1.1. Technology revolution and policy response
A revolution is taking place in the knowledge base of life sciences and
biotechnology, opening up new applications in healthcare, agriculture
and food production, and 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.
The expansion of the knowledge base is accompanied by an unprecedented
speed in transformation 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 are emerging,
offering the kind of skill-based jobs that sustain knowledge-based economies.
As probably the most promising of the frontier technologies, life sciences
and biotechnology can provide a major contribution to achieving the European
Community’s Lisbon Summit’s objective of becoming a leading knowledge-based
economy. The European Council in Stockholm in March 2001 confirmed this
and invited the Commission, together with the Council, to:
‘examine measures required to utilise the 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 fundamental values and ethical principles.
Europe’s current performance in life sciences and biotechnology is not
facilitating the achievement of that objective.
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 detracting attention in Europe from 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 to actively 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
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 wide range of issues at stake. These
issues can only in part be addressed by the Community - most depend on
many other public and private actors. In some areas such as product approvals,
safeguarding the internal market, agricultural and trade policies, the
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.
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:
- 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?
- 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?
- The scientific and technological revolution
is a global reality which creates new opportunities 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?
The Commission proposes a strategy to respond
with responsible, sciencebased, 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, to ensure proper governance,
and to meet Europe’s global responsibilities. This is a proposal for an
integrated strategy - its different elements are interdependent and mutually
Implementing this strategy requires an open, collaborative and sustained
process to develop coherent and credible policies. 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
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 technologies — 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 healthcare 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. human growth hormone without risk of Creutzfeldt-Jakob
disease, treatment for 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 the paradigm
shift in disease management towards both personalised and preventive medicine
based on genetic predisposition, targeted screening, diagnosis, and innovative
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 strokes, Alzheimer’s and Parkinson’s diseases,
burns and spinal-cord injuries.
In the agro-food area, biotechnology has the potential to deliver improved
food quality and environmental benefits through agronomically improved
crops. Since 1998, 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 (‘functional foods’) 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. 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, fertilisers 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
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 manufacturing, energy and pharmaceutical
industries. Modifications under development include alterations to carbohydrates,
oils, fats and proteins, fibre and new polymer 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 to processes such as bio-desulphurisation. Plant genomics also
contributes to conventional improvements through the use of marker-assisted
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, for example
based on use of enzymes (biocatalysis).
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for the Future on Risk - Life Sciences
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