In Russia, there are not enough drugs for the relief of epileptic seizures in children. The shortage of the drug “Suksilep” (international non-proprietary name ethosuximide) produced by the German company Mibe GmbH was reported in two charitable foundations – “Tradition” and “Right Direction”. Tradition states that “dozens of families have stopped receiving the drug.” Currently, the foundations have received 192 requests for the need for the drug, and applications continue to come, writes RBC.
Representatives of pharmacy chains confirmed the absence of the drug. The shortage of the medicine is caused by the fact that for several months officials could not change the rules for regulating prices for it, and supplies became unprofitable.
Parents of children also complain about the absence of two other drugs for epilepsy – “Zarontin” and “Petnidan” (in both the active ingredient is ethosuximide). These medicines are not registered in Russia.
Etosuximide is included in the list of vital and essential medicines. According to the analytical company DSM Group, 96% of its sales in 2021 came from government purchases, and only 4% from retail. Compared to the first seven months of last year, in 2021, Suksilep sales fell by more than 55%. So, if for the specified period in 2020 the drug was purchased for 23.7 million rubles, then in 2021 – for 10.6 million rubles.
Since the drug is on the VED (Essential and Essential Medicines) register, the state sets a maximum selling price for it. The fact that a medicine is on the list of vital ingredients does not legally impose on the relevant ministries the obligation to always have it available, says Sergey Shulyak, general director of DSM Group. “The responsibility for the production of the medicine lies with the Ministry of Industry and Trade. The Ministry of Health is responsible for purchasing the medicine, but it can only influence the manufacturer through negotiations, ”he explains.
The company “Mosfarma”, which also plans to release “Suksilep”, reported that the corresponding registration certificate was received only at the end of July. The company will carry out the final stage of the production cycle – packaging the drug for retail sale. The drug will appear on the market by the first quarter of 2022 after passing all quality tests.
The Ministry of Health says that they are aware of the current deficit. They explained that the total need for the drug throughout Russia is about 24 thousand packages. The ministry sent this information to the Ministry of Industry and Trade to take measures to provide the Russians with medicine.
Roszdravnadzor noted that in 2021 in Russia, drugs with the active substance etosuximide did not enter civilian circulation at all.
Back in March this year, Mibe GmbH informed the department about the suspension of Suksilep supplies to Russia. According to Pharmimex JSC, which supplies Suksilep to the Russian Federation, their termination was caused by the impossibility of re-registering the manufacturer’s maximum selling price, which at that time was 1,699 rubles and was unprofitable.
The price for “Suksilep” was re-registered in July and fixed at 2,242 rubles. The Ministry of Industry and Trade noted that they are considering the issue of resuming supplies, taking into account the new price.
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