Too chilly, too slow, or bureaucratic, the French health agencies? In recent weeks, more and more voices have been raised against these institutions. Because of them, many French patients would not have timely access to “innovative drugs”, the latest remedies from pharmaceutical laboratories. Worse: the Italians, the English or even the Germans would dispose of it well before us.
Thus, it would take an average of 497 days for a new treatment approved in Europe to reach the French, according to EFPIA, the lobby of European pharmaceutical industries and associations. Its national equivalent, the Leem, explains for its part that a Frenchman should wait 380 days longer than a German, before benefiting from these new products. A panorama… largely truncated, according to Health Insurance.
Faced with almost all barometers drawn up by the industry, the institution launched its own studies two years ago on the time it takes to access medication. Analyzes published in its annual report Load and products, a summary of recommendations which must be submitted soon to the government, and which L’Express has obtained. According to this document, the most relevant data sometimes turn out to be obscured by lobbies.
Thus, the waiting time for a new therapy is rather around 240 days on average, say the authors of this report. Why such a difference ? In their indicators put forward, European industrialists do not take into account the “early access” procedure. However, it makes it possible to obtain a drug urgently, before it is officially placed on the market. With this mechanism, France is only 85 days behind Germany, and ranks far ahead of Italy, England and Spain, recalls the Health Insurance.
Do not go faster than science
The institution also draws attention to national specificities, which sometimes make the data difficult to compare. Thus, Germany lets manufacturers set their prices for the first six months of marketing. In other words, it functions in a system of permanent urgent access, even if it means incurring unnecessary expenses. France is waiting for the end of tariff negotiations before authorizing the marketing of a product, when it goes through the traditional circuit.
Contrary to popular belief, the time required to assess whether a product is useful and safe is actually very close in Europe: 206 days in Germany, 222 days in Spain, and 230 days in France, on average. Better still, France has the shortest lead times for the most innovative drugs: 187 days on average, compared to 221 in Germany, 241 in Spain or 358 in England.
Health Insurance is not the first institution to qualify the discourse on the slowness of the tricolor. On March 31, the High Authority for Health (HAS) refuted “obstructing access to therapeutic innovation to the detriment of patients”. Its in-depth examinations, sometimes long or with a disappointing response for patients, serve to “ensure the real interest of new treatments, beyond promises and announcement effects”, she recalled.
Because innovation does not mean revolution: “Some products bring nothing compared to reference drugs. No need to rush their marketing”, explains Philippe Besset, president of the Federation of Pharmaceutical Unions of France (FSPF). Often, industrial reports take into account all new drugs in their time calculations, even when some do not improve the medical benefit provided, or when industrialists have simply decided to ignore France.
“Scientific retreat”
Doctors, experts, or patient associations, the fact remains that more and more players are calling for the long-term facilitation of bringing medical innovations to market, while France is testing a new circuit called “direct access”, in addition to early access. “The greatest number must be able to have access to the largest therapeutic arsenal as quickly as possible. Otherwise some patients will see their chances of getting better reduced”, pleads Pierre-Olivier Variot, boss of the Union of trade unions of community pharmacists.
Some patients and doctors believe that from the moment our neighbors are conquered, it should be the same in France. In recent months, several European countries have chosen to urgently put on sale certain new molecules against cancers, where the HAS has judged that data on efficacy and safety were lacking. What, in mirror, give the impression to patients that France is losing interest in them, despite the reality of the results available.
Faced with this increasingly urgent demand for speed, many scientists, including epidemiologist Dominique Costagliola, member of the Academy of Sciences, or Jean-Luc Cracowski, president of the National College of Medical Pharmacology, have indicated their concerns. They consider certain calls to dispense with the most serious but also the longest testing methods, the sacrosanct “randomized trial” in mind, as a “scientific setback” and a danger.