Avis juridique important

Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008) - Commission Statements Official Journal L 271 , 09/10/2002 P. 0001 - 0012

Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008) 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), Having regard to the opinion of the Economic and Social Committee(2), Having regard to the opinion of the Committee of the Regions(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), in the light of the joint text approved by the Conciliation Committee on 15 May 2002, Whereas: (1) The Community is committed to promoting and improving health, preventing disease, and countering potential threats to health, with a view to reducing avoidable morbidity and premature mortality and activity-impairing disability. To contribute to the well-being of European citizens, the Community must address in a coordinated and coherent way the concerns of its people about risks to health and their expectations for a high level of health protection. 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 greater involvement of individuals in decisions that concern their health. In this framework, attention should be given to the right of the Community population to receive simple, clear and scientifically sound information about measures to protect health and prevent diseases, with a view to improving quality of life. (2) Health is a priority and a high level of health protection should be ensured in the definition and implementation of all Community policies and activities. 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, eight action programmes were adopted, namely: - 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)(5), - 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)(6), - 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)(7), - 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)(8), - 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)(9), - Decision No 372/1999/EC of the European Parliament and of the Council of 8 February 1999 adopting a programme of Community action on injury prevention in the framework for action in the field of public health (1999 to 2003)(10), - 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)(11), and - 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)(12). Furthermore, Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 on setting up a network for the epidemiological surveillance and control of communicable diseases in the Community(13) was adopted. Pursuant to that Decision, the Commission adopted on 22 December 1999 Decision No 2000/57/EC on the early warning and response system for the prevention and control of communicable diseases(14). (4) Other activities in the context of the public health framework included Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community(15) and Recommendation 1999/519/EC of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields 0 Hz to 300 GHz(16). (5) 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, which indicated that a new health strategy and programme were needed in view of the new Treaty provisions, new challenges and experience so far. (6) The Council in its Conclusions of 26 November 1998 on the future framework for Community action in the field of public health(17), and in its Resolution of 8 June 1999(18), the Economic and Social Committee, in its opinion of 9 September 1998(19), the Committee of the Regions, in its Opinion of 19 November 1998(20), and the European Parliament, in its Resolution A4-0082/99 of 12 March 1999(21), welcomed the Commission communication of 15 April 1998 and supported the view that actions at Community level should be set out in one overall programme to run for a period of at least five years and comprising three general objectives, namely improving information for the development of public health, reacting rapidly to health threats and tackling health determinants through health promotion and disease prevention, underpinned by inter-sectoral action and the use of all appropriate Treaty instruments. (7) In its Resolution of 29 June 2000 on the follow-up to the Evora conference on health determinants, the Council considered that the increasing differences in health status and health outcomes between and within Member States called for renewed and coordinated 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, that an efficacious health monitoring system should be established for this purpose; stressed the importance of the new Community public health strategy building upon the activities on specific determinants taken in the existing programmes, especially with respect to tobacco, nutrition and alcohol and that it was important not only to ensure continuity with existing actions, but also to take forward work on these issues in a fully coherent and systematic way. (8) The Council reaffirms its Conclusions on combating tobacco consumption of 18 November 1999, in which it underlined the necessity of developing an overall strategy, and invited the Commission, inter alia, to strengthen cooperation between health and other policy areas, with the aim of ensuring a high level of health protection in these areas. (9) The Council on 18 November 1999 agreed unanimously a Resolution on the Promotion of Mental Health. (10) According to the WHO World Health Report 2000 the five major burdens of disease (in disability-adjusted life years) are: 1. neuropsychiatric disorders, 2. cardiovascular diseases, 3. malignant neoplasms, 4. unintentional injuries and 5. respiratory diseases. Infectious diseases, such as HIV/AIDS, and anti-microbial resistance are also becoming a threat to the health of all people in Europe. An important task of the programme would be to identify better the main burdens of disease in the Community and, in particular, the main health determinants. (11) The programme should contribute to the exchange of information on quality standards identified in the field of public health. (12) It is essential to collect, process and analyse data at Community level for the purpose of effective public health monitoring at Community level and in order to obtain objective, reliable and compatible and comparable information which could be exchanged and would enable the Commission and the Member States to improve information to the public and formulate appropriate strategies, policies and actions to achieve a high level of human health protection. Data from the private sector should also be taken into account for the completeness of the programme. All relevant statistics should be broken down and analysed by gender. (13) The Community and its Member States have at their disposal certain means and mechanisms in relation to information and monitoring in the field of public health. It is therefore necessary to ensure a high level of coordination between actions and initiatives taken by the Community and the Member States to implement the programme, to promote cooperation between Member States and to enhance the effectiveness of existing and future networks in the field of public health. (14) It is essential that the Commission ensure the effectiveness and the cohesion of measures and actions of the programme at both micro- and macro-level as well as the promotion of cooperation between the Member States. Any structural arrangements which would be established under the auspices of the Commission to this end should collect, monitor and evaluate data, and develop surveillance methods and a basis for rapid and coordinated responses to health threats. Such structural arrangements would consist of a strengthened central resource and closely involve the relevant institutions designated by the Member States. (15) There is in particular a need to ensure, relying on competent and relevant expertise, appropriate sustainable coordination, in the area of health information, of 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. Such coordination should also be ensured in the area of rapid reaction to health threats, 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. (16) It is essential that the Commission, through appropriate structural arrangements, ensures the effectiveness and cohesion of measures and actions contained in the programme and promotes cooperation between the Member States. To enable such structural arrangements to operate smoothly and effectively, it is essential to establish sustained cooperation with the health authorities of the Member States, while respecting Member States' responsibilities. (17) The Commission should make, as appropriate, further proposals on the kind of structural arrangements needed for the implementation of the public health strategy, especially regarding health monitoring and rapid reaction to health threats. (18) The overall aim of the public health programme is to contribute towards the attainment of a high level of physical and mental health and well-being and greater equality in health matters throughout the Community, by directing action towards improving public health, preventing human diseases and disorders, and obviating sources of danger to health with a view to combating morbidity and premature mortality, while taking gender and age into consideration. To fulfil this aim, actions should be guided by the need to increase life expectancy without disability or sickness, promote quality of life and minimise the economic and social consequences of ill health, thus reducing health inequalities, while taking into account the regional approach to health issues. Priority should be given to health-promoting actions that address the major burdens of disease. The programme should support the development of an integrated intersectoral health strategy to ensure that Community policies and actions contribute to protecting and promoting health. (19) In order to achieve this, the programme should take into account the importance of education, training and networking. (20) The Treaty requires that a high level of human health protection is ensured in the definition and implementation of all Community policies and activities. A strong link is to be established between all Community policies having an