The distress message was sent at the beginning of May. A simple email, sent by the French National Agency for the Safety of Medicines and Health Products (ANSM) to its European counterpart. The subject of the missive is brief: “Request for voluntary solidarity mechanism: methotrexate. » Faced with an imminent risk of shortage of this anticancer drug, indicated, among other things, in the treatment of acute leukaemia, non-Hodgkin’s lymphomas and osteosarcomas, France has decided to trigger this last resort Community procedure.
This is the first time that France has called on it since its establishment by the European Union in October 2023. This mechanism gives countries facing a critical shortage of medicines the opportunity to request help from the Twenty- Seven through a message sent by the European Medicines Agency to all member states. The latter then have five days to evaluate their stocks and respond, negatively or positively. Imagined by Belgium after the shortages of antibiotics which affected Europe during the winter of 2022, the mechanism has already made it possible since its adoption to help two other states, one short of 5-fluorouracil, and the other of cisplatin, two anticancer drugs.
Before throwing this bottle into the sea, the French drug “police force” exhausted all the regulatory arsenal at its disposal. In particular, it prohibited wholesale distributors from selling and exporting methotrexate outside the country, and explored existing therapeutic alternatives. In vain.
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A call for healthy solidarity
Accord Healthcare, which markets the anticancer drug in question in France, and whose supply difficulties stem from a quality problem encountered on its production line, nevertheless has competitors in the territory who can take over. Viatris and Teva laboratories both sell identical products. But manufacturers were soon no longer able to absorb the postponements, and the available stocks of methotrexate began to dangerously run out in the pharmacies of French hospitals. To the point of considering the occurrence of shortages from mid-June to mid-July on this treatment, which is nevertheless considered vital for patients.
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Faced with this impasse, the call for European solidarity made in May proved beneficial. Less than a week after launching its SOS, a Member State, Slovenia, came forward, indicating that it had stocks ready to be shared with France. Vials of Metotreksat, the Slovenian version of methotrexate, arrived in France at the beginning of June. They will be followed in the coming days by another delivery, this time from the United Kingdom. According to the ANSM, this will ensure the continuity of treatment for patients until the situation returns to normal, expected in mid-July.
