No C 31/14 Official Journal of the European Communities 6. 2. 91 
—indeed more significant than the effect of the pro- its conclusions on these issues with consequent pro­
posed Regulation—and asks the Commission to give posals as soon as practicable. 
Done at Brussels, 18 October 1990. 
The Chairman 
of the Economic and Social Committee 
Francois STAEDELIN 
(91/C 31/04) 
Opinion on the proposal for a Council Decision adopting a specific research and technological 
development programme in the field of biotechnology (1990-1994) (x) 
On 6 June 1990 the Council decided to consult the Economic and Social Committee, under 
Article 130Q (2) of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The Section for Energy, Nuclear Questions and Research, which was responsible for preparing 
the Committee's work on the subject, adopted its Opinion on 7 September 1990. The 
Rapporteur was Mr De Tavernier. 
At its 280th plenary session (meeting of 18 October 1990) the Economic and Social Committee 
adopted the following Opinion unanimously 
The Committee welcomes the proposed programme 
and broadly approves the Commission proposal. At the 
same time, it would make the following observations 
and recommendations. 
1. Introduction 
1.1. Research strand A—Life sciences and technol­
ogies—of the framework programme of Community 
activities in the field of research and technological 
development (R&TD) (1990-1994) (2) provides for the 
adoption and implementation of a new specific R&TD 
programme in the field of biotechnology for the five 
year period from 1990 to 1994, for which a proposed 
allocation of 164 million ECU is to be provided from 
the Community budget. 
1.2. One percent of this sum is to be spent on the 
centralized dissemination and exploitation of the results 
of the specific and supplementary research programmes, 
as provided for in Article 4 of the 1990-1994 framework 
programme Decision. 
(*) OJ No C 174, 16. 7. 1990, p. 53. 
(2) OJ No L 117, 8. 5. 1990, p. 28. 1.3. Annex II [Point 4(A)] of the framework pro­
gramme Decision states that the objective of this pro­
gramme—the fourth of its kind after BEP(3), BAP(4) 
and BRIDGE (5)—'is to reinforce basic biological know­
ledge as the common and integrated foundation needed 
for applications in agriculture, industry, health, 
nutrition and the environment'. 
1.4. The following is a list of the sectors covered by 
the proposed programme together with an indicative 
percentage breakdown of the appropriations: 
Area 1: Molecular approaches 35-40 
— Protein structure and function, 
(3) Programme in the field of biomolecular engineering (1982-
1986) (OJ No L 375, 20. 12. 1981, p. 1, as amended by OJ 
No L 305, 8. 11. 1983, p. 11). 
(4) Research action programme in the field of biotechnology 
(1985-1989) (OJ No L 83, 23. 3. 1985, p. 1, as amended by 
OJ No 206, 30. 7. 1988, p. 38). 
(5) Specific R&TD programme in the field of biotechnology 
(1990-1994) (OJ No L 360, 9. 12. 1989, p. 32). 
6. 2. 91 Official Journal of the European Communities No C 31/15 
— Structure and function of genes, 
— Expression of genes. 
Area 2: Cellular and organism approaches 45-55 
— Cellular regeneration, reproduction and develop­
ment of living organisms, 
— Metabolism of animals, plants and microbes; essen­
tial physiological tracts, 
— Communication systems within living matter. 
Area 3: Ecology and population biology 10-15 
— Ecological implications of biotechnology, 
— Conservation of genetic resources. 
1.5. For the most part, the programme will take 
the form of shared-cost research contracts. Concerted 
actions and accompanying measures are also planned. 
2. Preliminary remarks 
2.1. The Committee notes that, with a view to 
greater consistency and transparency in the implemen­
tation and management of Community research, the 
Commission has adopted a single format for the specific 
R&TD programmes referred for Opinion, regardless 
of their scientific and technical objectives and content. 
