PROPOSAL FOR A COUNCIL DECISION ADOPTING A SPECIFIC RESEARCH AND TECHNOLOGICAL DEVELOPMENT PROGRAMME IN THE FIELD OF BIOTECHNOLOGY ( 1990-1994 )
Date: 1990-05-28
Institutions: European Commission
Subjects: EU programme, biotechnology, research and development, research staff, vocational training

COMMISSION  OF  THE  EUROPEAN  COMMUNITIES 

C0MC90) 160 final - SYN 265 

Brussels, 28 May 1990 

Proposal  for a 

COUNCIL DECISION 

adopting  a specific  research and  technological  development 

programme  in the field of Biotechnology 

(1990-1994) 

(presented  by the Commission) 

-  1 -

CONTENTS 

Proposal  for  a Council  Decision  adopting  a 
specific  research  and  technological  development 
programme  in  the  field  of  Biotechnology  (1990-1994) 

ANNEX  I 
Scientific  and  technical  objectives  and  content 

ANNEX  I I 
Indicative  breakdown  of  expenditures 

ANNEX  I I I 
Rules  for  Implementing  the Programme  and  Activities 
for  Dissemination  and  Exploitation  of  the  Results 

Page 

11 

18 

19 

-  2 -

Proposal  for a 

COUNCIL DECISION 

adopting a specific  research  and  technological  development 

programme  in the field of Biotechnology 

(1990-94) 

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,^1) 

In cooperation with  the European Par I lament,<2) 

Having  regard  to the opinion of  the Economic and Social  Committee,(3> 

(1) OJ  No C 

(2) OJ No C 

(3) OJ No C 

-  3 -

Whereas  by  its  Decision  90/221/Euratom,  E E C( 4 ),  the  Council  adopted  a 

third  framework  programme  for  Community  activities  in  the  field  of 

research  and  technological  development  (1990-94),  specifying  Inter  alia 

the  activities  to  be  pursued  for  contributing  to  the  development  of  the 

European  potential  for  understanding  and  exploiting  the  properties  and 

structures  of  living  matter;  whereas  this  Decision  should  be  taken  in 

the  light  of  the  grounds  set  out  in  the  preamble  to  that  Decision; 

Whereas  Article  130k  of  the  Treaty  stipulates  that  the  framework 

programme  Is  to  be  implemented  through  specific  programmes  developed 

wi thin  each  act Ivlty; 

Whereas  an  estimate  should  be made  of  the  amount  of  Community  financial 

resources  needed  to  carry  out  this  specific  programme;  whereas  the 

definitive  amounts  will  be  fixed  by  the  budgetary  authority  in  line 

with  the  financial  perspectives  covering  the  period  1988-1992  included 

in  the  Inter Inst itut ional  Agreement  of  29  June  1988^5^  and  with  any 

future  financial  perspectives  covering  the  period  1993-1994; 

Whereas, 

pursuant 

to 

Article 

4 

and 

Annex 

I  of 

Decision 

90/221/Euratom,  EEC,  the  amount  deemed  necessary 

for  the  whole 

framework  programme  includes  an  amount  of  57  million  ecus  for  the 

centralized  dissemination  and  exploitation  of  results,  to  be  divided  up 

in  proportion  to  the  amount  envisaged  for  each  activity;  whereas  in 

view  of  the  importance  of  this  specific  programme  within  the  "Life 

Sciences  and  Technologies"  action  the  estimate  of  the  financial 

resources  needed  by  this  programme  is  to  be  reduced  by  1.64 mi I I ion 

ecus,  which  amount  is to  be  allocated  to  the  centralized  activities,  in 

order  to  comply  with  the  second  sentence  of  Article  130p  (2)  of  the 

Treaty; 

(4) OJ  No  L  117,  8.5.1990,  p.28. 

(5) OJ  No  L  185,  15.7.1988,  p.33 

-  4  -

Whereas  this  programme  must  be  Implemented  by  the  Commission;  whereas 

to  help  accomplish  this,  the  Member  States  are  bound,  pursuant  to 

Article  5  of  the  Treaty,  to  facilitate  the  achievement  of  its  tasks 

where  necessary,  notably  within  a  committee; 

Whereas  this  programme  must  be  Implemented  essentially  by  the  selection 

of  research  and  development  projects  to  enable  them  to  benefit  from 

Community  participation-,  whereas  the  Commission  should  encourage  the 

submission  of  such  projects  by  the  usual  means  of  publishing  calls  for 

proposals  in  the  Official  Journal;  whereas  a  special  procedure  should 

also  be  devised  so  as  to  maintain  a  degree  of  flexibility  enabling  the 

