The government is strengthening its means to combat drug scarcity. A decree published on Tuesday, August 5 in the official magazine, a little more expands the obligations of pharmaceutical laboratories in case of scarcity of shares or a cessation of the commercialization of one of its drugs, considered as an important therapeutic interest (MITM).
Within the two months of the declaration of scarcity of actions or marketing trial, the text formally forces pharmaceutical manufacturers to “put all their means to find a buyer.”
Assignment of manufacturing rights
The Pharmaceutical Laboratory whose medication is in shortage must make public “its intention to grant the exploitation or transfer the authorization to market the medications concerned about any appropriate means and make it appear on a dedicated page of its website, whose address is added to the National Agency for the Safety of Medicine and Health Products,” specifies the decree.
But if the laboratory cannot find a buyer, then the National Agency for the Safety of Medicines and Health Products (ANSM) can force it to “grant in an elegant and temporal period, to a public pharmaceutical structure the manufacture and exploitation of the medication to allow the continuity of the French market supply.”
Monitoring preparations, dispensing units …
These measures, which are directed directly to the pharmaceutical laboratories for the manufacture of medicines considered essential for the population, are added to other means to combat shortage.
For example, the minister responsible for health, can, after the opinion of the director of the ANSM, take an order that authorizes, exceptionally, pharmacies to make “officinal preparations” to meet the needs of patients, in particular those for whom the interruption of the treatment could be harmful.
The Minister of Health can also, if necessary, limit drug dispensing per unit. In February of this year, the General Director of Health (DGS), Grégory Emery, and the Director of Social Security (DSS), Pierre Pribile, by ministerial delegation, made a decree that forced pharmacies to deliver Quetiapina to the unit, to combat the scarcity of this antipsychotic medicine.
More than 1,000 shares of shares in 2024
In total according to the ANSM, 1,076 drug breaks were identified and 2,733 rupture risks were identified in 2024. Decreased numbers compared to the previous year, the winter of 2022-2023 was marked by a shortage of paracetamol and antibiotics such as amoxcillin, in a context of triple epidemic of COVVVI-19, influence and bronchiola.
At the end of 2024, 8,107 medications were recorded in the MITM list, published by the ANSM, for which laboratories must declare any risk or rupture of shares and have the 2021 obligation to build two months of security actions.
Source: BFM TV
