9. 7. 84 Official Journal of the European Communities NoC 182/7 
Proposal for a Council Decision adopting a multiannual research action programme of 
the European Economic Community in the field of biotechnology (1985 to 1989) 
COM(84) 230 final 
(Submitted by the Commission to the Council on 11 May 1984) 
(84/C 182/05) 
THE COUNCIL OF THE EUROPEAN 
COMMUNITIES, 
Having regard to the Treaty establishing the Euro­
pean Economic Community, and in particular 
Article 235 thereof, 
Having regard to the proposal from the Commis­
sion, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas Article 2 of the Treaty assigns to the Com­
munity inter alia the task of promoting throughout 
the Community a harmonious development of 
economic activities, a continuous and balanced 
expansion and an accelerated raising of the stan­
dard of living; 
Whereas, in its resolution of 14 January 1974 on an 
initial outline programme of the European Commu­
nities in the field of science and technology ('), the 
Council stated that the whole range of available 
ways and means should be used as appropriate, 
including concerted action projects and that when­
ever it proves desirable that third countries, parti­
cularly European ones, should be associated in 
these projects, steps should be taken to make this 
possible; 
Whereas, in its resolution of 25 July 1983 on the first 
framework programme for Community research, 
development and demonstration activities (2), the 
Council has approved the development of biotech­
nology as part of the objective 'promoting industrial 
competitiveness'; 
Whereas the ongoing multiannual research and 
training programme for the European Economic 
Community in the field of biomolecular engineer­
ing (3) has clearly underlined the possibility and util­
ity of a Community action for the exploitation of 
modern biology in agriculture and industry; Whereas the Commission submitted to the Council 
on 13 June 1983 a communication (4) on the role of 
the Community in biotechnology; 
Whereas the Commission submitted to the Council 
on 29 September 1983 a communication (5) on bio­
technology in the Community; 
Whereas a Community research action programme 
is necessary for the development of biotechnology 
in the Community and, particularly for: 
— the establishment of new methods for the syn­
thesis of compounds with high added value, 
— more efficient land use through the design of 
new crops which can provide important feed­
stocks for the European industries, 
— acceptability of the products of modern biotech­
nology through the use of new testing methods 
which render possible a more efficient and less 
costly evaluation of toxicity and biological 
activity, 
— new approaches in the detection, prevention 
and treatment of costly diseases, 
— protection of health and environment against 
risks which may be associated to new develop­
ments in modern biotechnology; 
Whereas the achievement of the objectives men­
tioned above requires that actions be implemented 
at Community level which lead to: 
— the establishment of a supportive infrastructure 
for biotechnology research in the Community, 
— the elimination, through research and through 
training, of bottlenecks which prevent the 
exploitation by industry and agriculture of the 
materials and methods originating from modern 
biology, 
— the experimental assessment of biohazards pos­
sibly associated with applications in agriculture 
and industry of biomolecular engineering; 
(') OJNoC7, 29. 1. 1974, p. 6. 
(2) OJ NoC 208, 4. 8. 1983. 
(3) OJ No L 375, 20. 12. 1981, p. 1. (4) COM(83) 328 final. 
(5) COM(83) 672 final/2 and Annex. 
NoC 182/8 Official Journal of the European Communities 9. 7. 84 
Whereas it is necessary to monitor developments in 
biotechnology, with a view to assess their strategic 
significance for Europe, and to promote effective 
concertation between the Community and its Mem­
ber States in matters affecting the development of 
biotechnology; 
Whereas the Treaty has not provided the necessary 
specific powers; 
Whereas account should be taken of the opinion of 
the Scientific and Technical Research Committee 
(CREST) on the Commission proposal, 
HAS DECIDED AS FOLLOWS: 
Article 1 
1. A research action programme for the European 
Community in the field of biotechnology is hereby 
adopted in the form set out in the Annex for a five-
year period starting on 1 January 1985. 
2. The programme includes work carried out as 
contract research, training and concerted action. 
The work will be carried out by means of shared 
cost contracts to be placed with appropriate indus­
trial organizations, research laboratories or univers­
ity institutes or combinations of them. 
The concerted actions consist of the coordination at 
Community level of research activities which are 
part of existing research programmes in the Member 
States and, where applicable, of the Community. 
Article 2 
The appropriations necessary for the execution of 
the programme are estimated at 88 520 000 ECU, 
including expenditure related to a staff of 26. 
Article 3 
The Commission will report to the Council and the 
European Parliament at the end of the third year of 
the programme and will propose, where appropriate, 
any amendments necessary. These amendments may 
lead to a revision of the programme in the course of 
the fourth year in accordance with the appropriate 
procedures. Article 4 
The Commission shall be responsible for the execu­
tion of the programme with regard to the contract 
research and shall be responsible for the coordina­
tion with regard to concerted actions. 
