Source: EURLEX
Language: en
Format: md

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,

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,

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 (') the
Council has adopted a framework programme of
Community research and technological development
(1987 to 1991), in which it provided for activities to be
undertaken in the field of health;

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
Community in the field of biotechnologies ( [2] ), of which
the second is still in progress, have shown the possibility
and usefulness of a Community action promoting the
utilization of modern biology for scientific and industrial

purposes;

O OJ No L 302, 24. 10. 1987, p. 1.
( [2] ) OJ No L 375, 20. 12. 1981, p. 1;

OJNoL83, 25. 3. 1985, p. 1.

Whereas the biotechnology programme presently in
progress does not include some fields of research
important for human health and the quality of life, for
the industrial development of biotechnologies with
medical aims and for the control of the increase of social

and health expenses;

Whereas 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 predictive medicine';

Whereas, as a result, a specific research and technological development programme is necessary in the field
of predictive medicine and, in particular, that it is
necessary to:

— develop the basic technologies concerning the study
of the human genome, as a prerequisite to a large
number of developments in biotechnology for health,
and to ensure the distribution of these technologies
widely in European laboratories, and

— 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;

Whereas the carrying out of the abovementioned goals
require the undertaking at Community level of actions
aiming at:

— filling some existing gaps in scientific and
technological knowledge, gaps which prevent the
full development of the resources of modern
biotechnologies in the medical field, and

— promoting, through concerted actions between
private and public laboratories, European transnational cooperation aimed at speeding up the
implementation of technologies already available
while promoting European scientific areas which will
encourage new approaches to be developed;

2. 2. 89 Official Journal of the European Communities No C 27/7

Whereas the Scientific and Technical Research

Committee (Crest) was consulted on the following

measures,

HAS ADOPTED THIS DECISION:

_Article 1_

A specific research and technological development
programme for the European Economic Community in
the field of predictive medicine: human genome analysis,
as defined in the Annex, is hereby adopted for a period
of three years commencing on 1 January 1989.

_Article 2_

The amount deemed necessary for the execution of the
programme is ECU 15 million, including expenditure on
a staff of two persons.

_Article 3_

Detailed rules for the implementation of the programme
are set out in the Annex.

_Article 4_

1. In the second year of the programme implementation, the Commission shall undertake a review of the
programme and it shall report to the Council and to the
European Parliament on the results of this review,
together, if necessary, with any proposals for modification or prolongation.

2. An evaluation of the results achieved shall be

conducted by independent experts and shall be published
in the form of a communication to the Council and to

the European Parliament.

_ANNEX_

3. The abovementioned reports shall be established
having regard to the objectives and evaluation criteria set
out in the Annex to this Decision and in conformity with
the provisions of Article 2 (2) of the framework

programme.

_Article 5_

1. The Commission shall be responsible for the
execution of the programme and shall be assisted in its
implementation by the Management and Coordination
Advisory Committee (CGC) on Medical and Health
Research, set up by Decision 84/338/Euratom, ECSC,
EEC (').

2. The contracts entered into by the Commission shall
regulate the rights and obligations of each party, and in
particular the methods of disseminating, protecting and
exploiting the research results.

_Article 6_

In conformity with Article 130 N of the EEC Treaty, the
Commission is authorized to negotiate agreements with
non-member States and international organizations,
particularly with non-member States taking part in
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.

_Article 7_

This Decision is addressed to the Member States.

(') OJ No L 177, 4. 7. 1984, p. 25.

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).

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.). 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._ 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 technology,

— 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.

(') OJ No C 14, 20. 1. 1987, p. 5.

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 abovementioned 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.