Opinion of the Economic and Social Committee on the "Communication from the Commission — Towards a strategic vision of life sciences and biotechnology: consultation document"
Date: 2002-02-21
Institutions: European Economic and Social Committee
Subjects: biotechnology, consumer information, genetically modified organism, labelling, research policy, technological change

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Opinion of the Economic and Social Committee on the ‘Communication from the Commission
— Towards a strategic vision of life sciences and biotechnology: consultation document’

(2002/C 94/07)

On 6 September 2001 the Commission decided to consult the Economic and Social Committee, under
Article 262 of the Treaty establishing the European Community, on the above-mentioned communication.

The Section for the Single Market, Production and Consumption, which was responsible for preparing
the Committee’s work on the subject, adopted its opinion on 25 January 2002. The rapporteur was
Mr Bedossa.

At its 388th Plenary Session of 20 and 21 February 2002 (meeting of 21 February), the Economic and
Social Committee adopted the following opinion by 83 votes to two with three abstentions.

1.

Introduction

itself a new strategic goal

At the European Council in Lisbon in March 2000, the
1.1.
European Union set
for the
next decade: to become the most competitive and dynamic
knowledge-based economy in the world capable of sustainable
economic growth with more and better jobs and greater social
cohesion.

1.2.
At the Stockholm European Council, which followed
Lisbon, the Commission again drew attention to the economic,
social and environmental potential of life sciences and biotech-
nology. It is with the aim of articulating this strategic vision
and implementing it by 2010 and beyond that the Commission
is initiating a broad and open discussion on the basis of this
communication.

1.3.
First, in accordance with the new principles of govern-
ance in Europe, and in order to adapt this comprehensive and
forward-looking approach to meet future challenges and the
Lisbon objectives, the Commission is now launching a broad
public debate on the issue, with the aim of reaching a
consensus if possible.

1.4.
To start with, it should be pointed out that the current
biotechnology boom is almost exclusively concentrated in
developed countries, namely northern America, Europe and
Japan and more recently China and Australia, too (and perhaps
other parts of Asia in the future).

1.5.
The developing world is largely a spectator, for reasons
which have to do with a lack of scientific know-how, with the
amount of financial resources available and with the scarcity
of ‘risk-taking’ entrepreneurs.

1.6.
All countries, and especially developing countries, are
concerned with the need to increase food resources and with
the problem of environmental pollution. There is a risk of
them being relegated to the role of observers without the
reassurance that the products being tested (e.g. medicines) are

being developed with their particular needs in mind. There is
a risk that their rich genetic heritage (animals or plants) that
helps to make up the planet’s biodiversity will be exploited
without payment by third parties or sold to the highest bidder.

1.7.
Life sciences and biotechnology raise countless ques-
tions that must be addressed at the appropriate level, on the
basis of subsidiarity; in the case of life sciences for which
ethical principles must be defined, for instance, responsibility
lies with the Member States.

To avoid problems, it must be possible to design a European
framework. The Council of Research Ministers reached a
political agreement on this on 10 December 2001.

This open, comprehensive,

1.8.
transparent and cross-
disciplinary debate concerns everybody: public authorities,
scientists, economic players, consumers, the general public,
organised civil society and social players.

1.9.

Every kind of issue must be addressed:

— broad scientific knowledge;

— improving health and increasing food resources;

— competitiveness;

— research;

— innovation;

— opportunities and risks;

— social context and ethical basis.

These issues shape public perceptions and must therefore be
considered rationally and honestly.

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2. General comments

2.2.2.

Genetic diagnosis is now becoming common.

Biotechnology is certainly a fascinating topic: it has a long
tradition since it is one of the oldest human farming skills,
used for example to produce bread, beer, wine, cheese and
other products of fermentation; to rear new species of animals
to produce vaccines,
and cultivate new types of plants;
antibiotics, etc. The term ‘biotechnology’ has been used for
several decades owing to the rapid advances made in the field.

2.1. What is biotechnology?

2.1.1.
To be logical and chronological, we should first
consider what has been discovered in the field of life sciences,
especially genetics.

