Six financial penalties were imposed by the ANSM in 2021 in relation to health products for an amount of €508,048, compared to seven financial penalties imposed in 2020 for an amount of €1,269,235. The sanctions pronounced last year were therefore less numerous than in 2020 and, above all, much less substantial!
On the basis of inspections or elements highlighting breaches of the Public Health Code, the ANSM initiates financial sanction procedures against operators of medicinal products and medical devices. These financial sanctions are mainly pronounced in the fields of advertising control, marketing and the activity of pharmaceutical establishments.
Which activities have been targeted by the ANSM in 2021?
In the context of the fight against supply tensions in the medicinal products market, wholesale distributors play a significant role and contribute to slowing down and neutralising certain stock shortages by distributing the quantities of medicinal products available on the national territory as well as possible. In the midst of the pandemic, the ANSM has therefore ensured that the public service obligations of these wholesale distributors are respected, and has imposed two sanctions for failure to meet these obligations.
As regards medical devices, it should be recalled that Regulation 2017/745 on medical devices (MDR) requires a certificate issued under this regulation (“MDR” certificate) for all medical devices placed on the market since 26 May 2021. On this point, the ANSM has three times sanctioned manufacturers who imported and placed on the market devices without a valid EC certificate of conformity.
However, ANSM did not impose any financial penalties for the advertising of health products, as was the case in 2020.
What are the financial penalties?
A financial penalty can have significant financial and reputational consequences for a manufacturer.
The amount of the financial penalty may be, depending on the type of practice sanctioned, up to
- 10% of the total turnover (excluding VAT) achieved in France during the last financial year, up to a maximum of one million euros. This ceiling is applicable in particular in the event of violation of pharmacovigilance rules, in regulatory matters (information to the health authorities) or in the event of disregard of the public service obligations of wholesale distributors;
- 30% of the turnover (excluding VAT) achieved in France during the last financial year for the product or group of products concerned by the breach, up to a maximum of one million euros. This ceiling is applicable in particular in the event of failure to comply with regulations on the labelling, instructions or names of health products, on the advertising of health products or on the safety stock of health products.
In 2021, on average, the amount of each sanction was €84,600, compared to €181,300 in 2020.
Can financial penalties be challenged?
On the one hand, financial sanctions can be contested upstream. The implementation of a sanction procedure by the ANSM implies the respect of an adversarial procedure prior to the pronouncement of the sanction: the industrialist will then have a minimum period of 8 days to present his observations. It is only at the end of this period that a financial sanction can be pronounced by the ANSM’s Director General.
On the other hand, once the sanction has been pronounced, the industrialist may contest it by means of an appeal:
- an informal appeal to the Director General of the ANSM may be lodged within two months of notification of the ANSM’s decision imposing the financial penalty;
- a contentious appeal before the administrative judge may be lodged within the same time limit or, if an informal appeal has been lodged within the two-month time limit and has been rejected by the administration, within two months of the rejection decision.