In brief
On 24 November 2022, the French Agency for the Safety of Medicines and Health Products (ANSM) issued three sentences against pharma companies that have failed to meet their reporting obligation regarding the risk of a medicinal products supply shortage or a supply shortage.
In more detail
Medicinal product shortages are a burning topic.
There has been a steady increase in the number of medicinal product supply shortages in Europe, up to 200 per year in 67% of countries.
In 2019, 1,504 alerts were reported to ANSM and this number increased to 2,446 in 2020. In this context, the risk of medicinal product shortages is closely monitored by ANSM.
To fight against medicinal product shortages, France has strengthened the system for preventing the risk of shortages, in particular by implementing a stockpiling obligation imposed on the marketing authorization holders/French, or so-called exploitants. In addition, they must inform ANSM, without delay, of any risk of a supply shortage or any supply shortage of medicinal products of a major therapeutic interest (MMTI) that they would face. MMTIs are defined as “medicinal product[s] for which an interruption of treatment is likely to threaten the vital prognosis of patients in the short or medium term, or represents a significant loss of chance for patients with regard to the seriousness or progressive potential of the disease”.
The French Public Health Code provides for severe sanctions in the event of non-compliance with this obligation and as of 1 October 2022, those sanctions have been strengthened to fight more efficiently against medicinal product shortages. In this context, ANSM can impose financial penalties that can go up to 30% of the global turnover for the concerned medicinal product, accompanied by daily penalty payments.
Implementing these strengthened provisions, on 24 November 2022, ANSM sanctioned three pharmaceutical companies for failing to inform ANSM in a timely manner of the risk of MMTI supply shortages they were facing that could have resulted in patients being deprived of treatments.
The imposed sanctions ranged from EUR 15,000 to EUR 255,000 and are published on the ANSM website.
In those decisions, ANSM outlines that pharmaceutical companies are due to anticipate any risk of shortages, by having an accurate and updated knowledge of their own stocks, and comparing the number of medicinal products on reserve with their production capacity and with the expected distribution of those medicinal products.