2.1.2.
Considerable progress has been made in understand-
ing the structure, function and reproduction of living cells. But
the concept of genetic heritage must be precisely defined
because genetic determination has not yet been completely
elucidated.

2.2.3.
strong public reaction.

However, GMOs in foodstuffs are provoking a very

2.2.4.
Biotechnology is now relevant to human health,
feeding the population and combating pollution. The role of
biotechnology is certain to expand; 25 % of new medical active
substances are now produced by biotechnology, and this will
increase to 50 %.

2.2.5.
There are considerable economic implications in
terms of competitiveness, economic growth and employment.

2.2.6.
The financial costs are high and return on investment
slow, requiring involvement of strong economic players, as in
most economic sectors that use new high-potential tech-
nologies.

2.1.3. Much work remains to be done in terms of under-
standing, decoding and interpreting genetic interactions in
order to improve human health.

2.2.7.
In many respects biotechnology is ultimately, like
the spheres of scientific
information technology, one of
application likely to produce profound upheavals in our
developed societies in future decades.

2.1.4.
Very quickly, in just a few years, genetic research has
developed the technical capacity to identify, isolate, reproduce
and transfer one or more genes to another living organism.
This is what is referred to as genetic engineering, which has
the pejorative connotation of genetic manipulation.

The next stage is to use molecular biology and
2.1.5.
genetic engineering in practical applications, especially in
biotechnology, whose main applications are in human health
(diagnostics and/or therapeutics) and agriculture (genetically
modified organisms, or GMOs). This must be broadened to
include new areas, such as production of fine chemicals and
bioremediation.

2.2. Biotechnology: an everyday reality

Biological techniques have existed for a very long
2.2.1.
time, and biological science has given the human race consider-
able capabilities:
in the form of
in the past microbiology,
vaccines, was used to treat diseases; now genetic science and
its applications are marking a real break with the past, and
public opinion is only gradually becoming aware of this
(vaccines, new medicines).

2.2.8.
Public opinion is thus confused and increasingly
vocal: it is difficult for the general public to follow scientific
advances, but there is a realisation that discovering the human
genetic heritage is a major breakthrough. This positive and
negative interest is expressed in language that is not always
adequate for the necessary task of informing and familiarising.
Generally speaking, the gulf between scientific experts and the
to available information and
general public with respect
knowledge is very wide. This problem and others were
addressed by the Committee in a previous opinion entitled
‘Science, society and the citizen in Europe’ (1) (points 3.1.3, 7.1
and 7.3).

2.2.9.
Beyond this often highly emotional response, people
are weighing up the importance of the ethical and political
issues raised by the very rapid progress and development of
biotechnology. Obviously this is nothing new in science, where
for a long time precautionary measures and regulations have
been required to protect researchers against the risks they
face when conducting their activities or to ensure rigorous
restrictions on human experimentation.

(1) OJ C 221, 7.8.2001, p. 1.

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2.2.9.1. What are the answers to these questions and who
should give the answers? The question must be presented with
issues are
all
acquiring an extra dimension in the form of a legitimate
concern to protect human beings and the environment.

its implications, especially since the ethical

Thus the almost limitless possibilities that genetic
2.2.10.
engineering seems to offer and the substantial growth in
genetic diagnostics are generating an ethical debate of unpre-
cedented intensity (e.g. on cloning, prevention of genetic
abnormalities). How can these questions be answered and who
should provide the answers to them?

2.3. The implications of biotechnology for Europe

2.3.1.
There are implications for the quality of research in
the life sciences and the extent to which it meets current social
expectations:

— competence and quality of scientists concerned, their

organisations and education systems;

— effectiveness of the innovation process;

— the role of public authorities in promoting the develop-

ment of life sciences and biotechnology;

— definition of

‘valuable’ research:

the pharmaceuticals

industry for health, agri-foodstuffs industry for GMOs;

3. Specific comments

the Council of Europe,

3.1.
This lengthy consultation document from the Com-
mission is based on 25 years of policies and texts relating to life
sciences and biotechnology. The Commission, the European
the Organisation for
Parliament,
Economic Cooperation and Development (OECD) and the
European Group on Ethics have produced a raft of opinions,
documents, rules and guidelines that join the many contri-
butions from the Member States, and from the numerous
professional players concerned.

