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.