Opinion of the Economic and Social Committee on the "Communication from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions: Life sciences and biotechnology — A Strategy for Europe"
Date: 2002-09-18
Institutions: European Economic and Social Committee
Subjects: action programme, biotechnology, life sciences, project evaluation, research policy

C 61/22

EN

Official Journal of the European Union

14.3.2003

therefore calls on the Commission and especially the
17.4.
Council
to identify the legal basis needed to strengthen
Community strategies on tourism. This is all the more urgent
given the economic and social importance of this sector in
Europe, the consolidation of the European economic area, the
process under way to reunify Europe and the project to create
a free trade area in the Mediterranean.

17.5.
A legal basis would foster the full development of
the sector and facilitate the establishment of a framework
programme for tourism that could harness Community pro-
grammes and initiatives in other policy areas in support of
tourism, where relevant. Organised civil society, the social
partners and national and Community institutions must all be
closely involved in defining such strategies and measures

Brussels, 18 September 2002.

during the annual European forums organised by the Com-
mission.

17.6.
As its specific contribution to the first European
Forum on tourism scheduled to be held in Brussels in
December 2002, the Committee highlights the need for action
to:

a)

b)

c)

temporarily boost the financial and human resources
available to the Commission’s Tourism Division, pending
the definition of a wider Community policy on tourism;

create a basic network of Tourism information and
consultancy points (TICP);

set up a group of experts to develop a Quality charter for
Europe’s tourist destinations and coordinate its appli-
cation.

The President

of the Economic and Social Committee

Göke FRERICHS

Opinion of the Economic and Social Committee on the ‘Communication from the Commission
to the Council, the European Parliament, the Economic and Social Committee and the Committee
of the Regions: Life sciences and biotechnology — A Strategy for Europe’

(2003/C 61/04)

On 25 January 2002 the Commission decided to consult the Economic and Social Committee,
under Article 262 of the Treaty establishing the European Community, on the above-mentionned
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 11 September 2002. The rapporteur was
Mr Bedossa.

At its 393rd Plenary Session of 18 and 19 September 2002 (meeting of 18 September), the Economic
and Social Committee adopted the following opinion by 124 votes to none with one abstention.

1.

Introduction

As part of its follow-up to the consultation document
1.1.
on a strategic vision of
life sciences and biotechnology,
to which the Committee contributed with its opinion of
21 February 2002 (1), the Commission is now briefing the EU
institutions on its definition of this strategy.

The Committee welcomes this initiative, noting that
1.2.
the strategy is accompanied by a well-constructed, precise,
dynamic and proactive action plan.

( 1) OJ C 94, 18.4.2002.

1.3.
The comprehensive consultation underpinning the
Commission’s action of course forms part of the rules of
governance which are intended to bring EU bodies closer to
organised civil society, NGOs and all actors in the life

14.3.2003

EN

Official Journal of the European Union

C 61/23

sciences: the relevant public and private professional sectors,
institutions, and national and European organisations.

(China, Australia, etc.) in a marginal position in this field. This
gap should be highlighted, as it represents a new form of
inequality regarding the ‘right to life’.

1.4.
The Committee’s analysis matches that of the Com-
it is clear that analysing the strategy cannot be a
mission:
simple task since the many challenges must be looked at one
by one if a response is to be formulated.

1.4.1.
The essence of the communication lies in its wide-
ranging approach, seeking to create sufficient impetus for all
actors to focus on identifying strengths and weaknesses and
agree on what action should be taken immediately and what
action needs further discussion and fine-tuning. This global
approach is the only one possible in this field.

1.4.2.
However, the political authorities must have the
final say in sounding out and taking the necessary strategic
decisions.

1.4.3.
The Committee stresses that it is vitally important to
create a structure for the governance of the life sciences and
biotechnology, integrated into the Union’s broader system of
democratic government. This structure will, in any event, have
to be compatible with Europe’s scientific heritage and clearly
acceptable to European society.

1.5.
The challenges relate to the quality of research in the
life sciences in the various EU countries, and the extent to
which it meets current social expectations; the effectiveness of
the innovation process, translating discoveries into practical
development of applications and the obstacles to the process;
the role of public authorities in promoting the development of
life sciences and biotechnology; the situation of the down-
stream sectors, which have a vital part to play in developing
‘valuable’ research — the pharmaceuticals industry for health,
agri-foodstuffs industry for GMOs; compatibility with the legal
framework, particularly for all aspects concerning (i) supervi-
sion of research and placement on the market, and (ii) industrial
property rights (one part of the wider body of intellectual
property); the amount of information provided, involvement
of and acceptance by the general public; and society’s necessary
ethical limits.