3.2.
The Commission is relaunching the consultation and
debate, to which it attaches primary importance. The European
Commission,
in which several Commissioners and depart-
ments are responsible for biotechnology, invites comments
from citizens, consumers, as well as organised civil society,
scientists, public authorities and players with economic inter-
ests in industry, agriculture or the services sector to contribute
to the Commission’s reflections on the policy paper in
preparation.

3.3.

Europe lagging behind

— compatibility with the legal framework:

3.3.1.
behind the United States in this area.

The debate is needed now because Europe is lagging

— supervision of research

— marketing authorisation

— industrial property rights;

— amount of information provided,

involvement of and
acceptance by the general public; the extent to which
advances that are problematic are acceptable to a general
public behaving like a cat on a hot tin roof: enthusiastic
about the distribution of genetically engineered insulin
but fearful and full of wild ideas when it comes to
consumption of GM cornflour, as if it were easier to
inject a medicine than to eat a fruit or salad;

— ethical limits imposed on society.

too,

Here,

2.3.2.
the Committee refers to its opinion
‘Science, society and the citizen in Europe’ (1). This opinion
formed the basis for an action plan.

(1) OJ C 221, 7.8.2001, p. 1.

3.3.2.
Several European countries have played a key role in
crucial discoveries in molecular biology. Life sciences research
in Europe is not inadequate, either quantitatively or qualitat-
ively: although publications may be slightly inferior in the
sphere of basic science, they are far superior in medical
research. An important indication is Europe’s contribution in
terms of completed sequencing of whole genomes.

3.3.3.
It is Europe’s research culture that has been more
relevant, such as the tradition of knowledge-sharing which
discourages patent applications, and the weakness of links
between research and industry, which produces misunder-
standing.

3.3.4.
Certain governments in Europe have been slow
to grasp the implications of biotechnology in terms of
competitiveness, growth and employment, whereas the Euro-
pean institutions were much quicker on the uptake.

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3.3.5.
Thus the development of biotechnology applications
in health was slow. The pharmaceuticals industry in Europe
also took a long time to become interested in active substances
produced by biotechnology.

3.3.6.
of new technologies, including biotechnology.

Lack of risk capital put a brake on the development

3.4.

Europe wakes up

3.4.5. More recently, European efforts have borne fruit and
the gap with the US has narrowed:

— ‘Biotech’ companies have developed rapidly, doubling in
number and number of staff between 1995 and 1998,
and they now occupy a growing number of market
niches;

— risk capital companies are being developed and markets
adapted to high technology companies are being estab-
lished;

3.4.1.
ing a ‘wake-up call’.

The Commission played an important role in provid-

— an appropriate legal framework with respect to market
authorisation (MA) and industrial property rights (IPR) is
being established at European and/or national level.

— In 1970 a first directive was issued,

followed by a

recommendation:

— 1978: the FAST programme

— 1982: the BEP programme

— 1984: the first RDFP (Research and Development
Framework Programme) with specific measures in
the spheres of health, agri-foodstuffs and chemicals.

3.4.2.
These measures were intended to provide a frame-
work for demonstration projects facilitating the transition
between research and marketing. They were implemented
cross-sectorally in research and training in basic biotechnology,
the aim being to systematically relieve bottlenecks that were
blocking the application of genetics, biochemistry and micro-
biology in both agriculture and industry.

— Discussion of rules and standards.

— A European approach to industrial property rights,
providing an opportunity to reconsider the Community
patent and its advantages over the European patent.

— Coordinating national and Community policies within a

specialised body.

3.4.3.
Awareness grew gradually at Member State level,
with the UK taking the lead, perhaps because of its intellectual
affinity with the United States, reinforced by the ultra-liberal
policies of the British government with respect to science.

3.5. Community research funding policy

— regulatory basis for Community action and the RTD&Ds.

The Single European Act in 1989 was the first piece of
legislation to establish Community competence in the
sphere of research by codifying rules and principles for
action and coordinating intervention mechanisms; the
framework programmes established on this basis set out
scientific and technological objectives and broadly define
the measures to be taken to achieve these objectives,
which must complement action taken by the member
states.

