Proposal for a Council Decision adopting a specific programme for research, technological development and demonstration on 'Quality of life and management of living resources` (1998 to 2002) (98/C 260/01) (Text with EEA relevance) COM(98) 305 final - 98/0177(CNS)

(Submitted by the Commission on 10 June 1998)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 130i(4) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Having regard to the opinion of the Economic and Social Committee,

Whereas by Decision No . . ./98/EC (1), the European Parliament and the Council adopted the fifth framework programme of the European Community (hereinafter referred to as 'the fifth framework programme`) for research, technological development and demonstration (hereinafter referred to as 'RTD`) activities for the period 1998 to 2002 specifying inter alia the activities to be carried out in the field of 'Quality of life and the management of living resources`;

Whereas Article 130i(3) of the Treaty stipulates that the framework programme shall be implemented through specific programmes developed within each activity under the framework programme, and that each specific programme shall define the detailed rules for implementing it, fix its duration and provide for the means deemed necessary;

Whereas, in accordance with Article 4(2) of Decision No 1110/94/EC of the European Parliament and of the Council of 26 April 1994 concerning the fourth framework programme of the European Community activities in the field of research, technological development and demonstration (1994 to 1998) (2) and Article 4(2) of the Council Decisions on the specific programmes implementing the fourth framework programme, the Commission has had an external assessment conducted which it has transmitted to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions together with its conclusions and comments;

Whereas the Scientific and Technical Research Committee has been consulted on the scientific and technological content of the specific programmes, as set out in the working paper adopted by the Commission on 5 November 1997 (3);

Whereas, in accordance with Article 130j of the Treaty, Council Decision 98/. . ./EC of . . . concerning the rules for the participation of undertakings, research centres and universities and for the dissemination of research results (4) (hereinafter referred to as 'the rules for participation and dissemination`) applies to this specific programme and allows the participation of the Joint Research Centre in the indirect actions covered by this specific programme;

Whereas, for the purpose of implementing this programme, in addition to cooperation covered by the Agreement on the European Economic Area or by an association agreement, it may be appropriate to engage in international cooperation activities, in particular on the basis of Article 130m of the Treaty, with third countries or international organisations;

Whereas implementation of this programme will also comprise activities and mechanisms aimed at stimulating, disseminating and exploiting RTD results, in particular vis-à-vis small and medium-sized enterprises, and activities to stimulate the mobility and training of researchers;

Whereas, in accordance with the objectives of the first action plan for innovation, research activities under the fifth framework programme should be geared more towards innovation;

Whereas the implementation of this programme should be monitored with a view to adapting it, where appropriate, to scientific and technological developments; whereas in due course there should also be an assessment of progress with the programme by independent experts,

HAS ADOPTED THIS DECISION

Article 1

In accordance with Article 3(1) of the fifth framework programme, the specific programme on 'Quality of life and management of living resources` (hereinafter referred to as 'the specific programme`) is hereby adopted for the period from [the date of adoption of this programme] to 31 December 2002.

Article 2

1. In accordance with Annex III to the fifth framework programme, the amount deemed necessary for carrying out the specific programme (hereinafter referred to as 'the amount`) is ECU 2 635 million, including a maximum of 6,30 % for the Commission's administrative expenditure.

2. An indicative breakdown of this amount is given in Annex I.

3. Of this amount

- ECU 547 million is for the period 1998 to 1999, and

- ECU 2 088 million is for the period 2000 to 2002.

Where appropriate, the latter figure will be adapted in accordance with Article 3(3) of the fifth framework programme.

4. The budgetary authority shall, in compliance with the scientific and technological objectives and priorities laid down in this Decision, set the appropriations for each financial year taking into account the availability of resources within the multiannual financial perspective.

Article 3

1. The general outlines, the scientific and technological objectives and the priorities for the specific programme are set out in Annex II. They are consistent with the fundamental principles and the three categories of selection criteria indicated in Annex I of the fifth framework programme.

2. In accordance with these principles and criteria the selection criteria indicated in Article 10 of the rules for participation and dissemination shall be applied for the selection of the RTD activities to be carried out.

A selection criterion specific to this programme shall also be applied: the participation of industrial entities in the shared-cost actions should be appropriate to the nature of the activity.

All these criteria shall be complied with in the implementation of the programme, including the work programme referred to in Article 5(1), although they may be weighted differently.

3. The rules for participation and dissemination shall apply to the specific programme.

4. Detailed rules for financial participation by the Community in the specific programme are defined in Article 4 of the fifth framework programme.

5. The indirect RTD actions under the specific programme are defined in Annexes II and IV to the fifth framework programme.

Specific rules for implementing the programme are set out in Annex III.

