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 sub­
sumed 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 particu­
lar, 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. Making use of research potential 
Despite serious concern as to the potential consequences 
of genetic engineering in general, we endorse the Com­
mission'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 her­
editary disease than by acquired disease or handicaps, 
predictive medicine may become one of the most effec­
tive 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. Ethical aspects of genetic research 
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 medi­
cine: 
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 jeopard­
ized 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 antici­
pated 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 gen­
etic 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 cri­
teria 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, con­
crete efforts must be made—in conjunction with the 
Commission's genetic research programme—to har­
monize 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 con­
cerned. 
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. The social impact of predictive 
medicine 
Predictive medicine will have certain social reper­
cussions. 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 gen­
etic 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 connec­
tion with recruitment or proficiency tests. This must be 
prohibited from the start. A corresponding veto should 
be incorporated in the catalogue of basic social Com­
munity standards which are long-standing demands. 
As proposed by the European Parliament's Committee 
on legal affairs and citizens' rights, the following con­
ditions 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 press­
ures 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 pro­
hibited, 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 predis­
position 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 screen­
ing 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 policy­
holder 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 research­
ing 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 essen­
tial 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 con­cerned, 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 pro­
tected, 
— 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 investi­
gation of ethical issues. Tenders should be approved 
only in consultation with the local Ethical Com­
mittees. 
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 ex­
treme fears. 
Special public relations work is therefore required. Top-
quality, 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 mod­
est. 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 dis­
eases or particular genetic defects. 
4.3. Article 3 
The detailed information on implementation of the 
programme should, from the outset, include as an essen­
tial 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 cata­
loguing 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 specifi­
cations. 
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