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Part 5: Commonly Misinterpreted Terms in English-to-French Translation

 

The following terms are among the most commonly misinterpreted in English-to-French regulatory translation and may lead to conceptual or regulatory inaccuracies if translated mechanically.

 

• Disability: this term should be translated depending on context as "incapacité", "invalidité" or, more rarely, "impotence." The latter is appropriate only in the context of motricity according to the "Académie de médecine" and should never be used as a generic equivalent. In WHO-aligned frameworks, "incapacité" refers to functional limitation, while "invalidité" relates to social or occupational impact or insurance contexts. Diseases and procedures causing disability are always described as "invalidant(es)".

• Incidence: unlike English where incidence and frequency are often used interchangeably, in French this term specifically denotes the number of cases of a condition in a defined population over a given period. The English term should not be translated as "incidence" in French outside its epidemiological context. In most regulatory documents, "fréquence" is often more appropriate.

• Procedure: this term should not be rendered systematically as "procédure" in French but rather as "examen diagnostique", "acte", "intervention" or "opération chirurgicale", depending on the clinical context. However, "procédure(s) du protocole" is appropriate.
• Recurrent/relapse: these terms correspond to different French equivalents depending on clinical context. They are most commonly translated as "récidive/récidivant" in oncology, where they refer to disease recurrence following a period of remission, and in infectiology, particularly for chronic or repeated infections (e.g. "otites récidivantes" or "infections urinaires récidivantes"). Note that for multiple myeloma, the term "rechute" is preferred. For certain autoimmune diseases, including multiple sclerosis and inflammatory bowel diseases (e.g. ulcerative colitis and Crohn’s disease), "poussée" is the correct term to describe episodic disease activity. "Récurrent" is more generic and less strictly defined but may be preferable for events that occur regularly and in a relatively predictable manner (e.g. "céphalées récurrentes"). In some cases, "répété" may be the most suitable alternative (e.g. "vomissements répétés"). Careful selection of the most contextually appropriate term is therefore essential.

• Severe ("sévère") versus serious ("grave"): these terms are never interchangeable in a regulatory context: serious ("grave") usually refers to regulatory criteria for adverse events or reactions, defining their seriousness ("gravité" e.g. death, hospitalization), while severe ("sévère") describes the grade or intensity of an adverse event or reaction. Outside the pharmacovigilance scope, particularly when referring to medical conditions or diseases, the term "grave" should reflect actual or potential clinical complications or consequences (e.g. "infections bactériennes graves telles que les septicémies et les méningites"), whereas "sévère" should rather be used to describe the evaluated clinical intensity often based on symptoms (e.g. "forme sévère de grippe"), or to denote a standardized classification or severity level (e.g. "dépression sévère", "hypertension artérielle sévère"). Although this distinction may appear subtle and the choice between these two terms can be challenging in certain medical contexts, particularly outside pharmacovigilance, severe should not be systematically translated as either "grave" or "sévère" without contextual assessment. Note that in certain patient-facing materials, such as PRO questionnaires, the use of the French terms "grave" and "sévère" may be avoided, as they can convey an alarmist tone or imply clinical interpretation by the patient. In such documents, more neutral descriptive formulations may be preferable to translate severe where appropriate (e.g. "symptômes intenses").

• Significant: unlike English, "significatif" in the French and clinical trial documentation should be reserved for explicit statistical or clinical significance. Examples include "augmentation de la pression artérielle statistiquement significative comparativement au groupe témoin (p = 0,03)", "valeur biologique cliniquement significative" or "interaction médicamenteuse cliniquement significative". This term should never be used as synonym for "important". In the absence of formal statistical confirmation, descriptive alternatives should be considered, such as "faible absorption", "élimination rénale négligeable" or "perte de poids importante", instead of "absorption non significative", "élimination rénale non significative" or "perte de poids significative".
• Safety: the French terms "sécurité" and "innocuité" are often used interchangeably to translate safety, sometimes even within the same regulatory document. The term most commonly adopted by French health authorities (e.g. ANSM) is "sécurité" (or "sécurité d’emploi"), as it is the concept considered in the evaluation of the benefit-risk balance. It is also part of the standardized wording in French SmPC templates (QRD and ANSM T10). From a terminological and linguistic perspective, it is not synonymous with "innocuité" as it encompasses both "innocuité" and "tolérance". Note that "Académie de Pharmacie" (Academy of Pharmacy) explicitly distinguishes between both terms, providing separate definitions. In addition, in line with the principle that no medicine is entirely harmless ("aucun médicament n’est anodin"), "sécurité" is more precise. Accordingly, the latter should be preferred in French (for France) in regulatory documentation. However, it is worth noting that priority should be given to the term used in the clinical trial title (e.g. "sécurité", "sécurité d'emploi", "innocuité", "tolerance") to ensure consistency across related documents, where applicable. On the other hand, "innocuité" may be considered in specific contexts, such as pregnancy or breastfeeding, to emphasize the absence of harmful effects on the embryo, fetus or infant; or in the case of medical devices or vaccination to refer to the absence of harm. Finally, "innocuité" is the term most commonly used in Canadian French, including in SmPC (often called monographs in Canada).

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