Article 4

In the light of the criteria set out in Article 3, and the scientific and technological objectives and priorities set out in Annex II, the Commission shall:

(a) monitor the implementation of the specific programme and, where appropriate, submit proposals for adapting it, in accordance with Article 5(1) of the fifth framework programme,

(b) have the external assessment provided for in Article 5(2) of the fifth framework programme conducted concerning the activities carried out in the fields covered by the specific programme.

Article 5

1. The Commission shall draw up a work programme specifying:

(a) the content of Annex II;

(b) the indicative timetable for the implementation of the specific programme;

(c) the coordination arrangements indicated in Annex III;

(d) and, where necessary, the selection criteria and the arrangements for applying them for each type of indirect RTD action.

The work programme shall be updated where appropriate.

2. For the purpose of implementing the indirect RTD actions, the Commission shall, on the basis of the work programme, initiate the procedures set out in the rules for participation and dissemination, primarily through calls for proposals.

Article 6

1. The Commission shall be responsible for the implementation of this specific programme.

2. It shall be assisted by a Programme Committee composed of representatives of the Member States and chaired by the representative of the Commission.

3. The representative of the Commission shall submit to the Programme Committee a draft of the measures to be taken concerning:

- the drawing-up and updating of the work programme referred to in Article 5(1),

- the drawing-up of the terms of reference for the external assessment provided for in Article 5(2) of the fifth framework programme,

- any adjustment to the indicative breakdown of the amount as set out in Annex I.

Article 7

1. The Programme Committee shall deliver its opinion on the draft measures referred to in Article 6(3) within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.

The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.

If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

If, on expiry of a period of six weeks from the referral of the matter to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.

2. The Commission shall regularly inform the Programme Committee of progress with the implementation of the specific programme, and shall in particular provide it with information about the results of the evaluation and selection of the indirect RTD actions.

Article 8

This Decision is addressed to the Member States.

(1) Common position 31/98, adopted by the Council on 23 March 1998 (OJ C 178, 10.6.1998, p. 1).

(2) OJ L 126, 18.5.1994, p. 1. Decision as last amended by Decision No 2535/97/EC (OJ L 347, 18.12.1997, p. 1).

(3) COM(97)553 final.

(4) COM(97)587 final (OJ C 40, 7.2.1998, p. 14).

ANNEX I

INDICATIVE BREAKDOWN OF THE AMOUNT

>TABLE>

ANNEX II

THE GENERAL OUTLINES, THE SCIENTIFIC AND TECHNOLOGICAL OBJECTIVES AND THE PRIORITIES

INTRODUCTION

Economic and political developments in Europe have globally resulted in greater prosperity, increased life expectancy and better working conditions. These improvements have, however, been accompanied by challenges such as higher health-care costs, an ageing population, and environmental degradation. Increasingly, a gap is becoming evident between natural resources, whether from agriculture and fisheries, mining or the global environment, and human activities. Paradoxically, this has occurred at a time when there is an 'explosion` in the knowledge base concerning the structure and working of all living things, pointing towards new developments in the corresponding sectors, e.g. health-care, pharmaceuticals, agriculture, food, etc.

Europe has a strong tradition and an excellent record in research and application of life sciences and technologies. Furthermore, Europe provides a huge single market with a tradition of receptiveness for bio-based products. It has, therefore, the potential to address and solve major challenges such as a varied and safe food supply, affordable health-care, better medicines, etc. The scientific basis on which living and natural materials are exploited for these ends is undergoing a dramatic change, in which the intimate and interactive workings of living beings are being revealed. With the progress of scientific knowledge in recent decades, one can now expect to probe more deeply the questions surrounding the production of food, the curing of diseases, and the sustainable management and use of biological resources. One can also anticipate clarifying their relationships with human behaviour and needs, industrial practices and consumer demands.

The strategic objective of the programme is to link the ability to discover to the ability to produce, in order to address the needs of society and to meet the requirements of the consumer, leading to future wealth and job creation. The strategy of this programme is to focus on specific areas where growing knowledge potentially contains technical answers to some of the pressing questions asked by the citizen which require to be tackled on a European scale.

The novelty of this approach is the willingness to couple the dynamics of massive knowledge production with few areas where there are expected to be desirable spin-offs, while pursuing the renewal of knowledge to reinforce European strengths in fields associated with further growth and quality of life.

The proposed scientific and technological solutions should be seen as part of an integrated 'system` approach, in which man is at the core of the issue of the 'quality of life` and of 'management of living resources`. Five key actions have been identified in which European research should make a contribution, by way of innovative products, processes or services, to problem resolution. These key actions are targeted at socio-economic needs and the Community's policy objectives, e.g. in agriculture and fisheries, industry and consumers, and in the fields of health and environment.

They are supplemented with research and technological development activities of a generic nature as well as support to research infrastructures aiming at building up, in the longer term, the knowledge base in areas of strategic importance for the future.

Meeting socio-economic needs. On the demand side, research should be developed which promotes health, reconcile economic developments with environmental requirements, and improves the response to consumer needs. On the supply side, there is huge potential for economic growth and job-creation in this field, both in the traditional industries including primary production and in the nascent high technology industries.

