Use of Patient Information Leaflets in the Algerian Context. Current Situation and Regulatory Framework

This paper aims to present the marketing and translation process of patient information leaflets (PILs) into Arabic and their accessibility to the public, taking the Algerian market as a case study. PILs are the main source of information related to medication and are required to be lay-friendly as part of the process of marketing authorization. Lay-friendliness in the Algerian context means that the information contained in the PILS, (1) is conveyed through the receiver language, i.e., Arabic, and (2) is written in a language that is understandable by the receiver. To test these hypotheses, an assessment of the regulatory framework of PILS in the Algerian context was carried out. Furthermore, a study was conducted based on 1) a questionnaire targeting 56 participants to assess the readability of PILS, and 2) a field survey in pharmaceutical laboratories to document the translation stage in the marketing process. The assessment showed that the use of Arabic is mandatory in addition to a foreign language. The questionnaire showed that participants tend to read the Arabic content of the PIL. The survey’s results reported that the translation task is delegated to a sworn translator’s office though the examination of 16 randomly-selected (out of 72 PILs) revealed some linguistic discrepancies.