Source: EURLEX
Language: en
Format: md

6. 3. 89 Official Journal of the European Communities No C 56/47

Opinion on the proposal for a Council Decision adopting a specific research programme in
the field of health - Predictive medicine: human genome analysis (1989-1991)

(89/C56/18)

On 9 August 1988, the Council decided to consult the Economic and Social Committee
under Article 130 q of the Treaty establishing the European Economic Community on the
abovementioned proposal.

The Section for the Protection of the Environment, Public Health and Consumer Affairs,
which was responsible for preparing the Committee's work on the subject, adopted its
Opinion on 29 November 1988. The Rapporteur was Mrs Tiemann.

At its 261st plenary session (meeting of 14 December 1988), the Economic and Social
Committee adopted the following Opinion with no dissenting votes and one abstention.

1. Introduction

1.1. The draft programme is part of the current
(1987-1991) 'framework research and technological
development programme' whose 'health' line, as subsumed under the 'quality of life' heading, provides for
new activities in connection with the development of
predictive medicine.

1.2. The programme's objective is to secure greater
insight into the human genome. This should, in particular, open up new scope for diagnosis so that analysis of
the human genome should make it possible to identify
particular susceptibilities and hence prevent illnesses or
treat them at an earlier stage and more effectively.

The initial step would be to compile genetic maps
which could be subsequently used to establish genetic
deviations. Ordered groups of DNA-fragments should
also be collected in clone libraries. This would provide
the basis for later work.

The programme is not concerned with blanket analyses
nor hereditary alterations to the genome and must not
be so in the future. The Commission document should

emphasize this more clearly in order to prevent any
misunderstandings and should specifically ban genetic
manipulation.

2. General comments

2.1. _The specific problems of predictive_ _medicine_

2.1.1. M a k i n g u s e of r e s e a r c h p o t e n t i a l

Despite serious concern as to the potential consequences
of genetic engineering in general, we endorse the Commission's objectives in principle. The Commission's
draft must, however, be adapted to take account of the
fundamental reservations set out below.

It would be deeply inhuman to withhold from patients
diagnostic procedures and forms of treatment which
apply the latest medical and scientific findings and
technological potential. It is therefore essential to secure
the most effective, useful and adequate treatment
required for individual cases or to carry out research.

Preventing illnesses or treating them effectively as early
as possible must be the top priority of any health
service. Even though fewer people are affected by hereditary disease than by acquired disease or handicaps,
predictive medicine may become one of the most effective ways of preventing disease, since common illnesses
such as cardiovascular disease, diabetes and cancer
frequently have a hereditary component.

These possibilities for research must be fully used in
order to preserve European industry's leading position
in this sector of the world market. A fundamental
principle must however be stressed: this kind of medical
policy must on no account be allowed to interfere with
the personality of the individual, his self-determination
and his social and working life.

2.1.2. E t h i c a l a s p e c t s of g e n e t i c r e s e a r c h

Our faith in science and the creativity of research should
not blind us to the fact that there must be limits, despite
the existence of ethical and moral standards and the
vast scale of scientific progress. If research is to serve
in the interests of mankind, self-restraint is required to
make the research findings controllable and to protect
them from abuse.

This applies in a very specific way to predictive medicine:

The human genome identifies an individual human
being, his individual characteristics and his personality.
Respect for human dignity and individuality therefore
call for a particular ethical sensitivity, special legal
provisos and possibly self-imposed restraint in all mat

No C 56/48 Official Journal of the European Communities 6. 3. 89

ters connected with the human genome. People's control
over their own decisions must on no account be jeopardized by genetic research.

In this context, particular reference should be made to
the report by the European Parliament Committee on
legal affairs and citizens rights on the ethical and legal
problems of genetic engineering.

The first phase of the research programme provides
primarily for setting up a research network. There is,
however, a danger in genetic research that findings may
become an end in themselves and that academic or

economic interests may make a subsequent pause for
reflection impossible. At this early stage therefore, a
thorough assessment should be made of: (1) the anticipated long-term value of the planned research for
patients and (2) the ethical involved. These must, on
no account, take second place to economy drives in
health services or political or commercial aspects. The
research programme must thus from the outset be
backed up by a programme of comprehensive research
into the risks and the possibilities of risk containment.

