Life sciences, genomics and biotechnology for health: Thematic Priority 1 under the Focusing and Integrating Community Research programme 2002-2006.
This Priority 1 thematic area falls under the Focusing and Integrating Community Research programme of the sixth framework programme 2002-2006. The priority thematic areas represent the bulk of expenditure under the sixth framework programme.
Through a highly focused Community research effort, the intention is to generate a substantial leveraging effect which, together with actions in other parts of the framework programme 2002-2006 and through open co-ordination with other - regional, national, European and international frameworks, will result in a coherent and highly effective common endeavour towards their overall objectives.
The sequencing of the human genome and many other genomes heralds a new age in human biology, offering unprecedented opportunities to improve human health and to stimulate industrial and economic activity. In making its contribution to realising these benefits, this theme will focus on integrating post-genomic research into the more established biomedical and biotechnological approaches, and will facilitate the integration of research capacities (both public and private) across Europe to increase coherence and achieve critical mass.
Integrated multidisciplinary research, which enables a strong interaction between technology and biology, is vital in this theme for translating genome data into practical applications. In addition, an essential element will be to involve key stakeholders, for example, as appropriate industry, healthcare providers and physicians, policy makers, regulatory authorities, patient associations, and experts on ethical matters, etc. in implementing the theme. Gender equity in the research will also be ensured.
The emphasis will be put on research aimed at bringing basic knowledge through to application, to enable real and consistent progress in medicine and improve the quality of life. This research may also have implications for research on areas such as agriculture and environment, which are addressed under other thematic priorities. It will be an integral component of the European Community effort to enhance the European biotechnology industry in line with the conclusions of the Stockholm Council. It will endeavour to create strong links with all activities that improve the framework conditions for innovation in the health sector of the biotechnology industry, especially in SMEs, including stimulating entrepreneurship and opportunities for investment through venture capital and the involvement of the European Investment Bank.
Attention will also be paid to the identification of regulatory bottlenecks in the development of new applications for genomics, to the anticipation at the earliest possible stage of the ethical implications and to the broader implications of developments in genomics research for society and citizens. This thematic priority area will also foster the implementation and development of the health strategy of the European Community. Throughout the thematic priority, international collaboration will be encouraged. Where appropriate, due account will be given to the European Community's commitment to poverty reduction in developing countries and the importance that improved health will bring to the process - in line with Article 177 of the Treaty and with the European Community's accelerated actions to combat HIV/AIDS, malaria and tuberculosis.
This thematic priority 1 will stimulate and sustain multidisciplinary basic research to exploit the full potential of genome information to underpin applications to human health.
The Community activities carried out under genomics and biotechnology for health address the following aspects:
Advanced genomics and its applications for health
_ Fundamental knowledge and basic tools for functional genomics in all organisms to foster the basic understanding of genomic information, by developing the knowledge base, tools and resources needed to decipher the function of genes and gene products relevant to human health and to explore their interactions with each other and with their environment.
Research actions will encompass the following:
- Gene expression and proteomics to enable researchers to better decipher the functions of genes and gene products as well as to define the complex regulatory networks (biocomplexity) that control fundamental biological processes. Research will focus on: developing high throughput tools and approaches for monitoring gene expression and protein profiles and for determining protein function and protein interactions;
- Structural genomics to enable researchers to determine, more effectively and at a higher rate than is currently feasible, the 3-D structure of proteins and other macromolecules, which is important for elucidating protein function and essential for drug design. Research will focus on: developing high throughput approaches for determining high-resolution 3-D structures of macromolecules;
- Comparative genomics and population genetics to enable researchers to use well characterised model organisms for predicting and testing gene function and to take full advantage of specific population cohorts available in Europe to determine the relationship between gene function and health or disease. Research will focus on: developing model organisms and transgenic tools; developing genetic epidemiology tools and standardised genotyping protocols;
- Bioinformatics to enable researchers to access efficient tools for managing and interpreting the ever-increasing quantities of genome data and for making it available to the research community in an accessible and usable form. Research will focus on developing bioinformatic tools and resources for data storage, mining and processing; developing computational biology approaches for in silico prediction of gene function and for the simulation of complex regulatory networks;
- Multidisciplinary functional genomics approaches to basic biological processes to enable researchers to study fundamental biological processes by integrating the above innovative approaches. Research will focus on: elucidation of the mechanisms underlying fundamental cellular processes, to identify the genes involved and to decipher their biological functions in living organisms
_ Applications of knowledge and technologies in the field of genomics and biotechnology for health
- Technological platforms for the developments in the fields of new diagnostic, prevention and therapeutic tools to foster academic and industrial collaboration through technological platforms where multidisciplinary approaches using cutting edge technologies arising from genomic research may contribute to health care progress and cost reduction through more precise diagnosis, individualised treatment and more efficient development pathways for new drugs and therapies, and other novel products of the new technologies. Research will focus on: rational and accelerated development of new, safer, more effective drugs including pharmacogenomics approaches; development of new diagnostics; development of new in vitro tests to replace animal experimentation; development and testing of new preventive and therapeutic tools, such as somatic gene and cell therapies (including in particular stem cell therapies) and immunotherapies; innovative research in post-genomics, which has high potential for application.
