OPINION OF THE COMMISSION pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's Common Position regarding the proposal for a DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL adopting a programme of Community action in the field of public health AMENDING THE PROPOSAL OF THE COMMISSION pursuant to Article 250 (2) of the EC Treaty

1. Introduction

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is to deliver an opinion on the amendments proposed by the European Parliament at second reading. The Commission sets out its opinion below on the 50 amendments adopted by Parliament.

2. Background

On 15 June 2000, the Commission submitted to the Council and to the European Parliament a proposal based on Article 152 of the EC Treaty for a Decision of the European Parliament and of the Council adopting a programme of Community action in the field of public health - COM(2000)285 final of 16 May 2000 - COD 2000/0119.

The Economic and Social Committee and the Committee of the Regions delivered their opinions on 20 November and 14 December 2000 respectively.

On 4 April 2001, the European Parliament delivered a first opinion on the Commission proposal and adopted a report with 110 amendments.

On 1 June 2001, having examined the amendments proposed by the European Parliament, the Commission adopted a modified proposal in accordance with Article 250 of the EC Treaty.

At its meeting on 31 July 2001, the Council adopted its Common Position in accordance with Article 251 of the EC Treaty.

The Commission delivered its opinion on the Common Position on 14 August 2001.

On 12 December 2001, the European Parliament adopted its second reading legislative resolution, including 50 amendments to the Common Position of the Council.

3. objective of the commission's proposal

The proposal is for a decision of the European Parliament and of the Council on a programme of Community action in the field of public health. It forms part of the European Community's Health Strategy, as set out in the Commission's communication of 16 May 2000. The proposed programme takes a horizontal and policy-driven approach. It focuses on three strands of action:

1. Improving health information and knowledge

A comprehensive health information system will be put in place which will provide policy makers, health professionals and the general public with the key health data and information that they need.

2. Responding rapidly to health threats

An effective rapid response capability will be created to deal with threats to public health, for example, arising from communicable diseases.

3. Addressing health determinants

The programme will help to improve the health status of the population and reduce premature deaths in the EU by tackling the determinants of health through health promotion and disease prevention measures.

4. Opinion of the Commission on the amendments by the European Parliament

As the second reading report of the European Parliament is based on the Common Position, the Commission amends its proposal also on the basis of the Common Position.

Moreover, the Commission is also taking the opportunity to

* put forward a revised financial sheet for the programme which takes account of the changes introduced by the Council and the European Parliament, especially in regard to putting in place appropriate structural arrangements to ensuring effective co-ordination and monitoring; and

* make a technical modification to clarify in Annex 4.1 of the Common Position that Community assistance can be provided to support the activities referred to in Article 3, and not just those described in Article 3.2.(a) which concern only the monitoring and rapid reaction systems.

In the following paragraphs detailed comments are given on each of the amendments.

4.1. Amendments fully accepted by the Commission

* Amendment n° 11 on Recital 15b (new) underlines the importance of education, training and networking. Such a contribution could be of value to support co-operation between Member States, and the amendment can therefore be accepted.

* Amendment n° 4 on Recital 10. This amendment underlines the need for effective public health monitoring at Community level and thus reinforces the need to set up a health monitoring system. It can thus be accepted by the Commission.

* Amendment n° 5 on Recital 10a refers to the need to co-ordinate actions taken by the Community and the Member States and to promote co-operation between Member States. This is acceptable as such co-ordination and co-operation are necessary for effective public health activities at Community level.

* Amendment n° 8 on Recital 13 refers to the necessity to ensure the effectiveness and cohesion of measures and actions through 'appropriate structural arrangements'. Such arrangements are needed to strengthen the Commission's capacities to implement and co-ordinate actions under the programme. The amendment is therefore acceptable.

* Amendment n° 12 on Recital 16 refers to the link to be established with "all Community policies having an impact on health", and Amendment n° 40 on Article 11a (new) refers to co-operation with other Community bodies, especially those responsible for food and feed safety, environmental protection and product safety. These amendments are acceptable in the framework of developing an integrated, intersectoral strategy.

* Amendment n° 14 on Recital 18 mentions the impact of transnational factors on health systems and adds environmental pollution and food contamination to examples of threats of a cross-border nature. These are factual considerations, and the amendment is acceptable to the Commission.