The ethical aspects which the Commission refers to
cannot be overemphasized. In this form, however, they
are too general and provide no effective protection
against possible abuse.

An Ethical Committee should be appointed to monitor
this and similar programmes. Its members should be
selected by the Member States to represent various
academic disciplines and the relevant social groups.

The Ethical Committee should define the limits of genetic research and establish ethical standards to which

all research must conform. In addition, this Committee
should assist the Commission in the implementation of
the programme, by scrutinizing all applications for
research contracts and checking annually that the criteria are being adhered to.

On the basis of the European Ethical Committee's
definitions,, the Commission should specify in a code
of practice the ethical and moral limits which must not
be overstepped in the framework of this programme.
The principles thus defined should be enshrined in a
framework Directive. In order to ensure adherence to
these principles outside this programme, however, concrete efforts must be made—in conjunction with the
Commission's genetic research programme—to harmonize legislation on genetic medicine in the long term.

The above code of practice must be accorded the same
binding force as legal provisions by the parties concerned.

It must therefore be framed both by doctors and other

researchers specialized in predictive medicine and by
lawyers and prominent persons of high moral standing.

2.1.3. T h e s o c i a l i m p a c t of p r e d i c t i v e
m e d i c i n e

Predictive medicine will have certain social repercussions. The Commission is called on to investigate,
in conjunction with social forces in the Community,
the potential social impact of the application of this
kind of medicine.

The consequences may be particularly acute for persons
who have been diagnosed as having a genetic defect
which cannot be treated because available therapy lags
decades behind the diagnostic potential created by genetic engineering.

Steps must be taken to ensure that the application of
predictive medicine does not impair the social, cultural
and economic development of whole social groups. The
well-being of the individual and his family rather than
any other social interests must be the criterion for
deploying the new diagnostic potential. Specifically,
any kind of discrimination against families who have
opted to keep a handicapped child must be made illegal.

There is a danger that the findings of genetic research
may in the future be used on the labour market as a
form of unfair employee selection procedure in connection with recruitment or proficiency tests. This must be
prohibited from the start. A corresponding veto should
be incorporated in the catalogue of basic social Community standards which are long-standing demands.

As proposed by the European Parliament's Committee
on legal affairs and citizens' rights, the following conditions should be laid down:

— genetic analyses must on no account be used for the
scientifically dubious and politically unacceptable
purpose of improving the population's gene pool,

— the principle of patient's right of self-determination
must take absolute precedence over economic pressures imposed by health care systems,

— the establishment of individual gene record cards
and their storage and possible evaluation by the
authorities or private organizations must be prohibited, such should only be permitted in the context
of individual medical genetic counselling,

— the development of genetic strategies for the social
problems must stop,

— the weeding out of individual workers with a predisposition to illness must never be the alternative to
a further reduction in objective risks at the place of
work,

6. 3. 89 Official Journal of the European Communities No C 56/49

— the general use of genetic analyses for.mass screening of employees should be outlawed,

— the employer's right to information and the scope
of company medical examinations on appointment
must be restricted to the applicant's current state of
health and aptitude for the proposed job and any
infringements of the right to obtain information
must be subject to prosecution,

— special measures must be taken to project genetic
data on workers from abuse by third parties,

— genetic analyses should not be made a requirement
for the conclusion of an insurance contract; a clause
specifying this should be included on the form given
to the insured person before the contract is signed,

— the insurer has no right to be notified by the policyholder of all the genetic data known to the latter.

2.2. _International_ _cooperation_

The programme contributes to the further development
of the high scientific standard of European medicine
and helps to secure its international competitivity.

Europe's democratic and constitutional traditions make
it particularly essential for it to make a commitment
on this issue. It is however strongly recommended that
the programme be carried out in conjunction with
researchers in other countries on the basis of reciprocal
information.

3. Special provisos on implementation

3.1. Special provisos governing the implementation
of the programme are at all events needed from the

outset.

