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Current issue #20, 2016

Current issue #20, 2016

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Russian GMP Inspectorate denies bias against foreign companies

The closer the year 2017, the more worried foreign drug manufacturers become in respect of receiving Russian GMP compliance certificates. None of the industry-related events can avoid discussing this issue. Therefore State Institute of Medicinal Products and Good Practices Director Vladislav Shestakov’s appearance at the EurasiaPharmConsulting-hosted business breakfast on inspecting drug manufacturer sites for GMP compliance created a sensation. Pharma companies’ representatives had so many questions that they would not let Mr. Shestakov go when the official part was over. He did not mind answering all of these questions.

[PharmVestnik # 20, 14/06/2016, p. 1, cont’d p. 7]

Brain form the USA, tablets from Russia

Local Pharma often prefers foreign, not Russian, science

The Committee for Science and Education Development under the Public Chamber intends to set up a biomedicine development workgroup. This segment needs investment; otherwise, it will not be possible to reach the target of channeling 1.77% of the GDP to the R&D as set by President Putin. Russian pharmaceutical companies may become one of the investment sources for biomedicine. However, the problem is that it is easier for them to open their own laboratories abroad than cooperate with Russian researchers.

[PharmVestnik # 20, 14/06/2016, p. 2]

GPP unites pharmacy chains

In the early summer, 36.6 Group announced creating a new pharmaceutical partnership, i.e. Good Pharmacy Partners. According to the Group’s spokespersons, already now this association is the largest in the European pharma market. All the Group’s pharmacy chains have already joined the partnership. Besides, it is based on pharmacy associations Alphega and United Marketing Group. Now the partnership is ready to expand its presence.

[PharmVestnik # 20, 14/06/2016, pp. 4-5]

Customer is not right

State customers’ disloyalty gets in the local manufacturers’ way

Medical device manufacturers acknowledge that just about one third of the state biddings invited fall under the “odd-may-out” regulation. The Russian Union of Industrialists and Entrepreneurs (RUIE) and the Chamber of Commerce and Industry (CCI) carefully monitor the state bidding practices and maintain a continuous dialog with the regulators, i.e. the Ministry of Industry and Trade responsible for the local industry support and the Ministry of Economic Development, the developer of the Federal Law No. 44. All agree that something needs to be changed in order to obligate the state customers procure local products. This topic was on the agenda of the RUIE and CCI joint meeting on July 2. Unfortunately, no representatives of either the Ministry of Health or healthcare providers were present. Therefore, their opinion on the state bidding remains unknown.

[PharmVestnik # 20, 14/06/2016, p. 6]

Understanding marks

By the “Editorial Fireplace” with Dmitry Efimov

Dmitry EFIMOV, CEO of JSC Nizhpharm, Senior Vice-President of STADA Russia, CIS & Southeastern Europe, related to PharmVestnik why the company was ready to mark its drugs and why the Nizhpharm brand was so sustainable.

[PharmVestnik # 20, 14/06/2016, p. 8]

Satisfying the patient

A discussion platform “Patient-centered healthcare in Russia: together only!” opened in Moscow

The implementation of a patient-centered model is one of the most pressing tasks of the contemporary global pharmaceutical industry. Are there prerequisites and opportunities for building a patient-centered healthcare system in Russia as a whole? What benefits from the implementation of such model will be in store for different healthcare system participants, i.e. patients, physicians, government etc.? Will patient centering evolve as a new paradigm of pharma company development in Russia? These are the questions to be answered by the participants of the discussion platform “Patient-centered healthcare in Russia: together only!” organized by Aston Group. On June 9, the first scheduled event took place.

[PharmVestnik # 20, 14/06/2016, p. 9]

Public Chamber adopted recommendations on drug coverage of orphan disease patients

The topic of drug availability for orphan disease patients, like a mirror, reflects many of the Russian problems in miniature. State officials more frequently report about success and achievements while at the same time recognizing “individual problems unresolved so far”. The regions would have been happy to fall in with such reports; however, the real situation they face day to day forces them to raise alarm and cry with all might hoping to be heard at the federal level. As always, one of the most complicated issues is shortage of finding. The proposals voiced in the course of the hearings “The problems and opportunities of drug coverage of orphan disease patients in Russia” have made the basis for the list of recommendations drafted by the Public Chamber and sent to the government, Ministry of Health, and regional authorities.

