www.checkbiotech.org ; www.raupp.info ; www.czu.cz

Guenter Verheugen, Vice President of the European Commission responsible for
Enterprise and Industry, speaks about the EC's New Biotech Policy to at
EuropaBIO'S Biotechnology Day, October 2005.

Ladies and Gentlemen, I would like to thank Mr Hans KAST [Chairman of
EuropaBio] for his kind invitation to address EuropaBio?s Biotechnology
Policy Day.

Biotechnology is of great importance to several of Europe?s industrial
sectors and will be a key component to increase our competitiveness.

The new Commission?s industrial policy for biotechnology will rely on two
building blocks: the relaunched Lisbon Strategy and the Commission?s
strategy and action plan for Life Sciences and Biotechnology.

It is now clear that, although the Lisbon objectives were appropriate, the
programme for achieving them was too ambitious. The new Commission has
looked again at these objectives and developed a clearer and more realistic
plan with a stronger focus and greater ownership of the process by Member
States. What we have adopted is a Partnership for Growth and Jobs.

This was always at the core of Lisbon but now each Member State?s role and
responsibility to deliver are more clearly stated. Ensuring this Partnership
is a success is my most important goal as Commissioner for Enterprise and
Industry.

Underpinning this will be a new European industrial policy that aims at
boosting economic growth and job-creation. The policy must be horizontal in
nature to create a better environment for all businesses, regardless of size
or sector. At its heart will be a drive to create the appropriate framework
conditions, in particular through better regulation, to allow European
industry to thrive. To set this out in greater detail we are currently
working on a Communication ?Strengthening the policy framework for EU
manufacturing ? an industrial policy for Growth and Employment?.

I expect that it will be adopted shortly.

This new policy will, of course, have to be adapted to the needs for each
sector. If Europe is to meet the economic competition from the United States
and the growing challenges from China, India and others we must enhance our
traditional strengths, i.e. competitiveness, innovation and excellence.
This, naturally, puts the knowledgebased economy with biotech as one of its
legs, at the forefront of our policy. It is my objective to ensure that we
create the conditions so that Europe, becomes the natural home for
biotechnological innovation.

Firstly, I would like to turn to the critical issue of competitiveness and
innovation. The long-term well-being of the biotech sector depends on
support for the science base. Industry already makes significant investments
in research and development [?6 billion per year], but we also note that the
US spends almost three times that amount. My objective is very clear: we
must ensure to provide adequate support to innovation but also ensure that
new innovations result in applications that are placed on the market and
generate revenues. Only then will we be able to gain a competitive
advantage.

In April this year, the Commission adopted two proposals which are
horizontal in nature but very important for the future of the life sciences
and biotechnology sector: In this context my colleague Janez Poto?nik will
refer to the 7th Research Framework Programme.

Under my responsibility, the Competitiveness and Innovation Programme will
be a new streamlined innovation agenda designed to specifically benefit SMEs
and startups.

It includes an Entrepreneurship and Innovation Programme with a substantial
budget of ?2.6 billion. Indeed, SMEs are doing much to develop the new
technologies on which the future of the biotech sector depends. The
programme also includes many new elements including a risk capital
instrument for High Growth and Innovative Companies, an enhanced role for
innovation business support networks and a twinning programme for policy
makers. Overall it is designed to support actions that develop the capacity
of enterprise and industry to innovate.

Ladies and Gentlemen, We are witnessing a surge in knowledge in biosciences.
Already now biotechnology and life sciences play an ever-increasing role in
our daily life, which will affect almost every field of human activity.
Fanciful biotech applications are not mere promises ? they are either
reality or are about to become so. In particular new drugs and therapies
prove the usefulness of biotech.

While biotechnology has had a belated start in Europe, but the situation has
improved. Europe has more than 1900 biotech companies, roughly as many as
the USA, among them many small and medium sized enterprises. We had 132
start-ups in 2003, compared to 83 in the USA.

But all is not well. The US biotechnology industry employs twice as many
people, spends almost 3 times more on research and development, raises 3
times more venture capital, and has access to 4 times as much debt finance.
US companies also generate twice as much revenues, and will continue to leap
ahead as they place more products on the market and have more products in
the pipeline than European companies.

We must rise to the challenge. Apart from improving the financing of
research and innovation, the Commission recognises that the problem with the
lack of follow-on finance needs to be addressed: many biotech companies find
it hard to raise more capital after 3-5 years, which is needed for the
development and trial phases before a new drug can be marketed. We need to
improve access to private investment in public equity (PIPE) and debt
financing, and raise the willingness among institutional investors to invest
in high-risk equity.