impact on health and the Community strategy for public health. Within the public health programme, a priority task will be to develop criteria and methodologies for evaluating policy proposals and their implementation. In developing the measures under the programme, and joint strategies and actions with other relevant Community programmes and actions, it should be ensured that these other Community policies and actions incorporate the health aspect, and that they are underpinned by intersectoral policy. (21) Achieving the overall aim, and the general objectives of the programme requires effective cooperation of the Member States, their full commitment in the implementation of Community actions, and the involvement of institutions, associations, organisations and bodies in the health field as well as the public at large. To ensure sustainability and 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 implementation of health promotional and preventive interventions and on quality criteria. A dialogue should be ensured with all key partners committed to improving public health and their expertise should be incorporated in an efficient and transparent Community knowledge base. Cooperation should be established with bodies and non-governmental organisations active in the field of health through appropriate mechanisms, such as health fora. (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 in so far 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 achieved by the Member States because of the complexity, transnational character and lack of complete control at Member State level over the factors affecting health, and therefore the programme should support and complement the Member States' actions and measures. The programme can provide a significant added value to health promotion and to health systems 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 experience and best practices and by providing a basis for a common analysis of the factors affecting public health. Also, the programme may have added value in the event of threats to public health of a cross-border nature, such as 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 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 Community health policy. (24) In order to ensure that actions can address broad health issues and threats effectively in cooperation with other Community policies and activities, while avoiding duplication, 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 structural funds and social policy could influence health determinants in a positive way. (25) Effective implementation of the measures and actions and achievement of the desired impact of the programme require comparability of the data collected. Compatibility and interoperability of the systems and networks for exchanging information and data for the development of public health would also make a valuable contribution and further efforts towards these objectives should be pursued. It is of prime importance that information is exchanged on the basis of comparable and compatible data. (26) In general, the measures and actions under the programme should take account of the development of new technologies and IT applications and, in particular, there should be close coordination with the plans drawn up and implemented in the field of public health under the integrated action programme for an electronic Europe (e-Europe), and other relevant programmes, while avoiding overlapping, and taking particular care to ensure equal accessibility to health information. (27) 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 exploited to make health information as accessible as possible to citizens. (28) In the execution of the programme, full use should be made of the relevant results generated from the Community research programmes, which support research in areas covered by the programme. (29) The experience acquired from different charters in the field of public health should be taken into account. (30) In the implementation of the Community programme there must be compliance with all the relevant legal provisions in the field of protection of personal data, and the establishment of mechanisms to ensure the confidentiality and security of those data. (31) The programme should last six years in order to allow sufficient time to implement measures to achieve its objectives. (32) It is essential that the Commission should ensure implementation of the programme in close cooperation with the Member States. In order to obtain scientific information and advice to implement the programme, cooperation with scientists and experts of international standing is desirable. (33) 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. (34) Close cooperation and consultation will be expected with Community bodies responsible for risk assessment, monitoring and research in the fields of food and feed safety, environmental protection and product safety. (35) This decision lays down, for the entire duration of the programme, a financial framework constituting the prime 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(22) for the budgetary authority during the annual budgetary procedure. The financial framework should correspond to the needs and objectives of the programme. (36) Funding from other Community policies earmarked for joint actions under the programme is additional to the financial framework laid down for the programme. (37) It is essential that there should be flexibility to allow redeployment of resources and adaptation of activities while respecting the need for transparency as well as the criteria for selecting and ordering priorities according to magnitude of risk or potential of effect, the outcome of evaluation, public concerns, availability of interventions or potential for their development, subsidiarity, added value and impact on other sectors. There is a need, however, to maintain a balance between the three objectives of the programme, allocating budget resources fairly between them. (38) Practical measures 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 measures should be emphasised. (39) The measures necessary for the implementation of 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(23). (40) The Agreement on the European Economic Area (EEA Agreement) provides for greater cooperation in the field of public health between the European Community and its Member States, on the one hand, and the countries of the European Free Trade Association participating in the European Economic Area (EFTA/EEA countries), on the other. Provision should also be made to open the programme to participation of the associated Central and Eastern European countries in accordance with the conditions established in the Europe Agreements, in their additional protocols and in the decisions of the respective Association Councils, of Cyprus, funded by additional appropriations in accordance with the procedures to be agreed with that country, as well as of Malta and Turkey, funded by additional appropriations, in accordance with the provisions of the Treaty. (41) The applicant countries should be actively involved in the development and implementation of the programme and consideration should be given to a strategic approach to health in those countries, and especially to their specific problems. (42) On the accession of new Member States, the Commission should report on the consequences of these accessions for the programme. (43) Cooperation with third countries and the competent international organisations in the sphere of health, such as the WHO, the Council of Europe and the OECD, should be fostered, not only in the field of collecting and analysing data (including indicators) but also in the field of intersectoral health promotion, in order to ensure cost effectiveness, avoid overlapping of activities and programmes and enforce synergy and interaction, taking particular account of specific arrangements for cooperation such as that between the WHO and the Commission. (44) In order to increase the value and impact of the programme there should be regular monitoring and evaluation, including independent external evaluations, 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 should be informed of the annual work plans which will be drawn up by the Commission. (45) The programme of Community action in the field of public health builds on the activities and the eight programmes under the previous framework and on the work of the network for epidemiological surveillance and control of communicable diseases in the Community, and pursues all the objectives and measures therein in the form of a global and integrated health strategy. The decisions concerning those eight programmes are covered by the new programme and should therefore be repealed with effect from 31 December 2002, 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 2003 and ending on 31 December 2008. Article 2 Overall aim and general objectives 1. The programme, which shall complement national policies, shall aim to protect human health and improve public health. 2. The general objectives of the programme shall be: (a) to improve information and knowledge for the development of public health; (b) to enhance the capability of responding rapidly and in a coordinated fashion to threats to health; (c) to promote health and prevent disease through addressing health determinants across all policies and activities. 3. The programme shall thereby contribute to: (a) ensuring a high level of human health protection in the definition and implementation of all Community policies and activities, through the promotion of an integrated and intersectoral health strategy; (b) tackling inequalities in health; (c) encouraging cooperation between Member States in the areas covered by Article 152 of the Treaty. Article 3 Community actions and activities 1. The general objectives of the programme as set out in Article 2 shall be pursued by means of the actions listed in the Annex. 