Brussels, Belgium
April 11, 2007
The European Commission has today
reviewed its strategy on Life Sciences and Biotechnology (see
IP/07/484). This sector has the potential to make a
significant contribution to the sustainability and
competitiveness of European industry and the quality of life of
Europe's inhabitants. This background note gives some key facts
and figures about the sector, outlines the revisions proposed to
the strategy and highlights some of the on-going and planned
support to research in this area.
Key facts and figures on
life sciences and biotechnology
The European dedicated
biotechnology industry directly employs 96500 people, mostly in
SMEs. Employment in industries that use biotechnology products
is many times higher. The industry is highly research intensive,
with 44% of its employees involved in R&D activities. In 2004,
the 2163 dedicated biotechnology companies spent €7.6 billion on
R&D.
The EU accounted for 34.8% of
biotechnology patents filed at the European Patent Office in
2002-2004, compared to 41.1% for the US.
According to a Eurobarometer
survey in 2006, one in two Europeans believe that biotechnology
will improve their quality of life. The survey showed widespread
support for medical and industrial applications of
biotechnology, though there was a more negative position on GM
foods (58% against, 42% in favour). The same survey showed that
the EU is more trusted than national governments on issues of
regulating biotechnology.
A few examples of
biotechnology products and processes
Recombinant human insulin, for
the treatment of diabetes, now accounting for 70% of the
worldwide market in insulin. Biotechnology has also enabled the
development of test for diagnosis of acute cardiovascular
diseases and infectious diseases such as HIV etc
Antibiotic productions
processes, resulting in a 37% reduction in use of electricity,
almost 100% reduction in use of solvents and 90% reduction in
waste water. Biofuels, biodegradable plastic and biotech enzymes
as brightening and cleaning agents in washing powder allowing
towash at lower temperature, are other examples.
Methods for the surveillance of
BSE, allowing many more samples to be tested so that the level
of surveillance required by Community legislation can be
maintained, thereby contributing to the protection of consumers
and continued trade for farmers. Similar tools can be used to
detect salmonella.
Production of recombinant
vaccines against diseases like Hepatitis B, which ensure that no
active part of the virus will be present in the vaccine product,
and thereby making it safer for the population.
Exploiting the natural
capabilities of certain bacteria to produce vitamins, and
thereby enhance the vitamin content of diary products.
Major proposed revisions to
the Life Sciences and Biotechnology Strategy
These fall under 5 main
headings and require the involvement of a wide range of players,
from the European Commission and Member States, to international
organisations such as the OECD, universities and research
organisations,industry , and Civil Society Organisations such as
environmental groups, patient and consumer organisations etc.
(1) Promote research and
market development for life sciences and biotechnology
applications and the Knowledge Based Bio-Economy
- Generate new knowledge
under FP7.
- Mobilise public and
private research funding and reinforce the coordination of
research.
- Implement the Joint
Technology Initiative on Innovative Medicine under FP7.
- Develop schemes to
finance/promote the establishment of multi-functional pilot
plants to demonstrate the potential of bio-based
applications and facilitate their market penetration
- Explore lead market
initiatives in the areas of eco-efficient bio-based products
(2) Foster competitiveness,
knowledge transfer and innovation from the science base to
industry
- Develop best practice in
the responsible licensing of genetic inventions.
- Promote knowledge transfer
by improving links between research organisations and
industry and incentives to innovation.
- Monitor the implementation
of Directive 98/44/EC on the legal protection of
biotechnological inventions and explore ways of facilitating
the patenting system for SMEs.
- Encourage Member States to
consider specific rules and/or incentives for Young
Innovative Companies.
- Promote the use of EIF/EIB
instruments and the Competitiveness and Innovation Framework
Programme to facilitate access to finance for biotechnology
companies; implement Risk–Sharing Finance Facilities
co-funded by FP7 and the EIB.
- Support the development
and integration of clusters and regional networks.
(3) Encourage debate on the
benefits and risk of life sciences and biotechnology
- Stimulate the possible
establishment of an institutionalised interface with
different stakeholders on benefits and risk of life sciences
and biotechnology.
- Set up proposals on how to
improve the cooperation with all relevant stakeholders to
ensure input in the Commission's activities.
