One more conflict in the Russian pharma business has come to an end. The story of the logistics operator Pharmat (Terminal-Vostok Group), and its ex-owner Dmitry Dain began in 2012 and ended in late December 2017. This period was quite eventful with Mr. Dain’s removal from control of the company, bankruptcy, criminal action, court proceedings, temporary detention center, and release. Mr. Dain is happy because justice has been met, and the judiciary and law enforcement systems have proven capable of admitting and eliminating their mistakes. The entrepreneur has decided to come back to business to pursue a digital health project. Importantly, this is not the first case of a top manager coming back to business after court action.
[PharmVestnik # 02, 23/01/2018, p. 1, cont’d p. 4]
// Regulatory & Legal
Drug manufacturers do not object to new pricing procedure approval taking a long time
Certain pharma industry spokespersons refer to the new draft VED pricing procedure as a “shock therapy”. This document detonated controversies in 2017 and is likely to remain a focus of heated discussion this year. As a reminder, the new drug price registration procedure was to be approved in the autumn of 2017; however, the deadline has been extended as there is still no consent among the market players.
[PharmVestnik # 02, 23/01/2018, p. 6]
// Regulatory & Legal
VED price cutting has “peaked”
With the updated VED pricing procedure pending approval, the issue of the low-end (under 50 RUB) drug prices is not to be overlooked. Manufacturers repeatedly try to draw attention to unprofitability of manufacturing low-end pharmaceuticals. Meanwhile, regulators maintain that the cheap drug depletion issue has been over-estimated.
[PharmVestnik # 02, 23/01/2018, p. 6]
// Health IT
Digital technologies to boost R&D efficacy
While healthcare providers are apprehensive about IT penetration, pharmaceutical manufacturers prioritize digital technologies. According to Big Pharma research, digital tools may help cut drug development costs. The big data emergence provides for multi-parameter analysis of the data on different types of targets, drug resistance dynamics, and clinical trials. Pharma market players admit that they need core databases, both international and Russian, and that they are even ready to share R&D information associated with new molecules.
[PharmVestnik # 02, 23/01/2018, p. 8]
// Insight – Clinical Nutrition
A review of state clinical nutrition procurement, 2012—2017
The review covers clinical nutrition procurement dynamics year-on-year over 5 consecutive years in value and real terms as well as price dynamics. It also ranks the TOP20 suppliers and summarizes basic procurement parameters for the Russian Federal Districts.
[PharmVestnik # 02, 23/01/2018, pp. 10-11]
// R&D – Pharma
St. Petersburg scientists continue working on a HIV vaccine
The HIV vaccine development programs started both in Russia and the USA 20 years ago. Dozens of candidate vaccines have been developed in the USA, and two of them have already passed Phase III clinical trials. In Russia, three vaccines have been developed, with St. Petersburg’s DNK-4 (DNA-4) already through Phase II trials. The reason for lagging is lack of funding. At the same time, the state expenditures associated with antiretroviral therapy for HIV keep going up from year to year.
[PharmVestnik # 02, 23/01/2018, p. 12]
// Regulatory & Legal
The new law drives state pharmacies to the verge of bankruptcy
State and municipal pharmacy chains had hardly taken a breather after working under the Federal Law # 44-FZ (On the Contract System of the Federal and Municipal Procurement of Goods, Works, and Services) before they faced a new threat. On 31 December 2017, the Federal Law # 505-FZ was signed that amends the Federal Law # 223-FZ “On Procurement of Goods, Works, and Services by Specific Types of Legal Entities”. Actually, these amendments bind over INN-based procurement of pharmaceuticals.
[PharmVestnik # 02, 23/01/2018, p. 12]
Experts: Clusters funded from a common source to disappear soon
In the past decade, clustering has emerged as one of the fundamental trends worldwide. In the nearest future, this trend is set to mount. However, experts believe that now it is time to go beyond speaking about the unity of purpose. As the socio-economic environment has changed dramatically, clusters need to change as well to meet their objectives.
[PharmVestnik # 02, 23/01/2018, p. 13]
// Regulatory & Legal
Russia joins international efforts to combat counterfeit medical products
On 15 December 2017, the State Duma unanimously adopted the law on the ratification of the Council of Europe MEDICRIME Convention for combatting counterfeit medical products and similar crimes posing public health threat. The document aims at making it an offence for counterfeit medical products, packaging, and regulatory submission documents. The convention ratification has necessitated changes to the Russian laws. Russian Health Minister Veronica Skvortsova has officially spoken on the importance of joining the international efforts.
[PharmVestnik # 02, 23/01/2018, p. 17]
// Regulatory & Legal
Patient to choose rehabilitation equipment on their own
This year will see the start of the implementation of a new mechanism associated with rehabilitation services coverage of the disabled in Russia. Within the framework of the Rehabilitation Industry Development Strategy, Russia implements a system of digital certificates for the acquisition of rehabilitation equipment. Under this system, disabled and mobility impaired people will be eligible for an individual choice, which will appreciably affect the relevant market structure. The details were voiced at a recent press conference hosted by the Ministry of Industry and Trade.
[PharmVestnik # 02, 23/01/2018, p. 18]
// Medical Manufacturing
Medical manufacturers expect help from officials to get protected against foreign competitors
In late December 2017, the Expert Panel of the State Duma Committee for Economic Policy, Innovative Development, and Entrepreneurship in Biotechnology, Pharmaceutical, and Medical Industry held a meeting to discuss prospects of export-oriented medical products in 2018. Apart from promotion on the world markets, the manufacturers were concerned about marketing their products in the EAEU. Facility directors complained about dumping and domination of Chinese products and demanded that 40% protective tariffs were introduced for certain types of medical equipment and devices.
[PharmVestnik # 02, 23/01/2018, p. 18]
// Medical Manufacturing
Prospects of international medical manufacturers in Russia
Sergey VANIN has been General Manager of the International Medical Devices Manufacturers Association (IMEDA) since July 2017. Half a year after his appointment, Mr. Vanin is ready to disclose his ideas about the Russian medical market potential, and the place of foreign manufacturers on that market.
[PharmVestnik # 02, 23/01/2018, p. 19]
// Insight – Medical Devices & Equipment
A review of screening device procurement, H117
Fluorography examination is the first step of health survey for early diagnostics of pulmonary tuberculosis. It is recommended on an annual basis for everybody aged 15+ years, except pregnant women. Given such large-scale target audience and examination frequency, healthcare providers shall be properly equipped with screening devices. But what’s going on in reality?
[PharmVestnik # 02, 23/01/2018, p. 20]