* Amendment n° 15 on Recital 20a (new) refers to the comparability and compatibility of data as well as to the interoperability of systems. This amendment is acceptable, as these characteristics are appropriate to a comprehensive European health information system.

* Amendment n° 16 on Recital 21a (new) refers to the 2000 Feira European Council which endorsed the eEurope 2002 Action Plan. This is acceptable, since it underlines the need for further action in this field which has been identified as a priority in the Annex to the Common Position.

* Amendment n° 17 on Recital 22 refers to the need to develop gender-specific statistics. This is a useful specification and thus acceptable for the Commission, but the text of this amendment should be added to Recital 10 on the processing of data.

* Amendment n° 19 on Recital 28 calls for the budget of the programme to be in accordance with the needs of the programme. This is acceptable since the resources for the implementation of the programme should be adequate for the objectives to be pursued. For the same reason the Commission can accept Amendment n° 20 on Recital 30, which calls for a fair allocation of the budget between the three objectives of the programme.

* Amendment n° 21 on Recital 30a (new) underlines the importance of "practical measures" in order to attain the objectives of the programme. This corresponds to the approach being taken which stresses the need to achieve concrete results and outcomes. This amendment is therefore acceptable to the Commission.

* Amendment n° 22 on Recital 37 mentions that the programme must build upon the work of the network for epidemiological surveillance and control of communicable diseases in the Community. This network will continue to pursue its activities on the basis of Decision N° 2119/98/EC which will continue in force. The amendment is therefore acceptable to the Commission insofar as it clarifies that the work of this network must be taken into account.

* Amendment n° 24 on Article 2 (2), which puts an emphasis on health determinants and n° 33 on Article 3.2. (db) (new), which mentions activities of non-profit, non-governmental European organisations, incorporate useful clarifications, and are acceptable to the Commission.

* Amendment n° 38 on Article 8.1(e) deletes the provision in the Common Position for the Programme Committee to be consulted on 'the arrangements for the preparation of any structural arrangements'. This is acceptable since the preparatory work for the establishment of the structural arrangements is the responsibility of the Commission in the context of the exercise of its executive powers under the Treaty.

* Amendment n° 39 on Article 11 adds the W.T.O. and FAO to the list of international organisations with which co-operation shall be encouraged. This is acceptable to the Commission, since both bodies deal with issues having an impact on health.

* Amendment n° 45 on Annex 1.7b calls for a joint action to improve information on medicines available on the Internet and for considering possibilities for a system of Community seals of approval for Internet sites. Developing these activities at Community level is a useful way to contribute to the co-operation between Member States for the provision of sound information for the Community population, as underlined in the Common Position. The Commission can therefore accept this amendment.

* Amendment n° 47 on Annex 2.3 refers to developing a vaccination and immunisation strategy. The Commission accepts this amendment as strengthening the overall Community strategy on public health, particularly in support of Member States' actions in preparedness and alert mechanisms.

* Amendment n° 48 on Annex 2.3a (new) covers health threats caused by unforeseen events, including terrorist acts. The Commission welcomes this in the context of the strengthening of the Community rapid response capability.

* Amendment n° 51 on Annex 3.1.adds physical activity to the list of life-style determinants of health. Amendment n° 53 on Annex 3.3. strengthens activities on social and economic health determinants by focussing on inequalities in access to health and on the assessment of the impact of social and economic factors. These additions reinforce the action to be taken on health determinants and are therefore acceptable.

* Amendment n° 60 on Annex 2.6a (new) refers to the development of strategies for reducing antibiotic resistance. The Commission accepts this amendment as strengthening the overall Community public health strategy in an area of particular concern to all Member States.

4.2. Amendments partly accepted by the Commission

* Amendment n° 1 on Recital 2a (new) refers to health as a priority - not a "marketable" commodity - and to the role of the Community. This statement of principle concerning the market falls outside the scope of the programme. The amendment should be reworded as: "Health should be a priority beyond political or financial compromises. Under Article 152 of the Treaty the Community is required to play an active role in this sector by taking measures which cannot be taken by individual states, in accordance with the principle of subsidiarity."

