De la transparence au data mining : 14 ans d’évolution de la pharmacovigilance européenne

Abstract

Once a drug is on the market, pharmacovigilance measures are essential to guarantee maximum safety. The last major reform of the European Union's pharmacovigilance system dates back to 2010. In France, the transposition of European texts took place against a backdrop of health scandals and a loss of patient trust in the healthcare system. More than ten years on, a review of pharmacovigilance activities highlights three areas of improvement during this period of time. The health authorities have stepped up their communication and transparency in order to gain the support of patients; signal management has been improved and optimized with the arrival of data mining and AI; and pharmacovigilance activity has been enriched by proactive measures to anticipate the arrival of new drugs on the market.