François Braun spoke on Monday of a list of “critical” drugs that the government is establishing to limit the risk of shortages. There is already a list of “drugs of major therapeutic interest”.
On the site of the National Agency for the Safety of Medicines (ANSM), the lines “supply tension” follow one another to those displaying “out of stock”. This establishment dependent on the Ministry of Health lists the drugs of major therapeutic interest (MITM) currently subject to supply difficulties.
On Monday, François Braun declared on RMC-BFMTV that his ministry was in the process of “finalizing”, with “all medical specialties”, a list of “essential drugs”, also called “critical”, for the month of May. .
According to our information, this list is drawn up jointly by the General Directorate of Health, with the ANSM and the learned societies of doctors.
After the establishment of this list, the authorities will have to “define all the manufacturing points” of these drugs, from the active ingredient to the bottling, detailed the Minister of Health. The objective is to “control the entire production chain” and thus “ensure that these essential drugs will always be available”.
A stock obligation of at least two months for MITMs
What is the difference between “critical” drugs and “drugs of major therapeutic interest”? MITMs are defined in the Public Health Code as “drugs or classes of drugs for which an interruption of treatment is likely to jeopardize the vital prognosis of patients in the short or medium term, or represents a significant loss of opportunity for patients with regard to the severity or evolutionary potential of the disease”.
Since September 1, 2021, pharmaceutical companies have been required to build up a safety stock of at least two months for MITMs. However, as the ANSM website shows, some MITMs are indeed affected by stock shortages.
François Braun assured Monday that “there is no medicine in absolute rupture”, but medicines “in tension”, with “less than a month of stock” and which we “cannot find in all the pharmacies”.
“Critical” drugs would be a sub-category of MITMs, with stricter criteria, the Ministry of Health told BFMTV. “To this list will be attached an analysis of the risks in terms of supply, and the necessary corrective solutions”, explained in February a press release from the ministries of Health and the Economy.
“The management rules can range from a reminder of good use, to the constitution of stock, or even to reindustrialization”, specifies the cabinet of the minister to BFMTV.
Several causes of the shortage
The drug supply problems that France has been experiencing for several months have several causes. François Braun explained for example on March 1 to the National Assembly that amoxicillin has “suffered from a very strong cyclical demand due to the meeting of several winter epidemics”, while this antibiotic is not effective once morest bronchiolitis. , the flu, Covid-19 or nasopharyngitis, reminds the ANSM on its site.
This increase in demand was associated with “insufficient anticipation by manufacturers, the health crisis having caused a drop in consumption by the population for several consecutive periods”, added François Braun at the beginning of March.
A report submitted to the government by a strategic mission dedicated to this subject pointed out in 2019 the role of supply disruptions in active ingredients in these shortages. These substances necessary for the manufacture of medicines are mainly produced outside Europe, which makes France dependent on countries such as India and China.