COMMISSION DECISION

of 23 February 2009

on the adoption of the Work Plan for 2009 for the implementation of the second programme of Community action in the field of health (2008 to 2013), and on the selection, award and other criteria for financial contributions to the actions of this programme

(Text with EEA relevance)

(2009/158/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Decision No 1350/2007/EC of the European Parliament and of the Council of 23 October 2007 adopting a second programme of Community action in the field of health (2008 to 2013)(1), and in particular Article 8(1) thereof,

Having regard to Commission Decision 2004/858/EC of 15 December 2004 setting up an executive agency, the ‘Executive Agency for the Public Health Programme’, for the management of Community action in the field of public health — pursuant to Council Regulation (EC) No 58/2003(2), and in particular Article 6 thereof,

Whereas:

(1) Decision No 1350/2007/EC (hereinafter referred to as the Programme Decision) established the second programme of Community action in the field of health (2008 to 2013), hereinafter referred to as ‘second Health Programme’.

(2) The second Health Programme is intended to complement, support and add value to the policies of the Member States and contribute to increased solidarity and prosperity in the European Union. The Programme's objectives are to improve citizens' health security; to promote health, including the reduction of health inequalities and to generate and disseminate health information and knowledge.

(3) Under Article 8 of the Programme Decision, the Commission shall adopt an annual Work Plan setting out priorities and actions to be undertaken, including the allocation of financial resources, criteria for the percentage of Community financial contribution, including criteria for assessing whether or not exceptional utility applies, the arrangements for implementing the joint strategies and actions referred to in Article 9 of the same Decision.

(4) Under Article 8 of the Programme Decision, the Commission shall adopt selection, award and other criteria for financial contributions to the actions of the Programme in accordance with Article 4 of the same Decision.

(5) According to Article 6 of Decision 2004/858/EC, the Executive Agency for Health and Consumers carries out certain activities for implementation of the programme on public health and should receive the necessary appropriations for that purpose.

(6) Under Article 75 of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities(3) (hereinafter referred to as the Financial Regulation), the commitment of the expenditure should be preceded by a financing decision adopted by the institution or the authorities to which powers have been delegated by the institution.

(7) Under Article 110 of the Financial Regulation, grants are subject to an annual programme, to be published at the start of the financial year.

(8) Under Article 166 of the Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities(4) (hereinafter referred to as implementing rules of the Financial Regulation) the annual work programme for grants is adopted by the Commission. It is to specify the basic act, the objectives and the schedule of calls for proposals with the indicative amount and the results expected.

(9) According to Article 90 of the implementing rules of the Financial Regulation, the decision adopting the annual work programme referred to in Article 110 of the Financial Regulation may be considered to be the financing decision within the meaning of Article 75 of the Financial Regulation, provided that this constitutes a sufficiently detailed framework.

(10) Under Article 168(1)(c) and (f) of the implementing rules of the Financial Regulation, the Commission can decide to award grants without a call for proposals to bodies with a duly substantiated

de jure

or

de facto

monopoly.

(11) The measures provided for in this Decision are in accordance with the opinion of the Committee of the second programme of Community action in the field of health (2008 to 2013),

HAS DECIDED AS FOLLOWS:

Article 1

1.   The Work Plan for 2009 for the implementation of the second programme of Community action in the field of health (2008 to 2013) as set out in Annex I and the selection, award and other criteria for financial contributions to the actions under the second Community Programme in the field of health (2008 to 2013), as set out in Annexes II, IV and V are hereby adopted.

They will serve as the financing decision for grants and contracts the awarding of which does not require a Commission decision.

2.   Within the maximum indicative budget of each specific action, cumulated changes not exceeding 20 % are not considered to be substantial provided that they do not significantly affect the nature and objectives of the Work Plan. The authorising officer, as referred to in Article 59 of the Financial Regulation, may adopt such changes in accordance with the principles of sound financial management.

3.   The Director-General for Health and Consumers shall ensure the overall implementation of this Work Plan.

Article 2

Grants identified in this Work Plan to bodies with a

de jure

or

de facto

monopoly are awarded under the conditions provided for in Article 168(1)(c) and (f) of the implementing rules of the Financial Regulation.

Article 3

The budget allocations necessary for management of the programme of Community action in the field of public health (2008 to 2013) shall be delegated to the ‘Executive Agency for Health and Consumers’ under the conditions and within the limits of the amounts laid down in the Work Plan in Annex I.

The operating subsidy entered in the budget line 17 01 04 30 shall be paid to the ‘Executive Agency for Health and Consumers’.

Article 4

The appropriations covered by the Work Plan in Annex I may be used to pay default interest in accordance with Article 83 of the Financial Regulation.

Done at Brussels, 23 February 2009.

For the Commission

Androulla

VASSILIOU

Member of the Commission

(1)  

OJ L 301, 20.11.2007, p. 3

.

(2)  

OJ L 369, 16.12.2004, p. 73

.

(3)  

OJ L 248, 16.9.2002, p. 1

.

(4)  

OJ L 357, 31.12.2002, p. 1

.

ANNEX I

Annual Work Plan 2009 including budgetary implications and funding criteria for grants

1.   GENERAL CONTEXT

1.1.   Policy and legal context

Decision 1350/2007/EC (hereinafter referred to as the Programme Decision) established the second programme of Community action in the field of health (2008 to 2013), hereinafter referred to as the second Health Programme.

The second Health Programme is intended to complement, support and add value to the policies of the Member States and contribute to increased solidarity and prosperity in the European Union. The Programme’s objectives are to improve citizens’ health security; to promote health, including the reduction of health inequalities and to generate and disseminate health information and knowledge.

In Article 8(1) of the Programme Decision it is stated that the Commission shall adopt:

(a) the annual Work Plan for the implementation of the Programme, setting out:

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

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

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

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

According to Article 75 of the Financial Regulation (FR) applicable to the general budget of the European Communities, the commitment of the expenditure should be preceded by a financing decision adopted by the institution or the authorities to which powers have been delegated by the institution. According to Article 90 of the detailed rules for the implementation of the Financial Regulation (IR), the decision adopting the annual work programme referred to in Article 110 of the FR, may be considered to be the financing decision provided that this constitutes a sufficiently detailed framework. This document aims to fulfil those obligations and present the different activities scheduled for 2009 which is the second year of the implementation of the second Health Programme.

The Executive Agency for Health and Consumers (EAHC) assists the Commission in the implementation of the Work Plan for 2009 according to the provisions of this Work Plan and of Commission Decision C(2008) 4943 of 9 September 2008 delegating powers to it.

1.2.   Resources

The Programme Decision sets a total budget of EUR 321 500 000 for the period from 1 January 2008 to 31 December 2013.

The budgetary authority has approved a total budget of EUR 48 480 000(1) for 2009 for the budget lines 17 03 06 and 17 01 04 02.

The budget line ‘17 01 04 02 — Expenditure on administrative management of the programme’ will be used for the organisation of workshops and experts meetings, publications, various communication activities and other current expenditure supporting the implementation of the objectives of the programme. The Commission will remain responsible for the implementation of this budget line.

Additional contributions from EFTA countries members of the European Economic Area (Iceland, Liechtenstein, and Norway) and candidate countries participating in the Programme are estimated at EUR 1 163 520 from EEA/EFTA countries and EUR 138 000 from Croatia(2).

The total budget for 2009 is therefore estimated at EUR 49 781 520:

— the total for the operating budget is estimated at EUR 48 261 000,

— the total for the administrative budget is estimated at EUR 1 520 520.

The budget line for administrative appropriations related to the EAHC is 17 01 04 30.

1.2.1.   Indicative amounts

The amounts indicated in the following chapters are indicative. In accordance with Article 90(4) of IR, non-substantial variations in the order of +/- 20 % of each item are possible under each financing mechanism.

2.   FINANCING MECHANISMS

The full range of financing mechanisms offered under the second Health Programme will be implemented in 2009. The budget for call for proposals for projects has been reduced and greater focus has been given to calls for tender and other financing mechanisms, such as joint actions and operating grants, with the aim to maximise the efficiency and added value of actions financed, and to ensure that finances are channelled more directly towards meeting programme objectives. However, in case resources from the operating budget would remain available at the end of 2009, these will be reallocated to the funding of grants selected through the 2009 call for proposals for projects as a priority.

All financing mechanisms will be executed under the responsibility of the EAHC, except point 2.9 which is under the direct responsibility of the Commission. Relevant calls and information will be published on the EAHC website(3).

2.1.   Call for proposals for projects

The grants should be financed under budget line 17 03 06 — Community action in the field of health. The total indicative amount for the call for proposals for projects is estimated at EUR 24 130 500 (around 50 % of the operating budget).

A call for proposals for projects will be published in the

Official Journal of the European Union

at the end of February 2009 (indicative date) describing the areas for funding, the selection and award criteria and the procedures for application and approval.

All projects should provide high European added value, be innovative in nature and the duration should not normally exceed three years. The expected impact of the project should be measured by appropriate indicators, preferably the healthy life years indicator. Where relevant, information should be included on how a gender perspective and health inequalities will be taken into account.

All proposals must demonstrate, where relevant, that synergies can be identified with current research activities funded under the health and related themes of the 7th Research Framework Programme(4).

