In accordance with Decision No 1350/2007/EC establishing a second programme of Community action in the field of health (2008-2013), the Commission presented a report on the independent ex post evaluation covering the implementation and results of the 2nd Health Programme.

This report presents the Programme and summarises the main conclusions from the mid-term and ex-post evaluations. It also outlines three areas, where implementation of the current 3rd Health Programme can be improved.

1) The objectives of the Programme : the overall aim of the Programme was to complement, support and add value to Member States’ policies and contribute to increased solidarity and prosperity in the European Union by protecting and promoting human health and safety and improving public health.

The Programme financed action geared to achieving three main objectives:

improving citizens’ health security and protecting them from health threats and emergencies, such as pandemics or natural disasters; promoting health and reducing health inequalities across Europe , whether relating to lifestyle, such as access to opportunities for physical activity, or to health care, such as access to the necessary medical intervention; generating health information and health knowledge and disseminating them to relevant parties, from the general public to policymakers and health professionals.

In addition to grants for projects and tenders, new funding mechanisms were introduced from the beginning of the Programme in the form of joint actions, operating grants, conferences and direct grants to international organisations.

Programme evaluation : external independent evaluations were conducted at mid-term (in 2010-2011) and ex-post (2014-2015). Both gave a positive assessment of the Programme with limitations. They:

confirmed the relevance of the actions funded , although underlining the weaknesses in the Programme design (large scope and non-explicit specific objectives); concluded that the Programme demonstrated EU added value mainly regarding identification of best practices, benchmarking for better decision making and networking; concluded that only actions that have an EU added value have the potential to impact on Member States’ health policies and that the impact depends on the uptake and implementation of the results by the Member States. In relation to outreach to relevant stakeholders the actions of the Programme were successful to varying degrees.

Overall assessment : the Commission noted that the Programme:

mobilised relevant stakeholders in all 28 Member States (with more of them being from EU 15 than EU 12 Member States) and three EEA EFTA countries (Norway, Iceland and Lichtenstein); covered a series of common health concerns (i.e concerning major chronic diseases, the health of an ageing population, the development of capacity to respond to cross-border health threats); provided a wide range of useful tools (i.e the EU information database for rare diseases) and best practices (i.e. for preventing the spread of HIV/AIDS, addressing obesity or applying cancer screening) for use at national and regional levels; promoted cooperation and coordination between Member States’ health authorities to keep health issues such as health inequalities, mental health, ageing, etc. high on their agenda.

However, both evaluations pointed out that the lack of explicit objectives and progress indicators in the Programme's design was conducive to the proliferation of priorities and made it difficult to define the overall results in a meaningful way.

Mid-term evaluation : the mid-term evaluation included a number of recommendations to: (i) improve the prioritisation of needs, (ii) fix more targeted and focused objectives, (iii) co-fund fewer actions, (iv) monitor on the basis of SMART indicators and (v) better disseminate outcomes. The lessons learnt from the evaluation were applied in the impact assessment accompanying the Commission’s proposal for the 3rd Health Programme. The Commission will make a particular effort to improve monitoring, reporting and dissemination, support the participation of less active Member States in the Programme and develop synergies with other EU programmes.

Those lessons learnt will be used for improving the implementation of the 3rd Health Programme and will feed into the three following main areas of action below:

improved monitoring, reporting and dissemination efforts : in order to ensure visibility, accountability as regards the use of its resources and above all its usefulness, it is important that the actions and their results are well known to the relevant key stakeholders. This intensified support for the dissemination efforts of individual actions has shown to be useful and to help extend the reach of relevant results. However, in light of the diversity and breadth of action, they cannot make up for the fact that some projects have not promoted their results to the specific audiences they are most relevant for. Therefore, in the 3rd Health Programme an effective dissemination strategy must be defined early on for all actions; encourage participation of all Member States and other participating countries : difficult economic circumstances are stated as among the reasons for some Member States' low participation. To address this the Commission has included the principle of ‘exceptional utility’ in the current 3rd Health Programme as a financial incentive to involve all Member States. Information days to promote the Programme should continue to be organised in all Member States and participating countries, the aim being that at least half of these events will take place in Member States underrepresented in the previous Programme period; develop synergies with other EU programmes : the 3rd Health Programme offers possibilities for such cooperation in supporting health in areas such as migration, dealing with emerging diseases relating to environmental factors such as climate change, innovation in health, health-sector reform and global health.

At the end of the 3rd Health Programme in 2020, the Commission will assess the extent to which the first three Programmes have produced positive impacts on Member States health policies in an effective, efficient, coherent and relevant way ensuring EU added value. The monitoring arrangements for the 3rd Health Programme will be used to support this broader assessment.

The report focuses on the Health Programme’s implementation in 2013. This was the last year of the implementation of the Second Health Programme established by Decision 1350/2007/EC.

It provides detailed information on the 2013 budget and its execution. It includes tables which set out in detail all actions co-funded as well as the contracts.

While the detailed evaluation of the Second Health Programme will be forthcoming in 2015, this report gives a comprehensive overview of its implementation in 2013, highlighting several actions that came to an end that year.

Main objectives of the programme : the programme, with a total budget of EUR 321 500 000, provided a wide range of funding instruments in order to achieve its objectives. These were: actions co-financed with Member State authorities (‘joint actions’), projects, co-funding for conferences and operating grants to specifically support non-governmental organisations and networks, direct agreements with international organisations, public procurement and other actions.

The Second Health Programme’s main aim was to 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.

This aim was broken down into three specific objectives:

to improve citizens’ health security, to promote health, including the reduction of health inequalities, to generate and disseminate health information and knowledge.

Implementing actions : various actions were co-funded under each objective.

In the area of health security , disease outbreaks do not respect borders. Therefore, it is essential to ensure that countries and communities across the EU are well prepared to respond to communicable and non-communicable diseases. In order to promote health , Member States and the EU have been able to help promote health and reduce health inequalities, including support towards increasing healthy life years and promoting healthy ageing. For example, the programme has helped to: (i) provide a better understanding of the issue of smoking uptake by young people and by women in particular, (ii) raise awareness on cardiovascular disease and diabetes, (iii) implement screening for cervical and colorectal cancers, and (iv) develop a worldwide online source of information on rare diseases. To disseminate health information , the programme has helped create synergies and improve evidence for policy making by developing and transferring health information and knowledge across the EU. Projects have also specifically supported innovation in health, including on improving understanding of how to set up electronic health records and introducing personalised medicine. In addition, the programme contributed to preparing, developing and implementing EU health policy action. Actions were funded focusing on implementing legislation, for instance in the fields of tobacco control and substances of human origin, on health inequalities, in support of the Commission strategy on, ‘Solidarity in Health: Reducing Health Inequalities in the EU’, and on cross-border health threats and patients’ rights in cross-border healthcare. Lastly, in the area of health services, access to high quality and safe healthcare, together with sound scientific advice and risk assessment, contribute to patient safety in the EU.

Working with and providing support to a wide range of public health players : the programme contributed significantly to supporting health policy action at EU and Member State level and helped the Member States, stakeholders and the EU to develop effective policies for the benefit of EU citizens. Many scientists, experts, academics, patients and civil society organisations came together under different themes to pool resources and knowledge to innovate and to provide added value for EU citizens. In total, 30 were co-funded for more than EUR 60 million. They covered themes as wide-ranging as rare diseases, health technology assessment and health workforce.

Important civil society stakeholders were supported through the operating grant instrument.

By co-funding pan-EU conferences, the programme enabled European exchanges and provided additional communication and dissemination opportunities. Nearly 150 pan-EU projects, financially supported with more than 100 million euros, allowed the European public health community to develop, test and implement a vast range of tools such as handbooks, guidelines and inventories to contribute to achieving the programme’s objectives.

This Commission Staff Working Document relates to the implementation of the second Programme of Community action in the field of health in 2012.

The report provides detailed information on all actions and projects funded in 2012 under the Programme, the relevant budget and its execution.

The following financing mechanisms were used to implement the work plan for 2012: (i) project grants; (ii) conference grants; (iii) operating grants; (iv) grants for joint actions; (v) direct grant agreements procurement (service contracts).

