# C_2008105EN.01000701.xml

| 25.4.2008 | EN | Official Journal of the European Union | C 105/7 |
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25.4.2008

EN

Official Journal of the European Union

C 105/7

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Opinion of the Committee of the Regions on ‘Mid-term review of the Strategy on Life Sciences and Biotechnology’

(2008/C 105/02)

THE COMMITTEE OF THE REGIONS

| — | acknowledges the key importance of life sciences and biotechnology for the EU's international competitiveness and sustainable development. It declares its willingness to contribute at regional level to successful continuation of the EU's strategy, however, in doing do, opportunities and risks must be weighed up and each individual measure of the strategy must be evaluated in terms of its risks and its benefits for citizens; |
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acknowledges the key importance of life sciences and biotechnology for the EU's international competitiveness and sustainable development. It declares its willingness to contribute at regional level to successful continuation of the EU's strategy, however, in doing do, opportunities and risks must be weighed up and each individual measure of the strategy must be evaluated in terms of its risks and its benefits for citizens;

| — | stresses the key role of cities and regions in supporting consolidation of capacity and boosting competitiveness of these technologies on the international stage, by cooperating between regions and across borders, creating and pooling regional biotechnology cluster, bringing together research, industry and financial backers; |
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stresses the key role of cities and regions in supporting consolidation of capacity and boosting competitiveness of these technologies on the international stage, by cooperating between regions and across borders, creating and pooling regional biotechnology cluster, bringing together research, industry and financial backers;

| — | encourages cities and regions to support knowledge transfer and innovation from the science base to industry. To the best of their ability, cities and regions should improve the supply of venture capital, also for cross-border cooperation, and support those applying biotechnological inventions in patenting and making use of patents. Financial institutions at regional, national and in particular at EU level should set up support programmes to enable risk-sharing for SMEs in the biotechnology sector; |
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encourages cities and regions to support knowledge transfer and innovation from the science base to industry. To the best of their ability, cities and regions should improve the supply of venture capital, also for cross-border cooperation, and support those applying biotechnological inventions in patenting and making use of patents. Financial institutions at regional, national and in particular at EU level should set up support programmes to enable risk-sharing for SMEs in the biotechnology sector;

| — | encourages informed societal debates on the benefits and risks of life sciences and biotechnology: Many cities and regions are already doing their best to educate the public on the fundamental scientific issues, methods, applications, legal requirements and ethical issues in the field of biotechnology. These initiatives must be pursued vigorously, and research, industry and public administration must also play a role here. |
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encourages informed societal debates on the benefits and risks of life sciences and biotechnology: Many cities and regions are already doing their best to educate the public on the fundamental scientific issues, methods, applications, legal requirements and ethical issues in the field of biotechnology. These initiatives must be pursued vigorously, and research, industry and public administration must also play a role here.

| Rapporteur | : | Karl DÖHLER (DE/EPP), Member of the Landtag of Bavaria |
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Rapporteur

:

Karl DÖHLER (DE/EPP), Member of the Landtag of Bavaria

Landtag

Reference document:

Communication from the Commission to the Council, to the European Parliament, to the European Economic and Social Committee and to the Committee of the Regions on the mid-term review of the Strategy on Life Sciences and Biotechnology

COM(2007) 175 final

Political recommendations

THE COMMITTEE OF THE REGIONS

| 1. | acknowledges the key importance of life sciences and biotechnology for the EU's international competitiveness and sustainable development. There is major scope for their application in the medical and pharmaceutical sectors, as well as in industrial processing and primary production (food, feed, regrowing raw materials, alternative energy) — thus paving the way for innovative approaches to pressing problems relating to healthcare, demographic ageing, energy supplies for a growing world population and global warming; |
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1.

acknowledges the key importance of life sciences and biotechnology for the EU's international competitiveness and sustainable development. There is major scope for their application in the medical and pharmaceutical sectors, as well as in industrial processing and primary production (food, feed, regrowing raw materials, alternative energy) — thus paving the way for innovative approaches to pressing problems relating to healthcare, demographic ageing, energy supplies for a growing world population and global warming;

| 2. | agrees with the Commission's view that life sciences and biotechnology contribute substantially to core EU policy goals in terms of health and sustainable development, economic growth and job creation; it therefore welcomes the European Commission's Strategy on promoting life sciences and biotechnology and acknowledges the successes which have been achieved in implementing the strategy; |
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2.

