CELEX: 51989PC0532
Language: en
Date: 1989-11-13
Title: MODIFIED PROPOSAL FOR A COUNCIL DECISION ADOPTING A SPECIFIC RESEARCH AND TECHNOLOGICAL DEVELOPMENT PROGRAMME IN THE FIELD OF HEALTH: HUMAN GENOME ANALYSIS: ( 1990 - 1991 )

COMMISSION OF THE EUROPEAN COMMUNITIES
                                                 COM (89) 532 final - SYN 146
                                                 Brussels, 13 November 1989
                MODIFIED PROPOSAL FOR A COUNCIL DECISION
  Adopting a specific research and technological development programme
                         in the field of health:
                   Human Genome Analysis: (1990-19S1)
            (Presented by the Comrussion in accordance with
              Article 149, paragraph 3 of the EEC Treaty)
                                         *
 ---pagebreak---                                      - 2 -
                            Explanatory Memorandum
A. The first reading of the "Proposal for a Council Decision adopting a
   specific research programme in the field of health: Predictive Medicine:
   Human Genome Analysis (1989 - 1991)"(*) was carried out by the European
   Parliament during the part-session from 13 - 17 February 1989.
   The essential message of the 38 amendnents adopted by the Parliament is as
   follows: "The technical content of the research programme proposed by the
   Commission is justified, but care must be taken to see that individual
   rights are protected and respected while it is being carried out.
   Furthermore, it is essential to guarantee that throughout the programme
   the ethical, social and legal problems which may arise out of applications
   of ever more precise knowledge of the human genome are examined and
   debated. This debate should also identify the limits beyond which such
   applications would become unacceptable by society".
B. The expression "Predictive Medicine" is no longer used in the title of the
   programme. It has reverted to "Human Genome Analysis", which corresponds
   to reality since the main aim is to increase our knowledge of human
   genetics. However, it is possible that this type of research, which will
   certainly lead to improvements in the treatment of patients suffering from
   certain diseases of genetic origin, will also lead subsequently to
   applications in predictive medicine. But the social acceptability of such
   applications must first be carefully evaluated.
   The modified proposal is drafted in such a way as to guarantee the respect
   both of rules accepted by or acceptable to our democratic society and of
   the integrity and dignity of the person, not only while the programme is
   running but also in its medium- and long-term consequences.
   The clear affirmation of the respect for the integrity and dignity of the
   person has consequences of which several aspects are defined in the
   modified proposal. The consequences both for the individual and for
   society of the application of the results obtained by research on the
   human genome must be analysed at the same time as the research is being
   (*) COM(88) 424 final, 20 July 1988
 ---pagebreak---                                     - 3 -
   carried out. Possible abuses must be identified, as must, where
   appropriate, recommended national or Community legislative measures. This
   task will be carried out by the Commission assisted by a high-level
   committee which it will set up for this purpose, representing different
   areas   of  science,   law, philosophy     and ethics, together      with
   representatives of patients* associations.
   The term "eugenics" which is contained in amendment no. 10 lacks
   precision. For this reason it is not used directly in the proposal. The
   approach described above guarantees the exclusion from the programme of
   any tendency towards a type of eugenics which would involve the
   "selection" of the human species by genetic means. This guarantee is
   further strengthened by the explicit exclusion of all research seeking to
   modify human genetic heritage by the alteration of germ cells, in
   accordance with Parliament's request (amendments nos. 21 and 33). But the
   modified proposal goes further: it excludes all intervention at any stage
   in the development of the embryo which might lead to hereditary changes.
   This technical possibility is indeed conceivable, and it must be rejected.
   Protection is guaranteed of the confidentiality of information gained
   during the research and of the anonymity of those concerned.
   The prenormative nature of the scientific data acquired, to be available
   to legislative authorities in particular, is highlighted.
   Lastly, progress reports on the research and on studies of ethical, social
   and legal problems will be submitted annually to the Council and the
   European Parliament, and measures will be taken to keep the public fully
   informed of the Community action.