Financing : the 2012 budget was used according to the three programme strands:

health security: a total of EUR 7 598 433, 49 was spent on this strand; health promotion: EUR 36 577 525,51 was spent in this area; health information: EUR 6 313 328,75 on health information.

Lastly, EUR 866 375,88 was invested in IT services necessary to support the three strands.

This Commission Staff Working Document relates to the implementation of the second Programme of Community action in the field of health in 2011 .

The report provides detailed information on all actions and projects funded in 2011 under the Programme, the relevant budget and its execution.

The following financing mechanisms were used to implement the work plan for 2011: (i) project grants; (ii) conference grants; (iii) operating grants; (iv) grants for joint actions; (v) direct grant agreements and (vi) procurement (service contracts).

Examples of key results achieved in 2011 of actions funded through the Programme are provided in an appendix to the document.

In accordance with the requirements of Decision No 1350/2007/EC establishing a second programme of Community action in the field of health (2008-13), the Commission presents a working document, providing detailed information on the budget for 2010 and its execution. Moreover, examples of key results of actions funded in 2010 are provided in an appendix to this report.

In brief, the budget for the second Health Programme for the period 2008-2013 is EUR 321.5 million. The estimated budget set out in the work plan for 2010 was EUR 47.1 million. This was broken down as follows:

Operational expenditure: EUR 45.7 million corresponding to budget line 17 03 06 — Community action in the field of health. With EFTA/EEA and Croatia credits as well as recovery credits from previous budgetary years, the total operational budget amounted to EUR 47.4 million. Administrative expenditure: EUR 1.4 million corresponding to budget line 17 01 04 02 — Expenditure on administrative management.

In accordance with the requirements of Decision No 1350/2007/EC, the Commission presents a Staff Working Document containing the conclusions of the midterm evaluation of the Health Programme 2008-2013.

The evaluation covers action under the Programme from 2008 to 2010. The overall purpose of this evaluation was to assess the progress achieved so far under the Health Programme 2008-2013 with a particular focus on impact and EU added value. The results of this evaluation have fed into the new Commission proposal for the Health for Growth programme 2014-2020 adopted on 9 November 2011.

The mid-term evaluation recommended a number of improvements to the Programme including better prioritisation of needs, more targeted and focused objectives, reduction of the number of actions to be co-funded, monitoring through SMART indicators, and better dissemination of the Programme outcomes.

The Commission proposal for the Health for Growth Programme 2014-2020 has already incorporated these recommendations and particular effort should be made to follow them up for the Programme's successful implementation.

As stipulated in Article 13(1) of Commission Decision No 1350/2007/EC establishing a second programme of Community action in the field of health (2008-13), this working document of the Commission's services aims at informing the Programme Committee, the European Parliament and the Council, on the implementation of the Health Programme in year 2009 with regard to the financial mechanisms and annual work priorities as decided by the Commission.

The programme’s overall budget for the period 2008-2013 is EUR 321.5 million and the budget for 2009 amounts to EUR 48.48 million split between:

operational expenditure: EUR 47 million (budget line 17 03 06), increased by an amount of approximately EUR 4 million to face the additional needs resulting from the H1N1 crisis; the final amount available under the operational budget reached EUR 52.3 million, taking also into account credits received from EFTA and candidate countries; administrative expenditure of an amount of EUR 1.48 million (budget line 1701 04 02)

Since 2005, technical, scientific and administrative assistance is provided by the Executive Agency for Health and Consumers (EAHC). In 2009, the Agency has managed an amount of EUR 39.5 million while Commission's services have managed the remainder, EUR 12.8 million.

Health priorities for 2009 were set by the Commission Decision 2009/58/EC of 23 adopting the Work Plan for 2009.

This paper focuses on the implementation of the health programme in 2008. It aims to inform the European Parliament and the Council of all actions and projects funded under the programme in 2008.

To recall, the programme is the key instrument in support of strategic objectives as adopted in the White Paper, "Together for Health: A Strategic Approach for the EU 2008-2013". It is structured in three parts:

1. improve the safety of citizens,

2. promote health,

3. produce and disseminate information and knowledge on health.

Its purpose is to complement and support Member States' policies, add value and contribute to strengthening the solidarity and prosperity in the European Union by protecting and promoting the health and safety of people and improving public health in general.

2008 was the first year of implementation of this programme (2nd Community Action Programme in the field of health covering the period 2008-2013).

The Commission shall manage and implement, in close cooperation with Member States through a wide range of projects, conferences, operating grants, service contracts and joint actions on the basis of annual priorities for action defined in the annual work plan 2008. These actions were subject to a tendering procedure launched by the Executive Agency for Health and Consumers (EAHC) on 29 February 29 2008.

In 2008, the programme also saw the participation of the EFTA countries who are members of the European Economic Area (Iceland, Liechtenstein and Norway).

Overview of the 2008 budget : the total budget allocated to the programme for the period 2008-2013 is EUR 321.5 million. For 2008, the budget totals EUR 47 830 000.

The wide range of financing mechanisms proposed by the second Health Programme has been exploited and implemented in 2008. Following the call for proposals, the EAHC received a total of 225 proposals. Of these:

154 were for action grants, 43 conferences, 26 applications for operating grants, two joint actions.

A total of 65 proposals were eventually funded.

Grant applications represented EUR 114 005 000 compared to an indicative budget available for EUR 28.541 million. The total volume of proposals for conferences amounted to EUR 1.065 million (budget available from EUR 70000 EUR) to EUR 3.771 million for operating subsidies (available budget of EUR 2.3 million) and EUR 6.214 million for joint actions (available budget of EUR 2.3 million).

The Commission’s working document sets out in detail these actions.

PURPOSE: to establish a second programme of Community action in the field of health for the period from 1 January 2008 to 31 December 2013.

LEGISLATIVE ACT: Decision No 1350/2007/EC of the European Parliament and of the Council establishing a second programme of Community action in the field of health (2008-13).

CONTENT: the programme complements, supports and adds value to the policies of the Member States and contributes to increased solidarity and prosperity in the European Union by protecting and promoting human health and safety and improving public health. The Council approved all of the amendments proposed by the European Parliament at second reading.

The programme pursues three main objectives:

1) To improve citizens’ health security:

Protect citizens against health threats : i) prevent health threats from communicable and non-communicable diseases, and health threats from physical, chemical or biological sources, including deliberate release acts, and take action in this regard; ensure high-quality diagnostic cooperation between Member States’ laboratories; ii) prevention, vaccination and immunisation policies; iii) improve preparedness and planning for health emergencies, including preparing for coordinated EU and international responses; iv) improve existing response capacity, including isolation facilities and mobile laboratories to deploy rapidly in emergencies; v) improve surge capacity and conduct of exercises of health emergency plans, as well as their inter-operability between Member States. Improve citizens’ safety : i) early identification of risks and analysis of their potential impact; exchange information on hazards and exposure; ii) safety, quality, availability, traceability and accessibility of organs and substances of human origin, blood, and blood derivatives; iii) improve patient safety through high-quality and safe healthcare, including in relation to antibiotic resistance and nosocomial infections.

2) Promote health:

Foster healthier ways of life and the reduction of health inequalities: i) increase life expectancy and promote healthy ageing; ii) identify the causes of and address health inequalities within and between Member States, including those related to gender differences; iii) improve solidarity between national health systems by supporting cooperation and patient and health professional mobility. Promote healthier ways of life and reduce major diseases and injuries by tackling health determinants: i) take action on key factors such as nutrition, physical activity and sexual health, and on addiction-related determinants (tobacco, alcohol, illegal drugs and pharmaceuticals used improperly); ii) promote action on the prevention of major diseases and rare diseases; iii) health effects of wider environmental determinants, including indoor air quality and exposure to toxic chemicals; iv) actions to help reduce accidents and injuries.

3) Generate and disseminate health information and knowledge:

Exchange knowledge and best practices: i) health issues within the scope of the Programme; ii) cooperation to enhance the application of best practices within Member States. Collect, analyse and disseminate health information: i) develop a sustainable health monitoring system with mechanisms for collection of comparable data; coordination of and follow-up to Community initiatives regarding registries on cancer; ii) 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; iii) analysis and technical assistance in support of the development or implementation of policies or legislation related to the scope of the Programme.

