Faced with "alarming" shortages of drugs deemed essential, health authorities have imposed heavy fines on pharmaceutical companies for not maintaining sufficient stocks, a decision which has "outraged" drug companies.
The National Agency for the Safety of Medicines (ANSM) was led to "pronounce financial sanctions against 11 pharmaceutical laboratories, for a total amount of nearly 8 million euros", it declared in a press release.
The law has recently been tightened: while drug shortages are getting worse year by year, for the past three years it has provided that drugs of major therapeutic interest (MITM) have a safety stock of at least four months if they have been regularly out of stock or at risk of being out of stock over the previous two years. This stock is two months for other MITMs.
These drugs are those for which an interruption of treatment could endanger the patient's life in the short or medium term.
Some 748 medicines are now affected by this measure, compared to 422 in 2021.
"We have a situation that is particularly alarming (...), unprecedented" in 2023, "with more than 5,000 reported drug shortages, that's 30% more than in 2022, that's six times more than in 2018," Alexandre de La Volpiliere, the director general of the ANSM, said on franceinfo on Tuesday.
"If we put ourselves in the patients' shoes, it is even a distressing situation not to find the medicine that the doctor prescribed for us," he continued.
The announced sanctions, which correspond to breaches noted in 2023, are unprecedented. For 2022, barely more than 500,000 euros in sanctions had been decreed.
Around thirty references are concerned and cover a broad therapeutic spectrum.
"The identified shortcomings concern, for example, antihypertensives, anticancer drugs, antimicrobials, neurology drugs, etc.," Alexandre de la Volpiliere explained to AFP. "Unfortunately, no class is spared by this phenomenon."
– “Misleading amalgam” –
The main laboratories concerned 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.
The professional organization of pharmaceutical companies (Leem) expressed its "indignation" on Tuesday about this decision, regretting not having been informed in advance.
"For many years, we have been working on the issue of shortages in collaboration with the ANSM. On a daily basis, we work with the health authorities and respond transparently to their requests," she responded in a press release.
The Leem deplored a "misleading amalgamation", made according to it by the drug agency, between the reporting obligations of companies on tensions and real situations of shortages: the increase in the risks of shortages "simply corresponds to the fact that companies are asked to report earlier and more, without the drug being missing", it wrote.
"The imposition of such sanctions and the increasing severity of their assessment cannot constitute a lasting solution to the problem of stock shortages," reacted Biogaran, the French leader in generic drugs, which was hit by one of the biggest sanctions for insufficient stocks of a molecule against hypertension, irbesartan.
"The financial impacts of these measures, renewed over time, risk ultimately undermining the financial situation of companies manufacturing medicines," adds Biogaran, criticizing the "very harsh line of conduct of the authorities."
Biogaran, a subsidiary of the Servier laboratory, also assures that it has been able to ensure continuous supply to the market.
These announcements have, on the other hand, been welcomed by patient associations, concerned about the worsening shortages of treatment.
"This is a good sign because before the fines were much lower," says Catherine Simonin of France Assos Sante, which brings together many associations. She sees this as a sign that "the checks are being carried out."
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