- Propose for the
establishment of international quantitative impact
indicators (including social and economic) and structured
collection of data.
- Adapt the action to the
new FP7, and produce guidance for EC funded activities to
address ethical issues.
- Anticipate the possible
ethical and socio-economic impact of emerging scientific
issues.
(4)
Ensure a sustainable contribution of modern biotechnology to
agriculture
- Assess
notified national and regional measures on co-existence and
study applicable national civil liability systems.
-
Re-evaluate by 2008 the possible need for further guidance
on co-existence at EU level.
- Support
research and develop guidelines for crop-specific
co-existence measures and exchange information on best
practices among Member States.
- Adopt
crop-specific labelling thresholds for seeds.
- Conduct
studies and support related research activities on potential
positive and negative long term effects of commercially
available GMOs.
- Explore
benefits and risks of GM crops used for industrial
transformation or molecular farming.
(5) Improve the
implementation of the legislation and its impact on
competitiveness
- Reinforce existing
networks with Member States to monitor the implementation of
the Strategy and address regulatory obstacles to
competitiveness.
- Pursue foresight
activities and the evaluation of the regulatory coverage on
emerging issues.
- Improve policy
coordination, including on cross cutting issues, with a
particular focus on newly emerging issues.
Contribution of past and
future EU Research Framework Programmes to life sciences and
biotechnology
The 6th Framework
Programme (2002-2006) allocated €500m to supporting exchanges,
training and fellowships in the area of life sciences and
biotechnology, as part of the Marie Curie Actions. This funded
about 1000 full-time PhD positions and supported the creation of
45 new research groups. It also supported 11 top-level "Chairs",
attracting world-class researchers (back) to Europe.
Still under FP6, €2.5 billion
was used to fund 613 projects in the field of life sciences,
genomics and biotechnology for health, looking at issues such as
fundamental genomics, poverty-related diseases, cancer,
cardio-vascular diseases, diabetes, age- and brain-related
diseases and rare diseases.
€756 million funded 186
projects in the field of food quality and safety, looking at
food processing and safety, nutrition, food-related diseases,
animal and plant production systems, forestry, animal and plant
biotechnology.
€20 million was awarded to
projects to develop biomass, under the sustainable development
theme.
Support was given to specific
actions to promote the debate on ethical, legal, social and
wider cultural aspects of life sciences and biotechnology
including on issues such as human embryonic stem cell, animal
cloning, genetic testing etc.
.SMEs were strongly
represented, accounting for 17% of all participants and 14% of
funding in the health theme, and 19% and 12% respectively in the
food quality and safety theme.
Other parts of FP6 (funding of
infrastructures, international co-operation and coordination of
national and regional research programmes) also supported
research in the field of life sciences and biotechnology.
Eight Technology Platforms,
to develop and foster public-private partnerships at
European level, have been launched in the area of life
sciences and biotechnology: Innovative Medicines
Initiatives, Nanomedicine - Nanotechnologies for Medical
Applications, Plant genomics and Biotechnology, Industrial
biotechnology under the sustainable Chemistry technology
platform, Food for Life, Sustainable animal breading and
reproduction, global Animal Health, Forestry and Biofuels.
The 7th Framework
Programme started in 2007. Within its Cooperation Programme, €8
billion are specifically dedicated to Life Sciences and
Biotechnologies. Some €6 billion will support health research
with another €2 billion supporting research on food, agriculture
and fisheries, and biotechnology. SMEs are expected to account
for 15% of these budgets, meaning funding of 1.2 billion euros.
FP7 is also encouraging frontier and riskier research in Life
Sciences through the new European Research Council. FP7’s People
Programme will support training and networking researchers,
career development and industry –academia partnerships. Actions
addressing the ethical and socio-economic aspects will continue
to be supported.
The Risk Sharing Finance
Facility will use money from the research programme to access
credit from the European Investment Bank, to increase the access
of European research to such finance. Life Sciences and biotech
companies stand to gain considerably from this facility, which
will also be used to support the development of major new
research infrastructures at European level, including in these
fields.
Building on the success of the
European Technology Platforms the next level of public and
private research partnership is the so-called Joint Technology
Initiatives. The Commission expects to propose in the near
future a JTI on Innovative Medicine. |