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;

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;

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

The financial envelope for the implementation of the Programme is set at EUR 321,500,000.

ENTRY INTO FORCE: 21/11/2007.

On 10 July 2007, the European Parliament adopted a compromise package which had been agreed with the Council in view of reaching a second reading agreement. Ways were found to respond to the concerns of the Parliament regarding the text of the Programme, by making modifications to the text, while reflecting the spirit of the Commission modified proposal.

The Commission accepts all amendments. The conclusion of the compromise package has been facilitated by a trilateral declaration which quotes the rules of budgetary flexibility for EU programmes under the Inter-Institutional Agreement (Article 37) in favour of the health programme.

In the trilateral declaration, the European Parliament, the Council and the Commission:

- share the view that the 2nd Programme of Community action in the field of Health (2007-2013) 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 management6 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;

- assure their willingness to evaluate in a sound manner the specific needs and circumstances of the Health Programme in the annual budget procedure.

The European Parliament adopted a resolution based on the compromise text negotiated by the rapporteur Antonios Trakatellis (EPP-ED, EL), made a few changes to the common position:

- the financial envelope for the implementation of the Programme for the period from 1 January 2008 to 31 December 2013 was set at EUR 321 500 000 ;

- the programme was initially due to run from 2007 to 2013, but under the compromise, it will now run from 1 January 2008 to 31 December 2013;

- the programme's objectives now include the reduction of health inequalities;

- 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;

- the Commission must present not later than 31 December 2010 , an external and independent interim evaluation report; it must present a Communication on the continuation of the Programme not later than 31 December 2011;

- eligible actions under the programme include supporting cooperation to enhance the application of best practice within Member States, including, where appropriate, supporting European Reference Networks.

The compromise text includes in the Annex a reference to patient and health professional mobility. The programme should also contribute to : i) address addiction-related determinants such as tobacco, alcohol , illegal drugs and improper use of pharmaceuticals ; ii) 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; iii) support cooperation to enhance the application of best practice within Member States, including, where appropriate, supporting European Reference Networks; iv) 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 on cancer screening.

Lastly, Decision No 1786/2002/EC will be repealed with effect from 1 January 2008. The Commission will 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.

The Committee on the Environment, Public Health and Food Safety adopted, by a very large majority at second reading, the report drafted by Antonios TRAKATELLIS (EPP-ED, EL) on the Council common position establishing a second programme of Community action in the field of health (2007-2013).

Firstly, are regards the budget, the report recalls that the budgets of the new multi-annual programmes in all policy areas were part of the negotiations on the new Financial Framework for 2007-2013. Member States' compromise in December 2005 left the funding of a number of policy areas much below the level that the Commission had originally proposed. The European Parliament was partly able to correct the situation in the negotiations with the Council in spring 2006, but the consequences of the deal were worse for some policy areas than others. One of the policy areas to suffer most was public health, and the Health Programme became the biggest victim.

The budget originally proposed by the Commission of EUR 969 million, increased by Parliament to EUR 1 500 million, shrank to just EUR 365.6 million. The common position fixed the financial for the implementation of the Programme for the period specified at EUR 365.6 million. The committee asks for the envelope to be increased by 10% (to EUR 402 160 000) to slightly rectify the drastic budget cut. The committee also included an amendment stating that the budgetary authority could decide to modify the annual programming foreseen by the Commission, which is purely indicative, and increase the commitment and payment appropriations over the first two or three years of the period, possibly with a monitoring clause, in accordance with the provisions of the Interinstitutional Agreement. The use of the Flexibility Instrument was also proposed to cover expenditure which could not be financed within the limits of the ceilings available for one or more other headings.

The recommendation includes the following provisions:

- the Commission should submit, during the course of this Framework Programme, proposals for Council Recommendations on the prevention, diagnosis and control of major diseases;

- the Programme should build on the achievements of the previous Programme for Community action in the field of public health (2003-2008). 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 provide citizens with better access to information and thereby increase their ability to make decisions which cater best for their interests;

- 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 networks of centres of reference for specific conditions should be developed. It is also important to allow alternatives, which may be preferable for social, ethical and other individual reasons;

- a first reading amendment was reintroduced stating that a holistic and pluralist approach to public health is necessary and therefore complementary and alternative medicine should be included in the actions supported by the Programme;

- 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-profit-making body designated through a transparent procedure by the Member State or the competent authority concerned and agreed by the Commission. These Community contributions should be granted on the basis of the criteria for patients' and consumers' organisations adopted by the European Medicines Agency;

- the report calls for the establishment of a Community system for cooperation between centres of reference to enhance the application of best practice within Member States;

- another first reading amendment has been reformulated which calls for the further development of a sustainable health monitoring system with mechanisms for collection of data and information, with appropriate indicators; collect data on health status and policies; establish Europe-wide registers on major diseases, such as cancer, and at the very least, on cervical cancer, breast cancer and colorectal cancer, based on the data collected when implementing the Council recommendation on cancer screening; develop methodologies and database maintenance; the statistical element of this system will be developed together with the Community Statistical Programme.

The Commission considers that the common position is in line with the objectives and the approach of its modified proposal. The Commission will support inter-institutional efforts to find an agreement in the course of the second reading.

The Council adopted its common position by unanimity. The common position was largely based on the Commission’s modified proposal issued on 24/05/2006. (Please see the summary of that date.)

To recall, the modified proposal adapted the scope and range of actions of the programme to the substantial reduction in the programme budget resulting from the Inter-institutional Agreement on the EU Financial Framework (2007-2013) as well as to the views expressed by the European Parliament. This split the health programme from the consumer protection programme, and introduced new focuses on health inequalities, promoting healthy ageing, and addressing children’s health and gender questions which reflect the European Parliament at first reading. (Please see the summary of 16/03/2006.)

The Council discussions concentrated on several specific issues concerning both the content and implementation of the programme:

- some Member States expressed reservations on substantive issues of content, such as the priority to be given to the reduction of major diseases and the work to be undertaken in improving the EU's capacity to respond to health threats, including the support to be given to networking of laboratories;

- a number of Member States wished to have more clarity on the financial mechanisms to be employed in the programme, such as how operational grants would be used, the functioning of the Programme Committee, and how the programme would be evaluated;

Ways were found to respond to the Member States reservations by making some small modifications to the text, while fully respecting the spirit of the Commission modified proposal. These included:

- adding a reference to major diseases in Article 2 in view of the European Parliament's concern about stressing reduction of major disease as a key objective of the programme;

- additional wording in Recital 32 and Article 13 to specify more precisely the nature and aims of the evaluation to be carried out;

- in Annex 1, point 1.1.1 on protecting citizens against health threats, a modification was made to clarify that the objective of the Community action was to help to strengthen Member States capabilities to support existing laboratories carrying out work with Community relevance, rather then to set up new Community mechanisms;

- in relation to the financial arrangements, the wording of Article 8 was kept unchanged, but a new Recital 33, guiding its interpretation, was added to make it clearer that Committee of the programme would be fully informed;

- in relation to operational grants to Non-Governmental Organisations (NGOs), the wording of Recital 26 and Article 4 was slightly modified to respond to Member States concerns about the scope of this provision, but the aim of the Commission's proposal was maintained.

Finally, as the co decision procedure is still continuing, it will not be possible to apply the new legal base from 2007. Accordingly, the existing legal base ((EC) 1786/2002) will be the one used to finance health actions in 2007. As a consequence, the budget line to be used in 2007 for operational expenditure remains the same as in 2006, but an internal transfer has been made to be able to use the budget allocated to the public health programme in 2007.

The Council adopted its common position by unanimity. The common position was largely based on the Commission’s modified proposal issued on 24/05/2006. (Please see the summary of that date.)

To recall, the modified proposal adapted the scope and range of actions of the programme to the substantial reduction in the programme budget resulting from the Inter-institutional Agreement on the EU Financial Framework (2007-2013) as well as to the views expressed by the European Parliament. This split the health programme from the consumer protection programme, and introduced new focuses on health inequalities, promoting healthy ageing, and addressing children’s health and gender questions which reflect the European Parliament at first reading. (Please see the summary of 16/03/2006.)