Commission,  in  the  face  of  the  continuous  evolution  and  gradual 

acceleration  of  technological  progress,  also  to  take  into  consideration 

spontaneous  proposals  consistent  with  the objectives  of  the  programme; 

Whereas  the  projects  to  be  carried  out  under  the  programme  must  be 

selected  with  special  attention  to  the  principle  of  economic  and  social 

cohesion  in  the  Community,  the  transnational  nature  of  the  projects  and 

the  support  to be  given  to small  and  medium-sized  enterprises; 

Whereas  it  is only  in  the  light  of  experience  gathered  in  the  course  of 

this  programme  that  the  Commission  will  be  able  to  propose  and  the 

Council  to  adopt  supplementary  programmes  by  having  recourse  to  the 

means  provided  for  in  Articles  1301,  130m  or  130o  of  the  Treaty,  if 

they  contribute  to  the  achievement  of  the  programme's  objectives,  in 

accordance  with  the  option  made  available  by  Article  2(2)  of 

Decision  90/221/Euratom,  EEC; 

Whereas,  in accordance  with  Article  130g  of  the Treaty,  the  Community's 

activities  aimed  at  strengthening  the  scientific  and  technological 

basis  of  European 

industry  and  encouraging 

it  to  become  more 

competitive  include  promoting  cooperation  on  research  and  technological 

development  with  third  countries  and  International  organizations; 

whereas  such  cooperation  may  prove  particularly  beneficial  for  the 

development  of  this  programme; 

-  5 -

Whereas  It  is  necessary,  as  Annex  II  to  Decision  90/221/Euratom,  EEC, 

provides,  to  reinforce  biological  knowledge  as  the  common  and 

integrated  foundation  needed  for  applications  in agriculture,  industry, 

nutrition  and  the  environment. 

Whereas  the  Scientific  and  Technical  Research  Committee  (CREST)  has 

been  consulted, 

HAS  ADOPTED  THIS  DECISION: 

-  o  -

Art icle 1 

A  specific  research  and  technological  development  programme  for  the 

European  Economic  Community  in  the  field  of  Biotechnology,  as  defined 

in  Annex  I,  is  hereby  adopted  for  a  period  of  five  years  as  from 

1  January  1990. 

Art icle  2 

1.  The  Community  funds  estimated  as  necessary  for  the  execution  of  the 

programme  under  this  Decision  amount  to  164  million  ecus.  Of  this 

amount  1.64  million  ecus  is drawn  for  the  centralized  dissemination 

and 

exploitation 

of 

results.  The 

amount 

thus 

reduced 

to 

162.36  million  ecus  includes  staff  costs  which  may  not  exceed  2%. 

An  indicative  breakdown  of  expenditure  is set  out  in Annex  II. 

2.  Should  the  Council  take  a  decision  in  implementation  of  Article 

1(4)  of  Decision  90/221/Euratom,  EEC,  this  Decision  shall  be 

adapted  to  take  account  of  the  abovementioned  decision. 

3.  The  budgetary 

authority 

shall 

decide  on  the  appropriations 

available  for  each  financial  year. 

Art icle  3 

Rules  for  the  implementation  of  the  programme  are  set  out  in Annex  III. 

Art icle  4 

The  rate  of  the  Community  financial  contribution  shall  be  laid  down  in 

accordance  with  Annex  IV  to  Decision  90/221/Euratom,  EEC. 

-  7  -

Article  5 

1.  During  1992  the Commission  shall  review  the  programme  and  address a 

report  on  the  results of  the  review  to  the Council  and  the  European 

Parliament,  together  with  proposals  for  any  necessary  changes. 

2.  At  the end  of  the  programme  the Commission  shall  assess  the  results 

obtained.  It shall  address  a  report  thereon  to  the Council  and  the 

European  Par I lament. 

3.  The  reports  shall  be  drawn  up  having  regard  to  the  objectives  set 

out  In Annex  I to  this Decision  and  in accordance  with  Article  2(4) 

of  Decision  90/221/Euratom,  EEC. 

Article  6 

1.  The  Commission  shall  be  responsible  for  the  execution  of  the 

programme.  It  shall  be  assisted  by  a  committee,  hereinafter 

referred  to  as  "the  Committee",  composed  of  representatives  of  the 

Member  States  and  chaired  by  a representative of  the  Commission. 

