COMMISSION IMPLEMENTING DECISION

of 1 December 2011

on the adoption of the 2012 work plan, serving as a financing decision, in the framework of the second programme of Community action in the field of health (2008-2013), the selection, award and other criteria for financial contributions to the actions of this programme and on the EU payment to the WHO Framework Convention on Tobacco Control

2011/C 358/06

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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

Having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Articles 53(a), 53(d), 75 and 110 thereof,

Having regard to 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 (3), and in particular Articles 90 and 168(1)(c) and (f) 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 (4), and in particular Article 6 thereof,

Whereas:

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

Under Article 8(1)(a) 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 EU financial contribution, including criteria for assessing whether or not exceptional utility applies, and the arrangements for implementing the joint strategies and actions referred to in Article 9 of the same Decision.

Under Article 8(1)(b) 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.

According to Articles 4 and 6 of Decision 2004/858/EC, the Executive Agency for Health and Consumers carries out certain activities for implementation of the second Health Programme and should receive the necessary appropriations for that purpose.

In accordance with Article 75 of Regulation (EC, Euratom) No 1605/2002 (hereinafter referred to as the ‘Financial Regulation’) and Article 90(1) of Regulation (EC, Euratom) No 2342/2002 (hereinafter referred to as the ‘Implementing Rules’), the commitment of expenditure from the EU budget shall be preceded by a financing decision setting out the essential elements of action involving expenditure and adopted by the institution or the authorities to which powers have been delegated by the institution.

In accordance with Article 110 of the Financial Regulation and Article 8(1) of the Programme Decision, an annual work plan for the implementation of the second Health Programme and the selection, award and other criteria for financial contributions to the actions of the second Health Programme have to be adopted.

The 2012 work plan being a sufficiently detailed framework in the meaning of Article 90(2) and (3) of the Implementing Rules, the present decision constitutes a financing decision for the expenditure provided in the work plan for grants, procurement and other actions.

Under Article 168(1)(c) of the Implementing Rules, grants may be awarded without a call for proposals to bodies with a de jure or de facto monopoly and under Article 168(1)(f) for actions with specific characteristics that require a particular type of body on account of its technical competence, its high degree of specialisation or its administrative power. In accordance with those provisions, it is appropriate to award grants without a call for proposals to the bodies indicated in the annexed work plan and under the conditions set therein.

Evidence has been obtained of the existence and proper operation of the elements listed in Article 56 of the Financial Regulation, within the Executive Agency for Health and Consumers, to be entrusted by the Commission with the implementation of EU funds in indirect centralised management.

This Decision should allow for the payment of interest due for late payment on the basis of Article 83 of the Financial Regulation and Article 106(5) of the Implementing Rules.

It is appropriate to define the terms ‘substantial change’ within the meaning of Article 90(4) of the Implementing Rules for the application of this Decision.

The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 10 of the Programme Decision,

HAS DECIDED AS FOLLOWS:

Article 1

The work plan for 2012 for implementing the second Health Programme, as set out in Annex I, and the selection, award and other criteria for financial contributions to the actions of this programme, as set out in Annexes II, III, IV, V, VI and VII, and the EU payment to the WHO Framework Convention on Tobacco Control are hereby adopted.

This Decision constitutes a financing decision in the meaning of Article 75 of the Financial Regulation.

Article 2

The maximum contribution authorised by this Decision for the implementation of the second Health Programme is set at EUR 51 130 200 to be financed from the following budget lines of the General Budget of the European Union for 2012:

and estimated additional contributions from the EFTA/EEA countries and Croatia for their participation in the Health Programme:

This brings up the total for budget line 17 03 06 to EUR 49 688 800 and the total for budget line 17 01 04 02 to EUR 1 441 400.

The maximum contribution authorised by this Decision for the payment to the WHO Framework Convention on Tobacco Control is set at EUR 200 000 under budget line 17 03 05 ‘International agreements and membership of international organisations in the field of public health and tobacco control’.

These appropriations may also cover interest due for late payment in accordance with Article 83 of the Financial Regulation.

The implementation of this Decision is subject to the availability of the appropriations provided in the draft budget for 2012 after the adoption of the budget for 2012 by the budgetary authority.

Article 3

The management system set up by the Executive Agency for Health and Consumers to be entrusted with implementing EU funds complies with the conditions for the delegation of tasks under indirect centralised management. The Executive Agency will adopt fraud prevention measures commensurate with the risks identified. The budget implementation of tasks related to project grants, operating grants, grants for joint actions, conference grants and direct grant agreements with international organisations and part of procurement can thus be entrusted to this entity.

The budget allocations necessary for the management of the second Health Programme 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 budget line 17 01 04 30 shall be paid to the Executive Agency for Health and Consumers.

Article 4

Cumulative changes of allocations to specific financial mechanisms included in Annex I not exceeding 20 % of the maximum contribution authorised by this Decision for each budgetary item are not considered to be substantial provided that they do not significantly affect the nature and objective of the work plan. This may include the increase of the maximum contribution authorised by this Decision up to 20 %.

The authorising officer, in accordance with Article 59 of the Financial Regulation, may adopt such changes in accordance with the principles of sound financial management and of proportionality.

The Director-General for Health and Consumers shall ensure the overall implementation of this financing Decision.

Article 5

Grants may be awarded without a call for proposals to bodies with de jure or de facto monopoly under Article 168(1)(c) of the Implementing Rules and for actions with specific characteristics that require a particular type of body on ground of technical competence, high degree of specialisation or administrative power under Article 168(1)(f), in accordance with the conditions detailed in the annexed work plan. A specific analysis of the monopoly situation will be carried out, supported by documentary evidence, before any grants are awarded to beneficiaries in a monopoly situation.

(1) OJ L 301, 20.11.2007, p. 3.

(2) OJ L 248, 16.9.2002, p. 1.

(3) OJ L 357, 31.12.2002, p. 1.

(4) OJ L 369, 16.12.2004, p. 73.

ANNEX I

Work plan 2012 for the second programme of Community action in the field of health (2008-2013)

1. GENERAL CONTEXT

1.1. Policy and legal context

Article 168 of the Treaty on the Functioning of the European Union (TFEU) and resulting legal obligations and other commitments are the basis for action presented in this work plan. The Treaty states that EU action in the area of public health is designed to improve public health, prevent physical and mental illness and diseases, and obviate sources of danger to physical and mental health. This is to be done in cooperation with the Member States. The EU Health Strategy set out in Commission White Paper Together for health: A strategic approach for the EU 2008-2013 (COM(2007) 630 final) (1) provides an overarching framework for all action under this work plan.

The second programme of Community action in the field of health (2008-2013) (hereinafter referred to as the ‘second health programme’ or ‘programme’) established by Decision No 1350/2007/EC (hereinafter referred to as the ‘Programme Decision’) supports this strategy. The mission of the health programme is to complement, support and add value to the policies of the Member States. It seeks to contribute to increased solidarity and prosperity in the EU by protecting and promoting human health and safety and by improving public health. The programme pursues the following objectives set out in Article 2(2) of the Programme Decision:

1. improving citizens health security;

2. promoting health, including the reduction of health inequalities;

3. generating and disseminating health information and knowledge.

Article 8(1) of the Programme Decision states that the Commission shall adopt:

(a) an 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 EU financial contribution, including criteria on exceptional utility; (iii) 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 Regulation (EC, Euratom) No 1605/2002 (hereinafter referred to as the ‘Financial Regulation’), the commitment of 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 (hereinafter referred to as the ‘Implementing Rules’), the decision adopting the annual work programme referred to in Article 110 of the Financial Regulation 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 actions for 2012.

In addition to the Member States of the European Union, the health programme is open to participation by third countries. EFTA/EEA countries: Iceland, Liechtenstein and Norway participate in the programme under the conditions specified in the EEA Agreement. Other third countries, in particular European neighbourhood policy countries, countries applying for, countries that are candidates for, or are acceding to membership of the EU and the western Balkan countries included in the stabilisation and association process, may participate in the programme provided that the necessary agreements are in place. Of these countries Croatia has concluded these arrangements and participates in the programme.

1.2. Resources

The Programme Decision sets a total budget of EUR 321 500 000 for the period 1 January 2008-31 December 2013. The budget for 2012 is EUR 49 700 000 subject to the budgetary authority's approval of the budget:

— EUR 48 300 000 for budget line 17 03 06 ‘EU action in the field of health’ (operational budget),

— EUR 1 400 000 for budget line 17 01 04 02 ‘Expenditure on administrative management’ (administrative budget).

Additional contributions from the EFTA/EEA countries and Croatia are estimated at EUR 1 292 200 from the EFTA/EEA countries and EUR 138 000 from Croatia.

This brings up the total for budget line 17 03 06 to EUR 49 688 800 and the total for budget line 17 01 04 02 to EUR 1 441 400.

The amounts given in the following chapters are indicative. In accordance with Article 90(4) of the Implementing Rules, non-substantial variations are possible for the amount allocated to each financing mechanism.

