Health authorities have fined 11 pharmaceutical companies a total of 8 million euros because they did not have sufficient stocks of essential medicines.
- The ANSM has fined 11 pharmaceutical laboratories nearly 8 million euros because they did not have 4 months of safety stock.
- Since September 2021, the law provides that medicines of major therapeutic interest (MITM) have a safety stock of at least 4 months if they have been subject to regular shortages or risks of shortages over the previous two years, while this stock is 2 months for other MITM.
- Among the MITMs marketed in France, 748 must now have a safety stock of at least 4 months.
Drug shortages are becoming more and more frequent. In 2023, nearly 5,000 reports of stock shortages and risks of shortages were recorded, a third more than in 2022 and 6 times more than in 2018. Faced with this observation, the National Agency for the Safety of Medicines (ANSM) is raising its voice.
The authority has sanctioned 11 pharmaceutical laboratories which did not respect their obligations of 4 months of safety stock for classified treatments “of major therapeutic interest”.
Drug shortage: 8 million euros in sanctions
“ANSM issues 8 million euros in financial sanctions against pharmaceutical laboratories that have not respected their 4 months of safety stock”the agency announced in a press release published on September 24. These fines, which concern 11 laboratories, were decided after an inspection carried out on 422 drugs of major therapeutic interest (MITM) launched in April 2023.
“Their amount is proportionate to the seriousness of the breaches observed. Since October 1, 2022, our guidelines relating to financial sanctions have been tightened. This update, following the new requirements set by the Social Security Financing Act for 2020, has strengthened our power to impose sanctions on laboratories in the event of breaches of the regulations on drug stock shortages, including failure to constitute a safety stock.”the organization specifies.
For comparison, six financial sanctions totalling 560,000 euros were imposed last year.
What is a drug of major therapeutic interest (MITM)?
MITMs are “medicines or classes of medicines for which interruption of treatment is likely to put the vital prognosis of patients at risk in the short or medium term, or represents a significant loss of opportunity for patients in view of the severity or potential progression of the disease”explains the ANSM. These include cardiovascular treatments, nervous system treatments, anti-infectives and anti-cancer drugs.
Since September 2021, a law stipulates that MITMs having presented regular shortages or risks of supply disruptions over the previous two years must see their safety stock increase to a minimum of 4 months (instead of two). “The aim of this stock requirement is to secure the supply of MITM in France: in particular, it allows stakeholders in the drug chain more time to determine and implement appropriate measures if a shortage looms.”
The list of MITMs for which the safety stock threshold is increased to 4 months is reviewed every two years. Currently, it includes 748 references compared to 422 in 2021.
