Much ado… and nothing
Market players urge state authorities to come to terms
Pharma market players keep criticizing legislature. At virtually every Pharma regulation conference, representatives both of local and foreign companies demonstrate mixed reaction to legislative initiatives of different agencies. At the same time, as most of these initiatives are still at the draft law stage, pharmaceutical companies are trying to assess the risks associated with their implementation, on the one hand, while wondering what are their chances to be implemented, on the other hand. Therefore businesses request that the government harmonized their requirements to Pharma.
[PharmVestnik # 39, 01/12/2015, p. 1, cont’d p 2]
Not sticks alone
Minpromtorg to encourage “deep localization”
The authorities are not ready to admit that businesses are right when stating that localization decisions are rather political than economic. The regulators retort that not a single investment decision is made without a thorough economic analysis. Therefore businesses shall take upcoming regulatory changes as carrots rather than sticks, such “carrots” being intended for those who have managed to reconcile politics and economics and have made decisions on localizing their manufacturing facilities in Russia.
[PharmVestnik # 39, 01/12/2015, p. 3]
Experts: healthcare spending is investment, not costs
On November 23, co-chairmen of All-Russia Patients Union Yan Vlasov and Yury Zhulyov as well as head of the National Medical Chamber Leonid Roshal wrote an open letter to the Russian government, parliament, Ministry of Finance, and Ministry of Health requesting to retain the healthcare expenditures in 2016 budget at the level of the year 2015 adjusted for inflation. The authors of this letter note that budget cuts will not be able to resolve all problems as Russia’s healthcare is not sufficiently funded; at the same time, they insist on increasing health spending in future. The experts believe that healthcare funding is investment, not costs.
[PharmVestnik # 39, 01/12/2015, p. 5]
Love under contract
Contract manufacturing makes it possible for foreign companies to solve localization task
Pharmtech & Ingredients International Exhibition that was hosted in late November in Moscow and presented equipment, raw materials, and technologies for pharmaceutical manufacturing attracted the participation of 365 Russian and foreign companies from 25 countries. At the exhibition, several contract drug manufacturing projects were presented. According to experts, this business model is becoming increasingly popular in Russia because it makes it possible for many foreign companies to be awarded a localized manufacturer status.
[PharmVestnik # 39, 01/12/2015, p. 7]
Help!
Doctors and patients are drowning in “pharmaceutical debris” sea
Experts state that the Russian Pharma market is oversupplied with drugs as there are too many similar generics and pharmaceuticals without proper evidence of efficacy. Officials keep reporting on the actions taken and suggest to wait and see the results of such actions.
[PharmVestnik # 39, 01/12/2015, p. 1, cont’d p. 8]
Russian Pharma market might have already tested the bottom
Consumption may start growing next year
Akrikhin Sales and Marketing Director Boris LIPARTELIANI took office in September 2014. Already at that time, OTC drug consumption has plummeted, with more challenges being faced in November when the ruble was set to free float, and RUB/EUR exchange rate reached 100:1. Mr. Liparteliani related how he organized the company’s work over the past year, and what was achieved in the corporate perspective.
[PharmVestnik # 39, 01/12/2015, p. 9]
Novelties in clinical trials
Pharma companies’ staff members in charge of clinical trials are looking forward to the introduction of orphan drug determination procedure as well as are getting accustomed to operating in compliance with the amendments to the federal law “On Drug Circulation” that have recently come in force. They shared their concerns and expectations at the “Clinical trials in Russia” conference held in late November in Moscow.
[PharmVestnik # 39, 01/12/2015, p. 10]
New Biotec President
Mikhail Stepanov took office as Biotec Group President at the end of November. Prior to this appointment, he worked at CJSC Imperia-Pharma for 15 years. Some market experts “read” this appointment as structural changes at Biotec in near future.
[PharmVestnik # 39, 01/12/2015, p. 10]
Safety labeling
In is planned to implement compulsory safety drug labeling in Russia in 2017 (see “Labeled packaging”, PharmVestnik # 36, 10/11/2015). The development of appropriate amendments to the federal law “On Drug Circulation” is underway. PharmVestnik found out what labeling types may be used, what such novelty may result in, and what Pharma professionals think of this issue.
[PharmVestnik # 39, 01/12/2015, p. 15]
Cold autumn of 2015
Rating of Russian pharmaceutical distributors, Q1-315
The number of “classical” pharmaceutical distributors has significantly reduced over the past year. Two big players have withdrawn from the market. But naturally, small-scale wholesalers who had been especially active in the Pharma retail sector had encountered economic problems much earlier. The number of such distributors reduced, as a minimum, by several dozens countrywide. The market share that has thus been “freed” has been promptly divided among the rest of the players. The first line companies that have been able to consolidate their positions demonstrate the highest growth rates.
[PharmVestnik # 39, 01/12/2015, pp. 16-18]
Cluster model and import substitution prospects in Pharma
Kaluga region accommodates 10 industrial parks with total area approximately 6,000 ha and Special Economic Zone Kaluga exceeding 1,000 ha. The pharmaceutical cluster operating in the region includes 5 anchor manufacturing facilities, i.e. Stada CIS, Novo Nordisk, Berlin-Chemie/Menarini, AstraZeneca, and Nearmedic. Finished drugs account for more than 80% of the cluster’s output; investments total about 450 mn USD. Anatoly SOTNIKOV, CEO of JSC Innovative Development Agency — Kaluga Region’s Cluster Development Center, and Irina KLIMOVA, Chairwoman of the Board of Mineral Resources Co. answered PharmVestnik’s questions.
[PharmVestnik # 39, 01/12/2015, p. 22]
Potential litigation ahead
The state unitary enterprise Dzhankoy-Sivash Pilot Plant (Republic of Crimea) is getting ready to resume manufacturing of Polysorb medication in compliance with the Russian legislation. The enterprise has been issued a drug manufacture, sales, and storage license; it has also confirmed its right to applicable trademarks. Experts believe that such move may result in litigation with another local manufacturer, i.e. CJSC Polysorb in Chelyabinsk region.
[PharmVestnik # 39, 01/12/2015, p. 23]
