# L_2007301EN.01000301.xml

| 20.11.2007 | EN | Official Journal of the European Union | L 301/3 |
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20.11.2007

EN

Official Journal of the European Union

L 301/3

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DECISION No 1350/2007/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 23 October 2007

establishing a second programme of Community action in the field of health (2008-13)

(Text with EEA relevance)

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,

Having regard to the Opinion of the European Economic and Social Committee (1),

Having regard to the opinion of the Committee of the Regions (2),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

Whereas:

| (1) | The Community can contribute to protecting the health and safety of citizens through actions in the field of public health. 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 by taking measures which cannot be taken by individual Member States, in accordance with the principle of subsidiarity. The Community fully respects the responsibilities of the Member States for the organisation and delivery of health services and medical care. |
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(1)

The Community can contribute to protecting the health and safety of citizens through actions in the field of public health. 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 by taking measures which cannot be taken by individual Member States, in accordance with the principle of subsidiarity. The Community fully respects the responsibilities of the Member States for the organisation and delivery of health services and medical care.

| (2) | The health sector is characterised on the one hand by its considerable potential for growth, innovation and dynamism, and on the other by the challenges it faces in terms of financial and social sustainability and efficiency of the health care systems due, among other things, to ageing of the population and to medical advances. |
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(2)

The health sector is characterised on the one hand by its considerable potential for growth, innovation and dynamism, and on the other by the challenges it faces in terms of financial and social sustainability and efficiency of the health care systems due, among other things, to ageing of the population and to medical advances.

| (3) | The programme of Community action in the field of public health (2003-08), adopted by Decision No 1786/2002/EC of the European Parliament and of the Council (4), was the first integrated Community programme in this field, and it has already delivered a number of important developments and improvements. |
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(3)

The programme of Community action in the field of public health (2003-08), adopted by Decision No 1786/2002/EC of the European Parliament and of the Council (4), was the first integrated Community programme in this field, and it has already delivered a number of important developments and improvements.

| (4) | Continued effort is required in order to meet the objectives already established by the Community in the field of public health. It is therefore appropriate to establish a second programme of Community action on health (2008-13) (hereinafter referred to as ‘the Programme’). |
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(4)

Continued effort is required in order to meet the objectives already established by the Community in the field of public health. It is therefore appropriate to establish a second programme of Community action on health (2008-13) (hereinafter referred to as ‘the Programme’).

| (5) | A number of serious cross-border health threats with a possible worldwide dimension exist and new ones are emerging which require further Community action. The Community should treat serious cross-border health threats as a matter of priority. The Programme should place emphasis on strengthening the Community’s overall capacities by further developing cooperation between the Member States. Monitoring, early warning and action to combat serious threats to health are important areas where an effective and coordinated response to health threats should be promoted at Community level. Action to ensure high-quality diagnostic cooperation between laboratories is essential in order to respond to health threats. The Programme should encourage the establishment of a system of Community reference laboratories. However, such a system needs to be based on a sound legal base. |
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(5)

A number of serious cross-border health threats with a possible worldwide dimension exist and new ones are emerging which require further Community action. The Community should treat serious cross-border health threats as a matter of priority. The Programme should place emphasis on strengthening the Community’s overall capacities by further developing cooperation between the Member States. Monitoring, early warning and action to combat serious threats to health are important areas where an effective and coordinated response to health threats should be promoted at Community level. Action to ensure high-quality diagnostic cooperation between laboratories is essential in order to respond to health threats. The Programme should encourage the establishment of a system of Community reference laboratories. However, such a system needs to be based on a sound legal base.

| (6) | According to the World Health Organisation (WHO) European Health report 2005, in terms of Disability Adjusted Life-Years (DALYs), the most important causes of the burden of disease in the WHO European Region are non-communicable diseases (NCDs — 77 % of the total), external causes of injury and poisoning (14 %) and communicable diseases (9 %). Seven leading conditions — ischaemic heart disease, unipolar depressive disorders, cerebrovascular disease, alcohol use disorders, chronic pulmonary disease, lung cancer and road traffic injuries — account for 34 % of the DALYs in the region. Seven leading risk factors — tobacco, alcohol, high blood pressure, high cholesterol, overweight, low fruit and vegetable intake and physical inactivity — account for 60 % of DALYs. In addition, communicable diseases such as HIV/AIDS, influenza, tuberculosis and malaria are also becoming a threat to the health of all people in Europe. An important task of the Programme, in cooperation, where appropriate, with the Community Statistical Programme, should be to identify better the main health burdens in the Community. |
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(6)

According to the World Health Organisation (WHO) European Health report 2005, in terms of Disability Adjusted Life-Years (DALYs), the most important causes of the burden of disease in the WHO European Region are non-communicable diseases (NCDs — 77 % of the total), external causes of injury and poisoning (14 %) and communicable diseases (9 %). Seven leading conditions — ischaemic heart disease, unipolar depressive disorders, cerebrovascular disease, alcohol use disorders, chronic pulmonary disease, lung cancer and road traffic injuries — account for 34 % of the DALYs in the region. Seven leading risk factors — tobacco, alcohol, high blood pressure, high cholesterol, overweight, low fruit and vegetable intake and physical inactivity — account for 60 % of DALYs. In addition, communicable diseases such as HIV/AIDS, influenza, tuberculosis and malaria are also becoming a threat to the health of all people in Europe. An important task of the Programme, in cooperation, where appropriate, with the Community Statistical Programme, should be to identify better the main health burdens in the Community.