* Amendment n° 3 on Recital 9a says that the programme should contribute to establishing quality standards in the field of public health and patients' rights, such as data protection and non-discrimination. This amendment can only be accepted without the second sentence. This refers to standards governing patients rights, and there are not such generally accepted standards. Moreover such a concept would go beyond the scope of the programme.

* Amendment n° 18 on Recital 22a (new) puts emphasis on experiences acquired in the field of public health and from applicable charters. This is acceptable with a general reference to making use of experience already gained: "The experience acquired from different charters in the field of public in health should be taken into account."

* Amendment no 26 on Article 3. 1. sets out in detail activities to be taken under the three strands of the programme. The part dealing with the Community capacity to counter health threats from various sources, including terrorist acts, is fully acceptable, but this should be part of Annex 2.3.a, combined with Amendment n° 48. The third indent of the 'a' part dealing with people's right to be informed about health questions is also acceptable, but it should be added to Annex 1.3. and reworded as "promoting the right of people to have sound information on health". The other parts of this amendment are not acceptable because they essentially duplicate actions, whose operational part is described in the Annex, or activities enumerated in Article 3.2.

* Amendments n° 29 on Article 3.2.d) (4) and 55 on Annex 3.5 a (new) concern promoting education and training activities in the field of public health. This addition is acceptable, but it should be reworded to take into account the subsidiarity principle: "Encouraging education and vocational training in the field of public health."

* Amendment n° 31 on Article 3.2. (d) (ba) (new) refers to the definition of good practice and sound guidelines for health. This part of the amendment is acceptable as it lends support to Member States' activities in this field. However the second part of this amendment concerning quality guidelines for medicine based on scientific data cannot be accepted by the Commission, since this concerns other policies or programmes.

* Amendment n° 32 on Article 3.2. (da) (new) refers to the promotion of an integrated health strategy by creating links between the public health framework and other policies and establishing criteria and methodologies for health impact assessment. The first part of this amendment is not acceptable, since it duplicates Article 2. 3(a). The second part is acceptable but should be incorporated in Article 4 " ---the objectives of the programme may be implemented as joint strategies and joint actions to create links ---- " The third part is unacceptable as it duplicates Annex 1.5.

* Amendment n° 54 on Annex 3.3. focuses on environmental pollution. The amendment is acceptable subject to some rewording to clarify the scope of action to be taken under the programme, such as, "Analysing the situation and developing strategies on health determinants related to the environment and contributing to the identification and assessment of the health consequences of environmental problems."

4.3. Amendments rejected by the Commission

There are 17 amendments that the Commission can not accept: 6, 7, 9, 10, 23, 27, 28, 34, 35, 36, 41, 43, 46, 50, 52, 56 and 57.

* Amendments n° 6 on recital 11, 34 on Article 5.2 and 57 on Annex 4.3.a (new) state that the Commission shall, within one year, take the preparatory measures to put in place structural measures. Amendments 34 and 57 require the Commission in addition to set up a co-ordinating centre. These three amendments are not acceptable to the Commission. A provision concerning the creation of a specific centre cannot be included in a Decision establishing an action programme. Moreover it is up to the Commission to determine its own internal structure and the timing of any measures in conformity with Article 218 of the EC Treaty.

* Amendment n° 7 on recital 11a(new) introduces new objectives for the structural arrangements, which go beyond the scope of the co-ordination of activities foreseen. It is therefore not acceptable to the Commission.

* Amendments n° 9 on recital 13a(new), calling for the consultation of NGOs through health fora; n° 10 on recital 15a (new) which mentions the three general objectives of the programme; and n° 28 on Article 3.2(d)(1) which refers to the need to break down data by gender, age, geographical location and income bracket are not acceptable as they duplicate existing provisions of the Common Position (recital 17, Article 2.2, and Annex 1.1. and 1.7.). For the same reason, the Commission cannot accept the following amendments: n° 23 on Article 2(1) which introduces a number of detailed objectives into the operational part of the programme, duplicating parts of recitals 1, 9 and 15 of the Common Position; n° 35 on Article 5(4) a (new) on the protection of personal data, which duplicates part of recital 23; and Amendment n° 43 on Annex 1.5. on the impact of the development of an integrated and intersectoral health strategy which duplicates parts of recital 16 and Articles 2 and 3.