Budget line 17 01 04 02 — ‘Expenditure on administrative management’ is intended to cover expenditure on studies, meetings of experts, information, publications and technical and administrative assistance for IT systems. These are directly linked to achieving the objectives of the programme or measures taken for this activity.

The Executive Agency for Health and Consumers (EAHC) assists the Commission in implementing this work plan according to Commission Decision C(2008) 4943 of 9 September 2008. The budget line for administrative appropriations related to EAHC is 17 01 04 30.

A total budget of EUR 200 000, subject to the approval of the budget by the budgetary authority, is foreseen for the EU payment to the WHO Framework Convention on Tobacco Control under budget line 17 03 05 ‘International agreements and membership of international organisations in the field of public health and tobacco control’.

2. FINANCING MECHANISMS

Appropriations available under budget line 17 03 06 ‘EU action in the field of health’ will be used to award project grants, operating grants, grants for joint actions, conference grants and direct grants to international organisations as well as to cover procurement and other actions. All grants are covered by written agreement.

In accordance with recital 33 of the Programme Decision, collaboration should be facilitated with third countries not participating in the programme. This should not involve funding from the programme. Nevertheless, travel and subsistence expenses for experts invited from or travelling to such countries can be considered eligible costs in duly justified, exceptional cases, where this directly contributes to the objectives of the programme.

2.1. Project grants

The total indicative amount for project grants is estimated at EUR 13 171 820. Project grants are calculated on the basis of eligible costs incurred. The maximum rate for EU co-financing is 60 %. However, this may go up to 80 % if a proposal meets the criteria for exceptional utility. Annex II contains the exclusion, eligibility, selection and award criteria for project grants. Annex VII contains the criteria for exceptional utility.

Only proposals that directly correspond to the topic and description as set out in this work plan and where ‘project grants’ is indicated as the financing mechanism will be considered for funding. Proposals which only address the wider subject area without matching the specific description of a given action will not be considered for funding.

The indicative timetable for publishing the call for proposals for project grants in the Official Journal is the fourth quarter of 2011.

2.2. Operating grants

The total indicative amount for operating grants is estimated at EUR 4 400 000. They are calculated on the basis of eligible costs incurred. The maximum rate for EU co-financing is 60 %. However, this may go up to 80 % if a proposal meets the criteria for exceptional utility.

Operating grants may be awarded to renew operating grants awarded to non-governmental bodies and specialised networks under the work plan for 2011. New operating grants may be awarded to non-governmental bodies and specialised networks active in areas corresponding to the three objectives of the health programme. Work under operating grants should directly contribute to reaching the priorities of the European Union as set out in Commission Communication COM(2010) 2020 of 3 March 2010Europe 2020 — A strategy for smart, sustainable and inclusive growth (2). Issues that are particularly relevant include active and healthy ageing, including health promotion and prevention of diseases; prevention of health inequalities, including ensuring better access to health care for all, and questions relating to the health workforce.

As laid down in Article 4(2) of the Programme Decision, 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. As a general rule, this exemption will apply to applicant organisations not receiving any of their funding from the private sector (3) or other conflicting interest for their functioning (core funding). For all other renewed operating grants, a decrease of one percentage point as compared to the EU co-financing percentage agreed in the grant agreement following the call for proposals 2011 will be applied. In any case, the amount of EU co-financing cannot be higher than the amount granted in 2011. Annex III contains the exclusion, eligibility, selection and award criteria for operating grants. Annex VII contains the criteria for exceptional utility.

The indicative timetable for publishing the call for proposals for operating grants in the Official Journal is the fourth quarter of 2011.

2.3. Grants for joint actions

The total indicative amount for joint actions is estimated at EUR 8 950 000. Joint actions allow the competent authorities of the Member States/other countries participating in the health programme and the European Commission to take forward work on jointly identified issues. Public bodies or non-governmental bodies based in a Member State/another country participating in the programme which participates in a joint action may participate in the joint action. However, they have to be expressly mandated to do so by the authorities of the Member State/other participating country concerned.

Grants for joint actions are calculated on the basis of eligible costs incurred. The maximum rate of EU co-financing is 50 %. However, this may go up to 70 % in cases of exceptional utility. Exceptional utility co-financing of 70 % is envisaged for the joint action ‘Facilitating collaboration on organ donation between national authorities in the EU’ (see point 3.1.4.2) because of its contribution to the effective implementation of EU legislation in this field. In other cases, the criteria for exceptional utility in Annex VII apply. Annex IV contains the exclusion, eligibility, selection, and award criteria for joint actions.

Member States/other countries participating in the health programme which intend to participate in one or more joint actions must declare their intention to the Commission prior to the expiry of the deadline for the submission of proposals. With the exception of NGOs operating at EU level, only organisations established in Member States/other countries participating in the programme which have made this declaration may apply to participate in joint actions.

The indicative timetable for publishing the call for proposals for joint actions in the Official Journal is the fourth quarter of 2011.

2.4. Conference grants

The total indicative amount for conferences is EUR 800 000: EUR 200 000 for Presidency conferences, and EUR 600 000 for other conferences. For administrative reasons, conferences eligible for co-funding, apart from Presidency conferences, must take place in 2013.

2.4.1. Presidency conferences — De jure monopoly

According to Article 168(1)(c) of the Implementing Rules, 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.

Presidency conferences which are highly political in nature and which involve representation at the highest level both from national authorities and European representatives are to be organised exclusively by the Member State holding the Presidency of the EU. Given the unique role of the Presidency in the framework of EU activities, the Member State responsible for the organisation of the event is considered as having a de jure monopoly.

Two conferences organised by the Presidencies of the European Union, one for the Presidency in the second half of 2012 and the other for the Presidency in the first half of 2013, may receive up to EUR 100 000 each. The maximum rate of EU co-financing is 50 % of eligible costs incurred.

The Presidency shall submit to EAHC a request for a grant for the conference concerned, via the Permanent Representation, using a form provided by EAHC. This has to be done at least four months before the event.

The Presidency conference to be financed under this work plan is ‘First Steps Towards a Healthy Ageing Process’ planned for September 2012 under the Cypriot Presidency.

2.4.2. Other conferences

Conference grants may be awarded for the organisation of conferences that correspond to the three objectives of the health programme. To be awarded funding, conferences should directly promote the priorities of the European Union as set out in Commission Communication COM(2010) 2020 of 3 March 2010Europe 2020 — A strategy for smart, sustainable and inclusive growth. Issues that are particularly relevant include active and healthy ageing, including health promotion and prevention of diseases; prevention of health inequalities, including ensuring better access to health care for all, and questions relating to the health workforce.

Conferences must have a broad European dimension. They have to be organised by a public or non-profit making body established in a country participating in the health programme and which has relevant experience of cooperation at EU level. Conferences may receive up to EUR 100 000 (maximum 50 % of the total budget). Annex V contains the exclusion, eligibility, selection and award criteria for conferences other than Presidency conferences.

The indicative timetable for publishing the call for proposals for conferences in the Official Journal is the fourth quarter of 2011.

2.5. Direct grant agreements with international organisations

The total indicative amount for direct grants is estimated at EUR 2 633 000. Direct grants will be based on effective collaboration with the Commission.

According to Article 168(1)(f) of the Implementing Rules, funding for actions with international organisations will be allocated through grant agreements without a call for proposals on topics specifically identified in this work plan. International organisations and their national or regional offices are not eligible for funding as main or associated beneficiaries under any calls for proposals. The maximum rate for EU co-financing is 60 % of the eligible costs actually incurred. In accordance with recital 33 of the Programme Decision, activities involving third countries not participating in the programme shall not be considered eligible costs. However, travel and subsistence expenses for experts invited from or travelling to such countries can be considered eligible costs in duly justified, exceptional cases, where this directly contributes to the objectives of the programme.

Funding through direct grants will be awarded to the following international organisations under this financing Decision because of their specific competence and high degree of specialisation in the areas covered by the direct grants set out in Sections 3.1, 3.2 and 3.3:

— Council of Europe (CoE),

— International Agency for Research on Cancer (IARC),

— International Organisation for Migration (IOM),

— Organisation for Economic Cooperation and Development (OECD).

2.6. Procurement

The total indicative amount for procurement is estimated at EUR 14 463 980.

Procurement covers activities such as the evaluation and monitoring of actions and policies; studies; provision of advice, data and information on health; scientific and technical assistance; communication and awareness-raising activities and information technology applications in support of policies. Calls for tenders are expected to be published in the first semester of 2012 in the Official Journal. Framework contracts and new service contracts will be used as indicated in this work plan.

2.7. Other actions

The total indicative amount for other actions is estimated at EUR 5 270 000.

This relates to contributions paid by the EU as subscriptions to bodies of which it is member in the meaning of Article 108(2)(d) of the Financial Regulation, administrative agreements with the Joint Research Centre (JRC) and special indemnities paid to experts for participating in meetings and work on scientific opinions under point 3.1.3.1 and advice on health systems under point 3.3.2.1.

