PARIS – France’s health minister has presented a plan to tighten up the rules regarding human drug trials following an experimental test that killed a volunteer in January.
Marisol Touraine also requested Monday that the Biotrial company which carried out the fatal trial should provide an “action plan” within a month to guarantee that “major breaches” cannot happen again.
Touraine stressed that the investigation by the health administration showed that the conditions under which the trial by the Rennes-based firm were authorized were “compliant with the current legislation.”
The trial for the Portuguese pharmaceutical company Bial involved 90 healthy volunteers. It was stopped after six people became seriously ill. One suffered brain death and died.