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Thursday, October 27, 2016

The Russians will not allow you to lose weight?

By 2020, the share of domestic drugs on the Russian pharmaceutical market in monetary terms must be 50%. The task set by the country’s leadership, it is registered in the Federal program “Pharma 2020”. But as it turns out, contributes to the fulfillment of such plans in life is not for all departments. What prevents import substitution in the pharmaceutical industry?

photo: pixabay.com

The majority of medicines Russia still buys abroad, prices – you-know-what. Private companies trying to establish production of medicines in his own country, frequently get hand – in front of them grows up to be a mountain of restrictions, “dissenting opinions” questionable orders. Consider the situation on a concrete example. The Russian company “Promomed” more than ten years successfully works in the pharmaceutical markets of Russia and countries near and far abroad.

A year ago, the company became a shareholder of one of the largest and oldest in the country’s pharmaceutical plants, “Biochemist”, located in Mordovia.

In the end the company with more than half a century of history has received a new development impulse. The company “Promomed” invested in OJSC “Biochemist” significant funds and launched a new production project. Now on the “Biochemist” has been release of large amounts of modern antibiotics, antitumor, cardiovascular, antiviral and other drugs. The Mordovian enterprise produces more than 100 kinds of medicines, 70 percent of which drugs from the list of vital and essential medicines. It would seem, here it, an example of successful import substitution: competitive products at prices cheaper than their Western counterparts, new jobs, cheap Russian drugs, taxes to the budget… But in reality all goes not so smoothly.

Among the numerous drugs the pharmaceutical company “Promomed” produces the means for the treatment of obesity (which is known to afflict more than 25% of the population of Russia) – “reduksin”.

Funds from the sale, including directed on reconstruction of the domestic giant “Biochemist”, launching new production lines for the production of vital and essential drugs.

For several years the drug had no complaints prescription of a physician, he proved its necessity. Truly a rare case: a domestic product significantly ahead of foreign competitors. But the situation suddenly changed: as reported by the Russian Agency of medical and social information (AMI), the Ministry of health has prepared a draft order, “prescriptive to include in the list of subject-quantitative accounting (PKU), all drugs containing not only poisonous substance “in pure form”, but potent substances in combination with other pharmacologically active ingredients”.

As experts underline, “in practice, this means not only complicated and expensive spectacularly and spetskhranenie these drugs, but also a significant complication of the procedure of obtaining a prescription for them. And most importantly: subject to the terms of the order is now an impressive list of drugs — until Korvalol, valocordin and Nurofen”. According to the Agency, AMI, while of vast range of medicines under the order of inclusion in the subject-quantitative account somehow got two of the drug is “useless” and “useless Met. The ones made by “Promomed”. What happens next is easy to guess: if the domestic drug ban, will rush to market the imported ones are of questionable quality and much more expensive price. Will also increase the risk of uncontrolled increase in turnover of illegally derived funds, in particular biologically active additives, mainly of Chinese origin.

The situation is already interested in public organizations. “In this regard, we are preparing anti-corruption examination according to this order, we understand why it appeared at all and why its got the domestic producers”, — said in January 2016, the Chairman of the Russian public organization “Center of counteraction of corruption in public authorities” Victor Kostromin.

And understood: the presidential Administration sent an official letter with a request to check on a possible conflict of interest and violation of anti-corruption legislation of the Russian Federation.

Drugs for the treatment of obesity are among the most studied in Russia in 2012-2014 was conducted by the research program “Spring” and “Primavera”, in which took part more than 100 thousand patients and more than 3 thousand most influential doctors. “Primavera” has become the largest in the world of endocrinology observational study. Both programs confirmed safety and efficacy.

Doubts about the order of the Ministry of health and in support of the drug was expressed by the Professor of the Department of endocrinology and diabetology MSMSU them. A. I. Evdokimova, Alevtina of orange, member of the Duma Committee on health, Alexander Petrov, senior lawyer of Lawyer Bureau “Egorov, Puginsky, Afanasiev and partners” Andrey Bashirov.

In defense of the producers of “Reduxine” was made by the head of Mordovia Vladimir Volkov. But Deputy Prime Minister Arkady Dvorkovich, as reported by the portal life.ru demanded from the Ministry of health to abolish discriminatory order.

On the basis of expert assessments, Arkady Dvorkovich issued a resolution that “the legal regulation of drugs “useless” and “useless Meth” is sufficient, and their inclusion in the list of drugs for medical use subject to substantive quantitative accounting, as well as the suspension of treatment sibutramine-containing drugs is unfounded. Continued work in these areas was considered unnecessary”.

Today, there is a stalemate: the reaction of the Russian government is, and about the reaction of the Ministry of health is not audible. Meanwhile, to the issue joined, and the General Prosecutor’s office. By checking on the Deputy’s request, the Supervisory authority came to the conclusion that “useless” and “useless Meth” are not subject to PKU and that the Ministry of health of the Russian Federation violated a number of regulations when preparing your order.

It is possible to assume that the pharmaceutical conflict involved on big money. It is known that in the treatment of obesity in need of about 2 million Russians. It is easy to guess what the turnover on the market matches this figure. This arithmetic is well understood and competitors.

The question remains: why officials are showing admirable persistence in relation to these medicines, paying no attention to the opinion of the Prosecutor General’s office, the RF Government and the expert community?

We will try to inform our readers about the situation.

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