agrees with the Commission's view that life sciences and biotechnology contribute substantially to core EU policy goals in terms of health and sustainable development, economic growth and job creation; it therefore welcomes the European Commission's Strategy on promoting life sciences and biotechnology and acknowledges the successes which have been achieved in implementing the strategy;

| 3. | stresses that the application of biotechnologies should go hand-in-hand with a broad social debate on the benefits and risks, including ethical issues, in order to promote public acceptance of such technologies; this requires the sharing of information on the scientific basis of these technologies; |
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3.

stresses that the application of biotechnologies should go hand-in-hand with a broad social debate on the benefits and risks, including ethical issues, in order to promote public acceptance of such technologies; this requires the sharing of information on the scientific basis of these technologies;

| 4. | welcomes the European networks of regions and clusters operating in the sphere of biotechnology and life sciences and calls on the European Commission to support these networks, with a view to promoting exchanges of experience, joint processing of project applications and common stances in the European political process; |
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4.

welcomes the European networks of regions and clusters operating in the sphere of biotechnology and life sciences and calls on the European Commission to support these networks, with a view to promoting exchanges of experience, joint processing of project applications and common stances in the European political process;

| 5. | is aware that cities and regions exercise substantial influence on the development of life sciences and biotechnologies. On the international scene, European biotechnology clusters are relatively small; networking is therefore of decisive importance for competitiveness. Creating clusters, bringing together research, industry and financial backers, sharing technological advances with the public, cooperating between regions and across borders and pooling regional biotechnology clusters — all these activities are dependent on support from cities and regions in order to consolidate capacity and boost competitiveness on the international stage; |
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5.

is aware that cities and regions exercise substantial influence on the development of life sciences and biotechnologies. On the international scene, European biotechnology clusters are relatively small; networking is therefore of decisive importance for competitiveness. Creating clusters, bringing together research, industry and financial backers, sharing technological advances with the public, cooperating between regions and across borders and pooling regional biotechnology clusters — all these activities are dependent on support from cities and regions in order to consolidate capacity and boost competitiveness on the international stage;

| 6. | recognises that that there is a strong need for many of the numerous actions to continue, and declares its willingness to contribute at regional level to successful continuation. In doing so, opportunities and risks must be weighed up, and each individual measure of the strategy must be evaluated in terms of its benefits for citizens; |
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6.

recognises that that there is a strong need for many of the numerous actions to continue, and declares its willingness to contribute at regional level to successful continuation. In doing so, opportunities and risks must be weighed up, and each individual measure of the strategy must be evaluated in terms of its benefits for citizens;

In relation to the mid-term review of the priorities set for the strategy

| 7. | underlines that cities and regions do their best to contribute to promoting research and market development for life sciences and biotechnology applications and the knowledge-based bio-economy. It calls on cities and regions to help educate users about the legal bases and administrative procedures in the area of biotechnology. As well as cooperating with Member States on improved coordination of research, the European Commission should also set up regional platforms or directly involve regional groupings in its work; |
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7.

underlines that cities and regions do their best to contribute to promoting research and market development for life sciences and biotechnology applications and the knowledge-based bio-economy. It calls on cities and regions to help educate users about the legal bases and administrative procedures in the area of biotechnology. As well as cooperating with Member States on improved coordination of research, the European Commission should also set up regional platforms or directly involve regional groupings in its work;

| 8. | supports steps to foster competitiveness, knowledge transfer and innovation from the science base to industry: awareness of the commercial potential of research findings needs to be raised; start-ups and exchanges between research and industry must be promoted. To the best of their ability, cities and regions should improve the supply of venture capital, also for cross-border cooperation, and support those applying biotechnological inventions in patenting and making use of patents. Financial institutions at regional, national and in particular at EU level should set up support programmes to enable risk-sharing for SMEs in the biotechnology sector; |
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8.

supports steps to foster competitiveness, knowledge transfer and innovation from the science base to industry: awareness of the commercial potential of research findings needs to be raised; start-ups and exchanges between research and industry must be promoted. To the best of their ability, cities and regions should improve the supply of venture capital, also for cross-border cooperation, and support those applying biotechnological inventions in patenting and making use of patents. Financial institutions at regional, national and in particular at EU level should set up support programmes to enable risk-sharing for SMEs in the biotechnology sector;

| 9. | sees the need to improve the labour market situation by helping put people in jobs and supporting employees' basic and continued training. Scientists and other profiles required for the development of biotechnological businesses should be encouraged to stay in Europe and the workforce dissuaded from emigrating and, if appropriate, recover highly qualified workers that may have been trained or obtained professional experience outside Europe through the creation of attractive conditions; |
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9.

