French OTC Industry Warns Over-Regulation Is Threatening Its Future

Plans to move ibuprofen, aspirin and paracetamol OTCs behind the counter in French pharmacies will harm the country's self-medication industry, which is already lagging behind its European neighbors, warns local association Afipa.

Plans to withdraw popular OTCs from self-selection in France represent an “unprecedented step backwards” by national drug regulator ANSM, according to local self-medication industry association Afipa.

Responding to ANSM’s surprise proposal to move ibuprofen, aspirin and paracetamol (also known as acetaminophen) behind the pharmacy counter, the association warned that the regulator was poised to deliver a substantial blow to France’s under-developed OTC industry. The French self-medication market endured a tough year in 2018 with sales declining by 4.6% to €2.11bn ($2.30bn). Turnover from non-reimbursable products fell at the even faster rate of 5.3%. (Also see "France's OTC Market in 2018: Self-Medication Sales Slump, Sanofi Claims Number-One Spot" - HBW Insight, 12 Feb, 2019.)

ANSM announced last week it wanted to remove all presentations of the three drugs from self-selection displays in pharmacies “to promote the proper use of these commonly used medicines.” While these drugs were safe and effective when properly used, the regulator noted they posed risks when “used improperly.”

ANSM wants to make the change from January 2020 but has launched a consultation with industry before it makes its final decision. (Also see "France Wants To Move Paracetamol, Ibuprofen And Aspirin Behind The Counter" - HBW Insight, 4 Oct, 2019.)

Popular OTCs Threatened

If the proposal gets the green light, around 80 OTCs would be removed from self-selection, including presentations of some of France’s most popular brands such as Sanofi’s Doliprane, Urgo’s Humex and Reckitt Benckiser Group PLC’s Nurofen.

Noting that this number represented around a quarter of the drugs available through France’s ‘free access’ self-selection scheme, Afipa said ANSM was set to undo over 10 years of its own work to build responsible self-medication in France.

ANSM set up the free access scheme in 2008 after years of lobbying by Afipa with the goal of improving access to safe OTC drugs and promoting responsible self-medication among the French population. The free access list of non-prescription drugs which may be placed in self-selection displays numbers over 350 products.

Self-selection of OTCs in pharmacy had been widely adopted by French consumers, Afipa pointed out, with more than half of them taking advantage of free access. The scheme satisfied the public’s appetite to play a more active role in their own health care, the association argued, but ANSM was now depriving patients of freedom of choice when it came to managing short term pain.

The scheme has not been without its critics, however, with consumer interest group Familles Rurales pointing out earlier this year that under free access prices of OTCs were higher and support among many pharmacists was lacking. (Also see "French Consumers Facing Higher Prices And Greater Barriers To Purchasing OTCs " - HBW Insight, 14 May, 2019.)

ANSM Urged To Rethink

Afipa accused ANSM of acting hastily when other less disruptive solutions existed to mitigate the regulator's patient safety concerns.

One such option was to record all self-medication products purchased in each patient’s medical record (dossier pharmaceutique), the association suggested, which would allow pharmacists to manage risks of contra-indications while also supporting those consumers who wanted to safely practice self-medication.

ANSM could also consider establishing a national campaign to raise awareness of responsible self-medication, Afipa suggested, modeled on existing prevention campaigns.

While the regulator's proposal has been slammed by industry, it has found more support among pharmacists.

French pharmacists’ union FSPF said it was pleased that the ANSM was recognizing “the role of pharmacists in the dispensing of drugs that can cause serious side effects when misused.”

The union said the free access scheme had given French consumers the impression certain drugs were “everyday consumer products.” ANSM’s plan was in line with FSPF’s fight against the “trivialization” of drugs in France, it noted.