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Out of competition


Commitments of public servants to support flagships of Russian pharmaceutical market went dash against the very first serious public procurement auctions. Yesterday, just the day Prime Minister Vladimir Putin held the meeting with active members of the Chamber of Commerce and Industry, it turned out that the Russian company "Pharm-Sintez" had been out of competition between suppliers within the Expensive Drug Assistance program for the Russian nationals. However, the offer of the company was perfectly in line with the import substitution policy declared by the government.


Overnight into Wednesday, a protocol of processing of applications for participation in the public auction for the right to supply drug products for the treatment of seven cost intensive nosologies to the government was released. Eight public servants from the Ministry of Healthcare and Social Development of the Russian Federation - members of the Purchasing Committee - unanimously decided to disqualify Milanfor, a novel Russian drug product for the treatment of hematopoietic malignancies by the “Pharm-Sintez” company, from participating in the auction. In substance, this drug is a generic product, id est a lower cost analogue of one of the most expensive medicines in the "7 nosologies" state program - Velcade, manufactured by the American company "Melenium" and distributed worldwide by the Belgium company "Janssen-Cilag". According to the marketing agency "DSM Group", in 2008 a purchase volume of this American medication in our country amounted to 200 million rub., the current cost per package in the commercial market is about 80 thousand rub. Viktor Dmitriev, the director general of the Association of Russian Pharmaceutical Manufacturers (ARPM), notifies to "Vremya novostej" (eng. - "News time"), "The Russian analogue is 30 % cheaper. This means that by disqualifying the domestic company form the auction the government has missed a chance to save budget".


"Pharm-Sintez” company, the specialists of which managed to synthesize an active substance, bortezomib, using a principally new technology and get round a western patent (the method of production of this substance, which is the component of Velcade, but not the molecule itself, is protected by patent in the territory of the Russian Federation) just does not understand what has happened. In fact, the novel product was developed under unfaltering surveillance of the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor), and despite its generic nature underwent extensive preclinical and clinical program. The expeditious approval procedure for this drug product was advocated for by such competent authorities as Valery Chisov, the chief oncologist of the Ministry of Healthcare and Social Development of the Russian Federation, and Andrey Vorobiev, the head of the Hematological Scientific Center of the Russian Academy of Medical Sciences. As the result, surprisingly this drug product was approved promptly - within nine months only. The Marketing Authorization was received by the executives of the “Pharm-Sintez” company on May, 15. As early as four days later the notarized copy of this document and other required papers were submitted to the Committee on purchasing of expensive products.


It is noteworthy that the only hint of the cause of disqualification is related to the Marketing Authorization. The protocol of the Committee states that it "does not conform to Federal Law #94-ФЗ "On Placement of Orders to Supply Goods, Carry out Works and Render Services for State and Municipal Needs" dd. 7/21/2005, article 12, part 1, item 1". That is it, no more words. The press service of the Ministry of Healthcare and Social Development of the Russian Federation has clarified to "News time" that the reference to the above stated items means that: a candidate for participation in the auction submitted invalid data. The authority was not able to clarify what exactly discrepancies or the more so falsities were in a document. As well no comments on complaints asserted by the “Pharm-Sintez” company have been provided yet.


Oleg Mikhailov, the director general of AO “Pharm-Sintez”, recites to "News time", "Today, through all my channels I have been making efforts to find out what is hidden under this wording and failed to get any answer". He continues, "The Marketing Authorization for our new drug product is no different from other Marketing Authorizations for other medicines, I have thoroughly inspected it. Either this is a mistake, or there is more behind the stated cause of disqualification". The entrepreneur himself, no wonder, assumes that it is all the fault of competitors with their intrigues. Mr. Mikhailov claims, "Of course, Janssen-Cilag cannot bear defeat, which would be an entry of our product into the market. This is a hundred-million-dollar loss for them".


According to him, in the span of just a day the “Pharm-Sintez” company received carbon copy-like letters from the patients from absolutely all the regions of Russia voicing their concerns about side effects of the new drug product, limited state of knowledge about it and its unknown amongst. Oleg Mikhailov assumes that the same letters signed by various people and sent from various cities were received by the Ministry of Health and Social Development of the Russian Federation as well on the eve of the auction.


Viktor Dmitriev from ARPM believes, "All the available documents, including these letters, the Russian manufacturer and our association will be filed to the public prosecution office, since this is clearly the case for investigation and judicial proceedings". According to him, the activities of the public servants discredit the President and the Prime Minister. The representative of Russian pharmaceutical manufacturers is assured, "In so doing they show their indifference to the big words spoken from the scaffolds: keep talking, but we will act as we need".