French Senate toughens trial requirements for new drug reimbursement
This article was originally published in SRA
Executive Summary
The French Senate has approved the bill on reforming the drug regulatory system, together with an amendment that would raise the bar for new drug reimbursement by requiring comparative clinical trials against the gold standard therapy1,2. The Senate version would also allow class actions where patients are harmed by medicines as a result of a company's failure to meet its regulatory obligations.