* Amendment n° 27 on Article 3.2.b refers to the development and implementation of health promotion and disease prevention in all Community policies involving ("as appropriate" deleted) NGOs, national organisations, institutions and activities. The Commission cannot accept this amendment. It duplicates parts of Articles 2.3 (a) and 4. Moreover, it removes the necessary flexibility in the choice of the most relevant partners for actions.

* Amendment n° 36 on Article 7.1. sets the financial framework for the implementation of the programme at EUR380 million, with each specific objective receiving a minimum of 25% of the budget. This amendment is unacceptable to the Commission. The imposition of a percentage to be spent on each objective removes the flexibility necessary for the programme. With regard to the total budget, the Commission maintains its proposal of EUR300 million. However, in view of the need to ensure adequate resources for the appropriate structural arrangements, requested by the Council and the European Parliament, the Commission is presenting a revised financial sheet, with an increase in expenditure for technical and administrative assistance.

* Amendment n° 41 on Article 12.1. is not acceptable to the Commission, since to report annually to the European Parliament on the implementation of the actions goes beyond the comitology requirements.

* Amendment n° 46 on Annex 2.2a(new) refers to informing the public in Member States and accession countries on communicable diseases, in particular resistant pathogens; Amendment n° 50 on Annex 2.6a introduces activities to assist applicant countries, e.g. by educating doctors; and Amendment n° 52 on Annex 3.1a(new) refers to campaigns to improve diet and eating habits. These amendments all raise subsidiarity issues and are not acceptable to the Commission.

* Amendment n° 56 on Annex 4.1.5 sets limits concerning the financial implementation of the programme. This is unacceptable since these restrictions would undermine the flexibility necessary to implement the programme.

5. Conclusion

The Commission is in favour of 33 amendments (9 in part) to the Common Position, out of the 50 voted by the European Parliament.

Pursuant to Article 250(2) of the EC Treaty, the Commission amends its proposal as set out above.

LEGISLATIVE FINANCIAL STATEMENT

Policy area: Public Health

Activity: PROGRAMME OF COMMUNITY ACTION

Title of action: proposal for a decision of the European Parliament and of the Council adopting a programme of Community action in the field of Public Health

1. BUDGET LINE(S) + HEADING(S)

B3-4308 and B3-4308A

2. OVERALL FIGURES

2.1. Total allocation for action (Part B): 300 EUR million for commitment

2.2. Period of application:

2002-2007

2.3. Overall multi-annual estimate on expenditure:

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

a) Schedule of commitment appropriations/payment appropriations (financial intervention) (see point 6.1.1)

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b) Technical and administrative assistance and support expenditure (see point 6.1.2)

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c) Overall financial impact of human resources and other administrative expenditure (see points 7.2 and 7.3)

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2.4. Compatibility with the financial programming and the financial perspective

|X| Proposal compatible with the existing financial programming

| | This proposal will entail reprogramming of the relevant heading in the financial perspective

| | This may entail application of the provisions of the Inter-institutional Agreement.

2.5. Financial impact on revenue:

|X|No financial implications (involves technical aspects regarding implementation of a measure)

OR

| | Financial impact - the effect on revenue is as follows:

3. BUDGET CHARACTERISTICS

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(1) Under the new framework set out in COM (99) 710, Candidate country (CC) participation in the programme is subject to a memorandum of understanding determining the terms and conditions for participation. The Commission will negotiate such a memorandum with each CC wishing to participate in the programme.

4. Legal basis :

Art. 152 of the Treaty establishing the European Community

5. DESCRIPTION AND GROUNDS

5.1. Need for Community intervention

5.1.1. Objectives pursued

The objective of the decision is to establish a programme of action, 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.