— biotechnology was a key element of the 4th and 5th
RTD&Ds (framework programmes for research, techno-
logical development and demonstration activities) of the
European Community.

Biotechnology is also an important part of the proposal
relating to the 6th RTD&D. However, the Committee
feels that the scope of research should not be too narrow,
e.g. restricted to medical applications only, but should
also include foodstuffs, fine chemicals and the environ-
ment.

Work under the 4th RTD&D was intended to focus on
improving basic biological knowledge of living systems
(the ‘cell factory’, genome sequencing). Some projects are
on a shared cost, others on a concerted action basis. SMEs
are crucial in this area and so their involvement has been
encouraged.

— evaluation data.

3.4.4.
The first specific programmes to promote biotechno-
logy were set up. The Dechema study was carried out in
Germany in 1972; France set up its own special programme in
1982; the Netherlands based its measures on the Schelperoort
Report; and Denmark launched a programme in 1987.

Implementing these programmes has led to the setting
up of ‘industrial platforms’, which are defined as groups
of companies involved in specific technology projects;
this has made it possible to promote collaborative efforts

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between research and industry,
to facilitate contacts
between SMEs and researchers, to better identify certain
areas of interest for industry and to bring about broader
participation of companies in these RTD&Ds. The com-
petitiveness of these high-risk — and sometimes high-
profit — companies has often been stymied because the
social and legal framework tends to discourage risk-
taking and business start-ups.

— developing a European research agenda.

pathogens escaping into the environment and that in certain
cases a cautious approach is adopted in developing clinical
trials.

3.7.2.
As a general rule it is recommended that ‘good
manufacturing practice’ be observed when using ‘low-risk’
recombinant organisms, a principle that has been the basis for
national safety rules in most OECD countries.

3.6.

Legal framework for developing biotechnology

— What precautions should be taken and limits set so that
research does not endanger researchers themselves and/or
human beings and the environment?

— What specific framework should be set up for in vivo

studies, whether human or animal?

— Where does free access to new knowledge end and
researchers’ right to legal protection for their discoveries
begin?

— These questions are very important since we are talking
about the very sensitive area of the genetic heritage of
plants, animals and humans, which is the memory and
history of the species.

— Because progress is very rapid,

in terms of genetic
engineering possibilities, i.e. applications, it is difficult to
keep track of the threshold between knowledge and
research.

— There are considerable economic and financial

impli-
cations in this sphere, which affects all questions of
industrial property.

— One specific issue is that of pathogenic micro-organisms,
their manipulation, and protection of the general public.

— These factors explain the significance of

the ethical
implications of biotechnology. The purpose of the ethical
debate is to draw up a framework of reference and this
involves deciding on the dividing line between what is
morally acceptable and what is not.

3.7.3.
This approach has usually been maintained in the
health sphere, whereas in agricultural applications (GMOs),
precautions and a special framework are required as soon as
substances are being handled outside of a closed environment
and there is therefore a risk of release into the environment.
The European directives adopted fall into two categories: the
first type establish a framework for the safety measures applied
in laboratories and industry, while the second specifically
concern genetically modified organisms. They also reflect not
just a difference in terms of government and public sensibilities,
but also an objective difference in terms of risk. Medical
applications of biotechnology have become widely accepted
alongside non-genetic techniques, whereas this is clearly not
the case for GMOs. The problem is that in the United States
this distinction is not made: although genetic engineering
applications require special attention in view of the scientific,
economic and risk assessment factors, they are all covered by
the standard legal procedures administered by the big federal
agencies:
the FDA (Food and Drugs Administration), the
EPA (Environment Protection Agency), the Department of
Agriculture, NIH, etc. The situation in Japan is the same.

3.8. Marketing authorisations

In all countries, clinical trials comprise three successive phases
which are lengthy and laborious. This illustrates the long-term
and risky nature of the investment required to research and
develop an active substance, and means that the sometimes
premature declarations of success on the part of biotechnology
companies should be treated with caution.

3.9.

Industrial property rights and the concept of patenting living
organisms

3.7.

