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: 2002-01-23
Institutions: European Commission
Subjects: action programme, biotechnology, competitiveness, ethics, genetically modified organism, innovation, life sciences, public awareness campaign

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COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE
COUNCIL, THE ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE
REGIONS

Life sciences and biotechnology (cid:151) A Strategy for Europe

(2002/C 55/03)

COM(2002) 27 final

PART I: A STRATEGY FOR EUROPE

1. THE STRATEGIC CHALLENGES

Life sciences and biotechnology are widely recognised to be, after information technology, the
next wave of the knowledge-based economy, creating new opportunities for our societies and
economies.

They also raise important policy and societal issues and have given rise to a broad public
debate, as confirmed in the comprehensive public consultation carried out by the
Commission during autumn 2001 (1). These issues must be addressed with great care and
In Europe, however, the relevant responsibilities fall across a broad range of
sensitivity.
policies and actors.
In the absence of a shared vision of what is at stake and without
common objectives and effective coordination, Europe has therefore only slowly and with
difficulty addressed the challenges and opportunities of these new technologies.

Our democratic societies should offer the necessary safeguards and channels of dialogue to
ensure that the development and application of life sciences and biotechnology take place
respecting the fundamental values recognised by the EU in the Charter of Fundamental
Rights.

Europe is faced with a major policy choice: either accept a passive and reactive role, and bear
the implications of the development of these technologies elsewhere, or develop proactive
policies to exploit them in a responsible manner, consistent with European values and
standards. The longer Europe hesitates, the less realistic this second option will be.

The Community is competent on important policy aspects of relevance, and the Commission
therefore has a particular responsibility to assist
in finding ways forward. The present
initiative proposes a framework for this.

1.1. Technology revolution and policy response

Broad and profound impacts which need
policy responses

A revolution is taking place in the knowledge base of
life sciences and biotechnology,
opening up new applications in health care, agriculture and food production, environmental
protection, as well as new scientific discoveries. This is happening globally. The common
knowledge base relating to living organisms and ecosystems is producing new scientific
disciplines such as genomics and bioinformatics and novel applications, such as gene
testing and regeneration of human organs or tissues. These in turn offer the prospect of
applications with profound impacts throughout our societies and economies, far beyond uses
such as genetically modified plant crops.

(1) Commission Communication (cid:145)Towards a strategic vision of life sciences and biotechnology: consultation document(cid:146),
COM(2001) 454 of 4 September 2001. The communication, public web-comments and results of a Commission
Stakeholder Conference held on 27 and 28 September 2001 are available at http://europa.eu.int/comm/biotechnology

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are

emerging, offering the kind of

The expansion of the knowledge base is accompanied by an unprecedented speed in trans-
formation of frontier scientific inventions into practical use and products and thus also
represents a potential for new wealth creation: old industries are being regenerated and
new enterprises
sustain
knowledge-based economies. As probably the most promising of the frontier technologies,
life sciences and biotechnology, can provide a major contribution to achieve the European
Community’s Lisbon Summit’s objective of becoming a leading knowledge-based economy.
in Stockholm in March 2001 confirmed this and invited the
The European Council
Commission,
full
potential of biotechnology and strengthen the European biotechnology sector’s competitiveness in
order to match leading competitors while ensuring that
those developments occur in a manner
which is healthy and safe for consumers and the environment, and consistent with common funda-
mental values and ethical principles.

together with the Council,

to examine measures

required to utilise

skill-based jobs

that

the

Europe’s current performance in life sciences and biotechnology is not
achievement of that objective.

facilitating the

Europese seems to be hesitating

In Europe and elsewhere, intensive public debate has emerged. While the public debate has
contributed to awareness and concrete improvements on important issues, it has also focused
narrowly on genetically modified organisms (GMOs) and specific ethical questions, on which
public opinion has become polarised. In the Community, like in other regions and countries,
the scientific and technological progress in these areas raises difficult policy issues and
complex regulatory challenges. Uncertainty about societal acceptance has contributed to
detract attention in Europe for the factors that determine our capacity for innovation and
technology development and uptake. This has stifled our competitive position, weakened our
research capability and could limit our policy options in the longer term.

Europe is currently at a crossroads: we need actively to develop responsible policies in a
forward-looking and global perspective, or we will be confronted by policies shaped by
others, in Europe and globally. The technology and its applications are developing rapidly:
the Commission believes that Europe’s policy choice is, therefore, not whether, but how to
deal with the challenges posed by the new knowledge and its applications.

1.2. A European strategy

Dispersed responsibility (cid:151) but the
Commission can contribute

The European Commission wishes to contribute actively to the reflection on these issues and
to address the challenges. In September 2001, it launched a broad public consultation on the
issues at stake (2). These issues can only in part be addressed by the
wide range of
Community: most depend on many other public and private actors. In some areas such as
the
product approvals, safeguarding the internal market, agricultural and trade policies,
Community has exclusive competence. On other aspects, the Community has no competence
or shares it with Member States. The ultimate responsibility for success or failure is therefore
a shared one.

But respecting the subsidiarity principle should not prevent Europeans from working together
towards common goals. Within a shared vision of the long-term and global opportunities and
challenges, we can develop clear strategic objectives and coherent and holistic approaches,
relying also on new forms of collaboration and monitoring,
in particular through open
coordination and benchmarking which underpins the Lisbon strategy.

(2) COM(2001) 454 of 4 September 2001

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The strategic priorities

With the present initiative, the European Commission proposes a strategy for Europe to
develop sustainable and responsible policies to address the following three broad questions.

(cid:151) Life sciences and biotechnology offer opportunities to address many of the global needs
relating to health, ageing, food and the environment, and to sustainable development.
How can Europe best attract the human, industrial and financial resources to develop and
apply these technologies to meet society’s needs and increase its competitiveness?

(cid:151) Broad public support is essential, and ethical and societal implications and concerns
must be addressed. How can Europe deliver effective, credible and responsible policies
which enjoy the confidence and support of its citizens?

(cid:151) The scientific and technological revolution is a global reality which creates new oppor-
tunities and challenges for all countries in the world, rich or poor. How can Europe best
respond to the global challenges, develop its domestic policies with a clear international
perspective and act internationally to pursue its interests?

A strategy and an action plan

The Commission proposes a strategy to respond with responsible, science-based, and people-
centred policies on an ethical basis. This strategy aims to allow Europe to benefit from the
positive potential of life sciences and biotechnology (sections 2 and 3), to ensure proper
governance (section 4), and to meet Europe’s global responsibilities (section 5). This is a
proposal for an integrated strategy (cid:151) its different elements are interdependent and mutually
reinforcing.

Implementing this strategy requires an open, collaborative and sustained process to develop
coherent and credible policies (section 6). The Commission also proposes an action plan for
concrete measures by the Commission and the Community, as well as recommendations for
other public and private actors, respecting the subsidiarity principle.

2. THE POTENTIAL OF LIFE SCIENCES AND BIOTECHNOLOGY

New solutions to real problems

Life sciences and biotechnology are widely regarded as one of the most promising frontier
technologies for the coming decades. Life sciences and biotechnology are enabling tech-
nologies:
like information technology, they may be applied for a wide range of purposes
for private and public benefits. On the basis of scientific breakthroughs in recent years, the
explosion in the knowledge on living systems is set to deliver a continuous stream of new
applications.