Increasing European added value. The major cross-border issues should be addressed selectively, such as health aspects of diseases (epidemiology, nutrition, food safety, ageing, rare diseases), or transboundary resources management (terrestrial and aquatic living resources). Other areas such as drug abuse, biosafety or bioethics, involve the reinforcement of scientific bases in support of Community policies. Many of the activities to be addressed in the programme (e.g. genome research, neurosciences, technology assessment), due to their size and complexity, are only feasible if they are addressed at the European level.

Improving European competitiveness. The programme will capitalise on specific scientific strengths in knowledge areas and in productive sectors with strong growth potential, such as the biotechnology and food industries. Thus, the heart of this programme, improving the quality of life, promoting life sciences and technologies and decoupling economic growth from environmental degradation, will contribute in the short and in the longer term to European competitiveness and employment. Europe must promote start-ups in particular in the areas of biotechnology and the agro-food industry which have recently shown a consistent growth rate.

Promoting biosafety. The assessment of the behaviour and impact on health of recombinant organisms (e.g. transgenic plants, microorganisms, vaccines, etc.) and of their fate in the environment, where relevant, is part of every key action.

Respecting an ethical framework. Full respect of human rights and fundamental ethical principles will be ensured throughout all activities in the specific programme in accordance with Article 6 of the European Parliament and Council Decision on the fifth framework programme.

LINKS AND COMPLEMENTARITY WITH THE OTHER PROGRAMMES

Coordination with other thematic programmes is based on promoting synergetic interactions and complementary activities and avoiding unnecessary duplication:

- Coordination with the specific programme on a 'User-friendly information society` is based on the following principle: activities concerned with information society technologies as such (which include development, demonstration and take-up actions) will be concentrated in the 'User-friendly information society` programme; activities concerned with the deployment, integration and adaptation of information society technologies in applications relating to the quality of life and the management of living resources will be conducted in this programme.

- Coordination with the programmes on 'Competitive and sustainable growth` and 'Preserving the ecosystem` is based on close interaction between the key action 'Health, food and environmental factors` of this programme and the key action 'Products, processes and organisation` of the programme on 'Competitive and sustainable growth` and the corresponding aspects of the programme on 'Preserving the ecosystem`. Similar interactions will be established between the key actions 'The cell factory` and 'Sustainable management of agriculture, fisheries and forestry, including integrated development of rural areas` with the relevant actions of the programmes on 'Competitive and sustainable growth` and 'Preserving the ecosystem`.

- Close coordination will be developed with the programme 'Confirming the international role of Community research`, in particular where collaboration with international initiatives could bring added value to European RTD efforts.

- Full use will be made of the possibilities offered by COST and Eureka and by co-operation with international organisations to foster synergy between actions and projects in this programme and nationally funded research activities. In the case of co-operation with Eureka, projects corresponding to priority themes of common interest may be developed in the context of the key actions.

- Specific activities aimed at facilitating the involvement of entities in third countries and maintaining links with specialists from third countries trained in Europe will be carried out, which will also contribute to the international dimension of the programme.

- Concerning innovation and the participation of SMEs, as new knowledge in the biosciences constantly drives innovation, research partnerships need to be flexible and inclusive. A competitive partnership requires a high level of interaction of biology, engineering, information management, standardisation, capital investment, intellectual property rights, etc., which brings success only on a single-project basis. It will be imperative that measures to stimulate e.g. SMEs and financial partners accompany programme management for each individual action. An 'innovation unit` will focus the promotion activities with a view to the deployment and use of the results of this programme; it will also help to ensure complementarity and an interface with the innovation activities implemented in the context of the programme on 'Innovation and participation of SMEs`.

- Training with a view to providing qualified human resources in the entrepreneurial and professional sectors, as well as socio-economic analysis of technology impacts, will be carried out within this programme, to accommodate the rapid turn-over of new expertise in many traditional fields.

(a) KEY ACTIONS

(i) Health, Food and Environmental Factors

Objectives and RTD priorities

The overall goal of this key action is to improve the health of European citizens by providing them with safe, healthy and varied food products and by reducing the negative impact of environmental factors such as air pollution, heavy metals, toxic substances, electromagnetic radiation and noise, as well as the effects of pollution at the workplace. A new multidisciplinary approach viewing the whole food chain as an integrated entity while examining issues of food safety, pre-normative aspects, new and improved raw materials, food processing, and a more profound understanding of the links between food consumption, well-being and health will be developed. This key action will also study in detail the interactions between environmental factors and human health. The following scientific and technological objectives will be pursued:

- Development of safe and flexible and new and/or improved manufacturing process and technologies

The aim is to improve the quality and consumer acceptability of food, while ensuring traceability of raw material and final products.

