Urgent shake-up
SoyuzPharma goes SRO and makes unprecedented decision
[PharmVestnik # 22, 05/07/2016, p. 1, cont’d p. 3]
An “orphan” case
Genetika Association dispels a myth on orphan drugs accessibility
Criticism aimed at the regulators on part of the Association of Rare Disease Patient Advocacy Organizations “Genetika” (Genetics) is gaining ground. The advocates of the rights of orphan disease patients insist that the persons under their care differ from those covered by drugs under the Seven Disease Program. They also demand regular co-funding from the federal budget. Finally, they warn that the situation in the regions will become much worse in case of shifting their patients to generics. The Ministry of Health officials were in the heat of the moment as well in the course of the 3rd Information Workshop “Rare Diseases: a Dialog with the Society” held in late June in Moscow.
[PharmVestnik # 22, 05/07/2016, p. 2]
Minpromtorg to support low-cost drug manufacturers
Reportedly, the Ministry of Industry and Trade (Minpromtorg) has prepared and submitted for a review to the Russian Government a draft resolution that will establish simplified pricing for local low-cost drug manufacturers. The idea is that the manufacturers will be relatively free to raise drug prices within a 50 RUB range. Experts are sure that this does not mean that all drugs under 49 RUB will disappear from the market.
[PharmVestnik # 22, 05/07/2016, p. 4]
A large network of nuclear medicine under development in Russia
The government is working on a nuclear medicine development concept. A road map has already been approved. At the same time, in parallel with this paperwork, Rosnano and PET Technology (a private company) have been promoting positron emission tomography (PET) as a new type of disease diagnostics for already five years. There is a government share in this project, but this is the case when the government participation is most efficient – just allocating funds.
[PharmVestnik # 22, 05/07/2016, p. 4]
Experts outlined actions to improve drug coverage of hemophilia patients
The life expectancy of a hemophilia patient without due treatments usually does not exceed 30 years, with 90% of the patients dying handicapped. Currently the lives of more than 8 thousand patients in Russia depend on timely and relevant drug provision. Recently, Russia has made its way to the “club” of the countries paying adequate attention to hemophilia treatment, which is not to imply that all problems have been overcome.
[PharmVestnik # 22, 05/07/2016, p. 5]
Pharmaceutical alcohol to be registered
The pharma community was taken aback by the news that manufacturers of alcohol drugs were required to join the Unified State Automated Information System (USAIS). This will obligate the manufacturers to purchase special equipment and declare manufacturing, storage, supply, and procurement of drugs with ethyl alcohol content >25%. Such requirement may have several outcomes, e.g. contraction of the market, withdrawal of specific popular drugs, and a dramatic alcohol content decrease in galenic medications. It is also worth noting that the USAIS is closely related to excise stamps. However, experts are sure that pharmaceutical companies should not worry about extension of such type of labeling to all drugs.
[PharmVestnik # 22, 05/07/2016, p. 6]
Cell drug manufacturers got segment-specific law
The law “On cell biopharmaceuticals” that is to become effective on January 1, 2017, will put new obligations upon pharma companies, first of all – gratuitousness and voluntary character of donation for cell drug development. The clinical trial procedures have been determined as well, in particular, informing a trial subject at different stages.
[PharmVestnik # 22, 05/07/2016, p. 6]
High demand for high-quality services
Just a few Russian pharmaceutical manufacturers have potential for localizing hi-tech drugs
Quite recently, Petrovax Pharm, a local manufacturer, signed another drug localization agreement with an international company. It goes about manufacturing of hi-tech cardiac drugs for Boehringer Ingelheim. Petrovax Pharm President Elena ARKHANGELSKAYA, a recent guest of the “Editorial Fireplace” rubric, shared information on this project as well as on the flu vaccine market, exports, and company’s own portfolio development.
[PharmVestnik # 22, 05/07/2016, p. 7]
Hemato-bureaucratic barrier
Problems persist in drug coverage of blood disorder patients
Hematologic and oncohematologic patients are worried about the fact that regional authorities fail to fulfil their obligations in respect of beneficiary drug coverage. Most of the patients have chronic diseases; therefore, treatment gaps may derail substantial treatment costs sustained in the preceding years.
[PharmVestnik # 22, 05/07/2016, p. 8]
Foreign manufacturer become more active in localizing hi-tech drugs
As soon as a discussion started on the implementation of the “odd-man-out” regulation in respect of the state bidding in Russia, and as soon as, together with that, foreign manufacturers began thinking about the presence of local analogs on the market, they started revising their strategies in Russia. All of a sudden, it turned out that packaging was not enough in order to be treated as a local manufacturer, whereas constructing facilities of their own was either too late or did not pay. Since 2014, news was coming increasingly often about full-cycle drug manufacture localization. Presently, there are about two dozens of such examples, which may give impetus to the development of contract manufacturing in Russia.
[PharmVestnik # 22, 05/07/2016, p. 10]
Venotonic market report, May 2015 — April 2016
According to the WHO, vein diseases are on the “civilization disease” list. Without doubt, vein diseases of the lower extremities are of a huge socioeconomic importance as their prevalence and morbidity directly affect the population’s working capacity.
[PharmVestnik # 22, 05/07/2016, pp. 12-13]
Drug state bidding report, Q116
Notwithstanding the fact that much has already been done for those interested in the state bidding information, far from all relevant data may be retrieved from the central bidding site (http://zakupki.gov.ru). This is exactly why bidding data collection, analysis, and relevant presentation services are in high demand. Cursor Marketing is one of the providers of such services. The agency monitors the entire state bidding cycle split into three blocks, i.e. Cursor.Procurement Plans, Cursor.Bid Monitoring, and Cursor.Contracts.
[PharmVestnik # 22, 05/07/2016, pp. 14-15]
Ukrainian pharma market report, Q116
The main reason behind market players’ interest in the Ukrainian pharma market is that it is affected by the same factors as the Russian market. Like Russia, the Ukraine is going through a consumer demand decrease due to economic factors. Besides, the Ukraine ranks first among the countries importing Russian drugs. According to RNC Pharma, the Russian drug export turnover related to the Ukraine grew by 90% in 2015. PharmVestnik publishes the first market report prepared by AP-Pharma Consulting.
[PharmVestnik # 22, 05/07/2016, pp. 18-19]
Is Pharmageddon upcoming?
Oncologists differ in their opinions on drug interchangeability
The symposium “Therapy without foreign drugs: Pharmageddon or new prospects?” within the framework of the 2nd St. Petersburg Cancer Forum “The White Nights” was marked by heated disputes with a touch of alarm. The disputes centered on local biosimilars, as the symposium was Biocad-sponsored. The main conclusion is that the Russian specialists still have certain doubts about biosimilar efficacy.
[PharmVestnik # 22, 05/07/2016, p. 20]
Detecting meldonium
A new doping control device developed in Siberia
While meldonium scandals keep shaking the sports world, Tomsk researchers are in the process of launching to the market of a new express analysis device for detecting meldonium content in the athletes’ blood and in the dietary supplements. It is expected that this portable biochemical analyzer will be on sale already this winter, and that its use will become a legal doping control practice.
[PharmVestnik # 22, 05/07/2016, p. 22]
