Amended 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 pursuant to Article 250(2) of the EC-Treaty)

EXPLANATORY MEMORANDUM

1. Background

In May 2000 the Commission put forward a communication on the health strategy of the European Community together with a proposal for a Decision of the European Parliament and the Council adopting a programme of Community action in the field of public health (2001-2006) - COM(2000)285 final of 16 May 2000 - 2000/0119 (COD). This new programme is intended to replace the eight existing action programmes in the field of public health.

On 4 April 2001, the European Parliament adopted a large number of amendments at its first reading. The Commission gave its opinion on each amendment, indicating which amendments it could accept in full or in part and which amendments could not be included. In the light of these developments, the Commission has drafted this amended proposal.

2. Purpose of the proposal

The proposal for a Decision 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 on the basis of a broad view of public health. The programme is intended to underpin and support policy development at Community level.

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 the key health data and information that they need.

(2) Responding rapidly to health threats

An effective rapid response capability will be put in place to deal with threats to public health, for example, arising from communicable diseases. The integration of the EU based on the principle of free movement increases the need for vigilance.

(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 underlying causes of ill health, through effective health promotion and disease prevention measures.

3. Amendments

The Commission has made a number of amendments to its original proposal. These are intended either to remove ambiguities from the original proposal, or to introduce new ideas which expand on the original text but do not change it fundamentally. The Commission has also made some minor editorial revisions to make the text clearer. These amendments also take account of the discussions in the other Institutions.

The main amendments to the original proposal can be grouped in several distinct categories reflecting key concerns of the European Parliament:

First: developing an integrated and coherent approach to health is a primary objective of the Community's health strategy. The Commission has therefore taken account of the Parliament's amendments 3, 24, 52, 53, 58 and 106 which aim to give more emphasis to this aspect of the programme's work by incorporating in the proposal more detailed wording on health impact assessment and related issues (Art. 2(1), Art. 3(1)a and Annex 1.2, fourth objective). However the Commission does not consider that establishing a totally separate strand of action in this area is consistent with its overall approach. It has therefore included a new, fourth objective on contributing to achieving an integrated health strategy, in the strand of action on health information.

Second: on the scope of the programme, the Commission has accepted those of the European Parliament's amendments which are in line with the general orientation of the programme (Art. 2, 3 and the annex). While fully respecting the principle of subsidiarity and the responsibilities of the Member States for the organisation and delivery of health services and medical care, the programme takes a broad view of public health which encompasses issues in relation to health determinants, health status and health systems, rather than focusing on specific diseases or conditions. In this context, it aims to improve health information, combat threats to health such as communicable diseases and tackle the factors underlying disease.

Some of the European Parliament's amendments which have been taken on by the Commission underline the programme's main thrust and clarify its role in addressing relevant and important issues, such as developing best practice and strategies on specific health-related areas and interventions (e.g. amendments 8, 14, 20, 22, 43, 51, 55, 61, 79, 80, 81, 87, 96, 101).

Third: the programme is intended to ensure that Community added value is maximised. The Commission has introduced a number of amendments concerning the implementation of the programme designed to achieve this objective. During the discussions with the European Parliament and the Council, it has become clear that there is a need to describe in more detail the way the programme is to be implemented. While the Commission cannot accept the inclusion of a reference to a specific, identified 'centre' or 'structure', it agrees that it is essential to ensure that the important new tasks to be performed in relation to developing a health information system and strengthening surveillance actions are properly co-ordinated and that networks established work together in an integrated fashion. The Commission is therefore proposing to include a number of specific references to appropriate structural arrangements which will be put in place to undertake the necessary technical and co-ordination work on health monitoring and disease surveillance (Recital 13, Art. 6). This will ensure that the essential technical and analytical expertise, closely involving the Member States, will be available.

These changes take account of a number of the European Parliament's amendments, such as 11, 49, 50 and 54.

