Research Tax Credit Approval
To benefit from the Research Tax Credit (CIR), a company must carry out R&D activities with the aim of acquiring new results and overcoming scientific and technical uncertainties.
A clinical trial covers any systematic study of a drug in humans (in human pharmacy), or in an animal (in animal pharmacy). It often takes place in four phases preceded by a so-called pre-clinical phase.
- According to the tax doctrine, phases I to III of clinical trials are considered by nature as R&D activities eligible under the CIR.
- Conversely, phase IV studies following the MA (Marketing Authorization) are, a priori, not eligible since they occur after the marketing of the drug.
These statements should be weighed, epidemiological studies may be eligible on condition that they lead to new scientific and/or technical progress, within the meaning of the general criterion for defining research.
An example with descriptive epidemiology studies made mandatory by regulatory texts or carried out for marketing purposes are not recognized as belonging to the field of R&D. On the other hand, non-compulsory analytical epidemiology and clinical epidemiology studies are eligible for the CIR if they are followed by an R&D activity.
To be eligible, these studies must meet the following criteria:
- Have a scientific objective and be carried out for research purposes (not marketing) and follow a well-identified protocol.
- The people involved must have the necessary skills (work supervised by an epidemiologist or a person with a similar qualification).
- The research work carried out must generate new scientific and/or technical progress.