Draft Annual Work Programme 2014 Submitted to Member States for Adoptionunder The

ANNEX3

Draft Annual Work Programme 2014 submitted to Member States for adoptionunder the examinationprocedure

(Annex IV of the work plan 2014 sets out the eligibility, exclusion, selection andaward criteria for joint actions. The eligibility criteria make direct reference to thenotification procedure.)

COMMISSION IMPLEMENTINGDECISION

ofXXX

concerning the work programme for 2014 in the framework of the third Programmeof the Union's action in the field of health (2014-2020) and the EU financial contributionto the WHO Framework Convention on Tobacco Control, serving as a financingdecision

(Text with EEArelevance)

THE EUROPEANCOMMISSION,

Having regard to the Treaty on the Functioning of the EuropeanUnion,

Having regard to Regulation (EU) No 282/2014 of the European Parliament and ofthe CouncilontheestablishmentofathirdProgrammefortheUnion’sactioninthefieldof health(2014-2020)andrepealingDecisionNo1350/2007/EC1,andinparticularArticle11 thereof,

Having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament andof theCouncilof25October2012onthefinancialrulesapplicabletothegeneralbudgetofthe UnionandrepealingCouncilRegulation(EC,Euratom)No1605/20022,andinparticular Article 84(2)thereof,

Whereas:

In order to ensure implementation of the third Programme for the Union's action in the fieldof health (2014-2020), it is necessary to adopt a financing decision and thework programme for 2014. Article 94 of Commission Delegated Regulation (EU,Euratom) No 1268/20123 establishes detailed rules on financingdecisions.

It is appropriate to authorise award of grants without a call for proposals to thebodies identified in the work programme and for the reasons providedtherein.

ThisDecisionshouldallowforthepaymentofinterestdueforlatepaymentonthebasisof Article92oftheFinancialRegulationandArticle111(4)ofDelegatedRegulation (EU, Euratom) No1268/2012.

FortheapplicationofthisDecision,itisappropriatetodefinetheterm'substantialchange' within the meaning of Article 94(4) of Delegated Regulation (EU, Euratom)No 1268/2012.

1OJ L […], [date], p.[…].

2OJ L 298, 26.10.2012, p.1.

3CommissionDelegatedRegulation(EU,Euratom)No1268/2012of29October2012ontherulesofapplicationofRegulation(EU,Euratom)No966/2012oftheEuropeanParliamentandoftheCouncilon the financial rules applicable to the general budget of the Union (OJ L 362, 31.12.2012, p.1).

The measures provided for in this Decision are in accordance with the opinion ofthe Programme Committee established by Article 17 of Regulation (EU) No282/2014.

HAS DECIDED ASFOLLOWS:

Article1

The workprogramme

The 2014 annual work programme for the implementation of the third Programme ofthe Union'sactioninthefieldofhealth(2014-2020),assetoutinAnnexI,andtheselection, award and other criteria for financial contributions to the actions of this programme, as setout in Annexes II, III, IV, V, VI and VII, and the EU payment to the WHOFramework Convention on Tobacco Control, areadopted.

The annual work programme constitutes a financing decision within the meaning of Article84 of the FinancialRegulation.

Article2 Unioncontribution

The maximum contribution for the implementation of the Programme for the year 2014 isset atEUR58579000,andshallbefinancedfromthefollowinglinesofthegeneralbudgetof the European Union for2014:

(a)budget line 17 03 01 — Encouraging innovation in healthcare and increasingthe sustainability of health systems, improving the health of the Union citizens andprotecting them from cross-border health threats: EUR 52 870000;

(b)budgetline17010402—SupportexpenditureforHealthforGrowthprogramme: EUR 1 500000;

(c)budgetline17010602—Consumers,HealthandFoodExecutiveAgency–CHAFEA (hereinafter ‘the Agency’) – Contribution from Health for Growthprogramme: EUR 4 209000.

Estimated additional contributions from EFTA countries members of the EuropeanEconomic Area for their participation in the Health Programme are: EUR 1 757370.

The maximum contribution for the EU payment to the WHO Framework Conventionon TobaccoControlissetatEUR200000andshallbefinancedfromthefollowinglineofthe General Budget of the European Union for2014:

— budget line 17 03 13 — International agreements and membership ofinternational organisations in the field of public health and tobaccocontrol.

Theappropriationsprovidedforinthefirst,secondandthirdparagraphmayalsocover interest due for latepayment.

