Russian pharmaceutical companies are giving up
According to the press service of the Association of Russian Pharmaceutical Manufacturers, there are no incentives for research activities of pharmaceutical companies in Russia.
An expanded meeting of the Board of the Chamber of Commerce and Industry of the Russian Federation was held on May 27 with the participation of Prime Minister of the Russian Federation Vladimir Putin. The meeting was attended by ARFP CEO Viktor Dmitriev. The issues of creating and supporting innovative growth points in the Russian economy as a key direction of anti-crisis actions of business and government were discussed. Within the framework of the meeting, the Chairman of the Government of the Russian Federation was given a list of promising innovative projects and developments supported by the Chamber of Commerce and Industry and associations of entrepreneurs, among which were projects of domestic pharmaceutical companies-members of the ARFP.
The pharmaceutical industry is traditionally considered one of the most knowledge-intensive industries, where the share of innovative projects is significantly higher than in other industries. At the same time, it is obvious that with the existing sales volumes and profits, even the leading Russian pharmaceutical companies have limited resources for the development and withdrawal of innovative drugs. Nevertheless, leading Russian companies are constantly updating their portfolios, replacing old generics with more modern ones, and even introducing innovative drugs. A vivid confirmation of this is the achievement of the domestic company "Pharm–Synthesis" to create the antitumor drug "Milanfor" - the world's first analogue of the foreign original drug "Velkade". Russian developers have created a unique method of drug production, different from the method of production of the originator company. The entire volume of studies has proven the effectiveness and safety of the drug.
However, according to the Association of Russian Pharmaceutical Manufacturers, such examples may remain isolated, since there are no incentives for the research activities of Russian pharma: loans and debt instruments are expensive, venture financing is poorly developed, there are no preferences for domestic producers in public procurement.
General Director of ARFP Viktor Dmitriev: "The drug "Milanfor" was not allowed to participate in the auction for delivery in the 2nd half of 2009 under the program "Seven nosologies". The formal explanation is non–compliance with legal requirements. How are calls for the creation of innovative products and import substitution linked to this? When switching from an expensive imported originator drug to a domestic "Milanfor", the savings of the state budget could amount to about 800 million rubles. Therefore, we believe that the innovative way of developing the country's economy in general and the Russian pharmaceutical industry in particular cannot be implemented without state support. The easiest way to stimulate innovation activity on the part of the state is to guarantee sales, i.e. the priority participation of domestic innovative products in public procurement."
Details can be found in the article by Marina Savchenkova (Farmvestnik)
A copy was not thrown into the Velcade
His Russian generic did not get to the auction for the "Seven nosologies"
The first generic of the global blockbuster Velcade, the Milanfor drug, developed by the Russian CJSC Pharm-Sintez, failed to break into the main market for itself – the state program "Seven Nosologies". This is the main news of the open auction held by the Ministry of Health and Social Development of Russia on May 27. Applications issued by lot No. 28 (bortezomib) with Milanfor distribution companies "Irwin-2" and "Vilana" were rejected by the commission at the stage of consideration. As a result, the victory for this lot went to Pharmstandard, which is acting this year at the auction as the distributor of the Velcade itself, which is produced by the Belgian Janssen-Silag. The Ministry of Health and Social Development explained the reason for rejecting the most intriguing application the very next day: "due to the unreliability of the information provided." The ministry's post-release contains a hint that the drug did not pass its rigorous safety and efficacy test. Pharm-Sintez and Irwin-2 intend to challenge the results of the auction for lot No. 28. Participants in auctions for "Seven Nosologies" acquired a similar experience exactly a year ago, when six distributors were not satisfied with the results of the auction and filed a complaint with the Federal Antimonopoly Service. Three of them managed to achieve victory during the replay.
An open auction for the right to conclude state contracts for the supply of drugs intended for the treatment of patients with malignant neoplasms of lymphoid, hematopoietic and related tissues, hemophilia, cystic fibrosis, pituitary nanism, Gaucher disease, multiple sclerosis, as well as after organ and (or) tissue transplantation, was held at the Ministry of Health and Social Development of Russia on May 27. The planned volume of purchases for the second half of the year amounted to about 16.4 billion rubles (the volume of purchases for the 1st half of 2009 was about 14 billion rubles).
The auction was announced on April 28, applications were accepted until May 19. From May 19 to May 26, applications were considered by a single commission. In total, 73 applications were received for 42 lots from 12 bidders. The record holders for the number of applications submitted were JSC "Pharmstandard" and CJSC "R-Pharm" – they submitted 13 applications each. 11 applications were received from CJSC "CV Protek", 10 – from JSC "Pharmimex", 6 – from CJSC "ROSTA", 4 – from LLC "Optimal Health" and LLC "Medipal-Onco", 3 – from LLC "Gemamed" and FSUE "RO "Medtech" Roszdrava, 2 – from Biotech LLC. One application was submitted by LLC "Vilana Company" and LLC "Irvin-2". 9 out of 12 applicants were allowed to participate in the auction, whose applications corresponded to the Federal Law FZ-94 "On State Order". In particular, the applications of the Federal State Unitary Enterprise "RO "Medtech" Roszdrav, which claimed lots No. 22, 23 and 24 (Tacrolimus), were rejected, the second applicant, CJSC R-Pharm, was recognized as the winner.