RTD priorities: improved use of raw materials, production and processing systems; development of food crops and functional foods; use of fishery by products and poorly exploited species; quality and traceability of raw materials and food products in the food chain; minimal processing and process control; advanced food technologies and packaging systems; improvement of traditional technologies; quality monitoring and quality assurance, including the development of methods for measuring quality.

- Development of tests to detect and processes to eliminate infectious and toxic agents

Research will focus on the hazards of food contaminants, their exact origins and strategies for safer food production.

RTD priorities: improved understanding and control of contamination conditions; rapid detection tests for pathogens, xenobiotics and hormones; new and safer methods of food production; new methodologies for assessing microbial, chemical and allergenic risks.

- Research into the role of food in promoting and sustaining health with respect to diet and nutrition, toxicology, epidemiology, environmental interaction, consumer choice and public health

The aim is to reduce diet-related risk factors contributing to chronic disease and to develop new approaches for improved nutrition and more balanced diets.

RTD priorities: the role and impact of food and diet on physiological functions, and physical and mental performance; the particular nutritional needs of defined population groups; links between diet and chronic diseases and disorders including genetic factors involved; consumer protection, attitudes and reactions with regard to food products, food-processing methods and labelling.

- Research into diseases and allergies related to or influenced by the environment, and research into their treatment and prevention

The focus is on health impairment caused directly by exposure to the environment and on ways on treatment and prevention, based on sound epidemiological data and an understanding of pathogenesis mechanisms.

RTD priorities: analysis and quantification of the impact of environmental factors on human health; assessment of the relative importance of, and the interactions between, factors impinging on health; improved understanding of the interrelations between environmental and public-health indicators for better treatment and prevention; development of an integrated approach to risk assessment taking into account environmental and public-health aspects.

- Development of new methods of diagnosis, risk assessment and of processes to reduce causes and harmful environmental health effects

The objective is to use a multi-disciplinary approach for better understanding of the interactions between the social and physical environment and health and to improve the identification of vulnerable groups to environmental exposures and to identify preventive measures in order to reduce causes and environmental factors hazardous to health.

RTD priorities: bio-markers (including bio-indicators) of environmental exposure, effect and/or susceptibility to environmental agents, including mixed exposures and cumulative effects; improvement of predictive toxicity testing and mechanism-based risk assessment aiming at an eventual reduction, refinement and eventual replacement of animal testing; improved methods and technologies for long and short-term exposure and effects assessment; epidemiological and biomedical studies on possible effects linked to non-ionising irradiation, particularly from cellular phones.

(ii) Control of Infectious Diseases

Objectives and RTD priorities

The overall goal of this key action is to combat established, emerging or re-emerging infectious diseases, linked to old, new or mutated agents in humans or animals. This would be achieved primarily by mixing complementary expertise in transdisciplinary projects, by linking these activities to national and international organisations, and by encouraging the interface between academic research, policy-makers, health-care providers and the human and animal health-care industry, pursuing the following scientific and technological objectives:

- The development of improved or novel mono-component, multi-component and combined vaccines, especially against viral diseases, including the support of multi-centre clinical trials

RTD priorities: vaccines against emerging and re-emerging infectious diseases and other diseases related to infectious agents (e.g. some cancers) with a view to reduction and eventual replacement of animal testing; vaccines against animal pathogens; development of European networks for clinical and field trials of vaccines and drugs including, where necessary, better understanding of the immune system.

- New and improved strategies to identify and control infectious diseases, directed at treatment and prevention and based on studies on pathogenesis, emergence of resistance and immunological control

RTD priorities: improved understanding of mechanisms of protection against infectious agents, of drug resistance and control of immunological responses; technologies for safer and more efficient vaccines and immunotherapy; specific risk factors, including xenotransplants influencing the spread of infectious diseases and development of new strains; development and validation of diagnostic tests; development of an early-warning system and response network for infectious diseases; improved methodologies for early and accurate detection of adverse reactions to drugs and vaccines.

- Aspects connected with public-health and care-delivery systems, notably management, prevention and surveillance aspects

RTD priorities: organisational and economic public-health aspects; surveillance, monitoring and assessment methodologies in prevention and cure; methodologies for product safety surveillance in the market place.

(iii) The 'Cell Factory`

Objectives and RTD priorities

This key action is aimed at helping the Community's enterprises, either established or starting up, to exploit the advances made in life sciences and technology, particularly in the fields of health, environment, agriculture, agro-industries and high value-added products such as chemicals. It is aimed at the development of multidisciplinary technologies based on the exploitation of the properties of micro-organisms, plants and animals, in particular at the tissue, cellular and sub-cellular levels. The objective is to understand the versatile functioning of cells and to develop bio-reactors, bio-molecules and bio-processes with high added value capable of enhancing the quality of life and health. Being a prerequisite to the functioning of cells as minute factories, sufficient knowledge will have to be secured of their blue-print at the scale at which they operate, through underpinning contributions of structural biology, physiology, nanobiotechnology, genomics and proteomics, with the support of notably physico-chemistry, bioinformatics and biochemical engineering. This key action should also aim at using RTD to reinforce the prenormative by making cell cultures available as models for medicine, pharmacology, toxicology and environmental monitoring as a substitute for testing. Emphasis would be put on the following scientific and technological objectives:

- New and innovative health-related processes and products particularly from molecular engineering (for example: diagnostics, antibiotics, anti-cancer agents, including plant produced therapeutics)

Research will focus on bio-products relevant to preventing, detecting and treating human and animal diseases and improving the quality of life.