The Council discussions concentrated on several specific issues concerning both the content and implementation of the programme:

- some Member States expressed reservations on substantive issues of content, such as the priority to be given to the reduction of major diseases and the work to be undertaken in improving the EU's capacity to respond to health threats, including the support to be given to networking of laboratories;

- a number of Member States wished to have more clarity on the financial mechanisms to be employed in the programme, such as how operational grants would be used, the functioning of the Programme Committee, and how the programme would be evaluated;

Ways were found to respond to the Member States reservations by making some small modifications to the text, while fully respecting the spirit of the Commission modified proposal. These included:

- adding a reference to major diseases in Article 2 in view of the European Parliament's concern about stressing reduction of major disease as a key objective of the programme;

- additional wording in Recital 32 and Article 13 to specify more precisely the nature and aims of the evaluation to be carried out;

- in Annex 1, point 1.1.1 on protecting citizens against health threats, a modification was made to clarify that the objective of the Community action was to help to strengthen Member States capabilities to support existing laboratories carrying out work with Community relevance, rather then to set up new Community mechanisms;

- in relation to the financial arrangements, the wording of Article 8 was kept unchanged, but a new Recital 33, guiding its interpretation, was added to make it clearer that Committee of the programme would be fully informed;

- in relation to operational grants to Non-Governmental Organisations (NGOs), the wording of Recital 26 and Article 4 was slightly modified to respond to Member States concerns about the scope of this provision, but the aim of the Commission's proposal was maintained.

Finally, as the co decision procedure is still continuing, it will not be possible to apply the new legal base from 2007. Accordingly, the existing legal base ((EC) 1786/2002) will be the one used to finance health actions in 2007. As a consequence, the budget line to be used in 2007 for operational expenditure remains the same as in 2006, but an internal transfer has been made to be able to use the budget allocated to the public health programme in 2007.

Package of legislative proposals following the Interinstitutional Agreement on

budgetary discipline and sound financial management

The conclusion on 17 May 2006 by the Commission, the Council and the European Parliament of the agreement on the 2007-2013 financial framework (Interinstitutional Agreement on budgetary discipline and sound financial management – please refer to procedure ACI/2004/2099 ) marks a real success for Europe, providing a stable financial framework for the political priorities of the enlarged Union for the next seven years. It is now up to the institutions and Member States to ensure that the financial resources available are used and implemented as well as possible. Action at European level must contribute true added value to that taken at national, regional or local level and must have an optimum impact on each European player. The Commission is ready to play a full role in all these areas.

The agreement marks a decisive step forward towards the ultimate objective of providing the Union with operational programmes by the beginning of 2007. Work must now be continued on each legislative act. To this end, the Commission intends to continue to provide momentum and act as a facilitator, as it has been doing since the start of the negotiations.

As part of the negotiations on the 2007-2013 financial framework, in October 2005 the European Parliament, the Council and the Commission adopted a joint declaration in which they undertook to continue work on the legislative proposals currently being discussed and then, once the interinstitutional agreement had been adopted and on the basis of amended proposals by the Commission, to reach agreement on each of these proposals. Thus, in accordance with Article 250(2) of the EC Treaty and in order to facilitate this phase for each legislative act, the Commission has adopted a total of 30 proposals, 26 of which are amended and 4 new.

The proposals amended as a result of the IIA are as follows:

Programmes concerning the external policy of the Union and development cooperation:

Ø COD/2004/0219 ( European Neighbourhood and Partnership Instrument )

Ø COD/2004/0220 ( development co-operation and economic co-operation instrument )

Solidarity and Management of Migration Flows Programme (JHA):

Ø COD/2005/0046 (European Refugee Fund)

Ø COD/2005/0047 ( External borders fund, 2007-2013 )

Ø COD/2005/0049 ( European Return Fund )

Fundamental Rights and Justice Programme (JHA):

Ø COD/2005/0037/A (DAPHNE )

Ø COD/2005/0037/B ( drugs prevention and information )

RDT Framework Programme and specific programmes :

Ø COD/2005/0043 ( RDT Framework Programme )

Ø CNS/2005/0044 (Nuclear Research Programme )

Ø CNS/2005/0184 ( Joint Research Centre - JRC )

Ø CNS/2005/0185 ( Transnational cooperation specific programme )

Ø CNS/2005/0186 ( Specific programme Ideas, frontier research )

Ø CNS/2005/0187 (S pecific programme supporting researchers )

Ø CNS/2005/0188 (RDT Capacities specific programme )

Ø CNS/2005/0189 ( specific programme direct actions by the Joint Research Centre JRC )

Ø CNS/2005/0190 ( fusion energy, nuclear fission and radiation protection specific programme)

Employment and social cohesion Programme: COD/2004/0158

Programmes in the fields of youth and education:

Ø COD/2004/0152 ( Youth )

Ø COD/2004/0153 ( Education – lifelong learning )

Consumer Protection and Public Health Framework programme:

Ø COD/2005/0042/A ( Public health )

Ø COD/2005/0042/B ( Consumers )

Programme in the fields of energy, environment and transport :

Ø COD/2004/0218 ( LIFE+)

Ø COD/2004/0154 ( TransEuropean networks in the areas of energy and transport )

Ø CNS/2004/0221 ( Decommissioning of the Bohunice nuclear plant )

GALILEO ( radio-navigation by satellite ): COD/2004/0156

In terms of new proposals , the Commission has already submitted three in the area of agriculture and rural development policy and fisheries and aquaculture policy:

Ø CNS/2006/0081 ( fisheries and aquaculture )

Ø CNS/2006/0082 ( rural development )

Ø CNS/2006/0083 ( common agricultural policy ).

Certain legislative acts do not form part of this package of measures, in particular those on which political agreement has been reached since 17 May. For these measures, the Commission has played a full part in helping to bring about agreement between the arms of the legislative authority. The same applies to the acts for which conclusion of the interinstitutional agreement does not modify the Commission’s original proposal. For all the others, which are included in the package presented, the changes proposed by the Commission take account of the content of the interinstitutional agreement adopted, either in a simplified form, where the financial resources allocated to each programme must be adapted, or in a more detailed form where the structure or even the content of the act must be revised. It should also be noted that four of the amended proposals contain amendments already voted on by the European Parliament at first reading and that one proposal has been divided into two amended proposals in response to a request by the Council and the European Parliament, although Parliament has not yet proceeded to a first reading of this proposal.

Based on these amended proposals, the Commission calls on the European Parliament and the Council to continue their discussions of these proposals and conclude them as soon as possible in order to ensure that all the legal instruments are available in time for the effective launch of the programmes in January 2007.

PURPOSE : to establish a second Programme of Community action in the field of Health (2007-2013) following the agreement of 17 May 2006 on the Financial Framework 2007-2013.

PROPOSED ACT : Decision of the European Parliament and of the Council.

CONTEXT : on 6 April 2005, the Commission proposed a wide-ranging and ambitious health and consumer protection programme 2007-2013 based on the assumption of a EUR 1 203 million budget (out of which EUR 969 million was for health ). This proposal foresaw a significant increase in existing Community health action from three to six action strands in order to address cross-border health challenges and to meet stakeholders’ expectations.

In its first reading Opinion of 16 March 2006 on the health part of the programme, the European Parliament endorsed the objectives and main actions proposed by the Commission, underlined its preference for a separate health programme, enlarged further the scope of proposed health action and requested a budget of EUR 1 500 million.

However, following the inter-institutional agreement on the Community Financial Framework 2007-2013, the final budget for health action was settled at EUR 365.6 million , i.e. approximately one third of the budget initially foreseen in the Commission proposal of April 2005. Given these resource constraints, it is necessary to take a more focused approach to Community health action.

CONTENT : the purpose of the current modified proposal is to replace the original Commission proposal of April 2005 as far as health action is concerned. In presenting a separate proposal for health action only, the Commission is responding positively to the approach favoured by the Parliament and the Economic and Social Committee as regards splitting its proposal into two. A separate proposal tackles consumer protection.