Another disquieting tendency taking place in the pharmaceutical sector, one
of the most promising fields of biotechnology, is the move of research
activities and the production of innovative drugs outside Europe. We must
not underestimate this widening gap. Losing R&D in life sciences is going to
have major social and economic consequences for Europe, for example: -
delayed access to innovative drugs for the European population, - an erosion
of the general European research base, and a continued ?brain drain? of
researchers from Europe to the US and elsewhere, - a loss of inventions, of
entrepreneurial talent, and a decline for the European biotechnology
industry.

To sum up, an overall strategy is needed, and we are in the comfortable
situation that it already exists. The Commission?s Biotechnology Strategy
has laid the groundwork for our catch-up efforts in 2002 and was welcomed by
Member States and the European Parliament.

The strategy covers all fields of biotechnology, green, white and red, and
addresses all major issue areas and policy fields, from R&D to the
regulatory framework and access to capital for SMEs. The promotion of
biotechnology is important, but also discussing the societal concerns. An
open and sincere debate about the benefits of biotechnology and the ethical
questions surrounding it, is necessary and the Commission will launch it in
the context of the mid-term review of the Strategy next year.

The debate must, however, remain science-based, and we must take a balanced
view on matters of concern, such as GMOs, and avoid taking extreme
positions. Clarity and knowledge will help to lower emotional prejudices.
The fact that Europeans widely accept medical uses of biosciences shows that
they are not against biotech per se.

This brings me to the controversial area of green biotech which provides new
solutions for sustainable agriculture, better crop yields, better food and
feed quality and renewable resources.

But its benefits are not limited to food and feed. Plant genomics is useful
for fermentation and other industrial processes, that we refer to as white
biotechnology. Genetically modified plants may become a major source of
material for biopharmaceuticals, mainly therapeutic proteins. They could
provide a costeffective, abundant and safe source of human antibodies,
vaccines, enzymes and other medicines.

However, we all know that public attitudes as well as Member States?
positions hamper the development in this area. The Commission confirmed in
March 2005 its full commitment to the current legislative framework on the
authorisation of GMOs and called for Member States to co-operate and
introduce balanced co-existence measures in order to strengthen Europe?s
economic potential. As you know, the Environment Council has recently taken
a divergent position.

Starting from the lime taken in March 2005 we will need to enter into a
discussion with Member States in which direction the train should move with
regard to GMO authorisation. Europe has to make up its mind whether it wants
to use the full potential of green biotech to become competitive vis-a-vis
countries like the USA, Canada, Australia, China and India.

In addition, we, the Commission, public authorities, academia and industry
together, should try to present the usefulness of GMOs to the public and
explain why it matters greatly to us, not only as food and feed. Industry
needs to demonstrate the benefits and the usefulness of their products.

Ladies and Gentlemen, to regain our position as a world-leading drug
developer, Europe needs to strengthen its scientific co-operation between
large companies, SMEs and academia. The integration of local clusters of
biotechnology companies and research centres, and increased co-operation
between different regions, are examples of what can be done.

The recent revision of the regulatory framework governing pharmaceuticals
has significantly contributed to a more competitive structure for industry.
Several measures will encourage innovation, in particular intellectual
property rights with long data exclusivity.

Other measures, which are particularly relevant to SMEs, include: - waivers
and deferrals for a number of fees, - easier access to scientific advice
from the Medicines Agency, EMEA, - special incentives for companies
developing orphan drugs, and - administrative support by establishing a
special ?SME Office? within the EMEA. In the field of innovative
pharmaceuticals, we are in the process of completing our legislation with
the long awaited regulation on advanced therapies and tissue engineered
products.

Further discussions related to the pharmaceutical sector will take place in
the Pharmaceutical Forum, a High Level Group I am about to set up together
with my colleague Markos Kyprianou, which will cover the Commission,
Parliamentarians, Member States and Stakeholders.

Ladies and Gentlemen, Europe is facing a huge healthcare challenge. The
Council?s Economic Policy Committee has estimated that, by 2050, there will
be only two working age citizens for each elderly person in the EU instead
of the current four. The increasingly elderly population will need ever
greater support from hard-pressed healthcare systems.

By investing in biotechnology and healthcare now, we can reap rewards in the
years to come through reduced hospital care and other long term support. For
patients, it will mean a better quality of life.

By keeping Europe at the cutting edge of biotechnology research, we will
also contribute to the more general goals of creating more highly-qualified
and well-paid jobs, boost economic growth and improve our terms-of-trade.

Let?s be clear: it will not be an easy task to achieve this. The Partnership
for Growth and Jobs is an essential and adequate tool to do this, and I am
convinced we are able to face the challenge and come out successful. Let?s
work together to achieve this.

[www.molecularlab.it]

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