The detailed implementation of the programme, 
particularly concerning the breakdown of the work 
between contract research and concerted actions, is 
set out in the Annex. 
Article 5 
The Commission will be assisted in the tasks listed 
in Article 4 by the Management and Consultative 
Committee (CGC) created by Council Deci­
sion . . . ('). 
Article 6 
With regard to the concerted actions in accordance 
with a procedure to be laid down by the Commis­
sion, after consulting the CGC the participating 
Member States and the Community shall regularly 
exchange all useful information concerning the exe­
cution of the research covered by such activities. 
The participating Member States shall provide the 
Commission with all information relevant for coor­
dination purposes. They shall also endeavour to 
provide the Commission with information on simi­
lar research planned or carried out by bodies which 
are not under their authority. 
Any information shall be treated as confidential if 
so requested by the Member State which provides it. 
Article 7 
1. In accordance with Article 228 of the Treaty, the 
Community may conclude Agreements with non-
Member States participating in European Coopera­
tion in the field of Scientific and Technical research 
(COST) with a view to ensuring cooperation 
between the Community concerted action projects 
referred to in the Annex and the relevant pro­
grammes of such States. 
2. The Commission is hereby authorized to nego­
tiate the Agreements referred to in paragraph 1. 
(') Draft Council Decision COM(83) 143 final (OJ No C 
113,27.4. 1983). 
9. 7. 84 Official Journal of the European Communities No C 182/9 
ANNEX 
RESEARCH ACTION PROGRAMME BIOTECHNOLOGY 
(1 January 1985 to 31 December 1989) 
ACTION I 
RESEARCH AND TRAINING 
Sub-programme I: contextual measures for R & D in biotechnology 
Content 
Measures to upgrade the quality and capabilities of facilities, resources and support services 
underpinning biotechnology research, particularly by the enhancement of existing activities in 
the Member States, but not excluding the development of new activities and collaboration in 
wider international activities where essential. 
Measures to enhance access to these facilities, and encourage their use, in research, teaching, 
agriculture, industry and health care. 
— Bio-informatics: 
— data-capture techniques (particularly advanced instrumentation and measurement, 
automated reading), 
— data banks, 
— computer modelling of biological structures and systems, 
— sophisticated computer software for the human interface with computerized facilities 
relating to the life sciences and biotechnology. 
— Collections of biotic materials: 
— organized collections of animal and plant cells, hybridomas, micro-organisms, their 
viruses, and all other forms of biotic material of potential use and relevance to biotech­
nology, 
— development of information and communication techniques for enhancing the quality 
and usefulness of such collections, 
— development of techniques for the identification, characterization, conservation and 
resuscitation of the materials held in such collections. 
Implementation 
Through cost-shared contracts with appropriate institutions, with provision as necessary for work­
shops and meetings. 
Financial means 
Estimated at 11 110 000 ECU including expenditure for a staff of four. 
Sub-programme 2: basic biotechnology ' 
Content 
Pre-competitive research and research through training in areas of basic biotechnology where 
technical and scientific bottlenecks prevent the applications of modern genetic and biochemical 
methods to agriculture and industry. 
No C 182/10 Official Journal of the European Communities 9. 7. 84 
— Enzyme engineering: 
— development and evaluation of bio-reactors (and particularly those which are multien-
zymatic, multiphasic or co-factor requiring) for industrial applications, depollution and 
detoxification ('), 
— modifications of enzyme properties, protein design, synthesis of artificial enzymes and 
development of new methods (including, for example, filtration, centrifugation and 
reverse osmosis) for large-scale and highly selective separation of proteins and other 
substances with industrial or agricultural value. 
— Genetic engineering: 
— improvement of soil- micro-organisms (particularly Rhizobium, bacteria of the rhizo-
sphere of graminaceae, mycorhiza) and of cultivated plants important for European agri­
culture ('), 
— exploitation of plant products (particularly ligno-cellulose) ('), 
— applications to animal husbandry (particularly the production of vaccines and hor­
mones (') and gene transfer in animals). 
— Physiology and genetics of species important to industry and to agriculture: 
— study of poorly understood basic functions in micro-organisms (particularly chemo-
autotrophs, methanotrophs, mycorhiza) which appear to be promising for future indus­
trial use, 
— analysis of factors governing the yield and stability of micro-organisms during industrial 
exploitation or in relation to symbiotic relationships with higher plants, 
— identification of factors and mechanisms governing important properties in cultivated 
plants (particularly in Triticum, Vicia, Brassica). 
