Two years later, after high-profile scandals related to the supply of Frisium and other similar drugs, seriously ill children in Russia began to receive the drugs they needed.

Frisium (clobazam), diazepam and midazolam are potent psychotropic substances that have an anticonvulsant effect and are used for epilepsy.

According to the Ministry of Health, about 2-3 thousand children are in need of such drugs.

The turnover of these substances in Russia is limited, and their illegal acquisition, storage and transportation are prosecuted under Article 228 of the Criminal Code of the Russian Federation and can be punished with 15 years in prison.

At the same time, until recently, these drugs were not registered in Russia, analogues with the same active ingredients were not produced. 

Parents of seriously ill children risked their own freedom to get the drug they needed.

In 2018, a Muscovite Ekaterina Konnova was going to sell unused diazepam for her son Arseny in microclysters.

She was facing a prison sentence for drug dealing.

In July 2019, a Muscovite Elena Bogolyubova was detained at the post office while receiving a parcel with 400 Frisium tablets, which her son Misha needed in case of Batten's illness.

She said that domestic anticonvulsants are not as effective and have strong side effects.

A similar incident occurred in mid-August.

A Muscovite was detained at the post office while receiving "Frisium" for her child.

After the situation was reported in the media, the criminal cases against the three women were dropped.

11-year-old Misha Bogolyubov died on February 11, 2021.

Expedited registration

The stories of Ekaterina Konnova and Elena Bogolyubova caused a wide public outcry.

As a result, the State Duma amended the laws on the circulation of medicines, which concerned the import of unregistered medicines into Russia.

At the end of December 2019, Russian President Vladimir Putin signed the corresponding federal law, which allowed the import of such medicines into the country to provide assistance to certain categories of patients.

In 2020, up to 22 million rubles were allocated for these purposes.

On March 1, 2020, a new procedure for the import of unregistered medicines came into force.

To receive the drug, a decision of the medical commission was required that the medicines registered in Russia did not help the child.

“I had to get a special prescription, wait a long time for the medicine to appear in the only pharmacy, go there through the whole city, carry a passport, SNILS with me, wait an hour for it to be unsecured, and all this for the sake of five diazepam enemas,” Ekaterina recalls Konnova. 

In August 2020, the Ministry of Health in an accelerated mode issued a re-registration certificate for Frisium for a period of five years to the French company Sanofi.

The drug was licensed in Russia for over 20 years, but the previous registration certificate expired in 1997, and it was not imported under the procedure for unregistered drugs.

In addition, the procedure for the supply of drugs has been simplified.

They are no longer purchased according to a personalized list: the regional ministries of health themselves calculate the need for medicines for the next month or year and draw up a corresponding application. 

The entities completed the first procurement procedures for the acquisition of Clobazam under the new rules in June 2021.

Thus, Frisium became available almost two years after the high-profile detentions of mothers.

At the same time, since the beginning of 2021, a shortage of necessary psychotropic drugs has emerged in a number of Russian regions.

“The procedure for registering applications from the regions is rather long and complicated, since the import, storage and circulation of narcotic and psychotropic medicines is strictly regulated.

As a result, situations often arise when in one region there is not enough drugs, and in another there is an excess.

Lack of the necessary drugs forces people to bring them from abroad or buy from unknown sellers on the Internet, which is a violation of the law, and carries the risk of receiving counterfeit drugs instead of drugs, ”explained Russian Prime Minister Mikhail Mishustin.

Due to the shortage of drugs, by a decree of the government of the Russian Federation, the regions were given the right to exchange unused stocks of psychotropic drugs that are not yet manufactured in the country.

This scheme will be in effect until the end of 2023, while Russia will not establish its own production.

Lida Moniava, the founder of the House with a Mayak charity foundation, believes that such a mechanism was relevant when the drugs were unregistered and were imported from abroad.

“Let's say a child in one region was dying, and there were still drugs left for him that a child in another region needed, then there was a redistribution,” she explained.

- Now that Midazolam and rectal Sibazon (trade name of diazepam) are produced at the Moscow Endocrine Plant, this makes no sense, each region must order the required amount of the drug on time.

Frisium is purchased from a foreign manufacturer, but now it is registered in Russia.

There are also no problems with the provision of Frisium, if the application was submitted in a modern and correct manner. "

"I feel like I'm at war"

According to the founder of the House with a Mayak charity foundation, the situation with the receipt of Frisium, cheeky Midazolam and rectal Sibazon has really changed for the better.