There is a huge need in global health care for novel and innovative approaches to meet the
needs of ageing populations and poor countries. There are still no known cures for half of
the world’s diseases, and even existing cures such as antibiotics are becoming less effective
due to resistance to treatments. Biotechnology already enables cheaper, safer and more ethical
production of a growing number of traditional as well as new drugs and medical services (e.g.
for
human growth hormone without
haemophiliacs with unlimited sources of coagulation factors free from AIDS and hepatitis
C virus, human insulin, and vaccines against hepatitis B and rabies). Biotechnology is behind
towards both personalised and preventive
the paradigm shift
targeted screening, diagnosis, and innovative
medicine based on genetic predisposition,
drug treatments. Pharmacogenomics, which applies information about the human genome
to drug design, discovery and development, will further support this radical change. Stem cell
research and xenotransplantation offer the prospect of replacement tissues and organs to treat
degenerative diseases and injury resulting from stroke, Altzheimer’s and Parkinson’s diseases,
burns and spinal-cord injuries.

risk of Creutzfeldt-Jakob disease,

in disease management

treatment

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through agronomically improved crops. Since 1998,

In the agro-food area, biotechnology has the potential to deliver improved food quality and
environmental benefits
the area
cultivated with genetically modified (GM) crops worldwide has nearly doubled to reach
some 50 million hectares in 2001 (in comparison with about 12 000 hectares in Europe).
Food and feed quality may be linked to disease prevention and reduced health risks. Foods
with enhanced qualities ((cid:145)functional foods(cid:146)) are likely to become increasingly important as
part of lifestyle and nutritional benefits. Plant genome analysis, supported by a FAIR research
project, has already led to the genetic improvement of a traditional European cereal crop
(called Spelt) with an increased protein yield (18 %) which may be used as an alternative
source of protein for animal feed (3). Considerable reductions in pesticide use have been
recorded in crops with modified resistance. The enhancement of natural resistance to
disease or stress in plants and animals can lead to reduced use of chemical pesticides,
fertilizers and drugs, and increased use of conservation tillage, and hence more sustainable
agricultural practices, reducing soil erosion and benefiting the environment. Life sciences and
biotechnology are likely to be one of the important tools in fighting hunger and malnutrition
and feeding an increasing human population on the currently cultivated land area, with
reduced environmental impact.

Biotechnology also has the potential to improve non-food uses of crops as sources of
industrial feedstocks or new materials such as biodegradable plastics. Plant-based materials
can provide both molecular building blocks and more complex molecules for the manu-
industries. Modifications under development
facturing, and energy and pharmaceutical
include alterations
fibre and new polymer
fats and proteins,
to carbohydrates, oils,
production. Under the appropriate economic and fiscal conditions, biomass could contribute
to alternative energy with both liquid and solid biofuels such as biodiesel and bioethanol as
well as processes such as bio-desulphurisation. Plant genomics also contributes to conven-
tional improvements through the use of marker-assisted breeding.

New ways to protect and improve the environment are offered by biotechnology including
bioremediation of polluted air, soil, water and waste as well as development of cleaner
industrial products and processes, e.g. based on use of enzymes (biocatalysis).

3. HARVESTING THE POTENTIAL

The economic dimension

The potential of life sciences and biotechnology is being exploited at an accelerating rate and
is likely to engender a new economy with creation of wealth and skilled jobs. Less certain is
the time profile and orientations of
fully
participate.

this development and whether Europe will

Some estimates suggest that by the year 2005 the European biotechnology market could be
worth over EUR 100 billion. By the end of the decade, global markets, including sectors
where life sciences and biotechnology constitute a major portion of new technology applied,
could amount to over EUR 2000 billion.

(3) http://europa.eu.int/comm/research/agro/fair/en/be1569.html

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Direct and indirect market potential of life sciences and biotechnology (1)

Industrial

EUR 1 500 billion market globally in 2010 in sustainable
(only partly
industrial
and environmental
estimated at
biotech) with environmental
EUR 90-120 billion (2)

technology
technology

Pharmaceutical

EUR 506 billion world market in 2004 (EUR 818 billion in
2010 assuming constant increase) (3)

Agricultural

Although there is a steady increase in area sown with
the future market value is
genetically modified seeds,
difficult to predict, as it would depend on the possible devel-
opment of a non-GM feed market. Million hectares world-
wide (4):

1998

28

1999

40

2000

44

2001

53

Allowing for the uncertainty of estimates from different sources, the above would imply
that in 2010 there would be a total world market (excluding agriculture) of above
EUR 2 000 billion in sectors where a major portion of the new technology and a
substantial part of the total technology comes from biotechnology companies.

___________
(1) Beyond quoted figures, comparative data on international competitiveness in biotechnology are
difficult
the main value factor is knowledge, and the usual statistical data on
turnover/sales/exports do not reveal the location where value in terms of intellectual property
has been added.

to establish:

(2) UK Government data: from the Department of Trade and Industry Bio-Wise programme launched

in 1999: OECD: POST Report 136, April 2000.

(3) IMS Health, (www.imshealth.com).
(4) ISAAA: International Service for the Acquisition of Agri-Biotech Applications.

Europeans are also likely to become major beneficiaries of solutions offered by life sciences
and biotechnology (cid:151) in the form of products and services for consumers, for public benefits
and throughout the production system. But to manage this development, to give us options,
to project our values and policy choices internationally, and to reap the benefits of a new
emerging economy, Europe should also command the knowledge base and its transformation
into new products, processes and services.

3.1. The knowledge base

Mastering the knowledge base through:

The life sciences revolution was born in, and is fed and nurtured by, research. Public research
laboratories and institutions of higher education are at the core of the science base inter-
acting also with enterprise-based research and that of other private bodies.

The success of any knowledge-based economy rests upon the generation, diffusion and
application of new knowledge.
Investments in research and development, education and
training and new managerial approaches are therefore of key importance in meeting the
challenges posed by life sciences and biotechnology.

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(cid:151) effective and innovative research

One of Europe’s main strengths is its science base; centres of scientific excellence in specific
technologies exist and are at the core of regional clusters of biotechnology development.
However, total European investment in R & D is lagging behind that of the United States of
America. Moreover, Europe suffers from fragmentation of public research support, and from
the low level of interregional cooperation in R & D, among companies and institutions from
different regions of several States.

The Commission aims to restore European leadership in life sciences and biotechnology
research. The 6th Community framework programme for research,
technological devel-
opment and demonstration activities (2002 to 2006) proposes this area as the first
priority and will provide a solid platform for constructing,
in collaboration with the
Member States, a European research area. This should reinforce R & D capacity and help
overcome existing fragmentation of research policies and efforts. When Europeans work
together, maximising collaboration and minimising duplication, we can better meet major
challenges such as the handling of the ever-increasing volumes of data and information and
ensuring full participation in global scientific initiatives.

Moreover, European research efforts should focus on the new prospects that are opening up
through multidisciplinary research. New discoveries are made most often in when biological
research is carried out in conjunction with other sciences and disciplines such as information
technology, chemistry and process engineering. For example, human genome analysis into
(cid:145)gluten allergy(cid:146) may ultimately lead to the development of allergen-reduced cereals. A first
fully integrated Community project has recently been launched to ensure leadership at the
genomes-medicine interface where biotechnology is yielding innovative approaches to
treatments of human and animal diseases.

(cid:151) research to meet society’s needs

Europe’s research agenda for life sciences should be based on the needs of its citizens and
attuned to our particular requirements. This calls for an approach which actively identifies
the needs and opportunities presented by European societies and seeks to address them
through innovative research. We need to further strengthen the links between research and
other Community policies, including the scientific basis for health and safety regulations. In
the same logic, it is also of utmost importance to involve scientists and researchers as closely
as possible in societal consensus building. New research partnerships should also be
encouraged amongst developed and developing nations to take full advantage of promising
technologies and biodiversity potential, the basis for future progress.

3.2. Europe’s capacity to offer scientific and technological solutions

Transforming science into applications

The potential for applications of life sciences and biotechnology promises to be a growing
source of wealth creation in the future, leading to the creation of jobs, many of which will be
highly skilled ones, and new opportunities for investment in further research.

If Europe is to benefit from this, excellence in the science base is not enough: it is essential to
have the capacity to translate knowledge into new products, processes and services, that in
turn will generate benefits to society, skilled jobs and prosperity. The development of new
capacity involves the encouragement of the entire research and innovation process to attract
and train researchers, to attract investment and resources, and to provide a balanced and
responsible legal, regulatory and policy framework.

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Europe’s fragile biotechnology sector

During the 1980s, biotechnology in Europe developed primarily within large companies
whereas, unlike the United States of America, the small company sector remained mostly
stagnant. While large companies in the pharmaceutical and chemical sectors continue to
exploit the technology to provide innovative products, we have seen a rapid expansion of
the small companies sector in Europe in the recent past. There are now more dedicated
biotechnology companies in Europe (1 570), than in the United States of America (1 273).
This is an encouraging demonstration of entrepreneurial potential in Europe.

