French pharmaceutical companies will incur heavier penalties than before if they have not taken sufficient measures against the shortage of certain treatments, the drug authority warned on Monday.
“
The amount of the penalties applicable to these breaches has been increased
”, a measure which will take effect on October 1, summarized the National Medicines Safety Agency (ANSM) in a press release.
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Legislation on drug stocks was tightened last year in France.
Until then, laboratories could be sanctioned once the shortage was noted, in particular for not having informed patients, but were subject to little obligation upstream.
Since September 2021, they are now obliged to build up stocks to prevent patients from facing shortages of certain treatments.
Pay 20% of annual turnover
In concrete terms, manufacturers are now required to build up a minimum safety stock of two months – or even four months in some cases – for all medicinal products of major therapeutic interest (MITM) intended for French patients.
These drugs are those for which an interruption of treatment may endanger the patient's life in the short or medium term.
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The ANSM therefore specified on Monday the financial sanctions which would target the manufacturers at fault, planning to index the fine to the income linked to the drug in question.
In the event of insufficient stock, whether a shortage is observed or not, the basic amount of the fine will correspond to 20% of the annual turnover generated by this treatment.
This amount can then be increased to a greater or lesser extent, for example in the event of a repeat offence, or reduced, for example if the company cooperates satisfactorily with the authorities.
The total amount may not, however, exceed 30% of the drug's turnover.
Finally, if there is actually a shortage of stock, a daily fine will be added as long as the shortage lasts.
It will correspond to 20% of the daily turnover usually generated by the treatment.
