A generic country
Discussion on compulsory licensing of anti-HIV drugs in Russia gaining ground
Antiretroviral drugs are the main candidates for compulsory licensing in the Russian Federation. Notwithstanding the fact that the Russian state is cautious regarding “expropriation” of international Pharma corporations’ intellectual property, it is time for manufacturers of advanced anti-HIV drugs to make allowance for Russia’s “poverty”. The issue of compulsory drug licensing, i.e. manufacturing without a rights holder’s permit, has been the subject of a heated discussion since the last year’s end. The arguments have been the economic crisis, a response to the Western sanctions as well as the necessity of the import substitution in respect of the drugs that have become too expensive because of the ruble crash.
[PharmVestnik # 34, 27/10/2015, p. 1, cont’d p. 3]
FAS pointed out controversy with EEC member states
Experts of Russia’s Federal Antimonopoly Service (FAS) characterized as “tortuous” the talks being conducted at the Eurasian Economic Commission (EEC) level on creating a common drug market in the territory of the EEC member states. A number of controversies have not been removed yet, which impede finalizing the efforts on forming a package of appropriate documents. A statement on the matter was made on October 16 in Moscow at the 7th Annual Conference “Antimonopoly Regulation in Russia”, within the framework of which a special section for discussing the development vectors of the drug and medical device market was held. The event was hosted by Vedomosti newspaper.
[PharmVestnik # 34, 27/10/2015, p. 1, cont’d p. 2]
Striving for legal certainty
PharmVestnik-TV marked its 1st anniversary together with the first hero of the “Editorial Fireplace” rubric, Head of Department for Social Sphere and Trade Control under the FAS Timofey NIZHEGORODTSEV. In his conversation with PharmVestnik Editor-in-Chief Herman Inozemtsev and reporter Polina Zvezdina, Mr. Nizhegorodtsev described what has changed in the FAS operations over the past year as well as confessed that the FAS had to put pressure on drug manufacturers for objective reasons only.
[PharmVestnik # 34, 27/10/2015, p. 4]
It is never long that comes at last
AstraZeneca finished constructing its plant
Late October saw a launching ceremony of AstraZeneca Russia’s manufacturing facility in Kaluga region. The total investments in this facility exceeded 224 mn USD. The company’s initial plan was to spend 150 mn USD and release the first drug lot already back in the spring of 2013. At the launching conference, AstraZeneca’s representatives have kept it to themselves why the original plan has not been implemented; however, according to what PharmVestnik has come to know, one of the reasons of changing the launching schedule was an adjustment of the desired output as well as the depth of localization.
[PharmVestnik # 34, 27/10/2015, p. 5]
Package, sir!
State bidders use discrepancies in drug origin to their benefit
Foreign pharmaceutical manufacturers dread the upcoming date of January 1, 2016: from that date on, drugs packaged in Russia will not be considered local. Very few people pay attention to the fact that for the drugs participating in the state bidding, packaging has not granted the status of a local product since 2008. Notwithstanding this fact, state bidders have managed to get around the law and save 15% of their costs.
[PharmVestnik # 34, 27/10/2015, p. 5]
Insulin pump
A newcomer in diabetes drug market
The state is really serious in what concerns insulin import substitution. President Putin ordered not only to take stock of the existing insulin manufacturing facilities but also develop a draft project of a new insulin production complex in the town of Pushchino. In the meantime, the already operating manufacturer Geropharm voiced intent to expand its insulin API production capacities.
[PharmVestnik # 34, 27/10/2015, p. 1, cont’d p. 7]
“Good luck” letters
Insurance companies continue looking for their place in compulsory health insurance system
Since 2016, the insurance companies operating in the compulsory health insurance system will be obligated to inform all insured parties in writing on the cost of treatment. The professional community differs in approaches to this novelty. The insurance companies are ready to comply with this regulation despite the paper and postal costs, but apparently provided that their other functions will remain the same. The economists wonder why the insurers have to support the paper industry in such a way. They also wonder whether the insurance companies should better focus on protecting the patient rights.
[PharmVestnik # 34, 27/10/2015, p. 8]
Power of national specifics
The drug registration and assessment regulations are one of the documents the Pharma community has been looking forward to most eagerly. These regulations have been developed against the background of tough discussion. First, it was only Russia that insisted on mandatory local clinical trials. Then Belarus took a similar position. Currently, virtually all EEU member states have signed under this requirement. The experts shared their opinions regarding why local clinical trials were necessary.
