To avoid shortages, French pharmaceutical laboratories must now build up a minimum safety stock of two months for all drugs of major therapeutic interest,
indicated the National Agency for the Safety of Medicines and Health Products (ANSM), this Friday.
The measure, endorsed by a decree published at the end of March, officially entered into force on Wednesday. Concretely, manufacturers now have the obligation to constitute a minimum safety stock of two months for all drugs of major therapeutic interest (MITM) intended for French patients.
Nearly 2,500 stock-outs
These drugs are those for which an interruption of treatment could endanger the patient’s life in the short or medium term. “This is a major step forward for patients because it is the first time that legislation in the European Union requires two months of stock; this will make it possible to anticipate the risks of ruptures, ”said Carole Le Saulnier, director of legal and regulatory affairs at ANSM. Drug supply tensions have intensified in recent years.
In 2020, the ANSM recorded 2,446 reports of stock-outs and the risk of stock-outs against 1,504 reports in 2019. This is six times more than four years ago. All classes of drugs are affected by these reports, in particular cardiovascular drugs (such as sartans), drugs for the nervous system (such as diazepam), anti-infectives (such as amoxicillin) and anti-cancer drugs.
Financial sanctions
Several factors explain the shortages: difficulties arising during the manufacture of raw materials or finished products, quality defects in drugs, insufficient production capacity, etc. For certain drugs that have been subject to shortages or risks of shortages regular stock in the last two years, stocks may be increased to four months after decision of the ANSM.
Conversely, in cases strictly limited by the decree (such as a shelf life incompatible with the constitution of a safety stock of two months), the stock may be reduced to less than 2 months. In these cases, you will have to submit a waiver request. Financial sanctions will be imposed on laboratories that contravene the new provisions, said the ANSM.