Unequal exchange: what will save drug-free patients

Russian patients have turned into laboratory rats and mice, on which experiments are carried out in Russian “maybe”

In the coming years, the Russians will face an increasing shortage of drugs, experts say.

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Back in October this year, at the XIV International Scientific Congress “Rational Pharmacotherapy” held in St. Petersburg, the ARFP General Director Victor Dmitriev statedthat in 2020 the situation with drug supply in the country will worsen.

According to him, the optimal model of drug supply in the country has not been created in recent years. “At the same time, the regulators of the system are countless, and each has different goals and different performance criteria (KPI),” he adds.

Since the beginning of 2019 alone, 900 applications have already been submitted from foreign manufacturers to withdraw their medicines from the market.

“In July of this year, the relevant department of the Ministry of Health and the Duma Health Protection Committee confirmed to us the information that 700 drugs are in the application for withdrawal from the Russian market. In particular, Japanese companies have warned about leaving the Russian Federation. A little later, Andrei Isaev, the first deputy head of the United Russia faction in the State Duma, reported about 900 foreign-made medicines leaving the Russian market, ”- wrote a member of the Federation Council on his Facebook page Anton Belyakov.

Patients and doctors have been ringing all the bells for a long time, but the Ministry of Health does not seem to hear these screams, limiting itself to “formal replies” that the department will figure everything out and everything will be fine.

The department was somehow obliged to react, because all last week in Russia parents of children suffering from cystic fibrosis went out to single pickets. They demanded the return of well-proven foreign antibiotics to circulation and not to prescribe generics instead.

And how to get them back if they are simply no longer shipped.

“They simply are no longer there and, apparently, will not be. Over time, there will probably be new analog drugs, but is there time, and will patients be able to adapt to new drugs? The problem lies not only in the mass withdrawal of proven foreign drugs, to which, by the way, the organism of very vulnerable patients adapts, but also in the fact that even generics that are often rejected by the body (analogue drugs containing the same active ingredient, but not necessarily analogous to the original on action) in full, all regions are not provided “, – writes Belyaev.

But first things first. Our department assures that generics are an excellent way out.

So, the chief freelance specialist, clinical pharmacologist of the Moscow Department of Health, Deputy Director of the Center for Clinical Pharmacology of the Scientific Center for the Expertise of Medicinal Products of the Ministry of Health Marina Zhuravleva told the publication Medvestnik.ru, which does not see a problem in the exclusion of a number of drugs produced by foreign companies from the GRLS.

“All of these drugs in the form of an international non-proprietary name are present in the GRLS, the approved instructions for their medical use have been promptly extended.” For example, according to her data, Avonex has at least 3 analogs, 25 drugs with the INN imatinib are registered, and 4 companies produce stavudine, ”the publication quotes Zhuravlev.

However, the problem with generics is that their effectiveness is unknown. This is a kind of “pig in a poke”. “The manufacturing company is not obliged to completely repeat the cycle of clinical trials, because it copies the drug. How effective and safe it is is being learned, as they say, empirically, ”she said. RIA Novosti Administrative Director of the AdVita Charitable Foundation Elena Gracheva.

Thus, Russian patients, thanks to the “wise” policy of the state, have turned into laboratory rats and mice, on which experiments on Russian “maybe” are carried out … What if this particular drug will work here.

But it doesn’t work, and everyone was under attack. First of all, patients with severe and chronic diseases such as oncology, diabetes, cystic fibrosis.

The same RIA Novosti leads a whole series of patient stories, one more terrifying than the other. “This summer, instead of Fortum, I was given a non-original drug. And all two weeks, while I was taking the course, I was tormented by terrible vomiting. In addition, the temperature rose, I felt drowsy, and there was a nasty taste in my mouth – as if you had eaten slop before, ”a 21-year-old patient with cystic fibrosis told the agency.

“According to the protocols, we were prescribed the anticancer drug Vincristine. The first three courses injected Romanian – everything was fine. And this time they put on the Russian one. On the seventh day after the first injection, Bogdan was unable to get up. He developed severe joint pains. Neither pain relievers nor massages helped. He shouted: “Mom, let them cut off my legs, I can’t do this anymore,” the mother of a small cancer patient from the Krasnoyarsk Territory told RIA Novosti.

But the mother of an eight-year-old boy with primary immunodeficiency was afraid to give the child an untested Russian drug, which, for some unknown reason, was sent instead of the recommended foreign-made drug.