The general objectives of the programme are:

* To improve information and knowledge for the development of public health

* To enhance the capability to respond rapidly and in a co-ordinated fashion to threats to health

* To promote health and prevent disease through action on health determinants and across all policies and activities

5.1.2. Measures taken in connection with ex ante evaluation

The ex ante evaluation was conducted in February/March 2000 by the evaluation cellule of DG Health and Consumer Protection, supported by two independent consultants. The evaluation report examined the existing eight programmes and the four mid-term evaluations carried out so as to assess the modifications and recommendations proposed in the evaluations and their links to the new programme. Finally, it examined the new draft programme and other documentation connected with it. Following the ex ante evaluation the proposal was substantially modified to make more explicit that the lessons learned from past interventions and approaches had been taken into account, and to respond to the need that had been identified in the evaluation to define more precisely the main priorities; to ensure that the way that the programme resources were divided up clearly matched the actions and objectives; and to strengthen planning and control mechanisms.

5.1.3. Measures taken following monitoring and evaluation

As is set out in Article 12 of the Common Position, in order to ensure the effectiveness of the programme there will be regular monitoring of its implementation in light of the objectives, and annual reports will be made to the Committee. After four years there will also be an external assessment of the programme by independentexperts. It will be possible to adjust or modify the programme's priority in the light of the monitoring and of developments that may take place in the general context of Community action in health and health-related fields.

5.2. Actions envisaged and arrangements for budget intervention

The 18 action areas are set out in Table 6.1.1. The actions will be pursued by means of a range of specific activities which will give rise to quantifiable outputs. These include setting up and operating networks; operation of structural arrangements; development of innovative or pilot projects; support for preparation of legislative instruments; development of tools for health impact assessment; preparation of reports, reviews and analyses; operation of consultation fora; and development of machinery for dissemination of information.

Financial support shall be given to those activities, as set out in the annex to the programme decision.

The Common Position of the Council and the amendments of the European Parliament both add to the actions originally proposed for the programme in pursuit of the objectives. In particular they specify that in view of the need to ensure that there is a properly co-ordinated EU response, especially in regard to monitoring of health and responding rapidly to health threats, a significant amount of the efforts of the programme must be put into the co-ordination of the activities to be undertaken by the Community and the Member States.

The programme must therefore ensure appropriate sustainable co-ordination of the actions to be taken. In the area of health monitoring this encompasses activities in relation to the following: definition of information needs, development of indicators, collection of data and information, comparability issues, exchange of data and information with and between Member States, continuing development of databases, analyses, and wider dissemination of information. Quantifiable outputs will be produced, in relation for example to provision of improved information on the health status of the overall EU population, as well as specific analyses by population group; health determinants, including the principal social, economic and environmental determinants; and health policies being pursued in key areas.

In the area of rapid reaction to health threats, such co-ordination should be ensured in respect of activities in relation to epidemiological surveillance, development of surveillance methods, exchange of information on guidelines and on prevention and control actions, mechanisms and procedures. Quantifiable outputs will concern for example common investigations, training, assessment and quality assurance (for the Community network on the epidemiological surveillance and control of communicable diseases), exchanges of information, and operation of vigilance networks...

The requirement for effective EU coordination has been reinforced by the conclusions of the European Council in Göteborg on 15-16 June 2001 on the need to undertake urgent action to establish an EU response capacity which can react rapidly to health threats, and the declaration by Heads of State and Government at Ghent on 19 October 2001 on health threats from the deliberate use of biological, chemical and other means. In this context, the Commission committed itself to put in place by 2005 an appropriately financed and effective facility, in order to analyse and provide scientific guidance on actions to be taken at Community level.

Appropriate structural arrangements will therefore be established to ensure the effectiveness and cohesion of measures and actions of the programme as well as the promotion of co-operation between the Member States. The structural arrangements to be used will be those that have been set out in the context of the Commission's externalisation initiative (Communication of 13 December 2000, COM (2000) 788 final).

These latter arrangements cover two kinds of functions.

Administrative and financial tasks

Technical and administrative assistance relating to ancillary tasks (such as collection of data on project implementation) and preparatory work (such as preparation of contracts). It concerns mainly the gathering and processing of factual information, following clear criteria and methods set out by the Commission and with well-defined results, (such as targets and specific deliverables) to ensure that there is no use of discretionary powers.

Scientific/Technical support

A technical role to support the implementation of the programme and provision of specialised expertise to the Commission services in relation to identifying and assessing health problems and developing and refining specific actions in response; monitoring of Community actions; and assisting in the co-ordination function, for example, concerning the work of networks.

