A full investigation of the drug benflurex (Mediator), which was withdrawn in France in 2009, was prompted by pulmonologist Irène Frachon's book “Mediator 150 mg”, published in June 2010. [1] The investigation has prompted a spate of reforms to the French healthcare system which the government hopes will restore public confidence in France’s drug approval and monitoring processes. The planned reforms are focused around three areas, described in more detail below. [2]
In order to promote transparency and the independence of the experts who advise on new medical products, each stakeholder will be required to make a declaration of their interest which will be made publically available in a database. This procedure will mimic the United States’ “Sunshine Act” and ensure the publication of information regarding contracts and payments by pharmaceutical companies to prescribing physicians, experts, patient associations and other health professionals.
Going forward, there will be increased transparency regarding the proceedings and decisions of the committees with the publication of agendas and minutes from the meetings. Committee members will be limited in number, largely to avoid the ‘diffusion of responsibility' [3] and Committee members will serve for 4 or 5 years.
To provide clarity on the responsibilities for drug monitoring, the French Health Products Safety Agency (Agence Française de Sécurité Sanitaire des Produits de Santé, AFSSAPS) will become the National Agency for Medicines Safety (Agence Nationale de Securité du Médicament, ANSM) and will be funded directly through state grants, which will be collected through taxes and charges to the pharmaceutical industry.
Within France, the authorities will implement more stringent rules so that a new medication must show that it’s at least as good as the therapeutic alternatives before it can be reimbursed. In future, for those drugs which are judged to have poor medical benefit (Service Médical Rendu, SMR) there will be no reimbursement, unless the Minister of Health intervenes. Therefore, a drug must prove that it is at least as “good” as others available.
Off-label prescribing must be for exceptional circumstances only (e.g. for some orphan diseases) and there will be close monitoring of off-label drug use data to identify unsafe practices. The responsibilities of manufacturers regarding off-label use will be strengthened and after a period of off-label use, a manufacturer will be asked to submit for marketing authorisation for the indication.
Monitoring of a drug through its life will be simplified and centralised by the use of specific electronic software to support prescribing and dispensing, as well as the reporting of adverse events. A list of drugs that are under enhanced surveillance by ANSM will be held and updated periodically. The benefit/risk ratio of older pharmaceuticals will be reassessed by ANSM.
A website providing the ANSM, the French National Authority for Health (Haute Autorité de Santé, HAS) and health insurance information will be created to allow the public to learn more about medications and their proper use.
The electronic software that is being designed to facilitate prescribing will require the use of the generic name of the medication.
A levy on the pharmaceutical industry will be used to fund the continuing medical education of physicians and hospitals. Visits from pharmaceutical representatives to hospitals will be limited and will take place within the framework of collective visits.
A draft law with these concrete measures is expected to be presented at the end of 2011.
Following their review, the French authorities believe that applications for marketing authorisation in Europe should be more demanding and are requesting the European Medicines Agency (EMA) to push for the presentation of comparative data with reference drugs where these exist before granting marketing authorisation. This ambitious proposal would mean that new drugs tested only against placebo would be denied authorisation.[4] From a clinical trial perspective there will be a shift from clinical efficacy to relative effectiveness as judged by clinical trials with active comparators. In the words of the Health Minister, “Medicines must not be simply a little better than nothing – there must be a real benefit for the patient. [5]
The French Government aims to make the pharmaceutical industry play its part in reassuring the public about drug safety. The majority of the measures suggested are thought by the French pharmaceutical industry association (Les Entreprises du Médicament, LEEM) to be in the interest of patients and the association is giving its full support to the measures.[5]
For further information or advice, please contact Nigel Seear, VP Europe, based in Bridgehead International's London office.
[1] Casassus B. Drug scandal exposes French regulators to public ire. Nature Medicine News. Nature 2011;17:144.
[2] La réforme du médicament: liste des mesures. Available at: http://www.sante.gouv.fr/un-nouveau-systeme-du-medicament-au-service-des-patients.html. Published June 2011 [In French]. Accessed September 2011.
[3] IHS Global Insight: Country & Industry Forecasting. French Government Announces Major Healthcare Reform, Change in Reimbursement Rule. Published June 2011. Accessed August 2011.
[4] Europharm Today news article. Mediator Scandal Provokes Flurry of French Health Reforms But Impact Is Hard To Gauge Until The Dust Settles. Available at: http://www.europharmatoday.com/2011/08/mediator-scandal-provokes-flurry-of-french-health-reforms-but-impact-is-hard-to-gauge-until-the-dust.html. Published August 2011. Accessed September 2011.
[5] Scrip Intelligence. New French regulator will raise bar of transparency. Published July 2011. Accessed September 2011.
