Shortage of drugs: authorities put pressure on manufacturers

For several years, many drugs have regularly deserted the shelves of French pharmacies. To overcome these stock shortages – far from being limited to the national territory -, public actors are always in search of the miracle cure.

The National Agency for the Safety of Medicines and Health Products (ANSM) announced on August 8 the strengthening of sanctions against manufacturers from 1er october. In the viewfinder: French pharmaceutical companies have not taken sufficient measures against the shortage of certain drugs. “The amount of the penalties applicable to these breaches has been increased,” the ANSM said in its press release.

20% of turnover

In the event of insufficient stock, manufacturers will be subject to a fine of 20% of the annual turnover generated by the treatment. Sanction to which may be added a second fine, daily this time, for the duration of the shortage.

The current legislation has already been strengthened several times in recent years. Since September 2021, manufacturers must secure the supply by building up stocks for two to four months for so-called “drugs of major therapeutic interest” (MITM), for which the interruption of treatment puts the patient at risk.

Multiple causes

“The shortage of stocks is not solely the fault of the French manufacturer, insists Philippe Besset, president of the Federation of French pharmaceutical unions. This concerns the entire manufacturing circuit. »

A multifactorial phenomenon, the shortage of medicines has various causes: “There may be shortages in the active ingredient, the increase in world demand, accidents in the factories themselves or even an overbidding between countries to capture medicines at the best price”, list Philippe Besset, for whom the tightening of the sanctions announced by the ANSM will not therefore solve everything.

A persistent shortage

In 2021, the ANSM received 2,160 reports of stockouts and risks of stockouts, i.e. more than five times more than in 2016 (405 reports). “Anti-infectives, drugs for the nervous system and anti-cancer drugs are particularly exposed,” underlines the ANSM.

The ANSM updates in real time on its website the list of unavailable drugs, such as Methotrexate used in the treatment of certain cancers or autoimmune diseases or in difficulty of supply, such as paracetamol.

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