As far as the allocation of resources for the call for proposal for projects is concerned, a balance between the programme’s different strands will be pursued, while taking into account the quality and quantity of proposals received, unless particular public health emergencies (e.g. pandemic influenza) arise to justify any reallocation of resources.

Given the complementary and motivational nature of Community grants, at least 40 % of the project costs must be funded from other sources. Consequently, normal financial contribution can be up to 60 % per project of the eligible costs for the projects considered. In each individual case the maximum percentage to be awarded will be determined.

A maximum Community contribution per beneficiary (i.e. per main and per associated beneficiary) of 80 % of eligible costs could be envisaged where a proposal is of exceptional utility, as specified under point 3.1. No more than 10 % of the number of funded projects should receive Community contribution of over 60 %.

It should be noted that the indicative amount for Community financial participation in the selected projects can vary from – 10 % to + 10 % in respect of the amount requested by the beneficiary.

The selection, award and other criteria for financial contributions to the actions of the Programme, in accordance with Article 4 of the Programme Decision, are detailed in Annex II.

Details concerning eligibility of travel costs and subsistence expenses are provided in Annex III.

2.2.   Calls for tender

Services procurements should be financed under 17 03 06 — Community action in the field of health. The indicative number of contracts are specified under points 3.2, 3.3 and 3.4 of this Work Plan. All contracts are service contracts.

The overall indicative amount for tenders would be up to EUR 9 652 000 (around 20 % of the operating budget), calls for tenders will be launched during the first semester as indicative date.

2.3.   Joint actions

Joint actions should be financed under budget line 17 03 06 — Community action in the field of health. The total indicative amount is estimated up to EUR 7 239 000 (around 15 % of the operating budget).

Certain actions in 2009 will be eligible for financing as joint actions by the Community and one or more Member States or by the Community and the competent authorities of other countries participating in the Programme. Participating countries will be invited to submit proposals through a call for proposals for joint actions explicitly identified as such under points 3.2, 3.3 and 3.4 of this Work Plan.

Community contributions may only 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.

The Community contribution for joint actions shall not exceed 50 %, except in cases of exceptional utility, where the Community contribution shall not exceed 70 %. Exceptional utility occurs for joint actions:

— meeting the criteria specified in point 3.1 and,

— consisting in the participation of bodies from at least 10 participating countries or in the participation of bodies from 3 participating countries, where the action is proposed by a body from a Member State which has acceded to the European Union since 1 May 2004 or by a candidate country.

The selection and award criteria for joint actions are detailed in Annex IV. The procedure for submitting proposals for joint Action will be published with the call for proposals for joint actions, along with the criteria and deadline for submission, at the end of February 2009.

Details concerning eligibility of travel costs and subsistence expenses are provided in Annex III.

2.4.   Operating grants

Operating grants should be financed under budget line 17 03 06 — Community action in the field of health. The total indicative amount is estimated at EUR 2 500 000 (around 5 % of the operating budget).

Financial support for activities may be awarded to European organisations which fulfil the criteria detailed in Annex V.

Preference will be given to those organisations which cover activities as specified in this Work Plan, points 3.2, 3.3 and 3.4 and activities in the field of cross-border health care, rare diseases, health workforce, patient safety, organ donation and transplantation, cancer prevention and control, flu vaccination, prudent use of antibiotics, childhood vaccination, mental health and youth health.

A call for proposals will be published in the

Official Journal of the European Union

at the end of February 2009, describing the areas for funding, the selection and award criteria and the procedures for application and approval.

The financial support shall not exceed 60 % of the expenditure involved in carrying out eligible activities. In cases of exceptional utility, the Community contribution shall not exceed 80 %. Exceptional utility may occur when activities have very significant European added value, as indicated in point 3.1.

As laid down in Article 4(2) of the applicable legal basis, the renewal of financial contributions set out in paragraph 1(b) to non-governmental bodies and specialised networks may be exempted from the principle of gradual decrease.

2.5.   Conferences in the field of public health and risk assessment

Financial contributions for conferences organised in the field of public health and risk assessment should be financed under budget line 17 03 06 — Community action in the field of health. The total indicative amount is estimated at EUR 1 100 000: EUR 300 000 for conferences organised by the Presidency of the Union and EUR 800 000 for other conferences.

For administrative reasons conferences eligible for co-funding must be held in the last two months of 2009 or in 2010.

2.5.1.   Conferences organised by the Presidency of the European Union

Three conferences organised by the Presidency of the European Union, one for each Presidency (second semester 2009 and 2010), are eligible for co-funding by the Community up to EUR 100 000 each, at the maximum community co-financing rate 50 % of the total eligible costs. Policy issues to be addressed in these conferences relate to improve citizens’ health security, to promote health, including the reduction of health inequalities, and to generate and disseminate health information and knowledge.

These events, highly political in nature and involving representation at the highest level both from National Authorities and European representatives, are to be organised exclusively by the Member State holding the Presidency. Given the unique role of the Presidency in the framework of Community activities, the Member State responsible for the organisation of the event is considered as a

de jure

monopoly.

According to Article 168(1)(c) of the IR, grants can be allocated without a call for proposals to organisations in a

de jure or de facto

monopoly situation, duly substantiated in the award decision.

The Presidency shall submit a request for grant to the Commission services, via the Permanent Representation, for the conference for which the contribution is requested at least four months before the event. This request for grant shall specify the conference topic, the draft programme, the provisional budget and the composition of the scientific and organisation committees.

2.5.2.   Other conferences

Financial contributions by the Community, in accordance with Article 2(2) and point 3 of the Annex to the Programme Decision, may be awarded for the organisation of conferences which:

— deal with one or more priorities of this Work Plan as described in points 3.2, 3.3 and 3.4 or with the following issues: cross-border health care, rare diseases, health workforce, patient safety, organ donation and transplantation, cancer prevention and control, flu vaccination, prudent use of antibiotics, childhood vaccination, mental health and youth health,

— have wide European Union dimension, e.g. with the participations of representations from 10 or more countries participating in the second Health Programme,

— are organised by a public body or a non-profit-making body agreed by the Commission, established in a country participating in the second Health Programme, operating at European level and with a balanced geographical coverage.

A call for proposals for conferences will be launched at the end of February 2009 describing the areas for funding, the selection and award criteria and the procedures for application and approval. Selected conferences are eligible for Community contribution up to EUR 100 000 per conference (maximum 50 % of the total budget of the conference), although co-financing is still requested.

2.6.   Cooperation with international organisations

Funding for actions with international organisations should be financed under budget line 17 03 06 — Community action in the field of health. The total indicative amount is estimated up to EUR 2 300 000, which is around 5 % of the operating budget.

In accordance with Article 12 of the Programme Decision, relations and cooperation with international organisations should be encouraged. This will be done with those international organisations having the capacities needed to tackle health priorities for the European Union identified in the annual Work Plan.

Funding for actions with the international organisations will be allocated through grant agreements without previous call for proposals as foreseen by Article 168(1)(f) of the IR, to a particular type of body on account of its technical competences, its high degree of specialisation or its administrative power.

In fact, these organisations have certain capacities linked to their specific tasks and responsibilities, which make them particularly qualified to carry out some of the actions set out in this Work Plan and for which direct grant agreements are considered to be the most appropriate procedure. Moreover, direct grant agreements will improve the synergies and responsiveness of the European Commission to international organisations where actions are jointly covered.

The amount of the financial contribution can be up to 60 % per organisation of the eligible costs for the actions considered. The Commission will determine in each individual case the maximum percentage to be awarded.

In 2009, the following international organisations may be funded for the implementation of actions specified under points 3.2, 3.3 and 3.4:

— Organisation for Economic Cooperation and Development (OECD),

— World Health Organisation (WHO),

— European Observatory on Health Policies and Health Systems,

— Joint United Nation Programme on HIV/AIDS (UNAIDS),

— The Council of Europe (CoE).

2.7.   Scientific Committees

The activity of Scientific Committees relevant to Public Health should be financed under budget line 17 03 06 — Community action in the field of health.

An overall amount of EUR 270 000 will be earmarked for the payment of allowances to participants in meetings relating to the work of the scientific committees and of rapporteurs for completion of scientific committee opinions, in the framework of the Scientific Committees(5). These allowances will cover all fields relevant to the second Health Programme, i.e. 100 % of costs for the SCHER (Scientific Committee on Health and Environmental Risks) and 50 % (as an indicative percentage) of costs for the SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks) and for coordination.

2.8.   Sub-delegation to DG regional policy

Articles 51 and 59 of the FR and Articles 6 to 8 of the internal rules on the implementation of the general budget of the European Communities(6) refer to the conditions and rules of the instrument of sub-delegation.

A sub-delegation for a maximum amount of EUR 200 000, under budget line 17 03 06 — Community action in the field of health, will be given to the Directorate-General Regional Policy for supporting the Urban Audit Perception survey which is organised through specific contracts within a framework contract of DG COMM. In this case the Directorate-General Regional Policy’s procedures shall apply.

2.9.   Other activities

Other activities like

— organisation of workshops and expert meetings, including seminars organised at national level among groups of experts to exchange best practices in the areas of the annual Work Plan,

— publications and various communication initiatives to promote the second Health Programme,

will be principally financed under the budget line 17 01 04 02 — Expenditure on administrative management of the programme through calls for tender.

For some specific technical matters, as described in Chapter 3, procurements through administrative agreements with the Joint Research Centre are envisaged which will be financed under budget line 17 03 06 — Community action in the field of health.

