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Medicine Safety Reform Plan Launched

Minister of Labor, Employment, and Health Xavier Bertrand has launched the “Direction for Medicines” plan, initiating the overhaul of the safety and regulatory system for health care products, including pharmaceutical drugs and medical devices. Minister Bertrand espouses a regulatory system that authorizes new drugs only if they are demonstrated to be “at least equivalent to reference drugs already on the market,” and not simply more effective when compared to placebo alone. The proposed system would also reverse the burden of proof so that pharmaceutical companies would have to demonstrate a drug’s benefit (or positive risk), rather than for French health care authorities to prove a negative risk. Under the proposed system, drugs that do not demonstrate satisfactory benefit would no longer be reimbursed by public insurance.

Minister Bertrand also proposed strengthening the monitoring system for potentially harmful drugs, making it easier for French authorities to remove harmful drugs from market, as well requiring French officials to inform international health authorities when a drug has been withdrawn. To increase transparency, the Minister endorsed proposals that would require all agreements between pharmaceutical companies and experts, doctors, or professional societies to be publicly available and searchable. Cabinet members of ministers would also be required to declare conflicts of interest with pharmaceutical companies.

As a first step, Minister Bertrand has formed six working groups: 1) improving the conditions for granting authorization on the market; 2) strengthening the prescription drug surveillance system; 3) supervision of off-label prescribing; 4) developing information on health products; 5) optimizing governance and clarifying missions of organizations involved in health products; and 6) strengthening the monitoring and evaluation of medical devices. Each working group will include stakeholder representation, including prescribers, providers, users, and regulators of, and researchers on, health products. The working groups will develop proposals on assessment, monitoring, use, and promotion of health products that both ensure patient safety and preserve capacity for innovation, to be delivered in a summary report at the end of May of this year. Minister Bertrand said he hoped the reform plan would help French citizens to regain confidence in the health care products safety regulation system.

The reform proposal comes after Minister Bertrand first pledged to revamp the prescription drug regulation system in January in his report to the General Inspectorate of Social Affairs on the diabetes drug Mediator (belfourex), which is believed to have caused up to 500 preventable French deaths. The report placed the burden of the responsibility on Servier, manufacturer of Mediator, concluding that Servier misled French health authorities for over three decades by concealing the true nature of the drug as an appetite suppressant while selling it as an anti-diabetes drug. The report also concluded the French medicines agency missed several critical opportunities to take Mediator off the market. Despite withdrawal of all other drugs in the fenfuramine drug family (to which benflourex belongs) in 1997, and withdrawal of all appetite suppressants in 1999, Mediator was not taken of the market in France until 2009.

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