| (7) | Eight leading causes of mortality and morbidity from NCDs in the WHO European Region are cardiovascular diseases, neuropsychiatric disorders, cancer, digestive diseases, respiratory diseases, sense organ disorders, musculoskeletal diseases and diabetes mellitus. The Programme, in synergy with other Community initiatives and funding, should contribute to better knowledge of and information on the prevention, diagnosis and control of major diseases. Accordingly, the Commission may submit, during the course of the Programme, proposals for pertinent Council Recommendations. The Programme should also foster appropriate coordination and synergies among Community initiatives regarding the collection of comparable data on major diseases, including cancer. |
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(7)

Eight leading causes of mortality and morbidity from NCDs in the WHO European Region are cardiovascular diseases, neuropsychiatric disorders, cancer, digestive diseases, respiratory diseases, sense organ disorders, musculoskeletal diseases and diabetes mellitus. The Programme, in synergy with other Community initiatives and funding, should contribute to better knowledge of and information on the prevention, diagnosis and control of major diseases. Accordingly, the Commission may submit, during the course of the Programme, proposals for pertinent Council Recommendations. The Programme should also foster appropriate coordination and synergies among Community initiatives regarding the collection of comparable data on major diseases, including cancer.

| (8) | Microbial resistance to antibiotics and nosocomial infections are becoming a threat to health in Europe. The lack of new effective antibiotics as well as the means to ensure the proper use of existing antibiotics are major concerns. Therefore it is important to collect and analyse relevant data. |
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(8)

Microbial resistance to antibiotics and nosocomial infections are becoming a threat to health in Europe. The lack of new effective antibiotics as well as the means to ensure the proper use of existing antibiotics are major concerns. Therefore it is important to collect and analyse relevant data.

| (9) | Strengthening the role of the European Centre for Disease Prevention and Control established by Regulation (EC) No 851/2004 of the European Parliament and of the Council (5) is important in the fight against communicable diseases. |
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(9)

Strengthening the role of the European Centre for Disease Prevention and Control established by Regulation (EC) No 851/2004 of the European Parliament and of the Council (5) is important in the fight against communicable diseases.

| (10) | The Programme should build on the achievements of the previous Programme for Community action in the field of public health (2003-08). It should contribute towards the attainment of a high level of physical and mental health and greater equality in health matters throughout the Community by directing actions 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. It should further contribute to providing citizens with better access to information and thereby increase their ability to make decisions which best cater for their interests. |
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(10)

The Programme should build on the achievements of the previous Programme for Community action in the field of public health (2003-08). It should contribute towards the attainment of a high level of physical and mental health and greater equality in health matters throughout the Community by directing actions 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. It should further contribute to providing citizens with better access to information and thereby increase their ability to make decisions which best cater for their interests.

| (11) | The Programme should place emphasis on improving the health condition of children and young people and promoting a healthy lifestyle and a culture of prevention among them. |
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(11)

The Programme should place emphasis on improving the health condition of children and young people and promoting a healthy lifestyle and a culture of prevention among them.

| (12) | The Programme should support the mainstreaming of health objectives in all Community policies and activities, without duplicating work carried out under other Community policies. Coordination with other Community policies and programmes is a key part of the objective of mainstreaming health in other policies. In order to promote synergies and avoid duplication, joint actions may be undertaken with related Community programmes and actions and appropriate use should be made of other Community funds and programmes, including the current and future Community framework programmes for research and their outcomes, the Structural Funds, the European Solidarity Fund, the European strategy for health at work, the programme of Community action in the field of consumer policy (2007-13) (6), the programme ‘Drugs prevention and information’, the programme ‘Fight against violence (Daphne)’ and the Community Statistical Programme within their respective activities. |
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(12)

The Programme should support the mainstreaming of health objectives in all Community policies and activities, without duplicating work carried out under other Community policies. Coordination with other Community policies and programmes is a key part of the objective of mainstreaming health in other policies. In order to promote synergies and avoid duplication, joint actions may be undertaken with related Community programmes and actions and appropriate use should be made of other Community funds and programmes, including the current and future Community framework programmes for research and their outcomes, the Structural Funds, the European Solidarity Fund, the European strategy for health at work, the programme of Community action in the field of consumer policy (2007-13) (6), the programme ‘Drugs prevention and information’, the programme ‘Fight against violence (Daphne)’ and the Community Statistical Programme within their respective activities.

| (13) | Special efforts should be undertaken to ensure coherence and synergies between the Programme and the Community’s external actions, particularly in the areas of avian influenza, HIV/AIDS, tuberculosis and other cross-border health threats. In addition, there should be international cooperation in order to promote general health reform and general health institutional issues in third countries. |
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(13)

Special efforts should be undertaken to ensure coherence and synergies between the Programme and the Community’s external actions, particularly in the areas of avian influenza, HIV/AIDS, tuberculosis and other cross-border health threats. In addition, there should be international cooperation in order to promote general health reform and general health institutional issues in third countries.

| (14) | Increasing Healthy Life Years (HLY) by preventing disease and promoting policies that lead to a healthier way of life is important for the well-being of EU citizens and helps to meet the challenges of the Lisbon process as regards the knowledge society and the sustainability of public finances, which are under pressure from rising health care and social security costs. |
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(14)

Increasing Healthy Life Years (HLY) by preventing disease and promoting policies that lead to a healthier way of life is important for the well-being of EU citizens and helps to meet the challenges of the Lisbon process as regards the knowledge society and the sustainability of public finances, which are under pressure from rising health care and social security costs.

| (15) | The enlargement of the European Union has brought additional concerns in terms of health inequalities within the EU and this is likely to be accentuated by further enlargements. This issue should, therefore, be one of the priorities of the Programme. |
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(15)

