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Current issue #17, 2018

22.05.2018

State Duma passes bills to counteract US sanctions

Recently, the State Duma of Russia has unanimously voted for the bill that may restrict sales of US drugs in this country. Court action may be taken against the Russian citizens who harbor the implementation of US sanctions in Russia.

[PharmVestnik # 17, 22/05/2018, p. 1, cont’d p. 2]

// Pharma Industry – General

Who will push the Russian pharma to a new level?

The Russian pharmaceutical industry and drug coverage system stand on the verge of major changes driven by the economic and political turbulence, new Cabinet, nearing completion of the Pharma-2020 Program, and development of the Pharma-2030 strategy. Russia has ambitions of developing proprietary drugs and emerging as a notable player on the world pharma market. It cannot do without large domestic players.

[PharmVestnik # 17, 22/05/2018, p. 4]

// Health Strategies & Programs

Political cowardice hampers launch of drug reimbursement programs

The Russian health system’s paradox is that more than 70% of the population pay for drugs out of their pocket. More to it, their decision to buy a specific pharmaceutical product is often guided by marketing professionals. Experts have no clue as to how to implement the president’s task of joining the 80+ Longevity Club by the end of the next decade. However, the opinions that the nonexistent drug reimbursement programs may trigger collapse of the entire healthcare system are being voiced in a clearer and tougher manner.

[PharmVestnik # 17, 22/05/2018, p. 5]

// Intellectual Property

Enforcement actions against intellectual property rights violators prove ineffective

The AIPM has continuously risen the issue of investment protection through guaranteed intellectual property rights in Russia within the framework of Adam Smith Pharma Conferences. This year, international pharma market players once again note that their dialogue with the regulators is ongoing, but the threat of intellectual property rights violations is still high. It is confirmed by the cases of generics selling on the Russian market prior to expiry of originator drug patents.

[PharmVestnik # 17, 22/05/2018, p. 6]

// Court Action

RIA Panda owner charged with tax default

Igor Vorobey, the owner and CEO of RIA Panda Ltd., has been detained by St. Petersburg law enforcement authorities for tax non-payment. He has been placed under house arrest.

[PharmVestnik # 17, 22/05/2018, p. 6]

// Regulatory & Legal – Pharma & Medical

Experts propose drug review and approval improvements

At least since 2016, the Russian State Duma has been playing up the initiative of implementing a fast-track review and approval procedure for innovative drugs. In late 2017, the relevant bill was adopted. PharmVestnik analyzes the bill together with market players.

[PharmVestnik # 17, 22/05/2018, p. 7]

// Government Action

What problems are solved through strategic national stockpiles?

Back in 2015, on the back of the sanction war that was gaining ground, Premier Dmitry Medvedev initiated the creation of a strategic national stockpile of drugs. Three years later, PharmVestnik explores into the fate of this order and the strategic national stockpiles of medicinal products existing in Russia.

[PharmVestnik # 17, 22/05/2018, p. 7]

// Drug Labeling

Pharmaceutical manufacturers unwilling to share their drug labeling preparation plans

The pilot drug labeling project will be completed in December 2018. In general, labeling will be binding from 1 January 2020, while for High-Cost (Seven Diseases) Program Drugs and VED-listed products, the deadline may be earlier. Preparation is underway, and both market players and regulators have something to ask each other about.

[PharmVestnik # 17, 22/05/2018, p. 8]

// Pharma Distribution

Distributors change their pharmacy chain policies

Currently, distributors are facing the highest risks in the last few years. The receivables due from pharmacies have resulted in the situation when early this year CV Protek publicly declared a drastic change in trade credit extension terms. One of the wholesale market leaders, Protek has made a focus on the profit margin not fearing a sales decline. Although not making any public declarations, many distributors started changing their relationships with pharmacies, too. Some of the market players have already felt these changes.

