HEALTH – Guest on Europe 1, on February 3, the Minister of Health declared the Amoxicillin shortage close to being resolved. The ANSM (National Medicines Safety Agency), in an information note of January 23, nevertheless warned of a disturbed situation until March. Its director, Christelle Ratignier-Carbonneil, recently auditioned in the Senate, announces solutions at European Union level “from 2024 or 2025”.
General practitioners, infectiologists, pulmonologists, pediatricians, geriatricians, ENT, pharmacists… All health professionals were informed by a note from the ANSM, released on January 23, of a “persistence of supply tensions”or even “ruptures de stocks” in France of Amoxicillin (alone or in combination with Clavulanic acid).
This degraded situation, which also concerns other commonly used drugs, such as paracetamol (Doliprane), should “last until March 2023”.
Out of the crisis according to the minister
“We are coming out of the crisis” of the shortage of Amoxicillin, nevertheless estimated the Minister of Health François Braun, during an interview on Europe 1, on February 3, 2023, indicating however a delay of “two weeks” in order to make up for any shortcomings.
Fifteen days later, ANSM forecasts are confirmed. On the site of the agency, a page, which lists the drugs of major therapeutic interest (ITM), still displays dozens of references out of stock or in supply tension. Among them are always Amoxicillin and Clavulanic acid.
Responsible for regulating the prescription of drugs, the High Authority for Health (HAS) must anticipate the stocks of molecules in order to draft its public health recommendations. Like the ANSM, the HAS does not rely on the Coué method practiced by the Minister of Health.
The crisis continues according to HAS and ANSM
“This is not a recent problem, but a growing problem. It is clear that the drug shortages we are experiencing are becoming more and more recurrent”, affirms its president Dominique Le Guludec, auditioned on February 9 by the Senate commission of inquiry about the shortage of drugs and the positioning of the French pharmaceutical industry.
However, French Braun seems to be convinced that it is a specific difficulty and of a seasonal nature, which could be explained for example by the simultaneous occurrence of several epidemics raging in winter. In his proposal for “plan blanc”, the minister recommends avoiding shortages in the “winter period”, by making “prior stocks (…) when you know you need them”.
But the analysis of the HAS is confirmed during a new session of the Senate Inquiry Committee, Wednesday, February 15, by the rapporteur Laurence Cohen (Communist group).
While questioning the director of the ANSM, Christelle Ratignier-Carbonneil, the senator recalls that “Scarcity is not a recent phenomenon. If we look at 2016, 600 reports were made. In 2019 there were 1500. 2400 in 2021. And today more than 3500. (These) have increased fivefold in a short time. This is not related to the Covid crisis.”
The abandonment of “old” molecules
The elected representative of Val-de-Marne, vice-president of the social affairs commission, remarks that the drugs most concerned are “the old ones, less expensive and therefore less profitable for operators”. Ms Cohen hypothesizes that the latter would experience more supply difficulties than the drugs “innovative” under patent and therefore still profitable for the pharmaceutical industry.
The senator is also surprised that this industry is not sanctioned by the penalties provided for by law, in the event of a negligent break in the production of a molecule. “I know you can impose financial penalties, she reminds the director of the ANSM, “but there are extremely few, with opacity on (their) amounts”. However, dissuasive sanctions could encourage producers to ensure that supplies are maintained.
Ms. Cohen also blames the relocation of industries for the “structural” nature of the shortages: “Many of us think that a certain number of industries should be relocated to have production in France. But we know full well that most of the factories are in China or India, for reasons of financial profitability, for the cost of labor but also for environmental reasons”.
“The European mesh”
After seeing that a “large number of EU countries are affected by the shortage of paracetamol and amoxicillin”Christelle Ratignier-Carbonneil, who is also vice-president of the EMA (the European Medicines Agency) explains “the European dimension” solutions : “There is work in progress for the revision of pharmaceutical legislation at European level, with a project starting around 2024 or 2025.”
The first project that “expected to be presented at the end of March (2023)”they inspire “the French legislative framework” in managing shortages and reporting obligations. “All the regulations will be taken over as a base”, according to the director of the ANSM.
Economically, thanks to “the European mesh”THE “vieux” antibiotics that are experiencing discontinuations “lack of attractiveness for manufacturers” could benefit from a once again profitable market due to its size.
“Globalization is not happy”
A demonstration that does not reassure Senator Alain Houpert (Les Républicains group): “We are insecure and your words worry me. The solutions you give are only band-aids (…). In the context of medicine, globalization is not happy. And I am a liberal”. He also mentions the need to “urgently” relocate the production lines to France.
In 2022, the Observatory of Transparency in Medicines Policies (OTMeds) publishes a report entitled “Relocation of the pharmaceutical industry in Europe and in the Member States.” This observatory, which “ensure the implementation in France of the ‘Resolution on Transparency’ of pharmaceutical markets voted at the World Health Assembly in May 2019”doubts the effectiveness of relocations within the European Union.
The latter, within the current economic system, would occur “only under current market conditions, based on the principle of supply and demand” and would be “doomed to failure”. Shortages are likely to last well beyond 2024 or 2025.