Acknowledgement: Prof David Hutchinson;
Three industry associations have challenged new legislation in France that allows the national regulator to temporarily authorise the use of a product in an France-map-colourunauthorised indication for economic reasons, even if an authorised alternative treatment is available. The off-label use of medications is already permissible for individual patients in very specific circumstances where there is a concrete medical need. However, with similar Italian legislation allowing off-label use on economic grounds, there is a growing concern that we may be seeing an increasing trend that compromises both patient safety and the robust European medicines regulation process in an effort to save money
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