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Current issue #15, 2016

Current issue #15, 2016

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Foreign pharmaceutical manufacturers developed a Code of Good Practices

In April 2016, a Code of Good Practices for the pharmaceutical industry came into force; the code was co-developed by the Federal Antimonopoly Service (FAS) and Association of European Businesses (AEB). Now the association members may be willing to join this document and thus protect themselves against conflicts with their counterparties. In essence, this code is a “side effect” of lengthy court proceedings between Israeli manufacturer Teva and Russian distributor Biotec. However, this document embraces not only manufacturer—distributor relationships but also other aspects of the pharma business.

[PharmVestnik # 15, 26/04/2016, p. 1, cont'd p. 4]

FAS considers mandatory licensing to be last resort

In mid-April, the Russian Union of Industrialists and Entrepreneurs, Federal Antimonopoly Service, and legal firm VEGAS LEX held a meeting in order to discuss the prospects of implementing mandatory licensing. The FAS snatched at the opportunity to explain that they did not consider mandatory licensing the main tool for increasing drug affordability and availability.

[PharmVestnik # 15, 26/04/2016, p. 2]

Experts advise to take care when splitting companies operating in Russia into local and foreign

Local manufacturers become increasingly active when claiming their rights to special preferences. The status of a “Russian” (local) manufacturer grows into a powerful reason in the struggle for a market share. However, while striving to win as influential patron as the government, businesses forget that foreign companies that have passed the entire localization path are as legitimate claimants upon all kinds of preferences as themselves. This point was brought to light, among other things, by leaders of the relevant associations who advocated the interests of the localized market players when speaking at a joint meeting of the Russian Union of Industrialists and Entrepreneurs commissions for healthcare, pharmaceutical, and medical industries.

[PharmVestnik # 15, 26/04/2016, p. 3]

Main pharma industry awards presented

On April 21, the results of the 16th Annual All-Russia Open Contest “Platinum Ounce” were summarized. Justice was done to the most promising ideas, best practices implemented, performance of business models etc.

[PharmVestnik # 15, 26/04/2016, p. 5]

Health Minister reports successes as of 2015

On April 20, a closing collegium of the Ministry of Health was held that discussed the achievements of the past year and tasks for this year. Health Minister Veronica Skvortsova, who was one of the speakers, made a very smooth and optimistic report that was vividly commented by the collegium members trying to catch all implications of the minister’s speech.

[PharmVestnik # 15, 26/04/2016, p. 5]

Underfunded medical device manufacturers revise their product portfolios

According to experts, the economic situation in Russia is unlikely to stabilize before 2019. They insist that it goes about stabilization, not about improvement or coming back to the before-the-crisis levels. Therefore, the worst-case decision is trying to wait out the hard times. Medical equipment and device manufacturers ought to learn how to live through the current environment, which means a revision of their business plans. According to analysts, the best strategic pathways are presently manufacturing low-cost products or launching exclusive commodities to the market.

[PharmVestnik # 15, 26/04/2016, p. 6]

WADA softened their position on meldonium

Mildronate manufacturer hopes that the drug’s reputation will be completely restored in 2017

On April 14, the World Anti-Doping Agency (WADA) issued a special statement saying that some athletes who tested positive for meldonium might be able to avoid sanctions. WADA experts do not have reliable scientific evidence on meldonium clearance period, and they supposed that it might still remain in the athletes’ bodies after January 1, 2016, even if taken before the WADA’s decision on adding it to the prohibited drug list. In turn, Mildronate manufacturer Grindex hopes for an open dialog with the WADA and will make every possible effort to have meldonium excluded from the prohibited drug list.

[PharmVestnik # 15, 26/04/2016, p. 7]

Russian as a trend

The underlying message of the import substitution strategy is not always understood in the right way. Most often, foreign companies take the import substitution vector as a restrictive policy, whereas the main objective of transformations underway in Russia is the export potential development. The latter was the topic of conversation within the framework of the “Editorial Fireplace” rubric with Interlek founder and CEO Farkhad ABUTALIEV who has been actively developing export business for more than 10 years.