Article3 Flexibilityclause

Cumulated changes to the allocations to specific actions not exceeding 20% of themaximum contributionsetinArticle2ofthisDecisionshallnotbeconsideredtobesubstantialwithin themeaningofArticle94(4)ofDelegatedRegulation(EU,Euratom)No1268/2012,where thosechangesdonotsignificantlyaffectthenatureoftheactionsandobjectiveofthework programme. The increase of the maximum contribution set in Article 2 of this Decisionshall not exceed20%.

The authorising officer responsible may adopt the changes referred to in the first paragraphin accordance with the principles of sound financial management andproportionality.

Article4 Grants

GrantsmaybeawardedwithoutacallforproposalstothebodiesidentifiedinAnnexIin accordance with the conditions specifiedtherein.

Done atBrussels,

[…]

Member of theCommission

For the Commission

ENANNEX I TOVII

ANNEXI

Public Health Programme - Work Programme for2014

1.INTRODUCTION

1.1.Policy and legalcontext

This work plan sets out the priorities and actions to be undertaken, including the allocationof resources,toimplementthethirdProgrammeoftheUnion’sactioninthefieldofhealth (2014-2020)(4)fortheyear2014.ItisbasedonArticle168oftheTreatyontheFunctioning of the European Union (TFEU) and ensuing legal obligations and policy commitments. Article 168 of the TFEU sets out the scope of EU action in the area of public health whichis to carry out actions to support, coordinate or supplement the actions of the MemberStates.

The EU Health Strategy (5) provides a policy framework for all the areas covered by thiswork plan.The‘Investinginhealth’StaffWorkingDocument(6)ofFebruary2013linkedthis policyframeworkmorecloselytothebroaderEurope2020strategy.Morespecifically,it stressedthenecessitytoinvestinsustainablehealthsystems,investinpeople’shealthand invest in reducing healthinequalities.

Takentogether,thesethreestrandsdemonstratethatahealthypopulationandsustainable health systems are decisive for a smart, sustainable and inclusivegrowth.

ThethirdProgrammeoftheUnion'sactioninthefieldofhealth(2014-2020)followsthis approachand:

• ComplementssupportsandaddsvaluetothepoliciesofMemberStatesaimedat improving the health of Union citizens and reducing health inequalities bypromoting health, encouraging innovation in health, increasing the sustainability ofhealth systems and protecting Union citizens from serious cross-border healththreats.

(4)Regulation (EU) No 282/2014 of the European Parliament and of the Council of 11 March 2014 ontheestablishment of a third Programme for the Union’s action in the field of health (2014-2020)andrepealing Decision No 1350/2007/EC

(5)Commission White Paper Together for Health: A strategic approach for the EU2008-2013

(COM(2007) 630final

(6)Commission Staff Working Document Investing in Health. SWD(2013)43 final. Brussels; 20February2013. Accompanying the Communication: Towards Social Investment for Growth and Cohesion–including implementing the European Social Fund 2014-2020. COM(2013)83 final, availableat:

• Focuses on the key issues where Europe can deliver added value and impactpositively in delivering mutual benefits across the EuropeanUnion.

The programme is built around the following four specificobjectives:

1.Promoting health, preventing diseases and fostering supportiveenvironments for healthy lifestyles taking into account the ‘health in all policies’principle;

2.Protecting Union citizens from serious cross-border healththreats;

3.Contributing to innovative, efficient and sustainable health systems,and

4.Facilitating access to better and safer healthcare for Unioncitizens.

ThesespecificobjectivesareexplicitlysetoutinArticle3ofRegulation(EU)No282/2014 of the European Parliament and of the Council on the establishment of a third Programmefor the Union’s action in the field of health (2014-2020) and repealing Decision No 1350/2007/EC (7) (hereinafter referred to as ‘the Programme Regulation’) andfurther specified in Annex I to thatRegulation.

Actionsproposedinthisannualworkprogrammeshouldcomplementandcreatesynergies with actions proposed in other policy areas, notably with relevant research projectsfunded underthe7thFrameworkProgrammeforResearchandInnovationaswellaswithresearch projects which may be funded under Horizon2020.

In addition to the Member States of the European Union, third countries can participate inthe Health Programme if the necessary agreements are in place. The EFTA/EEA countries Iceland and Norway do so under the conditions specified in the EEA Agreement. Otherthird countries, in particular European neighbourhood policy countries, countries that areapplying for,arecandidatesfor,orareaccedingtomembershipoftheEU,andthewesternBalkan countries included in the stabilisation and association process, may participate inthe programme.

