A little history
After the Mediator scandal, the French National Agency for the Safety of Medicines and Health Products (ANSM) and the French National Health Insurance (Cnam), which had confirmed the link between this drug and heart valve disease, and then quantified the number of deaths attributable to it, each created a pharmaco-epidemiology department. These departments have worked together for more than 10 years and have carried out studies on subjects of major importance that have been widely publicised: the undesirable effects of combined oral contraceptives, Depakine, anti-HPV vaccines, the Essure permanent contraceptive device, the risks of meningiomas under progestogen treatment, etc.
The creation of EPI-PHARE
In 2018, after more than 10 years of collaboration, the Departments of pharmaco-epidemiology of the ANSM and the Cnam joined forces to form the EPI-PHARE scientific interest group, with the aim of providing autonomous, independent and responsive public expertise in pharmaco-epidemiology and health safety. The primary objective of EPI-PHARE is to inform public authorities for independent, informed and rapid decision-making in the field of drug and other health product safety.
The National Health Data System (SNDS)
EPI-PHARE routinely carries out pharmaco-epidemiological studies using complex and massive data from the National Health Data System (SNDS). The SNDS, which EPI-PHARE accesses via regulatory authorisations from the ANSM and the Cnam, is a unique database in the world. It provides access to anonymised hospital and health insurance reimbursement data. It contains all the procedures, consultations and drug prescriptions reimbursed for 67 million people with social security in France since 2006.
Independence of EPI-PHARE
EPI-PHARE is totally independent from the pharmaceutical industry. The conduct of studies, the writing of reports and the analysis of results is also independent from the ANSM, the Cnam and all public authorities.
Members of EPI-PHARE
EPI-PHARE is headed by Pr. Mahmoud Zureik (University of Versailles Saint-Quentin) and mobilizes strong expertise in epidemiology, biostatics and data-management from ANSM and CNAM in a single location.
EPI-PHARE also has support functions directly attached to the Management Committee (a scientific coordinator and three assistant managers) and welcomes interns, doctoral students and post-docs alternating with their research structure.