2.2. Whilst sharing the Commission's concern in 
principle, the Committee feels that reducing draft 
Decisions to their lowest common denominator does 
nothing to facilitate the work of consultative bodies, 
far from it. This situation has made it necessary to 
rely on additional information, provided verbally or in 
writing by the Commission, which at least in part could 
well have figured in the draft Council Decision on the 
proposed new programme. 
2.3. The Committee also regrets that no mention is 
made under this approach of numerous original features 
of Community research into biotechnology, some of 
which are referred to in the present Opinion and which 
have generally made a significant contribution to the 
success of this research since 1982. 
3. Links between the proposed programme and the 
BRIDGE programme 
3.1. The proposed programme was due to run for 
five years from 1 January 1990. Whilst the delay in its 
adoption makes it unlikely that implementation will, 
in fact, commence before 1 January 1991, it should be remembered that the programme is intended to be 
executed in parallel with BRIDGE, which entered into 
force for four years (1990-1993) on 1 January 1990. 
3.2. This situation raises a number of questions con­
cerning, in particular, the scientific and technical con­
tent of the proposed new programme. The distinction 
between the research fields covered by the proposed 
new programme and those already covered by BRIDGE 
is not clear. 
3.3. Evaluation of the BRIDGE activities which will 
be expanded by the proposed new programme, and the 
new programme's new activities has been made better 
by additional information provided by the Commission 
while this Opinion was being drawn up. Since overlap­
ping and duplication cannot be automatically ruled 
out, this information should have been set out in an 
explanatory memorandum to the draft Decision on the 
proposed new programme. This explanatory memor­
andum should also have described the progress made 
in implementing the BRIDGE programme. 
3.4. The parallel implementation of the closely lin­
ked BRIDGE and new programmes will require appro­
priate management and coordination arrangements 
which will ensure that appropriations are used 
judiciously. For the same reason, it will be necessary to 
ensure close coordination of Community and national 
biotechnology research, and close coordination with 
other relevant Community programmes such as those 
on biomedicine, health and the environment. 
3.5. The Section welcomes the proposal that area 3 
(ecology and population biology) should include 
research into the ecological consequences of biotechno­
logy. 
This research will enhance the concerted measures of 
the BRIDGE programme concerned with monitoring 
biotechnology developments and their implications for 
the environment and society at large; it will thus meet 
the concern expressed in the Committee Opinion on 
the BRIDGE programme (*). 
4. Programme finance 
4.1. The Commission proposal provides for a 64 
million ECU increase in the biotechnology research 
budget by comparison with the BRIDGE programme. 
4.2. This increase would appear to be justified in 
view of the probable extension of the programme (see 
point 3.1 above), the vast scope for biotechnology 
(!) Opinion of 7 April 1989 (OJ No C 159, 26. 6. 1989, p. 26). 
No C 31/16 Official Journal of the European Communities 6. 2. 91 
research and the eagerness of scientific circles to partici­
pate in such programmes. In the latter connection, it 
should be noted—even if the figures must be treated 
cautiously—that the invitation to tender under the 
BRIDGE programme produced 1 884 proposals of 
which only 12 % were accepted. 
4.3. The Committee would point out, however, that 
the appropriation for programme activities in 1993 and 
1994 is subject to confirmation in the light of the 
'financial perspective' for 1993 and 1994, of the sum of 
3 200 million ECU deemed necessary for the framework 
programme in those two years (Article 1(4) of the 
Council Decision on the framework programme). 
4.4. The resultant financial uncertainty will do 
nothing to ensure the necessary continuity of research 
work. The rollover arrangements for the framework 
programme were adopted in order to accommodate this 
need for continuity. 
5. Programme implementation 
5.1. The Council Decision on the BRIDGE pro­
gramme provided for the implementation of the two 
following types of shared-cost research: 
— N projects, for the integration in adapted Com­
munity structures (European Laboratories Without 
Walls: EL WW) of research efforts in areas where 
the main bottlenecks result from gaps in basic 
knowledge. 
— T projects, for the removal, through a significant 
investment of skills and resources, of important 
bottlenecks resulting from structural and scale con­
straints. 
