2024-02-15 16:09:21
In a pharmacy in Riedisheim (Haut-Rhin), October 23, 2023. SEBASTIEN BOZON / AFP
They have almost become commonplace. Once extremely rare, drug shortages have been increasing rapidly for several years. In five years, stock-out and stock-out risk declarations filed by pharmaceutical manufacturers with the National Agency for the Safety of Medicines and Health Products (ANSM) have tripled. In 2023, they even broke a new record, with 4,925 reports recorded.
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In order to remedy this situation, which arouses the anger of patients, the socialist deputy for Tarn-et-Garonne Valérie Rabault tabled a bill at the end of January, “the first, stricto sensu, to be specifically dedicated to the subject of drug shortages”, explains the elected official. She wishes, through this text, which will be debated in the National Assembly on February 29, to strengthen the stockpiling obligations incumbent on pharmaceutical manufacturers.
Since September 1, 2021, laboratories marketing medicines in France must have a safety stock in order to guarantee supply in the event of a problem and thus allow them some time to find a solution. Depending on the medicine, these stocks must ensure coverage of national needs for periods ranging from one week to four months. But, in practice, few medications (422 specialties out of more than 12,000 authorized in France) are subject to the maximum threshold of four months, deplores the MP.
“Sanctions not dissuasive enough”
The text therefore suggests reviewing the modalities and proposes imposing the constitution of a minimum stock equivalent to four months of coverage, compared to two months currently, for all drugs said to be “of major therapeutic interest” (approximately half of the products currently on the market), and a two-month stock (compared to one month today) for other drugs. Will this be enough to prevent supply disruptions? “The causes of these shortages are multiple. The stock issue is not the only one, but it is one of the subjects on which we can have leverage for action », justifies the MP.
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At the same time, the proposed law plans to toughen the financial sanctions that can be imposed by the ANSM, the medicine policeman, against manufacturers in the event of failure to fulfill their obligations, in particular those relating to safety stocks. “The sanctions today are not dissuasive enough,” argues Ms. Rabault, joining the conclusions of the senatorial commission of inquiry into the shortage of medicines whose report was published in July 2023.
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