Co-funding and Coordination of national programmes

1. Instituto de Salud Carlos III www.isciii.es Consensus meeting of the EDCTP-II Brussels, Belgium, 27 & 28 September 2010 Under the umbrella of the Belgian Presidency of the Council of the European Union Co-funding and Coordination of national programmes Rafael De Andrés Medina EDCTP-I GA representative of Spain rdam@isciii.es This presentation does not represent a formal position of Spain

2. EDCTP-II - Principles (also learnt by the experience) • Transparency, predictability, efficiency • Flexible and variable geometry of actors, • Fairness and Win-Win: • No smaller nor big MS funding contributors is left behind • Liability limited and proportional to each MS initial binding funding commitment • Voting rights on financial issues linked to those entitled to financial liability • Simplification • Each project partner should be subjected just only to a singleco-fundinglegal framework • Doing more & fast with less administrative burden & cost • Faster and cheaper delivery of funds to selected consortia than in EDCTP-I

3. Public Funds Sources MSs = EU Member States and associate countries PRD (= poverty related diseases) countries EC = European Commission Private Funds EDCTP-II - R&D programme MSs driven with EC co-funding too • Public co-fundingIssues • Political • Legal: TEC art 185 (former 169) for R&D? • Structural: EEIG? • Operational • Governance • Fairness, Fast Speed and Simplification

4. EDCTP - Clinical trials (R&D and capacity building), their outcomes´deployment and sustainability • No common pot • Common pot • Real • Virtual • Conditions • European cross border or not, partial? • Just return or not ? • In cash • In kind • clear predictable eligibility • avoid creative accounting

5. EDCTP-II -MSs upfront initial binding R&D co-funding commitment • Political: • for the whole duration of the EDCTP-II R&D JP • Legally binding: • per annual work programme, specifying amount per funding instrument, e.g. a call, as well as central and national eligibility • According to each MS scientific community size: • to avoid bottle necks in funding project consortia Public Funds should serve as leverage to other Public and/or Private Funds

6. EDCTP-II - Ideas on Legal Enforcement Architecture for R&D Cooperation Pluri-annual legally binding agreement signed between EDCTP-II joint undertaking (EEIG?) and each EDCTP-II MS endorsed organisation to represent it MS upfront binding co-funding, national audits (+ EC provisions on auditing and records), reporting, liabilities, voting rights. • Pluri-annual legally binding Agreement signed betweenECand the EDCTP-II joint undertaking (EEIG?) • ECco-funding matching MSs´ joint upfront binding co-funding • cap co-funding to activities, accompanying measures, central administration) its records, its audits, its reporting

7. EDCTP-II - Operational Ideas • Work Programme • A set of scientific and technical activities linked to appropriations (that constitutes the EDCTP-II R&D JP budget) with its eligibility • Annualbindingor pluri-annual indicative commitments • Approval by a double majority representing • 50% number of participating MSs representing • 50% binding liable commitments (No MS is left behind principle)

8. EDCTP-II - Ideas onR&D Grant Simplification • Each project partner or each consortium should be just only subjected to a single legal framework • Sign a single grant contract either with the EDCTP-II-MS • funding organisation or with the EDCTP-II-(EEIG?) but • not two grant contracts, one withEDCTP-II-(EEIG?) and another with the EDCTP-II-MS funding organisation • A consortium is funded by Common Pot (MSs + EC matched funds) or • EC matched co-funding is channeled via theEDCTP-II-MS funding organisation too after justification of national public co-funds delivery to a project partner and delivered at one later to it

9. EDCTP-II - EuropeanMSs´and PRD Countries´S&T Health Institutions in Partnership Sub-Programme • Selection of partners after scientific an strategic and opportunity assessments • They draft after a comprehensive pluri-annual joint work programme (JWP) • JWP is approved after scientific and strategic and opportunity assessments • Midterm and final assessments • Slimmer administrative and assessing burden • A separate constituency for this Sub-programme or not?

10. EDCTP-II - Ideas on JP Administrations Costs • Central • % cap EC co-funding • Split along EDCTP-II JP duration + exit period • Escalating back administrative cost • No new activities • Duration (N years) - long enough until of projects / activities closing approved upon last EDCTP-II JP annual work programme • Each MS own • % cap MS co-funds devoted to national administration • matching the % EC co-funding for central administration • Room for additional efficiency • Long term convergence trend of MSs co-funding administrative regulations?

11. EDCTP-II - No MS is left behind in funding - principle • MSs co-funds are allocated to project partners from their respective initial binding co-funding commitments and matched by EC co-funding until its cap amount. • Co-fundig Rate-1 • If a MS increases its co-funding above its initial binding funding commitment, such increase will be matched just only by the remaining EC co-funds after these have matched all MSs co-funds allocated to projects from their respective initial binding co-funding commitments • Co-funding Rate-2

12. EDCTP-II - Ideas for R&D outcomes deployment and their sustainability EDCTP Coop jpi Sustainable Deployment Cooperation Joint Programming Initiative Networking Mentorship and capacity proliferation Capacity development Retain developed capacity to conduct clinical trials and clinical care and Public Health • It is not a R&D Joint Programming Initiative but needs Political Will • A Separate legal instrument (?) or at least or a voluntary multilateral cooperation decision of some MSs (MoU) aligned toEDCTP-IIR&D JP (co-decision?) • Separate MSs accession? • Similar (but not necessarily same) MSs´ composition • MSs´ cooperation upfront own binding funding commitments • A Separate constituency for EDCTP Coop jpi or not?

13. EDCTP-II - Ideas regarding R&D funding (1) and sustainable deployment after (2) • (1)EDCTP-II R&D JP • Actions • Short term: Projects and capabilities calls Sub-programme • Long term: European & PRD countries´ S&T health institutions in partnership Sub-Programme • Accompanying measures • Administration (EDCTP-IIR&DJP central and MSs´ own) • (2)EDCTP Coop jpi • Sustainable Deployment Cooperation Joint Programming Initiative • R&D outcomes´ deployment after R&D and their sustainability • Short term actions Sub-programme • Long term actions Sub-programme • Administration (EDCTPCoop jpi central and MSs´ own) • May be linked to EDCTP-II R&D JP

14. EDCTP-II - Questionsfor Debate that Affect Costs • Just only a single binding commitment and constituency for the whole EDCTP or separateones • by disease(s), geographical area(s), institutional partnership? • for each or for any Sub-programme(s) or not? • Just return, Common pot (real?, virtual?) or not? • Should Public funds serve as leverage to other Public and/or Private Funds too? • Relations/partnership with ESFRI BMS, e.g ECRIN? • Including R&D outcomes´deployment and their sustainability? • Only EDCTP-II R&D JP orEDCTP Coop jpi too or combined? • Which political/legal instrument(s)? • Separate constituencies (or not) for • Long term vision and advice? • Proposals´ evaluation? • Funders? • Performers? • Stakerholders?

15. Thank you very much! Acknowledgement for input to these author´s personal opinions- Almudena Gonzalez, ISCIII EDCTP-I GA proxy- EDCTP-I JP: GA, ENNP, EC and Executive Secretariat officers´discussions - AAL JP: GA, EB, NCPs, EC and CMU officers´discussionsNo other than the author is responsible for this presentation