51998AP0451

A4-0451/98

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) (COM(98)0305 - C4-0433/98 - 98/0177(CNS))

The proposal was approved with the following amendments:

(Amendment 2)

Fourth citation a (new)

>Original text>

>Text following EP vote>

Having regard to the Commission's report: The State of Women's Health in the European Community (COM(97)0224),

(Amendment 3)

Recital 6a (new)

>Original text>

>Text following EP vote>

Whereas, in view of the consequences of biotechnological research and its application for developing countries in the field of the environment, the social economy and health, particular consideration should be given to the interests of those countries as regards access to the results of research activities;

(Amendment 4)

Recital 6b (new)

>Original text>

>Text following EP vote>

Whereas the Commission's efforts to simplify and speed up application and selection procedures and increase transparency must be continued, particularly with a view to simplifying the procedure for firms, especially SMEs, research centres and universities wishing to take part in a Community RTD action;

(Amendment 5)

Recital 7

>Original text>

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;

>Text following EP vote>

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 European centres of excellence, and activities to stimulate the mobility and training of researchers; where projects are of equal scientific merit, priority shall be accorded to those submitted by SMEs. All necessary measures will be introduced to facilitate increased participation by SMEs in the research programme. A specific report on the subject will be submitted to the European Parliament and the Council when the programme is reviewed;

(Amendment 6)

Recital 8a (new)

>Original text>

>Text following EP vote>

Whereas the Community policy on equal opportunities must be taken into account in the implementation of this programme;

(Amendment 8)

Article 2(1), (2), and (3)

>Original text>

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 2635 million, including a maximum of 6,30% for the Commission's administrative expenditure.

>Text following EP vote>

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 2413 million, including a maximum of 6,30% for the Commission's administrative expenditure.

>Original text>

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

>Text following EP vote>

2.

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

>Original text>

3. Of this amount

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3.

Of this amount

>Original text>

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

>Text following EP vote>

-

ECU 553 million is for the period 1998 to 1999, and

>Original text>

- ECU 2088 million is for the period 2000 to 2002.

>Text following EP vote>

-

ECU 1860 million is for the period 2000 to 2002.

>Original text>

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

>Text following EP vote>

Where appropriate, the latter figure will be adapted in accordance with Article

2 of the fifth framework programme.

(Amendment 9)

Article 2(4)

>Original text>

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.

>Text following EP vote>

4.

The budgetary authority shall, in compliance with the scientific and technological objectives laid down in this Decision, set the appropriations for each financial year.

(Amendment 10)

Article 5(1), 2nd subparagraph

>Original text>

The work programme shall be updated where appropriate.

>Text following EP vote>

The work programme shall be updated where appropriate.

The Commission shall publish the work programme and every updated version thereof in paper and electronic form (on the Internet).

(Amendment 11)

Article 5(1a) (new)

>Original text>

>Text following EP vote>

1a. The Commission shall determine and publish, including electronically, guidelines for evaluating projects which shall, in particular, take account of the frequency with which the original publications cited by applicants are quoted.

(Amendment 12)

Article 5(2a) (new)

>Original text>

>Text following EP vote>

2a. Calls for tenders for RTD will take into account the EU's policies on equal opportunities.

(Amendment 13)

Article 5(2b) (new)

>Original text>

>Text following EP vote>

2b. All calls for proposals will contain a written statement on equal opportunities.

(Amendment 14)

Article 6(3), 3rd indent

>Original text>

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

>Text following EP vote>

-

any adjustment to the indicative breakdown of the amount as set out in Annex I, if consistent with the allocations laid down annually by the budgetary authority.

(Amendment 15)

Article 7(1)

>Original text>

1. The Programme Committee shall deliver its opinion on the 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.

>Text following EP vote>

1.

The Programme Committee shall deliver its opinion on the measures referred to in Article 6(3) within a time limit which the Chairman may lay down according to the urgency of the matter, if necessary by taking a vote.

>Original text>

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

>Text following EP vote>

The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.

>Original text>

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.

>Text following EP vote>

The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee of the manner in which its opinion has been taken into account.

>Original text>

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.

>Text following EP vote>

The Committee shall meet as a rule in public, unless a specific duly motivated decision is taken to the contrary and published in good time. It shall publish agendas two weeks in advance of its meetings (also on the Internet). It shall publish minutes of its meetings (also on the Internet). It shall establish a public register of declarations of interest by its members.

