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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 That Decision should therefore be repealed,

HAVE DECIDED AS FOLLOWS: