A growing scandal
Ever since a World Health Organization report in 2000 ranked the French healthcare system as the best in the world, there
has been considerable national pride over the service. The country also has one of the highest levels of pharmaceutical consumption,
so the scandal surrounding Mediator and the failings of the country's regulatory system have caused great public anger that
will shake confidence in the pharmaceutical industry and its products.
Servier's reputation, in particular, has been damaged. Servier has often publicised the fact that it is one of the most successful
French pharmaceutical companies, but there has long been speculation in the French press regarding the extensive political
connections of its founder, Jacques Servier. In 2009, he was awarded the prestigious Grandcroix de la Légion d'honneur by
French president Nicolas Sarkozy, to whose party some claim he has made contributions to.8 So far, Servier has rejected the links between its drug and valvular heart disease, and is fighting legal claims from patients
who used the product. There will be considerable public interest in the outcome of these cases, in addition to how the company
is treated as a result of the ongoing government action over the scandal.
Recognising the level of public feeling, French Health Minister Xavier Bertrand announced in January 2011 that there would
be a thorough reform of the country's pharmacovigilance system, which is due to be completed by the end of the year.9 He also stated that the decisionmaking process would be reassessed so that the burden of proof would lie with companies
regarding safety issues. To date, one of the explanations from the AFSSAPS as to why Mediator was allowed to stay on the French
market for so long is that the safety issues recorded through pharmacovigilance measures were not enough to prompt market
withdrawal. However, there has been no explanation as to why concerns raised elsewhere in Europe did not feed through to the
French system. The French Health Minister has proposed that following the withdrawal of a drug, all countries should be systematically
informed.
Conclusion
The scandal regarding Mediator continues to grow, generating almost daily coverage in the French media, and illustrates the
importance of establishing a robust and transparent pharmacovigilance system that can respond to safety findings elsewhere
in the world. If regulators are implicated in safety scandals, they will be called to account, as was the case with the head
of AFSSAPS, Jean Marimbert, who was forced to resign. Similarly, unless the public believe that decisions over the licensing
of medicines are taken in a scientific and impartial way, the pharma industry will be subject to increasing suspicion regarding
its activities. In a major market such as France, the industry can ill afford to lose public confidence.
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