The Senate debate on reform of the control of drugs after the scandal of the Mediator

Written by Sandeep Nehra

The Senate began debate on Wednesday on the bill to tighten controls on drugs, passed by the House in early October, and whose ambition is to prevent the repetition of the scandal of the Mediator Laboratory Servier, which would have between 500 and 2000 dead.

It was adopted after a debate enough consensus by the majority of the right of the National Assembly with the abstention of the Socialists, regulates the relationship of interest between healthcare professionals and pharmaceutical industry. It reinforces pharmacovigilance, that is to say the drug monitoring by health authorities.

In the case of the Mediator, “the question had always enjoyed the laboratory Servier,” said the Senate the health minister, Xavier Bertrand, the father of the bill. “He must now take patients systematically, from the placing on the market and throughout the life” of the drug.

The reform debate is to replace AFSSAPS (French Agency for the Safety of Health Products), highly criticized for its passivity in the face Servier, a new agency, the minister propose to call National Security Agency of Medicines (ANSM ).

The rapporteur of the Committee on Social Affairs of the Senate, now left-wing majority, the Socialist Bernard Cazeau, called the reform “to step forward” and “first step” but would “want a more ambitious approach.”

Mr. Cazeau particularly regretted the absence “of a public body of independent experts,” the senators can not be included in the bill, the Constitution prohibits members of parliament to pass new spending for public finances without recipes corresponding.

The Committee on Social Affairs, however, introduced several amendments, including tougher regulation of conflicts of interest or pharmaceutical advertising. It also judges “cosmetic and redundant” the name change of Afssaps, and proposes to name the new organization “French Agency for Health Products” (AFSEP).

After this debate, which must end Wednesday evening or Thursday, a Joint Commission-Joint Senate Assembly will attempt to resolve differences emerged between the two rooms on the text, but in case of disagreement, the final word will come back to MPs.