RTD priorities: Improved understanding of the cell, gene functions and gene-delivery methods applicable to the development of new diagnostic and therapeutic substances and strategies; anti-cancer agents, antibiotics, antibodies and therapeutics, vaccine production, novel in vitro testing and screening methods as alternatives to animal testing; cells as production units and as diagnostic and detection tools.

- Energy-efficient bio-remediation and waste bio-treatment processes

The objective is to prevent, detect, monitor, treat and remove pollution as well as to maximise the economic value of waste.

RTD priorities: new bio-processes for preventing industrial pollution, treating, upgrading, and/or recycling bioaccumulable wastes and industrial by-products; bioassays and biosensors; bio-degradation of recalcitrant chemicals by microbial catalysts alone or in combination with plant systems and/or chemical catalysts; biodiversity and ecological dynamics of natural and introduced populations.

- New biological processes and products, new processing technologies using micro-organisms, plants or animals for agri-food and agro-industry and high-value-added chemical applications

The focus is on high-value bio-molecules and bio-processes leading to enhanced exploitation of renewable resources and to enhanced expression of desirable characteristics for micro-organisms, plants and animals.

RTD priorities: approaches at genome level and exploiting the cellular and sub-cellular characteristics of improved micro-organisms, plants and animals taking into account socio-economic, agronomic, ecological and/or consumer perspectives; development of methods and strategies for identifying recombinant organisms and their residues in the environment and their impact on human and animal health; new biocatalysts; use of terrestrial and marine organisms as a source of new valuable products; identification and sustainable use of metabolic and genetic diversity.

(iv) Sustainable agriculture, fisheries and forestry, including integrated development of rural areas

Objectives and RTD priorities

The aim is to develop knowledge and technologies for the production and exploitation of living resources, including forests, covering the whole production chain, taking into account the highly competitive international context and in the light of the need for adaptation to the evolution of the common agricultural and fisheries policies, whilst also providing the scientific basis for Community regulations and standards, and to promote the multi-functional role of forests and the sustainable management and utilisation of forest resources as an integral factor of rural development. The priority areas are as follows:

- New and/or improved systems of production and exploitation in agriculture, fisheries and aquaculture, including the multi-functional management of forests

These systems will combine competitiveness, sustainable management of resources, product quality and employment.

RTD priorities:

For agriculture: sustainable farm production systems and methods and corresponding ex-ante and ex-post control and analysis; diversification of production and activities; support to Community policies on plant health (prevention prediction, protection), animal health (prevention, control, eradication of major diseases and zoonoses) and animal welfare; identification and characterisation of the quality of agro-food products and agricultural farm-processed products and farm-processing technologies; definition of parameters, specifications, methods, forms of organisation and technologies for total quality; organic farming systems; plant and animal breeding and genetic resources.

For fisheries: support to integrated fishery management linking resource conservation, means of capture, interactions with ecosystems, market requirements and socio-economic considerations, identification and characterisation of the quality of marine products and technologies; development of new concepts for the sustainable use of marine living resources.

For aquaculture: sustainable production systems with the reduction of impact on ecosystems and diversification of cultivated species (both plant and animal); improvement of production techniques; promotion of genetic improvement, disease resistance and control.

For forests: multifunctional management of forests; support to forest policy issues; diversification (non-wood uses, agro-sylvo-pastoral systems), multifunctional and sustainable management combining quality production with conservation and protection. Forests ecosystems biodiversity and protection of forests soils. Sustainable and multi-purpose utilisation of forest resources; the forestry-wood chain; strategies for the sustainable management and utilization of forest resources; efficient, environment-friendly processes and recycling technologies; high value added and diversified products accounting for market needs, and consumer requirements.

- Integrated production and exploitation of biological materials for non-food uses

This will cover integrated production and processing chains with the emphasis on enduse and market requirements.

RTD priorities: industrial products from the 'green` chemical, biopolymers and bioenergy integrated chains.

- Support for common policies

The aim is to develop methods of control, surveillance and protection to support the sound implementation of the common agricultural and fisheries policies and related activities and to provide support for Community regulations by prenormative research activities. This research may also be useful to the Community in the context of international trade negotiations and of dispute settlements in the framework of WTO, in the area of agriculture.