sees the need to improve the labour market situation by helping put people in jobs and supporting employees' basic and continued training. Scientists and other profiles required for the development of biotechnological businesses should be encouraged to stay in Europe and the workforce dissuaded from emigrating and, if appropriate, recover highly qualified workers that may have been trained or obtained professional experience outside Europe through the creation of attractive conditions;

| 10. | points out that biotechnology offers promising future alternatives for the chemical industry, in addition to its applications in health, food and animal feed. Already, 85 % of world-wide enzyme requirements are produced in Europe. Enzymatic and bio-catalytic procedures promise substantial savings in resources and energy and thus offer new kinds of approaches for maintaining a sustainable economy; |
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10.

points out that biotechnology offers promising future alternatives for the chemical industry, in addition to its applications in health, food and animal feed. Already, 85 % of world-wide enzyme requirements are produced in Europe. Enzymatic and bio-catalytic procedures promise substantial savings in resources and energy and thus offer new kinds of approaches for maintaining a sustainable economy;

| 11. | is aware that the public's attitude to bio-technological applications in the food and animal feed sector is critical. On one hand there is currently widespread general rejection of these applications of gene technology in agriculture by the majority of consumers; on the other hand, the public are extremely positive about them, where the health and environmental advantages of the products are clear; |
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11.

is aware that the public's attitude to bio-technological applications in the food and animal feed sector is critical. On one hand there is currently widespread general rejection of these applications of gene technology in agriculture by the majority of consumers; on the other hand, the public are extremely positive about them, where the health and environmental advantages of the products are clear;

| 12. | encourages informed societal debates on the benefits and risks of life sciences and biotechnology: Many cities and regions are already doing their best to educate the public on the fundamental scientific issues, methods, applications, legal requirements and ethical issues in the field of biotechnology. These initiatives must be pursued vigorously; |
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12.

encourages informed societal debates on the benefits and risks of life sciences and biotechnology: Many cities and regions are already doing their best to educate the public on the fundamental scientific issues, methods, applications, legal requirements and ethical issues in the field of biotechnology. These initiatives must be pursued vigorously;

| 13. | calls on research, industry and public administration to play a role here; all relevant stakeholder groups must be involved in the dialogue together in one forum. Cities and regions should provide stronger support for research projects looking into the socio-economic and ethical issues in the field of biotechnology, and for dissemination of the resulting findings. They should set up specialist networks which could, on an ad hoc basis, advise on current security-related, socio-economic and ethical issues. Cities and regions can support rational, science-based and transparent product authorisation decision-making processes; |
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13.

calls on research, industry and public administration to play a role here; all relevant stakeholder groups must be involved in the dialogue together in one forum. Cities and regions should provide stronger support for research projects looking into the socio-economic and ethical issues in the field of biotechnology, and for dissemination of the resulting findings. They should set up specialist networks which could, on an ad hoc basis, advise on current security-related, socio-economic and ethical issues. Cities and regions can support rational, science-based and transparent product authorisation decision-making processes;

| 14. | suggests that the European Commission, when approving projects under the 7th framework programme, attach greater importance to the phase of using experts to communicate research results to the public; research should continue to focus on the agricultural applications of gene technology, risks and environmental and economic issues in this area; |
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14.

suggests that the European Commission, when approving projects under the 7th framework programme, attach greater importance to the phase of using experts to communicate research results to the public; research should continue to focus on the agricultural applications of gene technology, risks and environmental and economic issues in this area;

| 15. | shares the opinion of the European Commission on the importance of biotechnology applied to medical care from the economic and public health points of view. Continued progress in simplification and legislative clarification aspects in this sector is supported, as rapid technological advances have slowed this sector down as a result of legislative uncertainty. The drafting of guidelines and international recommendations eliminating barriers and facilitating the development of these applications would be recommendable; |
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15.

shares the opinion of the European Commission on the importance of biotechnology applied to medical care from the economic and public health points of view. Continued progress in simplification and legislative clarification aspects in this sector is supported, as rapid technological advances have slowed this sector down as a result of legislative uncertainty. The drafting of guidelines and international recommendations eliminating barriers and facilitating the development of these applications would be recommendable;

| 16. | also sees a possible role for modern biotechnology in the sustainable development of agriculture. It supports the European Commission's view that it should be possible for all forms of agriculture, whether conventional, organic or with genetically modified plants, to co-exist on an equal footing. It points out, however, that topographical, climatic or structural conditions could make it difficult for conventional and organic forms of agricultural production to coexist alongside genetically modified crops in certain regions. Informed consumers should be allowed to choose the extent to which modern biotechnological products succeed on the market. Consequently, many cities and regions will feel that the use of agricultural biotechnology is beneficial, whereas other regions will take advantage of conventional or organic farming methods; |
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16.

