Russian pharmaceutical companies lag behind foreign ones in terms of drug innovation

Although most players in the Russian pharmaceutical industry call the creation of new drugs important for themselves, they invest little in their development and noticeably lag behind manufacturers in other countries in terms of innovation, a study by the Agency for Transformation and Economic Development (ATRE) showed. This directly affects patients who are at risk of not receiving quality treatment. The companies themselves complain about a lack of funding and poor regulation. And experts call the main obstacle for the industry the shortage of research personnel, which worsened with the beginning of the Russian-Ukrainian military conflict.

Kommersant has at its disposal the results of the ATRE study, from which it follows that 88% of 40 Russian pharmaceutical companies surveyed in August-September 2023 named the development of new drugs as one of their priorities. The creation of new drugs turned out to be more important than replacing imports to Russia, some of which began to fall out after the outbreak of hostilities in Ukraine, analysts conclude.

However, they note, efforts by manufacturers to embrace innovation in developing new drugs to meet domestic demand “remain insufficient.” Thus, only a quarter of the companies surveyed allocate more than 15% of revenue to research and development.

The current situation affects access to modern treatments, and patients “may not receive a number of breakthrough therapies,” ATRE concludes. According to the survey, 33% of companies have no innovative drugs in their portfolio, and for 13% this figure does not exceed 5% (see infographic for more details). The prospects for the introduction of such drugs to the Russian market by international companies remain uncertain, the study notes. After the outbreak of hostilities in Ukraine, they suspended research in the Russian Federation on new drugs, which is necessary for their registration in the country.

However, even the innovations currently used in the Russian pharmaceutical industry can hardly be called advanced. 83% of companies use one or two technology platforms, while in global practice more than three are used. In addition, 54% of enterprises are developing original drugs based on small chemical structures, the boom for which began to subside abroad several years ago. Now they have begun to use more complex technologies, the ATRE study emphasizes.

During the survey, the companies themselves cited complex registration rules, lack of government support and inaccessibility of financing as a limiting factor for bringing new drugs to market. In the Russian Federation, regulation of the introduction of new drugs has lagged behind countries with a developed regulatory system, although the new rules for registration of drugs at the EAEU level, to which the pharmaceutical industry is now moving, are already close to European ones, explains Ilya Yasny, head of scientific expertise at LanceBio Ventures.

The head of the scientific and educational center for mathematical modeling in drug development at Sechenov First Moscow Medical University, Kirill Peskov, believes that the lack of funding is not the most important limiting factor. According to him, many pharmaceutical companies compensate for the lack of investment by increasing the productivity of their research process, but in our country this is hampered by a shortage of highly qualified scientific personnel. As an ATRE survey shows, 81% of companies lack such personnel. According to Ilya Yasny, the outflow of personnel in the industry worsened with the departure of units abroad after the outbreak of the military conflict. Pik Pharma Development Director Sergei Morozov calls the systemic shortage of personnel, the training of which has not been given attention in the country for a long time. This hinders the development of new drug molecules, he adds.

In addition, state support alone is not enough, and the number of private investors in Russia is not enough, Mr. Yasny points out. An analysis of the volume of investments in R&D in Russia showed that only three or four companies are really trying to switch to an innovation model, notes Kirill Peskov. General Director of PSK Pharma Evgenia Shapiro says that the company reserves the issue of budget when planning a new product, relying less on government support. According to her, the company lacks detailed paid consultations with the Ministry of Health and the Ministry of Industry and Trade, which would help quickly bring innovative complex products to the market.

Polina Gritsenko