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Expert: The drug circulation system in the Russian Federation must be changed

 Spokesman for the Russian President Dmitry Peskov commented on the situation with the import of unregistered drugs into the Russian Federation and the prosecution of such cases.

Of course, everyone perfectly understands the need to solve this situation so that both children and adolescents, as well as adult children of their parents, will not endure torment. At the same time, we all know that, unfortunately, there are attempts to cover up with this topic, the distribution of potent substances and drugs, which is illegal. Here you need to find a middle ground, and the issue has been dealt with for a long time,” Peskov told reporters.

In general, the registration of the drug in the Russian Federation takes one and a half to two years. Only the developer of the drug can initiate this procedure, however, experts say that pharmaceutical companies are not in a hurry to enter the Russian market, since it is not profitable for them.

Firstly, in many cases, pharmaceutical companies will have to conduct repeated clinical trials of the drug in Russia, and the manufacturer must pay for it. An exception is made only for medicines for orphans (the so-called orphans, because they are extremely rare) diseases.

Secondly, at the time of registration, the GMP commission should go to the production sites and assess compliance with the technologies. Travel is also paid by the manufacturer, and given that there may be several sites, the costs do not cover potential profits. If we are talking about orphan diseases, the market will ultimately be too small.

The president of the Patient Advocates League and member of the Expert Council under the Government of the Russian Federation, Alexander Saversky, believes that a gray drug supply system has developed in Russia.

On the one hand, in the country the law allows the circulation of only registered drugs. On the other hand, there is an order under which this law can be violated if medicine is imported for personal use. Moreover, in the opinion of the state, only the manufacturer is interested in the registration, not the patients. This system needs to be changed: let the circulation of a specific drug be limited, but people should not risk getting into jail for pills.

Moreover, if the drug is not registered in Russia, but is listed in international treatment protocols, there is accurate information that it can help or fundamentally change the course of the disease, then the doctor has every right to prescribe it, regardless of the price of the issue.
Especially when it comes to children - they are legally entitled to the most modern treatment.

“If a medical committee makes a decision that ignores the most advanced methods, then it commits a crime. If the doctor says that someone on top urged him not to prescribe the medicine, because, say, there is no money, then this is a violation of the law and we must go to the prosecutor's office. In our practice, there are enough examples when the court obliged the authorities of the regions to purchase a drug not registered in Russia for patients, ”the expert summed up.

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