C. As far as the European Parliament*s amendments are concerned:
   -  amendnents Nos. 1, 3, 4, 7, 11, 12, 16, 17, 21, 22, 23, 28, 32, 33, 35
      and 36 have been incorporated in the modified proposal. Amendnents 21
      and 33 have been supplemented to clarify the exclusion of all work
      seeking to "select" the human species.
 ---pagebreak---                               - 4 -
the intentions expressed in amendments nos. 5, 6, 8, 9, 10, 13, 20, 25,
26 and 41 are incorporated in the modified proposal in different terms,
sometimes regrouped or at places in the text other than those foreseen
in the amendments.
amendments nos. 14, 15, 18, 19, 24, 27, 29, 30, 31, 34, 39 and 44
(budgetary amendment) are not incorporated in the proposal. However,
the modified proposal expresses the ideas contained in some of these
amendments, especially nos. 14, 15, 18, 19, 27, 29, 30 and 39.
 ---pagebreak---                                       - 5 -
                   MODIFIED PROPOSAL FOR A COUNCIL DECISION
    Adopting a specific research and technological development programme
                             in the field of health:
                       Human Genome Analysis: (1990-1991)
                (Presented by the Commission in accordance with
                  Article 149, paragraph 3 of the EEC Treaty)
THE COUNCIL OF THE EUROPEAN COMMUNITIES
Having regard to the Treaty establishing the European Economic Community, and
in particular to Article 130 Q (2) thereof,
Having regard to the proposal from the Commission(*),
In cooperation with the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee^),
Whereas Article 130 K of the Treaty stipulates that the framework programme
shall be implemented through specific programmes developed within each
activity;
Whereas by its Decision of 28 September 1987(4) the Council has adopted a
framework programme of Community research and technological development
(1987-1991), in which it provided for activities to be undertaken in the
field of healthj
     h OJ H*
     2
       ) OJ N°
     3
       ) OJ N° C 56/47, 6.3.1989
     4
       ) OJ N° L 302, 24.10.87, p. 1
 ---pagebreak---                                      - 6 -
Whereas, for the evaluation of each specific programme and the selection of
Community actions, the framework programme sets out criteria among which is
that of contributing to the strengthening of the economic and social
cohesion of the Community, consistent with the pursuit of scientific and
technical quality;
Whereas two successive pluriannual programmes of research and training of the
European Economic Coniminity in the field of biotechnologies(5), of which the
second is still in progress, have shown the possibility and usefulness of a
Cormunity action promoting the utilization of modern biology for scientific
and industrial purposes;
Whoreas the framework programme has foreseen in its activity "Quality of
life" under the "Health" line 1.1, the initiation of new activities relating
to the development of knowledge of the human genome;
Whereas a specific programme to study the human genome is therefore necessary
and, in particular, it is necessary to:
    develop and spread the basic technologies concerning the study of the
    human genome, with the intention of improving knowledge of matters of
    medical importance,
    improve the resolution of the human genetic map and to refine the
    physical map by the creation of ordered clone libraries, as a basis for
    locating    genes of medical importance and for a better general
    understanding of gene function, and
    organise networks and coordination, on a European and international
    scale, of researchers from all disciplines working in this field;
Whereas the carrying out of the above-mentioned goals requires the
undertaking at Community level of actions aiming at:
    filling some existing gaps in scientific and technological knowledge, and
    encouraging cooperation between European research institutions with a
    view to furthering the development of existing technologies while
     5
       ) OJ N° L 375, 20.12.1981, p. 1; OJ N° L 83, 25.3.1985, p. 1
 ---pagebreak---                                     - 7 -
    promoting all research sectors capable of generating new lines of
     research;
Whereas, simultaneously, measures will be taken to promote cooperation
between the Community programme and similar ones developed in non-Member
States or by international organizations;
Whereas the right to a genetic identity forms part of the integrity and the
dignity of an individual, and this principle is recognized in the
constitutions and laws of Member States and in the Community legal system as
forming part of the fundamental rights for which respect is ensured;
Whereas the results which can be achieved from human genome research require
the development of an integrated approach taking into account ethical, social
and legal aspects of their possible applications and the need to avoid any
improper use of those results;
Whereas there are good grounds for guaranteeing the right of an individual
in complete possession of the facts to choose whether or not to be informed