Fourth: the Commission's original proposal foresaw that the programme should have an advisory committee. Following discussions in the Parliament and in the Council on the issue of comitology, the Commission has now taken up the European Parliament's amendments to introduce a mixed management/advisory committee (Art. 9 and 10) as this follows the precedents of existing public health programmes and is in line with Article 2 of Council Decision 1999/468/EC.

The Commission is, however, proposing a revised distribution of tasks between the management and the advisory modes of the Committee. This is intended to establish an effective balance between the need to ensure that the Committee can play an effective role in implementing the programme and the need to avoid creating unnecessary bureaucratic procedures (amendments 42, 73 and 74).

Finally: on financial issues the Commission has decided, in response to the European Parliament's amendment 103, to raise the maximum percentage of a project's costs that can be covered by a subvention to 70% (Annex 4.1). However, the Commission proposes that the overall programme budget should stay at 300MEUR which is in line with the mid-term Financial Perspective.

2000/0119(COD)

Amended 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)

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:

(1) The Community is committed to promoting and improving health, reducing avoidable morbidity and premature mortality and activity-impairing disability, preventing disease, and countering potential threats to health. The Community must address in a co-ordinated and coherent way the concerns of its people about risks to health and their expectations for a high-level of gender-specific 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. The Community should take into account people's right to receive simple, clear and scientifically sound information about their illnesses, available treatment and ways of improving their quality of life.

(2) 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.

(3) 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.

(4) In the context of Community action in the field of public health, 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 [14] was adopted.

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

(5) Other activities in the context of the public health framework included the Council Recommendation 98/463/EC 29 June 1998 [15] on the suitability of blood and plasma donors and the screening of donated blood in the European Community and Recommendation 1999/519/EC of12 July 1999 on the limitation of exposure of the general public to electromagnetic fields 0 Hz to 300 GHz [16].

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

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

(6) 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.

(7) 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 health information, reacting rapidly to health threats and tackling health determinants, underpinned by inter-sectoral action and the use of all appropriate Treaty instruments. In this respect, it is essential to have objective, reliable and comparable information to enable rigorous monitoring to be carried out in the field of health at Community level; since mechanisms for providing this type of information already exist in the Member States and in the Community, it is necessary to ensure a high level of co-ordination between actions and initiatives at European level, to promote co-operation between Member States and to ensure the effectiveness of existing and future networks in the field of public health.

[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.

(8) The major burdens of disease in Europe are neuropsychiatric disorders, cardiovascular diseases, malignant neoplasms, unintentional injuries and respiratory diseases.

(9) Infectious diseases, especially sexually transmitted diseases, are becoming a threat for the health of people in Europe.

(10) In its resolution of 29 June 2000 on the follow-up to the Evora conference on health determinants [23], the Council considered that the increasing differences in health status and health outcomes between and within Member States call for renewed and co-ordinated efforts at national and Community level, welcomed the Commission's commitment to submit a proposal for a new public health programme containing a specific strand of action aimed at addressing health determinants by means of health promotion and disease prevention underpinned by intersectoral policy and agreed that there was a need to develop the appropriate knowledge-base for this and, therefore, an efficacious health monitoring system must be established for this purpose.

[23] OJ C 218, 31.7.2000, p. 8.

(11) The Council adopted unanimously a resolution on the promotion of mental health on 18 November 1999 [24].

[24] OJ C 86, 24.3.2000, p. 1.

(12) It is essential to collect, process and analyse health data at Community level in order to obtain objective, reliable and comparable information enabling the Community and the Member States to monitor public health and to take appropriate action to achieve a high level of health protection, evaluate its results and facilitate public information.

(13) The Community and the Member States have at their disposal certain means and mechanisms in relation to information and surveillance; it is therefore essential to co-ordinate the measures and actions taken by the Community and the Member States to implement the programme.

(14) It is essential that the Commission, through appropriate structural arrangements, ensures the effectiveness and cohesion of measures and actions of the programme and promotes the co-operation between the Member States.

