Brussels, May 23-24, 2008

Grigorij KoganEuropean Commission, DG Research

Directorate Health – Medical and Public Health Research Unitgrigorij.kogan@ec.europa.eu

EUNEFRON EUNEFRON Kick-off meeting Kick-off meeting

Health Theme in FP7 Health Theme in FP7

Seventh Framework Programme 2007-2013

Total FP7 budget: € 54,582 billion

Cooperation

32,413*

*of which Health € 6,1 billion

JRC (EC) 1,751

Euratom

4,061Capacities 4,097

People 4,75

7,51Ideas

FP7: HealthObjectives: Rationale: Improving health of European citizens

Addressing global health issues including emerging epidemics

Increasing competitiveness of European health-related industries

Sequencing of human genome and recent advances in post-genomics to integrate vast amounts of data Translational research to bring knowledge into the clinic Clinical research international multi-centre trials

Reinforce health policy-driven research comparison of national policies Strong EU-based biomedical research strengthen competitiveness of industries and SMEs

FP7: Health3 sub-themes

Sub-theme 1: Biotechnology,

generic toolsand medical technologies

for human health

Sub-theme 2: Translating research for

human healthSub-theme 3:

Optimising the delivery of health care to European

citizens

Translational research in major diseases: cancer; cardiovascular

diseases; brain and related diseases; diabetes/obesity; rare diseases; other

chronic diseases (e.g. rheumatic, respiratory, musculo-skeletal diseases,

arthritis)

Key figures from the 1st and 2nd calls in FP7 Health theme

1st call 2nd call

call 2007-A (19 April 2007) call 2007-B (18 Sept. 2007) budget: € 635 million (2007) € 567 million (2008)

proposals received: 914 902 proposals evaluated: 893 865 ineligible: 21 37

ceilings not respected: 11 23 minimum n° partners: 5 11 withdrawn, test or incomplete: 5 1

2.4.4. Rare Diseases 1st Call

Topics for the first call: Natural course and pathophysiology of rare diseases (FP) Research capacity-building in the field of rare diseases (CA or SA)Outcome of evaluation: 53 proposals evaluated, 34 (64%) above threshold, 11 (21%) short-listed both topics covered Very high impact for rare diseases, but also direct and indirect implications for more common diseases

No topics in second call

2.4.5. Other Chronic diseases1st call

Topics for first call: Osteoarthritis (IP) Inflammatory bowel disease (FP) Osteoporosis: signalling pathways in bone formation & homeostasis (FP) Genetic factors of Osteoporosis (FP) Intervertebral disc degeneration: prevention and repair (FP) Innovative concepts in COPD pathogenesis (FP) Hearing impairment and degeneration (CA/SA) Impairment of touch and proprioception at old age (CA/SA) Visual impairment and degeneration (CA/SA)Outcome of evaluation: 50 proposals evaluated, 28 (56%) above threshold, 11 (22%) short-listed 8 out of 9 topics covered

2.4.5. Other Chronic diseases2nd call

Topics in the second call: Understanding and combating age-related muscle weakness (IP) Translational research for a treatment of urinary incontinence (FP) Early processes in pathogenesis of chronic inflammatory diseases (IP)

Outcome of evaluation: 35 proposals evaluated, 24 (69%) above threshold, 3 shortlisted (8.6%) All 3 topics covered for 2.4.5-12: Due to its broad scope, the topic received 26 proposals, including some very good ones. One project that received 15 points was selected for funding.

3rd call for proposals for the Health theme

The 3rd call is expected be published in July 2008 drawing on the budget for 2009: ~€ 590m there will in fact be two calls, published in parallel:

2008-A will use the single stage submission/evaluation approach for most of the areas of the work programme with an expected deadline: Nov. 2008 2008-B will use a 2-stage submission/evaluation

only for areas 1.1 & 2.1. with expected deadlines: Oct. 2008 for 1st stage

Feb./March for 2nd stageBased on proposals of European Commission

services, subject to confirmation in call text (July 2008).

Collaborative researchin the Health theme

2: Translating research for human health Integrating biological data and processes:

large-scale data gathering, systems biology Research on the brain and related diseases,

human development and ageing Translational research in major infectious diseases Translational research in other major diseases

Based on proposals of European Commission services,

subject to confirmation in call text (July 2008).

2.4.4. – Rare Diseases

Proposed topics for the 3rd call: • Rare neurological diseases. Funding scheme: Small or medium-scale focused research projects, max. € 6m Specification of the analysis of genetic risk factors

• Preclinical development of substances with a clear potential as orphan drugs. Funding scheme: Small or medium-scale focused research projects, max. € 3m Linked to the EU designated orphan medicinal products register

Based on proposals of European Commission services,

subject to confirmation in call text (July 2008).

2.4.5. – Other Chronic Diseases

Proposed topics for the 3rd call: Prevention and treatment of non-alcoholic fatty liver disease (NAFLD). Funding scheme: Small or medium-scale focused research projects, max. € 6m Cellular and molecular mechanisms in the development of chronic kidney disease (CKD). Funding scheme: Large scale integrated project, max. € 12m

Based on proposals of European Commission services,

subject to confirmation in call text (July 2008).

Reporting (1)

During the course of your project, you should submit:

The deliverables identified in Annex I of the Grant Agreement, according to the timetable specified in the Deliverables list. A periodic report within 60 days of the end of each reporting period (including the last reporting period). The reporting periods are defined in Article 4 of the Grant Agreement as 12, 30, 48, and 60 months since the start of the project. The periodic report comprises:Overview of progress of the work, including a publishable summary report

The report should devote a section to describing the handling of the ethical aspects of theproject. An explanation of the use of the resources A Financial Statement (Form C – Annex VI of the Grant Agreement) from each beneficiary and each third party, if applicable, together with a summary financial report consolidating the claimed Community contribution of all the beneficiaries (and third parties) in an aggregate form. Financial statements should be accompanied by certificates, when this is appropriate (see Article II.4.4 of the Grant Agreement).

