Amended proposal for a COUNCIL DECISION adopting a specific research and technological development programme in the field of Biotechnology ( 1990­1994 )
Date: 1991-10-18
Institutions: European Commission
Subjects: EU programme, biotechnology, research and development, research staff, vocational training

COMVIISSION  OF  THE  EUROPEAN  COMMUNITIES 

COM(91)386 

f i n a l-  SYN  265 

B r u s s e l s, 

i s O c t o b er  1991 

Amended proposal  for a 

COUNCIL PEC)?IQN 

adopting a specific research and technological  development 

programme  in the field of Biotechnology 

(1990-1994) 

(presented by the Commission pursuant  to Article  149(3) 
of the EEC-Treaty) 

A-

Justification 

On  28th  May  1990,  the  Commission  presented  its  proposal  for  a  specific  programme  of 
research  and  technological  development  in  the  field  of  biotechnology  (COM(90)160  final  -
SYN  265). The  Economic  and  Social  Committee  gave  an  opinion  on  the  proposal  on  18th 
October  1990. The European  Parliament  examined  it in first reading on 9 October  1991, and 
voted  62 amendments. 

Amendments  2  and  3,  as  well  as  12  and  14  in  their  latter  parts,  are  compatible  with  the 
measures  adopted  for  other  specific  programmes  and  can  be  accepted  by the  Commission  in 
an appropriate form. The other amendments of horizontal character fall outside the  agreement 
of the three Presidents of 17 April or the decisions relating to preceding programmes, and have 
not  been  taken  up  : this concerns  numbers  13, 14 (2 first parts),  15, 16, 40 to  50, 53 and 55. 

Certain  amendments  did  not  respect  the  limits of  the  areas  of  competence  attributed  to  this 
programme, by excess or deficiency  : these are numbers 9,12 (first  part), 17, 26, 28, 37, 51, 54, 
58, 60 to 64, 66 and  67. Others, on  the  contrary,  constituted  useful  additions  to  the  technical 
description  of  the objectives  and  are  taken  up, as they are or subject  to  reformulation,  in  the 
modified  proposal  of  the  Commission  : numbers  1, 4, 6 to 8,  11,18, 22 to 25, 27, 29 to 36, 38, 
52, 69 and 72. 

So far  as concerns  Community regulation  on genetically  modified  organisms, the  Commission 
will conform  to the content of the directives adopted by Council, as expressed  in its version of 
amendments 5 and 19. Ethical concerns will be taken into account by including in the  modified 
proposal  amendments  numbers  8,  11,  29  and  38,  and  by  substituting  for  amendment  20  the 
"recital" on social and economic impact received from  the trilogue, but enlarged  to include  the 
concept  of  ethics.  Amendment  number  8  completes  the  references  which  the  Commission 
intends  to make  to the  ethical impact  of  the  research work. Amendment  number  10 will  not 
be  taken  up.  The  part  of  amendment  59  relating  to  the  protection  of  animals  against 
unnecessary  suffering  inflicted  in  laboratories  is  taken  up  in  a  formulation  referring  to  the 
Community  Directive  in  force. 

Amendment  38 is added, in a modified  version,  to  the indicative breakdown  of expenses,  and 
includes certain  elements  of  amendment  39 which  in its other  parts  is not  acceptable. 

The modifications  to the original proposal, underlined,  appear  hereafter  in the order  in which 
they should  appear  in  the  text. 

The  proposal  thus  modified  is presented  by the  Commission  in  accordance with  paragraph  3 
of Article  149 of  the  EEC  Treaty. 

-I' 

Amended Proposal for a 
COUNCIL  DECISION 

adopting a specific research and technological development 
pmgranune in the field of Biotechnology 
(1990-1994) 

The  proposal  for  a  Council  Decision  adopting  a  specific  research  and  technological 
development  programme  in  the  field  of  Biotechnology  (COM/90/160  final  -  SYN  265)  is 
amended  as follows : 

| 

* 
\ 
\ 
\ 
^ 
j 
j 
I 

Recital  2 a  (new) 

Whereas research and technological development 
in  this field should  be linked  to various  relevant 
Community policies  and  objectives; 

Recital 3 a  (new) 

Whereas  basic 
field  of 
biotechnology  must  be  encouraged  throughout 
the  Community; 

research 

the 

in 

Recital 3 b  (new) 

Whereas, in  addition  to  the  specific  programme 
concerning  human  resources  and  mobility,  it  is 
necessary  to  encourage  the  training  of  research 
workers  in the  context  of this programme; 

Recital  3 c (new) 

Whereas,  in  the  context  of  this  programme,  an 
assessment  should  be  made  of  the  ethical, 
economic  and  social  impact  as  well  as  of  any 
eventual  technological  risks; 

- 3-

Recital 6 a (new) 

Whereas  biological  research.  in 
particular  that  which  uses  the 
methods of recombinant DNA. is often 
subject  to national  laws with which 
the contractors must comply; 