The enlargement of the European Union has brought additional concerns in terms of health inequalities within the EU and this is likely to be accentuated by further enlargements. This issue should, therefore, be one of the priorities of the Programme.

| (16) | The Programme should help to identify the causes of health inequalities and encourage, among other things, the exchange of best practices to tackle them. |
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(16)

The Programme should help to identify the causes of health inequalities and encourage, among other things, the exchange of best practices to tackle them.

| (17) | It is essential to systematically collect, process and analyse comparable data, within national constraints, for an effective monitoring of the state of health in the European Union. This 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. Compatibility and interoperability of the systems and networks for exchanging information and data for the development of public health should be pursued in the actions and support measures. Gender, socioeconomic status and age are important health considerations. Data collection should wherever possible build on existing work, and proposals for new collections should be costed and based on a clear need. The collection of data should be in compliance with the relevant legal provisions on the protection of personal data. |
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(17)

It is essential to systematically collect, process and analyse comparable data, within national constraints, for an effective monitoring of the state of health in the European Union. This 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. Compatibility and interoperability of the systems and networks for exchanging information and data for the development of public health should be pursued in the actions and support measures. Gender, socioeconomic status and age are important health considerations. Data collection should wherever possible build on existing work, and proposals for new collections should be costed and based on a clear need. The collection of data should be in compliance with the relevant legal provisions on the protection of personal data.

| (18) | Best practice is important because health promotion and prevention should be measured on the basis of efficiency and effectiveness, and not purely in economic terms. Best practice and latest treatment methods for diseases and injuries should be promoted in order to prevent further deterioration of health, and European reference networks for specific conditions should be developed. |
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(18)

Best practice is important because health promotion and prevention should be measured on the basis of efficiency and effectiveness, and not purely in economic terms. Best practice and latest treatment methods for diseases and injuries should be promoted in order to prevent further deterioration of health, and European reference networks for specific conditions should be developed.

| (19) | Action should be taken in order to prevent injuries by collecting data, analysing injury determinants and disseminating relevant information. |
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(19)

Action should be taken in order to prevent injuries by collecting data, analysing injury determinants and disseminating relevant information.

| (20) | Health services are primarily the responsibility of Member States but cooperation at Community level can benefit both patients and health systems. Activities funded by the Programme as well as new proposals developed as a result of these should have due regard to the Council Conclusions on common values and principles in European Union Health Systems (7) adopted in June 2006 that endorse a statement on the common values and principles of EU Health Systems and invite the institutions of the European Union to respect them in their work. The Programme should take due account of future developments as regards Community action on health services as well as the work of the High Level Group on Health Services and Medical Care, which provides an important forum for collaboration and exchange of best practice between Member States’ health systems. |
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(20)

Health services are primarily the responsibility of Member States but cooperation at Community level can benefit both patients and health systems. Activities funded by the Programme as well as new proposals developed as a result of these should have due regard to the Council Conclusions on common values and principles in European Union Health Systems (7) adopted in June 2006 that endorse a statement on the common values and principles of EU Health Systems and invite the institutions of the European Union to respect them in their work. The Programme should take due account of future developments as regards Community action on health services as well as the work of the High Level Group on Health Services and Medical Care, which provides an important forum for collaboration and exchange of best practice between Member States’ health systems.

| (21) | The Programme should contribute to the collection of data, the promotion and development of methods and tools, the establishment of networks and various kinds of cooperation and the promotion of relevant policies on patient mobility as well as on the mobility of health professionals. It should facilitate the further development of the European e-Health Area, through joint European initiatives with other EU policy areas, including regional policy, while contributing towards work on quality criteria for health-related websites and towards a European health insurance card. Telemedicine should be taken into account as telemedicine applications may contribute to cross-border care while ensuring medical care at home. |
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(21)

The Programme should contribute to the collection of data, the promotion and development of methods and tools, the establishment of networks and various kinds of cooperation and the promotion of relevant policies on patient mobility as well as on the mobility of health professionals. It should facilitate the further development of the European e-Health Area, through joint European initiatives with other EU policy areas, including regional policy, while contributing towards work on quality criteria for health-related websites and towards a European health insurance card. Telemedicine should be taken into account as telemedicine applications may contribute to cross-border care while ensuring medical care at home.

| (22) | Environmental pollution is a serious risk to health and a major source of concern for European citizens. Special action should focus on children and other groups which are particularly vulnerable to hazardous environmental conditions. The Programme should complement the actions taken within the European Environment and Health Action Plan 2004-10. |
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(22)

Environmental pollution is a serious risk to health and a major source of concern for European citizens. Special action should focus on children and other groups which are particularly vulnerable to hazardous environmental conditions. The Programme should complement the actions taken within the European Environment and Health Action Plan 2004-10.

| (23) | The Programme should address genderrelated and ageing-related health issues. |
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(23)

The Programme should address genderrelated and ageing-related health issues.

| (24) | The Programme should recognise the importance of a holistic approach to public health and take into account, where appropriate and where there is scientific or clinical evidence about its efficacy, complementary and alternative medicine in its actions. |
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(24)

The Programme should recognise the importance of a holistic approach to public health and take into account, where appropriate and where there is scientific or clinical evidence about its efficacy, complementary and alternative medicine in its actions.

| (25) | The precautionary principle and risk assessment are key factors for the protection of human health and should therefore be part of further integration into other Community policies and activities. |
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(25)

The precautionary principle and risk assessment are key factors for the protection of human health and should therefore be part of further integration into other Community policies and activities.