2.  The  contracts  concluded  by  the  Commission  shall  govern  the  rights 

and  obligations  of  each  party,  including  the  procedures  for 

disseminating,  protecting  and  exploiting  the  research  results,  in 

accordance  with  the  arrangements  adopted  pursuant  to  the  second 

paragraph  of  Article  130k of  the  Treaty. 

3.  A  work  programme  for  each  year  shall  be  drawn  up  and  updated  where 

necessary.  It  shall  set  out  the  detailed  objectives  and  types  of 

projects  to  be  undertaken,  and  the  financial  arrangements  to  be 

made  for  them.  The  Commission  shall  make  calls  for  proposals  for 

projects  on  the basis of  the  annual  work  programmes. 

- 8 -

Article 7 

1.  In  the  cases  envisaged 

in  Article  8(1),  the  Commission 

representative  shall  submit  to  the  Committee  a  draft  of  the 

measures  to  be  taken.  The  Committee  shall  deliver  its opinion  on 

the draft  within  a time  limit  which  the chairman may  set  according 

to  the  urgency  of  the  matter.  The  opinion  shall  be  delivered  by 

qualified majority  as provided  for  in Article  148(2) of  the Treaty 

in the case of  decisions which  the Council  is required  to adopt  on 

a  proposal  from  the  Commission.  The  votes  of  the  Member  States' 

representatives  within  the  Committee  shall  be  weighted  in  the 

manner  set out  in that Article.  The chairman shall  not  vote. 

2.  The Commission  shall  adopt  the measures envisaged where  they are in 

accordance with  the Committee's opinion. 

3.  If  the  measures  envisaged  are  not  in  accordance  with  the 

Committee's  opinion, or  if no opinion  is delivered,  the  Commission 

shall  forthwith  submit  to  the  Council  a  proposal  relating  to  the 

measures  to  be  taken.  The  Council  shall  act  by  a  qualified 

majority. 

4.  If the Council  has not  acted  within one month  of  submission  of  the 

proposal, the proposed measures shall  be adopted  by the Commission. 

Article 8 

1.  The procedure  laid down  in Article 7 shall  apply  to: 

the preparation  and updating of  the work programmes  referred  to 

in Article 6(3); 

evaluation of  the projects  referred  to  in point  2 of Annex  III, 

as  well  as  the  estimated  amount  of  the  Community's  financial 

contribution  when  these  projects  are  submitted  through  the 

ordinary  procedure  referred  to  in point  4 of Annex  III  and  the 

abovementioned amount  is more  than 5 million ecus; 

evaluation  of  all  projects  submitted  through  the  exceptional 

procedure  referred  to  In  point  4  of  Annex  III,  as  well  as  the 

estimated  amount  of  the Community's  financial  contribution; 

measures  for  evaluating  the  programme. 

2.  The  Commission  may  consult  the  Committee  on  any  matter  falling 

within  the  scope of  the  programme. 

3.  The  Commission  shall  inform  the Committee  with  regard  to; 

the  progress of  the  programme; 

planned  calls  for  proposals,  referred  to  in Article  6 (3); 

projects,  referred  to  In  point  2  of  Annex  III,  submitted 

through  the  ordinary  procedure,  for  which  the  Community 

contribution  is  less  than  5  million  ecus,  and  the  results  of 

their  evaluation; 

accompanying  measures,  referred  to  in point  2 of  Annex  ill; 

concerted  actions,  referred  to  in point  2 of  Annex  III. 

Article  9 

In  implementing  this  programme,  supplementary  programmes  within  the 

meaning  of  Article  1301,  participation  within  the  meaning  of  Article 

130m  and  Joint  undertakings  or  any  other  structures  within  the  meaning 

of  Article  130o  of  the  Treaty  may  also  be  decided  on  as  the  need 

ar ises. 

-  10 -

Article  10 

Where  cooperation  with  third  countries  and  international  organisations 

aiming  at  achieving  the  objectives  of  this  programme  requires  legal 

undertakings  between  the Community  and  the  third  parties  concerned,  the 

Commission  shall  be authorized  to negotiate,  in accordance  with  Article 

130n  of  the  Treaty,  International  agreements  laying  down  the  terms  of 

such  cooperation. 

Decisions  on  the  conclusion  of  such  agreements  shall  be  adopted  In 

accordance  with  the  procedure  referred  to  In  Article  130q  (2)  of  the 

Treaty. 

Article  11 

This Decision  Is addressed  to  the Member  States. 

