This is an unprecedented conviction in a context of drug shortages. Health authorities have just ordered a dozen pharmaceutical laboratories to pay a total of eight million euros for not having maintained sufficient stocks of treatments considered essential, they announced on Tuesday 24 September.
“The National Agency for the Safety of Medicines (ANSM) imposes economic sanctions of 8 million euros on pharmaceutical laboratories that have not respected their four-month safety stock”he said in a press release.
In recent years, the law has been tightened towards pharmaceutical groups to reinforce their obligations regarding drug stocks. These measures, adopted as drug shortages worsen year after year, oblige companies to maintain two months’ stocks, or in some cases four months’ stocks, of drugs said to be of great therapeutic interest. These drugs are those whose interruption of treatment could endanger the patient’s life in the short or medium term.
The penalties announced on Tuesday, which relate to infringements observed in 2023, are unprecedented. For 2022, just over 500,000 euros in fines had been imposed.
Biogaran, Sandoz or Viatris sanctioned
This time, there are around thirty references covering a wide therapeutic spectrum. “The identified deficiencies concern, for example, antihypertensives, anticancer drugs, antimicrobials, neurological drugs…”“explained Alexandre de la Volpilière, director general of ANSM, to Agence France-Presse. “Unfortunately, no social class is exempt from this phenomenon.”
“In the laboratories, the main ones are Biogaran, Sandoz, Viatris: the biggest sanctions concern generic drugs, which corresponds to the major supply disruptions we have seen in recent years”he added.
One of the largest sanctions, for example, affects Biogaran, the French generics giant, for insufficient stocks of a molecule against hypertension, irbesartan.
These announcements were welcomed by patient associations, concerned about the worsening shortage of treatments. “It is a good sign because before the fines were much lower”welcomes Catherine Simonin from France’s Assos Santé, which brings together numerous associations. She sees it as a sign that “Controls are carried out”.