2.8. EU payment to the WHO Framework Convention on Tobacco Control

The European Union is a full party to the WHO Framework Convention on Tobacco Control (FCTC). Payment of the 2012 EU contribution to the FCTC will be made under budget line 17 03 05 ‘International agreements and membership of international organisations in the field of public health and tobacco control’, and not from the health programme. The amount of this payment is based on the decision on the work plan and budget for the financial period 2012-2013 taken by the Fourth Conference of the Parties to the Convention in November 2010 (FCTC/COP/4/20).

The EU contribution is set at USD 145 225 for 2012. To cover for fluctuations of the exchange rate, the maximum amount is set at EUR 200 000 for 2012. The FCTC Secretariat will manage the funds according to WHO financial rules.

3. PRIORITIES FOR 2012

Actions under this work plan are broadly geared towards supporting the delivery of EU priorities set out in the Europe 2020 Strategy and responding to legislative obligations and policy commitments. The Smart growth and Inclusive growth priorities under the Europe 2020 Strategy are of particular relevance for this work plan. The objectives of the Europe 2020 Strategy match those of the EU Health Strategy, which maintains that investing in health can boost innovation, create new skills and jobs and reduce inequalities in health.

In 2012 the health programme will contribute to the objectives of the following flagships under the Europe 2020 Strategy:

The Pilot Innovation Partnership on active and healthy ageing under the Flagship Initiative Innovation Union (4) has inspired action under this work plan to enable European citizens to lead active, healthy and independent lives for as long as possible. This action will promote physical and mental health, including promoting better nutrition and physical activity, and preventing behaviour that is harmful to health. Ways will be sought to prevent the onset of major and chronic diseases through action such as cancer screening. The provision of relevant advice and information will support Member States in their efforts to arrive at and maintain sustainable and efficient health care systems. Action will also be taken to explore ways to develop innovative products and services that respond to the ageing challenge. All action ultimately seek to contribute to the overall aim of the partnership to add an average of two years of healthy life for everyone in Europe.

The European platform against poverty and social exclusion (5) of the Europe 2020 Strategy has inspired actions related to inequalities. These actions seek to improve access of vulnerable populations to healthcare, support their social inclusion and combat the discrimination they face. They contribute to reaching the EU target of reducing poverty and social exclusion by at least 20 million by 2020.

The Agenda for new skills and jobs (6) provides the framework for work on the health workforce. This work seeks to contribute to reaching the Europe 2020 Strategy's employment target for 2020 of 75 % of the working-age population at work. It supports especially the aims under priority 2 of the Agenda, namely equipping people with the right skills for employment.

Furthermore, this work plan responds to additional challenges where action can provide real EU value-added. A safe and secure society is a prerequisite for economic growth and the well-being of citizens. A number of cross-border health threats in the past few years have clearly demonstrated the need and value-added of coherent and effective action at EU level. Actions envisaged under this work plan focus on exploring and setting up efficient mechanisms for detecting and preventing the spread of various cross-border health threats, or minimising their impact. This work plan also envisages support for safe and secure systems and mechanisms in support of EU legislation on the safety and quality of organs and substances of human origin, blood, and blood derivatives. Activities seek to obtain and maintain the trust and confidence of EU citizens in this area. In the same way, legislation in the area of cross-border healthcare will be supported by targeted action.

Keeping people healthy and active for longer has a positive impact on productivity and competitiveness. Complementary action is therefore planned on the main risk factors for health such as nutrition, alcohol abuse and smoking as well as in the area of major, chronic and rare diseases.

Finally, several activities are envisaged to comply with the programme's third objective ‘Generate and disseminate health information and knowledge’. Partly in cooperation with external partner organisations, a series of activities are planned to collect data, to produce scientific evidence and to effectively process information to citizens, stakeholders and policy makers.

3.1. Actions under the first objective ‘Improve citizens’ health security’

3.1.1. Protect citizens against health threats — Develop risk management capacity and procedures, improve preparedness and planning for health emergencies (point 1.1.3 in Annex to Programme Decision)

3.1.1.1. Public health preparedness and response training and exercises

The objective of this action is to improve and reinforce the EU's preparedness to respond to potential risks. National and EU evaluations of the 2009 pandemic clearly demonstrate the need to reinforce preparedness by sharing best practices and further developing common tools at EU level. This action seeks to increase Member State officials’ knowledge of cross-border risks and management of the public health response to these, and the effective use of related IT tools.

This action is composed of three work packages. The first should deliver two sessions of training and exercises for Member State officials on preparedness for, and response to, serious cross-border health threats. The training and exercises will cover the responsibilities and roles of different stakeholders; preparedness; crisis communication and the use of IT tools. The second work package will continue the exchange of experts started in 2011 aiming to share best practice and experience on crisis management between officials/stakeholders from the EU Member States. The third work package consists of developing a new e-learning module for the Health Emergency & Diseases Information System (Hedis) application and a description of the different roles and functions to complement those developed in 2010.

[Framework contract and call for tenders]

3.1.2. Protect citizens against health threats — Develop strategies and mechanisms for preventing, exchanging information on and responding to health threats from communicable and non-communicable diseases and health threats from physical, chemical or biological sources, including deliberate release acts (point 1.1.1 in Annex to Programme Decision)

3.1.2.1. Public health response coordination in the face of chemical events

The objective of this action is to ensure an efficient response to serious cross-border events caused by chemical agents through the setting up of an EU-level pilot network while ensuring complementarities with the work of other sectors, such as the EU civil protection mechanism (CPM). Such a network will ensure that experiences of and best practices adopted by one Member State following an incident benefit all Member States. It will enable an efficient and coherent EU-level response to potentially devastating cross-border events. This is of particular value for Member States with less capacity and expertise to respond to chemical events. No formal arrangements exist in the field of public health at EU level to coordinate responses to such events. The ad hoc arrangements used so far have clearly demonstrated the need and value-added of putting in place a structured mechanism to trigger risk assessment and coordination of public health measures at EU level. This action will support Member States in implementing the new International Health Regulations.

This action should closely consider the experiences gained from the network for surveillance and control of communicable diseases created by Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community (7). It should be built on: (a) draft document ‘SOPs for the HSC Network for the risk assessment and risk management of chemical events’ prepared by the Commission with input from the Chemical, Biological and Radio Nuclear (CBRN) Section of the Health Security Committee (HSC) and which is available as part of the outcomes of the CARRA-NET initiative; (b) input provided by the ‘Chemical and Radiation Risk Assessment Network (CARRA-NET)’ project that started in October 2010 under service contract No EAHC/2010/Health/12 for the implementation of framework contract No EAHC/2009/Health/06 Lot 2 concerning multiple framework contracts with reopening of competition on external assistance concerning activities in the area of health security ‘For establishing risk assessment networks of toxic industrial chemicals and radioactive threats and risks’ — the tender was awarded to the Health Protection Agency and the results will pave the way for establishing future networks for chemicals and radioactive threats; (c) lessons learnt from the three regional table top ‘IRIDIUM’ exercises on chemical events implemented in 2011 — the three exercises have been implemented under the specific subject ‘Chemical exercises’ under the framework contract No SANCO/C3-2007-01 (8); and (d) input provided by the initiative ‘Chemical and Radiological Inventory of Medical Countermeasures (CARIMEC)’ that was launched in December 2010 under service contract No EAHC/2010/Health/17 for the implementation of framework contract No EAHC/2009/Health/06 Lot 2 concerning multiple framework contracts with reopening of competition on external assistance concerning activities in the area of health security ‘For establishing an inventory of public health measures and medical countermeasures to respond to toxic industrial chemicals and radioactive threats and risks’. The CARIMEC initiative is carried out by the Health Protection Agency.

The network should start functioning in pilot mode in 2013-2014. It should be fully linked to the existing mechanisms and structures developed and put in place in other sectors, such as the ‘Lessons learned’ programme under the EU civil protection mechanism with regard to major disasters, including chemical incidents, for which it has been activated. The pilot will give guidance on the need for and scope of further action, including a more permanent mechanism.

[Project grants] Indicative amount: EUR 450 000

3.1.2.2. The impact on air transport of health threats due to biological, chemical and radiological agents

The objective of this action is to ensure an efficient response at EU level to serious cross-border health threats on aircraft. No formal arrangements exist at EU level to coordinate response to such threats. The ad hoc arrangements used so far have clearly demonstrated the need and value-added of putting in place a structured mechanism to trigger risk assessment and coordination of measures at EU level. This action will support Member States in implementing the new International Health Regulations.

This action should build on the results and experiences gained in the framework of projects financed by the health programme in the area of maritime transport, in particular ‘Assessing the usefulness of an EU ship sanitation programme and coordinated action for the control of communicable diseases in cruise ships and ferries’ (SHIPSAN) and ‘EU Ship Sanitation Training Network’ (SHIPSAN TRAINET) (9).