Biotechnology Industry in Europe compared to the United States of America

Note: European data for 2000 and 2001 are adjusted by the inclusion of the Swiss biotech company Serono

However, the European SMEs are relatively small companies, whereas the United States of
America biotechnology industry started earlier, produces more than three times the revenues
of the European industry, employs many more people (162 000 against 61 000), is much
more strongly capitalised and in particular has many more products in the pipeline.

The Commission’s 2001 report on competitiveness (Chapter V) analysed in detail why
commercial development of EU industry currently lags behind that of the United States of
America in the biotechnology sector. Intellectual property rights were identified as a relevant
factor to be taken into account.

Structurally, biotechnology SMEs are very capital-intensive, and investments have long
payback periods. Risk capital funding has been increasingly available, but does not appear
to be sufficient at all stages of the long company development process. Insufficient supply of
skilled personnel may develop into a major constraint for industry development.

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Comparison of employment

Action for Europe’s biotechnology
sector

Eliminating such bottlenecks is as important as fostering an entrepreneurial Europe with
sufficient
innovation and economic risk-taking to create the necessary
dynamics. Europe’s competitiveness should be enhanced through three main pillars for
action: the resource base, networks and a pro-active role for public authorities.

incentives for

education (4)

and engineering knowledge has

(cid:151) Reinforcing the resource base is of prime importance for this knowledge-based industry;
this calls first of all for enhancing life sciences education (lifelong learning for scientists,
general awareness of the public). We also need training across disciplines and special-
including the potential for take-up of information and communication tech-
isation,
nologies in biotechnology; new ideas tend to emerge at the junction of specialisation.
Scientific
to be matched with entrepreneurial
management skills for successful company operation. This action pillar contributes
and employment (5) objectives. Comprehensive,
directly to Europe’s
up-to-date and publicly and freely available bioinformatics data are the basis for
advances in biotechnology. In order to flourish, companies need access to high quality
public and private databases and tools. While maintaining strong public research, public
support and intellectual property rules should encourage collaboration, especially public/
In the border region
private ones,
between research and application,
in
particular well-managed risk capital and Europe-wide rules for intellectual property
rights, make all the difference. The full implementation of Directive 98/44/EC of the
European Parliament and of the Council on the legal protection of biotechnological
inventions will considerably improve legal certainty for industry. The clarification of
the legislative environment within the Community will provide innovative firms in the
various industries using biotechnology with an incentive to continue or even increase
their investments in research. In addition, the adoption of the Community patent would
promote the competitiveness of the Community companies.

the conditions for exploitation of knowledge,

that mobilise resources and support

innovation.

(4) 10-year-objectives in education and life-long learning.
(5) Employment policy guidelines for 2002: improving employability; developing entrepreneurship and job creation;

encouraging adaptability of businesses and their employees.

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(cid:151) We need to network Europe’s biotechnology communities to facilitate open access to
knowledge, skills and best practises, and to create a close community of actors and
institutions involved in biotechnology. European-wide intellectual property protection
must be completed to provide an affordable basis for technology transfer and coop-
eration. Links between the university and the industry spheres need to be strengthened.
Research cooperation and technology transfer among regions and Member States must be
enhanced. There is a need to promote and facilitate different forms of networking and
linking-up to overcome current
fragmentation. Benchmarking allows the sharing of
knowledge of good practices (e.g. on business clusters and incubators). An intelligent
management of diversity may exploit the network benefits of regional clusters that are
specialised in specific technologies.

(cid:151) The fast development of biotechnology and the broad range of potential applications
requires a proactive role for public authorities to monitor the impact on competi-
the existing policy framework and to anticipate emerging issues and
tiveness of
proactively adapt policies. This will need a pooling of
the knowledge available to
public decision-makers, through information exchange and networking.

4. A KEY ELEMENT FOR RESPONSIBLE POLICY: GOVERNING LIFE SCIENCES AND

BIOTECHNOLOGY

technology revolution calls

The
governance through:

for

The public debate on life sciences and biotechnology and the fundamental values affected
highlight the need for responsible and coherent policies to govern these fast-moving tech-
nologies. All key stakeholders have stressed the importance of governance, i.e. attention to
the way public authorities prepare, decide, implement and explain policies and actions.

The Commission proposes to apply the highest standards of governance of life sciences and
biotechnology along five main action lines:

(cid:151) societal dialogue and scrutiny should accompany and guide the development of

life

sciences and biotechnology,

(cid:151) life sciences and biotechnology should be developed in a responsible way in harmony

with ethical values and societal goals,

(cid:151) informed choice should facilitate demand-driven applications,

(cid:151) science-based regulatory oversight should enhance public confidence,

(cid:151) basic regulatory principles and legal obligations should be respected to safeguard the

Community single market and international obligations.

4.1. Societal scrutiny and dialogue

(cid:151) inclusive informed and structured
dialogue

Life sciences and biotechnology have given rise to significant public attention and debate. The
Commission welcomes this public debate as a sign of civic responsibility and involvement.
Life sciences and biotechnology should continue to be accompanied and guided by societal
dialogue.

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Dialogue in our democratic societies should be inclusive, comprehensive, well informed
and structured. Constructive dialogue requires mutual respect between participants, inno-
vative approaches, and time. It should be structured in agreement with stakeholders to allow
progress, for example in the provision of better information and mutual understanding.
Experience also shows how important
the local and
levels, as well as internationally, and the Commission invites Member States and
national
local actors to take relevant initiatives.

is that dialogue takes place at

it

Dialogue should be open for all stakeholders. Public authorities should help to ensure
participation by stakeholders with limited resources. Economic operators,
industry and
users, who have economic interests at stake, as well as the scientific community, bear a
particular responsibility for active participation. The Commission invites these parties to
respond to public concerns, for example through transparency of their visions, policies
and ethical standards.

for meaningful dialogue. Providing it requires
Relevant public information is essential
focused and proactive efforts. It is especially important that the information needs formulated
by the broad public are taken seriously and responded to. We shall also strive for a balanced
and rational approach, distinguishing between real issues, on which we must act, and false
claims.

4.2. Developing life sciences and biotechnology in harmony with ethical values and

societal goals

(cid:151) balancing benefits against disad-
vantages

Without broad public acceptance and support, the development and use of life sciences and
biotechnology in Europe will be contentious, benefits will be delayed and competitiveness
will be likely to suffer.

The debate and the public consultation carried out by the Commission (6) indicate that the
European public is quite prepared and capable to enter into complex weighting of benefits
against disadvantages, guided by fundamental values. Although sometimes polarised, the
public debate demonstrates many points of converging views.

Public opinion depends crucially on the perceived benefits of life sciences and biotechnology.
Eurobarometer surveys reveal that public expectations of biotechnology, apart from medical
advances, are moderate. And there is also considerable public uncertainty about some
applications, and aversion towards their distributional impacts and the risks involved.

There is broad support for many guiding values and goals. Some of these, such as the
freedom of research, intrinsic value of new knowledge and the moral obligations to help
alleviate illness or hunger, tend to favour the development and application of these new
technologies. Others help to clarify the criteria and conditions for the development and
applications of life sciences and biotechnology, in particular the need to take into account
the ethical and societal implications, and the importance of transparency and accountability
in decision-making, minimising risk, and freedom of choice.

It is therefore of key importance to support information and dialogue to help the public and
stakeholders better understand and appreciate these complex issues and to develop methods
and criteria for assessing benefits against disadvantages or risks, including the distribution of
impacts among different parts of society.

(6) The Commission intends to publish these comments on the Internet.