[PharmVestnik # 15, 26/04/2016, p. 8]

36.6 Group not to close major pharmacy businesses

In mid-April, 36.6 Group representatives disclosed their plans for managing Alliance Healthcare Russia assets in the short term. The new owner will retain the company’s major projects, i.e. the Association of Independent Pharmacies Alphega and the pharmacy computerization application InfoApteka.

[PharmVestnik # 15, 26/04/2016, p. 9]

Pharmaceutical advertising market as reflected in specialized printed media

The promotional activity rate is a sensitive ‘gauge” of the state of affairs in an industry. Even such narrowly specialized segment as drug advertising that targets physicians and pharmacists reflects general trends of the financial and economic crisis of 2015. An analysis of pharmaceutical advertising in specialized media was made based on quarterly study by Contenta Medical IndexTM titled “Monitoring of Drug Advertising and Context Analysis of Scientific Articles in Specialized Medical and Pharmaceutical Media”. The sample was derived based on the list of media present in the monitoring as of 2013—2015, without those added recently.

[PharmVestnik # 15, 26/04/2016, p. 12]

Methods of PDE5 inhibitor detection in “male” dietary supplements approved

This March, the State Food Safety Service under the Ministry of Agriculture of the Republic of Armenia suspended imports of dietary supplements Alikaps and Sealex Forte. The reason was the undeclared ingredients, namely PDE5 inhibitors, detected in these supplements. A similar decision was made a month before by the Republic of Belarus, another EEU member.

[PharmVestnik # 15, 26/04/2016, p. 13]

Russian drug export analysis, 2015

PharmVestnik published quite a few ratings for various sectors of the Russian pharma market as of 2015. However, drug export operations, although less impressive in size than most other sectors, but still very important, have been overlooked. This report was prepared to make up for this information gap.

[PharmVestnik # 15, 26/04/2016, p. 14]

A new term in import

There is nothing new about the initiative of implementing parallel import principles in Russia; nevertheless, disputes around it continue. A possible reason behind these disputes is different viewpoints on what the parallel import in fact is. Thus, intellectual property ombudsman Anatoly Semyonov proposed a new term, namely a transnational principle of parallel import use.

[PharmVestnik # 15, 26/04/2016, p. 15]

Dietary supplement market report, 2015

Dietary supplements were in focus of the state and regulatory authorities in 2015. Since January 2015, the Federal Law No. 532-FZ “On amendments to individual regulatory acts of the Russian Federation with regard to action against circulation of fraudulent, counterfeit, poor-quality, and non-registered drugs and medical devices as well as fraudulent dietary supplements” dated 31.12.2014 came into force. This law toughened the criminal and administrative responsibility for selling fraudulent dietary supplements. The impact of this and other factors is reflected in the dietary supplement market report prepared by DSM Group.

[PharmVestnik # 15, 26/04/2016, pp. 16-17]

Biotherapeutics used in rheumatoid arthritis produce both clinical and economic effect

According to the Ministry of Health, nearly 300,000 patients diagnosed with rheumatoid arthritis were registered in Russia as of 2014. According to IMS Health, NSAID sales in Russia totaled 31.7 bn RUB in 2015. Acad. Vadim MAZUROV, Rheumatologist-in-Chief of the Northwestern Federal District, St. Petersburg General Practitioner-in-Chief, told PharmVestnik about the main issues related to drug coverage of this patient group.

[PharmVestnik # 15, 26/04/2016, p. 20]

All-Russia People’s Front struggles for beneficiary’s rights

According to the Ministry of Health of Perm Territory, not all citizens within this territory entitled to beneficiary drug coverage are able to use their rights in full. This is inadmissible as the required drug presence or absence often translates into a life-or-death situation.

[PharmVestnik # 15, 26/04/2016, p. 21]

Association of Volgograd municipal unitary pharmacies proved viable

When in the end of 2015 Volgograd City Duma decided to unite 10 municipal unitary pharmacies and one optics store into a single municipal unitary enterprise Volgograd-Volgopharm, they were willing to optimize costs and increase cost effectiveness. It is unlikely that someone would have thought that just after a quarter, the cost effectiveness would be seven-digit. Volgograd-Volgopharm Pharmacy Chain Director Svetlana SUKHOMLINOVA discusses other restructuring results as well.

[PharmVestnik # 15, 26/04/2016, p. 21]

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