In accordance with recital 23 of the Programme Regulation, collaboration should be facilitated with third countries not participating in the programme. This should notinvolve funding from the programme. Nevertheless, travel and subsistence expenses for experts invitedfromortravellingtosuchcountriescanbeconsideredeligiblecostsindulyjustified, exceptional cases, where this directly contributes to the objectives of theprogramme.

1.2.Resources

OnthebasisoftheobjectivesgiveninthethirdProgrammeoftheUnion'sactioninthefield of health (2014-2020), this work programme contains the actions to be financed andthe budget breakdown for year 2014 asfollows:

(7)OJ L 86, 21.3.2014, p.1.

2.GRANTS

All grants are covered by writtenagreements.

2.1.Grants forprojects

Under the overall operational budget reserved for grants, EUR 12 300 000 will be reservedfor projects. The budget line is17.03.01.

Project grants are calculated on the basis of eligible costs incurred. The maximum rate forEU co-financingis60%.However,thismaybeupto80%ifaproposalmeetsthecriteriafor exceptional utility set out in Annex VII. Annex II contains the eligibility, exclusion,selection and award criteria for projectgrants.

Aprojectgrantshouldbeofsufficientsize,sothatambitiousobjectiveswithhighEuropean added value can be reached and an efficient European dissemination strategyimplemented.

Onlyproposalsthatdirectlycorrespondtothetopicanddescriptionassetoutinthiswork planwillbeconsideredforfunding.Proposalsthatonlyaddressthethematicareabutdonot match the specific description of a given action will not be considered forfunding.

All grants for projects will be implemented through a call for proposals organisedand managedbytheConsumer,HealthandFoodExecutiveAgency(CHAFEA,hereaftercalled ‘theAgency’).

2.1.1.Actions under thematic priority 1 - Promoting health, preventing diseasesand fosteringsupportiveenvironmentsforhealthylifestylestakingintoaccountthe ‘health in all policies’principle

2.1.1.1.Makinguseofthepotentialofinnovationforthepreventionandmanagementof major chronic diseases (diabetes, cardiovascular diseases…) (Point 1.4. of Annex I to the ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

Description of the activities to be funded under the call forproposals

Implementation

Indicative timetable and indicativeamount

2.1.1.2.Promoting early diagnosis and screening of preventable chronic diseases (Point1.4. of Annex I to the ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

Description of the activities to be funded under a call forproposals

Implementation

Indicative timetable and indicativeamount

2.1.1.3.Developing innovative approaches to promote the professional reintegrationof people with chronic diseases and improving their employability (Point 1.4. of Annex I to the ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

Description of the activities to be funded under a call forproposals

Implementation

Indicative timetable and indicativeamount

2.1.2Actions under thematic priority 2 – Protecting Union citizens from serious cross-border healththreats

No action is foreseen in2014.

2.1.3.Actions under thematic priority 3 - Contributing to innovative, efficientand sustainable healthsystems

2.1.3.1.Supportinareasrelatedtoadherence,frailty,integratedcareandmulti-chronic conditions (Point 3.5. of Annex I to the ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

Description of the activities to be funded under a call forproposals

Implementation

Indicative timetable and indicativeamount

2.1.3.2.Financialsupportforstatisticaldataintheareaofmedicinalproductpricingin Member States (Point 3.6. of Annex I to the ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

Description of the activities to be funded under a call forproposals

Implementation

Indicative timetable and indicativeamount

2.1.3.3.Towards a sustainable health monitoring and reporting system (Point 3.7. of AnnexI to the ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

Description of the activities to be funded under a call forproposals

Implementation

Indicative timetable and indicativeamount

2.1.4.Actions under thematic priority 4 - Facilitating access to better andsafer healthcare for Unioncitizens

2.1.4.1.Healthcare associated infections - Prevention and control in nursing homes andlong- term facilities (Point 4.4. of Annex I to the ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

(9)

Description of the activities to be funded under a call forproposals

Implementation

Indicative timetable and indicativeamount

2.2.Grants for actions co-financed with Member Stateauthorities

Under the overall operational budget reserved for grants, EUR 18 593 000 will be reservedfor grants for actions co-financed with Member State authorities. The budget line is17.03.01.

Grantsforactionsco-financedwithMemberStateauthorities(inshort‘JointActions’)are, accordingtoArticle7.2(a)oftheProgrammeRegulation,‘actionshavingaclearUnion addedvalueco-financedbythecompetentauthoritiesthatareresponsibleforhealthinthe Member States or in the third countries participating in the Programme pursuant to article6, or by public sector bodies and non-governmental bodies, as referred to in Article 8(1),acting individually or as a network, mandated by these competentauthorities.’