of his genetic characteristics;
Whereas, in the absence of clear standards and provisions concerning possible
developments in the field of genome analysis, there may be a risk on the one
hand that attempts are made to intervene in the human genome in order to
make the modifications so obtained hereditary, and on the other hand that
genetic analyses are carried out for monitoring purposes which may have a
profound effect on social life; whereas there are, accordingly, good grounds
for taking the necessary steps to preclude unacceptable developments,
particularly as regards predictive medicine;
Vfoereas, furthermore, it is necessary to develop during the course of the
programme the prenormative aspects arising from human genome analysis by
establishing a reliable scientific data set which could provide a basis for
political authorities to establish sound,, clear and responsible regulations;
Whereas the Scientific and Technical ResearchCommittee (CREST) was consulted
on the following measures,
 ---pagebreak---                                     - 8 -
HAS ADOPTED THIS DECISION:
                                  Article 1
A specific research and technological development programme for the European
Economic Community in the field of Human Genome Analysis, as defined in the
Annex, is hereby adopted for a period of two years commencing on 1 January
1990.
                                  Article 2
The amount deemed necessary as the financial contribution from the Community
for the execution of the programme is 15 million ECU, including costs of a
staff of two persons.
                                  Article 3
Detailed rules for the implementation of the programme are set out ia the*?
Annex.
                                  Article 4
1. The Commission shall send to the Council and to the European Parliament
    an annual report on the progress of the programme.
2.  In the second year of the programme implementation, the Commission shall
    undertake a review of the programme and it shall send the results of this
    review to the Council and to the European Parliament, together, if
    necessary, with any proposals for modification or prolongation of the
    programme.
3. An evaluation of the results achieved shall be carried out by independent
    experts and published in the form of a communication to the Council and
    to the European Parliament.
4. The above-mentioned reports shall be established taking account of the
    objectives and evaluation criteria set out in the Annex to this decision
    and in conformity with the provisions of Article 2, paragraph 2 of
    Decision 87/516/Euratom, EEC.
 ---pagebreak---                                                          - 9 -
                                                       Article 5
The Commission shall be responsible for the implementation of the programs.
It shall be assisted in its execution by an advisory committee, hereinafter
called "the committee", composed of representatives of Member States and
chaired by a representative of the Commission.
                                                       Article 6
1. The Commission shall submit to the committee a draft of the measures to
    be taken. The conrtittee shall give its opinion within a period set by the
    chairman according to the urgency of the matter, decided by a vote if
    necessary.
2. The opinion shall be recorded in the report of the meeting; moreover,
    each Member State shall have the right to have its own opinion recorded
    in the report.
3. The Commission shall take due note of the opinion given by the committee.
    It shall inform the committee of the procedures through which that
    opinion was taken into consideration.
                                                       Article 7
The procedures laid down in Article 6 shall apply in particular to:
    the contents of the calls for proposals;
    the assessment of the proposed projects and the estimated amount of the
    Community's contribution to themj
    departures from the general rules governing Community participation set
    out in the Annex;,
    the participation in                     any project by non-Coramunity organizations and
    enterprises referred to in Article 8(2);
    the measures to be undertaken to evaluate the programme;
    arrangements for the dissemination, protection and exploitation of the
    results of research carried out under the programme.
                                                       Article S
1.  The Commission i s authorized, in conformity with Article 130 N of the EEC
    Treaty, to negotiate agreements with non-member States and international
    o r g a n i z a t i o n s , p a r t i c u l a r l y with non-member S t a t e s taking part in
 ---pagebreak---                                     - 10 -
    European cooperation in the field of scientific and technical research
    (COST) and with countries which have concluded scientific and technical
    framework cooperation agreements with the Community, with a view to
    associating them fully or partially with the programme.