Recital 6 b  (new) 

Whereas the Community issued two directives on 
23  April  1990  (Directive  90/219/EEC  on  the 
contained  use  of  genetically  modified  micro 
organisms  and  Directive  90/220/EEC  on  the 
deliberate  release  into 
the  environment  of 
genetically  modified  organisms^  on  recombinant 
DNA  technologies,  which  the  Member  States 
undertook  to  bring  into  force  through  laws, 
regulations and administrative provisions no later 
than  23 October 1991; 

Recital  7 a  (new) 

Whereas  research  in  biotechnology  may lead  to 
improvements  of  agricultural  and 
industrial 
efficiency  and  viability,  of  preservation  of 
environment  and health,  and of  quality  products 
for  the  consumer; 

li-

Recital  9 a  (new) 

to 

Whereas 
u n d e r t a k en 
ensure 
necessary  consideration 
t he  e t h i c al 
and  social 
t h e se 
a p p l i c a t i o ns 
i n d u s t r y, 
environment;  whereas 
w i ll  ensure  t h at 
a v a i l a b le 
the  content  of  the  programme; 

a c t i o ns  should  be 
the 
t h at 
is  given 
to 
e f f e c ts  of 
t h e ir 
and 
a g r i c u l t u r e, 
the 
and 
a c t i o ns 
is  made 
the  public  concerning 

p r o j e c t s, 
in 
health 

such 
information 

care 

to 

Recital 9 b  (new) 

the 

contextual 

conditions 
the  beneficial  development  of 
be 
in  Europe 
can 
c o n c e r t a t i on 

Whereas 
for 
biotechnology 
i m p r o v ed 
a c t i v i t i e s; 

t h r o u gh 

Recital  10 a  (new) 

the 

r e s u l ts  which  may  be 
Whereas 
achieved  by  genetic  research  make  it 
integrated 
necessary 
to  adopt  an 
the 
approach  which  takes  account  of 
l e g al 
e t h i c al 
s c i e n t i f i c, 
aspects  of  possible  applications  and 
of 
the 
r e s u l ts  are  not  used  in  an  improper 
m a n n er 
misrepresentation; 

to  ensure 

s u b j e ct 

the  need 

t h at 

and 

or 

to 

Recital  10 b (new) 

Whereas  the  Commission  has  announced  its 
intention  to  establish  an  appropriate  advisory 
structure  to  examine  the  ethical  implications  of 
biotechnology; 

9 

Article 1 

and 

specific 

research 

A 
technological 
development  programme  for  the  European 
Economic  Community 
field  of 
biotechnology,  as defined  in Annex I, is  hereby 
adopted for a period beginning on ... and ending 
on 31 December  1994. 

the 

in 

Article 6, 3rd paragraph 

A work programme shall be drawn up at 
the start of  the  programme and shall  be 
regularly  revised.  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 
for 
shall  make 
proposals for projects on the basis of the 
work programme. 

calls 

-6 

Annex I, 4th paragraph,  third  sentence 

Deleted. 

Annex I, 4th  paragraph,  fourth  sentence 

For  all  projects  conducted  in  this  framework, 
contractors  will  always be  requested  to  provide, 
using  a suitable  form,  information  necessary  for 
the detailed  evaluation  of  the social, ethical  and 
ecological  impact  of  their  studies  and,  where 
responsible 
necessary,  approval 
authorities.  The 
relevant 
Community directives must be applied  as regards 
the  ecological  impact. 

from 
provisions 

the 

of 

Annex I, Area  1, 1st  paragraph 

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  potentially  useful 
proteins  (new drugs, industrial  enzymes, etc.). 

Annex I, Area  I, 2nd  paragraph 

Target  areas  w i ll 
and 
p r o t e i ns 
b i o l o g i c al  membranes. 

include  enzymes 
w i th 

a s s o c i a t ed 

f-

Annex  I, Area  1, 4th  paragraph, 
first sentence 

is 

The  goal 
u n d e r s t a n d i ng  of  b i o l o g i c al 
genetic  mechanisms. 

to  a r r i ve  at  a  greater 
and 

Annex I, Area 1, 5th paragraph 

Efforts  will  be  undertaken  to 
contribute  to  the  sequencing  work 
on the entire genome of yeast, which 
displays  a  genetic  structure  and 
organization  (genome)  comparable  to 
that  of  plants  and  animals,  and  to 
initiate  a  Community  effort  for 
sequencing 
genes  in  suitable 
microorganism,  plant  and  animal 
species. 

Annex I, Area 1, 8th paragraph 

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,  factors 
affecting 
polymerases,  their  interactions 
with  signals,  ligands,  DNA  and 
posttranscriptional  processes. 
A 
specific  objective  is  the  analysis 
of  a  number  of  DNA  polymerases  and 
transcription  factors  in  yeast, 
plants and mammalian cells. 

transcription,  RNA-

-? 