It is for example essential to establish now:

— that the Commission must immediately work out a
programme with the specific objective of researching the scope for protecting Community citizens
from the improper application of knowledge about
the human genome,

— that there can be no medical grounds or ethical
justifications for hereditary alternation of genome
structure. Genetic manipulation of this nature must
be banned outright,

— that the programme will confine itself exclusively
to genetic maps and clone libraries which are essential for the pursuit of research and that precise
confidential records will be kept of these,

— that investigations of human genome structures can
only be carried out with the full knowledge and
unequivocal, written consent of the person con

cerned, with strict regard for personal rights and in
accordance with the guidelines for the practice of
medicine based on ethical and moral principles,

— that the scientists involved in the research are bound
to absolute secrecy as regards the subjects' personal
circumstances and that personal data are fully protected,

— that there is cooperation between medical lawyers,
moral theologians, psychologists and, if necessary,
experts from other fields such as sociologists, and
with employers' organizations, trade unions and
consumer associations. Specific contracts should be
issued alongside the programme for the investigation of ethical issues. Tenders should be approved
only in consultation with the local Ethical Committees.

3.2. _Public relations_

Attitudes towards genetic research in general and the
proposed programme in particular vary widely, ranging
from inadmissible playing down of the dangers to extreme fears.

Special public relations work is therefore required. Topquality, objective information techniques must be used
to brief the public about the aims and purpose of
the programme, its immediate value and the possible
repercussions for future generations. The Commission
must give this public relations work top priority since
the programme's health policy objectives can only be
achieved on the basis of a broad social consensus.

The Commission must also provide information
throughout the world on the problems and dangers of
genetic research so that the Community can take the
credit for creating due awareness of the problems.

4. Specific comments

4.1. _Article 1_

Within the three-year time-scale envisaged, it should
be possible to establish a research network and, by
coordinating ongoing activities, which are at present
being conducted separately, lay the foundation stone
for major research results in the future.

These efforts will lead to the refinement of existing
genetic maps. It will not, however, be possible to
achieve the required degree of accuracy for the entire
human genome in the space of three years.

No C 56/50 Official Journal of the European Communities 6. 3. 89

4.2. _Article 2_

4.2.1. The proposed financial resources seem modest. This must not be a reason for not carrying out the
required ethical assessment and information campaign.

At any rate it is absolutely essential to ensure that
funding will be provided for carrying out the five-year
follow up programme as soon as the corresponding
research findings are available for the first phase.

4.2.2. In this context, thought should be given to
whether the research programme could be launched
now and resources at least concentrated on specific
areas where significant results can be achieved. The
clone libraries could conceivably be restricted to certain
chromosome regions or additional families could be
selected for the purposes of research into specific diseases or particular genetic defects.

4.3. _Article 3_

The detailed information on implementation of the
programme should, from the outset, include as an essential component the provisos designed to safeguard the
abovementioned ethical aspects.

4.4. _Article 4(1) and (2)_

The Economic and Social Committee must also be

briefed about the assessment of the results.

4.5. _Article 5(1)_

4.5.1. It would definitely be possible to implement
the programme more efficiently if individual central

Done at Brussels, 14 December 1988.

institutions (e.g. for data compilation and processing)
actively took on the role of providing services and
catering for distribution, while independent groups of
research workers would be responsible for the research
aspect of processing the data and producing or cataloguing clones.

4.5.2. The most crucial stages of research should be
put out to public tender in order to ensure that contracts
are awarded on an objective basis. When awarding the
tenders, the Commission should take account of the
views of independent, qualified experts in respect of the
technical quality of the tenders.

4.6. _Article 5(2)_

4.6.1. It is essential to draw up contracts specifying
rights and obligations.

4.6.2. The allocation of ressources must be made
dependent on whether applications satisfy these specifications.

This is the only way to achieve the objectives of the
research programme and to ensure that the provisos
(see above) are adhered to.

The sample contract which is to be used for awarding
contracts, does not yet meet these requirements. It
is therefore proposed that a special codicil be added
committing the applicant to the objectives and provisos
of the programme. The European Ethical Committee
must ensure that all contracts conform to the standards
agreed in the code of practice called for above.

_The_ _Chairman_

_of the Economic and Social_ _Committee_

Alberto MASPRONE