3.   PRIORITY AREAS FOR 2009

Priority actions for 2009 have been selected in line with the Programme Decision. These priorities should be considered in the context of actions already funded under the previous Programme(7) and the fact that further priorities will be defined in later years of the Programme period.

The Health Programme aims to promote synergies with other Community Programmes without duplicating work carried out under these. The 7th Research Framework Programme under the third pillar of the Health Theme entitled: ‘Optimising the delivery of health care to European Citizens’, is complementary to Community actions in the field of health under all objectives of the second Health Programme. Efforts will be made to identify and avoid overlap/duplication between health programme successful proposals and FP7 projects selected for funding under the calls to date.

Proposals to the Health Programme must fully comply with the aims, objectives and methods set out in the Programme Decision. In particular proposals should not contain significant elements which relate to research. All proposals must demonstrate, where relevant, that synergies can be identified with relevant current research activities funded under the Scientific Support to Policies’ activities of the 6th Framework Programme(8) as well as projects to be funded under the health and related themes of the 7th Research Framework Programme. In particular proposals should demonstrate that overlap/duplication with FP7 will be avoided in presenting proposals to the 2009 Work Plan.

3.1.   Issues of strategic importance

In line with the actions referred to in Article 2(2) of the Programme Decision, and the commitment in the EU health strategy(9) to work across sectors for improving health, high preference will be given to actions that have significant European added value in the following areas:

— Contribution to:

— improving the health of European citizens, as measured where possible by appropriate indictors, including the healthy life years indicator,

— reducing health inequalities in and between EU Member States and regions,

— building capacity for development and implementation of effective public health policies particularly in areas of high need;

— Involvement of new (non-traditional) actors for health in sustained, cooperative and ethically sound actions, both at regional or local level and across participating countries. This includes the public sector, the private sector and stakeholders among wider civil society whose primary aims are not limited to public health (for example among the youth, ethnic groups and other public interest spheres such as environment and sport).

Proposals should also demonstrate the evidence base and ability to provide measurable results where possible.

Proposals which meet the above mentioned criteria can be considered of exceptional utility. Applicants must be able to demonstrate how the proposed action will contribute to the abovementioned criteria.

Priorities are listed in sections corresponding to the strands referred to in the Programme Decision.

3.2.   Priority actions for the first objective ‘Improve citizens' health security’

3.2.1.   Protect citizens against health threats

1.

Activities of the programme of Community action in the field of health 2008-2013 regarding protection of citizens against health threats contribute to the implementation of EU policies and initiatives relevant to health threats regarding the Decision creating a Community surveillance network(10). The aim is to develop strategies and mechanisms to respond to health threats and emergencies, and also support the management of risks linked to communicable diseases (CDs) on the basis of risk assessment carried out by European Centre for Disease Control (ECDC)(11).

2.

The programme covers as well identification of additional health threats, such as those posed by physical and chemical agents. Activities to coordinate and support the health security preparedness, response capacity and planning of the Member States against biological, chemical and radiological agent attacks are being developed by the Health Security Committee (HSC)(12).

3.

The WHO considers pandemic influenza one of the most serious threats for public health. A pandemic virus could evolve from avian viruses that currently circulate in poultry and wild birds in many parts of the world. The Commission is among the major donors contributing to the global response to avian influenza and is supportive of the ‘One World One Health’ approach that seeks to integrate public and animal health(13).

In the field of health security, proposals should consider the following:

— take into account the European Neighbourhood policy to increase consistency and partnership,

— support the participation of candidate countries as associated partners where possible and as collaborating partners in general,

— address interoperability between mechanisms, health systems, plans and strategies with a particular focus on cross sectoral activities, including those targeting health risks and diseases at the interface between public health, animal health and ecosystems,

— projects should also identify economic and social impact of the activities pursued in quantifiable terms as well as address further possible positive and negative impacts (externalities) of public health actions.

3.2.1.1.   Develop prevention (Annex — points 1.1.1-1.1.2)

Exchange practices on promotion of vaccination in Member States (MS), in particular regarding hard to reach populations

Support for policy initiatives on vaccination (Proposal for a Council Recommendation for MS to reach 75 % seasonal flu vaccination coverage in risk groups, proposal for a Council Recommendation to improve/maintain high vaccination coverage against certain childhood diseases). Specific activities should focus on measles and rubella(14), seasonal influenza(15), HPV, tetanus and new vaccines against pneumococcal disease.

Ways to promote vaccination should consider the following elements:

— existing knowledge deficits on vaccines and vaccination issues(16) in selected and broader population groups,

— evidence-based ways to reduce barriers to implement vaccination and improve public perception of benefits of vaccination(17),

— evidence-based and highly effective health promotion actions in support of vaccination,

— results and current activities of vaccine projects, in particular those financed by the Community under the Public Health Programme(18), and the proceedings of the ‘meeting on vaccination strategy’(19) on 13-14 February 2008 organised in collaboration between the Commission and the Public Health Executive Agency should be taken into consideration.

[Call for proposals for projects]

Identifying existing modelling tools and their use to face existing and emerging threats

Expanding the knowledge on how to use existing modelling tools in MS is an important issue to address at the European level for the purpose of:

— effectively measuring cost-effectiveness of policies such as their implementation and the impact assessment of new vaccines and other preventative measures,

— impact assessment of diseases,

— consequences of climate change in the health sector,

— supporting decision-making (potential impact of specific measures such as social distancing).

[Tender through administrative agreement with the Joint Research Centre (JRC)(20)]

3.2.1.2.   Support preparedness (Annex — points 1.1.1-1.1.2-1.1.3-1.1.5)

Information exchange on health threats and on preparedness plans

Information exchange on preparedness plans refers to generic preparedness and specific preparedness (biological, chemical, radio-nuclear and climate change aspects). The information can concern mechanisms of implementation, evaluation of impact, cross-sectoral aspects and communication towards professionals and public.

The activities concerning the information exchange could consist of the following:

— identification of best practices on crisis management and analysis of the conditions of their transfer in various areas, such as management of the information; communication towards professionals, media and public; reference guidelines on how to manage a crisis; logistic aspects for a crisis, such as how to set up a crisis team, mechanisms of coordination; training of staff and support staff to deal with the unexpected or training curricula (nature of training, target, content),

— information exchange between experts and policymakers and communication with the public and media,

— dissemination to EU Member States of key actions identified within the global health security initiative (GHSI) such as media communication activities and pandemic influenza, laboratory relevant issues or medical countermeasures by a workshop in the remit of the EU communicators’ network(21).

[Call for tender]

— monitoring information exchange mechanisms for crisis management and linking with international exchange tools, including enhanced cooperation with Joint Research Centre (JRC) activities in this field and at Global Health Security Action Group (GHSAG)(22) level.

[Tender through administrative agreement with the JRC]

Underpinning rapid development of pharmaceutical countermeasures including vaccines, for new and emerging threats

The likelihood of new pathogens emerging in previously uninfected areas is increasing, capable of causing widespread disease, led by factors such as expanding travel, climate and other environmental change, and evolution of the pathogen/vector/reservoir relationship. The challenge is to enable the rapid development, production and licensing of vaccines for new and emerging diseases to protect the population of Europe and beyond.

The activity to be developed is the following:

— development of a process to accelerate production release of vaccines in case of emergency needs,

— strengthening network of clinical centres to support extensive vaccine development,

— developing broadly applicable platforms for vaccines.

[Call for proposals for projects]

Health sector’s adaptation to consequences of climate change

Europe is taking measures to address global warming and to prevent possibly catastrophic changes to the climate(23) (24). All the sectors of healt-hcare systems will be concerned by adaptation to consequences of climate change (health care, prevention and health education, health threats field including consequences of climate change on communicable diseases, as well as other health problems such as respiratory disorders).

— The actions under this point could address information sharing, comparison and analysis of transferability of measures and activities on early adaptation on consequences of climate change on health.

[Call for proposals for projects],

3.2.1.3.   Improve early detection and control for health threats including communicable diseases

Capacity building and training in high burden countries on tuberculosis control (evidence-based standards) and at risk populations

The European Commission called on the European Centre for Disease Prevention and Control (ECDC) in March 2007 to develop a proposal for an action plan to fight tuberculosis (TB) in the EU(25). Many EU Member States show a positive evolution in TB trends and will likely move towards a pre-eradication situation. However, there are still very diverse situations between countries(26), and control efforts are challenged by problems such as drug resistant TB and high level of transmission within vulnerable groups.

— Support to Member States in the fight against tuberculosis, in particular in the high burden countries. Capacity building and training would contribute to building up of national plans. There is also a need to develop and adapt methods for control in low prevalence countries, when TB is focused in specific hard to reach risk groups.

— The development of tools to evaluate control programmes performance based on cohort analysis.

[Call for proposals for projects]

Support awareness, early diagnosis, prevention and control of viral hepatitis

Different types of viral hepatitis are important communicable diseases with high medical, social and economic consequences and potential serious longer term sequelae. ECDC is responsible for surveillance of such diseases(27). Population and professionals must be aware of available measures for prevention, mitigation and control.

— Training of professionals, specific information towards the public and professionals are examples of relevant activities.