>Original text>

>Text following EP vote>

These provisions shall be adopted in accordance with the European Parliament position on a new act laying down the principles governing European Union committees chaired by the Commission and the implementing powers of the Commission.

(Amendment 16)

Article 7(2)

>Original text>

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.

>Text following EP vote>

2. Pursuant to Article 5(4) of the Framework Programme the Commission shall regularly inform the Council and the European Parliament as well as the Programme Committee of progress with the implementation of the specific programme, and shall in particular provide them with information about the results of the evaluation and selection of the indirect RTD actions - including the participation of SMEs - and the simplification of administrative procedures.

(Amendment 17)

Article 7a (new)

>Original text>

>Text following EP vote>

Article 7a

>Original text>

>Text following EP vote>

Protection of the financial interests of the European Communities shall be guaranteed in accordance with Regulation (EC, Euratom) No 2988/95 on the protection of the European Communities' financial interests(1).

____________

(1) OJ L 312, 23.12.1995, p. 1.

(Amendment 18)

Annex I

>Original text>

(a) Key actions 76,1%

>Text following EP vote>

(a)

Key actions 75-78%

>Original text>

(i) health, food and environmental factors 19,0%

>Text following EP vote>

(i) health, food and environmental factors 18-20%

>Original text>

(ii) control of infectious diseases 12,7%

>Text following EP vote>

(ii) control of infectious diseases 12-14%

>Original text>

(iii) the 'cell factory' 15,2%

>Text following EP vote>

(iii) the 'cell factory' 14-16%

>Original text>

(iv) sustainable agriculture, fisheries and

forestry, including integrated

development of rural areas 21,6%

>Text following EP vote>

(iv) sustainable agriculture, fisheries

and forestry, including integrated

development of rural areas 20-22%

>Original text>

(v) the ageing population 7,6%

>Text following EP vote>

(v) the ageing population anddisabled

people 7-9%

>Original text>

(b) Research and technological development

activities of a generic nature 20,9%

>Text following EP vote>

(b)

Research and technological development

activities of a generic nature 20-22%

>Original text>

(c) Support for research infrastructures 3,0%

>Text following EP vote>

(c)

Support for research infrastructures 2-3%

>Original text>

TOTAL ECU 2635 million

>Text following EP vote>

TOTAL

ECU 2413 million (*) (**)

>Original text>

>Text following EP vote>

(*) Of which on average 10% for SMEs

>Original text>

>Text following EP vote>

(**) The Commission shall continuously monitor the level of participation by SMEs in the research activities and shall take appropriate initiatives to support suitable and effective participation on their part. Such initiatives may consist, in the event of difficulties with the participation of SMEs in the key actions, in strengthening the specific measures targeted at them (CRAFT, premiums for exploratory awards).

(Amendment 19)

Annex II, INTRODUCTION, 1st paragraph

>Original text>

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.

>Text following EP vote>

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, environmental degradation

and ethical aspects. 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.

(Amendment 20)

Annex II, INTRODUCTION, 2nd paragraph

>Original text>

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.

>Text following EP vote>

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 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, the sustainable management and use of biological resources

and the preservation or re-establishment of stable ecosystems. One can also anticipate clarifying their relationships with human behaviour and needs, industrial practices and consumer demands.

(Amendment 21)

Annex II, INTRODUCTION, 3rd paragraph

>Original text>

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.

>Text following EP vote>

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, job creation and improvements in the state of the environment. 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. Fundamental ethical values must be respected, where necessary by appropriate legal measures.

(Amendment 22)

Annex II, INTRODUCTION, 4th paragraph

>Original text>

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.

>Text following EP vote>

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 which is ethically and environmentally sustainable and geared to the future, and with quality of life.

(Amendment 23)

Annex II, INTRODUCTION, 5th paragraph

>Original text>

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, eg in agriculture and fisheries, industry and consumers, and in the fields of health and environment.

>Text following EP vote>

The proposed scientific and technological solutions should be seen as part of an integrated 'system' approach, in which

human beings are 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, eg in agriculture and fisheries, industry and consumers, and in the fields of health and environment. The gender dimension being relevant to most topics, it will be integrated throughout the programme, by making use of appropriate methodological and analytical tools, including statistical key data broken down by sex.

