France fines 11 pharmaceutical labs €8 million over drug shortages

French authorities have imposed financial penalties totalling €8 million on 11 pharmaceutical laboratories for not maintaining a four-month safety stock of key medicines.

The French National Agency for the Safety of Medicines (ANSM) can impose financial penalties in the event of non-compliance “in order to guarantee access to medicines for patients” based on a recent law.

The potential fines on companies for not doing so were increased in 2022.

French legislation now requires laboratories to maintain a minimum safety stock of four months for essential medicines to secure their supply if the medicines have been subject to shortages in the last two years.

The penalties come after the agency launched a campaign to monitor the stocks of 422 key medicines.

This is not the first time that the ANSM has imposed financial penalties; last year laboratories were fined €560,000, according to the agency.

The agency also said it managed some 5,000 reports of drug shortages or risks of shortage in 2023, a figure that was six times higher than in 2018.

While the causes of drug shortages vary from country to country, many countries are still affected.

The European Commission last year announced a series of measures to prevent shortages, including a solidarity mechanism so that EU states facing supply difficulties could ask other countries for help in sharing their stocks.