Regulatory tightening on dispensing alcohol drugs to be resolved shortly
[PharmVestnik # 03, 31/01/2017, p. 1, cont’d p. 4]
Experts highlight vagueness of wording of draft law on mandatory licensing
In mid-January, Association Inpharma acquainted the Federal Antimonopoly Service (FAS) with its standing on and assessment of potential risks of implementing mandatory licensing. To remind, February 2nd is the deadline for the completion of public discussion of the draft law amending the Federal Law “On protection of competition” and the Civil Code of the Russian Federation. Analysis of the opinions voiced both by businesses and relevant associations suggests that the mandatory licensing supporters represent a rather small group. When speaking against this procedure, businesses place primary emphasis upon the fact that mandatory licensing already legally exists in Russia, while the adoption of a new law may be fraught with many unpleasant aftereffects.
[PharmVestnik # 03, 31/01/2017, p. 3]
The existing drug certification and declaration system to pass into oblivion
The EAEU common market provides for unification of specific processes, including cancellation of certain procedures typical for national legislation systems. Changes will occur in the drug quality control system as well. Back in 2015, the Union of Professional Pharmaceutical Organizations called on the relevant ministries to pay attention to the existence of duplicate procedures. On the one hand, from the viewpoint of legal language, pharmaceutical manufacturers must obtain declarations of conformity, and in case of manufacturing immunobiologicals they must undergo certification; on the other hand, certification and declaration are not provided for in the EAEU regulations. PharmVestnik has a draft resolution intended to remedy the situation; however, experts believe that this will take about two years.
[PharmVestnik # 03, 31/01/2017, p. 4]
Regulations for faithful players
Implementation of new GDP standards will streamline relationships in pharma distribution
On March 1st, the MoH order on the implementation of GDP standards in the drug storage and transportation segment will come in force. PharmVestnik investigated the implications of this document together with ProfitMed Corporate Development Director Igor KLIMANOV.
[PharmVestnik # 03, 31/01/2017, p. 5]
Not all of experts believe that vaccination decreases ARVI and flu morbidity rates
In this epidemiological season, the ARVI and flu morbidity rates were not too high due to mass population vaccination all over Russia. Morbidity slowdown is expected in late January – February 2017. Some prominent medical speakers voiced this information during the roundtable discussion of the epidemiological situation in Russia on January 19th. At the same time, other experts believe that the epidemiological threshold has been exceeded in many Russian regions. However, this was mentioned without prejudice to the importance of mass vaccination.
[PharmVestnik # 03, 31/01/2017, p. 6]
Supplement manufacturers seeks for RUIE support
Manufacturers of dietary supplements count on strengthening their lobbying capabilities due to self-regulation. They rely on support of the Russian Union of Industrialists and Entrepreneurs (RUIE) to that end. Presently, the RUIE, Institute of Nutrition, and other relevant organizations are working on a draft regulation intended to broaden the mandate of self-regulatory supplement manufacturers.
[PharmVestnik # 03, 31/01/2017, p. 7]
Up-to-date cancer treatments require new funding approaches
A cancer morbidity rate growth is a worldwide trend. Science, in particular pharmacology, forge ahead, due to which diagnozed cancer is no longer a death sentence in economically developed countries. Russia also takes an active interest in implementing innovative treatment techniques. Domestic scientists have quite a lot of solutions to offer, but all innovative drugs are extremely expensive. Experts admit that the government will not be able to afford to pay for the next-generation cancer treatments.
[PharmVestnik # 03, 31/01/2017, p. 8]
Sourcing issues are often key to Private Label development
In late January, PharmVestnik Editor-in-Chief visited a regular event hosted under the aegis of Stamegna. The event was intended to bring together the interests of parapharmaceutical manufacturers and large pharmacy chain purchasers. The Editor-in-Chief shares his observations and conclusions.
[PharmVestnik # 03, 31/01/2017, p. 9]
Mistrust impedes telehealth
Assistant to the President for Internet Herman Klimenko is one of the Internet ‘founding fathers’ in Russia. According to him, healthcare and medicine have never submitted to the Internet. Herman KLIMENKO and PharmVestnik Editor-in-Chief Herman INOZEMTSEV discussed the reasons for that as well as routes that telehealth development in Russia may take at Radio Media Metrix.
[PharmVestnik # 03, 31/01/2017, p. 10]
More than manufacture
Localization in a country at the example of a company
The huge Russian market will always be attractive for large international pharmaceutical manufacturers notwithstanding all foreign policy discords. The government has always been and remains one of the key business partners as government biddings cover 25% of the demand (DSM, 2015). Presently, the state policy in the drug circulation area targets cutting on imports and creating preferences for local pharmaceutical manufacturers. As a result, foreign companies have to localize in Russia, and local companies are interested in mastering advanced technologies employed by the industry leaders. Despite skepticism of certain experts, the business community keeps acting. PharmVestnik gets to know how foreign companies are doing in Russia on the example of Pfizer.
[PharmVestnik # 03, 31/01/2017, p. 11]
Lawyers and FAS dispute about drug interchangeability concept
The drug interchangeability concept appeared for the first time in the Federal Law “On drug circulation” several years ago; however, drug interchangeability has not become a widely-used practice on the pharma market so far. But the Federal Antimonopoly Service (FAS) makes a wide use of this concept already today. In particular, the agency has circulated several letters on drug interchangeability. The Patient Advocacy League does not agree with the FAS’ approach.
[PharmVestnik # 03, 31/01/2017, p. 12]
Good opportunities for buying Big Pharma stocks now
Stock exchange is a ribbon indicating the economic state as a whole and by sector. As of 2016, this indicator showed that pharmaceutical stocks were not the so-called “security papers” any longer. Stock market players realized that the pharma industry faced dramatic changes and that it was not clear what each of the companies would bring along by the end of the global transformation. Therefore, traders began selling off pharma stocks. Thus, if someone has a long-held dream to become a transnational pharma company’s stockholder, the good time is now.
[PharmVestnik # 03, 31/01/2017, p. 14]
Antitussive and expectorant drug market report
Cough accompanies basically all cold-related diseases not only bringing discomfort to the patient but also helping him/her get rid from sputum that appears because of disease. Thus, cough serves for human body protection rather than being harmful. Cough may be cured using a number of drugs surveyed.
[PharmVestnik # 03, 31/01/2017, pp. 20-21]
Finished and bulk drug import to Russia, 2016
Over the last two years, the bulk drug import rate was significantly higher than that of finished drugs both in value and real terms. As of 2016, bulk imports exceeded a psychologically important value of 100 bn RUB (release for free circulation prices); currently, on average, each 9th imported drug dose gets to Russia in bulk. As compared with the pre-crisis 2014 year, the bulk drug share in the total drug imports in value terms increased nearly 1.5-fold and reached 17%.
[PharmVestnik # 03, 31/01/2017, pp. 22-23]
Specialists discuss orphan disease patient treatment
Annually, St. Petersburg spends about 1 bn RUB for drug coverage of orphan disease patients, but nobody can evaluate the efficiency of the money spent even given the shortage of funds.
[PharmVestnik # 03, 31/01/
