CELEX: 51991PC0386
Language: en
Date: 1991-10-18
Title: Amended proposal for a COUNCIL DECISION adopting a specific research and technological development programme in the field of Biotechnology ( 1990­1994 )

COMVIISSION OF THE EUROPEAN COMMUNITIES
                                        COM(91)386    f i n a l - SYN 265
                                        Brussels,  i s O c t o b e r 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)
 ---pagebreak---  ---pagebreak---                                                    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.
 ---pagebreak---                                                -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  j
development programme in the field of Biotechnology (COM/90/160 final - SYN 265) is j
amended as follows :                                                                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 research in the field of
                     biotechnology must be encouraged throughout
                     the Community;
                                      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;
 ---pagebreak---                            -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;
 ---pagebreak---                                    li-
                       Recital 9 a (new)
   Whereas                        a c t i o n s should be
   undertaken             to     ensure         that   the
   necessary consideration i s given to
   t h e e t h i c a l and social e f f e c t s of
   these            projects,                and     their
   applications                 in         agriculture,
   industry,            health        care       and   the
   environment; whereas such a c t i o n s
   w i l l ensure t h a t information i s made
   a v a i l a b l e t o the public concerning
   the content of the programme;
                      Recital 9 b (new)
    Whereas the contextual conditions
    for the beneficial development of
    biotechnology in Europe can be
    improved            through            concertation
    activities;
                     Recital 10 a (new)
   Whereas the r e s u l t s which may be
   achieved by genetic research make i t
   necessary t o adopt an integrated
   approach which takes account of the
   s c i e n t i f i c , e t h i c a l and l e g a l
   aspects of possible applications and
   of the need to ensure t h a t the
   r e s u l t s are not used in an improper
   manner               or       subject              to
   misrepresentation;
                     Recital 10 b (new)
Whereas the Commission has announced its
intention to establish an appropriate advisory
structure to examine the ethical implications of
biotechnology;
 ---pagebreak---                            9
                    Article 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 beginning on ... and ending
on 31 December 1994.
           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 shall make calls for
       proposals for projects on the basis of the
       work programme.
 ---pagebreak---                              -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
necessary, approval from the responsible
authorities. The provisions of relevant
Community directives must be applied as regards
the ecological impact.
             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 l l include enzymes
  and          proteins      associated      with
  b i o l o g i c a l membranes.
 ---pagebreak---                                 f-
        Annex I, Area 1, 4th paragraph,
                        first sentence
The goal i s to a r r i v e at a greater
u n d e r s t a n d i n g of b i o l o g i c a l and
genetic mechanisms.
         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                 transcription,          RNA-
 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.
 ---pagebreak---                                                               -?
                            Annex I, Area 2, 1st paragraph, 2nd sentence
                                                           Research will     be
                            centred               on      the     control    of
                            development,              c e l l commitment and
                            c e l l totipotency in higher organisms
                            s t a r t i n g with the simplest l e v e l s of
                            o r g a n i z a t i o n , namely gametes, eggs,
                            proliferating                  lines    and   their
                            reorganization                   into  organs   and
                            embryos. Research p r o j e c t s on human
                            embryos are not included in the
                            programme.
                                        Annex I, Area 2, 3rd paragraph
                          The goal is to provide to industrial and
                          agricultural undertakings the basic knowledge
                          necessary for a more rational utilisation of
                          resources at the levels of production,
                          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 . , t i iùjx ). iLions ' on the protection of
                          animals ased for experimental purposes will be
                          applied.
                                        \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
 ---pagebreak---                  - 5 -
      Annex I, Area 2, 6th paragraph
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    for    use    in the
assessment     of   biotechnologically
produced      compounds       will     be
developed, with special attention to
immune reactions in 'drug targeting'
and    immunotoxicology       as    such.
Synergism with protein engineering
will be assured.
      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,
pharmacological         and     genetic
characterization of newly discovered
neuroreceptors        systems       will
constitute a specific objective of
the programme.
 ---pagebreak---                              -</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
  introduction of         genetically modified or
 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
 ongoing research in BRIDGE, fishes and
 insects).
             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
materials; this support will be restricted to
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.
 ---pagebreak---                            -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.
 ---pagebreak---                                                                      ISSN 0254-1475
                                                              COM(91) 386 final
                                                      DOCUMENTS
EN                                                                              15
                                 Catalogue number : CB-CO-91-444-EN-C
                                                             ISBN 92-77-76473-2
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