Rating of most influential subjects of the Russian Pharma market, 2015
[PharmVestnik # 8, 07/03/2016, p. 1, cont’d pp. 4-6]
Fee calculation methods for foreign drug manufacturing site audits have not been canceled
The methods of calculating fees for foreign drug manufacturing site audits had been heavily criticized by the professional community even before they were tested in practice. The fact that the document approving such methods has come into force has not prevented certain experts from insisting on its revision and consequently on changing the audit fee arrangement. The Federal Antimonopoly Service (FAS) held a closed meeting on the issue, but an attempt to calculate fees based on different methods has failed as the cost of the Russian GMP compliance audits has gone up instead of being reduced.
[PharmVestnik # 8, 07/03/2016, p. 2]
FAS cautions MoH
The FAS charged the Russian Ministry of Health with violation the law “On protection of competition” and called on the latter to remedy the violation. According to the FAS, the MoH was overdoing when making amendments to the State Registry of Maximum Drug Sale Prices thus putting obstacles to adequate operations of drug manufacturers.
[PharmVestnik # 8, 07/03/2016, p. 3]
Good cause
A way to preserve cheaper drugs on the market was found back in early February
The Ministry of Industry and Trade (Minpromtorg) maintains that there is no need in heavy regulation of prices for cheaper drugs. This was the ministry’s response to the government’s request for developing actions supporting manufacturers in the low-cost drug segment. The manufacturers themselves asked to deregulate prices. However, it looks like there is no consensus among the relevant ministries.
[PharmVestnik # 8, 07/03/2016, p. 3]
A license controversy
Minpromtorg filed a lawsuit against Pharm-Sintez
On March 9, Moscow Arbitration court will initiate hearings on the Ministry’s of Industry and Trade lawsuit against Pharm-Sintez regarding observance of the license requirements and conditions. The manufacturer makes it clear that it goes about the contract manufacturing site.
[PharmVestnik # 8, 07/03/2016, p. 7]
The price of parallel import legalization
The initiative of implementing the parallel import (PI) principles in Russia is so long-standing that when enlarging on the issue within the framework of the EEU—CIS Pharma Forum, the FAS speaker (the FAS being a heavy PI lobbyist) had to go back into the past in order to rationalize the agency’s position. But notwithstanding the fact that it took nearly 10 years to study all pros and cons of the PI mechanism, the government is in no hurry to make a final decision. In the course of the forum, the experts proposed to discuss PI based on the example of the CIS countries that have to live with it either legally or not always legally.
[PharmVestnik # 8, 07/03/2016, p. 7]
Not by competition alone
NatsImBio strengthens its market presence
PharmVestnik met with National Immunobiological Company’s (NatsImBio) CEO Nickolay SEMYONOV to discuss the opportunities of using an unified supplier, where the development funding was coming from, and the company’s plans for the nearest future.
[PharmVestnik # 8, 07/03/2016, p. 8]
Mandatory licensing to be continued
The FAS submitted a draft law on mandatory licensing for public debate. The intents specified at the state information disclosure website manifest a new stage in the development of the story associated with the attempts to neutralize unwanted patents. The FAS officials pointed out that they were primarily concerned with HIV drugs.
[PharmVestnik # 8, 07/03/2016, p. 9]
In good time
EEU to refrain from setting up a common pharmacovigilance and inspection body for a time being
The necessity of creating a supranational structure to perform drug registration or control functions in the EEU common market will arise only after 2025. An important prerequisite is that by that time, the EEU members will have to demonstrate an adequate operation of the decentralization and mutual recognition procedure. The ECE officials clarified that this was a national security issue related to drug coverage. Experts agree that it is premature to discuss such structure now, partly because the market “commonness” prospects are doubtful.
[PharmVestnik # 8, 07/03/2016, p. 11]
Common vacuum
Experts unveil causes torpedoing common drug market launch in EEU
The situation regarding a common drug market launch in the EEU is rather complex. De jure, the drug circulation based on common regulations started in the EEU member-countries on January 1, 2016, pursuant to the international agreement. De facto, it is currently impossible to register drugs according to the EEU regulations as the legal framework differences have not been overcome so far. Consequently, it will be incorrect to say that 2016 is the first year of the common Pharma market operation until the entire package of documents is approved by all EEU members. Within the framework of the EEU—CIS Pharma Forum held in Moscow on March 1, the regulators and Pharma community tried to answer the question on what was in the way of launching a common drug market in the EEU.
[PharmVestnik # 8, 07/03/2016, p. 12]
Inexorable logic
Vadim Myzyaev on business consolidation and unfair competition intolerance
In March, the “Editorial Fireplace” rubric hosted Protek Group President Vadim MYZYAEV. Mr. Myzyaev summed up the 2015 results for the group, shared some business development plans (e.g., pharmacy chain expansion and construction of a solid dosage form facility in Sergiyev Posad district of Moscow region) as well as his vision of a completely new approach to making business in the changed macroeconomic environment.
[PharmVestnik # 8, 07/03/2016, p. 13]
Orphan breakthrough
Regional authorities impose part of orphan drug costs on Mandatory Medical Insurance system
The orphan drug provision problem has been burning for the Federal subjects for many years running. A proposal to shift the responsibility to the federal level keeps being voiced at a variety of expert sites. However, the problem had not been resolved systematically so far; therefore the regional authorities are trying to find a solution on their own, in particular, shift the drug coverage of rare disease patients onto the Mandatory Medical Insurance funds.
[PharmVestnik # 8, 07/03/2016, p. 14]
India strives to build up presence on Russian Pharma market
The Indian Pharma industry is associated with a few companies that have been successfully operating in Russia for a long time. But the number of Indian Pharma companies doing business in Russia may grow shortly. This was one of the topics discussed at the Indian—Russian Pharmaceutical Forum held under the aegis of PHARMEXCIL (Pharmaceuticals Export Promotion Council). The Russian Association of Pharmaceutical marketing was among the forum partners.
[PharmVestnik # 8, 07/03/2016, p. 15]
Different approaches to market size evaluation
AlphaRM evaluated the Russian out-of-pocket drug sector as of 2015 at 693.2 bn RUB and 5 bn package units.
[PharmVestnik # 8, 07/03/2016, pp. 16-17]
Two pharmacy chains in Krasnodar territory facing acquisition
Zdravservice (managing company of pharmacy chain Tvoy Doctor) from Tula strengthens its grip in the Southern Russia. Less than a year ago, the company acquired Russkaya Troyka wholesaler in Ksasnodar having turned it into Zdravservice-Yug, and currently it focuses on retailers. It looks like two regional pharmacy chains, namely Sanpharma and Ketgut-Pharma, are getting ready to become part of Tvoy Doctor.
[PharmVestnik # 8, 07/03/2016, p. 20]
Unlimited access
Pharmacy chain opens center for disabled
In Omsk, a center selling orthopedic and medical devices for the disabled people was launched that fully complies with the Accessible Environment Federal Program.
[PharmVestnik # 8, 07/03/2016, p. 21]
Copter-borne to nuclear pharmacy
Radiopharmaceutical marker underdeveloped so far
PET Technology Co. (a Rosnano’s affiliate) has constructed and tested the first in Sverdlovsk region PET (positron emission technology) center. The center is to start screening patients on March 17. According to FAS experts, the only drawback of this project is that radiotracers will have to be flown 500 km.
[PharmVestnik # 8, 07/03/2016, p. 21]
