FAS pledges of no double game
It looked like the battles around drug sales at food stores have stopped. But, reportedly, the Ministry of Industry and Trade is updating the bill ‘with all findings considered’. The industry players are downright concerned with the news. Recently, certain pharma people got hold of the second variant of the explanatory note to the bill reading quite differently from the published version. In particular, it is proposed to permit selling OTC drugs with post factum notification, which pharma considers a discrimination in respect of pharmacies. The Federal Antimonopoly Service (FAS) calls on the pharma community to calm down stating that this bill does not have any ‘double bottom’.
[PharmVestnik # 11, 03/04/2018, p. 1, cont’d p. 4]
// Pharma Retailing
Analysts forecast pharmacy reduction in 2018
The start of the year demonstrated that analysts were right when forecasting further consolidation of the pharmacy market. The market has witnessed the strategic deals of Samson-Pharma acquisition by Erkapharm and Pharmart acquisition by Pharmland (Ufa, Bashkortostan). On the back of large deals, experts increasingly often speak about financial problems of pharmacies. Certain analysts are sure that the market implosion, namely a reduction in the number of pharmacies, will take place earlier than initially forecasted: the process will start already this year.
[PharmVestnik # 11, 03/04/2018, p. 2]
// Regulatory & Legal – Drug Procurement
FAS suspicions in respect of MoH transpired just before formation of a new Russian government
A few days after the presidential election, it has transpired that the Federal Antimonopoly Service (FAS) suspected the Ministry of Health (MoH) of the violation of the Competition law. Allegedly, the MoH might have created advantages for R-Pharm Group in drug procurement. The MoH officials deny the charge, while R-Pharm people assert that they have not been inspected by the FAS. The Ministry filed a complaint against the FAS with the General Prosecutor’s Office. It is possibly not a coincidence that this case became public right now when the government cabinet make-up is being discussed.
[PharmVestnik # 11, 03/04/2018, p. 3]
// Drug Procurement
Increasingly often, bidding front runners yield to outsiders
The winner of the past teriflunomide bidding within the framework of the High-Cost Disease program (VZN) was the only bidder, i.e. R-Pharm packing French Aubagio. Valenta Pharm, the second contender that was the bidding front runner, had refused to bid for some unknown reason. Market players suppose that R-Pharm might have tempted Valenta with a generous offer. In turn, French Sanofi demonstrated that they could afford to substantially cut prices, if required.
[PharmVestnik # 11, 03/04/2018, p. 3]
// Counterfeit Drugs
Market experts differ in their approaches to counterfeit drug control measures
A bill was presented to the State Duma that provided for upgrading penalties for counterfeit drug distribution in Russia. The bill authors propose a 12-year imprisonment for such violation. The reason for this initiative was a nearly 4-fold (since 2015) growth in the number of criminal proceedings associated with counterfeit drug sales.
[PharmVestnik # 11, 03/04/2018, p. 6]
// Health Insurance
Proposal to cancel MHI system voiced by chairperson of the Federation Council is likely to be president-approved
The Mandatory Health Insurance (MHI) system has been once again criticized by a public figure. Following fierce criticism from ex-Chairman of the State Duma’s Health Committee Sergey Kalashnikov, Chairwoman of the Federation Council Valentina Matvienko spelled out that the current MHI system did not offer even quasi-insurance. Mrs. Matvienko noted that the government was making payments from the budgetary funds to the MHI Fund as well as was bearing the costs of the Fund’s establishment. After that, the money would go to insurance companies. Experts believe that this move may be considered a preparation for shifting over to budgetary funding of the insurance system.
[PharmVestnik # 11, 03/04/2018, p. 7]
// Clinical Trials – EAEU
EEC offered a master class in clinical trials for pharma community
The pharma community is getting prepared for a transition to a new regulatory environment of the EAEU common drug market. The first regulatory submissions have already been made in line with the new regulations. Results of clinical trials are key to these submissions. The participants of the practical conference ‘Clinical Trials in Russia and the EAEU’ learned from a Eurasian Economic Commission’s (EEC) expert how to conduct trials in accordance with the common Eurasian Union’s regulations.
[PharmVestnik # 11, 03/04/2018, p. 11]
// Health IT
Rostech Center for Informatization to present an upgraded MHI GIS
Rostech’s daughter company has set to eliminate the weak points in the Mandatory Health Insurance (MHI) information system. The insurance GIS upgrades are designed to standardize and unite separate software solutions used by regional healthcare providers as well as provide useful patient services. At the same time, experts apprehend that it may take too long to implement an upgraded system.
[PharmVestnik # 11, 03/04/2018, p. 13]
// Insight – Imports
Imports of finished and bulk medicinal products to Russia, 2017
According to RNC Pharma, last year, total imports of finished dosage forms to Russia increased by 8.5% in rubles, the positive trend persisting the second year running. On the contrary, imports of bulk medicinal products went down for the first time since 2014 (-13.9%). Importantly, these product groups demonstrated reversed import dynamics in real terms.
[PharmVestnik # 11, 03/04/2018, pp. 16-17]
// Insight – Hospitals
Hospital segment of the Russian pharma market, 2017
According to AlphaRM, in 2017, drug supplies to Russian healthcare institutions amounted to 131.7B RUB (0.65B units). Per capita, the government spent 4.4 product units at a total cost of 897 RUB for disease prevention and treatment services.
[PharmVestnik # 11, 03/04/2018, pp. 18-19]
// Regulatory & Legal – General
Stavropol territorial government failed to terminate investment agreement with Escom
The court of arbitration of Stavropol Territory has declined to rule in favor of the territorial government seeking to terminate an investment agreement with Research and Production Association Escom and recover damages worth 917M RUB to the territorial budget and worth 13M RUB to the city of Stavropol budget. The court reminded the territorial authorities that they were 3 years late to perform under the agreement, thus giving the pharma company the right to suspend the project funding.
[PharmVestnik # 11, 03/04/2018, p. 23]