Alexander Semenov spoke at the conference “What is happening in the pharmaceutical market?”
President of the Acticomp Alexander Semyonov took part in a strategic discussion within the framework of the XV international conference “What is happening in the pharmaceutical market?”, which was held on October 2 in Moscow.
The discussion was devoted to the topic “Pharma-2030: pharmaceutical substances, full-cycle production and the second wheel”. It was also attended by: GR Director of Geropharm Vilena Galkina, Editor-in-Chief of the Chemical Expert magazine Georgy Khachiyan, General Director of the Roskhimreaktiv Association Irina Vendilo, Head of the contract development department of Valenta Pharm Yuri Chirgadze. The discussion was moderated by the Chairman of the Board of the Association of Pharmaceutical Manufacturers of the EAEU, Alexey Kedrin.
“One of the fundamental principles of the Pharma-2030 strategy, adopted in June of this year, is Russia’s import independence in the production of pharmaceutical substances, their components and the corresponding full cycle,” Alexander Semyonov emphasized at the beginning of his speech. – And the “second odd one out” program is a critical factor stimulating the construction of our own full-cycle API production in Russia. And in order to avoid the temptation to re-stick labels, a traceability system is being introduced.”
As part of the traceability system, Mipromtorg of the Russian Federation will receive data from various state regulatory and supervisory authorities, from which it is possible to formulate a complete picture of whether the substance is actually produced in Russia (that is, there must be at least one stage of synthesis). “We believe that over time, approximately by 2028, it is necessary to increase the number of synthesis stages to obtain a certificate of origin and, accordingly, preferences at auctions. This is the only way we can achieve true import independence,” noted Alexander Semyonov.
Also, in achieving import independence, incentives from the state play a big role, such as tax preferences, preferential loan programs and, of course, certain subsidies to companies that build new production facilities and produce in-demand APIs.
“Of course, it is also extremely important to review the list of SZLS. I really hope that this work will be successfully completed no later than mid-2024, and I believe that the updated list of SZLS will become an obvious guideline for the application of the support and incentive measures that I spoke about,” emphasized Alexander Semyonov.
At the end of his speech, Alexander Semyonov drew attention to the fact that the production of pharmaceutical substances and intermediates becomes cheaper in terms of cost depending on the volume: the larger they are, the lower the cost, and the easier it is for Russian manufacturers to compete with Chinese and Indian companies. In this regard, he showed conference participants several slides clearly demonstrating the structure of the Russian generics market. Now this market is almost equally divided between foreign and Russian manufacturers. The share of foreign manufacturers in 2022 amounted to 552 billion rubles, according to IQVIA. Accordingly, if these generics are produced in Russia, this will open up enormous potential for manufacturers of both pharmaceutical substances and their intermediates.