For the third time since its creation, France used the European solidarity mechanism for medicines to avoid a shortage of an anti-cancer drug, methotrexate. “Libé” takes stock of this system.
Slovenia to the aid of France. Thanks to the European voluntary solidarity mechanism for medicines put in place in October 2023, French pharmacies will be able to obtain methotrexate, a drug used against certain leukemias and certain lymphomas, with strong supply constraints in the territory. What “overcome the production difficulties of the three laboratories concerned, Accord, Teva, Viatris, until the return of stocks expected in mid-July 2024, and to ensure the continuity of treatment of patients”according to a press release from the National Agency for the Safety of Medicines and Health Products (ANSM) on Tuesday, June 25.
What is the European voluntary solidarity mechanism for medicines?
In the winter of 2022, several European countries ran out of antibiotics, these essential molecules for fighting bacterial infections. The European Union has therefore put in place a plan to combat drug shortages. One of the measures put in place was this solidarity mechanism. Concretely, the ANSM reported at the end of April, by email, to the European Medicines Agency (EMA) the very strong tensions it was experiencing on its stocks of methotrexate. After ensuring that the ANSM has put in place, without success, all possible measures to deal with this supply crisis, the European Medicines Agency – and more precisely, the Executive Steering Group on shortages and safety of medicines – transmits the request to all European countries. Depending on the state of their internal market, they can decide to come to the aid of the country in distress. They must decide in five days. In this case, it was Slovenia which responded to the call. It authorized its suppliers to contact French laboratories to help them out with a certain number of boxes of medicines. Transactions take place between laboratories, not between States. This is the third time that this mechanism has been used. In the first two cases, it also involved anticancer drugs, 5-Flurouracil, and cisplatin, but the EMA does not communicate the names of the countries concerned.
What are the consequences for patients?
By avoiding a complete disruption of supply, health agencies are making it possible to avoid a disruption in treatment. Only problem: the Slovenian bottles arrived on national territory at the beginning of June with instructions written… in Slovenian. The ANSM has prepared a comparative document to help pharmacies navigate and avoid making dosage errors. “Methotrexate 5g Medac initially intended for the United Kingdom will also be imported by the Accord laboratory. It will be made available to health establishments at the end of June.also specifies the health agency on its website.
Where are the supply tensions for other medicines?
To date, according to the ANSM list, more than 100 drugs have already been put back on the market since January 2024, around fifty are still out of stock (such as xylocaine, a local anesthetic or the antibiotic Claventin) and more than a hundred are experiencing supply tensions (such as treatments for epilepsy or diabetes in particular). In February, the government presented a plan to combat shortages. Relocating factories, better monitoring production capacities, making a list of essential drugs, raising awareness among doctors, not enough to convince Bernard Bégaud, professor of pharmacology at the University of Bordeaux, for whom it is necessary to start thinking about drug prices if we really want to secure the supply of essential products. The dissolution after the European elections has turned this strategy upside down. It will be up to the government resulting from the National Assembly elected on July 7 to implement this plan.