The Commission therefore proposes to refocus the scope of the programme along three broad objectives:

Objective 1: Improve citizens’ health security

Axis 1: Protect citizens against health threats: the Community Strategic objectives for 2005-2009 stress the importance of countering threats to citizens’ health and safety at EU level (including bioterrorism). Surveillance simply provides the information necessary for the Community to decide what needs to be done. To protect citizens, the EU needs technical and operational capability to prepare for and respond to health threats (inside or outside the EU). The programme will therefore support the development of EU capacity to co-ordinate a response at European level. It will contribute to enhancing the effectiveness of national structures with action to improve risk management and health emergency planning; facilitate co-ordination of actions in health emergencies; improve preparedness for health emergencies; and facilitate networking and exchange of best practice. The programme will further help Member States to develop their own infrastructure, capacity and co-ordination arrangements needed to respond to a threat.

Axis 2: Improve citizens’ safety: citizens are confronted with many and varied threats to their safety in addition to possible pandemics. This proposal takes account of the Parliament’s requests for the Community to treat serious cross-border health threats as a matter of priority, to co-ordinate closely work under the programme with work by the ECDC, and for action to be taken on injury prevention and

on organs.

Objective 2 : Promote health for prosperity and solidarity

Axis 1: Foster healthy, active ageing and help bridge inequalities: Europe ’s population is growing older and the proportion of working people is falling. Against this background a key challenge is to ensure that the population ages in good health. In addition, poor population health translates into lower productivity and labour participation. Thus a population in bad health impacts negatively on economic growth and the health gap feeds into the economic gap. The EU Regional policy can support investment in health infrastructure in convergence regions, as well as human resources throughout the European Union. This programme will also encourage Member States to invest in health in co-operation with other policies. This programme will take forward action to identify the causes of health inequalities within and between Member States with a particular emphasis on the situation in the new Member States; and will encourage exchange of best practice to address such inequalities. This modified proposal therefore takes full account of the Parliament’s requests for action on health inequalities to be a priority of the programme and will seek to contribute to bridging the health gap across the EU. In addition, the modified proposal takes account of the Parliament’s request for the programme to focus on cross-border issues. Synergies and complementarities would be sought with the health related cross border projects under the regional policy territorial cooperation objective. The programme will foster co-operation between health systems on a number of growing cross-border issues such as the mobility of patients and health professionals.

Axis 2 : Promote healthier ways of life by tackling health determinants: promoting good health therefore requires tackling the life-style factors (e.g. nutrition, physical activity and sexual health), and addictions (e.g. tobacco, alcohol, drugs) that undermine health, as well as broader socio-economic and environmental health determinants. This proposal foresees focused action in particular on lifestyle determinants and addiction-related determinants. Action to support healthy diets can contribute to reducing heart disease, and action on sexual health can contribute to fighting HIV/AIDS.

Objective 3: Generate and disseminate health knowledge

Axis 1 : exchange knowledge and best practice added value and focus on cross-border issues : exchange of best practice will target issues where the Community can provide genuine added-value in bringing together expertise from different countries, as is the case with rare diseases, or cross-border issues related with co-operation between health systems. It will also include horizontal issues

such as gender-related aspects of health or children’s health. Other key issues of common interest to all Member States such as mental health will also be covered.

Axis 2 : Collect, analyse and disseminate health information : to generate and disseminate health knowledge means expanding existing work to develop an EU health monitoring system that feeds into all health activities, using the Community Statistical Programme as necessary. The programme will continue efforts to develop indicators and other tools, and to collect data and information as a basis for policymaking. In addition, as envisaged in the original Commission proposal, the programme will increasingly focus on providing analysis and disseminating information to citizens in a user-friendly manner, such as the Health portal. A stronger focus on communication with citizens will also underpin efforts to bring Europe – and European health policy – closer to its citizens.

It should also be noted that this modified proposal aligns future health action more explicitly with the overall Community objectives of prosperity, solidarity and security and seeks to further exploit synergies with other policies, as highlighted by the European Parliament. The current modified proposal has incorporated to the extent possible the Parliament’s concerns on key strategic issues such as the need to promote healthy ageing, to address health inequalities across the EU, to take gender health issues into account and to focus on cross-border issues.

However, in the light of the budgetary constraints, this modified proposal does not include a specific action strand to tackle individual diseases (as in the Commission original proposal which was further strengthened by the European Parliament). Instead, in view of the limited resources, the Commission aims to help reduce the burden of diseases by tackling the most important health determinants. Nevertheless, in cases where there is important added value in Community level action on a specific disease (e.g. on rare diseases or mental health), provisions are made under the relevant objectives of the modified proposal. In addition, action on co-operation between health systems (a separate strand in the Commission original proposal) has been considerably streamlined and incorporated into all the three objectives for Community health action.

This modified proposal keeps the instruments and main implementing provisions of the initial Commission proposal of April 2005 and takes on board a number of European Parliament amendments which add detail and transparency to the initial proposal. In line with better regulation principles, particular efforts will be made to ensure policy coherence between this instrument and other Community programmes.

As requested by the Parliament in its first reading Opinion, the programme will strengthen synergies with other Community policies and programmes such as regional development and the Structural Funds, the Community statistical programme, the Community strategy for health and safety at work, the Sustainable development strategy, the Framework research programmes and the Lisbon agenda; and will seek to pursue, where appropriate, joint actions with other policies. Civil society participation in health policy-making will be promoted. Major initiatives under this programme will take full account of consultation with stakeholders. In addition, the Commission has taken on board the Parliament’s request for the draft Decision to provide clear criteria for NGOs eligible for core grants. This contributes to providing more transparency in the text, in accordance with better regulation principles. However, in the light of budgetary constraints, this modified proposal brings down the maximum core funding in exceptional cases from 95% (as in the original Commission proposal and endorsed by the Parliament) to 80%. The existing Public Health Programme puts a strong focus on co-financing cross-border action through project grants. The Commission proposes that the future programme will reduce the proportion of co-financing of projects and focus more on calls for tender in order to maximise the efficiency, effectiveness and added-value of actions financed under the programme, and as a means to ensure that resources are clearly channelled to needs related to the programme objectives.

Lastly, this programme is being developed as part of a broad-ranging health strategy, which will be presented by the Commission in 2007. The programme covers essentially those actions that require financial resources. The future strategy will bring together under a comprehensive framework the broad range of Community heath action and define goals and priorities. Key issues, such as the mainstreaming of health concerns in other policies, addressing health inequalities, and responding to international issues will be developed further in the strategy.

For further information concerning the financial implications of this measure, please refer to the financial statement.

PURPOSE : to establish a second Programme of Community action in the field of Health (2007-2013) following the agreement of 17 May 2006 on the Financial Framework 2007-2013.

PROPOSED ACT : Decision of the European Parliament and of the Council.

CONTEXT : on 6 April 2005, the Commission proposed a wide-ranging and ambitious health and consumer protection programme 2007-2013 based on the assumption of a EUR 1 203 million budget (out of which EUR 969 million was for health ). This proposal foresaw a significant increase in existing Community health action from three to six action strands in order to address cross-border health challenges and to meet stakeholders’ expectations.

In its first reading Opinion of 16 March 2006 on the health part of the programme, the European Parliament endorsed the objectives and main actions proposed by the Commission, underlined its preference for a separate health programme, enlarged further the scope of proposed health action and requested a budget of EUR 1 500 million.

However, following the inter-institutional agreement on the Community Financial Framework 2007-2013, the final budget for health action was settled at EUR 365.6 million , i.e. approximately one third of the budget initially foreseen in the Commission proposal of April 2005. Given these resource constraints, it is necessary to take a more focused approach to Community health action.

CONTENT : the purpose of the current modified proposal is to replace the original Commission proposal of April 2005 as far as health action is concerned. In presenting a separate proposal for health action only, the Commission is responding positively to the approach favoured by the Parliament and the Economic and Social Committee as regards splitting its proposal into two. A separate proposal tackles consumer protection.

The Commission therefore proposes to refocus the scope of the programme along three broad objectives:

Objective 1: Improve citizens’ health security

Axis 1: Protect citizens against health threats: the Community Strategic objectives for 2005-2009 stress the importance of countering threats to citizens’ health and safety at EU level (including bioterrorism). Surveillance simply provides the information necessary for the Community to decide what needs to be done. To protect citizens, the EU needs technical and operational capability to prepare for and respond to health threats (inside or outside the EU). The programme will therefore support the development of EU capacity to co-ordinate a response at European level. It will contribute to enhancing the effectiveness of national structures with action to improve risk management and health emergency planning; facilitate co-ordination of actions in health emergencies; improve preparedness for health emergencies; and facilitate networking and exchange of best practice. The programme will further help Member States to develop their own infrastructure, capacity and co-ordination arrangements needed to respond to a threat.