2. These actions shall be implemented in close cooperation with Member States through support to activities of a transversal nature, which may be used to implement all or part of the actions and which may, where appropriate, be combined. These activities are the following: (a) Activities related to the monitoring and rapid reaction systems (i) network activities operated through structures designated by Member States and other activities of Community interest for the purposes of public health monitoring and providing national information, as well as data at Community level, in furtherance of the objectives of the programme; (ii) activities to counter health threats, including major diseases, and react to unforeseen events, enable investigations and coordinate response; (iii) preparation, establishment and operation of appropriate structural arrangements coordinating and integrating networks for health monitoring and for rapid reaction to health threats; (iv) development of appropriate links between the actions concerning the monitoring and rapid reaction systems. (b) Activities on health determinants development and implementation of health promotion and disease prevention activities across all Community policies and involving, as appropriate, non-governmental organisations, innovative or pilot projects and networks between national institutions and activities. (c) Activities related to legislation (i) preparatory work for Community legislative instruments in the field of public health; (ii) health impact assessment of Community legislation; (iii) coordination of the position of the Community and its Member States in fora in which health-related matters are discussed. (d) Activities related to consultation, knowledge and information (i) development and dissemination to competent authorities in Member States, to health and other professionals and, where appropriate, to other stakeholders and the general public of health information, knowledge, including statistics, reports, reviews, analysis, and advice on issues of common interest to the Community and to Member States; (ii) information and consultation on health and health-related matters at the Community level, involving all stakeholders such as patients' organisations, health professionals, health care providers, trade unions, social partners and NGOs in the field of public health; (iii) sharing of experience and exchange of information on health-related matters between the Community and authorities and competent organisations of Member States; (iv) encouraging education and vocational training in the field of public health relevant to the objectives of the programme; (v) developing and maintaining networks for the exchange of information on best practice in public health and the effectiveness of health policies; (vi) obtaining scientific information and advice from high-level scientists and experts; (vii) supporting and promoting activities by the Community and the Member States with regard to good practice and to sound guidelines for public health based on scientific data. (e) Promotion of coordination at the European level of non-governmental organisations which are developing activities defined as priorities under the programme. They may be operating either singly or in the form of several coordinated associations. Article 4 Joint strategies and actions To ensure a high level of human health protection in the definition and implementation of all Community policies and activities, the objectives of the programme may be implemented as joint strategies and joint actions by creating links with relevant Community programmes and actions, notably in the areas of consumer protection, social protection, health and safety at work, employment, research and technological development, internal market, information society and information technology, statistics, agriculture, education, transport, industry and environment, and with actions undertaken by the Joint Research Centre and relevant Community bodies with which cooperation shall be fostered. Article 5 Implementation of the programme 1. The Commission shall ensure the implementation, in close cooperation with the Member States, of the actions set out in the programme, in accordance with the provisions of Article 9 and ensuring its harmonious and balanced development. 2. In order to assist implementation, the Commission shall ensure, through appropriate structural arrangements closely associating the Member States, the coordination and integration of networks for health monitoring and rapid reaction to health threats. 3. The Commission and Member States shall take appropriate action, within their respective areas of competence, to ensure the efficient running of the programme and to develop mechanisms at Community and Member State 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 shall, in close cooperation with the Member States, pursue the comparability of data and information and, where possible, the compatibility and interoperability of the systems and networks for exchange of data and information on health. 5. In implementing the programme the Commission, together with the Member States, shall ensure compliance with all relevant legal provisions regarding personal data protection and, where appropriate, the introduction of mechanisms to ensure the confidentiality and safety of such data. 6. The Commission, in close cooperation with the Member States, shall ensure the transition between those actions developed within the public health programmes adopted by the Decisions referred to in Article 13 which contribute to the priorities set out in this programme, and those to be implemented under this programme. Article 6 Consistency and complementarity The Commission shall ensure that there is consistency and complementarity between the actions to be implemented under the programme and those implemented under other Community policies and activities, including the policies mentioned in Article 4. In particular, the Commission shall identify those proposals of particular relevance to the objectives and actions of the programme, and inform the Committee referred to in Article 9 of how health considerations are taken into account in these proposals and of their expected health impact. Article 7 Funding 1. The financial framework for the implementation of the programme for the period specified in Article 1 is hereby set at EUR 312 million. Expenditure on technical and administrative assistance related to the structural arrangements referred to under Article 3(2)(a)(iii), and activities arising therefrom, shall be met from the overall budget of the programme. 2. The annual appropriations shall be authorised by the budgetary authority within the limits of the financial perspective. Article 8 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(2): (a) the annual plan of work for the implementation of the programme, setting out priorities and actions to be undertaken, including allocation of resources; (b) the arrangements, criteria and procedures for selecting and financing 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 12; (e) the arrangements for the preparation of any structural arrangements for the coordination of health monitoring and rapid reaction to health threats; (f) the arrangements for transmitting, exchanging and disseminating information and for rapid reaction on health threats under the programme, without prejudice to the implementation measures carried out under Decision 2119/98/EC. 2. The measures necessary for the implementation of this Decision relating to all other matters shall be adopted in accordance with the advisory procedure referred to in Article 9(3). Article 9 Committee 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at two months. 3. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 4. The Committee shall adopt its rules of procedure. Article 10 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 11 International cooperation In the course of implementing the programme, cooperation with third countries and with international organisations competent in the sphere of public health, in particular the World Health Organisation, the Council of Europe and the Organisation for Economic Cooperation and Development, or able to have an impact on public health such as the World Trade Organisation and the United Nations Food and Agriculture Organisation shall be encouraged in accordance with the procedure laid down in Article 9(3). In particular, the health information system and the capacity to respond to health threats should be, where appropriate and possible, coordinated with the activities of the World Health Organisation. Article 12 Monitoring, evaluation and dissemination of results 1. The Commission, in close cooperation with the Member States, shall regularly monitor, where appropriate with the help of experts, the implementation of the actions of the programme in the light of the objectives. It shall report annually to the Committee. The Commission shall transmit a copy of its main findings to the European Parliament and to the Council. 2. At the request of the Commission, Member States shall submit information on the implementation and the impact of this programme. 3. By the end of the fourth year of the programme, the Commission shall have an external assessment conducted by independent qualified experts of the implementation and achievements during the three first years of the programme. It shall also assess the impact achieved on health and the efficiency of the use of resources, as well as the consistency and complementarity with other relevant programmes, actions and initiatives implemented under other Community policies and activities. The Commission shall communicate the conclusions thereof, accompanied by its comments, to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions. The Commission shall also submit to those institutions and bodies a final report on the implementation of the programme by the end of the year which follows the end of the programme. 