18. 2. 91 Official Journal of the European Communities No C 41/1 
II 
(Preparatory Acts) 
ECONOMIC AND SOCIAL COMMITTEE 
Opinion on the proposal for a Council Decision adopting a specific research and technological 
development (R&TD) programme in the field of biomedicine and health (1990-1994) (*) 
(91/C 41/01) 
On 6 June 1990 the Council decided to consult the Economic and Social Committee, under 
Article 130 Q of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The Section for Protection of the Environment, Public Health and Consumer Affairs, which 
was responsible for preparing the Committee's work on the subject, adopted its Opinion on 
30 October 1990. The Rapporteur was Mr Colombo. 
At its 281st plenary session (meeting of 20 November 1990), the Economic and Social 
Committee unanimously adopted the following Opinion. 
1. Foreword 
1.1. The Committee endorses the general approach 
and content of the new research and technological 
development (R&TD) programme on biomedicine and 
health. The programme forms part of the third frame­
work programme of Community activities in the field of 
R&TD (1990-1994) (2), particularly the section dealing 
with life sciences and technologies. 
1.2. The biomedicine and health programme con­
tinues the work begun in the previous research and 
development (R&TD) programmes in the medical and 
health research sector, and in the programme on human 
genome analysis which was adopted in June 1990 after 
a long and controversial debate. 
2. Earlier work 
2.1. EEC involvement in the field of medical and 
health research dates back to the adoption of the first 
three-year programme in 1978. This contained three 
projects with a budget of 1,09 million ECU. The fourth 
(!) OJ No C 174, 16. 7. 1990, p. 65. 
(2) OJ No L 117, 8. 5. 1990, p. 28, ESC Opinion in OJ No C 56, 
7. 3. 1990. programme (1987-1991) (3) has a budget of 65 million 
ECU and includes 140 projects grouped as follows: 
Sub-programme I: major health problems 
— cancer, 
— AIDS, 
— age-related health problems, 
— environment and life-style related health problems 
(breakdown in human adaptation, nutrition, con­
sumption of illicit drugs, infections). 
Sub-programme II: health resources 
— medical technology development, 
— health services research. 
2.2. The programme is flanked by the human 
genome analysis programme which has been allocated 
15 million ECU for the years 1989-1990 (4). The Com­
mission is to be helped in the implementation of the 
latter by an ad hoc advisory committee and by a com­
mittee of leading figures from different fields of science, 
law, philosophy and ethics, as well as representatives 
(3) OJ No L 334, 24. 11. 1987, p. 20. 
(4) Doc. COM(90) 251 final — SYN 146. 
No C 41/2 Official Journal of the European Communities 18. 2. 91 
of patients' associations. The ESC Opinion (x) on this 
programme laid particular stress on the need for such 
machinery to assess the ethical and social implications 
of research in this area, and the need for precise contrac­
tual constraints (exclusion of modifications to germ-
cells or embryo-cells, protection of anonymity, etc.). 
2.3. The Committee is pleased that its request to be 
sent the reports assessing the programme has been met 
in the final Council Decision. 
3. Content and implementing arrangements of the new 
programme 
3.1. In accordance with the breakdown of resources 
stipulated in the framework programme, the biomedi-
cine programme is to receive 133 million ECU; 1,33 
million of this is to be allocated to centralized action 
for the dissemination and exploitation of results. 
3.2. The research areas have been redefined, and 
there are some important innovations. 
3.3. The first area is harmonization of methodolo­
gies and protocols in epidemiological, biological and 
clinical research. This extends sub-programme II of the 
previous programme, with the inclusion of drug testing 
and screening for risk factors, especially in the context 
of occupational health. 
3.4. The second area — application to diseases of 
great socio-economic impact — continues the work on 
AIDS, cancer, and age-related health problems. Two 
new topics are included: cardiovascular disease and 
mental and neurological disorders. 
3.5. The third area continues the human genome 
analysis programme. Emphasis is put on medical appli­
cations which contribute to the well-being of patients. 
3.6. Annex II gives an indicative breakdown of 
expenditure for the three areas, without giving details. 
3.7. Research on environment and life-style related 
health problems, begun in the previous programme, 
is no longer mentioned specifically. According to the 
Commission, these areas will be covered by other separ­
ate programmes, such as the fifth medical research 
(J) OJ No C 56, 6. 3. 1989, p. 47. programme run by DG V and the environmental R&D 
programme which includes epidemiological research. 
3.8. Specific reference could usefully be made to 
coordination with other public health programmes such 
as 'Europe against cancer', where the biomedicine pro­
gramme is responsible for research. 
