While drug stock-outs have increased in recent years, the National Agency for the Safety of Medicines and Health Products (ANSM) has just announced the obligation for pharmaceutical laboratories to provide a safety stock. . A measure which concerns drugs for which an interruption of treatment may endanger the life of the patient in the short or medium term.
Medicines of major therapeutic interest must now have a safety stock
From September 1, 2021, pharmaceutical companies are required to build up a minimum safety stock of two months for all drugs of major therapeutic interest (MITM) intended for French patients. This is what the National Agency for the Safety of Medicines and Health Products (ANSM) has just announced on Friday 03 September. Indeed, the measure, endorsed by a decree published at the end of March, officially entered into force on Wednesday, September 01, 2021.
Medicines affected by this new obligation
As the ANSM details, this concerns “ the classes of drugs for which an interruption of treatment is likely to jeopardize the vital prognosis of patients in the short or medium term, or represents a significant loss of opportunity for patients in view of the severity or the progressive potential of the disease “. This can be cardiovascular drugs, drugs for the nervous system, anti-infective or anti-cancer drugs. The complete list of drugs of therapeutic interest affected by the measure must be unveiled during the month of October.
Safety stocks that can go up to four months
Moreover, if drugs of major therapeutic interest have been the subject of regular stockouts or risks of stockouts in the last two years, the ANSM may decide to increase safety stocks for up to four months. In this case, the laboratories concerned will have six months to set up the stocks. Conversely, there may be some exceptions for certain drugs whose shelf life is incompatible with the constitution of a two-month safety stock. For the latter, the safety stock may be reduced to less than two months.
Avoid drug shortages that have increased in recent months
This obligation comes at a time when drug supply tensions have intensified in recent years. For example, the ANSM indicates that it recorded 2,446 reports of stockouts and the risk of stock-outs in 2020 against 1504 reports in 2019. This is six times more than four years ago. This is why the obligation to have safety stocks will make it possible to anticipate more effectively the risks of stockouts as declared by Carole Le Saulnier, director of legal and regulatory affairs at ANSM: ” 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 ”.