“In Moscow, these anticonvulsants containing narcotic drugs and psychotropic substances can be obtained in one or two days,” says Lida Moniava. - The patient comes to a therapist or neurologist at the polyclinic, or at a non-state medical institution that is authorized by regional health authorities to issue prescriptions for narcotic drugs and psychotropic drugs. The doctor can also prescribe prescriptions for these drugs at the patient's home. The same scheme is used to provide anesthetic narcotic drugs, for example, fentanyl or morphine. "

“We had problems since December last year, and only in May I received an imported drug, apparently, the child left and was handed over to me.

Now there are no problems, I go to a neurologist, he writes out a prescription and they quickly give me the medicine at the pharmacy.

This is a very great achievement, ”notes Ekaterina Konnova.

However, the drug supply system did not work everywhere.

For example, Bogdana, the son of a resident of Ufa, Lilia Yumagulova, was not given to klobaz: he does not take "Frisium", but an analogue with the same active ingredient - "Urbanil".

“In February I received the last batch, a pack of 30 tablets is enough for 20 days. When I opened the last pack in mid-June, I started sounding the alarm. I contacted both the Ministry of Health of Bashkiria and the Moscow Endocrine Plant. It turned out that there were no applications for the drug from our region at all. As a result, I was given the remnants of the “Urbanil” that had miraculously remained in the warehouse. We have the medicine by the end of the year, it is not clear what will happen next. And if you haven't made an application for the next year? While the holidays, while swinging - and all this time the child will be left without medicine, ”complains Lilia Yumagulova.

A resident of Kursk, Tatyana Nikolaeva (surname has been changed

- RT

), also

encountered problems in obtaining drugs

.

For more than a year now, she has been unable to get diazepam for her son, who has epilepsy, and while the drug was in an “illegal” status, it was given out.

“The supplies stopped after they started producing it in Russia,” she notes.

- There is also no supply of clonazepam in the city, getting each pack is like a quest, all the time there are some obstacles.

My child is 11 years old, and all these years I feel like in a war.

So I sit and think that one box is over, the last one remains, and then what to do if it is not there again ... "

Stability at stake

“Of course, the situation has changed dramatically for the better. I would even say that we have made a huge breakthrough, ”says Ekaterina Romanova, head of the social and legal department of the House with a Mayak children's hospice in the Moscow region. The system of drug supply in Moscow is getting better faster, she says: "The level of knowledge of doctors in the capital is much higher, they know what drugs to prescribe and how to prescribe them correctly, they understand that there is no need to demand any decisions of the federal council, the level of the polyclinic is enough."

At the same time, even in the neighboring Moscow region, according to Ekaterina Romanova, the situation is much more complicated: “There are not pharmacies authorized to dispense drugs in every city, and some families have to travel to neighboring settlements to get medicine.

That is, there are drugs in the region, but these delays threaten the stability of its receipt. "

It's not that the question is that there is no money in the regional budget for medicines - they are not at all expensive (the price of 10-13 rubles per tablet appears in the government procurement of 2021.

- RT

);

there is rather a reluctance to understand the procurement algorithm, continues Ekaterina Romanova.

“Perhaps part of this can also be explained by the fact that drugs are still not in clinical guidelines, and some doctors simply do not know about the existence of such drugs,” she adds. “Accordingly, training, clarifying conversations is necessary, that is, neurologists must understand what to assign, what documents to require, how to write out and how to form an application to the local Ministry of Health, so that they, in turn, submit it for purchase.”

Unfortunately, drugs (from the former unregistered) have not yet been included in the VED list and not all patients in Moscow can get them for free, says Lida Moniava: “In addition, many patients have no grounds for preferential provision (for example, citizens of the neighboring countries), and Moscow purchased only subsidized drugs. It turns out that those patients who can get these drugs only for a fee are deprived of such an opportunity. "

Meanwhile, work on the liberalization of legislation regarding psychotropic drugs required for patients with severe neurological diseases continues. So, on the portal of draft normative acts regulation.gov.ru posted two documents. The first is proposed to double the "state quota for production, storage, import (export)" of clobazam from September 1 and for six years - from 10 thousand to 20 thousand gr. The Ministry of Economic Development and Trade approved the project as a whole, but due to the peculiarities of Russian legislation, it will be able to enter into force if it is adopted by the government of the Russian Federation no earlier than March 1 of the next year.

The second draft regulation proposes to “remove some control measures” in respect of including diazepam, clobazam and midazolam in certain quantities. If the document is adopted, then changes to the legislation lasting six years will start working from March 1, 2022.