“Odd man out”
Resolution limiting access of foreign manufacturers to state bidding signed
On November 30, Premier Dmitry Medvedev signed the government resolution that had been nicknamed the “odd man out” by Pharma market players. It took really long to sign this document the concept of which has been one of the most debatable. The document has not been changed dramatically over the period its development was underway. The first draft that used to read as “Russia, Belarus, and Kazakhstan” currently reads as “the Eurasian Economic Union (EEU) member states”. The deadline starting from which the packaging stage will not be considered local manufacturing any longer has been postponed for a year. The experts who have warned about “surprises” associated with the regulatory enforcement of this document are eager to see how this novelty would come out in bidding.
[PharmVestnik # 40, 08/12/2015, p. 1, cont’d p. 5]
Ready Steady Go!
Pharma industry against prolongation of common drug market launch deadline
Less than a month is left until the agreement on drug and medical device circulation within the EEU common market comes in force. And it is right now that the debates on possible postponing of the deadline that have been underway over the past year have become especially fierce. The business community maintains that some regulators are trying to put a brake on the process and postpone the launch of the common market indefinitely. Thus, the product circulation regulations currently in force will continue to apply, which runs counter to the basic agreement signed by the presidents of the EEU member states. Quite recently, it has emerged that the second level documents need to undergo further legal treatment, which in itself sets the professional community wondering. Proceeding from the EEU basic agreement, businesses insist that all procedures associated with the formation of the legal framework for launching a common drug market must be completed on time. They are ready to operate in a common market environment.
[PharmVestnik # 40, 08/12/2015, p. 1, cont’d p. 2]
Spare money
In early December, DSM Group marketing agency made an attempt at highlighting healthcare problems in the Republic of Crimea. To this end, the agency held a special forum. Representatives of the respective Crimean authorities as well as local businesses made the basic problems underlying the new Russian region’s development abundantly clear. The permanent blackouts have not been able to disrupt the discussion.
[PharmVestnik # 40, 08/12/2015, p. 3]
Two heads are better
Fully localized companies to be granted double preferences
At the end of November, the Russian Ministry of Industry and Trade (Minpromtorg) voiced readiness to grant 30% price preferences to pharmaceutical companies manufacturing APIs of their own. Experts have no doubts that such measure will prove efficacious in terms of improving the investment environment in the Russian Pharma market as well as beneficial for domestic and localized manufacturers. However, analysts forecast new problems in store for the health system players that are not associated with manufacturing.
[PharmVestnik # 40, 08/12/2015, p. 4]
Rostech agitated Russian Pharma market
Neither Russian nor foreign manufacturers understand the state corporation’s role in the industry
Presently, virtually all efforts by the executive authorities are aimed are retaining the investment appeal of the Russian industry. However in practice, all such efforts prove to be just statements. Sometimes the authorities take steps that are difficult to explain proceeding from the current market situation, e.g. making a statement about a single source of drug purchases and nominating Rostech as the single provider of specific drugs.
[PharmVestnik # 40, 08/12/2015, p. 1, cont’d p. 6]
What regulation is missing that might have made Pharma happy
When summing up the first results of 2016, the Russian Pharma market players agree that the legislation has remained unharmonized. Representatives of pharmaceutical companies maintain that a clear understanding of the legal environment vector will help them develop the best strategies for operating in the Russian market. Therefore when PharmVestnik’s Editor-in-Chief Herman Inozemtsev who moderated the “State Regulation of the Pharmaceutical Industry” conference asked what regulation the industry was missing, the response came as break smiles of the audience. Everybody understands too well that less than 30 days are left until the EEU drug and medical device common market is to be launched, and a local manufacturer’s status is to be clearly defined. Together with that, it is to be made clear how and when drug manufacturing sites are to be inspected for GMP compliance.
