Russia plans to legalize telehealthcare services
Experts of the Internet Initiatives Development Foundation together with the Federation Council and Russia’s Ministry of Health are drafting a law that will, firstly, give a clear definition of a hazy notion of “telehealth” and, secondly, legalize online medical advice. This document has a “working” status and has not been posted for public discussion so far. However, it is already known that the principal novelty of this draft law is the method of payment for such services. As PharmVestnik came to know from the document developers, they suggest that doctors receive payment from the Compulsory Health Insurance funds for advice using information and communications technologies.
[PharmVestnik # 26, 01/09/2015, p. 1, cont’d p. 4]
VED list lacks “luxury”
Medical community asks not to save on innovative drugs
The main cause of the absence in the VED list of many innovative drugs is their economic “infeasibility”. The medical community understands that perfectly well, however asks the Ministry of Health at least to attempt finding a balance between things feasible in terms of the budget and those that make a patient’s life longer and better. Doctors do not believe that Russia will be able to set up manufacturing of innovative drugs on its own quickly, and at the same time, they are not always successful when trying to treat their patients with cheaper drugs.
[PharmVestnik # 26, 01/09/2015, pp. 2-3]
Pharmstandard may win back its status of the largest supplier for “Seven Diseases” program
One more high-cost originator drug has been substituted with a local generic in the state bidding within the framework of the “Seven Diseases” program. It goes about Janssen’s Velcade used in treatment of hematopoietic neoplasms and F-Sintez’s Boramilan. It is already the second large position lost by Pharmstandard under this program. However, one should not write off the Russian pharmaceutical giant, as the latter seems to have found a way out of the situation.
[PharmVestnik # 26, 01/09/2015, p. 5]
Parallel import initiative took international turning
A regular meeting of the Eurasian Economic Committee in late August charged an ad-hoc working group with the development of a decision-making mechanism on potential implementation of parallel import for specific commodity categories. The deadline is December 31, 2015. Opponents of this mechanism rely upon experts from the Republic of Belarus.
[PharmVestnik # 26, 01/09/2015, p. 6]
Not just “odd-man-out”
The pharma industry has concerns regarding what agency and in what way will be determining the country of origin of the drugs participating in the state bidding. Currently, the agency responsible for drug certification is the Chamber of Commerce and Industry. However, far from all pharmaceutical manufacturers are ready to accept the procedure proposed by the chamber and insist that the drug origin be determined by another agency.
[PharmVestnik # 26, 01/09/2015, p. 6]
Ministry’s of Health warning
Shortly, ministry plans to monitor drug prices, discuss state bidding for medical devices, and promote healthy lifestyle
The Ministry of Health signed a cooperation agreement with the public organization “National Health League”. This document envisages joint efforts in public healthcare, disease prevention, and healthy lifestyle formation. On August 26, Minister of Health Veronica Skvortsova and President of the National Health League Leo Bokeria held a press conference on that occasion. However, they had to not only release the information about this agreement but also cover some other burning issues of the Russian healthcare.
[PharmVestnik # 26, 01/09/2015, p. 7]
Nothing to substitute with
Why Children’s Rehabilitation and Hearing Health Services Center was left without speech processors
The Federal State Budgetary Institution “Children’s Rehabilitation and Hearing Health Services Center” all of a sudden found itself without speech processing cochlear implants. The reason voiced by the manufacturer’s representative in Russia was the absence of these devices in the country. Given a low competition in this market segment, the center has nothing to do but agree with the terms offered by the distributor and wait until November. The center had to include such terms and conditions in its online auction documentation as well. Meanwhile, on August 24, the information was posted on the state purchase website regarding another bidding for the same speech processors, however in a larger volume. The customer was St. Petersburg Research Institute of Otorhinolaryngology and Speech. The devices were to be supplied in the period of mid-September to mid-November. The Children’s Rehabilitation and Hearing Health Services Center’s management has to wonder what they have done to displease the distributor.