This action should cover at least the main international airports in the EU Member States, with the involvement and collaboration of main airlines and airport authorities. This action should: (a) define the scope and standard operating procedures (SOPs), in particular the role of the different authorities involved and a satisfactory coordination mechanism; (b) identify contact points for a network of public health authorities for the surveillance of and response to health threats due to communicable diseases and other threats which could impact on international conveyance areas at designated airports; (c) assist Member States and their airport authorities to develop core capacities and to implement the new International Health Regulations, with a particular focus on the implementation of core capacity requirements for the surveillance of and response to health threats due to communicable diseases and other cross-border threats which could impact on international conveyance areas at designated airports; (d) explore the impact on additional requirements for airport infrastructure, both in terms of personnel and equipment; and (e) based on experience in the maritime transport sector, create a network of public health authorities responsible for civil air transportation, with authority over at least the main international airports in the Member States, with the involvement and collaboration of airlines. Consistency with similar measures adopted by the International Civil Aviation Organisation (ICAO) and European Civil Aviation Conference (ECAC) has to be ensured in order to avoid duplication.

In the first phase a network should be created covering at least the main hub airports in the EU Member States (minimum 8 Member States and around 10 airports) with the involvement and collaboration of major European airlines (minimum 8 airlines with a total number of around 300 vectors). In the second phase, a set of SOPs and procedures for consultation should be agreed and tested. Finally, a limited number of events should be followed up and evaluated. Core capacity development should take place in parallel for surveillance, response and needs assessment. The network should start functioning in pilot mode in 2013-2014. The pilot will give guidance on the need for and scope of further action, including a more permanent mechanism.

[Project grants] Indicative amount: EUR 600 000

3.1.2.3. The impact on maritime transport of health threats due to biological, chemical and radiological agents, including communicable diseases

The objective of this action is to create an integrated and sustainable strategy at EU level for safeguarding the health of travellers and crew of passenger and cargo ships and preventing the cross-border spread of diseases. Control of and response to serious cross-border health threats through maritime transport, such as communicable diseases or threats from chemical, biological and radiological agents, is a cross-border issue that needs to be addressed at EU level. Incoming migration through the sea borders also makes improving communicable disease surveillance and monitoring of maritime transport essential.

This action will support the implementation of Decision No 2119/98/EC and its implementation measures, such as Commission Decision 2000/57/EC of 22 December 1999 on the early warning and response system for the prevention and control of communicable diseases under Decision No 2119/98/EC of the European Parliament and of the Council (10), Directive 2010/65/EU of the European Parliament and of the Council of 20 October 2010 on reporting formalities for ships arriving in and/or departing from ports of the Member States and repealing Directive 2002/6/EC (11), and the new International Health Regulations. It also supports the enforcement of Council Directive 2009/13/EC of 16 February 2009 implementing the Agreement concluded by the European Community Shipowners’ Associations (ECSA) and the European Transport Workers’ Federation (ETF) on the Maritime Labour Convention, 2006, and amending Directive 1999/63/EC (12).

This action should build on the results and experiences gained in the framework of projects financed by the health programme in the area of maritime transport, in particular ‘Assessing the usefulness of a EU ship sanitation programme and coordinated action for the control of communicable diseases in cruise ships and ferries’ (SHIPSAN) and ‘EU Ship Sanitation Training Network’ (SHIPSAN TRAINET).

This action should focus on: (a) operational functioning of the communication platform developed by the SHIPSAN project for coordinating responses to real events on board cruise ships; (b) extension to cargo ships of a suitable and sustainable mechanism for guidance, updating of technical guidelines, training packages, exercise programmes and assessment guidance under the ship sanitation control certificates developed by the SHIPSAN project. This will include a permanent link to the existing mechanisms for communicable disease control in ships under Decision No 2119/98/EC and its implementing measures; (c) training for staff on board cargo ships, public health staff in ports, and officials responsible for maintaining the link between ships, port authorities and public health authorities responsible for notifying other Member States, the Commission and the European Centre for Disease Control; (d) a mechanism enabling risk assessment and support for risk management activities; and (e) examining the feasibility of using the SHIPSAN project to implement the Maritime Declaration of Health in an electronic format as set out in Directive 2010/65/EU.

[Joint action] Indicative amount: EUR 1 800 000

3.1.2.4. Improvement of HIV prevention in Europe

The objective of this joint action is to promote the integration of quality assurance (QA) and quality improvement (QI) practices into HIV prevention programmes with the aim of improving the effectiveness of HIV prevention programmes. More effective prevention programmes will help reduce the number of new HIV infections in Europe. They will also contribute to the fight against discrimination and social exclusion, which people affected with HIV often experience.

This joint action supports the implementation of Commission Communication COM(2009) 569 final of 26 October 2009Combating HIV/AIDS in the European Union and neighbouring countries, 2009-2013 (13). This Communication provides the framework for supporting national strategy development and steers HIV policy coordination between the Member States. It specifically focuses on more effective prevention to tackle HIV transmission. This action, together with other projects related to HIV prevention, translates into action the prevention targets defined in the HIV action plan for 2009-2013 (14). This joint action will contribute to overcoming discrimination and increasing the integration of people with disabilities, ethnic minorities and immigrants, men having sex with men and other vulnerable groups. People most at risk of HIV often belong to these groups.

The envisaged joint action would cover the development and mainstreaming of methodologies and tools for QA/QI in HIV prevention. This would include: (a) development and validation of a charter of standards and principles for QA and QI by key stakeholders; (b) dissemination of these standards; (c) monitoring their mainstreaming into prevention strategies and activities with a particular focus on the key priority groups identified in the EU strategy; (d) building a sustainable network of organisations following up the implementation of QA/QI in HIV prevention programmes which could provide advice on QA/QI in HIV prevention; and (e) identifying and supporting evidence-based demonstration pilots.

Outcomes would include a validated charter on quality assurance and improvement in HIV prevention programmes for implementation across Europe and beyond; a guide on the successful implementation of HIV prevention programmes; an analysis of effective dissemination channels for public health information; a network of quality assurance and HIV prevention experts; and a framework for monitoring and assessing the impact of HIV prevention programmes.

This joint action will contribute to the development and implementation of more effective HIV prevention programmes, which can also be adapted to other regions.

[Joint action] Indicative amount: EUR 1 500 000

3.1.3. Improve citizens’ safety — Scientific advice (point 1.2.1 in Annex to Programme Decision)

3.1.3.1. Scientific and technical assistance for the functioning of the Commission's Scientific Committees and communication on risks, including special indemnities

The objective of this action is to provide the Commission with independent and high-quality advice on health risks. This helps to ensure a robust scientific basis for EU policies and measures in line with better regulation principles. Such advice is provided by the Scientific Committees in accordance with Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts on consumer safety, public health and the environment and repealing Decision 2004/210/EC (15). This action contributes to increasing the role of science in EU policy debate and it helps to inform citizens of risks. It also enables stakeholders and the general public to better understand EU policies and related proposals. This action has two components: firstly, special indemnities paid to experts for their work on scientific opinions, and secondly, scientific and technical assistance for the functioning of the Scientific Committees and risk communication.

Special indemnities are paid to experts for their work on scientific opinions as provided for in Decision 2008/721/EC.

[Other actions] Indicative amount: EUR 270 000

Scientific and technical assistance for the functioning of the Scientific Committees and risk communication includes: (a) search, analysis and synthesis of scientific literature; (b) preparation of layman versions of scientific opinions; (c) preparation of summaries; (d) data search; (e) establishment of the bibliography of topics addressed by the Committees; and (f) revision of texts. This support is necessary, as members of the Committees do not benefit from any support from their organisations. It also covers the organisation of scientific hearings, working meetings and thematic workshops.

[Calls for tenders]

3.1.4. Improve citizens’ safety — Safety and quality of organs and substances of human origin, blood, and blood derivatives (point 1.2.2 in Annex to Programme Decision)

3.1.4.1. Monitoring the implementation of EU legislation on blood, blood components and tissues and cells

The objective of this action is to assess Member States’ implementation of EU legislation with regard to blood and blood components and tissues, and produce related reports on the state of play. The relevant pieces of legislation are: (a) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (16) and related implementing measures (17); and (b) Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (18) and related implementing Directives (19).

The collection and supply of blood and blood components is a high-value activity for the Member States’ public health systems, offering and supporting many treatment options. These activities also contribute to developments in the pharmaceutical sector. The risk of transmitting diseases is inherent to the use of blood and blood components and can lead to potential safety and quality risks. Directive 2002/98/EC and related implementing measures seek to respond to these concerns. The tissues and cells sector is growing fast, providing an increasing number of treatments. It will contribute to economic growth as well as to the development of the pharmaceutical sector. This will only be possible if the safety and quality of collected substances of human origin can be guaranteed. Directive 2004/23/EC and related implementing Directives seek to respond to these concerns.