(Amendment 24)

Annex II, INTRODUCTION, 7th paragraph

>Original text>

Meeting socio-economicneeds. On the demand side, research should be developed which promotes health, reconciles 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.

>Text following EP vote>

Meeting socio-economicneeds. On the demand side, research should be developed which promotes health, reconciles economic developments with environmental requirements, and improves the response to consumer needs. The transposition of the results of the programme's research must be considered in conjunction with the socio-economic environment and the consequences to be expected therefrom, and thus calls for particular care. Dialogue with the public with regard to ethical and social issues and the consequences of medical and biotechnology research and the application thereof will be undertaken or pursued as part of the programme. In this area, it is not a matter of bringing about public 'acceptance', but primarily of creating transparency, so that a properly informed public may make an 'enlightened', and thus responsible, judgment about biotechnology and its applications. 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.

(Amendment 25)

Annex II, INTRODUCTION, 8th paragraph

>Original text>

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.

>Text following EP vote>

Increasing European added value. The major cross-border issues should be addressed selectively, such as gender-specific health aspects of diseases (epidemiology, nutrition, food safety, ageing, disabilities and 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. various activities in the areas of genome research, neurosciences and technology assessment), due to their size and complexity, are only feasible if they are addressed at the European level.

(Amendment 26)

Annex II, INTRODUCTION, 9th paragraph

>Original text>

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.

>Text following EP vote>

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 area of biotechnology, which has recently shown a consistent growth rate.

(Amendment 27)

Annex II, INTRODUCTION, 10th paragraph

>Original text>

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.

>Text following EP vote>

Promoting biosafety. The assessment of the behaviour and impact on human and animal 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. This programme should, moreover, provide the scientific basis for the further development of a framework of Community law on biotechnology to guarantee the safety of humankind and the environment.

(Amendment 28)

Annex II, LINKS AND COMPLEMENTARITY WITH THE OTHER PROGRAMMES,

introduction

>Original text>

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

>Text following EP vote>

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

To that end, efficient networks with clear decision-making structures should be set up inside the Commission. The Commission shall inform the European Parliament, before the programme enters into force, about the measures it has taken in this respect:

(Amendment 29)

Annex II, LINKS AND COMPLEMENTARITY WITH THE OTHER PROGRAMMES,

3rd indent

>Original text>

- 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.

>Text following EP vote>

-

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. Priority should be given, in this connection, to the Central European states that have applied for EU membership and the MEDA states.

(Amendment 30)

Annex II (a)(i), 1st paragraph

>Original text>

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:

>Text following EP vote>

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

and gender-sensitive 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, including the health effects of nutrition during pregnancy and lactation, 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:

(Amendment 31)

Annex II (a)(i), 1st indent, heading and 1st paragraph

>Original text>

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

>Text following EP vote>

- Development of safe and flexible and new and/or improved selection, production and processing processes

>Original text>

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

>Text following EP vote>

The aim is to improve the quality of food in terms of its composition and/or keeping qualities, while ensuring traceability of raw materials and final products, together with the opportunity for consumers to be informed in accordance with the principles of clarity and transparency.

(Amendment 32)

Annex II (a)(i), 1st indent, 2nd paragraph

>Original text>

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.

>Text following EP vote>

RTD priorities: improved use of raw materials, production and processing systems; development of food crops and foods incorporating raw materials with new properties (e.g. a lower allergen content), containing substances beneficial to health and with better keeping qualities, while avoiding secondary elements which are harmful or undesirable; 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.

(Amendment 33)

Annex II (a)(i), 2nd indent

>Original text>

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

>Text following EP vote>

- Development of tests to detect and processes to eliminate infectious and toxic agents, antibiotics, contamination by radioactive substances or the effects of irradiation

>Original text>

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

>Text following EP vote>

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

>Original text>

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.

>Text following EP vote>

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

(Amendment 34)

Annex II (a)(i), 3rd indent, 2nd paragraph

>Original text>

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.

>Text following EP vote>

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; the use of health-promoting properties of micro-organisms or plants to produce nutraceuticals; the dietary advantages of organic foodstuffs; consumer protection, attitudes and reactions with regard to food products, food-processing methods and labelling. Links should be established with Key action (v):'The Ageing Population and Disabled People'.