— Technology of cells and tissues cultured in vitro: 
— analysis of factors governing yield and stability during continuous cultivation or in 
mixed populations, 
— control of the differentiation of plant cells and of their regeneration in entire plants ('), 
— methodology of animal cell cultures (in particular for the production of monoclonal 
antibodies) 
— development of micro-analytical methods for the identification and quantification of 
biologically important molecules, 
— study of cell biology applied to the prevention, detection and treatment of a few 
selected diseases which are particularly important from a socio-economic point of view. 
— Screening methods for the evaluation of the toxicological effects and of the biological activ­
ity of molecules: 
the tests (essentially in vitro and non-invasive in vivo) to be developed should contribute to a 
better understanding of structure-function relationships and to the uniformization of screen­
ing procedures throughout the Community. 
— Assessment of risks: 
development of new methods for detecting contamination and for the assessment of possible 
risks associated with applications in industry (particularly during downstream processing) 
and agriculture of biomolecular engineering ('). 
Implementation 
Through cost-shared research contracts, training contracts, short-term training grants, courses, 
consultations of national experts, organization of study-group meetings, participation in seminars 
and symposia, and publications. 
(') Continuation from 1 April 1986 to 31 December 1989 of a project presently implemented in 
the framework of the biomolecular engineering programme (April 1982 to March 1986). 
9. 7. 84 Official Journal of the European Communities No C 182/11 
Financial means 
The appropriations necessary for the implementation of the sub-programme are estimated at 
69 000 000 ECU, including expenditure for a staff of 14 (>). 
COST activities associated to the programme as category II 
Content 
— aquatic primary biomass (marine macroalgae), 
— plant in vitro culture. 
Implementation 
Through the organization of meetings, consultation of experts, publications, exchange of research 
workers between laboratories, coordination contracts. 
Financial means 
The appropriations estimated necessary for the implementation of these activities are estimated at 
1 500 000 ECU. 
Involvement in the activities of the 'Technology, growth and employment' working group created at 
the Versailles summit of 1982 (2) 
Content 
Coordination and concertation in basic biology 
— area 1: data banks, 
— area 2: collections of biotic materials. 
Implementation 
Through the organization of meetings, consultations of experts, publications. 
Financial means 
The appropriations estimated as necessary for the implementation of these activities are esti­
mated at 500 000 ECU. 
ACTION II 
CONCERTATION 
Content 
A concertation activity will be implemented with the objectives of improving standards and capa­
bilities in the life sciences, and enhancing the strategic effectiveness with which these are applied 
to the social and economic objectives of the Community and its Member States. 
(') Includes the staff of five of the ongoing biomolecular engineering programme (April 1982 to 
March 1986) who will be assigned to the sub-programme on 1 April 1986. 
(2) Technology, growth, employment: report to the seven Heads of State and Governments and 
to the representatives of the European Communities. Coll. Rapports Officiels, January 1983. 
NoC 182/12 Official Journal of the European Communities 9. 7. 84 
In conjunction with the relevant services in the Community and the Member States, the follow­
ing tasks will be executed: 
— monitoring the strategic implications of developments elsewhere in the world for biotechnol­
ogy-based industry in Europe, 
— working with the services of the Community, Member States and other interested parties to 
identify ways in which the contextual conditions of operation for biotechnology in the Com­
munity may be further improved, to promote its development in all useful applications, and 
the supporting scientific capabilities, 
— responding to the needs for research and information in support of the specific actions of 
other services of the Commission, 
— identifying opportunities for enhancing through concertation and cooperation the effective­
ness of biotechnology-related programmes in the Member States, and promoting collabora­
tive initiatives in biotechnology with and between industry and universities, 
— consideration of how the safe and sustainable exploitation of the renewable natural resource 
systems in Europe may be enhanced by the application of biotechnology, 
— promoting in cooperation with developing countries and relevant institutions the pursuit of 
the same task (see preceding paragraph) within their respective regions, 
— monitoring and assessing developments in biotechnology bearing on safety and other 
aspects of the 'social dimensions', 
— disseminating knowledge and increasing public awareness of the nature and potential of 
biotechnology and the life sciences, to raise the quality of public debate, 
— establishing an ad hoc system of collaboration between groups and individuals with inter­
ests and capabilities in the life sciences and biotechnology; so creating networks, as informal 
and flexible as possible, adapted to the particular problems under study: the networks to 
have the triple function of providing an active input into the programme, encouraging coor­
dination through the exchange of information between the participants, and assisting the 
broader diffussion of information envisaged in the preceding task. 
Implementation 
Essentially through in-house work, the setting-up and the exploitation of an organized informa­
tion base and through missions, but will include as necessary the commissioning of study reports, 
the organization of workshops and meetings, support for the production of reports and diffusion 
of information. 
Financial means 
Estimated at 6 410 000 ECU including expenditure for a staff of eight.