Proposal for a DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL adopting a programme of Community action in the field of public health (2001-2006)

(Presented by the Commission)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152 thereof,

Having regard to the proposal from the Commission [1],

[1] OJ C [...], [...], p. [...].

Having regard to the opinion of the Economic and Social Committee [2],

[2] OJ C

Having regard to the opinion of the Committee of the Regions [3],

[3] OJ C

Acting in accordance with the procedure laid down in Article 251 of the Treaty [4],

[4] OJ C

Whereas:

The Community is committed to promoting and improving health, reducing avoidable mortality and activity-impairing disability, preventing disease, and countering potential threats to health. The Community must address in a coordinated and coherent way the concerns of its people about risks to health and their expectations for a high-level of health protection and, therefore, all health-related activities of the Community must have a high degree of visibility and transparency and allow consultation and participation of all stakeholders in a balanced way, in order to promote better knowledge and communication flows and thus enable a larger involvement of individuals in decisions that concern their health.

In the context of the public health framework set out in the Commission communication of 24 November 1993 on the framework for action in the field of public health [5], eight action programmes were adopted, namely:

[5] COM(93) 559 final of 24.11.1993.

- Decision No 645/96/EC of the European Parliament and of the Council of 29 March 1996 adopting a programme of Community action on health promotion, information, education and training within the framework for action in the field of public health (1996 to 2000) [6];

[6] OJ L 95, 16.4.1996, p. 1.

- Decision No 646/96/EC of the European Parliament and of the Council of 29 March 1996 adopting an action plan to combat cancer within the framework for action in the field of public health (1996 to 2000) [7];

[7] OJ L 95, 16.4.1996, p. 9.

- Decision No 647/96/EC of the European Parliament and of the Council of 29 March 1996 adopting a programme of Community action on the prevention of AIDS and certain other communicable diseases within the framework for action in the field of public health (1996 to 2000) [8];

[8] OJ L 95, 16.4.1996, p. 16.

- Decision No 102/97/EC of the European Parliament and of the Council of 16 December 1996 adopting a programme of Community action on the prevention of drug dependence within the framework for action in the field of public health (1996 to 2000) [9];

[9] OJ L 19, 22.1.1997, p. 25.

- Decision No 1400/97/EC of the European Parliament and of the Council of 30 June 1997 adopting a programme of Community action on health monitoring within the framework for action in the field of public health (1997 to 2001) [10];

[10] OJ L 193, 22.7.1997, p. 1.

- Decision No 372/1999/EC of the European Parliament and of the Council of 8 February 999 adopting a programme of Community action on injury prevention in the framework for action in the field of public health (1999 to 2003) [11];

[11] OJ L 46, 20.2.1999, p. 1.

- Decision No 1295/1999/EC of the European Parliament and of the Council of 29 April 1999 adopting a programme of Community action on rare diseases within the framework for action in the field of public health (1999 to 2003) [12]; and

[12] OJ L 155, 22.6.1999, p. 1.

- Decision No 1296/1999/EC of the European Parliament and of the Council of 29 April 1999 adopting a programme of Community action on pollution-related diseases in the context of the framework for action in the field of public health (1999 to 2001) [13].

[13] OJ L 155, 22.6.1999, p. 7.

Other activities in the context of the public health framework included the Council Recommendation 98/463/EC 29 June 1998 [14] on the suitability of blood and plasma donors and the screening of donated blood in the European Community of Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community [15], and Recommendation 1999/519/EC on 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields 0 Hz to 300 GHz [16].

[14] OJ L 203, 21.7.1998, p. 14.

[15] OJ L 268, 3.10.1998, p. 1.

[16] OJ L 199, 30.7.1999, p. 59.

The public health framework was reviewed in the Commission communication of 15 April 1998 on the development of public health policy in the European Community [17], which indicated that a new health strategy and programme were needed in view of the new Treaty provisions, new challenges and experience so far;

[17] COM(1998) 230 final.