Axis 2: Improve citizens’ safety: citizens are confronted with many and varied threats to their safety in addition to possible pandemics. This proposal takes account of the Parliament’s requests for the Community to treat serious cross-border health threats as a matter of priority, to co-ordinate closely work under the programme with work by the ECDC, and for action to be taken on injury prevention and

on organs.

Objective 2 : Promote health for prosperity and solidarity

Axis 1: Foster healthy, active ageing and help bridge inequalities: Europe ’s population is growing older and the proportion of working people is falling. Against this background a key challenge is to ensure that the population ages in good health. In addition, poor population health translates into lower productivity and labour participation. Thus a population in bad health impacts negatively on economic growth and the health gap feeds into the economic gap. The EU Regional policy can support investment in health infrastructure in convergence regions, as well as human resources throughout the European Union. This programme will also encourage Member States to invest in health in co-operation with other policies. This programme will take forward action to identify the causes of health inequalities within and between Member States with a particular emphasis on the situation in the new Member States; and will encourage exchange of best practice to address such inequalities. This modified proposal therefore takes full account of the Parliament’s requests for action on health inequalities to be a priority of the programme and will seek to contribute to bridging the health gap across the EU. In addition, the modified proposal takes account of the Parliament’s request for the programme to focus on cross-border issues. Synergies and complementarities would be sought with the health related cross border projects under the regional policy territorial cooperation objective. The programme will foster co-operation between health systems on a number of growing cross-border issues such as the mobility of patients and health professionals.

Axis 2 : Promote healthier ways of life by tackling health determinants: promoting good health therefore requires tackling the life-style factors (e.g. nutrition, physical activity and sexual health), and addictions (e.g. tobacco, alcohol, drugs) that undermine health, as well as broader socio-economic and environmental health determinants. This proposal foresees focused action in particular on lifestyle determinants and addiction-related determinants. Action to support healthy diets can contribute to reducing heart disease, and action on sexual health can contribute to fighting HIV/AIDS.

Objective 3: Generate and disseminate health knowledge

Axis 1 : exchange knowledge and best practice added value and focus on cross-border issues : exchange of best practice will target issues where the Community can provide genuine added-value in bringing together expertise from different countries, as is the case with rare diseases, or cross-border issues related with co-operation between health systems. It will also include horizontal issues

such as gender-related aspects of health or children’s health. Other key issues of common interest to all Member States such as mental health will also be covered.

Axis 2 : Collect, analyse and disseminate health information : to generate and disseminate health knowledge means expanding existing work to develop an EU health monitoring system that feeds into all health activities, using the Community Statistical Programme as necessary. The programme will continue efforts to develop indicators and other tools, and to collect data and information as a basis for policymaking. In addition, as envisaged in the original Commission proposal, the programme will increasingly focus on providing analysis and disseminating information to citizens in a user-friendly manner, such as the Health portal. A stronger focus on communication with citizens will also underpin efforts to bring Europe – and European health policy – closer to its citizens.

It should also be noted that this modified proposal aligns future health action more explicitly with the overall Community objectives of prosperity, solidarity and security and seeks to further exploit synergies with other policies, as highlighted by the European Parliament. The current modified proposal has incorporated to the extent possible the Parliament’s concerns on key strategic issues such as the need to promote healthy ageing, to address health inequalities across the EU, to take gender health issues into account and to focus on cross-border issues.

However, in the light of the budgetary constraints, this modified proposal does not include a specific action strand to tackle individual diseases (as in the Commission original proposal which was further strengthened by the European Parliament). Instead, in view of the limited resources, the Commission aims to help reduce the burden of diseases by tackling the most important health determinants. Nevertheless, in cases where there is important added value in Community level action on a specific disease (e.g. on rare diseases or mental health), provisions are made under the relevant objectives of the modified proposal. In addition, action on co-operation between health systems (a separate strand in the Commission original proposal) has been considerably streamlined and incorporated into all the three objectives for Community health action.

This modified proposal keeps the instruments and main implementing provisions of the initial Commission proposal of April 2005 and takes on board a number of European Parliament amendments which add detail and transparency to the initial proposal. In line with better regulation principles, particular efforts will be made to ensure policy coherence between this instrument and other Community programmes.

As requested by the Parliament in its first reading Opinion, the programme will strengthen synergies with other Community policies and programmes such as regional development and the Structural Funds, the Community statistical programme, the Community strategy for health and safety at work, the Sustainable development strategy, the Framework research programmes and the Lisbon agenda; and will seek to pursue, where appropriate, joint actions with other policies. Civil society participation in health policy-making will be promoted. Major initiatives under this programme will take full account of consultation with stakeholders. In addition, the Commission has taken on board the Parliament’s request for the draft Decision to provide clear criteria for NGOs eligible for core grants. This contributes to providing more transparency in the text, in accordance with better regulation principles. However, in the light of budgetary constraints, this modified proposal brings down the maximum core funding in exceptional cases from 95% (as in the original Commission proposal and endorsed by the Parliament) to 80%. The existing Public Health Programme puts a strong focus on co-financing cross-border action through project grants. The Commission proposes that the future programme will reduce the proportion of co-financing of projects and focus more on calls for tender in order to maximise the efficiency, effectiveness and added-value of actions financed under the programme, and as a means to ensure that resources are clearly channelled to needs related to the programme objectives.

Lastly, this programme is being developed as part of a broad-ranging health strategy, which will be presented by the Commission in 2007. The programme covers essentially those actions that require financial resources. The future strategy will bring together under a comprehensive framework the broad range of Community heath action and define goals and priorities. Key issues, such as the mainstreaming of health concerns in other policies, addressing health inequalities, and responding to international issues will be developed further in the strategy.

For further information concerning the financial implications of this measure, please refer to the financial statement.

The European Parliament adopted a resolution drafted by Antonios TRAKATELLIS (EPP-ED, EL) and made some amendments to the Commission’s proposal. The Commission had originally suggested a single action programme for health and consumer protection, with an overall budget of EUR 1,203 million, of which EUR 969 million were earmarked for health. The Commission hoped to achieve more efficiency by combining the two areas but Parliament, while in favour of pooling administrative resources, decided that the two areas, which come under different legal bases (Articles 152 and 153 of the EC Treaty) in which the EU has different powers, should be split into two separate programmes. The Committee on Internal Market and Consumer Protection thus dealt only with consumer protection, while the Environment and Public Health Committee was left to address the health component. Commissioner Kyprianou still insisted on the original approach and stated that the Commission would reject amendments that split the programme. Parliament affirmed that the wording of the title must make it clear that this proposal would deal with health only and would be the second Community action programme in the field of public health, covering the period from 1 January 2007 to 31 December 2013. Other amendments include the following:

- The budget for the programme should be increased to EUR 1 500 million for the seven-year period starting on 1 January 2007 since extra funding was required for new actions.

- Such new actions should include: Monitoring the resistance of bacteria to antibiotics and of nosocomial infections, and developing strategies to prevent and treat them; developing measures to prevent disease and injury in socially isolated individuals and to raise the awareness of immigrants in matters of health; encouraging Member States to establish genuinely independent drug scrutiny boards to monitor the usage and effects of all new prescription drugs from the date of their approval; identification of the causes of health inequalities; analysis of genetic determinants and personal and biological factors of major diseases and development of prevention strategies, including genetic screening, but excluding the possibility that data could be used for employment, insurance, eugenic or family planning purposes; the development of strategies and the exchange of correct practices in order to prevent disability, where possible, and promote the health of people with disabilities; support for the development of education units on nutrition for parents and children; support for actions to improve diagnosis and therapy for older persons; and gender and age aspects of health.

- The Commission must ensure that the Programme ties in optimally with other Community programmes, actions and funds. In particular, cooperation with the 7th Framework Programme of Research should reinforce the impact of the Programme.

- The Programme will complement , support and add value to the policies of the Community and Member States and contribute to protecting and promoting human health and safety , preventing human illness, diseases and injuries and improving public health .