4. The Commission shall make the results of actions undertaken and the evaluation reports publicly available. Article 13 Repeal The following Decisions are hereby repealed on 31 December 2002: 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 14 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, 23 September 2002. For the European Parliament The President P. Cox For the Council The President M. Fischer Boel (1) OJ C 337 E, 28.11.2000, p. 122 and C 240 E, 28.8.2001, p. 168. (2) OJ C 116, 20.4.2001, p. 75. (3) OJ C 144, 16.5.2001, p. 43. (4) Opinion of the European Parliament of 4 April 2001 (OJ C 21, 24.1.2002, p. 161), Council Common Position of 31 July 2001 (OJ C 307, 31.10.2001, p. 27) and Decision of the European Parliament of 12 December 2001 (not yet published in the Official Journal). Decision of the European Parliament of 3 July 2002 and Decision of the Council of 26 June 2002. (5) OJ L 95, 16.4.1996, p. 1. Decision as last amended by Decision No 521/2001/EC (OJ L 79, 17.3.2001, p. 1). (6) OJ L 95, 16.4.1996, p. 9. Decision as last amended by Decision No 521/2001/EC. (7) OJ L 95, 16.4.1996, p. 16. Decision as last amended by Decision No 521/2001/EC. (8) OJ L 19, 22.1.1997, p. 25. Decision as amended by Decision No 521/2001/EC. (9) OJ L 193, 22.7.1997, p. 1. Decision as amended by Decision No 521/2001/EC. (10) OJ L 46, 20.2.1999, p. 1. (11) OJ L 155, 22.6.1999, p. 1. (12) OJ L 155, 22.6.1999, p. 7. Decision as amended by Decision No 521/2001/EC. (13) OJ L 268, 3.10.1998, p. 1. (14) OJ L 21, 26.1.2000, p. 32. (15) OJ L 203, 21.7.1998, p. 14. (16) OJ L 199, 30.7.1999, p. 59. (17) OJ C 390, 15.12.1998, p. 1. (18) OJ C 200, 15.7.1999, p. 1. (19) OJ C 407, 28.12.1998, p. 21. (20) OJ C 51, 22.2.1999, p. 53. (21) OJ C 175, 21.6.1999, p. 135. (22) OJ C 172, 18.6.1999, p. 3. (23) OJ L 184, 17.7.1999, p. 23. ANNEX ACTIONS AND SUPPORT MEASURES 1. To improve health information and knowledge for the development of public health by: 1.1. developing and operating a sustainable health monitoring system to establish comparable quantitative and qualitative indicators at Community level on the basis of existing work and of accomplished results, and to collect, analyse and disseminate comparable and compatible age- and gender-specific information on human health at Community level concerning health status, health policies and health determinants, including demography, geography and socioeconomic situations, personal and biological factors, health behaviours such as substance abuse, nutrition, physical activity, sexual behaviour, and living, working and environmental conditions, paying special attention to inequalities in health; 1.2. developing an information system for the early warning, detection and surveillance of health threats, both on communicable diseases, including with regard to the danger of cross-border spread of diseases (including resistant pathogens), and on non-communicable diseases; 1.3. improving the system for the transfer and sharing of information and health data including public access; 1.4. developing and using mechanisms for analysis, advice, reporting, information and consultation with Member States and stakeholders on health issues relevant at Community level; 1.5. improving analysis and knowledge of the impact of health policy developments and of other Community policies and activities, such as the internal market as it affects health systems, in contributing to a high level of human health protection, including developing criteria and methodologies for assessing policies for their impact on health and developing other links between public health and other policies; 1.6. reviewing, analysing, and supporting the exchange of experiences on, health technologies, including new information technologies; 1.7. supporting the exchange of information and experiences on good practice; 1.8. developing and operating a joint action with the plans drawn up under e-Europe to improve availability to the general public on the Internet of information on health matters, and considering the possibilities for establishing a system of recognisable Community seals of approval for Internet sites. The existing data and the information provided by the system is to be easily accessible to the Community, relevant users in Member States and, as appropriate, international organisations. The statistical element of the system will be developed, in collaboration with Member States, using as necessary the Community Statistical Programme to promote synergy and avoid duplication. 2. To enhance the capability of responding rapidly and in a coordinated fashion to threats to health by: 2.1. enhancing the capacity to tackle communicable diseases by supporting the further implementation of Decision No 2119/98/EC on the Community network on the epidemiological surveillance and control of communicable diseases; 2.2. supporting the network's operation, in the Member States and the countries participating on the basis of Article 10 of this decision, in particular in relation to common investigations, training, continuous assessment, quality assurance and, where appropriate, in relation to its contribution to the actions described in the Annex, points 1.2 and 1.3; 2.3. developing strategies and mechanisms for preventing, exchanging information on and responding to non-communicable disease threats, including gender-specific health threats and rare diseases; 2.4. exchanging information concerning strategies in order to counter health threats from physical, chemical or biological sources in emergency situations, including those relating to terrorist acts, and developing or using, when appropriate, Community approaches and mechanisms; 2.5. exchanging information on vaccination and immunisation strategies; 2.6. enhancing the safety and quality of organs and substances of human origin, including blood, blood components and blood precursors by developing high standards of quality and safety for the collection, processing, storage and distribution and use of these substances; 2.7. implementing vigilance networks for human products, such as blood, blood components and blood precursors; 2.8. promoting strategies and measures concerning the protection of human health from possible adverse effects from environmental agents such as ionising and non-ionising radiation and noise; 2.9. developing strategies for reducing antibiotic resistance. 3. To promote health and prevent disease through action on health determinants across all Community policies and activities by: 3.1. preparing and implementing strategies and measures, including those related to public awareness, on life-style related health determinants, such as nutrition, physical activity, tobacco, alcohol, drugs and other substances and on mental health, including measures to take in all Community policies and age- and gender-specific strategies; 3.2. analysing the situation and developing strategies on social and economic health determinants, in order to identify and combat inequalities in health and to assess the impact of social and economic factors on health; 3.3. 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 factors; 3.4. analysing the situation and exchange information on genetic determinants and the use of genetic screening; 3.5. developing methods to evaluate quality and efficiency of health promotion strategies and measures; 3.6. encouraging relevant training activities related to the above measures. 4. Support measures 4.1. Community assistance may be provided to support the actions and activities referred to in Article 3. 4.2. In carrying out the programme, the Commission may require additional resources, including recourse to experts, for instance for the monitoring system, the evaluation of the programme or the preparation of new legislation. It may also require experts to work for the Community structural arrangements for the coordination and integration of networks for health monitoring and for rapid reaction to health threats. The report referred to in Article 12(1) shall be accompanied, if need be, by any proposal regarding adjustment of the requirements. 4.3. The Commission may also undertake information, publication and dissemination of actions. It may also undertake evaluation studies and organise seminars, colloquia or other meetings of experts. Commission Statements Declaration on structural arrangements in order to ensure the effective implementation of the programme, in conformity with Article 5 of the Decision, the Commission intends to proceed as follows: 1. it will take the necessary steps to ensure the functioning of the Committee established under Articles 8 and 9 of the Decision. This Committee will be composed of representatives designated by the Member States, as laid down in Decision 1999/468/EC; 2. in full respect of the provisions of Article 218(2) of the EC treaty, it will operate its departments in the best way in order to facilitate attaining the three general objectives of the programme set out in Article 2 of the Decision; 3. in accordance with point 4 of the Annex to the Decision, the Commission will make use of scientific and technical experts to reinforce its capacity in the specific areas of action of the programme. Such experts will work with the Commission services in conformity with the relevant administrative rules; 4. the Commission also intends to make full use of the possibilities described in its Communication on externalisation (COM(2000) 788) and proposed regulation (COM(2001) 808). This may include examining the setting up of an executive agency in order to assist the Commission in implementing certain tasks of the programme once the proposed Regulation currently before the Council, is adopted. The Commission further declares that the actions envisaged in points 1 and 2 will be implemented not later than the beginning of 2003, when the programme comes into effect; point 3 will begin early in the programme as soon as the relevant arrangements can be made, and point 4 will be considered later in the programme once the proposed Regulation is adopted. Declaration on Article 7 The financial framework of the programme shall be reviewed in the context both of the accession of new Member States and the preparation for the revision of the financial perspective, taking account of the establishment of the structural arrangements, and of developments concerning key priorities; financial proposals will be made, if appropriate.