The Council in its conclusions of 26 November 1998 on the future framework for Community action in the field of public health [18], and in its Resolution of 8 June 1999 [19], the Economic and Social Committee, in its opinion of 9 September 1998 [20], the Committee of the Regions, in its opinion of 19 November 1998 [21], and the European Parliament, in its Resolution A4-0082/99 of 12 March 1999 [22], welcomed the Commission communication of 15 April 1998 and supported the view that actions at Community level should be set out in one overall programme to run for a period of at least five years and comprising three general objectives, namely improving information for the development of public health, reacting rapidly to health threats and tackling health determinants through health promotion and disease prevention, underpinned by inter-sectoral action and the use of all appropriate Treaty instruments;

[18] OJ C 390, 15.12.1998, p. 1.

[19] OJ C 200, 15.7.1999, p. 1.

[20] OJ C 407, 28.12.1998, p. 26.

[21] OJ C 51, 22.2.1999, p. 53.

[22] OJ C 175, 21.6.1999, p. 135.

The overall aim of the public health programme should be to make a contribution towards the attainment of a high level of health protection by directing action towards improving public health, preventing human illness and diseases, and obviating sources of danger to health. Action should be guided by the need to prevent premature death, increase life expectancy without disability or sickness, promote quality of life and physical and mental well-being, and minimise the economic and social consequences of ill health, thus reducing health inequalities;

Achieving this aim, and the general objectives of the programme requires effective cooperation of the Member States, their full commitment in the implementation of Community actions, and the involvement of actors in the health field as well as the public at large;

In accordance with the principles of subsidiarity and proportionality set out in Article 5 of the Treaty, Community action on matters which do not fall within the exclusive competence of the Community, such as public health, should be undertaken only if and insofar as, by reason of its scale or effects, its objective can be better achieved by the Community. The objectives of the programme cannot be sufficiently accomplished by the Member States because of the complexity, transnational character and lack of complete control at Member State level over the factors affecting health status and health systems. The programme will enable the Community to contribute towards fulfilling its Treaty obligations in the field of public health while fully respecting the responsibilities of the Member States for the organisation and delivery of health services and health care. This Decision does not go beyond what is necessary to achieve those objectives.

The measures under the programme underpin the health strategy of the Community and will yield Community added value by responding to needs in health policy and health systems arising out of conditions and structures established through Community action in other fields, by addressing new developments, new threats and new problems for which the Community would be in a better position to act to protect its people, by bringing together activities undertaken in relative isolation and with limited impact at national level and by complementing them in order to achieve positive results for the people of the Community, and by contributing to the strengthening of solidarity and cohesion in the Community.

In order to ensure that actions can address broad health issues and threats effectively in cooperation with other Community policies and activities the programme should provide for the possibility of undertaking joint actions with related Community programmes and actions.

In the execution of the programme, full use should be made of the results generated from the Community research programmes, which support research in areas covered by the programme.

The programme should last six years in order to allow sufficient time to implement measures to achieve its objectives.

It is essential that the Commission should ensure implementation of the programme in close cooperation with the Member States. Moreover, in order to obtain scientific information and advice, the Commission should cooperate with high-level committees of scientific experts.

Consistency and complementarity should be ensured between actions to be implemented under the programme and those envisaged or implemented under other policies and activities, in particular in the light of the requirement to ensure a high level of human health protection in the definition and implementation of all Community policies and activities.

This Decision lays down, for the entire duration of the programme, a financial framework constituting the principal point of reference, within the meaning of point 33 of the interinstitutional agreement of 6 May 1999 between the European Parliament, the Council and the Commission on budgetary discipline and improvement of the budgetary procedure [23], for the budgetary authority during the annual budgetary procedure.

[23] OJ C 172, 18.6.1999, p. 1.

It is essential that there should be flexibility to allow re-deployment of resources and adaptation of activities while respecting the criteria for selecting and ordering priorities according to magnitude of risk or potential of effect, public concerns, availability of interventions or potential for their development, subsidiarity, added value and impact on other sectors.

In accordance with Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [24], measures for the implementation of this decision should be adopted by use of the advisory procedure provided for in Article 3 of that Decision.

[24] OJ L 184, 17.7.1999, p. 23.

The Agreement on the European Economic Area (EEA Agreement) provides for greater cooperation in the field of public health between the European Community and its Member States, on the one hand, and the countries of the European Free Trade Association participating in the European Economic Area (EFTA/EEA countries), on the other. Provision should also be made to open the programme to participation of the associated Central and Eastern European countries in accordance with the conditions established in the Europe Agreements, in their additional protocols and in the decisions of the respective Association Councils, of Cyprus, funded by additional appropriations in accordance with the procedures to be agreed with that country, as well as of Malta and Turkey, funded by additional appropriations, in accordance with the provisions of the Treaty.

