Opinion of the European Economic and Social Committee on the "Communication from the Commission to the European Parliament, to the Council and to the European Economic and Social Committee on Life Sciences and Biotechnology — A strategy for Europe Progress report and future orientations" (COM(2003) 96 final)
Date: 2003-07-16
Institutions: European Economic and Social Committee
Subjects: EU research policy, biotechnology, report

30.9.2003

EN

Official Journal of the European Union

C 234/13

4.3.
The Committee asks the Commission to include a
reminder, in the explanatory statement to this directive, that
this overall prevention policy has three main aspects:

— Increasing the sense of responsibility of all road and street
users (pedestrians, cyclists, motorcyclists, vehicle drivers
etc.).

— Education and information in the form of repeated
training to encourage respect for the highway code.

— Redesigning roads and streets to give priority to the
physical separation of different user categories, as the
best form of prevention is to avoid collisions whenever

possible between vehicles, pedestrians, cyclists etc. The
design changes must be made systematically when road
repairs are being carried out, and must be supported
by appropriate financial
incentives available to local
authorities.

4.4.
The Committee is pleased that the Commission has
undertaken a review of the whole of Directive 70/156/EEC,
which has been amended about thirty times since it was first
issued. This updating must be co-ordinated with the car
manufacturing industry, users’ associations and others. The
Committee takes the view that this would be an opportunity
to clarify the content of an overall policy on accident
prevention for road and street users.

Brussels, 16 July 2003.

The President

of the European Economic and Social Committee

Roger BRIESCH

Opinion of the European Economic and Social Committee on the ‘Communication from the
Commission to the European Parliament, to the Council and to the European Economic and
Social Committee on Life Sciences and Biotechnology — A strategy for Europe Progress report
and future orientations’

(COM(2003) 96 final)

(2003/C 234/03)

On 6 March 2003 the European Commission decided to consult the European 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 June 2003. The rapporteur was
Mr Braghin.

At its 401st Plenary Session on 16 and 17 July 2003 (meeting of 16 July), the European Economic and
Social Committee adopted the following opinion by 111 votes to one, with two abstentions.

1.

Introduction

1.1.
In January 2002 the Commission presented a Strategy
for Europe on life sciences and biotechnology, consisting of
two parts — policy orientations and a 30-point plan to
transform policy into action.

the EESC has commented in depth on the documents it
received (1).

In its Opinion on the Communication on Life
1.2.1.
sciences and biotechnology — A Strategy for Europe, the EESC
put forward a series of proposals, including the call for the
precautionary principle to prevail — also in the context of
biomonitoring — and to be applied at every stage; for the

The European institutions have

1.2.
supported the
integrated approach proposed by the Commission, and

(1) EESC opinions: OJ C 96 of 18.4.2002 and OJ C 61 of 14.3.2003.

C 234/14

EN

Official Journal of the European Union

30.9.2003

principle of liability for the cost of damage/inconvenience
resulting from the use of such technology to be clearly stated;
for the action plan to be fleshed out to include aspects such as
educating all young Europeans to be aware of these sciences;
for a precise definition of the responsibilities of each of the
players;
for
traceability and clear and understandable labelling; for con-
sumer expectations to be recognised at international level by
adopting risk-benefit criteria in all negotiating fora; for a
continuous debate to be conducted to ensure proper assess-
ment of scientific advances; for a communication strategy to
be defined and for information to be objective.

for transparency at every stage of research;

The Barcelona European Council examined the strategy
1.3.
and stressed the importance of frontier technology as a key
factor for future growth. It also called for appropriate measures
and a timetable to be developed to enable Community
businesses to exploit the potential of biotechnology while
taking account of the precautionary principle and addressing
ethical and social concerns.

1.4.
The Competitiveness Council of 26 November 2002
adopted a series of important conclusions covering a vast array
of measures, including the development of human resources,
greater resources for research, intellectual property protection,
the creation of online platforms available on the Internet, the
pro-active role for public authorities,
the participation of
society and social dialogue, the regulatory framework and
international cooperation.

