Nizhny Novgorod case
Russian regions cannot escape the “odd-man-out” regulation
[PharmVestnik # 2, 26/01/2016, p. 1, cont’d p. 2]
Excessive selfness
The Russian FAS has put forward another proposal on how to improve the local Pharma market. This time excessive drug registration requirements got the scolding, namely compulsory local clinical trials. In the FAS’ opinion, the latter have to be excluded from the registration process of the drugs already selling in the USA and the European Union. The Ministry of Health does not share the colleagues’ enthusiasm.
[PharmVestnik # 2, 26/01/2016, p. 3]
They sometimes come back
Roszdravnadzor follow-up calls to pharmacies threaten with license suspension
In January, information agencies spread that news about Health Minister Veronica Skvortsova’s statement regarding license termination for the pharmacies caught for the second time with overpricing the vital and essential drugs (VED). This statement has not come as unexpected for the pharmacy community. Back in October 2015, PharmVestnik already announced a draft regulation providing for new types of offences and sanctions for medical and pharmaceutical workers. No respective amendment has been approved so far, but that looks like a matter of time.
[PharmVestnik # 2, 26/01/2016, p. 3]
Regions form drug lists disregarding VED
Approximately 74% of all drugs are paid for out of pocket in Russia. These are the findings of the Audit Chamber of the Russian Federation that conducted an audit on the efficiency and targeted use of the state allocations earmarked for the implementation of the government obligations regarding drug coverage of specific citizen categories. The auditors believe that this percentage is not ultimate as the patients’ out-of-pocket drug expenses have been growing year-on-year.
[PharmVestnik # 2, 26/01/2016, p. 4]
New year, old formulation
Methods of detecting drug components in dietary supplements lagging behind
It turned out in 2015 that Rospotrebnadzor (Federal Service for Consumer Rights Protection and Human Welfare) lacked validated methods for detecting drug ingredients in dietary supplements. This fact has been revealed after a few professional associations checked a number of popular erectile dysfunction products. Nearly all of them contained PDE5 inhibitors. Without proper methods, Rospotrebnadzor has failed to confirm the independent study results; therefore the agency has immediately charged Peoples' Friendship University of Russia and the Nutrition Research Institute with the methods development. A draft document was ready by the end of September; however, its approval has been delayed. Meantime, Rospotrebnadzor is still unable to revoke from the market any dietary supplement containing undeclared ingredients.
[PharmVestnik # 2, 26/01/2016, p. 4]
Sales of strong analgesics plummeted
Over the past three years, sales of narcotic analgesics kept fairly stable at slightly below 1 bn RUB a year. However in fact this is just part of the demand. Experts note that the situation with painkiller coverage of seriously ill patients was more or less normal in 2011. Sales have reduced nearly threefold since that time. For Pharma companies operating in the Russian market, selling analgesics is a charitable act rather than business.
[PharmVestnik # 2, 26/01/2016, p. 5]
Ebola effect
World community met the news on the Russian Ebola vaccine with mixed perception
On January 13, President Putin declared that Russia was able to develop a more efficacious Ebola vaccine than those currently available to doctors. This piece of news was made less sensational by the WHO that stated the next day that the Ebola epidemic was over; however, already on January 15, one more case of Ebola-related death was confirmed. Nonetheless, the WHO officials have downplayed the news on the vaccine developed in Russia. The alternation of these events that gave rise to completely opposite viewpoints both from foreign and Russian experts undoubtedly has a certain political implication.
[PharmVestnik # 2, 26/01/2016, p. 6]
Putting pressure on self-treatment
The regulators have been seeking ways to resolve the self-treatment issue in Russia for a long time. Next time, this issue will be discussed in St. Petersburg. Restricted sales of specific listed drugs to patients under 18 years are considered as a potential measure. The author of this initiative is sure that the most effective way will be an extension of the Rx drug list. Experts are still not ready to support such measure.
[PharmVestnik # 2, 26/01/2016, p. 7]
Local manufacturers lobby breakthrough drug idea
Russian manufacturers continue coming up with proposals on reducing the drug registration procedure. In early December 2015, respective draft amendments to the basic industry law were developed by the Business Russia (Delovaya Rossiya) Association, and closer to the New Year, BIOCAD contributed their proposals as well. The latter proposed to register “breakthrough” drugs after two phases of clinical trials.
[PharmVestnik # 2, 26/01/2016, p. 7]
“New” old opportunities
R-Pharm to promote MSD drugs in Kazakhstan
The US and Russian companies are coordinating the details of partnership that will make it possible for R-Pharm to promote MSD products in Kazakhstan, while the foreign manufacturer will retain its rights to register new drugs in the republic as well pharmacovigilance functions. Such collaboration model is relatively widespread in the world market and is quite familiar to R-Pharm. However, market experts remind that its viability is as a rule limited in time as the model functions until the players’ interests diverge.
[PharmVestnik # 2, 26/01/2016, p. 10]
Crisis affected erectile dysfunction drug and supplement market
Against the background of erectile dysfunction drugs the sales of which reduced in real terms over the past five years, dietary supplements have held their positions for a long time. The reasons why the supplements were so stable are their relatively low prices and more liberal dispensing terms as compared with drugs.
[PharmVestnik # 2, 26/01/2016, p. 11]
The price of “social” format
In the past year, the authorities of many Russian regions initiated setting up socially oriented pharmacies. Some operating pharmacies were turned into discounters maintaining minimum markups. These projects hit the revenues of specific state enterprises; however, they hope to increase profitability in 2016 against the background of the overall shrinking demand.
[PharmVestnik # 2, 26/01/2016, p. 14]