Cooperation with third countries and the competent international organisations in the sphere of health should be fostered.

In order to increase the value and impact of the programme there should be monitoring and evaluation of the measures taken. It should be possible to adjust or modify the programme in the light of these evaluations and of developments that may take place in the general context of Community action in health and health-related fields.

The programme of Community action in the field of public health builds on the activities and the programmes under the previous framework in order to ensure a smooth transition therefrom, while adapting and expandings on their actions. The decisions concerning those programmes should therefore be repealed with effect from the date of entry into force of this Decision,

HAVE DECIDED AS FOLLOWS:

Article 1

Establishment of the programme

1. This decision establishes a programme of Community action in the field of public health, hereinafter referred to as "the programme".

2. The programme shall be implemented in the period starting on 1 January 2001 and ending on 31 December 2006.

Article 2

Overall aim and general objectives

1. The programme shall aim to make a contribution towards the attainment of a high level of health protection by directing action towards improving public health, preventing human illness and diseases, and obviating sources of danger to health.

2. The programme shall have the following general objectives:

(a) To improve information and knowledge for the development of public health and the strengthening and maintenance of effective health interventions and efficient health systems, by developing and operating a well-structured and comprehensive system for collecting, analysing, evaluating and imparting health information and knowledge to competent authorities, health professionals and the public, and by undertaking assessments of and reporting on health status and health-related policies, systems and measures;

(b) To enhance the capability of responding rapidly and in a coordinated fashion to threats to health by the development, strengthening and assistance to the capacity, operation and inter-linking of surveillance, early warning and rapid reaction mechanisms covering health hazards;

(c) To address health determinants through health promotion and disease prevention measures, through support to and the development of broad health promotion activities and disease prevention actions and specific risk reduction and elimination instruments.

Article 3

Community actions

1. The general objectives of the programme as set out in Article 2 shall be pursued by means of the following groups of actions, the objectives and operational content of which are described in the Annex:

(a) Improving health information, by:

- developing and operating a health monitoring system;

- developing and using mechanisms for analysis, advice, reporting, information and consultation on health issues.

(b) Responding rapidly to health threats, by:

- enhancing the capacity to tackle communicable diseases;

- strengthening the capacity to tackle other health threats.

(c) Addressing health determinants, by:

- developing strategies and measures on lifestyle-related health determinants;

- developing strategies and measures on socio-economic health determinants;

- developing strategies and measures on health determinants related to the environment.

2. The actions set out in paragraph 1 shall be implemented through the following types of measures, which may, where appropriate, be combined and involve the countries referred to in Article 9:

(a) Support for the preparation of Community legislative instruments and for cooperation on the position of the Community and its Member States in fora in which health-related matters are discussed.

(b) Support for the development of the statistical part of health information in the context of the Community Statistical Programme and for the preparation and dissemination of reports and communications on the situation on specific health topics in all Member States as well as reviews and advice on issues of interest to the Community and to all Member States.

(c) Development of, and support for information and consultation on health and health-related matters at Community level, involving representative organisations of patients, health professionals and other stakeholders.

(d) Support for the mobilisation of resources to counter health threats and react to unforeseen events, undertake investigations, and coordinate responses at Community and Member State level.

(e) Support for the sharing of experience and exchange of information between the Community and authorities and competent organisations in the Member States, and for building capacity to plan for, and respond to health threats and provide appropriate training.

(f) Promotion of the availability and, where appropriate, provision of information by the Community and authorities and competent organisations in the Member States, to health professionals and to the public.

(g) Support for the development and implementation by the Community and the Member States of disease prevention and health promotion activities involving, as appropriate, non-governmental organisations, and to innovative or pilot projects of value to all Member States.

Article 4

Joint actions

As part of the effort to ensure a high level of health protection in the definition and implementation of all Community policies and activities, the measures of the programme may be implemented as joint actions with related Community programmes and actions, notably in the areas of consumer protection, social protection, research and technological development, telematic interchange of data between administrations (IDA), statistics, education and environment, and with actions undertaken by the Joint Research Centre and Community agencies.