Combating major diseases.
_ Application-oriented genomic approaches to medical knowledge and technologies to develop improved strategies for the prevention and management of human disease and for living and ageing healthily. It will concentrate exclusively on integrating the genomic approach through all relevant organisms into more established medical approaches for investigating disease and health determinants. The emphasis will be put on transnational research aimed at bringing basic knowledge through to clinical application.
Research actions will focus on the following:
- Combating cardiovascular disease, diabetes, and rare diseases to improve the prevention and management of important causes of mortality and ill health in Europe and to pool Europe's research resources for tackling rare diseases. Research will focus on integrating clinical expertise and resources with relevant model systems and advanced tools in functional genomics to generate breakthroughs in the prevention and management of these diseases.
- Combating resistance to antibiotics and other drugs to confront the major threat to public health caused by drug resistant pathogens. Research will focus on: exploitation of the knowledge of microbial genomes and on host-pathogen interactions for the development of vaccines and alternative therapeutic strategies to circumvent the problem of antimicrobial and other drug resistance; development of strategies for optimal usage of antimicrobials; support to the European Community network for epidemiological surveillance and control of communicable diseases.
- Studying the brain and combating diseases of the nervous system to use genome information to understand better the functioning and dysfunctioning of the brain, in order to gain new insight into mental processes, to combat neurological disorders and diseases, and to improve brain repair. Research will focus on: understanding the molecular and cellular bases of brain function, damage, plasticity and repair, learning, memory and cognition; developing strategies for prevention and management of neurological and mental disorders and diseases.
- Studying human development and the ageing process to better understand human development, with special emphasis on the ageing process, in order to develop the evidence base for improving public health strategies to promote healthy living and healthy ageing. Research will focus on: understanding human development from conception to adolescence; exploring the molecular and cellular determinants of healthy ageing including their interactions with environmental, behavioural and gender factors.
_ Combatting cancer to develop improved patient-oriented strategies, from prevention to diagnosis and treatment, for combating cancer. The research will therefore concentrate on translating the new knowledge being created by genomics and other fields of basic research into applications that improve clinical practice and public health.
Research will focus on:
- Establishing facilities for the exploitation of research on cancer in Europe; encouraging the development of evidence-based guidelines for good clinical practice and improved public health strategies by accelerating the translation of existing research results into applications.
- Supporting clinical research, particularly clinical trials, aimed at validating new and improved interventions.
- Supporting translational research aimed at bringing basic knowledge through to applications in clinical practice and public health.
_Confronting the major communicable diseases linked to poverty to confront the global emergency caused by the three major communicable diseases - HIV/AIDS, malaria and tuberculosis - through the development of effective disease interventions, particularly for use in developing countries. It is envisaged that developing countries will be significant partners in the implementation of this line and, as appropriate, participate directly in specific activities within it, in particular through the clinical trials platform. Research will focus on: developing promising candidate interventions (vaccines, therapies and HIV microbicides) against the target diseases by sponsoring research over the full spectrum from basic molecular research, taking advantage of microbial genomics, through to pre-clinical testing and proof-of-principle; establishing a clinical trials programme to unite and support Europe's clinical trial activities specifically targeted at interventions for use in developing countries; establishing an AIDS Therapy Trials Network in Europe to improve the coherence and complementarity of clinical trials of AIDS therapies for European use.
The Commission shall be responsible for the implementation of the specific programme. The Commission shall draw up a work programme for the implementation of the specific programme, setting out in greater detail the objectives and scientific and technological priorities and the timetable for implementation. The work programme shall take account of relevant research activities carried out by the Member States, Associated States and European and international organizations and shall be updated where appropriate.
