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Import substitution is in focus again

21 September 2015

A round table entitled "Import substitution in medicine and pharmaceutical industry" was held on September 16 as part of the Import Substitution International Specialized Exhibition.

Moderators of the event were O.N. Kolotilova, Director of the Department for Development of Pharmaceutical and Medical Industry and V.A. Dmitriev, General Director of the Association of the Russian Pharmaceutical Manufactures.

Andrey Akhantev, Economic Security Director of GEROPHARM, made a presentation on development prospects of pharmaceutical substances production in Russia.

Today, considering government policy on import substitution and the results of state federal programme PHARMA-2020, a stage of pharmaceutical industry development aimed at creation of conditions for manufacturing of finished drug products only is coming to a close. Now a new stage is beginning and it implies the creation of technology clusters. Thus, awareness is growing that domestic pharmaceutical industry can not only reproduce the existing international products, but also has competences to implement a number of necessary technologies starting from the most important stage of drug product development, i. e. raw materials (substances).

Drug safety of the country means the creation of modern facilities capable to manufacture socially significant drug products from substance to finished dosage form on the territory of the Russian Federation, which is particularly pertinent in the current political situation.

Sharing the views of a Russian pharmaceutical manufacturer, Andrey Akhantev stressed that the enactment of Federal Law No. 44 became not only a positive event, but also an important breakthrough for the domestic industry, as for the first time in the history of the Russian pharmaceutical market, local producers gained equal access to the market. However, if we analyse its practical application, we can highlight a few yet existing gaps.

“Today the effective legislation in the field of public procurement does not allow to fully support Russian manufacturers,” says Andrey Akhantev. “It is important to amend Federal Law No. 44 to allow the Government to set real preferences. It seems to us that it is necessary to quickly adopt localization rules to stimulate production of substances, implement scale of preferences in terms of public procurement for drug manufacturers based on localization degree, formalize the “odd man out” policy and implement a new measure: special investment contracts allowing to purchase a guaranteed volume of manufactured products from a single supplier.” Summing up his presentation, Andrey Akhantev reiterated that Federal Law No. 44 established the necessary framework for future development of the industry and additional steps taken to adopt normative legal acts will help to implement the whole range of promising support measures.

Olga Kolotilova, Director of the Department for Development of Pharmaceutical and Medical Industry, has noted that measures for provision of preferences for Russian pharmaceutical manufacturers based on localization degree are currently under development, and that only till the end of this year drug packaging will be enough to consider the drug a product of distributed manufacturing.

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