Article 5

Implementation

1. The Commission shall ensure the implementation of the actions set out in Article 3. To this end, it shall adopt, in accordance with Article 8 (2), measures concerning the annual plan of work and for monitoring.

2. The Member States shall take appropriate action to secure, nationally, the coordination, organisation and the follow-up needed for the attainment of the objectives of the programme, involving all the parties concerned with public health in accordance with national legislation and practice. They shall endeavour to take the necessary steps to ensure the efficient running of the programme.

The Commission and Member States shall take appropriate action to develop mechanisms established at Community and national level to achieve the objectives of the programme. They shall ensure that appropriate information is provided about actions supported by the programme and that the widest possible participation is obtained in actions requiring implementation through local and regional authorities and non-governmental organisations.

3. The Commission, in cooperation with the Member States, shall ensure the transition between the actions developed within the public health programmes referred to in Article 12 and those to be implemented under the programme.

Article 6

Consistency and complementarity

The Commission shall ensure that there is consistency and complementarity between the actions to be implemented under the programme and those implemented under other Community policies and activities. In particular, the Commission shall identify those proposals of relevance to the objectives and actions of the programme and shall inform the committee referred to in Article 8 (1).

Article 7

Funding

1. The financial framework for the implementation of the programme for the period referred to in Article 1 is hereby set at EUR 300 million.

2. The annual appropriations shall be authorised by the budgetary authority within the limits of the financial perspectives.

Article 8

Committee

1. The Commission shall be assisted by a committee composed of representatives of the Member States and chaired by the representative of the Commission.

2. Where reference is made to this paragraph, the advisory procedure laid down in Article 3 of Decision 1999/468/EC shall apply, in compliance with Article 7(3) and Article 8 thereof.

Article 9

Participation of the EFTA/EEA countries, the associated Central and Eastern European countries, Cyprus, Malta and Turkey

The programme shall be open to the participation of:

(a). The EFTA/EEA countries in accordance with the conditions established in the EEA Agreement.

(b) The associated countries of Central and Eastern Europe, in accordance with the conditions laid down in the Europe Agreements, in their Additional Protocols and in the Decisions of the respective Association Councils;

(c) Cyprus, funded by additional appropriations in accordance with the procedures to be agreed with that country.

(d) Malta and Turkey, funded by additional appropriations in accordance with the provisions of the Treaty.

Article 10

International cooperation

In the course of implementing the programme, cooperation with third countries and with international organisations competent in the sphere of public health, in particular the World Health Organisation, the Council of Europe and the Organisation for Economic Cooperation and Development, shall be fostered.

Article 11

Monitoring, evaluation and dissemination of results

1. The Commission shall identify performance indicators, monitor achievement of results, and carry out independent evaluations in the third year (mid-term evaluation) and during the last year (ex-post evaluation) of the programme. The evaluations shall particularly assess the impact achieved and the efficiency of the use of resources.

2. The Commission shall make the results of actions undertaken and the evaluation reports publicly available.

3. The Commission shall submit a mid-term report to the European Parliament and to the Council during the third year and a final report upon completion of the programme. It shall incorporate into these reports information on Community financing within the framework of the programme and on consistency and complementarity with other relevant programmes, actions and initiatives, as well as the relevant evaluation results. The reports shall also be submitted to the Economic and Social Committee and the Committee of the Regions.

Article 12

Repeal

The following decisions are hereby repealed:

Decision No 645/96/EC, Decision No 646/96/EC, Decision No 647/96/EC, Decision No 102/97/EC, Decision No 1400/97/EC, Decision No 372/1999/EC, Decision No 1295/1999/EC, Decision No 1296/1999/EC.

Article 13

Entry into force

This Decision shall enter into force on the date of its publication in the Official Journal of the European Communities.

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX

SPECIFIC OBJECTIVES AND ACTIONS

1. Improving health information and knowledge

1.1. Developing and operating a health monitoring system

1st Objective: To establish Community indicators for health status, diseases and health determinants, methods for the collection of data for monitoring and analysis, and create corresponding databases

(1) Complete the framework for the stepwise establishment of health indicators fully covering health status, diseases, health resources and interventions, and health determinants, and collect relevant data using methods to be agreed;

(2) Implement the framework for establishing indicators, collecting data and integrating it in databases, and develop versions of the databases for use by health professionals and the public.