Decision No 1786/2002/EC of the European Parliament and of the Council

of 23 September 2002

adopting a programme of Community action in the field of public health (2003-2008)

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),

Having regard to the opinion of the Economic and Social Committee(2),

Having regard to the opinion of the Committee of the Regions(3),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), in the light of the joint text approved by the Conciliation Committee on 15 May 2002,

Whereas:

(1) The Community is committed to promoting and improving health, preventing disease, and countering potential threats to health, with a view to reducing avoidable morbidity and premature mortality and activity-impairing disability. To contribute to the well-being of European citizens, the Community must address in a coordinated and coherent way the concerns of its people about risks to health and their expectations for a high level of health protection. 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 greater involvement of individuals in decisions that concern their health. In this framework, attention should be given to the right of the Community population to receive simple, clear and scientifically sound information about measures to protect health and prevent diseases, with a view to improving quality of life.

(2) Health is a priority and a high level of health protection should be ensured in the definition and implementation of all Community policies and activities. 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, eight action programmes were adopted, namely:

- 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)(5),

- 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)(6),

- 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)(7),

- 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)(8),

- 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)(9),

- Decision No 372/1999/EC of the European Parliament and of the Council of 8 February 1999 adopting a programme of Community action on injury prevention in the framework for action in the field of public health (1999 to 2003)(10),

- 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)(11), and

- 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)(12).

Furthermore, Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 on setting up a network for the epidemiological surveillance and control of communicable diseases in the Community(13) was adopted. Pursuant to that Decision, the Commission adopted on 22 December 1999 Decision No 2000/57/EC on the early warning and response system for the prevention and control of communicable diseases(14).

(4) Other activities in the context of the public health framework included Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community(15) and Recommendation 1999/519/EC of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields 0 Hz to 300 GHz(16).

(5) 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, which indicated that a new health strategy and programme were needed in view of the new Treaty provisions, new challenges and experience so far.

(6) The Council in its Conclusions of 26 November 1998 on the future framework for Community action in the field of public health(17), and in its Resolution of 8 June 1999(18), the Economic and Social Committee, in its opinion of 9 September 1998(19), the Committee of the Regions, in its Opinion of 19 November 1998(20), and the European Parliament, in its Resolution A4-0082/99 of 12 March 1999(21), welcomed the Commission communication of 15 April 1998 and supported the view that actions at Community level should be set out in one overall programme to run for a period of at least five years and comprising three general objectives, namely improving information for the development of public health, reacting rapidly to health threats and tackling health determinants through health promotion and disease prevention, underpinned by inter-sectoral action and the use of all appropriate Treaty instruments.

(7) In its Resolution of 29 June 2000 on the follow-up to the Evora conference on health determinants, the Council considered that the increasing differences in health status and health outcomes between and within Member States called for renewed and coordinated 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, that an efficacious health monitoring system should be established for this purpose; stressed the importance of the new Community public health strategy building upon the activities on specific determinants taken in the existing programmes, especially with respect to tobacco, nutrition and alcohol and that it was important not only to ensure continuity with existing actions, but also to take forward work on these issues in a fully coherent and systematic way.

(8) The Council reaffirms its Conclusions on combating tobacco consumption of 18 November 1999, in which it underlined the necessity of developing an overall strategy, and invited the Commission, inter alia, to strengthen cooperation between health and other policy areas, with the aim of ensuring a high level of health protection in these areas.

(9) The Council on 18 November 1999 agreed unanimously a Resolution on the Promotion of Mental Health.

(10) According to the WHO World Health Report 2000 the five major burdens of disease (in disability-adjusted life years) are: 1. neuropsychiatric disorders, 2. cardiovascular diseases, 3. malignant neoplasms, 4. unintentional injuries and 5. respiratory diseases. Infectious diseases, such as HIV/AIDS, and anti-microbial resistance are also becoming a threat to the health of all people in Europe. An important task of the programme would be to identify better the main burdens of disease in the Community and, in particular, the main health determinants.

(11) The programme should contribute to the exchange of information on quality standards identified in the field of public health.

(12) It is essential to collect, process and analyse data at Community level for the purpose of effective public health monitoring at Community level and in order to obtain objective, reliable and compatible and comparable information which could be exchanged and would enable the Commission and the Member States to improve information to the public and formulate appropriate strategies, policies and actions to achieve a high level of human health protection. Data from the private sector should also be taken into account for the completeness of the programme. All relevant statistics should be broken down and analysed by gender.

(13) The Community and its Member States have at their disposal certain means and mechanisms in relation to information and monitoring in the field of public health. It is therefore necessary to ensure a high level of coordination between actions and initiatives taken by the Community and the Member States to implement the programme, to promote cooperation between Member States and to enhance the effectiveness of existing and future networks in the field of public health.

(14) It is essential that the Commission ensure the effectiveness and the cohesion of measures and actions of the programme at both micro- and macro-level as well as the promotion of cooperation between the Member States. Any structural arrangements which would be established under the auspices of the Commission to this end should collect, monitor and evaluate data, and develop surveillance methods and a basis for rapid and coordinated responses to health threats. Such structural arrangements would consist of a strengthened central resource and closely involve the relevant institutions designated by the Member States.

(15) There is in particular a need to ensure, relying on competent and relevant expertise, appropriate sustainable coordination, in the area of health information, of 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. Such coordination should also be ensured in the area of rapid reaction to health threats, 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.

(16) It is essential that the Commission, through appropriate structural arrangements, ensures the effectiveness and cohesion of measures and actions contained in the programme and promotes cooperation between the Member States. To enable such structural arrangements to operate smoothly and effectively, it is essential to establish sustained cooperation with the health authorities of the Member States, while respecting Member States' responsibilities.

(17) The Commission should make, as appropriate, further proposals on the kind of structural arrangements needed for the implementation of the public health strategy, especially regarding health monitoring and rapid reaction to health threats.

(18) The overall aim of the public health programme is to contribute towards the attainment of a high level of physical and mental health and well-being and greater equality in health matters throughout the Community, by directing action towards improving public health, preventing human diseases and disorders, and obviating sources of danger to health with a view to combating morbidity and premature mortality, while taking gender and age into consideration. To fulfil this aim, actions should be guided by the need to increase life expectancy without disability or sickness, promote quality of life and minimise the economic and social consequences of ill health, thus reducing health inequalities, while taking into account the regional approach to health issues. Priority should be given to health-promoting actions that address the major burdens of disease. The programme should support the development of an integrated intersectoral health strategy to ensure that Community policies and actions contribute to protecting and promoting health.

