In 2021, the French drug agency determined that the stocks of hundreds of specific pharmaceutical products must be maintained by pharmaceutical companies at a level equivalent to 4 months of coverage usual public consumption. In April 2023, the agency checked for the first time whether the pharmaceutical sector was complying with this rule.
As a result of its inspections, the agency today published on its website 33 decisions imposing fines totaling almost EUR 8,000,000, on 11 pharmaceutical companies, for alleged infringement of the law, as interpreted by the agency. This is a very impressive change in the agency's approach, as it has generally imposed only a very limited number of fines per year.
In the decisions published today, it appears that the generic companies are bearing the heavier burden: while only half of the sanctioned companies are generic companies, they account for almost 85 % of the number of sanctions and the amount of fines. For the first time, the maximum level of EUR 1,000,000 has been reached, and many fines are above EUR 500k. These sanctions can be contested before the French administrative court, as other companies have already done over the last year, based on legal but also very concrete arguments concerning each product.
The question is now whether the agency will take new unfavorable decisions, based on its draft sanctions which have already been shared with some companies, and whether the agency will now develop its regular inspections on this basis, potentially exposing the pharmaceutical sector, which has already been weakened by the level of clawback taxes, to an unsustainable level of sanctions.
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