5.2. It was also stated that the Community contri­
bution to an N project was not to exceed 400 000 ECU 
per year, and that the contribution to a T project could 
vary between 1 and 3 million ECU per year. 
5.3. The Commission has provided assurances that 
N and T projects will be implemented under the pro­
posed new programme; however, the Committee feels 
that this should have been specified in the draft Decision 
on the ground that it is an innovative new departure 
which, according to its Opinion on the BRIDGE pro­
grammes i1), 'should help to introduce the flexibility necessary to ensure better matching of funds and avail­
able resources to Europe's biotechnological research 
needs'. 
5.4. The EL WW are, it will be remembered, open 
transnational associations comprising teams engaged in 
multi-disciplinary research on a specific objective. At 
present, there are more than thirty ELWW, grouping 
university laboratories, public and private research 
establishments and industrial undertakings. 
5.5. The group of experts responsible for evaluating 
the BAP programme identified the setting-up of the 
ELWW as one of its principal successes because of their 
contribution to the elimination of national frontiers 
between laboratories. The Committee itself welcomed 
this initiative and said it could be profitably extended 
to other programmes. It is a pity that this has still not 
been done. 
6. Participation of industry and the agricultural sector 
in the programme 
6.1. The Committee would emphasize that the active 
involvement of the industrial and agricultural sectors 
in the development of biotechnology potential is crucial 
to the success of Community research in this field. 
Moreover, in addition to their involvement in research 
projects, it regards the establishment of close cooper­
ation with these sectors during project implementation 
as indispensable for the elaboration and subsequent 
commercial exploitation of the results obtained. 
6.2. In this connection, the Committee would draw 
attention to its Opinions on the review of the BAP 
programme(2) and the BRIDGE programmed). 
6.3. The Committee has repeatedly emphasized the 
difficulties which face small and medium-sized (SME) 
enterprises wishing to participate in the Community 
research programmes, including the biotechnology pro­
gramme, and has issued numerous clear-cut proposals 
for remedies. 
6.4. The Committee is aware that very few small 
and medium-sized businesses can call on the human 
and material resources necessary for direct, active par­
ticipation in research projects. Consequently, along 
with measures to increase such involvement, energetic 
action aimed at the dissemination and exploitation of 
research results for the benefit of SME in particular is 
regarded as especially important for their full partici­
pation in the process of technological innovation. 
(!) Op. cit. 2.6. (2) Opinion of 27 January 1988 (OJ No C 80, 18. 3. 1988, p. 7). 
(3) Op. cit., point 3.3. 
6. 2. 91 Official Journal of the European Communities No C 31/17 
6.5. In this connection, special efforts must be made 
to ensure full involvement by the agricultural sector in 
the development of biotechnology potential, so as to 
enhance its support for and participation in a process 
which will partially determine its future. Here, the 
Committee would refer to its Opinion of 29 March 
1990 on increasing the use of agricultural and forestry 
resources in the non-food and industrial energy sectors: 
prospects opened up by research and technological 
innovation (1). 
6.6. At the same time, the Committee is pleased 
to note that associations of SME, including European 
Economic Interest Groupings (EEIG), will be able to 
participate in research projects. These partnerships 
should help SME to attain the 'critical mass' necessary 
for full participation in research activities. 
6.7. These partnerships could play an important role 
in the agricultural sector, in particular by promoting 
cooperation within the sector; this will permit greater 
involvement of the agricultural sector in research and 
remedy the present concentration of R&TD, especially 
biotechnology R&D, in the hands of a few major 
industrial firms. 
6.8. At all events, industrial and agricultural SME 
cannot increase their participation in Community 
research programmes, irrespective of the form this tak­
es, unless they are fully informed about those pro­
grammes, the conditions to be fulfilled for participation 
and the formalities and steps to be taken. Greater efforts 
are again called for here. 
