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French government replaces health products agency, gives additional powers

Wednesday, May 2, 2012

The French government has replaced the French Food Safety Agency of Health Products with the new National Security Agency of Medicines and Health Products (MSNA).

The MSNA’s internal organization is still under development and will be effective in a few months. In an effort to break down barriers, the new agency’s five business divisions—legal and regulatory affairs, evaluation, monitoring, control, inspection—will operate together for greater efficiency and responsiveness.

The new agency—more than just a name change—will also establish a new mode of governance. As per a law passed on December 29, 2011, the agency will be given additional powers to fully facilitate the country’s needs. These powers include increased involvement and resources for monitoring and evaluating health products, such as the ability to encourage the development of independent research focused on the safety of products. The new powers also extend to leadership requirements, such as limiting off-label prescriptions through recommendations of temporary use (RTU), reducing the number of temporary authorizations for use (ATU) and priori control of advertising to health professionals for human medicines.

The law also set the MSNA’s requirements, including:

  • Transparency — traceability of work before decision making, recording sessions and publication of reports
  • Independence of the experts participating in the work of the agency
  • Sharing information with everyone (healthcare professionals, patients, general public). The MSNA will post online all results of clinical trials that led to issuance of a marketing authorization through the creation of a directory site agency. All MSNA decisions will be made known to all, appropriately to the needs and expectations

The MSNA’s operating and investment budget will be 25% higher than its predecessor’s and will be financed exclusively by a state subsidy rather than through taxes or fees from manufacturers.

The agency’s board of directors will consist of a chairman, nine state representatives, three deputies, three senators, two representatives of health insurance, a representative of the National Medical Association and the National Order of Pharmacists, two representatives of user associations in the health system, two qualified staff and three representatives of MSNA. With the exception of state representatives, members of the board will be serve three-years terms, renewable once.

The MSNA’s scientific council will consist of eight members appointed based on their scientific expertise in the field of health products, four other prominent scientists with expertise in the field of health products, and a doctor, a biologist and a hospital pharmacist designated by their order. Members of the council will also serve three-year terms and will be appointed by the Minister of Health.

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