Co-funding and Coordination of national programmes

Rafael De Andrés MedinaEDCTP-I GA representative of Spain

rdam@isciii.es

Brussels, Belgium, 27 & 28 September 2010

Consensus meeting of the

EDCTP-II Under the umbrella of the

Belgian Presidency of the Council of the European Union

This presentation does not represent a formal position of Spain

Instituto de Salud Carlos IIIwww.isciii.es

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

single co-funding legal framework

Doing more & fast with less administrative burden & cost •Faster and cheaper delivery of funds to selected consortia than in EDCTP-I

Public Funds Sources• MSs = EU Member States and associate countries• PRD (= poverty related diseases) countries• EC = European Commission Private Funds

Public co-funding Issues• Political• Legal: TEC art 185 (former 169) for R&D?

• Structural: EEIG?• Operational• Governance

• Fairness, Fast Speed and Simplification

EDCTP-II - R&D programme MSs driven

with EC co-funding too

• No common pot• Common pot

• Real• Virtual

Conditions• European cross border or not, partial?• Just return or not ?

EDCTP - Clinical trials (R&D and capacity building),

their outcomes´deployment and sustainability

• In cash• In kind

• clear predictable eligibility• avoid creative accounting

•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

EDCTP-II - MSs upfront initial binding R&D co-funding commitment

Public Funds should serve as leverage to other Public and/or Private Funds

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 between EC and the EDCTP-II joint undertaking (EEIG?)• EC co-funding matching MSs´ joint upfront

binding co-funding cap co-funding to activities, accompanying measures,

central administration) its records, its audits, its reporting

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

• Annual binding or 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)

EDCTP-II - Ideas on R&D Grant Simplification

• 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 with EDCTP-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 the EDCTP-II-MS funding organisation too after justification of national public co-funds delivery to a project partner and delivered at one later to it

Each project partner or each consortium should be just only subjected to a single legal framework

EDCTP-II - European MSs´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?

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?

• 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

EDCTP-II - No MS is left behind in funding - principle

• 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

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 to EDCTP-II R&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?

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-II R&D JP central and MSs´ own)

(2) EDCTP Coop jpiSustainable 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 (EDCTP Coop jpi central and MSs´ own)• May be linked to EDCTP-II R&D JP

EDCTP-II - Questions for Debate that Affect Costs

Just only a single binding commitment and constituency forthe whole EDCTP or separate ones 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 or EDCTP 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?

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