This action will deliver two reports containing an assessment of key points for all Member States. The resulting reports will contribute to (a) reports on Member States’ experiences in implementing Directive 2004/23/EC, as required by Article 26(2), and Directive 2002/98/EC, as required by Article 26(2); (b) identifying Member States with successful implementation and supporting Member States which have encountered problems; (c) helping enforce the implementation of this legislation; and (d) identifying systemic problems which may require changes in legislation. The estimated time for delivery of the reports is end-2013.

[Call for tenders]

3.1.4.2. Facilitating collaboration on organ donation between national authorities in the EU

The objective of this action is to support Member States in organising optimal allocation and use/transplantation of donated organs through multilateral and bilateral arrangements and through transplantation in other Member States. This action will help implement Commission Communication COM(2008) 819/3 of 8 December 2008Action Plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States (20).

This action seeks to set up an EU-level IT platform for the multilateral exchange of organs. Most Member States have national allocation bodies to match available organs with potential recipients and ensure the optimal allocation and use of every organ. Some Member States have joined efforts within a multi-country exchange organisation, such as Eurotransplant and Scandiatransplant. However, not all organs can be matched, allocated and used within these countries or multi-country zones. This is particularly true for highly immunised patients, children and rare organs. An EU-level platform that connects the existing organ allocation bodies in Europe will enable this. This action covers the development of protocols and agreed formats for easy and fast data exchange. Preparatory work has already been undertaken within the ‘Coordinating a European initiative among national organisations for organ transplantation’ (COORENOR) project funded by the health programme. This will be developed further, a concrete platform will be set up and the number of Member States involved will be increased. Careful legal, financial and operational preparation leading to concrete agreements between Member States will contribute to the sustainability of the platform.

This action will also help national authorities to establish bilateral agreements to exchange organs between Member States. Not all Member States have transplant programmes for every type of organ. Establishing organ-specific bilateral agreements between Member States gives EU citizens’ access to care in a transplant centre in another Member State that is specialised in the organ of their need. These organs can also be procured in one Member State and sent to another. Existing agreements have increased the mobility of patients and utilisation of organs in Europe. This action will explore existing practices, identify opportunities for bilateral agreements, help Member States develop bilateral agreements and establish an operational set-up. Work undertaken within the COORENOR project will contribute to this.

This action will also address issues which hinder EU citizens in accessing transplantation programmes in other Member States. This action will deliver an overview of patient mobility patterns in the Member States for organ transplantation and related problems, together with proposals to address these. This action will also deliver an overview of consent systems and methods for the mutual understanding of these systems by the Member States to facilitate donation in other Member States when potential organ donors die outside their national borders. The estimated time of delivery of results is end-2015.

[Joint action] Indicative amount: EUR 1 150 000

3.1.4.3. Dissemination of best practices in organ donation/transplantation

The objective of this action is to help effectively disseminate best practices in the donation and transplantation of organs, tissues, cells and blood through the Council of Europe (CoE). This action derives from several projects funded by the health programme and the work done by various working groups to identify and develop best practices in the EU. These cover in particular: (a) public awareness campaigns; (b) donor identification, recruitment and management; (c) living donation of organs; (d) quality practices in blood and tissue establishments, in particular on collection, testing, processing, storage and distribution; (e) monitoring the safety of human substances; (f) collaboration with intensive care units; and (g) follow-up of post-donation and post-transplant/transfusion.

Owing to its outreach and structure, CoE can significantly contribute to the dissemination of best practice and reach out to additional audiences. These include health professionals and establishments, represented in many of the expert groups managed by CoE, and representatives of competent authorities in its expert groups. These competent authorities are responsible for organising donation, transplantation and transfusion activities in the Member States.

To leverage this outreach and make sure that additional groups are able to benefit from the knowledge developed with the help of EU funding, CoE will develop and implement a dissemination plan for different target groups and geographic coverage. Concrete activities may include conferences, platform building, awareness campaigns, distribution of references through emailing/websites, publication of leaflets/guidance materials and training.

These activities will contribute to a better implementation of the safety and quality requirements as laid down in Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (21); Directive 2002/98/EC and its implementing legislation, and Directive 2004/23/EC and its implementing legislation. They will also contribute to improving the efficiency of systems and accessibility to substances of human origin, in particular for organs, in line with the Commission action plan on organ donation and transplantation.

[Direct grant to CoE] Indicative amount: EUR 100 000

3.2. Actions under the second objective ‘Promote health’

3.2.1. Increasing healthy life years and promoting healthy ageing (point 2.1.1 in Annex to Programme Decision)

3.2.1.1. Support to the European Innovation Partnership on active and healthy ageing

The objective of this action is to contribute to active and healthy ageing, a priority under the Europe 2020 Strategy. This action will support the implementation of the European Innovation Partnership in the field of active and healthy ageing set out in Commission Communication COM(2010) 546 final of 6 October 2010 on Europe 2020 Flagship Initiative — Innovation Union.

This action will focus on a number of concrete activities in line with the Strategic Implementation Plan of the Partnership. It seeks to support the deployment of innovative solutions for care provision in terms of innovative policies and business models for collaborative and integrated care systems, based on a continuum of care approach. It will also focus on chronic disease management, addressing in particular patients with multiple chronic conditions. It will cover three different types of action: (a) seed money for pilot projects on change of care delivery; (b) support for a partnership approach towards change in care delivery; and (c) supporting older people's health.

(a) Supporting change of care delivery

Support in the form of seed money will be provided in order to prepare and execute change in social and health care systems leading to provision of integrated care based on innovative business models and technologies. This activity seeks to assist in change towards the implementation of integrated care systems that are based on patient-centred, coordinated, integrated and continuous care models. Based on existing evidence the care models will, in particular, address the management of chronic diseases. Integrated models should help to reduce long-term disability and frailty of patients with multiple chronic conditions and reduce unnecessary and avoidable hospitalisation. Apart from supporting systems change, this action will also ensure the transfer of knowledge gained in the process of change implementation to other relevant entities, i.e. entities responsible for care organisation and delivery across the EU.

(b) Partnering for change

This action seeks to support stakeholder cooperation in changing social and care systems. Activities to be addressed through a partnership approach may include: (a) outlining new business models reflecting innovative solutions, in particular addressing the management of multiple chronic conditions; (b) development of new care pathways along the continuum of care; (c) development of guidelines based on new solutions/business models; (d) development of training modules for care providers which reflect these new solutions/business models; (e) development of guidelines for informal care provision; and (f) support for related public procurement modernisation, including functional specification for tenders, quality criteria, interoperability requirements, joint pre-commercial procurement, and promotion of a life-cycle value approach to investment valuation. This action will focus on activities that can demonstrably be put into practice.

(c) Supporting older people’s health

This action seeks to maximise the impact of resources promoting the health of older people, through (a) better collaboration and coordination, e.g. support and dissemination of models of good/best practice to promote the health of ageing populations; strengthening data systems; (b) capacity building, e.g. development of health literacy programmes; gerontology training; (c) support to interventions that help prevent the onset of frailty; and (d) identifying measures to ensure that ageing considerations are taken into account in devising new health policies.

[Project grants] Indicative amount: EUR 4 021 820

3.2.2. Identifying the causes of, addressing and reducing health inequalities within and between Member States in order to contribute to prosperity and cohesion; supporting cooperation on issues of cross-border care and patient and health professional mobility (point 2.1.2 in Annex to Programme Decision)

3.2.2.1. Fostering health provision for migrants, the Roma and other vulnerable groups

The objective of this action is to improve the access and appropriateness of health care services, health promotion and prevention to meet the needs of migrants, the Roma and other vulnerable ethnic minority groups, including irregular/illegal migrants.

This action has two components. The first focuses on promoting appropriate health care provision to migrants at the southern borders of the EU, thereby increasing public health safety in the EU in the longer run. This action is based on the results of the ‘Increasing Public Health Safety Alongside the New Eastern European Border Line’ project funded by the first public health programme in 2006. This action supports the implementation of Decision No 2119/98/EC; Decision 2000/57/EC; Council Directive 2003/9/EC of 27 January 2003 laying down minimum standards for the reception of asylum seekers (22), and the new International Health Regulations. It also contributes to the implementation of Commission Communication COM(2011) 292 of 24 May 2011A dialogue for migration, mobility and security with the southern Mediterranean countries.

The second component focuses on the Roma and other vulnerable ethnic minority groups, including irregular/illegal migrants. This action will contribute to reaching the aims of the Europe 2020 Strategy on the need to reduce health inequalities. It makes a direct contribution to the implementation of Commission Communication COM(2010) 758 final of 16 December 2010The European Platform against Poverty and Social Exclusion: A European framework for social and territorial cohesion (23), Commission Communication COM(2009) 567 final of 20 October 2009Solidarity in health: reducing health inequalities in the EU (24), Commission Communication COM(2010) 133 final of 7 April 2010The social and economic integration of the Roma in Europe (25) and Commission Communication COM(2011) 173 final of 5 April 2011An EU Framework for National Roma Integration Strategies up to 2020 (26).

