The professional medicine union (Leem) calls on Tuesday for the lifting of obstacles to access to medicines in France, based on a study in which it participated, showing that excessive evaluation times delay the availability of certain innovative treatments. A third of drugs (34%) that received marketing authorization at European level between 2018 and 2021 were not available to French patients at the end of 2022, compared to 13% in Germany and 19% in Italy, this report finds. drawn up by the independent firm Roland Berger, which compiles public data, internal Leem studies and a survey of pharmaceutical companies.
For example, none of the last five antipsychotics available in Europe is accessible in France, nor any of the three new background treatments for migraine, underlines Leem. In France, “the time for placing on the market is very far from the target of 180 days” set by European regulations since it takes on average around 500 days for a drug to be available, according to this study which appears in the run-up to the conclusions of the mission of experts created by Prime Minister Elisabeth Borne on the system of financing and regulation of health products.
However, if we take into account the early access procedure which allows certain patients to access innovative medicines before they have obtained marketing authorization and their prices have been negotiated, the average access to drugs drops to 213 days, the report calculates. But this derogatory system, which applies in the context of rare, serious or disabling diseases when no appropriate product is available but there is an urgent need to treat, “remains limited”. As for the level of attractiveness of the territory, the study notes that “the situation is not catastrophic” even if “overall, France exports less and less the mature drugs that it produces and imports more and more products innovative that it does not produce enough”.
Of the new drugs having obtained an authorization between 2017 and 2022, only 48 are produced on French territory, against 122 in Germany, details the study. With its participation in 13% of clinical trials on patients initiated by manufacturers worldwide in 2021, France ranks 3rd in Europe behind Spain and then Germany. More generally, the manufacturers surveyed cite the complexity of regulation as the main obstacle to the development of their activity.