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Current issue #4, 2018

Current issue #4, 2018

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Current issue #4, 2018
Rosta under credit watch

For nearly a decade, Rosta was a TOP4 national pharmaceutical distributor. However, in 2017, the company was quick to fall out from the top ranks. Now, quite a few pharmaceutical manufacturers try to recover their assets as Rosta keeps sinking deeper. Some experts believe that it was the creditors’ impatience that triggered off the snowball effect of the action for debt. PharmVestnik seeks to sort the situation out.

[PharmVestnik # 04, 06/02/2018, p. 1-2]

// Health Strategies

FAS rejects MoH’s Healthy Lifestyle Strategy

The draft Healthy Lifestyle Strategy Until 2025 aimed at a 25% reduction of mortality caused by non-infectious diseases has caught heat one more time. In October 2017, the Federal Antimonopoly Service (FAS) of Russia criticized the previous draft strategy version. Now the FAS states that the observations have not been considered in the finalized document. While being fiercely critical, the antitrust agency proposes mechanisms to implement certain strategic provisions. E.g., the FAS rejects putting a ban on selling alcohol products but proposes a solution through adding emetic agents to such products.

[PharmVestnik # 04, 06/02/2018, p. 3]

// Regulatory & Legal – General

Interchangeable drugs determined in Russia with some matters still outstanding

Since 1 January 2018, the National Drug Register includes a new entry, i.e. interchangeability. Whether this concept puts the record straight is still unclear. The Federal Antimonopoly Service pursues its own research and declines to comment. What the public procurement authorities have to do in the meantime is unclear, too. Finally, the dosage form interchangeability remains an open question.

[PharmVestnik # 04, 06/02/2018, p. 3]

// Regulatory & Legal – Dietary Supplements

Supplements market to undergo revision

In the Healthcare Competition Development Road Map drafted by the Federal Antimonopoly Service and adopted by the Russian Government in January 2018, there is a special focus on the dietary supplements market. Pursuant to this document, before September 2018, the regulatory environment in the dietary supplements area needs to be improved through imposing a ban on marketing authorization of dietary supplements containing pharmaceuticals. However, certain experts consider the development of additional regulations a redundancy and propose granting wider market monitoring powers to the Federal Service for Consumer Rights Protection and Human Welfare (Rospotrebnadzor).

[PharmVestnik # 04, 06/02/2018, p. 4]

// Health Management

Oncologists call for joining efforts in malignant tumor management

On the World Cancer Day, the Russian Society of Clinical Oncology (RUSSCO) presented a brochure “The Truth about the Russian Oncology: Problems and Potential Solutions”. According to its authors, renowned oncologists Sergey Tyulyandin and Nikolay Zhukov, the primary objective is recruiting supporters in cancer control.

[PharmVestnik # 04, 06/02/2018, p. 4]

// R&D – Pharma

Russian nuclear medicine has world market prospects

Within the framework of the development of the Eurasian Biomedical Technology Platform, the Eurasian Economic Commission and Rosatom Corporation focus on the nuclear segment development at medical clusters. It is planned to reproduce modified radiopharmaceutical molecules right at radiology centers under the principle of compounding pharmacies. Experts believe that the Russian nuclear medicine can be competitive on the world market.

[PharmVestnik # 04, 06/02/2018, p. 6]

// Regulatory & Legal – Pharma & Medical

Pharmaceutical manufacturers not ready to report under new form

In 2017, pharmaceutical manufacturers received a new extended statistical reporting form No. 2-LEK (prom). The officials from the relevant regulatory agency think that collecting more detailed data will improve market analysis and provide for strategy formulation. In turn, market players believe that the government would better focus on pressure points, while Pharma will formulate a strategy on its own.