2. VThere framework agreements for scientific and technical co-operation
    between European non-Member States and the European Communities have been
    concluded, organizations and enterprises established in those countries
    may, on the basis of the criterion of mutual benefit, become partners in
    a project undertaken within the programme.
                                  Article 9
This Decision is addressed to the Member States.
Done at                       ,                     .....1989
                                           For the Council,
                                           The President
 ---pagebreak---                                     - 11 -
                                    ANNEX
          for a specific research programme in the field of health:
                            Human Genome Analysis
1. OBJECTIVES
Use and improvement of new biotechnologies in the study of the human genome
for a better understanding of the mechanisms of genetic function, as well as
the prevention and treatment of human diseases. In the pursuit of these
objectives, optimal cooperation will be sought with the programmes of non-
member States and international organizations.
At the same time measures will be taken to develop an integrated approach to
the ethical, social and legal aspects of possible applications of results
obtained through the programme to ensure that they are not misused and also,
with prenormative aspects in mind, to establish a set of bioethical
principles to be followed in the developments to come.
Alteration of germ cells or any stage of embryo development with the aim of
modifying human genetic characteristics in a hereditary manner is excluded
from the programme objectives.
2. TECHNICAL CONTENT
Precompetitive Ccmnunity research, setting up and reinforcement of networks
of European laboratories, and training, intended to allow the use of modern
technologies for the study and setting up of the human genetic map as well as
possible medical applications of the knowledge gained.
The research described below will require the use of data-processing
facilities for the handling of data, and the development of integrated
databases to serve European networks.
 ---pagebreak---                                    - 12 -
2.1 IMPROVEMENT OF THE HUMAN GENETIC MAP
Establishment of a Europe-based network, extending worldwide, for the
collection and mapping of the DNA of large families, in order to provide
research scientists with well-characterized genetic material and sets of
probes to determine the location of the relative positions of genes on the
chromosomes.
2.2 SETTING UP OF ORDERED CLONE LIBRARIES OF HUMAN DNA
Setting up of a European network of laboratories working on establishing
overlapping clone libraries, and support for limited sequencing of cDNA.
2.3 IMPROVEMENT OF THE METHODS AND BASIS FOR THE STUDY OF THE HUMAN GENOME
New biochemical reagents (restriction enzymes, etc.). Improvement of methods
for the detection and localization of genetic markers (techniques for
labelling DNA probes, amplification of genes, etc.). Development of new
vectors for the cloning of large DNA fragments and of procedures for the
transfection of chromosomes. Development of model          systems   for  the
reproducible and stable expression of medically important genes both in vivo
and in vitro aimed at the well-being of patients. Development of new
computer software for the storage and manipulation of data from genome
sequencing and mapping.
2.4 TRAINING
Setting up of a training programme to assist with the technology transfer of
molecular genetics methods, in particular to Member States in which these
techniques are currently underdeveloped.
3.  BPU34ENTATION
3.1 The programme shall be implemented through cost-shared or marginal cost
    contracts, support to centralized facilities and networks, training
    contracts, training grants, courses, consultations with national experts,
    organization of study-group meetings, participation in seminars and
    symposia, publications, studies, dissemination of results to all
    interested groups, and organization of public presentations.
 ---pagebreak---                                     - 13 -
    Community participation will be up to a maximum of 50% in the case of
    cost-shared contracts and could reach 100% in other cases.
    Participants may be research institutions, universities, private
    enterprises, or combinations of them, located in Member States or in the
    non-member States referred to in Article 7, or competent organizations in
    a position to make a significant contribution.
    Projects must be carried out by participants from more than one country,
    and include at least one participant from one Member State.
    Fellows coming from non-^nember States will be accepted in the training
    programme, provided that they meet the required conditions and that their
    costs are covered from other sources, such as other Community programmes
    or actions which support fellows coming from developing countries.