Annex I, Area  2,  1st paragraph,  2nd  sentence 

on 

c e ll 

totipotency 

Research  will 
t he 

be 
of 
c o n t r ol 
c e n t r ed 
commitment 
and 
development, 
in  higher  organisms 
c e ll 
s t a r t i ng  with  the  simplest  l e v e ls  of 
o r g a n i z a t i o n,  namely  gametes,  eggs, 
t h e ir 
p r o l i f e r a t i ng 
r e o r g a n i z a t i on 
and 
embryos.  Research  p r o j e c ts  on  human 
embryos 
the 
programme. 

and 
organs 

l i n es 
into 

are  not 

included 

in 

Annex I, Area  2, 3rd  paragraph 

at 

to 

the 

to  provide 

The  goal  is 
industrial  and 
agricultural  undertakings  the  basic  knowledge 
necessary  for  a  more  rational  utilisation  of 
resources 
production, 
levels  of 
transformation  and  animal-rearing. 
The analysis of biological material with a view to 
studying  and  safeguarding  human  health  will 
make  use  of  new  animal  models  including,  as 
necessary,  transgenic  animals.  All  unnecessary 
suffering  will  be  strictly  avoided,  and 
the 
G  anm . 
animals  ased  for  experimental  purposes  will  be 
applied. 

,  t i iùjx ). iLions  '  on  the  protection  of 

\anex I, Area  2, 4th  paragraph 

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, 
extremopirilcinicroorganisms,metabolicpathways 
under extreme environments, nitrate assimilation 
in  plants,  food  utilization  and  metabolic  control 
in  animals,  etc). 

;  Council  Directive  86/609/EEC of 24/11/1986 

- 5-

Annex I, Area 2, 6th paragraph 

substances 

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 
(antigens). 
Concerning  pre-normative objectives, 
pharmacological  and  toxicological 
test  systems  for  use  in  the 
assessment  of  biotechnologically 
produced 
be 
compounds 
developed, with  special  attention to 
immune reactions  in  'drug targeting' 
and  immunotoxicology  as  such. 
Synergism  with  protein  engineering 
will  be assured. 

will 

Annex I, Area 2, 7th paragraph 

In  neurobiology,  attention  will  be 
given  to  the  basic  unit  of  the 
brain,  the  neurons  and  their 
i nteractions. 
The  biochemical, 
genetic 
pharmacological 
characterization  of newly discovered 
n e u r o r e c e p t o rs 
will 
constitute  a  specific  objective  of 
the programme. 

systems 

and 

- < / o-

Annex  I, Area  3, 2nd  paragraph 

Particularly  in  the  case  of  micro-organisms,  the 
systematic analysis of possible risks will be carried 
out  taking  into  consideration  the  need  for  a 
comprehensive  understanding  of  the  relevant 
characteristics of the ecosystems involved, such as 
the  soil.  Research  will  include  the  analysis  of 
representative  examples of  interactions  between 
microbial populations and other organisms in the 
ecosystems;  the  study  of  the  impact  of  the 
genetically  modified  or 
introduction  of 
genetically  marked  micro-organisms  on 
the 
rhizosphere or leaf surface; the determination  of 
the  behaviour  and  effects  upon  ecosystems  of 
organisms,  including  those  modified  by  genetic 
engineering  (including  as  a  complement 
to 
in  BRIDGE,  fishes  and 
ongoing 
insects). 

research 

Annex I, Area  3, heading 
between  2nd  and  3rd  paragraphs 

Biological  diversity 

Annex I, Area  3, 4th  paragraph, 
first  sentence 

Taxonomy  will  be  revitalized  with  inputs  from 
molecular  biology,  providing  specific  and  target 
support  to  decentralized  collections  of  biotic 
to 
materials;  this  support  will  be  restricted 
research  and  will  exclude  the  maintenance  or 
expansion  of  existing  collections;  a  systematic 
assessment  of  the  residual  genetic  variability  of 
agricultural and industrial species of regional and 
traditional  importance will be  initiated. 

-u-

Annex I, Area 3, 4th paragraph, 
second sentence 

A systematic assessment of  the residual genetic 
variability of microbial, plant and animal species, 
with particular emphasis on species and varieties 
which  have  played  a  major  role  in  traditional 
European agriculture and  food. 

Annex I, Area 3, 6th paragraph 

Work  in  this  area  will  link  into  Community 
research programmes dealing with environmental 
issues and international cooperation. 

Annex H, last sentence 

The breakdown between different  areas does not 
exclude the possibility that  projects  could cover 
several areas. 
Tent percent of the amount will be allocated to 
basic research. Between 5 and 7% of the amount 
will be allocated to training of researchers. 
Three percent of the amount will be allocated to 
the  assessment  of  ethical  and  socio-economic 
effects  and technological risks. 

ISSN 0254-1475 

COM(91) 386 final 

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ISBN 92-77-76473-2 

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