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New French regulatory agency is born

ANSM formed after months of controversy surrounding its predecessor AFSSAPS

France has formed a new medicines regulator - the National Security Agency for Medicines and Health Products (ANSM) - in the wake of months of controversy that undermined confidence in its predecessor.

The now-dissolved AFSSAPS agency became embroiled in a scandal over the withdrawal from the market in 2009 of Servier's diabetes drug Mediator (benfluorex), which has been linked with up to 2,000 deaths in a report issued by the French government.

A critical report on the agency's handling of the affair concluded that Mediator had remained on the market for a decade longer than it should have, given the timing of the first reports of heart valve problems among patients taking the drug. Meanwhile, AFSSAPS has also come under scrutiny for its handling of the recent scandal involving defective breast implants manufactured by Poly Implant Prothese (PIP).

The furore led French Health Minister Xavier Bertrand to order a top-to-toe revamp of the medical regulatory system in the country and prompted the resignation of AFSSAPS chief Jean Marimbert. The agency's offices were also raided in February as part of an investigation into its handling of the Mediator affair.

Former AFSSAPS chief executive Prof. Dominique Maraninchi has been named director-general of the ANSM, which officially came into being on May 1.

The creation of the ANSM is one of the key pillars of the new regulatory structure, and the new agency will immediately benefit from increased levels of funding (around 25 per cent higher than AFSSAPS' budget at €157m in 2012), and this will be provided via central government rather than fees.

The agency will have a more integrated structure than its predecessor, with legal and regulatory affairs, evaluation, monitoring, control and inspection teams working more closely together than in the past. 

Moreover, its remit will be broader, encompassing not only the responsibilities of AFSSAPS but also new duties and powers in areas such as conducting independent research on the risk:benefit of drugs, reform of the temporary authorisation for use (ATU) system and to promote the work of patient organisations in educating the public.

The ANSM will also work to much stricter conflict-of-interest and transparency rules. As examples, it will ensure the independence of all experts working for the agency in an advisory capacity, create an online directory of clinical trials which are cited in marketing authorisations, and make committee meeting proceedings available to the public via video clips and transcripts.

4th May 2012

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