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20. 3. 89 Official Journal of the European Communities No C 70/1

II

_(Preparatory Acts)_

# COMMISSION

Proposal for a Council Decision adopting a specific research and technological development
programme in the field of biotechnology (1990 to 1994) — Biotechnology research for innovation,

development and growth in Europe (BRIDGE)

_COM(88) 806 final_ — _SYN 182_

_(Submitted by the Commission on 5 January 1989)_

(89/C 70/01)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Economic Community, and in particular Article 130Q (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 130K of the Treaty stipulates that the
framework programme shall be implemented through
specific programmes developed within each activity;

Whereas, by its Decision 87/516/Euratom/EEC 0), the
Council has adopted a framework programme of Community research and technological development (1987 to
1991), providing _inter alia_ for activities ensuring the
exploitation and optimum use of biological resources;

Whereas, for the selection of Community actions, the
framework programme sets out criteria among which is
that of contributing to the strengthening of economic and
social cohesion of the Community consistent with the
pursuit of scientific and technical quality;

Whereas the activities provided for in the framework
programme include, in particular:

— the establishment of Community R&D for contributing
a transnational dimension to national efforts and for

facilitating technology transfer towards industry and
agriculture in the areas of infrastructures, basic
biotechnology and risk analysis,

(!) OJ No L 302, 24. 10. 1987, p. 1.

— the continuous evaluation of the strategic significance of
new developments in biotechnology and promotion of
the essential coherence between the different areas of

Community policy concerned with biotechnology;

Whereas the multiannual research and training programme
for the European Economic Community in the field of
biomolecular engineering ( [2] ) and the ongoing multiannual
research action programme for the European Economic
Community in the field of biotechnology (1985 to 1989) ( [3] )
( [4] ) have clearly demonstrated the utility of Community
actions in biotechnology and the need for their expansion;

Whereas the participation of European non-Member States
wholly or partially with projects in this programme is
desirable;

Whereas it is desirable to involve small and medium-sized

enterprises to the maximum extent possible in the
biotechnology research and development programme;

Whereas the implementation of research and training
actions in the COST framework is an essential element to

complement R&D projects in the field of biotechnology;

Whereas the Scientific and Technical Committee (Crest)
has been consulted,

HAS ADOPTED THIS DECISION:

_Article 1_

_A_ specific research and technological development programme for the European Economic Community in the
field of biotechnology, as defined in the Annex, is hereby
adopted for a period of five years, from 1 January 1990.

( [2] ) OJ No L 375, 20. 12. 1981, p. 1.
( [3] ) OJ N o L 83, 23.3. 1985, p. 1.
( [4] ) OJ No L 206, 30. 7. 1988, p. 38.

No C 70/2 Official Journal of the European Communities 20. 3. 89

_Article 2._

The amount deemed necessary for the execution of the
programme is 100 million ECU, including expenditure on a
staff of 30.

_Article 3_

Detailed rules for the implementation of the programme
and the rate of the Community's financial participation are
set out in the Annex.

The contracts entered into by the Commission shall
regulate the rights and obligations of each party, in
particular the methods of disseminating, protecting and
exploiting the research results.

_Article 4_

In the third year of implementation of the programme, the
Commission shall review it and shall report to the Council
and to the European Parliament on the results thereof,
together, if necessary, with any proposals for modification
or prolongation.

An evaluation of the results achieved shall be conducted by
the Commission, which shall report thereon to the Council
and the Parliament.

The abovementioned reports shall be established having
regard to the objectives set out in the Annex to this Decision
and in conformity with the provisions of Article 2(2) of
Decision 87/516/Euratom/EEC.

_Article '5_

The Commission shall be responsible for implementing the

programme.

The Commission shall be assisted by a Committee of an
advisory nature, hereinafter referred to as 'the Committee',

composed of the representatives of the Member States and
chaired by the representative of the Commission.

_Article 6_

The Commission shall submit to the Committee a draft of

the measures to be taken. The Committee shall deliver its

opinion within a time limit which the Chairman may lay
down according to the urgency of the matter, if necessary
by taking a vote.

The opinion shall be recorded in the minutes of the
Committee; in addition, each Member State shall have the
right to have its position recorded in the minutes.

The Commission shall take the utmost account of the

opinion delivered by the Committee. It shall inform the
Committee of the manner in which its opinion has been
taken into account.

_Article 7_

The Commission is hereby authorized to negotiate, in
accordance with Article 130N of the Treaty, agreements
with non-member States and international organisations,
in particular with those countries participating in European
cooperation in the field of scientific and technological
research (COST), and those having concluded framework
agreements in scientific and technical cooperation with the
Community with a view to associating them wholly or
partly in concerted actions within this programme.