- The Programme will also contribute to encouraging cooperation among Member States and tackling inequalities of all kinds in the field of health which exist amongst and within Member States so that all EU citizens have access to health care of a comparable standard, irrespective of sex, age, ethnic origin, education or place of residence.

- The proportion of EU funding for NGOs which specialise in health promotion should be 75%, rather than 60% as proposed by the Commission. Parliament added that as a general rule the Commission can, as a general rule, seek to grant core funding on a two-year basis by means of a framework partnership convention. In accordance with Article 163 of the Implementing Rules of the Financial Regulation, such a partnership establishes a long-term cooperation between the recipient and the Commission, but shall not exceed two years.

- The Commission must ensure, in close cooperation with the Member States, for the attainment of the objectives of the Programme the necessary cooperation and communication with the European Centre for Disease Prevention and Control.

- The Commission must submit the following reports: an external and independent interim evaluation report on the results obtained and the qualitative and quantitative aspects of the implementation of the Programme three years after its adoption, making it possible to assess the impact of measures on all countries; a Communication on the continuation of the Programme no later than four years after its adoption; no later than 31 December 2015, a detailed external and independent ex-post evaluation report covering the implementation and results of the Programme, to be drawn up on completion of its implementation. In addition, it must publish every two years after the adoption of the Programme a report on Health Status in the European Union based on all data and indicators and including a qualitative and quantitative analysis.

- C oordination and cooperation must be ensured between the Commission and the Member States on a variety of matters.

The committee adopted the report by Antonios TRAKATELLIS (EPP-ED, EL) amending the proposal under the 1st reading of the codecision procedure. The original proposal as submitted by the Commission consisted of a single action programme for health and consumer protection. However, on 30 June 2005 the EP Conference of Presidents decided that the proposal should be split into two parts (i.e. two separate programmes) and allocated to two different committees on the grounds that the two areas come under different legal bases (Articles 152 and 153 of the EC Treaty) in which the EU has different powers. The Environment Committee was therefore made responsible for drawing up a report on the health action programme, and the Internal Market Committee was given responsibility for a report on the action programme for consumer protection (see factfile COD/2005/0042B).

The committee amended the wording of the title to make it clear that this proposal would deal with health only and would be a continuation of the first integrated Community action programme in the field of public health (2003-2008). The other key amendments were as follows:

- MEPs clarified the aims and objectives of the programme, which should include "preventing human illness, diseases and injuries and improving public health", improving "information and knowledge for the development of public health" and contributing to "mainstreaming of health objectives";

- they added further objectives, such as "the promotion of a multi-faceted approach to health", tackling inequalities between and within Member States by guaranteeing access to healthcare for all according to comparable standards and without discrimination, facilitating patient mobility and improving transparency between national healthcare systems;

- the budget for the programme should be increased from EUR 1 203 million, as allocated by the Commission for the health protection aspects of its original proposal, to EUR 1 500 million for the seven-year period starting on 1 January 2007. MEPs argued that the extra funding was needed to cover the addition of new actions and measures;

- such new actions should include: monitoring the resistance of bacteria to antibiotics and the resistance of nosocomial infections, and developing strategies to prevent and treat them; developing measures to prevent disease and injury in socially isolated individuals and to "raise the awareness of immigrants in matters of health"; identifying injury-related health determinants; improving diagnosis and therapy for older people; identifying and addressing the causes of health inequalities; improving crossborder cooperation, in particular for the treatment of rare diseases, as well as exchanges of information on the services and treatments available and on reimbursements; and collecting and analysing data on disabilities, lifestyle-related factors and sub-fertility;

- the methods of implementing the programme and the terms of funding should be defined by the programme's management committee;

- the proportion of EU funding for NGOs which specialise in health promotion should be 75%, rather than 60% as proposed by the Commission;

- provision should be made for an external and independent evaluation of the results of the programme;

- coordination and cooperation must be ensured between the Commission and the Member States .

The Council took note of a progress report on a proposal aimed at establishing a programme of Community action in the field of health and consumer protection for 2007-2013. The Council decided to come back to this issue at a future meeting.

The adoption of the programme is conditional on the budgetary amount that will be decided for the 2007-2013 period in the framework of the financial perspectives, and on the outcome of discussions in the European Parliament.

The Council held a debate on the Community programme on action in the field of health and consumer protection 2007-2013.

The debate gave delegations an opportunity to state their initial reactions to the Commission proposal which brings together, in a single integrated programme, the objectives pursued by the two public health and consumer protection programmes currently in place. Delegations also stressed the need to enhance the added value of the common actions in this area, pointing, in particular, that it would be useful to improve cooperation between Member States' health systems and to improve the way in which cross-border health threats (pandemics) were addressed. They also pointed to the need to deal with the risk factors in order to prevent major diseases.

Following the debate, the President concluded that these objectives were very broadly shared by the delegations.

PURPOSE : proposal to establish a Programme of Community action in the field of Health and Consumer protection 2007-2013 to improve EU citizens’ quality of life in terms of their health and their consumer interests.

PROPOSED ACT : Decision of the European Parliament and of the Council.

CONTENT : the proposal and the Commission’s Communication bring together Public Health and Consumer protection policies and programmes under one framework. This is due to the fact that many objectives of health and consumer actions under Treaty articles 152 and 153 are shared: promoting health protection, information and education, safety and integration of health and consumer concerns into all policies. Health and consumer policies also use many similar types of actions to pursue their objectives e.g. information to citizens, consultation of stakeholders, mainstreaming activities, risk assessment. Bringing the two areas together will thus lead to greater policy coherence, economies of scale and increased visibility.

The EU, national and regional authorities, citizens, businesses and civil society have a role to play in improving the health, wellbeing and welfare of European citizens. There are, however, several shared health and consumer policy challenges that only action at EU level can tackle. Greater mobility and more communication have benefited citizens. But they have also increased the risk of spreading health threats such as SARS and other communicable diseases (which cannot be addressed by individual Member States alone) and scams e.g. from bogus lotteries. The complexity of modern life has brought more choice for citizens. But it has also made it harder for them to make the best choices.

The proposed strategy and programme aim to implement articles 152 and 153 of the Treaty as regards Community action on health and consumer protection, by complementing national action with value-added measures which cannot be taken at national level. Bringing health and consumer protection under a common framework will lead to important synergies in terms of objectives and actions, and enhance policy coherence. Merging the two programmes will also streamline administrative procedures (with a common set of tools and a unified budget) and increase visibility of policy actions vis-à-vis European citizens and within the EU institutions.

EU Health and Consumer policies have three core joint objectives:

- Protect citizens from risks and threats which are beyond the control of individuals and that cannot be effectively and completely tackled by individual Member States alone.

- Increase the ability of citizens to take better decisions about their health and consumer interests. This means increasing the opportunities they have to exercise real choice and also equipping them with the knowledge they need.

- Mainstream health and consumer policy objectives across all Community policies in order to put health and consumer issues at the centre of policy-making. The EU Treaty recognises this by requiring that all policies take health and consumer interests into account.

With regard to health, the Programme reinforces the three strands of the Public Health Programme (information, threats and determinants), and creates three new ones: response to threats, disease prevention and co-operation between health systems. Annex II to the proposal provides an exhaustive list of actions planned under each strand.

With regard to consumer protection, the proposal foresees that a European Consumer Institute created within the single executive agency of the programme will be the cornerstone for implementing the actions. Implementing the programme and managing the additional resources means efficient and structured organisation. The proposal discusses the extension of the Health Executive Agency to include a consumer department as the most cost effective way of proceeding.

Four strands of actions are foreseen:

-Better understanding of consumers and markets. This includes developing and updating its scientific knowledge base and assessment tools on consumer exposure to chemicals, including with respect to general product safety, and to contribute to the application of REACH.

- Better consumer protection regulation;

- Better enforcement, monitoring and redress;

- Better informed and educated consumers.

Actions will contribute to ensure an equally high level of protection for all EU consumers, wherever they live, travel to or buy from in the EU, from risks and threats to their interests. Action covers the safety of goods and services; the fairness of commercial practices and contractual rights for consumers; affordable access to essential services, protection from rogue traders and access to effective means of redress. Actions will also contribute to increase the capacity of consumers to promote their own interests, as individuals or though consumer organisations, i.e., helping consumers help themselves. This includes the provision of information to consumers about their rights, means of redress but also products and the opportunities of the internal market.

