France Fines Pharma Giants €8 Million for Failing to Stock Essential Medications Amid Rising Drug Shortages
September 24, 2024In an effort to alleviate some of the financial burden, the pharmaceutical industry is advocating for certain medications to be available over-the-counter, potentially saving up to 1.1 billion euros in costs.
On September 24, 2024, the French National Agency for the Safety of Medicines and Health Products (ANSM) imposed unprecedented fines totaling 8 million euros on eleven pharmaceutical companies for failing to maintain adequate stocks of essential medications.
The fine represents a 14% increase compared to the previous year, underscoring the seriousness of the situation and the need for pharmaceutical companies to adhere to stricter stock regulations.
Major companies affected by these sanctions include Biogaran, which received the largest penalty of 4 million euros for insufficient stocks of irbesartan, a medication used to treat hypertension.
ANSM defines a drug of major therapeutic interest as one where treatment interruption poses a risk to patients' vital prognosis in the short or medium term.
Recent laws have tightened regulations, mandating pharmaceutical companies to keep two to four months' worth of critical therapeutic medications to ensure patient safety.
The identified stock shortages encompass around thirty medications across various therapeutic categories, including antihypertensives, anticancer drugs, antimicrobials, and neurological medications.
Patient associations have welcomed these increased fines, viewing them as a positive step towards more effective regulatory oversight in addressing the medication shortage crisis.
The ANSM emphasized that the 8 million euro fine serves as a reminder of the pharmaceutical industry's obligations regarding safety stock levels, rather than a comprehensive solution to the ongoing shortages.
This significant penalty marks a stark contrast to the just over 500,000 euros in fines imposed in 2022, highlighting a growing concern over drug shortages that have escalated in recent years.
The sanctions are a direct response to alarming medication shortages that have been increasingly reported, with nearly 5,000 reports recorded in 2023, a 33% rise from the previous year.
The companies were penalized for not maintaining the mandatory four-month safety stock of essential drugs, a requirement established to prevent treatment interruptions that could jeopardize patient lives.
Summary based on 7 sources
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Actual News Magazine • Sep 24, 2024
2024 - ANSM fines 11 pharmaceutical companies 8 million euros for low stocks of certain drugs