    The contracts concluded by the Commission will govern the rights and the
    obligations of each party, in particular the means of distribution,
    protection and exploitation of the results of the research.
3.2 The drawing up of research contracts can only take place if the
    contracting parties undertake to abstain from all research seeking to
    modify the genetic constitution of human beings by alteration of germ
    cells or of any stage of embryo development which may make these
    alterations hereditary.
    The contracts shall regulate the granting of licences arising out of
    research projects and in particular there shall be no right to exploit on
    an exclusive basis any property rights in respect of human DNA. In
    addition, the Commission shall reserve the right to publish the results
    of the research performed within the scope of the contracts.
    The contracts will guarantee that the members of the            families
    participating in the studies referred to in paragraph 2.1 above will be
    fully informed about and have consented to the use and study of their
    DNA. The contracts will also guarantee complete protection of the
    confidentiality and anonymity of the personal data, obtained in the
    programme.
 ---pagebreak---                                     - 14 -
3.3 The Commission will ensure that during the execution of the programme
    there will be wide-ranging and in-depth discussions of the ethical,
    social and legal aspects of human genome analysis and that possible
    misuses will be identified regarding applications of the results obtained
    or of future developments of that research. It will ensure that the far-
    reaching consequences of the research will be evaluated in a responsible
    manner, and will submit to the Council and to the European Parliament an
    annual report, possibly with legislative recommendations arising as much
    from the research policy angle as frcm the legal one. To this end, the
    Commission will obtain advice from experts in different fields of
    science, law, philosophy and ethics, together with representatives of
    patients1 associations.
4.  EVALUATION CRITERIA
The Communication from the Commission to the Council relating to the
evaluation of Community research and development programmes(°) states that
the objectives and milestones for each research programme have to be set out
in verifiable and, where possible, quantitative form. These reference marks
are listed below:
4.1 The long-term objective of this programme is to contribute to a better
    understanding of the mechanisms of genetic function as well as to the
    fight against human diseases arising from genetic variation (including
    genetic diseases sensu stricto and many common diseases with a genetic
    component, such as heart disease and cancer), through early diagnosis,
    prevention, and improvement of prognosis and therapy. The Commission
    proposes to achieve this objective by:
    - the management of networks of laboratories set up around European
       facilities for (a) the improvement of the human genetic map and (b) the
       setting up of ordered clone libraries of human DNA, either of the
       complete genome or of selected chromosomes, together with cDNA
       sequencing;
     6
       ) OJ N° C 14, 20.1.87, p. 5
 ---pagebreak---                                     - 15 -
    - the launching of a programme of precompetitive research aiming at
      improvement of the methods and basis for the study of the human genome;
    - the setting up of a programme of training to increase the distribution
      of modern genetic technologies in Europe, and to improve technological
      know-how in European laboratories;
    - the promotion of cooperation with non-member States and international
      organizations.
4.2 The primary short-term objective is that the programme should succeed in
    establishing the above-mentioned European networks of laboratories in the
    fields of:
    - the human genetic map
    - ordered clone libraries of human DNA and cDNA sequencing
    - improvement of the methods and basis for the study of the human genome,
    all using data-processing facilities for data-handling and developing
    integrated data bases.
    These objectives should be verifiable in 1991.
4.3 Particular objectives to be attained within two years of the programme
    implementation are as follows:
4.3.1 Concerning the human genetic map:
      - the present total of 40 well-studied large families which form the
        basis for the genetic map should be increased to 60 families;
      - genetic material frem these families, and DNA probes, should be made
        available to the European laboratories concerned while respecting the
        individual rights of those families;
      - a central facility should be identified to pool the results and
        establish an improved genetic map at the 1 to 5" centimorgan level,
        and an integrated databank should be set up.
 ---pagebreak---                                     - 16 -
4.3.2 The strategies for setting up ordered clone libraries of human DNA
      should be compared and a better approach defined; facilities for
      maintaining the stocks of cloned DNA fragments should be established,
      and the available clones       dispatched    to interested     European
      labofa" tories.
