CELEX: 51988PC0424
Language: en
Date: 1988-07-20
Title: PROPOSAL FOR A COUNCIL DECISION ADOPTING A SPECIFIC RESEARCH PROGRAMME IN THE FIELD OF HEALTH: PREDICTIVE MEDICINE: HUMAN GENOME ANALYSIS ( 1989-1991 )

No C 27/6                                Official Journal of the European Communities                                   2. 2. 89
                                                                II
                                                         (Preparatory Acts).
                                                   COMMISSION
                Proposal for a Council Decision adopting a specific research programme in the field of health
                                  — Predictive medicine: Human genome analysis (1989 to 1991)
                                                 COM(88) 424 final — SYN 146
                                         (Submitted by the Commission on 27 July 1988)
                                                           (89/C 27/07)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                             Whereas the biotechnology programme presently in
                                                                     progress does not include some fields of research
Having regard to the Treaty establishing the European                important for human health and the quality of life, for
Economic Community, and in particular to Article                     the industrial development of biotechnologies with
                                                                     medical aims and for the control of the increase of social
130 Q (2) thereof,
                                                                     and health expenses;
Having regard to the proposal from the Commission,
                                                                     Whereas the framework programme has foreseen in its
                                                                     activity 'Quality of life' under the 'Health' line 1.1, the
In cooperation with the European Parliament,                         'Initiation of new activities relating to the development
                                                                     of predictive medicine';
Having regard to the opinion of the Economic and
Social Committee,                                                    Whereas, as a result, a specific research and techno-
                                                                     logical development programme is necessary in the field
Whereas Article 130 K of the Treaty stipulates that the              of predictive medicine and, in particular, that it is
framework programme shall be implemented through                     necessary to:
specific programmes developed within each activity;
                                                                     — develop the basic technologies concerning the study
                                                                          of the human genome, as a prerequisite to a large
Whereas by its Decision of 28 September 1987 (') the                      number of developments in biotechnology for health,
Council has adopted a framework programme of                              and to ensure the distribution of these technologies
Community research and technological development                          widely in European laboratories, and
(1987 to 1991), in which it provided for activities to be
undertaken in the field of health;
                                                                     — improve the resolution of the human genetic map and
                                                                          to refine the physical map by the creation of ordered
Whereas, for the evaluation of each specific programme                    clone libraries, as a basis for locating genes of
and the selection of Community actions, the framework                     medical importance and for a better general
programme sets out criteria among which is that of                        understanding of gene function;
contributing to the strengthening of the economic and
social cohesion of the Community, consistent with the
pursuit of scientific and technical quality;                         Whereas the carrying out of the abovementioned goals
                                                                     require the undertaking at Community level of actions
                                                                     aiming at:
Whereas two successive pluriannual programmes of
research and training of the European Economic                       — filling some existing gaps in scientific and
Community in the field of biotechnologies (2), of which                   technological knowledge, gaps which prevent the
the second is still in progress, have shown the possibility               full development of the resources of modern
and usefulness of a Community action promoting the                        biotechnologies in the medical field, and
utilization of modern biology for scientific and industrial
purposes;
                                                                     — promoting, through concerted actions between
                                                                          private and public laboratories, European trans-
                                                                          national cooperation aimed at speeding up the
O OJ No L 302, 24. 10. 1987, p. 1.                                        implementation of technologies already available
(2) OJ No L 375, 20. 12. 1981, p. 1;                                      while promoting European scientific areas which will
    O J N o L 8 3 , 25. 3. 1985, p. 1.                                    encourage new approaches to be developed;
 ---pagebreak--- 2. 2. 89                                 Official Journal of the European Communities                                   No C 27/7
Whereas the Scientific and Technical                 Research         3.    The abovementioned reports shall be established
Committee (Crest) was consulted on the               following        having regard to the objectives and evaluation criteria set
measures,                                                             out in the Annex to this Decision and in conformity with
                                                                      the provisions of Article 2 (2) of the framework
                                                                      programme.
HAS ADOPTED THIS DECISION:
                                                                                                Article 5
                            Article 1
                                                                      1.    The Commission shall be responsible for the
A specific research and technological development                     execution of the programme and shall be assisted in its
programme for the European Economic Community in                      implementation by the Management and Coordination
the field of predictive medicine: human genome analysis,              Advisory Committee (CGC) on Medical and Health
as defined in the Annex, is hereby adopted for a period               Research, set up by Decision 84/338/Euratom, ECSC,
of three years commencing on 1 January 1989.                          EEC (').
                            Article 2                                 2.    The contracts entered into by the Commission shall
                                                                      regulate the rights and obligations of each party, and in
The amount deemed necessary for the execution of the                  particular the methods of disseminating, protecting and
programme is ECU 15 million, including expenditure on                 exploiting the research results.
a staff of two persons.
                                                                                                Article 6
                            Article 3
                                                                      In conformity with Article 130 N of the EEC Treaty, the
Detailed rules for the implementation of the programme                Commission is authorized to negotiate agreements with
are set out in the Annex.                                             non-member States and international organizations,
                                                                      particularly with non-member States taking part in
                            Article 4                                 European cooperation in the field of scientific and
                                                                      technical research (COST) and with countries which
1.    In the second year of the programme implemen-                   have concluded scientific and technical framework
tation, the Commission shall undertake a review of the                cooperation agreements with the Community, with a
programme and it shall report to the Council and to the               view to associating them fully or partially with the
European Parliament on the results of this review,                    programme.
together, if necessary, with any proposals for modifi-
cation or prolongation.