[PharmVestnik # 20, 14/06/2016, p. 10]

Moscow to sell Stolichnye Apteki pharmacy chain once again

Shortly, bidding to acquire JSC Stolichnye Apteki is to be invited via the website investmoscow.ru. The knockdown bid is 5623 mn RUB. This is not a very high price taking into account the floor area of the realty tied-in with the pharmacies. However, experts doubt anyway that this asset will find a customer quickly.

[PharmVestnik # 20, 14/06/2016, p. 11]

Pediatricians need a wider range of children’s dosage forms

The issue of shortage of children’s dosage forms has existed for a number of years. The manufacturers are not in a hurry to conduct clinical trials, the more so that the Ministry of Health officials do not seem to be looking for ways to accommodate their requests. As a result, pediatricians are faced with the problems hampering treatment of their patients.

[PharmVestnik # 20, 14/06/2016, p. 12]

The risk effect

The Russian Government considers an opportunity of testing a risk-sharing model in regions

In the course of the congress “The Right to Drug” organized by the Patient Advocacy League, Director of the Department of Drug Coverage and Medical Device Circulation Regulation under the MoH Elena Maksimkina informed the audience that the ministry was expecting Vice-Premier Igor Shuvalov’s order to implement a risk-sharing model within the framework of individual pilot drug reimbursement projects. The MoH’s spokeswoman explained that it would be necessary to set up specific control authorities when launching such project. A separate order was expected in respect of this issue. It is the regulators’ intention that a drug without confirmed efficacy will not reimbursed from the budget will all the risks being shouldered by the manufacturer. According to Mrs. Maksimkina, the objective of this pilot project is to find out what amendments to the applicable regulations are required in order to lawfully operate this model in Russia.

[PharmVestnik # 20, 14/06/2016, p. 14]

Far away from Moscow

Stereotypes of purchasing medical products in Russia

Analysis of the state bidding market is somewhat similar to website promotion. On the one hand, there exist logical steps providing for achieving appreciable results. On the other hand, market players would often mention the so-called “market specifics” that makes it possible to outdistance competitors and strike a deal on better terms. Stereotypes have been persistent in respect of the state bidding system. PharmVestnik ventures to find out whether they are true based on the data being provided by IMS Health to their customers.

[PharmVestnik # 20, 14/06/2016, pp. 16-17]

Who made the tablet?

Import substitution dynamics in selected Rx drug categories

The term “import substitution” has been gradually evolving as a slogan like “perestroika” and “glasnost” in the near past. This short report considers the pharma industry restructuring from foreign to local manufacturing sites based on the IMS Health and State Drug Register data.

[PharmVestnik # 20, 14/06/2016, p. 18]

Lawyers discussed pharma industry situation

The issues of fair and unfair competition in the Russian pharmaceutical market were the focus of attention of St. Petersburg EY Legal Practice head Anna Kostyra speaking at a panel session of St. Petersburg International Legal Forum. This session running on May 20 was hosted by the EEU Association of Pharmaceutical Manufacturers under the auspices of the Russian Ministry of Industry and Trade.

[PharmVestnik # 20, 14/06/2016, p. 20]

Foreign investors’ expectations and concerns in Kazakhstan

Within the framework of the KIHE-2016 exhibition, a forum “Investment opportunities of Alma-Ata healthcare” was held under the auspices of Alma-Ata Health Department. Among the forum participants was Chairman of the Board of the Association of Kazakhstan Foreign Investor Council Ulf Vokurka.

[PharmVestnik # 20, 14/06/2016, p. 20]

Klassika pharmacy chain to go a discount store

A new social project launched in the Urals

Klassika pharmacy chain (Chelyabinsk) has launched discount pharmacy chain “Zabota” (Care) to the regional market. This new project is positioned as social. Market players note that not everyone is able to operate in a low price segment.

[PharmVestnik # 20, 14/06/2016, p. 21]

Why such a lot of generics?

Pharmaceutical care quality being improved in Primorie

In late May, Vladivostok was the venue of PRIM-PHARMA’2016 conference attended by the Primorie pharma market players. The key questions on the conference agenda were a struggle against doubtful generics and palliative care for those living in remote areas.

[PharmVestnik # 20, 14/06/2016, p. 21]

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