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Our democratic societies should offer the necessary safeguards to ensure that the devel-
opment and application of life sciences and biotechnology take place respecting the funda-
mental values recognised by the EU in the Charter of Fundamental Rights, in particular by
confirming the respect for human life and dignity. The Community has also banned funding
of research into human reproductive cloning. Support should be given to the Franco-German
initiative, addressed to the United Nations, for a worldwide convention on the prohibition of
human reproductive cloning. Other issues such as stem cell research clearly require attention
and further debate. Europe has also taken clear positions on the importance of freedom of
choice for consumers as well as for economic operators with respect to GM foods, and we
have established broad societal agreement on the need to safeguard European agricultural
practices.

implications. The Commission considers that

However, scientific and technological progress will continue to give rise to new ethical or
these issues should be addressed
societal
proactively and with a broad perspective,
the moral obligations
towards present and future generations and the rest of the world. We should not content
ourselves with acting defensively only when our core values are being transgressed.

taking into account

These issues cannot be adequately addressed within the narrow context of regulatory product
approvals but require more flexible and forward-looking approaches. Europe needs an active
and ongoing public dialogue, accompanied by focused fact-finding on both benefits and
disadvantages to allow the public to contribute to the complex process of setting priorities.
In the context of its Science and Society initiative (7), the Commission has already proposed a
series of actions intended to strengthen the ethical dimension in sciences and new tech-
nologies.

To be at the forefront of developments, Europe should have the capacity for foresight/pros-
pective analysis and the necessary expertise to help clarify the often complex issues for policy
makers and the public, and to place them in their scientific and socioeconomic context. The
Commission welcomes the key role played by the European Group on Ethics in Science
and New Technologies since its creation in the early 1990s and proposes, as part of the
present strategy, to enhance its role and to reinforce the networking with and between
national ethical bodies. To this end, an additional
the other
Community institutions is envisaged.

targeted consultation of

Moreover, transparency, accountability and participatory approaches in public policy-making
need to be reinforced. These objectives coincide with those of the Commission’s White Paper
on European Governance (8) and will be pursued through the actions proposed therein.

4.3. Demand-driven applications through informed choice

(cid:151) giving consumers and economic
operators informed choice

The regulatory oversight applied to the development and use of life sciences and biotech-
nology is the expression of societal choices. Regulation and other public policy measures set
the rules and conditions, under which life sciences and biotechnology may be developed and
applied. Regulation should therefore ensure that market mechanisms function effectively to
obtain the stated objectives. This is the purpose of Europe’s policy of mandatory labelling
which aims to ensure that consumer’s preferences are translated into incentives for producers
to adapt supply.

(7) COM(2001) 714 of 4 December 2001.
(8) COM(2001) 428 final of 25 July 2001.

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As far back as 1990 and after lengthy discussions, the Community opted for a science-based
regulatory approach that subjects all commercial uses of genetically modified organisms to ex
ante public scrutiny and safety approval on a case-by-case basis, prior to any application,
release into the environment or marketing. As a result of this approach, a revised framework
legislation on GMOs has been adopted and will enter into force in October 2002. The new
in authorising new
legislation provides a sound basis to overcome the present standstill
products.

(cid:151) Under the Community’s regulatory approach in sectors where pre-marketing author-
isation is required, authorisation is granted after a scientific evaluation of the risks
which the product may present for human and animal health or for the environment,
taking into account other factors legitimate to the matter under consideration. In the logic
of this approach, it is for the markets to determine whether products survive. But it is
essential to ensure that the market mechanisms work effectively so that consumers can
exercise choice and thus send clear signals to suppliers. Over the last five years, Europe
has pioneered solutions to ensure informed consumer choice through labelling. These
need urgently to be completed and put into application.

(cid:151) In order to fully apply the principle of freedom of choice for economic operators and
to safeguard sustainability and diversity of agriculture in Europe, public authorities in
partnership with farmers and other private operators need to develop agronomical and
other measures to facilitate the coexistence of different agricultural practices without
excluding GM crops.

4.4. Confidence in science-based regulatory oversight

Where safety is an issue, Community legislation is science based and its application with
respect to specific decisions will be in accordance with the precautionary principle (9). The
European Agency for Evaluation of Medicinal Products is a successful example of setting high
standards of scientific advice and effective risk communication. With the creation of the
European Food Safety Authority (EFSA), the already high standards of excellence,
inde-
pendence and transparency of scientific advice in that field will be taken further and new
emphasis will be placed on risk communication. EFSA will be responsible for scientific
assessments of environmental, human and animal health effects of GMOs and GM food
and feed, and will have a forward-looking responsibility for identifying emerging risks,
including those potentially arising from the application of biotechnology in agri-food
production. These are essential contributions to public trust in the scientific basis for regu-
latory oversight for the safety of existing foods and medicines as well as new applications.
Building public confidence and understanding must be a permanent concern.

(cid:151) fostering public confidence in science
and regulation

(cid:151) There is a general need to enhance public trust in the role of science in our societies.
The Commission has proposed an action plan on Science and Society to promote
to better take into account public needs in setting the scientific
scientific culture,
agenda, and to place science at
the heart of European policies. Public authorities,
economic operators and the scientific community should actively present relevant
knowledge
scientific
knowledge is always advancing and therefore regularly improves our reference points.
Moreover,
it is an essential part of the process of public understanding and policy
formulation to also evaluate the risks of not taking action, for example against the
evolution of new or drug-resistant diseases and in areas where current agricultural
practices are unsustainable.

and facilitate understanding on key issues,

including that

(9) Commission’s communication on the precautionary principle COM(2000) 1 final of 2 February 2000, and the Nice

European Council conclusions.

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(cid:151) Biotechnological inventions require high capital investment, long development cycles and
comprehensive regulatory approval. Effective patent protection is a crucial incentive to
R & D and innovation and an essential means of guaranteeing return on investment.
Moreover, the disclosure of information in patent publication has been important in
contributing to the overall development of biotechnology. In view of the rapid scientific
progress, legislation on intellectual property needs to be monitored very closely. Regular
assessments need to be made on whether the patent regime satisfies the needs of
researchers and companies.
the Community and its Member States
should ensure that the interpretation of the essential criteria of novelty, invention and
utility in the field of life sciences is not left exclusively to courts and patent offices. As
regards the international context, there is a need to work towards a level playing field in
patent protection in industrialised countries. Steps need to be taken in view of promoting
international dialogue on this issue.

In this respect,

(cid:151) The basis for Community regulation of these new technologies should be more trans-
parent and better communicated. For example, we should be clearer about how regulators
deal with risk: potential risk, scientific uncertainty (e.g. the absence of zero risk, the
application of the precautionary principle), weighing of comparative risks, the role of
the different stages of risk analysis, the role of risk-management measures such as moni-
toring and safeguards, and their proportionality with risk. In addition, whilst underlining
the importance of legal certainty and predictability, we need to stress the reversibility of
regulatory decisions when justified and highlight the ongoing work on international
risk-analysis methodologies and development of anticipatory risk
convergence of
analysis methodologies. Publicly funded research in support of regulatory oversight is
of particular importance for public confidence.

(cid:151) Specific initiatives proposed in the Commission’s White Paper on European Governance
are particularly relevant
in particular the planned
for enhancing public confidence,
improvements for openness and accountability in risk governance and in use of expertise.

(cid:151) Confidence in our regulatory oversight is a responsibility of public authorities but also
requires the responsible participation of other stakeholders such as the biotechnology
industry, other economic operators, the scientific community, NGOs and the media.

4.5. Regulatory principles

(cid:151) reconciling policy objectives in regu-
lation of life sciences

Community regulation currently governs such diverse aspects such as the patenting of
biotechnological inventions, the authorisation of pharmaceutical products, contained use of
genetically modified microorganisms, and release and marketing of products consisting of or
derived from GMOs, including foods, feeds and seeds. This regulatory framework has evolved
gradually over the last 25 years, with major developments in recent years.

In order to improve the coherence, transparency and efficiency of Community regulation, the
Commission suggests that Community regulatory activity should respect the following prin-
ciples:

(cid:151) Risk governance and product authorisation: Products of biotechnology should,

in
accordance with the established regulatory principles and frameworks, be authorised
found to be safe for
on the basis of a comprehensive scientific risk assessment
human, animal or plant life and health and the environment. In cases where scientific
evidence is insufficient, inconclusive or uncertain, and where possible risks are judged to
be unacceptable, risk management measures should be based on the precautionary
principle. Risk management should take into account the results of risk assessment and
other factors legitimate to the matter under consideration in order to achieve the chosen
level of protection. Procedures for authorisation should be transparent, risk assessments
should be published and made available for public comment as part of the authorisation
procedures. Communication needs to be an integral part of risk assessment and risk
management activity.

if

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(cid:151) Safeguarding the internal market: To secure the functioning of the internal market and
legal certainty, Community legislation should be drafted and periodically reviewed to
ensure coherence and efficiency,
including with regard to its practical feasibility and
enforceability.
Implementation of and compliance with Community law should be
carefully monitored, and any problem of compliance should be addressed and resolved
in a transparent and
among concerned parties according to existing procedures
predictable manner.