Done  at 

, 

For  the  Counc11, 

The  President 

11 

Annex  1 

SCIENTIFIC AND TECHNICAL OBJECTIVES AND CONTENT 

This specific programme fully reflects  the approach embodied in the Third  Framework 

Programme  in  terms  of  the  scientific  and  technical  goals  and  the  underlying  aims 

which  it  pursues. 

Paragraph 4A of Annex II of the  Framework  Programme  forms  an integral part  of  the 

present  specific  programme. 

Pre-normative  research will be carried  out  in each of  the areas described  below, with 

emphasis  on  the  safety  assessment  of  new  techniques  and  novel  products. 

The  ethical  and  social  implications  of  biotechnology  will  be  monitored  and  studied. 

A  multidisciplinary  approach  involving  representatives  from  the  various  sciences, 

professions  and  activities  concerned  will  be pursued.  Special  attention  will  obviously 

be  given  to  the  areas  of  biotechnology  covered  by  Community  research.  For  all 

projects  conducted  in this framework,  contractors  will be requested  to provide, when 

applicable, information  necessary for  the detailed evaluation  of the social, ethical and 

ecological impact of their studies, and, where necessary, approval from the responsible 

authorities. 

Information  technology will be used throughout the programme for collecting, pooling, 

analyzing,  distributing  or  simulating  data. 

Research  will  be  carried  out  at  the  level  of  molecules,  cells,  organisms  and 

populations.  Integration  between  levels  will  be  assured. 

The  following  presents  an  analytical  description  of  the  content  of  the  programme, 

based  on  and  taking  account  of  the  above  elements. 

-  12 

-

Area  1.  Molecular approaches 

Protein structure and function 

Research  under  this  theme  is  aimed  at  two  goals.  First,  to  understand  and  control 

biological functions carried out by proteins (enzymes, hormones, antibodies, receptors, 

body structures, etc.). Second, to produce tailor-made proteins adapted to the specific 

requirements  of  man  (new  drugs, industrial  enzymes,  artificial  organs, etc.). 

Target areas will include enzymes and proteins associated with biological membranes 

participating  in energy  transduction  (chemi-osmotic  enzymes); immunoglobulins and 

their interactions with antigens, protein messengers and receptors. The latter work is 

connected  with  research described  below  on biological  communication systems. 

A  specific  objective  of  the  programme  will  be  the  analysis  of  structure-function 

relationships  for a number of  membrane proteins. 

Structure and function  of genes 

The  ultimate  goal  is  to  provide  the  knowledge  necessary  for  a  rational  use  of 

biological  species  important  in  agriculture,  industry  and  the  diagnosis  of  genetic 

disorders. The study of the genetic  message in representative  species will  be pursued 

at two levels: precise ordering of the genes within chromosomes (gene mapping) and 

detailed  determination  of  the  chemical  composition  of  genes  (gene  sequencing). 

Efforts  will  be undertaken  to complete  the sequencing work of  the entire genome of 

yeast,  which  displays  a  genetic  structure  and  organisation  (genome)  comparable  to 

that  of  plants  and animals,  and  to  initiate  a Community  effort  for sequencing  genes 

in a model plant species (Arabidopsis) and physical mapping in Drosophila.  This work 

will  complete  research  under  the  BRIDGE  programme  on  mapping  the  genes  in 

Arabidopsis  and on sequencing  certain chromosomes  in yeast. 

-  13  -

A specific objective will be the sequencing of more than 10 million nucleotides in the 

organisms studied. 

Close  liaison  will  be  maintained  with  research  under  the  Human  Genome  Analysis 

programme  to  ensure  that  developments  in  methodology,  mapping  and  sequencing 

techniques  are shared  with  mutual  benefit. 

Expression  of genes 

In order to make  full  use of  the  above  information  on gene  structure,  the  processes 

through which  the  information  stored  as DNA in the genes  is expressed  in  the form 

of active proteins will be studied in some models of practical importance. Transcription 

factors,  RNA polymerases,  their  interactions  with  signals,  ligands  and  DNA will  be 

examined.  A specific  objective  is the analysis of a number of  DNA polymerases and 

transcription  factors  in yeast,  plants  and mammalian cells. 

Area 2.  Cellular and organism  approaches 

-  14 

-

Cellular regeneration,  reproduction  and development of living organisms 

In order to provide  basic knowledge  required by biotechnology,  comparative  studies 

of  reproductive  events  (meiotic  pairing,  gamete  packaging,  gamete  recognition  and 

fertilization),  cell-cell  interaction  and  cell  replication  in  animals  and  plants  will  be 

undertaken. Research will be centred on the control of development, cell commitment 

and  cell  totipotency  in  higher  organisms  starting  with  the  simplest  levels  of 

organisation,  namely  gametes,  eggs,  proliferating  lines  and their reorganisation  into 

organs and embryos. 

