The French National Agency for the Safety of Medicines and Health Products (ANSM) has updated on 08/08/2022 its guidelines for the determination of financial penalties in case of non-compliance of pharmaceutical companies with the regulation of medicinal products for which they are responsible:
- New non-compliance cases subject to financial penalties are now listed in an Annex 3.
- The amount of the penalties applicable to the non-compliances has been increased.
- The approach followed by the Agency when it pronounces a financial penalty is clarified.
- The financial penalties are proportionate to the seriousness of the infringements found.
The document and its amended Annex 1 and new Annex 3 are scheduled to enter into force on 1 October 2022.
Obligations of pharmaceutical companies in terms of stock of medicines:
- to establish a safety stock for all medicines intended for the French market.
- to prepare shortage management plans (PGP) for all Medicines of Major Therapeutic Interest (MITM) marketed in France.
Minimum stock period for medicines:
- Medicines of Major Therapeutic Interest (MITM): 2 months.
When the medicine is likely to be out of stock or has been out of stock regularly during the previous two calendar years, the ANSM may decide to increase the safety stocks to 4 months of coverage of needs.
- Non-MITM drugs: 1 week.
This period is increased to 1 month for medicines contributing to a public health policy defined by the Ministry of Solidarity and Health.
Drug shortage regulation:
- The Social Security Financing Act for 2020 (Article 48) introduced obligations for Marketing Autorisation (MA) holders and companies exploiting a medicine.
- Decree No. 2021-349, applicable since 1 September 2021, defined the conditions for the implementation of these obligations.
Why pharmaceutical companies must have a safety stock for medicines?
- The obligation to hold safety stocks makes it possible to anticipate more effectively the risks of stock-outs of marketed essential medicines and to improve their availability to patients in France.
All classes of medicines are concerned by stock-outs or risks of stock-outs. Medicines more particularly exposed are cardiovascular medicines, nervous system medicines and anti-infectives for systemic use.
Non-compliances subject to financial penalties :
- Not establish a safety stock for all medicines intended for the French market.
- Not informing ANSM, at least 1 year before the envisaged or foreseeable date of suspension or discontinuation of a MITM for which there are no alternatives available on the French market, or not indicating the reason for such action.
- Discontinue the marketing of a MITM before the end of the time necessary to put in place alternative solutions.
- Not informing ANSM of the list of medicines for which a shortage management plan (PGP) is required or not to prepare a PGP.
- Not to include adequate measures in the PGP or not to implement the measures envisaged.
- Guidelines for determining financial penalties
- Annex 1: Guidelines for determining financial penalties: weighting criteria for breaches of drug regulation (excluding breaches of drug stock-outs provided in Annex 3).
- Annex 3: Guidelines for determining financial penalties: weighting criteria for non-compliance with drug stock-outs.
- Decision of 24/06/2021 establishing the modalities and format for the declaration of any risk of stock shortage or of any stock shortage of a MITM.