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Current issue #16, 2018


Tatiana Golikova bound to work wonders in social sphere

The fact that Vladimir Putin was elected the President of Russia once again guarantees continuation of the external and internal policies pursued in his preceding presidential term. Therefore, it would seem that there is no room for shocks and sensations. However, apparently, the social sphere is set for sweeping changes. Premier Dmitry Medvedev nominated Tatiana Golikova as vice-presidential candidate for social issues. Most experts approved of this nomination. Mrs. Golikova is considered the right person for this position. Without her strong measures and cast-iron will, it would be very difficult for public health to achieve the goals specified in the President’s May Decree.

[PharmVestnik # 16, 15/05/2018, p. 1, cont’d p. 4]

// R&D – Pharma

CancerFund to support oncology R&D

Science is nearing its final battle with cancer. The latest scientific advances inspire hope as to a total victory over cancer, which will undoubtedly be one of the human greatest achievements. On the other hand, malignant tumors become increasingly widespread from year to year. If the negative trend prevails, they will come to dozens of millions in near future. Ways to reverse the situation were the focus of discussion at the starting conference of the Cancer Research Support Fund (CancerFund).

[PharmVestnik # 16, 15/05/2018, p. 2]

// Pharmacovigilance

Segregated liability to help decriminalize medical errors

The recent case of Dr. Misyurina has not only made people take sides with those standing for patients or those supporting doctors but has also made us see that the root causes of therapeutic failures are much more complex that negligent infliction of death or medical malpractice. At the same time, medical professionals themselves are not in a hurry to report adverse drug or medical device reactions to pharmacovigilance authorities. As a result, it is doctors that are made responsible for negative treatment outcomes. Now it is government officials that call on health providers not to assume full responsibility but share it with pharmaceutical manufacturers.

[PharmVestnik # 16, 15/05/2018, p. 6]

// Counterfeit Drugs

While Roscomnadzor1 is after Telegram messenger, counterfeit drugs keep selling online

Increasingly often, people complain about defective medical devices and deplorable results of using cosmeceuticals. Thanks largely to the population complaints, for the first tome over the past 5 years, the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) has managed to reduce the number of counterfeit drugs twofold. Roszdravnadzor reported the results of counterfeit products control on 26 April at a meeting with Moscow Government.

[PharmVestnik # 16, 15/05/2018, p. 6]

// Vaccination

Vaccination to become a healthy lifestyle factor

Traditionally, April ended with the World Immunization Week initiated by the WHO back in 2005. Russia hosted several events within the framework of the vaccination benefit awareness campaign. The attendees of the briefing hosted by the RBC discussed the national immunization priorities and opportunities in Russia.

[PharmVestnik # 16, 15/05/2018, p. 8]

// Digital Health

Internet blocking discourages digital health investment

The tempest in a teapot around Telegram messenger blocking by the Federal Service for Supervision of Communications, Information Technology, and Mass Media (Roscomnadzor) has drawn a response not only among the messenger users but also among IT companies operating in the health segment as some of the local players have been left without their lawful communication channels. Some have IT architecture based on Microsoft tools; others used Slack, the office messaging app. The situation is clearly not to the benefit of the digital health investment environment.

[PharmVestnik # 16, 15/05/2018, p. 14]

// Health Investment

The path to long-term drug supply contracts runs through an obligation to invest

Through the end of May, publicly owned joint-stock company Pharmstandard is to decide whether it is going to build a manufacturing facility in the Republic of Karelia. The Republic’s administration proposes that the company does not only invest in a new manufacturing site in that region but also participate in biddings to supply drugs to a public procurement authority on a long-term basis that would be cost-effective for the Republic’s budget. Another offset contract is likely to be signed. Obviously, regional authorities are in no way against long-term agreements. But if these are only possible against cross obligations to invest, companies should think about what they can bring to the table.

[PharmVestnik # 16, 15/05/2018, p. 15]

// Pharma Retailing – FMCG Relationships

The reports of an FMCG retailer capturing the pharma market in the south of Russia are greatly exaggerated

Magnit Cosmetic and Magnit stores operating in Rostov Region are running a campaign: a customer that has paid for products purchased at these stores receives a 10% discount coupon to Tander pharmacies. Experts do not consider such cross-marketing efforts very effective given the pharmacy chain’s small coverage; they also note that places to locate pharmaceutical sales outlets are strange.

[PharmVestnik # 16, 15/05/2018, p. 19]

// Pharma Retailing – FMCG Relationships

A federal FMCG retailer to open pharmacies or drogeries in the Urals

Magnit, a federal FMCG retail chain, is looking for managers to open pharmacies in Sverdlovsk region. Proceeding from the job description published, executives-to-be will have limited powers. Market players believe that, given such approach, this pharmaceutical project may prove ineffective.