At the same time, with regard to pre-normative research, in vitro test systems will be 

elaborated  which  take  into  account  the  high  specificity  of  modern  drugs  and  their 

potential  toxic effects  during cell  differentiation  and organogenesis. 

Metabolism  of animals, plants and microbes;  essential physiological tracts 

The  objective  is  to  provide  industrial  and  agricultural  operators  with  the  basic 

knowledge  required  for  a  more  rational  exploitation  of  resources  in  production, 

processing and animal husbandry. New animal models, more representative of human 

material, will be developed for biological analysis, including the use, where necessary, 

of  transgenic  animals  relevant  to  the study of  human  health  and  its protection. 

Research  will  concern  the  regulatory  mechanisms  governing  some  of  the  biological 

functions  or  metabolic  activities  in  species  which  are  important  to  man  (e.g.,  as 

specific  objectives,  production  and  secretion  in microorganisms,  metabolic  pathways 

under  extreme  environments,  nitrate  assimilation  in  plants,  food  utilisation  and 

metabolic  control  in animals, etc.). 

Communication systems  within  living matter 

-  15  -

The goal is to provide industrial  biotechnologists,  agricultural  and medical operators 

with a new approach to dealing with the complexity of living systems. This emerging 

subject will  be studied  at  the cellular and systemic  level. 

Research  will  be  focused  on  the  immune  and  the  nervous  systems.  Immunological 

studies  will  concern  the  complex  interaction  between  the  three  main  types  of  cells 

(antigen  presenting  cells,  T-lymphocytes  and  B-lymphocytes)  responsible  for  the 

reaction  of  the  animal  body  to  foreign  substances  (antigens).  Concerning  pre-

normative objectives, pharmacological and toxicological test systems will be developed, 

with special attention to immune reactions in "drug targeting" and immunotoxicoiogy 

as such.  Synergism with  protein engineering  will  be assured. 

In neurobiology, attention will be given to the basic unit of the brain, the neuron. The 

production, release and specific  reception of chemical messengers used by neurons to 

communicate  among  themselves  and  to  transmit  messages  to  target  cells  such  as 

muscles and glands will  be a priority. The biochemical,  pharmacological  and genetic 

characterisation of newly discovered neuroreceptors systems will constitute a specific 

objective  of  the  programme  in  view  of  possible  applications  to  the  diagnosis  and 

treatment  of  pathological  behaviour.  The  interaction  between  neurons  and  the 

development  of neural  networks will  also be studied. This research will  complement 

projects  undertaken  in  the  ESPRIT  and  SCIENCE  programmes,  dealing  with  the 

informatic,  behavioural,  cognitive  and physiological  aspects  of  neurobiology. 

Area 3.  Ecology and population biology 

-  16  -

Ecological implications of Biotechnology 

The goal is to study the environmental implications of biotechnology and, in particular 

of the release by man of living organisms  in the environment  in connection with the 

industrial,  agricultural  and environmental  policies  of  the Community. 

Particularly in the case of microorganisms, the systematic analysis of possible adverse 

effects  will  be  carried  out  taking  into  consideration  the  need  for  a  comprehensive 

understanding  of  the  ecosystems  involved.  Research  will  include  the  analysis  of 

representative examples of interactions between microbial populations and with their 

hosts;  the  study  of  the  impact  of  the  introduction  of  genetically  modified 

microorganisms  on  natural  microbial  populations 

in  different  habitats;  the 

determination of the behaviour and effects  upon ecosystems of organisms modified by 

genetic engineering (including as a complement to ongoing research in BRIDGE, fishes 

and insects). 

Conservation  of genetic resources 

The aim is to ascertain the real dimension of  the problem of loss of genetic diversity. 

Knowledge of genetic erosion in plants, animals and microorganisms will be pursued, 

collected  and circulated. 

Taxonomy will  be revitalised  with  inputs  from  molecular  biology,  providing  specific 

and  target  support  to  decentralised  collections  of  biotic  materials;  a  systematic 

assessment  of  the residual  genetic  variability of agricultural  and industrial  species of 

regional  and  traditional  importance  will  be initiated. 

These  activities  will  be  carried  out  in  cooperation  with  relevant  international 

organisations  and countries outside  the  European Community. 