(Amendment 35)

Annex II (a)(i), 4th indent, 1st and 2nd paragraphs

>Original text>

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

>Text following EP vote>

The focus is on health impairment caused directly by exposure to the environment and on ways of treatment and prevention, based on sound epidemiological data and an understanding of pathogenesis mechanisms. Research should also be conducted into the impact of environmental pollutants at the workplace, including the interactions between risk factors at the workplace and in the environment and the aetiology of occupational diseases and diseases related to or influenced by the environment.

>Original text>

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.

>Text following EP vote>

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; bio-markers (including bio-indicators) of environmental exposure, particularly to endocrine disruptors of proven effect, effect and/or susceptibility to environmental agents, including mixed exposures and cumulative effects; improvement of predictive toxicity testing (primarily by in vitro methods) and risk assessment aiming in particular at the reduction, refinement and eventual replacement of animal testing; improved methods and technologies for long- and short-term exposure and effects assessment.

(see Am. 36)

(Amendment 36)

Annex II (a)(i), 5th indent

>Original text>

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

>Text following EP vote>

Deleted

(see Am. 35)

>Original text>

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.

>Text following EP vote>

>Original text>

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;

>Text following EP vote>

(Amendment 37)

Annex II (a)(ii), 1st indent, 2nd paragraph

>Original text>

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.

>Text following EP vote>

RTD priorities: vaccines against emerging and re-emerging infectious diseases 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 which require special measures (e.g. closed security installations, test centres).

(Amendment 38)

Annex II (a)(ii), 2nd indent, 2nd paragraph

>Original text>

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.

>Text following EP vote>

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 (e.g. xenotransplants) influencing the spread of infectious diseases and development of new and resistant 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.

(Amendment 39)

Annex II (a)(ii), 3rd indent

>Original text>

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

>Text following EP vote>

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

>Original text>

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.

>Text following EP vote>

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

(Amendment 40)

Annex II (a)(iii), 2nd indent

>Original text>

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

>Text following EP vote>

- Material-efficient and energy-efficient bio-remediation and waste bio-treatment processes

>Original text>

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

>Text following EP vote>

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

>Original text>

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.

>Text following EP vote>

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 used for these purposes.

(Amendment 41)

Annex II (a)(iii), 3rd indent

>Original text>

- 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

>Text following EP vote>

- New biological and biotechnological processes and products, new processing technologies using micro-organisms, plants or animals for agri-food and agro-industry and related upstream activities (eg plant breeding) and high-value-added chemical applications

>Original text>

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.

>Text following EP vote>

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.

>Original text>

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.

>Text following EP vote>

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; research into the plant genomes of various key crops (monocotyledonous and dicotyledonous plants); new methods of increasing plants' capacity to take up nutrients, rate of photosynthesis and stress tolerance and guaranteeing yields; 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 and the optimisation of traditional products; identification and sustainable use of metabolic and genetic diversity.

(Amendment 42)

Annex II (a)(iv), title and 1st paragraph

>Original text>

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

>Text following EP vote>

(iv) Ecologically sustainableagriculture, fisheries and forestry, with due regard to the integrated development of rural areas

>Original text>

Objectives and RTD priorities

>Text following EP vote>

Objectives and RTD priorities

>Original text>

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:

>Text following EP vote>

The aim is to develop knowledge and technologies for the production

and ecologically sustainable 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 ecologically sustainable management and utilisation of forest resources as an integral factor of rural development. In the agricultural sector, careful consideration should be given to questions concerning the preservation of the genetic heritage and biological diversity with regard to the seed of indigenous plant species that have demonstrated their ability to adapt to, for example, adverse climatic conditions such as drought, or their resistance to specific pests. At the same time, even more resistant species of plants should be developed to meet the requirements of extensive dry farming .Similarly, particular attention should be given to the management of edaphic resources to combat soil erosion. The priority areas are as follows:

(Amendment 43)

Annex II (a)(iv), 1st indent, 1st paragraph and RTD priority 1, 1st paragraph

>Original text>

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

>Text following EP vote>

These systems will combine competitiveness,

ecologically sustainable management of resources, product quality, animal protection and employment.

>Original text>

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 andgenetic resources.

>Text following EP vote>

RTD priorities:

For agriculture: ecologically and economically sustainable farm production systems and methods, the development of plants suitable for such systems and corresponding ex-ante and ex-post control and analysis; diversification of production and activities; support to Community policies on plant health and plant breeding (prevention -eg by breeding resistant crop plants- 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.

