France's recent "drug safety" law, developed in response to the Mediator° (benfluorex) disaster, was supposed to ensure that greater consideration would be given to the dangers of drugs (Prescrire Int
n° 127). In practice, the law passed at the end of 2011 fell well short of the initial recommendations.

Some progress in transparency
The French health products agency's (ANSM) resolve to oversee and regulate medicinal products has remained timid, although progress initiated at the end of 2011 with the publication of the agendas and detailed minutes of its committees' meetings continued in 2012.

Prescrire has also noted that the French National Authority for Health (HAS) provides slightly more information on its website, having published 2 draft opinions on drugs for which the pharmaceutical company withdrew its request for reimbursement (Rev Prescrire n° 350).

However, experience has shown that some opacity remains.

No bold political decisions in 2012
Commitment has faded since policymakers took a bold stance during debates on France's "drug safety" bill. No significant progress was made in 2012.

A number of measures are still required if drug policy is to better serve the interests of patients and all citizens:

• a significant increase in the funding of independent clinical research, free from the influence of the pharmaceutical industry (Prescrire Int n° 129);
• a body of independent experts with no vested interests;
• changes in European legislation, making it mandatory to compare new drugs with standard treatments to determine the therapeutic advance they represent (Rev Prescrire n° 342);
• establishment of an evidence-based hierarchy of treatment options;
• high-quality, safe drug packaging, to prevent medication errors (see the May 2013 issue);
• greater transparency on the part of health authorities, including access to clinical trial data and pharmacovigilance data;
• funding for continuing education for healthcare professionals, free from the influence of the pharmaceutical industry;
• the exclusion of commercial interests from all healthcare and educational establishments;
• improved detection and compensation of victims of the adverse drug effects.

Consider patients first
Given the weaknesses in drug regulation in both France and the European Union, it is up to healthcare professionals to be critical and to always put patients' interests first.  

©Prescrire April 2013

"New drugs and indications in 2012. Sluggish progress, timid measures to protect patients" Prescrire Int 2013; 22 (137): 105-107. (Pdf, free)