“He was supposed to undergo therapy with foreign immunoglobulin. But from the Ministry of Health they sent there … a domestic one. “How do you know what will not suit you, you haven’t tried it yet,” says Irina. “Can you imagine my shock? Naturally, I immediately called the republican hospital, they promised to instill us with a foreign drug. However, the place was only a week later. “

Her son did not survive these seven days – he fell into a coma, and five days later he died in intensive care. “Our patient organization of patients with primary immunodeficiency appealed to the Investigative Committee. It turned out that the doctors from the district hospital had indeed sent the documents for the foreign drug to the Ministry of Health. It is still not clear why they sent the domestic one, ”RIA Novosti writes.

As a result, the Ministry of Health was forced to admit the problem. In the department promised “To discuss with pharmaceutical manufacturers the issue of ensuring sufficient supplies of original medicines to the domestic market”. Patients will be asked for information on all adverse reactions to generics …

Well, you get the idea – we stubbornly “go our own way.” Director of the Department of Pharmaceutical Provision and Regulation of Circulation of Medical Devices of the Ministry of Health Elena Maksimkina at the briefing on December 4 explainedthat it is thanks to generics that it is possible to reach a greater number of patients with treatment.

She also assured the public that the ministry is also negotiating with manufacturers whose drugs are leaving. So, according to her, the MSD company allegedly completely stops the production of the antibiotic Tienam, and the problems with antibiotics Fortum and Kolistin are connected with the fact that the manufacturer “makes changes to the registration dossier and this is connected with the suspension of supplies.”

The experts are not so optimistic. They indicate that the withdrawal of foreign drugs from the domestic market has not begun yet.

“Even before that, the withdrawal from the Russian market in 2017 of oncological drugs“ Medak ”(“ Medac GmbH ”, Germany) was a disaster for Russian oncology. The company supplied to Russia “Asparaginase” – the main drug for the treatment of lymphoblastic leukemia. It is not yet possible to replace it with a Russian analogue. And this is not the only drug that Medak has withdrawn from Russia. From 2017 to 2018, at least somehow this “hole” was closed by “Trela”, but it also stopped working in Russia in 2018. Big problems with the supply of cytosar (cytarabine) Swiss Sandoz (a subsidiary of Novartis) – the main drug for the treatment of acute myeloid leukemia. Reduced supply of cytarabine and Pfizer.
For a long time in Russia there is no oncaspar – a drug that is prescribed for acute lymphoblastic leukemia, if the patient has an asparaginase intolerance.
For cardiologists, the withdrawal of the drug Atenolol Nycomed from the Russian market was a shock. The Japanese pharmaceutical company Takeda announced after April 2019 that it had stopped supplying it to the Russian market, ”writes Belyakov.

The reason for this situation, according to the General Director of ARFP Victor Dmitriev, is the “price press”. “Sometimes the auction price is 80% lower than the cost price. At the same time, the manufacturer can raise the cost of drugs from the VED list by no more than 10%. As a result, drugs that are not included in the list will rise in price, and if all drugs produced by a pharmaceutical company are included in VED, then the manufacturer will simply stop their production, ”he says.

“Sadly, the production of drugs is the same business as any other. And almost nobody cares about the moral aspect here. The unreasonably low initial maximum contract price established by the new rules has led to the fact that it has become simply unprofitable for many foreign manufacturers and providers to import drugs into the country at fixed prices, he echoes Belyakov… – But there is another side of the coin: for foreign companies producing medicines and substances, the most attractive, of course, is the segment of state purchases. Only now from state purchases even many “whales” of the world pharmaceutical production were thrown out in Russia. And here, as I see it, a very ill-conceived, sometimes corrupt, import substitution system made its contribution.

The public procurement system for providing state and municipal needs with drugs from the list of vital and essential drugs, with the principle known as “extra third”, obviously does not work. The Resolution No. 1289 adopted in 2015 by the Government of Russia “On the establishment of restrictions on the admission of foreign medicinal products in public procurement” provides that the state customer must reject all applications containing proposals for the supply of medicinal products originating from foreign countries (with the exception of the member states of the Eurasian Economic Union (EAEU)), provided that at least two bids have been submitted for participation in determining the supplier, which meet the requirements of the procurement documentation and contain proposals for the supply of medicinal products, the countries of origin of which are the member states of the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Armenia and the Kyrgyz Republic). Roughly speaking, if there are 2 Russian bidders, then a foreign manufacturer, except for manufacturers from the listed countries, is not even allowed to participate in the tender. “

What is the output left for foreign pharmaceutical companies to do? They simply stop unprofitable deliveries, taking into account the loss of the Russian market, its production.

Is Russia now ready for the mass withdrawal of foreign drugs? Obviously not. The necessary drugs are imported according to “gray” schemes or even purchased from veterinarians.

And both patients and doctors who are forced to work in conditions of a shortage of drugs with all the attendant risks become hostages of this situation.

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