Prime Minister Philippe announced on Thursday the "strengthening of a number of sanctions" that can go up to one million euros against laboratories that do not anticipate enough the shortage of drugs. These sanctions will be introduced in the Social Security 2020 financing bill.
"The need to have exemplary behavior"
The head of the government said he wanted to "strengthen a number of sanctions that can be imposed when the information of the national agency is not sufficient, when it is too late or when the building of stocks is not to the height of the requirement and interest we detect "at a press conference. Édouard Philippe stressed "the need to have exemplary behavior" evoking a "difficult subject and raising concerns on the side of the French," after receiving a delegation Matignon companies in the field of medicine (Leem).
The Minister of Health Agnès Buzyn has detailed the three cases for which sanctions will be provided and which will appear in the PLFSS 2020. Manufacturers will now have to "increase the duration of stocks available on the national territory to alleviate any shortages" s' these are "drugs of major therapeutic interest or have no alternative". For these drugs, "two to four months of mandatory security stock" will be required, detailed Édouard Philippe on his Twitter account.
sanctions
Sanctions will also be provided in case of a stoppage of marketing if they have "not sufficiently informed the drug agency in advance" or if they have "not prepared enough alternatives in advance" . Finally, they will have to avoid "failures in risk management". Matignon then said in a statement that in the event of a break, "the company may be subject to a penalty for each day of break up to a maximum of 30% of the average daily turnover in France, within the limit of 10% of the annual turnover or 1 million euros.
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Reacting to the announcement of this plan, Frédéric Collet, the president of Leem, stressed that there were "already sanctions, especially on the information that must be given". "France is one of the countries with the widest regulatory framework around drug availability, we already have a very comprehensive arsenal, and I'm not sure that new sanctions would improve the situation," he said. he estimated with AFP.
Rising demand and a "tense flow" policy
The Minister of Health had already unveiled an "interim roadmap" which included the generalization in 2020 of a platform allowing pharmacists, among other things, to report supply disruptions to the laboratory concerned. Supply tensions for drugs have increased in recent years, due to multiple factors: rising global demand, selling prices of some treatments deemed unattractive by laboratories or intermediaries but also a "tense flow" to limit stocks, high concentration of production sites, sometimes located at great distances, in India or China ...
A quarter of the French have already been denied the delivery of a drug or a vaccine because of shortage, according to a survey published in January at the initiative of France Assos Health. And according to the National Agency for the Safety of Medicines and Health Products (ANSM), reports of supply tensions have been multiplied by 20 in 10 years, reaching 868 cases in 2018.