(Amendment 44)

Annex II (a)(iv), 1st indent, RTD priority 4

>Original text>

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.

>Text following EP vote>

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. Methods of reafforesting severely damaged forest areas. Enhancement of the protective functions of forests and forest soils in mountain areas, especially their capacity to retain precipitation (primarily to prevent flooding). Sustainable and multi-purpose utilisation of forest resources; environment-friendly forestry-wood chain, wood-processing and processing of waste from the wood and paper industry;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.

(Amendment 45)

Annex II (a)(iv), 2nd indent, 2nd paragraph

>Original text>

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

>Text following EP vote>

RTD priorities: industrial products from the 'green' chemical, biopolymers and biomass as a primary energy source integrated chains. Non-polluting methods of producing and improving traditional or new biodegradable fibres and increasing the energy content of the vegetable biomass

(Amendment 46)

Annex II (a)(iv), 3rd indent, 2nd paragraph

>Original text>

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

>Text following EP vote>

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

(Amendment 47)

Annex II (a)(iv), 4th indent, 2nd paragraph

>Original text>

RTD priorities: analysis of the situation and changes under way, taking into account the relationships 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.

>Text following EP vote>

RTD priorities: analysis of the situation and changes under way, taking into account the relationships between all the sectors involved and the factors influencing technological and socio-economic changes; diversification and job opportunities; development of integrated approaches to rural and coastal development, 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 (eg in terms of communications infrastructure); 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.

(Amendment 48)

Annex II (a)(v), title

>Original text>

(v) The Ageing Population

>Text following EP vote>

(v) The Ageing Population and Disabled People

(Amendment 49)

Annex II (a)(v), 1st paragraph

>Original text>

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.

>Text following EP vote>

The overriding goal of this key action is to promote

the quality of life, health and independence of elderly and disabled people 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 costs of health-care systems. A thematic focus on gender will be integrated into the different parts of this key action. Special attention will be given to the impact of the changing age pyramid on the situation of women, with particular reference to the issue of care for family dependants and to the inadequacy of social infrastructures and social measures.

(Amendment 50)

Annex II (a)(v), 3rd indent, 1st paragraph

>Original text>

- 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

>Text following EP vote>

- Demographic and epidemiological RTD into ageing and its accompanying infirmities to enable prediction of the size and nature of the ageing population as a basis for policy and planning

(Amendment 51)

Annex II (a)(v), 3rd indent, 2nd paragraph

>Original text>

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.

>Text following EP vote>

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

(Amendment 52)

Annex II (a)(v), 4th indent

>Original text>

- 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

>Text following EP vote>

- RTD into new approaches to delaying the onset of disability and restricted mobility, to reducing the challenge to older and/or disabled 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

>Original text>

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.

>Text following EP vote>

RTD priorities: methodology for investigating quality of life, social integration for people with disabilities 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, including those in the field of medical technology.

(Amendment 53)

Annex II (a)(v), 5th indent, 1st paragraph

>Original text>

- 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

>Text following EP vote>

- RTD into effective and efficient delivery of health and social care services to older people and the disabled, including consideration of gender-determined needs and also comparative research on the financing of long term care and the pension system

(Amendment 54)

Annex II (b), 2nd paragraph

>Original text>

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.

>Text following EP vote>

Efficient interaction between research laboratories and industry will be promoted. Clustering of projects involving core centres

, associated laboratories and European centres of excellence in biotechnology 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.

(Amendment 55)

Annex II (b), 1st indent, title

>Original text>

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

>Text following EP vote>

- Chronic and degenerative diseases and their distinctive gender-determined features such as cancer, diabetes, cardiovascular diseases and rare diseases

(Amendment 56)

Annex II (b), 1st indent, 1st paragraph

>Original text>

Major challenges in biomedical research are the elucidation of the aetiology and pathogenesis of multi factorial diseases (genetic, environmental, lifestyle) 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).

>Text following EP vote>

Major challenges in biomedical research are the elucidation of the aetiology and pathogenesis of multi factorial diseases (genetic, environmental, lifestyle) of high (e.g. cardiovascular, cancer, diabetes) or low (e.g. rare diseases) morbidity. There is an urgent need to improve

gender-specific 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).

