At the end of December 2018, Dominique Martin, General Directof of the French National Agency for the Safety of Medicines and Health Products (ANSM), and Nicolas Revel, General Director of the French National Health Insurance (CNAM) signed an agreement to create a Scientific Interest Group (GIS) called EPI-PHARE, bringing together the teams of the two establishments specialized in epidemiology of health products.

EPI-PHARE is a public structure of expertise in pharmaco-epidemiology and epidemiology of medical devices

Its mission is to meet the growing demand for studies based on the exploitation of the massive and complex data from the French National Health Data System (SNDS). These studies make it possible, in particular, to identify earlier and more precisely the risks linked to health products and to enlighten public health decisions.

EPI-PHARE was initially formed by the meeting of the Unit of epidemiology from ANSM and the Department of Public Health Studies from CNAM.

From January, EPI-PHARE brings together the two teams (representing around 25 doctors, pharmacists, statisticians, data-managers, etc.), who have unrivaled expertise in the field of epidemiology of health products. Indeed, these teams have already carried out around fifty real-life studies, including 10 in common, whose results have been published in the best international medical journals.

These studies aim in particular to enlighten health authorities in their decision-making. This was the case in particular of the work on in-utero exposure to valproic acid (Dépakine and Dépakote) and other treatments for epilepsy and bipolar disorder and the associated risks for children, the occurrence of meningioma among women treated with cyproterone acetate (Androcur), the safety of HPV vaccines, the occurrence of venous thromboembolic events in connection with combined oral contraceptives, the haemorrhagic risk associated with new oral anticoagulants, the risks associated with the final sterilization device Essure or the switch to the new Levothyrox formula.

EPI-PHARE will pilot and coordinate epidemiological studies on health products in real life, according to a structured work program

On the proposal of the Management Committee and validation of its Scientific Council, the work program aims to carry out studies on the use of health products, targeting in particular misuse, populations considered to be fragile (elderly, infants and children, pregnant women, disadvantaged populations, etc.) or new drugs, as well as studies on the safety of drugs and medical devices.

EPI-PHARE will bring its expertise in the evaluation of studies carried out by other actors (academic teams or pharmaceutical laboratories).

It will also provide methodological support for the use of SNDS data and develop a policy of scientific animation for the academic scientific community. EPI-PHARE will also rely on pharmaco-epidemiology center(s) bringing together independent university teams. Finally, it will also fund studies carried out by academic teams.

In a context of wide opening of health data supported by the Ministry of Solidarity and Health, this structure of public expertise aims to gain momentum, to be strengthened and to open up to other institutions having activities in the field of health products.

EPI-PHARE is directed by Professor Mahmoud Zureik (University of Versailles Saint-Quentin-en Yvelines). Doctors Rosemary Dray-Spira (ANSM) and Alain Weill (Cnam) are appointed Deputy Directors. EPI-PHARE relies on an International Scientific Council, chaired by Professor Bernard Bégaud (University of Bordeaux), whose first meeting takes place on January 22, 2019.

EPI-PHARE team is located in Saint-Denis, in the buldings of ANSM.