At the Lisbon Summit in March 2000, European heads of state and government set the goal of 'making Europe the most competitive knowledge-based economy in the world by 2010'. The following year, the Stockholm Summit confirmed this ambition and stressed the importance of biotechnology in achieving it. The Commission was charged with developing the strategy. A first consultation paper was circulated in September 2001. That autumn, 320 contributions were received from governments, the European Group on Ethics (EGE), industrialists, researchers and individual citizens. These were all taken into account when drafting the final document, published in January 2002 and submitted in March to European leaders gathered in Barcelona.
This strategic vision is rooted in an inescapable fact: although Europe has a solid skills base in the life sciences, the use it makes of this scientific excellence falls far short of US performances in this sector. The Commission document states that one of Europe's major weaknesses is that 'total European investment in research and development lags behind that of the United States. Europe also suffers from the fragmented nature of aid to public research as well as the low level of inter-regional co-operation in research and development between companies and institutions in different regions of several Member States.' Thus, the lack of common goals and a shared vision of what is really at stake has meant that Europe has been slow to seize the challenges and opportunities of the new biotechnological age.
Strengthening the knowledge base
To correct the situation, Europe must first improve its capacity to use the potential advantages of these technologies by developing concrete research and development. 'When Europe works together, it is strong,' stated European Research Commissioner Philippe Busquin at the Biovision Forum (Lyons, February 2001), citing the example of European co-operation in genome sequencing. But he also added that 'aid to European coordination will also be important in the case of key emerging technologies, such as those promised by research on stem cells, xenotransplantation, nanobiotechnology and proteomics.
The Sixth Framework Programme (2002-2006), now finally adopted by the Union, is designed to be a key instrument in supporting this research. It includes two thematic priorities (Life sciences, genomics and biotechnology in the service of health – with a budget of €2 255 million euros, and Food quality and safety – €685 million) which will be fully open to biotechnology while two others will have recourse to it (Nanotechnologies and Sustainable development and global change). This thematic concentration will be further strengthened by the very nature of the support which will be aimed above all at the implementation of integrated projects and the creation of networks of excellence able to generate co-operation throughout the European Research Area. Other programmes – such as support for SMEs and innovation, for the mobility of researchers, and for scientific infrastructures – will also encourage this mobilisation.
This aid for research and innovation must not, however, conceal another key aspect of the biotechnological revolution: the need to exercise control over the ethical and social choices presented by the applications generated by this new knowledge. In Europe, as elsewhere, development must be clearly in line with the sensitivities of society. If not, the whole dynamic could be lost. Hence the importance of the second principle of European strategy: responsible governance of the life sciences and biotechnology.
The present subjects for public debate range from genetically modified foods to the use of embryonic human stem cells, these issues representing just some of the changes brought about by progress in the life sciences. The aim of forums for dialogue with society, such as those organised by the European group for life sciences,(1) is to broaden the discussion by presenting well-founded hopes in terms of combating diseases and hunger in the world. This group has already organised three open conferences on genetics, stem cells and gene patenting. Its next forum will look at the contribution of the life sciences to agricultural renewal in developing areas. Other bodies will be asked to participate in the interests of impartial vigilance, such as the European Group on Ethics. Finally, the seventh priority axis of the Sixth Framework Programme, Citizens and governance in a knowledge-based society, will finance research on the socio-economic impact of biotechnology.
Rhythm and regulations
Encouraging society's support for biotechnology also means getting the products of biotechnology on to the market as quickly as possible. 'We must ensure that new products are safe for the consumer and the environment while at the same time providing the clarity and visibility which the societies which market them need so much,' explained Philippe Busquin at the Biovision Forum. New more coherent rules that are standardised at European level will therefore apply to the distribution of new medicines, such as conditional authorisation for one year and an accelerated examination of files on products of importance to public health. The regulations governing agri-biotechnology will also see some changes with the harmonisation of legislation on the use of GMOs in animal feedingstuffs, their detection, and the monitoring of any risks (or benefits) for the environment. In all cases the approach is the same: to reduce the margin of uncertainty surrounding the risks and benefits, and to provide objective facts as a basis for regulated monitoring with a view to international recognition.
An international vision
As the biotechnological revolution concerns the whole planet, there is a need to 'respond to this global challenge' – the third strand of European strategy – through international dialogue on regulatory matters, in particular within multilateral forums such as the World Trade Organisation (WTO), the Protocol on Biosecurity, or the various UN agencies. It is within these bodies that such issues must be debated if the Union is to play a leading role in setting a course, standards and recommendations on the basis of international scientific consensus.
The international approach must also take into account its special responsibility towards developing countries. The biotechnologies offer many new opportunities for providing global food security, combating Aids and preserving biodiversity. 'The life sciences and biotechnology are not a panacea and will not resolve the problems of distribution affecting the developing world. On the other hand, they will be one of the instruments in achieving this,' states the Commission's strategic document. Through increased scientific co-operation, Europe must help the developing countries to manage the risks, challenges and possibilities of these new technologies, in accordance with the choices made by each one of them.(2)
The adoption of this European strategy will serve as a reference for meeting the challenges presented by the explosion in the life sciences. It is nevertheless difficult today to say what will be the questions raised by developments in biotechnologies over the next five or ten years. This is why the Commission wants to receive regular reports on the coherence of EU policies and legislation. All those with a stake in European biotechnologies are already invited to participate in the refining and implementation of the initiatives proposed.
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