(15) The overall aim of the public health programmeis to contribute towards the attainment of a high level of physical and mental healthand well-being and greater equity in health matters throughout the Community, by directing action towards improving public health, combating morbidity and premature mortality, preventing human diseases and disorders, and obviating sources of danger to health, while taking gender and age into consideration. To fulfil this aim, action should be guided by the need to 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 taking into account the regional dimension, thus reducing health inequalities;

(16) The general objectives of the programme shall be

- to improve information and knowledge for the development of public health

- to enhance the capability of responding rapidly to threats to health

- to address health determinants

(17) In order to achieve these objectives, the programme should take into account the importance of education and training, networking and supporting the development of centres of excellence.

(18) Achieving the overall aim, and the general objectives of the programme requires effective co-operation of the Member States, their full commitment in the implementation of Community actions, and the involvement of institutions, associations, organisations and bodies in the health field as well as the public at large. To ensure sustainability and the efficient use of existing Community investment and capacity, established Community and national networks should be used to pull together expertise and experience from Member States on effective methods for the implementation of public health interventions, quality criteria and disease prevention activities.

(19) To enable the programme to operate smoothly and effectively, it is essential to establish sustained co-operation with the health authorities of the Member States, and with bodies and non-governmental organisations active in the health sector.

(20) Data from the private sector in the field of health should also be taken into account for the completeness of the programme.

(21) The Community has opened negotiations with a number of countries with a view to accession, and the Community Institutions are in the process of considering the health impact of enlargement; the candidate countries should be actively involved in the development and implementation of the new programme.

(22) 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 and therefore the programme should support and co-ordinate the Member States' actions and measures 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 can provide significant added value to promoting health in the Community through the support of structures and programmes which enhance the capabilities of individuals, institutions, associations, organisations and bodies in the health field by facilitating the exchange of best practice and training and by providing a basis for a common analysis of the factors affecting public health. Also, the programme can have added value in the event of threats to public health of a cross-border nature, e.g. infectious diseases, environmental pollution or food contamination, to the extent that they prompt joint strategies and actions. 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.

(23) 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. The new health strategy and public health action programme should provide the opportunity to further develop the citizens' dimension of EC health policy.

(24) The programme should in this context contribute to the definition of minimum quality standards applicable to health and minimum standards governing patients' rights.

(25) In order to ensure that actions can address broad health issues and threats effectively in co-operation with other Community policies and activities the programme should provide for the possibility of undertaking joint actions with related Community programmes and actions. A proactive use of other Community policies, such as the structural funds and social policy, could influence health determinants in a positive way. A strong link should be established between EC industrial policy in areas relevant to health (such as pharmaceuticals and other medical products) and the EC strategy for public health. Measures will be taken in order to better integrate health concerns into all EC policies.

(26) In developing the measures under the programme and joint actions with relevant Community programmes and activities, it should be ensured that health requirements are incorporated into other Community policies and actions, and are underpinned by intersectoral policy to ensure a high level of human health protection in the definition and implementation of all Community policies and actions.

(27) Effective implementation of the measures and actions and the achievement of the desired impact of the programme require comparability of the data collected and the compatibility and interoperability of the systems and networks for exchanging information and data on health. It is of prime importance that information is exchanged on the basis of comparable and compatible data.

(28) In general, the measures and actions under the programme should take account of the development of new technologies and information technology applications in the health sector.

(29) In the implementation of the measures and actions under the programme and, in particular, those relating to information technology in the field of public health, overlapping should be avoided.

(30) The experience acquired from different charters in the field of public health should be taken into account.

(31) The Feira European Council in June 2000 endorsed the 'e-Europe 2002 Action Plan on An Information Society For All' which under Health Online urges Member States to develop an infrastructure of user-friendly, validated and interoperable systems for health education, disease prevention and medical care, it is essential, that the new information technology is harnessed to empower European citizens to play an active role in managing their health, and to improve overall quality of health care while at the same time ensuring equity in health information.

