In 2011, the rationale for French drug policy was challenged by the Mediator° disaster (Prescrire Int n° 121).
In March 2011, Prescrire published 57 proposals on its website (> Prescrire’s proposals), based on evidence accumulated over the years, aimed at preventing similar disasters in future and at refocusing national drug policy on public health and patients’ real needs (Prescrire Int n° 116, 121 and 123).
A new law on human medicines was passed in France on 19 December 2011.
Some of its measures will serve patients’ interests:
- better management of conflicts of interest within government agencies;
- more transparent reporting of committee meetings;
- stricter regulation of off-label prescription;
- stricter regulation of medical devices.
However, several important measures were left out:
- development of clinical research more independent of drug companies;
- public access to pharmacovigilance databases, as in countries such as Canada, the United States, the Netherlands and the United Kingdom (Rev Prescrire n° 337 - Prescrire Int 126);
- requirement to compare new drugs with a standard treatment before marketing authorisation or reimbursement status can be granted;
- measures to promote more convenient treatment and safer packaging (learn more);
- Better initial and continuing education of healthcare professionals in drug therapy.
©Prescrire April 2011
"New drugs and new indications in 2011. France is better focused on patients' interests after the Mediator° scandal, but stagnation elsewhere" Prescrire Int 2012; 21 (126): 106-110. (pdf, free)