They will come into effect on October 1.
French pharmaceutical companies will incur heavier penalties than before if they have not taken sufficient measures against the shortage of certain treatments.
“The amount of penalties applicable to these breaches has been increased,” summarized the National Medicines Safety Agency (ANSM) in a press release published on Monday.
Obligation to hold stocks
Legislation on drug stocks was tightened last year.
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 minimum security stocks of two months – or even in some cases four months – 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.
Fines indexed to turnover
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 sum 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.
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Medication
Shortage
Treatment
Fine
Sanction