A roundtable titled Dialysis and Extracorporeal Hemocorrection in Russia: Current Status and Prospects for Import Substitution was held as part of the international BIOPROM Forum. The discussion brought together leading medical experts and representatives of domestic manufacturers of dialysis medications and medical devices. Topics included the challenges of chronic kidney disease, statistics on renal replacement therapy in Russia, and strategies to strengthen technological sovereignty and drug safety for dialysis patients. Special attention was given to advancing import substitution in peritoneal dialysis, the most accessible form of home dialysis therapy.
Sergey Glagolev, Deputy Minister of Health of the Russian Federation, in his speech, highlighted national goals to increase life expectancy, stating:
“Today, kidney failure stands at the intersection of many socially significant diseases that directly impact workforce productivity and overall life expectancy.”
Yevgeny Shutov, Professor, Doctor of Medical Sciences, Head of the Nephrology and Hemodialysis Department at the Russian Medical Academy of Continuous Professional Education, Head of the Interdistrict Nephrology Center of the Moscow Multidisciplinary Research and Clinical Center named after S.P. Botkin, emphasized that global cases of chronic kidney disease will continue to rise. According to data for 2023 in Russia, most patients requiring renal replacement therapy received hemodialysis, while peritoneal dialysis lagged significantly. Expanding peritoneal dialysis is critical, as it is a cost-effective home therapy and yields better post-transplant outcomes compared to hemodialysis.
Natalya Lineva, Chief Freelance Specialist on Hemodialysis for the Nizhny Novgorod Region, emphasized the importance of developing peritoneal dialysis as a method of renal replacement therapy because it allows patients to visit a dialysis center only once a month. The risk of death in peritoneal dialysis patients is significantly lower, as is the financial burden on the budget. Natalya Lineva stated separately that peritoneal dialysis necessitates a state program overseen at the federal level.
Yury Polushin, Academician of the Russian Academy of Sciences, Professor, Doctor of Medical Sciences, Distinguished Physician of the Russian Federation, Honorary President of the Federation of Anesthesiologists and Reanimatologists of Russia, President of the Russian Association of Anesthesiologists-Intensivists, Head of the Anesthesiology and Reanimatology Department at the Federal State Budgetary Educational Institution of Higher Education I.P. Pavlov St. Petersburg State Medical University of the Ministry of Health of Russia, pointed out that 60% of ICU patients show signs of acute kidney injury, with 25% requiring renal replacement therapy. According to studies, timely extracorporeal blood purification reduces the incidence of acute kidney injury transitioning to chronic kidney disease. The expert also emphasized the importance of developing domestic equipment and consumables for extracorporeal hemocorrection.
According to Yevgeny Selyutin, Chief Freelance Specialist on Renal Replacement Therapy for the Orenburg Region, dialysis is covered by state guarantees and is included in compulsory health insurance. However, to fulfill these guarantees, medicines, consumables, and high-tech devices must be available.
Dmitry Pavlyukov, Deputy Head of the Federal Service for Healthcare Supervision, stated:
“In recent years, domestic regulators have developed various methods of preventing shortage of medical devices. The system performed flawlessly for peritoneal dialysis. Legislative changes were made to allow products to be marketed to open closed systems if their quality, safety, and efficacy were demonstrated in trials. This fundamentally altered the Russian Federation's protection in the event of market changes.”
Nikolay Panikarovsky, CEO of Pharmasyntez-Medtech LLC, shared:
“Over the past year, the Pharmasyntez Group has made unprecedented strides by launching Diasolution and Diasolution PD, addressing critical shortages in peritoneal dialysis solutions. All necessary NOVADIAL supplies were promptly registered and delivered to clinics. Pharmasyntez-Medtech is currently building two dialysis device plants, with production scheduled to begin in 2025.”
Ekaterina Shikina, Deputy Director of the Pharmaceutical and Medical Industry Development Department at Russia’s Ministry of Industry and Trade, emphasized:
“For many years, the Ministry of Industry and Trade, in collaboration with the Ministry of Health, has fostered an open dialogue between doctors and industry. It is critical to make the right decisions when the therapeutic area is dominated by foreign players.”
Sergey Glagolev summarized the discussion by stating that the key to import substitution for hemodialysis is the full cycle and creation of Russian semipermeable membranes, as well as the creation of dialyzers compatible with the entire range of hemodialysis equipment currently used in the Russian Federation. Another critical area is the development of a comprehensive set of niche medical plastics, without which hemodialysis is impossible.
A key outcome of the discussion was a cooperation agreement between Pharmasyntez and Rosatom State Corporation to ensure domestic production of dialysis equipment and medications.