Current issue #21, 2017

VED pricing methodology proposed by MoH fixes prices

Judging by the Russian Government draft resolution “On state registration and reregistration of maximum selling prices for VED-listed products”, the Russian Ministry of Health is about to plot a pricing revolution. The reform’s overall objective is to shift from the cost plus pricing to an indicative method, which is not only to result in fair drug prices but also place all market players on an equal footing. The current pricing methodology is thought to prejudice Russian manufacturers’ rights in price reregistration. However, good intentions may result in ill deeds, which is often the case in this country.

[PharmVestnik # 21, 27/06/2017, p. 1, cont’d p. 4]

MoH revises drug list forming rules

The Russian Government adopted amendments to the resolution No. 819 on approval of drug list forming rules. These are minimal so far. The most significant amendment is a direct relationship between the list of high-cost drugs procured under the Seven Diseases program and the targeted federal budget allocations. However, deeper changes will concern the new drug evaluation criteria, such as efficacy, health economic studies, etc. These amendments will be made later.

[PharmVestnik # 21, 27/06/2017, p. 2]

Full-scale contract manufacturing may start in Russia on January 1, 2018

Contract manufacturing does exist in Russia, but it has been limited so far. According to the State Institute of Medicinal Products and Good Practices, as of 2016, 83% of all pharmaceuticals in value terms were manufactured for own requirements, and just 17% — under the contract. Up to date, local manufacturing sites were used by foreign players as a means of getting access to the Russian market. The classical contract manufacturing when a product for several markets is being manufactured at one site is either nonexistent or very rare in this country. Several months ago, the economic barrier has been removed. Now one is to wait for the regulatory barriers to be lifted.

[PharmVestnik # 21, 27/06/2017, p. 6]

Foreign companies support local manufacture

Experts believe that the relationships between Russian and foreign pharmaceutical manufacturers at the local market gets to a new development level. This is not an opposition any longer; this is a fair competition and a meaningful dialogue. Naira ADAMYAN, Sanofi Russia GM and AIPM Chairperson of the Board, speaks about her vision of potential future developments.

[PharmVestnik # 21, 27/06/2017, p. 8]

API manufacturer awaits flexible decision-making from government

St. Petersburg authorities and Active Component CJSC signed a Letter of Intent within the framework of St. Petersburg International Economic Forum. Active Component CEO Alexander SEMENOV speaks about the current regulatory status of the pharma industry and government – business relationship development prospects.

[PharmVestnik # 21, 27/06/2017, p. 14]

Review of musculoskeletal drug segment (ATC_M) on Russian pharma market, Q216—Q117

A wide range of drugs are used for treatment of locomotor diseases, primarily anti-inflammatory and anti-rheumatic agents. Also used are centrally acting myorelaxants; bone tissue disease drugs, including bone damage preventers; and cartilage repair & joint mobilization drugs.

[PharmVestnik # 21, 27/06/2017, p. 16]

Review of pharmacy dietary supplement sales, Q117

As of Q117, the Russian pharmacy market demonstrates a significant growth. The drug segment sales grew by 19% year-on-year (y-on-y). The parapharmaceutical segment has been going up, too. Over the first three months of 2017, the latter segment size is 52.2 bn RUB (in consumer prices), up 14.4% y-on-y.

Dietary supplements represent the most receptive parapharmaceutical segment on the Russian market with a 23% share of total parapharmaceutical sales. In 2015—2016, this segment grew at a lower rate than the pharmacy market overall. However, in 2017, it is rising.

[PharmVestnik # 21, 27/06/2017, pp. 18-19]

Review of pharmacy drug sales, Q117

The recent pharmacy drug market trends have been characterized by fluctuations. Currently, the market is at its high both due to the epidemiological situation and relatively low H116 sales.

[PharmVestnik # 21, 27/06/2017, pp. 20-21]

Europe-Biopharm CEO charged with serious fraud

Maya Mikhaleva, Research and Production Center Europe-Biopharm CEO, is charged with serious fraud. She is accused of imitation of project implementation after having received 90 m RUB from the Ministry of Education and Science for the development of a deep processing technology for pumpkin.

[PharmVestnik # 21, 27/06/2017, p. 23]

Ribbon-cutting ceremony for API microreactor synthesis plant at St. Petersburg

On June 15^th, at St. Petersburg Technopark, a ribbon-cutting ceremony was held for the Regional Engineering Center for API Microreactor Synthesis. The plant that is unique for this country will provide for creating any variants of chemical molecules for R&D as well as for conducting preclinical and clinical trials of the drugs based on locally synthesized APIs.

[PharmVestnik # 21, 27/06/2017, p. 23]