Officials are against innovation
How an American tail wags a Russian dogSvetlana Sinyavskaya, STRF.ru
Retelling the facts stated by the injured party is a thankless task, especially in such a corrupt sphere as healthcare.
Let's make a reservation right away, in this publication we will not look for an answer to the question of which antitumor drug is better: the American "Velcade" or its Russian counterpart "Milanfor". However, concrete facts once again force us to raise the question of the integrity of the public procurement system.
CJSC Pharm-Sintez is a leading domestic pharmaceutical company founded in 1998 with the aim of producing high–tech substances and medicines that have proven themselves in world clinical practice as the most effective and safe. Carries out a full production cycle from the synthesis of active molecules (substances) to the production of modern ready-made dosage forms. It is included in the list of system-forming enterprises of strategic importance for the economy of the Russian Federation.
Withdraw from the gameOn May 19, 2009, Pharm-Sintez completed the creation and registration of the domestic antitumor drug Milanfor (the active ingredient is bortezomib) for the treatment of multiple myeloma (a blood tumor disease).
This is the first high–tech generic of the American drug "Velcade", the leader in terms of sales of DLO in 2008 - Russia allocated more than six billion rubles for the purchase of this drug (data from the "Monthly Retail Audit of the pharmaceutical market of the Russian Federation" by DSM Group). The cost of one package of "Velcade" is more than 74 thousand rubles, "Milanfora" is 30 percent cheaper. The entire technological cycle for the production of a domestic drug, including the synthesis and production of the substance, is carried out in Russia, moreover, a plant that meets all American and European standards is being built in the Kaluga Region for the production of Milanfor. The very appearance of this generic, according to Viktor Dmitriev, General Director of the Association of Russian Pharmaceutical Manufacturers, proves "the ability of domestic pharmaceutical manufacturers to implement import substitution programs and create high-tech drugs for the treatment of diseases included in the Seven Nosologies program." However, on May 27, the drug "Milanfor" was withdrawn from an open auction for delivery in the second half of 2009 under the "Seven Nosologies" program. One of the most expensive lots at the last auction with a volume of 2.5 billion rubles went to the company "Pharmstandard", which acted as a distributor of the drug "Velkade" – we note, at the maximum price and without any struggle.
The Ministry of Health and Social Development did not clearly explain the reasons for the withdrawal from the auction: in an official press release issued the day after the auction, it was noted that the application for the drug "Milanfor" was rejected "due to the unreliability of the information provided." Nevertheless, the press release says, "The Ministry of Health and Social Development supports the development of the domestic pharmaceutical industry as an import substitution and the development of innovative drugs, but at the same time imposes strict (emphasis added) requirements for the safety and effectiveness of medicines regardless of the country of manufacture." In the antimonopoly service, where Pharm-Sintez applied, it was decided to cancel the results of these auctions (there was a similar precedent last year, see the certificate), but the general director of Pharm-Sintez, Oleg Mikhailov, has not yet seen a written decision of the FAS.
However, the misadventures of Milanfor did not end with the withdrawal from the auction. Recently, on behalf of Roszdravnadzor, the registration of this drug was suspended. According to Viktor Dmitriev, this happens extremely rarely, for example, when "an extremely serious side effect is detected, as well as if the company issues a marriage." Neither one nor the other was revealed. The reasons why Roszdravnadzor decided to suspend the validity of the registration certificate are also unclear. "Officially, I was given an order where the basis for action is... the order of the Ministry of Health and Social Development, – says Oleg Mikhailov. – They do not make any claims to us, so I sent a letter to Tatiana Golikova with a request to cancel this decision as illegal."
How the appeal went a year ago: on April 25, 2008, Roszdrav, at the insistence of the Federal Antimonopoly Service, was forced to re-auction seven lots, after six distributors (ROSTA CJSC, Biotek LLC, R-Pharm CJSC, Pharmimex OJSC, Irwin 2 LLC and LLC "Optimal Health") appealed to the antimonopoly Authority against the organization and conduct of the auction on April 10 and 11, 2008. On April 17, the FAS considered the complaints of distributors and decided to cancel the protocols for reviewing applications for participation in the auction of seven lots and to re-conduct auctions for them. Contacting the FAS helped three distributors out of six.
Methods of struggleOn the eve of the auction, the Ministry of Health and Social Development and Roszdravnadzor received letters in which patient organizations, to put it mildly, criticized the drug Milanfor.
A drug that has not yet entered the trade, as it has just managed to get a registration certificate! "I saw these letters, some of them were simply written under a carbon copy," says Viktor Dmitriev. – The question arises involuntarily: and at whose expense are such shares provided? It is no secret that patient organizations exist for the money of multinational companies, which, to be fair, help patients, and on the other hand, sometimes become an instrument of unethical competition. All this reminded me of the old days when working collectives made statements like "We have not read Pasternak, but we are terribly dissatisfied with what he writes.""
Oleg Mikhailov has no doubt about the safety of the Milanfor drug: "This medicine is used in the treatment of rare diseases, there are a little more than two thousand such patients in Russia. Usually simplified schemes are applied to the registration of such drugs, but we have passed this registration in full. In-depth preclinical studies were conducted, and not only on small laboratory animals, but also on large ones. The data from clinical studies also show the safety and efficacy of our drug, which is identical to its analogues." Milanfor is not the first complex pharmacological drug that Pharm–Synthesis brings to the market, but it is the first time the company has encountered such "fierce opposition". "We are completely at a loss... We hope common sense will win after all. I want to believe that officials from the Ministry of Health and Social Development gave inaccurate information, based on which they made such decisions. Otherwise, it all looks too scary," Oleg Mikhailov believes.
Every year in our country about 1000 patients with a diagnosis of multiple myeloma are registered, this is about 10-15% of hematological tumors. The disease of multiple myeloma is the cause of death of almost every fifth patient with hematological tumors, while more than 25% of patients with blood cancer die within the first year from the moment of diagnosis. To a large extent, the high mortality rate from onco-hematological diseases in Russia is due to the lack of a guaranteed opportunity for citizens to receive affordable and highly effective medical care at the same time.
The Strategy for the development of the pharmaceutical industry of the Russian Federation until 2020 is based on two main theses: the creation of innovative drugs and the import substitution program. If every worthwhile innovative drug makes its way to the domestic market with such a fight, and the reasons for the verdict "not fit" will be hidden by officials, the strategy will not be implemented.
Portal "Eternal youth" http://vechnayamolodost.ru/11.06.2009