the discomfort of generic producers

the discomfort of generic producers

Essential medicines but abandoned because they are not very profitable, and worsening shortages: generic manufacturers are worried about an economic model which is running out of steam and seems to them to be incompatible with health sovereignty.

To combat supply problems, the French Biogaran, generic laboratory of the Servier group, has decided to increase its minimum security stocks of medicines, going from 3 months to 3.5, even 4 months on all of its 900 references.

This is more than required by the French health authorities, which set the stocks for drugs of major therapeutic interest (MITM) at two months – even four months in rare cases.

“We made this decision because it is increasingly difficult to forecast demand, and we anticipate a complex year 2023, as manufacturers have difficulty receiving inputs” (components: editor’s note), explains to the AFP Jérôme Wirotius, CEO of Biogaran.

But inventory is only part of the problem. Manufacturers point the finger at the low price of so-called mature molecules, whose patent has fallen into the public domain, and which have often been neglected by large laboratories in favor of much more expensive drugs.

If the phenomenon is global, the prices set by the health authorities in France are, they say, particularly low.

Thus, a box of antibiotics is sold for a few euros: far from the treatments of tens of thousands of euros reimbursed by health insurance, or which can exceed one million euros in the case of gene therapies.

“A bottle of pediatric amoxicillin is sold for 76 euro cents: with inflation, for each bottle sold, we lose money”, specifies Jérôme Wirotius.

According to a recent study by the French association of generic manufacturers, Gemme, France would even be the least profitable country of the main European markets for the pharmaceutical sector (behind Great Britain, Spain or Germany in particular) .

– Export –

Faced with this, “the State manages the shortages”, irritates Alexandre Williams, the CEO of the pharmaceutical manufacturing laboratory Inpharmasci. “But upstream, there is this price problem,” he judges. “If they want to survive, French manufacturers must export”.

The entrepreneur cites in particular the case of a drug that he produces as a subcontractor. This one, sold for around 5 euros in France, costs 50 times more in the United States.

“Some international laboratories will take the decision to favor other countries in the face of low prices in France”, agrees Jérôme Wirotius, of Biogaran, which sells almost all of its drugs on the French market.

In Germany, where the problem of shortages also arises, the government recently decided to raise the price of certain molecules. A total of 180 drugs will be affected for three months.

A temporary solution favored by the leader of Biogaran, who alerted the State and sent a list of 160 essential molecules manufactured in France and “for which we have gone into negative margin”, while inflation is fueling the costs of production.

French manufacturers are also demanding to no longer be subject to the “safeguard clause”, a tax mechanism which concerns both very expensive innovative drugs and those sold for a few cents. And which could, they judge, strongly harm health sovereignty.

If this safeguard clause was maintained in the last social security budget, the government has also invested – since the pandemic – in the relocation of drugs, with support for many pharmaceutical companies, in particular to repatriate the active ingredient. paracetamol.

The government is “fully mobilized”, specifies to AFP the Ministry of Health, which “studies all the avenues allowing to take appropriate measures in the matter”.

“We must be in a logic of anticipation rather than reaction”, estimates David Simonnet, CEO of the group of active principles Axyntis, which benefited from State funding to repatriate the active principles of norepinephrine and adrenaline.

But once it has been decided to manufacture a molecule again, “it takes two to three years”, he recalls, also stressing the importance of support from the public authorities.