[PharmVestnik # 26, 01/09/2015, p. 9]
“Green route” for local APIs
Russian manufacturers raise the issue of preferences in API registration
A massive launch of local API production has been included in the government’s import substitution plan to provide for the national security. In response to the government orders, the relevant ministries have developed actions to support API production, which have boiled down to funding local manufacturers. However, experts believe that funding alone will not be able to revive the industry. Presently, the Russian chemical API market is characterized by a complete lack of manufacturing facilities meeting GMP requirements, up-to-date technologies as well as dependence on intermediate import. Therefore, manufacturers are sure that this segment will not be able to do without additional support measures including a revision of the existing API registration system.
[PharmVestnik # 26, 01/09/2015, p. 10]
Via administrative stages
Ministry of Industry and Trade developed regulations for issuing drug manufacturing stage certificates
Drafts regulations for issuing certificates regarding drug manufacturing stages in the EEU territory were submitted for public discussion. After the “odd-man-out” resolution comes in force, the regulators intend to support local manufacturers depending on the manufacture localization “depth”. The Ministry of Industry and Trade decided to start from developing its own regulations on providing this new type of state services.
[PharmVestnik # 26, 01/09/2015, p. 11]
Loophole in law
The authorities lack “authority” to discontinue online sales of dietary supplements
Online drug sales were prohibited back in 2007 pursuant to the Cabinet resolution “On Approval of Online Sales Procedure”. However, in practice, the question on the legality of such sales remains unresolved. Online sales of dietary supplements attract much less attention than those of drugs, which results in flourishing supplement trading. Director of Civil Department of law office “Cliff” Veronica KAZAKEVICH shared with PharmVestnik observer Elena Mekshun her opinion on the reasons why such practice exists.
[PharmVestnik # 26, 01/09/2015, p. 12]
New procedure
Pharmaceutical manufacturers operating in the Russian market have just a month left until October 1 to submit their applications for reregistration of maximum admissible prices for vital and essential drugs (VED). However, a new price registration procedure has not been approved so far, and it was only in mid-August that the Federal Antimonopoly Service started working on a relevant document. Market players discussed with PharmVestnik observer Anna Kurskaya the price reregistration prospects this year.
[PharmVestnik # 26, 01/09/2015, p. 13]
Vein tonic market report
Over the past three years, the vein tonic market grew by 28% in value terms. This trend is mostly due to the growing prices in this segment, an average price going up 17% a year.
[PharmVestnik # 26, 01/09/2015, pp. 14-15]
Diversity of pharmas
Rating of Russian pharmaceutical distributors, Q1-215
Seemingly, the top distributors feel quite well; the total concentration in the sector has significantly increased year on year. Most companies in the rating are also doing well, with positive dynamics demonstrated by 11 out of 15 wholesalers. What causes anxiety is the fact that there are two large, if not to say industry-forming, players among those four whose standings have deteriorated over the year. After what happened to Oriola and Imperia-Pharma, such dynamics is at least distressing. On the other hand, putting the famous psychoanalyst’s phrase in other words, “something a shrinking market share is just a shrinking market share”.
[PharmVestnik # 26, 01/09/2015, pp. 16-18]
Riding devaluation waves
Ruble falling in August will have negative effect on pharma market
Experts believe that in conditions of the already low demand it will be difficult for drug manufacturers to shuffle off the inflation burden totally on consumers; however, price hike cannot be avoided. Market players think that the current ruble crash is not as dramatic as the preceding one, although confirm that the situation is jitters both for consumers and pharmaceutical business.
[PharmVestnik # 26, 01/09/2015, p. 19]
Inexperienced head doctors charged with law violations
The end of summer in the south of Russia was marked by exposing a number of corruption cases in healthcare. The pay-offs in themselves were not very large ranging from 50 thousand to 400 thousand Rubles. However, it is distressing that it was the “new wave” head doctors that came to the attention of the law enforcement authorities. These doctors-in-chief were appointed quite recently after regional health ministries refused to prolong employment agreements with their predecessors.
[PharmVestnik # 26, 01/09/2015, p. 21]
Falling tenge
On August 20, devaluation of Kazakhstan national currency took place, which has become a climax of rumors spreading before that. This is the fifth devaluation of tenge in its rather short history. The pharma market is again in expectation of price growth.
[PharmVestnik # 26, 01/09/2015, p. 21]