                                                                                                Article 7
2.    An evaluation of the results achieved shall be                  This Decision is addressed to the Member States.
conducted by independent experts and shall be published
in the form of a communication to the Council and to
the European Parliament.                                              (') OJ No L 177, 4. 7. 1984, p. 25.
                                                              ANNEX
              for a specific research programme in the field of health — Predictive medicine: Human genome analysis
              1. OBJECTIVES
              Use and improvement of new biotechnologies for risk-forecasting, early diagnosis, prevention, prognosis
              and treatment of some human diseases, and for a better understanding of the mechanisms of heredity.
              2. CONTENT
              Precompetitive Community research, setting up and reinforcement of networks of European laboratories,
              and training intended to allow the use of modern biotechnologies for the improvement of risk-forecasting,
              early diagnosis, prevention, prognosis and treatment of some human diseases (in particular hereditary
              diseases and cancers).
 ---pagebreak--- No C 27/8                              Official Journal of the European Communities                                       2. 2. 89
          2.1. Improvement of the genetic map of man
          Establishment of a Europe-based network, with a worldwide extent, for the collection of the DNA of large
          families, in order to provide free of charge to research scientists well-characterized genetic material and a
          set of probes to determine the location of the relative positions of genes on the chromosomes. Possible
          provision of computer facilities to handle the data.
          2.2. Setting up of an ordered clone library of human DNA
          Setting up of a European network of laboratories working on establishing overlapping cloned libraries, and
          support for limited sequencing of cDNA.
          2.3. Research on the improvement of advanced genetic technologies
          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.). Devel-
          opment 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. Development of new computer software for the collection and
          manipulation of data from genome sequencing and mapping.
          2.4. Training
          Setting up a training programme to assist with the technology transfer of molecular genetics methods to
          Member States in which these techniques are currently underdeveloped and, in particular, the transfer of
          techniques into the clinical field.
           3. IMPLEMENTATION
          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, and publications.
           The Commission participation may range from about 50 % in the case of cost-shared contracts and may
           reach 100 % in other cases.
           Participants may be research institutions, universities, private enterprises, or combinations of them, located
           in Member States or in the third countries referred to in Article 6.
           Projects must be carried out by participants from more than one country, and include at least one
           participant from one Member State.
           EVALUATION CRITERIA
           The Community plan of action relating to the evaluation of Community research and development
           programmes (') states that the milestones and objectives for each research programme have to be set out in
           verifiable and, where appropriate, quantitative form. These are listed below:
            1.   The long-term objective of this programme is to contribute 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 forecasting the risk, early diagnosis,
                 prevention, improvement of prognosis and, ultimately, therapy. The Commission proposes to achieve
                 this objective by:
                 — the management of a network 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,
                 — the launching of a programme of precompetitive research contracts on advanced genetic tech-
                     nology,
                 — the setting up of a programme of training to increase the distribution of modern genetic techno-
                     logies in Europe, and to improve technological know-how in European laboratories.
           (') OJ No C 14, 20. 1. 1987, p. 5.
 ---pagebreak--- 2. 2. 89                             Official Journal of the European Communities                                    No C 27/9
         2.   The primary short-term objective is that the programme should succeed in establishing the abovemen-
              tioned European networks of laboratories in the field of:
              — the human genetic map,
              — ordered clone libraries of human DNA and cDNA sequencing,
              — advanced genetic technologies.
              These objectives should be verifiable in 1990 to 1991.
         3.   Particular objectives to be attained within three years of the programme implementation are as
              follows:
         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 from these families, and DNA probes, should be made available free of charge to
                  interested European laboratories,
              — a central facility should be set up to pool the results and establish an improved genetic map at the
                  1 to 5 centimorgan level.
         3.2. The strategies for setting up ordered clone libraries of human DNA should be compared and an
              approach defined; facilities for maintaining the stocks of cloned DNA fragments should be established
              and the available clones dispatched free of charge to interested European laboratories.
         3.3. Substantial improvements should be obtained in the following advanced genetic technologies:
              — new reagents, such as restriction enzymes,
              — methodology for cloning large DNA fragments and for the transfection of chromosomes,
              — gene vectors adapted to human cells in vitro,
              — methodology for the detection of a particular gene in a cell (examples: how to make the use of
                  DNA probes and gene amplification easier),
              — localization, cloning and sequencing of new genes, especially those which are disease-related,
              — new computer software for the storage, collation and analysis of DNA sequence data.
         4.   In addition, the programme should ensure that the following general criteria are met:
         4.1. That throughout the execution of the programme, the projects should have taken adequately into
              consideration the complex ethical aspects of human genetics, avoiding any manipulation of human
              germ cells, and any risk to the environment.
         4.2. That medical developments are actually or potentially facilitated by the results obtained.
         4.3. That potential opportunities for commercial developments are obtained.
         4.4. That the overall technological level of the participating European laboratories has been increased.
         4.5. Taking account of the results of Community, national or private sector research activities in human
              genetics, the evaluation panel shall consider whether the predictive medicine programme has
              contributed to the application of the results of the said activities in regions of the Community other
              than those in which the research was conducted.