In Russia, drugs for the treatment of cancer disappear. How do the authorities solve the problem and what do experts say?

Since the fall of 2019, doctors and representatives of charitable organizations complain about the disappearance of drugs from the Russian market for the treatment of oncological diseases, including onkaspara - the main drug for the treatment of all lymphoblastic leukemia. In February, Prime Minister Mikhail Mishustin proposed measures to improve oncological medical care and the availability of drugs.

“Such things” tell why foreign manufacturers of cancer recycles leave the Russian market, how experts evaluate the effectiveness of domestic generics and will be able to change the situation of Mishustin’s assignments.

Photo: pxher.com

Problems with drug supplies

In September 2019, dozens of tenders for the purchase of drugs necessary for the treatment of cancer were not held. Director of the Institute of Hematology, Immunology and Cellular Technology of the NSC DGOI named after Dmitry Rogachev, Professor Alexei Maschan in an interview with Novaya Gazeta , said that the problem is systemic: in the past few years, both unregistered drugs and registration have disappeared. According to him, foreign manufacturers leave Russia due to disadvantageous conditions, and there is no full import substitution in the country: domestic companies "do not produce drugs with which foreign ones have gone, or produce the wrong amount in which the country is needed, and not in the forms."

Ekaterina Chistyakova, Director of the Development of the Charitable Foundation “Give Life”, also spoke about the drug crisis in the Russian regions and the deterioration of the situation in the field of children's oncology. In her opinion, the regional clinics “do not want to contact” with the order and bring unregistered drugs to Russia through official channels, despite the purchase scheme developed in 2011 by the Ministry of Health.

Patients complained not only of the inaccessibility of original drugs, but also about the quality of Russian analogues. Professor Alexei Maschan stated that due to the inefficiency of the domestic drug “Asparaginaz”, the number of relapses of acute lymphobia leukemia increased, and Winkristin has severe side effects. In February, the community of Russian oncologists asked the Ministry of Health to improve the supply of drugs for children with cancer, purchase original drugs instead of generics and accelerate registration of vital drugs with proven effectiveness. According to oncologists, medicines should be purchased by trade names, and now the medical institutions are acquiring the cheapest drugs, mostly Russian.

The Ministry of Health named the use of reproduced drugs with a common practice, which allows "to increase the availability of drug therapy while maintaining its quality." The department also said that interruptions in the provision of drugs for leukemia therapy occurred due to the temporary cessation of the supply of pharmaceutical substance of the citizens, on the basis of which several drugs are made.

Ekaterina Chistyakova told “such matters” about an acute shortage of onkaspara in Russia - the main drug for the treatment of all lymphoblastic leukemia. The problem arose due to the fact that since 2018, the rights to Onkaspar moved to the French pharmaceutical company Servier, and the drug in Russia has gone to re-register. In February , it became known that Servier began preparation of the registration dossier on Onkaspar. “How much time will the process of re -registration take, we don’t know, even up to two years. Therefore, funds and parents have to purchase an unregistered analogue of this medicine abroad, ”Chistyakova explained.

Ekaterina Shergova, director of the Life Foundation, noted in a conversation with TD that onkaspar will be registered in Russia again no earlier than 2021. Therefore, philanthropists began to “sound the alarm” and publicly appeal to the government with a request to take some steps to provide children with medicine during re-registration.

According to Shergova, the medicine needs two thousand children with acute leukemia and their treatment without "onkaspara" is impossible

Funds are trying to help: for example, 800 thousand rubles are being collected for the treatment of a boy from Mari El - the existing analogues of the drug are not suitable for him. But philanthropists cannot provide medicines with medicines - this is an additional load of more than 300 million rubles a year.

“If we focus on the statements of the Prime Minister, we, doctors and parents of sick children, finally heard. We hope that the promises will be fulfilled, the first batch of medicine will be imported by the state in the country in the near future, ”said the director of the Life Foundation.

