No C 27/6 Official Journal of the European Communities 2. 2. 89 
II 
(Preparatory Acts). 
COMMISSION 
Proposal for a Council Decision adopting a specific research programme in the field of health 
— Predictive medicine: Human genome analysis (1989 to 1991) 
COM(88) 424 final — SYN 146 
(Submitted by the Commission on 27 July 1988) 
(89/C 27/07) 
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, 
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 (') the 
Council has adopted a framework programme of 
Community research and technological development 
(1987 to 1991), in which it provided for activities to be 
undertaken in the field of health; 
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 
Community in the field of biotechnologies (2), of which 
the second is still in progress, have shown the possibility 
and usefulness of a Community action promoting the 
utilization of modern biology for scientific and industrial 
purposes; 
O OJ No L 302, 24. 10. 1987, p. 1. 
(2) OJ No L 375, 20. 12. 1981, p. 1; 
OJNoL83, 25. 3. 1985, p. 1. Whereas the biotechnology programme presently in 
progress does not include some fields of research 
important for human health and the quality of life, for 
the industrial development of biotechnologies with 
medical aims and for the control of the increase of social 
and health expenses; 
Whereas 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 predictive medicine'; 
Whereas, as a result, a specific research and techno­
logical development programme is necessary in the field 
of predictive medicine and, in particular, that it is 
necessary to: 
— develop the basic technologies concerning the study 
of the human genome, as a prerequisite to a large 
number of developments in biotechnology for health, 
and to ensure the distribution of these technologies 
widely in European laboratories, and 
— 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; 
Whereas the carrying out of the abovementioned goals 
require the undertaking at Community level of actions 
aiming at: 
— filling some existing gaps in scientific and 
technological knowledge, gaps which prevent the 
full development of the resources of modern 
biotechnologies in the medical field, and 
— promoting, through concerted actions between 
private and public laboratories, European trans­
national cooperation aimed at speeding up the 
implementation of technologies already available 
while promoting European scientific areas which will 
encourage new approaches to be developed; 
2. 2. 89 Official Journal of the European Communities No C 27/7 
Whereas the Scientific and Technical Research 
Committee (Crest) was consulted on the following 
measures, 
HAS ADOPTED THIS DECISION: 
Article 1 
A specific research and technological development 
programme for the European Economic Community in 
the field of predictive medicine: human genome analysis, 
as defined in the Annex, is hereby adopted for a period 
of three years commencing on 1 January 1989. 
Article 2 
The amount deemed necessary for the execution of the 
programme is ECU 15 million, including expenditure on 
a staff of two persons. 
Article 3 
Detailed rules for the implementation of the programme 
are set out in the Annex. 
Article 4 
1. In the second year of the programme implemen­
tation, the Commission shall undertake a review of the 
programme and it shall report to the Council and to the 
European Parliament on the results of this review, 
together, if necessary, with any proposals for modifi­
cation or prolongation. 
2. An evaluation of the results achieved shall be 
conducted by independent experts and shall be published 
in the form of a communication to the Council and to 
the European Parliament. 3. The abovementioned reports shall be established 
having regard to the objectives and evaluation criteria set 
out in the Annex to this Decision and in conformity with 
the provisions of Article 2 (2) of the framework 
programme. 
Article 5 
1. The Commission shall be responsible for the 
execution of the programme and shall be assisted in its 
implementation by the Management and Coordination 
Advisory Committee (CGC) on Medical and Health 
Research, set up by Decision 84/338/Euratom, ECSC, 
EEC ('). 
2. The contracts entered into by the Commission shall 
regulate the rights and obligations of each party, and in 
particular the methods of disseminating, protecting and 
exploiting the research results. 
Article 6 
In conformity with Article 130 N of the EEC Treaty, the 
Commission is authorized to negotiate agreements with 
non-member States and international organizations, 
particularly with non-member States taking part in 
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. 
Article 7 
This Decision is addressed to the Member States. 
(') OJ No L 177, 4. 7. 1984, p. 25. 
ANNEX 
for a specific research programme in the field of health — Predictive medicine: Human genome analysis 
1. OBJECTIVES 
Use and improvement of new biotechnologies for risk-forecasting, early diagnosis, prevention, prognosis 
and treatment of some human diseases, and for a better understanding of the mechanisms of heredity. 