The statistical element of this work will be developed as part of the Community Statistical Programme.

2nd Objective: To improve the system for the transfer and sharing of health data

(1) Review and improve the system linking the Commission and Member State health administrations via the Internet and other means in order to transfer and share Community indicators and data;

(2) Make the health data collected in the information system available on Commission and Member States' Web sites and regularly update it, for access by administrations, health professionals and the public.

1.2. Developing and using mechanisms for analysis, advice, reporting, information and consultation on health issues

1st Objective: Developing mechanisms for analysis and advice on health issues

(1) Develop and operate a Community network to undertake analysis and the preparation of reports on health status and on the impact of health determinants and policies, identify risk factors and gaps in knowledge and forecast trends for use in policy formulation, priority setting and resource allocation;

(2) Develop and operate a Community network to monitor and undertake analysis and provide advice on health technologies;

(3) Develop and operate a benchmarking mechanism for Community strategies and national policies and activities on disease prevention, health promotion and health protection, with appropriate parameters and data sets;

(4) Develop and operate a Community network to monitor, undertake analysis and provide advice on clinical guidelines and quality and good practice in health care interventions.

2nd Objective: Reporting on health issues

(1) Report on Community health status and identify trends giving rise to concern; report on the impact of selected activities, policies and measures and health determinants;

(2) Present reviews, advice and guidelines on health technologies, health interventions and quality and good practice.

3rd Objective: Consultation and information and dissemination of reports, advice and recommendations

(1) Make available reports, reviews, advice and guidelines referred to in section 1.2 of this Annex on Commission and Member States' Web sites and through other appropriate means;

(2) Develop and use mechanisms for informing and consulting representative organisations of patients, health professionals and other stakeholders about health-related matters at Community level;

(3) Identify key information about health and health services, including issues related to access and entitlements, and make it available, as appropriate, notably to people moving from one Member State to another.

2. responding rapidly to health threats

2.1. Enhancing the capacity to tackle communicable diseases

1st Objective: Support the further implementation of Decision 2119/98/EC on the Community network on the epidemiological surveillance and control of communicable diseases

(1) Develop:

(a) case definitions, epidemiological and surveillance methods, technical means and procedures, and define nature and type of data to be collected and transmitted concerning prioritised diseases or special issues;

(b) procedures for the information, consultation and coordination between Member States, for the prevention and control of communicable diseases, including provisions for a Community incident investigation team;

(c) guidelines on the protective measures to be taken, in particular at external frontiers and in emergency situations; links with applicant countries and other third countries;

(2) Assemble surveillance data and network inventories held in existing databases;

(3) Underpin the network operation in particular in relation to common investigations, training, continuous assessment and quality assurance.

2nd Objective: To enhance the safety and quality of human blood

(1) Complete and implement the framework on high standards of quality and safety for the collection, processing, storage and distribution and use of whole blood, blood components, and blood precursors;

(2) Develop and operate a haemovigilance network and prepare guidelines on the optimum use of blood.

3rd Objective: To enhance the safety and quality of organs and substances of human origin

(1) Develop and implement a Community strategy on organs and substances of human origin;

(2) Develop and operate a Community network on organs and substances of human origin.

2.2. Strengthening the capacity to tackle other health threats

1st Objective: To develop strategies and mechanisms for responding to non-communicable disease threats

Review and develop strategies on responses to non-communicable disease threats, including, if appropriate, developing a Community network with links to existing surveillance, notification and alert mechanisms;

2nd Objective: To promote the formulation of guidelines and measures on electromagnetic fields and other physical agents

Review and further develop guidelines and advice on protective and preventive measures on exposure to:

1) electromagnetic fields;

2) other physical agents, such as optical and ultra-violet radiation, laser radiation, pressure, noise and vibration.

3. addressing health determinants

3.1. Developing strategies and measures on lifestyle-related health determinants

Objective: To develop and implement, in close cooperation with the Member States, strategies and measures on life-style related health determinants supporting, in particular, their integration in overall health promotion and disease prevention policies

Further develop and implement Community strategies, including benchmarking and analysis of policies and measures, preparation of reports and guidelines, setting up networks, identification of scope and objectives of further Community action, and prepare Community instruments on lifestyle-related health determinants.