1.7. Where biotechnology is concerned, scientific and
industrial developments — and, of course, the markets — are
played out at a global level, as for all leading-edge technologies.
It is therefore logical that they should be paralleled by the
growth of a body of legal standards, especially at European
level. Two areas are involved: supervision of experimental
research and clinical trials in human health; and industrial
property rights, especially the thorny problem of how far
living organisms can be patented.

1.8.
A debate focused on the ethical issues arising from
advances in biology and biotechnology developed early on —
largely at the initiative of the scientific community itself. The
debate has been on an international scale from the outset, but
has underscored significant differences in approach between
the EU and the United States.

A technological revolution is taking place with regard
1.9.
to biotechnology, the economic consequences of which are
reshaping certain features of our society:

— freedom of research may only be allowed within a

framework of well-defined rules;

— guidelines are needed in order to give education and

training an interdisciplinary character;

— the administrative requirements for pursuing research

must be simplified.

2. General comments

2.1.
The Committee notes that the Commission gives a
precise description of the problems arising from the need to
implement a genuine, useful and effective strategy in response
to this technological revolution, to which a political response
must be provided:

2.1.1.
response must be political.

The implications are profound and far-reaching: the

1.6.
The EU fell behind significantly during the 1980s, but
is now attempting, with some success, to catch up. Where
human health or agriculture are concerned, countries which
are either on the move or experiencing upheavals are as much
concerned as the richer countries, even if they are currently

— New scientific disciplines and their applications represent

a common foundation of knowledge.

— The prospective applications may produce profound
upheavals in our societies and economies, far beyond
GMO crops.

C 61/24

EN

Official Journal of the European Union

14.3.2003

— These sciences seem likely to help achieve the objective
set at Lisbon of making the EU a leading knowledge-
based economy, as confirmed by the Stockholm Council.

2.2.

The EU seems to be holding back.

2.2.1.
Securing public backing for these sciences is difficult:
the EU must therefore devise a responsible policy with a
worldwide focus on the future. The EU must have a part to
play. Its voice will only be heard if it is a major player in this
sphere.

The European Commission notes that responsibilities
2.3.
are fragmented, but that respecting the subsidiarity principle
should not prevent Europeans from working together towards
common goals. The Committee shares this view.

2.6.1.

In order to bring this about:

— the knowledge base must be mastered, disseminated and

new knowledge applied;

— in the context of effective and innovative research, the
EU’s leadership in this field should be restored, and
European efforts should focus on the new prospects
opened up through multi-disciplinary research, since
biotechnology is yielding innovative approaches in all
these areas;

— if research must be based on the needs of citizens, then it

must enjoy societal consensus;

— applying science in practical terms is essential. Developing
new capacity involves encouraging the entire research
and innovation process. The fragile condition of SMEs is
evident.

2.4.
The three strategic priorities which the Commission
identifies should enable sustainable and responsible policies to
be developed:

2.6.2.
of problems:

In this regard, the Commission points to a number

— The opportunities provided by the life sciences must
harness human, industrial and financial resources in order
to boost competitiveness.

— The support of informed, educated public opinion is
essential, consequently ethical and societal concerns must
be addressed.

— The EU faces a global reality, and must be capable of
responding in the way most appropriate to its best
interests. The Commission therefore proposes an inte-
grated strategy, deploying a concrete, realistic action
plan, flanked by recommendations which respect the
subsidiarity principle.

— the insufficient supply of skilled personnel must be

remedied;

— the need to eliminate all bottlenecks.

2.6.3.

Three areas for action are identified:

— reinforcing the (financial or human) resource base for this

knowledge-based sector;

— networking Europe’s biotechnology communities;

— a pro-active role for public authorities.

New solutions to real problems are brought to bear in

2.5.
the following areas:

2.7. Managing the life sciences

— health care;

2.7.1.
The Committee fully agrees with the conditions
described by the Commission. This technological revolution
calls for governance based on the following:

— the agri-food sector;

— Inclusive, informed and structured dialogue with society.

— non-food uses of crops;

— improving the environment.