| (26) | This Decision establishes, for the entire duration of the Programme, a financial envelope which constitutes the prime reference within the meaning of point 37 of the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management (8), for the budgetary authority during the annual budgetary procedure. |
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(26)

This Decision establishes, for the entire duration of the Programme, a financial envelope which constitutes the prime reference within the meaning of point 37 of the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management (8), for the budgetary authority during the annual budgetary procedure.

| (27) | In order to ensure a high level of coordination between actions and initiatives taken by the Community and Member States in the implementation of the Programme, it is necessary to promote cooperation between Member States and to enhance the effectiveness of existing and future networks in the field of public health. The participation of national, regional and local authorities at the appropriate level in accordance with the national systems should be taken into account in regard to the implementation of the Programme. |
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(27)

In order to ensure a high level of coordination between actions and initiatives taken by the Community and Member States in the implementation of the Programme, it is necessary to promote cooperation between Member States and to enhance the effectiveness of existing and future networks in the field of public health. The participation of national, regional and local authorities at the appropriate level in accordance with the national systems should be taken into account in regard to the implementation of the Programme.

| (28) | It is necessary to increase EU investment in health and health-related projects. In this regard, Member States are encouraged to identify health improvements as a priority in their national programmes. Better awareness about the possibilities of EU funding for health is needed. Exchange of experience between the Member States on funding health through the Structural Funds should be encouraged. |
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(28)

It is necessary to increase EU investment in health and health-related projects. In this regard, Member States are encouraged to identify health improvements as a priority in their national programmes. Better awareness about the possibilities of EU funding for health is needed. Exchange of experience between the Member States on funding health through the Structural Funds should be encouraged.

| (29) | Non-governmental bodies and specialised networks can also play an important role in meeting the objectives of the Programme. In pursuing one or more objectives of the Programme, they may require Community contributions to enable them to function. Hence, detailed eligibility criteria, provisions regarding financial transparency and the duration of Community contributions for non-governmental bodies and specialised networks qualifying for Community support should be set out 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 (9). Such criteria should include the obligations of such bodies and networks in establishing clear objectives, action plans and measurable results representing a strong European dimension and a real added value for the objectives of the Programme. Given the particular nature of the organisations concerned and in cases of exceptional utility, it should be possible for the renewal of Community support to the functioning of such bodies and specialised networks to be exempted from the principle of gradual decrease of the extent of Community support. |
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(29)

Non-governmental bodies and specialised networks can also play an important role in meeting the objectives of the Programme. In pursuing one or more objectives of the Programme, they may require Community contributions to enable them to function. Hence, detailed eligibility criteria, provisions regarding financial transparency and the duration of Community contributions for non-governmental bodies and specialised networks qualifying for Community support should be set out 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 (9). Such criteria should include the obligations of such bodies and networks in establishing clear objectives, action plans and measurable results representing a strong European dimension and a real added value for the objectives of the Programme. Given the particular nature of the organisations concerned and in cases of exceptional utility, it should be possible for the renewal of Community support to the functioning of such bodies and specialised networks to be exempted from the principle of gradual decrease of the extent of Community support.

| (30) | Implementation of the Programme should be carried out in close cooperation with relevant organisations and agencies, in particular with the European Centre for Disease Prevention and Control. |
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(30)

Implementation of the Programme should be carried out in close cooperation with relevant organisations and agencies, in particular with the European Centre for Disease Prevention and Control.

| (31) | The measures necessary for the implementation of this Decision should be adopted in accordance with Decision 1999/468/EC, respecting the need for transparency as well as a reasonable balance between the different objectives of the Programme. |
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(31)

The measures necessary for the implementation of this Decision should be adopted in accordance with Decision 1999/468/EC, respecting the need for transparency as well as a reasonable balance between the different objectives of the Programme.

| (32) | The Agreement on the European Economic Area (hereinafter referred to as ‘the EEA Agreement’) provides for cooperation in the field of 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 (hereinafter referred to as ‘the EFTA/EEA countries’), on the other. Provision should also be made to open the Programme to participation by other countries, in particular the neighbouring countries of the Community and countries that are applying for, are candidates for, or are acceding to, membership of the European Union, taking particular account of the potential for health threats arising in other countries to have an impact within the Community. |
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(32)

The Agreement on the European Economic Area (hereinafter referred to as ‘the EEA Agreement’) provides for cooperation in the field of 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 (hereinafter referred to as ‘the EFTA/EEA countries’), on the other. Provision should also be made to open the Programme to participation by other countries, in particular the neighbouring countries of the Community and countries that are applying for, are candidates for, or are acceding to, membership of the European Union, taking particular account of the potential for health threats arising in other countries to have an impact within the Community.

| (33) | Appropriate relations with third countries not participating in the Programme should be facilitated in order to help achieve the objectives of the Programme, taking account of any relevant agreements between those countries and the Community. This may involve third countries taking forward complementary activities to those financed through the Programme on areas of mutual interest, but should not involve a financial contribution under the Programme. |
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(33)

Appropriate relations with third countries not participating in the Programme should be facilitated in order to help achieve the objectives of the Programme, taking account of any relevant agreements between those countries and the Community. This may involve third countries taking forward complementary activities to those financed through the Programme on areas of mutual interest, but should not involve a financial contribution under the Programme.

| (34) | It is appropriate to develop cooperation with relevant international organisations such as the United Nations and its specialised agencies, in particular the WHO, as well as with the Council of Europe and the Organisation for Economic Cooperation and Development, with a view to implementing the Programme through maximising the effectiveness and efficiency of actions relating to health at Community and international level, taking into account the particular capacities and roles of the different organisations. |
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(34)