RTD priorities: reliable, transparent and cost-effective methods of monitoring, assessment and control; prenormative research to provide the scientific basis for regulation in the context of the common agricultural and fisheries policies.

- New tools and models for the integrated and sustainable development of rural and other relevant areas

This approach is based on optimisation of the specific potential of each area, including at regional level, the diversification of activities and land use and the involvement of the people concerned.

RTD priorities: analysis of the situation and changes under way, taking into account the relationship between all the sectors involved and the factors influencing technological and socio-economic changes; diversification and job opportunities; development of the 'integrated rural and fishery development` concept, with the investigation of potentials and constraints, the elaboration of new models and tools, including for spatial planning and the improvement of the organisational capacity of local actors; support to follow-up and evaluation of rural and coastal development programmes and policies with tools to monitor, assess and forecast socio-economic and environmental benefit.

(v) The Ageing Population

Objectives and RTD priorities

The overriding goal of this key action is to promote quality of life and healthy ageing and independence in old age by preventing and treating age-related diseases and disability, and their societal consequences. A complementary objective will be to reduce the need for long-term care and limit the constantly increasing costs of health-care systems.

- RTD into age-related illnesses and health problems with high morbidity where there is a real prospect of significant prevention, treatment or delay in onset

RTD priorities: studies on major age-related diseases (e.g. Parkinson's and Alzheimer's diseases), physiology and pathophysiology of ageing and disability; co-morbidity studies.

- RTD into biological, psychological, social and economic determinants of healthy ageing and of the mechanisms leading to disability

RTD priorities: cellular and molecular bases of ageing; genetic predisposition; immunology of ageing; basic biological and psychological mechanisms underlying age-related changes (including occupational and genetic effects); model studies for specific ageing processes; biomarkers; endocrine, neurocrine and metabolic factors of ageing; psychological implications of ageing.

- Demographic and epidemiological research on ageing and disability trends to enable prediction of the size and nature of the ageing population as a basis for policy and planning

RTD priorities: clinical trials; analysis and quantification of demographic, medical, sociological, lifestyle (including exercise, mobility and nutrition) and environmental factors; prevention; methodology linked to collection of specific data.

- RTD into new approaches to delaying the onset of disability, to reducing the challenge to older people of their social and physical environment, including the design and development of products and services adapted to their needs (e.g. in housing, transport and leisure) and to supporting mental and physical functioning

RTD priorities: methodology relating to quality of life, social integration and coping mechanisms; technologies contributing to less dependency; research on sensory degeneration; psychomotor, sensory and cognitive impairments; rehabilitation and replacement therapies; intervention assessment studies; assessment and quantification of needs and design/development of competitive and adapted products and services.

- RTD into effective and efficient delivery of health and social care services to older people, including comparative research on the financing of long term care and pensions

RTD priorities: health care outcome research for elderly and disabled, research into specific health services and social care services, as well as into health care services organisation; efficiency and quality of health care delivery for the elderly; impact of ageing on the evolution and financing of care systems, notably for long term care, and of pensions.

(b) RESEARCH AND TECHNOLOGICAL DEVELOPMENT ACTIVITIES OF A GENERIC NATURE

These activities have a longer-term impact that may even preclude the possibility of satisfying some of the citizens' expressed needs, for as long as fragmentary knowledge is not pooled together to a sufficient degree of completeness. There is, in the related disciplines, a time-dependent need for integration of the science base, which is why industry, services and policy-making in Europe must maintain or reinforce their response capacity in a rapidly changing world.

Efficient interaction between research laboratories and industry will be promoted. Clustering of projects involving core centres and associated laboratories will be encouraged to create a critical mass, to promote interaction between basic and applied research and to ensure maximum transfer of knowledge to and from industry and undertakings. Support ranging from training of young scientists to fellowships for senior researchers will be developed.

- Chronic and degenerative diseases (in particular cancer and diabetes), cardiovascular diseases and rare diseases

Major challenges in biomedical research are the elucidation of the aetiology and pathogenesis of multi factorial diseases (genetic, environmental, life-style) of high (e.g. cardiovascular, cancer, diabetes) or low (e.g. rare diseases) morbidity. There is an urgent need to improve diagnosis, treatment, prevention and surveillance through epidemiology and applying advances in modern technology, requiring a multinational approach. The objective is to increase knowledge with regard to the epidemiology, pathogenesis and diagnosis of diseases by integrating basic and clinical research, and to apply modern technology to the treatment and control of major diseases, including rare (e.g., Creutzfeldt-Jakob disease) and 'orphan` diseases (e.g. illnesses which are prevalent in developing countries but are receiving less attention for research in industrialised countries).

RTD priorities: contribution of molecular, genetic, environmental and life-style factors and their interactions to the aetiology, pathophysiology, progress and outcome of diseases, leading to new approaches to prevention, diagnosis and treatment. Evaluation of novel interventions where multinational, large-scale studies/trials are required, and optimum use of databases, registries, reagents and sample banks.