Harvesting the potential of

the life sciences and
2.6.
biotechnology is likely to engender a new economic dimen-
sion, creating wealth and skilled jobs.

— Developing these sciences in harmony with ethical values
and societal goals, balancing benefits against disadvan-
tages, guided by the Charter of Fundamental Rights.

— Giving consumers and economic operators the infor-
mation to make free choices. The new, revised framework
legislation on GMOs, applicable from October 2002,
should overcome the present standstill
in authorising
new products.

14.3.2003

EN

Official Journal of the European Union

C 61/25

— All actors making the necessary efforts to build confi-

2.8.2.2.

This strategy should be implemented through:

dence, with science-based regulatory oversight.

2.7.2.
The Committee welcomes the Commission’s stance
that patent protection is the only effective means of creating a
for protecting
crucial
investment.

incentive for R&D and is essential

2.7.3.
In order to reconcile the policy objectives in regu-
lation of life sciences, the Commission puts forward four
principles:

— risk governance and product authorisation;

— safeguarding the internal market;

— proportionality and consumer choice;

— predictability, modernisation and impact assessment.

2.8.

The EU in the world

2.8.1.
The Commission describes its agenda for inter-
national collaboration, in response to international diversity.
The Committee agrees that open, multilateral and rules-based
trading systems should be set up. The EU already possesses a
wealth of experience in this area, particularly in connection
with the OECD and the Codex Alimentarius. The role and
efficiency of EU participation should be enhanced.

2.8.2.
The Committee notes with satisfaction that the
Commission considers the EU to bear a special responsibility
towards the developing world to meet its urgent needs and to
put Europe’s capacities to the service of these countries.

2.8.2.1.

For this purpose:

— monitoring of progress;

— coherence of EU policies;

— coordination and benchmarking;

— and, above all, ongoing attention entailing vigilance and

political impetus.

The Committee endorses the Commission’s pro-
2.8.2.3.
posal to set up a permanent forum,
if possible involving
stakeholders, to which the Committee would aim to contribute.

2.9. The action plan

2.9.1.
After describing the challenges raised by the life
sciences and biotechnology strategy, the Commission sets out
its 30-point action plan, explaining the commitments and
the strategy is to attain its goals. The
tactics required if
Committee appreciates the helpful way in which each action
comprises:

— a detailed description;

— a list of implementers;

— a specific and/or open-ended timeframe.

2.9.2.
The Commission’s proactive approach is the more
remarkable in that the action plan takes account of the
subsidiarity principle.

3. Specific comments

The Committee welcomes the strategic plan, the scope of
which can be gauged from the description. However,
in
the Committee’s view two particular aspects are not made
completely clear:

— the EU should support negotiated multilateral

frame-

works;

3.1.

Life sciences research

— the EU should contribute to technical assistance, capacity-

building and technology transfer;

3.1.1.
public research, conducted by:

In the biological sciences, a key role is played by

— the EU should encourage equitable and balanced North-

South partnerships;

— major public scientific or technological establishments;

— the Committee believes, as does the Commission, that
dispersed responsibilities must be overcome, on the basis
of a shared vision for a cooperative approach.

— businesses, usually in the pharmaceuticals, seed pro-

duction or agro-chemical sectors.

— large associations, largely in receipt of private funding;

C 61/26

EN

Official Journal of the European Union

14.3.2003

3.1.2.
However, the accelerating rate of knowledge, and the
speed with which the potential applications of scientific
progress are subject to intellectual appropriation, oblige more
and more entrepreneurs to engage in upstream research, which
is not necessarily located in the EU.

rate which encapsulates the race underway to complete the
sequencing of the human genome and commence unlocking
the secrets of the human proteome.

3.1.3.
In order to meet the challenge laid down by the
Commission, the examples drawn from the United States —
even if they are not directly transferable to the EU — point out
the way to develop biotechnology. Biotechnology must be
developed vigorously and in closer cooperation between
players and the EU.

It is necessary to:

— stimulate life sciences research, particularly in the area of

applied genetics;

— improve the link between research and innovation by
generating the right legal, financial and even psychologi-
cal conditions for rapid progress from knowledge to
innovative applications;

— intensify industrial involvement at the upstream stages,
by expanding cooperation with outside laboratories and
with biotech industries;

— ensure the EU plays its intended role: to give impetus to
biotechnological development without trying to control
everything, to remove statutory and regulatory obstacles
and cut through red tape deterring or hampering initiat-
ive, to ensure that industrial choices are consistent and,
above all, to organise for a united, dynamic and durable
policy.