Hence,theyallowthenominatednationalauthoritiesoftheMemberStates/othercountries participating in the Programme and the European Commission to take forward work onjointly identifiedissues.

Grantsforsuchactionsarecalculatedonthebasisofeligiblecostsincurred.Themaximum rateofEUco-financingis60 %.Thismaybeupto80%ifaproposalmeetsthecriteriafor exceptional utility set out in Annex VII. Annex IV contains the eligibility, exclusion,selection and award criteria for theseactions.

2.2.1.Actions under thematic priority 1 - Promoting health, preventing diseasesand fosteringsupportiveenvironmentsforhealthylifestylestakingintoaccountthe ‘health in all policies’principle

2.2.1.1.Facilitating the sharing of good practices between the EU Member States onnational policiesrelatedtounbalanceddietaryhabitsandphysicalinactivity(Point1.1.of Annex I to the ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

Descriptionoftheactivitiestobefundedbyagrantawardedwithoutacallforproposalson the basis of Article 190(1)(d) of the Rules ofApplication

Implementation

Indicative timetable and indicativeamount

(10)WhitePaperCOM(2007)279of30May2007onaStrategyforEuropeonNutrition,OverweightandObesity related healthissues.

2.2.1.2.Improvement of HIV and co-infection prevention and treatment in priorityregions and priority groups in the European Union (Point 1.3. of Annex I to theProgramme Regulation)

Priorities of the year, objectives pursued and expectedresults

Descriptionoftheactivitiestobefundedbyagrantawardedwithoutacallforproposalson the basis of Article 190(1)(d) of the Rules ofApplication

Implementation

Indicative timetable and indicativeamount

(11)Commission Staff Working Document SWD(2014) 106 of 14 March 2014 on an Action PlanonHIV/AIDS in the EU and neighbouring countries:2014-2016.

2.2.1.3.PromotingtheimplementationinMemberStatesofcoordinatedactionstoimprove thesituationofpeoplewithdementiaandtheircarers(Point1.4.ofAnnexItothe ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

Descriptionoftheactivitiestobefundedbyagrantawardedwithoutacallforproposalson the basis of Article 190(1)(d) of the Rules ofApplication

Implementation

Indicative timetable and indicativeamount

2.2.2.Actions under thematic priority 2 - Protecting Union citizens from seriouscross- border healththreats

2.2.2.1.Efficient response to highly dangerous and emerging pathogens at EU level -Phase II (Point 2.3. of Annex I to the ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

Descriptionoftheactivitiestobefundedbyagrantawardedwithoutacallforproposalson the basis of Article 190(1)(d) of the Rules ofApplication

Implementation

Indicative timetable and indicativeamount

2.2.3.Actions under thematic priority 3 - Contributing to innovative, efficientand sustainable healthsystems

2.2.3.1.Technical and scientific co-operation allowing improved coordination andresource sharing between Member States (Point 3.1. of Annex I to the ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

Descriptionoftheactivitiestobefundedbyagrantawardedwithoutacallforproposalson the basis of Article 190(1)(d) of the Rules ofApplication

Implementation

Indicative timetable and indicativeamount

2.2.3.2.eHealth support for the eHealth Network by national competent authorities (Point 3.2. of Annex I to the ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

Descriptionoftheactivitiestobefundedbyagrantawardedwithoutacallforproposalson the basis of Article 190(1)(d) of the Rules ofApplication

Implementation

Indicative timetable and indicativeamount

2.2.4.Actions under thematic priority 4 - Facilitating access to better andsafer healthcare for Unioncitizens

2.2.4.1.Support to the implementation of Council Recommendation andCommission Communication on Rare Diseases, in particular to an EU wide rarediseases information database (Point 4.1. of Annex I to the ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

Descriptionoftheactivitiestobefundedbyagrantawardedwithoutacallforproposalson the basis of Article 190(1)(d) of the Rules ofApplication

(12)CouncilRecommendation(2009/C151/02)of8June2009onanactioninthefieldofrarediseases,OJ C 151(3.7.2009).

