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Life sciences and biotechnology: A strategy for Europe
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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 reinforcing.

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 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 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 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, for example based on use of enzymes (biocatalysis).

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