It is appropriate to develop cooperation with relevant international organisations such as the United Nations and its specialised agencies, in particular the WHO, as well as with the Council of Europe and the Organisation for Economic Cooperation and Development, with a view to implementing the Programme through maximising the effectiveness and efficiency of actions relating to health at Community and international level, taking into account the particular capacities and roles of the different organisations.

| (35) | The successful implementation of the objectives under the Programme should be based on good coverage of the issues included in the annual work plans, on selection of appropriate actions and funding of projects, which all have an in-built appropriate monitoring and evaluation process in place, and on regular monitoring and evaluation, including independent external evaluations, which should measure the impact of actions and demonstrate their contribution to the overall objectives of the Programme. Programme evaluation should take into account the fact that the achievement of the Programme objectives may require a longer time period than the duration of the Programme. |
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(35)

The successful implementation of the objectives under the Programme should be based on good coverage of the issues included in the annual work plans, on selection of appropriate actions and funding of projects, which all have an in-built appropriate monitoring and evaluation process in place, and on regular monitoring and evaluation, including independent external evaluations, which should measure the impact of actions and demonstrate their contribution to the overall objectives of the Programme. Programme evaluation should take into account the fact that the achievement of the Programme objectives may require a longer time period than the duration of the Programme.

| (36) | The annual work plans should cover the main foreseeable activities to be funded from the Programme through all the different funding mechanisms, including calls for tender. |
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(36)

The annual work plans should cover the main foreseeable activities to be funded from the Programme through all the different funding mechanisms, including calls for tender.

| (37) | Since the objectives of this Decision cannot be sufficiently achieved by the Member States due to the trans-national nature of the issues involved, and can therefore, by reason of the potential for Community action to be more efficient and effective than national action alone in protecting the health and safety of citizens, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Decision does not go beyond what is necessary in order to achieve those objectives. |
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(37)

Since the objectives of this Decision cannot be sufficiently achieved by the Member States due to the trans-national nature of the issues involved, and can therefore, by reason of the potential for Community action to be more efficient and effective than national action alone in protecting the health and safety of citizens, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Decision does not go beyond what is necessary in order to achieve those objectives.

| (38) | In accordance with Article 2 of the Treaty, which provides that equality between men and women is a principle of the Community, and in accordance with Article 3(2) thereof, which provides that the Community shall aim to eliminate inequalities, and to promote equality between men and women in all Community activities including the attainment of a high level of health protection, all objectives and actions covered by the Programme contribute to promoting a better understanding and recognition of men’s and women’s respective needs and approaches to health. |
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(38)

In accordance with Article 2 of the Treaty, which provides that equality between men and women is a principle of the Community, and in accordance with Article 3(2) thereof, which provides that the Community shall aim to eliminate inequalities, and to promote equality between men and women in all Community activities including the attainment of a high level of health protection, all objectives and actions covered by the Programme contribute to promoting a better understanding and recognition of men’s and women’s respective needs and approaches to health.

| (39) | It is appropriate to ensure a transition between the Programme and the previous programme it replaces, in particular regarding the continuation of multi-annual arrangements for its management, such as the financing of technical and administrative assistance. As of 1 January 2014, the technical and administrative assistance appropriations should cover, if necessary, the expenditure related to the management of actions not yet completed by the end of 2013. |
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(39)

It is appropriate to ensure a transition between the Programme and the previous programme it replaces, in particular regarding the continuation of multi-annual arrangements for its management, such as the financing of technical and administrative assistance. As of 1 January 2014, the technical and administrative assistance appropriations should cover, if necessary, the expenditure related to the management of actions not yet completed by the end of 2013.

| (40) | This Decision replaces Decision No 1786/2002/EC. That Decision should therefore be repealed, |
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(40)

This Decision replaces Decision No 1786/2002/EC. That Decision should therefore be repealed,

HAVE DECIDED AS FOLLOWS:

Article 1

Establishment of the Programme

The second programme of ‘Community action in the field of health (2008-13)’ covering the period from 1 January 2008 to 31 December 2013 (hereinafter referred to as ‘the Programme’) is hereby established.

Article 2

Aim and objectives

1.   The Programme shall complement, support and add value to the policies of the Member States and contribute to increased solidarity and prosperity in the European Union by protecting and promoting human health and safety and improving public health.

2.   The objectives to be pursued through the actions set out in the Annex shall be:

| — | to improve citizens’ health security, |
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—

to improve citizens’ health security,

| — | to promote health, including the reduction of health inequalities, |
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—

to promote health, including the reduction of health inequalities,

| — | to generate and disseminate health information and knowledge. |
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—

to generate and disseminate health information and knowledge.

The actions referred to in the first subparagraph shall, where appropriate, support the prevention of major diseases and contribute to reducing their incidence as well as the morbidity and mortality caused by them.

Article 3

Funding

1.   The financial envelope for the implementation of the Programme for the period specified in Article 1 is hereby set at EUR 321 500 000.

2.   Annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework.

Article 4

Financial contributions

1.   Financial contributions by the Community shall not exceed the following levels:

| (a) | 60 % of costs for an action intended to help achieve an objective forming part of the Programme, except in cases of exceptional utility, where the Community contribution shall not exceed 80 %; and |
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(a)

60 % of costs for an action intended to help achieve an objective forming part of the Programme, except in cases of exceptional utility, where the Community contribution shall not exceed 80 %; and

| (b) | 60 % of costs for the functioning of a non-governmental body or a specialised network, which is non-profit-making and independent of industry, commercial and business or other conflicting interests, has members in at least half of the Member States, with a balanced geographical coverage, and pursues as its primary goal one or more objectives of the Programme, where such support is necessary to pursue those objectives. In cases of exceptional utility, the Community contribution shall not exceed 80 %. |
| --- | --- |

(b)

60 % of costs for the functioning of a non-governmental body or a specialised network, which is non-profit-making and independent of industry, commercial and business or other conflicting interests, has members in at least half of the Member States, with a balanced geographical coverage, and pursues as its primary goal one or more objectives of the Programme, where such support is necessary to pursue those objectives. In cases of exceptional utility, the Community contribution shall not exceed 80 %.