Implementation

Indicative timetable and indicativeamount

2.2.4.2.Strengthening the Member States’ capacity of monitoring and control in the fieldof bloodtransfusionandtissueandcelltransplantation(Point4.5.ofAnnexItothe ProgrammeRegulation)

Priorities of the year, objectives pursued and expectedresults

Descriptionoftheactivitiestobefundedbyagrantawardedwithoutacallforproposalson the basis of Article 190(1)(d) of the Rules ofApplication

Implementation

Indicative timetable and indicativeamount

2.3.Financial contribution to the functioning of non-governmental body(Operating grants)

Under the overall operational budget reserved for grants, EUR 4 650 000 will be reservedfor operating grants. The budget line is17.03.01.

Operatinggrantsarecalculatedbasedoneligiblecostsincurred.ThemaximumrateforEU co-financingis60%.However,thismaygoupto80%ifaproposalmeetsthecriteriafor exceptional utility set out in Annex VII. Annex III contains the exclusion, eligibility,selection and award criteria for operating grants. Annex VI contains the criteria for independencefrom industry, commercial and business or other conflictinginterests.

The call for proposals 2014 aims at providing financial contributions (operating grants) tothe functioning of non-governmental bodies, including networks, through the conclusionof frameworkpartnershipagreements(FPA)foradurationofmaximumthreeyears–covering the operating years 2015, 2016, 2017 – and, subsequently, of specific grant agreements forthe financialyear2015.TheFPAwillincludeamulti-annualworkprogrammefortheperiod 2015-2017 as an annex, including a budgetplan.

ApplicantswhoreceiveaFPAareeligibleforthespecificgrantagreement.Theywillbe invited to submit a simplified grant application. This will include an annual workprogramme and budget. Signing an FPA does not guarantee annualco-funding.

Operating grants may be awarded to non-governmental bodies, including networks, activein areas corresponding to the four objectives of the Health Programme, according tothe eligibility criteria established by Article 8(2) of the Programme Regulation and in Annex III to the present decision. Work under operating grants should contribute to achievingthe priorities of the European Union as set out in Commission Communication COM (2010)2020 of 3 March 2010 EUROPE 2020 — A Strategy for smart, sustainable and inclusive growth(13).

Priorities for the year2014

(13)

Descriptionoftheactivitiestobefundedbyaspecificgrantawardedunderaframework partnership

Implementation

Indicative timetable and indicativeamount

2.4.Presidency conference grants – De juremonopoly

According to Article 190(1)(c) of Delegated Regulation (EU) No 1268/2012, grants canbe allocatedwithoutacallforproposalstoorganisationsinadejureordefactomonopoly situation, duly substantiated in the awarddecision.

Presidency conferences, which are highly political in nature and involve representation atthe highestnationalandEuropeanlevels,aretobeorganisedexclusivelybytheMemberState holding the Presidency of the European Union. Given the unique role of the Presidency inthe framework of EU activities, the Member State responsible for organising the eventis considered as having a de juremonopoly.

TwoconferencesorganisedbythePresidenciesoftheEuropeanUnionmayreceiveupto EUR 100 000 each. The maximum rate of EU co-financing is 50 % of eligible costsincurred.

ThePresidencyconferencestobefinancedunderthisworkplanareaconference‘Healthin the Mediterranean area’ planned under the Italian Presidency and a conference‘Healthy Lifestyles’ under the LatvianPresidency.

Implementation

Indicative timetable and indicativeamount

2.5.Direct grant agreements with internationalorganisations

The overall budgetary allocation reserved for actions implemented via direct grantsto international organisations amounts to EUR 2 750 000. The budget line is17.03.01.

InaccordancewithArticle190(1)(f)ofDelegatedRegulation(EU)No1268/2012,funding for actions with international organisations will be allocated through grant agreementswithout a call for proposals on topics specifically identified in this work plan.International organisationsandtheirnationalorregionalofficesarenoteligibleforfundingasmainor associated beneficiaries under any calls for proposals. The maximum rate for EUco-financing is 60 % of the eligible costs actually incurred. In accordance with recital 23 of theProgramme Regulation, activities involving third countries not participating in the programme shall notbe consideredeligible.However,travelandsubsistenceexpensesforexpertsinvitedfromor travellingtosuchcountriescanbeconsideredeligiblecostsindulyjustified,exceptional cases, where this directly contributes to the objectives of theprogramme.

Funding through direct grants will be awarded to the international organisationsbelow because of their specific competence and high degree of specialisation in the areas coveredby the direct grants set out in the respective sections of this workprogramme:

—Council of Europe(CoE)

TheCouncilofEuropehasspecificexpertiseintheharmonisationandco-ordinationof standardisation, regulation and quality control of medicines, bloodtransfusion, transplantation of organs, tissues and cells, pharmaceuticals and pharmaceuticalcare.