[PharmVestnik # 34, 27/10/2015, p. 9]
Activated coal evolution
Enterosorbent market report, September 2014 — August 2015 (MAT August 2015)
Activated coal is rightfully considered to be the first enterosorbent in history. It is still used in medical practice to treat both flatulency and severe heavy metal poisoning. However, presently the enterosorbent market segment boasts a wide range of agents used in a variety of symptoms and diseases.
[PharmVestnik # 34, 27/10/2015, pp. 10-11]
The difference is in retail
Target appraisal of promotion budget allocation efficiency in pharmaceutical retail
Despite the economic slowdown, and partly due to such slowdown, Russia’s pharmaceutical retail sector continues developing virtually at a higher rate than before the crisis. Individual pharmacy chains report on new advances while increasing their outlet numbers, turnover, and, naturally, market share. However, the quality issues regarding the pharmacy chain status and development are often beyond the scope of such reports. Meanwhile, some relatively small chains may outstrip leading pharmaceutical retailers if we take a closer look at them.
[PharmVestnik # 34, 27/10/2015, pp. 12-13]
No escape from court
It follows from practical experience of Moscow Court of Arbitration that pharmaceutical companies, pharmacies, and other healthcare agencies lead the ranks in terms of the number of proceedings among all plaintiff and defendant categories.
[PharmVestnik # 34, 27/10/2015, p. 15]
Drugs before money
Drug coverage system being improved in Russia’s regions
Since early 2000s, the drug reimbursement system for patients eligible for benefits has been functioning successfully in Krasnoyarsk territory. Under this system, patients can get their drugs on the day they visit a doctor, and health organizations are able to manage their treatment processes. The drug coverage system in the Republic of Crimea is organized in a similar way. The regional authorities believe that this experience needs to be expanded to the entire Russia Federation territory.
[PharmVestnik # 34, 27/10/2015, p. 16]
Chimeras and reality
The Laboratory of Molecular Genetics of Pathogenic Microorganisms under St. Petersburg Institute of Experimental Medicine that has recently marked its 125th anniversary has completed preclinical trials of two new vaccines — one pneumococcal, the other group B streptococcal. The streptococcal vaccine studies were funded from the “Pharma—2020” federal program. Prof. Alexander SUVOROV, Head of Molecular Microbiology Department of St. Petersburg Institute of Experimental Medicine, related to PharmVestnik in what way the locally developed vaccines will differ in principle from those already existing or being developed on a global scale.
[PharmVestnik # 34, 27/10/2015, p. 17]
Two medical and pharmaceutical plants to be built in Southern Russia
At a regular economic forum in Sochi, the governors of two Southern Russian regions signed large-scale investment agreements in the medical and pharmaceutical field. Krasnodar territory intends to construct a syringe and blood transfusion device manufacturing facility jointly with Chinese partners, while the Karachai-Cherkess Republic plans to build a medical glass production plant.
[PharmVestnik # 34, 27/10/2015, p. 17]
Broad Pharma M&A picture still unclear
The panic in the Pharma and biotech stock segment caused by Hillary Clinton's statement on intent to set limits to high drug prices has disturbed the peace of top managers. Over the three weeks that have passed since the wannabe president’s statement, the NASDAQ traded stocks lost 130 bn USD. In Russia, little attention is usually paid to the stock market when planning M&A’s. However, the M&A process has slowed down in this country as well, but for different reasons.
[PharmVestnik # 34, 27/10/2015, p. 18]
Refunding for no-effect
Drug and medical device manufacturers may share risks with hospitals and insurance companies
In June 2014, Susan DeVore, President and CEO of Premier, Inc., when speaking to the audience of top managers of drug and medical device manufacturing companies, asked who of the audience was willing to tie-in their drug or device prices with the treatment outcomes. According to her, just a few hands raised. She believes that the majority of the audience was scared because the very idea of sharing risks is rather new, Bloomberg writes.
Meanwhile in Russia, there are risk-sharing projects that are already being implemented.
[PharmVestnik # 34, 27/10/2015, p. 19]
Advertising without PR
Advantages and risks of marketing agreements
This autumn, the State Duma deputies once again touched upon the drug media advertising ban issue. It embraces all nonmedical carriers, including SMS mailing and outdoor banners. If the appropriate amendments to the law “On Advertising” are approved after all, pharmacies will remain one of the very few drug promotion channels. A demand for marketing agreements between drug manufacturers and pharmacy chains may also go up given the pharmacists’ growing impact on the customer choice.
[PharmVestnik # 34, 27/10/2015, p. 24]