For further information concerning the financial implications of this measure, please refer to the financial statement.

COMMISSION’S IMPACT ASSESSMENT

For further information about the context of this issue, please refer to the summary relating to the Commission’s proposal for a health and consumer protection strategy (COM(2005)0115).

1- POLICY OPTIONS AND IMPACTS

Five options were evaluated.

1.1- Option 1 - No action: t his action would not be in line with the Treaty which provides for intervention at Community level in health and consumer protection policy as laid down in Articles 152 and 153. This would appear to call into question everything that has already been achieved in the area of health and consumer protection policy at Community level. This option, therefore, cannot be retained.

1.2- Option 2 - Continuation of the two programmes under way with the same budget (status quo): t his would have the advantage of better continuity in the approach to each of the programmes with respect to national authorities (Health and Consumer Affairs generally fall under different ministries) and non-governmental organizations (consumer associations rarely deal with health questions in detail and vice versa). However, the disadvantages of this approach would be that the current budget would neither permit an optimal implementation of the obligations of the Treaty nor respond to the political will to do more for citizens in the area of health and consumer protection.

1.3- Option 3 - Continuation of two separate programmes, each with increased funding: as is the case for Option 2, this would offer the advantage of better continuity. A larger budget would enable a wider range of measures and more effective projects. However, the disadvantages would stem from the lack of synergies that would result from the merging of the two programmes – greater efficiency and visibility.

1.4- Option 4 - A merged programme with increased funding: this would enable Community action to be more effective and efficient resulting in an increased volume and extent of measures undertaken and would allow the Community to implement more fully Articles 152 and 153 of the Treaty. There would be budgetary and administrative advantages as well as greater synergies and visibility.

1.5- Option 5: presentation of a joint programme when the two current programmes come to an end. This option would have the advantage of being able to take into account the results of the operation of the current programmes. It would enable a more detailed consultation of Member States and all the parties concerned to take place. However, it should be noted that the two programmes do not finish the same year (2008 for the health programme and 2007 for the consumer one). In addition, this option would not fit in with the timing fixed by the 2007-2013 financial perspectives.

IMPACTS

- Economic: improving health and consumer confidence will contribute to boosting growth and employment by enhancing competitiveness. Better health contributes to productivity, labour force participation and sustainable growth. Improved confidence will encourage consumers to buy goods and services across borders.

- Social: Communication and awareness measures will help citizens have better access to healthcare and to cross-border goods and services. There will be better protection against dangerous products and other health threats. Citizens’ ability to take better decisions both about their health and their consumer interests will be increased. More informed consumers will be able to opt to make healthy choices of the products they consume. Action under the health determinants and the information strands of the new programme is particularly relevant in raising awareness of the effects on health of food and drinks, alcohol, tobacco and drugs. In addition, action under the strand ‘to achieve synergies between health systems’ will impact positively on consumers’ access to cross-border goods and services, in particular health services.

- Environmental: the selected option seeks to increase capacity to fight natural or man-made health threats – thus countering adverse effects both on the environment and human health. However, the impact that health policies have on the environment is minor compared to the impact that environment has on health. The environment, therefore, has a potential negative impact on human health.

- Innovation and research: the integration of health and consumer interests in other policies, such as research will allow the possibility of fostering the exchange of good practice between Member States and the development of centres of excellence.

- Public health and safety: the chosen option will improve the health status of European citizens to promote health as a human right, encourage health investment as a means to bridge the health gap by pursuing the following specific objectives: protecting citizens against health threats, promoting policies that lead to a healthier lifestyle, contributing to reducing the incidence of major diseases and to the development of more effective and efficient health systems.

- Governance and participation: The proposed strategy and programme seek to ensure that health and consumer protection policies are shaped in closer partnership with citizens and stakeholders and that their concerns are better taken into account in policy-making.

CONCLUSION : Only the selected option with increased funding for a merged health-consumer protection programme will allow the Community to efficiently achieve the objectives that it has set itself in this field.

2- FOLLOW-UP

The Commission, in close cooperation with the Member States, will undertake a regular follow-up of the implementation of the programme. In December 2010, it will, with the assistance of external experts, draw up a mid-term report providing a first evaluation of the results in order to determine whether any changes need to be made for the second half of the programme. An ex post evaluation report will be drawn up after the seventh year of the programme’s operation to be submitted no later than 31/12/2015).

PURPOSE : proposal to establish a Programme of Community action in the field of Health and Consumer protection 2007-2013 to improve EU citizens’ quality of life in terms of their health and their consumer interests.

PROPOSED ACT : Decision of the European Parliament and of the Council.

CONTENT : the proposal and the Commission’s Communication bring together Public Health and Consumer protection policies and programmes under one framework. This is due to the fact that many objectives of health and consumer actions under Treaty articles 152 and 153 are shared: promoting health protection, information and education, safety and integration of health and consumer concerns into all policies. Health and consumer policies also use many similar types of actions to pursue their objectives e.g. information to citizens, consultation of stakeholders, mainstreaming activities, risk assessment. Bringing the two areas together will thus lead to greater policy coherence, economies of scale and increased visibility.

The EU, national and regional authorities, citizens, businesses and civil society have a role to play in improving the health, wellbeing and welfare of European citizens. There are, however, several shared health and consumer policy challenges that only action at EU level can tackle. Greater mobility and more communication have benefited citizens. But they have also increased the risk of spreading health threats such as SARS and other communicable diseases (which cannot be addressed by individual Member States alone) and scams e.g. from bogus lotteries. The complexity of modern life has brought more choice for citizens. But it has also made it harder for them to make the best choices.

The proposed strategy and programme aim to implement articles 152 and 153 of the Treaty as regards Community action on health and consumer protection, by complementing national action with value-added measures which cannot be taken at national level. Bringing health and consumer protection under a common framework will lead to important synergies in terms of objectives and actions, and enhance policy coherence. Merging the two programmes will also streamline administrative procedures (with a common set of tools and a unified budget) and increase visibility of policy actions vis-à-vis European citizens and within the EU institutions.

EU Health and Consumer policies have three core joint objectives:

- Protect citizens from risks and threats which are beyond the control of individuals and that cannot be effectively and completely tackled by individual Member States alone.

- Increase the ability of citizens to take better decisions about their health and consumer interests. This means increasing the opportunities they have to exercise real choice and also equipping them with the knowledge they need.

- Mainstream health and consumer policy objectives across all Community policies in order to put health and consumer issues at the centre of policy-making. The EU Treaty recognises this by requiring that all policies take health and consumer interests into account.

With regard to health, the Programme reinforces the three strands of the Public Health Programme (information, threats and determinants), and creates three new ones: response to threats, disease prevention and co-operation between health systems. Annex II to the proposal provides an exhaustive list of actions planned under each strand.

With regard to consumer protection, the proposal foresees that a European Consumer Institute created within the single executive agency of the programme will be the cornerstone for implementing the actions. Implementing the programme and managing the additional resources means efficient and structured organisation. The proposal discusses the extension of the Health Executive Agency to include a consumer department as the most cost effective way of proceeding.

Four strands of actions are foreseen:

-Better understanding of consumers and markets. This includes developing and updating its scientific knowledge base and assessment tools on consumer exposure to chemicals, including with respect to general product safety, and to contribute to the application of REACH.

- Better consumer protection regulation;

- Better enforcement, monitoring and redress;

- Better informed and educated consumers.

Actions will contribute to ensure an equally high level of protection for all EU consumers, wherever they live, travel to or buy from in the EU, from risks and threats to their interests. Action covers the safety of goods and services; the fairness of commercial practices and contractual rights for consumers; affordable access to essential services, protection from rogue traders and access to effective means of redress. Actions will also contribute to increase the capacity of consumers to promote their own interests, as individuals or though consumer organisations, i.e., helping consumers help themselves. This includes the provision of information to consumers about their rights, means of redress but also products and the opportunities of the internal market.

For further information concerning the financial implications of this measure, please refer to the financial statement.