The Communication in question is the first report on
1.5.
this matter. It sets out the results achieved in policy develop-
ment and on the ground, and anticipates a number of emerging
issues which are fundamental to the success of the Action
Plan.

Some Member States have not yet been able to
1.6.
transform the aims of the European Council conclusions
into action in areas which are vital to the development of
biotechnology and life sciences.

1.7.
The biotech industry, considered one of the sectors of
the economy with the greatest potential for medium to long-
term growth, groups together various technologies where
innovation and competitiveness play a key role. Biotech
enterprises largely grow out of the spin-off from universities
or large businesses (following mergers or acquisitions) and
operate with venture capital or ‘business angel’ type arrange-
ments (local networks of private investment providing funding
and consultancy to young enterprises).

1.8.
Biotech enterprises are predominantly SMEs, typically
widely inter-disciplinary and highly specialised, although very
diverse, with great capacity for invention and a high rate of
growth (despite the crisis faced by the biotech food business).
It has been found (1)
that a high concentration of such
businesses are located in clusters where it is easier to build a
technological basis and a critical mass of knowledge, and
interact in terms of exchanging expertise and selecting staff
with high potential.

Breaking new ground in the field of molecular biology
1.9.
and biotechnology has driven the sector into rapid expansion
throughout the world over the past thirty years, with substan-
tial growth recorded both in R&D activity and in terms of
employment. The motor for such progress in knowledge and
business partly lies in the inter-disciplinary nature of the
industry and cooperation between academia and business,
forging particularly effective synergies.

1.10.
The features of the industry as detailed above provide
insight into the concerns raised in the Communication with
regard to some strategically-important areas, such as research,
securing funding and a system for protecting intellectual
property, since negligence and delays risk jeopardising the
long-term success of biotechnology in the EU.

2. Comments on the main aspects of the strategy and

on the proposals

2.1.

European research

European research, including research in life sciences
2.1.1.
and biotechnology, suffers from insufficient resources and
from fragmentation, and cooperation between Community
and national programmes, science and industry is still under-
developed, with resources trailing behind those in the main
competing nations.

2.1.1.1.
The amount of Community resources allocated
appears inadequate when compared to the amount invested
annually by the main American research centres and the level
of national investments is not high enough to compensate for
this shortfall. In addition, national research activities lack the
coordination needed to improve efficiency.

(1) Innovation and competitiveness in European biotechnology,
(Various authors), Enterprise Papers No 7, 2002, European
Commission.

30.9.2003

EN

Official Journal of the European Union

C 234/15

2.1.1.2.
It is also true that in the life sciences and biotechno-
logy industry, research and development generally do not
require large, centralised European infrastructures or major
projects, and progress is often the product of a variety of
approaches and procedures, which may also involve SMEs and
smaller research institutes. On the other hand, the process of
transforming promising research ideas into competitive and
marketable results is often long and very risky (especially when
complex authorisation procedures are required, such as for
medicinal products). Therefore, for this approach to be success-
ful, enterprises must have solid financial support, plenty of
flexibility and the ability to absorb risks.

2.1.3.
The EESC considers that priority should be given to
putting together a complete package of regulatory, entrepre-
fiscal and financial measures to encourage both
neurial,
dedicated businesses and universities and public research
centres to take on the business risk. Notably, this implies
simplifying access to public funding, flexibility within a clear
framework (due to the long timeframes of research, which
must however show flexibility in adapting to the rapid,
unpredictable pace of scientific development), fiscal and finan-
cial support for innovative businesses and capital markets that
encourage access to venture capital and support start-up
companies as they grow, with funding to help during economic
downturns and the inevitable periods of crisis.

2.1.1.3.
Funding policy must be better designed for interac-
tion and complementarity between SMEs and large enterprises.
This is the only way to accelerate the process of translating
knowledge into products, which otherwise lack the coherence
and resources needed for development.

2.1.1.4.
The fragmentation of funding for research is not
only due to the large number of funds of insufficient size, but
also to an organisational problem. Thus far there has been a
lack of a coordinated strategy to combine different skills and
roles and to properly coordinate the range and spread of
activity. There is also a need for close, effective, interdisciplin-
ary cooperation between research institutes and industry and,
in addition, to improve mobility and cooperation between
industry and research institutes.