3.2. Challenges relating to ethics and acceptability

3.2.1.
issues.

Biotechnology raises major and complex ethical

3.2.1.1.
These ethical questions relate firstly to the very
nature of genetic research and its applications, particularly
with regard to human health: the stakes are life itself, our
genetic heritage which is gradually revealing its wealth and
complexity, the potentialities it heralds, and the almost unlimi-
ted horizons it offers in particular to medical applications and
to the cognitive sciences.

3.2.2.
Thanks to the breakthroughs of the last few decades,
the discoveries and initial applications are accelerating at a

3.2.3.
Differences of ethical approach extend beyond the
bounds of biotechnology, and often involve more than
bioethics alone. They concern the values, stated or underlying,
of different human societies. A distinction is often drawn
between western European society’s Kantian, normative
approach and the more utilitarian approach of the English-
speaking world, which is suspicious of pre-established prin-
ciples, preferring to judge the morality of an act in the light of
its practical consequences. This difference in the hierarchy of
values is an example of why American government and
opinion is reluctant to introduce specific legislation governing
biotechnology.

3.2.4.
according to historical background:

Even within the EU, sensibilities vary appreciably

— one of the great unknowns of the future ethical debate
on biotechnology is the stance which countries such as
China or India will adopt once they are directly involved;

— the ethical debate has become simultaneously more
necessary and more difficult as a result of fiercer scientific
and economic competition. This applies to the ethics
of both scientific communication and experimentation.
Since Dolly’s birth, the many declarations on the ‘pro-
gress’ of cloning clearly point to the need for more urgent
and deeper ethical reflection.

3.3. Transgenesis, the environment and public perceptions

It is in order to wonder why transgenesis provokes
3.3.1.
so much questioning, whereas conventional selection has
never aroused any reaction. This may be explained by the
particular features of transgenesis. Being faster, and able to
cross the species barrier,
the
ecosystem. For some, however, environmental problems are
simply a pretext for rejecting all GMOs without admitting their
real motives, which may be ethical, religious or ideological.

is more likely to upset

it

3.3.2.
Environmental protection is a matter of concern to a
growing number of consumers. They are no longer interested
only in the quality and price of food, but also in how it is
produced and its environmental impact. The BSE saga has
suddenly revealed to them that agriculture is capable of leaving
to satisfy the
behind material contingencies

in order

14.3.2003

EN

Official Journal of the European Union

C 61/27

requirements of downstream industries. They have lost some
of their faith in science, and attach greater importance to the
risk factor. They are demanding guarantees.

3.3.3.
The problem lies in knowing where to draw the line
between the safeguards which the public is entitled to demand
and those which researchers cannot provide. Scientific progress
entails risk which is difficult to evaluate. Society accepts risk
when it can discern its own interest
in such techniques,
describing this as ‘acceptable risk’.

objectives are either understated or insufficiently explicit in the
light of the overall objective, which is of vital importance to
the EU’s future and especially sensitive in terms of public
opinion, mainly due to the questions and polemics it arouses
in all the EU Member States and all sectors of society.

The Committee calls for two general principles to apply
4.2.
before detailed responses are framed, and for consolidation to
ensue.

3.3.4.
In the case of plant and animal transgenesis, the risk/
benefit ratio is unclear: hence the complex nature of the
debate.

4.2.1.

P r e v e n t i o n
p r i n c i p l e (2)

a n d

t h e

p r e c a u t i o n a r y

3.3.5.
It would seem crucial that a case-by-case social
evaluation of the risk/benefit ratio be made for each OMG if
they are to possess legitimacy and hence be accepted by the
general public.

3.4.

Education

The Commission’s

3.4.1.
strategy, however, does not
appear to take sufficient account of the pressing need to make
all the peoples of Europe, and young people in particular,
aware of this body of knowledge. The entire educational
system should reflect this need.

3.4.2.
As in its opinion on the Communication from the
Commission — Towards a strategic vision of life sciences
and biotechnology: consultation document (1), the Committee
suggests that the Commission:

— assume responsibility for encouraging pilot education
programmes to inform the general public about progress
achieved in the life sciences and biotechnology;

— devise a plan involving a range of Community policies,

in particular by means of:

4.2.1.1.
The precautionary principle must prevail and be
applied consistently, also in the context of biomonitoring. It
must be applied at every stage. The difficulty is that it must be
recognised in the same way by the entire international
community, and be applied uniformly at international level.
This is clearly not the present picture. The EU should propose
an international conference to consolidate application.