(19) In order to achieve this, the programme should take into account the importance of education, training and networking.

(20) The Treaty requires that a high level of human health protection is ensured in the definition and implementation of all Community policies and activities. A strong link is to be established between all Community policies having an impact on health and the Community strategy for public health. Within the public health programme, a priority task will be to develop criteria and methodologies for evaluating policy proposals and their implementation. In developing the measures under the programme, and joint strategies and actions with other relevant Community programmes and actions, it should be ensured that these other Community policies and actions incorporate the health aspect, and that they are underpinned by intersectoral policy.

(21) Achieving the overall aim, and the general objectives of the programme requires effective cooperation of the Member States, their full commitment in the implementation of Community actions, and the involvement of institutions, associations, organisations and bodies in the health field as well as the public at large. To ensure sustainability and 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 implementation of health promotional and preventive interventions and on quality criteria. A dialogue should be ensured with all key partners committed to improving public health and their expertise should be incorporated in an efficient and transparent Community knowledge base. Cooperation should be established with bodies and non-governmental organisations active in the field of health through appropriate mechanisms, such as health fora.

(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 in so far 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 achieved by the Member States because of the complexity, transnational character and lack of complete control at Member State level over the factors affecting health, and therefore the programme should support and complement the Member States' actions and measures. The programme can provide a significant added value to health promotion and to health systems 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 experience and best practices and by providing a basis for a common analysis of the factors affecting public health. Also, the programme may have added value in the event of threats to public health of a cross-border nature, such as 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 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 Community health policy.

(24) In order to ensure that actions can address broad health issues and threats effectively in cooperation with other Community policies and activities, while avoiding duplication, 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 structural funds and social policy could influence health determinants in a positive way.

(25) Effective implementation of the measures and actions and achievement of the desired impact of the programme require comparability of the data collected. Compatibility and interoperability of the systems and networks for exchanging information and data for the development of public health would also make a valuable contribution and further efforts towards these objectives should be pursued. It is of prime importance that information is exchanged on the basis of comparable and compatible data.

(26) In general, the measures and actions under the programme should take account of the development of new technologies and IT applications and, in particular, there should be close coordination with the plans drawn up and implemented in the field of public health under the integrated action programme for an electronic Europe (e-Europe), and other relevant programmes, while avoiding overlapping, and taking particular care to ensure equal accessibility to health information.

(27) 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 exploited to make health information as accessible as possible to citizens.

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

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

(30) In the implementation of the Community programme there must be compliance with all the relevant legal provisions in the field of protection of personal data, and the establishment of mechanisms to ensure the confidentiality and security of those data.

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

(32) It is essential that the Commission should ensure implementation of the programme in close cooperation with the Member States. In order to obtain scientific information and advice to implement the programme, cooperation with scientists and experts of international standing is desirable.

(33) 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.

(34) Close cooperation and consultation will be expected with Community bodies responsible for risk assessment, monitoring and research in the fields of food and feed safety, environmental protection and product safety.

(35) This decision lays down, for the entire duration of the programme, a financial framework constituting the prime 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(22) for the budgetary authority during the annual budgetary procedure. The financial framework should correspond to the needs and objectives of the programme.

(36) Funding from other Community policies earmarked for joint actions under the programme is additional to the financial framework laid down for the programme.

(37) It is essential that there should be flexibility to allow redeployment of resources and adaptation of activities while respecting the need for transparency as well as the criteria for selecting and ordering priorities according to magnitude of risk or potential of effect, the outcome of evaluation, public concerns, availability of interventions or potential for their development, subsidiarity, added value and impact on other sectors. There is a need, however, to maintain a balance between the three objectives of the programme, allocating budget resources fairly between them.

(38) Practical measures 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 measures should be emphasised.

(39) The measures necessary for the implementation of 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(23).

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

(41) The applicant countries should be actively involved in the development and implementation of the programme and consideration should be given to a strategic approach to health in those countries, and especially to their specific problems.

(42) On the accession of new Member States, the Commission should report on the consequences of these accessions for the programme.

(43) Cooperation with third countries and the competent international organisations in the sphere of health, such as the WHO, the Council of Europe and the OECD, should be fostered, not only in the field of collecting and analysing data (including indicators) but also in the field of intersectoral health promotion, in order to ensure cost effectiveness, avoid overlapping of activities and programmes and enforce synergy and interaction, taking particular account of specific arrangements for cooperation such as that between the WHO and the Commission.

(44) In order to increase the value and impact of the programme there should be regular monitoring and evaluation, including independent external evaluations, 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 should be informed of the annual work plans which will be drawn up by the Commission.

(45) The programme of Community action in the field of public health builds on the activities and the eight programmes under the previous framework and on the work of the network for epidemiological surveillance and control of communicable diseases in the Community, and pursues all the objectives and measures therein in the form of a global and integrated health strategy. The decisions concerning those eight programmes are covered by the new programme and should therefore be repealed with effect from 31 December 2002,

HAVE DECIDED AS FOLLOWS:

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 2003 and ending on 31 December 2008.

Article 2

Overall aim and general objectives

1. The programme, which shall complement national policies, shall aim to protect human health and improve public health.

2. The general objectives of the programme shall be:

(a) to improve information and knowledge for the development of public health;

(b) to enhance the capability of responding rapidly and in a coordinated fashion to threats to health;

(c) to promote health and prevent disease through addressing health determinants across all policies and activities.

3. The programme shall thereby contribute to:

(a) ensuring a high level of human health protection in the definition and implementation of all Community policies and activities, through the promotion of an integrated and intersectoral health strategy;

(b) tackling inequalities in health;

(c) encouraging cooperation between Member States in the areas covered by Article 152 of the Treaty.

Article 3

Community actions and activities

1. The general objectives of the programme as set out in Article 2 shall be pursued by means of the actions listed in the Annex.

2. These actions shall be implemented in close cooperation with Member States through support to activities of a transversal nature, which may be used to implement all or part of the actions and which may, where appropriate, be combined. These activities are the following:

(a) Activities related to the monitoring and rapid reaction systems

(i) network activities operated through structures designated by Member States and other activities of Community interest for the purposes of public health monitoring and providing national information, as well as data at Community level, in furtherance of the objectives of the programme;

(ii) activities to counter health threats, including major diseases, and react to unforeseen events, enable investigations and coordinate response;

(iii) preparation, establishment and operation of appropriate structural arrangements coordinating and integrating networks for health monitoring and for rapid reaction to health threats;

(iv) development of appropriate links between the actions concerning the monitoring and rapid reaction systems.

(b) Activities on health determinants

development and implementation of health promotion and disease prevention activities across all Community policies and involving, as appropriate, non-governmental organisations, innovative or pilot projects and networks between national institutions and activities.

(c) Activities related to legislation

(i) preparatory work for Community legislative instruments in the field of public health;

(ii) health impact assessment of Community legislation;

(iii) coordination of the position of the Community and its Member States in fora in which health-related matters are discussed.