However, the main sensation was something else. The Unified Commission, by a general decision, rejected the applications for lot No. 28 of Irwin-2 LLC and Vilana Company LLC, to which Pharm-Sintez CJSC transferred a power of attorney for the supply of Milanfor (bortezomib), the first generic of the antitumor blockbuster Velcade, which is produced by Janssen-Silag. This is one of the most expensive lots at the last auction. Its volume is more than 2.5 billion rubles.
As Oleg Mikhailov, General Director of Pharm-Sintez CJSC, told FV, it follows from the protocol of consideration of applications that "something is wrong with a copy of the registration certificate for the drug." "What is wrong, non-compliance with what legal requirements is imputed to us, I tried to find out by all means available to me, but I could not. The fact that two of our suppliers were refused at once suggests that it's not about the supplier, but about our drug," says Mr. Mikhailov. The General director of the Association of Russian Pharmaceutical Manufacturers, who supported the desire of Pharm-Synthesis to get into the "Seven Nosologies" with his drug, Viktor Dmitriev also notes that for two days he was in touch with the staff of the Ministry of Health and Social Development and did not receive any negative information about Milanfor's application.
The Ministry of Health and Social Development did not delay with explanations. The official press release issued the day after the auction noted that the application for the drug Milanfor was rejected due to the unreliability of the information provided. "This group of drugs, like others, has requirements for safety, efficacy and quality, which is confirmed by data from preclinical and clinical studies. 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 requirements for the safety and effectiveness of drugs regardless of the country of manufacture," the press release says. In accordance with paragraph 5 of Article 36 of Federal Law No. 94-FZ on state order, the auction for the lot of bortezomib was declared invalid. At the maximum price without a struggle, it was received by the company "Pharmstandard", which in this particular case acted as a distributor of Milanfor's only competitor – the original Velcade drug.
Lyudmila Melnik, CEO of Irvin-2 LLC, and Oleg Mikhailov told FV that they were already preparing documents for an appeal to the Federal Antimonopoly Service (FAS) of Russia. We are ready to support our colleagues in the ARFP. "We will not stand aside, because this is a matter of principle. We hear calls for import substitution and the development of innovative medicines every day, and this is what we face in practice," laments Viktor Dmitriev.- The domestic drug is 30% cheaper, and we are not allowed in fact without explanation. At the same time, we are faced with an aggressive, clearly orchestrated campaign denigrating the domestic drug, mass letters copied by patient organizations and "specialists" who "have not seen or used the drug, but are categorically against its purchases." I think that this should be the subject of close investigation by the control and antimonopoly authorities," says Mr. Dmitriev. Oleg Mikhailov also suggested that if Pharm-Sintez protests the results of the auction, the registration certificate of Milanfor itself, issued in mid-May by Roszdravnadzor, will be questioned. "If we do not resist, then we will be left without an auction, but with the drug," Mr. Mikhailov said.
According to the protocol of consideration of applications, the auction was declared invalid for another 17 lots. The state contract for each of these lots was concluded by the Ministry of Health and Social Development of Russia with the only auction participant at the initial (maximum) contract price. For 8 of the 18 lots, the state contract was concluded with JSC "Pharmimex", for three – with CJSC "CV Protek" and CJSC "R-Pharm", for two – with LLC "Biotek", one – with JSC "Pharmstandard" and LLC "Medipal-Onco".
None of the bidders showed interest in lots No.35-38, formed according to the INN "Cyclosporine". Lots No. 20 and No. 21 of the INN "Mycophenolate mofetil" were not drawn either. As noted in the protocol of consideration of applications, applications for these two lots were received from Optimal Health LLC, but their consideration is postponed to June 8, 2009.
For the remaining 18 lots, the auction was held on May 27. The competition unfolded only for lot No. 14 (blood clotting factor), although from two to four companies had to participate in the bidding for many lots. Many participants left the race before the start of the auction. The auction documentation notes that "authorized representatives of the auction participants ... did not appear at the auction ..., did not register and did not receive a numbered card." As a result, state contracts at the maximum price were concluded for 17 lots. Thus, only one of the 36 lots the state managed to achieve savings: for lot No. 14, the price decreased from 158.34 million to 156.76 million.
Thus, the largest number of lots was won by CV Protek – 10. Pharmimex took 9 lots, R–Pharm took 6, ROSTA and Medipal-Onco took 4, BIOTEK took 2, and Pharmstandard and Optimal Health took one lot each.
Also on the day of the auction, the Ministry of Health and Social Development announced when the fate of the auction for somatropin (growth hormone) will be decided, the struggle for which, as in the case of bortezomib, should unfold between suppliers of foreign drugs and Russian – Rastan (produced by Pharmstandard). Applications will be accepted until June 17, their consideration is scheduled for June 23. In accordance with the requirements of the FAS, two lots were formed – "Somatropin lyophilizate for the preparation of a solution for subcutaneous administration of 1.33-6 mg" worth more than 71 million rubles and "Somatropin solution, lyophilizate for the preparation of a solution for subcutaneous administration of 5.3-10 mg" worth more than 198 million rubles. The auction will take place on June 24.
The results of the open auction for the right to conclude a state contract for the supply of expensive medicines for the 2nd half of 2009 in the framework of centralized procurement are here.
How was the appeal a year ago
A year ago, on April 25, 2008, Roszdrav, at the insistence of the Federal Antimonopoly Service, was forced to hold repeated auctions for seven lots, after six distributors at once (ROSTA CJSC, Biotek LLC, R-Pharm CJSC, Pharmimex OJSC, Irwin 2 LLC and LLCOptimal 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.
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