(cid:151) Proportionality and consumer choice: Community regulatory requirements should be
proportionate to the degree of identified risk and should conform with the Community’s
international obligations. As proposed by the Commission, Community legislation should
facilitate consumer choice through ensuring that consumers/users are informed in cases
where a food, feed or seed is genetically modified or derived from GMOs.

(cid:151) Predictability, modernisation and impact assessment: The Commission should peri-
odically publish a rolling regulatory work programme (see point 6) to improve predicta-
bility, transparency and quality of regulation. Regulation should continue to be regularly
reviewed to be up to date with scientific and technological progress, for evaluation of
impacts and for conformity with the present principles.

5. EUROPE IN THE WORLD (cid:151) RESPONDING TO GLOBAL CHALLENGES

A global reality

The revolution in life sciences and biotechnology is global. Research is fundamentally inter-
national: knowledge and experts circulate throughout the world. A growing number of
countries are actively pursuing biotechnologies, and the resulting products and services
will increasingly be traded on global markets, with a premium for first innovators.

. . . which should be reflected in our
policies and priorities

It is also clear that great diversity exists between countries and regions with respect to their
capacities to develop, regulate and apply the new products and services. Even greater
diversity may emerge with respect to the priorities and societal values that will shape the
approaches and choices to developing and using these new technologies.

European policies should not be developed in isolation. We need to embrace the wider
international context which shapes both challenges and opportunities for Europe, and we
must respond with responsible and proactive policies at the global level. A main objective
must be to ensure that
the EU maintains competitiveness vis-(cid:224)-vis major industrialised
countries such as the United States of America and Japan. Moreover, whatever policies
Europe will decide regarding life sciences and biotechnology, they will have important inter-
national impacts, in particular for developing countries. The interests of these countries must
also be taken into account. We must integrate the international dimension into all relevant
policies, and we need to develop an international agenda, based on our fundamental values
and long-term objectives, to actively promote balanced and responsible policies globally, in
particular towards the developing world.

5.1. A European agenda for international collaboration

Managing international diversity

International collaboration is required to manage the novel issues raised by life sciences and
biotechnology and the diversity of capacities and policies in different countries and regions
towards their applications.

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Trade in goods and services is already being affected due to divergent product approval rates.
International trade friction may also emerge if countries and regions adopt divergent regu-
latory frameworks. There is a need for international dialogue on regulatory issues to develop
mutual understanding of basic principles and values underlying regulatory developments in
different countries.

The Community is committed to open, multilateral, and rules-based trading systems. We
should therefore promote respect and implementation of existing international agreements.
Given the particular issues raised by life sciences and biotechnology, the Community should
promote solutions and dialogue at international level that:

(cid:151) ensure mutual supportiveness between relevant international Agreements and in

particular between the WTO Agreements and the Biosafety Protocol;

(cid:151) support a coherent, comprehensive, effective,

transparent and inclusive approach to
biotechnology across the relevant international forums in order to avoid overlaps and
make the best use of their respective expertise (including FAO, UNEP, CBD, WTO, WHO
and Unctad (10)). Europe should continue to play a full part, in particular in the OECD
and the Codex Alimentarius, and notably its ad hoc Intergovernmental Task Force on
Biotechnology, to promote within these organisations the development and periodic
review of harmonised guidelines with respect to the risk analysis, the labelling and the
traceability of products derived from modern biotechnology. The role and efficiency of EU
participation in international discussions
including through
discussions with developed and developing countries. Dialogue should promote mutual
understanding of concerns and objectives of different countries and regions, such as the
EU/US Biotechnology Forum which delivered its final report in December 2000 (11). Early
policy dialogue about forthcoming legislation may reduce the potential for international
friction.

should be enhanced,

5.2. Europe’s responsibilities towards the developing world

Potential to meet the urgent needs of the
developing world

Life sciences and biotechnology hold the promise of meeting some of the fundamental needs
for food and health facing the developing world. The UNDP, in its 2001 Human Devel-
opment Report, highlights the potential of biotechnology for the developing world (12). Some
emerging economies such as China,
India and Mexico have already initiated ambitious
national development programmes.

the developing world, but

Life sciences and biotechnology are not a panacea and will not resolve the distributional
problems of
tools. New
capacities should help developing countries reconcile yield increases, sustainable use of
natural resources, economic efficiency and social acceptability. Potential applications must
be adequately researched and assessed, taking full account of both the environmental safety
issues and the needs expressed by the populations concerned to reduce poverty and
strengthen food security and nutritional quality.

they will be one of

the important

(10) Food and Agriculture Organisation, United Nations Environmental Programme, Convention on Biological Diversity,
World Trade Organisation, World Health Organisation, United Nations Convention on Trade and Development.

(11) http://europa.eu.int/comm/external_relations/us/biotech/biotech.htm
(12) http://www.undp.org/hdr2001/

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Putting European capacities to the
service of developing countries

As a major actor in life sciences and technologies, Europe has a particular responsibility to
help the developing world deal with the risks, challenges and opportunities, and to facilitate
the safe and orderly development of these technologies at the global level. Europe already
holds an influential position in international deliberations on life sciences and biotechnology.
This needs to be taken forward with responsible policies to achieve our strategic objectives
life sciences and biotechnology in developing
and to allow the safe and efficient use of
countries.

(cid:151) Europe should continue to promote protection of biodiversity and the implementation of
the Biosafety Protocol for international trade in living modified organisms. Moreover,
Europe should continue to support negotiated multilateral frameworks such as the
Convention on Biological Diversity and the FAO International Undertaking on Plant
Genetic Resources. These international instruments regulate access to genetic resources
and the sharing of the benefits arising from their use, in view of providing compensation
to the centres of origin of genetic resources and the holders of traditional knowledge used
in biotechnological
inventions. The Community should contribute to ensure that the
including intellectual property
benefits generated by biotechnological
income, are properly shared with the providers of genetic resources or traditional
knowledge.

inventions,

(cid:151) Europe should contribute to technical assistance, capacity-building and technology
transfer to allow developing countries to participate in negotiating and implementing
international agreements and standards, notably on risk governance, and to safely develop
and apply these new technologies if they so wish. Europe should support local initiatives
for dialogue on biotechnology among public and private stakeholders and civil society in
partner countries.

(cid:151) Europe should encourage equitable and balanced North-South partnerships and public

research for demand-driven applications of life sciences and biotechnology.

(cid:151) Domestic European policies with regard to life sciences and biotechnology are bound
to have major impacts on developing countries. Whilst not compromising EU food safety
requirements or consumer information policies, we should provide technical assistance
and capacity-building to ensure that our policies do not, unwittingly, prevent developing
countries from harvesting desired benefits. In particular, we should guard against regu-
latory requirements that may be manageable only in the industrial world but are
unachievable by developing countries, thereby either upsetting existing trade or effectively
blocking developing countries from developing life sciences and biotechnology at their
own wish and pace.

6. IMPLEMENTATION AND COHERENCE ACROSS POLICIES, SECTORS AND ACTORS

Overcoming dispersed responsibilities
through collaboration

Europe does not have a single policy for life sciences and biotechnology but a patchwork of
specific regulation, overlaid by many sectoral and horizontal policies at
international,
Community, Member State and local levels. If, with so many actors and policies involved,
Europe is to successfully manage life sciences and biotechnology and reap the benefits for
society, we should proceed on the basis of a shared vision for a cooperative approach and
with effective implementing mechanisms to compensate for absence of overall responsibility
and control. Without such mechanisms, life sciences and biotechnology risk to continue to
suffer indecision or short-sighted and local solutions.