3.2. Developing strategies and measures on socio-economic health determinants

Objective: To contribute to the formulation and implementation of strategies and measures on socio-economic determinants

(1) Develop a methodology for benchmarking and linking strategies to identify health inequalities using data from the Community health information system, and, if appropriate, develop Community instruments relating to health services and insurance arrangements and to the impact on them of Community policies and activities. Actions will also cover questions related to consumption, cost-effectiveness and expenditure on medicinal products;

(2) Review and identify obstacles to access to health services across internal borders in the Community and, if appropriate, develop guidelines.

3.3. Develop strategies and measures on health determinants related to the environment

Objective: To contribute to the formulation and implementation of strategies and measures on health determinants related to the environment

(1) Contribute to the further development and implementation of guidelines and recommendations issued by the European Ministerial Environmental Health Conference and to the monitoring of effectiveness of national strategies and measures;

(2) Identify and prepare reports on good practice in monitoring, early warning systems and measures on pollutants and associated diseases, and, if appropriate, prepare guidelines.

4. CARRYING OUT THE ACTIONS

(1) The actions to be taken may be funded by service contracts following calls for tender or by subsidies for joint financing with other sources. In the latter case, the level of financial assistance by the Commission may not exceed, as a general rule, 50% of the expenditure actually incurred by the recipient.

(2) In carrying out the programme, the Commission may require additional resources, including recourse to experts. These requirements will be decided in the context of the Commission's ongoing assessment of resource allocation.

(3) The Commission may also undertake information, publication and dissemination actions. It may also undertake evaluation studies and organise seminars, colloquia or other meetings of experts.

(4) The Commission will prepare annual work plans setting out the priorities and actions to be undertaken. Moreover, it will also specify the arrangements and criteria to be applied in selecting and financing actions under this programme. In so doing, it will seek the opinion of the Committee mentioned in Article 8.

(5) Actions undertaken will fully respect the principles of data protection.

FINANCIAL STATEMENT

1. Title of operation

Proposal for a Decision of the European Parliament and of the Council adopting a programme of Community action in the field of public health (2001-2006)

2. Budget headings involved

B3-4300, B3-4301, B3-4302, B3-4303, B3-4304, B3-4305, B3-4306, B3-4307

3. Legal basis

Article 152 of the Treaty establishing the European Community

4. Description of operation

4.1 Objective

The objective of the decision is to establish a programme of action comprising incentive measures, the overall aim of which is to make a contribution towards the attainment of a high level of health protection by directing action towards improving public health, preventing human illness and diseases and obviating sources of danger to health.

4.2 Period covered and arrangements for renewal

The proposed programme covers a period of six years beginning on 1 January 2001. The Commission shall carry out an evaluation of the actions undertaken and will submit relevant mid-term and final reports, and if appropriate, propose an extension.

5. Classification of expenditure or revenue

5.1 Compulsory/Non-compulsory expenditure

NCE

5.2 Differentiated/Non-differentiated appropriations

5.3 Type of revenue involved

Appropriations to cover the funding of actions carried out on the initiative of the Commission or to provide financial support for projects by third parties.

6. Type of expenditure or revenue

- Subsidy for joint financing with other sources in the public and/or private sector

- Service contracts following calls for tenders

7. Financial impact

7.1 Method of calculating the total cost of operation (relation between individual and total costs)

Commitment appropriations EUR million (at current prices)

>TABLE POSITION>

The figures shown above are indicative. The actual amounts will be set in the annual budgetary procedures.

As a general rule, the level of financial assistance from the Commission may not exceed 50% of the expenditure actually incurred by the recipients.

7.2 Itemised breakdown of cost

The figures given below are indicative. They provide estimates for the level of expenditure corresponding to the different areas of the programme. The actual amounts will be determined in accordance with the outcome of the annual budgetary procedures.

EUR million (at current prices)

>TABLE POSITION>

7.3 Operational expenditure for studies, experts etc. included in Part B of the budget

Commitment appropriations EUR million (at current prices)

>TABLE POSITION>

7.4 Schedule of commitment and payment appropriations

EUR million

>TABLE POSITION>

8. Fraud prevention measures

All proposals for subsidies will be assessed for technical content and financial criteria which include adequacy of own resources, sound finances and financial management, past record of performance or reliability as regards the capability of fulfilling the terms of subsidy, relationship between partners in a given project and potential for effective accounting and control. These also apply in cases of service contracts.