The Commission shall be assisted by a committee. The Commission shall regularly report on the overall progress of the implementation of the specific programme and information on financial aspects and the use of instruments shall be included. The Commission shall arrange for the independent monitoring and assessment of the framework programme to be conducted concerning the activities carried out in the fields covered by the specific programme.
The new instruments networks of excellence and integrated projects will be used from the start of the programme in each thematic priority area and, where deemed appropriate, as a priority means, while maintaining the use of specific targeted projects and coordination actions. In addition to research and technological development, they may incorporate the following types of activity, where they are of specific relevance to the objectives sought:
- Demonstration, dissemination and exploitation;
- Cooperation with researchers and research teams from third countries;
- Human resource development,including the promotion of training of researchers; development of research facilities and infrastructure of specific relevance to the research being undertaken; and promotion of better links between science and society, including women in science.
Specific targeted research projects and coordination actions, as well as specific support actions, may also be used in the spirit of the 'stairway of excellence' in the implementation of the thematic priorities. However, the size of projects is not a criterion for exclusion, and access to new instruments is ensured for SMEs and other small entities
. In certain cases, when a project receives the maximum level of co-financing authorised under the framework programme or an overall grant, an additional contribution from the Structural Funds could be granted. In the case of participation of entities from the associated candidate countries, an additional contribution from the pre-accession financial instruments could be granted under similar conditions. In the case of participation of organisations from Mediterranean or developing countries, a contribution of the MEDA programme and of the financial instruments of the Community's aid to development could be envisaged.
In carrying out the programme, the Commission may have recourse to technical assistance. In 2004 an evaluation will be undertaken by independent experts of the efficiency of each of the three types of new instruments (networks of excellance, integrated projects and article 169) in the execution of the Sixth Framework Programme.
During the implementation of this programme and in the research activities arising from it, fundamental ethical principles are to be respected. These include the principles reflected in the Charter of fundamental rights of the EU, including the following: protection of human dignity and human life, protection of personal data and privacy, as well as animals and the environment in accordance with Community law and relevant international conventions and codes of conduct. Account will also be taken to the opinions of the European Group of Advisers on the Ethical Implications of Biotechnology (1991-1997) and the opinions of the European Group on Ethics in Science and New technologies (as from 1998).
Through a highly focused Community research effort, the intention is to generate a substantial leveraging effect which, together with actions in other parts of the framework programme 2002-2006 and through open co-ordination with other - regional, national, European and international frameworks, will result in a coherent and highly effective common endeavour towards their overall objectives.
The sequencing of the human genome and many other genomes heralds a new age in human biology, offering unprecedented opportunities to improve human health and to stimulate industrial and economic activity. In making its contribution to realising these benefits, this theme will focus on integrating post-genomic research into the more established biomedical and biotechnological approaches, and will facilitate the integration of research capacities (both public and private) across Europe to increase coherence and achieve critical mass.
Integrated multidisciplinary research, which enables a strong interaction between technology and biology, is vital in this theme for translating genome data into practical applications. In addition, an essential element will be to involve key stakeholders, for example, as appropriate industry, healthcare providers and physicians, policy makers, regulatory authorities, patient associations, and experts on ethical matters, etc. in implementing the theme. Gender equity in the research will also be ensured.
The emphasis will be put on research aimed at bringing basic knowledge through to application, to enable real and consistent progress in medicine and improve the quality of life. This research may also have implications for research on areas such as agriculture and environment, which are addressed under other thematic priorities. It will be an integral component of the European Community effort to enhance the European biotechnology industry in line with the conclusions of the Stockholm Council. It will endeavour to create strong links with all activities that improve the framework conditions for innovation in the health sector of the biotechnology industry, especially in SMEs, including stimulating entrepreneurship and opportunities for investment through venture capital and the involvement of the European Investment Bank.
Attention will also be paid to the identification of regulatory bottlenecks in the development of new applications for genomics, to the anticipation at the earliest possible stage of the ethical implications and to the broader implications of developments in genomics research for society and citizens. This thematic priority area will also foster the implementation and development of the health strategy of the European Community. Throughout the thematic priority, international collaboration will be encouraged. Where appropriate, due account will be given to the European Community's commitment to poverty reduction in developing countries and the importance that improved health will bring to the process - in line with Article 177 of the Treaty and with the European Community's accelerated actions to combat HIV/AIDS, malaria and tuberculosis.