2.1.1.5.
Research and education must be better integrated
in order to enrich the scientific basis, but in this respect,
Europe is hampered by institutional and organisational barriers
including limited mobility of
researchers and excessive
bureaucracy. It would be useful to examine specific initiatives
to attract academic researchers to industrial projects by
developing science parks and providing ad hoc venture capital.

Recent experience has shown that the financial world
2.1.4.
tends to target short-term profitability, without considering
that research in the biotech industry demands long timeframes,
often in excess of ten years. This makes it difficult to build
assets which could become profitable given more time for
their development. Moreover, the fact that biotech businesses
may produce services as well as products is often neglected.
These businesses present
less of a risk but capital gains
and investment returns are slower to materialise. An overly
speculative approach penalises biotech service providers,
which nonetheless represent a European business asset.

2.1.4.1.
The EESC believes that the European Union should
take steps to introduce the concept of long-term support for
entrepreneurship, of development strategies hand in hand with
the assessment of intermediate objectives and staff training
plans, including business training, in order for the concept of
investment to be translated into tangible action. This approach
is all the more necessary given that venture capital often
abandons new initiatives as soon as they become listed or if
they are not extremely profitable, which harms SMEs that may
have the potential to grow given financial support which is
better suited to the needs of the industry.

2.1.2.
The Sixth Framework Programme (FP6) is a useful
starting point, provided that the topics laid down and the
selection criteria take account of the diversification of this
sector of research and ensure long-term programming can be
secured. However, the level of private sector spending needed
to reach the objective of 3 % of annual GDP by 2010 is only
realistic if a range of suitable policies is developed swiftly
and coherently and if the conditions (political, institutional,
infrastructure etc.) are created to encourage private investment
in research and development (R&D).

2.1.5.
The EESC is aware that these policies are a matter for
the Member States, but the EU should play an active role in
promoting an open method of cooperation with a view to
developing a method to assess successful policies (bench-
marking in various sectors), creating the means to set up a
more coherent, harmonised and stimulating environment for
research and innovation, as well as encouraging public funding
to address this need and providing Community policies with
the indirect mechanisms that can promote research.

C 234/16

EN

Official Journal of the European Union

30.9.2003

The Commission should take

2.1.6.
a more robust
approach in ensuring Member States apply the principles and
adopted policy choices across the board. It should play the
role of ‘facilitator’ in finding appropriate solutions and should
promote fora, conferences and high-level meetings to exchange
ideas and solutions.

2.2.

Science and society

2.2.1.
In its Communication, the Commission states that it
is committed to ensuring that the ethical, legal, social and
wider cultural aspects, as well as the different schools of
thought, are taken into account and form part of the research
and development process. It also states that it will take steps
to make the ethical and social debate an integral part of the
research and development process.

2.2.2.
This approach stems from the fact that the swift
development of the life sciences industry has given rise to great
expectations for curing disease and improving quality of life,
which at the same time raises concern over the ethical and
social repercussions.

2.2.3.
The EESC endorses the approach and shares the view
that public authorities, research institutes and businesses must
take on board concerns over the conditions in which key
decisions are made in this industry, otherwise the concerns of
a poorly or misinformed public will provoke delays and crises
in the development of new technologies.

2.2.4.
The EESC considers education and training pro-
cedures crucial to foster proper understanding of the life
sciences and biotechnology. Equally crucial are integrated
Community policies in the field of education, as previous
opinions have discussed in detail (1).

The EESC endorses the ban on human cloning as laid
2.2.5.
down in Article 3 of the Charter of Fundamental Rights of the
EU, reaffirmed by the European Group on Ethics in Sciences
and New Technologies (EGE), and calls for the European
institutions to support the initiatives under way to set up a
world convention on this issue.

2.2.6.
The EESC also supports the cautious approach taken
in limiting FP6 funding for research on human embryonic

stem cells and calls for the Commission’s draft proposals to
strike a fair balance between ethical concerns and research
needs.