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Implementation through:

The Commission proposes to structure and support implementation of the present strategy
and the enclosed action plan through the following measures:

(cid:151) monitoring

(cid:151) Monitoring of progress in policy development and on the ground, and anticipatation
of emerging issues in this fast-developing area, the Commission will, starting in 2002
and ending in 2010, present a regular life science and biotechnology report, including a
rolling work programme for legislation.

(cid:151) coherence of EU policies

(cid:151) We need to ensure coherence across Community legislation and policies directly
regulating, or indirectly impacting on, the development and application of life sciences
and biotechnology. The Commission will, as part of its life science and biotechnology
reports, review the coherence of Community policies and legislation affecting life sciences
and biotechnology and launch initiatives and proposals as appropriate. Particular
attention will be given to ensure that regulation on life sciences and biotechnology
adequately integrates our international objectives and facilitates innovation and inter-
national competitiveness, that Community research contributes coherently and effectively
to Community objectives, and that other Community policies and objectives (e.g.
in
environment, public health and consumer protection, education, employment, agriculture,
trade and development policies) adequately reflect the long-term and global importance
of life sciences and biotechnology. The Commission will evaluate whether existing inter-
national forums and bilateral dialogues are sufficiently effective and provide adequate
flow of
the domestic coordination mechanisms can be
improved.

information, and whether

(cid:151) coordination and benchmarking

(cid:151) Where different levels of competence apply, the strategy should be a reference for
collaboration between different actors (Community, national and local public authorities,
economic operators,
the Lisbon strategy,
the scientific community, etc.). As part of
coherent action for life sciences and biotechnology should be pursued through the
established methods of coordination and benchmarking. In addition, new forms of colla-
boration and partnerships between stakeholders should be encouraged. Together with
Member States, the Commission will also assess whether current patterns of competence
and mechanisms of cooperation allow the effective achievement of
the strategic
objectives,
is a need to reinforce
Community competence in accordance with the Treaty.

including reassessment as

to whether

there

(cid:151) political attention

(cid:151) The Commission invites all institutions and public actors to strive for better coherence in
their action. For its own part, it will seek to provide the vigilance and political impetus
to keep momentum in implementing the present strategy, through its own action or
through recommendations and invitations to other parties. The Commission intends to
hold more regular orientation debates, coinciding with the adoption of
the above-
mentioned Commission life science and biotechnology report.

(cid:151) In order to facilitate transparency and structured dialogue on the further development
and implementation of the proposed strategy for life sciences and biotechnology, the
Commission will organise a broadly based stakeholders’ forum, including representatives
of the candidate countries and third countries.

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7. A FRAMEWORK FOR DIALOGUE AND ACTION

A framework for action now and for
developing future action

It is time to clarify the strategic opportunities and challenges facing Europe. Life sciences and
biotechnology are a global reality and essential for the objective of developing dynamic and
innovative knowledge-based economies. We have to face the difficult questions and identify
our strategic objectives to avoid the pitfalls of short-term solutions to long-term challenges
and of local solutions to global challenges.

Recognising that life sciences and biotechnology raise particular challenges, the Commission
undertook to propose a strategy and concrete actions. It now presents this initiative for a
coherent, collaborative and sustained effort.

The present initiative draws on a thorough analysis (13) of the strengths and weaknesses of
European biotechnology, and a broad public debate and the specific public consultation
launched by the Commission in September 2001. The initiative should,
itself
inspire further dialogue. The attached action plan suggests a broad scope of measures
according to the orientations set out in Chapters 3 to 6 of this Communication. It constitutes
a framework, within which some actions can be launched in the short-term while other
actions for the medium and longer term are identified and suggested for further development
in collaboration with Member States and stakeholders.

in turn,

The Commission now invites the Community institutions and bodies, the Member States,
protagonists and the public to contribute to refine and implement the proposed strategy by
defining detailed measures under both short- and medium-term actions and the time plan for
their deliverables, as a first decisive step towards an effective and coherent European biotech-
nology policy.

(13) European Competitiveness Report 2001, Luxembourg 2001; (cid:145)Innovation and competitiveness in European biotech-

nology(cid:146), Enterprise Papers No 7, 2002, European Commission.

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PART II: ACTION PLAN

1. HARVESTING THE POTENTIAL

The resource base

Investing in People

Action 1

The Commission will together with competent authorities in Member States (1) identify the education
needs in life sciences within the 10-year objectives for learning in the knowledge society (2) and:

(a) strengthen a broad education and understanding of life sciences;

(b) develop and train a skilled workforce in life sciences;

by issuing recommendations for curricula and teacher training. Community support can be provided
under the Comenius and Erasmus programmes.

(c) As set out in its communication on the European area of lifelong learning (3), the Commission will
industry, academia and others to identify measures to promote
the scientific workforce.

work with Member States,
continuing education and refresh the current competence of
Community support can be provided under the Leonardo programme.

(d) The Commission and Member States should support discussion forums for specialist scientists, with
the objective of stimulating an exchange across disciplines. Vital discoveries frequently happen at
the point where disciplines intersect. Community support can be provided under the Erasmus
programme.

Implementer: Member States, Commission, private sector.

Time frame: 2003 to 2010.

(1) Where reference is being made to the Member States in the action plan, the Commission will examine with

interested candidate countries their participation.

(2) Education Council Report to the European Council 5980/01.
(3) COM(2001) 678.

Action 2

The Commission will explore with Member States

(a)

the opportunity and best way to establish efficient methods to match a skilled workforce with
job opportunities,
involving effective communication of open positions, collaboration with
established companies and a labour force aware of available employment options.

(b) possible measures to attract and retain scientists and avoid brain drain. In achieving this,
the Communication (cid:145)A
specific reference will be paid to the initiatives
mobility strategy for the research area(cid:146) (1), which aims at improving the overall environment
of researchers and their families in the EU. Due attention will also be paid to the increased
mobility opportunities offered by the forthcoming sixth framework programme (2002 to 2006),
and more particularly to the measures aimed at attracting foreign researchers and supporting the
return of EU researchers established in other parts of the world.

launched under

Implementer: Member States, Commission.

Time frame: 2003 onwards.

(1) COM(2001) 331 final of 20 June 2001, as supplemented by the Council’s resolution of 20 December 2001

concerning (cid:145)The reinforcement of the mobility strategy within the European research area(cid:146).

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Generating and exploiting knowledge

Research

Action 3

The Commission will enhance its support for life sciences and biotechnology research, tech-
nological development, demonstration and training activities under
framework
programme 2002 to 2006 aimed at contributing towards the creation of the European research area.

the next

Biotechnology research will be supported under the thematic priorities, including:

1. Genomics and biotechnology for health;

3. Nanotechnologies;

5. Food quality and safety;

6. Sustainable development;

7. Citizens and governance.

Specific measures will be provided to encourage SME participation, international cooperation and
mobility and training of researchers.

The new instruments of Networks of Excellence and Integrated Projects will facilitate the objectives of
Europe-wide collaborations, attaining critical mass and simplification of administrative procedures.

The Commission and the Member States should also in collaboration with the European Investment
Fund (EIF) develop a competitive bioinformatics infrastructure in support of biotechnology
research and focus support for the development of research in computational biology and biomedical
informatics.

Implementer: Member States, EIF, Commission.

Time frame: 2002 to 2006.

Management and legal services

Action 4

Enhancing the supply of specific management and legal skills:

(a) Member States and national biotechnology associations should examine the opportunity of
level;

creating self-sustained networks of biotechnology company managers at the national

(b) Member States and the Commission should promote collaboration between law schools, law firms
and companies for the development of specific legal competence needed by biotechnology
companies.

Implementer: Member States, academia, professional associations, Commission.

Time frame: 2003 onwards.

