In brief
In August 2022, the French Agency for the Safety of Health Products (ANSM) published an updated version of its guidelines for determining financial penalties, which will come into effect on 1 October 2022.
In more detail
The ANSM is responsible for monitoring health safety, which allows it to impose penalties to prevent and sanction the actions of operators that fail to comply with their obligations.
Since the entry into force of Law 2011-2012 on 29 December 2011, the ANSM, in cases provided for by the French Public Health Code (FPHC), has the power to impose financial penalties against the authors of breaches.
The level of financial penalties varies according to the nature of the breaches and takes into account, where appropriate, any repetition of the breaches. Depending on the nature of the breach, the maximum amount of the financial penalty imposed may be 10% of the company’s turnover for the last financial year (up to a maximum of EUR 1 million), or 30% of the company’s turnover for the last financial year for the product or group of products concerned (up to a maximum of EUR 1 million). The sanction may be accompanied by a daily penalty.
To ensure transparency and consistency of its decisions and to guarantee a certain degree of predictability and legibility of the sanction policy carried out, the ANSM had published, as early as 2015, guidelines aimed at explaining how financial sanctions are determined by its services.
Briefly:
- A base amount is fixed with respect to the intrinsic nature of the breach.
- This base amount is then adjusted with regard to the gravity of the breach, its impact on public health and its duration. It will then be personalized to take into account the company’s behavior.
- The amount of the sanction thus obtained is finally adjusted, on the one hand, to bring it up to the legal maximum and, on the other hand, to take into account, if necessary, the financial difficulties that may be encountered by the company.
The Social Security Financing Bill for 2020 has strengthened the legislative framework for supply tensions, aimed at preventing shortages of medicines. The legislator has introduced new obligations on marketing authorization holders and pharma companies operating the products (French so-called “exploitant”). For instance, these same companies must have a minimum safety stock of medicines intended for the French market and located on French territory or that of another EU country. New penalties, including financial penalties, have also been adopted to sanction failure to comply with these new obligations.
As a result, in August 2022, the ANSM issued updated guidance, including a specific appendix on the weighting criteria applicable to the breaches of the provisions aimed at preventing shortages of medicines. The importance given to these sanctions is illustrated by the fact that all breaches are associated with the highest base amount (i.e., 20% of the company’s turnover for the last financial year for the product or group of products concerned). In addition, in accordance with Article L. 5471-1 of the FPHC, a daily penalty is automatically added.
Other parts of the ANSM guidelines were not substantially modified; in particular, some clarifications regarding the calculation methods were added.
These updated ANSM guidelines will enter into force on 1 October.
