In a decision published this week (28 June 2023), the French Drug Agency has once again sanctioned a pharmaceutical company for a shortage of medicines which occurred last year. The fine amounts to 210,000 euros, calculated on the product turnover. For several years, the French agency has regularly and financially sanctioned shortages related to sensitive medicines, as this creates a hardship for many patients and one that continues to grow. Similar decisions in the context of shortages have also already been taken in the Netherlands and in Spain. The particularity here is that it is a generic company that has been fined for having almost no antibiotic medicines in stock, instead of having a 2-month supply, a situation faced by many companies.
In practice, some legal teams wonder whether this decision could be extended to other companies in a similar situation. In any case, from a legal standpoint, this type of decision can be negotiated with the French agency and even, like in the other countries, challenged in the French administrative courts.
In many other European countries (e.g.: Austria, Germany, the Netherlands, Spain), there are similar regulations on drug shortages. Some of them mainly focus on the obligation to report the shortages to the authorities. If the obligation is infringed, the local regulations often provide for financial penalties by the health authorities, sometimes up to EUR 1 million or so (e.g. France, the Netherlands, Spain). In Belgium, there is even a criminal sanction (i.e. not administrative). This litigation situation may accelerate as shortages have become a major concern in many European countries and at the EU level.
In practice, some legal teams wonder whether this decision could be extended to other companies in a similar situation. In any case, from a legal standpoint, this type of decision can be negotiated with the French agency and even, like in the other countries, challenged in the French administrative courts.
In many other European countries (e.g.: Austria, Germany, the Netherlands, Spain), there are similar regulations on drug shortages. Some of them mainly focus on the obligation to report the shortages to the authorities. If the obligation is infringed, the local regulations often provide for financial penalties by the health authorities, sometimes up to EUR 1 million or so (e.g. France, the Netherlands, Spain). In Belgium, there is even a criminal sanction (i.e. not administrative). This litigation situation may accelerate as shortages have become a major concern in many European countries and at the EU level.