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Exploitation of intellectual property

Action 5

A strong, harmonised and affordable European intellectual property protection system, func-
tioning as an incentive to R & D and innovation will be finalised by:

(a) Member States urgently transposing into national laws Directive 98/44/EC on the legal protection

of biotechnological inventions;

(b) the Council adopting the Community patent regulation;

(c) Member States and the Commission clarifying rules on ownership of

intellectual property
stemming from public research and monitoring the effect of implementation of patent legislation
on research and innovation;

(d) encouraging awareness training in the strategic use of IPR during the entire research and inno-
vation process and raising awareness among academics of the commercial potential of their
research, encouraging entrepreneurship and movement between academia and companies;

(e) taking steps to promote international dialogue and cooperation with a view to working towards a
level playing field with industrialised countries in patent protection on biotechnology inventions,
ensuring an effective level of protection for innovation in this field.

Implementer: Member States, Council, Commission.

Time frame: 2002 onwards.

Capital base

Action 6

The Commission should together with the European Investment Bank (EIB) and the European
Investment fund (EIF) strengthen the capital base for the biotechnology industry, by:

(a) seeking to stimulate investments in research and technological

innovation via complementary
financing on the basis of the cooperation agreement signed in June 2001 between the Commission
and the EIB group;

(b) seeking to stimulate investments in business incubators through the EIF start-up facility;

(c) studying measures to support technology transfer mechanisms, such as financing of patent pools

or other methods for patent exploitation;

(d) studying measures to encourage commercial financing of companies based on a medium-term

investment perspective.

Implementer: EIB Group, Commission.

Time frame: 2002 onwards.

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Action 7

The Commission will strengthen the work of
the Biotechnology and Finance Forum by the
inclusion of relevant major stakeholders to provide advice into policy development in the field of
capital supply.

Implementer: Commission.

Time frame: 2002.

Networking Europe’s biotechnology communities

Networks in Europe

Action 8

The Commission will:

(a) support creation of a commercial biotechnology web portal for Europe that will help free
access to information and networking available Internet platforms. The contents of such a portal
will have to be defined based on the requirement of economic viability and sustained demand;

(b) develop its newly created Commission website to provide a broad entry platform into the

Commission’s work on biotechnology.

Implementer: Commission.

Time frame: 2002 and 2003.

Action 9

Member States, their regions, the Commission and EIB should support:

(a) stronger interregional cooperation, e.g. through a network of biotechnology regions. Cross-
border and interregional cooperation can receive funding from the Interreg programmes (notably
Interreg IIIB and IIIC).

(b) networks of biotechnology clusters. In addition, the Commission will organise a European
competition between biotechnology innovation clusters, to highlight their capability to develop
a cluster with a focus of excellence in a specific scientific field.

Implementer: Member States, Regions, EIB, Commission.

Time frame: 2003 to 2006.

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A proactive role for public authorities

Action 10

The Commission will establish:

(a) a competitiveness monitoring function and a contact network with Member States
ministries with responsibility for competitiveness in biotechnology. Monitoring should
include impact on European competitiveness of legislation and policy measures;

(b) a competitiveness in biotechnology advisory group with industry and academia to assist in
identification of issues affecting European competitiveness. The group will provide input into the
Commission’s regular reports on life sciences and biotechnology.

Implementer: Member States, Commission.

Time frame: 2002.

Action 11

Transparency in the administrative process:

(a) the Commission and Member States, as regulatory authorities, should aid applicants, especially

from start-up companies and SMEs, requesting approval through the regulatory process;

(b) the Commission will issue a guide to Community regulation for users and for entrepreneurs
who have limited staff and expertise in the regulatory and legal fields. Such a guide should also
benefit non-EU (e.g. developing world) applicants and the general public.

Implementer: (a) Member States, Commission; (b) Commission.

Time frame: 2003 onwards.

Action 12

In collaboration with the involved actors, the Commission will benchmark good practices in
clustering biotech companies and in the work of business incubators and disseminate results.
The Commission will also establish with Member States a programme for benchmarking relevant
elements of biotechnology policies, in addition to existing benchmarking structures.

Implementer: Commission.

Time frame: 2003 onwards.

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2. A KEY ELEMENT FOR RESPONSIBLE POLICY: GOVERNING LIFE SCIENCES AND BIOTECHNOLOGY

Societal scrutiny and dialogue

Action 13

The Commission, Member States, organisations,
institutions and other actors should engage in a
structured dialogue at various levels to develop an understanding and information exchange
on life sciences and biotechnology. The Commission will in particular help mobilise all key actors
in the public debate and facilitate participation of stakeholders with limited resources.

In particular:

(a) the Commission will propose a framework for a process of dialogue and follow-up with
the European strategy for life sciences and biotechnology. The
stakeholders as a result of
framework will notably include a broadly based stakeholders’ forum.
the
Commission will take the initiative to better explain Europe’s regulatory approach (including
the application of
risk management, monitoring,
safeguards and reversibility of regulatory decisions);

the precautionary principle,

In this process,

the role of

(b) the Commission will take initiatives, and invites the scientific community and other stakeholders
to assist, to promote awareness of key scientific paradigms underlying regulatory oversight
such as scientific uncertainty, absence of zero risk, comparative risks, that science is
continuously evolving and therefore continuously improves our reference points, and the articu-
lation between the steps in the risk-analysis process. Within their respective fields, the European
Food Safety Authority and the European Agency for the Evaluation of Medicinal Products will play
an important role in general risk communication, including the scientific background for their
conclusions of risk assessments;

(c) Beyond these two specific initiatives, the Commission will also encourage public debates on
including specific interest
biotechnology between scientists,
focussing on specific technological
groups, such as patients groups,
developments,
in such developments and offer early information on
potential benefits and risks. Developers in the scientific community and in industry have a
specific responsibility in actively explaining the background and the benefits of their products.

industry and civil society,

farmers and consumers,

to raise public interest

Implementer: Member States, industry, academia, civil society, EFSA, EMEA, Commission.

Time frame: 2002 onwards.

Developing life sciences and biotechnology in harmony with ethical values and societal goals

Action 14

issues and dissemination of results,

The Commission will strengthen and focus Community support for research into socio-
economic and ethical
including criteria for assessing the
benefits of using biotechnology in agri-food production,
to facilitate future reporting and to
provide a good basis for societal decisions on the application of biotechnology and life sciences.
The Commission will programme research support to a more systematic mapping of benefits and
disadvantages/risks which should include a strong component for dissemination of information and
debate.

The Commission will ensure that ethical, legal and social implications are taken into account at
the earliest possible stages of Community supported research by means of funding bioethics
research and of providing an ethical review of research proposals received.

Implementer: Commission.

Time frame: 2002 to 2006.

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Action 15

The Commission proposes to enhance the role of the European Group on Ethics. In addition, the
Commission will
launch a separate consultation of the other Community institutions on possible
structural and procedural improvements. The Commission will also promote collaboration between
Community, national and local
levels by promoting networking of national and local ethical
bodies and elected representatives. The Commission will organise a network of academic and
professional experts for ad hoc advice on specific socioeconomic aspects.

Implementer: Ethical bodies, legislatures, Commission.

Time frame: 2002.

Action 16

The Commission will develop, jointly with the European Parliament, outreach measures to
inform about the analysis of ethical issues at the EU level.

While respecting cultural pluralism, the Commission will work with public and private partners to
identify areas where it is possible to establish consensus on ethical guidelines/standards or
best practice. Areas might include stem cell research, biobanks, xenotransplantation, genetic testing
and use of animals in research. Such guidelines could, when appropriate, take the form of self-regu-
latory initiatives in the scientific community and industry.

Implementer: European Parliament, Member States, regions, industry, institutions, Commission.

Time frame: 2002 onwards.

Demand-driven applications through informed choice

Action 17

The Commission will take initiative to develop, in partnership with Member States, farmers and other
private operators, research and pilot projects to clarify the need, and possible options, for agronomic
and other measures to ensure the viability of conventional and organic farming and their
sustainable coexistence with genetically modified crops. Moreover, the Commission recognises the
importance of safeguarding the existing genetic resources in agriculture. It will launch a new action
programme for the conservation, characterisation, collection and utilisation of genetic resources in
agriculture in the Community.

Implementer: Member States, professional associations, other operators, Commission.

Time frame: 2002 onwards.