It will (a) establish a mechanism for networking and exchanging good practice between the Member States, accession countries and relevant international organisations on improving the access and appropriateness of health care services, health promotion and prevention to meet the needs of migrants, the Roma and other vulnerable ethnic minority groups, including irregular/illegal migrants; (b) document the legal and policy framework, including review of national health plans and support for the development and monitoring of national action plans for migrants/ethnic minorities to include a specific focus on the Roma; (c) develop benchmarking criteria and consensus guidelines on good practice on access to care for the Roma and other vulnerable ethnic minority and migrant groups; and (d) review training and capacity building programmes in relation to ethnic/migrant health and development of a consensus framework for capacity building for professionals, including basic components of a training programme and the operational aspects of its delivery and evaluation. It will result in strengthened policies and initiatives at national and sub-national levels to address the healthcare needs of the Roma, migrants and minority groups, and a contribution to the inclusion of the Roma, migrants and other vulnerable groups.

[Direct grant to IOM] Indicative amount: EUR 1 533 000

3.2.2.2. Identifying best practices in tobacco control to reduce health inequalities

The objectives of this action are to analyse the consumption of tobacco in various groups in society and the role of tobacco use as a contributor to the current and future gap in health outcomes. It will also analyse the impact of the interventions taken by the EU, Member States and third countries to reduce tobacco-related inequalities. These measures target in particular lower educational, occupational and income groups, different gender and age groups and specific socially disadvantaged groups, such as disabled persons, homeless people, young people with special needs and migrants.

This action will provide a comprehensive picture of the challenges posed by tobacco-related inequalities throughout the EU, providing an evidence base and contribute to the sharing of best practices. Given that certain marginal groups are difficult to reach, it is useful for the Member States to learn from each other’s experience and avoid using resources on measures that have proved ineffective. This action will deliver a study presenting a comprehensive analysis of current and future tobacco-related inequalities and an overview of the most cost-effective measures to address these. It will contain recommendations on integrating health equity considerations into tobacco-control policies and legislation at Member States’ and EU level. Expected results will provide national and EU policy-makers with a thorough understanding of good practices in reducing tobacco-related inequalities. The estimated timeline for the delivery of the study is end-2013.

[Framework contract/call for tenders]

3.2.2.3. Study on patient empowerment in relation to the Cross-border Healthcare Directive

The objective of this action is to support the Member States in implementing Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (27). The transposition date of the Directive is 25 October 2013. Under Article 6 of the Directive Member States are required to designate one or more National Contact Points (NCPs) to provide patients with ‘appropriate information on all essential aspects of cross-border healthcare [that] is necessary in order to enable [them] to exercise their rights on cross-border healthcare in practice.’

This action seeks to design and roll-out a prospective study aiming to assess how NCPs can best formulate and present information to patients. The assessment criteria to be used will address patient satisfaction, information retention and information understanding, notably consistency in patient choices. Research hypotheses will be formulated and relevant literature will be screened. A preliminary study design distinguishing primary/secondary outcomes to be measured in randomised patient groups will be drafted. The results of this study are to be translated into recommendations for Member States.

This action will contribute to patient empowerment by increasing clarity on patients’ rights as regards cross-border treatment; patient safety by providing information on healthcare providers, and on the quality and safety standards of the healthcare they provide; and by enhancing Member States’ cooperation on cross-border healthcare through the network of national contact points that will exchange information.

[Framework contract]

3.2.2.4. Forecasting health workforce needs for effective planning in the EU

The objectives of this action are to provide a platform for Member States to work together on forecasting health workforce needs and workforce planning methodologies and to find possible solutions to the shortage of the health workforce in Europe. This action was announced in Commission Communication COM(2010) 0682 final of 23 November 2010An Agenda for new skills and jobs: A European contribution towards full employment (28). It will directly contribute to reaching the aims of priority 2 Equipping people with the right skills for employment set out in the Communication. Member States also requested the setting up of such a platform in the Council conclusions on investing in Europe's health workforce of tomorrow: Scope for innovation and collaboration adopted on 7 December 2010 (29).

Comprehensive and integrated forecasting mechanisms and strategies would help Member States to assess the number and kind of health workforce their health systems require. Adequate forecasting and planning contributes to ensuring the sustainability of health systems and meeting current and future challenges. These include an ageing workforce and ageing patients; increased services to manage chronic conditions, mental health, long-term care and social care; new patterns of health workforce and the growing migration of health workers across countries. Action at EU level can also add value in mapping the skills and competences needed for the future and helping to equip health workers with the necessary education, as well as determining crucial factors for a satisfactory working environment.

This action aims to: (a) provide information and exchange best practices about planning methodologies in use. It will provide analyses on the factors determining their success, including the local context, culture and workforce structure. A database of best practices and guidelines for improved modelling will be developed (2013-2014) and an EU-level permanent platform will be created (2015); (b) estimate future needs in terms of skills and competences of the health workforce and their distribution. A report on the different methodologies used in the EU will be produced, together with user's guidelines on how to estimate future needs (2013); (c) advise on how workforce-planning capacities can be built up in Member States (2014). This action will identify experts on workforce planning in Member States that can assist competent authorities in other Member States to build up workforce planning capacities; (d) develop EU guidance on how donor and receiving countries can cooperate in order to find a mutually beneficial solution in terms of training capacities and circular mobility (2014-2015); and (e) provide information on mobility trends of health professionals in Member States (2013-2015). Such collaboration has been initiated within different research and innovation projects, like ‘HEALTH PROfessional Mobility in THe European Union Study’ (PROMeTHEUS) (30) or ‘Nurse Forecasting: Human Resources Planning in Nursing’ (RN4CAST) (31), but it needs to be further supported. The EU platform will also have this function. This joint action should capitalise on PROMETHEUS, RN4CAST and the ‘Mobility for Health Professionals’ (MoHProf) (32) projects and make use of their results and outcomes. This action will contribute to the implementation of the ‘WHO Global Code of Practice on the International Recruitment of Health Personnel’ which serves as an ethical framework to guide Member States in the recruitment of health workers, especially those from the developing countries facing critical shortage of health workers, by helping EU Member States to take effective measures to educate, retain and sustain an appropriate health workforce built on an evidence-based health workforce plan (point 5.4 of the Code). This action will also include a work package on how to sustain collaboration once the joint action is over.

[Joint action] Indicative amount: EUR 3 000 000

3.2.3. Addressing health determinants to promote and improve physical and mental health and taking action on key factors such as nutrition and physical activity, and on addiction-related determinants such as tobacco and alcohol (point 2.2.1 in Annex to Programme Decision)

3.2.3.1. Mental health and well-being

The objective of this joint action is to establish a process for structured work on mental health involving Member States, stakeholders in the health and other relevant sectors, and international organisations, in particular the WHO and the OECD. This joint action will build on the 2009-2011 thematic conferences under the European Pact for Mental Health and Well-being launched under the Slovenian Presidency in 2008. The Council conclusions on the European Pact for Mental Health and Well-being: results and future action adopted in June 2011 (33) invite Member States and the Commission to set up a joint action on mental health and well-being under the health programme.

This joint action will develop a reference framework for commonly supported activities to promote mental health and well-being and prevent mental health problems through health and social policies and life settings. Aspects to be addressed include: (a) tackling mental disorders, with a particular focus on depression, through health and social systems, including the de-institutionalisation of health services, their integration into local communities and their networking with social services, (b) the availability and training of the health workforce, (c) promoting healthy environments in workplaces and (d) promoting the mental health and well-being of children and young people through the integration of mental health into school settings and local community environments, parents’ awareness-raising activities and training of school professionals.

This joint action will have three components. The first, ‘Mental health action framework’ will develop commonly endorsed reference frameworks for action on mental health through health systems and social policy as well as in key life environments such as schools and workplaces. Peer reviews will be used as an instrument to learn from each other. Coordinated awareness-raising activities will be considered. The second component, ‘Mental health compass’, further develops the ‘EU compass for action on mental health and well-being’ into a mechanism to collect, review and disseminate good practices from health and other key sectors. The third component, ‘Mental health information’, will focus on collecting data on the mental health status in Member States. The impact of social determinants will be considered and vulnerable groups will be identified. A study will be commissioned on the importance of mental health and well-being for public health in the EU and its relevance for the Europe 2020 Strategy.

This joint action should capitalise on the research and innovation projects listed below, foster their implementation in clinical practice, and make use of their results and outcomes: ‘Clinical decision making and outcome in routine care for people with severe mental illness’ (CEDAR) (34), ‘Children of Prisoners, Interventions & Mitigations to Strengthen Mental Health’ (COPING) (35), ‘European Network of Bipolar Research Expert Centres’ (ENBREC), ‘Prevalence, 1-year incidence and symptom severity of mental disorders in the elderly: Relationship to impairment, functioning (ICF) and service utilisation’ (MentDis_ICF65+) (36), ‘Financing systems’ effects on the Quality of Mental health care in Europe’ (REFINEMENT), ‘A Roadmap for Mental Health Research in Europe’ (ROAMER), ‘Save Young Lives in Europe: Promote health through prevention of risk-taking and self-destructive behaviours’ (SEYLE) (37), ‘Tailored implementation for chronic diseases’ (TICD) and ‘Work Together to Stop Truancy Among Youth’ (WE-STAY).

