Submitted to the state Duma a bill banning the imports of us pharmaceuticals plunged a significant part of the population of Russia in shock. MPs said that many of the medicines we produce are not worse than the Americans and can easily reject them. Vice-speaker of the state Duma Pyotr Tolstoy generally advised Russians to be treated by the bark of oak or hawthorn. Later, however, began to make excuses and say that it was a joke, but we are not joking. Experts believe that the refusal of the us drugs may lead to disaster — replacement of original drugs will be cheap, low quality counterparts.
In the list of drugs that may fall under the ban — 140 brands. Among them are many well-known drugs (antipyretic, laxative, used in diseases of the joints, high blood pressure, impotence problems, etc.), but there are drugs prescribed for Oncology, orphan diseases, cystic fibrosis.
Patient organizations are sounding the alarm, arguing that the sanctions fall the majority of patients with hepatitis, Oncology, rheumatoid arthritis, epilepsy. League of protection of patients is collecting signatures for a petition about the inadmissibility to prohibit the importation of drugs on .org. Some days it was signed by over 140 thousand people. The state Duma is to consider going back on may 15.
And these sanctions are first and foremost for our people, — said Elena Grigorenko, an expert Agency for examination and analysis of the pharmaceutical market “Signum market access”. — You can prohibit American sodas, it’s too bad, but no one will die, but with drugs it’s different. In these very thin areas as Oncology, Oncohematology, especially children — it can lead to tragic consequences. And to become a country of sales of substandard drugs from India and China — also do not want.
Quickly enough to the news to react Chinese, Indian, African producers will try to enter our market with their products. Already a third of the country intensified. That doesn’t always mean worse quality, but always much lower liability for drug and patients. Their task is to register the medicine and sell, and observational studies, they have, as a rule, not lead. Because they are generic manufacturers, not the original developers.
“SP”: — And drugs-analogs — generic — what is so bad? There are experts who say that the formula is the same, nothing!
— For example, you have a lip formed herpes. You go to your pharmacy and you, as usual, they ask: you the drug cheaper or more expensive? You buy a cheaper one (Russian or Belarusian counterpart), and for a week the herpes is, but if you bought the original drug, herpes would be held for 3 days.
“SP”: — Why?
Because when a company invents a new molecule is very long and very expensive, and they always have something new. And when then starts to produce analogues of the formula I repeat, and know-how no one can crack. Therefore, the original drugs less “side effects” and the higher the efficiency.
And the second point, which we decided not to speak. When you produce a generic, he’s given up on testing the Ministry of health, they check its quality — in large numbers, in all methods. But then it starts selling. And then someone monitors what is happening — and of what substance he is made of? Nobody knows! We have conducted control of each imported series only in appearance and packaging. Serious drugs examined several samples of the party. But this is not for all. And if it is produced here — especially not such a strong control.
For example, the case of one Indian company that makes antibiotics. In Moscow and St. Petersburg, it sells a quality product, and for the Ural poor. Imagine: children with pneumonia inject the drug, and it doesn’t help — it’s easy cut! And when they began to look for the cause, it became clear that the hospital rules were to purchase the cheapest product and the cheapest was this Indian generic. Moreover, it is not fake, not counterfeit, just there not reported 10% of the active substance. For drugs like ascorbic acid is not that important, but when it comes to antibiotics, oncoimmunology — it’s scary!
No one will tell you that generics are bad, they are all over the world. But it is necessary to establish control, so the generic is not hanging within the 20% margin of error. For drug it very much.
“SP”: — the American and European manufacturers and other quality standards?
— Of course! Their plants are also located throughout the world, but there are standards that they follow. Because in America and Europe decided to sue corporations if something went wrong. Of course, it happens that they slip up — but the frequency is much less.
I’m worried — if this ban is introduced, there will be nothing to treat children transplanted — and this is very bad. We will again ask all those who travels abroad to bring the drugs. Our country at all its strange rules — for example, on compulsory licensing, when throughout the world, has a patent on the drug, and we have — we just may cease to be interesting here this highly innovative Pharma. And we are left without access to the latest developments. Will wait for your own? But I guess it will happen not in our life. And I would like now.
“SP”: — the Doctors say that many modern drugs in our market and now are not presented…
In recent years, observed a significant decline in interest in the Russian market. We do not register baby dosage — doctors have to use drugs to adults. It is very difficult to obtain permission for such research, and companies usually do not spend the money for it. In America and in Europe there are new drugs, but in Russia they appear only years later.
Two years we recorded a cancer drug, allowing to recover when melanoma, lung cancer — was glad that he finally became available for our patients. But in the meantime, the world is already out drugs that not only treat lung cancer but also bladder cancer. We have nothing like this — if a person has bladder cancer, in fact, is the sentence. This year alone, the drug finally will appear in Russia.
“SP”: — Why is this happening?
— We have a complicated regulatory system — for example, to obtain a permit to register a child drug can only after the studies conducted on adults. Although it’s inconclusive, and it is a huge additional costs. And resolution is difficult to obtain. On the one hand, that’s right, on the other hand, many drugs can’t get through. And then — if the Europeans know that they have registered the drug, and the state will buy it, then we are not in doubt — guaranteed sales not — and do not want to risk big money. But going after the Chinese generic can quickly register. State any protective measures. And interest in Russia falls.
As a result, situations such as the recent — when the child died at the Morozov hospital on anesthesia. It turned out that we have no drug that should be in every intensive care unit — from hyperthermia (when the anesthesia, there is a side reaction in the form of high temperature from which the person dies). We don’t have companies it is unprofitable, and the government does not want to fill in the gaps. Although the Ministry of health could say: the drugs we need, won’t you take money for signing up — bring.
“SP”: — And why you can’t do quality drugs here?
— Everything we do — basically, pour simple solutions do vitamins. There are some generics, in very small quantities. You heard that in Russia worked on some new concept of cancer, cardiovascular drug? It is very, very expensive, need money and clinical studies, and registration is millions of dollars. And the state does not guarantee that such a drug buy. And also generic manufacturers have to work in the fields, to prove that his drug is worthy. And they are not really falling. The original manufacturer can reduce the price by the same percentage.
While we have nothing, this is a very long investment, and need 20 years or more to this industry has earned. And then we can be indignant and say Americans don’t want your drugs. Now just need to be honest to say that in this direction they went further than we did. And hasty decisions here to make, otherwise they will strike first of all on ourselves.