Russian charitable foundations published an open letter in which they spoke about the lack of drugs for the treatment of patients with cancer. The letter is addressed to Russian President Vladimir Putin, Federation Council Chairman Valentina Matvienko, State Duma Chairman Viacheslav Volodin and "other legislators and officials." It was signed by the actor Konstantin Khabensky's charitable foundation, the Gift of Life, AdVita and Enbi funds.
"According to the results of a survey of representatives of medical institutions in 80% of the country's regions, conducted by the National Medical Research Center of Hematology, Russia has a critical shortage of 26 essential anticancer drugs, including vincristine, etoposide, daunorubicin, mitoxantrone, idarubicin, methotrexate, cytarabine, carboplatin, and others, "the letter says.
According to charitable organizations, vincristine and etoposide are absent in hospitals in the Bryansk, Sverdlovsk, Volgograd, Murmansk, Tambov, Tula, Ulyanovsk, Tyumen, Chelyabinsk, Kaliningrad, Rostov regions, as well as in the Altai and Khabarovsk regions.
As noted by the funds, the shortage of drugs is associated with a decrease in their production.
According to the drug registry data, vincristine is produced in Russia by three companies - the Blokhin National Medical Research Center (NMRC) of Oncology (Vinkristin-RONTs), the Israeli company Tev (Vinkristin-Teva) and Veropharm (Vero-Vincristine ").
As Ekaterina Shergova, the head of the Give Life Foundation, explained to the Pharmaceutical Bulletin, now only NMIC produces vincristine in Russia.
Tev confirmed that since March 2019, "the import of the medicine was forcedly suspended." The importer found itself "at a disadvantage, as a foreign manufacturer, due to the peculiarities of the public procurement system," writes Mediazona.
"Pharmaceutical Bulletin", citing data from the analytical company RNC Pharm, wrote that from January to May 2020, vincristine in Russia was produced only by the Blokhin National Medical Research Center. In total, the company shipped only 34.7 thousand packages to the market, while the annual demand for vincristine is 160-200 thousand bottles.
The authors of the letter confirm that one company cannot meet all the demand for this drug. "The current situation with the provision of medicines is a direct threat to the life and health of millions of Russian cancer patients, including tens of thousands of children. We believe that it is necessary to take urgent measures to eliminate the acute shortage of cancer drugs," the letter says.
Charitable foundations demand to organize urgent procurement of drugs "with which the most difficult situation has developed" and distribute them to hospitals, revise the procedure for forming the initial minimum contract price and completely abolish the "extra third" rule when it comes to drugs for cancer patients.
Let us remind you that the “extra third” rule was introduced by the Russian bureaucracy as part of the import substitution policy, which became a response to international sanctions after the annexation of the Ukrainian Crimea in 2014. Government decree N 1289 of November 30, 2015 in Russia introduced restrictions on state purchases of foreign-made medicines.
When purchasing medicines included in the list of vital and essential medicines (VED), state and municipal customers are required to reject applications offering medicines produced in countries outside the Eurasian Economic Union (EAEU) if at least two applications have been received offering a medicinal product with the same international non-proprietary name (or, in the absence of one, with the same chemical or grouping name), originating from the EAEU countries.At the same time, the EAEU includes only Russia, Kazakhstan, Belarus, Kyrgyzstan and Armenia.
Doctors have sounded the alarm, actively seeking the abolition of the "third excess" rule, at least since the beginning of 2020. At a meeting of pediatric oncologists from 71 regions of Russia on January 24-25, 2020, it was noted that the deterioration in the quality of available drugs has already led to a decrease in survival: for example, in recent years, the frequency of relapses in acute lymphoblastic leukemia (this is the most frequent cancer in children) has increased from 4 % to 15%, and about 100 children die a year who could be cured.
In February, 160 oncologists and hematologists in a collective letter pointed out the side effects and adverse reactions that occur in children when generics are used in therapy. Doctors asked for permission to purchase medicines for children according to the hematological and oncological profile by trade name instead of purchases by the international non-proprietary name (INN).
Following a meeting with Prime Minister Mikhail Mishustin, instructions were given to improve cancer care, including a proposal to work out the issue of lifting restrictions on the purchase of a number of drugs, RBC wrote.
As noted by the deputy general director of the NMITs Alexei Maschan, Mishustin, together with Deputy Prime Minister Tatyana Golikova, managed to convince the Federal Antimonopoly Service and the Ministry of Industry and Trade of the need for changes. “The presence of foreign manufacturers and the ability to purchase [drugs] from them are fundamentally important for us, because Russian drugs have their own shortcomings in quality, dosage forms, etc. But nevertheless, there remains the issue of competition in terms of the minimum contract price. we will fight for our children, "Maschan said.
De facto, medical institutions now have the opportunity to choose a specific drug and purchase it, Yuri Zhulev, co-chairman of the All-Russian Union of Patients and a member of the expert council of the State Duma Committee on Health Protection for Rare Diseases, explained to RBC. "The doctors noticed that the treatment results worsened, there was dissatisfaction with analog drugs, and the" third extra "does not take into account the features that affect the effectiveness of treatment. I have no doubt that this decision will give a signal for discussion and, possibly, a change in the system as a whole, but we need to see how it will work for some time, "Zhulev added.
At the same time, experts began to pay attention to a more serious problem than just the low quality of domestic drugs. There was a threat of drug shortages. As Irina Borovova, President of the Hello Cancer Patients Association, said, many drugs left the market because of the "third extra" rule, as manufacturers were not satisfied with the terms of the auction. "Immediately after the original manufacturers left the market, the price of an analogue increased several times. Of course, the Russian pharmaceutical market should develop, but foreign manufacturers should also remain on the market. Pediatric hematology oncology is a very sensitive area, such patients urgently need treatment due to acute conditions, and no time to wait, "she warned back in August. Since then, the problem has only worsened, and the professional community is forced to again turn to the country's leadership with a demand to take urgent measures.
"If urgent action is not taken, the resulting shortage of drugs will soon lead to the death of thousands of people and throw Russian oncology back decades," the representatives of charitable foundations said in an open letter.