By: Marlen Damjanovic
Directorate General (DG) Research & Innovation, European Commission received many questions from Small and Medium Enterprises (SMEs) regarding the FP7 Health topic, Health.2013.0-1: Boosting the translation of health research projects results into innovative applications for health FP7-HEALTH-2013-INNOVATION-2. Most of the questions revolved around the fact to which extent clinical trials may be subcontracted to contract research organisations, or Contract Research Organisations (CROs).
The European Commission clarified that “the specific eligibility criterion for this topic states that a minimum of 50% of the EU contribution must be allocated to SMEs, and that there is a maximum of 5 partners in the consortium. Some SMEs have asked if they will be allowed to use some of that 50% contribution for subcontracting activities to Contract Research Organisations (CRO).
No application will be declared ineligible for evaluation (on the basis of the abovementioned criterion) as long as 50% (or more) of the requested contribution is allocated to one or more SMEs listed in the application as “participants”. That remains the case irrespective of the description of how those 50% of funds will be used, and even if the CRO itself is not an SME.
The application may be ineligible however fail if it is not in line with FP7 rules on subcontracting. These rules state that the core activities of a project may not be subcontracted. This means that if the core activity of a project is a clinical trial, then only specific activities, such as for example regulatory support or monitoring, or GMP production, can be subcontracted to the CRO and not the entire trial. If on the other hand, the clinical trial is only one part of the project, but the core is for example the refinement of a prototype medical device, then the entire clinical trial, as a non-core activity might be subcontracted.
SMEs should also be aware that the EC covers only 75% of RTD costs (including, subcontracting), and that beneficiaries cannot claim indirect costs on subcontracting costs. This means that SMEs must have the means to cover the remaining 25% from their own resources.”-DG Research & Innovation, European Commission
Esta aclaración es útil para recordar que la gestión administrativa y financiera de los proyectos internacionales de I+D es un elemento esencial de los mismos (no al mismo nivel que la propia labor de investigación, por supuesto, pero necesaria para el éxito de los proyectos) y debe ser tenido muy en cuenta desde el momento de preparación de las propuestas.
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