- Research into genomes and diseases of genetic origin

The aim of this activity is to identify the physiological functions of genes and to improve the understanding of the meaning of sequence information. The new knowledge and technologies deriving from this generic action should promote the exploitation of genome information to the benefit of European health, industry and the environment. The organisation of collaboration in this area will underpin the development of expression systems to facilitate the study of genes of industrial and agronomic interest as well as the design of effective molecular and gene-based preventive and therapeutic strategies for human and animal disease.

RTD priorities: this area will address the meaning of genome information. This will require structural studies; comparative analyses of genomes and proteomes; development of novel and user-friendly informatics approaches to enable acquisition of, access to and interpretation of genomic and functional data; development of novel expression systems, model organisms, mutant, transgenic and hybrid organisms; development and application of underpinning biochemistry, biophysical, statistical and computational approaches. Particular emphasis will be given to improve the knowledge and understanding of genetic diseases.

- Neurosciences

This activity will provide new insights and a better understanding of the mechanisms governing the interrelationship of biological and psychological processes, to promote new diagnostic (e.g. imaging), preventive and therapeutic approaches to neurological and psychiatric disorders and to underpin opportunities for education, innovation in health-care and computational industries. In this context, synergy and an appropriate flow of information will be strengthened with 'the human frontier` science programme.

RTD priorities: understanding cell communication, including mechanisms of learning and memory; mechanisms of brain development, disorder and repair, and their clinical, epidemiological and social implications. Brain theory, computational neurosciences, and neuroinformatics; human behaviour, cognition and functional mapping of the brain. Integration of theoretical and experimental approaches; integration of basic and clinical research in developing innovative diagnostic, preventive and therapeutic strategies based on novel genetic, cellular, non-invasive, pharmacological and psychological approaches.

- Public-health and health-services research

Improvement of health systems: To improve the health of European citizens and the effectiveness and cost-effectiveness of health-promotion and health-care technologies and interventions, enhance health and safety at work, evaluate health-care models, develop the evidence base for clinical practice and health policy, and study public-health variations across Europe.

RTD priorities: improved methodologies in epidemiology; identification of new health determinants (including factors leading to inequalities in health) and etiologic factors of disease through common methodologies and comparative research; socio-economic and organisational determinants of prevention, care and health services; work-related exposure to biological, chemical and physical agents and to physical and mental stress.

Fighting drug-related problems: To prevent and, where appropriate, control drug-related health problems through establishing the psychological and socio-economic factors involved in drug-taking and drug abuse, developing better understanding of the long-term health and social consequences of abuse, and developing more effective treatment strategies.

RTD priorities: comparative and analytical research on biological and social causes, risk factors and effects of drug addiction and misuse; psychological and socio-economic factors of drug abuse; long-term health effects of drug consumption; physical detection aspects, drug profiling and biological monitoring of drugs.

- Study of problems relating to biomedical ethics and bioethics in the context of respect for fundamental human values

The objective is to identify the ethical, legal and social questions raised, not only by biomedical and biological research alone but also, more broadly, by scientific and technological developments to understand and address issues of public concern, and to analyse the ethical dimension of legal and regulatory measures.

RTD priorities: ethical aspects of life sciences research and its application to medical practice, animals, plants, and the environment (1).

- Study of the socio-economic aspects of life sciences and technologies within the perspective of sustainable development (the impact on society, economy and employment)

Competitiveness and sustainable development will together be the source of the Union's future wealth and employment opportunities, ensuring an enhanced quality of life for Europe's citizens.

Simultaneous pursuit of these objectives is only possible through an adequate recognition of the key interrelations between technologies, environment and society and integration of knowledge into sustainable development policies.

Socio-economic research is also needed to enhance the quality of the public debate, as illustrated by the interest shown in the applications of modern biotechnologies. The regulatory process in life sciences and technologies and its impact on citizens' confidence influences public opinion, which in turn has a strong impact on decision-makers.

The objectives are to assist in the construction of strategies and models for sustainable development and to provide a sound scientific basis for the conception and implementation of relevant policies, exploiting knowledge and technologies from the life sciences and technologies (including the creation of employment opportunities in the bioindustries); and to develop a better understanding of the links between science and policy, including the ways in which opinions on the benefits and risks of technological progress are formed and are reflected in their regulatory process.

RTD priorities: technology evaluation and assessment, public perception, education and opinion forming in the field of life sciences and technologies; analysis of social and economic driving forces and of new opportunities in the bioindustries; development of indicators and knowledge bases relevant to decision-making and regulation; analysis of the social and economic aspects of the links between life sciences and technologies and policies in the field of industry, agriculture, fisheries, environment, sustainable development, public-health, etc.

(c) SUPPORT FOR RESEARCH INFRASTRUCTURES

Objectives

To broaden access, to make optimum use of and to improve the consistency of the existing European research fabric at Community level.