(Amendment 57)

Annex II (b), 1st indent, 2nd paragraph

>Original text>

RTD priorities: contribution of molecular, genetic, environmental and lifestyle 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 data-bases, registries, reagents and sample banks.

>Text following EP vote>

RTD priorities: contribution of molecular, genetic, environmental and lifestyle factors and their influence on the aetiology, pathophysiology, progress and outcome of diseases, leading to new approaches to prevention, diagnosis and treatment, including the development of orphan drugs. Evaluation of novel therapies where multinational, large-scale studies/trials are required, and optimum use of data-bases, registries, reagents and sample banks.

(Amendment 58)

Annex II (b), 2nd indent, 1st paragraph

>Original text>

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.

>Text following EP vote>

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.

It has emerged very clearly over the past few years that diagnostic possibilities using human genetics are making very rapid strides, whereas therapeutic approaches exist only in a very few cases. The aim must be to make every effort to ensure that the gap between diagnostic and therapeutic possibilities does not widen. In connection with this issue, projects offering a therapeutic approach should be encouraged as a matter of priority. While respecting ethical rules, products and services in the field of medical technology likewise have a role to play.

(Amendment 59)

Annex II (b), 2nd indent, 2nd paragraph

>Original text>

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.

>Text following EP vote>

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 with strict regard to ethical principles and the principles of biosafety; 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 and the further development of medical technology, while respecting ethical rules.

(Amendment 60)

Annex II (b), 4th indent, title

>Original text>

- Public-health and health-services research

>Text following EP vote>

- Research into public health services which will also include gender-determined differences

(Amendment 77)

Annex II (b), 4th indent, 1st paragraph

>Original text>

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.

>Text following EP vote>

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,

including evaluation of the effectiveness, the safety and the area of application of non-conventional therapies taking into account their preventive role and the possibilities offered by an individual and holistic approach to health, 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.

(Amendment 61)

Annex II (b), 4th indent, 2nd paragraph

>Original text>

RTD priorities: improved methodologies in epidemiology; identification of new health determinants (including factors leading to inequalities in health) and aetiologic 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.

>Text following EP vote>

RTD priorities: improved methodologies in epidemiology; identification of new health determinants (including factors leading to inequalities in health) and aetiologic factors of disease through common methodologies and comparative research; improved health education (eg by means of programmes publicising and explaining the links between nutrition and health); socio-economic and organisational determinants of prevention, care and health services; exposure at the workplace and in the home to products in everyday use, to biological, chemical and physical agents and to physical and mental stress.

(Amendment 62)

Annex II (b), 4th indent, 4th paragraph

>Original text>

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.

>Text following EP vote>

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, substitution substances and techniques, and methods, models and scenarios for ending dependency.

(Amendment 63)

Annex II (b), 5th indent, title and 1st paragraph

>Original text>

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

>Text following EP vote>

- Study of problems relating to medical ethics and bioethics

>Original text>

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.

>Text following EP vote>

The objective is to identify the ethical, legal and social questions raised, not only by medical and biological research alone but also, more broadly, by scientific and technological developments to understand and promote public discussion of issues of public concern, and to analyse the ethical dimension of legal and regulatory measures. In view of the rapid advances being made in the field of biotechnology, this programme should also contribute to the formulation of ethical guidelines for the development of biotechnological research. One of the guiding ethical principles is that individuals shall be protected from discrimination on grounds of their genetic inheritance or predispositions and that an individual's genetic data obtained under this programme or otherwise shall only be transmitted to a third party with the prior informed and written consent of that individual.

(Amendment 64)

Annex II (b), 5th indent, 2nd paragraph

>Original text>

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

>Text following EP vote>

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

(Amendment 65)

Annex II (b), 5th indent, footnote, 2nd and 3rd paragraphs

>Original text>

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 Implications of Biotechnology (1991-1996) and the opinions of the European Group on Ethics in Science and New Technologies (as from 1998); 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.

>Text following EP vote>

Research will be carried out also taking into account:

the relevant declarations and decisions of the European Parliament; the European Convention on Human Rights and Biomedicine of the Council of Europe; the opinions of the Group of Advisors on the Ethical Implications of Biotechnology (1991-1996) and the opinions of the European Group on Ethics in Science and New Technologies (as from 1998); 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.

>Original text>

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.