Where framework agreements for scientific and technical
cooperation between non-member States and the European
Communities have been concluded, organisations and
enterprises established in those countries may participate in
a project undertaken within this programme.

_Article 8_

This Decision is addressed to the Member States.

_TECHNICAL_ _ANNEX_

ACTION I: RESEARCH AND TRAINING

CONTENT

Information infrastructure

1.1. _Culture collections_

Development of a communication system for easy and rapid access to the most important service culture
collections within the Community; to be achieved through support to:

— a Promotion Centre for Culture Collections, specifically designed for providing to European users
(distribution of catalogues, patent regulations, printed and visual material, etc.) adequate
information on expertise and services available in different European Culture Collections; and

20. 3. 89 Official Journal of the European Communities No C 7 0 / 3

— a Centralized European Data Bank, primarily on micro-organisms and subsequently extended to
other biotic materials (animal and plant cells, viruses, plasmids, etc.). The first phase towards this
objective to involve the harmonisation of formats and data in the main service culture collections of
the European Community.

1.2. _Processing and analysis of bio(techno)logical_ _data_

— applications of information technology (specialised software and equipment) such as required for
the implementation of the activities in protein engineering and gene sequencing (see also 2.1 and 2.3
below); and

— updating and design of knowledge bases for storing and classifying bio(techno)logical data such as
sequences, genetic maps, protein and biopolymer structures, risk assessment data; and

— exploitation of existing or newly developed information technology for rapid access to European
knowledge bases and closed sequencing networks via an electronic network including electronic
input, on-line catalogues, electronic ordering, etc.

2. Enabling technologies

2.1. _Protein design!molecular_ _modelling_

— multi-disciplinary approaches including genetic engineering and advanced structural methods
aiming at improving the properties (such as stability, pH optimum, substrate specificity, etc.) of
interesting proteins and their complexes (including glycoproteins); and

— development of methods to understand and predict structure/function relationships of proteins,
such as those involved in folding, stability, crystallisation, including theoretical methods for
simulation of these properties, and their interactions with other related molecules.

2.2. _Biotransformation_

— development of biological reactions using new strains of cells or novel enzymes for synthesis of key
intermediates needed for the production of high added value substances (particular attention to be
given to the bioconversion of agricultural surpluses) and for converting pollutants to innocuous
compounds; and

— research addressing the problem of genetic and physiological stability of the free or immobilised
genetically modified microbes or cells under biotransformation conditions; and

— research addressing the problem of enzymatic activity under extreme environments (organic
solvents, pHs, temperatures, immobilisation); and

— development of methods for the isolation and purification of biotransformation products (up- and
downstream processing); and

— development of specialised software and mathematical modelling for the control and analysis of
biotechnological processes.

2.3. _Gene mapping, genome sequencing, novel cloning methods_

— sequencing the genome of yeast _(Saccharomyces cerevisiae)_ or parts therof and of _Bacillus subtilis_ ;
and

— development of molecular genetic techniques to identify new meaningful plant genes, using the
_Arabidopsis_ genome as a resource; characterisation of the identified genes; and

— development of advanced sequencing procedures and technology (see 1.2) and integration of these
procedures and technology in the sequencing projects.

3. Cellular biology

3.1. _Physiology and molecular genetics of industrial_ _micro-organisms_

— gene stability and expression, post-translational processes, genetic and metabolic regulation of
overproduction, transport and secretion. These studies, adapted in each case to the current state of
the art, will concentrate on some industrially interesting micro-organisms such as the genera lactic

No C 70/4 Official Journal of the European Communities 20. 3. 89

acid bacteria, _Streptomyces, Pseudomonas, Bacillus, Clostridium, Corynebacterium,_ and including
the larger groups of lactic acid bacteria, extremophiles, yeasts and filamentous fungi.

3.2. _Basic biology of plants and associated organisms_

— core processes for sexual breeding: mechanisms of flower initiation and evocation; differentiation of
sex cells; molecular bases of gamete recognition and selection systems; and

— fundamentals of plant cell regeneration: genetics and molecular biology of somatic and zygotic
embryoge,nesis; perception and transduction of growth-promoting signals; and

— molecular interfaces of plants and associated organisms: molecular bases of host-range and
virulence; characterisation of plant defence reactions; development of genetic techniques for
pathogenic fungi or mycorrhizae; regulation from plant/microbial signals of the expression of
microbial/plant genes; structural and functional identification of genes involved in N2-fixing
symbioses; and

— physiological attributes of crops: storage processes; stress physiology; nitrogen use efficiency.