2.   The renewal of financial contributions set out in paragraph 1(b) to non-governmental bodies and specialised networks may be exempted from the principle of gradual decrease.

3.   Financial contributions by the Community may, where appropriate given the nature of the objective to be achieved, include joint financing by the Community and one or more Member States or by the Community and the competent authorities of other participating countries. In this case, the Community contribution shall not exceed 50 %, except in cases of exceptional utility, where the Community contribution shall not exceed 70 %. These Community contributions may be awarded to a public body or a non-governmental body, which is non-profit-making and independent of industry, commercial and business or other conflicting interests, and pursues as its primary goal one or more objectives of the Programme, designated through a transparent procedure by the Member State or the competent authority concerned and agreed by the Commission.

4.   Financial contributions by the Community may also be given in the form of a lump sum and flat-rate financing where this is suited to the nature of the actions concerned. For such financial contributions, the percentage limits stipulated in paragraphs 1 and 3 shall not apply, although co-financing is still required.

Article 5

Administrative and technical assistance

1.   The financial allocation of the Programme may also cover expenses pertaining to preparatory, monitoring, control, audit and evaluation activities required directly for the management of the Programme and the realisation of its objectives, in particular studies, meetings, information and publication actions, expenses linked to informatics networks focusing on information exchange, as well as all other technical and administrative assistance expense that the Commission may have recourse to for the management of the Programme.

2.   The financial allocation may also cover the technical and administrative assistance expenses necessary to ensure the transition between the Programme and the measures adopted under Decision No 1786/2002/EC. If necessary, appropriations could be entered in the budget beyond 2013 to cover similar expenses, in order to enable the management of actions not yet completed by 31 December 2013.

Article 6

Methods of implementation

Actions in pursuit of the aim and objectives set out in Article 2 shall make full use of appropriate available methods of implementation, including in particular:

| (a) | direct or indirect implementation by the Commission on a centralised basis; and |
| --- | --- |

(a)

direct or indirect implementation by the Commission on a centralised basis; and

| (b) | joint management with international organisations, where appropriate. |
| --- | --- |

(b)

joint management with international organisations, where appropriate.

Article 7

Implementation of the Programme

1.   The Commission shall ensure the implementation, in close cooperation with the Member States, of the actions and measures set out in the Programme in accordance with Articles 3 and 8.

2.   The Commission and the 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 appropriate participation is obtained.

3.   For the attainment of the objectives of the Programme, the Commission shall, in close cooperation with the Member States:

| (a) | pursue the comparability of data and information, and the compatibility and interoperability of the systems and networks for exchange of data and information on health; and |
| --- | --- |

(a)

pursue the comparability of data and information, and the compatibility and interoperability of the systems and networks for exchange of data and information on health; and

| (b) | ensure the necessary cooperation and communication with the European Centre for Disease Prevention and Control and other relevant EU agencies in order to optimise the use of Community funds. |
| --- | --- |

(b)

ensure the necessary cooperation and communication with the European Centre for Disease Prevention and Control and other relevant EU agencies in order to optimise the use of Community funds.

4.   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.

Article 8

Implementation measures

1.   The measures necessary for the implementation of this Decision relating to the following shall be adopted in accordance with the procedure referred to in Article 10(2):

| (a) | the annual work plan for the implementation of the Programme, setting out:






  (i) | priorities and actions to be undertaken, including the allocation of financial resources; |
| --- | --- | --- |

(a)

the annual work plan for the implementation of the Programme, setting out:

(i)

priorities and actions to be undertaken, including the allocation of financial resources;

| (ii) | criteria for the percentage of Community financial contribution, including criteria for assessing whether or not exceptional utility applies; |
| --- | --- |

(ii)

criteria for the percentage of Community financial contribution, including criteria for assessing whether or not exceptional utility applies;

| (iii) | the arrangements for implementing the joint strategies and actions referred to in Article 9; |
| --- | --- |

(iii)

the arrangements for implementing the joint strategies and actions referred to in Article 9;

| (b) | selection, award and other criteria for financial contributions to the actions of the Programme in accordance with Article 4. |
| --- | --- |

(b)

selection, award and other criteria for financial contributions to the actions of the Programme in accordance with Article 4.

2.   Any other measures necessary for the implementation of this Decision shall be adopted in accordance with the procedure referred to in Article 10(3).

Article 9

Joint strategies and actions

1.   To ensure a high level of human health protection in the definition and implementation of all Community policies and activities and to promote the mainstreaming of health, the objectives of the Programme may be implemented as joint strategies and joint actions by creating links with relevant Community programmes, actions and funds.

2.   The Commission shall ensure the optimal synergy of the Programme with other Community programmes, actions and funds.

Article 10

Committee

1.   The Commission shall be assisted by a committee (hereinafter referred to as ‘the 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.