In vivo studies and market authorisation

The role of government is to enact adequate rules
3.7.1.
and application provisions to protect research and researchers,
and to ensure that there is no risk of toxic substances or

3.9.1.
The rapid development of science and technology,
and the proliferation of research and discoveries, are promot-
ing changes in industrial property law because in addition to
traditional concerns, questions are being asked about the
nature of innovation and whether it is moral or immoral to
patent a given development.

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3.9.1.1.
Property rights are intended to be international, so
as to protect inventions as effectively as possible. Agreements
on intellectual property rights in the business context establish
a set of rules, some of which explicitly concern biotechnology.

These are:

— human cloning processes;

In addition to the World Intellectual Property Organ-
3.9.2.
isation (WIPO), there is the European Patent Office (EPO),
which only provides for a joint patent issuing procedure, with
different application procedures remaining at national level.

3.9.2.1.
introduced without delay.

A single Community patent must therefore be

3.9.3.
The main difference between European and US
patent law is that in the United States only the original inventor
has the right to take out a patent, rather than the first applicant.

3.9.4.

Positive law and patentability in biotechnology

— processes for modifying the germline genetic identity of

human beings;

— use of human embryos for industrial or commercial ends;

— processes for modifying the genetic identity of animals

that cause them unnecessary suffering.

The directive tasks the European Group on Ethics with
evaluating the ethical aspects of biotechnology, e.g. by fixing
the scope of protection granted, taking many of the European
Parliament’s concerns into account. This directive should have
been transposed into Member States’ national law by 30 July
2000. It has many implications, given its binding nature,
both in terms of the European Patent Convention and at
international level.

Three levels have to be considered: national, European and
global. European law takes precedence over the other levels,
since a European directive prevails over national law, which
must conform with the directive.

3.11. Biotechnology and bioethics

The Committee again refers to its opinion ‘Science, society and
the citizen in Europe’ (1).

3.9.5.
There is no doubt that US decisions and the position
of the European Patent Office, which obviously bases itself on
the provisions of
the European Patent Convention, have
complicated the situation against a background of intensified
economic competition. America has a competitive advantage,
which may be an obstacle to innovation in Europe or even
encourage relocalisation of European research activity. There
is fierce global competition in the life sciences sector between
American and European research laboratories and a race to
protect discoveries; this can be confirmed by considering
applications lodged with the EPO.

3.11.1.
Since the 1975 Asilomar Conference, a large num-
ber of bioethics committees have addressed issues relating to
all life science studies or medical applications that are likely to
pose problems of respect for human dignity, the right of
consent or the principle of non-discrimination. Such com-
mittees will now have a significant influence on positive law
because they provide answers to often anxious questions from
the public and because, since their pronouncements are
consensus-based,
the ‘collective
conscience’ on bioethical problems.

they express the state of

3.10. The European directive

After many setbacks, Directive 98/44/EC of the European
Parliament and of the Council of 6 July 1998 now stipulates
that a clear distinction must be drawn between discoveries that
are by their nature unpatentable and inventions that are. Thus
the human body, at any stage in its formation or development,
including germ cells, cannot be patented. The directive sets out
certain exceptions based on considerations of public policy
and morality.

3.11.2.
In 1997 the International Bioethics Committee
(IBC) drew up the Universal Declaration on the Human
Genome and Human Rights.

In 1997 the Council of Europe drew up the ‘Convention for
the protection of human rights and dignity of the human being
with regard to the application of biology and medicine:
Convention on Human Rights and Biomedicine’.

(1) OJ C 221, 7.8.2001, p. 1.

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3.11.3.
Since 1998, the European Group on Ethics has
regularly issued opinions on Community directives or regu-
lations. The ‘doctrine’ evolving from these opinions is anal-
ogous with that of
the Council of Europe, with prime
importance placed on human dignity, and on banning patents
on the human body, IPRs, reproductive cloning, etc.

3.11.4.
The international approach to these bioethical
questions demonstrates that an international awareness, also
at European level, is evolving with regard to these many and
very vexed issues.

3.11.5.
But questions need to be asked about the emergence
of a bioethics law that reflects both modern value systems and
a perceived need to erect safeguards in the path of scientific
progress.

transgenic foodstuffs. Other applications — such as fine
chemicals production and bioremediation — are less
controversial.

