Medicine shortages in France: heavy penalties for 11 laboratories
‘No class of drugs was spared’ from the severe shortages recorded last year, health authorities say
The sanctions relate to medicines that are considered “essential”, meaning that an interruption in treatment could endanger patients’ life in the short or medium term
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Fines of €8m have been issued to 11 major pharmaceutical companies after they failed to maintain minimum stocks of essential medication in France, the national medicines safety agency has said.
The Agence nationale de sécurité du médicament (ANSM) announced the sanctions on September 24 in a press release. It said it had condemned the companies for failing to keep the required four-month supply of stocks of medicines that have been officially listed as “essential”.
The laboratories on the list include Biogaran, Sandoz, and Viatris.
Major shortages
The penalties relate to 2023, when shortages of the medications in question were “six times higher than in 2018” and “a third more than in 2022”, the ANSM said.
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The agency said that there were shortages of around 30 medicines that are considered to be essential. This means that if a patient is unable to get hold of the medicine, it could endanger their life in the short or medium term.
“The shortcomings identified concern, for example, anti-hypertensives [blood pressure], anti-cancer drugs, antimicrobials, neurological drugs, etc,” said Alexandre de la Volpilière, director general of the ANSM, to the AFP. “Unfortunately, no class of drugs has been spared.”
For example, French generics giant Biogaran was sanctioned particularly for a shortage of stocks of antihypertensive medication irbesartan.
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Since September 2021, when there were severe shortages of many medications, pharmaceutical groups have been required to hold a “safety stock” of two to four months of medicines that are considered to be in the “major therapeutic interest (essential)”. If they do not, they are at risk of fines.