This thematic priority 1 will stimulate and sustain multidisciplinary basic research to exploit the full potential of genome information to underpin applications to human health.
The Community activities carried out under genomics and biotechnology for health address the following aspects:
Advanced genomics and its applications for health
_ Fundamental knowledge and basic tools for functional genomics in all organisms to foster the basic understanding of genomic information, by developing the knowledge base, tools and resources needed to decipher the function of genes and gene products relevant to human health and to explore their interactions with each other and with their environment.
Research actions will encompass the following:
- Gene expression and proteomics to enable researchers to better decipher the functions of genes and gene products as well as to define the complex regulatory networks (biocomplexity) that control fundamental biological processes. Research will focus on: developing high throughput tools and approaches for monitoring gene expression and protein profiles and for determining protein function and protein interactions;
- Structural genomics to enable researchers to determine, more effectively and at a higher rate than is currently feasible, the 3-D structure of proteins and other macromolecules, which is important for elucidating protein function and essential for drug design. Research will focus on: developing high throughput approaches for determining high-resolution 3-D structures of macromolecules;
- Comparative genomics and population genetics to enable researchers to use well characterised model organisms for predicting and testing gene function and to take full advantage of specific population cohorts available in Europe to determine the relationship between gene function and health or disease. Research will focus on: developing model organisms and transgenic tools; developing genetic epidemiology tools and standardised genotyping protocols;
- Bioinformatics to enable researchers to access efficient tools for managing and interpreting the ever-increasing quantities of genome data and for making it available to the research community in an accessible and usable form. Research will focus on developing bioinformatic tools and resources for data storage, mining and processing; developing computational biology approaches for in silico prediction of gene function and for the simulation of complex regulatory networks;
- Multidisciplinary functional genomics approaches to basic biological processes to enable researchers to study fundamental biological processes by integrating the above innovative approaches. Research will focus on: elucidation of the mechanisms underlying fundamental cellular processes, to identify the genes involved and to decipher their biological functions in living organisms
_ Applications of knowledge and technologies in the field of genomics and biotechnology for health
- Technological platforms for the developments in the fields of new diagnostic, prevention and therapeutic tools to foster academic and industrial collaboration through technological platforms where multidisciplinary approaches using cutting edge technologies arising from genomic research may contribute to health care progress and cost reduction through more precise diagnosis, individualised treatment and more efficient development pathways for new drugs and therapies, and other novel products of the new technologies. Research will focus on: rational and accelerated development of new, safer, more effective drugs including pharmacogenomics approaches; development of new diagnostics; development of new in vitro tests to replace animal experimentation; development and testing of new preventive and therapeutic tools, such as somatic gene and cell therapies (including in particular stem cell therapies) and immunotherapies; innovative research in post-genomics, which has high potential for application.
Combating major diseases.
_ Application-oriented genomic approaches to medical knowledge and technologies to develop improved strategies for the prevention and management of human disease and for living and ageing healthily. It will concentrate exclusively on integrating the genomic approach through all relevant organisms into more established medical approaches for investigating disease and health determinants. The emphasis will be put on transnational research aimed at bringing basic knowledge through to clinical application.
Research actions will focus on the following:
- Combating cardiovascular disease, diabetes, and rare diseases to improve the prevention and management of important causes of mortality and ill health in Europe and to pool Europe's research resources for tackling rare diseases. Research will focus on integrating clinical expertise and resources with relevant model systems and advanced tools in functional genomics to generate breakthroughs in the prevention and management of these diseases.
- Combating resistance to antibiotics and other drugs to confront the major threat to public health caused by drug resistant pathogens. Research will focus on: exploitation of the knowledge of microbial genomes and on host-pathogen interactions for the development of vaccines and alternative therapeutic strategies to circumvent the problem of antimicrobial and other drug resistance; development of strategies for optimal usage of antimicrobials; support to the European Community network for epidemiological surveillance and control of communicable diseases.
- Studying the brain and combating diseases of the nervous system to use genome information to understand better the functioning and dysfunctioning of the brain, in order to gain new insight into mental processes, to combat neurological disorders and diseases, and to improve brain repair. Research will focus on: understanding the molecular and cellular bases of brain function, damage, plasticity and repair, learning, memory and cognition; developing strategies for prevention and management of neurological and mental disorders and diseases.