[Call for proposals for projects]

Early detection of health threats and health impact assessment of events

There is a renewed interest in syndromic surveillance methods. Several European countries have already developed broad syndromic surveillance under different themes (infectious diseases, environmental health, veterinary), with different sources of data (emergency departments, mortality, telephone help lines) and use different methods (retrospective or prospective studies).

— A review of European syndromic surveillance could be developed including more Member States and defining a common approach taking into account existing projects.

[Call for proposal for projects]

3.2.1.4.   Enhance capacity building (Annex — points 1.1.1-1.1.4)

Support implementation of International Health Regulations (IHR) in MS

The International Health Regulations (IHR)(28) (2005) have been implemented since 15 June 2007. At European level, Commission Decision 2000/57/EC(29) has been amended by Commission Decision 2008/351/EC(30) in order to transmit notifications through the EWRS at the same time as through the IHR.

The activities supporting the implementation of IHR in MS have been identified:

— survey and comparison of national legislation of MS dealing with security or health measures in relation to a public health emergency (crisis situation),

— impact of health emergency measures on other policies such as mobility, immigration or protection of human rights,

— current policies and practices in implementing the core capacities under IHR among MS and relationships to EU legal provisions.

[Call for proposals for projects]

Support network of chemical, radiological, and nuclear reference laboratories and rapid assessment of toxic industrial chemicals and radioactive threats and development of scientifically validated public health counter-measures

The activities to be developed will support the HSC priorities on chemical and radionuclear issues. In 2009, priority should be given to:

— inventory and audit of ‘national reference laboratories’ for chemicals and radioactive substances including a workshop on sharing capabilities and capacities,

— updating assessment of toxic industrial chemicals — development of protocols on rapid threat and risk analysis,

— updating assessment of radioactive agents — development of protocols on rapid threat and risk analysis.

[Call for tender]

3.2.2.   Improve citizens’ safety (Annex — point 1.2)

3.2.2.1.   Improve rational use of antibiotics and fighting antimicrobial and antiviral resistance(31) (Annex — points 1.2.3)

Further development of protocols and monitoring of rational use of antibiotics

The activities to be developed are the following:

— use of antibiotics in ambulatory care and in hospitals: analysis and report, including assessment of the burden of costs of treatment of drug resistant cases, including interfaces between hospitals, Community care, animals, food. This should also cover health effects and cost-benefit analysis of reduction in use of antibiotics in treating human illness.

[Call for proposals for projects]

3.2.2.2.   Improving patient safety through high-quality and safe health care (Annex — point 1.2.3)

— Exchange of best practice between MS, as well as research on epidemiology of health care associated infections and on cost-effectiveness of infection prevention and control.

[Call for proposals for projects]

— Providing tools for measuring and improving quality and safety of health care: develop guidelines or tools aiming at assessing the quality of health care provided by different health-care settings and to promote best practice; develop measurement systems to enable increasing compliance with treatment protocols.

[Call for proposals for projects]

— Implementation of the action set out in COM(2008) 689 on telemedicine for the benefit of patients, health-care systems and society to foster collaboration between health professionals and patients in key areas for greater application of telemedicine as set out in that Communication, in order to develop specific recommendations on how to improve confidence in and acceptance of telemedicine, also taking into account ethical and privacy related aspects.

[Call for proposals for projects]

3.2.2.3.   Safety of nanomaterials (Annex — point 1.2.1)

— Joint Action on the safety of nanomaterials: (i) to strengthen, expand, and share the knowledge required for the assessment of the hazard, exposure, and overall risk of nanomaterials; (ii) to accelerate the exploitation of existing data and the exchange of best practices in risk assessment and management; and (iii) to promote the establishment of robust methodologies throughout the EU.

[Joint action]

3.2.2.4.   Safety of blood, tissues, cells, organs (Annex — point 1.2.2)

— Promote the accessibility and training on specific methodology to increase organ donation in particular on Quality Improvement Programmes on organ donation.

[Call for proposals for projects]

— Design procedures and IT tools for exchange of human organs between Member States with the purpose of offering surplus organs to other countries and with special reference to the exchange of organs for urgent and difficult to treat patients.

[Call for tenders]

— Ad hoc cooperation with the Council of Europe on specific matters related to human substances (blood, tissues, cells, organs).

[Direct grant agreement with the Council of Europe]

— On blood and tissues and cells specific questions remain on the reporting systems and rapid response to serious adverse events and reactions and coding. Projects will be prioritised to help developing methodologies in this area.

[Call for proposals for projects]

— Principle of unpaid donation of tissues/cells/blood/plasma: analysis of daily practices.

[Call for tenders]

3.3.   Priority actions for the second objective ‘Promote health’

Activities under this section are designed to prevent major diseases and reduce health inequalities across the EU, by tackling key health determinants such as nutrition and physical activity, alcohol, tobacco and drug consumption as well as social and environmental health determinants.

In 2009, priority actions under this objective will aim to contribute to reducing health inequalities within and between the EU Member States and regions; promoting the Health in All Policies approach as well as assessing and promoting sustainable health investment at national and regional level, therefore supporting the strategic themes outlined in the EU health strategy. Following the adoption of the Commission proposal for a Directive on patients’ rights in cross-border health care(32), underlying issues raised by the proposal will be addressed. As regards health determinants, the focus will be in particular on determinants and settings affecting the health of children and young people.

3.3.1.   Foster healthier ways of life and the reduction of health inequalities (Annex — point 2.1)

3.3.1.1.   Promoting Health in All Policies approach (Annex — point 2.1.1)

— Promotion of health impact assessment: set up actions to encourage the use of health impact assessment as a tool for health oriented policy making at European, national and regional (local) level, taking into account equity aspects.

[Call for proposals for projects]

— Developing methodologies for implementing Health in All Policies approach in policy development and implementation.

[Call for proposals for projects]

— Mapping of health-related projects and actions co-financed by the European Institutions and relevant International Organisations in the period of 2003 onwards.

[Call for tenders]

— Study on the impact of the EU policies on health and the health systems.

[Call for tenders]

3.3.1.2.   Public health capacity building (Annex — point 2.1.1)

— Developing tools, procedures and pilot work to improve interaction between public health researchers and policy development at EU level.

[Call for proposals for projects]

— Developing handbooks to support the integration of mental health promotion and mental disorder prevention into the training and work practice of professionals in youth, social, school, workplace environments, taking account of the activities under the European Pact for mental health and well-being(33).

[Call for proposals for projects]

— Promotion of the uptake of injury prevention in vocational training in public health: development of modular curricula for application in the health sector.

[Call for proposals for projects]

— Supporting implementation of EU strategies on key health determinants (nutrition and networking of stakeholders health forum).

[Call for tenders]

— Improving communication skills of health professionals in order to better address the needs of patients, taking into consideration gender, age and other socioeconomic and cultural variables: establish a mapping of communication training given to health professionals with the aim of including communication in public health education programmes, and possibly setting up a programme leading to master study.

[Call for proposals for projects]

— Developing public health capacity: based on an inventory of public health delivery capacity across Member States to identify gaps, needs and proposals for development, including consideration of networking needs at EU level.

[Call for tenders]

3.3.1.3.   Investment in health (Annex — points 2.1.1 and 2.1.2)

— Analytical study to assess the correlation between the investment for better health (including health systems) and the economic growth and development (Annex — point 2.1.1).

[Call for tenders]

— Promoting health investments in the EU Member States and regions through exchange of good practices and cooperation with EU institutions and bodies (e.g. the European Investment Bank), international organisations, private companies and NGOs (Annex — point 2.1.2).

[Call for proposals for projects]

— Initiatives to identify best practices to improve effectiveness and sustainability of regional health investment (Annex — point 2.1.2).

[Call for proposals for projects]

3.3.1.4.   Reduction of health inequalities (Annex — Point 2.1.2)

— Development and dissemination of good practice regarding strategies to tackle inequalities in health between and within Member States and regions of countries participating in the programme.

[Call for proposals for projects]

— Develop and share health systems’ good practice in addressing health inequalities.

[Call for proposals for projects]

— Study on the dimension and implications of inequalities in health status and health provision between the Member States.

— Organisational and technical support for EU networking to tackle health inequalities.

[Call for tender]

3.3.1.5.   Supporting cooperation on issues of cross-border care (Annex — point 2.1.2)

— Measure the equivalence of treatments in the health care systems in the EU: measure comparability of national criteria and decision making processes adopted for the reimbursement/accreditation of medical interventions.

[Call for tender/Direct grant agreement with the European Observatory on Health Policies and Health Systems]

3.3.2.   Promote healthier ways of life and reduce major diseases and injuries by tackling health determinants (Annex — point 2.2)

3.3.2.1.   Children and young people (Annex — point 2.2.1)

— Implementation of the Commission youth health initiative: provide support for Member States and stakeholder cooperation as well as for networking.

— Survey of self regulatory approaches in the field of responsible advertising, with particular focus on protection of young people.

[Call for tender]

— Healthy lifestyles media campaign targeting young people, aiming at empowering them in choosing healthy lifestyle options.

[Joint action]

— Development of the role of youth organisations, youth workers, schools and educational institutions and vocational training organisations in promoting health of young people.

[Call for proposals for projects]

— Promotion of health and prevention of injuries and illness in young people at work.

[Call for proposals for projects]

— Health promotion activities addressing the needs of young people (aged 15-25) who are neither in work nor in education.

