Government regulation and Russian pharmaceutical manufacturing-2017: the dialogue has been happened

The IX Annual conference «Government regulation and Russian pharmaceutical manufacturing-2017: continuation of the dialogue» took place in Moscow. This is a mutual project of the Russian Pharmaceutical Manufactures (ARPM) with the Association of International Pharmaceutical Manufacturers (AIPM).


The Deputies of State Duma, members of the Russian Ministry of Health,  the Ministry of Economic Development of the Russian Federation, the Federal Antimonopoly Service, the Federal Service for Surveillance in Healthcare and the Eurasian Economic Commission took part in this event. In a format of live dialogue business and state representatives have exchanged with their ideas about the most relevant issues in the pharmaceutical industry. Over 250 participants visited the conference.


In the cource of the IX Conference speakers have delibirated the questions of government regulations and the main trends of the pharmaceutical market, including the medicines labelling, collaboration in EurAsEC. Business representatives got a unique opportunity to hear comments directly from the experts and to discuss some outstanding issues with the state members.


The Deputy Director of the Pharmaceutical and Medical Industry of Russian Minister of Trade and Industry Alexey Alekhine thanked the associations for the regular meetings and the feedback possibility.


He noticed  that one of the main vectors supported by the Ministry is the development of  pharmaceutical substances’ manufacturers. In addition, he mentioned that «there is no any premise to invest in new pharmaceutical substances by manufacturers of ready-to-use medicines».


The particular attention was paid to possibility of participating in government procurements on a level with current manufacturers of substances and manufacturers of ready-to-use medicines, which signed the special investment contract (SPIC). This instruction was made by the Deputy Director of the Russian Federation Government Arcady Dvorkovich.


«If a manufacturer of ready-to-use medicines having a SPIC gets the possibility to participate in government procurememnts on a level with a full cycle manufacturer, which uses Russian made pharmaceutical substance, it allows to increase rivalry in this segment and to decrease a price as a result» — Alexey Alekhinу says.


The CEO of the ARPM Viktor Dmitriev has noticed that the substances’ manufacturers are worried of the substances production authentication  in Russian Federation. The settlement suggestions aligned with other expert initiatives to improve the decree, have been sent to the Federal jurisdiction.


«Recently there was a session of a new government procurement committee in the Chamber of Commerce and Industry of the Russian Federation. This is not accidentally as the Healthcare is at the first place in the sphere of government procurement. Many questions arise, including a legislation. Last few years a good tandem between the dedicated committees and the commissions of the Chamber of Commerce and Industry of the Russian Federation and the Russian Union of Industrialists and Entrepreneurs has appeared. Almost all the issues we solve mutually at the level of executive power and legislative authority.», — the speaker mentioned.


According to Olga Chepurina, a Head of Product Circulation Control Department of the Federal Tax Service of Russia, the Department gets ready to control an info-system of medicines’ circulation.


«Considering an expirience of fur labelling implementation we defined the main points for labelling of medicines, including the unique algorithm of medicine labelling, real-time tracking of expiration date and other factors.», — the speaker emphasized.


The participants of the session «The main trends of a modern pharmaceutical market development» discussed the issues of GMP-inspection,  implementation of the automatic system for monitoring of medicines movement from manufacturers to consumers. According to Valentina Kosenko, a Head of medical products Quality Control  Department of the Russian Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, more than 30 pharmaceutical manufacturers, 7 pharmaceutical distributors, 300 medical organizations and pharmacies, including pharmacy chains of federal and regional levels take part voluntarily in this experiment in 9 regions of Russia.


At the «Government regulation and Russian pharmaceutical industry» conference we did our best to respond all the questions that concern business, Viktor Dmitriev says.


«Last year we had many events with the Association of international pharmaceutical manufacturers, have signed a collaborative memorandum. The reaction was ambiguous, having said that, our common opinion is that this is a right decision. We have more mutual points than disagreements. That is why it is necessary to collaborate to make effective quick decisions», — the speaker mentioned.




The organizers thank all participants and guests of the event and welcome to «Government regulation and Pharmaceutical industry: continuation of the dialogue» conference in 2018!

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