They have become almost commonplace. Once extremely rare, drug shortages have been increasing rapidly in recent years. In five years, out-of-stock and out-of-stock risk declarations submitted by pharmaceutical manufacturers to the National Agency for the Safety of Medicines and Healthcare products (ANSM) have tripled. In 2023 they even set a new record with 4,925 reports recorded.
To remedy this situation, which is causing the anger of patients, the Socialist MP for Tarn-et-Garonne, Valérie Rabault, presented a bill at the end of January. “the first, strictly speaking, to specifically address the issue of drug shortages”, explains the elected official. With this text, which will be debated in the National Assembly on February 29th, she would like to strengthen the stockpiling obligations of pharmaceutical manufacturers.
Since 1um From September 2021, laboratories marketing medicines in France must have a safety stock to ensure supplies in the event of a problem, giving them some time to find a solution. Depending on the drug, these stocks must cover national needs for a period of between one week and four months. But in practice Only a few medicines (422 of more than 12,000 specialties approved in France) are subject to the four-month maximum, regrets the deputy.
“Sanctions not enough of a deterrent”
The text therefore proposes to review the modalities and to require the creation of a minimum stock equivalent to a four-month supply, compared to the current two months, for all medicinal products said to be of “great therapeutic interest” (approximately half of those currently available). products on the market). market) and a two-month supply (compared to one month today) for other medications. Will this be enough to prevent supply disruptions? “The causes of these bottlenecks are varied. The issue of shares is not the only thing, but it is one of the issues where we can have room for maneuver “, justifies the MP.
At the same time, the proposed law provides for a tightening of the financial sanctions that the pharmaceutical police ANSM can impose on manufacturers if they fail to meet their obligations, in particular those related to safety stocks. “Today’s sanctions are not a deterrent enough” asks MMe Rabault thus agreed with the conclusions of the senatorial commission of inquiry into drug shortages, whose report was published in July 2023.
You still have 35% of this article left to read. The rest is reserved for subscribers.