This joint action will support Member States in (a) improving their mental health services and strengthening promotion and prevention; (b) fostering partnerships between the health sector and other sectors to promote mental health and well-being; (c) preventing mental disorders and providing support to people with mental disorders; (d) managing the transition from institutional care services to community based care models; (e) promoting the social inclusion of people with mental health problems and tackling their discrimination and stigmatisation; and (f) developing mental health indicators. The outcomes of this joint action will be summarised in a report in 2015 proposing reference frameworks for action on mental health and options for further EU-level action.

[Joint action] Indicative amount: EUR 1 500 000

3.2.3.2. Local community including school-based initiatives to prevent overweight and obesity among children and adolescents

The objective of this action is to contribute to the reduction of overweight and obesity-related diseases among young people. This action supports the implementation of A Strategy for Europe on Nutrition, Overweight and Obesity-related health issues (38) and directly responds to discussions in the High Level Group on Nutrition and Physical Activity and at the EU Platform for action on diet, physical activity and health.

Measures under this action seek to develop innovative interventions and campaigns aimed at promoting a balanced diet and physical activity for children and adolescents in relevant settings. They seek to facilitate the exchange of know-how in the design of interventions targeting children and adolescents, with a particular focus on socially deprived groups. They also seek to scale up proven successful initiatives targeting local communities and schools and to develop innovative media campaigns targeting children and adolescents. The EPODE (39) or Shape up (40) partnership approaches involving all civil society and other local actors under the lead of local and/or school authorities could serve as examples. Comprehensive campaigns including a communication and educational dimension focusing on balanced nutrition and physical activity for adolescents anchored on solid public-private partnerships targeting several Member States or regions should be considered. This action intends to support projects that would network existing initiatives, identify and disseminate good practice and support the development and scaling up of local/regional partnership initiatives, including campaigns targeting the promotion of balanced diets and active lifestyles towards children, particularly in regions where these cooperative approaches are not yet fully in place. The resulting good practice should be presented so that it can be easily applied in different settings across Member States and feed into WHO Euro good practices material. This action should capitalise on the research and innovation projects listed below, foster their implementation in clinical practice, and make use of their results and outcomes: ‘EuropeaN Energy balance Research to prevent excessive weight Gain among Youth’ (ENERGY) (41), ‘Sustainable prevention of obesity through integrated strategies’ (SPOTLIGHT), ‘Temptations to Eat Moderated by Personal and Environmental Self-regulation Tools’ (TEMPEST) (42), and ‘Tailored implementation for chronic diseases’ (TICD). Initiatives aiming to generate change, such as to prevent overweight and obesity, should also include or be based on behavioural studies.

These measures are expected to increase local community-based interventions in the EU and generate a positive change in the behaviour of children and adolescents, in particular in socially deprived groups. Ultimately this action seeks to contribute to the decrease in overweight/obesity rates or other validated proxy indicators in the target population of children and adolescents by 2020.

[Project grants] Indicative amount: EUR 1 200 000

3.2.3.3. Evaluation of the Strategy for Europe on Nutrition, Overweight and Obesity-related health issues

The objective of this action is to evaluate the implementation of the six-year Strategy for Europe on Nutrition, Overweight and Obesity-related health issues set out in COM(2007) 279 final of 30 May 2007. The strategy aims to set out an integrated EU approach to this key public health concern, which places a considerable burden on health systems and the economy as a whole due to work absenteeism, loss of productivity and early retirement. EU action in this area help Member States to achieve a high level of health of EU citizens, thereby reducing the costs of ill health. This action should capitalise on the research and innovation projects listed below, foster their implementation in clinical practice, and make use of their results and outcomes: ‘Effective Environmental Strategies for the Prevention of Alcohol Abuse among Adolescents in Europe’ (AAA-PREVENT) (43), ‘Alcohol Measures for Public Health Research Alliance’ (AMPHORA) (44), and ‘Optimizing delivery of health care interventions’ (ODHIN). This will contribute to reaching the Europe 2020 Strategy's goals on better jobs, innovation and active and healthy ageing.

This action covers: (a) analysing evidence-based information on the implementation of the strategy by Member States and the Commission; (b) assessing the contribution from EU stakeholders, in particular within the EU Platform for action on diet, physical activity and health; (c) assessing the contribution of EU policies; (d) assessing the strategy's support to Member States; and (e) supporting the impact assessment process leading to follow-up to the strategy. This action should provide a significant input into policy decisions on follow-up action. The estimated period for delivering this action is one year.

[Framework contract]

3.2.3.4. Action to prevent and reduce harm from alcohol

The objectives of this action are to protect children and young people from harmful alcohol consumption and to raise awareness of lower-risk consumption patterns. This action will support the implementation of the EU alcohol strategy set out in Commission Communication COM(2006) 625 final of 24 October 2006An EU strategy to support Member States in reducing alcohol-related harm (45). It also responds to Council conclusions of 1 December 2009 on alcohol and health (2009/C 302/07) (46) which invite the Commission to consider further steps to protect children, adolescents and young people from alcohol-related harm.

This action has two components. The first focuses on assessing the extent and effectiveness of the use of alcoholic product labels to communicate health-related information. Alcoholic beverage labels are increasingly used in the EU, mainly on a voluntary basis by alcohol producers. However, there is not adequate information on the extent of these practices or on their effectiveness in terms of visibility and information value. Previous summaries of voluntary labelling schemes have relied on information gathered through surveys. Research towards a comprehensive picture involves fieldwork to gather representative samples of alcoholic beverage packages from retail outlets across the Member States to assess the effectiveness of health-related information. With regard to curbing underage drinking, legal age limits for selling and serving alcoholic beverages are amongst the most effective instruments. Previous work on best practices in increasing compliance with age limits has mainly focussed on initiatives of NGOs or operators in the alcoholic beverage sector. However, in order to have a comprehensive picture, experiences from initiatives involving local or national authorities should also be taken into account, especially as research findings suggest that results may be best achieved through multi-stakeholder cooperation. Examples of good practices will be collected and the exchange and dissemination of good practices will be facilitated. This action will enable Member States, NGOs and industry to focus their ongoing or planned activities on best practice approaches on labelling and enforcement of age limits for selling and serving alcoholic beverages. The estimated period for delivering this action is one year.

[Call for tenders]

The second component focuses on up to three pilot projects aimed at mainstream youth organisations at EU level. The aim is to develop good practice and working methods to support healthy choices and enhance life skills to prevent alcohol-related harm integrated into regular youth activities, or through peer support. This component should result in a better overview of good practices and methods to prevent alcohol-related harm in the work of mainstream youth organisations.

[Project grants] Indicative amount: EUR 500 000

3.2.3.5. Monitoring of the European Platform for action on diet, physical activity and health as well as the European Alcohol and Health Forum

The objective of this action is to obtain an independent analysis of and information about the progress of the Platform for action on diet, physical activity and health and the European Alcohol and Health Forum led by key stakeholders and main economic operators willing to support Member States in improving the health of European citizens. It is in support of the Strategy for Europe on Nutrition, Overweight and Obesity-related health issues as set out in COM(2007) 279 final and the EU Strategy to support Member States in reducing alcohol-related harm as set out in COM(2006) 625 final.

This action will contribute to: (a) gaining a better understanding of the Platform and Forum members’ commitments and their relevance for the aims of the Platform and the Forum; (b) fine-tuning these commitments; (c) understanding what needs to be done and how to better integrate all commitments; (d) engendering wider stakeholder trust; and (e) eventually spreading good practices. This action will facilitate plenary discussions on the Platform and Forum’s commitments in each key area. These are consumer information, including labelling; education; promotion of physical activity; marketing and advertising; composition of foods, availability of healthy food options, and portion sizes; and advocacy, policy work and information exchange to improve the impact of individual initiatives; as well as key areas of the Alcohol Forum’s action as developed in its charter. This action also covers annual reports on the Platform and Forum’s achievements including individual commitments and the Platform and Forum’s commitments. The estimated period for deliverables is two years.

[Framework contract]

3.2.3.6. Communication campaign aimed at encouraging smoking cessation

The objectives of this action are to raise awareness about tobacco damage and encouraging people to quit smoking. It targets young adults, groups within society where smoking prevalence is higher than average, and disadvantaged groups. The gender aspect will also be considered. This action underpins EU efforts in the area of tobacco control and supports the implementation of Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products (47), Directive 2003/33/EC of the European Parliament and of the Council of 26 May 2003 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products (48), Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (49) and Council Recommendation 2003/54/EC of 2 December 2002 on the prevention of smoking and on initiatives to improve tobacco control (50).