[PharmVestnik # 40, 08/12/2015, p. 8]
Pharma CFOs offered anticrisis formula for 2016
Some analysts do not foresee serious financial shocks for pharmaceutical companies next year – just because the market cannot sink any deeper. But whereas at the beginning of this year some experts believed that the ruble would be able to win its positions back, now one cannot even dream about that. Besides, the EEU common drug market is to be launched already next year. The government will be focused on the implementation of the import substitution programs as well. That is why the companies that have more than once declared that they were ready for changes are nonetheless revising their strategies for the coming year.
[PharmVestnik # 40, 08/12/2015, p. 10]
Added value
The media often mention pharmacies that have been fined for exceeding the maximum admissible VED (Vital and Essential Drugs) prices. A natural question arises: Why does that happen? The most popular answer is likely to be like this: They are willing to earn as much as possible even selling the VED. This may be one of the reasons. But there is one more reason that has to do not so much with business as with regulation, namely the VAT.
[PharmVestnik # 40, 08/12/2015, p. 10]
What we need is balance
The “Editorial Fireplace” rubric invited Akrikhin President Denis CHETVERIKOV. He told PharmVestnik about the results of his work over the last 18 months as well as shared his vision of the Russian pharmaceutical market.
[PharmVestnik # 40, 08/12/2015, p. 11]
Boehringer Ingelheim to localize a biotech drug
The company may become one of the first beneficiaries of the special investment contract
Boehringer Ingelheim voiced its drug localization plans back in December 2014. However, no further information regarding the localization progress has been received from this manufacturer over the past year. Boehringer Ingelheim LLC CEO Pavol DOBROCKI told PharmVestnik whether such plans were likely to be implemented.
[PharmVestnik # 40, 08/12/2015, p. 12]
Experts discussed pressing import substitution and drug localization issues
The meeting of the Russian Association of Pharmaceutical Marketing titled “The Russian and Foreign Drug Manufacturers in the Era of Import Substitution: Parity? Competition? Where Will the Pendulum Swing?” held on November 26 was not quite regular. A special guest at that meeting was a Minpromtorg representative. The participants emphasized a growth of the local drug manufacture. However, opinions were voiced that, while struggling to become increasingly independent from imported pharmaceuticals, Russia shall be more active developing the innovative component of the national Pharma. As Minpromtorg’s position in resolving this issue is very important, experts still hope to get answers to the “unsolvable questions”.
[PharmVestnik # 40, 08/12/2015, pp. 14-15]
Evolutionary changes
At the end of November, Mikhail STEPANOV took charge of Biotec Group. Mr. Stepanov has a vast experience in managing holding companies. In his interview to PharmVestnik, Mr. Stepanov related his vision of Biotec’s process management structure in the short term as well as the corporate development prospects.
[PharmVestnik # 40, 08/12/2015, p. 16]
Glimpse of market
[PharmVestnik # 40, 08/12/2015, p. 19]
Localization of manufacture of certain out-of-pocket drugs in Russia
The ‘odd man out” resolution approved by the Russian government provides for limiting access of imported drugs to state bidding. According to IMS Health, the state sector accounts for approximately 33% of the Russian Pharma market, the rest being taken by retail drug sales. Foreign companies take different approaches when making decisions on localization of manufacture for the drugs mainly selling via retail channels.
[PharmVestnik # 40, 08/12/2015, pp. 20-21]
Concealed reactions
According to the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor), over the last five years, the number of adverse event (AE) reports in the “Pharmacovigilance” computerized information system increased twofold — from 10,000 to 21,000 annually. However, patients keep complaining about the unsatisfactory drug quality, while doctors report AE cases much less frequently than in Europe.
[PharmVestnik # 40, 08/12/2015, p. 24]
How to evaluate the invaluable
St. Petersburg to set up a regional system for assessing medical technologies
In 2016, St. Petersburg authorities intend to earmark 75 bn RUB from the city budget for healthcare needs. This money is clearly not to be enough; therefore the efficiency of spending is an issue. But who and how may assess that efficiency? The participants of the “Health Economics Efficiency” session held within the framework of the 5th International Partnering Forum “Life Sciences Invest” tried to find an answer to this question.
[PharmVestnik # 40, 08/12/2015, p. 25]
