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Brussels, Belgium
March 5, 2003
In its first progress report
since adopting the EU strategy on life sciences and
biotechnology in 2002, the European Commission today indicated
that the risk of diverging policies in Member States could
seriously hamper the effectiveness and consistency of the EU
strategy in this field. While progress has been made in some
areas, such as the adoption of the EU 6th
Research Framework Programme and the EU regulatory framework for
GMOs, others are suffering from serious delays. For instance,
Member States are slow in transposing biotechnology patents
legislation. These delays increase the risk of failing to meet
in the area of life sciences and biotechnology the March 2000
Lisbon European Council objectives, for Europe to become the
most competitive and dynamic knowledge-based economy in the
world. Decisive action and concrete commitments are now urgent:
these include in particular more research and financial
resources, and completing the system for the protection of
intellectual property rights.
"A recent Commission survey of
private biotech companies and public research institutes reveals
that 39% of the respondents have cancelled research projects on
Genetically Modified Organisms (GMOs) over the last four years,"
said European Research Commissioner Philippe Busquin. "In the
private sector alone, 61% of respondents have cancelled research
projects in this field. Furthermore, between 1998 and 2001, the
number of notifications for GMO field trials in the EU declined
by 76 %. Now that legitimate consumer and environmental concerns
have been tackled by strict EU legislation, it is time to
reverse this downward trend. If we do not react, we will be
dependent on technology developed elsewhere in the world within
the next ten years."
Enterprise and Information
Society Commissioner Erkki Liikanen said: "Practically the
entire European biotechnology industry is facing difficulties
due to the collapse in investor confidence in knowledge-based
industries. Many small biotechnology enterprises, working on
medical, industrial, agricultural and environmental
applications, are unable to get the funding they need to turn
their research findings into a commercial reality. If a large
number of such enterprises were to fail, it would seriously
undermine knowledge that is critical to the long-term
competitiveness of major European industries. Concerted action,
involving public authorities as well as the private sector, is
needed to improve the investment climate for biotechnology in
Europe."
The EU Strategy for life sciences
and biotechnology
In January 2002, the Commission
adopted a Strategy for Europe on Life Sciences and
Biotechnology, including policy recommendations and a 30-point
Action Plan (COM(2002) 27 final). It proposes a comprehensive
roadmap up to 2010 and puts the sector at the forefront of
frontier technologies, helping the European Union meet its
long-term strategic goal established by the Lisbon European
Council in March 2000: to become the most competitive and
dynamic, knowledge-based economy in the world, capable of
sustainable growth with more and better jobs within a decade.
The Action Plan tackles issues
such as human resources in life sciences, research, management
of biotech companies, legal issues, intellectual property
rights, access to finance, networking of players in this field,
the role of public authorities and regulators, public debate and
dialogue with stakeholders, ethics, pharmaceutical legislation,
GMO regulation, the international framework, and EU policy in
developing countries (including agriculture, genetic resources
and health).
European institutions support
this integrated approach as the way to achieve the Lisbon
objective of promoting this high-technology area. Life sciences
and biotech can foster growth, create new jobs and benefit a
wide range of sectors such as health and agriculture, while at
the same time contributing to broader goals, such as sustainable
development.
In anticipation of the 2003
Spring Council, the German Federal Chancellor Gerhard Schröder,
French President Jacques Chirac and British Prime Minister Tony
Blair have stressed the potential of biotechnology to improve
European industrial competitiveness and ensure employment
opportunities. At the same time, they underlined the importance
of developing all aspects of European business to achieve the
Lisbon Strategy.
Progress, delays and the need for
action
Today's report assesses progress
in implementing the strategy in fields such as research, science
and society, competitiveness, innovation, access to finance and
intellectual property, Genetically Modified Organisms (GMOs),
and international issues (the impact of the current situation on
GMOs on our relations with trade partners and developing
countries).
In line with the Action Plan
timetable, the Commission has made progress on a wide range of
specific actions and has supported various independent actions
undertaken by European regions, academia and industry alike. In
some Member States a number of measures are already in place,
which tie in with the Biotechnology Strategy.
Research
Although strategy implementation
is still at an early stage, a certain amount of progress has
been made. A notable achievement has been the adoption of the 6th
EU Research Framework Programme (FP6 2003-2006), which will
continue to underpin basic scientific research and help to build
the European Research Area in this and other fields. FP6 devotes
€2.225 billion to life sciences, genomics and biotechnology for
health. A further €685 million will be dedicated to food quality
and safety.
However this is a relatively
small amount compared to private investment in this field.
European biotech companies invested €7.5 billion in research
last year, and biotech-related industry, such as pharmaceuticals
and chemicals, substantially more.
These companies are making a
bigger contribution than other sectors to achieving the
Barcelona European Council target, to allocate 3% of Gross
Domestic Product (GDP) to research in Europe. If the current
trend towards moving biotech research outside Europe continues,
this contribution will decrease.
Competitiveness and innovation
To foster competitiveness and
innovation in this field, the Commission calls for better
co-ordinated research across Europe, better access to finance,
in particular to risk capital, and for clear, equitable,
affordable and effective intellectual property rights regime in
Europe. This requires the swift adoption of the Commission
proposal for a Community Patent, and transposition into national
legislation of the Directive on biotechnological inventions (Dir
98/44/EC) by non-compliant Member States.
GMOs
Considerable progress has been
made on the legislative framework surrounding GMOs. The new
regulatory framework on GMOs, including the Commission's
proposals on traceability and labelling of GMOs and on GM food
and feed, provides legal certainty for operators. It also
addresses public concerns and aids consumer choice, thereby
encouraging further public acceptance of GMO use. It is also
important that the regulatory framework is clear and predictable
if the rapid decline in European GMO field research is to be
reversed.
Science and society
Rapid advances in life sciences
have created high expectations for curing diseases and improving
quality of life, while raising concerns as to their ethical and
social consequences. The Commission is committed to ensuring
that ethical, legal, social and wider cultural aspects are taken
into account in policy-making and research funding. Sensitive
issues include human reproductive cloning. The Commission
supports a worldwide ban on this issue. On human embryonic stem
cell research, the Commission will present a report to the
European Parliament and Council shortly, as the basis for an
inter-institutional seminar on this kind of research.
International issues
Biotechnology is currently
discussed in many international fora. This is a reflection of
the different concerns and objectives surrounding biotechnology,
but raises a question of international governance. It is
therefore essential to create an adequate forum for promoting an
open and transparent dialogue between all stakeholders
concerned, facilitating mutual understanding of the concerns and
objectives of the different countries and regions. Therefore the
Commission recommends giving further consideration (together
with our trading partners) to the need for a multilateral
consultative forum to contribute to building international
consensus on biotechnology
For further information please
visit:
http://europa.eu.int/comm/biotechnology/introduction_en.html
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