To facilitate and to encourage the development of RTD facilities in response to emerging needs.

In order to reinforce the European added value and the optimisation of the required efforts, Community support will be directed towards:

- transnational co-ordination, integrated management of, specific aspects of operation of, access to and improvement of existing facilities;

- co-ordination and complementation of national or multinational initiatives to develop facilities needed at the European level;

- networking of communities of researchers and users through research projects and specific training activities centred on appropriate infrastructures, or co-operation of several partners, leading to an integrated service provider;

- increasing the compatibility of dispersed systems, aiming to provide rapid and effective integration of facilities and resources.

Classes of infrastructures

- Biological data and collections of biological material. Databases, information services and networks of biological expertise; major specialised instrumentation for the study of biological structures; collections of genetic materials, living and non-living specimens; breeding of animals to develop models of human diseases.

- Clinical research facilities, including pre-clinical research and clinical trials.

- Facilities for aquaculture and fishery research.

(1) Research activities under this programme must comply with the international conventions and codes of conduct, and in particular the Helsinki Declaration of the World Medical Association adopted by the World Medical Assembly.

Research will be carried out also taking into account: the European Convention on Human Rights and Biomedicine of the Council of Europe; the opinions of the Group of Advisors on the Ethical Implication of Biotechnology and the opinions of the European Group on Ethics in Science and New Technologies; the Universal Declaration on the Human Genome and Human Rights of UNESCO of 11 November 1997 and the resolutions of the WHO, as well as EC legislation (Council Directives of 26 January 1965 and 20 May 1975 on the approximation of the laws, regulations and administrative provisions relating to proprietary medicinal products (65/65/EEC and 75/319/EEC; Council Directive 86/609/EEC of 24 November 1986 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the protection of animals used for experimental and other scientific purposes.

No research modifying or seeking to modify the genetic constitution of human beings by alteration of germ cells or of any stage of embryo development which may make this alteration hereditary, and research activities aiming at the creation of individuals by reproductive cloning whether it involves embryo splitting or nucleus transfer will be carried out under the present programme.

Concerning animal experimentation, the principles of replacement by alternative methods, reduction of the number of animals and the refinement of experiments must be applied. Animal suffering must be avoided or kept to a minimum. These principles must be applied particularly rigorously to the animal species that are the closest to human beings.

Modification of the genetic heritage of animals and animal cloning will be envisaged within this programme only for objectives which are justified on ethical grounds and when carried out under conditions respection animal welfare and the genetic diversity.

Participants in EC research projects must conform to national legislation and applicable codes of conduct and seek the approval of the relevant ethics committee prior the start of the RTD activities.

ANNEX III

SPECIFIC RULES FOR IMPLEMENTING THE PROGRAMME

The specific programme will be implemented through the indirect RTD actions defined in Annexes II and IV to the fifth framework programme. In addition, the following rules specific to this programme will apply:

1. Accompanying measures

The accompanying measures will comprise in particular:

- studies in support of the specific programme, including the preparation of future activities,

- the exchange of information, conferences, seminars, workshops and scientific and technical meetings,

- recourse to external expertise, including access to scientific databases, in particular for the purposes of the monitoring of the specific programme provided for in Article 5(1) of the fifth framework programme, the external assessment provided for in Article 5(2) of the fifth framework programme and the evaluation of indirect RTD actions and the monitoring of their implementation,

- dissemination, information and communication activities, including scientific publications, activities for the exploitation of results and the transfer of technologies, encouragement of innovation financing and assistance with the protection of intellectual property.

- training schemes related to RTD activities covered by the specific programme,

- support for schemes to provide information and assistance for research players, including SMEs,

- recourse to external capacities for the establishment of and access to services and networks for information, assistance and promotion of research and innovation.

2. Coordination arrangements

The Commission will endeavour to ensure complementarity between the indirect RTD actions within the programme, in particular by grouping them around a common objective, and to avoid duplication, while respecting the legitimate interests of proposers of indirect RTD actions.

Coordination will also be ensured between actions under the specific programme and those carried out in:

- other specific programmes implementing the fifth framework programme,

- the research and training programmes implementing Council Decision 98/. . ./Euratom of . . ., concerning the fifth framework programme of the European Atomic Energy Community (Euratom) for research and training activities (1998-2002),

- other European research frameworks such as Eureka and COST,

- other Community research-related instruments such as PHARE, TACIS, MEDA, the EIF, the Structural Funds and the EIB.

It will comprise:

(i) the identification of common themes or priorities, resulting in particular in:

- the exchange of information,

- the carrying out of work decided upon jointly, entailing in particular the joint initiation of one of the procedures referred to in Article 9 of the rules for participation and dissemination,

(ii) the reassignment of proposals for indirect RTD actions between specific programmes or between a specific programme and a research and training programme.