Mishustin's instructions

On February 14, Prime Minister Mikhail Mishustin gave instructions for improving oncological medical care and the availability of drugs. Until March 12, the Ministry of Health, the Ministry of Industry and Trade, the Ministry of Finance, the Ministry of Economic Development and the Federal Antimonopoly Service must submit proposals for the cancellation of restrictions on the purchase of foreign drugs (they are provided for by the Government Decree of November 30, 2015). The founder of the Hospice Fund “Vera” Nyuta Federmeser, in a conversation with RBC, called this decision the abolition of “dragon measures”. In her opinion, the Cabinet Resolution of 2015 was designed to stimulate the development of Russian pharmaceuticals, but this did not happen due to a lack of competition.

Until March 14, the Ministry of Health should compile a list of drugs for the treatment of cancer, which can be purchased by trade names. The program director of the Higher School of Oncology (VSU) Polina Shilo considers the compilation of such a list a good idea, but is afraid that it can be composed formally. To prevent this from happening, she believes, the Ministry of Health needs to be involved in work on the list of unregistered drugs of experienced experts, chemotherapists, oncologists, and heads of departments of large hospitals, " who in the daily regime have the case . "

Mishustin also instructed the Ministry of Health and the Ministry of Finance to prepare proposals to provide patients with the same drugs in both the hospital and on outpatient treatment. The administrative director of the Advita Foundation Elena Grachevacalled this decision the Ravilny: now the hospital can purchase one drug, and the region for its clinic is another.

Gracheva also called an important opportunity to use drugs in the treatment of children's oncology, which are prescribed off-lab (according to indications not approved by state regulatory authorities not mentioned in the instructions for use). “There are a lot of cases when the medicine was invented to treat one disease, but it turned out to be effective with another. This is a very important story: to quickly and freely begin treatment with a medicine that is not registered or registered for something else, but world experience has already shown that it works, ”she explained.

Comparison of generics and original drugs

The most unsuccessful experts call the proposal of Roszdravnadzor to compare original drugs and Russian generics. As Nyuta Federmeser noted, "Roszdravnadzor is also a structure inside the system, and the system is not interested in identifying any violations in itself." This is evidenced by Polina Shilo, and also draws attention to the problem from the point of view of clinical trials.

“ In order to say that generics are the same as original drugs, the Roszdrava needs to conduct Non-inferiority-huge studies for each generic. Conditionally, you need to take a thousand people who will be treated with original drugs, and a thousand people to test every generic. These studies must be large, otherwise the difference from the point of view of statistics cannot be proved. Everything that is carried out is not so is a little profanity from a scientific point of view , ”says the speaker.

According to her, for such large-scale research, a lot of money needs a lot and the manufacturers may simply not have it. Therefore, Shilo says, all checks and comparative tests will most likely be formal. “ The most unpleasant thing is that few people will understand it ,” the expert believes.

Shilo also noted that there is no unequivocal answer about the quality of Russian generics: one cannot say that they are generally ineffective. “ Using generics, we never know for sure whether they work just like an original drug ,” says Polina Shilo. In this case, everything rests on clinical studies again: in order to confirm that generics work in the same way as original drugs, you must again conduct large studies financed by the company, the manufacturer of generic.

"You cannot postpone for later"

Polina Shilo notes that interruptions in the supply of drugs were before, but "not as serious and catastrophic as now." The problem was more affected by children's oncology, although there are problems in the adult, she says.

“ We have the biggest problem with“ carboplatin ”, and the drug is quite widely used. For example, for the treatment of gynecological diseases: uterine body cancer, cervix, ovaries, breast cancer. It is also used in some lung cancer schemes. It is both foreign and Russian production. So, for four months of foreign “carboplatin” there are no foreign “carboret, because foreign pharmaceutical companies have taken it from the Russian market ,” said Shilo.

According to her, the problem is largely related to the complex Russian public procurement system. Foreign companies are not very willing to conduct even clinical research in Russia " just because of the attitude to business . " Due to problems with deliveries, says Shilo, patients do not receive treatment on time, which affects its effectiveness.

“ Time is the most important resource for patients. For tumors of different localizations, of different types of cancer, their terms-in some cases, you need to start treatment within a day, in some cases you can delay for a couple of weeks. You need to start on time. The treatment of cancer is not something that can be postponed for later , ”says the expert.