4.3.3 Substantial improvements should be obtained in the following research
      fields to improve the methods and the basis for the study of the human
      genome:
    - New reagents, such as restriction enzymes,
    - Methodology for cloning large DNA fragments and for the transfection of
      chromosomes,
    - Gene vectors adapted to human somatic cells in vitro,
    - Ifethodology for the detection of a particular gene in a cell,
    - Localization, cloning and sequencing of new genps, especially those
      which are disease-related,
    - New computer software for the storage, collation and analysis of DNA
      sequence data.
4.4 In addition, the programme should ensure that the following general
    criteria are met:
4.4.1 That throughout the execution of the programme, the ethical, social and
      legal aspects of human genome analysis should be the subject of wide-
      ranging and in-depth discussions, and possible abuses of the results or
      later developments of the work should be identified; principles for
      their utilization and control should be proposed.
4.4.2 That the drawing up of research contracts shall presuppose that the
      contracting parties undertake to abstain from all research seeking to
      nodify the genetic constitution of human beings by alteration of germ
      cells or of any stage of embryo development which may make these
      alterations hereditary.
 ---pagebreak---                                    - 17 -
4.4.3 The members of the families taking part in the studies mentioned in
      paragraph 2.1 must have been informed and given their consent, and the
      confidentiality and anonymity of personal data must be ensured.
4.4.4 That the development and the application of somatic gene therapy are
      not provided for within the framework of the present programme.
4.4.5 That actual or potential medical applications should be facilitated.
4.4.6 That potential opportunities for commercial developments should be
      obtained.
4.4.7 That the overall technological standard of the participating European
      laboratories must have been improved.
4.4.8 That taking account of the results of Community, national or commercial
      research activities in human genetics, the evaluation panel should
      consider whether the human genome analysis has contributed to the
      development of the results of the said activities in regions of the
      Community other than those in which the research was conducted. The
      evaluation panel should also ascertain whether cooperation with non-
      member States and international organizations has indeed been achieved
      and whether this cooperation has had positive results.
 ---pagebreak---                                    •      -AS-
                               FICHE FINANCIERE
                     PROGRAMME ANALYSE PU CENOME HUMAIN
Les points 1 à 4 de la fiche financière originale de la proposition
COH<88)424 restent inchangés.
5.   INCIDENCE FINANCIERE PE L'ACTION SUR LES CREP1TS D'INTERVENTION
      (Y conprls les dépenses de personnel (l agent de catégorie A, 1
     agent de catégorie C) et les dépenses de fonctionnement
     administratif et technique).
5.1. Çoftt tOtll M m U l U tPUtt 11 dUTéi «lYllMto        ^ »i° Ecus
5.2. Part dans la financement
      • du budget communautaire                           15 Mio Ecus
     - des budgets nationaux et )
      - d'autres secteurs au        )......               15 Mio Ecus
        niveau national             )
5.3. Echéancier plurlannuel du budget cosmunautalre
5.3.1. Crédits d'engagement en Millions d'Ecua
                           looo»      îooi                    TSiïâL
Personnel                   0,21      0.21                     0,42
Fonctionnement              0,20      0,25                     0,45
Contrats et bourses        12,09      2,04                    14,13
Total                      12,5       2,5                     15,00
5.3.2. Crédita de paiement en Million* d'Ecua
                           1000»      1001     1002  1993     IPJAL
Personnel                  0,21       0,21       •      *      0,42
Fonctionnement             0,20       0,25       -      -      0,43
Contrats et bourses        3,79       5,54     3,10  1,70     14,13
Total                      4,2        6,0      3,10  1,70     15,00
      * Ces montants figurent à 1*APB 90 - H t sont aujeti à modification
        au cours de la procédure budgétgalre en cours.
 ---pagebreak---                                                                      ISSN 0254-1475
                                                              COM(89) 532 final
                                                      DOCUMENTS
EN                                                                              05
                                Catalogue number : CB-CO-89-485-EN-C
                                                             ISBN 92-77-54138-5
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