also sees a possible role for modern biotechnology in the sustainable development of agriculture. It supports the European Commission's view that it should be possible for all forms of agriculture, whether conventional, organic or with genetically modified plants, to co-exist on an equal footing. It points out, however, that topographical, climatic or structural conditions could make it difficult for conventional and organic forms of agricultural production to coexist alongside genetically modified crops in certain regions. Informed consumers should be allowed to choose the extent to which modern biotechnological products succeed on the market. Consequently, many cities and regions will feel that the use of agricultural biotechnology is beneficial, whereas other regions will take advantage of conventional or organic farming methods;

| 17. | attaches considerable importance to the co-existence of differing agricultural practices, not only in the interests of good farming, but also of tolerance and trust between neighbouring farmers in the exchange of information, coordination and cooperation. The European Commission is urged to develop guidelines for co-existence and practicable labelling thresholds for seeds with traces of genetically modified organisms as soon as possible. In so doing, a solution should also be found for ‘constructs’ which the EU has not yet authorised and assessed for safety, but which other countries have, using similar criteria; |
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17.

attaches considerable importance to the co-existence of differing agricultural practices, not only in the interests of good farming, but also of tolerance and trust between neighbouring farmers in the exchange of information, coordination and cooperation. The European Commission is urged to develop guidelines for co-existence and practicable labelling thresholds for seeds with traces of genetically modified organisms as soon as possible. In so doing, a solution should also be found for ‘constructs’ which the EU has not yet authorised and assessed for safety, but which other countries have, using similar criteria;

| 18. | believes it is urgent to carry out research into the steps which farmers need to take in order to secure conventional and organic farming and their long term co-existence with technically modified plants, possible long-term repercussions of GMOs, and the benefits and risks of GMOs used for regrowing raw materials. It advocates an action programme for preserving, characterising, collecting and using genetic resources in EU agriculture; |
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18.

believes it is urgent to carry out research into the steps which farmers need to take in order to secure conventional and organic farming and their long term co-existence with technically modified plants, possible long-term repercussions of GMOs, and the benefits and risks of GMOs used for regrowing raw materials. It advocates an action programme for preserving, characterising, collecting and using genetic resources in EU agriculture;

| 19. | welcomes the existing legislative framework in the field of life sciences and biotechnology, but recognises the continuing need for measures to ensure greater consistency between legislation in various areas, for example in intellectual property law. In addition, given the need for EU competitiveness in the field of biotechnology, opportunities must be examined for bringing the legislative framework into line with what is widely accepted at international level. Cities and regions are committing themselves — within their competences — to uniform implementation of European legislation; to this end, there should be inter-regional and international dialogue; |
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19.

welcomes the existing legislative framework in the field of life sciences and biotechnology, but recognises the continuing need for measures to ensure greater consistency between legislation in various areas, for example in intellectual property law. In addition, given the need for EU competitiveness in the field of biotechnology, opportunities must be examined for bringing the legislative framework into line with what is widely accepted at international level. Cities and regions are committing themselves — within their competences — to uniform implementation of European legislation; to this end, there should be inter-regional and international dialogue;

With regard to implementing the 2002 30-point Action Plan

| 20. | feels it is necessary for information on life sciences to be improved, particularly in terms of employees' and teachers' basic and further training. Inter-disciplinary dialogue between scientists is to be encouraged; |
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20.

feels it is necessary for information on life sciences to be improved, particularly in terms of employees' and teachers' basic and further training. Inter-disciplinary dialogue between scientists is to be encouraged;

| 21. | recommends clarifying the intellectual property legislation in the field of public research and explaining to academics the importance of translating research findings into commercial use. To this end, it also is important to step up international dialogue; |
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21.

recommends clarifying the intellectual property legislation in the field of public research and explaining to academics the importance of translating research findings into commercial use. To this end, it also is important to step up international dialogue;

| 22. | believes it necessary to improve the supply of capital to the biotechnology sector, especially SMEs, through investment in research and technological development as well as through start-ups, support for technology transfer and commercial financing for businesses. Further development of the biotechnology industry in Europe should be based on uniform criteria; |
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22.