3.3. _Biotechnology of animal cells_

— animal cell engineering and culture technology leading to new or improved productions of important
substances for industrial and zootechnical purposes; and

— animal genetics: mapping and sequencing of important genes; methods of gene transfer; gene
expression and regulation; and

— animal husbandry: improved immunity through genetically engineered vaccines of second
generation.

4. Pre-normative Research

Pre-normative Research in biotechnology places itself at both ends of the research-developmentexploitation chain.

4.1. _Safety assessments associated with the release of genetically engineered organisms_

— monitoring and control techniques: sampling and probes for engineered organisms and introduced
segments of DNA; methods and instrumentation for high resolution automated microbial
identification and the establishment of adequate data bases; creation of a bank of specific probes and
chemical signatures for a large number of specific micro-organisms; eradication methods; and

— assessment techniques: biological containment; gene stability and gene transfer; development of
microcosms and simulating methods for impact analysis; and

— acquisition of fundamental knowledge on gene behaviour (horizontal transfer between species,
rearrangement of introduced genes in the host organism) and on the survival and adaptation of
released organisms, in particular soil bacteria, and including modification of host range and tissue
range for engineered viruses; and

— novel constructions: biologically contained organisms; suicide vectors or constructions which can
not develop outside the host organism; engineered organisms which can be destroyed in the
environment by known and specific techniques.

4.2. In vitro _evaluation of the toxicity and pharmacological activity of molecules_

— development of cellular and multicellular systems as surrogates for _in vivo_ tissues and organs; and

— research addressing the problems of preparation, storage maintenance and growth of human cell
cultures; and

— development of cell lines in which functional properties are better preserved.

IMPLEMENTATION

Training actions shall be implemented through training contracts and courses for any of the themes
defined above. The cost of these actions shall be borne by the Community.

20. 3. 89 Official Journal of the European Communities No C 70/5

Research actions are to be implemented through cost-shared research contracts for each of the themes
defined above. The Community financial contribution shall not normally exceed 50 % of total
allowable projects costs. Alternatively, in respect of universities and similar institutes of higher
education, the Community financial contribution shall normally be 100 % of the marginal costs.

Two types of transnational research projects are foreseen:

— N projects, for the integration in adapted Community structures (European Laboratories Without
Walls: ELWW) of research efforts in areas where the main bottlenecks result from gaps in basic
knowledge. The contribution of the Community in such projects shall not exceed ECU 400 000 per
year per project, and

— T projects, for the removal, through a significant investment of skills and resources, of important
bottlenecks resulting from structural and scale constraints; the contribution of the Community in
such projects may vary from one to three million ECU per year per project.

Cost activities (category II) associated to Action I

CONTENT

— Marine primary biomass

— _In vitro-cuhmes_ for the purification and propagation of plants

— Methods for early detection and identification of plant diseases

— Vesicular-arbuscular (VA) mycorrhizae

— Development of vaccines against coccidiosis.

IMPLEMENTATION

Implementation shall take place through the organisation of meetings, consultation of experts,
publications, exchange of research workers between laboratories, and coordination contracts.

ACTION II: CONCERTATION

CONTENT

In conjunction with the relevant Commission services and the Member States, the following tasks will be
executed:

— monitoring developments in biotechnology, particularly in the field of R&D, assessing their
implications, and hence informing services of the Commission and interested public authorities
having related responsibilities,

— identifying possible ways in which the contextual conditions for the beneficial development of
biotechnology in Europe may be improved, and the effectiveness and coherence of Member State and
Community biotechnology programmes and related policies enhanced; including those involving
international collaboration,

— disseminating knowledge and helping to increase public awareness and understanding of the nature,
potential, and possible risks associated with biotechnology,

— identifying the need for, and helping to promote greater activity in the biotechnology small firm
sector in the Community.

IMPLEMENTATION

The action will continue to develop the work (begun under BAP) of _ad hoc_ collaboration between
groups and individuals with interests and capabilities in the life sciences and biotechnology, so creating
networks, as informal and flexible as possible, adapted to the needs of encouraging coordination
through the exchange of information between the participants, and assisting the broader diffusion of
information required by the above tasks.

Specifically, the work will involve in-house analysis, the setting-up and the exploitation of an organised
information base, and missions. It will also include as necessary the commissioning of study reports, the
organisation of workshops and meetings, and support for the production of reports and diffusion of
information.