[Call for proposals for projects]

3.3.2.2.   Ageing (Annex — point 2.2.1)

— Study on the implications of ageing on citizens’ health-care needs i.e. on how European Health systems need to adapt in order to meet the health-care needs of an ageing society (building on existing data and analysis).

[Call for tender]

3.3.2.3.   Health at workplace (Annex — point 2.2.1)

— Improving health at work, in particular by promoting better work organisation and job control, taking into account economic aspects.

[Call for proposals for projects]

3.3.2.4.   Nutrition and physical activity (Annex — point 2.2.1)

In line with the White Paper on nutrition and physical activity(34) and the work of the EU Platform for action on diet, physical activity and health:

— Implementation and exchange of good practice on comprehensive initiatives to address the reduction of the levels of saturated and trans-fats, salt and sugar in manufactured foods.

[Call for proposals for projects]

— Promoting physical activity through infrastructure and healthy lifestyles, urban/regional planning and better use of the physical environment, with a particular focus on children and young people: promoting and sharing good practice at local/regional level.

[Call for proposals for projects]

— Creating an EU-wide overview of the different types of local community approaches to reduce child obesity, including school-based initiatives.

— Evaluation of the EU Platform on Diet, Physical Activity and Health as a model for effective cooperation in the fight against obesity at EU level.

[Call for tenders]

— Promote European networking in the field of Physical Activity.

[Direct grant agreement with WHO]

3.3.2.5.   Sexual health and HIV-AIDS (Annex — point 2.2.1)

In line with the Commission communication on combating HIV/AIDS(35) and in line with development towards policy initiatives on young people and sexual health, and encouraging cooperation with third countries in eastern Europe according to Article 12 of Decision No 1350/2007/EC on the Health Programme 2008-2013, a particular priority will be given to:

Sexual health (Annex — point 2.2.1)

— Contributing towards an increased knowledge base on sexual behaviour of young people across Europe.

[Call for proposals for projects]

— Developing activities promoting and strengthening comprehensive sexual education.

[Operating grant]

— Contributing towards the development and promotion of sexual health policies.

[Call for proposals for projects]

— Contributing towards the prevention of sexually transmitted infections.

[Call for proposals for projects]

HIV/AIDS

— Activities focusing on the implementation of issues set out in the HIV/AIDS action plan 2005-2009, in particular on access to testing, treatment and care, on activities towards improving the situation in eastern Europe, including with regards to injecting drug users (IDUs), and on health promotion for young people and risk groups.

[Call for proposals for projects]

— Dissemination and exchange of good practices, to intensify awareness-raising initiatives and to contribute to future European policy developments (with a particular focus on strategies to sensitise risk groups for HIV testing).

[Call for proposals for projects]

— Improving the overall situation in eastern Europe in terms of policy development and implementation. Improving the situation of people living with HIV/ADS, with a focus on prevention and projects targeting the accessibility to affordable antiretrovirals.

[Call for proposals for projects]

— Supporting networks and groups combating HIV/AIDS, concentrating in particular on risk groups and the situation in the eastern Europe.

[Operating grant]

— Awareness raising on HIV/AIDS with a particular focus on eastern Europe: Support to the World AIDS conference 2010 in Vienna.

[Direct grant agreement with UNAIDS]

3.3.2.6.   Mental health (Annex — point 2.2.1)

In line with the overall strategic approach on mental health(36), as also reflected in the European Pact for Mental Health and Well-being(37),

— Developing partnerships for action to use the media and the Internet for promoting mental health, preventing mental disorders and to combating stigma, with a specific focus on young people and at the workplace, and for addressing the related challenges, such as suicidal and self-destructive behaviour as well as eating disorders.

[Call for proposals for projects]

— Supporting implementation of EU strategies on mental health.

— Summarising the economic, social and health benefits of action on mental health for the EU, with a focus on the priority themes of the European Pact for mental health and well-being.

[Call for tenders]

3.3.2.7.   Addiction prevention (Annex — point 2.2.1)

Tobacco

Actions are developed in line with the overall EU approach on tobacco control as well as the Framework Convention on Tobacco Control.

— Study on tobacco and product liability: economic means to strengthen product liability and its implementation and enforcement mechanisms need to be reviewed in detail to improve the internalisation of external costs of smoking.

— Study on tobacco sales legislation in order to protect young people.

[Call for tenders]

— Capacity building on tobacco control strategies across all policies, mainly in the areas of taxation and illicit trade.

[Call for proposals for projects]

— Development of innovative strategies and best practices, including health professionals and teachers’ training programmes, concerning all types of tobacco products consumption prevention and cessation methods and services. Gender perspective, health inequalities, key settings and target groups must be considered when developing such strategies and programmes as appropriate.

[Call for proposals for projects]

— Support in implementation of tobacco directives, in particular regarding tobacco ingredients and pictorial warnings: After the adoption of the new textual warnings also the pictorial warnings should be updated for a full implementation of Tobacco Products Directive.

[Tender through administrative agreement with JRC and call for tenders]

Alcohol (Annex — point 2.2.1)

In line with the Commission’s Communication on an EU strategy to support Member States in reducing alcohol-related harm(38), and in order to further develop policies to reduce alcohol-related harm, a particular priority will be given to projects focusing on the following:

— Alcohol and workplaces: identify and bring together good practice for effective actions in this area, involving employers (and their organisations), trade unions and health professionals. This should include developing possibilities of how to implement good practice on a wider scale and identifying gaps in current approaches.

[Call for proposals for projects]

— Curbing under-age drinking: identify and bring together good practice concerning issues such as education directed at children, their parents and retail employees. Of particular importance is the enforcement of the legal age limits for selling alcohol.

[Call for proposals for projects]

— Work on the impact of marketing communication on consumption, especially by young people, and on monitoring the effectiveness and transparency of self-regulatory mechanisms.

[Call for proposals for projects]

Illicit drugs (Annex — point 2.2.1)

In line with the EU Drugs Strategy and Action Plans(39), the Drug prevention and information programme(40) and Council Recommendation 2003/488/EC of 18 June 2003 on the prevention and reduction of health-related harm associated with drug dependence(41).

Developing, implementing and evaluating drug demand reduction activities, in particular:

— Prevention of first/experimental use among young people in different settings taking into account the interrelation to other health issues (including mental health) and social issues (e.g. social exclusion).

[Call for proposals for projects]

— Prevention of polydrug use, specifically the concomitant use with alcohol including the prevention of drink-drugs-driving taking into account previous work undertaken in this field, in the context of road safety actions.

[Call for proposals for projects]

— Selective and innovative prevention approaches using IT tools for users of drugs showing problematic behaviours.

[Call for proposals for projects]

3.3.2.8.   Prevention of major and rare diseases (Annex — point 2.2.2)

Cancer

— Development of indicators or indexes specifically concerning cancer to better support action on cancer across the EU.

[Call for proposals for projects]

Rare diseases

— Developing European cooperation on rare diseases, in particular regarding their recognition, shared information on them, and cross-border cooperation in diagnosis and treatment through European reference networks.

[Call for proposals for projects]

— Implementing the Commission Communication COM(2008) 679 final on Rare Diseases: Europe’s challenges:

— evaluation of population newborn screening practices in Member States,

— repertorying rare diseases information, diagnosis and treatment using existing European initiatives (in particular Orphanet).

[Call for tenders]

— Support to pilot reference networks and networks of information.

[Call for proposals for projects/Operating grant]

3.3.2.9.   Healthy environments (Annex — point 2.2.3)

In line with the European Environment and Health Action Plan(42):

— Quantification of emission of key indoor air pollutants from consumer products such as personal care and cleansing products and environmental tobacco smoke (ETS), and information on the use pattern of these products in EU Member States.

[Call for proposals for projects]

— Studies on the expected impact of actions on indoor air quality, electromagnetic fields and training of professionals in the environment and health area.

[Call for tender]

— Developing European health-based ventilation guidelines for homes, offices and public places such as schools and nursery homes. These guidelines should help Member States in revising existing building codes and practices in the light of energy efficiency of buildings.

[Call for proposals for projects]

3.3.2.10.   Injury prevention(43) (Annex — point 2.2.4)

Strengthening of networking of good practices in the seven priority areas highlighted in the Council Recommendation of 31 May 2007 on the prevention of injury and the promotion of safety(44) with a view to encouraging focused actions in all Member States.

[Call for proposals for projects]

3.4.   Priority actions for the third objective ‘Generate and disseminate health information and knowledge’

3.4.1.   Exchange knowledge and best practice (Annex — point 3.1.2)

— Facilitate the exchange of knowledge, best practice and the provision of technical assistance (twinning, consultancy) between Member States and countries participating in the Programme.

[Call for tender]

— Building on the expertise already developed in the field of health technology assessment, ensure the continuation and development of Health Technology Assessment (HTA) in the EU, including work on relative effectiveness (RE) of drugs.

[Joint action]

3.4.2.   Collect, analyse and disseminate health information (Annex — point 3.2.1)

— Collect data on the perception of health and well-being at the urban level in 75 cities in the EU, Croatia and Turkey through the Urban Audit Perception Survey.

[Sub-delegation to DG regional policy]

— Implementing DG Health and Consumers modules (tobacco, organs, antimicrobial resistance, vaccination, seasonal influenza vaccination) in the Commission survey tools (Eurobarometer).