(32) 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. A breakdown by gender should be made of all relevant statistics.

(33) In the implementation of the programme, all relevant legal provisions in the field of data protection must be respected.

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

(35) It is essential that the Commission should ensure implementation of the programme in close co-operation with the Member States. In order to obtain scientific information and advice to implement the programme, co-operation with high-level committees of scientists and experts of international standing is desirable.

(36) In order to increase efficiency, consultation with NGOs will be organised through health fora.

(37) 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.

(38) 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 [25], for the budgetary authority during the annual budgetary procedure.

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

(39) The programme creates the necessary transparency for the Community's activities in the health sector and ensures the necessary flexibility to set priorities in the light of events. This will allow the limited amount of funds available to be used sensibly and in a targeted manner.

(40) Practical actions are essential in order to attain the objectives of the programme. Consequently, when implementing the programme and earmarking resources under it, the importance of practical actions has to be emphasised.

(41) 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, the outcome of evaluations, public concerns, availability of interventions or potential for their development, subsidiarity, added value and impact on other sectors.

(42) The implementing measures for this Decision should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [26].

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

(43) The Agreement on the European Economic Area (EEA Agreement) provides for greater co-operation 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. It will be necessary to involve the candidate countries in the development and implementation of the programme and also to devise a strategic approach to health in those countries, which are affected by specific problems.

(44) Co-operation with third countries and the competent international organisations in the sphere of health, such as WHO and OECD should be fostered, not only in the field of collecting and analysing data, but also in the field of intersectoral health promotion. Particular attention shall be paid to co-operation with WHO in order to ensure cost-effectiveness, avoid overlapping of activities and programmes and foster synergy and interaction.

(45) Close co-operation and consultation should be fostered with Community bodies responsible for risk assessment, monitoring and research in the fields of food and feed safety, environmental protection and product safety.

(46) In order to increase the value and impact of the programme there should be regular 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 European Parliament will receive for information the annual work plans which will be elaborated by the Commission.

(47) In order to improve the evaluation of the measures and actions under the programme and draw conclusions, the programme should be subject to independent external evaluations.

(48) The programme of Community action in the field of public health builds on the activities and the programmes under the previous framework, and on the network for epidemiological surveillance and control of communicable diseases in the Community in order to ensure a smooth transition therefrom, while adapting and expanding 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 [n] and ending on 31 December [n + 5].

Article 2

Overall aim and general objectives

1. The programme, which shall complement national policies, shall aim to contribute towards the attainment of a high level of physical and mental health and well-being and greater equity in health matters throughout the Community, by directing action towards improving public health, combating morbidity and premature mortality, preventing human diseases and disorders, and obviating sources of danger to health, while taking gender and age into consideration. The programme shall support the development of an integrated health strategy to ensure that Community policies and activities contribute to health protection and promotion.

2. The programme shall have the following general objectives:

(a) To improve information and knowledge for the development of public health, in order to optimise health status, strengthen efficient health systems, conduct effective health interventions and develop methods to tackle health inequalities. This should be done by developing and operating a well-structured and comprehensive system for collecting, monitoring, analysing, evaluating and imparting comparable and compatible health information and knowledge to all key partners and actors, by ensuring a dialogue with them, by incorporating their expertise in the development of an efficient and transparent Community knowledge-base on health, 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 co-ordinated 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 interdisciplinary health promotion activities and disease prevention actions, such as immunisation campaigns, and specific risk reduction and elimination instruments, and by means of measures to achieve equity in health.

3. The programme shall therefore assist in:

- promoting an integrated strategy in the field of public health, through the development of intersectoral policy in the definition and implementation of all Community policies and activities to ensure a high level of human health protection and promotion,

- tackling health inequalities between and within Member States,

- encouraging co-operation between the Member States on matters covered by Article 152 of the Treaty.