4.2.2. A c c o u n t a b i l i t y

This principle (damage/inconvenience) should be
4.2.2.1.
appropriately stated in the Proposal for a Directive of the
Parliament and of the Council on environmental liability with
regard to the prevention and remedying of environmental
damage (3).

4.2.3.
The Committee considers that the proposed action
plan should be fleshed out with the following points, which it
considers to be of major significance:

4.2.3.1.
Educating all young Europeans to be aware of
these sciences, by setting up a framework programme and
earmarking the necessary funds.

— measures to introduce a school curriculum that is

more open to the life sciences and biotechnology;

4.2.3.2.
more precise, specifying those of:

The responsibilities of each of the players must be

— efforts to remove obstacles that prevent European

citizens having access to this knowledge.

— the European institutions;

4. The Committee’s proposals

— the Member States,

in keeping with the subsidiarity
principle. The public authorities must define their
responsibilities before making any decisions and ensure
the decisions are implemented once taken;

4.1. While the Commission’s communication appears bal-
anced and well-structured, and the action plan clearly set out,
proactive and practical, a certain number of principles and

— experts or expert groups on which the decision-making

process relies.

( 1) OJ C 94, 18.4.2002.

(2) OJ C 268, 19.9.2000.
(3) COM(2002) 17 final.

C 61/28

EN

Official Journal of the European Union

14.3.2003

4.2.3.3.

Information for choice:

4.3. A Community patent

— aiming to achieve transparency at every stage in research;

— ensuring the establishment of traceability and clear and

legible labelling for all products;

— implementing statutory labelling provisions;

— supplementing European legislation by adopting Com-
munity rules on seeds and animal feedstuffs containing
GMOs;

— labelling intermediate products;

— ensuring that consumer expectations are recognised at
international level, calling for risk-benefit criteria to be
adopted in all negotiating forums.

4.2.3.4.

An ongoing debate:

— to ensure proper evaluation and assessment of scientific

advances;

— to define a communication strategy to enhance the
coherence and transparency of EU policy in this area,
which must be constantly renewed and broadened,
especially by informing and educating young people;

— information must be objective, and the public authorities

must guarantee the plurality of debate.

4.2.3.5.

The duty to share must be recalled at every stage.

— the developing world is unfortunately more of an
onlooker than a direct participant. This is all the more
worrying since these countries are affected by food
insecurity, health requirements and by problems of
pollution and the environment;

— the EU must address the issue of solidarity as an essential
criterion: solidarity between rich and poor countries, and
solidarity with regard to the shared responsibility to
protect the environment, which will require more public
funding to combat poverty and to ensure food self-
sufficiency.

Brussels, 18 September 2002.

Rapid scientific and technical progress, coupled with
4.3.1.
the explosion in research, is helping to drive developments in
industrial property law, as questions about innovation and
about the morality of ‘patenting’ various advances are added
to more traditional questions.

4.3.1.1.
Property law is geared to protecting inventions
internationally as effectively as possible. Trade-related intellec-
tual property rights agreements lay down a set of rules, some
of which specifically address biotechnology.

4.3.2.
In addition to the World Intellectual Property Organ-
isation (WIPO), there is a European Patents Office (EPO), which
however provides only a common procedure for filing patents:
implementation procedures remain in the hands of individual
countries.

4.3.2.1.
last — be brought into being as a matter of urgency.

A single Community patent must therefore — at

4.3.3.
The essential difference with American patent law is
that in the USA, only the ‘first to invent’, rather than the ‘first
to file’, is entitled to a patent.

5. Conclusion

it

It is essential that the EU play its part: its voice will
5.1.
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,
in
particular, a Community patent. Innovation clearly demands
new, dynamic, constructive and transparent forms of manage-
ment in order to reflect the scale of the new fields being
opened up by research and the speed at which this is occurring.
A creative approach is called for, with greater emphasis
than before on stimulating and providing incentives and
opportunities. Ensuring the EU’s place in the biotechnology
sector means acting with determination and resolve.

The President

of the Economic and Social Committee

Göke FRERICHS