Where does it come from? In this new weekly meeting, Paris Match examines in detail a statement made by a politician. Today, a sentence from presidential candidate Arnaud Montebourg, who denounced the drug shortages on Saturday.
“It is in France that we lack 400 drugs, including even the famous paracetamol, out of stock” – Arnaud Montebourg, September 4, 2021, in Clamecy, in the Nièvre.
Wanting to be the champion of “made in France” that he praised so much when he was minister, Arnaud Montebourg gave several examples illustrating the deindustrialization of France on Saturday when he declared his candidacy in Clamecy, in Nièvre. Among the problems aggravated by the pandemic, he notably denounced the shortages of drugs. But in doing so, the former socialist has apparently underestimated the scale of the phenomenon.
The National Agency for the Safety of Medicines and Health Products (ANSM) closely monitors the supply difficulties for “drugs of major therapeutic interest” (MITM), those for which an interruption of treatment presents a danger to the patient. the patients. ANSM data show a very strong increase in the number of reports for stockouts and the risk of stockouts (the same drug can be reported several times): from 44 in 2008 to 438 in 2014 (year of Arnaud Montebourg’s departure from the government), then 2,446 last year.
Changes in the regulations explain part of this surge, first from 2012, with the entry into force of an obligation to report in 2012. More recently, the regulatory context has evolved in a more restrictive way for producers. , which has contributed to the increase in reports of shortages. The ANSM has been asking since last year “to declare the risks of stock-outs and stock-outs as early as possible”. In addition, financial sanctions against companies failing to comply with these obligations have been stepped up.
The phenomena of shortages are nonetheless real, and their consequences can be serious. “Between 5 and 10% of these reports to the ANSM require the implementation of measures to reduce the impact of the supply tension for patients: quantitative, qualitative quotas (for example reservation of stock for certain indications) or even imports of similar drugs from other countries ”, indicates the ANSM on its website.
In a study published in November 2020, the UFC-Que Choisir association stresses that the shortages do not only affect “presentations”, but also “international non-proprietary names” (INN). However, when an INN is the subject of a shortage, it is impossible to substitute a drug with another of a different brand (another “presentation”) but of the same composition. In 2018, 399 DCIs suffered a shortage, a figure similar to that stated by Arnaud Montebourg. The count was not available for the years 2019 and 2020.
According to the association, which studied a sample of drugs reported to be out of stock with the ANSM last July, the drugs most concerned are first the oldest and cheapest. They are also essential, since a clear majority of them are reimbursed at least in part, a characteristic linked, recalls the association, to “actual service”. “If all classes of drugs are affected by the ruptures, the three therapeutic classes most frequently concerned are anti-infectives (antibiotics), anticancer drugs and central nervous system drugs (antiparkinsonian, antiepileptic)”, further analyzes the UFC-Que Choisir.
The ANSM database, consulted by Paris Match on September 8, listed 64 drugs currently out of stock, 35 of which have been in this situation since at least April 19.
The case of paracetamol, cited by Arnaud Montebourg, has become emblematic. At the start of the pandemic, in spring 2020, this drug was rationed, while the French were building up stocks to deal with the coronavirus. Even if paracetamol is the flagship product of certain French laboratories under the names of Doliprane (manufactured by Sanofi) or Efferalgan (Upsa), production is currently very dependent on foreign suppliers. “The raw material, in fact, comes from abroad. It’s another job, that of a chemist. Ten years ago, it was Rhodia, a subsidiary of Rhône-Poulenc, which produced it. Today, we buy 85% of the active principle of paracetamol in the United States ”, explained in Paris Match in 2020 François Duplaix, boss of Upsa laboratories. The government has since announced its intention to relocate part of the production of the active ingredient to France and a plant should come into operation in 2023, to produce 10,000 tonnes of paracetamol per year, which will be absorbed by the production of Sanofi and Upsa.
Faced with the more general phenomenon of drug shortages, the public authorities have once again adjusted the regulations. Since September 1, the ANSM requires that laboratories constitute “a minimum two-month safety stock” for MITMs. In some cases, the ANSM may increase the safety stocks to four months. Laboratories may also request exemptions for this stock to be less than two months, for example for MITMs “whose shelf life is incompatible with the constitution of a safety stock of 2 months”.