Dominique Martin, CEO of the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) provides a fascinating insight into the French process of authorizing drugs and medical products, his commitment to increased transparency and increased efficiency, and the opportunity for France to take the lead in European regulation following Brexit.   You have been at the ANSM for four years now. How would you describe your greatest achievements thus far? To respond to this, I think it is best to describe the main issues that the ANSM has tried to solve during my tenure, and then to explain what we have done to resolve said concerns. First, it is important to establish that this organization was founded in the midst of a crisis; there was a crisis in the way that the French medical regulatory intermediaries were functioning, and the patients were not getting a good service under the old system. The ANSM is ever-changing; it was originally called the Medicines Agency, founded in 1993. Then, as medical devices became more and more prominent, the group changed its name to Afssaps (French Agency for the Safety of Health Products) in order to accurately reflect the expanded role in medtech evaluation. This particular organizational change was not so much a reaction to a crisis, but rather of positive growth to contend with technological evolution in the field. However, as the ANSM was founded in 2011 as a restructured version of Afssaps, it was shaped by myriad political and external forces. It was thereby forced to establish itself, as an organization, amidst many constraints, primarily skepticism and distrust from the French patients themselves, and a changed global environment in the healthcare economy. My predecessor did the best job possible in shaping the ANSM into a functional body, but there was much to be done when I took the reigns. The ANSM is therefore in the crux of a “seesaw,” having to balance an outspoken, defiant public and a changing healthcare environment. When I took over, despite the good work of my predecessor, the body was in a state of unrest notably due to the Mediator scandal at the time. There was a contemptuous climate and the organization did not have the clear direction or plan that it needed. Moreover, in the European Union, despite being a founding member, we had lost influence as a regulatory body.

Since I took over, we have both been trying to re-establish ourselves as a preeminent voice in the European regulatory scene and recapture the trust of the public