2.2.6.1.
Opinions remain divided over this issue, addressed
in the inter-institutional seminar of 24 April 2003, not
only amongst the institutions, but also within the scientific
community. Although Member States agree on the use of adult
stem cells, some do not permit research to be carried out on
embryonic stem cells.

2.2.6.2.
In fact, over and above the ethical concerns
involved, there is no consensus on the benefits and risks of
using embryonic rather than adult stem cells. As a result, the
precautionary principle favours maintaining the moratorium
on European funding for research on embryonic stem cells
until a consensus is reached on the document
that the
Commission is preparing on this matter.

2.2.6.3.
However it should be noted that the research
techniques practised by biotech enterprises do not make
practical use of human embryonic cells due to the problems
of rejection and the risks of developing undesired cells and
contamination with animal matter, despite the increased
difficulties of isolating, cultivating and differentiating adult
stem cells.

2.3.

Intellectual property

2.3.1.
The Commission states that a clear, equitable, afford-
able and effective patent regime applied consistently across the
EU is crucial to fully exploit the potential of biotechnology
and regrets the delay in transposing Directive 98/44/EC on the
legal protection of biotech inventions.

2.3.2.
The EESC shares this view and therefore supports the
Commission’s efforts to speed up implementation of this
directive and calls for the political agreement reached on
3 March 2003 on the Community patent to lead to the swift
adoption of the respective regulation.

2.3.3.
Although it does not fully take on board the rec-
ommendations put forward by the EESC in its opinion on the
Community patent (2), the compromise reached must rapidly
close the current legislative loophole and provide an essential
boost to European competitiveness.

2.3.4.
The EESC emphatically urges the Commission to take
steps to ensure the biopatent Directive is swiftly transposed, as
the biotech industry needs the legal protection of a patent
regime for biotech inventions.

( 1) On this issue, see the Opinion on the consultation document

submitted in 2002, published in OJ C 61 of 14.3.2003

(2) EESC opinion OJ C 155 of 29.5.2001.

30.9.2003

EN

Official Journal of the European Union

C 234/17

2.4. Genetically Modified Organisms (GMOs)

2.4.1.
The Communication welcomes the significant pro-
gress made on the regulatory framework for GMOs, including
the political agreement reached on the two Commission
proposals establishing a comprehensive Community system to
trace and label GMOs, and the steps towards implementing
the Cartagena Protocol.

2.5.2.
The EESC would like to see the Commission carry
out an active role in setting up a multilateral consultative
forum to foster dialogue between parties that currently rep-
resent widely-ranging positions and to promote greater coher-
ence between the agreements reached in different fora. This
would provide a proper context for the new EU regulations
that have been approved or are in the pipeline, and overcome
the existing differences of opinion, notably in the Word Trade
Organisation (WTO).

2.4.2.
The EESC welcomes the two proposals on tracing
and labelling GMOs, which it supported in its recent opinions,
and the progress made in implementing and transposing the
Cartagena Protocol, which grants all signatory countries the
freedom to carry out a risk assessment prior to authorising
import of a new GMO.

2.5.3.
The EESC supports such initiatives, and is convinced
that in order to manage innovation in the biotech industry,
common standards and principles must be identified at
international level, whilst respecting the legitimately diverse
approaches adopted in different parts of the world.

The EESC however regrets that so far only a few
2.4.3.
countries have transposed Directive 2001/18/EC, which pro-
vides for a more comprehensive authorisation procedure for
GMOs. It calls on the Commission to take decisive action to
make the directive operational, which may include initiating
proceedings against those Member States in default.

2.6. Competitiveness

The EESC welcomes the creation of the European
2.4.4.
Network of GMO Laboratories (ENGL) on 4 December 2002
in Brussels, which acts as a scientific and technical EU network
of excellence with regard to Community GMO regulation. It
particularly endorses the fact that the Commission’s Joint
Research Centre (JRC) will coordinate ENGL’s activities and act
as the EU reference laboratory.

