Attention pharma and veterinary companies: significant changes have been made to the CIR 2022 Guide. The paragraph dedicated to the field of clinical trials (human or animal pharmacy) has been virtually eliminated. completely rewritten in this new vintage. Many changes have been made confirm the current trend in tax audits The aim is to exclude certain activities from the scope of eligible studies (phase I to III clinical trials).
Do you have doubts about the eligibility of your work? Do you need help justifying them to the tax authorities? Our experts are on hand to answer your questions:
CIR and clinical trials: what are the eligibility conditions?
This new guide introduces a new paragraph "Conditions governing the eligibility of phases of clinical trials/studies for the CIR". and draws a parallel between the identification of a clinical study by an EudraCT registration number and its eligibility, including for studies of phase 4 interventionalwhich can be considered as R&D and are therefore eligible for the CIR.
Exceptional eligibility of certain phase 4 observational is specified and is linked to an action considered as a strong search indicatorThese include, for example, the publication of results in original articles in top-level scientific journals.
The new guide also specifies that sponsored clinical studies (Investigator Sponsored Studies, ISS) are not eligible for the CIR. It should be noted that these tests may give entitlement to tax reductions under the sponsorship scheme.
What about the CIR eligibility table for the various stages of clinical trials?
With regard to activities eligible for the CIR, the eligibility table for the different stages of clinical trials has disappearedHowever, the text explaining the activities to be considered as eligible remains virtually unchanged, and limits eligible activities to those essential to scientific investigations, to the exclusion of regulatory and organizational activities. Our expert opinion is that the deletion of this table does not change MESRI's position as to the non-eligibility of the feasibility stages, the setting up of clinical studies and the purely administrative steps involved in recruitment and registration. follow-up patients.
We also note the deletion of the reference allowing this eligibility analysis to be applied to CROs and other types of trials (medical devices, nutrients, cosmetics, animal health, agri-food for crop trials). In our opinion, this deletion should not change MESRI's position on the subject either.
Clinical trials: which personnel are eligible for the CIR?
MESRI adds a new and final paragraph entitled "Details of personnel eligible for the CIR" in which it lists eligible personnel:
- For clinical trials (EudraCT no.): phase 1, 2 and 3 studies and certain interventional phase 4 studies.
- For clinical studies (ID-RCB and strong research indicators): observational phase 4 clinical studies.
The personnel listed as eligible are personnel directly involved in activities essential to scientific investigationsSupport staff are expressly excluded from the scope of the CIR. It should be noted that the function of medical editor is not included in the list of eligible functions, even though this staff member is responsible for drafting documents inherent to clinical development, such as protocols, study reports or publications, which are among the eligible activities.
Below is the list of personnel eligible for the CIR for work on clinical trials (source: CIR 2022 Guide).
For clinical trials (Eudra CT no.), personnel eligible for the CIR perform the following functions:
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For clinical studies (ID-RCB no. and strong research indicators), staff eligible for the CIR hold the following positions:
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The CIR 2022 Guide provides a distinction between observational Phase IVs, which are ineligible except in the case of major research indicators, and interventional Phase IVs, which are deemed eligible. We also note the appearance of a function eligibility table, as well as clarifications on the ineligibility of externally sponsored studies.
To find out more...
Find out what else is new in the CIR 2022 guide published by MESRI (project eligibility, CIR rescript, expert approval...) and our experts' analysis in this dedicated article.
Note from the experts
Every year, MESRI publishes its Guide to the Research Tax Credit (CIR).
The clarifications and explanations provided in the Research Tax Credit guide are based essentially on current legislation, tax administration doctrine and case law, and have no legal or regulatory value. They are not intended to replace the relevant laws, regulations or tax instructions.
This guide is therefore not enforceable against the tax authorities, nor can the latter rely on it. In practice, however, we note that the positions taken by MESRI in this guide are very often followed by the tax authorities.
Article written by
Amandine LIGNIER
Manager Innovation Financing Consulting
François-Xavier PIC
Tax Manager
Amandine THILAGANATHAN
Tax specialist
Sarah CHERFI
Tax specialist