>Text following EP vote>

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

genetically identical human individuals by cloning, whether it involves embryo splitting or nucleus transfer-i.e. the production of humans or human embryos with the same genetic material as living or dead persons - will be carried out under the present programme. Owing to the different views within the European Union of the ethical problems associated with these technologies, no research in which embryos are destroyed will be carried out, either.

(Amendment 66)

Annex II (b), 5th indent a (new)

>Original text>

>Text following EP vote>

- Research relating to the disabled

>Original text>

>Text following EP vote>

The aim of this activity is to enhance the quality of life and independence of disabled people, notably through improving their social and physical environment and the effective and efficient delivery of the health and social care services available to them.

(Amendment 67)

Annex II (b), 6th indent, title

>Original text>

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

>Text following EP vote>

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

(Amendment 68)

Annex II (b), 6th indent, 3rd paragraph

>Original text>

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.

>Text following EP vote>

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.

This calls for the existence of an informed public which, on the basis of transparency regarding the substance, objectives and methods of biotechnology, will make a meaningful contribution to the debate on questions concerning the advisability of such research and can reach an informed consumer decision independently. Increased funding must be made available for this purpose, which will ultimately also be to the benefit of the competitiveness of European biotechnology.

(Amendment 69)

Annex II (b), 6th indent, 5th paragraph

>Original text>

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 relevantto 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.

>Text following EP vote>

RTD priorities: technology evaluation and assessment, systematic provision of information to the public 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 relevantto 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, equal opportunities for men and women, etc.

(Amendment 70)

Annex II (c), Objectives, 1st paragraph

>Original text>

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

>Text following EP vote>

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

and in the countries applying for EU membership, while ensuring appropriate protection for intellectual property in accordance with the relevant principles of the fifth framework programme and the rules on participation and the dissemination of results.

(Amendment 71)

Annex II (c), Classes of infrastructures, 2nd indent

>Original text>

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

>Text following EP vote>

-

Clinical research facilities, including pre-clinical research and clinical trials which will also cover gender-specific aspects

(Amendment 72)

Annex II (c), Classes of infrastructures, 2nd indent a (new)

>Original text>

>Text following EP vote>

- Structures for research into harmful substances and endocrine disruptors, particularly in drinking water, other food products and objects in daily use at all stages of human lives.

(Amendment 75)

Annex II(c), Classes of infrastructures, 3rd indent a (new)

>Original text>

>Text following EP vote>

- Activities in order to interface and coordinate interconnection with the European High-speed Research Network of the corresponding activity of the programme on the 'User-friendly Information Society¨.

(Amendment 73)

Annex III (2), 1st paragraph

>Original text>

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.

>Text following EP vote>

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 setting up the requisite networks and administrative arrangements, and to avoid duplication, while respecting the legitimate interests of proposers of indirect RTD actions.

The Commission will, after consulting the external scientific advisory group, establish groups of related research projects.

(Amendment 74)

Annex III (2), 3rd paragraph (-i) (new)

>Original text>

>Text following EP vote>

(-i) ensuring that calls for proposals or tenders are worded so precisely that there is a sharp decline in the number of ineligible applications, a success rate of over 20% and, after consultation of the external scientific advisory group, the establishment of groups of related research projects,

Legislative resolution embodying Parliament's opinion on the proposal for a Council decision adopting a specific programme for research, technological development and demonstration on 'quality of life and management of living resources' (COM(98)0305 - C4-0433/98 - 98/0177(CNS))(Consultation procedure)

The European Parliament,

- having regard to the Commission proposal to the Council, COM(98)0305 - 98/0177(CNS) ((OJ C 260, 18.8.1998, p. 1.)),

- having been consulted by the Council pursuant to Article 130i(4) of the EC Treaty (C4-0433/98),

- having regard to Rule 58 of its Rules of Procedure,

- having regard to the report of the Committee on Research, Technological Development and Energy and the opinions of the Committee on Budgets, the Committee on External Economic Relations, the Committee on Fisheries and the Committee on Women's Rights (A4-0451/98),

1. Approves the Commission proposal, subject to Parliament's amendments;

2. Calls on the Commission to alter its proposal pursuant to Article 189a(2) of the EC Treaty;

3. Asks to be consulted again should the Council intend to make substantial modifications to the Commission proposal;

4. Instructs its President to forward this opinion to the Council and Commission.