2. CONTENT 
Precompetitive Community research, setting up and reinforcement of networks of European laboratories, 
and training intended to allow the use of modern biotechnologies for the improvement of risk-forecasting, 
early diagnosis, prevention, prognosis and treatment of some human diseases (in particular hereditary 
diseases and cancers). 
No C 27/8 Official Journal of the European Communities 2. 2. 89 
2.1. Improvement of the genetic map of man 
Establishment of a Europe-based network, with a worldwide extent, for the collection of the DNA of large 
families, in order to provide free of charge to research scientists well-characterized genetic material and a 
set of probes to determine the location of the relative positions of genes on the chromosomes. Possible 
provision of computer facilities to handle the data. 
2.2. Setting up of an ordered clone library of human DNA 
Setting up of a European network of laboratories working on establishing overlapping cloned libraries, and 
support for limited sequencing of cDNA. 
2.3. Research on the improvement of advanced genetic technologies 
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.). Devel­
opment 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. Development of new computer software for the collection and 
manipulation of data from genome sequencing and mapping. 
2.4. Training 
Setting up a training programme to assist with the technology transfer of molecular genetics methods to 
Member States in which these techniques are currently underdeveloped and, in particular, the transfer of 
techniques into the clinical field. 
3. IMPLEMENTATION 
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, and publications. 
The Commission participation may range from about 50 % in the case of cost-shared contracts and may 
reach 100 % in other cases. 
Participants may be research institutions, universities, private enterprises, or combinations of them, located 
in Member States or in the third countries referred to in Article 6. 
Projects must be carried out by participants from more than one country, and include at least one 
participant from one Member State. 
EVALUATION CRITERIA 
The Community plan of action relating to the evaluation of Community research and development 
programmes (') states that the milestones and objectives for each research programme have to be set out in 
verifiable and, where appropriate, quantitative form. These are listed below: 
1. The long-term objective of this programme is to contribute 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 forecasting the risk, early diagnosis, 
prevention, improvement of prognosis and, ultimately, therapy. The Commission proposes to achieve 
this objective by: 
— the management of a network 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, 
— the launching of a programme of precompetitive research contracts on advanced genetic tech­
nology, 
— the setting up of a programme of training to increase the distribution of modern genetic techno­
logies in Europe, and to improve technological know-how in European laboratories. 
(') OJ No C 14, 20. 1. 1987, p. 5. 
2. 2. 89 Official Journal of the European Communities No C 27/9 
2. The primary short-term objective is that the programme should succeed in establishing the abovemen-
tioned European networks of laboratories in the field of: 
— the human genetic map, 
— ordered clone libraries of human DNA and cDNA sequencing, 
— advanced genetic technologies. 
These objectives should be verifiable in 1990 to 1991. 
3. Particular objectives to be attained within three years of the programme implementation are as 
follows: 
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 from these families, and DNA probes, should be made available free of charge to 
interested European laboratories, 
— a central facility should be set up to pool the results and establish an improved genetic map at the 
1 to 5 centimorgan level. 
3.2. The strategies for setting up ordered clone libraries of human DNA should be compared and an 
approach defined; facilities for maintaining the stocks of cloned DNA fragments should be established 
and the available clones dispatched free of charge to interested European laboratories. 
3.3. Substantial improvements should be obtained in the following advanced genetic technologies: 
— new reagents, such as restriction enzymes, 
— methodology for cloning large DNA fragments and for the transfection of chromosomes, 
— gene vectors adapted to human cells in vitro, 
— methodology for the detection of a particular gene in a cell (examples: how to make the use of 
DNA probes and gene amplification easier), 
— localization, cloning and sequencing of new genes, especially those which are disease-related, 
— new computer software for the storage, collation and analysis of DNA sequence data. 
4. In addition, the programme should ensure that the following general criteria are met: 
4.1. That throughout the execution of the programme, the projects should have taken adequately into 
consideration the complex ethical aspects of human genetics, avoiding any manipulation of human 
germ cells, and any risk to the environment. 
4.2. That medical developments are actually or potentially facilitated by the results obtained. 
4.3. That potential opportunities for commercial developments are obtained. 
4.4. That the overall technological level of the participating European laboratories has been increased. 
4.5. Taking account of the results of Community, national or private sector research activities in human 
genetics, the evaluation panel shall consider whether the predictive medicine programme has 
contributed to the application of the results of the said activities in regions of the Community other 
than those in which the research was conducted.