-  17  -

Work  in  this  area  will  link  into  Community  research  programmes  dealing  with 

environmental  issues.  ' 

-  18  -

Annex II 

INDICATIVE BREAKDOWN OF EXPENDITURES 

in %, for the period  1990-1994. 

Area  1.  Molecular approaches 

35  - 40 

Area 2.  Cellular and organism  approaches 

45  - 55 

Area 3.  Ecology and population  biology 

1 0 - 15 

The breakdown between different  areas does not exclude  the possibility that projects 

could cover several areas. 

-  19 -

Annex  111 

Rules  for  Implementing  the  Programme 

and  Activities  for  Dissemination  and  Exploitation  of  the  Results 

1.  The  Commission  shall  Implement  the  programme  on  the  basis  of  the 

scientific  and  technical  content  described  in Annex  I. 

2.  The  rules  for  implementing  the  programme,  referred  to  In Article  3, 

comprise  research 

and 

technological 

development 

projects, 

accompanying  measures  and  concerted  actions. 

The  projects  shall  be  the  subject  of  shared-cost  research  and 

technological  development  contracts. 

The  accompanying  measures  consist  of  applying  the  means  to  ensure 

proper  technical  execution,  management  and  evaluation  of  the 

programme,  as  well  as  adequate  dissemination  and  accessibility  of 

the  results,  and  coordination,  training  and  consciousness-raising 

of  the participants  In the  programme. 

The  concerted  actions  are  those  defined 

In  the  Financial 

Régulât Ion. 

3.  The  participants  In  the  projects  must  be  natural  or  legal  persons 

established  in  the  Community,  such  as  universities,  research 

organizations  and  industrial  firms,  Including  small  and  medium-

sized  enterprises,  or  associations  thereof,  In  particular  European 

Economic  Interest  Groupings  (EElGs). 

Natural  or  legal  persons  established  In  countries  which  have 

concluded  agreements  with  the  Community  foreseeing  scientific  and 

technical 

research,  may,  based  on  the  criterion  of  mutual 

advantage,  take  part  In  the  projects  undertaken  in  the  context  of 

this  programme.  The  contracting  parties  under  such  arrangements 

shall  not  benefit  from  Community  funding.  They  shall  contribute  to 

the general  administrative  costs. 

-  ?0  -

4.  The  choice  of  projects  shall  be  carried  out  according  to  the 

following  order  of  priority,  the  first  method  being  the  rule,  the 

second  the  exception: 

The  participants  in  the  projects  shall  be  selected  on  the  basis  of 

the  ordinary  procedure  of  calls  for  proposals  referred  to  In 

Article  6  (3) and  published  In  the  Official  Journal  of  the  European 

Commun(ties. 

The  Commission  may  also  accept 

proposals  according 

to  an 

exceptional  procedure  and  under  the  conditions  mentioned  below, 

when 

they 

make 

a  particularly 

promising 

and 

significant 

contribution  as  regards  the  originality  of  the  theme  proposed,  the 

novelty  of  the  scientific  and  technical 

approach 

and 

the 

methodology  of  execution,  also  taking  into  account  the  particular 

nature  of  the  proposers. 

A  favourable  technical  evaluation  of  such  proposals  shall  not  by 

itself  be  a  sufficient  justification  for  accepting  a  project;  this 

exceptional  procedure  may  only  apply  after  verification  that  the 

nature  of  the  project,  as  defined  above,  does  not  justify  the  use 

of  the  normal  procedure  for  calls  for  proposals. 

The  exceptional  procedure  must  be  completed  before  the  ordinary 

procedure  in  such  a  way  that  the  available  amount  for  the 

Community's  financial  participation  in  projects  retained  by  the 

ordinary  procedure  can  be  determined  precisely.  The  closing  date 

for  the  exceptional  procedure  shall  be  published  each  year  in  the 

Official  Journal. 

The  amount  of  the  financial  participation  of  the  Community  for  all 

the  projects  retained  by  the  exceptional  procedure  will  be  decided 

each  year,  in  relation  to  the  projects  selected  according  to 

particularly  strict  criteria  of  excellence.  In  any  case,  this 

amount  may  not  exceed  15%;  it may  be  revised  each  year  In  the  light 

of  exper ience. 

-  21  -

The Commission  shall  draw up  a vade mecum  setting out  all  the  rules 

applicable  to  this exceptional  procedure  in order  to guarantee  full 

transparency. 

5.  The  projects  must  involve  at  least  two  mutually  independent 

partners  established  in different  Member  States. 