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 health monitoring and surveillance systems which would incorporate the work of existing Community networks in the field of public health, including the epidemiological surveillance network;

- developing and using mechanisms for analysis, advice, reporting, information and consultation on health issues in accordance with best practice, in order to identify the most appropriate public health strategies.

- promoting the right of people to be informed about their illnesses, treatments and ways of improving the quality of their lives;

- promoting an integrated health strategy through the development of intersectoral policy by developing links between the public health framework and other policies as well as criteria and methodologies for assessing policies for their impact on health.

(b) Responding rapidly to health threats, by:

- enhancing the capacity to tackle communicable diseases, notably by recommending immunisation programmes;

- strengthening the capacity to tackle gender-specific and other health threats.

(c) Addressing health determinants, by:

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

- developing strategies and measures on social and 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 11:

(a) Support for the preparation of Community legislative instruments and for co-operation 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, including data collection broken down by gender, age, geographical location and level of income, 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, such as appropriate consensus conferences and fora, involving representative organisations of patients, health professionals, NGOs in the field of health, healthcare industry, trade unions, social partners and other stakeholders. Such conferences and fora should be flexible to reflect the health area under discussion at a particular time.

(d) Support for and promotion of activities by the Community and the Member States to define and determine good practice, sound guidelines for health and quality guidelines and minimum standards based on scientific data.

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

(f) 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.

(g) 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.

(h) 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 social partners, and to innovative or pilot projects of value to all Member States with a particular focus on major health burdens.

(i) Encouraging education and vocational training in the field of public health.

(j) Support for obtaining scientific information and advice to achieve the objectives of the programme with the use of high-level scientists and experts.

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 actions and the measures of the programme may need to be implemented as joint actions with related Community programmes and actions, notably in the areas of consumer protection, social protection, health and safety at work, transport, agriculture, industry, economic and social cohesion, research and technological development, telematic interchange of data between administrations (IDA), statistics, information society and information technology (e.g. 'e-Europe'), education and environment, and with actions undertaken by the Joint Research Centre and Community agencies, such as the European Environment Agency.

Article 5

Comparability, compatibility and interoperability

The implementation of the actions and measures developed within the programme should ensure the comparability of the data and information, where possible, and the compatibility and interoperability of the systems and networks for the exchange of data and information on health.

Article 6

Implementation of the programme and co-operation with the Member States

1. The Commission shall ensure the implementation of the Community actions set out in Article 3 in close co-operation with the Member States. To this end, it shall adopt, in accordance with Article 10, measures concerning the annual plan of work and for monitoring.

2. The Commission shall ensure through appropriate structural arrangements, with which the Member States are closely associated, the co-ordination and integration of networks for health monitoring and rapid reaction to health threats.

3. The Member States shall take appropriate action to secure, nationally, the co-ordination, 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.

4. The Commission, in co-operation with the Member States, shall ensure the transition between the actions developed within the public health programmes referred to in Article 15 and those to be implemented under the programme.

Article 7

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 9.

Article 8

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 9

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, hereinafter designated "the Committee".

2. Where reference is made to this paragraph, the management procedure laid down in Article 4 of Decision 1999/468/EC shall apply, subject to the provisions of Article 7 and Article 8 thereof. The period provided for by Article 4(3) of Decision 1999/468/EC shall be two months.

3. 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 and Article 8 thereof.

4. The Committee shall draw up its rules of procedure.

Article 10

Implementation measures

1. The measures necessary for the implementation of this Decision relating to the matters referred to below shall be adopted in accordance with the management procedure referred to in Article 9, paragraph 2;

(a) the annual plan of work for the implementation of the programme, setting out priorities and actions to be undertaken, indicating the allocation of resources;

(b) the arrangements, criteria and procedures for selecting the actions of the programme;

(c) the arrangements for implementing the joint strategies and actions referred to in Article 4;

(d) the arrangements for evaluating the programme referred to in Article 14.

2. The necessary measures for the implementation of this Decision as regards other matters shall be adopted in accordance with the advisory procedure referred to in Article 9, paragraph 3.