Article 11

Participation of third countries

The Programme shall be open to the participation of:

| (a) | the EFTA/EEA countries in accordance with the conditions established in the EEA Agreement; and |
| --- | --- |

(a)

the EFTA/EEA countries in accordance with the conditions established in the EEA Agreement; and

| (b) | third countries, in particular countries to which the European Neighbourhood Policy applies, countries that are applying for, are candidates for, or are acceding to, membership of the European Union, and the western Balkan countries included in the stabilisation and association process, in accordance with the conditions laid down in the respective bilateral or multilateral agreements establishing the general principles for their participation in Community programmes. |
| --- | --- |

(b)

third countries, in particular countries to which the European Neighbourhood Policy applies, countries that are applying for, are candidates for, or are acceding to, membership of the European Union, and the western Balkan countries included in the stabilisation and association process, in accordance with the conditions laid down in the respective bilateral or multilateral agreements establishing the general principles for their participation in Community programmes.

Article 12

International cooperation

In the course of implementing the Programme, relations and cooperation with third countries that are not participating in the Programme and relevant international organisations, in particular the WHO, shall be encouraged.

Article 13

Monitoring, evaluation and dissemination of results

1.   The Commission, in close cooperation with the Member States, shall monitor the implementation of the actions of the Programme in the light of its objectives. It shall report yearly to the Committee on all actions and projects funded through the Programme, and shall keep the European Parliament and the Council informed.

2.   At the request of the Commission, which shall avoid a disproportionate increase in the administrative burden of the Member States, Member States shall submit any available information on the implementation and impact of the Programme.

3.   The Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions:

| (a) | not later than 31 December 2010, an external and independent interim evaluation report on the results obtained in relation to the objectives of the Programme and the qualitative and quantitative aspects of its implementation as well as its consistency and complementarity with other relevant Community programmes, actions and funds. The report shall in particular make it possible to assess the impact of measures on all countries. The report shall contain a summary of the main conclusions, and it shall be accompanied by remarks by the Commission; |
| --- | --- |

(a)

not later than 31 December 2010, an external and independent interim evaluation report on the results obtained in relation to the objectives of the Programme and the qualitative and quantitative aspects of its implementation as well as its consistency and complementarity with other relevant Community programmes, actions and funds. The report shall in particular make it possible to assess the impact of measures on all countries. The report shall contain a summary of the main conclusions, and it shall be accompanied by remarks by the Commission;

| (b) | not later than 31 December 2011, a communication on the continuation of the Programme; |
| --- | --- |

(b)

not later than 31 December 2011, a communication on the continuation of the Programme;

| (c) | not later than 31 December 2015, an external and independent ex-post evaluation report covering the implementation and results of the Programme. |
| --- | --- |

(c)

not later than 31 December 2015, an external and independent ex-post evaluation report covering the implementation and results of the Programme.

4.   The Commission shall make the results of actions undertaken pursuant to this Decision publicly available and shall ensure their dissemination.

Article 14

Repeal

Decision No 1786/2002/EC shall be repealed with effect from 1 January 2008.

The Commission shall adopt any administrative arrangement necessary to ensure the transition between the measures adopted under Decision No 1786/2002/EC and those implemented under the Programme.

Article 15

Entry into force

This Decision shall enter into force on the day following its publication in the Official Journal of the European Union.

Official Journal of the European Union

Done at Strasbourg, 23 October 2007.

For the European Parliament

The President

H.-G. PÖTTERING

For the Council

The President

M. LOBO ANTUNES

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(1)  
  OJ C 88, 11.4.2006, p. 1.

1

(2)  
  OJ C 192, 16.8.2006, p. 8.

2

(3)  Opinion of the European Parliament of 16 March 2006 (OJ C 291 E, 30.11.2006, p. 372), Council Common Position of 22 March 2007 (OJ C 103 E, 8.5.2007, p. 11) and Position of the European Parliament of 10 July 2007 (not yet published in the Official Journal). Council Decision of 9 October 2007.

3

(4)  
  OJ L 271, 9.10.2002, p. 1. Decision as amended by Decision No 786/2004/EC (OJ L 138, 30.4.2004, p. 7).

4

(5)  
  OJ L 142, 30.4.2004, p. 1.

5

(6)  Decision No 1926/2006/EC of the European Parliament and of the Council (OJ L 404, 30.12.2006, p. 39).

6

(7)  
  OJ C 146, 22.6.2006, p. 1.

7

(8)  
  OJ C 139, 14.6.2006, p. 1.

8

(9)  
  OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

9

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ANNEX

Actions referred to in Article 2(2)

1.   Improve citizens’ health security.

1.1.   Protect citizens against health threats.

1.1.1.   Develop strategies and mechanisms for preventing, exchanging information on and responding to health threats from communicable and non-communicable diseases and health threats from physical, chemical or biological sources, including deliberate release acts; take action to ensure high-quality diagnostic cooperation between Member States’ laboratories; support the work of existing laboratories carrying out work with relevance to the Community; work on the setting up of a network of Community reference laboratories.

1.1.2.   Support the development of prevention, vaccination and immunisation policies; improve partnerships, networks, tools and reporting systems for immunisation status and adverse events monitoring.

1.1.3.   Develop risk management capacity and procedures; improve preparedness and planning for health emergencies, including preparing for coordinated EU and international responses to health emergencies; develop risk communication and consultation procedures on counter-measures.

1.1.4.   Promote the cooperation and improvement of existing response capacity and assets, including protective equipment, isolation facilities and mobile laboratories to deploy rapidly in emergencies.

1.1.5.   Develop strategies and procedures for drawing up, improving surge capacity of, conducting exercises and tests of, evaluating and revising general contingency and specific health emergency plans and their inter-operability between Member States.

1.2.   Improve citizens’ safety.

1.2.1.   Support and enhance scientific advice and risk assessment by promoting the early identification of risks; analyse their potential impact; exchange information on hazards and exposure; foster integrated and harmonised approaches.

