Russian pharmaceutical science has reached a level where innovative drugs generate genuine interest in the West, yet advanced developments continue to face serious regulatory barriers domestically. Dmitry Kudlay, Vice President of GENERIUM JSC and Corresponding Member of the Russian Academy of Sciences, stated this at the industry round table “Innovations in Russian Pharma: Breakthrough or Utopia?” organized by the Kommersant Publishing House.
Science Without Borders: Breaching the Blood-Brain Barrier
In his report, Dmitry Kudlay emphasized that Russian platform solutions and original developments are highly sought after abroad today. A prime example of global recognition was the presentation of research on a drug capable of penetrating the blood-brain barrier (BBB) to treat lysosomal disorders (Hunter syndrome).
A report on this mechanism was presented by Russian specialists at a conference in the USA, where it garnered immense interest. The uniqueness of the technology lies in its ability to deliver therapeutic molecules directly into the brain, precisely targeting the central nervous system.
“We are not even talking about a class of drugs; we are talking about a mechanism of action. The technology is breaking through into the world <…>. The main point is, if a global conference was held in the US, Russian specialists reported exactly at this level of conference, where there are no barriers, because they are interested in gaining access to this knowledge”.
— Dmitry Kudlay, Vice President of GENERIUM JSC
According to him, foreign countries gladly want access to Russian technological platforms, just as Russia accepts charitable supplies from foreign companies.
From Generics to Innovations: What the Industry Offers
Answering a question about the presence of real innovations in the country, the Generium representative listed specific breakthrough solutions implemented through a full production cycle:
- The country’s first generic drug from the oligonucleotide platform (nusinersen), the introduction of which has already saved the state budget about 2 billion rubles.
- An innovative platform for delivering large molecules across the blood-brain barrier.
The full-cycle production of drugs at such a high technological level is a powerful positive signal for the entire pharmaceutical industry.
Internal Barriers: Federal Law 44-FZ and Essential Drug Lists
Despite scientific triumphs, the path of Russian innovations to the patient remains thorny. Dmitry Kudlay drew regulators’ attention to the imperfections in the current system for market access and inclusion in state drug lists.
“We see that often a drug, even with proven efficacy, does not make it into public procurement and does not reach patients.”
— Dmitry Kudlay, Vice President of GENERIUM JSC
The expert harshly criticized the egalitarian approach to admission to the Vital and Essential Drugs (VED) list, where unique Russian platforms are forced to fight for inclusion on exactly the same terms as products from manufacturers in unfriendly countries.
“It shouldn’t be like this. We will not achieve the national development goals in this area if we let in unfriendly countries on the same terms.”
— Dmitry Kudlay, Vice President of GENERIUM JSC
Furthermore, the speaker noted the negative impact of Federal Law No. 44-FZ (on public procurement), which equalizes all suppliers and makes it impossible to strengthen the positions of full-cycle Russian pharma companies. Bureaucratic difficulties with targeted charitable deliveries of drugs directly from manufacturers to medical institutions also hinder progress.
Supporting Full-Cycle Companies is Key to National Security
Concluding his speech, Dmitry Kudlay emphasized that achieving national development goals requires clear state policy. This necessitates creating conditions where the first tier of large Russian full-cycle manufacturers receives tangible government support. According to the expert, such a strategy will compel businesses to invest even more actively in knowledge- and capital-intensive niches, guaranteeing Russia’s technological sovereignty.