[PharmVestnik # 04, 06/02/2018, p. 8]

// Monitoring – EAEU

Liberalization of drug registration process in Ukraine turned into a criminal action

There are pieces of both good and bad news coming from Ukraine. On the one hand, the State Expert Center (SEC) of the Ministry of Health of Ukraine has announced that the drug registration process will be made easier and cheaper soon. On the other hand, local mass media report that a criminal action has been initiated against the SEC regarding unlawful issuance of marketing authorizations.

[PharmVestnik # 04, 06/02/2018, p. 10]

// Insight – Pharmaceuticals

Report on retail drug sales, 2017

The key parameter that characterizes the out-of-pocket segment is the sales growth, both year-on-year and accrued. Based on this parameter, drug manufacturers, distributors, and pharmacy chains make their forecasts and plans as well as make adjustments proceeding from interim results. It is the weather and seasonal disease prevalence, not macro factors, that mainly affect the market growth.

[PharmVestnik # 04, 06/02/2018, pp. 11-13]

// Insight – Pharmacies

Rating of Russian pharmacy chains, 2017

In emergencies, different entities act differently. Ultimately, those who fail to adjust themselves to the situation drop out, and those who manage to adjust develop new strategies. As a rule, the survivors share common features, sometimes formerly nonexistent. After the collapse in 2014—2015 and cautious recovery in 2016, new, already established trends became manifest in 2017 that had been generated by pharmaceuticals retailers in the very beginning of the new economic cycle.

[PharmVestnik # 04, 06/02/2018, pp. 14-17]

// Insight – Pharmaceuticals

Review of government procurement of enteral nutrition, 2014—2017

Patients in the public health system require not only treatment but also nutrition. There are specific patient groups that need special agents for complete enteral nutrition. According to Headway Company, in 2014-2016, the government budget allocations for procurement of enteral nutrition products were growing year over year. However, in 2017, the ascending trend in the budget allocations in this segment was set to reverse.

[PharmVestnik # 04, 06/02/2018, pp. 18-19]

// R&D – Pharma

Scientists develop a new targeted drug delivery method

St. Petersburg State University was awarded a grant for setting up a biohybrid lab to produce specifically modified live cells (biohybrids) that are a symbiosis of synthetic components and human cell. The lab will be led by Professor Arto Urtti of University of Helsinki, Finland.

[PharmVestnik # 04, 06/02/2018, p. 20]

// Regulatory & Legal – General

Retail chains are increasingly interested in selling medical products

Ural retailers started selling pharmacy goods that do not require pharmaceutical licensing. Experts forecast a dilution of the pharmacy product range, especially if a law permitting drug sales at foodstores is adopted.

[PharmVestnik # 04, 06/02/2018, p. 21]

// Health Strategies

Sverdlovsk pharmaceutical facilities invited to cooperation

Andret Tsvetkov, a new Health Minister of Sverdlovsk region, called on regional pharmaceutical and medical manufacturers for setting up a website where they would be able to post information about their products. The main objective is increasing the share of local manufacturers in hospital procurement.

[PharmVestnik # 04, 06/02/2018, p. 22]

// Regulatory & Legal – General

The government of Novosibirsk region to inspect Koltsovo Biotechnology Park

Regional MPs passed a no-confidence motion against the senior management of Koltsovo Biotechnology Park. The debates on the findings of the managing company audit by the Chamber of Control and Accounts resulted in claimed misallocation of public funds. The MPs hinted that Andrey Bekarev, CEO of OJSC Koltsovo Biotechnology Park Managing Company, was acting in the best interest of one of the residents, i.e. SFM-Pharm LLC, of which he was a co-owner. The top manager said that he was ready to terminate the agreement with the biotechnology park if budget damage was confirmed.

[PharmVestnik # 04, 06/02/2018, p. 22]

// Monitoring – EAEU

Licensing pharma business in Belarus

The licensing and license termination procedures, applicant, and license holder requirements are set forth in the Regulations on Licensing of Certain Types of Activity approved by the Order of the President of the Republic of Belarus, No. 450 of 01.09.2010.

[PharmVestnik # 04, 06/02/2018, p. 23]

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