Very important: Never forget to acknowledge financial support from the EC given to the Project in any presentation at the meetings, publications, communications, etc.

Reporting (2)

At the end of the project you should submit:

A final report, within 60 days after the end of the project. This final report shall comprise:

A final publishable summary report covering results, conclusions and socio-economic impact of the project.A report covering the wider societal implications of the project, in the form of a questionnaire, including gender equality actions, ethical issues, efforts to involve other actors and to spread awareness, as well as the plan for the use and dissemination of foreground.

Reporting (3) After you receive the final payment from the EC, you should submit:

The coordinator shall submit a report on the distribution of the Community financial contribution between beneficiaries (see Article II.4.3 of the Grant Agreement). This report must be submitted 30 days after receipt of the final payment (not required for intermediate payments).

The consortium shall transmit the reports and other deliverables through the coordinator to the Commission by electronic means (Article II.4.5 of the Grant Agreement).

In addition, Form C must be signed by the authorised person(s) within the beneficiary’s organisation and the certificates on the financial statements and on the methodology must be signed by an authorised person of the auditing entity, and the originals shall be sent to the Commission.

Each periodic report shall be in the form of ONE single report in electronic format, preferably in PDF format and include, where applicable, a copy (properly scanned) of the signed pages, the originals being sent in parallel by post. The signed pages concerned are the Forms C, the self declaration of the coordinator and the audit certificates or certificates on the methodology.

The reports submitted to the Commission, in particular their publishable parts, shall be of a suitable quality to enable direct publication without any additional editing. By submitting the publishable reports to the Commission, you are also certifying that they include no confidential material (Article II.4.7).

Reporting (4)

Commission has 105 days to evaluate and execute the corresponding payment No tacit approval of reports Automatic payment of interests (NEW) for unjustified delays

by the EC

After reception Commission may: Approve Suspend the time-limit requesting revision/completion Reject them giving justification, possible termination Suspend the payment

Reporting (5)The guidance on how to write the periodic and final reports is

published on the CORDIS web-site ftp://ftp.cordis.europa.eu/pub/fp7/docs/project_reporting_en.pdf. Please be careful to follow the structure provided and to complete all of the sections described. Please ensure that any acronyms used are clearly explained.

Financial aspects

• waives the obligation to verify the financial capacity of the participants• waives the obligation to request additional financial guarantee •BUT financial capacity still to be checked

If coordinator is private (if found to be financially weak may not be coordinator)If participant apply for more than 500 000 EUR EC contributionIf exceptional circumstances when on the basis of the info already available there are justified grounds to doubt the financial capacity of these participants

Under FP7 protection of EC financial interests via Guarantee Fund

Financial aspects

• All beneficiaries to indirect actions participate including public bodies• Commission to deduct the participation when paying the advance • Deduction = 5% of the total Community contribution

Participant’s Guarantee Fund

Financial aspects

• Normally at the end of the action the amount contributed to the Fund shall be returned to the participant• The amount to be returned shall be equal to = Contribution to the fund under this grant agreement x fund index

Participant’s Guarantee Fund

Financial aspects

• Is to be defined during negotiations • As indicative general rule, for projects of more than 2 periods = 160% of the average EC funding per period•2 limits:

5% to be transferred to the PGF10% retention will be kept until last payment

Advance payment

Financial aspects

• Only one advance payment, paid within 45 days as of GA entry into force• Advance payment remains the property of the Commission until the last payment• Interest generated by the prefinancing

•Must be reported by the coordinator if prefinancing ≥ 50 000 EUR (current version of Financial Regulation and Implementing Rules) •will be deducted from the EC contribution•NB interest generated by part of prefin transferred from Coo to other beneficiaries (if any) will not need to be reported

•The interest generated on the amount of the prefinancing will be offset against the subsequent payment

Advance payment

Financial aspects

• Project running over 3 reporting periods with 2,990,000 EUR contribution •Prefinancing = finances per average reporting period 2,990,000: 3 = 996,666.7 x 160% = 1,594,666 EUR• Contribution to the guarantee fund: 2,990,000 x 5% = 149,500•Net amount to be transferred to the coordinator: 1,594,666– 149,500 = 1,445,166 EUR

Advance payment

Financial aspects

• After approval of the periodic reports• calculated on the basis of the accepted eligible costs and reimbursement rates•Correspond to the accepted EC contribution– under FP7 the advance remains pre-financing until the end of the project•Limitation: advance + interim payments may not exceed 90% of the total EC contribution

Interim payment

Financial aspects

• After approval of the final reports• = difference between the calculated EC contribution minus the amounts already paid•Limited to the maximum EC contribution •At this stage the Commission will order the Fund to release the amount of the Guarantee fund

Final Payment

Financial aspects

• Project duration 3 years• Maximum EC contribution 3,000,000• Ceiling 2,700,000 (10% retention)

•Prefinancing: 1,600,000 (including 5% guarantee fund 150,000) interest generated 20,000•P1 accepted costs 1,000,000 Payment 980,000•P2 accepted costs 800,000 Payment limited to 100,000•P3 accepted costs 1,200,000 Final payment 300,000 (+ reimbursement of 150,000 max 120,000 min (if private entity) from the Guarantee Fund)

Example of payments

Useful documentshttp://cordis.europa.eu/fp7/find-doc_en.html