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Confidence in science-based regulatory oversight

Pharmaceutical legislation

Action 18

Parliament and the Council are invited to speed up the adoption of the three legislative proposals,
revising the Community pharmaceutical legislation, including measures:

(a) to develop and reinforce the system of giving scientific advice and to increase the access of
the European Agency for Evaluation of Medicinal Products’ (EMEA) scientific committees to high
level expertise through the creation of expert panels and permanent working groups. The
increased level of expertise will also help the revision and development of European guidelines
on the quality, safety and efficacy aspects of biotechnological medicinal products;

(b) to introduce an accelerated procedure for products with a major public health interest that
will allow the assessment and authorisation of a medicinal product within a shortened time scale;

(c) to introduce a procedure allowing a conditional authorisation valid for one year, but
renewable. This will allow products of major public health interest but
for which certain
studies are still in progress to be given a conditional access to the market during the finalisation
of the studies.

Implementer: European Parliament, Council.

Time frame: 2002.

Genetically modified organisms (GMO) legislation

Short-term regulatory actions

Action 19

Parliament and the Council are invited to speed up the adoption of the two following legislative
proposals:

(a) proposal for a regulation of the European Parliament and of the Council on traceability and
labelling of genetically modified organisms and traceability of food and feed derived from
genetically modified organisms.

b) proposal for a regulation of the European Parliament and of the Council on genetically

modified food and feed.

Implementer: European Parliament, Council.

Time frame: 2002.

Action 20

The Commission continues its work with a view to finalising the legislative proposals which have
already been announced, such as initiatives concerning GM plant-propagating material, environmental
liability and the implementation of the Biosafety Protocol.

Implementer: European Parliament, Council, Commission.

Time frame: 2002 to 2003.

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Implementation and enforcement activities

Action 21

The Commission will ensure that legislation is enforced in a uniform and effective way across
the Community and adopt appropriate implementing measures required under relevant legis-
lation,
including the necessary guidance for detection and sampling methodology. The
Commission will also establish a molecular register that is accessible to the public, containing
information on events of genetic modification.

Implementer: Commission.

Time frame: 2002 to 2003.

Specific long-term regulatory actions

Action 22

The Commission will report on the feasibility of options to improve further the consistency and
efficiency of the framework for authorising GMOs for deliberate release into the environment,
including a centralised Community authorisation procedure.

Implementer: Commission.

Time frame: 2003.

Action 23

The Commission will support the development of methodologies for monitoring potential long-term
environmental impacts of GMOs as compared with conventional crops, and methodologies for the
monitoring of effects of genetically modified food and feed as compared with conventional
food and feed. With the establishment of the European Food Safety Authority, the work on the early
identification of emerging risks will be reinforced and upgraded.

Implementer: Commission.

Time frame: 2002.

3. EUROPE IN THE WORLD (cid:151) RESPONDING TO GLOBAL CHALLENGES

A European agenda for international collaboration

Action 24

The Commission should continue to play a leading role in developing international guidelines,
standards and recommendations in relevant sectors, based on international scientific consensus and, in
particular, push for the development of a consistent, science-based, focused, transparent, inclusive and
integrated international system dealing with food safety issues.

Implementer: Commission.

Time frame: 2002.

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2.3.2002

Europe’s responsibilities towards the developing world

Agriculture

Action 25

The Commission will in cooperation with Member States support:

(a) the redefining of national research towards an appropriate mix of traditional techniques and

new technologies, based on priorities developed with local farmers;

(b) the establishment of effective research partnerships between public and private research organi-
sations in developing countries and in the EU, and the adequate capacity and infrastructure for
developing countries to enter
in accordance with international
into such partnerships,
commitments under the Conventions;

(c) subregional, regional and international organisations,

in particular the International Agri-

cultural Research Centres.

Implementer: Member States, Commission.

Time frame: 2002 onwards.

Genetic resources

Action 26

The Commission and the Member States will support the conservation and sustainable use of
genetic resources in developing countries and their equitable sharing of benefits arising from their
use by:

(a) supporting the development and enforcement of effective measures to conserve, to use
sustainably and to provide access to genetic resources and traditional knowledge, as well
as to share equitably the benefit arising from them, including income generated by intellectual
property protection. Support for local communities is vital to conserve indigenous knowledge
and genetic resources;

(b) supporting the participation of delegates from developing countries in the negotiations of

relevant international conventions.

(c) supporting measures to promote greater regional coordination in legislation to minimise
in
disparities in access, benefits and also trade in products derived from genetic resources,
accordance with international commitments.

Implementer: Member States, Commission.

Time frame: 2002 onwards.

Health

Action 27

The Commission and the Member States should work with the international community to
concretise the commitment to research to combat HIV/AIDS, malaria, TB and other main
poverty-related diseases and also identify effective measures to support developing countries in
establishing the structures needed to deploy a health policy.

Implementer: Member States, Commission.

Time frame: 2002 onwards.

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Responsible and careful use

Action 28

The Commission should support:

(a) the safe and effective use of modern biotechnologies in developing countries, based on their

autonomous choice and on their national development strategies;

(b) measures to increase the capacity of developing countries to assess and manage risk for

man and the environment, under conditions prevailing in the country;

(c) the development of appropriate administrative,

legislative and regulatory measures

in the

developing countries, for the proper implementation of the Cartagena Protocol;

(d) that international research on social, economic and environmental impacts are effectively adapted
to take into account conditions prevailing in developing countries and that the findings are
subsequently disseminated to them in an appropriate format;

(e) that the international regulatory requirements remain manageable by developing countries, so as

not to impede their trade and production prospects.

Implementer: Commission.

Time frame: 2002 onwards.

4. IMPLEMENTATION AND COHERENCE ACROSS POLICIES, SECTORS AND ACTORS

Action 29

The Commission will enhance:

(a) the general foresight function across Commission services, and in particular its role in tech-
through its Institute for Prospective Technological Studies (IPTS), for early

nology foresight
identification of newly emerging issues and of elements of a policy response;

(b) its monitoring and review function to assess

(cid:151) the relevance, coherence and effectiveness of legislation and policy,

(cid:151) the extent to which policy objectives are achieved and legislation enforced,

(cid:151) the societal and economic impact of legislation and policy measures.

In pursuit of these objectives and to further strengthen policy coherence, the Commission

(c) will reinforce continuous coordination between its services and calls upon Member States to also
provide enhanced foresight/review functions and a coordinated interface for a dialogue on these
issues.

Implementer: Commission, Member States.

Time frame: from 2002 onwards.

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2.3.2002

Action 30

The Commission will present a regular report on life sciences and biotechnology to monitor
progress and indicate possible specific proposals to ensure policy and legislative coherence. The report
will draw on the conclusions under actions 11 and 30.

Implementer: Commission.

Time frame: 2003 onwards.

Final report of the Hearing Officer in case COMP/37.859 (cid:151) De Post/La Poste

(Pursuant to Article 15 of Commission Decision 2001/462/EC, ECSC of 23 May 2001 on the terms
of reference of hearing officers in certain competition proceedings (cid:151) OJ L 162, 19.6.2001, p. 21)

(2002/C 55/04)

(Text with EEA relevance)

The draft Decision gives rise to the following observations regarding the right to be heard:

The proceedings in this case took a normal course both in its written and its oral phase. The Statement of
Objections, adopted by the Commission on 1 June 2001, was sent to La Poste, the only undertaking
concerned, on 6 June 2001. The latter was granted access to the Commission’s file on 12 June 2001. La
Poste responded to the Statement of Objections on 12 July 2001, after the initial time limit of one month
which expired on 6 July had been extended by six days.

The complainant HAYS received non-confidential versions of the Commission’s Statement of Objections
and of the response submitted by La Poste. HAYS commented on both in writing before the Oral Hearing.
The Oral Hearing was held on 24 July 2001. Both La Poste and HAYS presented their arguments. Requests
of a procedural nature were tabled neither during nor after the meeting.

It follows from the above observations that the rights of defence have been fully respected. The same is
true of the complainant’s right to be heard. The draft Decision deals only with objections in respect of
which La Poste has been afforded the opportunities of making known its views.

Done at Brussels, 28 September 2001.

Helmuth SCHR(cid:214)TER