[Call for tender]

3.4.2.1.   European Health Information System (Annex — point 3.2.1)

— Joint Action for the implementation of the pilot European Health Examination Survey.

[Joint action]

— To improve or to create sustainable systems of information on major and chronic diseases and conditions such as in cardiovascular diseases, autism spectrum disorders, neuro-degenerative conditions/dementias and in oral health. Development of sentinel networks, coordination of registers and hospital discharge information and use of health surveys.

[Call for tender]

— Revision of the International Classification of Diseases.

[Direct agreement with WHO/Call for tender]

— Collecting, analysing and reporting on clinical data providing information on the prevalence and morbidity of contact dermatitis in Europe.

[Call for tender]

— Multiannual framework to further develop and improve data, indicators and analysis relating to health and in particular health care in cooperation with the OECD, in support of the work of the Health Committee of the OECD.

[Direct grant agreement with OECD]

— Multiannual framework to develop and improve information and analysis through the European Observatory on Health Policies and Health Systems.

[Direct grant agreement with the European Observatory on Health Policies and Health Systems]

— WHO Health Evidence Network direct grant agreement to support the Health Information and Knowledge System.

[Direct grant agreement with WHO]

— Establishing mechanisms to assemble ‘state of the art’ data, information, evidence and technical advice on specific health topics.

[Call for tender]

3.4.2.2.   Dissemination and application of health information (Annex — point 3.2.2)

— Actions concerning dissemination and application of health information:

— analysis of users of EU health information and their information needs,

— piloting mechanisms to improve and monitor dissemination and application by different stakeholders of health-related information provided through the Commission,

— providing summaries of health information related to key objectives and priorities of the health strategy; Commission’s key proposals and actions in health and the overall health situation of the Member States,

— development and management of the EU Public Health Portal and other ICT tools for the collection and dissemination of health information.

[Call for tenders]

— Communication activities in the field of Health, including:

— Health Programme (2008 to 2013): support for activities which aim to communicate the outputs of the activities financed through the Programme Decision,

— Public Health Programme (2003 to 2008): final report and promotion of results of the Programme,

— communication activities on the Commission’s policy priorities for the implementation of the EU health strategy, including the Europe for Patients campaign in the form of a EU health journalism prize.

[Call for tenders]

3.4.3.   Analysis and reporting (Annex — point 3.2.3)

— Actions:

— analysis of the relevance of health for other policies and issues, such as the Lisbon agenda, social issues, economic growth and sustainable development, consumers, regional development and cohesion, environment, transport and education,

— reporting on four key health issues: men’s health, musculoskeletal conditions, cardiovascular diseases and children’s health (1-12 years).

[Call for tenders]

(1)  Indicative amount, subject to approval of the Budget Authority.

(2)  Indicative amount: this figure is the maximum amount and depends on the actual amount of the contribution paid by EEA/EFTA and candidate countries.

(3)  http://ec.europa.eu/eahc/

(4)  

OJ L 412, 30.12.2006, p. 1

.

(5)  Commission Decision 2008/721/EC (

OJ L 241, 10.9.2008, p. 21

).

(6)  Commission Decision of 15 March 2005 on the internal rules on the implementation of the general budget of the European Communities (Commission section).

(7)  See http://ec.europa.eu/health/ph_projects/project_en.htm

(8)  Council Decision 2002/834/EC of 30 September 2002 adopting a specific programme for research, technological development and demonstration: ‘Integrating and strengthening the European Research Area’ (2002 to 2006) (

OJ L 294, 29.10.2002, p. 1

). FP6 public health related projects under scientific support to policies — Cordis web page: http://www.cordis.lu/lifescihealth/ssp.htm

(9)  See http://ec.europa.eu/health/ph_overview/strategy/health_strategy_en.htm COM(2007) 630 final of 23.10.2007.

(10)  Decision No 2119/98/EC of the European Parliament and of the Council (

OJ L 268, 3.10.1998, p. 1

).

(11)  Proposals received under Health Programme calls should not overlap those falling under the remit of the ECDC. The ECDC Strategic multiannual programme 2007-2013 can be found at http://www.ecdc.europa.eu/en/About_us/Key_documents/Documents/ECDC_MAS_.pdf

(12)  The HSC priorities for 2008-2013 can be found at http://ec.europa.eu/health/ph_threats/Bioterrorisme/docs/keydo_bio_05_en.pdf

(13)  Further information can be found at: http://www.undg.org/docs/9517/GoE-final-SeS-statement.pdf

(14)  See WHO plan for measles and rubella elimination: http://www.euro.who.int/Document/E87772.pdf

(15)  See WHO resolution on seasonal flu vaccination: http://www.who.int/gb/ebwha/pdf_files/WHA56/ea56r19.pdf

(16)  See scientific advice ECDC seasonal flu vaccination in children: http://ecdc.europa.eu/documents/pdf/Flu_vacc_18_Jan.pdf. Scientific advice on HPV: http://ecdc.europa.eu/pdf/HPV_report.pdf. Scientific advice on risk groups for seasonal flu: http://ecdc.europa.eu/en/files/pdf/Publications/priority_risk_groups_forinfluenza_vaccination.pdf

(17)  See ‘meeting on vaccination strategy’ below.

(18)  See Europa website: http://ec.europa.eu/health/ph_projects/action2_en.htm

(19)  http://ec.europa.eu/health-eu/doc/vaccination_workshop.pdf, http://ec.europa.eu/phea/technical_meetings/technical_meetings_en.html

(20)  The Joint Research Centre is a research-based policy support organisation and in integral part of the European Commission. The JRC is providing the scientific advice and technical know-how to support a wide range of EU policies including health threats. http://ec.europa.eu/dgs/jrc/index.cfm

(21)  The EU communicators’ network works under the umbrella of the HSC. Its mandate focuses on crisis communication, including communication preparedness aspects, on issues related to health threats. The network also communicates about risk management which includes the reactive communication in a crisis e.g. preparing contributions for publication on the Internet during an event or harmonising messages which can be used in the event.

(22)  In November 2001, the first ministerial meeting of the Global Health Security Initiative (GHSI) was held in Ottawa, to discuss global health security. The World Health Organisation is a technical adviser to the GHSI and the European Commission a Member. A Global Health Security Action Group (GHSAG) of experts was tasked with developing proposals and concrete actions to improve global health security. The GHSAG also serves as a network of rapid communication/reaction in the event of a crisis. http://www.ghsi.ca/english/background.asp

(23)  Green paper on ‘adapting to climate change in Europe — option for EU actions’ of 29 June 2007 (see page 16 on health aspects): http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri = COM:2007:0354:FIN:EN:PDF

(24)  Information on White Paper on adaptation to climate change can be found on the following links: http://ec.europa.eu/research/environment/newsanddoc/article_4059_en.htm http://ec.europa.eu/environment/climat/adaptation/stakeholder_consultation.htm

(25)  The document of reference is the TB action plan of ECDC: http://ecdc.europa.eu/pdf/080317_TB_Action_plan.pdf See also the Berlin declaration on TB: http://www.euro.who.int/document/e90833.pdf

(26)  Plan to stop TB in 18 high-priority countries of the WHO European region: http://www.euro.who.int/document/E91049.pdf

(27)  See pages 107-115 in the ECDC report on the status of communicable diseases in the EU and EEA/EFTA countries: http://ecdc.europa.eu/pdf/ECDC_epi_report_2007.pdf

(28)  International Health Regulation 2005: http://www.who.int/csr/ihr/en/

(29)  

OJ L 21, 26.1.2000, p. 32

.

(30)  

OJ L 117, 1.5.2008, p. 40

.

(31)  Council Recommendation 2002/77/EC of 15 November 2001 on the prudent use of antimicrobial agents in human medicine (

OJ L 34, 5.2.2002, p. 13

).

The report from the Commission to the Council on the basis of Member States’ reports on the implementation of Recommendation 2002/77/EC on the prudent use of antimicrobial agents in human medicine (22 December 2005): http://ec.europa.eu/health/ph_threats/com/mic_res/com684_en.pdf

(32)  See http://ec.europa.eu/health/ph_overview/co_operation/healthcare/cross-border_healthcare_en.htm

(33)  http://ec.europa.eu/health/ph_determinants/life_style/mental/mental_health_en.htm

(34)  http://ec.europa.eu/health/ph_determinants/life_style/nutrition/documents/nutrition_wp_en.pdf

(35)  Communication from the Commission to the Council and the European Parliament (COM(2005) 654 final of 15.12.2005).

(36)  Green paper ‘Promoting the mental health of the population. Towards a strategy on mental health for the EU’ (COM(2005) 484 final of 14.10.2005).

(37)  http://ec.europa.eu/health/ph_determinants/life_style/mental/mental_health_en.htm

(38)  COM(2006) 625 of 24.10.2006.

(39)  http://register.consilium.europa.eu/pdf/en/04/st15/st15074.en04.pdf

(40)  http://ec.europa.eu/justice_home/funding/drugs/funding_drugs_en.htm

(41)  

OJ L 165, 3.7.2003, p. 31

.

(42)  Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee: ‘The European Environment and Health Action Plan 2004-2010’ (COM(2004) 416 final of 9.6.2004).

(43)  Activities implemented to reduce alcohol-related harm (see above), and especially those aimed at curbing drink-driving, will also contribute to injury prevention.

(44)  

OJ C 164, 18.7.2007, p. 1

.