3.9. Annex III covers the implementation of research 
projects by means of shared-cost contracts, accompany­
ing measures and concerted actions. According to the 
Commission, concerted actions are to remain the main 
instrument as they have a multiplier effect when funding 
is limited (25x according to the Commission's estimates 
on the basis of past experience). However, investment 
is to be increased in common structures (centralized 
services), for which the Community is to provide 100% 
financing. Shared-cost activities are also to be integrated 
into the existing research networks. 
4. General Comments 
4.1. The Committee notes that the procedures and 
rules laid down in the body of the proposal largely 
follow the new approach of the third framework pro­
gramme and are common to all the specific pro­
grammes. 
The Committee realizes that there was a need for 
rationalization and coordination. However, it is con­
cerned that the results and organizational know-how 
gleaned from the preceding programmes should not be 
jeopardized or lost. 
4.2. The Committee therefore urges that special 
attention be paid to achieving a smooth transition from 
the existing to the new programmes, making full use 
of the experience gained. 
4.3. The Committee deplores the fact that the assess­
ment report on the previous programme was not 
published until after the presentation of the new pro­
gramme, and is manifestly incomplete as it only con­
tains partial data on results. This is clearly not the best 
way to relaunch Community research in this sector. 
4.4. The Committee asks to participate fully in the 
review of the programme scheduled in Article 5, and 
to receive the report mentioned in Article 5(2), which is 
at present only to be sent to the Council and Parliament. 
18. 2. 91 Official Journal of the European Communities No C 41/3 
4.5. Articles 6 and 7 provide for a committee to assist 
the Commission under procedure Ilia. The Committee 
is concerned that abandoning the advisory committee 
procedure could create problems as regards the admin­
istrative continuity of the programme, and is adamant 
that the new procedure must meet the special require­
ments of the human-genome analysis programme — 
where ethical and social considerations come into play. 
4.6. The Committee stresses the special features of 
the new programme, which does not simply aim to 
make European research competitive; its intrinsic aim 
is to improve the quality of human life and health, and 
it must combine the principle of subsidiarity with that 
of economic and social cohesion. 
4.7. It would however be useful to include pharma-
cobiological industrial research in the programme. This 
is an important link between university research and 
the final field of application, with valuable economic 
and social spin-off. Particular attention should be given 
to the need to involve small firms operating in this 
sector, and to provide them with adequate information. 
4.8. The Committee notes the tendency hitherto to 
give priority to concerted actions and liaison networks. 
However, coordination of researchers is merely a means 
to an end; it is not an end in itself. If tangible results 
are to be achieved, instruments must be strengthened, 
involving the best researchers wherever they are, and 
focusing on centres of excellence, with a view to an 
expansion of financing. 
4.9. The Committee notes that Community funding 
for biomedicine research will now have increased more 
than one hundred fold since the cautious start made by 
the pilot programmes in 1978. However, it is still mainly 
used to coordinate national activities, and is insufficient 
to secure a real joint leap forward. 
4.10. The Committee is concerned that the selection 
of research networks and project leaders should be 
subject to proper technical and scientific criteria. The 
Done at Brussels, 20 November 1990. use of the special procedure (sixth recital) is not entirely 
clear. 
Furthermore, the composition of the research networks 
must take account of the need to make the best use 
of existing potential. Third countries which can offer 
suitable skills should be involved where appropriate. 
5. Comments on scientific and technical content 
(Annex I) 
5.1. As regards the scientific content of the pro­
gramme, the Committee urges the Commission to abide 
by a largely preventive approach to health problems 
and research into the social and environmental causes 
of disease, forging appropriate links with other pro­
grammes. 
5.2. The Committee wonders why the Commission 
does not explicitly mention socio-economic and ethical 
considerations among its criteria for research, and has 
not included these areas in its areas of research (as it 
has in the R&D programmes on the environment and 
on biotechnology). The socio-economic and ethical 
implications of the present programme make develop­
ment of this research strand indispensable. 
5.3. The Committee stresses the need to adhere to 
the proposed breakdown. Research on diseases which 
are today particularly emotive should not detract from 
the study of cardiovascular diseases and age-related 
illnesses such as Alzheimer's disease; these too present 
serious medical and social problems. 
5.4. However, the Committee considers that the pro­
gramme should retain a somewhat flexible approach 
and might also include research not specifically 
mentioned in the proposal, provided that it ties in 
with the scientific areas covered and involves diseases 
affecting wide areas of the population and wide age 
groups (e.g. diabetes). 
5.5. The Committee calls for the closest possible 
coordination with other public health programmes, and 
with the AIM programme. 
The Chairman 
of the Economic and Social Committee 
Francois STAEDELIN