(d) Activities related to consultation, knowledge and information

(i) development and dissemination to competent authorities in Member States, to health and other professionals and, where appropriate, to other stakeholders and the general public of health information, knowledge, including statistics, reports, reviews, analysis, and advice on issues of common interest to the Community and to Member States;

(ii) information and consultation on health and health-related matters at the Community level, involving all stakeholders such as patients' organisations, health professionals, health care providers, trade unions, social partners and NGOs in the field of public health;

(iii) sharing of experience and exchange of information on health-related matters between the Community and authorities and competent organisations of Member States;

(iv) encouraging education and vocational training in the field of public health relevant to the objectives of the programme;

(v) developing and maintaining networks for the exchange of information on best practice in public health and the effectiveness of health policies;

(vi) obtaining scientific information and advice from high-level scientists and experts;

(vii) supporting and promoting activities by the Community and the Member States with regard to good practice and to sound guidelines for public health based on scientific data.

(e) Promotion of coordination at the European level of non-governmental organisations which are developing activities defined as priorities under the programme. They may be operating either singly or in the form of several coordinated associations.

Article 4

Joint strategies and actions

To ensure a high level of human health protection in the definition and implementation of all Community policies and activities, the objectives of the programme may be implemented as joint strategies and joint actions by creating links with relevant Community programmes and actions, notably in the areas of consumer protection, social protection, health and safety at work, employment, research and technological development, internal market, information society and information technology, statistics, agriculture, education, transport, industry and environment, and with actions undertaken by the Joint Research Centre and relevant Community bodies with which cooperation shall be fostered.

Article 5

Implementation of the programme

1. The Commission shall ensure the implementation, in close cooperation with the Member States, of the actions set out in the programme, in accordance with the provisions of Article 9 and ensuring its harmonious and balanced development.

2. In order to assist implementation, the Commission shall ensure, through appropriate structural arrangements closely associating the Member States, the coordination and integration of networks for health monitoring and rapid reaction to health threats.

3. The Commission and Member States shall take appropriate action, within their respective areas of competence, to ensure the efficient running of the programme and to develop mechanisms at Community and Member State 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 shall, in close cooperation with the Member States, pursue the comparability of data and information and, where possible, the compatibility and interoperability of the systems and networks for exchange of data and information on health.

5. In implementing the programme the Commission, together with the Member States, shall ensure compliance with all relevant legal provisions regarding personal data protection and, where appropriate, the introduction of mechanisms to ensure the confidentiality and safety of such data.

6. The Commission, in close cooperation with the Member States, shall ensure the transition between those actions developed within the public health programmes adopted by the Decisions referred to in Article 13 which contribute to the priorities set out in this programme, and those to be implemented under this programme.

Article 6

Consistency and complementarity

The Commission shall ensure that there is consistency and complementarity between the actions to be implemented under the programme and those implemented under other Community policies and activities, including the policies mentioned in Article 4. In particular, the Commission shall identify those proposals of particular relevance to the objectives and actions of the programme, and inform the Committee referred to in Article 9 of how health considerations are taken into account in these proposals and of their expected health impact.

Article 7

Funding

1. The financial framework for the implementation of the programme for the period specified in Article 1 is hereby set at EUR 312 million.

Expenditure on technical and administrative assistance related to the structural arrangements referred to under Article 3(2)(a)(iii), and activities arising therefrom, shall be met from the overall budget of the programme.

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

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(2):

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

(b) the arrangements, criteria and procedures for selecting and financing 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 12;

(e) the arrangements for the preparation of any structural arrangements for the coordination of health monitoring and rapid reaction to health threats;

(f) the arrangements for transmitting, exchanging and disseminating information and for rapid reaction on health threats under the programme, without prejudice to the implementation measures carried out under Decision 2119/98/EC.

2. The measures necessary for the implementation of this Decision relating to all other matters shall be adopted in accordance with the advisory procedure referred to in Article 9(3).

Article 9

Committee

1. The Commission shall be assisted by a Committee.

2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at two months.

3. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4. The Committee shall adopt its rules of procedure.

Article 10

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 11

International cooperation

In the course of implementing the programme, cooperation with third countries and with international organisations competent in the sphere of public health, in particular the World Health Organisation, the Council of Europe and the Organisation for Economic Cooperation and Development, or able to have an impact on public health such as the World Trade Organisation and the United Nations Food and Agriculture Organisation shall be encouraged in accordance with the procedure laid down in Article 9(3). In particular, the health information system and the capacity to respond to health threats should be, where appropriate and possible, coordinated with the activities of the World Health Organisation.

Article 12

Monitoring, evaluation and dissemination of results

1. The Commission, in close cooperation with the Member States, shall regularly monitor, where appropriate with the help of experts, the implementation of the actions of the programme in the light of the objectives. It shall report annually to the Committee. The Commission shall transmit a copy of its main findings to the European Parliament and to the Council.

2. At the request of the Commission, Member States shall submit information on the implementation and the impact of this programme.

3. By the end of the fourth year of the programme, the Commission shall have an external assessment conducted by independent qualified experts of the implementation and achievements during the three first years of the programme. It shall also assess the impact achieved on health and the efficiency of the use of resources, as well as the consistency and complementarity with other relevant programmes, actions and initiatives implemented under other Community policies and activities. The Commission shall communicate the conclusions thereof, accompanied by its comments, to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions. The Commission shall also submit to those institutions and bodies a final report on the implementation of the programme by the end of the year which follows the end of the programme.

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

Article 13

Repeal

The following Decisions are hereby repealed on 31 December 2002:

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 14

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, 23 September 2002.

For the European Parliament

The President

P. Cox

For the Council

The President

M. Fischer Boel

(1) OJ C 337 E, 28.11.2000, p. 122 and C 240 E, 28.8.2001, p. 168.

(2) OJ C 116, 20.4.2001, p. 75.

(3) OJ C 144, 16.5.2001, p. 43.

(4) Opinion of the European Parliament of 4 April 2001 (OJ C 21, 24.1.2002, p. 161), Council Common Position of 31 July 2001 (OJ C 307, 31.10.2001, p. 27) and Decision of the European Parliament of 12 December 2001 (not yet published in the Official Journal). Decision of the European Parliament of 3 July 2002 and Decision of the Council of 26 June 2002.

(5) OJ L 95, 16.4.1996, p. 1. Decision as last amended by Decision No 521/2001/EC (OJ L 79, 17.3.2001, p. 1).

(6) OJ L 95, 16.4.1996, p. 9. Decision as last amended by Decision No 521/2001/EC.

(7) OJ L 95, 16.4.1996, p. 16. Decision as last amended by Decision No 521/2001/EC.

(8) OJ L 19, 22.1.1997, p. 25. Decision as amended by Decision No 521/2001/EC.

(9) OJ L 193, 22.7.1997, p. 1. Decision as amended by Decision No 521/2001/EC.