7. Shared-cost research activities 
7.1. Shared-cost projects are to be selected by two 
procedures: by issuing calls for tenders (the usual 
method), or in exceptional cases by accepting 'unsolic­
ited proposals', i.e. proposals not made in response to 
calls for tenders. The exceptional procedure, whose 
implementing conditions are set out in Annex III, is 
a completely new departure for Community research 
programmes but is already used in countries such as 
the US and Japan. 
7.2. The Committee agrees with the Commission 
that the exceptional procedure should provide the flexi­
bility needed to cope with unforeseen research develop­
ments. 
(!) OJ No C 124, 21. 5. 1990, p. 47. 7.3. Apart from the need to ensure that implemen­
tation of the exceptional procedure is totally trans­
parent, the Commission will have to make a greater 
effort to provide information on Community research 
programmes and the rules governing their implemen­
tation and eligibility, so as to ensure universal access 
and thus further the reinforcement of economic and 
social cohesion which is the target of Community 
R&TD activities. 
8. Training 
8.1. Whereas the BRIDGE programme, like its pre­
decessors, made express provision for training activi­
ties, earmarking 12 million ECU for this purpose, the 
proposed new programme does not indicate that such 
activities are to be continued or that any funds are to 
be provided for training. 
8.2. The Committee has already stressed that these 
activities should continue to receive particular attention 
because of the need to: 
— ensure that research staff are able to constantly 
adapt to complex technology and rapid advances in 
knowledge, and 
— enable certain Member States, less well-equipped 
in terms of research infrastructure and scientific 
personnel, to participate fully in the research activi­
ties of the programme. 
8.3. The Committee has noted the inclusion, without 
further details, of training among the proposed new 
programme's accompanying measures. It considers, 
however, that this reference does not guarantee that 
training activities—whose success must be emphasized-
—will receive the appropriate commitment and 
funding. 
8.4. The Committee therefore urges that a portion of 
the funds for the proposed new programme be explicitly 
earmarked for training, as in the case of the BRIDGE 
programme. 
9. Concerted actions 
9.1. Annex III to the draft Decision simply states 
that the concerted actions are those defined in the 
financial Regulation. Pursuant to that Regulation, these 
No C 31/18 Official Journal of the European Communities 6. 2. 91 
activities will take the form of Community measures to 
coordinate Member States' individual research activi­
ties. 
9.2. This definition fails to clarify the nature of 
the concerted actions to be implemented under the 
proposed programme and, unlike BRIDGE, entirely 
disregards the need for specific actions in conjunction 
with the programme's objectives. As a result, the future 
role of the CUBE unit (*) is not defined either. 
9.3. It should be noted that these concerted actions 
are of particular importance both for an evaluation of 
the consequences of biotechnological developments and 
for public information and awareness. 
9.4. This aspect was stressed in the Committee Opin­
ion on the 1990-1994 framework programme (2), which 
also said that Commission units such as CUBE should 
be given the funds they need to do their job properly. 
9.5. The concerted-action projects conducted under 
BRIDGE should therefore be extended. Assurances to 
this effect are not enough. 
10. Ethical aspects of research in the field of biotechno­
logy 
10.1. The Committee has repeatedly drawn attention 
to the ethical, social and other implications of biological 
and biotechnological research, and has called on the 
Commission to take appropriate action. See the Com­
mittee Opinions on the Commission proposals regard­
ing analysis of the human genome (3) and the BRIDGE 
programme. 
10.2. In this connection, it welcomes the Com­
mission's intention to carry out a detailed evaluation 
of the social, ethical and ecological impact of projects 
implemented under the biotechnology programme. This 
initiative represents a first step towards the establish­
ment of 'an overall balance ... between long-term utility 
of current or planned research and ethical aspects tran­
scending commercial, political and economic consider­
ations', which the Committee regards as indispensable. 
10.3. The Committee considers, however, that this 
evaluation should not be limited to the results of 
(a) Concertation Unit for Biotechnology in Europe. 
(2) Opinion of 15 November 1989 [OJ No C 56, 7. 3. 1990, p. 34 
(7.16.4)]. 