ANNEX II

General principles and selection, award and other criteria for financial contributions to the actions under the Second Community Programme in the field of health (2008 to 2013)

CALL FOR PROPOSALS FOR PROJECTS

(Decision No 1350/2007/EC of the European Parliament and of the Council of 23 October 2007, Article 4(1)(a))

This document applies only to co-funding of individual actions under the second Health Programme through grants after calls for proposals for projects.

1.   GENERAL PRINCIPLES

1.   The Financial Regulation and its Implementing Rules are the reference documents for the implementation of the second Health Programme.

2.   Grants must comply with the following principles:

— co-financing rule: external co-financing from a source other than Community funds is required, either by way of the beneficiary’s own resources or the financial resources of third parties. Contributions in kind from third parties may be considered as co-financing if considered necessary or appropriate (Article 113 of the Financial Regulation and Article 172 of the Implementing Rules),

— no-profit rule: the grant may not have the purpose or effect of producing a profit for the beneficiary (Articles 109(2) of the Financial Regulation and 165 of the Implementing Rules),

— no-retroactivity rule: expenditure eligible for financing must be incurred after the agreement is signed. In exceptional cases, it may be acceptable to consider expenditure that was incurred from the date of submission of the grant application, but not earlier (Article 112 of the Financial Regulation),

— no-cumulation rule: only one grant may be awarded for a specific action carried out by a given beneficiary per financial year (Article 111 of the Financial Regulation)(1).

3.   Proposals for actions (projects) will be evaluated on the basis of three categories of criteria:

— exclusion and eligibility criteria, to assess the applicant’s eligibility — Article 114 of the Financial Regulation,

— selection criteria, to assess the applicant’s financial and operational capacity to complete the proposed action — Article 115 of the Financial Regulation,

— award criteria, to assess the quality of the proposal taking into account its cost.

These three categories of criteria will be considered consecutively during the evaluation procedure. A project which fails to meet the requirements of one category will not be considered at the next evaluation stage and will be rejected.

4.   In respect of the second Health Programme, priority will be given to projects which:

— have an innovative character in relation to the existing situation and are not of a recurrent nature,

— provide added value at European level in the field of public health: projects are to yield relevant economies of scale, involve an appropriate number of eligible countries in relation to the scope of the project and are capable of being replicated elsewhere,

— contribute to and support the development of Community policies in the field of public health,

— devote adequate attention to an efficient management structure, a clear evaluation process and a precise description of the expected results,

— include a plan for using and disseminating the results at European level to appropriate target audiences.

2.   EXCLUSION AND ELIGIBILITY CRITERIA

1.   Applicants will be excluded from participation in an award procedure of the second Health Programme if they:

(a) are bankrupt or being wound up, are having their affairs administered by the courts, have entered into an arrangement with creditors, have suspended business activities, are the subject of proceedings concerning those matters, or are in any analogous situation arising from a similar procedure provided for in national legislation or regulations;

(b) have been convicted of an offence concerning their professional conduct by a judgment which has the force of

res judicata

;

(c) have been guilty of grave professional misconduct proven by any means which the contracting authority can justify;

(d) have not fulfilled obligations relating to the payment of social security contributions or the payment of taxes in accordance with the legal provisions of the country in which they are established or with those of the country of the Authorising Officer or those of the country where the contract is to be performed;

(e) have been the subject of a judgment which has the force of

res judicata

for fraud, corruption, involvement in a criminal organisation or any other illegal activity detrimental to the Communities’ financial interests;

(f) are currently subject to an administrative penalty referred to in Article 96(1) of the Financial Regulation;

(g) have received unlawful aid, on which the Commission has adopted a negative decision involving a recovery order, and the aid has not been recovered in accordance with Article 14 of Council Regulation (EC) No 659/1999 of 22 March 1999 laying down detailed rules for the application of Article 93 of the EC Treaty(2).

Evidence: Candidates shall provide a declaration on their honour, duly signed and dated, stating that they are not in one of the situations listed above.

2.   Any proposals received after the deadline for receipt, any incomplete proposals or failing to meet the formal requirements laid down in the call for proposals will be excluded from participation in the ‘second Health Programme’, with the exception of obvious clerical errors within the meaning of Article 178(2) of the Implementing Rules.

Each application must be complete and contain at least the following documents:

— administrative data on the main partner and associated partners,

— technical description of the project,

— global budget of the project and the requested level of Community co-financing.

Evidence: Application content.

3.   Actions which have already commenced by the date on which the grant application is registered will be excluded from participation in the Public Health Programme.

Evidence: The scheduled commencement date and duration of the action must be specified in the grant application.

3.   SELECTION CRITERIA

Only proposals which have satisfied the requirements of the exclusion criteria will be eligible to be evaluated. All the following selection criteria have to be fulfilled.

1.   Financial capacity

Applicants must have stable and sufficient sources of funding to maintain their activity throughout the period during which the activity is being carried out and to participate in its co-funding.

Evidence: Applicants must supply the profit and loss account and the balance sheets for the past two complete financial years.

The verification of financial capacity will not apply to public bodies, or to international public organisations created by intergovernmental agreements or to specialist agencies created by the latter.

2.   Operational capacity

The applicant must have the professional resources, competences and qualifications required to complete the proposed action.

Evidence: Applicants must supply the organisation’s most recent annual activity report including operational, financial and technical details and the curricula vitae of all relevant professional staff in all the organisations involved in the project.

3.   Additional documents to be supplied at the request of the Commission

If so requested, applicants must supply an external audit report produced by an approved auditor, certifying the accounts for the last financial year available and giving an assessment of the applicant’s financial viability.

4.   AWARD CRITERIA

Only projects which have satisfied the requirements of the exclusion and the selection criteria will be eligible for further evaluation on the basis of the following award criteria.

1.   

Policy and contextual relevance of the project

(40 points, threshold: 20 points)

(a) Project’s contribution to the second Community Programme in the field of Health and its annual work plan in terms of meeting the objectives and priorities (8 points).

(b) Strategic relevance in terms of relevance to the EU health strategy(3) and in terms of expected contributions to the existing knowledge and implications for health (8 points).

(c) Added value at European level in the field of public health (8 points):

— impact on target groups, long-term effect and potential multiplier effects such as replicable, transferable and sustainable activities,

— contribution to, complementarity, synergy and compatibility with EU relevant policies and other programmes.

(d) Pertinence of the geographical coverage (8 points)

Applicants must ensure that a geographical coverage of the project is appropriate with regard to its objectives, explaining the role of the eligible countries as partners and the relevance of the project resources or target populations they represent.

Proposals at national or sub-national dimension (i.e. which involve only one eligible country or a region of a country) will be rejected.

(e) Adequacy of the project with social, cultural and political context (8 points)

Applicants must relate the project with the situation of the countries or specific areas involved, ensuring the compatibility of the envisaged actions with culture and views of the target groups.

2.   

Technical quality of the project

(30 points, threshold: 15 points)

(a) Evidence base (6 points)

Applicants must include the problem analysis and clearly describe the factors, the impact, the effectiveness and applicability of measures proposed.

(b) Content specification (6 points)

Applicants must clearly describe the aims and objectives, target groups including relevant geographical factors, methods, anticipated effects and outcomes.

(c) Innovative nature, technical complementarity and avoidance of duplication of other existing actions at EU level (6 points)

Applicants must clearly identify the progress the project intends to accomplish within the field in relation with the state of the art and ensure that there will be neither inappropriate duplication nor overlap, whether partial or total, between projects and activities already carried out at European and international level.

(d) Evaluation strategy (6 points)

Applicants must clearly explain the kind and adequacy of methods proposed and indicators chosen.

(e) Dissemination strategy (6 points)

Applicants must clearly illustrate the adequacy of envisaged strategy and methodology proposed to ensure transferability of results and sustainability of the dissemination.

3.   

Management quality of the project and budget

(30 points, threshold: 15 points)

(a) Planning and organisation of the project (5 points)

Applicants must describe the activities to be undertaken, timetable and milestones, deliverables, nature and distribution of tasks, risk analysis.

(b) Organisational capacity (5 points)

Applicants must describe the management structure, competency of staff, responsibilities, internal communication, decision making, monitoring and supervision.

(c) Quality of partnership (5 points)

Applicants must describe the partnerships envisaged in terms of extensiveness, roles and responsibilities, relationships among the different partners, synergy and complementarity of the various project partners and network structure.

(d) Communication strategy (5 points)

Applicants must describe the communication strategy in terms of planning, target groups, adequacy of channels used, visibility of EU co-funding.

(e) Overall and detailed budget including financial management (10 points, threshold: 5 points)

Applicants must ensure that budget be relevant, appropriate, balanced and consistent in itself, between partners and with the specific objectives of the project. Budget should be distributed within partners at a minimum reasonable level, avoiding excessive fragmentation.

Applicants must describe financial circuits, responsibilities, reporting procedures and controls.

Any project failing to achieve the threshold marks will be rejected.

Following the evaluation, proposals recommended for funding are drawn up in a list, ranked according to the total marks awarded. Depending on budget availability, the highest ranked proposals will be awarded for co-funding. The remaining proposals recommended for co-funding will be placed on a reserve list.

(1)  This means that a specific action, submitted by one applicant for a grant, can be approved for co-financing by the Commission only once a year, regardless of the length of this action.