Requests for final payment must be accompanied by an evaluation of the operational and financial status of the project concerned.

- Specific control measures envisaged

Checks in situ will be carried out using appropriate selection criteria (scale of subsidy, interim report, results of on-going monitoring, information on progress with the execution of the relevant work-plan). In cases where there are reasons to believe that the performance of a project that has received a subsidy, or that of a service contract, is seriously being compromised, an urgent check will be carried out and, if there are remaining suspicions, the service concerned will refer the matter to the relevant audit services and the Anti-fraud Service.

9. Elements of cost-effectiveness analysis

9.1 Objectives; target population

- General objectives: links with the overall aim

The overall aim of the programme is to make a contribution towards the attainment of a high level of health protection by directing action towards improving public health, preventing human illness and diseases, and obviating sources of danger to health. Its general objectives are:

* To improve information and knowledge for the development of public health and the strengthening and maintenance of effective health interventions and efficient health systems, by developing and assisting in the operation of a well-structured and comprehensive system for collecting, analysing, evaluating and imparting health information and knowledge to competent authorities, health professionals and the public, and by undertaking assessments of and reporting on health status and health-related policies, systems and measures;

* To enhance the capability of responding rapidly and in a coordinated fashion to threats to health by the development, strengthening and assistance to the capacity, operation and inter-linking of surveillance, early warning and rapid reaction mechanisms covering health hazards;

* To address health determinants through health promotion and disease prevention measures, through support to and the development of broad health promotion activities and disease prevention actions and specific risk reduction and elimination instruments.

- Specific and quantifiable objectives

Objectives that are specific and quantifiable have been set for all the actions under the programme.

- Target population: distinguish for any individual objectives; indicate the end-beneficiaries of the Community's financial contribution and the intermediaries involved.

The general population and target population sub-groups are the ultimate beneficiaries of the actions being undertaken. The programme foresees actions permitting the monitoring of health status among the public at large as well as particular groups at risk, and the timely identification of adverse trends so that long-term plans can be formulated to address the factors that are implicated. Using Member States as key multiplier-effect parties, it actively promotes the implementation of strategies on health determinants that have significant effect on health, especially slow acting ones the effects of which only manifest themselves later in life. Finally, the programme aims at providing an effective shield over the peoples of the Community to protect them against rapidly acting agents of disease and accidents in leisure, travel or work.

The direct beneficiaries of the Community's financial contribution are governmental or quasi-governmental agencies and institutes competent in health matters, associations of health professionals and learned institutions, and representative NGOs active in the field of health information, prevention of diseases and health promotion. Criteria for eligibility, depending on the type of action to be undertaken (Article 3 of the proposed decision), are the involvement of partners from all Member States or the potential for the action to benefit and/or be applicable in all Member States, integration in the strategy of the Community and the Member States, and added value.

9.2 Grounds for the operation

- Need for Community financial aid, with particular regard to the principle of subsidiarity

The present proposal for a decision by the European Parliament and the Council pursuant to Article 152 of the EC Treaty is adopted in an area where the Community does not have exclusive competence. The objectives of the programme cannot be sufficiently accomplished by the Member States because of the complexity, trans-national character and lack of complete control at Member State level over the factors affecting health status and health systems.

In the absence of the proposed programme of action, neither the Community nor the Member States will have an adequate basis on which to plan future health policies and measures and prepare to counter in an effective way the threats to health, whether known or unforeseen, and health professionals and the public would be deprived of key information concerning health and health services.

- Choice of ways and means

The actions to be implemented under the programme have been so designed as to have tangible aims and measurable outputs benefiting all the Member States and they will yield added value in a number of ways:

* They would lead to the setting up of sustainable procedures and structures, in particular networks, and the production of data and information necessary for the assessment of Community policies and activities;

* They will foster and underpin policy formulation at Member State and Community level and may lead to the preparation of legislative instruments;

* They would support activities that expand and consolidate efforts already undertaken by Member States;

* They would enable the production of reports and the conduct of analysis on a unique and large scale and quality in the Community.