— Another trait that seems to be typical of the public debate
in Europe generally is the low level of education and
information of ordinary people. This is exacerbated by
the timid and overcautious, or abstruse, debate conducted
by most researchers, or by pseudo-experts.

— Only if all people become engaged in the ethical and
political debate on biotechnology can there be smooth
progress without the upheavals and polemic generated
throughout Europe by the GMO debate.

3.11.6.
As the chairman of the European Group on Ethics
noted in a recent statement: ‘There surely cannot be a level
playing field between an all-powerful and prevailing science,
even if it is contested, and a disarmed and uncertain ethical
is strongly represented in the political
stand, even if
debate’ (1).

it

4. Specific comments

4.1. Challenges

3.12. Biotechnology and public opinion

4.1.1.
opportunities provided by new and traditional technologies.

To mobilise research so as to capitalise on the

It

is difficult

to discern a single global public
3.12.1.
opinion about
the
divergence between American and European consumers on
GMOs.

the implications of biotechnology; cf.

4.1.1.1.
Plant transgenesis offers many potential benefits: a
wide range of applications, meeting new needs, reducing the
use of phytosanitary products and the possibility of developing
new products.

3.12.2.
Sensitivity to certain issues varies between countries
depending on philosophy, religion or historical experience (cf.
the Nordic and Mediterranean countries).

4.1.2.
conforming with the European agricultural model.

To harness the economic benefits of GMOs while

3.12.3.

There are some points of convergence, however:

— People have a keen interest in and awareness of biotech-
nology applications. In Europe, public opinion is split
between hope and anxiety.

— Europeans consider the benefits to outweigh the risks
to developing biotechnology for health
with respect
including genetic diagnostics. On the other
purposes,
hand, public opinion in Europe is unfavourable towards

4.1.2.1.
Farmers must be guaranteed access to these new
techniques, but they should maintain some independence from
agrochemical companies while assuming the responsibility
that falls to them in this connection.

4.1.3.
To provide a response to the legitimate concerns of
consumers and the general public in Europe. The technical and
economic aspects of research and research findings must be
explicitly separated in the minds of the general public.

(1) Ms Lenoir, President of the European Group on Ethics, EGE

opinion, 1998.

The European Union must allow its consumers to
4.1.3.1.
transgenetic techniques by
benefit
providing guarantees of the safety, origin and nature of food
products.

from the potential of

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4.2.

Strategy

4.2.1.
be won.

To create a context in which consumer support can

4.2.1.1.
This strategy means dispelling fears that are some-
times unfounded, offering a choice of products and involving
consumers and the general public in the debate.

— efforts to remove obstacles that prevent European citizens
having access to this knowledge and the ethical code
relating to it.

4.2.4.4.
The Committee believes in particular that obstacles
can be removed and that this requires a system of lifelong
learning which gives everybody the means of interpreting
information and checking the validity of their knowledge (2);
this will enable all Europeans not only to access and acquire
knowledge, but also to be involved in:

4.2.2.

To manage the use of biotechnology.

— assessing the validity of relevant knowledge;

The European Union must master the scientific
4.2.2.1.
aspects of genetic engineering to ensure that discoveries are
used for the maximum benefit of people.

— monitoring its scope and rate of application;

— defining a bioethical code in this sphere.

4.2.3.

To clarify responsibilities.

Public authorities, businesses, farmers and con-
4.2.3.1.
sumers must be made accountable in the spheres that are
relevant to them: the precautionary principle must prevail (1).

4.2.4.
There must be a strategic vision of the life sciences
and biotechnology in the context of a knowledge-based
Europe.

4.2.4.1.
The ESC considers the task of informing the general
public of the European Community regularly and creatively
about developments and the pace of progress in life sciences
and biotechnology to be of paramount importance; in the
medium and long term this is certainly consistent with the
key Community objective of establishing a knowledge-based
society.

4.2.4.2. Within the above framework, management of the
relationship between European society and life sciences and
biotechnology must be consistent with the Community action
plan on learning which is in the pipeline, a plan that is based
on the principle of life-long learning and its development
using information technologies.

