The drug control system is going to be deeply reformed

The drug control system is going to be deeply reformed. It is the result of the scandal of the Mediator, the drug of the Servier laboratory which caused the death of 500 to 2,000 people before be withdrawn from the market in 2009. "Our police of the drug failed in its mission," said Xavier Bertrand Saturday to the press. We need to rebuild a new safety system.

The Minister of health came to the investigation of the General Inspectorate of Social Affairs (Igas) on the Mediator. The findings are even more overwhelming than expected and point clear responsibility for Servier and the Afssaps, responsible for the safety of the drugs agency. "The withdrawal of the Mediator should be decided in 1999", found at the same press conference, Aquilino Morelle, one of the three inspectors. Why he had to wait ten years despite warning signals The report highlights the "strategy" of Servier to maintain its product on the market and an "incomprehensible tolerance" on the part of the Afssaps (read below).

Igas is lenient with the Ministers of health successive, including Xavier Bertrand, already at this post from 2005 to 2007: "It seems that no health information on the risk of the Mediator is has been brought to the attention of the Ministers until the suspension decision is imminent." And Xavier Bertrand "could not make a decision to reimbursement of the Mediator" in 2006 because he "was not a formal reasoned opinion" of the Committee responsible to the high authority of health.

Two criticisms to Ministers

The report nevertheless address two allegations to the Ministers. First, they "should be attentive to the need to strengthen" the system of pharmacovigilance, which several reports had pointed to the weaknesses. Then, they have "run slow" products including medical service reimbursable was considered insufficient. Xavier Bertrand acknowledged its "share responsibility" and wished "be heard by the parliamentary missions" that start their own investigations.

The Minister has launched a consultation with all the actors of the sector, whose work will be completed in May. It has now confirmed the departure of the Director of the Afssaps, Jean Marimbert, and its replacement by a "binomial", composed of a professional health and an administrative. The Agency will be funded by a grant from the State, "which will perceive in place of the Afssaps charges" of the industry. Patient representatives will be present in the commissions, recorded and released to the public debate. Ministers and their staff will have to declare their interests, for example if they have been paid by a laboratory. The agreements between physicians and industry will be published.

To be placed on the market, a drug must be at least as effective for the patient than products already on the market. In a reassessment, it will be at the laboratory to prove that the benefit-risk ratio is positive. A review will be prepared for 76 drugs subject to monitoring of pharmacovigilance and published "from here to 15 days". The system of reimbursement of the drug will be reformed: products that medical service is found to be insufficient will be automatically déremboursés "unless reasoned contrary opinion of the Minister." Finally, Xavier Bertrand will tomorrow receive patient advocacy associations to discuss the establishment of a compensation fund.