- advantages over possible alternatives (comparative advantages)

The programme provides enough flexibility through the drawing-up of annual work plans to allow deployment of resources and adaptation of activities to address emerging priorities, unanticipated events, and adjustments in the form of outputs, while respecting the fundamental criteria of selecting and ordering priorities according to the magnitude of risk or potential of effect, public concerns, availability of instruments and methods for effective intervention and response or potential for their development, subsidiarity and added value, and likely impact on other sectors. The action programmes undertaken in the past suffered from a lack of flexibility to handle new or re-emerging threats and could not allow the re-deployment of resources.

9.3 Monitoring and evaluation of the operation

- Performance indicators selected

*output indicators (measurement of resources employed and efficiency)

The programme provides for quantifiable deliverables, annual work plans and on-going monitoring of actions undertaken using as indicators the number and quality of networks to be established, guidelines and reports to be issued, ad hoc surveys on health status, health systems and public perceptions, effectiveness of strategies and quality of information, and up-take, emulation and multiplier effects in Member States by competent authorities and local groups and associations.

*impact indicators (measurement of performance against objectives)

The programme is subject to evaluation, especially on performance, including effectiveness against objectives for each of the action involved, by Commission staff and by independent experts using direct, i.e. health-related indicators and indirect measurements (e.g. setting-up and proper operation of mechanisms and procedures for health improvement).

- Details and frequency of planned evaluations

The Commission submits evaluation reports mid-way and at the end of the programme in which the effectiveness and added value of the actions will be evaluated.

- Assessment of the results obtained (where the operation is to be continued or renewed)

In the light of the evaluations mentioned above, the Commission may propose an extension of the programme, if appropriate.

10. Administrative expenditure (Section III, Part A of the budget)

Actual mobilisation of the necessary administrative resources will depend on the Commission's annual decision on the allocation of resources, taking into account the number of staff and additional amounts authorised by the budgetary authority.

10.1 Effect on the number of posts

>TABLE POSITION>

If additional resources are required, indicate the pace at which they will have to be made available.

10.2 Overall financial impact of additional human resources

No resources additional to those existing in the Directorate are envisaged.

EUR

>TABLE POSITION>

The amounts given must express the total cost of additional posts for the entire duration of the operation, if this duration is predetermined, or for 12 months if it is indefinite.

10.3 Increase in other administrative expenditure as a result of the operation

No increase in other administrative expenditure is envisaged.

EUR

>TABLE POSITION>

The amounts given must correspond to total expenditure arising from the operation if its duration is predetermined or expenditure for 12 months if it is indefinite.

IMPACT ASSESSMENT FORM THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE TO SMALL AND MEDIUM-SIZED ENTERPRISES (SMEs)

Title of proposal

Proposal for a Decision of the European Parliament and of the Council adopting a programme of Community action in the field of public health

Document reference number

The proposal

1. Taking account of the principle of subsidiarity, why is Community legislation necessary in this area and what are its main aims-

In accordance with Article 152 of the EC Treaty, the Commission is presenting this proposal for a programme of incentive measures for adoption by the European Parliament and the Council. The overall aim of the programme is to make a contribution towards the attainment of a high-level of health protection by directing action towards improving public health, preventing human illness and diseases and obviating sources of danger to health. The objectives of the programme cannot be sufficiently accomplished by the Member States because of the complexity, trans-national character and lack of complete control at Member State level over the factors affecting health status and health systems.

The impact on business

2. Who will be affected by the proposal-

There will be no effects on business by this proposal. The programme provides for the financing of actions encouraging cooperation between Member States, promoting coordination of their policies and programmes, promoting the exchange of information on health status and health determinants, and the sharing of experience on strategies to counter threats to health and prevent disease.

3. What will business have to do to comply with the proposal-

There are no requirements placed on business.

4. What economic effects is the proposal likely to have-

There are no economic effects on employment, investment and the creation of new business or on the competitiveness of business by this proposal.

5. Does the proposal contain measures to take account of the specific situation of small and medium-sized firms (reduced or different requirements etc)-

As there are no effects on business, there is no need for such measures.

Consultation

6. List the organisations that have been consulted about the proposal and outline their main views.

No organisation has been consulted about this proposal. The proposal forms part of the Commission strategy on health on which there is consensus among, and support from, all Community Institutions, following an in-depth debate launched by the Commission with its communication COM(1998) 230 of 15 April 1998, and has benefited from the advice of the High-level Committee on Health.