ARPM and authorities discussed the current situation of the market

International conference “Pharmaceutical business in Russia: Perspective development of the pharmaceutical market in 2016” took place in Moscow. A session on “Law and business. Changes in regulation and their effect on the pharmaceutical market” were held as a part of the conference. The session was moderated by Director General of the Association of the Russian Pharmaceutical Manufacturers, Victor Dmitriev.


Participants of the meeting discussed legislative changes and their application. Director of the department of drug provision and circulation of medical devices of the Ministry of Health, Elena Maksimkina, said that the majority of regulation wishing the Eurasian Economic Union (EAEU) are approved and submitted to the Prime Minister. However, the procedure of identification of an interchangeability of medicines at the stage of its registration is still unclear. This issue has to be resolved in order to finally confirm the new legislation. The transition period to the new legislation will still be held, and there will be no disruption of medical supply.


Head of the coordination department of a mutual market of medicines and medical equipment of the Department of technical regulation of the EAEU, Dmitry Shekin confirmed that during the Committee meeting on February 12, the legal papers of the mutual market were discussed and the only disagreement was regarding mutual position on interchangeability.


The meeting participants also spoke about access to foreign medicines to the market. Accordion to Elena Maksimkina, the media does not fairly represent the situation. It states that due to obligated clinical trials foreign medicines can not access the Russian market. This is not the case. In particular, foreign medicines had a share greater than Russian medicines on the List of Essential Drugs.


Head of the Department of control in social and trade areas of the Federal Antimonopoly Service (FAS), Timophey Nigegorodcev spoke on the changes in regulation. It was possible to refuse the term “original medicine” which helped to minimize the risk of unfair competition between companies; get closer to finding a solution regarding interchangeability; protect producer at the stage of price registration. Mr. Nigegorodcev also mentioned the topic of a single distributor. According to Mr. Nigegorodcev it is important to identify where such mechanism of state purchases will be appropriate. The mechanism should be simple and transparent to all market members.


Head if the Institute of Healthcare Economics, Larisa Popovich mentioned that invest climate is very sensitive to changes in legislation. Regulation has to be transparent and mandatory for every member of the market. Without identification of the main strategic goal, it is impossible to tune legal regulation.


The topic of the market control also was discussed at the meeting. Head of the quality control of the Rosdravnadzor noted that the most efficient way to control the quality of medical goods is by holding random tests. The agency started its work in this direction in 2016. This is the least expensive and most rational mechanism of control, that allows to quickly apply restrictions to unfair producers. 



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