Frisium is an anticonvulsant drug not registered in Russia. It is used by patients with epilepsy. In Russia, there have already been several cases of detention of mothers of sick children who tried to illegally buy this medicine. After a public outcry, the women were released, and the Ministry of Health promised to resolve the issue of drug registration and purchase.
However, new obstacles have arisen, due to which patients may never receive the necessary drugs, said Lidia Moniava, director of the House with a Lighthouse foundation.
Lydia Moniava Director of the House with a Lighthouse Foundation “Despite all the promises that the drug is about to be purchased, to date none of the children have received any medicine, and their parents continue to buy Frisium, Diazepam in microclysters and other drugs for the treatment of epilepsy illegally on the black market. This means that with each new purchase, a new criminal case may be initiated against these parents. The situation on the black market is also bad now, because against the background of all this hype, many resellers got scared, left the market, it became much more difficult to buy the drug, now it costs two or three times more - in general, it is becoming more and more difficult for parents to provide children. … As for the official procurement, we expect the drug to be imported at the end of October, but the problem is that it will be possible to obtain it only on the basis of extracts from federal councils, medical commissions, that is, medical documents. Today, 90% of patients do not have these documents, and so far there is no really working mechanism for how they can draw up these documents. In the city of N, a mother comes to the clinic and says that her child needs Frisium. The polyclinic answers her: “We don't know anything, we don't know such a drug. We don't know how to help you. " It is not clear where further this mother should go. And while there are no clear explanations from the Ministry of Health and there is no really working mechanism, we think that at the end of October, when the drug is imported into the country, only 10% of children will be able to receive it."
Elena Bogolyubova, whose child has epilepsy, had a consultation almost a month ago, but, according to her, the main problem is to transfer these documents to the Ministry of Health.
“We passed the consultation and received an official conclusion that the child needs the drug Frisium. In principle, it was not so problematic, in contrast to the transfer of this council with a certain package of documents to the Ministry of Health. They sent them electronically from the district polyclinic by mail, sent a package of documents from the hospice - there was silence in response. Then they requested at the beginning the original of the council, then a notarized copy, but the notaries did not certify such originals, because they were not numbered and not stitched. Such councils in this form, at least in our case, have never been drawn up for 15 years. Then, when we finally found out that maybe we would certify a copy in the district clinic with seals from the doctor and the head physician, because we cannot give the original, because it is valid for a year, and there are no guarantees that we will be provided with the drug for a year. … When, nevertheless, we agreed that the document certified by the seals in the clinic would suit me, I took the document to the Palliative Care Center so that it could be handed over to the Ministry of Health. And it is not clear there, maybe the Ministry of Health now requires originals anyway. It seems that there is no clear procedure at all. What is needed, what document, in what form to provide the Ministry of Health, and in what time frame they will provide drugs, it is generally unclear."
The Ministry of Health collects information on the need for unregistered drugs in all regions of the country.All children in need of "Frisium" will be fully provided, the press service of the ministry said on September 23.
Health Minister Veronika Skvortsova previously announced that the registration procedure for Frisium will take place in an accelerated mode without clinical trials. The international pharmaceutical company Sanofi, which produces the drug, will submit an application for registration in Russia within a month.