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Current issue #13, 2018

24.04.2018

Fundamental changes in subsidized drug coverage have become imminent

Experts believe that the fundamental changes in drug coverage of the population groups eligible for benefits that will require political will from the government include cancellation of benefits monetization, implementation of pharmaceutical insurance, and transfer of the orphan disease treatment funding to the federal level. The reform supporters are sure that by canceling monetization the state will stop inappropriate expenditures of the funds allocated for subsidized drug coverage. State Duma deputies and experts discussed the current situation and future developments in the pharmaceutical market on 4 April at the Parlamentskaya Gazeta (Parliament Newspaper) venue.

[PharmVestnik # 13, 17/04/2018, p. 1, cont’d p. 4]

// Regulatory & Legal – EAEU

EEC does not consider Russian labeling an obstacle for EAEU drug market

In early April, Kazakhstan’s mass media announced the government plans for implementing by 2023 an internal tracking system for imported drugs based on 2D DataMatrix barcodes applied to secondary packaging. In Russia, a similar pilot project has been completed, and drug labeling will become compulsory staring from 2020. Within the framework of the EAEU common pharmaceutical market, the development of such system that will require an integration of all five member-states is at the stage of discussion.

[PharmVestnik # 13, 17/04/2018, p. 2]

// Health Insurance

Nearly 9,000 insurance agents operate in Russia

Russia’s Health Minister Veronica Skvortsova believes that health insurance companies champion the main human right to health. Mrs. Skvortsova said it in so many words at a meeting that summed up the results of the work of the insurance agent institution established in 2016. The Minister’s words are likely to be taken as a response to Chairwoman of the Federation Council Valentina Matvienko who has recently stated that the current mandatory health insurance (MHI) system was useless. It looks like the main fight over the MHI system is still ahead.

[PharmVestnik # 13, 17/04/2018, p. 4]

// Regulatory & Legal – Dietary Supplements

Pharmacies may lose part of their product range because of supplement labeling

From 1 July 2018, Mercury Federal Veterinary Information System will become fully operative in Russia. The system aims at tracking products manufactured from animal starting materials all the way from the manufacturer to the retailer. Dietary supplements made of animal starting materials are on the list of products eligible for tracking by Mercury, which means that both distributors and pharmacies dealing with such products must connect to the system.

[PharmVestnik # 13, 17/04/2018, p. 6]

// Disease Management

The number of cancer immunotherapeutics to grow

The latest immunotherapy advances make it possible to state a breakthrough in cancer treatment. Statistics confirm immunotherapy efficacy in cancer management, while leading pharma companies keep receiving marketing authorizations for new drugs. The press conference of the Russian Society of Clinical Oncology (RUSSCO) focused on prospects and specifics of immunotherapy as a revolutionary cancer treatment approach.

[PharmVestnik # 13, 17/04/2018, p. 8]

// Regulatory & Legal – Drug Pricing

Federal Antimonopoly Service penalized a pharma company for an unregulated drug price

In April 2018, the anti-trust proceedings were completed against OOO Novartis Pharma, a Russian division of Novartis. The case itself was rather rare as it concerned a lapatinib drug the price for which was not regulated by the government. Last year, the company failed to have this drug included on the VED list. Meanwhile, the drug was approved back in 2008 and since then it has been purchased by governmental customers that have complained about its monopoly price.

[PharmVestnik # 13, 17/04/2018, p. 10]

// Import Substitution

Local drug labeling equipment enters mass production

The Center for Advanced Technology Development has gone ahead with large-batch assembly of the equipment for semi-automated batching and aggregation at Rustech manufacturing sites. Because a high percentage of components are manufactured locally the price for a set of Liniya-K equipment starts at 3.5M RUB, which is much cheaper than imported analogs. The batch specifics include the facility-adaptive capacity and fast implementation.

[PharmVestnik # 13, 17/04/2018, p. 11]

// Vaccination

Moscow to implement a rotavirus immunization program

In line with the Russian Ministry of Health plans, the National Immunization Schedule is to be extended in two years to include, in particular, a rotavirus vaccine. Yet another stepping stone to improved immunization is a free rotavirus immunization program for infants to be implemented by Moscow Health Department. The participants of the press conference to mark the program launch assumed that local immunobiologicals may make their way to the Russian vaccine market shortly.

[PharmVestnik # 13, 17/04/2018, p. 12]

// Biomedical Technologies

Russia short of laws and lab animals to implement biomedical technologies

The work on the legal framework to develop and implement biomedical cell products (BMCP) is underway in Russia. On 28 February, the government approved a roadmap for the development of biotechnology and genetic engineering for 2018—2020 that provides for drafting bills on biomedicine and biopharmaceuticals as well as setting up BMCP R&D centers. Federal Law # 180-FZ that regulates BMCP-related issues came into force in early 2017; however, the Russian market has not seen any products of the kind yet.

[PharmVestnik # 13, 17/04/2018, p. 13]

// Contests & Awards

Winners of Platinum Ounce’2017 award announced

On 12 April, the winners of Platinum Ounce’2017 award, a pharmaceutical Oscar of the kind, were announced in Moscow. They included pharmaceutical manufacturers, distributors, pharmacy chains, persons, and best projects. According to experts, for many years, this award has been part of market competition.

[PharmVestnik # 13, 17/04/2018, pp. 14-15]

// Telehealth

Lack of e-document management procedure hampers telehealth

The 14th MedSoft International Forum was the venue for IT companies offering healthcare solutions to discuss the status of the legal framework that has become a barrier to the industry development. Unlike their younger colleagues launching health apps and professional communities, members of the Medical Information Technology Development Association were not so optimistic about telehealth prospects.

[PharmVestnik # 13, 17/04/2018, p. 16]

// Digital Health

Wearable device data in demand by pharma companies

The Russian IT company that has developed smart fitness trackers capable of recording any confidential patient data sells the information to US pharma firms. According to the developers, there are no customers for such database in Russia so far, all the more so as the database itself is underdeveloped.

[PharmVestnik # 13, 17/04/2018, p. 17]

// Insight – Drug Procurement

Insulin procurement contracts made in 2017: a review

This analysis is made by PharmVestnik analysts based on Zakupki (Procurement) data analytics platform. Currently, Russia is among the TOP5 countries in terms of diabetes mellitus incidence rate. In this country, there are about 250,000 type 1 diabetes patients in continuous need for insulin injections. Although type 2 diabetes is considered insulin-independent, it has been found that nearly all patients with this type of diabetes mellitus also require insulin injections at a certain disease stage.

[PharmVestnik # 13, 17/04/2018, pp. 22-24]

// M&A

A Bashkortostan pharmacy chain closed an acquisition deal

Pharmland pharmacy chain (Ufa, Bashkortostan) has acquired Istochnik Zdorovya pharmacy chain from Ekaterinburg. The latter’s ex-owner is sure that most local players will surrender to more powerful competitors shortly. Local players agree that not all of them will be able to ride the storm, however they do not admit to a desperate condition.

[PharmVestnik # 13, 17/04/2018, p. 26]

// Budgets & Funding

Battle for funding among drug developers intensifies

Today, funding remains the key competition factor for pharmaceutical clusters. To win government support, clusters use a variety of approaches and technologies. PharmVestnik investigates into the most promising approaches.

[PharmVestnik # 13, 17/04/2018, p. 27]

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