Current issue #11, 2016


No one confessed of authoring draft amendments on cancelling API manufacture audits

PharmVestnik got hold of draft amendments to the Federal law FZ-61 “On Drug Circulation” that is allegedly being reviewed by a variety of executive bodies and is shortly to be considered by Dmitry Medvedev’s Cabinet. Having leaked into the industry, the document caused resentment among local API manufacturers despite the fact that its declared aim was creating “additional opportunities for drug manufacturers”.

[PharmVestnik # 11, 29/03/2016, p. 1, cont’d p. 5]

A stumbling term

Ministry of Health has given hostage to situation in common drug market

Over the three months after the launch of the common pharma market, drug manufacturers have been unable to receive comprehensive answers to questions relating to product registration in the common market. The MoH’s explanations have left the local manufacturers perplexed rather than satisfied. The regulators do not have other explanations to offer as the documents in respect of product registration have not been approved yet. Experts explain that the situation was created by the Federal Antimonopoly Service insisting that the notion of interchangeability be accepted by the common market. The MoH has given hostage to the situation, and there is little hope that it may be resolved soon.

[PharmVestnik # 11, 29/03/2016, p. 2]

One phase would be enough

Companies obligated to conduct clinical trials when registering drugs in Eurasian Economic Union (EEU)

Pharma companies continue their active preparations to operating in a common drug market within the EEU. As of today, basically all major underlying documents have been prepared. Notwithstanding the fact that the Regulations for Human Drug Registration and Assessment have not been approved yet, manufacturers may already start preparatory work. The thing is that the EEU member countries have failed to agree just on one item so far, namely whether a drug interchangeability statement needs to be included in the drug registration regulations.

[PharmVestnik # 11, 29/03/2016, p. 3]

In the footsteps of meldonium

110 samples tested positive: Who’s to blame and what’s next?

The scandal associated with the use by some Russian athletes of meldonium that is on the banned drug list is getting rich in new details. All athletes whose samples tested positive behave differently – whom public coming-outs to holding to conspiracy theory. However, experts agree that doctors in sports medicine were aware that meldonium had been entered into the banned drug list long before the official disclosure of the fact. The fatal mistake is that everybody implicitly trusted the patient information leaflet where the drug elimination period was out of reality.

[PharmVestnik # 11, 29/03/2016, p. 4]

Pharmaceutical retailers oppose drug sales at supermarkets

Basically for the first time in Russia’s new history, the pharmacist professional community demonstrated a uniform approach. Over the past week, the notification of the development of a draft document to permit sales of a limited drug range at supermarkets attracted 2500 affirmative votes vs. 10 “nays”. Besides, pharmacists notified the Russian Government, Presidential Administration, and Federation Council about their disagreement with this regulatory initiative.

[PharmVestnik # 11, 29/03/2016, p. 6]

Federal Mandatory Medical Insurance Fund (FFOMS) to bear major costs of high-tech medical services

The MoH developed amendments to the high-tech medical services funding procedure for federal medical institutions. Supposedly, starting from 2017, a one-channel system will be put in operation, whereby the FFOMS will become the source of funding high-tech medical services not included in the baseline mandatory medical insurance program. The MoH insists that this approach will not affect the size and nature of high-tech medical services funding; the only thing to change is the cash flow logistics, which will make the fund allocation process more transparent.

[PharmVestnik # 11, 29/03/2016, p. 7]

Doing it his way

Oleg Zherebtsov on manufacture and costs

Solopharm (St. Petersburg) CEO Oleg ZHEREBTSOV stepped into the entrepreneurship path in 1988 when being a student. Since then, he has tried a lot of areas – from selling computers to setting up a hypermarket chain. In 2010, he started a pharma business project from scratch. He talked about his own way and his vision of the pharma industry as a guest of the “Editorial Fireplace” rubric.

[PharmVestnik # 11, 29/03/2016, p. 8]

API manufacturers count on extra subsidies

The regulations on subsidizing local drug and API manufacturers approved in October 2015 affected the industry development beneficially. However, after just 6 months, API manufacturers developed and submitted to the Ministry of Industry and Trade new proposals on the document improvement.

[PharmVestnik # 11, 29/03/2016, p. 9]

It’s time to roll up sleeves

Pharma industry getting ready to operate in a common market

The issue of approval of the drug registration regulations will be considered at the level of the relevant vice premiers, which may accelerate the decision-making. Pharma companies have already been getting ready for operating in the new environment for a while, which means that the time has come to share their experience.

[PharmVestnik # 11, 29/03/2016, p. 10]

Welcome to chains

AlphaRM presents data on pharmacy numbers in Russia as of March 1, 2016

The number of pharmacies in Russia’s regions correlates with the population numbers and regional sales turnovers. A percentage of chain pharmacies depends on the urban population size, but the pharmacy chain profit rates differ significantly by region.

[PharmVestnik # 11, 29/03/2016, p. 12]

Originator substitution by generics is not always a way to cost-saving

The current macroeconomic situation makes the respective players take all measures to saving on drug purchase budgets. To this end, the regulators approve documents making it easier for new players to enter the market. They believe that the competition among manufacturers (especially generic manufacturers) will push the drug prices down, which is not always the case.

[PharmVestnik # 11, 29/03/2016, pp. 14-15]

Report on sales of marine water and marine salt drugs, 2015

Over the past 3 years, the market of marine water and marine salt drugs grew by nearly 25%. In 2015, a new leader emerged in this segment.

[PharmVestnik # 11, 29/03/2016, p. 17]

Experts differ in their attitude to foreign manufacturer site audits

Auditing the foreign drug manufacturer sites has drawn a lot of response in the professional community. The arguments of the supporters and opponents of this initiative are sometimes intertwined in a strange way.

[PharmVestnik # 11, 29/03/2016, p. 18]

Report on anti-inflammatory drug sales, 2015

Joint lesion is a widespread pathology of the 21st century. According to the WHO, up to 20% of the world population suffers from the locomotor system diseases. A variety of drugs influencing different sections of the pathologic process are prescribed to treat these diseases.

[PharmVestnik # 11, 29/03/2016, pp. 20-21]

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