believes it necessary to improve the supply of capital to the biotechnology sector, especially SMEs, through investment in research and technological development as well as through start-ups, support for technology transfer and commercial financing for businesses. Further development of the biotechnology industry in Europe should be based on uniform criteria;

| 23. | agrees with the moves in the European Commission's ‘Lead Market’ initiative to identify ‘bio-based products’ as a lead market and calls on the European Commission to take account of the potential available in the regions of Europe in its measures to promote and consolidate these lead markets; |
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23.

agrees with the moves in the European Commission's ‘Lead Market’ initiative to identify ‘bio-based products’ as a lead market and calls on the European Commission to take account of the potential available in the regions of Europe in its measures to promote and consolidate these lead markets;

| 24. | calls for further efforts to boost a more open approach and transparency in relation to the European technology platform (ETP) operating in the area of life sciences and bio-technology, so that as well as the industry and research community, other stakeholders such as local and regional authorities and particularly SMEs can become involved; |
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24.

calls for further efforts to boost a more open approach and transparency in relation to the European technology platform (ETP) operating in the area of life sciences and bio-technology, so that as well as the industry and research community, other stakeholders such as local and regional authorities and particularly SMEs can become involved;

| 25. | advocates a greater commitment by bio-technology regions in the ERA-Net Initiative under the 7th research framework programme to coordinate national and regional research programmes; |
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25.

advocates a greater commitment by bio-technology regions in the ERA-Net Initiative under the 7th research framework programme to coordinate national and regional research programmes;

| 26. | welcomes a stronger role for the European Group on Ethics. Cooperation between the Community and national and regional levels on ethical and socio-economic issues should be promoted. Ethical guidelines on e.g. stem cell research, biobanks, xenotransplantation, genetic tests and animal testing should be developed; |
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26.

welcomes a stronger role for the European Group on Ethics. Cooperation between the Community and national and regional levels on ethical and socio-economic issues should be promoted. Ethical guidelines on e.g. stem cell research, biobanks, xenotransplantation, genetic tests and animal testing should be developed;

| 27. | supports the continuation of the activities relating to reference materials and validation of detection methods and advocates the development of methods for monitoring the adverse effects of genetically modified organisms, food and feed. The leading role of the European Commission in the further development of international guidelines, standards and recommendations, particularly in the field of food safety, is to be welcomed; |
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27.

supports the continuation of the activities relating to reference materials and validation of detection methods and advocates the development of methods for monitoring the adverse effects of genetically modified organisms, food and feed. The leading role of the European Commission in the further development of international guidelines, standards and recommendations, particularly in the field of food safety, is to be welcomed;

| 28. | declares its willingness, in collaboration with the European Commission and the Member States, to scrutinise research policy to see whether it embodies an appropriate mix of conventional technology and new technology. It promises to take steps to support the establishment of effective research partnerships between developing countries and the EU. Sub-regional, regional and international organisations, in particular the International Agricultural Research Centres, are to be supported; |
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28.

declares its willingness, in collaboration with the European Commission and the Member States, to scrutinise research policy to see whether it embodies an appropriate mix of conventional technology and new technology. It promises to take steps to support the establishment of effective research partnerships between developing countries and the EU. Sub-regional, regional and international organisations, in particular the International Agricultural Research Centres, are to be supported;

| 29. | welcomes the European Commission's activities aimed at ensuring safe and effective use of modern biotechnology in the developing countries and fostering the capacity of these states to assess and manage risk. Working in collaboration with the international community, the EU has to boost the contribution of research to combating HIV/AIDS, malaria, tuberculosis and other diseases brought about by poverty. It acknowledges the European Commission's and the Member States' efforts to support the conservation and sustainable use of genetic resources in the developing countries; |
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29.

welcomes the European Commission's activities aimed at ensuring safe and effective use of modern biotechnology in the developing countries and fostering the capacity of these states to assess and manage risk. Working in collaboration with the international community, the EU has to boost the contribution of research to combating HIV/AIDS, malaria, tuberculosis and other diseases brought about by poverty. It acknowledges the European Commission's and the Member States' efforts to support the conservation and sustainable use of genetic resources in the developing countries;

| 30. | calls for a stronger forward-looking function for all European Commission departments, especially in the technological field, with a view to facilitating the early identification of newly emerging issues. The relevance, coherence and effectiveness of legislation and policies and their implementation and social and economic impact are to be reviewed. |
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30.

calls for a stronger forward-looking function for all European Commission departments, especially in the technological field, with a view to facilitating the early identification of newly emerging issues. The relevance, coherence and effectiveness of legislation and policies and their implementation and social and economic impact are to be reviewed.

Brussels, 6 February 2008.

The President

of the Committee of the Regions

Luc VAN DEN BRANDE

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