This action will complement and underpin smoking cessation efforts undertaken by Member States. It will convey a coherent message in all Member States, generating economies of scale and ultimately contributing to reducing health inequalities across the EU. Specific activities will be developed and implemented in cooperation with Member States’ health authorities in order to secure synergies and ensure effective coordination.

The action consisting of the campaign is a sustained structural effort with a total duration of three years. The first year of the campaign (2011) saw the development and up-take of the concept. The second year (2012) focuses on rewarding ex-smokers, and the third year (2013) showcases ex-smokers’ testimonials so as to further promote smoking cessation and demonstrate the first results of the campaign. The most suitable media will be used to target specific groups, such as women in lower socio-economic groups. The components of the campaign under this work plan are: (a) awareness-raising events with a European dimension such as road shows, stands, and workshops at the work place; (b) publicity material, such as publications and videos, to help reach the aims of the campaign; and (c) maintaining and feeding a website and an iCoach tool in all official languages of the European Union. It also covers testing, scientific advice, data collection, evidence and evaluation.

[Call for tenders]

3.2.3.7. Scientific and technical support to the EU Health Forum

The objective of this action is to provide scientific and technical support to the ‘European Health Forum’. Active involvement of health stakeholders in policy development, with a specific reference to the ‘Health Forum’, is set out in Commission Communication COM(2007) 630 final of 23 October 2007Together for Health: A Strategic Approach for the EU 2008-2013. This action also contributes to the aims of the European Innovation Partnership in the field of active and healthy ageing.

This action covers organising and supporting activities of the ‘EU Health Policy Forum’ and of the ‘Open Forum’ in 2013. This includes scientific and technical work related to the following strategic priority areas: (a) economic change: health as an economic driver and cost; (b) demographic change: its impact on health systems and health needs; (c) environmental change: its impact on the organisation of health services and impact on health; (d) social change and public health; and (e) technological change: innovation and development.

This action allows active engagement of health stakeholders and meaningful input by them into EU policies, in particular to the European Innovation Partnership Initiative on active and healthy ageing. The work of the ‘Health Forum’ also helps to ensure that EU activities on health are relevant to and understood by the public health scene at large.

[Framework contract]

3.2.4. Prevention of major and rare diseases (point 2.2.2 in Annex to the Programme Decision)

3.2.4.1. Providing information on cancer and pursuing efforts towards better cancer prevention and control

The objectives of this action are to obtain the latest available information on the cancer burden in the EU and to advance work on cancer prevention and control on the basis of the latest scientific developments and knowledge. This action directly contributes to reaching the aims of the European Innovation Partnership in the field of active and healthy ageing. Given the limited resources and expertise available nationally, action at EU level creates significant economies of scale.

This action responds to the need for accurate and comparable data on cancer incidence, prevalence, cure, survival and mortality in the EU as advocated in Commission Communication COM(2009) 291 final of 24 June 2009 on Action Against Cancer: European Partnership (51). These data will provide a basis for framing an effective cancer policy.

It also responds to the need to update cancer screening guidelines as set out in the Council Recommendation 2003/878/EC of 2 December 2003 on cancer screening (52). The aim is to provide a new edition of the European Guidelines for quality assurance in breast cancer screening and diagnosis reflecting the latest scientific developments. The estimated timeline for delivery is three years.

It also seeks to develop the Voluntary European Accreditation Scheme for Breast Cancer Service. This is in response to the Council conclusions of 10 June 2008 on reducing the burden of cancer (53) and European Parliament requests such as the European Parliament Written Declaration of 14 December 2009 on the fight against breast cancer in the European Union (0071/2009). The estimated period for delivery is three years.

[Administrative agreement with JRC] Indicative amount: EUR 3 500 000

This action will also provide training on digital mammography for health professionals involved in screening programmes based on the results of the ‘European Cooperation on Development and Implementation of Cancer Screening and Prevention Guidelines’ project (54). This comprises the preparation and provision of two training courses. This action contributes to the implementation of Recommendation 2003/878/EC. The estimated period for delivery is one year.

[Administrative agreement with JRC/Direct grant to IARC] Indicative amount: EUR 500 000

This action will also seek to benchmark comprehensive cancer care providing interdisciplinary treatment for patients, and yield examples of best practice in comprehensive cancer care. This is in response to Commission Communication COM(2009) 291 final of 24 June 2009 on Action Against Cancer: European Partnership which aims to reduce cancer inequalities by 70 % by 2020.

[Project grants] Indicative amount: EUR 500 000

3.2.4.2. Preventing chronic diseases

The objective of this action is to help the Member States to develop and implement more cost-effective policies on chronic disease prevention.

This action seeks to support projects that examine the cost-effectiveness of integrated approaches to chronic disease prevention with a particular focus on diabetes, cardiovascular diseases or respiratory diseases. This will include the cost-effectiveness of various interventions to prevent, screen and treat chronic diseases. Projects will also consider an emphasis on reducing health inequalities and the effect on populations with the highest rates of premature death. Work will be focused on economic evaluation, in particular cost-effectiveness analysis, and estimates for scaling up to national and international levels.

By contributing to reductions in premature mortality and morbidity, including in vulnerable groups, this action will contribute to the objectives of Commission Communication COM(2009) 567 of 20 October 2009Solidarity in health: reducing health inequalities in the EU. It also responds to the Council conclusions: ‘Innovative approaches for chronic diseases in public health and healthcare systems’ adopted on 7 December 2010 (55). This action will be informed by and contribute to the implementation of the outcome document from the UN high-level special session on non-communicable diseases.

[Project grants] Indicative amount: EUR 1 400 000

3.2.4.3. Support for European rare diseases information networks

The objective of this action is to support the setting up of new rare disease registers or rare disease information networks. This action contributes to the implementation of Commission Communication COM(2008) 679 final of 11 November 2008 on Rare diseases: Europe’s challenges (56) and Council Recommendation of 8 June 2009 on an action in the field of rare diseases (2009/C 151/02) (57).

Rare disease registries and information networks are key instruments for increasing knowledge about rare diseases and developing clinical research. They are the only way to pool data in order to achieve a sufficient sample size for epidemiological research and/or clinical research. Owing to the small size of samples at national level, these registers and information networks can only be created at EU level. Collaborative efforts to establish data collection and maintain them will be considered, provided that these resources are open and accessible. Registration of patients is a key to any further action to improve their quality of life. It is necessary for the designation of orphan drugs, for establishing research priorities and for the designation and accreditation of European Reference Networks (ERN) for rare diseases. This action will also contribute to the reflection on criteria for designating ERN in the framework established by Directive 2011/24/EU. Priority areas for this action are rare tumours, rare anaemias, cerebral palsies, neuromuscular diseases, cystic fibrosis, rare neurological disorders and rare syndromes associated with autism. Other rare diseases may also be considered. This action seeks to co-finance at least five networks.

[Project grants] Indicative amount: EUR 4 500 000

3.3. Actions under the third objective ‘Generate and disseminate health information and knowledge’

3.3.1. European Health Information System (point 3.2.1 in Annex to Programme Decision)

3.3.1.1. Evaluation of the use and impact of indicators developed by the Joint Action for European Community Health Indicators and Monitoring

The objective of this action is to evaluate the use and impact of the indicators developed by the ‘Joint Action for European Community Health Indicators and Monitoring’ financed by the health programme under the work plan for 2009. The European Community Health Indicators (ECHI) are the main component of the European health monitoring system, which enables the Commission and Member States to identify and exchange best practices as set out in Article 168 of the TFEU, and to assess the performance and sustainability of their health systems as set out in the Europe 2020 Strategy. This action seeks to assess the extent to which these indicators are used in decision-making in the Member States and at EU level. It will analyse how Member States use ECHI indicators in monitoring and evaluating their health policies and in assessing the performance of their health systems, with a particular focus on sustainability.

[Framework contract]

3.3.1.2. Collection and dissemination of health information via cooperation with the Organisation for Economic Cooperation and Development

The objective of this action is to collect, through cooperation with the Organisation for Economic Cooperation and Development (OECD), information essential for policy-making in the areas of health care and health systems. This relates to: (a) information for the European Innovation Partnership in the field of active and healthy ageing that will pilot innovative approaches to health and social care delivery for an ageing population; (b) responding to the Member States’ demand for support and advice on the sustainability of national health systems by investigating the cost-effectiveness of prevention measures and the effectiveness, efficiency and impact of health interventions; and (c) developing and promoting key indicators in health care and health care systems.

This action has two work packages. The first work package focuses on assessing the cost-effectiveness of chronic disease prevention activities and the overall economic implications of chronic diseases comparing alternative policy/intervention scenarios for future chronic disease prevention policies. It should include interventions relating to the principle risk factors for major chronic diseases (smoking, nutrition, physical activity and harmful alcohol consumption) as well as chronic disease prevention/management programmes for canc