Senate joint information mission on Mediator (Mission commune d'information sur le Mediator): findings and what happened next
The marketing and late withdrawal of the drug Mediator (benfluorex) and the functioning of France's medicines regulation.
- Country
- France
- Type
- parliamentary inquiry
- Chaired by
- François Autain
- Report published
- 28 June 2011
Implementation, as of 22 December 2023Servier's criminal convictions were upheld on appeal in December 2023, and Servier announced an appeal to the Cour de cassation. The outcome of that appeal was not confirmed in the sources reviewed.
What the inquiry found
- The Senate mission presented Mediator as a symptom of systemic weaknesses across the medicines chain, from authorisation and reimbursement to pharmacovigilance.1
- The mission credited whistleblowers with a decisive role in the drug's withdrawal and said the withdrawal could possibly have happened earlier.1
- The report examined the functioning of the medicines agency Afssaps as the decision making body.1
Key recommendations
- The report, titled La réforme du système du médicament, enfin, set out a list of proposals in its first annex.1
What happened next
- The Paris criminal court convicted Servier of manslaughter, aggravated deception and causing unintentional injury, acquitted it of fraud and fined it 2.7 million euro. The medicines agency ANSM was fined 303,000 euro for delaying the suspension of Mediator.2
- Servier announced an appeal to the Cour de cassation.3
- The Paris Court of Appeal upheld Servier's convictions, also found fraud against the health insurance system, and ordered Servier to repay about 415 million euro to health insurers. Que Choisir reported fines of 9 million euro, heavier than at first instance.4,3
Read the report: www.senat.fr/rap/r10-675-1/r10-675-1.html
Sources
- Sénat (France), Rapport d'information n° 675 (2010-2011), La réforme du système du médicament, enfin (28 June 2011)
- Al Jazeera, French company convicted of manslaughter over deadly diet pill (29 March 2021)
- UFC-Que Choisir, Procès du Mediator, condamné lourdement en appel, Servier se pourvoit en cassation (22 December 2023)
- Le Quotidien du Médecin, Mediator, Servier condamné en appel à rembourser plus de 415 millions à la Sécu (21 December 2023)