6.  The  Commission  may  encourage  the  participants  to  form  a  European 

Economic  Interest  Grouping  (EEIG)  or  make  other  arrangements  for 

carrying  out  projects,  such  as  those  on  a  large  scale,  permitting 

decentralized  management  adapted  to  the  specific  requirements  of 

the  project. 

7.  The  knowledge  acquired  during  the  course  of  the  projects  shall  be 

disseminated  on  the  one  hand  within  the  specific  programme  and  on 

the  other  hand  by  means  of  a centralized  activity,  pursuant  to  the 

decision  referred  to  in  the  third  paragraph  of  Article  4  in 

Decision  90/221/Euratom,  EEC. 

22> 

FINANCIAL  STATEMENT 

1. 

BUDGET  HEADING  AND  TITLE 

Part  B  of  the  general  budget 

Subsection  6,  Item  6221 

Specific  programme  of  Community  RTD  activities  in  the  field  of 

Bioterfinolopv  n99Q-1994l 

2.( 

LEGAL  BASE 

Article  130  Q(2)  of  the  Treaty. 

3. 

OBJECTIVES  AND  DESCRIPTION 

See  Annex  I  of  the  proposal. 

4. 

FINANCIAL  IMPLICATIONS 

/ 

ounts  deemed  necessary  in  MIOECU  : 

Programme  implementation 

Centralized  action  for  dissemination  and 

exploitation 

TOTAL 

162.36 

1.64 

164.00 

The  indicative operational  breakdown  of the  162.36 MIOECU  for  the  programme  implementation 

is  given  in  Annex  II  of  the  proposal. 

ÙM 

Indicative  multiannual  schedule  (in  MIOECU)  : 

1990  1991 

1992 

1993 

1994  ') 

TOTA 

Commitments 

Payments 

30 

8 

39.30 

22.10 

59 

38 

34.06 

94.26 

162.36 

162.36 

The  definitive  yearly  amounts  will be  determined  by the  budgetary  authority  in  accordance  with 

the  financial  perspectives  for  the period  1990 -1992 (annexed  to  the  Interinstitutional  Agreement 

of  29 June  1984)  and  with  subsequent  financial  perspectives  which  may be  adopted  for  1993 and 
H4. 

5. 

STAFF  AND  ADMINISTRATIVE  EXPENDITURE 

In  addition  to  the  principal  means  of  action  which  are  contracts  (annex  III),  the  above  amounts 

include  programme-related  staff  and  administrative  expenditure  estimated  at  no  more  that  7 

MIOECU. 

The  expenditure  on  staff  will not exceed  2% of  the amount  deemed  necessary  for  the  programme 

implementation.  This  implies  a  maximum  of  30 statutory  posts  (A,B  and/or  C)  at  any given  time 

during  the  life  of  the  programme. The  infrastructure  costs related  to  statutory  staff  will be  borne 

uy  Part  A  of  the  budget. 

')  for  the  payment  appropriations:  1994  and  beyond 

^5 

6. 

IMPLICATIONS  FOR  REVENUE 

The  contributions  by  third  country  contractors  towards  the  cost  of  administration  of  the 

programme  will  be  reused  pursuant  to  articles  27.2 and  96  of  the  Financial  Regulation2). 

7. 

TYPES  OF  CONTROL 

Control  will  be  exercised  by: 

the  Programme  Management  Committee  (scientific  control) 

the  services  of  the  DG  responsible  for  the  execution  of  the  programme,  possibly 

assisted  by  independent  experts 

the  Commission's  Financial  Controller. 

In  accordance  with  Article  2  of  the  Financial  Regulation  2),  the  use  of  appropriations  will  be 

subject  to  analyses  of  cost-effectiveness  and  the  realization  of  quantified  objectives  will  be 

monitored. 

External  audit  may  be  carried  out  by  the  Court  of  Auditors  in  accordance  with  the  Treaty. 

:)  Financial  Regulation  of  21  December  1977, as  last  amended  by  Regulation 

610/90  of  March  1990. 

ze 

FICHE  D'IMPACT  SUR  17V COMPETITIVITE  ET L'EMPLOI 

I -  Justification  en  faveur  de  la  proposition 

Le  programme  de  recherche  et  de  développement  technologique  proposé  a 

pour  objectif  primordial  de  contribuer,  à  moyen  et  à  long  terme,  à  la 

promotion  de  la  compétitivité  industrielle,  des  innovations  agricoles  et  de  la 

croissance  économique  dans  la  Communauté. 

En  l'absence  d'un 

tel  programme,  le  champ  des  nouvelles  technologies 

auxquelles  donne  régulièrement  naissance  la  biologie  moderne,  sera  moins 

vite  exploité  par  l'industrie  et  l'agriculture  européennes. 