However the EESC does not support the statement
2.4.5.
made in the Communication (paragraph 3(d), page 17) declar-
ing that openly explaining and documenting the benefits of
the use of GMOs is, first and foremost, a task for the biotech
industry. This is a cultural and educational problem that can
only be properly tackled by public authorities, whether at
national, local or Community level, jointly and in cooperation
with stakeholders. Failure to do this will lead to a lack of
credibility, fragmentation and unsatisfactory efforts, as well as
an economic burden for SMEs that would jeopardise the
balance and competitiveness of the sector.

2.5.

International issues

that

The Communication states

2.5.1.
the debate on
biotechnology and related issues is being extended in an
array of international fora and new initiatives led by several
international organisations. Moreover it notes that, despite the
fact that they play a key role in specific sectors, there is
no appropriate platform to promote open and transparent
dialogue between interested parties.

Uncoordinated and contrasting initiatives have hith-
2.6.1.
erto reduced the impact, efficacy and coherence of
the
European strategy in this industry, and have led to the
persistence if not the widening of the existing gap between
Europe and its main international competitors. The European
biotech industry is still lagging behind in terms of size of
enterprise, direct and indirect employment, profitability and
product distribution networks.

2.6.1.1.
Public authorities, both at national and Community
level, must be aware of the importance of a coherent set of
actions providing clear and transparent information, training,
a clear reference framework and appropriate incentives in
order to achieve more rapid growth in this industry which
represents great potential for sustainable development.

2.6.2.
The study carried out on ‘Innovation and competi-
tiveness in European biotechnology’ (1) begins by noting that
the competitiveness of the industry does not only concern
enterprises, but also the wider complement of institutions,
infrastructure and policies which have a dynamic impact on
business activity. It goes on to identify situations and methods
that should be backed up through long-term public action.
The EESC invites the Commission and the Member States to
discuss the content and the proposals listed herein, and use
them as a launch pad for more robust policies,
to be
implemented according to a set timetable.

(1) Enterprise Papers No 7, 2002, European Commission.

C 234/18

EN

Official Journal of the European Union

30.9.2003

3. Recommendations

3.1.
The competitiveness of the biotech industry is a key
element in achieving the Lisbon objectives. The EESC considers
it a matter of top priority that the EU and Member States take
on board this objective and identify all appropriate means by
which to achieve it, working together to eliminate all barriers
to competitiveness.

3.2.
The ‘cluster’ and ‘biotech incubator’ models represent
a yardstick to assess competitiveness, synergies, technological
transfer and the most useful approaches for funding. Cooper-
ation between Member States and the Commission and
learning and sharing best practices should be particularly
strong in this sector, in order to find ways to trigger a more
accelerated process of growth.

3.3.
The innovative biotech industry is predominantly made
up of a large number of SMEs, which form the grassroots of
innovation. However, the existing tools to stimulate research,
technological transfer and finance are not always designed
with SMEs in mind. More effort should be made to understand
the types of businesses that compose the industry (products

and services) and the specific needs for funding. This especially
implies simplifying access to European funding, and to funding
for technological processes instead of just research in the strict
sense (notably by ensuring the quality of processes as well as
products, potential for industrial replication, building capaciti-
es and fine-tuning tested methods).

Taking on board such details would involve revising
3.4.
the very concept of risk capital in order for it to adapt to the
specificities of the industry, and in order to ensure that aspects
such as the duration of research, the professionalism of staff
and the requirements of regulatory bodies are taken into
account.

3.5.
The EESC notes with a degree of pessimism that, on
the one hand, the Member States have not taken sufficient
steps to swiftly achieve the goals laid down in the conclusions
adopted by the Competitiveness Council on 26 November
2002, and on the other hand, that the Commission report
does not specifically address the delays and the difficulties
encountered in developing the 30-point plan (European Com-
mission working document SEC(2003) 248). The Committee
therefore hopes that the next annual report will include a
detailed analysis of the achievements, failings and delays with
respect to the approved plan.

Brussels, 16 July 2003.

The President

of the European Economic and Social Committee

Roger BRIESCH