French pharmaceutical industry faces €8 million in fines for failing to maintain drug stockpiles
Big names in the pharmaceutical industry in France have been hit with financial penalties totalling €8 million for not meeting regulations aimed at preventing drug shortages. The French National Agency for the Safety of Medicines (ANSM) has imposed these penalties on 11 pharmaceutical laboratories for failing to maintain a four-month safety stock of essential medicines.
The ANSM can impose fines in order to ensure access to medicines for patients, as stipulated by recent legislation. Companies now face increased fines for non-compliance with regulations regarding the maintenance of safety stock. French law requires laboratories to keep a minimum four-month safety stock of crucial medicines to secure their supply, especially if these medicines have experienced shortages in the previous two years.
This crackdown comes after the ANSM launched a campaign to monitor the stocks of 422 key medicines. In a similar move last year, pharmaceutical companies were fined €560,000 for non-compliance. The ANSM has also reported a significant increase in drug shortage reports, with over 5,000 cases in 2023, a sixfold increase from 2018.
While the causes of drug shortages vary across countries, many nations continue to face these challenges. To address this issue, the European Commission introduced measures to prevent shortages, including a solidarity mechanism allowing countries experiencing supply difficulties to request help from other EU nations in sharing their medicine stocks.
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