMto ^ »i° Ecus 
5.2. Part dans la financement 
• du budget communautaire 15 Mio Ecus 
- des budgets nationaux et ) 
- d'autres secteurs au )...... 15 Mio Ecus 
niveau national ) 
5.3. Echéancier plurlannuel du budget cosmunautalre 
5.3.1. Crédits d'engagement en Millions d'Ecua 
looo» îooi TSiïâL 
0,42 
0,45 14,13 
Total 12,5 2,5 15,00 
5.3.2. Crédita de paiement en Million* d'Ecua 
1000» 1001 1002 1993 IPJAL 
Personnel 0,21 
Fonctionnement 0,20 
Contrats et bourses 3,79 
Total 4,2 6,0 3,10 1,70 15,00 
* Ces montants figurent à 1*APB 90 - Ht sont aujeti à modification 
au cours de la procédure budgétgalre en cours. Personnel 0,21 0.21 
Fonctionnement 0,20 0,25 
Contrats et bourses 12,09 2,04 
0,21 
0,25 
5,54 • 
-
3,10 * 
-
1,70 0,42 
0,43 
14,13 
ISSN 0254-1475 
COM(89) 532 final 
DOCUMENTS 
EN 05 
Catalogue number : CB-CO-89-485-EN-C 
ISBN 92-77-54138-5 
Office for Official Publications of the European Communities 
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