French health authorities have just ordered around ten pharmaceutical groups, including the French company Biogaran and the Swiss company Sandoz, to pay a total of eight million euros for failing to maintain sufficient stocks of medicines deemed essential, a sanction of unprecedented scale, in a context of shortages in the country.
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“The National Agency for the Safety of Medicines (ANSM) has imposed 8 million euros in financial sanctions on pharmaceutical laboratories that have not respected their 4-month safety stock,” according to a press release from this French body published on Tuesday.
These sanctions come in a context where French law has been tightened in recent years towards pharmaceutical groups in order to strengthen their obligations in terms of drug stocks.
These measures, taken at a time when drug shortages are worsening year after year in the country, are forcing companies to maintain stocks of two months, or in some cases four months, of drugs deemed to be of major therapeutic interest.
These drugs are those for which an interruption of treatment could endanger the patient’s life in the short or medium term.
The sanctions announced on Tuesday, which correspond to breaches noted in 2023, are unprecedented. For 2022, just over €500,000 in sanctions had been decreed.
This time, around thirty references are concerned and cover a broad therapeutic spectrum.
“The identified shortcomings concern, for example, antihypertensives, anticancer drugs, antimicrobials, neurology drugs, etc.,” Alexandre de la Volpilière, director general of the ANSM, explained to AFP. “Unfortunately, no class is spared from this phenomenon.”
“As for the laboratories, the main ones are Biogaran, Sandoz, Viatris: the biggest sanctions concern generic drugs, which corresponds to the main supply disruptions that we have seen in recent years,” he added.
One of the biggest sanctions, for example, affects Biogaran, the leader in generic drugs in France and a subsidiary of the Servier laboratory, for insufficient stocks of a molecule against hypertension.
The problem does not only affect France: in April 2023, pediatricians from different European countries warned of a risk to “the health of our children and young people” due to the lack of medicines throughout Europe. Elsewhere, the United States and Canada are also affected.
The causes of shortages are multiple, often with a link to the international context: insufficient production capacity, complexity of manufacturing chains, increase in the need for medicines against a backdrop of ageing populations, concentration of manufacturers, difficulties in supplying raw materials, quality defects in medicines, effects of international crises, inflation, etc.