(10) OJ L 46, 20.2.1999, p. 1.

(11) OJ L 155, 22.6.1999, p. 1.

(12) OJ L 155, 22.6.1999, p. 7. Decision as amended by Decision No 521/2001/EC.

(13) OJ L 268, 3.10.1998, p. 1.

(14) OJ L 21, 26.1.2000, p. 32.

(15) OJ L 203, 21.7.1998, p. 14.

(16) OJ L 199, 30.7.1999, p. 59.

(17) OJ C 390, 15.12.1998, p. 1.

(18) OJ C 200, 15.7.1999, p. 1.

(19) OJ C 407, 28.12.1998, p. 21.

(20) OJ C 51, 22.2.1999, p. 53.

(21) OJ C 175, 21.6.1999, p. 135.

(22) OJ C 172, 18.6.1999, p. 3.

(23) OJ L 184, 17.7.1999, p. 23.

ANNEX

ACTIONS AND SUPPORT MEASURES

1. To improve health information and knowledge for the development of public health by:

1.1. developing and operating a sustainable health monitoring system to establish comparable quantitative and qualitative indicators at Community level on the basis of existing work and of accomplished results, and to collect, analyse and disseminate comparable and compatible age- and gender-specific information on human health at Community level concerning health status, health policies and health determinants, including demography, geography and socioeconomic situations, personal and biological factors, health behaviours such as substance abuse, nutrition, physical activity, sexual behaviour, and living, working and environmental conditions, paying special attention to inequalities in health;

1.2. developing an information system for the early warning, detection and surveillance of health threats, both on communicable diseases, including with regard to the danger of cross-border spread of diseases (including resistant pathogens), and on non-communicable diseases;

1.3. improving the system for the transfer and sharing of information and health data including public access;

1.4. developing and using mechanisms for analysis, advice, reporting, information and consultation with Member States and stakeholders on health issues relevant at Community level;

1.5. improving analysis and knowledge of the impact of health policy developments and of other Community policies and activities, such as the internal market as it affects health systems, in contributing to a high level of human health protection, including developing criteria and methodologies for assessing policies for their impact on health and developing other links between public health and other policies;

1.6. reviewing, analysing, and supporting the exchange of experiences on, health technologies, including new information technologies;

1.7. supporting the exchange of information and experiences on good practice;

1.8. developing and operating a joint action with the plans drawn up under e-Europe to improve availability to the general public on the Internet of information on health matters, and considering the possibilities for establishing a system of recognisable Community seals of approval for Internet sites.

The existing data and the information provided by the system is to be easily accessible to the Community, relevant users in Member States and, as appropriate, international organisations.

The statistical element of the system will be developed, in collaboration with Member States, using as necessary the Community Statistical Programme to promote synergy and avoid duplication.

2. To enhance the capability of responding rapidly and in a coordinated fashion to threats to health by:

2.1. enhancing the capacity to tackle communicable diseases by supporting the further implementation of Decision No 2119/98/EC on the Community network on the epidemiological surveillance and control of communicable diseases;

2.2. supporting the network's operation, in the Member States and the countries participating on the basis of Article 10 of this decision, in particular in relation to common investigations, training, continuous assessment, quality assurance and, where appropriate, in relation to its contribution to the actions described in the Annex, points 1.2 and 1.3;

2.3. developing strategies and mechanisms for preventing, exchanging information on and responding to non-communicable disease threats, including gender-specific health threats and rare diseases;

2.4. exchanging information concerning strategies in order to counter health threats from physical, chemical or biological sources in emergency situations, including those relating to terrorist acts, and developing or using, when appropriate, Community approaches and mechanisms;

2.5. exchanging information on vaccination and immunisation strategies;

2.6. enhancing the safety and quality of organs and substances of human origin, including blood, blood components and blood precursors by developing high standards of quality and safety for the collection, processing, storage and distribution and use of these substances;

2.7. implementing vigilance networks for human products, such as blood, blood components and blood precursors;

2.8. promoting strategies and measures concerning the protection of human health from possible adverse effects from environmental agents such as ionising and non-ionising radiation and noise;

2.9. developing strategies for reducing antibiotic resistance.

3. To promote health and prevent disease through action on health determinants across all Community policies and activities by:

3.1. preparing and implementing strategies and measures, including those related to public awareness, on life-style related health determinants, such as nutrition, physical activity, tobacco, alcohol, drugs and other substances and on mental health, including measures to take in all Community policies and age- and gender-specific strategies;

3.2. analysing the situation and developing strategies on social and economic health determinants, in order to identify and combat inequalities in health and to assess the impact of social and economic factors on health;

3.3. 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 factors;

3.4. analysing the situation and exchange information on genetic determinants and the use of genetic screening;

3.5. developing methods to evaluate quality and efficiency of health promotion strategies and measures;

3.6. encouraging relevant training activities related to the above measures.

4. Support measures

4.1. Community assistance may be provided to support the actions and activities referred to in Article 3.

4.2. In carrying out the programme, the Commission may require additional resources, including recourse to experts, for instance for the monitoring system, the evaluation of the programme or the preparation of new legislation. It may also require experts to work for the Community structural arrangements for the coordination and integration of networks for health monitoring and for rapid reaction to health threats. The report referred to in Article 12(1) shall be accompanied, if need be, by any proposal regarding adjustment of the requirements.

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

Commission Statements

Declaration on structural arrangements

in order to ensure the effective implementation of the programme, in conformity with Article 5 of the Decision, the Commission intends to proceed as follows:

1. it will take the necessary steps to ensure the functioning of the Committee established under Articles 8 and 9 of the Decision. This Committee will be composed of representatives designated by the Member States, as laid down in Decision 1999/468/EC;

2. in full respect of the provisions of Article 218(2) of the EC treaty, it will operate its departments in the best way in order to facilitate attaining the three general objectives of the programme set out in Article 2 of the Decision;

3. in accordance with point 4 of the Annex to the Decision, the Commission will make use of scientific and technical experts to reinforce its capacity in the specific areas of action of the programme. Such experts will work with the Commission services in conformity with the relevant administrative rules;

4. the Commission also intends to make full use of the possibilities described in its Communication on externalisation (COM(2000) 788) and proposed regulation (COM(2001) 808). This may include examining the setting up of an executive agency in order to assist the Commission in implementing certain tasks of the programme once the proposed Regulation currently before the Council, is adopted.

The Commission further declares that the actions envisaged in points 1 and 2 will be implemented not later than the beginning of 2003, when the programme comes into effect; point 3 will begin early in the programme as soon as the relevant arrangements can be made, and point 4 will be considered later in the programme once the proposed Regulation is adopted.

Declaration on Article 7

The financial framework of the programme shall be reviewed in the context both of the accession of new Member States and the preparation for the revision of the financial perspective, taking account of the establishment of the structural arrangements, and of developments concerning key priorities; financial proposals will be made, if appropriate.