A cost-effectiveness assessment of externalising certain elements of the public health programme will be used to support possible decisions. This assessment will involve external consultants chosen by call for tender.

5.2.1. Arrangements for budget intervention (rate and form of the required financial assistance):

- grants to finance projects (including partnerships) intended to help achieve an objective of the programme with other financing sources in the public and/or private sector. Grants will be provided to public or private bodies (such as NGOs or academic institutions) for the implementation of projects proposed in areas under the programme which produce a real added value for the European Community, such as the development of innovative approaches for tackling specific health determinants.

- operating grants for representative organisations in the health field working at EU level and pursuing an objective of general European interest, according to criteria set up in the framework of the programme's management procedure. The awarding of these grants will be more limited, and provided in conformity with the financial regulation.

- contracts following calls for tenders. Projects proposed by the various organisations in the health field must be complemented by initiatives precisely defined and directly monitored by the Commission, in particular in the field of health monitoring and rapid reaction to health threats. Appropriate technical specifications will be defined to buy specific services.

These arrangements for budget intervention and the externalisation of tasks will be done in accordance with the relevant provisions of the financial regulation applicable to the general budget of the European Communities.

5.3. Methods of implementation

Direct management by the Commission using either permanent or temporary staff and by externalisation which includes several possibilities (outsourcing to private sector, delegating to national public bodies and executive agencies). The arrangements envisaged for this externalisation are in the first instance outsourcing of technical and administrative assistance to private law entities.

This delegation of part of the management of the public health programme will exclude tasks involving the exercise of discretionary powers or those appropriate to a public authority. It will make use of specialised staff for implementing work programmes, undertaking analyses and studies and executing support activities while keeping political orientations, decisions and control within the Commission services.

The profiles of the specialist staff to be used include epidemiologists, microbiologists, public health specialists, rapid reaction specialists, IT specialists and social scientists.

In the medium-term, once the necessary legal base is available, the aim is to set up an executive agency in charge of the co-ordination and integration of networks for health monitoring and rapid response to health threats (Common Position Art. 5.2).

Structural arrangements require a certain capacity to carry out tasks effectively. The necessary resources will be made available for them out of the total budget for the programme. The Commission has made an estimation of the tasks required and corresponding resources needed. This is set out in table 6.1.2. The initial assessment shows that the global cost required could be of the order of EUR15.3 Million over the period of the programme. A study using outside consultants is being launched to refine this calculation.

The funding for establishing and operating these structural arrangements, initially by way of outsourcing of technical and administrative assistance, will necessarily mean some reduction in the amount available for spending on the operational budget. Therefore the Commission has had to reconsider the amount to be spent on each of the three strands of the programme. In doing so, the Commission has taken into account the need to ensure that:

- there is a fair distribution of the budget between the strands;

- an appropriate response is given to the requests of the European Council to strengthen actions in regard to communicable diseases and health threats;

- the wishes of EP and Council concerning the prioritisation of actions under the programme are reflected

6. FINANCIAL IMPACT

6.1. Total financial impact on Part B - (over the entire programming period)

6.1.1. Financial intervention

EUR million (at current prices)

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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.

6.1.2. Technical and administrative assistance, support expenditure and IT expenditure (Commitment appropriations)

Commitments in EUR million

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6.2. Calculation of costs by measure envisaged in Part B (over the entire programming period)

Details concerning calculation of costs by measures over the entire period will be defined in the light of the annual work plans to be adopted under the programme, which will specify for each of the 18 actions described in table 6.1 the type of outputs, and an estimation of their number.

The Common Position (see Article 8) 1.a)) explicitly foresees that the annual plan of work shall be adopted in accordance with the management procedure, "setting out priorities and actions to be undertaken, including allocation of resources".

To assist the programme Committee in giving its opinion on the annual work plans and measures to be taken, the Commission services are developing a number of planning tools to be used for the implementation of the programme. These will help to set each year's work plan in the context of the development of the work of the programme as a whole, and show how individual activities link with other to constitute the programme's actions and enable the overall objectives to be reached.

The tools include:

- for each strand of action, identification of concrete outputs to be achieved, a) by the time of the initial evaluation of the programme after four years and b) by the end of the programme;

- for each strand of action, a series of milestones to be reached during the period of implementation, with indicative dates for achievement. These may include specific networks to be established, step by step development of the structural arrangements, relevant legislative instruments, etc; and

- an instrument to manage actions, timetabling and financial planning.