(2)  

OJ L 83, 27.3.1999, p. 1

.

(3)  COM(2007) 630 final; http://ec.europa.eu/health/ph_overview/strategy/health_strategy_en.htm

ANNEX III

Eligibility of travel and subsistence expenses

These guidelines apply to the reimbursement of travel and subsistence expenses:

— of staff employed by the beneficiary (main and associated beneficiaries) of grants and experts invited by the beneficiary to participate in working groups,

— when explicitly provided for in service contracts.

1.   Flat-rate subsistence allowances cover all subsistence expenses during missions, including hotels, restaurants and local transport (taxis and/or public transport). They apply in respect of each day of a mission at a minimum distance of 100 km from the normal place of work. The subsistence allowance varies depending on the country in which the mission is carried out. The daily rates correspond to the sum of the daily allowance and the maximum hotel price set out in Commission Decision C(2004) 1313(1) as amended.

2.   Missions in countries other than EU 27, acceding and applicant countries and EFTA-EEA countries will be subject to the prior agreement of the Commission. This agreement will relate to the objectives of the mission, its costs and the reasons therefor.

3.   Travel expenses are eligible under the following conditions:

— travel by the most direct and most economic route,

— distance of at least 100 km between the place of the meeting and the normal place of work,

— travel by rail: first class,

— travel by air: economy class, unless a cheaper fare can be used (e.g. Apex); air travel is allowed only for return journeys of more than 800 km,

— travel by car: reimbursed on the basis of the equivalent first class rail fare.

(1)  Commission Decision of 7 April 2004 concerning general implementing provisions adopting the Guide to missions for officials and other servants of the European Commission.

ANNEX IV

Criteria for financial contributions to joint actions under the second Community Programme in the field of health (2008 to 2013)

(Decision No 1350/2007/EC of the European Parliament and of the Council of 23 October 2007, Article 4(3))

1.   EXCLUSION AND ELIGIBILITY CRITERIA

Joint actions may be implemented with public bodies or non-governmental bodies:

— which are non-profit making and independent of industry, commercial and business or other conflicting interests,

— which pursue as their primary goal one or more objectives of the programme,

— which are designated by a transparent procedures by the participating country in the second Community Programme of health,

— which do not pursue general objectives directly or indirectly contrary to the policies of the European Union or associated with an inadequate image,

— which have provided to the Commission satisfactory accounts of their membership, internal rules and sources of funding,

— which are not in any of the situations of exclusion listed in Articles 93 and 94 of the Financial Regulation.

2.   SELECTION CRITERIA

The selection criteria make it possible to assess the applicant’s financial standing and operational capability to complete the proposed work programme.

Applicants must have the professional resources, competences and qualifications required to complete the proposed action.

Applicants must have adequate financial resources to maintain their activity throughout the period during which the activity is being carried out and to participate in its co-funding.

Each applicant must provide:

— a clear, exhaustive and well detailed estimated budget of the expenses in relation to the corresponding activities carried out by each body taking part to the joint project,

— a declaration concerning both the availability of sufficient financial own resources that will cover those expenses not supported by the Community’s contribution and a decision to commit its own sources in the case of a lack of financial support awarded by the Community,

— a copy of the annual accounts for the last financial year for which the accounts have been closed preceding the submission of the application (for non-profit bodies other than public bodies).

The joint action participants must be bodies to which Member States have attributed tasks concerning public health activities, as appropriate to the area covered in the call for proposals.

3.   AWARD CRITERIA

— Action’s contribution to the second Community Programme in the field of health and its annual work plan in terms of meeting the objectives and priorities.

— Potential benefits of the cooperation activities in terms of expected contributions to the existing knowledge or increased effectiveness in the area covered.

— Adequate number of Member States participating ensuring that a geographical coverage of the action is appropriate with regard to its objectives, explaining the role of the eligible countries as partners and the relevance of the project resources or target populations they represent.

— Clarity and quality of the objectives, work plan, organisation and description of the results and benefits expected as well as communication and dissemination strategies.

— Balanced participation of proponents in the activities planned.

ANNEX V

Criteria for financial contributions to the functioning of a non-governmental body or a specialised network

(Decision No 1350/2007/EC of the European Parliament and of the Council of 23 October 2007, Article 4(1)(b))

1.   EXCLUSION AND ELIGIBILITY CRITERIA

Financial contributions by the Community may be awarded for the functioning of a non-governmental body or specialised network (hereinafter referred to as organisation) which:

— is non-profit-making and independent of industry, commercial and business or other conflicting interests,

— has members in at least half of the Member States,

— has a balanced geographical coverage,

— pursues as its primary goal one or more objectives of the programme,

— does not pursue general objectives directly or indirectly contrary to the policies of the European Union or associated with an inadequate image,

— has provided to the Commission satisfactory accounts of their membership, internal rules and sources of funding,

— has provided to the Commission their annual work plan for the financial year and the most recent annual activity report and, if available the most recent evaluation report,

— is not in any of the situations of exclusion listed in Articles 93 and 94 of the Financial Regulation.

The criterion ‘independent from industry, commercial and business or other conflicting interest’ refers to three aspects which all have to be fulfilled by the applicant organisation:

 

Legal independence

Two legal entities shall be regarded as independent of each other where neither is under the direct or indirect control of the other or under the same direct or indirect control of a third entity as the other.

Control may in particular take either of the following forms:

(a) the direct or indirect holding of more than 50 % of the nominal value of the issued share capital in the legal entity concerned, or of a majority of the voting rights of the shareholders or associates of that entity;

(b) the direct or indirect holding of decision-making powers, in fact or in law, in the legal entity concerned.

However, the following relationships between legal entities shall not in themselves be deemed to constitute controlling relationships:

(a) the direct or indirect holding of more than 50 % of the nominal value of the issued share capital of the applicant organisation or a majority of voting rights of the shareholders or associates of the legal entities is held by the same public body;

(b) the legal entities concerned are owned or supervised by the same public body.

 

Financial independence

As a general rule, applicant organisations receiving more than 20 % funding from the private sector(1), for their functioning (core funding) shall be considered as financially dependent.

 

Transparency of the applicant’s activities and funding

(a) all activities should be published in the applicant’s annual report(2). Applicants working with private sector actors regarded ineligible for example by the nature of their activity which is incompatible with the basic principles of the European Union as stated in Article 2 and 3 of the Treaty establishing the European Community, can be considered unacceptable;

(b) all information on funding is to be made available to the public via the applicant’s website, broken down by type (core and project funding, contribution in kind) and by funding entity;

(c) existing position statements of applicants regarding their requirement on transparency are to be publicly available.

2.   SELECTION CRITERIA

The selection criteria make it possible to assess the applicant organisation’s financial and operational capacity to complete the proposed work programme.

Only organisations with the resources necessary to ensure their functioning can be awarded a grant. As evidence of this they must:

— attach a copy of the organisation’s annual accounts for the last financial year for which the accounts have been closed preceding the submission of the application. If the grant application is from a new European organisation the applicant must produce the annual accounts (including balance sheet and profit-and-loss statement) of the member organisations of the new body for the last financial year for which the accounts have been closed preceding the submission of the application,

— present a detailed forward budget for the organisation, balanced in terms of income and expenditure,

— attach an external audit report produced by an approved auditor in case of operating grant applications in excess of EUR 100 000, certifying the accounts for the last financial year available and giving an assessment of the applicant organisation’s financial viability.

Only organisations with the necessary operational resources, skills and professional experience may be awarded a grant. To this end, the following information must be enclosed in support of the application:

— the organisation’s most recent annual activity report, or, in the case of a newly constituted organisation, the curricula vitae of the members of the management board and other staff and the annual activity reports of the new body’s member organisation,

— any references relating to participation in or applications for actions financed by the European Commission, conclusion of grant agreements and conclusion of contracts from the Community budget.

3.   AWARD CRITERIA

The award criteria make it possible to select work programmes that can guarantee compliance with the Commission’s objectives and priorities and can guarantee proper dissemination and communication including visibility of the Community financing.

To this end, the annual work programme presented with a view to obtaining Community funding must fulfil the following criteria:

(a) Policy and contextual relevance

The annual work programme must be consistent with the objectives of the second Community Programme in the field of health as regards the annual work plan for 2009.

(b) Technical quality of the proposed work programme

The work programme must be clear, realistic and well detailed, in particular as regards the following aspects:

— clarity of the objectives and their suitability for achieving the expected results,

— description of the activities planned, tasks and responsibilities and timetables, including actions on communication and dissemination,

— description of the internal and external evaluation of the actions and of the indicators to be used in order to verify that the objectives of the work programme have been achieved.

The work programme must be cost-effective and thus demonstrate that the budget is commensurate with the resources to be used.

(c) Management quality

The organisation applying for funding must:

— guarantee an appropriate governing structure, management processes, human and financial resources and administration, and good working relationships with relevant partners and stakeholders,

— be able to demonstrate the level of achievement of its organisational objectives and its capacity to achieve result.

(1)  The term ‘private sector’ covers ‘for-profit’ companies/enterprises/corporations, business organisations or other entities irrespective of their legal nature (registered/not registered), ownership (wholly or partially privately owned/state owned) or size (large/small), if they are not controlled by the public.

(2)  Collaborators in a position that could lead to a conflict of interest (Article 52 of the Financial Regulation and Article 34 of the Implementing Rules) shall be listed.