1.2.2.   Help to enhance the safety and quality of organs and substances of human origin, blood, and blood derivatives; promote their availability, traceability and accessibility for medical use while respecting Member States’ responsibilities as set out in Article 152(5) of the Treaty.

1.2.3.   Promote measures to improve patient safety through high-quality and safe healthcare, including in relation to antibiotic resistance and nosocomial infections.

2.   Promote health.

2.1.   Foster healthier ways of life and the reduction of health inequalities.

2.1.1.   Promote initiatives to increase healthy life years and promote healthy ageing; support measures to promote and explore the impact of health on productivity and labour participation as a contribution to meeting the Lisbon goals; support measures to study the impact on health of other policies.

2.1.2.   Support initiatives to identify the causes of, address and reduce health inequalities within and between Member States, including those related to gender differences, in order to contribute to prosperity and cohesion; promote investment in health in cooperation with other Community policies and funds; improve solidarity between national health systems by supporting cooperation on issues of cross-border care and patient and health professional mobility.

2.2.   Promote healthier ways of life and reduce major diseases and injuries by tackling health determinants.

2.2.1.   Address health determinants to promote and improve physical and mental health, creating supportive environments for healthy lifestyles and preventing disease; take action on key factors such as nutrition and physical activity and sexual health, and on addiction-related determinants such as tobacco, alcohol, illegal drugs and pharmaceuticals used improperly, focusing on key settings such as education and the workplace, and across the life cycle.

2.2.2.   Promote action on the prevention of major diseases of particular significance in view of the overall burden of diseases in the Community, and on rare diseases, where Community action by tackling their determinants can provide significant added value to national efforts.

2.2.3.   Address the health effects of wider environmental determinants, including indoor air quality, exposure to toxic chemicals where not addressed by other Community initiatives, and socio-economic determinants.

2.2.4.   Promote actions to help reduce accidents and injuries.

3.   Generate and disseminate health information and knowledge.

3.1.   Exchange knowledge and best practice.

3.1.1.   Exchange knowledge and best practice on health issues within the scope of the Programme.

3.1.2.   Support cooperation to enhance the application of best practice within Member States, including, where appropriate, supporting European reference networks.

3.2.   Collect, analyse and disseminate health information.

3.2.1.   Develop further a sustainable health monitoring system with mechanisms for collection of comparable data and information, with appropriate indicators; ensure appropriate coordination of and follow-up to Community initiatives regarding registries on cancer, based, inter alia, on the data collected when implementing the Council Recommendation of 2 December 2003 on cancer screening (1); collect data on health status and policies; develop, with the Community Statistical Programme, the statistical element of this system.

3.2.2.   Develop mechanisms for analysis and dissemination, including Community health reports, the Health Portal and conferences; provide information to citizens, stakeholders and policy makers, develop consultation mechanisms and participatory processes; establish regular reports on health status in the European Union based on all data and indicators and including a qualitative and quantitative analysis.

3.2.3.   Provide analysis and technical assistance in support of the development or implementation of policies or legislation related to the scope of the Programme.

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(1)  
  OJ L 327, 16.12.2003, p. 34.

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TRILATERAL DECLARATION REGARDING THE SECOND COMMUNITY HEALTH PROGRAMME 2008-13

The European Parliament, the Council and the Commission:

| — | share the view that the second programme of Community action in the field of health (2008-13) must be provided with financial means that allow fully for its implementation; |
| --- | --- |

—

share the view that the second programme of Community action in the field of health (2008-13) must be provided with financial means that allow fully for its implementation;

| — | recall Article 37 of the Interinstitutional Agreement on budgetary discipline and sound financial management (1) stating that the budgetary authority and the Commission undertake not to depart by more than 5 % from the budget unless new, objective, long-term circumstances arise for which specific reasons are given. Any increase resulting from such variation must remain within the existing ceiling of the heading concerned; |
| --- | --- |

—

recall Article 37 of the Interinstitutional Agreement on budgetary discipline and sound financial management (1) stating that the budgetary authority and the Commission undertake not to depart by more than 5 % from the budget unless new, objective, long-term circumstances arise for which specific reasons are given. Any increase resulting from such variation must remain within the existing ceiling of the heading concerned;

1

| — | assure their willingness to evaluate in a sound manner the specific needs and circumstances of the health programme in the annual budget procedure. |
| --- | --- |

—

assure their willingness to evaluate in a sound manner the specific needs and circumstances of the health programme in the annual budget procedure.

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(1)  
  OJ C 139, 14.6.2006, p. 1.

1

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COMMISSION DECLARATION

1.

On 24 May 2006, the Commission issued an amended proposal for a second programme of Community action in the field of health (2007-13) (1). In Article 7, the reference amount of the programme was proposed to be set at EUR 365,6 million for the period starting in 2007 and ending in 2013.

2.

Because of delays in the legislative procedure, on 23 March 2007 the Commission informed the Budget Authority that the start of the new public health programme will have to be postponed to budget year 2008 (2). As a consequence, the envelope of the new public health programme 2008-13 would need to be adjusted to the level of EUR 321,5 million.

3.

An amount of EUR 44,1 million will be used in the 2007 budget year under the present public health programme (3) in order to ensure maximum continuity concerning public health actions. Therefore, the total envelope for public health actions financed from the programmes over the period 2007-13 sums up to EUR 365,6 million.

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(1)  COM(2006) 234.

1

(2)  COM(2007) 150.

2

(3)  Decision No 1786/2002/ΕC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-08) (OJ L 271, 9.10.2002, p. 1).

3

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