Article 11

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 12

International co-operation

In the course of implementing the programme, co-operation 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 Co-operation and Development, and with other international organisations, such as the Food and Agriculture Organisation and the World Trade Organisation shall be fostered.

Article 13

Co-operation with relevant Community bodies

Co-operation shall be fostered with Community bodies in relevant areas of work, especially with those bodies responsible for food and feed safety, environmental protection and product safety.

Article 14

Monitoring, evaluation and dissemination of results

1. The Commission shall identify performance indicators and shall, in close co-operation with the Member States, regularly monitor, where appropriate with the support of experts, the implementation of the actions of the programme in the light of the objectives, and shall report regularly to the Committee.

2. The Commission shall undertake a mid-term evaluation of the programme in the fourth year, involving independent experts. The evaluation shall cover the impact of the programme and the efficiency of the use of resources, as well as the consistency and complementarity with relevant programmes, actions and initiatives implemented under other Community policies and activities. At the request of the Commission, Member States shall submit reports on the implementation and the impact of the programme. The Commission shall communicate the conclusions of the evaluation to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions. The Commission shall also submit to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions a final report on the implementation of the programme one year after the conclusion of the programme.

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

Article 15

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 16

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 quantitative and qualitative Community indicators for health status, diseases and health determinants, methods for the collection of data for monitoring and analysis, and create corresponding databases that are age and gender-specific

(1) Complete the framework for the stepwise establishment of gender-specific 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 interoperating means and systems 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 or Community networks:

(a) to undertake analysis and the preparation of reports on health status and on the impact of health determinants and policies including disease prevention and treatment, identify risk factors and gaps in knowledge and forecast trends for use in policy formulation, priority setting and resource allocation;

(b) to monitor and undertake analysis and provide advice on health technologies;

(c) to monitor and undertake analysis and provide advice on clinical guidelines and quality and good practice in health interventions, including recommendations for preventive measures;

(d) to monitor and undertake analysis on networks linking health service providers;

(2) 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;

(3) Develop and operate a joint action with the plans drawn up under 'e-Europe' to improve information on medicines available to the general public on the internet, reviewing sources of medical information available and examining the possibilities for establishing a system of recognisable Community seals of approval to designate sites as trustworthy.

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 best 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.

4th Objective: Contributing to achieving an integrated health strategy

(1) Identify and review opportunities for joint actions with Community programmes and agencies to develop intersectoral approaches tackling major factors influencing health;

(2) Support the development of health impact assessment methodologies and other relevant tools;

(3) Support pilot projects on the health impact of Community policies and actions.

2. Responding rapidly to health threats

2.1. Enhancing the capacity to tackle communicable diseases

1st Objective: Incorporate the work and support the further implementation of Decision 2119/98/EC on the Community network on the epidemiological surveillance and control of communicable diseases in order to take actions against diseases, including preventable 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 (e.g. AIDS) or special issues;

(b) procedures for the information, consultation and co-ordination between Member States and with the candidate countries, 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 including epidemics or pandemics of preventable diseases; links with candidate countries and other third countries;

(2) Assemble and analyse surveillance data and network inventories held in existing databases and organisations in order to identify the most appropriate public health strategies;

(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.

4th Objective: To draw a Community vaccination strategy

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 co-operation 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 social and economic health determinants

Objective: To contribute to the formulation and implementation of strategies and measures on social and 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) Develop a strategy for analysing and assessing the impact of social and economic factors (such as working and housing conditions) on health;

(4) Define and disseminate good practice on actions and policies related to social and economic determinants of health and reducing inequalities.

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;

(3) Promote the drawing up of guidelines and measures relating to the various forms of environmental pollution which have an impact on health. Analyse and develop information, prevention and protection measures to combat all forms of pollution (noise, chemical, food, etc) which affect the environment and human health;

(4) Develop strategies for reducing antibiotic resistance.

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, 70% 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 9.

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