The ANSM has just published the list of medicinal products of major therapeutic interest (MITM) that must be subject to a minimum safety stock increased to 4 months.
As a reminder, since September 1, 2021, laboratories marketing a MITM must establish a minimum safety stock of two months reserved for patients treated on French territory. By decision of the ANSM, and under certain conditions, this period may be increased, without exceeding four months of coverage of needs, or may be decreased and be less than two months.
Which medicinal products are affected by the increased 4-month safety stock?
Article 3 of Decree no. 2021-349[1] allows the Director General of the ANSM to decide unofficially to increase the safety stock threshold, up to a maximum of four months’ coverage of needs, for MITM at risk of being out of stock or regularly out of stock in the previous two calendar years.
In order to strengthen the security of patient access to certain MITMs, ANSM has decided to increase the duration of safety stocks to four months for 422 MITM, out of a total of 6,000 MITM currently marketed in France.This list published by ANSM is established in light of supply difficulties observed in 2019 and 2020.
The list includes medicinal products for Parkinson’s disease, epilepsy, high blood pressure, certain antibiotics and some anticancer medicinal products.
This list will be revised every two years. Thus, in 2023, the list of MITM concerned will be based on ruptures or risks of ruptures observed in 2021 and 2022.
Which medicinal products are affected by the less than 2 months safety stock?
Decree no. 2021-349 allows the Director General of the ANSM to decide, at the request of the marketing authorization holder (MA) or the pharmaceutical company operating the medicinal product, to lower the safety stock threshold for a MITM. This request can be made at any time, including for new MA.
The laboratory may invoke several reasons to benefit from this decrease in safety stock, such as:
- incompatibility of the shelf life with the two-month safety stock requirement ;
- the personalization of the treatment per patient or the manufacture of the medicinal product from products of human origin;
- the seasonality of the needs of the specialty;
- the specialty concerned is a gas for medical use.
It is important to note that the silence kept by the Director General of the Agency for more than two months from the submission of a request for modification of the safety stock threshold by marketing authorization holders and pharmaceutical companies exploiting medicinal products is equivalent to a refusal decision.
The ANSM has published the list of 98 MITM benefiting from this exemption, most of which are manufactured from products of human origin (67 out of 98).
How soon should the laboratory build up the minimum stock?
The laboratory marketing the MITM concerned by the increase of the safety stock to 4 months has 6 months to set up the safety stock from the date of the ANSM decision. As part of the inspections carried out by the ANSM on manufacturers, a check will be made to ensure that the safety stocks correspond to the provisions of the decree and the decisions taken by the ANSM.
What are the penalties for non-compliance with security stocks?
Financial penalties may be imposed on an industrialist who fails to comply with his obligations in terms of security stock intended for the national market.
The amount of the financial penalties can be up to 30% of the sales (excluding VAT and exports) made in France during the last financial year for the product or group of products concerned, up to a maximum of one million euros.
In addition, the agency may add to this financial penalty a daily penalty for each day of supply disruption observed, which may be up to 30% of the average daily turnover achieved in France by the company in the last financial year for the product concerned.
Finally, the MSHA may decide to publish financial penalty decisions on its website.
These sanctions can be challenged upstream and in an appeal (see our article of February 16, 2022).
[1] Decree n°2021-349 of March 30, 2021 relating to the security stock intended for the national market.
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