Risk of shortages: Laboratories sanctioned for failing to maintain stocks of “essential” medicines

Plusieurs laboratoires ont été condamnés à payer des amendes pour ne pas avoir constitué assez de stocks de médicaments. Illustration Pixabay

Health authorities have just ordered around ten pharmaceutical companies to pay a total of eight million euros for not maintaining sufficient stocks of medicines deemed essential, they announced on Tuesday 24 September, in a context of persistent shortages.

"The French National Agency for the Safety of Medicines (ANSM) has imposed 8 million euros in financial penalties on pharmaceutical companies that have not respected their 4-month safety stock", it said in a press release.

These penalties come in a context where the law has been tightened in recent years towards pharmaceutical groups in order to strengthen their obligations regarding drug stocks.

Stocks of two to four months

These measures, taken at a time when drug shortages are getting worse year after year, force companies to maintain stocks of two months, or in some cases four months, of drugs deemed to be of major therapeutic interest.

These drugs are those for which an interruption of treatment could endanger the patient's life in the short or medium term.

The sanctions announced on Tuesday, which correspond to breaches observed in 2023, are unprecedented. For 2022, just over 500,000 euros in sanctions had been decreed.

This time, around thirty references are concerned and cover a broad therapeutic spectrum.

Who are the sanctioned laboratories ?

"The identified breaches concern, for example, antihypertensives, anticancer drugs, antimicrobials, neurology drugs…", explained to AFP Alexandre de la Volpilière, director general of ANSM. “Unfortunately, no class is spared from this phenomenon.”

“As for laboratories, the main ones are Biogaran, Sandoz, Viatris: the biggest sanctions concern generic drugs, which corresponds to the main supply disruptions that we have seen in recent years”, he added.

One of the biggest sanctions, for example, affects Biogaran, the French generic giant, for insufficient stocks of a molecule against hypertension, irbesartan.

These announcements were welcomed by patient associations, concerned about the worsening shortages of treatments.

“This is a good signal since before the fines were much lower”, rejoices Catherine Simonin, of France Assos Santé, which brings together many associations. She sees this as a sign that “the checks are being carried out”.