4.2.4.3.
The action plan will require various integrated
Community policies in the sphere of education, in particular:

4.2.4.5.
mission strategy to provide for:

In any event, the Committee expects the Com-

— responsibility for developing pilot education programmes
to inform the general public about progress achieved in
the life sciences and biotechnology, and the avenues
opened by these advances;

— a minimum obligation to coordinate related measures
taken at national and European level in order to establish
and apply certain rules in research, both in the public and
private sector.

4.3. General principles

— Prevention and precautionary principle: the precautionary
principle must prevail and be applied at every stage, also
in the context of biomonitoring. This principle must be
recognised and applied at international level.

— Information and transparency:

transparency at every
stage by providing information makes it possible to dispel
fears and include the general public in the democratic
process.

— measures to introduce a school curriculum that is more

open to the life sciences and biotechnology;

— Accountability: measures must be taken and those who
take decisions about the production of an approved GMO
must bear the cost of damage or inconvenience.

(1) See ESC opinion, OJ C 268, 19.9.2000, p. 6.

(2) OJ C 157, 25.5.1998.

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4.4.

Proposals

4.4.1.

E v a l u a t e

4.4.1.8.
evaluation and authorisation procedures.

Harmonise and guarantee the complementarity of

4.4.1.8.1.
It is crucial that agreement be reached on evalu-
ation methods in order to avoid incoherence and to check the
compatibility of evaluation and decision-making criteria.

4.4.1.1.
accepted definition of the precautionary principle.

Agree on an internationally recognised and

4.4.1.9.
the ultimate decision-maker.

Strengthen the role of the Council of Ministers as

The meaning and scope of the precautionary
4.4.1.1.1.
principle must be better clarified at Community level, with the
aim of establishing a single definition in order to facilitate
application of the principle and avoid disputes and problems
of consistency between national, Community and international
rights.

4.4.2.

E n c o u r a g e

4.4.2.1.
GMO research.

Ensure that the European Union is involved in

4.4.1.2.
Ensure the legitimacy of committees and European
expert committees by guaranteeing independence, multidisci-
plinarity and transparency.

4.4.2.1.1.
Transgenesis and genomics are scientific and
economic challenges for public and private research, agri-
culture and the food sector, independence from international
groups.

The human,

4.4.1.2.1.
financial, material and logistical
resources of these committees must be strengthened so that
cases can be properly evaluated. If the consultation process is
broad-based and collective it will be independent. Participation
of qualified representatives of the social groups involved in the
debate will provide assurance with respect to procedures and
the appointment of experts.

4.4.1.3.
studies on:

Improve the method of evaluation and carry out

4.4.2.2.

Open new fields of research:

— respond to questions still being raised about GMOs:
detection of GMOs with fixing of European standards;
environmental assessment;

— give priority to quality initiatives: Europe must give
priority to strategies designed to improve food quality in
order to maintain its autonomy, ability to choose and
food heritage.

— environmental impact: experts must have exact infor-
mation about the environment in which GMOs are to be
introduced in order to eliminate grey areas in environ-
mental issues;

4.4.2.3.
Guarantee the status and independence of the
European Community by promoting a balance between
spheres of research.

— agri-foodstuff and industrial procedures.

4.4.1.4. Widen committees’ evaluation remit.

4.4.1.4.1.
Civil society requests information on the impact
of GMOs on the environment, fauna, animal stock, nutritional
risks and real economic gains.

4.4.1.5.
approach.

Formalise

the

global

and multidisciplinary

4.4.2.3.1.
The European Union must encourage the devel-
opment of a balance between traditional research, alternative
solutions and understanding of the genome by discussing
issues of biosafety in more detail.

4.4.2.4.
provided by transgenetic research.

Involve developing countries in the opportunities

4.4.2.5.

Protect the assets of European intellectual property.

4.4.3. M o n i t o r , h o l d a c c o u n t a b l e , c o n t r o l

4.4.1.6.
are reversible.

Regularly evaluate issues and ensure that decisions

4.4.3.1.

Practise and step up biomonitoring.

4.4.1.7.
there must be a system for socially validating their work.