[PharmVestnik # 17, 22/05/2018, p. 8]

// Contract Manufacturing – Pharma

Experts: in Russia, export opportunities are underdeveloped

In Russia, the pharma facility localization process has slowed down, however, it has not stopped altogether. Aiming at tax advantages granted by the government to local manufacturers, foreign players increasingly often decide to develop contract manufacturing, which is faster and cheaper. However, this strategy has pitfalls: in particular, contract manufacturing precludes exports.

[PharmVestnik # 17, 22/05/2018, p. 11]

// Health IT

MoH regulates patient data reporting

On 5 May, Russia’s Prime Minister signed Government Resolution # 555 “On the Uniform State Health Information System”. For the first time, this document spells out the regulations for healthcare providers reporting to the Federal Uniform Information System. At the same time, pharma companies will theoretically have an opportunity to use patient data in their studies. Despite that the data in the register of medical e-documents as part of the Uniform State Health Information System will be anonymized, experts believe that is will still be valuable for pharma companies.

[PharmVestnik # 17, 22/05/2018, p. 12]

// Disease Management

Antibiotic resistance may cancel medical advances

A successful high-tech surgery may result in patient’s death because of a hospital-acquired infection resistant to most powerful antibiotics. Experts think that the humankind may return to the pre-antibiotic age as it is considered that cephalosporins have already lost their efficacy. In 2011, bacteria were discovered in Russia that were resistant to virtually all known antibiotics. In persons infected with these bacteria, the death rate nears 80%.

[PharmVestnik # 17, 22/05/2018, p. 13]

// Insight – Pharmacies

Retail drug sales, Q118 (DSM Group)

The Russian pharma market is in the state of uncertainty once again. Primarily, market players watch the legislative initiatives that may dramatically change the pharmacy sector, e.g., drug sales through FMCG channels and legalization of OTC drug sales online. On the other hand, the figures that reflect the current market state are of interest, too. At the end of 2017, drug sales in value terms slowed down, with sales in real terms in negative territory. Therefore, the results of the 1st quarter 2018 are important to forecast the sector development in 2018.

[PharmVestnik # 17, 22/05/2018, pp. 16-17]

// Insight – Pharmacies

Retail drug sales, Q118 (PharmVestnik analysis based on IQVIA data)

Although the end of 2018 is far ahead, the 1st q results give cause for optimism. Even though pharma companies generated lower revenues in the first two months of the year due to the relatively warm winter with less ARVI and influenza cases, March was rather cold. As a result, in was in March that there was movement in the market, with growing sales of respiratory and systemic antibacterial drugs. As of Q118, pharmacy sales went down by 1.7% in real terms, while the sector posted a 2.1% growth in value terms year over year.

[PharmVestnik # 17, 22/05/2018, pp. 18-19]

// Insight – Animal Health

Imports of animal health products and supplementary feeds to Russia, 2017

According to RNC Pharma, the dynamics of animal health product supplies to Russia was overall positive as of 2017. Animal drug imports reached 23.8B RUB in release for free circulation prices, up 7.7% year over year. Imports of supplementary feeds demonstrated lower growth dynamics at 6.1% in rubles, but were higher in absolute values at 32.8B RUB.

[PharmVestnik # 17, 22/05/2018, p. 20-21]

// Pharma Manufacturing

Manufacturers sustain damage losing bids to bottom-feeders

Research and Production Association Escom has launched production of drinking water and is finishing construction of a facility to manufacture infusion solutions in plastic bottles. The facility executives resisted dealing with plastic containers as long as possible referring to the European experience of filling such solutions into glass bottles only. However, imperfect legislation and bottom-feeders that win most of the bids with below-cost pricing have left them no choice.

[PharmVestnik # 17, 22/05/2018, p. 22]

// Pharma Manufacturing

A new player to emerge in amino acid preparation market

Pharmasintez invests 580M RUB into the first in Russian parental nutrition line. It will be part of East-Pharm facility located in Primorie Territory. So far, the Russian inpatient clinics have used imported amino acid preparations. The new player may press foreign manufacturers through 30% price cuts.

[PharmVestnik # 17, 22/05/2018, p. 23]

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