2.  Caractéristiques  des  entreprises  concernées 

A long terme, les agriculteurs,  les  fournisseurs  de l'agriculture,  les  industries 

de  transformation  des  produits  agricoles,  les  industries  de  la  santé,  les 

secteurs  chimique  et  pharmaceutique  sont  directement  concernés  par  la 

proposition. 

A court  et  moyen  terme,  cependant,  les  secteurs  immédiatement  concernés 

par  les résultats  du  programme  sont  ceux du  diagnostic  et  du  traitement  des 

troubles  immunologiques  et  neurobiologiques  et,  dans  une  moindre  mesure, 

de  la  microbiologie  industrielle.  L'accroissement  des  efforts  communautaires 

en  faveur  du  génie  des  protéines  et  du  séquençage  des  génomes  devrait 

promouvoir  encore  davantage  les  innovations  dans  le  domaine  de  la  bic-

inf^rmatiau?  ei  de  l'instrumentation. 

2^ 

3.  Obligations  que  le  programme  impose  aux  entreprises 

Il  s'agit  des  mêmes  obligations  qui  sont  imposées  à  tous  les  laboratoires 

participant  au  programme,  à  savoir 

conformité  de 

la  recherche  proposée  à 

l'annexe 

technique  du 

programme 

partage  des  frais  (en  règle  générale  à  50%) 

coopération  transnationale 

libre  accès  des  sites  aux  agents  de  la  Commission 

participation  à  des  séminaires  et  à  des  réunions  de  contractants 

organisés  par  la  Cbrnrnission 

rapports  annuels  d'activités  et  de  résultats. 

4.  Obligations  indirectes  susceptibles  d'être  imposées  aux  entreprises  par  les 

autorités  nationales,  régionales  ou  locales 

Obligation  de  suivre  les  normes  et  règlements  nationaux  qui  concernent 

certaines recherches en génie génétique et l'exploitation  des résultats de  cène 

recherche. 

5.  Dispositions  relatives  aux  PME 

L'action  de  recherche  du  présent  programme  ne  prend  aucune  disposition 

spécifique  à  l'égard  des  PME  qui  devraient  pourtant  en  être  largement 

bénéficiaires.  Souvent  incapables  d'effectuer  à  elles  seules  de  longues  et 

difficiles  recherches,  ces entreprises  dépendent  des  résultats  de  la  recherche-

développement  financée  par des  fonds  publics.  Leur  participation  aux  projets 

sera  examinée  d'un  oeil  favorable  lors  de  la  sélection  des  propositions. 

2« 

La dissemination  de  l'information  relative  aux  résultats  de  la  recherche,  et 

tout  particulièrement  à  l'intention  des  PME, sera  mise  au  premier  rang  des 

priorités. 

Les conditions  de  participation  privilégient  les  PME en  ce  sens  que  tous  les 

participants  à  un  projet  BIOTECH seront  traités  sur  un  pied  d'égalité. 

6. 

Incidence  probable  : 

a) 

sur  la  compétitivité  des  entreprises 

BIOTECH  ne  devrait  avoir  aucun  effet  immédiat  sur  la  compétitivité  des 

entreprises. Toutefois,  il pourrait  avoir divers effets  à court et  moyen termes 

et  de  nombreux  effets  à  long  terme  - voir point  1. 

b) 

sur  l'emploi 

Les effets  du programme sur l'emploi sont difficiles  à évaluer. Toutefois,  une 

meilleure  compétitivité  internationale  de  la  biotechnologie  européenne 

pourrait contribuer à réduire le déclin à long terme de l'agriculture et devrait 

avoir  des  conséquences  favorables  sur  l'emploi  dans  divers  secteurs 

industriels,  en  particulier dans les  firmes  à fort  potentiel  de  croissance  dans 

des  créneaux  spécialisés  du  marché  à haute  valeur  ajoutée. 

7.  Consultations  des  organisations  représentatives 

La liste des organisations industrielles consultées durant la phase préparatoire 

du  piogranmie  inclut,  notamment,  le  groupe  de  travail  "biotcchnologie" du 

comité  consultatif  de  la  recherche  et  du  développement  industriel  de  la 

Commission  des  Communautés  européennes  (IRDAC). 

ISSN 0254-1475 

COM(90) 160 final 

DOCUMENTS 

EN 

16 

Catalogue number  : CB-CO-90-243-EN-C 
ISBN 92-77-60745-9 

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