The various committees must be interlinked and

Biomonitoring is a system for biological monitor-
4.4.3.1.1.
ing of plant cultures produced from genetically modified
organisms that are on the market.

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Official Journal of the European Communities

18.4.2002

4.4.3.2.
Establish an intermediate stage between field
studies and authorisation for national cultivation by creating
special geographical zones where the impact of GMO can be
evaluated under real conditions.

— Establish traceability: a safety feature that is relevant for

every stage of production.

— Implement statutory labelling provisions:

— Collect and collate basic agronomic and environmental

— set a threshold beyond which production will be

reports.

considered GM or non-GM;

— Take specific measures.

— adopt approved analytical methods and harmonise

at the international level.

— Establish new methods of managing cultivation practices.

— Supplement European legislation:

— Study the impact of GMOs on the environment, health

and farming practices.

4.4.3.3.
Guarantee farmers access to new and traditional
techniques, and allow them to remain autonomous vis-à-vis
funding bodies.

4.4.4. D e f i n e r e s p o n s i b i l i t i e s

— European institutions.

— State: public authorities must define responsibilities
before decisions are taken and shoulder these responsi-
bilities once decisions have been taken.

— Experts, whose advice supports decision-making pro-

cesses.

— Industry, which must meet public expectations in respect

of strategies, transparency and guarantees.

— Farmers: a general debate must take place and legal
measures be introduced to clarify the responsibility of
producers.

— Consumers: must be provided with choices, educated and

informed about GMOs and their applications.

— adopt Community rules on:

— seeds

— animal feedstuffs containing GMOs

— Label intermediate products.

— Discuss the future of non-GMO production.

— Recognise consumer expectations at the international
level: Europe must call for risk-benefit criteria to be
adopted in all negotiating forums: Codex Alimentarius
Commission , the World Trade Organisation (WTO) and
the Biosafety Protocol.

— Continue the debate:

— establish an ongoing debate on scientific advances;

— define a communication strategy to enhance the
coherence and transparency of communication
policy;

— initiate and broaden discussions;

— sensitise and educate young people about

life

sciences;

— provide objective information: government must

guarantee the plurality of the debate.

4.4.5.

I n f o r m a n d p r o v i d e c h o i c e

5. Conclusions

— Aim to achieve transparency: this applies to every stage

in research relating to food applications.

An extraordinary range of issues is at stake — scientific,
5.1.
financial, legal, ethical and political — in relation to biotechno-
logy applications.

— Ensure clear and legible labelling and traceability for all
agricultural and food products in the European Union
containing GMOs.

— Current breakthroughs concern only the developed
countries: the United States, Europe, Japan and, in the
future, parts of Asia.

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Official Journal of the European Communities

C 94/33

— The developing world is an onlooker, for reasons that
have less to do with scientific knowledge than with the
financial resources that are needed. This
amount of
situation is all
the more worrying since developing
countries are also affected by the need to increase food
resources, by health requirements and by problems of
pollution and the environment.

— It

that

is very important

this global dimension of
biotechnology should not be obscured by the debate
between developed countries. The ethical debate is driven
above all by the question of respect for human dignity in
the face of advances in scientific knowledge and of
economic competition. It must also address the issue of
solidarity as an essential criterion: solidarity between rich
and poor countries and solidarity with regard to the
accepted responsibility to protect the environment, which
will require more public funding to combat poverty and
food insecurity.

Brussels, 21 February 2002.

it

It is essential that the EU play its part: its voice will
5.2.
only be heard if
is a major player in the sphere of
biotechnology and it is imperative that there should be greater
awareness in the EU of the implications for competitiveness,
growth and job creation. Thus the various stakeholders must
mount a strong and sustained effort
to cooperate, and
there must be a shared strategy and instruments, such as a
Community patent. A creative approach is called for, with
greater emphasis than before on stimulating and providing
incentives and opportunities.
In conclusion, ensuring the
EU’s place in the biotechnology sector means acting with
determination and resolve.

5.3.
The Committee is prepared to play a role here by
providing information, initiating an ongoing debate, ensuring
a rational choice of objectives to promote the creation of jobs
and new businesses and maintaining links with civil society.

The President

of the Economic and Social Committee

Göke FRERICHS