- Studying human development and the ageing process to better understand human development, with special emphasis on the ageing process, in order to develop the evidence base for improving public health strategies to promote healthy living and healthy ageing. Research will focus on: understanding human development from conception to adolescence; exploring the molecular and cellular determinants of healthy ageing including their interactions with environmental, behavioural and gender factors.
_ Combatting cancer to develop improved patient-oriented strategies, from prevention to diagnosis and treatment, for combating cancer. The research will therefore concentrate on translating the new knowledge being created by genomics and other fields of basic research into applications that improve clinical practice and public health.
Research will focus on:
- Establishing facilities for the exploitation of research on cancer in Europe; encouraging the development of evidence-based guidelines for good clinical practice and improved public health strategies by accelerating the translation of existing research results into applications.
- Supporting clinical research, particularly clinical trials, aimed at validating new and improved interventions.
- Supporting translational research aimed at bringing basic knowledge through to applications in clinical practice and public health.
_Confronting the major communicable diseases linked to poverty to confront the global emergency caused by the three major communicable diseases - HIV/AIDS, malaria and tuberculosis - through the development of effective disease interventions, particularly for use in developing countries. It is envisaged that developing countries will be significant partners in the implementation of this line and, as appropriate, participate directly in specific activities within it, in particular through the clinical trials platform. Research will focus on: developing promising candidate interventions (vaccines, therapies and HIV microbicides) against the target diseases by sponsoring research over the full spectrum from basic molecular research, taking advantage of microbial genomics, through to pre-clinical testing and proof-of-principle; establishing a clinical trials programme to unite and support Europe's clinical trial activities specifically targeted at interventions for use in developing countries; establishing an AIDS Therapy Trials Network in Europe to improve the coherence and complementarity of clinical trials of AIDS therapies for European use.
The Commission shall be responsible for the implementation of the specific programme. The Commission shall draw up a work programme for the implementation of the specific programme, setting out in greater detail the objectives and scientific and technological priorities and the timetable for implementation. The work programme shall take account of relevant research activities carried out by the Member States, Associated States and European and international organizations and shall be updated where appropriate.
The Commission shall be assisted by a committee. The Commission shall regularly report on the overall progress of the implementation of the specific programme and information on financial aspects and the use of instruments shall be included. The Commission shall arrange for the independent monitoring and assessment of the framework programme to be conducted concerning the activities carried out in the fields covered by the specific programme.
The new instruments networks of excellence and integrated projects will be used from the start of the programme in each thematic priority area and, where deemed appropriate, as a priority means, while maintaining the use of specific targeted projects and coordination actions. In addition to research and technological development, they may incorporate the following types of activity, where they are of specific relevance to the objectives sought:
- Demonstration, dissemination and exploitation;
- Cooperation with researchers and research teams from third countries;
- Human resource development,including the promotion of training of researchers; development of research facilities and infrastructure of specific relevance to the research being undertaken; and promotion of better links between science and society, including women in science.
Specific targeted research projects and coordination actions, as well as specific support actions, may also be used in the spirit of the 'stairway of excellence' in the implementation of the thematic priorities. However, the size of projects is not a criterion for exclusion, and access to new instruments is ensured for SMEs and other small entities
. In certain cases, when a project receives the maximum level of co-financing authorised under the framework programme or an overall grant, an additional contribution from the Structural Funds could be granted. In the case of participation of entities from the associated candidate countries, an additional contribution from the pre-accession financial instruments could be granted under similar conditions. In the case of participation of organisations from Mediterranean or developing countries, a contribution of the MEDA programme and of the financial instruments of the Community's aid to development could be envisaged.
In carrying out the programme, the Commission may have recourse to technical assistance. In 2004 an evaluation will be undertaken by independent experts of the efficiency of each of the three types of new instruments (networks of excellance, integrated projects and article 169) in the execution of the Sixth Framework Programme.
During the implementation of this programme and in the research activities arising from it, fundamental ethical principles are to be respected. These include the principles reflected in the Charter of fundamental rights of the EU, including the following: protection of human dignity and human life, protection of personal data and privacy, as well as animals and the environment in accordance with Community law and relevant international conventions and codes of conduct. Account will also be taken to the opinions of the European Group of Advisers on the Ethical Implications of Biotechnology (1991-1997) and the opinions of the European Group on Ethics in Science and New technologies (as from 1998).