(3) OJ No C 56, 6. 3. 1989, p. 47. research projects. An initial evaluation should be made 
when proposals are submitted. Proposals for research 
projects liable to have an adverse social, ethical or 
ecological impact should not be selected or receive 
Community funding. 
10.4. The Committee would also point out that the 
two Opinions mentioned in point 10.1 call for the 
setting-up of an ethical committee comprising, in 
addition to scientists, philosophers, sociologists, theo­
logians and legal experts, representatives of the social 
circles concerned, to conduct a broadly-based, compre­
hensive examination of all the ethical and moral impli­
cations of research covered by programmes like the 
present. 
10.5. This committee's activities should ultimately 
lead to the definition of ethical guidelines for all 
research activities. These could form the basis for a 
code of conduct laying down the ethical and moral 
limits to such programmes, as the Committee has also 
proposed. 
11. Programme review and evaluation of results 
11.1. Article 5 of the draft Decision provides both for 
a review of the programme in 1992 and an assessment of 
its results on completion. It also states that the reports 
in question are to be drawn up with reference to (a) 
the programme's scientific and technical objectives and 
content, as defined in Annex I to the draft, and (b) the 
criteria for selecting Community R&TD actions set out 
in Annex III to the 1990-1994 framework programme 
Decision. 
11.2. The Committee has doubts about the value of 
reviewing the proposed new programme in 1992, given 
that a start cannot be made on the programme till 1 
January 1991 at the earliest and having regard to the 
time which will elapse before research projects are 
selected and contracts signed. The Committee therefore 
considers that the review should be carried out 'in the 
course of the third year of implementation'. 
11.3. The scope of the interim review can be 
questioned to the extent that it will coincide with the 
review of the BRIDGE and framework programmes. It 
is just conceivable that this review will lead to the 
presentation of a new biotechnology programme in 
6. 2. 91 Official Journal of the European Communities No C 31/19 
1993 encompassing the research activities covered by 
BRIDGE and the present programme. 
11.4. The Committee notes that in the past it has 
usually been laid down that reviews of specific pro­
grammes are to take account of their special criteria. 
The BRIDGE programme decision, for instance, has an 
Annex III entitled 'Programme objectives and evalu­
ation criteria'. It therefore seems fair to query the 
reasons for this new Commission approach, particu­
larly as the programme's specific objectives are 
described in very broad terms. 
11.5. It would seem essential that, like the review 
at the project stage, the social ethical and ecological 
consequences should be taken into account when assess­
ing the results of the proposed new programme. 
11.6. Th Committee notes that once again the Econ­
omic and Social Committee is not explicitly listed 
among the recipients of the reports on the proposed 
new programme and of its results. The Commission 
has never given a proper reason for this practice, which 
runs counter to EEC Treaty Article 130Q. 
11.7. It must be recalled that, in accordance with 
Article 130Q, the Committee must be consulted on any 
proposal to change, extend or renew research pro-
Done at Brussels, 18 October 1990. grammes. The Committee, just as much as the Council 
and the Commission, needs these reports if it is to 
evaluate Commission proposals. The Committee there­
fore urges the Commission and the Council to amend 
Article 5 of the draft Decision. 
12. Staff expenditure 
12.1. The financial statement attached to the draft 
Decision states that staff expenditure will not exceed 
2 % of the Community's financial contribution to the 
programme. The Commission states that this is the sum 
needed to recruit two staff to add to the 28 currently 
responsible for the implementation of BRIDGE (since 
the relevant expenditure will come under this pro­
gramme up to its expiry in 1993), and the retention of 
this staff in 1994 for the implementation of the proposed 
new programme by itself. 
12.2. In other words, the Commission has confirmed 
that the thirty staff members are to manage and 
implement both the BRIDGE programme and the pro­
posed new programme. It is a pity that this is not stated 
clearly in the draft Decision, especially as this is a 
principle of good management and should help to 
ensure the necessary coherence in the implementation 
and monitoring of research activities. 
The Chairman 
of the Economic and Social Committee 
Francois STAEDELIN