[PharmVestnik # 16, 15/05/2018, p. 19]

// Cluster Projects

Red tape and shortage of skilled personnel hamper cluster development

In late April, St. Petersburg was the venue of the 3rd International Conference ‘Clusters open borders: a Eurasian Pattern’. The event focused on discussing the opportunities of cluster cooperation both with each other and partners outside Russia as international expansion has emerged as major cluster development trend.

[PharmVestnik # 16, 15/05/2018, p. 20]

// Contract Manufacturing – Pharma

Strengths and weaknesses of contract manufacturing in Russia

Contract pharmaceutical manufacturing has been gaining ground in Russia since GMP standards have been made mandatory in this country. The main customers are local manufacturers with a shortage of in-house resources as well as foreign companies planning development in the Russian market.

[PharmVestnik # 16, 15/05/2018, p. 23]

// Insight – Pharmacies

Rating of Russian pharmacy chains, Q118

For the first time while AlphaRM experts have been covering the Russian pharmacy market, the sales share of the TOP 300 pharmacy chains reached 70%. The market leaders are continuously improving their key indicators through costly but effective M&A deals thus consolidating the market. Concurrently, there is stratification of pharmacies based on sales, with an increasing percentage of both high-profit and low-profit businesses. The growth of high-profit pharmacies may be attributed to post-crisis recovery and successful adaptation to the new business environment. The ‘losers’ have failed to adapt to the new environment, including higher requirements to retail partners on part of suppliers. It is not a question of if but when unprofitable pharmacies will close. However, for several months running, AlphaRM analysts have noted a lower growth of the number of pharmacies year over year. Thus, in March – October 2017, the month-over-month growth rate (in terms of the number of pharmacies) was 0.4–1%, whereas in November 2017 – March 2018, this index did not exceed 0.3%.

[PharmVestnik # 16, 15/05/2018, pp. 24-30]

// Medical Devices – EAEU

Russia considers extension of transition period for medical devices circulation in EAEU

A unique situation has emerged on the EAEU market: as if it exists and at the same time is nonexistent. Companies may file submissions for their products approval in accordance with the EAEU regulations, but the approval process is impossible because the relevant information system is not ready yet. It cannot be said that business worry a lot about the situation. But the timeframe for the transition periods as per the first-tier primary document pool are an issue. Russia was the first to voice doubts that the member-countries would have enough time to shift over to the new requirements.

[PharmVestnik # 16, 15/05/2018, p. 31]

// Regulatory & Legal – Pharma & Medical

Medical device approval procedure is still a challenge

From more than one hundred questions collected from businesses by the hosts of the 20th All-Russia Forum ‘Medical devices circulation in Russia’, the lion’s share of the questions focused on medical device approval issues. Roszdravnadzor, an event partner, provided for an impressive number of experts that were answering medical manufacturers’ questions for a few hours. At the same time, no Ministry of Health experts were present; this fact has been discussed eagerly, though in whisper.

[PharmVestnik # 16, 15/05/2018, p. 32]

// Regulatory & Legal – Pharma & Medical

Procedural procurement control stimulates negative selection

Experts state that in 2018, the contract system will undergo many changes. They also maintain that this topsy-turvy system needs a fresh start. A study conducted by the Competitiveness Enhancement Institute demonstrated that the current control over government procurement procedures made no sense.

[PharmVestnik # 16, 15/05/2018, p. 33]

// Regulatory & Legal – Pharma & Medical

Imbalances in the medical devices circulation system

The missing legislative definition of an ‘unapproved medical device’ provides for a variety of interpretations, while the existing definition of a ‘defective medical device’ makes is possible to consider defective any product with documentation data gaps. Lawyers state that such situation causes imbalances and extremities in the medical device market.

[PharmVestnik # 16, 15/05/2018, p. 33]

// Insight – Medical Devices & Equipment

A comparative analysis of government procurement of infant incubators and phototherapy devices in Russia, Q1-316 – Q1-317

This analysis was prepared by Medconsult. According to Russia’s Health Minister Veronica Skvortsova, the infant mortality in the Russian Federation has decreased to 6.5 per 1,000 live newborns. The Minister confirmed that, according to the WHO, the infant mortality rate in Russia was lower than in Europe. Thus, this rate is 6.5—6.6 per 1,000 newborns in the Euro area countries and 6.6 per 1,000 newborns in the USA. Principle medical equipment needed to care for newborns is infant incubators and phototherapy devices.

[PharmVestnik # 16, 15/05/2018, p. 34]

[1] Federal Service for Supervision of Communications, Information Technology, and Mass Media.

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