On the basis of these tools, detailed proposals will be drawn up for specific activities under the actions of the programme for each year, including costs and recommended financial means which will be incorporated in the annual work programmes to be considered by the Committee.

A schedule of the indicative costs for each of the 18 actions of the programme by year is given in table 6.1.1.

7. IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE

7.1. Impact on human resources

- 2002

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1) - policy conception, formulation and development, including establishment of annual work programmes- policy and budget implementation, including definition of technical specifications, approval of applications for funding, selection of contractors - policy evaluation in conformity with the legal base

- 2003 - 2007

The following table indicates changes foreseen in resources in the subsequent years of the programme.

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These indicative changes are based on an initial assessment of the potential resource implications of the programme over the first four years. In addition, there will be a mid -term evaluation which inter alia will look at resource aspects (cf Article 12 of the Common Position). The entry of candidate countries into the EU will also need to be reflected in the resources available for the programme in its later years.

7.2. Overall financial impact of human resources (2002)

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* The amounts are total expenditure for twelve months. For years n+(x) : [(increase of permanent staff x 108 800) + 8 926 000] (see table 7.4)

7.3. Other administrative expenditure deriving from the action

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* The amounts are total expenditure for twelve months. For years n+(x) : - Missions : [increase of permanent staff x (330 000 / total staff) + 330 000] see table 7.4 - Meetings/Conferences/Information systems : The indicative amounts are stable.

7.4. Total cost of action for the 6 years (EUR million)

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The need for human and administrative resources will be covered within the allocation granted to the managing dg in the framework of the annual allocation procedures.

8. FOLLOW-UP AND EVALUATION

8.1. Follow-up arrangements

Adequate follow-up information will be collected, from the outset of each action, on the inputs, outputs and results of the intervention. In practice this means i.) Identification of indicators for inputs, outputs and results ii.) Putting in place methods for the collection of data. See point 8.2.

8.2. Arrangements and schedule for the planned evaluation

Performance indicators selected

*output indicators (measurement of resources employed and efficiency)

The programme provides for annual work plans which will determine quantifiable deliverables, and on-going monitoring of actions will be undertaken. Relevant indicators will include reports and analyses undertaken, development of guidelines and establishment of effective networks, together with up-take and multiplier effects in Member States by competent authorities and local groups and associations.

*impact indicators (measurement of performance against objectives)

The impact and performance of the programme, including effectiveness against objectives of the actions, will be subject to detailed evaluation arrangement, using direct, i.e. health-related indicators and indirect measurements (e.g. setting up and proper operation of mechanisms and procedures for health monitoring and rapid response).

Specific indicators will be included in the contractual framework to be developed for outsourcing arrangements.

To facilitate the evaluation process, measurable quantitative and qualitative benchmarks are being identified for the three strands of the programme. These will be finalised before the programme comes into effect so that they are available for the development of the annual work plans and the establishment of the monitoring process, the assessments and the evaluations foreseen in Article 12. 1 and 12. 3 of the Common Position.

In addition these benchmarks will be used in relation to the submission of information by the Member States to the Commission on the implementation and impact of the programme (see Art 12. 2 of the Common Position).

Details and frequency of planned evaluations

The Commission will have an external assessment of the implementation and achievements during the four first years of the programme. It will also assess the impact achieved on health and the efficiency of the use of resources, as well as consistency and complementarity with other Community programmes and initiatives. The Commission will communicate these conclusions with its comments, to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions. The Commission will also submit to them a final report on the implementation of the programme. The evaluation reports will be made publicly available.

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.

9. ANTI-FRAUD 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. Specific rules governing the characteristics and monitoring of outsourcing contracts will be implemented, following the Commission guide and model contract.

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

All measures will take account of Article 3(4) of the financial regulation, as well as SANCO international audit recommendations, in conformity with the International Control Standards of the Commission, including the UCLAF «Guide to testing for vulnerability to fraud » of 18.4.1997.

- 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 of service contracts, the Commission will regularly monitor that the contractors comply with the rules laid down in the contracts. 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 Office.